Ignite Creation Date:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2026-03-06 @ 5:48 PM
Study NCT ID:
NCT03135834
Status:
COMPLETED
Last Update Posted:
2023-08-08
First Post:
2017-04-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Trial to Describe the Immunogenicity and Safety of 2 Doses of Bivalent rLP2086 (Trumenba) and a Pentavalent Meningococcal Vaccine in Healthy Subjects >=10 to <26 Years of Age.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-07-14', 'type': 'ACTUAL'}}}}, 'interventionBrowseModule': {'meshes': [{'id': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'C484699', 'term': 'factor H-binding protein, Neisseria meningitidis'}, {'id': 'C556088', 'term': 'MenACWY-CRM vaccine'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from the study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'SAE of "pregnancy" for 1 participant during booster vaccination phase (Stage 2) was recorded erroneously and was reported in result of outcome measure 37.\n\nOne participant had an SAE which was recorded after 8 months of vaccination 2 and one participant had an SAE after 15 months of Vaccination 2. This time period did not present Stage 1 or Stage 2. Hence, it was not included in related outcome measure summary. However, these participants were included in adverse events module for Stage 1.'}}, 'adverseEventsModule': {'timeFrame': 'Systematic assessment: Local reactions and systemic events recorded within 7 days of each vaccination; Non-systematic collection: SAEs recorded from Month 0 to 6 months after Vaccination 2 (up to Month 12) and 6 months after Booster Vaccination (Booster Vaccination was at Month 54); Non-SAEs recorded from Month 0 to 1 month after Vaccination 2 ( up to Month 7); within 48 hours of blood draw at Month 18, 30 and 42; and 1 month after Booster Vaccination', 'description': 'Same event may appear as both AE and SAE, but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Safety population for Stage 1: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Safety population for Stage 2: participants who received booster vaccination and for whom safety data were available.', 'eventGroups': [{'id': 'EG000', 'title': 'Stage 1: Group 1: MenABCWY + Saline (ACWY-Naive)', 'description': 'Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.', 'otherNumAtRisk': 272, 'deathsNumAtRisk': 272, 'otherNumAffected': 267, 'seriousNumAtRisk': 272, 'deathsNumAffected': 1, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Stage 1: Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive)', 'description': 'Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.', 'otherNumAtRisk': 534, 'deathsNumAtRisk': 534, 'otherNumAffected': 508, 'seriousNumAtRisk': 534, 'deathsNumAffected': 0, 'seriousNumAffected': 6}, {'id': 'EG002', 'title': 'Stage 1: Group 3: MenABCWY + Saline (ACWY-Experienced)', 'description': 'Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.', 'otherNumAtRisk': 271, 'deathsNumAtRisk': 271, 'otherNumAffected': 259, 'seriousNumAtRisk': 271, 'deathsNumAffected': 0, 'seriousNumAffected': 6}, {'id': 'EG003', 'title': 'Stage 1: Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced)', 'description': 'Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.', 'otherNumAtRisk': 523, 'deathsNumAtRisk': 523, 'otherNumAffected': 502, 'seriousNumAtRisk': 523, 'deathsNumAffected': 0, 'seriousNumAffected': 9}, {'id': 'EG004', 'title': 'Stage 2: Group 1: MenABCWY + Saline (ACWY-Naive)', 'description': 'Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.', 'otherNumAtRisk': 114, 'deathsNumAtRisk': 114, 'otherNumAffected': 54, 'seriousNumAtRisk': 114, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG005', 'title': 'Stage 2: Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive)', 'description': 'Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.', 'otherNumAtRisk': 65, 'deathsNumAtRisk': 65, 'otherNumAffected': 37, 'seriousNumAtRisk': 65, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG006', 'title': 'Stage 2: Group 3: MenABCWY + Saline (ACWY-Experienced)', 'description': 'Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.', 'otherNumAtRisk': 101, 'deathsNumAtRisk': 101, 'otherNumAffected': 72, 'seriousNumAtRisk': 101, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG007', 'title': 'Stage 2: Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced)', 'description': 'Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.', 'otherNumAtRisk': 73, 'deathsNumAtRisk': 73, 'otherNumAffected': 57, 'seriousNumAtRisk': 73, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 534, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 271, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 523, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Pectus excavatum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 534, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 271, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 523, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 534, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 271, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 523, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 534, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 271, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 523, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 534, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 271, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 523, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 534, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 271, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 523, 'numAffected': 7}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 534, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 271, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 523, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 101, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 534, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 271, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 523, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 534, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 271, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 523, 'numAffected': 11}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 534, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 271, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 523, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Seasonal allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 534, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 271, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 523, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Acute sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 534, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 271, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 523, 'numAffected': 13}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Bacterial vaginosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 534, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 271, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 523, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 534, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 271, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 523, 'numAffected': 13}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 534, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 271, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 523, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 65, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 101, 'numAffected': 4}, {'groupId': 'EG007', 'numAtRisk': 73, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 534, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 271, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 523, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 534, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 271, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 523, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 534, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 271, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 523, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Impetigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 534, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 271, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 523, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 534, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 271, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 523, 'numAffected': 18}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Nasopharyngitis', 'stats': 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'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Glioma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 534, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 271, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 523, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Dyskinesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 534, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 271, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 523, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 534, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 271, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 523, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Migraine with aura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 534, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 271, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 523, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Abortion spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 534, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 271, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 523, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 101, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Aggression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 534, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 271, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 523, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Conversion disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 534, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 271, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 523, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 534, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 271, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 523, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Depression suicidal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 534, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 271, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 523, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Major depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 534, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 271, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 523, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Oppositional defiant disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 534, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 271, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 523, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 534, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 271, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 523, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 534, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 271, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 523, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Ovarian cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 534, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 271, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 523, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 534, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 271, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 523, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 101, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 534, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 271, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 523, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 101, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}, {'term': 'Psychotic disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 272, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 534, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 271, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 523, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 114, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 65, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v25.1'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Stage1: Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level >= Lower Limit of Quantitation (LLOQ) for All 4 Primary Test Strains Combined 1 Month After Vaccination 2 (Group 2 and 4 Combined)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '814', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM)', 'description': 'Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.'}], 'classes': [{'categories': [{'measurements': [{'value': '74.3', 'groupId': 'OG000', 'lowerLimit': '71.2', 'upperLimit': '77.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month after Vaccination 2', 'description': 'Percentage of participants who achieved an hSBA titer \\>= LLOQ for all 4 primary MenB test strains combined (LLOQ was 1:16 for A22 and 1:8 for A56, B24, and B44) was reported in this outcome. Analysis for this outcome measure was planned for combined Group 2 and 4.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Stage 1 evaluable immunogenicity population(EIP)=all participants randomized to study group of interest,received all investigational products as randomized,had blood drawn for assay testing in required time frames at Months 0 and 7,had valid and determinate assay results,received no prohibited vaccines/treatment,had no major protocol violation determined by medical monitor.'Number of Participants Analyzed'=participants with valid and determinate hSBA results on all 4 strains at given time point."}, {'type': 'PRIMARY', 'title': 'Stage1: Percentage of Participants With Fold Rise >=4 in hSBA for Each of the 4 Primary MenB Test Strains From Baseline to 1 Month After Vaccination 2 (Group 2 and 4 Combined)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '864', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM)', 'description': 'Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.'}], 'classes': [{'title': 'PMB80 (A22)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '827', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '73.8', 'groupId': 'OG000', 'lowerLimit': '70.6', 'upperLimit': '76.7'}]}]}, {'title': 'PMB2001 (A56)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '823', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '95.0', 'groupId': 'OG000', 'lowerLimit': '93.3', 'upperLimit': '96.4'}]}]}, {'title': 'PMB2948 (B24)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '835', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '67.4', 'groupId': 'OG000', 'lowerLimit': '64.1', 'upperLimit': '70.6'}]}]}, {'title': 'PMB2707 (B44)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '850', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '86.4', 'groupId': 'OG000', 'lowerLimit': '83.9', 'upperLimit': '88.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline (blood draw prior to Vaccination 1) to 1 month after Vaccination 2', 'description': 'The 4-fold increase: a) participants with baseline hSBA titer below limit of detection (LOD or an hSBA titer \\<1:4), response was defined as hSBA titer \\>=1:16 or LLOQ (whichever titer is higher); b) Participants with baseline hSBA titer \\>= LOD and \\< LLOQ, response was defined as hSBA titer \\>= 4 times the LLOQ; c) participants with baseline hSBA titer \\>= LLOQ, response was defined as hSBA titer \\>=4 times baseline titer. Four primary MenB test strains were PMB80 (A22), PMB2001 (A56), PMB2948 (B24) and PMB2707 (B44). Analysis for this outcome measure was planned for combined Group 2 and 4.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Stage 1 EIP analyzed. All participants reported under \'Overall Number of Participants Analyzed\' contributed data to the table but may not have evaluable data for every row. "Number Analyzed": participants with valid and determinate hSBA titers for given strain at both specified time point and baseline.'}, {'type': 'PRIMARY', 'title': 'Stage1: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 (Group 2 and 4 Combined)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1044', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM)', 'description': 'Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.'}], 'classes': [{'title': 'Redness: Any', 'categories': [{'measurements': [{'value': '16.9', 'groupId': 'OG000', 'lowerLimit': '14.6', 'upperLimit': '19.3'}]}]}, {'title': 'Redness: Mild', 'categories': [{'measurements': [{'value': '6.8', 'groupId': 'OG000', 'lowerLimit': '5.3', 'upperLimit': '8.5'}]}]}, {'title': 'Redness: Moderate', 'categories': [{'measurements': [{'value': '8.0', 'groupId': 'OG000', 'lowerLimit': '6.5', 'upperLimit': '9.9'}]}]}, {'title': 'Redness: Severe', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '1.2', 'upperLimit': '3.1'}]}]}, {'title': 'Swelling: Any', 'categories': [{'measurements': [{'value': '17.0', 'groupId': 'OG000', 'lowerLimit': '14.7', 'upperLimit': '19.4'}]}]}, {'title': 'Swelling: Mild', 'categories': [{'measurements': [{'value': '9.8', 'groupId': 'OG000', 'lowerLimit': '8.0', 'upperLimit': '11.7'}]}]}, {'title': 'Swelling: Moderate', 'categories': [{'measurements': [{'value': '6.9', 'groupId': 'OG000', 'lowerLimit': '5.4', 'upperLimit': '8.6'}]}]}, {'title': 'Swelling: Severe', 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '0.8'}]}]}, {'title': 'Pain at injection site: Any', 'categories': [{'measurements': [{'value': '85.0', 'groupId': 'OG000', 'lowerLimit': '82.6', 'upperLimit': '87.1'}]}]}, {'title': 'Pain at injection site: Mild', 'categories': [{'measurements': [{'value': '41.2', 'groupId': 'OG000', 'lowerLimit': '38.2', 'upperLimit': '44.2'}]}]}, {'title': 'Pain at injection site: Moderate', 'categories': [{'measurements': [{'value': '39.1', 'groupId': 'OG000', 'lowerLimit': '36.1', 'upperLimit': '42.1'}]}]}, {'title': 'Pain at injection site: Severe', 'categories': [{'measurements': [{'value': '4.7', 'groupId': 'OG000', 'lowerLimit': '3.5', 'upperLimit': '6.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '7 days after Vaccination 1', 'description': 'Local reactions (redness, swelling, and pain) at the site of investigational product administration were recorded in e-diary. Redness and swelling were measured and recorded in caliper units. Each caliper unit represented 0.5 cm. Redness and swelling were graded as mild (\\>2.0 to 5.0 cm), moderate (\\>5.0 to 10.0 cm) and severe (\\>10.0 cm). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity).', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Vaccination 1 safety population included participants who received the first dose of investigational product (MenABCWY+saline or bivalent rLP2086+MenACWY-CRM) at Visit 1 (Month 0), and for whom safety information from Visit 1 (Month 0) to prior to Visit 3 (Month 6) was available. Here, 'Overall Number of participants Analyzed' signifies number of participants with known values. Analysis was planned for combined Group 2 and 4."}, {'type': 'PRIMARY', 'title': 'Stage1: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 (Group 2 and 4 Combined)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '903', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM)', 'description': 'Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.'}], 'classes': [{'title': 'Redness: Any', 'categories': [{'measurements': [{'value': '14.7', 'groupId': 'OG000', 'lowerLimit': '12.5', 'upperLimit': '17.2'}]}]}, {'title': 'Redness: Mild', 'categories': [{'measurements': [{'value': '5.2', 'groupId': 'OG000', 'lowerLimit': '3.8', 'upperLimit': '6.9'}]}]}, {'title': 'Redness: Moderate', 'categories': [{'measurements': [{'value': '8.4', 'groupId': 'OG000', 'lowerLimit': '6.7', 'upperLimit': '10.4'}]}]}, {'title': 'Redness: Severe', 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '2.0'}]}]}, {'title': 'Swelling: Any', 'categories': [{'measurements': [{'value': '14.3', 'groupId': 'OG000', 'lowerLimit': '12.1', 'upperLimit': '16.7'}]}]}, {'title': 'Swelling: Mild', 'categories': [{'measurements': [{'value': '6.4', 'groupId': 'OG000', 'lowerLimit': '4.9', 'upperLimit': '8.2'}]}]}, {'title': 'Swelling: Moderate', 'categories': [{'measurements': [{'value': '7.5', 'groupId': 'OG000', 'lowerLimit': '5.9', 'upperLimit': '9.4'}]}]}, {'title': 'Swelling: Severe', 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '1.0'}]}]}, {'title': 'Pain at injection site: Any', 'categories': [{'measurements': [{'value': '82.2', 'groupId': 'OG000', 'lowerLimit': '79.5', 'upperLimit': '84.6'}]}]}, {'title': 'Pain at injection site: Mild', 'categories': [{'measurements': [{'value': '38.9', 'groupId': 'OG000', 'lowerLimit': '35.7', 'upperLimit': '42.1'}]}]}, {'title': 'Pain at injection site: Moderate', 'categories': [{'measurements': [{'value': '37.9', 'groupId': 'OG000', 'lowerLimit': '34.7', 'upperLimit': '41.1'}]}]}, {'title': 'Pain at injection site: Severe', 'categories': [{'measurements': [{'value': '5.4', 'groupId': 'OG000', 'lowerLimit': '4.0', 'upperLimit': '7.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '7 days after Vaccination 2', 'description': 'Local reactions (redness, swelling, and pain) at the site of investigational product administration were recorded in e-diary. Redness and swelling were measured and recorded in caliper units. Each caliper unit represented 0.5 cm. Redness and swelling were graded as mild (\\>2.0 to 5.0 cm), moderate (\\>5.0 to 10.0 cm) and severe (\\>10.0 cm). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity).', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Vaccination 2 safety population included participants who received the second dose of investigational product (MenABCWY or bivalent rLP2086) at Visit 3 (Month 6), and for whom safety information from Visit 3 (Month 6) up to and including Visit 4 (month 7) was available. Here, 'Overall Number of Participants Analyzed' signifies number of participants with known values. Analysis was planned for combined Group 2 and 4."}, {'type': 'PRIMARY', 'title': 'Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 (Group 2 and 4 Combined)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1044', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM)', 'description': 'Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.'}], 'classes': [{'title': 'Fever: >= 38.0 degree C', 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000', 'lowerLimit': '5.3', 'upperLimit': '8.4'}]}]}, {'title': 'Fever: 38.0 to 38.4 degree C', 'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG000', 'lowerLimit': '2.9', 'upperLimit': '5.4'}]}]}, {'title': 'Fever: 38.5 to 38.9 degree C', 'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000', 'lowerLimit': '1.3', 'upperLimit': '3.2'}]}]}, {'title': 'Fever: 39.0 to 40.0 degree C', 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '1.2'}]}]}, {'title': 'Fever: > 40.0 degree C', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.4'}]}]}, {'title': 'Fatigue: Any', 'categories': [{'measurements': [{'value': '51.9', 'groupId': 'OG000', 'lowerLimit': '48.8', 'upperLimit': '55.0'}]}]}, {'title': 'Fatigue: Mild', 'categories': [{'measurements': [{'value': '25.4', 'groupId': 'OG000', 'lowerLimit': '22.8', 'upperLimit': '28.1'}]}]}, {'title': 'Fatigue: Moderate', 'categories': [{'measurements': [{'value': '23.7', 'groupId': 'OG000', 'lowerLimit': '21.1', 'upperLimit': '26.4'}]}]}, {'title': 'Fatigue: Severe', 'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000', 'lowerLimit': '1.9', 'upperLimit': '4.1'}]}]}, {'title': 'Headache: Any', 'categories': [{'measurements': [{'value': '46.5', 'groupId': 'OG000', 'lowerLimit': '43.4', 'upperLimit': '49.5'}]}]}, {'title': 'Headache: Mild', 'categories': [{'measurements': [{'value': '25.1', 'groupId': 'OG000', 'lowerLimit': '22.5', 'upperLimit': '27.8'}]}]}, {'title': 'Headache: Moderate', 'categories': [{'measurements': [{'value': '19.0', 'groupId': 'OG000', 'lowerLimit': '16.6', 'upperLimit': '21.5'}]}]}, {'title': 'Headache: Severe', 'categories': [{'measurements': [{'value': '2.4', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '3.5'}]}]}, {'title': 'Chills: Any', 'categories': [{'measurements': [{'value': '18.5', 'groupId': 'OG000', 'lowerLimit': '16.2', 'upperLimit': '21.0'}]}]}, {'title': 'Chills: Mild', 'categories': [{'measurements': [{'value': '11.5', 'groupId': 'OG000', 'lowerLimit': '9.6', 'upperLimit': '13.6'}]}]}, {'title': 'Chills: Moderate', 'categories': [{'measurements': [{'value': '5.7', 'groupId': 'OG000', 'lowerLimit': '4.4', 'upperLimit': '7.3'}]}]}, {'title': 'Chills: Severe', 'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000', 'lowerLimit': '0.7', 'upperLimit': '2.1'}]}]}, {'title': 'Vomiting: Any', 'categories': [{'measurements': [{'value': '3.7', 'groupId': 'OG000', 'lowerLimit': '2.7', 'upperLimit': '5.1'}]}]}, {'title': 'Vomiting: Mild', 'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000', 'lowerLimit': '1.9', 'upperLimit': '4.1'}]}]}, {'title': 'Vomiting: Moderate', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000', 'lowerLimit': '0.4', 'upperLimit': '1.6'}]}]}, {'title': 'Vomiting: severe', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.4'}]}]}, {'title': 'Diarrhea: Any', 'categories': [{'measurements': [{'value': '14.1', 'groupId': 'OG000', 'lowerLimit': '12.0', 'upperLimit': '16.3'}]}]}, {'title': 'Diarrhea: Mild', 'categories': [{'measurements': [{'value': '10.7', 'groupId': 'OG000', 'lowerLimit': '8.9', 'upperLimit': '12.8'}]}]}, {'title': 'Diarrhea: Moderate', 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000', 'lowerLimit': '2.3', 'upperLimit': '4.5'}]}]}, {'title': 'Diarrhea: Severe', 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.5'}]}]}, {'title': 'Muscle pain: Any', 'categories': [{'measurements': [{'value': '28.4', 'groupId': 'OG000', 'lowerLimit': '25.7', 'upperLimit': '31.3'}]}]}, {'title': 'Muscle pain: Mild', 'categories': [{'measurements': [{'value': '15.8', 'groupId': 'OG000', 'lowerLimit': '13.6', 'upperLimit': '18.2'}]}]}, {'title': 'Muscle pain: Moderate', 'categories': [{'measurements': [{'value': '11.6', 'groupId': 'OG000', 'lowerLimit': '9.7', 'upperLimit': '13.7'}]}]}, {'title': 'Muscle pain: Severe', 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '1.9'}]}]}, {'title': 'Joint pain: Any', 'categories': [{'measurements': [{'value': '19.6', 'groupId': 'OG000', 'lowerLimit': '17.3', 'upperLimit': '22.2'}]}]}, {'title': 'Joint pain: Mild', 'categories': [{'measurements': [{'value': '10.2', 'groupId': 'OG000', 'lowerLimit': '8.5', 'upperLimit': '12.3'}]}]}, {'title': 'Joint pain: Moderate', 'categories': [{'measurements': [{'value': '8.6', 'groupId': 'OG000', 'lowerLimit': '7.0', 'upperLimit': '10.5'}]}]}, {'title': 'Joint pain: Severe', 'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '1.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '7 days after Vaccination 1', 'description': 'Systemic events fever, vomiting, diarrhea, headache, fatigue, chills, muscle pain other than muscle pain at the injection site, and joint pain were recorded by using an e-diary. Fever was defined as \\>=38.0 degree Celsius (C) and categorized to 38.0 to 38.4 degree C, 38.5 to 38.9 degree C, 39.0 to 40.0 degree C and \\>40.0 degree C. Headache, fatigue, chills, muscle pain and joint pain were graded as mild (did not interfere with activity), moderate (some interference with activity) and severe (prevented daily activity). Vomiting was graded as mild (1-2 times in 24 hours), moderate (\\>2 times in 24 hours) and severe (required IV hydration). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours) and severe (\\>=6 in 24 hours).', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Vaccination 1 safety population included participants who received the first dose of investigational product (MenABCWY+saline or bivalent rLP2086+MenACWY-CRM) at Visit 1 (Month 0), and for whom safety information from Visit 1 (Month 0) to prior to Visit 3 (Month 6) was available. Here, "Overall Number of Participants Analyzed": number of participants with known values. Analysis was planned for combined Group 2 and 4.'}, {'type': 'PRIMARY', 'title': 'Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 (Group 2 and 4 Combined)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '903', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM)', 'description': 'Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.'}], 'classes': [{'title': 'Fever: >= 38.0 degree C', 'categories': [{'measurements': [{'value': '3.2', 'groupId': 'OG000', 'lowerLimit': '2.2', 'upperLimit': '4.6'}]}]}, {'title': 'Fever: 38.0 to 38.4 degree C', 'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000', 'lowerLimit': '1.1', 'upperLimit': '3.0'}]}]}, {'title': 'Fever: 38.5 to 38.9 degree C', 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '1.4'}]}]}, {'title': 'Fever: 39.0 to 40.0 degree C', 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '1.4'}]}]}, {'title': 'Fever: > 40.0 degree C', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.4'}]}]}, {'title': 'Fatigue: Any', 'categories': [{'measurements': [{'value': '45.2', 'groupId': 'OG000', 'lowerLimit': '41.9', 'upperLimit': '48.5'}]}]}, {'title': 'Fatigue: Mild', 'categories': [{'measurements': [{'value': '23.0', 'groupId': 'OG000', 'lowerLimit': '20.3', 'upperLimit': '25.9'}]}]}, {'title': 'Fatigue: Moderate', 'categories': [{'measurements': [{'value': '19.2', 'groupId': 'OG000', 'lowerLimit': '16.6', 'upperLimit': '21.9'}]}]}, {'title': 'Fatigue: Severe', 'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '4.3'}]}]}, {'title': 'Headache: Any', 'categories': [{'measurements': [{'value': '41.6', 'groupId': 'OG000', 'lowerLimit': '38.4', 'upperLimit': '44.9'}]}]}, {'title': 'Headache: Mild', 'categories': [{'measurements': [{'value': '23.1', 'groupId': 'OG000', 'lowerLimit': '20.4', 'upperLimit': '26.0'}]}]}, {'title': 'Headache: Moderate', 'categories': [{'measurements': [{'value': '16.5', 'groupId': 'OG000', 'lowerLimit': '14.1', 'upperLimit': '19.1'}]}]}, {'title': 'Headache: Severe', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '1.2', 'upperLimit': '3.1'}]}]}, {'title': 'Chills: Any', 'categories': [{'measurements': [{'value': '18.5', 'groupId': 'OG000', 'lowerLimit': '16.0', 'upperLimit': '21.2'}]}]}, {'title': 'Chills: Mild', 'categories': [{'measurements': [{'value': '11.6', 'groupId': 'OG000', 'lowerLimit': '9.6', 'upperLimit': '13.9'}]}]}, {'title': 'Chills: Moderate', 'categories': [{'measurements': [{'value': '6.2', 'groupId': 'OG000', 'lowerLimit': '4.7', 'upperLimit': '8.0'}]}]}, {'title': 'Chills: Severe', 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '1.4'}]}]}, {'title': 'Vomiting: Any', 'categories': [{'measurements': [{'value': '2.8', 'groupId': 'OG000', 'lowerLimit': '1.8', 'upperLimit': '4.1'}]}]}, {'title': 'Vomiting: Mild', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '1.2', 'upperLimit': '3.1'}]}]}, {'title': 'Vomiting: Moderate', 'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '1.6'}]}]}, {'title': 'Vomiting: Severe', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.4'}]}]}, {'title': 'Diarrhea: Any', 'categories': [{'measurements': [{'value': '10.6', 'groupId': 'OG000', 'lowerLimit': '8.7', 'upperLimit': '12.8'}]}]}, {'title': 'Diarrhea: Mild', 'categories': [{'measurements': [{'value': '7.6', 'groupId': 'OG000', 'lowerLimit': '6.0', 'upperLimit': '9.6'}]}]}, {'title': 'Diarrhea: Moderate', 'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '3.8'}]}]}, {'title': 'Diarrhea: Severe', 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '1.1'}]}]}, {'title': 'Muscle pain: Any', 'categories': [{'measurements': [{'value': '21.4', 'groupId': 'OG000', 'lowerLimit': '18.7', 'upperLimit': '24.2'}]}]}, {'title': 'Muscle pain: Mild', 'categories': [{'measurements': [{'value': '11.5', 'groupId': 'OG000', 'lowerLimit': '9.5', 'upperLimit': '13.8'}]}]}, {'title': 'Muscle pain: Moderate', 'categories': [{'measurements': [{'value': '7.8', 'groupId': 'OG000', 'lowerLimit': '6.1', 'upperLimit': '9.7'}]}]}, {'title': 'Muscle pain: Severe', 'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000', 'lowerLimit': '1.3', 'upperLimit': '3.3'}]}]}, {'title': 'Joint pain: Any', 'categories': [{'measurements': [{'value': '18.7', 'groupId': 'OG000', 'lowerLimit': '16.2', 'upperLimit': '21.4'}]}]}, {'title': 'Joint pain: Mild', 'categories': [{'measurements': [{'value': '11.2', 'groupId': 'OG000', 'lowerLimit': '9.2', 'upperLimit': '13.4'}]}]}, {'title': 'Joint pain: Moderate', 'categories': [{'measurements': [{'value': '6.5', 'groupId': 'OG000', 'lowerLimit': '5.0', 'upperLimit': '8.3'}]}]}, {'title': 'Joint pain: Severe', 'categories': [{'measurements': [{'value': '1.0', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '1.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '7 days after Vaccination 2', 'description': 'Systemic events fever, vomiting, diarrhea, headache, fatigue, chills, muscle pain other than muscle pain at the injection site, and joint pain were recorded by using an e-diary. Fever was defined as \\>=38.0 degree C and categorized to 38.0 to 38.4 degree C, 38.5 to 38.9 degree C, 39.0 to 40.0 degree C and \\>40.0 degree C. Headache, fatigue, chills, muscle pain and joint pain were graded as mild (did not interfere with activity), moderate (some interference with activity) and severe (prevented daily activity). Vomiting was graded as mild (1-2 times in 24 hours), moderate (\\>2 times in 24 hours) and severe (required IV hydration). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours) and severe (\\>=6 in 24 hours).', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Vaccination 2 safety population included participants who received the second dose of investigational product (MenABCWY or bivalent rLP2086) at Visit 3 (Month 6), and for whom safety information from Visit 3 (Month 6) up to and including Visit 4 (month 7) was available. Here, "Overall Number of Participants Analyzed": number of participants with known values. Analysis was planned for combined Group 2 and 4.'}, {'type': 'PRIMARY', 'title': 'Stage1: Percentage of Participants With Antipyretic Medication Use Within 7 Days After Vaccination 1 (Group 2 and 4 Combined)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1044', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM)', 'description': 'Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.'}], 'classes': [{'categories': [{'measurements': [{'value': '18.6', 'groupId': 'OG000', 'lowerLimit': '16.3', 'upperLimit': '21.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '7 days after Vaccination 1', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Vaccination 1 safety population included participants who received the first dose of investigational product (MenABCWY+saline or bivalent rLP2086+MenACWY-CRM) at Visit 1 (Month 0), and for whom safety information from Visit 1 (Month 0) to prior to Visit 3 (Month 6) was available. Here, "Overall Number of Participants Analyzed": number of participants with known values. Analysis was planned for combined Group 2 and 4.'}, {'type': 'PRIMARY', 'title': 'Stage1: Percentage of Participants With Antipyretic Medication Use Within 7 Days After Vaccination 2 (Group 2 and 4 Combined)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '903', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM)', 'description': 'Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.4', 'groupId': 'OG000', 'lowerLimit': '12.2', 'upperLimit': '16.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '7 days after Vaccination 2', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Vaccination 2 safety population included participants who received the second dose of investigational product (MenABCWY or bivalent rLP2086) at Visit 3 (Month 6), and for whom safety information from Visit 3 (Month 6) up to and including Visit 4 (month 7) was available. Here, "Overall Number of participants Analyzed": number of participants with known values. Analysis was planned for combined Group 2 and 4.'}, {'type': 'PRIMARY', 'title': 'Stage1: Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Vaccination 1 (Group 2 and 4 Combined)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1057', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM)', 'description': 'Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days after Vaccination 1', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Vaccination 1 safety population included participants who received the first dose of investigational product (MenABCWY+saline or bivalent rLP2086+MenACWY-CRM) at Visit 1 (Month 0), and for whom safety information from Visit 1 (Month 0) to prior to Visit 3 (Month 6) was available. Analysis was planned for combined Group 2 and 4.'}, {'type': 'PRIMARY', 'title': 'Stage1: Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Vaccination 2 (Group 2 and 4 Combined)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '946', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM)', 'description': 'Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days after Vaccination 2', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Vaccination 2 safety population included participants who received the second dose of investigational product (MenABCWY or bivalent rLP2086) at Visit 3 (Month 6), and for whom safety information from Visit 3 (Month 6) up to and including Visit 4 (month 7) was available. Analysis was planned for combined Group 2 and 4.'}, {'type': 'PRIMARY', 'title': 'Stage1: Percentage of Participants With at Least 1 SAE Within 30 Days After Any Vaccination (Group 2 and 4 Combined)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1057', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM)', 'description': 'Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days after any vaccination', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Stage 1 Safety population: participants who had received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Analysis was planned for combined Group 2 and 4.'}, {'type': 'PRIMARY', 'title': 'Stage1: Percentage of Participants With at Least 1 SAE During the Stage 1 Vaccination Phase (Group 2 and 4 Combined)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1057', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM)', 'description': 'Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '1.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Stage 1 Vaccination Phase: From Vaccination 1 through 1 month after Vaccination 2 (7 Months)', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Stage 1 Safety population: participants who had received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Analysis was planned for combined Group 2 and 4.'}, {'type': 'PRIMARY', 'title': 'Stage1: Percentage of Participants With at Least 1 SAE During the Stage 1 Follow-up Phase (Group 2 and 4 Combined)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '950', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM)', 'description': 'Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '1.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Stage 1 Follow-up phase: From 1 month after Vaccination 2 through 6 months after Vaccination 2 (5 Months)', 'description': "An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event. There was one participant who did not meet criteria for Stage 1 follow-up safety population. The subject's SAE happened in the follow-up phase but was not included in the follow-up safety population for Stage 1 (but in the safety population for Stage 1). Therefore, the SAE was not included in the follow-up table but in the broadly defined throughout Stage 1 table.", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Stage 1 Follow-up Safety population: participants who received at least 1 dose of investigational product and for whom safety information was available from after Visit 4 (Month 7) up to and including Visit 5 (Month 12). Analysis was planned for combined Group 2 and 4. Here overall number of participants analysed included those participants who met criteria for Stage 1 Follow-up safety population.'}, {'type': 'PRIMARY', 'title': 'Stage1: Percentage of Participants With at Least 1 SAE Throughout the Stage 1 (Group 2 and 4 Combined)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1057', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM)', 'description': 'Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000', 'lowerLimit': '0.7', 'upperLimit': '2.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Throughout Stage 1: From the Vaccination 1 through 6 months after Vaccination 2 (12 Months)', 'description': "An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event. There was one participant who did not meet criteria for Stage 1 follow-up safety population. The subject's SAE happened in the follow-up phase but was not included in the follow-up safety population for Stage 1 (but in the safety population for Stage 1). Therefore, the SAE was not included in the follow-up table but in the broadly defined throughout Stage 1 table.", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Stage 1 Safety population: participants who had received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Analysis was planned for combined Group 2 and 4. Here overall number of participants analysed included those participants who met criteria for Stage 1 safety population.'}, {'type': 'PRIMARY', 'title': 'Stage1: Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Vaccination 1 (Group 2 and 4 Combined)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1057', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM)', 'description': 'Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.3', 'groupId': 'OG000', 'lowerLimit': '4.9', 'upperLimit': '8.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days after Vaccination 1', 'description': 'Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Vaccination 1 safety population included participants who received the first dose of investigational product (MenABCWY+saline or bivalent rLP2086+MenACWY-CRM) at Visit 1 (Month 0), and for whom safety information from Visit 1 (Month 0) to prior to Visit 3 (Month 6) was available. Analysis was planned for combined Group 2 and 4.'}, {'type': 'PRIMARY', 'title': 'Stage1: Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Vaccination 2 (Group 2 and 4 Combined)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '946', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM)', 'description': 'Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.8', 'groupId': 'OG000', 'lowerLimit': '7.0', 'upperLimit': '10.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days after Vaccination 2', 'description': 'Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Vaccination 2 safety population included participants who received the second dose of investigational product (MenABCWY or bivalent rLP2086) at Visit 3 (Month 6), and for whom safety information from Visit 3 (Month 6) up to and including Visit 4 (month 7) was available. Analysis was planned for combined Group 2 and 4.'}, {'type': 'PRIMARY', 'title': 'Stage1: Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Any Vaccination (Group 2 and 4 Combined)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1057', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM)', 'description': 'Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.3', 'groupId': 'OG000', 'lowerLimit': '11.3', 'upperLimit': '15.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days after any vaccination', 'description': 'Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Stage 1 Safety population: participants who had received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Analysis was planned for combined Group 2 and 4.'}, {'type': 'PRIMARY', 'title': 'Stage1: Percentage of Participants With at Least 1 Medically Attended AE During the Stage 1 Vaccination Phase (Group 2 and 4 Combined)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1057', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM)', 'description': 'Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.'}], 'classes': [{'categories': [{'measurements': [{'value': '26.7', 'groupId': 'OG000', 'lowerLimit': '24.0', 'upperLimit': '29.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Stage 1 Vaccination Phase: From Vaccination 1 through 1 month after Vaccination 2 (7 Months)', 'description': 'Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Stage 1 Safety population: participants who had received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Analysis was planned for combined Group 2 and 4.'}, {'type': 'PRIMARY', 'title': 'Stage1: Percentage of Participants With at Least 1 Medically Attended AE During the Stage 1 Follow-up Phase (Group 2 and 4 Combined)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '950', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM)', 'description': 'Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.6', 'groupId': 'OG000', 'lowerLimit': '14.3', 'upperLimit': '19.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Stage 1 Follow-up phase: From 1 month after Vaccination 2 through 6 months after Vaccination 2 (5 Months)', 'description': 'Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Stage 1 Follow-up Safety population: participants who received at least 1 dose of investigational product and for whom safety information was available from after Visit 4 (Month 7) up to and including Visit 5 (Month 12). Analysis was planned for combined Group 2 and 4.'}, {'type': 'PRIMARY', 'title': 'Stage1: Percentage of Participants With at Least 1 Medically Attended AE Throughout the Stage 1 (Group 2 and 4 Combined)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1057', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM)', 'description': 'Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.'}], 'classes': [{'categories': [{'measurements': [{'value': '33.7', 'groupId': 'OG000', 'lowerLimit': '30.8', 'upperLimit': '36.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Throughout Stage 1: From the Vaccination 1 through 6 months after Vaccination 2 (12 Months)', 'description': 'Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Stage 1 Safety population: participants who had received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Analysis was planned for combined Group 2 and 4.'}, {'type': 'PRIMARY', 'title': 'Stage1: Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition (NDCMC) Within 30 Days After Vaccination 1 (Group 2 and 4 Combined)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1057', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM)', 'description': 'Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '0.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days after Vaccination 1', 'description': 'A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Vaccination 1 safety population included participants who received the first dose of investigational product (MenABCWY+saline or bivalent rLP2086+MenACWY-CRM) at Visit 1 (Month 0), and for whom safety information from Visit 1 (Month 0) to prior to Visit 3 (Month 6) was available. Analysis was planned for combined Group 2 and 4.'}, {'type': 'PRIMARY', 'title': 'Stage1: Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition (NDCMC) Within 30 Days After Vaccination 2 (Group 2 and 4 Combined)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '946', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM)', 'description': 'Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days after Vaccination 2', 'description': 'A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Vaccination 2 safety population included participants who received the second dose of investigational product (MenABCWY or bivalent rLP2086) at Visit 3 (Month 6), and for whom safety information from Visit 3 (Month 6) up to and including Visit 4 (month 7) was available. Analysis was planned for combined Group 2 and 4.'}, {'type': 'PRIMARY', 'title': 'Stage1: Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition (NDCMC) Within 30 Days After Any Vaccination (Group 2 and 4 Combined)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1057', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM)', 'description': 'Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '1.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days after any Vaccination', 'description': 'A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population for Stage 1 included participants who had received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Analysis was planned for combined Group 2 and 4.'}, {'type': 'PRIMARY', 'title': 'Stage1: Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition (NDCMC) During the Stage 1 Vaccination Phase (Group 2 and 4 Combined)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1057', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM)', 'description': 'Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '1.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Stage 1 Vaccination Phase: From Vaccination 1 through 1 month after Vaccination 2 (7 Months)', 'description': 'A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population for Stage 1 included participants who had received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Analysis was planned for combined Group 2 and 4.'}, {'type': 'PRIMARY', 'title': 'Stage1: Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition (NDCMC) During the Stage 1 Follow-up Phase (Group 2 and 4 Combined)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '950', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM)', 'description': 'Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '0.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Stage 1 Follow-up phase: From 1 month after Vaccination 2 through 6 months after Vaccination 2 (5 Months)', 'description': 'A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Stage 1 Follow-up Safety population: participants who received at least 1 dose of investigational product and for whom safety information was available from after Visit 4 (Month 7) up to and including Visit 5 (Month 12). Analysis was planned for combined Group 2 and 4.'}, {'type': 'PRIMARY', 'title': 'Stage1: Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition (NDCMC) Throughout the Stage 1 (Group 2 and 4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1057', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM)', 'description': 'Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '1.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Throughout Stage 1: From the Vaccination 1 through 6 months after Vaccination 2 (12 Months)', 'description': 'A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population for Stage 1 included participants who had received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Analysis was planned for combined Group 2 and 4.'}, {'type': 'PRIMARY', 'title': 'Stage1: Percentage of Participants With at Least 1 AE Within 30 Days After Vaccination 1 (Group 2 and 4 Combined)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1057', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM)', 'description': 'Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.8', 'groupId': 'OG000', 'lowerLimit': '11.8', 'upperLimit': '16.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days after Vaccination 1', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs did not include local reaction and systemic events collected by systematic approach.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Vaccination 1 safety population included participants who received the first dose of investigational product (MenABCWY+saline or bivalent rLP2086+MenACWY-CRM) at Visit 1 (Month 0), and for whom safety information from Visit 1 (Month 0) to prior to Visit 3 (Month 6) was available. Analysis was planned for combined Group 2 and 4.'}, {'type': 'PRIMARY', 'title': 'Stage1: Percentage of Participants With at Least 1 AE Within 30 Days After Vaccination 2 (Group 2 and 4 Combined)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '946', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM)', 'description': 'Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.7', 'groupId': 'OG000', 'lowerLimit': '12.5', 'upperLimit': '17.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days after Vaccination 2', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs did not include local reaction and systemic events collected by systematic approach.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Vaccination 2 safety population included participants who received the second dose of investigational product (MenABCWY or bivalent rLP2086) at Visit 3 (Month 6), and for whom safety information from Visit 3 (Month 6) up to and including Visit 4 (month 7) was available. Analysis was planned for combined Group 2 and 4.'}, {'type': 'PRIMARY', 'title': 'Stage1: Percentage of Participants With at Least 1 AE Within 30 Days After Any Vaccination (Group 2 and 4 Combined)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1057', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM)', 'description': 'Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.'}], 'classes': [{'categories': [{'measurements': [{'value': '24.1', 'groupId': 'OG000', 'lowerLimit': '21.6', 'upperLimit': '26.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days after any vaccination', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs did not include local reaction and systemic events collected by systematic approach.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Stage 1 Safety population: participants who had received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Analysis was planned for combined Group 2 and 4.'}, {'type': 'PRIMARY', 'title': 'Stage1: Percentage of Participants With at Least 1 AE During Vaccination Phase (Group 2 and 4 Combined)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1057', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM)', 'description': 'Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.'}], 'classes': [{'categories': [{'measurements': [{'value': '40.7', 'groupId': 'OG000', 'lowerLimit': '37.7', 'upperLimit': '43.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Stage 1 Vaccination Phase: From Vaccination 1 through 1 month after Vaccination 2 (7 Months)', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs did not include local reaction and systemic events collected by systematic approach.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Stage 1 Safety population: participants who had received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Analysis was planned for combined Group 2 and 4.'}, {'type': 'PRIMARY', 'title': 'Stage1: Percentage of Participants With at Least 1 Immediate AE After Vaccination 1 (Group 2 and 4 Combined)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1057', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM)', 'description': 'Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000', 'lowerLimit': '0.4', 'upperLimit': '1.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 minutes after Vaccination 1', 'description': 'Immediate AE was defined as AE occurring within the first 30 minutes after investigational product administration.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Vaccination 1 safety population included participants who received the first dose of investigational product (MenABCWY+saline or bivalent rLP2086+MenACWY-CRM) at Visit 1 (Month 0), and for whom safety information from Visit 1 (Month 0) to prior to Visit 3 (Month 6) was available. Analysis was planned for combined Group 2 and 4.'}, {'type': 'PRIMARY', 'title': 'Stage1: Percentage of Participants With at Least 1 Immediate AE After Vaccination 2 (Group 2 and 4 Combined)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '946', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM)', 'description': 'Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '0.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 minutes after Vaccination 2', 'description': 'Immediate AE was defined as AE occurring within the first 30 minutes after investigational product administration.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Vaccination 2 safety population included participants who received the second dose of investigational product (MenABCWY or bivalent rLP2086) at Visit 3 (Month 6), and for whom safety information from Visit 3 (Month 6) up to and including Visit 4 (Month 7) was available. Analysis was planned for combined Group 2 and 4.'}, {'type': 'PRIMARY', 'title': 'Stage1: Number of Participants Who Missed School/Work Due to AE During the Stage 1 Vaccination Phase (Group 2 and 4 Combined)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1057', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM)', 'description': 'Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.'}], 'classes': [{'categories': [{'measurements': [{'value': '171', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Stage 1 Vaccination Phase: From Vaccination 1 through 1 month after Vaccination 2 (7 Months)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Stage 1 Safety population: participants who had received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Analysis was planned for combined Group 2 and 4.'}, {'type': 'PRIMARY', 'title': 'Stage2: Percentage of Participants With Local Reactions Within 7 Days After Booster Vaccination: Group 1 Through Group 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenABCWY + Saline (ACWY-Naive)', 'description': 'Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}, {'id': 'OG001', 'title': 'Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive)', 'description': 'Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.'}, {'id': 'OG002', 'title': 'Group 3: MenABCWY + Saline (ACWY-Experienced)', 'description': 'Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}, {'id': 'OG003', 'title': 'Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced)', 'description': 'Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.'}], 'classes': [{'title': 'Redness: Any', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '13.6', 'groupId': 'OG000', 'lowerLimit': '6.0', 'upperLimit': '25.0'}, {'value': '28.6', 'groupId': 'OG001', 'lowerLimit': '14.6', 'upperLimit': '46.3'}, {'value': '21.6', 'groupId': 'OG002', 'lowerLimit': '12.9', 'upperLimit': '32.7'}, {'value': '25.5', 'groupId': 'OG003', 'lowerLimit': '14.7', 'upperLimit': '39.0'}]}]}, {'title': 'Redness: Mild', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5.1', 'groupId': 'OG000', 'lowerLimit': '1.1', 'upperLimit': '14.1'}, {'value': '11.4', 'groupId': 'OG001', 'lowerLimit': '3.2', 'upperLimit': '26.7'}, {'value': '9.5', 'groupId': 'OG002', 'lowerLimit': '3.9', 'upperLimit': '18.5'}, {'value': '14.5', 'groupId': 'OG003', 'lowerLimit': '6.5', 'upperLimit': '26.7'}]}]}, {'title': 'Redness: Moderate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.4', 'groupId': 'OG000', 'lowerLimit': '0.4', 'upperLimit': '11.7'}, {'value': '11.4', 'groupId': 'OG001', 'lowerLimit': '3.2', 'upperLimit': '26.7'}, {'value': '8.1', 'groupId': 'OG002', 'lowerLimit': '3.0', 'upperLimit': '16.8'}, {'value': '9.1', 'groupId': 'OG003', 'lowerLimit': '3.0', 'upperLimit': '20.0'}]}]}, {'title': 'Redness: Severe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5.1', 'groupId': 'OG000', 'lowerLimit': '1.1', 'upperLimit': '14.1'}, {'value': '5.7', 'groupId': 'OG001', 'lowerLimit': '0.7', 'upperLimit': '19.2'}, {'value': '4.1', 'groupId': 'OG002', 'lowerLimit': '0.8', 'upperLimit': '11.4'}, {'value': '1.8', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '9.7'}]}]}, {'title': 'Swelling: Any', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '18.6', 'groupId': 'OG000', 'lowerLimit': '9.7', 'upperLimit': '30.9'}, {'value': '25.7', 'groupId': 'OG001', 'lowerLimit': '12.5', 'upperLimit': '43.3'}, {'value': '18.9', 'groupId': 'OG002', 'lowerLimit': '10.7', 'upperLimit': '29.7'}, {'value': '18.2', 'groupId': 'OG003', 'lowerLimit': '9.1', 'upperLimit': '30.9'}]}]}, {'title': 'Swelling: Mild', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '10.2', 'groupId': 'OG000', 'lowerLimit': '3.8', 'upperLimit': '20.8'}, {'value': '11.4', 'groupId': 'OG001', 'lowerLimit': '3.2', 'upperLimit': '26.7'}, {'value': '6.8', 'groupId': 'OG002', 'lowerLimit': '2.2', 'upperLimit': '15.1'}, {'value': '9.1', 'groupId': 'OG003', 'lowerLimit': '3.0', 'upperLimit': '20.0'}]}]}, {'title': 'Swelling: Moderate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '8.5', 'groupId': 'OG000', 'lowerLimit': '2.8', 'upperLimit': '18.7'}, {'value': '11.4', 'groupId': 'OG001', 'lowerLimit': '3.2', 'upperLimit': '26.7'}, {'value': '12.2', 'groupId': 'OG002', 'lowerLimit': '5.7', 'upperLimit': '21.8'}, {'value': '7.3', 'groupId': 'OG003', 'lowerLimit': '2.0', 'upperLimit': '17.6'}]}]}, {'title': 'Swelling: Severe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '6.1'}, {'value': '2.9', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '14.9'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '4.9'}, {'value': '1.8', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '9.7'}]}]}, {'title': 'Pain at injection site: Any', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '79.3', 'groupId': 'OG000', 'lowerLimit': '66.6', 'upperLimit': '88.8'}, {'value': '85.7', 'groupId': 'OG001', 'lowerLimit': '69.7', 'upperLimit': '95.2'}, {'value': '85.1', 'groupId': 'OG002', 'lowerLimit': '75.0', 'upperLimit': '92.3'}, {'value': '85.5', 'groupId': 'OG003', 'lowerLimit': '73.3', 'upperLimit': '93.5'}]}]}, {'title': 'Pain at injection site: Mild', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '41.4', 'groupId': 'OG000', 'lowerLimit': '28.6', 'upperLimit': '55.1'}, {'value': '25.7', 'groupId': 'OG001', 'lowerLimit': '12.5', 'upperLimit': '43.3'}, {'value': '36.5', 'groupId': 'OG002', 'lowerLimit': '25.6', 'upperLimit': '48.5'}, {'value': '47.3', 'groupId': 'OG003', 'lowerLimit': '33.7', 'upperLimit': '61.2'}]}]}, {'title': 'Pain at injection site: Moderate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '36.2', 'groupId': 'OG000', 'lowerLimit': '24.0', 'upperLimit': '49.9'}, {'value': '45.7', 'groupId': 'OG001', 'lowerLimit': '28.8', 'upperLimit': '63.4'}, {'value': '47.3', 'groupId': 'OG002', 'lowerLimit': '35.6', 'upperLimit': '59.3'}, {'value': '38.2', 'groupId': 'OG003', 'lowerLimit': '25.4', 'upperLimit': '52.3'}]}]}, {'title': 'Pain at injection site: Severe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '9.2'}, {'value': '14.3', 'groupId': 'OG001', 'lowerLimit': '4.8', 'upperLimit': '30.3'}, {'value': '1.4', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '7.3'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '6.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '7 days after booster vaccination', 'description': 'Local reactions (redness, swelling, and pain) at the site of investigational product administration were recorded in e-diary. Redness and swelling were measured and recorded in caliper units. Each caliper unit represented 0.5 cm. Redness and swelling were graded as mild (\\>2.0 to 5.0 cm), moderate (\\>5.0 to 10.0 cm) and severe (\\>10.0 cm). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity).', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Booster vaccination safety population included participants who received the booster dose of investigational product (MenABCWY or bivalent rLP2086) at Visit 10 (Month 54), and for whom safety information from Visit 10 (Month 54) up to and including Visit 11 (Month 55) was available. Here, 'Overall Number of Participants Analyzed' signifies number of participants with known values."}, {'type': 'PRIMARY', 'title': 'Stage2: Percentage of Participants With Systemic Events Within 7 Days After Booster Vaccination: Group 1 Through Group 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenABCWY + Saline (ACWY-Naive)', 'description': 'Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}, {'id': 'OG001', 'title': 'Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive)', 'description': 'Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.'}, {'id': 'OG002', 'title': 'Group 3: MenABCWY + Saline (ACWY-Experienced)', 'description': 'Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}, {'id': 'OG003', 'title': 'Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced)', 'description': 'Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.'}], 'classes': [{'title': 'Fever: >= 38.0 degree C', 'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '13.9'}, {'value': '2.6', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '13.5'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '4.7'}, {'value': '1.8', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '9.6'}]}]}, {'title': 'Fever: 38.0 to 38.4 degree C', 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '8.9'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '9.0'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '4.7'}, {'value': '1.8', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '9.6'}]}]}, {'title': 'Fever: 38.4 to 38.9 degree C', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '6.0'}, {'value': '2.6', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '13.5'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '4.7'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '6.4'}]}]}, {'title': 'Fever: 38.9 to 40.0 degree C', 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000', 'lowerLimit': '0.4', 'upperLimit': '11.5'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '9.0'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '4.7'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '6.4'}]}]}, {'title': 'Fever: > 40.0 degree C', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '6.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '9.0'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '4.7'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '6.4'}]}]}, {'title': 'Fatigue: Any', 'categories': [{'measurements': [{'value': '46.7', 'groupId': 'OG000', 'lowerLimit': '33.7', 'upperLimit': '60.0'}, {'value': '61.5', 'groupId': 'OG001', 'lowerLimit': '44.6', 'upperLimit': '76.6'}, {'value': '61.8', 'groupId': 'OG002', 'lowerLimit': '50.0', 'upperLimit': '72.8'}, {'value': '66.1', 'groupId': 'OG003', 'lowerLimit': '52.2', 'upperLimit': '78.2'}]}]}, {'title': 'Fatigue: Mild', 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000', 'lowerLimit': '14.7', 'upperLimit': '37.9'}, {'value': '25.6', 'groupId': 'OG001', 'lowerLimit': '13.0', 'upperLimit': '42.1'}, {'value': '50.0', 'groupId': 'OG002', 'lowerLimit': '38.3', 'upperLimit': '61.7'}, {'value': '37.5', 'groupId': 'OG003', 'lowerLimit': '24.9', 'upperLimit': '51.5'}]}]}, {'title': 'Fatigue: Moderate', 'categories': [{'measurements': [{'value': '21.7', 'groupId': 'OG000', 'lowerLimit': '12.1', 'upperLimit': '34.2'}, {'value': '30.8', 'groupId': 'OG001', 'lowerLimit': '17.0', 'upperLimit': '47.6'}, {'value': '10.5', 'groupId': 'OG002', 'lowerLimit': '4.7', 'upperLimit': '19.7'}, {'value': '23.2', 'groupId': 'OG003', 'lowerLimit': '13.0', 'upperLimit': '36.4'}]}]}, {'title': 'Fatigue: Severe', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '6.0'}, {'value': '5.1', 'groupId': 'OG001', 'lowerLimit': '0.6', 'upperLimit': '17.3'}, {'value': '1.3', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '7.1'}, {'value': '5.4', 'groupId': 'OG003', 'lowerLimit': '1.1', 'upperLimit': '14.9'}]}]}, {'title': 'Headache: Any', 'categories': [{'measurements': [{'value': '36.7', 'groupId': 'OG000', 'lowerLimit': '24.6', 'upperLimit': '50.1'}, {'value': '53.8', 'groupId': 'OG001', 'lowerLimit': '37.2', 'upperLimit': '69.9'}, {'value': '46.1', 'groupId': 'OG002', 'lowerLimit': '34.5', 'upperLimit': '57.9'}, {'value': '55.4', 'groupId': 'OG003', 'lowerLimit': '41.5', 'upperLimit': '68.7'}]}]}, {'title': 'Headache: Mild', 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000', 'lowerLimit': '14.7', 'upperLimit': '37.9'}, {'value': '20.5', 'groupId': 'OG001', 'lowerLimit': '9.3', 'upperLimit': '36.5'}, {'value': '34.2', 'groupId': 'OG002', 'lowerLimit': '23.7', 'upperLimit': '46.0'}, {'value': '39.3', 'groupId': 'OG003', 'lowerLimit': '26.5', 'upperLimit': '53.2'}]}]}, {'title': 'Headache: Moderate', 'categories': [{'measurements': [{'value': '8.3', 'groupId': 'OG000', 'lowerLimit': '2.8', 'upperLimit': '18.4'}, {'value': '28.2', 'groupId': 'OG001', 'lowerLimit': '15.0', 'upperLimit': '44.9'}, {'value': '10.5', 'groupId': 'OG002', 'lowerLimit': '4.7', 'upperLimit': '19.7'}, {'value': '14.3', 'groupId': 'OG003', 'lowerLimit': '6.4', 'upperLimit': '26.2'}]}]}, {'title': 'Headache: Severe', 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000', 'lowerLimit': '0.4', 'upperLimit': '11.5'}, {'value': '5.1', 'groupId': 'OG001', 'lowerLimit': '0.6', 'upperLimit': '17.3'}, {'value': '1.3', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '7.1'}, {'value': '1.8', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '9.6'}]}]}, {'title': 'Chills: Any', 'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000', 'lowerLimit': '3.8', 'upperLimit': '20.5'}, {'value': '17.9', 'groupId': 'OG001', 'lowerLimit': '7.5', 'upperLimit': '33.5'}, {'value': '18.4', 'groupId': 'OG002', 'lowerLimit': '10.5', 'upperLimit': '29.0'}, {'value': '14.3', 'groupId': 'OG003', 'lowerLimit': '6.4', 'upperLimit': '26.2'}]}]}, {'title': 'Chills: Mild', 'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000', 'lowerLimit': '3.8', 'upperLimit': '20.5'}, {'value': '12.8', 'groupId': 'OG001', 'lowerLimit': '4.3', 'upperLimit': '27.4'}, {'value': '15.8', 'groupId': 'OG002', 'lowerLimit': '8.4', 'upperLimit': '26.0'}, {'value': '12.5', 'groupId': 'OG003', 'lowerLimit': '5.2', 'upperLimit': '24.1'}]}]}, {'title': 'Chills: Moderate', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '6.0'}, {'value': '5.1', 'groupId': 'OG001', 'lowerLimit': '0.6', 'upperLimit': '17.3'}, {'value': '2.6', 'groupId': 'OG002', 'lowerLimit': '0.3', 'upperLimit': '9.2'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '6.4'}]}]}, {'title': 'Chills: Severe', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '6.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '9.0'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '4.7'}, {'value': '1.8', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '9.6'}]}]}, {'title': 'Vomiting: Any', 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000', 'lowerLimit': '0.4', 'upperLimit': '11.5'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '9.0'}, {'value': '2.6', 'groupId': 'OG002', 'lowerLimit': '0.3', 'upperLimit': '9.2'}, {'value': '1.8', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '9.6'}]}]}, {'title': 'Vomiting: Mild', 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '8.9'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '9.0'}, {'value': '1.3', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '7.1'}, {'value': '1.8', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '9.6'}]}]}, {'title': 'Vomiting: Moderate', 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '8.9'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '9.0'}, {'value': '1.3', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '7.1'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '6.4'}]}]}, {'title': 'Vomiting: severe', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '6.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '9.0'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '4.7'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '6.4'}]}]}, {'title': 'Diarrhea: Any', 'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '13.9'}, {'value': '10.3', 'groupId': 'OG001', 'lowerLimit': '2.9', 'upperLimit': '24.2'}, {'value': '9.2', 'groupId': 'OG002', 'lowerLimit': '3.8', 'upperLimit': '18.1'}, {'value': '12.5', 'groupId': 'OG003', 'lowerLimit': '5.2', 'upperLimit': '24.1'}]}]}, {'title': 'Diarrhea: Mild', 'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '13.9'}, {'value': '7.7', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '20.9'}, {'value': '7.9', 'groupId': 'OG002', 'lowerLimit': '3.0', 'upperLimit': '16.4'}, {'value': '7.1', 'groupId': 'OG003', 'lowerLimit': '2.0', 'upperLimit': '17.3'}]}]}, {'title': 'Diarrhea: Moderate', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '6.0'}, {'value': '2.6', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '13.5'}, {'value': '1.3', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '7.1'}, {'value': '5.4', 'groupId': 'OG003', 'lowerLimit': '1.1', 'upperLimit': '14.9'}]}]}, {'title': 'Diarrhea: Severe', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '6.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '9.0'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '4.7'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '6.4'}]}]}, {'title': 'Muscle Pain: Any', 'categories': [{'measurements': [{'value': '18.3', 'groupId': 'OG000', 'lowerLimit': '9.5', 'upperLimit': '30.4'}, {'value': '30.8', 'groupId': 'OG001', 'lowerLimit': '17.0', 'upperLimit': '47.6'}, {'value': '31.6', 'groupId': 'OG002', 'lowerLimit': '21.4', 'upperLimit': '43.3'}, {'value': '23.2', 'groupId': 'OG003', 'lowerLimit': '13.0', 'upperLimit': '36.4'}]}]}, {'title': 'Muscle pain: Mild', 'categories': [{'measurements': [{'value': '13.3', 'groupId': 'OG000', 'lowerLimit': '5.9', 'upperLimit': '24.6'}, {'value': '10.3', 'groupId': 'OG001', 'lowerLimit': '2.9', 'upperLimit': '24.2'}, {'value': '22.4', 'groupId': 'OG002', 'lowerLimit': '13.6', 'upperLimit': '33.4'}, {'value': '19.6', 'groupId': 'OG003', 'lowerLimit': '10.2', 'upperLimit': '32.4'}]}]}, {'title': 'Muscle pain: Moderate', 'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '13.9'}, {'value': '12.8', 'groupId': 'OG001', 'lowerLimit': '4.3', 'upperLimit': '27.4'}, {'value': '7.9', 'groupId': 'OG002', 'lowerLimit': '3.0', 'upperLimit': '16.4'}, {'value': '3.6', 'groupId': 'OG003', 'lowerLimit': '0.4', 'upperLimit': '12.3'}]}]}, {'title': 'Muscle pain: Severe', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '6.0'}, {'value': '7.7', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '20.9'}, {'value': '1.3', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '7.1'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '6.4'}]}]}, {'title': 'Joint Pain: Any', 'categories': [{'measurements': [{'value': '18.3', 'groupId': 'OG000', 'lowerLimit': '9.5', 'upperLimit': '30.4'}, {'value': '25.6', 'groupId': 'OG001', 'lowerLimit': '13.0', 'upperLimit': '42.1'}, {'value': '21.1', 'groupId': 'OG002', 'lowerLimit': '12.5', 'upperLimit': '31.9'}, {'value': '16.1', 'groupId': 'OG003', 'lowerLimit': '7.6', 'upperLimit': '28.3'}]}]}, {'title': 'Joint pain: Mild', 'categories': [{'measurements': [{'value': '15.0', 'groupId': 'OG000', 'lowerLimit': '7.1', 'upperLimit': '26.6'}, {'value': '12.8', 'groupId': 'OG001', 'lowerLimit': '4.3', 'upperLimit': '27.4'}, {'value': '11.8', 'groupId': 'OG002', 'lowerLimit': '5.6', 'upperLimit': '21.3'}, {'value': '12.5', 'groupId': 'OG003', 'lowerLimit': '5.2', 'upperLimit': '24.1'}]}]}, {'title': 'Joint pain: Moderate', 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000', 'lowerLimit': '0.4', 'upperLimit': '11.5'}, {'value': '10.3', 'groupId': 'OG001', 'lowerLimit': '2.9', 'upperLimit': '24.2'}, {'value': '9.2', 'groupId': 'OG002', 'lowerLimit': '3.8', 'upperLimit': '18.1'}, {'value': '3.6', 'groupId': 'OG003', 'lowerLimit': '0.4', 'upperLimit': '12.3'}]}]}, {'title': 'Joint pain: Severe', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '6.0'}, {'value': '2.6', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '13.5'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '4.7'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '6.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '7 days after booster vaccination', 'description': 'Systemic events fever, vomiting, diarrhea, headache, fatigue, chills, muscle pain and joint pain were recorded in an e-diary. Fever was defined as \\>=38.0 degree Celsius (C) and categorized to 38.0 to 38.4 degree C, 38.5 to 38.9 degree C, 39.0 to 40.0 degree C and \\>40.0 degree C. Headache, fatigue, chills, muscle pain and joint pain were graded as mild (did not interfere with activity), moderate (some interference with activity) and severe (prevented daily activity). Vomiting was graded as mild (1-2 times in 24 hours), moderate (\\>2 times in 24 hours) and severe (required IV hydration). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours) and severe (\\>=6 in 24 hours).', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Booster vaccination safety population included participants who received the booster dose of investigational product (MenABCWY or bivalent rLP2086) at Visit 10 (Month 54), and for whom safety information from Visit 10 (Month 54) up to and including Visit 11 (Month 55) was available. Here, 'Overall Number of Participants Analyzed' signifies number of participants with known values."}, {'type': 'PRIMARY', 'title': 'Stage2: Percentage of Participants With Antipyretic Medication Use Within 7 Days After Booster Vaccination: Group 1 Through Group 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenABCWY + Saline (ACWY-Naive)', 'description': 'Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}, {'id': 'OG001', 'title': 'Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive)', 'description': 'Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.'}, {'id': 'OG002', 'title': 'Group 3: MenABCWY + Saline (ACWY-Experienced)', 'description': 'Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}, {'id': 'OG003', 'title': 'Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced)', 'description': 'Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000', 'lowerLimit': '8.3', 'upperLimit': '28.5'}, {'value': '20.5', 'groupId': 'OG001', 'lowerLimit': '9.3', 'upperLimit': '36.5'}, {'value': '13.2', 'groupId': 'OG002', 'lowerLimit': '6.5', 'upperLimit': '22.9'}, {'value': '10.7', 'groupId': 'OG003', 'lowerLimit': '4.0', 'upperLimit': '21.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '7 days after booster vaccination', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Booster vaccination safety population included participants who received the booster dose of investigational product (MenABCWY or bivalent rLP2086) at Visit 10 (Month 54), and for whom safety information from Visit 10 (Month 54) up to and including Visit 11 (Month 55) was available. Here, 'Overall Number of Participants Analyzed' signifies number of participants with known values."}, {'type': 'PRIMARY', 'title': 'Stage2: Percentage of Participants With at Least 1 SAE During Booster Vaccination Phase: Group 1 Through Group 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenABCWY + Saline (ACWY-Naive)', 'description': 'Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}, {'id': 'OG001', 'title': 'Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive)', 'description': 'Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.'}, {'id': 'OG002', 'title': 'Group 3: MenABCWY + Saline (ACWY-Experienced)', 'description': 'Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}, {'id': 'OG003', 'title': 'Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced)', 'description': 'Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '5.4'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '8.8'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '4.7'}, {'value': '1.8', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '9.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Booster vaccination phase: From booster vaccination through 1 month after booster vaccination', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event. SAE of "pregnancy" for one participant during the booster vaccination phase was recorded erroneously and hence it was included in results of Group 4.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Booster vaccination safety population included participants who received the booster dose of investigational product (MenABCWY or bivalent rLP2086) at Visit 10 (Month 54), and for whom safety information from Visit 10 (Month 54) up to and including Visit 11 (Month 55) was available.'}, {'type': 'PRIMARY', 'title': 'Stage2: Percentage of Participants With at Least 1 SAE During the Booster Follow-up Phase: Group 1 Through Group 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenABCWY + Saline (ACWY-Naive)', 'description': 'Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}, {'id': 'OG001', 'title': 'Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive)', 'description': 'Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.'}, {'id': 'OG002', 'title': 'Group 3: MenABCWY + Saline (ACWY-Experienced)', 'description': 'Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}, {'id': 'OG003', 'title': 'Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced)', 'description': 'Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '5.4'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '9.3'}, {'value': '2.6', 'groupId': 'OG002', 'lowerLimit': '0.3', 'upperLimit': '9.1'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '6.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Booster follow-up phase: From 1 month after booster vaccination through 6 months after booster vaccination (up to 5 months)', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Booster Follow-up safety population for Stage 2 included participants who received the booster dose of investigational product and for whom safety information was available from after Visit 11 (Month 55) up to and including Visit 12 (Month 60).'}, {'type': 'PRIMARY', 'title': 'Stage2: Percentage of Participants With at Least 1 SAE Throughout Booster Phase: Group 1 Through Group 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenABCWY + Saline (ACWY-Naive)', 'description': 'Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}, {'id': 'OG001', 'title': 'Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive)', 'description': 'Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.'}, {'id': 'OG002', 'title': 'Group 3: MenABCWY + Saline (ACWY-Experienced)', 'description': 'Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}, {'id': 'OG003', 'title': 'Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced)', 'description': 'Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0.Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '5.4'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '8.8'}, {'value': '2.6', 'groupId': 'OG002', 'lowerLimit': '0.3', 'upperLimit': '9.1'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '6.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Throughout Booster phase: From booster vaccination through 6 months after booster vaccination', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event. SAE of "pregnancy" for one participant during the booster vaccination phase was recorded erroneously and hence it was reported in result of outcome measure 37 for Group 4. Subsequently correction was made by the trial site and not included in subsequent phase/results. Hence, that 1 participant is not included in results of Group 4 here.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Booster safety population included participants who received the booster dose of investigational product (MenABCWY or bivalent rLP2086) at Visit 10 (Month 54), and for whom safety information from Visit 10 (Month 54) up to and including Visit 12 (Month 60) was available.'}, {'type': 'PRIMARY', 'title': 'Stage2: Percentage of Participants With at Least 1 Medically Attended AE During Booster Vaccination Phase: Group 1 Through Group 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenABCWY + Saline (ACWY-Naive)', 'description': 'Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}, {'id': 'OG001', 'title': 'Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive)', 'description': 'Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.'}, {'id': 'OG002', 'title': 'Group 3: MenABCWY + Saline (ACWY-Experienced)', 'description': 'Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}, {'id': 'OG003', 'title': 'Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced)', 'description': 'Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.0', 'groupId': 'OG000', 'lowerLimit': '3.4', 'upperLimit': '18.5'}, {'value': '5.0', 'groupId': 'OG001', 'lowerLimit': '0.6', 'upperLimit': '16.9'}, {'value': '2.6', 'groupId': 'OG002', 'lowerLimit': '0.3', 'upperLimit': '9.1'}, {'value': '7.1', 'groupId': 'OG003', 'lowerLimit': '2.0', 'upperLimit': '17.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Booster vaccination phase: From booster vaccination through 1 month after booster vaccination', 'description': 'Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Booster vaccination safety population included participants who received the booster dose of investigational product (MenABCWY or bivalent rLP2086) at Visit 10 (Month 54), and for whom safety information from Visit 10 (Month 54) up to and including Visit 11 (Month 55) was available.'}, {'type': 'PRIMARY', 'title': 'Stage2: Percentage of Participants With at Least 1 Medically Attended AE During the Booster Follow-up Phase: Group 1 Through Group 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenABCWY + Saline (ACWY-Naive)', 'description': 'Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}, {'id': 'OG001', 'title': 'Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive)', 'description': 'Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.'}, {'id': 'OG002', 'title': 'Group 3: MenABCWY + Saline (ACWY-Experienced)', 'description': 'Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}, {'id': 'OG003', 'title': 'Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced)', 'description': 'Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000', 'lowerLimit': '0.4', 'upperLimit': '10.4'}, {'value': '13.2', 'groupId': 'OG001', 'lowerLimit': '4.4', 'upperLimit': '28.1'}, {'value': '6.5', 'groupId': 'OG002', 'lowerLimit': '2.1', 'upperLimit': '14.5'}, {'value': '7.1', 'groupId': 'OG003', 'lowerLimit': '2.0', 'upperLimit': '17.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Booster Follow-up Phase: From 1 month after booster vaccination through 6 months after booster vaccination (up to 5 months)', 'description': 'Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Booster Follow-up safety population for Stage 2 included participants who received the booster dose of investigational product and for whom safety information was available from after Visit 11 (Month 55) up to and including Visit 12 (Month 60).'}, {'type': 'PRIMARY', 'title': 'Stage2: Percentage of Participants With at Least 1 Medically Attended AE Throughout Booster Phase: Group 1 Through Group 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenABCWY + Saline (ACWY-Naive)', 'description': 'Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}, {'id': 'OG001', 'title': 'Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive)', 'description': 'Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.'}, {'id': 'OG002', 'title': 'Group 3: MenABCWY + Saline (ACWY-Experienced)', 'description': 'Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54'}, {'id': 'OG003', 'title': 'Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced)', 'description': 'Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.4', 'groupId': 'OG000', 'lowerLimit': '4.3', 'upperLimit': '20.3'}, {'value': '15.0', 'groupId': 'OG001', 'lowerLimit': '5.7', 'upperLimit': '29.8'}, {'value': '7.8', 'groupId': 'OG002', 'lowerLimit': '2.9', 'upperLimit': '16.2'}, {'value': '14.3', 'groupId': 'OG003', 'lowerLimit': '6.4', 'upperLimit': '26.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Throughout Booster Phase: From booster vaccination through 6 months after booster vaccination', 'description': 'Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Booster safety population included participants who received the booster dose of investigational product (MenABCWY or bivalent rLP2086) at Visit 10 (Month 54), and for whom safety information from Visit 10 (Month 54) up to and including Visit 12 (Month 60) was available.'}, {'type': 'PRIMARY', 'title': 'Stage2: Percentage of Participants With at Least 1 NDCMC During Booster Vaccination Phase: Group 1 Through Group 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenABCWY + Saline (ACWY-Naive)', 'description': 'Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}, {'id': 'OG001', 'title': 'Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive)', 'description': 'Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.'}, {'id': 'OG002', 'title': 'Group 3: MenABCWY + Saline (ACWY-Experienced)', 'description': 'Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, Participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}, {'id': 'OG003', 'title': 'Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced)', 'description': 'Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '5.4'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '8.8'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '4.7'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '6.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Booster Vaccination Phase: From booster vaccination through 1 month after booster vaccination', 'description': 'A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Booster vaccination safety population included participants who received the booster dose of investigational product (MenABCWY or bivalent rLP2086) at Visit 10 (Month 54), and for whom safety information from Visit 10 (Month 54) up to and including Visit 11 (Month 55) was available.'}, {'type': 'PRIMARY', 'title': 'Stage2: Percentage of Participants With at Least 1 NDCMC During the Booster Follow-up Phase: Group 1 Through Group 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenABCWY + Saline (ACWY-Naive)', 'description': 'Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}, {'id': 'OG001', 'title': 'Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive)', 'description': 'Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.'}, {'id': 'OG002', 'title': 'Group 3: MenABCWY + Saline (ACWY-Experienced)', 'description': 'Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}, {'id': 'OG003', 'title': 'Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced)', 'description': 'Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '5.4'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '9.3'}, {'value': '2.6', 'groupId': 'OG002', 'lowerLimit': '0.3', 'upperLimit': '9.1'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '6.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Booster Follow-up Phase: From 1 month after booster vaccination through 6 months after booster vaccination (up to 5 months)', 'description': 'A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Booster Follow-up safety population for Stage 2 included participants who received the booster dose of investigational product and for whom safety information was available from after Visit 11 (Month 55) up to and including Visit 12 (Month 60).'}, {'type': 'PRIMARY', 'title': 'Stage2: Percentage of Participants With at Least 1 NDCMC Throughout Booster Phase: Group 1 Through Group 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenABCWY + Saline (ACWY-Naive)', 'description': 'Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}, {'id': 'OG001', 'title': 'Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive)', 'description': 'Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.'}, {'id': 'OG002', 'title': 'Group 3: MenABCWY + Saline (ACWY-Experienced)', 'description': 'Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}, {'id': 'OG003', 'title': 'Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced)', 'description': 'Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '5.4'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '8.8'}, {'value': '2.6', 'groupId': 'OG002', 'lowerLimit': '0.3', 'upperLimit': '9.1'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '6.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Throughout Booster Phase: From booster vaccination through 6 months after booster vaccination', 'description': 'A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Booster safety population included participants who received the booster dose of investigational product (MenABCWY or bivalent rLP2086) at Visit 10 (Month 54), and for whom safety information from Visit 10 (Month 54) up to and including Visit 12 (Month 60) was available.'}, {'type': 'PRIMARY', 'title': 'Stage2: Percentage of Participants With at Least 1 AE During Booster Vaccination Phase: Group 1 Through Group 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenABCWY + Saline (ACWY-Naive)', 'description': 'Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}, {'id': 'OG001', 'title': 'Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive)', 'description': 'Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.'}, {'id': 'OG002', 'title': 'Group 3: MenABCWY + Saline (ACWY-Experienced)', 'description': 'Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}, {'id': 'OG003', 'title': 'Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced)', 'description': 'Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.4', 'groupId': 'OG000', 'lowerLimit': '6.3', 'upperLimit': '24.0'}, {'value': '10.0', 'groupId': 'OG001', 'lowerLimit': '2.8', 'upperLimit': '23.7'}, {'value': '10.4', 'groupId': 'OG002', 'lowerLimit': '4.6', 'upperLimit': '19.4'}, {'value': '17.9', 'groupId': 'OG003', 'lowerLimit': '8.9', 'upperLimit': '30.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Booster Vaccination Phase: From booster vaccination through 1 month after booster vaccination', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs did not include local reaction and systemic events collected by systematic approach.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Booster vaccination safety population included participants who received the booster dose of investigational product (MenABCWY or bivalent rLP2086) at Visit 10 (Month 54), and for whom safety information from Visit 10 (Month 54) up to and including Visit 11 (Month 55) was available.'}, {'type': 'PRIMARY', 'title': 'Stage2: Percentage of Participants With at Least 1 Immediate AE After Booster Vaccination: Group 1 Through Group 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenABCWY + Saline (ACWY-Naive)', 'description': 'Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}, {'id': 'OG001', 'title': 'Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive)', 'description': 'Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.'}, {'id': 'OG002', 'title': 'Group 3: MenABCWY + Saline (ACWY-Experienced)', 'description': 'Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}, {'id': 'OG003', 'title': 'Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced)', 'description': 'Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '0.0'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '0.0'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '0.0'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '0.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 minutes after booster vaccination', 'description': 'Immediate AE was defined as AE occurring within the first 30 minutes after investigational product administration.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Booster vaccination safety population included participants who received the booster dose of investigational product (MenABCWY or bivalent rLP2086) at Visit 10 (Month 54), and for whom safety information from Visit 10 (Month 54) up to and including Visit 11 (Month 55) was available.'}, {'type': 'PRIMARY', 'title': 'Stage2: Number of Participants Who Missed School/Work Due to AE After Booster Vaccination: Group 1 Through Group 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenABCWY + Saline (ACWY-Naive)', 'description': 'Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}, {'id': 'OG001', 'title': 'Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive)', 'description': 'Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.'}, {'id': 'OG002', 'title': 'Group 3: MenABCWY + Saline (ACWY-Experienced)', 'description': 'Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}, {'id': 'OG003', 'title': 'Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced)', 'description': 'Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Booster Vaccination Phase: From booster vaccination through 1 month after booster vaccination', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Booster vaccination safety population included participants who received the booster dose of investigational product (MenABCWY or bivalent rLP2086) at Visit 10 (Month 54), and for whom safety information from Visit 10 (Month 54) up to and including Visit 11 (Month 55) was available.'}, {'type': 'SECONDARY', 'title': 'Stage1: Percentage of Participants With hSBA Titer Level >= LLOQ for 4 Primary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '864', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM)', 'description': 'Stage 1: ACWY-naive and experienced participants who received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.'}], 'classes': [{'title': 'PMB80 (A22) 1 month after Vaccination 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '852', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '91.0', 'groupId': 'OG000', 'lowerLimit': '88.8', 'upperLimit': '92.8'}]}]}, {'title': 'PMB2001 (A56) 1 month after Vaccination 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '854', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '99.4', 'groupId': 'OG000', 'lowerLimit': '98.6', 'upperLimit': '99.8'}]}]}, {'title': 'PMB2948 (B24) 1 month after Vaccination 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '842', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '79.3', 'groupId': 'OG000', 'lowerLimit': '76.4', 'upperLimit': '82.0'}]}]}, {'title': 'PMB2707 (B44) 1 month after Vaccination 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '853', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '94.5', 'groupId': 'OG000', 'lowerLimit': '92.7', 'upperLimit': '95.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month after Vaccination 2', 'description': 'Percentage of participants who achieved an hSBA titer \\>= LLOQ for all 4 primary MenB test strains combined (LLOQ was 1:16 for A22 and 1:8 for A56, B24, and B44) was reported in this outcome measure. Four primary MenB test strains were PMB80 (A22), PMB2001 (A56), PMB2948 (B24) and PMB2707 (B44).', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Stage 1 EIP analyzed. Here "Overall Number of Participants analyzed" included all participants who were measured and analyzed. Here, \'Number Analyzed\' signifies number of participants with valid and determinate hSBA results on all 4 strains at given time point. Analysis was planned combined for Group 2 and 4.'}, {'type': 'SECONDARY', 'title': 'Stage1: Percentage of Participants With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for All 4 Primary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '864', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM)', 'description': 'Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.'}], 'classes': [{'title': 'PMB80 (A22) 1 Month after Vacc 2 >=1:4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '852', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '91.7', 'groupId': 'OG000', 'lowerLimit': '89.6', 'upperLimit': '93.4'}]}]}, {'title': 'PMB80 (A22) 1 Month after Vacc 2 >=1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '852', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '91.5', 'groupId': 'OG000', 'lowerLimit': '89.5', 'upperLimit': '93.3'}]}]}, {'title': 'PMB80 (A22) 1 Month after Vacc 2 >=1:16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '852', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '91.0', 'groupId': 'OG000', 'lowerLimit': '88.8', 'upperLimit': '92.8'}]}]}, {'title': 'PMB80 (A22) 1 Month after Vacc 2 >=1:32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '852', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '80.2', 'groupId': 'OG000', 'lowerLimit': '77.3', 'upperLimit': '82.8'}]}]}, {'title': 'PMB80 (A22) 1 Month after Vacc 2 >=1:64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '852', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '54.9', 'groupId': 'OG000', 'lowerLimit': '51.5', 'upperLimit': '58.3'}]}]}, {'title': 'PMB80 (A22) 1 Month after Vacc 2 >=1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '852', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '27.3', 'groupId': 'OG000', 'lowerLimit': '24.4', 'upperLimit': '30.5'}]}]}, {'title': 'PMB2001 (A56) 1 Month after Vacc 2 >=1:4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '854', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '99.5', 'groupId': 'OG000', 'lowerLimit': '98.8', 'upperLimit': '99.9'}]}]}, {'title': 'PMB2001 (A56) 1 Month after Vacc 2 >=1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '854', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '99.4', 'groupId': 'OG000', 'lowerLimit': '98.6', 'upperLimit': '99.8'}]}]}, {'title': 'PMB2001 (A56) 1 Month after Vacc 2 >=1:16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '854', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '99.1', 'groupId': 'OG000', 'lowerLimit': '98.2', 'upperLimit': '99.6'}]}]}, {'title': 'PMB2001 (A56) 1 Month after Vacc 2 >=1:32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '854', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '97.0', 'groupId': 'OG000', 'lowerLimit': '95.6', 'upperLimit': '98.0'}]}]}, {'title': 'PMB2001 (A56) 1 Month after Vacc 2 >=1:64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '854', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '87.7', 'groupId': 'OG000', 'lowerLimit': '85.3', 'upperLimit': '89.8'}]}]}, {'title': 'PMB2001 (A56) 1 Month after Vacc 2 >=1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '854', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '69.2', 'groupId': 'OG000', 'lowerLimit': '66.0', 'upperLimit': '72.3'}]}]}, {'title': 'PMB2948 (B24) 1 Month after Vacc 2 >=1:4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '842', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '81.2', 'groupId': 'OG000', 'lowerLimit': '78.4', 'upperLimit': '83.8'}]}]}, {'title': 'PMB2948 (B24) 1 Month after Vacc 2 >=1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '842', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '79.3', 'groupId': 'OG000', 'lowerLimit': '76.4', 'upperLimit': '82.0'}]}]}, {'title': 'PMB2948 (B24) 1 Month after Vacc 2 >=1:16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '842', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '74.0', 'groupId': 'OG000', 'lowerLimit': '70.9', 'upperLimit': '76.9'}]}]}, {'title': 'PMB2948 (B24) 1 Month after Vacc 2 >=1:32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '842', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '47.9', 'groupId': 'OG000', 'lowerLimit': '44.4', 'upperLimit': '51.3'}]}]}, {'title': 'PMB2948 (B24) 1 Month after Vacc 2 >=1:64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '842', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '24.9', 'groupId': 'OG000', 'lowerLimit': '22.1', 'upperLimit': '28.0'}]}]}, {'title': 'PMB2948 (B24) 1 Month after Vacc 2 >=1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '842', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.6', 'groupId': 'OG000', 'lowerLimit': '7.7', 'upperLimit': '11.8'}]}]}, {'title': 'PMB2707 (B44) 1 Month after Vacc 2 >=1:4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '853', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '96.2', 'groupId': 'OG000', 'lowerLimit': '94.7', 'upperLimit': '97.4'}]}]}, {'title': 'PMB2707 (B44) 1 Month after Vacc 2 >=1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '853', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '94.5', 'groupId': 'OG000', 'lowerLimit': '92.7', 'upperLimit': '95.9'}]}]}, {'title': 'PMB2707 (B44) 1 Month after Vacc 2 >=1:16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '853', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '89.0', 'groupId': 'OG000', 'lowerLimit': '86.7', 'upperLimit': '91.0'}]}]}, {'title': 'PMB2707 (B44) 1 Month after Vacc 2 >=1:32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '853', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '68.6', 'groupId': 'OG000', 'lowerLimit': '65.3', 'upperLimit': '71.7'}]}]}, {'title': 'PMB2707 (B44) 1 Month after Vacc 2 >=1:64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '853', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '41.0', 'groupId': 'OG000', 'lowerLimit': '37.7', 'upperLimit': '44.4'}]}]}, {'title': 'PMB2707 (B44) 1 Month after Vacc 2 >=1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '853', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '19.2', 'groupId': 'OG000', 'lowerLimit': '16.6', 'upperLimit': '22.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month after Vaccination 2 (Vacc 2)', 'description': 'Percentage of participants who achieved an hSBA titer \\>= 1:4, \\>= 1:8, \\>= 1:16, \\>= 1:32, \\>= 1:64, \\>= 1:128 for all 4 primary MenB test strains was reported in this outcome measure. Four primary MenB test strains were PMB80 (A22), PMB2001 (A56), PMB2948 (B24) and PMB2707 (B44).', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Stage 1 EIP analyzed. Here "Overall Number of Participants analyzed" included all participants who were measured and analyzed. Here, \'Number Analyzed\' signifies number of participants with valid and determinate hSBA results on all 4 strains at given time point. Analysis was planned for combined Group 2 and 4.'}, {'type': 'SECONDARY', 'title': 'Stage1: hSBA Geometric Mean Titers (GMTs) for All 4 Primary MenB Test Strains Combined 1 Month After Vaccination 2 (Group 2 and 4 Combined)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '864', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM)', 'description': 'Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.'}], 'classes': [{'title': 'PMB80 (A22) 1 month after Vacc 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '852', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '49.3', 'groupId': 'OG000', 'lowerLimit': '46.2', 'upperLimit': '52.6'}]}]}, {'title': 'PMB2001 (A56) 1 month after Vacc 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '854', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '139.5', 'groupId': 'OG000', 'lowerLimit': '130.6', 'upperLimit': '149.1'}]}]}, {'title': 'PMB2948 (B24) 1 month after Vacc 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '842', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '21.2', 'groupId': 'OG000', 'lowerLimit': '19.6', 'upperLimit': '22.9'}]}]}, {'title': 'PMB2707 (B44) 1 month after Vacc 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '853', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '37.8', 'groupId': 'OG000', 'lowerLimit': '35.1', 'upperLimit': '40.8'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 month after Vaccination 2 (Vacc 2)', 'description': 'GMTs were calculated using all participants with valid and determinate hSBA titers at the given time point. LLOQ = 1:16 for A22; 1:8 for A56, B24, and B44. Titers below the LLOQ were set to 0.5 \\* LLOQ for analysis. Four primary MenB test strains were PMB80 (A22), PMB2001 (A56), PMB2948 (B24) and PMB2707 (B44).', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Stage 1 EIP analyzed. Here "Overall Number of Participants analyzed" included all participants who were measured and analyzed. Here, \'Number Analyzed\' signifies number of participants with valid and determinate hSBA results on all 4 strains at given time point. Analysis was planned for combined Group 2 and 4.'}, {'type': 'SECONDARY', 'title': 'Stage1: Percentage of Participants With hSBA Titer Level >= LLOQ for 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM)', 'description': 'Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.'}], 'classes': [{'title': 'PMB3175 (A29) 1 month after Vacc 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '95.2', 'groupId': 'OG000', 'lowerLimit': '90.7', 'upperLimit': '97.9'}]}]}, {'title': 'PMB3010 (A06) 1 month after Vacc 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '89.3', 'groupId': 'OG000', 'lowerLimit': '83.4', 'upperLimit': '93.6'}]}]}, {'title': 'PMB824 (A12) 1 month after Vacc 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '83.4', 'groupId': 'OG000', 'lowerLimit': '76.7', 'upperLimit': '88.9'}]}]}, {'title': 'PMB3040 (A07) 1 month after Vacc 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '96.8', 'groupId': 'OG000', 'lowerLimit': '92.7', 'upperLimit': '99.0'}]}]}, {'title': 'PMB1672 (A15) 1 month after Vacc 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '89.1', 'groupId': 'OG000', 'lowerLimit': '83.3', 'upperLimit': '93.4'}]}]}, {'title': 'PMB1989 (A19) 1 month after Vacc 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '90.4', 'groupId': 'OG000', 'lowerLimit': '84.9', 'upperLimit': '94.4'}]}]}, {'title': 'PMB648 (B16) 1 month after Vacc 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '77.4', 'groupId': 'OG000', 'lowerLimit': '70.3', 'upperLimit': '83.6'}]}]}, {'title': 'PMB866 (B09) 1 month after Vacc 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '71.1', 'groupId': 'OG000', 'lowerLimit': '63.6', 'upperLimit': '77.8'}]}]}, {'title': 'PMB1256 (B03) 1 month after Vacc 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '74.4', 'groupId': 'OG000', 'lowerLimit': '67.0', 'upperLimit': '80.9'}]}]}, {'title': 'PMB431 (B15) 1 month after Vacc 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '85.0', 'groupId': 'OG000', 'lowerLimit': '78.7', 'upperLimit': '90.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month after Vaccination 2 (Vacc 2)', 'description': 'Percentage of participants who achieved an hSBA titer greater than or equal to LLOQ for 10 Secondary MenB test strains combined (LLOQ = 1:16 for A06, A12, and A19; 1:8 for A07, A15, A29, B03, B09, B15, and B16) was reported in this outcome measure.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Stage 1 EIP analyzed. Here "Overall Number of Participants analyzed" included all participants who were measured and analyzed. Here, \'Number Analyzed\' signifies number of participants with valid and determinate hSBA results on all 10 strains at given time point. Analysis was planned for combined Group 2 and 4.'}, {'type': 'SECONDARY', 'title': 'Stage1: Percentage of Participants With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for Each of the 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM)', 'description': 'Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.'}], 'classes': [{'title': 'PMB3175 (A29) 1 Month after Vacc 2 >=1:4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '95.8', 'groupId': 'OG000', 'lowerLimit': '91.5', 'upperLimit': '98.3'}]}]}, {'title': 'PMB3175 (A29) 1 Month after Vacc 2 >=1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '95.2', 'groupId': 'OG000', 'lowerLimit': '90.7', 'upperLimit': '97.9'}]}]}, {'title': 'PMB3175 (A29) 1 Month after Vacc 2 >=1:16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '92.2', 'groupId': 'OG000', 'lowerLimit': '87.0', 'upperLimit': '95.8'}]}]}, {'title': 'PMB3175 (A29) 1 Month after Vacc 2 >=1:32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '71.7', 'groupId': 'OG000', 'lowerLimit': '64.2', 'upperLimit': '78.4'}]}]}, {'title': 'PMB3175 (A29) 1 Month after Vacc 2 >=1:64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '38.0', 'groupId': 'OG000', 'lowerLimit': '30.5', 'upperLimit': '45.8'}]}]}, {'title': 'PMB3175 (A29) 1 Month after Vacc 2 >=1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13.9', 'groupId': 'OG000', 'lowerLimit': '9.0', 'upperLimit': '20.1'}]}]}, {'title': 'PMB3010 (A06) 1 Month after Vacc 2 >=1:4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '89.9', 'groupId': 'OG000', 'lowerLimit': '84.2', 'upperLimit': '94.1'}]}]}, {'title': 'PMB3010 (A06) 1 Month after Vacc 2 >=1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '89.3', 'groupId': 'OG000', 'lowerLimit': '83.4', 'upperLimit': '93.6'}]}]}, {'title': 'PMB3010 (A06) 1 Month after Vacc 2 >=1:16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '89.3', 'groupId': 'OG000', 'lowerLimit': '83.4', 'upperLimit': '93.6'}]}]}, {'title': 'PMB3010 (A06) 1 Month after Vacc 2 >=1:32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '79.9', 'groupId': 'OG000', 'lowerLimit': '72.8', 'upperLimit': '85.8'}]}]}, {'title': 'PMB3010 (A06) 1 Month after Vacc 2 >=1:64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '54.7', 'groupId': 'OG000', 'lowerLimit': '46.6', 'upperLimit': '62.6'}]}]}, {'title': 'PMB3010 (A06) 1 Month after Vacc 2 >=1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '22.0', 'groupId': 'OG000', 'lowerLimit': '15.8', 'upperLimit': '29.3'}]}]}, {'title': 'PMB824 (A12) 1 Month after Vacc 2 >=1:4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '89.2', 'groupId': 'OG000', 'lowerLimit': '83.2', 'upperLimit': '93.6'}]}]}, {'title': 'PMB824 (A12) 1 Month after Vacc 2 >=1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '87.9', 'groupId': 'OG000', 'lowerLimit': '81.7', 'upperLimit': '92.6'}]}]}, {'title': 'PMB824 (A12) 1 Month after Vacc 2 >=1:16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '83.4', 'groupId': 'OG000', 'lowerLimit': '76.7', 'upperLimit': '88.9'}]}]}, {'title': 'PMB824 (A12) 1 Month after Vacc 2 >=1:32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '52.9', 'groupId': 'OG000', 'lowerLimit': '44.8', 'upperLimit': '60.9'}]}]}, {'title': 'PMB824 (A12) 1 Month after Vacc 2 >=1:64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '18.5', 'groupId': 'OG000', 'lowerLimit': '12.7', 'upperLimit': '25.4'}]}]}, {'title': 'PMB824 (A12) 1 Month after Vacc 2 >=1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '4.5'}]}]}, {'title': 'PMB3040 (A07) 1 Month after Vacc 2 >=1:4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '96.8', 'groupId': 'OG000', 'lowerLimit': '92.7', 'upperLimit': '99.0'}]}]}, {'title': 'PMB3040 (A07) 1 Month after Vacc 2 >=1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '96.8', 'groupId': 'OG000', 'lowerLimit': '92.7', 'upperLimit': '99.0'}]}]}, {'title': 'PMB3040 (A07) 1 Month after Vacc 2 >=1:16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '96.8', 'groupId': 'OG000', 'lowerLimit': '92.7', 'upperLimit': '99.0'}]}]}, {'title': 'PMB3040 (A07) 1 Month after Vacc 2 >=1:32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '94.3', 'groupId': 'OG000', 'lowerLimit': '89.4', 'upperLimit': '97.3'}]}]}, {'title': 'PMB3040 (A07) 1 Month after Vacc 2 >=1:64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '68.8', 'groupId': 'OG000', 'lowerLimit': '60.9', 'upperLimit': '75.9'}]}]}, {'title': 'PMB3040 (A07) 1 Month after Vacc 2 >=1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '31.2', 'groupId': 'OG000', 'lowerLimit': '24.1', 'upperLimit': '39.1'}]}]}, {'title': 'PMB1672 (A15) 1 Month after Vacc 2 >=1:4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '89.1', 'groupId': 'OG000', 'lowerLimit': '83.3', 'upperLimit': '93.4'}]}]}, {'title': 'PMB1672 (A15) 1 Month after Vacc 2 >=1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '89.1', 'groupId': 'OG000', 'lowerLimit': '83.3', 'upperLimit': '93.4'}]}]}, {'title': 'PMB1672 (A15) 1 Month after Vacc 2 >=1:16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '87.3', 'groupId': 'OG000', 'lowerLimit': '81.2', 'upperLimit': '91.9'}]}]}, {'title': 'PMB1672 (A15) (n=165) 1 Month after Vacc 2 >=1:32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '69.7', 'groupId': 'OG000', 'lowerLimit': '62.1', 'upperLimit': '76.6'}]}]}, {'title': 'PMB1672 (A15) 1 Month after Vacc 2 >=1:64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '30.3', 'groupId': 'OG000', 'lowerLimit': '23.4', 'upperLimit': '37.9'}]}]}, {'title': 'PMB1672 (A15) 1 Month after Vacc 2 >=1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.5', 'groupId': 'OG000', 'lowerLimit': '2.5', 'upperLimit': '10.1'}]}]}, {'title': 'PMB1989 (A19) 1 Month after Vacc 2 >=1:4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '92.2', 'groupId': 'OG000', 'lowerLimit': '87.1', 'upperLimit': '95.8'}]}]}, {'title': 'PMB1989 (A19) 1 Month after Vacc 2 >=1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '92.2', 'groupId': 'OG000', 'lowerLimit': '87.1', 'upperLimit': '95.8'}]}]}, {'title': 'PMB1989 (A19) 1 Month after Vacc 2 >=1:16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '90.4', 'groupId': 'OG000', 'lowerLimit': '84.9', 'upperLimit': '94.4'}]}]}, {'title': 'PMB1989 (A19) 1 Month after Vacc 2 >=1:32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '84.4', 'groupId': 'OG000', 'lowerLimit': '78.0', 'upperLimit': '89.6'}]}]}, {'title': 'PMB1989 (A19) 1 Month after Vacc 2 >=1:64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '61.1', 'groupId': 'OG000', 'lowerLimit': '53.2', 'upperLimit': '68.5'}]}]}, {'title': 'PMB1989 (A19) 1 Month after Vacc 2 >=1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '28.7', 'groupId': 'OG000', 'lowerLimit': '22.0', 'upperLimit': '36.2'}]}]}, {'title': 'PMB648 (B16) 1 Month after Vacc 2 >=1:4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '79.3', 'groupId': 'OG000', 'lowerLimit': '72.3', 'upperLimit': '85.2'}]}]}, {'title': 'PMB648 (B16) 1 Month after Vacc 2 >=1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '77.4', 'groupId': 'OG000', 'lowerLimit': '70.3', 'upperLimit': '83.6'}]}]}, {'title': 'PMB648 (B16) 1 Month after Vacc 2 >=1:16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '73.8', 'groupId': 'OG000', 'lowerLimit': '66.4', 'upperLimit': '80.3'}]}]}, {'title': 'PMB648 (B16) 1 Month after Vacc 2 >=1:32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '51.2', 'groupId': 'OG000', 'lowerLimit': '43.3', 'upperLimit': '59.1'}]}]}, {'title': 'PMB648 (B16) 1 Month after Vacc 2 >=1:64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '28.7', 'groupId': 'OG000', 'lowerLimit': '21.9', 'upperLimit': '36.2'}]}]}, {'title': 'PMB648 (B16) 1 Month after Vacc 2 >=1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.1', 'groupId': 'OG000', 'lowerLimit': '3.0', 'upperLimit': '10.9'}]}]}, {'title': 'PMB866 (B09) 1 Month after Vacc 2 >=1:4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '74.7', 'groupId': 'OG000', 'lowerLimit': '67.4', 'upperLimit': '81.1'}]}]}, {'title': 'PMB866 (B09) 1 Month after Vacc 2 >=1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '71.1', 'groupId': 'OG000', 'lowerLimit': '63.6', 'upperLimit': '77.8'}]}]}, {'title': 'PMB866 (B09) 1 Month after Vacc 2 >=1:16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '63.3', 'groupId': 'OG000', 'lowerLimit': '55.4', 'upperLimit': '70.6'}]}]}, {'title': 'PMB866 (B09) 1 Month after Vacc 2 >=1:32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '34.3', 'groupId': 'OG000', 'lowerLimit': '27.2', 'upperLimit': '42.1'}]}]}, {'title': 'PMB866 (B09) 1 Month after Vacc 2 >=1:64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.4', 'groupId': 'OG000', 'lowerLimit': '4.7', 'upperLimit': '13.7'}]}]}, {'title': 'PMB866 (B09) 1 Month after Vacc 2 >=1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.4', 'groupId': 'OG000', 'lowerLimit': '0.7', 'upperLimit': '6.1'}]}]}, {'title': 'PMB1256 (B03) 1 Month after Vacc 2 >=1:4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '77.4', 'groupId': 'OG000', 'lowerLimit': '70.3', 'upperLimit': '83.6'}]}]}, {'title': 'PMB1256 (B03) 1 Month after Vacc 2 >=1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '74.4', 'groupId': 'OG000', 'lowerLimit': '67.0', 'upperLimit': '80.9'}]}]}, {'title': 'PMB1256 (B03) 1 Month after Vacc 2 >=1:16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '64.0', 'groupId': 'OG000', 'lowerLimit': '56.2', 'upperLimit': '71.4'}]}]}, {'title': 'PMB1256 (B03) 1 Month after Vacc 2 >=1:32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '42.1', 'groupId': 'OG000', 'lowerLimit': '34.4', 'upperLimit': '50.0'}]}]}, {'title': 'PMB1256 (B03) 1 Month after Vacc 2 >=1:64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '23.2', 'groupId': 'OG000', 'lowerLimit': '16.9', 'upperLimit': '30.4'}]}]}, {'title': 'PMB1256 (B03) 1 Month after Vacc 2 >=1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.3', 'groupId': 'OG000', 'lowerLimit': '3.8', 'upperLimit': '12.4'}]}]}, {'title': 'PMB431 (B15) 1 Month after Vacc 2 >=1:4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '87.4', 'groupId': 'OG000', 'lowerLimit': '81.4', 'upperLimit': '92.0'}]}]}, {'title': 'PMB431 (B15) 1 Month after Vacc 2 >=1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '85.0', 'groupId': 'OG000', 'lowerLimit': '78.7', 'upperLimit': '90.1'}]}]}, {'title': 'PMB431 (B15) 1 Month after Vacc 2 >=1:16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '72.5', 'groupId': 'OG000', 'lowerLimit': '65.0', 'upperLimit': '79.1'}]}]}, {'title': 'PMB431 (B15) 1 Month after Vacc 2 >=1:32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '36.5', 'groupId': 'OG000', 'lowerLimit': '29.2', 'upperLimit': '44.3'}]}]}, {'title': 'PMB431 (B15) 1 Month after Vacc 2 >=1:64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '15.0', 'groupId': 'OG000', 'lowerLimit': '9.9', 'upperLimit': '21.3'}]}]}, {'title': 'PMB431 (B15) 1 Month after Vacc 2 >=1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.4', 'groupId': 'OG000', 'lowerLimit': '0.7', 'upperLimit': '6.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month after Vaccination 2 (Vacc 2)', 'description': 'Percentage of participants who achieved an hSBA titer \\>= 1:4, \\>= 1:8, \\>= 1:16, \\>= 1:32, \\>= 1:64, \\>= 1:128 for each of the 10 secondary MenB test strains was reported in this outcome measure. 10 secondary MenB test strains were PMB3175 (A29), PMB3010 (A06), PMB824 (A12), PMB3040 (A07), PMB1672 (A15), PMB1989 (A19), PMB648 (B16), PMB866 (B09), PMB1256 (B03) and PMB431 (B15).', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Stage 1 EIP analyzed. Here "Overall Number of Participants analyzed" included all participants who were measured and analyzed. Here, \'Number Analyzed\' signifies number of participants with valid and determinate hSBA results on all 10 strains at given time point. Analysis was planned for combined Group 2 and 4.'}, {'type': 'SECONDARY', 'title': 'Stage1: hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM)', 'description': 'Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.'}], 'classes': [{'title': 'PMB3175 (A29) 1 month after Vacc 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '35.7', 'groupId': 'OG000', 'lowerLimit': '30.9', 'upperLimit': '41.2'}]}]}, {'title': 'PMB3010 (A06) 1 month after Vacc 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '159', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '46.0', 'groupId': 'OG000', 'lowerLimit': '39.7', 'upperLimit': '53.1'}]}]}, {'title': 'PMB824 (A12) 1 month after Vacc 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '23.7', 'groupId': 'OG000', 'lowerLimit': '21.2', 'upperLimit': '26.5'}]}]}, {'title': 'PMB3040 (A07) 1 month after Vacc 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '60.7', 'groupId': 'OG000', 'lowerLimit': '53.6', 'upperLimit': '68.8'}]}]}, {'title': 'PMB1672 (A15) 1 month after Vacc 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '28.4', 'groupId': 'OG000', 'lowerLimit': '24.7', 'upperLimit': '32.7'}]}]}, {'title': 'PMB1989 (A19) 1 month after Vacc 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '53.5', 'groupId': 'OG000', 'lowerLimit': '46.3', 'upperLimit': '61.9'}]}]}, {'title': 'PMB648 (B16) 1 month after Vacc 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '20.8', 'groupId': 'OG000', 'lowerLimit': '17.5', 'upperLimit': '24.6'}]}]}, {'title': 'PMB866 (B09) 1 month after Vacc 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13.9', 'groupId': 'OG000', 'lowerLimit': '12.0', 'upperLimit': '16.2'}]}]}, {'title': 'PMB1256 (B03) 1 month after Vacc 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '164', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '17.7', 'groupId': 'OG000', 'lowerLimit': '14.8', 'upperLimit': '21.3'}]}]}, {'title': 'PMB431 (B15) 1 month after Vacc 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '17.3', 'groupId': 'OG000', 'lowerLimit': '15.1', 'upperLimit': '19.8'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 month after Vaccination 2 (Vacc 2)', 'description': 'GMTs were calculated using all participants with valid and determinate hSBA titers at the given time point. LLOQ = 1:16 for A06, A12, and A19; 1:8 for A07, A15, A29, B03, B09, B15, and B16. Titers below the LLOQ were set to 0.5\\*LLOQ for analysis.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Stage 1 EIP analyzed. Here "Overall Number of Participants analyzed" included all participants who were measured and analyzed. Here, \'Number Analyzed\' signifies number of participants with valid and determinate hSBA results on all 10 strains at given time point. Analysis was planned for combined Group 2 and 4.'}, {'type': 'SECONDARY', 'title': 'Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=LLOQ for ACWY Test Strains 1 Month After the Vaccination 1: Groups 1, 2, 3 and 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}, {'value': '534', 'groupId': 'OG001'}, {'value': '271', 'groupId': 'OG002'}, {'value': '523', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenABCWY + Saline (ACWY-Naive)', 'description': 'Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}, {'id': 'OG001', 'title': 'Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive)', 'description': 'Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.'}, {'id': 'OG002', 'title': 'Group 3: MenABCWY + Saline (ACWY-Experienced)', 'description': 'Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}, {'id': 'OG003', 'title': 'Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced)', 'description': 'Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.'}], 'classes': [{'title': 'MenA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}, {'value': '510', 'groupId': 'OG001'}, {'value': '218', 'groupId': 'OG002'}, {'value': '411', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '99.2', 'groupId': 'OG000', 'lowerLimit': '97.3', 'upperLimit': '99.9'}, {'value': '98.4', 'groupId': 'OG001', 'lowerLimit': '96.9', 'upperLimit': '99.3'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '98.3', 'upperLimit': '100.0'}, {'value': '99.3', 'groupId': 'OG003', 'lowerLimit': '97.9', 'upperLimit': '99.8'}]}]}, {'title': 'MenC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '262', 'groupId': 'OG000'}, {'value': '509', 'groupId': 'OG001'}, {'value': '264', 'groupId': 'OG002'}, {'value': '506', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '92.4', 'groupId': 'OG000', 'lowerLimit': '88.5', 'upperLimit': '95.3'}, {'value': '88.6', 'groupId': 'OG001', 'lowerLimit': '85.5', 'upperLimit': '91.2'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '98.6', 'upperLimit': '100.0'}, {'value': '99.4', 'groupId': 'OG003', 'lowerLimit': '98.3', 'upperLimit': '99.9'}]}]}, {'title': 'MenW', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}, {'value': '512', 'groupId': 'OG001'}, {'value': '219', 'groupId': 'OG002'}, {'value': '414', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '98.5', 'groupId': 'OG000', 'lowerLimit': '96.2', 'upperLimit': '99.6'}, {'value': '95.5', 'groupId': 'OG001', 'lowerLimit': '93.3', 'upperLimit': '97.1'}, {'value': '99.5', 'groupId': 'OG002', 'lowerLimit': '97.5', 'upperLimit': '100.0'}, {'value': '99.5', 'groupId': 'OG003', 'lowerLimit': '98.3', 'upperLimit': '99.9'}]}]}, {'title': 'MenY', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'OG000'}, {'value': '510', 'groupId': 'OG001'}, {'value': '218', 'groupId': 'OG002'}, {'value': '413', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '99.6', 'groupId': 'OG000', 'lowerLimit': '97.9', 'upperLimit': '100.0'}, {'value': '96.9', 'groupId': 'OG001', 'lowerLimit': '95.0', 'upperLimit': '98.2'}, {'value': '99.5', 'groupId': 'OG002', 'lowerLimit': '97.5', 'upperLimit': '100.0'}, {'value': '99.8', 'groupId': 'OG003', 'lowerLimit': '98.7', 'upperLimit': '100.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month after Vaccination 1', 'description': 'Percentage of participants who achieved an hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY titer \\>=LLOQ for ACWY test strains (LLOQ = 1:8 for all MenA, MenC, MenW, and MenY strains) was reported in this outcome measure.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Stage 1 modified intent-to-treat (mITT) population: all randomized participants who had received at least 1 study vaccination, who had at least 1 valid and determinate primary strain MenB or MenA/C/W/Y assay result available at any time point from Month 0 to 7. "Overall Number of Participants Analyzed": participants who were measured and analyzed for the outcome measure. \'Number Analyzed\': participants with valid and determinate hSBA results for ACWY test strains at the given time point.'}, {'type': 'SECONDARY', 'title': 'Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for ACWY Test Strains 1 Month After the Vaccination 1: Groups 1, 2, 3 and 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}, {'value': '534', 'groupId': 'OG001'}, {'value': '271', 'groupId': 'OG002'}, {'value': '523', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenABCWY + Saline (ACWY-Naive)', 'description': 'Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}, {'id': 'OG001', 'title': 'Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive)', 'description': 'Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.'}, {'id': 'OG002', 'title': 'Group 3: MenABCWY + Saline (ACWY-Experienced)', 'description': 'Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}, {'id': 'OG003', 'title': 'Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced)', 'description': 'Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.'}], 'classes': [{'title': 'MenA >=1:4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}, {'value': '510', 'groupId': 'OG001'}, {'value': '218', 'groupId': 'OG002'}, {'value': '411', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '99.6', 'groupId': 'OG000', 'lowerLimit': '97.9', 'upperLimit': '100.0'}, {'value': '98.4', 'groupId': 'OG001', 'lowerLimit': '96.9', 'upperLimit': '99.3'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '98.3', 'upperLimit': '100.0'}, {'value': '99.3', 'groupId': 'OG003', 'lowerLimit': '97.9', 'upperLimit': '99.8'}]}]}, {'title': 'MenA >=1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}, {'value': '510', 'groupId': 'OG001'}, {'value': '218', 'groupId': 'OG002'}, {'value': '411', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '99.2', 'groupId': 'OG000', 'lowerLimit': '97.3', 'upperLimit': '99.9'}, {'value': '98.4', 'groupId': 'OG001', 'lowerLimit': '96.9', 'upperLimit': '99.3'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '98.3', 'upperLimit': '100.0'}, {'value': '99.3', 'groupId': 'OG003', 'lowerLimit': '97.9', 'upperLimit': '99.8'}]}]}, {'title': 'MenA >=1:16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}, {'value': '510', 'groupId': 'OG001'}, {'value': '218', 'groupId': 'OG002'}, {'value': '411', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '98.5', 'groupId': 'OG000', 'lowerLimit': '96.2', 'upperLimit': '99.6'}, {'value': '98.0', 'groupId': 'OG001', 'lowerLimit': '96.4', 'upperLimit': '99.1'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '98.3', 'upperLimit': '100.0'}, {'value': '99.3', 'groupId': 'OG003', 'lowerLimit': '97.9', 'upperLimit': '99.8'}]}]}, {'title': 'MenA >=1:32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}, {'value': '510', 'groupId': 'OG001'}, {'value': '218', 'groupId': 'OG002'}, {'value': '411', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '97.7', 'groupId': 'OG000', 'lowerLimit': '95.1', 'upperLimit': '99.2'}, {'value': '93.9', 'groupId': 'OG001', 'lowerLimit': '91.5', 'upperLimit': '95.8'}, {'value': '99.5', 'groupId': 'OG002', 'lowerLimit': '97.5', 'upperLimit': '100.0'}, {'value': '99.0', 'groupId': 'OG003', 'lowerLimit': '97.5', 'upperLimit': '99.7'}]}]}, {'title': 'MenA >=1:64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}, {'value': '510', 'groupId': 'OG001'}, {'value': '218', 'groupId': 'OG002'}, {'value': '411', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '90.9', 'groupId': 'OG000', 'lowerLimit': '86.8', 'upperLimit': '94.1'}, {'value': '86.3', 'groupId': 'OG001', 'lowerLimit': '83.0', 'upperLimit': '89.1'}, {'value': '99.1', 'groupId': 'OG002', 'lowerLimit': '96.7', 'upperLimit': '99.9'}, {'value': '98.3', 'groupId': 'OG003', 'lowerLimit': '96.5', 'upperLimit': '99.3'}]}]}, {'title': 'MenA >= 1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}, {'value': '510', 'groupId': 'OG001'}, {'value': '218', 'groupId': 'OG002'}, {'value': '411', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '75.0', 'groupId': 'OG000', 'lowerLimit': '69.3', 'upperLimit': '80.1'}, {'value': '71.2', 'groupId': 'OG001', 'lowerLimit': '67.0', 'upperLimit': '75.1'}, {'value': '95.4', 'groupId': 'OG002', 'lowerLimit': '91.7', 'upperLimit': '97.8'}, {'value': '96.4', 'groupId': 'OG003', 'lowerLimit': '94.1', 'upperLimit': '97.9'}]}]}, {'title': 'MenC >=1:4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '262', 'groupId': 'OG000'}, {'value': '509', 'groupId': 'OG001'}, {'value': '264', 'groupId': 'OG002'}, {'value': '506', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '95.4', 'groupId': 'OG000', 'lowerLimit': '92.1', 'upperLimit': '97.6'}, {'value': '93.3', 'groupId': 'OG001', 'lowerLimit': '90.8', 'upperLimit': '95.3'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '98.6', 'upperLimit': '100.0'}, {'value': '99.4', 'groupId': 'OG003', 'lowerLimit': '98.3', 'upperLimit': '99.9'}]}]}, {'title': 'MenC >=1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '262', 'groupId': 'OG000'}, {'value': '509', 'groupId': 'OG001'}, {'value': '264', 'groupId': 'OG002'}, {'value': '506', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '92.4', 'groupId': 'OG000', 'lowerLimit': '88.5', 'upperLimit': '95.3'}, {'value': '88.6', 'groupId': 'OG001', 'lowerLimit': '85.5', 'upperLimit': '91.2'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '98.6', 'upperLimit': '100.0'}, {'value': '99.4', 'groupId': 'OG003', 'lowerLimit': '98.3', 'upperLimit': '99.9'}]}]}, {'title': 'MenC >=1:16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '262', 'groupId': 'OG000'}, {'value': '509', 'groupId': 'OG001'}, {'value': '264', 'groupId': 'OG002'}, {'value': '506', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '88.2', 'groupId': 'OG000', 'lowerLimit': '83.6', 'upperLimit': '91.8'}, {'value': '80.9', 'groupId': 'OG001', 'lowerLimit': '77.3', 'upperLimit': '84.3'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '98.6', 'upperLimit': '100.0'}, {'value': '99.2', 'groupId': 'OG003', 'lowerLimit': '98.0', 'upperLimit': '99.8'}]}]}, {'title': 'MenC >=1:32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '262', 'groupId': 'OG000'}, {'value': '509', 'groupId': 'OG001'}, {'value': '264', 'groupId': 'OG002'}, {'value': '506', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '76.3', 'groupId': 'OG000', 'lowerLimit': '70.7', 'upperLimit': '81.3'}, {'value': '67.8', 'groupId': 'OG001', 'lowerLimit': '63.5', 'upperLimit': '71.8'}, {'value': '98.9', 'groupId': 'OG002', 'lowerLimit': '96.7', 'upperLimit': '99.8'}, {'value': '98.2', 'groupId': 'OG003', 'lowerLimit': '96.7', 'upperLimit': '99.2'}]}]}, {'title': 'MenC >=1:64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '262', 'groupId': 'OG000'}, {'value': '509', 'groupId': 'OG001'}, {'value': '264', 'groupId': 'OG002'}, {'value': '506', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '61.8', 'groupId': 'OG000', 'lowerLimit': '55.7', 'upperLimit': '67.7'}, {'value': '55.0', 'groupId': 'OG001', 'lowerLimit': '50.6', 'upperLimit': '59.4'}, {'value': '97.3', 'groupId': 'OG002', 'lowerLimit': '94.6', 'upperLimit': '98.9'}, {'value': '97.2', 'groupId': 'OG003', 'lowerLimit': '95.4', 'upperLimit': '98.5'}]}]}, {'title': 'MenC >=1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '262', 'groupId': 'OG000'}, {'value': '509', 'groupId': 'OG001'}, {'value': '264', 'groupId': 'OG002'}, {'value': '506', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '50.8', 'groupId': 'OG000', 'lowerLimit': '44.5', 'upperLimit': '57.0'}, {'value': '45.6', 'groupId': 'OG001', 'lowerLimit': '41.2', 'upperLimit': '50.0'}, {'value': '95.5', 'groupId': 'OG002', 'lowerLimit': '92.2', 'upperLimit': '97.6'}, {'value': '94.1', 'groupId': 'OG003', 'lowerLimit': '91.6', 'upperLimit': '96.0'}]}]}, {'title': 'MenW >=1:4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}, {'value': '512', 'groupId': 'OG001'}, {'value': '219', 'groupId': 'OG002'}, {'value': '414', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '99.6', 'groupId': 'OG000', 'lowerLimit': '97.9', 'upperLimit': '100.0'}, {'value': '97.7', 'groupId': 'OG001', 'lowerLimit': '95.9', 'upperLimit': '98.8'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '98.3', 'upperLimit': '100.0'}, {'value': '99.5', 'groupId': 'OG003', 'lowerLimit': '98.3', 'upperLimit': '99.9'}]}]}, {'title': 'MenW >=1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}, {'value': '512', 'groupId': 'OG001'}, {'value': '219', 'groupId': 'OG002'}, {'value': '414', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '98.5', 'groupId': 'OG000', 'lowerLimit': '96.2', 'upperLimit': '99.6'}, {'value': '95.5', 'groupId': 'OG001', 'lowerLimit': '93.3', 'upperLimit': '97.1'}, {'value': '99.5', 'groupId': 'OG002', 'lowerLimit': '97.5', 'upperLimit': '100.0'}, {'value': '99.5', 'groupId': 'OG003', 'lowerLimit': '98.3', 'upperLimit': '99.9'}]}]}, {'title': 'MenW >=1:16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}, {'value': '512', 'groupId': 'OG001'}, {'value': '219', 'groupId': 'OG002'}, {'value': '414', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '96.2', 'groupId': 'OG000', 'lowerLimit': '93.1', 'upperLimit': '98.2'}, {'value': '89.3', 'groupId': 'OG001', 'lowerLimit': '86.2', 'upperLimit': '91.8'}, {'value': '99.5', 'groupId': 'OG002', 'lowerLimit': '97.5', 'upperLimit': '100.0'}, {'value': '99.3', 'groupId': 'OG003', 'lowerLimit': '97.9', 'upperLimit': '99.9'}]}]}, {'title': 'MenW >=1:32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}, {'value': '512', 'groupId': 'OG001'}, {'value': '219', 'groupId': 'OG002'}, {'value': '414', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '82.2', 'groupId': 'OG000', 'lowerLimit': '77.0', 'upperLimit': '86.6'}, {'value': '75.0', 'groupId': 'OG001', 'lowerLimit': '71.0', 'upperLimit': '78.7'}, {'value': '99.5', 'groupId': 'OG002', 'lowerLimit': '97.5', 'upperLimit': '100.0'}, {'value': '98.1', 'groupId': 'OG003', 'lowerLimit': '96.2', 'upperLimit': '99.2'}]}]}, {'title': 'MenW >=1:64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}, {'value': '512', 'groupId': 'OG001'}, {'value': '219', 'groupId': 'OG002'}, {'value': '414', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '65.9', 'groupId': 'OG000', 'lowerLimit': '59.8', 'upperLimit': '71.6'}, {'value': '56.1', 'groupId': 'OG001', 'lowerLimit': '51.6', 'upperLimit': '60.4'}, {'value': '99.1', 'groupId': 'OG002', 'lowerLimit': '96.7', 'upperLimit': '99.9'}, {'value': '96.6', 'groupId': 'OG003', 'lowerLimit': '94.4', 'upperLimit': '98.1'}]}]}, {'title': 'MenW >=1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}, {'value': '512', 'groupId': 'OG001'}, {'value': '219', 'groupId': 'OG002'}, {'value': '414', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '43.9', 'groupId': 'OG000', 'lowerLimit': '37.9', 'upperLimit': '50.2'}, {'value': '38.1', 'groupId': 'OG001', 'lowerLimit': '33.9', 'upperLimit': '42.4'}, {'value': '98.6', 'groupId': 'OG002', 'lowerLimit': '96.0', 'upperLimit': '99.7'}, {'value': '94.0', 'groupId': 'OG003', 'lowerLimit': '91.2', 'upperLimit': '96.1'}]}]}, {'title': 'MenY >=1:4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'OG000'}, {'value': '510', 'groupId': 'OG001'}, {'value': '218', 'groupId': 'OG002'}, {'value': '413', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '98.6', 'upperLimit': '100.0'}, {'value': '99.2', 'groupId': 'OG001', 'lowerLimit': '98.0', 'upperLimit': '99.8'}, {'value': '99.5', 'groupId': 'OG002', 'lowerLimit': '97.5', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG003', 'lowerLimit': '99.1', 'upperLimit': '100.0'}]}]}, {'title': 'MenY >=1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'OG000'}, {'value': '510', 'groupId': 'OG001'}, {'value': '218', 'groupId': 'OG002'}, {'value': '413', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '99.6', 'groupId': 'OG000', 'lowerLimit': '97.9', 'upperLimit': '100.0'}, {'value': '96.9', 'groupId': 'OG001', 'lowerLimit': '95.0', 'upperLimit': '98.2'}, {'value': '99.5', 'groupId': 'OG002', 'lowerLimit': '97.5', 'upperLimit': '100.0'}, {'value': '99.8', 'groupId': 'OG003', 'lowerLimit': '98.7', 'upperLimit': '100.0'}]}]}, {'title': 'MenY >=1:16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'OG000'}, {'value': '510', 'groupId': 'OG001'}, {'value': '218', 'groupId': 'OG002'}, {'value': '413', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '98.9', 'groupId': 'OG000', 'lowerLimit': '96.7', 'upperLimit': '99.8'}, {'value': '92.9', 'groupId': 'OG001', 'lowerLimit': '90.4', 'upperLimit': '95.0'}, {'value': '99.5', 'groupId': 'OG002', 'lowerLimit': '97.5', 'upperLimit': '100.0'}, {'value': '99.3', 'groupId': 'OG003', 'lowerLimit': '97.9', 'upperLimit': '99.8'}]}]}, {'title': 'MenY >=1:32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'OG000'}, {'value': '510', 'groupId': 'OG001'}, {'value': '218', 'groupId': 'OG002'}, {'value': '413', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '92.4', 'groupId': 'OG000', 'lowerLimit': '88.5', 'upperLimit': '95.3'}, {'value': '82.4', 'groupId': 'OG001', 'lowerLimit': '78.8', 'upperLimit': '85.6'}, {'value': '99.1', 'groupId': 'OG002', 'lowerLimit': '96.7', 'upperLimit': '99.9'}, {'value': '99.0', 'groupId': 'OG003', 'lowerLimit': '97.5', 'upperLimit': '99.7'}]}]}, {'title': 'MenY >=1:64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'OG000'}, {'value': '510', 'groupId': 'OG001'}, {'value': '218', 'groupId': 'OG002'}, {'value': '413', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '78.3', 'groupId': 'OG000', 'lowerLimit': '72.9', 'upperLimit': '83.2'}, {'value': '66.9', 'groupId': 'OG001', 'lowerLimit': '62.6', 'upperLimit': '70.9'}, {'value': '99.1', 'groupId': 'OG002', 'lowerLimit': '96.7', 'upperLimit': '99.9'}, {'value': '97.1', 'groupId': 'OG003', 'lowerLimit': '95.0', 'upperLimit': '98.5'}]}]}, {'title': 'MenY >=1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'OG000'}, {'value': '510', 'groupId': 'OG001'}, {'value': '218', 'groupId': 'OG002'}, {'value': '413', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '62.0', 'groupId': 'OG000', 'lowerLimit': '55.8', 'upperLimit': '67.9'}, {'value': '48.6', 'groupId': 'OG001', 'lowerLimit': '44.2', 'upperLimit': '53.1'}, {'value': '98.6', 'groupId': 'OG002', 'lowerLimit': '96.0', 'upperLimit': '99.7'}, {'value': '94.9', 'groupId': 'OG003', 'lowerLimit': '92.3', 'upperLimit': '96.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month after Vaccination 1', 'description': 'Percentage of participants who achieved an hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY titer \\>=1:4, \\>=1:8, \\>=1:16, \\>=1:32, \\>=1:64, \\>=1:128 for ACWY test strains was reported in this outcome measure.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Stage 1 mITT population included all randomized participants who had received at least 1 study vaccination and who had at least 1 valid and determinate primary strain MenB or MenA/C/W/Y assay result available at any time point from 0 to 7 months. "Overall Number of Participants Analyzed": participants who were measured and analyzed for the outcome measure and \'Number Analyzed\' signifies number of participants with valid and determinate hSBA results for ACWY test strains at the given time point.'}, {'type': 'SECONDARY', 'title': 'Stage1: hSBA Geometric Mean Titers (GMTs) for ACWY Test Strains 1 Month After Vaccination 1: Groups 1, 2, 3 and 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}, {'value': '534', 'groupId': 'OG001'}, {'value': '271', 'groupId': 'OG002'}, {'value': '523', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenABCWY + Saline (ACWY-Naive)', 'description': 'Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}, {'id': 'OG001', 'title': 'Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive)', 'description': 'Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.'}, {'id': 'OG002', 'title': 'Group 3: MenABCWY + Saline (ACWY-Experienced)', 'description': 'Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}, {'id': 'OG003', 'title': 'Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced)', 'description': 'Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.'}], 'classes': [{'title': 'MenA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}, {'value': '510', 'groupId': 'OG001'}, {'value': '218', 'groupId': 'OG002'}, {'value': '411', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '215.8', 'groupId': 'OG000', 'lowerLimit': '184.6', 'upperLimit': '252.4'}, {'value': '203.2', 'groupId': 'OG001', 'lowerLimit': '178.7', 'upperLimit': '231.0'}, {'value': '568.6', 'groupId': 'OG002', 'lowerLimit': '492.9', 'upperLimit': '656.0'}, {'value': '916.1', 'groupId': 'OG003', 'lowerLimit': '809.1', 'upperLimit': '1037.3'}]}]}, {'title': 'MenC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '262', 'groupId': 'OG000'}, {'value': '509', 'groupId': 'OG001'}, {'value': '264', 'groupId': 'OG002'}, {'value': '506', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '111.5', 'groupId': 'OG000', 'lowerLimit': '87.2', 'upperLimit': '142.6'}, {'value': '81.4', 'groupId': 'OG001', 'lowerLimit': '68.1', 'upperLimit': '97.4'}, {'value': '814.9', 'groupId': 'OG002', 'lowerLimit': '689.4', 'upperLimit': '963.2'}, {'value': '827.0', 'groupId': 'OG003', 'lowerLimit': '722.5', 'upperLimit': '946.6'}]}]}, {'title': 'MenW', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}, {'value': '512', 'groupId': 'OG001'}, {'value': '219', 'groupId': 'OG002'}, {'value': '414', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '98.4', 'groupId': 'OG000', 'lowerLimit': '80.7', 'upperLimit': '120.0'}, {'value': '71.2', 'groupId': 'OG001', 'lowerLimit': '61.5', 'upperLimit': '82.4'}, {'value': '1214.9', 'groupId': 'OG002', 'lowerLimit': '1032.0', 'upperLimit': '1430.1'}, {'value': '1176.7', 'groupId': 'OG003', 'lowerLimit': '1017.9', 'upperLimit': '1360.2'}]}]}, {'title': 'MenY', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'OG000'}, {'value': '510', 'groupId': 'OG001'}, {'value': '218', 'groupId': 'OG002'}, {'value': '413', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '141.9', 'groupId': 'OG000', 'lowerLimit': '118.8', 'upperLimit': '169.4'}, {'value': '96.6', 'groupId': 'OG001', 'lowerLimit': '83.9', 'upperLimit': '111.2'}, {'value': '1174.0', 'groupId': 'OG002', 'lowerLimit': '990.3', 'upperLimit': '1391.9'}, {'value': '1000.2', 'groupId': 'OG003', 'lowerLimit': '872.1', 'upperLimit': '1147.1'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 month after Vaccination 1', 'description': 'GMTs were calculated using all participants with valid and determinate hSBA titers at the given time point. LLOQ = 1:8 for all MenA, MenC, MenW, and MenY. Titers below the LLOQ were set to 0.5\\*LLOQ for analysis.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Stage 1 mITT population included all randomized participants who had received at least 1 study vaccination and who had at least 1 valid and determinate primary strain MenB or MenA/C/W/Y assay result available at any time point from 0 to 7 months. "Overall Number of Participants Analyzed": participants who were measured and analyzed for the outcome measure and \'Number Analyzed\' signifies number of participants with valid and determinate hSBA results for ACWY test strains at the given time point.'}, {'type': 'SECONDARY', 'title': 'Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:8 (or LLOQ, Whichever is Higher) for ACWY Test Strains 1 Month After the Vaccination 1 in Groups 2 and 4, and 1 Month After Vaccination 2 in Groups 1 and 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '534', 'groupId': 'OG000'}, {'value': '523', 'groupId': 'OG001'}, {'value': '242', 'groupId': 'OG002'}, {'value': '244', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive)', 'description': 'Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.'}, {'id': 'OG001', 'title': 'Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced)', 'description': 'Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.'}, {'id': 'OG002', 'title': 'Group 1: MenABCWY + Saline (ACWY-Naive)', 'description': 'Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}, {'id': 'OG003', 'title': 'Group 3: MenABCWY + Saline (ACWY-Experienced)', 'description': 'Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}], 'classes': [{'title': 'MenA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '510', 'groupId': 'OG000'}, {'value': '411', 'groupId': 'OG001'}, {'value': '232', 'groupId': 'OG002'}, {'value': '191', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '98.4', 'groupId': 'OG000', 'lowerLimit': '96.9', 'upperLimit': '99.3'}, {'value': '99.3', 'groupId': 'OG001', 'lowerLimit': '97.9', 'upperLimit': '99.8'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '98.4', 'upperLimit': '100.0'}, {'value': '99.5', 'groupId': 'OG003', 'lowerLimit': '97.1', 'upperLimit': '100.0'}]}]}, {'title': 'MenC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '509', 'groupId': 'OG000'}, {'value': '506', 'groupId': 'OG001'}, {'value': '231', 'groupId': 'OG002'}, {'value': '237', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '88.6', 'groupId': 'OG000', 'lowerLimit': '85.5', 'upperLimit': '91.2'}, {'value': '99.4', 'groupId': 'OG001', 'lowerLimit': '98.3', 'upperLimit': '99.9'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '98.4', 'upperLimit': '100.0'}, {'value': '99.6', 'groupId': 'OG003', 'lowerLimit': '97.7', 'upperLimit': '100.0'}]}]}, {'title': 'MenW', 'denoms': [{'units': 'Participants', 'counts': [{'value': '512', 'groupId': 'OG000'}, {'value': '414', 'groupId': 'OG001'}, {'value': '233', 'groupId': 'OG002'}, {'value': '191', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '95.5', 'groupId': 'OG000', 'lowerLimit': '93.3', 'upperLimit': '97.1'}, {'value': '99.5', 'groupId': 'OG001', 'lowerLimit': '98.3', 'upperLimit': '99.9'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '98.4', 'upperLimit': '100.0'}, {'value': '99.5', 'groupId': 'OG003', 'lowerLimit': '97.1', 'upperLimit': '100.0'}]}]}, {'title': 'MenY', 'denoms': [{'units': 'Participants', 'counts': [{'value': '510', 'groupId': 'OG000'}, {'value': '413', 'groupId': 'OG001'}, {'value': '233', 'groupId': 'OG002'}, {'value': '191', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '96.9', 'groupId': 'OG000', 'lowerLimit': '95.0', 'upperLimit': '98.2'}, {'value': '99.8', 'groupId': 'OG001', 'lowerLimit': '98.7', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '98.4', 'upperLimit': '100.0'}, {'value': '99.5', 'groupId': 'OG003', 'lowerLimit': '97.1', 'upperLimit': '100.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'For Group 2 and 4: 1 month after Vaccination 1; For Group 1 and 3: 1 month after Vaccination 2', 'description': 'Percentage of participants who achieved an hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY titer \\>= LLOQ for ACWY test strains (LLOQ = 1:8 for all MenA, MenC, MenW, and MenY strains) was reported in this outcome measure.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Stage 1 mITT population included all randomized participants who had received at least 1 study vaccination and who had at least 1 valid and determinate primary strain MenB or MenA/C/W/Y assay result available at any time point from 0 to 7 months. "Overall Number of Participants Analyzed": participants who were measured and analyzed for the outcome measure and \'Number Analyzed\' signifies number of participants with valid and determinate hSBA results for ACWY test strains at the given time point.'}, {'type': 'SECONDARY', 'title': 'Stage1: Percentage of Participants With MenA, MenC, MenW, and MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and, >=1:128 for ACWY Test Strains 1 Month After Vaccination 1 in Groups 2 and 4, and 1 Month After Vaccination 2 in Groups 1 and 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '534', 'groupId': 'OG000'}, {'value': '523', 'groupId': 'OG001'}, {'value': '242', 'groupId': 'OG002'}, {'value': '244', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive)', 'description': 'Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.'}, {'id': 'OG001', 'title': 'Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced)', 'description': 'Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.'}, {'id': 'OG002', 'title': 'Group 1: MenABCWY + Saline (ACWY-Naive)', 'description': 'Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}, {'id': 'OG003', 'title': 'Group 3: MenABCWY + Saline (ACWY-Experienced)', 'description': 'Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}], 'classes': [{'title': 'MenA >=1:4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '510', 'groupId': 'OG000'}, {'value': '411', 'groupId': 'OG001'}, {'value': '232', 'groupId': 'OG002'}, {'value': '191', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '98.4', 'groupId': 'OG000', 'lowerLimit': '96.9', 'upperLimit': '99.3'}, {'value': '99.3', 'groupId': 'OG001', 'lowerLimit': '97.9', 'upperLimit': '99.8'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '98.4', 'upperLimit': '100.0'}, {'value': '99.5', 'groupId': 'OG003', 'lowerLimit': '97.1', 'upperLimit': '100.0'}]}]}, {'title': 'MenA >=1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '510', 'groupId': 'OG000'}, {'value': '411', 'groupId': 'OG001'}, {'value': '232', 'groupId': 'OG002'}, {'value': '191', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '98.4', 'groupId': 'OG000', 'lowerLimit': '96.9', 'upperLimit': '99.3'}, {'value': '99.3', 'groupId': 'OG001', 'lowerLimit': '97.9', 'upperLimit': '99.8'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '98.4', 'upperLimit': '100.0'}, {'value': '99.5', 'groupId': 'OG003', 'lowerLimit': '97.1', 'upperLimit': '100.0'}]}]}, {'title': 'MenA >=1:16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '510', 'groupId': 'OG000'}, {'value': '411', 'groupId': 'OG001'}, {'value': '232', 'groupId': 'OG002'}, {'value': '191', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '98.0', 'groupId': 'OG000', 'lowerLimit': '96.4', 'upperLimit': '99.1'}, {'value': '99.3', 'groupId': 'OG001', 'lowerLimit': '97.9', 'upperLimit': '99.8'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '98.4', 'upperLimit': '100.0'}, {'value': '99.5', 'groupId': 'OG003', 'lowerLimit': '97.1', 'upperLimit': '100.0'}]}]}, {'title': 'MenA >=1:32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '510', 'groupId': 'OG000'}, {'value': '411', 'groupId': 'OG001'}, {'value': '232', 'groupId': 'OG002'}, {'value': '191', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '93.9', 'groupId': 'OG000', 'lowerLimit': '91.5', 'upperLimit': '95.8'}, {'value': '99.0', 'groupId': 'OG001', 'lowerLimit': '97.5', 'upperLimit': '99.7'}, {'value': '97.8', 'groupId': 'OG002', 'lowerLimit': '95.0', 'upperLimit': '99.3'}, {'value': '99.5', 'groupId': 'OG003', 'lowerLimit': '97.1', 'upperLimit': '100.0'}]}]}, {'title': 'MenA >=1:64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '510', 'groupId': 'OG000'}, {'value': '411', 'groupId': 'OG001'}, {'value': '232', 'groupId': 'OG002'}, {'value': '191', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '86.3', 'groupId': 'OG000', 'lowerLimit': '83.0', 'upperLimit': '89.1'}, {'value': '98.3', 'groupId': 'OG001', 'lowerLimit': '96.5', 'upperLimit': '99.3'}, {'value': '92.2', 'groupId': 'OG002', 'lowerLimit': '88.0', 'upperLimit': '95.3'}, {'value': '97.4', 'groupId': 'OG003', 'lowerLimit': '94.0', 'upperLimit': '99.1'}]}]}, {'title': 'MenA >=1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '510', 'groupId': 'OG000'}, {'value': '411', 'groupId': 'OG001'}, {'value': '232', 'groupId': 'OG002'}, {'value': '191', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '71.2', 'groupId': 'OG000', 'lowerLimit': '67.0', 'upperLimit': '75.1'}, {'value': '96.4', 'groupId': 'OG001', 'lowerLimit': '94.1', 'upperLimit': '97.9'}, {'value': '69.4', 'groupId': 'OG002', 'lowerLimit': '63.0', 'upperLimit': '75.3'}, {'value': '92.7', 'groupId': 'OG003', 'lowerLimit': '88.0', 'upperLimit': '95.9'}]}]}, {'title': 'MenC >=1:4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '509', 'groupId': 'OG000'}, {'value': '506', 'groupId': 'OG001'}, {'value': '231', 'groupId': 'OG002'}, {'value': '237', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '93.3', 'groupId': 'OG000', 'lowerLimit': '90.8', 'upperLimit': '95.3'}, {'value': '99.4', 'groupId': 'OG001', 'lowerLimit': '98.3', 'upperLimit': '99.9'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '98.4', 'upperLimit': '100.0'}, {'value': '99.6', 'groupId': 'OG003', 'lowerLimit': '97.7', 'upperLimit': '100.0'}]}]}, {'title': 'MenC >=1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '509', 'groupId': 'OG000'}, {'value': '506', 'groupId': 'OG001'}, {'value': '231', 'groupId': 'OG002'}, {'value': '237', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '88.6', 'groupId': 'OG000', 'lowerLimit': '85.5', 'upperLimit': '91.2'}, {'value': '99.4', 'groupId': 'OG001', 'lowerLimit': '98.3', 'upperLimit': '99.9'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '98.4', 'upperLimit': '100.0'}, {'value': '99.6', 'groupId': 'OG003', 'lowerLimit': '97.7', 'upperLimit': '100.0'}]}]}, {'title': 'MenC >=1:16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '509', 'groupId': 'OG000'}, {'value': '506', 'groupId': 'OG001'}, {'value': '231', 'groupId': 'OG002'}, {'value': '237', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '80.9', 'groupId': 'OG000', 'lowerLimit': '77.3', 'upperLimit': '84.3'}, {'value': '99.2', 'groupId': 'OG001', 'lowerLimit': '98.0', 'upperLimit': '99.8'}, {'value': '99.6', 'groupId': 'OG002', 'lowerLimit': '97.6', 'upperLimit': '100.0'}, {'value': '99.6', 'groupId': 'OG003', 'lowerLimit': '97.7', 'upperLimit': '100.0'}]}]}, {'title': 'MenC >=1:32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '509', 'groupId': 'OG000'}, {'value': '506', 'groupId': 'OG001'}, {'value': '231', 'groupId': 'OG002'}, {'value': '237', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '67.8', 'groupId': 'OG000', 'lowerLimit': '63.5', 'upperLimit': '71.8'}, {'value': '98.2', 'groupId': 'OG001', 'lowerLimit': '96.7', 'upperLimit': '99.2'}, {'value': '97.4', 'groupId': 'OG002', 'lowerLimit': '94.4', 'upperLimit': '99.0'}, {'value': '99.6', 'groupId': 'OG003', 'lowerLimit': '97.7', 'upperLimit': '100.0'}]}]}, {'title': 'MenC >=1:64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '509', 'groupId': 'OG000'}, {'value': '506', 'groupId': 'OG001'}, {'value': '231', 'groupId': 'OG002'}, {'value': '237', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '55.0', 'groupId': 'OG000', 'lowerLimit': '50.6', 'upperLimit': '59.4'}, {'value': '97.2', 'groupId': 'OG001', 'lowerLimit': '95.4', 'upperLimit': '98.5'}, {'value': '90.9', 'groupId': 'OG002', 'lowerLimit': '86.4', 'upperLimit': '94.3'}, {'value': '98.3', 'groupId': 'OG003', 'lowerLimit': '95.7', 'upperLimit': '99.5'}]}]}, {'title': 'MenC >=1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '509', 'groupId': 'OG000'}, {'value': '506', 'groupId': 'OG001'}, {'value': '231', 'groupId': 'OG002'}, {'value': '237', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '45.6', 'groupId': 'OG000', 'lowerLimit': '41.2', 'upperLimit': '50.0'}, {'value': '94.1', 'groupId': 'OG001', 'lowerLimit': '91.6', 'upperLimit': '96.0'}, {'value': '78.8', 'groupId': 'OG002', 'lowerLimit': '72.9', 'upperLimit': '83.9'}, {'value': '92.8', 'groupId': 'OG003', 'lowerLimit': '88.8', 'upperLimit': '95.8'}]}]}, {'title': 'MenW >=1:4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '512', 'groupId': 'OG000'}, {'value': '414', 'groupId': 'OG001'}, {'value': '233', 'groupId': 'OG002'}, {'value': '191', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '97.7', 'groupId': 'OG000', 'lowerLimit': '95.9', 'upperLimit': '98.8'}, {'value': '99.5', 'groupId': 'OG001', 'lowerLimit': '98.3', 'upperLimit': '99.9'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '98.4', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG003', 'lowerLimit': '98.1', 'upperLimit': '100.0'}]}]}, {'title': 'MenW >=1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '512', 'groupId': 'OG000'}, {'value': '414', 'groupId': 'OG001'}, {'value': '233', 'groupId': 'OG002'}, {'value': '191', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '95.5', 'groupId': 'OG000', 'lowerLimit': '93.3', 'upperLimit': '97.1'}, {'value': '99.5', 'groupId': 'OG001', 'lowerLimit': '98.3', 'upperLimit': '99.9'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '98.4', 'upperLimit': '100.0'}, {'value': '99.5', 'groupId': 'OG003', 'lowerLimit': '97.1', 'upperLimit': '100.0'}]}]}, {'title': 'MenW >=1:16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '512', 'groupId': 'OG000'}, {'value': '414', 'groupId': 'OG001'}, {'value': '233', 'groupId': 'OG002'}, {'value': '191', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '89.3', 'groupId': 'OG000', 'lowerLimit': '86.2', 'upperLimit': '91.8'}, {'value': '99.3', 'groupId': 'OG001', 'lowerLimit': '97.9', 'upperLimit': '99.9'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '98.4', 'upperLimit': '100.0'}, {'value': '99.5', 'groupId': 'OG003', 'lowerLimit': '97.1', 'upperLimit': '100.0'}]}]}, {'title': 'MenW >=1:32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '512', 'groupId': 'OG000'}, {'value': '414', 'groupId': 'OG001'}, {'value': '233', 'groupId': 'OG002'}, {'value': '191', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '75.0', 'groupId': 'OG000', 'lowerLimit': '71.0', 'upperLimit': '78.7'}, {'value': '98.1', 'groupId': 'OG001', 'lowerLimit': '96.2', 'upperLimit': '99.2'}, {'value': '99.6', 'groupId': 'OG002', 'lowerLimit': '97.6', 'upperLimit': '100.0'}, {'value': '99.5', 'groupId': 'OG003', 'lowerLimit': '97.1', 'upperLimit': '100.0'}]}]}, {'title': 'MenW >=1:64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '512', 'groupId': 'OG000'}, {'value': '414', 'groupId': 'OG001'}, {'value': '233', 'groupId': 'OG002'}, {'value': '191', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '56.1', 'groupId': 'OG000', 'lowerLimit': '51.6', 'upperLimit': '60.4'}, {'value': '96.6', 'groupId': 'OG001', 'lowerLimit': '94.4', 'upperLimit': '98.1'}, {'value': '97.0', 'groupId': 'OG002', 'lowerLimit': '93.9', 'upperLimit': '98.8'}, {'value': '99.0', 'groupId': 'OG003', 'lowerLimit': '96.3', 'upperLimit': '99.9'}]}]}, {'title': 'MenW >=1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '512', 'groupId': 'OG000'}, {'value': '414', 'groupId': 'OG001'}, {'value': '233', 'groupId': 'OG002'}, {'value': '191', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '38.1', 'groupId': 'OG000', 'lowerLimit': '33.9', 'upperLimit': '42.4'}, {'value': '94.0', 'groupId': 'OG001', 'lowerLimit': '91.2', 'upperLimit': '96.1'}, {'value': '89.7', 'groupId': 'OG002', 'lowerLimit': '85.1', 'upperLimit': '93.3'}, {'value': '97.9', 'groupId': 'OG003', 'lowerLimit': '94.7', 'upperLimit': '99.4'}]}]}, {'title': 'MenY >=1:4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '510', 'groupId': 'OG000'}, {'value': '413', 'groupId': 'OG001'}, {'value': '233', 'groupId': 'OG002'}, {'value': '191', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '99.2', 'groupId': 'OG000', 'lowerLimit': '98.0', 'upperLimit': '99.8'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '99.1', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '98.4', 'upperLimit': '100.0'}, {'value': '99.5', 'groupId': 'OG003', 'lowerLimit': '97.1', 'upperLimit': '100.0'}]}]}, {'title': 'MenY >=1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '510', 'groupId': 'OG000'}, {'value': '413', 'groupId': 'OG001'}, {'value': '233', 'groupId': 'OG002'}, {'value': '191', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '96.9', 'groupId': 'OG000', 'lowerLimit': '95.0', 'upperLimit': '98.2'}, {'value': '99.8', 'groupId': 'OG001', 'lowerLimit': '98.7', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '98.4', 'upperLimit': '100.0'}, {'value': '99.5', 'groupId': 'OG003', 'lowerLimit': '97.1', 'upperLimit': '100.0'}]}]}, {'title': 'MenY >=1:16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '510', 'groupId': 'OG000'}, {'value': '413', 'groupId': 'OG001'}, {'value': '233', 'groupId': 'OG002'}, {'value': '191', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '92.9', 'groupId': 'OG000', 'lowerLimit': '90.4', 'upperLimit': '95.0'}, {'value': '99.3', 'groupId': 'OG001', 'lowerLimit': '97.9', 'upperLimit': '99.8'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '98.4', 'upperLimit': '100.0'}, {'value': '99.5', 'groupId': 'OG003', 'lowerLimit': '97.1', 'upperLimit': '100.0'}]}]}, {'title': 'MenY >=1:32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '510', 'groupId': 'OG000'}, {'value': '413', 'groupId': 'OG001'}, {'value': '233', 'groupId': 'OG002'}, {'value': '191', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '82.4', 'groupId': 'OG000', 'lowerLimit': '78.8', 'upperLimit': '85.6'}, {'value': '99.0', 'groupId': 'OG001', 'lowerLimit': '97.5', 'upperLimit': '99.7'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '98.4', 'upperLimit': '100.0'}, {'value': '99.5', 'groupId': 'OG003', 'lowerLimit': '97.1', 'upperLimit': '100.0'}]}]}, {'title': 'MenY >=1:64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '510', 'groupId': 'OG000'}, {'value': '413', 'groupId': 'OG001'}, {'value': '233', 'groupId': 'OG002'}, {'value': '191', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '66.9', 'groupId': 'OG000', 'lowerLimit': '62.6', 'upperLimit': '70.9'}, {'value': '97.1', 'groupId': 'OG001', 'lowerLimit': '95.0', 'upperLimit': '98.5'}, {'value': '97.4', 'groupId': 'OG002', 'lowerLimit': '94.5', 'upperLimit': '99.0'}, {'value': '99.5', 'groupId': 'OG003', 'lowerLimit': '97.1', 'upperLimit': '100.0'}]}]}, {'title': 'MenY >=1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '510', 'groupId': 'OG000'}, {'value': '413', 'groupId': 'OG001'}, {'value': '233', 'groupId': 'OG002'}, {'value': '191', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '48.6', 'groupId': 'OG000', 'lowerLimit': '44.2', 'upperLimit': '53.1'}, {'value': '94.9', 'groupId': 'OG001', 'lowerLimit': '92.3', 'upperLimit': '96.8'}, {'value': '89.7', 'groupId': 'OG002', 'lowerLimit': '85.1', 'upperLimit': '93.3'}, {'value': '95.3', 'groupId': 'OG003', 'lowerLimit': '91.2', 'upperLimit': '97.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'For Group 2 and 4: 1 month after Vaccination 1; For Group 1 and 3: 1 month after Vaccination 2', 'description': 'Percentage of participants who achieved an hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY titer \\>=1:4, \\>=1:8, \\>=1:16, \\>=1:32, \\>=1:64, \\>=1:128 for ACWY test strains was reported in this outcome measure.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Stage 1 mITT population included all randomized participants who had received at least 1 study vaccination and who had at least 1 valid and determinate primary strain MenB or MenA/C/W/Y assay result available at any time point from 0 to 7 months. "Overall Number of Participants Analyzed": participants who were measured and analyzed for the outcome measure and \'Number Analyzed\' signifies number of participants with valid and determinate hSBA results for ACWY test strains at the given time point.'}, {'type': 'SECONDARY', 'title': 'Stage1: hSBA GMTs for ACWY Test Strains 1 Month After Vaccination 1 in Groups 2 and 4 and 1 Month After Vaccination 2 in Groups 1 and 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '534', 'groupId': 'OG000'}, {'value': '523', 'groupId': 'OG001'}, {'value': '242', 'groupId': 'OG002'}, {'value': '244', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive)', 'description': 'Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.'}, {'id': 'OG001', 'title': 'Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced)', 'description': 'Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.'}, {'id': 'OG002', 'title': 'Group 1: MenABCWY + Saline (ACWY-Naive)', 'description': 'Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}, {'id': 'OG003', 'title': 'Group 3: MenABCWY + Saline (ACWY-Experienced)', 'description': 'Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}], 'classes': [{'title': 'MenA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '510', 'groupId': 'OG000'}, {'value': '411', 'groupId': 'OG001'}, {'value': '232', 'groupId': 'OG002'}, {'value': '191', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '203.2', 'groupId': 'OG000', 'lowerLimit': '178.7', 'upperLimit': '231.0'}, {'value': '916.1', 'groupId': 'OG001', 'lowerLimit': '809.1', 'upperLimit': '1037.3'}, {'value': '151.3', 'groupId': 'OG002', 'lowerLimit': '134.1', 'upperLimit': '170.7'}, {'value': '337.3', 'groupId': 'OG003', 'lowerLimit': '291.7', 'upperLimit': '390.0'}]}]}, {'title': 'MenC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '509', 'groupId': 'OG000'}, {'value': '506', 'groupId': 'OG001'}, {'value': '231', 'groupId': 'OG002'}, {'value': '237', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '81.4', 'groupId': 'OG000', 'lowerLimit': '68.1', 'upperLimit': '97.4'}, {'value': '827.0', 'groupId': 'OG001', 'lowerLimit': '722.5', 'upperLimit': '946.6'}, {'value': '229.1', 'groupId': 'OG002', 'lowerLimit': '194.7', 'upperLimit': '269.5'}, {'value': '498.7', 'groupId': 'OG003', 'lowerLimit': '429.1', 'upperLimit': '579.6'}]}]}, {'title': 'MenW', 'denoms': [{'units': 'Participants', 'counts': [{'value': '512', 'groupId': 'OG000'}, {'value': '414', 'groupId': 'OG001'}, {'value': '233', 'groupId': 'OG002'}, {'value': '191', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '71.2', 'groupId': 'OG000', 'lowerLimit': '61.5', 'upperLimit': '82.4'}, {'value': '1176.7', 'groupId': 'OG001', 'lowerLimit': '1017.9', 'upperLimit': '1360.2'}, {'value': '274.1', 'groupId': 'OG002', 'lowerLimit': '242.7', 'upperLimit': '309.7'}, {'value': '570.9', 'groupId': 'OG003', 'lowerLimit': '484.3', 'upperLimit': '673.0'}]}]}, {'title': 'MenY', 'denoms': [{'units': 'Participants', 'counts': [{'value': '510', 'groupId': 'OG000'}, {'value': '413', 'groupId': 'OG001'}, {'value': '233', 'groupId': 'OG002'}, {'value': '191', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '96.6', 'groupId': 'OG000', 'lowerLimit': '83.9', 'upperLimit': '111.2'}, {'value': '1000.2', 'groupId': 'OG001', 'lowerLimit': '872.1', 'upperLimit': '1147.1'}, {'value': '301.5', 'groupId': 'OG002', 'lowerLimit': '266.6', 'upperLimit': '341.0'}, {'value': '558.6', 'groupId': 'OG003', 'lowerLimit': '470.0', 'upperLimit': '663.9'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'For Group 2 and 4: 1 month after Vaccination 1; For Group 1 and 3: 1 month after Vaccination 2', 'description': 'GMTs were calculated using all participants with valid and determinate hSBA titers at the given time point. LLOQ = 1:8 for all MenA, MenC, MenW, and MenY. Titers below the LLOQ were set to 0.5\\*LLOQ for analysis.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Stage 1 mITT population included all randomized participants who had received at least 1 study vaccination and who had at least 1 valid and determinate primary strain MenB or MenA/C/W/Y assay result available at any time point from 0 to 7 months. "Overall Number of Participants Analyzed": participants who were measured and analyzed for the outcome measure and \'Number Analyzed\' signifies number of participants with valid and determinate hSBA results for ACWY test strains at the given time point.'}, {'type': 'SECONDARY', 'title': 'Stage1: Percentage of Participants With hSBA Titer Level >= LLOQ for 4 Primary MenB Test Strains 1 Month After Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '438', 'groupId': 'OG000'}, {'value': '864', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1+3 Combined (MenABCWY + Saline)', 'description': 'Stage 1: ACWY-naive and experienced participants who received an intramuscular injection of 0.5 mL of MenABCWY vaccine and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54'}, {'id': 'OG001', 'title': 'Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM)', 'description': 'Stage 1: ACWY-naive and experienced participants who received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.'}], 'classes': [{'title': 'PMB80 (A22) 1 month after Vacc 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '433', 'groupId': 'OG000'}, {'value': '852', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '91.0', 'groupId': 'OG000', 'lowerLimit': '87.9', 'upperLimit': '93.5'}, {'value': '91.0', 'groupId': 'OG001', 'lowerLimit': '88.8', 'upperLimit': '92.8'}]}]}, {'title': 'PMB2001 (A56) 1 month after Vacc 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '435', 'groupId': 'OG000'}, {'value': '854', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '98.6', 'groupId': 'OG000', 'lowerLimit': '97.0', 'upperLimit': '99.5'}, {'value': '99.4', 'groupId': 'OG001', 'lowerLimit': '98.6', 'upperLimit': '99.8'}]}]}, {'title': 'PMB2948 (B24) 1 month after Vacc 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '426', 'groupId': 'OG000'}, {'value': '842', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '84.3', 'groupId': 'OG000', 'lowerLimit': '80.5', 'upperLimit': '87.6'}, {'value': '79.3', 'groupId': 'OG001', 'lowerLimit': '76.4', 'upperLimit': '82.0'}]}]}, {'title': 'PMB2707 (B44) 1 month after Vacc 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '436', 'groupId': 'OG000'}, {'value': '853', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '95.4', 'groupId': 'OG000', 'lowerLimit': '93.0', 'upperLimit': '97.2'}, {'value': '94.5', 'groupId': 'OG001', 'lowerLimit': '92.7', 'upperLimit': '95.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month after Vaccination 2 (Vacc 2)', 'description': 'Percentage of participants who achieved an hSBA titer \\>=LLOQ for all 4 primary MenB test strains (LLOQ was 1:16 for A22 and 1:8 for A56, B24, and B44) was reported in this outcome measure.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Stage 1 EIP analyzed. Here, "Overall Number of Participants Analyzed" signifies number of participants measured and analyzed for this outcome measure. "Number Analyzed" signifies number of participants with valid and determinate hSBA results for each strains at given time point. Analysis was planned for combined Group 1 and 3 and combined Group 2 and 4.'}, {'type': 'SECONDARY', 'title': 'Stage1: Percentage of Participants With >=4 Fold Rise in hSBA for 4 Primary MenB Strains and Composite Response (hSBA >=LLOQ for All 4 Primary MenB Strains Combined) From Baseline-1 Month After Vaccination 2 (Group 1 and 3 Combined;Group 2 and 4 Combined)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '438', 'groupId': 'OG000'}, {'value': '864', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1+3 Combined (MenABCWY + Saline)', 'description': 'Stage 1: ACWY-naive and experienced participants who received an intramuscular injection of 0.5 mL of MenABCWY vaccine and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54'}, {'id': 'OG001', 'title': 'Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM)', 'description': 'Stage 1: ACWY-naive and experienced participants who received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.'}], 'classes': [{'title': 'PMB80 (A22)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '422', 'groupId': 'OG000'}, {'value': '827', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '75.8', 'groupId': 'OG000', 'lowerLimit': '71.5', 'upperLimit': '79.8'}, {'value': '73.8', 'groupId': 'OG001', 'lowerLimit': '70.6', 'upperLimit': '76.7'}]}]}, {'title': 'PMB2001 (A56)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '418', 'groupId': 'OG000'}, {'value': '823', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '94.7', 'groupId': 'OG000', 'lowerLimit': '92.1', 'upperLimit': '96.7'}, {'value': '95.0', 'groupId': 'OG001', 'lowerLimit': '93.3', 'upperLimit': '96.4'}]}]}, {'title': 'PMB2948 (B24)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '422', 'groupId': 'OG000'}, {'value': '835', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '76.1', 'groupId': 'OG000', 'lowerLimit': '71.7', 'upperLimit': '80.1'}, {'value': '67.4', 'groupId': 'OG001', 'lowerLimit': '64.1', 'upperLimit': '70.6'}]}]}, {'title': 'PMB2707 (B44)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '432', 'groupId': 'OG000'}, {'value': '850', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '91.7', 'groupId': 'OG000', 'lowerLimit': '88.6', 'upperLimit': '94.1'}, {'value': '86.4', 'groupId': 'OG001', 'lowerLimit': '83.9', 'upperLimit': '88.6'}]}]}, {'title': 'Composite hSBA response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '418', 'groupId': 'OG000'}, {'value': '814', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '79.9', 'groupId': 'OG000', 'lowerLimit': '75.7', 'upperLimit': '83.6'}, {'value': '74.3', 'groupId': 'OG001', 'lowerLimit': '71.2', 'upperLimit': '77.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 1 month after Vaccination 2', 'description': 'Percentage of participants who achieved an hSBA titer greater than or equal to LLOQ for all 4 primary MenB test strains combined (LLOQ was 1:16 for A22 and 1:8 for A56, B24, and B44) was reported in this outcome measure.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Stage 1 EIP analyzed. Here, "Overall Number of Participants Analyzed" signifies number of participants measure and analyzed for this outcome measure. "Number Analyzed" signifies number of participants with valid and determinate hSBA results on all 4 strains at given time point. Analysis was planned for combined Group 1 and 3 and combined Group 2 and 4.'}, {'type': 'SECONDARY', 'title': 'Stage1: Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for Each of the 4 Primary MenB Test Strains From 1 Month After Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '438', 'groupId': 'OG000'}, {'value': '864', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1+3 Combined (MenABCWY + Saline)', 'description': 'Stage 1: ACWY-naive and experienced participants who received an intramuscular injection of 0.5 mL of MenABCWY vaccine and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54'}, {'id': 'OG001', 'title': 'Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM)', 'description': 'Stage 1: ACWY-naive and experienced participants who received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.'}], 'classes': [{'title': 'PMB80 (A22) >=1:4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '433', 'groupId': 'OG000'}, {'value': '852', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '91.9', 'groupId': 'OG000', 'lowerLimit': '88.9', 'upperLimit': '94.3'}, {'value': '91.7', 'groupId': 'OG001', 'lowerLimit': '89.6', 'upperLimit': '93.4'}]}]}, {'title': 'PMB80 (A22) >=1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '433', 'groupId': 'OG000'}, {'value': '852', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '91.7', 'groupId': 'OG000', 'lowerLimit': '88.7', 'upperLimit': '94.1'}, {'value': '91.5', 'groupId': 'OG001', 'lowerLimit': '89.5', 'upperLimit': '93.3'}]}]}, {'title': 'PMB80 (A22) >=1:16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '433', 'groupId': 'OG000'}, {'value': '852', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '91.0', 'groupId': 'OG000', 'lowerLimit': '87.9', 'upperLimit': '93.5'}, {'value': '91.0', 'groupId': 'OG001', 'lowerLimit': '88.8', 'upperLimit': '92.8'}]}]}, {'title': 'PMB80 (A22) >=1:32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '433', 'groupId': 'OG000'}, {'value': '852', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '82.4', 'groupId': 'OG000', 'lowerLimit': '78.5', 'upperLimit': '85.9'}, {'value': '80.2', 'groupId': 'OG001', 'lowerLimit': '77.3', 'upperLimit': '82.8'}]}]}, {'title': 'PMB80 (A22) >=1:64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '433', 'groupId': 'OG000'}, {'value': '852', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '58.0', 'groupId': 'OG000', 'lowerLimit': '53.2', 'upperLimit': '62.7'}, {'value': '54.9', 'groupId': 'OG001', 'lowerLimit': '51.5', 'upperLimit': '58.3'}]}]}, {'title': 'PMB80 (A22) >=1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '433', 'groupId': 'OG000'}, {'value': '852', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27.9', 'groupId': 'OG000', 'lowerLimit': '23.8', 'upperLimit': '32.4'}, {'value': '27.3', 'groupId': 'OG001', 'lowerLimit': '24.4', 'upperLimit': '30.5'}]}]}, {'title': 'PMB2001 (A56) >=1:4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '435', 'groupId': 'OG000'}, {'value': '854', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '98.9', 'groupId': 'OG000', 'lowerLimit': '97.3', 'upperLimit': '99.6'}, {'value': '99.5', 'groupId': 'OG001', 'lowerLimit': '98.8', 'upperLimit': '99.9'}]}]}, {'title': 'PMB2001 (A56) >=1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '435', 'groupId': 'OG000'}, {'value': '854', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '98.6', 'groupId': 'OG000', 'lowerLimit': '97.0', 'upperLimit': '99.5'}, {'value': '99.4', 'groupId': 'OG001', 'lowerLimit': '98.6', 'upperLimit': '99.8'}]}]}, {'title': 'PMB2001 (A56) >=1:16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '435', 'groupId': 'OG000'}, {'value': '854', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '98.6', 'groupId': 'OG000', 'lowerLimit': '97.0', 'upperLimit': '99.5'}, {'value': '99.1', 'groupId': 'OG001', 'lowerLimit': '98.2', 'upperLimit': '99.6'}]}]}, {'title': 'PMB2001 (A56) >=1:32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '435', 'groupId': 'OG000'}, {'value': '854', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '96.8', 'groupId': 'OG000', 'lowerLimit': '94.7', 'upperLimit': '98.2'}, {'value': '97.0', 'groupId': 'OG001', 'lowerLimit': '95.6', 'upperLimit': '98.0'}]}]}, {'title': 'PMB2001 (A56) >=1:64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '435', 'groupId': 'OG000'}, {'value': '854', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '90.1', 'groupId': 'OG000', 'lowerLimit': '86.9', 'upperLimit': '92.8'}, {'value': '87.7', 'groupId': 'OG001', 'lowerLimit': '85.3', 'upperLimit': '89.8'}]}]}, {'title': 'PMB2001 (A56) >=1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '435', 'groupId': 'OG000'}, {'value': '854', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '74.0', 'groupId': 'OG000', 'lowerLimit': '69.6', 'upperLimit': '78.1'}, {'value': '69.2', 'groupId': 'OG001', 'lowerLimit': '66.0', 'upperLimit': '72.3'}]}]}, {'title': 'PMB2948 (B24) >=1:4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '426', 'groupId': 'OG000'}, {'value': '842', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '86.9', 'groupId': 'OG000', 'lowerLimit': '83.3', 'upperLimit': '89.9'}, {'value': '81.2', 'groupId': 'OG001', 'lowerLimit': '78.4', 'upperLimit': '83.8'}]}]}, {'title': 'PMB2948 (B24) >=1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '426', 'groupId': 'OG000'}, {'value': '842', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '84.3', 'groupId': 'OG000', 'lowerLimit': '80.5', 'upperLimit': '87.6'}, {'value': '79.3', 'groupId': 'OG001', 'lowerLimit': '76.4', 'upperLimit': '82.0'}]}]}, {'title': 'PMB2948 (B24) >=1:16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '426', 'groupId': 'OG000'}, {'value': '842', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '80.8', 'groupId': 'OG000', 'lowerLimit': '76.7', 'upperLimit': '84.4'}, {'value': '74.0', 'groupId': 'OG001', 'lowerLimit': '70.9', 'upperLimit': '76.9'}]}]}, {'title': 'PMB2948 (B24) >=1:32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '426', 'groupId': 'OG000'}, {'value': '842', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '58.5', 'groupId': 'OG000', 'lowerLimit': '53.6', 'upperLimit': '63.2'}, {'value': '47.9', 'groupId': 'OG001', 'lowerLimit': '44.4', 'upperLimit': '51.3'}]}]}, {'title': 'PMB2948 (B24) >=1:64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '426', 'groupId': 'OG000'}, {'value': '842', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '31.0', 'groupId': 'OG000', 'lowerLimit': '26.6', 'upperLimit': '35.6'}, {'value': '24.9', 'groupId': 'OG001', 'lowerLimit': '22.1', 'upperLimit': '28.0'}]}]}, {'title': 'PMB2948 (B24) >=1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '426', 'groupId': 'OG000'}, {'value': '842', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.4', 'groupId': 'OG000', 'lowerLimit': '10.3', 'upperLimit': '17.0'}, {'value': '9.6', 'groupId': 'OG001', 'lowerLimit': '7.7', 'upperLimit': '11.8'}]}]}, {'title': 'PMB2707 (B44) >=1:4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '436', 'groupId': 'OG000'}, {'value': '853', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '97.2', 'groupId': 'OG000', 'lowerLimit': '95.2', 'upperLimit': '98.6'}, {'value': '96.2', 'groupId': 'OG001', 'lowerLimit': '94.7', 'upperLimit': '97.4'}]}]}, {'title': 'PMB2707 (B44) >=1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '436', 'groupId': 'OG000'}, {'value': '853', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '95.4', 'groupId': 'OG000', 'lowerLimit': '93.0', 'upperLimit': '97.2'}, {'value': '94.5', 'groupId': 'OG001', 'lowerLimit': '92.7', 'upperLimit': '95.9'}]}]}, {'title': 'PMB2707 (B44) >=1:16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '436', 'groupId': 'OG000'}, {'value': '853', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '92.4', 'groupId': 'OG000', 'lowerLimit': '89.5', 'upperLimit': '94.7'}, {'value': '89.0', 'groupId': 'OG001', 'lowerLimit': '86.7', 'upperLimit': '91.0'}]}]}, {'title': 'PMB2707 (B44) >=1:32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '436', 'groupId': 'OG000'}, {'value': '853', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '72.9', 'groupId': 'OG000', 'lowerLimit': '68.5', 'upperLimit': '77.1'}, {'value': '68.6', 'groupId': 'OG001', 'lowerLimit': '65.3', 'upperLimit': '71.7'}]}]}, {'title': 'PMB2707 (B44) >=1:64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '436', 'groupId': 'OG000'}, {'value': '853', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '48.9', 'groupId': 'OG000', 'lowerLimit': '44.1', 'upperLimit': '53.7'}, {'value': '41.0', 'groupId': 'OG001', 'lowerLimit': '37.7', 'upperLimit': '44.4'}]}]}, {'title': 'PMB2707 (B44) >=1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '436', 'groupId': 'OG000'}, {'value': '853', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.0', 'groupId': 'OG000', 'lowerLimit': '18.2', 'upperLimit': '26.2'}, {'value': '19.2', 'groupId': 'OG001', 'lowerLimit': '16.6', 'upperLimit': '22.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month after Vaccination 2', 'description': 'Percentage of participants who achieved an hSBA titer \\>=1:4, \\>=1:8, \\>=1:16, \\>=1:32, \\>=1:64, and \\>=1:128 for all 4 primary MenB test strains was reported in this outcome measure.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Stage 1 EIP analyzed. Here, "Overall Number of Participants Analyzed" signifies number of participants measure and analyzed for this outcome measure. "Number Analyzed" signifies number of participants with valid and determinate hSBA results on all 4 strains at given time point. Analysis was planned for combined Group 1 and 3 and combined Group 2 and 4.'}, {'type': 'SECONDARY', 'title': 'Stage1: hSBA GMTs for Each of the 4 Primary MenB Test Strains 1 Month After Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '438', 'groupId': 'OG000'}, {'value': '864', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1+3 Combined (MenABCWY + Saline)', 'description': 'Stage 1: ACWY-naive and experienced participants who received an intramuscular injection of 0.5 mL of MenABCWY vaccine and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54'}, {'id': 'OG001', 'title': 'Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM)', 'description': 'Stage 1: ACWY-naive and experienced participants who received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.'}], 'classes': [{'title': 'PMB80 (A22)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '433', 'groupId': 'OG000'}, {'value': '852', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '51.0', 'groupId': 'OG000', 'lowerLimit': '46.7', 'upperLimit': '55.7'}, {'value': '49.3', 'groupId': 'OG001', 'lowerLimit': '46.2', 'upperLimit': '52.6'}]}]}, {'title': 'PMB2001 (A56)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '435', 'groupId': 'OG000'}, {'value': '854', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '152.3', 'groupId': 'OG000', 'lowerLimit': '138.5', 'upperLimit': '167.5'}, {'value': '139.5', 'groupId': 'OG001', 'lowerLimit': '130.6', 'upperLimit': '149.1'}]}]}, {'title': 'PMB2948 (B24)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '426', 'groupId': 'OG000'}, {'value': '842', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26.6', 'groupId': 'OG000', 'lowerLimit': '23.9', 'upperLimit': '29.7'}, {'value': '21.2', 'groupId': 'OG001', 'lowerLimit': '19.6', 'upperLimit': '22.9'}]}]}, {'title': 'PMB2707 (B44)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '436', 'groupId': 'OG000'}, {'value': '853', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '43.3', 'groupId': 'OG000', 'lowerLimit': '39.1', 'upperLimit': '47.9'}, {'value': '37.8', 'groupId': 'OG001', 'lowerLimit': '35.1', 'upperLimit': '40.8'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 month after Vaccination 2', 'description': 'GMTs were calculated using all participants with valid and determinate hSBA titers at the given time point. LLOQ =1:16 for A22; 1:8 for A56, B24, and B44. Titers below the LLOQ were set to 0.5\\*LLOQ for analysis.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Stage 1 EIP analyzed. Here, "Overall Number of Participants Analyzed" signifies number of participants measure and analyzed for this outcome measure. "Number Analyzed" signifies number of participants with valid and determinate hSBA results on all 4 strains at given time point. Analysis was planned for combined Group 1 and 3 and combined Group 2 and 4.'}, {'type': 'SECONDARY', 'title': 'Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW and hSBA-MenY Titers >=1:8 (or LLOQ) for ACWY Test Strains Before Vaccination 1 and Before Vaccination 2: Groups 1, 2, 3 and 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}, {'value': '534', 'groupId': 'OG001'}, {'value': '271', 'groupId': 'OG002'}, {'value': '523', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenABCWY + Saline (ACWY-Naive)', 'description': 'Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}, {'id': 'OG001', 'title': 'Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive)', 'description': 'Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.'}, {'id': 'OG002', 'title': 'Group 3: MenABCWY + Saline (ACWY-Experienced)', 'description': 'Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}, {'id': 'OG003', 'title': 'Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced)', 'description': 'Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.'}], 'classes': [{'title': 'MenA Before Vacc 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'OG000'}, {'value': '528', 'groupId': 'OG001'}, {'value': '219', 'groupId': 'OG002'}, {'value': '418', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '15.9', 'groupId': 'OG000', 'lowerLimit': '11.8', 'upperLimit': '20.8'}, {'value': '22.9', 'groupId': 'OG001', 'lowerLimit': '19.4', 'upperLimit': '26.7'}, {'value': '53.9', 'groupId': 'OG002', 'lowerLimit': '47.0', 'upperLimit': '60.6'}, {'value': '52.6', 'groupId': 'OG003', 'lowerLimit': '47.7', 'upperLimit': '57.5'}]}]}, {'title': 'MenA Before Vacc 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '238', 'groupId': 'OG000'}, {'value': '463', 'groupId': 'OG001'}, {'value': '200', 'groupId': 'OG002'}, {'value': '385', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '91.6', 'groupId': 'OG000', 'lowerLimit': '87.3', 'upperLimit': '94.8'}, {'value': '86.2', 'groupId': 'OG001', 'lowerLimit': '82.7', 'upperLimit': '89.2'}, {'value': '99.0', 'groupId': 'OG002', 'lowerLimit': '96.4', 'upperLimit': '99.9'}, {'value': '98.4', 'groupId': 'OG003', 'lowerLimit': '96.6', 'upperLimit': '99.4'}]}]}, {'title': 'MenC Before Vacc 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '267', 'groupId': 'OG000'}, {'value': '526', 'groupId': 'OG001'}, {'value': '264', 'groupId': 'OG002'}, {'value': '511', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '38.6', 'groupId': 'OG000', 'lowerLimit': '32.7', 'upperLimit': '44.7'}, {'value': '39.0', 'groupId': 'OG001', 'lowerLimit': '34.8', 'upperLimit': '43.3'}, {'value': '59.5', 'groupId': 'OG002', 'lowerLimit': '53.3', 'upperLimit': '65.4'}, {'value': '61.1', 'groupId': 'OG003', 'lowerLimit': '56.7', 'upperLimit': '65.3'}]}]}, {'title': 'MenC Before Vacc 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '460', 'groupId': 'OG001'}, {'value': '243', 'groupId': 'OG002'}, {'value': '474', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '92.9', 'groupId': 'OG000', 'lowerLimit': '88.9', 'upperLimit': '95.8'}, {'value': '76.5', 'groupId': 'OG001', 'lowerLimit': '72.4', 'upperLimit': '80.3'}, {'value': '98.4', 'groupId': 'OG002', 'lowerLimit': '95.8', 'upperLimit': '99.5'}, {'value': '98.3', 'groupId': 'OG003', 'lowerLimit': '96.7', 'upperLimit': '99.3'}]}]}, {'title': 'MenW Before Vacc 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '268', 'groupId': 'OG000'}, {'value': '527', 'groupId': 'OG001'}, {'value': '218', 'groupId': 'OG002'}, {'value': '418', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '32.1', 'groupId': 'OG000', 'lowerLimit': '26.5', 'upperLimit': '38.0'}, {'value': '34.5', 'groupId': 'OG001', 'lowerLimit': '30.5', 'upperLimit': '38.8'}, {'value': '61.9', 'groupId': 'OG002', 'lowerLimit': '55.1', 'upperLimit': '68.4'}, {'value': '60.8', 'groupId': 'OG003', 'lowerLimit': '55.9', 'upperLimit': '65.5'}]}]}, {'title': 'MenW Before Vacc 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '242', 'groupId': 'OG000'}, {'value': '467', 'groupId': 'OG001'}, {'value': '199', 'groupId': 'OG002'}, {'value': '385', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '99.2', 'groupId': 'OG000', 'lowerLimit': '97.0', 'upperLimit': '99.9'}, {'value': '91.0', 'groupId': 'OG001', 'lowerLimit': '88.0', 'upperLimit': '93.4'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '98.2', 'upperLimit': '100.0'}, {'value': '99.0', 'groupId': 'OG003', 'lowerLimit': '97.4', 'upperLimit': '99.7'}]}]}, {'title': 'MenY Before Vacc 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '265', 'groupId': 'OG000'}, {'value': '528', 'groupId': 'OG001'}, {'value': '219', 'groupId': 'OG002'}, {'value': '421', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '54.0', 'groupId': 'OG000', 'lowerLimit': '47.8', 'upperLimit': '60.1'}, {'value': '58.1', 'groupId': 'OG001', 'lowerLimit': '53.8', 'upperLimit': '62.4'}, {'value': '79.9', 'groupId': 'OG002', 'lowerLimit': '74.0', 'upperLimit': '85.0'}, {'value': '77.9', 'groupId': 'OG003', 'lowerLimit': '73.6', 'upperLimit': '81.8'}]}]}, {'title': 'MenY Before Vacc 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '463', 'groupId': 'OG001'}, {'value': '198', 'groupId': 'OG002'}, {'value': '382', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '98.5', 'upperLimit': '100.0'}, {'value': '97.2', 'groupId': 'OG001', 'lowerLimit': '95.2', 'upperLimit': '98.5'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '98.2', 'upperLimit': '100.0'}, {'value': '99.5', 'groupId': 'OG003', 'lowerLimit': '98.1', 'upperLimit': '99.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Before Vaccination 1 (Vacc 1) [Day 1], Before Vaccination 2 (Vacc 2) [173 to 194 Days After Visit 1]', 'description': 'Percentage of participants who achieved an hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY titer \\>=LLOQ for ACWY test strains (LLOQ = 1:8 for all MenA, MenC, MenW, and MenY strains) was reported in this outcome measure.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Stage 1 mITT population included all randomized participants who had received at least 1 study vaccination and who had at least 1 valid and determinate primary strain MenB or MenA/C/W/Y assay result available at any time point from 0 to 7 months. "Overall Number of Participants Analyzed": participants who were measured and analyzed for the outcome measure and \'Number Analyzed\' signifies number of participants with valid and determinate hSBA results for ACWY test strains at the given time point.'}, {'type': 'SECONDARY', 'title': 'Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for ACWY Test Strains Before Vaccination 1 and Before Vaccination 2: Groups 1, 2, 3 and 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}, {'value': '534', 'groupId': 'OG001'}, {'value': '271', 'groupId': 'OG002'}, {'value': '523', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenABCWY + Saline (ACWY-Naive)', 'description': 'Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}, {'id': 'OG001', 'title': 'Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive)', 'description': 'Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.'}, {'id': 'OG002', 'title': 'Group 3: MenABCWY + Saline (ACWY-Experienced)', 'description': 'Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}, {'id': 'OG003', 'title': 'Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced)', 'description': 'Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.'}], 'classes': [{'title': 'MenA Before Vacc 1 >=1:4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'OG000'}, {'value': '528', 'groupId': 'OG001'}, {'value': '219', 'groupId': 'OG002'}, {'value': '418', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '26.3', 'groupId': 'OG000', 'lowerLimit': '21.1', 'upperLimit': '32.0'}, {'value': '33.3', 'groupId': 'OG001', 'lowerLimit': '29.3', 'upperLimit': '37.5'}, {'value': '64.4', 'groupId': 'OG002', 'lowerLimit': '57.7', 'upperLimit': '70.7'}, {'value': '65.8', 'groupId': 'OG003', 'lowerLimit': '61.0', 'upperLimit': '70.3'}]}]}, {'title': 'MenA Before Vacc 1 >=1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'OG000'}, {'value': '528', 'groupId': 'OG001'}, {'value': '219', 'groupId': 'OG002'}, {'value': '418', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '15.9', 'groupId': 'OG000', 'lowerLimit': '11.8', 'upperLimit': '20.8'}, {'value': '22.9', 'groupId': 'OG001', 'lowerLimit': '19.4', 'upperLimit': '26.7'}, {'value': '53.9', 'groupId': 'OG002', 'lowerLimit': '47.0', 'upperLimit': '60.6'}, {'value': '52.6', 'groupId': 'OG003', 'lowerLimit': '47.7', 'upperLimit': '57.5'}]}]}, {'title': 'MenA Before Vacc 1 >=1:16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'OG000'}, {'value': '528', 'groupId': 'OG001'}, {'value': '219', 'groupId': 'OG002'}, {'value': '418', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '14.4', 'groupId': 'OG000', 'lowerLimit': '10.5', 'upperLimit': '19.2'}, {'value': '18.0', 'groupId': 'OG001', 'lowerLimit': '14.8', 'upperLimit': '21.5'}, {'value': '40.2', 'groupId': 'OG002', 'lowerLimit': '33.6', 'upperLimit': '47.0'}, {'value': '41.6', 'groupId': 'OG003', 'lowerLimit': '36.9', 'upperLimit': '46.5'}]}]}, {'title': 'MenA Before Vacc 1 >=1:32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'OG000'}, {'value': '528', 'groupId': 'OG001'}, {'value': '219', 'groupId': 'OG002'}, {'value': '418', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '8.5', 'groupId': 'OG000', 'lowerLimit': '5.5', 'upperLimit': '12.5'}, {'value': '10.6', 'groupId': 'OG001', 'lowerLimit': '8.1', 'upperLimit': '13.6'}, {'value': '24.2', 'groupId': 'OG002', 'lowerLimit': '18.7', 'upperLimit': '30.4'}, {'value': '22.0', 'groupId': 'OG003', 'lowerLimit': '18.1', 'upperLimit': '26.3'}]}]}, {'title': 'MenA Before Vacc 1 >=1:64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'OG000'}, {'value': '528', 'groupId': 'OG001'}, {'value': '219', 'groupId': 'OG002'}, {'value': '418', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5.2', 'groupId': 'OG000', 'lowerLimit': '2.9', 'upperLimit': '8.5'}, {'value': '5.5', 'groupId': 'OG001', 'lowerLimit': '3.7', 'upperLimit': '7.8'}, {'value': '12.8', 'groupId': 'OG002', 'lowerLimit': '8.7', 'upperLimit': '17.9'}, {'value': '15.1', 'groupId': 'OG003', 'lowerLimit': '11.8', 'upperLimit': '18.9'}]}]}, {'title': 'MenA Before Vacc 1 >=1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'OG000'}, {'value': '528', 'groupId': 'OG001'}, {'value': '219', 'groupId': 'OG002'}, {'value': '418', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000', 'lowerLimit': '1.3', 'upperLimit': '5.8'}, {'value': '4.0', 'groupId': 'OG001', 'lowerLimit': '2.5', 'upperLimit': '6.0'}, {'value': '7.8', 'groupId': 'OG002', 'lowerLimit': '4.6', 'upperLimit': '12.1'}, {'value': '6.2', 'groupId': 'OG003', 'lowerLimit': '4.1', 'upperLimit': '9.0'}]}]}, {'title': 'MenA Before Vacc 2 >=1:4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '238', 'groupId': 'OG000'}, {'value': '463', 'groupId': 'OG001'}, 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Before Vacc 2 >=1:64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '242', 'groupId': 'OG000'}, {'value': '467', 'groupId': 'OG001'}, {'value': '199', 'groupId': 'OG002'}, {'value': '385', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '56.6', 'groupId': 'OG000', 'lowerLimit': '50.1', 'upperLimit': '62.9'}, {'value': '41.1', 'groupId': 'OG001', 'lowerLimit': '36.6', 'upperLimit': '45.7'}, {'value': '95.5', 'groupId': 'OG002', 'lowerLimit': '91.6', 'upperLimit': '97.9'}, {'value': '89.1', 'groupId': 'OG003', 'lowerLimit': '85.5', 'upperLimit': '92.0'}]}]}, {'title': 'MenW Before Vacc 2 >=1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '242', 'groupId': 'OG000'}, {'value': '467', 'groupId': 'OG001'}, {'value': '199', 'groupId': 'OG002'}, {'value': '385', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '34.3', 'groupId': 'OG000', 'lowerLimit': '28.3', 'upperLimit': '40.6'}, {'value': '24.2', 'groupId': 'OG001', 'lowerLimit': '20.4', 'upperLimit': '28.3'}, {'value': '84.4', 'groupId': 'OG002', 'lowerLimit': '78.6', 'upperLimit': '89.2'}, {'value': '79.0', 'groupId': 'OG003', 'lowerLimit': '74.5', 'upperLimit': '82.9'}]}]}, {'title': 'MenY Before Vacc 1 >=1:4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '265', 'groupId': 'OG000'}, {'value': '528', 'groupId': 'OG001'}, {'value': '219', 'groupId': 'OG002'}, {'value': '421', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '67.2', 'groupId': 'OG000', 'lowerLimit': '61.2', 'upperLimit': '72.8'}, {'value': '70.3', 'groupId': 'OG001', 'lowerLimit': '66.2', 'upperLimit': '74.1'}, {'value': '87.7', 'groupId': 'OG002', 'lowerLimit': '82.6', 'upperLimit': '91.7'}, {'value': '89.5', 'groupId': 'OG003', 'lowerLimit': '86.2', 'upperLimit': '92.3'}]}]}, {'title': 'MenY Before Vacc 1 >=1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '265', 'groupId': 'OG000'}, {'value': '528', 'groupId': 'OG001'}, {'value': '219', 'groupId': 'OG002'}, {'value': '421', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '54.0', 'groupId': 'OG000', 'lowerLimit': '47.8', 'upperLimit': '60.1'}, {'value': '58.1', 'groupId': 'OG001', 'lowerLimit': '53.8', 'upperLimit': '62.4'}, {'value': '79.9', 'groupId': 'OG002', 'lowerLimit': '74.0', 'upperLimit': '85.0'}, {'value': '77.9', 'groupId': 'OG003', 'lowerLimit': '73.6', 'upperLimit': '81.8'}]}]}, {'title': 'MenY Before Vacc 1 >=1:16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '265', 'groupId': 'OG000'}, {'value': '528', 'groupId': 'OG001'}, {'value': '219', 'groupId': 'OG002'}, {'value': '421', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '44.2', 'groupId': 'OG000', 'lowerLimit': '38.1', 'upperLimit': '50.4'}, {'value': '46.6', 'groupId': 'OG001', 'lowerLimit': '42.3', 'upperLimit': '50.9'}, {'value': '67.1', 'groupId': 'OG002', 'lowerLimit': '60.5', 'upperLimit': '73.3'}, {'value': '65.8', 'groupId': 'OG003', 'lowerLimit': '61.0', 'upperLimit': '70.3'}]}]}, {'title': 'MenY Before Vacc 1 >=1:32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '265', 'groupId': 'OG000'}, {'value': '528', 'groupId': 'OG001'}, {'value': '219', 'groupId': 'OG002'}, {'value': '421', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '21.1', 'groupId': 'OG000', 'lowerLimit': '16.4', 'upperLimit': '26.5'}, {'value': '26.7', 'groupId': 'OG001', 'lowerLimit': '23.0', 'upperLimit': '30.7'}, {'value': '38.4', 'groupId': 'OG002', 'lowerLimit': '31.9', 'upperLimit': '45.1'}, {'value': '40.9', 'groupId': 'OG003', 'lowerLimit': '36.1', 'upperLimit': '45.7'}]}]}, {'title': 'MenY Before Vacc 1 >=1:64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '265', 'groupId': 'OG000'}, {'value': '528', 'groupId': 'OG001'}, {'value': '219', 'groupId': 'OG002'}, {'value': '421', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '10.9', 'groupId': 'OG000', 'lowerLimit': '7.5', 'upperLimit': '15.3'}, {'value': '11.2', 'groupId': 'OG001', 'lowerLimit': '8.6', 'upperLimit': '14.2'}, {'value': '21.9', 'groupId': 'OG002', 'lowerLimit': '16.6', 'upperLimit': '28.0'}, {'value': '20.2', 'groupId': 'OG003', 'lowerLimit': '16.5', 'upperLimit': '24.3'}]}]}, {'title': 'MenY Before Vacc 1 >=1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '265', 'groupId': 'OG000'}, {'value': '528', 'groupId': 'OG001'}, {'value': '219', 'groupId': 'OG002'}, {'value': '421', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.9', 'groupId': 'OG000', 'lowerLimit': '2.6', 'upperLimit': '8.2'}, {'value': '6.3', 'groupId': 'OG001', 'lowerLimit': '4.3', 'upperLimit': '8.7'}, {'value': '10.0', 'groupId': 'OG002', 'lowerLimit': '6.4', 'upperLimit': '14.8'}, {'value': '10.5', 'groupId': 'OG003', 'lowerLimit': '7.7', 'upperLimit': '13.8'}]}]}, {'title': 'MenY Before Vacc 2 >=1:4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '463', 'groupId': 'OG001'}, {'value': '198', 'groupId': 'OG002'}, {'value': '382', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '98.5', 'upperLimit': '100.0'}, {'value': '98.9', 'groupId': 'OG001', 'lowerLimit': '97.5', 'upperLimit': '99.6'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '98.2', 'upperLimit': '100.0'}, {'value': '99.5', 'groupId': 'OG003', 'lowerLimit': '98.1', 'upperLimit': '99.9'}]}]}, {'title': 'MenY Before Vacc 2 >=1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '463', 'groupId': 'OG001'}, {'value': '198', 'groupId': 'OG002'}, {'value': '382', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '98.5', 'upperLimit': '100.0'}, {'value': '97.2', 'groupId': 'OG001', 'lowerLimit': '95.2', 'upperLimit': '98.5'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '98.2', 'upperLimit': '100.0'}, {'value': '99.5', 'groupId': 'OG003', 'lowerLimit': '98.1', 'upperLimit': '99.9'}]}]}, {'title': 'MenY Before Vacc 2 >=1:16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '463', 'groupId': 'OG001'}, {'value': '198', 'groupId': 'OG002'}, {'value': '382', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '98.3', 'groupId': 'OG000', 'lowerLimit': '95.8', 'upperLimit': '99.5'}, {'value': '92.9', 'groupId': 'OG001', 'lowerLimit': '90.1', 'upperLimit': '95.0'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '98.2', 'upperLimit': '100.0'}, {'value': '99.2', 'groupId': 'OG003', 'lowerLimit': '97.7', 'upperLimit': '99.8'}]}]}, {'title': 'MenY Before Vacc 2 >=1:32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '463', 'groupId': 'OG001'}, {'value': '198', 'groupId': 'OG002'}, {'value': '382', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '87.0', 'groupId': 'OG000', 'lowerLimit': '82.1', 'upperLimit': '91.0'}, {'value': '77.1', 'groupId': 'OG001', 'lowerLimit': '73.0', 'upperLimit': '80.9'}, {'value': '99.0', 'groupId': 'OG002', 'lowerLimit': '96.4', 'upperLimit': '99.9'}, {'value': '95.8', 'groupId': 'OG003', 'lowerLimit': '93.3', 'upperLimit': '97.6'}]}]}, {'title': 'MenY Before Vacc 2 >=1:64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '463', 'groupId': 'OG001'}, {'value': '198', 'groupId': 'OG002'}, {'value': '382', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '69.9', 'groupId': 'OG000', 'lowerLimit': '63.6', 'upperLimit': '75.6'}, {'value': '56.2', 'groupId': 'OG001', 'lowerLimit': '51.5', 'upperLimit': '60.7'}, {'value': '94.9', 'groupId': 'OG002', 'lowerLimit': '90.9', 'upperLimit': '97.6'}, {'value': '88.5', 'groupId': 'OG003', 'lowerLimit': '84.8', 'upperLimit': '91.5'}]}]}, {'title': 'MenY Before Vacc 2 >=1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '463', 'groupId': 'OG001'}, {'value': '198', 'groupId': 'OG002'}, {'value': '382', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '41.0', 'groupId': 'OG000', 'lowerLimit': '34.7', 'upperLimit': '47.5'}, {'value': '31.1', 'groupId': 'OG001', 'lowerLimit': '26.9', 'upperLimit': '35.5'}, {'value': '86.4', 'groupId': 'OG002', 'lowerLimit': '80.8', 'upperLimit': '90.8'}, {'value': '80.6', 'groupId': 'OG003', 'lowerLimit': '76.3', 'upperLimit': '84.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Before Vaccination 1 (Vacc 1) [Day 1], Before Vaccination 2 (Vacc 2) [173 to 194 Days After Visit 1]', 'description': 'Percentage of participants who achieved an hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY titer \\>=1:4, \\>= :8, \\>=1:16, \\>=1:32, \\>=1:64, \\>=1:128 for ACWY test strains was reported in this outcome measure.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Stage 1 mITT population included all randomized participants who had received at least 1 study vaccination and who had at least 1 valid and determinate primary strain MenB or MenA/C/W/Y assay result available at any time point from 0 to 7 months. "Overall Number of Participants Analyzed": participants who were measured and analyzed for the outcome measure and \'Number Analyzed\' signifies number of participants with valid and determinate hSBA results for ACWY test strains at the given time point.'}, {'type': 'SECONDARY', 'title': 'Stage1: hSBA GMTs for ACWY Test Strains Before Vaccination 1 and Before Vaccination 2: Groups 1, 2, 3 and 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}, {'value': '534', 'groupId': 'OG001'}, {'value': '271', 'groupId': 'OG002'}, {'value': '523', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenABCWY + Saline (ACWY-Naive)', 'description': 'Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}, {'id': 'OG001', 'title': 'Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive)', 'description': 'Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.'}, {'id': 'OG002', 'title': 'Group 3: MenABCWY + Saline (ACWY-Experienced)', 'description': 'Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}, {'id': 'OG003', 'title': 'Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced)', 'description': 'Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.'}], 'classes': [{'title': 'MenA Before Vacc 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '270', 'groupId': 'OG000'}, {'value': '528', 'groupId': 'OG001'}, {'value': '219', 'groupId': 'OG002'}, {'value': '418', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5.7', 'groupId': 'OG000', 'lowerLimit': '5.1', 'upperLimit': '6.3'}, {'value': '6.3', 'groupId': 'OG001', 'lowerLimit': '5.7', 'upperLimit': '6.8'}, {'value': '11.0', 'groupId': 'OG002', 'lowerLimit': '9.3', 'upperLimit': '13.0'}, {'value': '10.7', 'groupId': 'OG003', 'lowerLimit': '9.6', 'upperLimit': '12.0'}]}]}, {'title': 'MenA Before Vacc 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '238', 'groupId': 'OG000'}, {'value': '463', 'groupId': 'OG001'}, {'value': '200', 'groupId': 'OG002'}, {'value': '385', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '42.7', 'groupId': 'OG000', 'lowerLimit': '36.1', 'upperLimit': '50.4'}, {'value': '47.2', 'groupId': 'OG001', 'lowerLimit': '40.8', 'upperLimit': '54.5'}, {'value': '158.7', 'groupId': 'OG002', 'lowerLimit': '132.6', 'upperLimit': '189.8'}, {'value': '214.6', 'groupId': 'OG003', 'lowerLimit': '187.7', 'upperLimit': '245.3'}]}]}, {'title': 'MenC Before Vacc 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '267', 'groupId': 'OG000'}, {'value': '526', 'groupId': 'OG001'}, {'value': '264', 'groupId': 'OG002'}, {'value': '511', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '7.5', 'groupId': 'OG000', 'lowerLimit': '6.6', 'upperLimit': '8.5'}, {'value': '7.5', 'groupId': 'OG001', 'lowerLimit': '6.8', 'upperLimit': '8.2'}, {'value': '11.9', 'groupId': 'OG002', 'lowerLimit': '10.2', 'upperLimit': '13.8'}, {'value': '13.4', 'groupId': 'OG003', 'lowerLimit': '11.9', 'upperLimit': '15.1'}]}]}, {'title': 'MenC Before Vacc 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '460', 'groupId': 'OG001'}, {'value': '243', 'groupId': 'OG002'}, {'value': '474', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '61.5', 'groupId': 'OG000', 'lowerLimit': '49.5', 'upperLimit': '76.3'}, {'value': '32.7', 'groupId': 'OG001', 'lowerLimit': '27.8', 'upperLimit': '38.5'}, {'value': '253.1', 'groupId': 'OG002', 'lowerLimit': '213.0', 'upperLimit': '300.8'}, {'value': '186.7', 'groupId': 'OG003', 'lowerLimit': '161.9', 'upperLimit': '215.2'}]}]}, {'title': 'MenW Before Vacc 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '268', 'groupId': 'OG000'}, {'value': '527', 'groupId': 'OG001'}, {'value': '218', 'groupId': 'OG002'}, {'value': '418', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '7.0', 'groupId': 'OG000', 'lowerLimit': '6.2', 'upperLimit': '7.9'}, {'value': '7.0', 'groupId': 'OG001', 'lowerLimit': '6.4', 'upperLimit': '7.5'}, {'value': '10.5', 'groupId': 'OG002', 'lowerLimit': '9.1', 'upperLimit': '12.2'}, {'value': '11.0', 'groupId': 'OG003', 'lowerLimit': '9.8', 'upperLimit': '12.3'}]}]}, {'title': 'MenW Before Vacc 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '242', 'groupId': 'OG000'}, {'value': '467', 'groupId': 'OG001'}, {'value': '199', 'groupId': 'OG002'}, {'value': '385', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '62.6', 'groupId': 'OG000', 'lowerLimit': '53.5', 'upperLimit': '73.1'}, {'value': '39.1', 'groupId': 'OG001', 'lowerLimit': '34.4', 'upperLimit': '44.5'}, {'value': '376.8', 'groupId': 'OG002', 'lowerLimit': '311.4', 'upperLimit': '456.0'}, {'value': '255.5', 'groupId': 'OG003', 'lowerLimit': '221.4', 'upperLimit': '295.0'}]}]}, {'title': 'MenY Before Vacc 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '265', 'groupId': 'OG000'}, {'value': '528', 'groupId': 'OG001'}, {'value': '219', 'groupId': 'OG002'}, {'value': '421', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '10.5', 'groupId': 'OG000', 'lowerLimit': '9.1', 'upperLimit': '12.1'}, {'value': '11.5', 'groupId': 'OG001', 'lowerLimit': '10.4', 'upperLimit': '12.7'}, {'value': '19.2', 'groupId': 'OG002', 'lowerLimit': '16.3', 'upperLimit': '22.5'}, {'value': '19.0', 'groupId': 'OG003', 'lowerLimit': '16.8', 'upperLimit': '21.4'}]}]}, {'title': 'MenY Before Vacc 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '463', 'groupId': 'OG001'}, {'value': '198', 'groupId': 'OG002'}, {'value': '382', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '83.6', 'groupId': 'OG000', 'lowerLimit': '71.4', 'upperLimit': '97.8'}, {'value': '58.6', 'groupId': 'OG001', 'lowerLimit': '52.0', 'upperLimit': '66.0'}, {'value': '395.2', 'groupId': 'OG002', 'lowerLimit': '327.8', 'upperLimit': '476.3'}, {'value': '264.0', 'groupId': 'OG003', 'lowerLimit': '228.5', 'upperLimit': '305.0'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Before Vaccination 1 (Vacc 1) [Day 1], Before Vaccination 2 (Vacc 2) [173 to 194 Days After Visit 1]', 'description': 'GMTs were calculated using all participants with valid and determinate hSBA titers at the given time point. LLOQ = 1:8 for all MenA, MenC, MenW, and MenY strains. Titers below the LLOQ were set to 0.5\\*LLOQ for analysis. Confidence intervals were back transformations of confidence levels based on the Student t distribution for the mean logarithm of the concentrations, or the mean of the ratio.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Stage 1 mITT population included all randomized participants who had received at least 1 study vaccination and who had at least 1 valid and determinate primary strain MenB or MenA/C/W/Y assay result available at any time point from 0 to 7 months. "Overall Number of Participants Analyzed": participants who were measured and analyzed for the outcome measure and \'Number Analyzed\' signifies number of participants with valid and determinate hSBA results for ACWY test strains at the given time point.'}, {'type': 'SECONDARY', 'title': 'Stage1: Percentage of Participants With hSBA Titer Level >=LLOQ for 4 Primary MenB Test Strains Before Vaccination 1 and Before Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '438', 'groupId': 'OG000'}, {'value': '864', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1+3 Combined (MenABCWY + Saline)', 'description': 'Stage 1: ACWY-naive and experienced participants who received an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}, {'id': 'OG001', 'title': 'Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM)', 'description': 'Stage 1: ACWY-naive and experienced participants who received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.'}], 'classes': [{'title': 'PMB80 (A22) Before Vacc 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '427', 'groupId': 'OG000'}, {'value': '839', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25.3', 'groupId': 'OG000', 'lowerLimit': '21.2', 'upperLimit': '29.7'}, {'value': '25.1', 'groupId': 'OG001', 'lowerLimit': '22.2', 'upperLimit': '28.2'}]}]}, {'title': 'PMB80 (A22) Before Vacc 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '425', 'groupId': 'OG000'}, {'value': '842', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '41.6', 'groupId': 'OG000', 'lowerLimit': '36.9', 'upperLimit': '46.5'}, {'value': '41.9', 'groupId': 'OG001', 'lowerLimit': '38.6', 'upperLimit': '45.3'}]}]}, {'title': 'PMB2001 (A56) Before Vacc 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '421', 'groupId': 'OG000'}, {'value': '833', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.8', 'groupId': 'OG000', 'lowerLimit': '10.6', 'upperLimit': '17.4'}, {'value': '12.8', 'groupId': 'OG001', 'lowerLimit': '10.6', 'upperLimit': '15.3'}]}]}, {'title': 'PMB2001 (A56) Before Vacc 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '412', 'groupId': 'OG000'}, {'value': '811', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '52.2', 'groupId': 'OG000', 'lowerLimit': '47.2', 'upperLimit': '57.1'}, {'value': '45.7', 'groupId': 'OG001', 'lowerLimit': '42.3', 'upperLimit': '49.2'}]}]}, {'title': 'PMB2948 (B24) Before Vacc 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '434', 'groupId': 'OG000'}, {'value': '855', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.4', 'groupId': 'OG000', 'lowerLimit': '7.7', 'upperLimit': '13.6'}, {'value': '11.9', 'groupId': 'OG001', 'lowerLimit': '9.8', 'upperLimit': '14.3'}]}]}, {'title': 'PMB2948 (B24) Before Vacc 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '430', 'groupId': 'OG000'}, {'value': '843', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26.5', 'groupId': 'OG000', 'lowerLimit': '22.4', 'upperLimit': '31.0'}, {'value': '24.2', 'groupId': 'OG001', 'lowerLimit': '21.3', 'upperLimit': '27.2'}]}]}, {'title': 'PMB2707 (B44) Before Vacc 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '434', 'groupId': 'OG000'}, {'value': '861', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.7', 'groupId': 'OG000', 'lowerLimit': '2.1', 'upperLimit': '5.9'}, {'value': '4.5', 'groupId': 'OG001', 'lowerLimit': '3.2', 'upperLimit': '6.1'}]}]}, {'title': 'PMB2707 (B44) Before Vacc 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '421', 'groupId': 'OG000'}, {'value': '843', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.8', 'groupId': 'OG000', 'lowerLimit': '15.1', 'upperLimit': '22.8'}, {'value': '16.5', 'groupId': 'OG001', 'lowerLimit': '14.0', 'upperLimit': '19.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Before Vaccination 1 (Vacc 1) [Day 1], Before Vaccination 2 (Vacc 2) [173 to 194 Days After Visit 1]', 'description': 'Percentage of participants who achieved an hSBA titer \\>=LLOQ for all 4 primary MenB test strains (LLOQ was 1:16 for A22 and 1:8 for A56, B24, and B44) was reported in this outcome measure.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Stage 1 EIP analyzed. Here, "Overall Number of Participants Analyzed" signifies number of participants measured and analyzed for this outcome measure. "Number Analyzed" signifies number of participants with valid and determinate hSBA results for each strains at given time point. Analysis was planned for combined Group 1 and 3 and combined Group 2 and 4.'}, {'type': 'SECONDARY', 'title': 'Stage1: Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for Each of the 4 Primary MenB Test Strains Before Vaccination 1 and Before Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '438', 'groupId': 'OG000'}, {'value': '864', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1+3 Combined (MenABCWY + Saline)', 'description': 'Stage 1: ACWY-naive and experienced participants who received an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}, {'id': 'OG001', 'title': 'Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM)', 'description': 'Stage 1: ACWY-naive and experienced participants who received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.'}], 'classes': [{'title': 'PMB80 (A22) Before Vacc 1 >=1:4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '427', 'groupId': 'OG000'}, {'value': '839', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '34.7', 'groupId': 'OG000', 'lowerLimit': '30.1', 'upperLimit': '39.4'}, {'value': '36.6', 'groupId': 'OG001', 'lowerLimit': '33.3', 'upperLimit': '40.0'}]}]}, {'title': 'PMB80 (A22) Before Vacc 1 >=1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '427', 'groupId': 'OG000'}, {'value': '839', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '31.9', 'groupId': 'OG000', 'lowerLimit': '27.5', 'upperLimit': '36.5'}, {'value': '31.8', 'groupId': 'OG001', 'lowerLimit': '28.7', 'upperLimit': '35.1'}]}]}, {'title': 'PMB80 (A22) Before Vacc 1 >=1:16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '427', 'groupId': 'OG000'}, {'value': '839', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25.3', 'groupId': 'OG000', 'lowerLimit': '21.2', 'upperLimit': '29.7'}, {'value': '25.1', 'groupId': 'OG001', 'lowerLimit': '22.2', 'upperLimit': '28.2'}]}]}, {'title': 'PMB80 (A22) Before Vacc 1 >=1:32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '427', 'groupId': 'OG000'}, {'value': '839', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.0', 'groupId': 'OG000', 'lowerLimit': '8.2', 'upperLimit': '14.4'}, {'value': '11.4', 'groupId': 'OG001', 'lowerLimit': '9.4', 'upperLimit': '13.8'}]}]}, {'title': 'PMB80 (A22) Before Vacc 1 >=1:64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '427', 'groupId': 'OG000'}, {'value': '839', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.7', 'groupId': 'OG000', 'lowerLimit': '2.9', 'upperLimit': '7.1'}, {'value': '4.4', 'groupId': 'OG001', 'lowerLimit': '3.1', 'upperLimit': '6.0'}]}]}, {'title': 'PMB80 (A22) Before Vacc 1 >=1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '427', 'groupId': 'OG000'}, {'value': '839', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '3.0'}, {'value': '0.8', 'groupId': 'OG001', 'lowerLimit': '0.3', 'upperLimit': '1.7'}]}]}, {'title': 'PMB80 (A22) Before Vacc 2 >=1:4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '425', 'groupId': 'OG000'}, {'value': '842', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '48.2', 'groupId': 'OG000', 'lowerLimit': '43.4', 'upperLimit': '53.1'}, {'value': '49.8', 'groupId': 'OG001', 'lowerLimit': '46.3', 'upperLimit': '53.2'}]}]}, {'title': 'PMB80 (A22) Before Vacc 2 >=1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '425', 'groupId': 'OG000'}, {'value': '842', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '44.5', 'groupId': 'OG000', 'lowerLimit': '39.7', 'upperLimit': '49.3'}, {'value': '46.6', 'groupId': 'OG001', 'lowerLimit': '43.1', 'upperLimit': '50.0'}]}]}, {'title': 'PMB80 (A22) Before Vacc 2 >=1:16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '425', 'groupId': 'OG000'}, {'value': '842', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '41.6', 'groupId': 'OG000', 'lowerLimit': '36.9', 'upperLimit': '46.5'}, {'value': '41.9', 'groupId': 'OG001', 'lowerLimit': '38.6', 'upperLimit': '45.3'}]}]}, {'title': 'PMB80 (A22) Before Vacc 2 >=1:32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '425', 'groupId': 'OG000'}, {'value': '842', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23.5', 'groupId': 'OG000', 'lowerLimit': '19.6', 'upperLimit': '27.9'}, {'value': '23.5', 'groupId': 'OG001', 'lowerLimit': '20.7', 'upperLimit': '26.5'}]}]}, {'title': 'PMB80 (A22) Before Vacc 2 >=1:64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '425', 'groupId': 'OG000'}, {'value': '842', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.9', 'groupId': 'OG000', 'lowerLimit': '7.2', 'upperLimit': '13.1'}, {'value': '9.0', 'groupId': 'OG001', 'lowerLimit': '7.2', 'upperLimit': '11.2'}]}]}, {'title': 'PMB80 (A22) Before Vacc 2 >=1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '425', 'groupId': 'OG000'}, {'value': '842', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000', 'lowerLimit': '1.3', 'upperLimit': '4.6'}, {'value': '3.2', 'groupId': 'OG001', 'lowerLimit': '2.1', 'upperLimit': '4.6'}]}]}, {'title': 'PMB2001 (A56) Before Vacc 1 >=1:4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '421', 'groupId': 'OG000'}, {'value': '833', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19.5', 'groupId': 'OG000', 'lowerLimit': '15.8', 'upperLimit': '23.6'}, {'value': '17.5', 'groupId': 'OG001', 'lowerLimit': '15.0', 'upperLimit': '20.3'}]}]}, {'title': 'PMB2001 (A56) Before Vacc 1 >=1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '421', 'groupId': 'OG000'}, {'value': '833', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.8', 'groupId': 'OG000', 'lowerLimit': '10.6', 'upperLimit': '17.4'}, {'value': '12.8', 'groupId': 'OG001', 'lowerLimit': '10.6', 'upperLimit': '15.3'}]}]}, {'title': 'PMB2001 (A56) Before Vacc 1 >=1:16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '421', 'groupId': 'OG000'}, {'value': '833', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.7', 'groupId': 'OG000', 'lowerLimit': '7.9', 'upperLimit': '14.0'}, {'value': '11.0', 'groupId': 'OG001', 'lowerLimit': '9.0', 'upperLimit': '13.4'}]}]}, {'title': 'PMB2001 (A56) Before Vacc 1 >=1:32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '421', 'groupId': 'OG000'}, {'value': '833', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000', 'lowerLimit': '4.5', 'upperLimit': '9.5'}, {'value': '7.6', 'groupId': 'OG001', 'lowerLimit': '5.9', 'upperLimit': '9.6'}]}]}, {'title': 'PMB2001 (A56) Before Vacc 1 >=1:64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '421', 'groupId': 'OG000'}, {'value': '833', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.8', 'groupId': 'OG000', 'lowerLimit': '2.2', 'upperLimit': '6.1'}, {'value': '4.3', 'groupId': 'OG001', 'lowerLimit': '3.0', 'upperLimit': '5.9'}]}]}, {'title': 'PMB2001 (A56) Before Vacc 1 >=1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '421', 'groupId': 'OG000'}, {'value': '833', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000', 'lowerLimit': '1.5', 'upperLimit': '4.9'}, {'value': '2.4', 'groupId': 'OG001', 'lowerLimit': '1.5', 'upperLimit': '3.7'}]}]}, {'title': 'PMB2001 (A56) Before Vacc 2 >=1:4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '412', 'groupId': 'OG000'}, {'value': '811', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '56.6', 'groupId': 'OG000', 'lowerLimit': '51.6', 'upperLimit': '61.4'}, {'value': '50.6', 'groupId': 'OG001', 'lowerLimit': '47.1', 'upperLimit': '54.1'}]}]}, {'title': 'PMB2001 (A56) Before Vacc 2 >=1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '412', 'groupId': 'OG000'}, {'value': '811', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '52.2', 'groupId': 'OG000', 'lowerLimit': '47.2', 'upperLimit': '57.1'}, {'value': '45.7', 'groupId': 'OG001', 'lowerLimit': '42.3', 'upperLimit': '49.2'}]}]}, {'title': 'PMB2001 (A56) Before Vacc 2 >=1:16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '412', 'groupId': 'OG000'}, {'value': '811', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '47.1', 'groupId': 'OG000', 'lowerLimit': '42.2', 'upperLimit': '52.0'}, {'value': '41.2', 'groupId': 'OG001', 'lowerLimit': '37.8', 'upperLimit': '44.7'}]}]}, {'title': 'PMB2001 (A56) Before Vacc 2 >=1:32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '412', 'groupId': 'OG000'}, {'value': '811', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '35.2', 'groupId': 'OG000', 'lowerLimit': '30.6', 'upperLimit': '40.0'}, {'value': '30.9', 'groupId': 'OG001', 'lowerLimit': '27.8', 'upperLimit': '34.3'}]}]}, {'title': 'PMB2001 (A56) Before Vacc 2 >=1:64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '412', 'groupId': 'OG000'}, {'value': '811', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.4', 'groupId': 'OG000', 'lowerLimit': '17.5', 'upperLimit': '25.6'}, {'value': '19.0', 'groupId': 'OG001', 'lowerLimit': '16.3', 'upperLimit': '21.9'}]}]}, {'title': 'PMB2001 (A56) Before Vacc 2 >=1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '412', 'groupId': 'OG000'}, {'value': '811', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000', 'lowerLimit': '7.2', 'upperLimit': '13.3'}, {'value': '9.5', 'groupId': 'OG001', 'lowerLimit': '7.6', 'upperLimit': '11.7'}]}]}, {'title': 'PMB2948 (B24) Before Vacc 1 >=1:4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '434', 'groupId': 'OG000'}, {'value': '855', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.1', 'groupId': 'OG000', 'lowerLimit': '10.9', 'upperLimit': '17.7'}, {'value': '14.6', 'groupId': 'OG001', 'lowerLimit': '12.3', 'upperLimit': '17.2'}]}]}, {'title': 'PMB2948 (B24) Before Vacc 1 >=1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '434', 'groupId': 'OG000'}, {'value': '855', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.4', 'groupId': 'OG000', 'lowerLimit': '7.7', 'upperLimit': '13.6'}, {'value': '11.9', 'groupId': 'OG001', 'lowerLimit': '9.8', 'upperLimit': '14.3'}]}]}, {'title': 'PMB2948 (B24) Before Vacc 1 >=1:16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '434', 'groupId': 'OG000'}, {'value': '855', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.2', 'groupId': 'OG000', 'lowerLimit': '4.1', 'upperLimit': '8.9'}, {'value': '8.2', 'groupId': 'OG001', 'lowerLimit': '6.4', 'upperLimit': '10.2'}]}]}, {'title': 'PMB2948 (B24) Before Vacc 1 >=1:32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '434', 'groupId': 'OG000'}, {'value': '855', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.7', 'groupId': 'OG000', 'lowerLimit': '2.1', 'upperLimit': '5.9'}, {'value': '4.2', 'groupId': 'OG001', 'lowerLimit': '3.0', 'upperLimit': '5.8'}]}]}, {'title': 'PMB2948 (B24) Before Vacc 1 >=1:64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '434', 'groupId': 'OG000'}, {'value': '855', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '2.3'}, {'value': '2.3', 'groupId': 'OG001', 'lowerLimit': '1.4', 'upperLimit': '3.6'}]}]}, {'title': 'PMB2948 (B24) Before Vacc 1 >=1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '434', 'groupId': 'OG000'}, {'value': '855', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.3'}, {'value': '1.1', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '2.0'}]}]}, {'title': 'PMB2948 (B24) Before Vacc 2 >=1:4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '430', 'groupId': 'OG000'}, {'value': '843', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30.5', 'groupId': 'OG000', 'lowerLimit': '26.1', 'upperLimit': '35.1'}, {'value': '28.0', 'groupId': 'OG001', 'lowerLimit': '25.0', 'upperLimit': '31.2'}]}]}, {'title': 'PMB2948 (B24) Before Vacc 2 >=1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '430', 'groupId': 'OG000'}, {'value': '843', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26.5', 'groupId': 'OG000', 'lowerLimit': '22.4', 'upperLimit': '31.0'}, {'value': '24.2', 'groupId': 'OG001', 'lowerLimit': '21.3', 'upperLimit': '27.2'}]}]}, {'title': 'PMB2948 (B24) Before Vacc 2 >=1:16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '430', 'groupId': 'OG000'}, {'value': '843', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.4', 'groupId': 'OG000', 'lowerLimit': '17.6', 'upperLimit': '25.6'}, {'value': '20.2', 'groupId': 'OG001', 'lowerLimit': '17.5', 'upperLimit': '23.0'}]}]}, {'title': 'PMB2948 (B24) Before Vacc 2 >=1:32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '430', 'groupId': 'OG000'}, {'value': '843', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.2', 'groupId': 'OG000', 'lowerLimit': '8.3', 'upperLimit': '14.5'}, {'value': '11.0', 'groupId': 'OG001', 'lowerLimit': '9.0', 'upperLimit': '13.3'}]}]}, {'title': 'PMB2948 (B24) Before Vacc 2 >=1:64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '430', 'groupId': 'OG000'}, {'value': '843', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.1', 'groupId': 'OG000', 'lowerLimit': '3.2', 'upperLimit': '7.6'}, {'value': '5.7', 'groupId': 'OG001', 'lowerLimit': '4.2', 'upperLimit': '7.5'}]}]}, {'title': 'PMB2948 (B24) Before Vacc 2 >=1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '430', 'groupId': 'OG000'}, {'value': '843', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.3', 'groupId': 'OG000', 'lowerLimit': '1.1', 'upperLimit': '4.2'}, {'value': '2.3', 'groupId': 'OG001', 'lowerLimit': '1.4', 'upperLimit': '3.5'}]}]}, {'title': 'PMB2707 (B44) Before Vacc 1 >=1:4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '434', 'groupId': 'OG000'}, {'value': '861', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.1', 'groupId': 'OG000', 'lowerLimit': '4.9', 'upperLimit': '10.0'}, {'value': '7.2', 'groupId': 'OG001', 'lowerLimit': '5.6', 'upperLimit': '9.1'}]}]}, {'title': 'PMB2707 (B44) Before Vacc 1 >=1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '434', 'groupId': 'OG000'}, {'value': '861', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.7', 'groupId': 'OG000', 'lowerLimit': '2.1', 'upperLimit': '5.9'}, {'value': '4.5', 'groupId': 'OG001', 'lowerLimit': '3.2', 'upperLimit': '6.1'}]}]}, {'title': 'PMB2707 (B44) Before Vacc 1 >=1:16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '434', 'groupId': 'OG000'}, {'value': '861', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '3.9'}, {'value': '3.3', 'groupId': 'OG001', 'lowerLimit': '2.2', 'upperLimit': '4.7'}]}]}, {'title': 'PMB2707 (B44) Before Vacc 1 >=1:32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '434', 'groupId': 'OG000'}, {'value': '861', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '2.3'}, {'value': '2.1', 'groupId': 'OG001', 'lowerLimit': '1.2', 'upperLimit': '3.3'}]}]}, {'title': 'PMB2707 (B44) Before Vacc 1 >=1:64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '434', 'groupId': 'OG000'}, {'value': '861', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '2.0'}, {'value': '1.2', 'groupId': 'OG001', 'lowerLimit': '0.6', 'upperLimit': '2.1'}]}]}, {'title': 'PMB2707 (B44) Before Vacc 1 >=1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '434', 'groupId': 'OG000'}, {'value': '861', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '1.7'}, {'value': '0.3', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '1.0'}]}]}, {'title': 'PMB2707 (B44) Before Vacc 2 >=1:4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '421', 'groupId': 'OG000'}, {'value': '843', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29.2', 'groupId': 'OG000', 'lowerLimit': '24.9', 'upperLimit': '33.8'}, {'value': '25.7', 'groupId': 'OG001', 'lowerLimit': '22.8', 'upperLimit': '28.8'}]}]}, {'title': 'PMB2707 (B44) Before Vacc 2 >=1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '421', 'groupId': 'OG000'}, {'value': '843', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.8', 'groupId': 'OG000', 'lowerLimit': '15.1', 'upperLimit': '22.8'}, {'value': '16.5', 'groupId': 'OG001', 'lowerLimit': '14.0', 'upperLimit': '19.2'}]}]}, {'title': 'PMB2707 (B44) Before Vacc 2 >=1:16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '421', 'groupId': 'OG000'}, {'value': '843', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.5', 'groupId': 'OG000', 'lowerLimit': '10.4', 'upperLimit': '17.2'}, {'value': '11.7', 'groupId': 'OG001', 'lowerLimit': '9.6', 'upperLimit': '14.1'}]}]}, {'title': 'PMB2707 (B44) Before Vacc 2 >=1:32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '421', 'groupId': 'OG000'}, {'value': '843', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.6', 'groupId': 'OG000', 'lowerLimit': '5.3', 'upperLimit': '10.6'}, {'value': '5.8', 'groupId': 'OG001', 'lowerLimit': '4.3', 'upperLimit': '7.6'}]}]}, {'title': 'PMB2707 (B44) Before Vacc 2 >=1:64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '421', 'groupId': 'OG000'}, {'value': '843', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000', 'lowerLimit': '1.8', 'upperLimit': '5.5'}, {'value': '2.8', 'groupId': 'OG001', 'lowerLimit': '1.8', 'upperLimit': '4.2'}]}]}, {'title': 'PMB2707 (B44) Before Vacc 2 >=1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '421', 'groupId': 'OG000'}, {'value': '843', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '2.1'}, {'value': '1.4', 'groupId': 'OG001', 'lowerLimit': '0.7', 'upperLimit': '2.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Before Vaccination 1 (Vacc 1) [Day 1], Before Vaccination 2 (Vacc 2) [173 to 194 Days After Visit 1]', 'description': 'Percentage of participants who achieved an hSBA titer \\>=1:4, \\>=1:8, \\>=1:16, \\>=1:32, \\>=1:64, and \\>=1:128 for each of the 4 primary MenB test strains was reported in this outcome measure.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Stage 1 EIP analyzed. Here, "Overall Number of Participants Analyzed" signifies number of participants measured and analyzed for this outcome measure. "Number Analyzed" signifies number of participants with valid and determinate hSBA results for each strain at given time point. Analysis was planned for combined Group 1 and 3 and combined Group 2 and 4.'}, {'type': 'SECONDARY', 'title': 'Stage1: hSBA GMTs for Each of the 4 Primary MenB Test Strains Before Vaccination 1 and Before Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '438', 'groupId': 'OG000'}, {'value': '864', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1+3 Combined (MenABCWY + Saline)', 'description': 'Stage 1: ACWY-naive and experienced participants who received an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}, {'id': 'OG001', 'title': 'Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM)', 'description': 'Stage 1: ACWY-naive and experienced participants who received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.'}], 'classes': [{'title': 'PMB80 (A22), Before vacc 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '427', 'groupId': 'OG000'}, {'value': '839', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.8', 'groupId': 'OG000', 'lowerLimit': '10.2', 'upperLimit': '11.5'}, {'value': '10.7', 'groupId': 'OG001', 'lowerLimit': '10.3', 'upperLimit': '11.1'}]}]}, {'title': 'PMB80 (A22), Before vacc 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '425', 'groupId': 'OG000'}, {'value': '842', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.7', 'groupId': 'OG000', 'lowerLimit': '12.8', 'upperLimit': '14.8'}, {'value': '13.8', 'groupId': 'OG001', 'lowerLimit': '13.1', 'upperLimit': '14.5'}]}]}, {'title': 'PMB2001 (A56), Before vacc 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '421', 'groupId': 'OG000'}, {'value': '833', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.2', 'groupId': 'OG000', 'lowerLimit': '4.9', 'upperLimit': '5.7'}, {'value': '5.3', 'groupId': 'OG001', 'lowerLimit': '5.0', 'upperLimit': '5.6'}]}]}, {'title': 'PMB2001 (A56), Before vacc 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '412', 'groupId': 'OG000'}, {'value': '811', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.0', 'groupId': 'OG000', 'lowerLimit': '11.4', 'upperLimit': '14.8'}, {'value': '11.4', 'groupId': 'OG001', 'lowerLimit': '10.4', 'upperLimit': '12.5'}]}]}, {'title': 'PMB2948 (B24), Before vacc 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '434', 'groupId': 'OG000'}, {'value': '855', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.6', 'groupId': 'OG000', 'lowerLimit': '4.4', 'upperLimit': '4.9'}, {'value': '4.9', 'groupId': 'OG001', 'lowerLimit': '4.7', 'upperLimit': '5.1'}]}]}, {'title': 'PMB2948 (B24), Before vacc 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '430', 'groupId': 'OG000'}, {'value': '843', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.3', 'groupId': 'OG000', 'lowerLimit': '5.8', 'upperLimit': '6.9'}, {'value': '6.2', 'groupId': 'OG001', 'lowerLimit': '5.9', 'upperLimit': '6.6'}]}]}, {'title': 'PMB2707 (B44), Before vacc 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '434', 'groupId': 'OG000'}, {'value': '861', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.2', 'groupId': 'OG000', 'lowerLimit': '4.1', 'upperLimit': '4.4'}, {'value': '4.3', 'groupId': 'OG001', 'lowerLimit': '4.2', 'upperLimit': '4.5'}]}]}, {'title': 'PMB2707 (B44), Before vacc 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '421', 'groupId': 'OG000'}, {'value': '843', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.4', 'groupId': 'OG000', 'lowerLimit': '5.1', 'upperLimit': '5.8'}, {'value': '5.3', 'groupId': 'OG001', 'lowerLimit': '5.0', 'upperLimit': '5.5'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Before Vaccination 1 (Vacc 1) [Day 1], Before Vaccination 2 (Vacc 2) [173 to 194 Days After Visit 1]', 'description': 'GMTs were calculated using all participants with valid and determinate hSBA titers at the given time point. LLOQ =1:16 for A22; 1:8 for A56, B24, and B44. Titers below the LLOQ were set to 0.5\\*LLOQ for analysis. CIs were back transformations of confidence levels based on the Student t distribution for the mean logarithm of the hSBA titers.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Stage 1 EIP analyzed. Here, "Overall Number of Participants Analyzed" signifies number of participants measured and analyzed for this outcome measure. "Number Analyzed" signifies number of participants with valid and determinate hSBA results for each of the 4 strains at given time point. Analysis was planned for combined Group 1 and 3 and combined Group 2 and 4.'}, {'type': 'SECONDARY', 'title': 'Stage2: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:8 (or LLOQ if Higher) for ACWY Test Strains During Persistence Phase: Groups 1, 2, 3 and 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '101', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenABCWY + Saline (ACWY-Naive)', 'description': 'Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}, {'id': 'OG001', 'title': 'Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive)', 'description': 'Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.'}, {'id': 'OG002', 'title': 'Group 3: MenABCWY + Saline (ACWY-Experienced)', 'description': 'Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}, {'id': 'OG003', 'title': 'Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced)', 'description': 'Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54.'}], 'classes': [{'title': 'MenA 12 Months after Vacc 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '91.1', 'groupId': 'OG000', 'lowerLimit': '84.2', 'upperLimit': '95.6'}, {'value': '71.2', 'groupId': 'OG001', 'lowerLimit': '57.9', 'upperLimit': '82.2'}, {'value': '97.9', 'groupId': 'OG002', 'lowerLimit': '88.9', 'upperLimit': '99.9'}, {'value': '100.0', 'groupId': 'OG003', 'lowerLimit': '84.6', 'upperLimit': '100.0'}]}]}, {'title': 'MenA 24 Months after Vacc 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '88.1', 'groupId': 'OG000', 'lowerLimit': '80.2', 'upperLimit': '93.7'}, {'value': '70.0', 'groupId': 'OG001', 'lowerLimit': '56.8', 'upperLimit': '81.2'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '94.1', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG003', 'lowerLimit': '90.5', 'upperLimit': '100.0'}]}]}, {'title': 'MenA 36 Months after Vacc 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '88.4', 'groupId': 'OG000', 'lowerLimit': '80.2', 'upperLimit': '94.1'}, {'value': '72.2', 'groupId': 'OG001', 'lowerLimit': '58.4', 'upperLimit': '83.5'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '93.7', 'upperLimit': '100.0'}, {'value': '97.0', 'groupId': 'OG003', 'lowerLimit': '84.2', 'upperLimit': '99.9'}]}]}, {'title': 'MenA 48 Months after Vacc 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '81.7', 'groupId': 'OG000', 'lowerLimit': '70.7', 'upperLimit': '89.9'}, {'value': '63.4', 'groupId': 'OG001', 'lowerLimit': '46.9', 'upperLimit': '77.9'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '91.2', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG003', 'lowerLimit': '85.2', 'upperLimit': '100.0'}]}]}, {'title': 'MenC 12 Months after Vacc 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '76.8', 'groupId': 'OG000', 'lowerLimit': '67.9', 'upperLimit': '84.2'}, {'value': '51.6', 'groupId': 'OG001', 'lowerLimit': '38.6', 'upperLimit': '64.5'}, {'value': '96.3', 'groupId': 'OG002', 'lowerLimit': '87.3', 'upperLimit': '99.5'}, {'value': '91.3', 'groupId': 'OG003', 'lowerLimit': '72.0', 'upperLimit': '98.9'}]}]}, {'title': 'MenC 24 Months after Vacc 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '97', 'groupId': 'OG002'}, {'value': '71', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '75.2', 'groupId': 'OG000', 'lowerLimit': '65.7', 'upperLimit': '83.3'}, {'value': '47.5', 'groupId': 'OG001', 'lowerLimit': '34.6', 'upperLimit': '60.7'}, {'value': '96.9', 'groupId': 'OG002', 'lowerLimit': '91.2', 'upperLimit': '99.4'}, {'value': '94.4', 'groupId': 'OG003', 'lowerLimit': '86.2', 'upperLimit': '98.4'}]}]}, {'title': 'MenC 36 Months after Vacc 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '95', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '96', 'groupId': 'OG002'}, {'value': '67', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '67.4', 'groupId': 'OG000', 'lowerLimit': '57.0', 'upperLimit': '76.6'}, {'value': '44.4', 'groupId': 'OG001', 'lowerLimit': '30.9', 'upperLimit': '58.6'}, {'value': '96.9', 'groupId': 'OG002', 'lowerLimit': '91.1', 'upperLimit': '99.4'}, {'value': '95.5', 'groupId': 'OG003', 'lowerLimit': '87.5', 'upperLimit': '99.1'}]}]}, {'title': 'MenC 48 Months after Vacc 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '58', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '62.0', 'groupId': 'OG000', 'lowerLimit': '49.7', 'upperLimit': '73.2'}, {'value': '38.1', 'groupId': 'OG001', 'lowerLimit': '23.6', 'upperLimit': '54.4'}, {'value': '98.7', 'groupId': 'OG002', 'lowerLimit': '92.9', 'upperLimit': '100.0'}, {'value': '89.7', 'groupId': 'OG003', 'lowerLimit': '78.8', 'upperLimit': '96.1'}]}]}, {'title': 'MenW 12 Months after Vacc 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '99.1', 'groupId': 'OG000', 'lowerLimit': '95.1', 'upperLimit': '100.0'}, {'value': '83.9', 'groupId': 'OG001', 'lowerLimit': '72.3', 'upperLimit': '92.0'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '92.6', 'upperLimit': '100.0'}, {'value': '95.5', 'groupId': 'OG003', 'lowerLimit': '77.2', 'upperLimit': '99.9'}]}]}, {'title': 'MenW 24 Months after Vacc 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '99.0', 'groupId': 'OG000', 'lowerLimit': '94.7', 'upperLimit': '100.0'}, {'value': '78.7', 'groupId': 'OG001', 'lowerLimit': '66.3', 'upperLimit': '88.1'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '94.1', 'upperLimit': '100.0'}, {'value': '94.6', 'groupId': 'OG003', 'lowerLimit': '81.8', 'upperLimit': '99.3'}]}]}, {'title': 'MenW 36 Months after Vacc 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '94.8', 'groupId': 'OG000', 'lowerLimit': '88.4', 'upperLimit': '98.3'}, {'value': '77.8', 'groupId': 'OG001', 'lowerLimit': '64.4', 'upperLimit': '88.0'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '93.7', 'upperLimit': '100.0'}, {'value': '97.0', 'groupId': 'OG003', 'lowerLimit': '84.2', 'upperLimit': '99.9'}]}]}, {'title': 'MenW 48 Months after Vacc 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '91.4', 'groupId': 'OG000', 'lowerLimit': '82.3', 'upperLimit': '96.8'}, {'value': '70.7', 'groupId': 'OG001', 'lowerLimit': '54.5', 'upperLimit': '83.9'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '91.2', 'upperLimit': '100.0'}, {'value': '91.3', 'groupId': 'OG003', 'lowerLimit': '72.0', 'upperLimit': '98.9'}]}]}, {'title': 'MenY 12 Months after Vacc 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '96.8', 'upperLimit': '100.0'}, {'value': '98.4', 'groupId': 'OG001', 'lowerLimit': '91.3', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '92.6', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG003', 'lowerLimit': '84.6', 'upperLimit': '100.0'}]}]}, {'title': 'MenY 24 Months after Vacc 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '61', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '96.4', 'upperLimit': '100.0'}, {'value': '93.4', 'groupId': 'OG001', 'lowerLimit': '84.1', 'upperLimit': '98.2'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '94.1', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG003', 'lowerLimit': '90.5', 'upperLimit': '100.0'}]}]}, {'title': 'MenY 36 Months after Vacc 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '96.3', 'upperLimit': '100.0'}, {'value': '90.7', 'groupId': 'OG001', 'lowerLimit': '79.7', 'upperLimit': '96.9'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '93.7', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG003', 'lowerLimit': '84.2', 'upperLimit': '100.0'}]}]}, {'title': 'MenY 48 Months after Vacc 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '94.9', 'upperLimit': '100.0'}, {'value': '95.2', 'groupId': 'OG001', 'lowerLimit': '83.8', 'upperLimit': '99.4'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '91.2', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG003', 'lowerLimit': '84.6', 'upperLimit': '100.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12, 24, 36 and 48 months after Vaccination 2 (Vacc 2)', 'description': 'Percentage of participants who achieved an hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY titer \\>=LLOQ for ACWY Test Strains (LLOQ = 1:8 for all MenA, MenC, MenW, and MenY strains) was reported in this outcome measure.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Stage 2 mITT population included all participants who signed the ICD at Month 18 and who had at least 1 valid and determinate primary strain MenB or MenA/C/W/Y assay result available in Stage 2. "Overall Number of Participants Analyzed": participants who were measured and analyzed for the outcome measure and \'Number Analyzed\' signifies number of participants with valid and determinate hSBA results for ACWY test strains at the given time point.'}, {'type': 'SECONDARY', 'title': 'Stage2: Percentage of Participants With hSBA Titer Level >=LLOQ for 4 Primary MenB Test Strains During Persistence Phase (Group 1 and 3 Combined; Group 2 and 4 Combined)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1+3 Combined (MenABCWY + Saline)', 'description': 'Stage 1: ACWY-naive and experienced participants who received an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}, {'id': 'OG001', 'title': 'Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM)', 'description': 'Stage 1: ACWY-naive and experienced participants who received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.'}], 'classes': [{'title': 'PMB80 (A22) 12 months after Vacc 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '32.7', 'groupId': 'OG000', 'lowerLimit': '25.6', 'upperLimit': '40.5'}, {'value': '26.5', 'groupId': 'OG001', 'lowerLimit': '17.4', 'upperLimit': '37.3'}]}]}, {'title': 'PMB80 (A22) 24 months after Vacc 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '36.7', 'groupId': 'OG000', 'lowerLimit': '30.0', 'upperLimit': '43.9'}, {'value': '28.9', 'groupId': 'OG001', 'lowerLimit': '21.2', 'upperLimit': '37.6'}]}]}, {'title': 'PMB80 (A22) 36 months after Vacc 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29.2', 'groupId': 'OG000', 'lowerLimit': '22.8', 'upperLimit': '36.3'}, {'value': '25.9', 'groupId': 'OG001', 'lowerLimit': '18.2', 'upperLimit': '34.8'}]}]}, {'title': 'PMB80 (A22) 48 months after Vacc 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28.1', 'groupId': 'OG000', 'lowerLimit': '20.8', 'upperLimit': '36.3'}, {'value': '31.9', 'groupId': 'OG001', 'lowerLimit': '22.7', 'upperLimit': '42.3'}]}]}, {'title': 'PMB2001 (A56) 12 months after Vacc 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000', 'lowerLimit': '26.1', 'upperLimit': '41.2'}, {'value': '32.1', 'groupId': 'OG001', 'lowerLimit': '22.4', 'upperLimit': '43.2'}]}]}, {'title': 'PMB2001 (A56) 24 months after Vacc 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '34.7', 'groupId': 'OG000', 'lowerLimit': '28.1', 'upperLimit': '41.8'}, {'value': '33.6', 'groupId': 'OG001', 'lowerLimit': '25.6', 'upperLimit': '42.4'}]}]}, {'title': 'PMB2001 (A56) 36 months after Vacc 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '186', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29.0', 'groupId': 'OG000', 'lowerLimit': '22.6', 'upperLimit': '36.1'}, {'value': '33.9', 'groupId': 'OG001', 'lowerLimit': '25.4', 'upperLimit': '43.2'}]}]}, {'title': 'PMB2001 (A56) 48 months after Vacc 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '34.5', 'groupId': 'OG000', 'lowerLimit': '26.8', 'upperLimit': '42.8'}, {'value': '29.6', 'groupId': 'OG001', 'lowerLimit': '20.8', 'upperLimit': '39.7'}]}]}, {'title': 'PMB2948 (B24) 12 months after Vacc 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30.9', 'groupId': 'OG000', 'lowerLimit': '24.0', 'upperLimit': '38.6'}, {'value': '28.2', 'groupId': 'OG001', 'lowerLimit': '19.0', 'upperLimit': '39.0'}]}]}, {'title': 'PMB2948 (B24) 24 months after Vacc 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33.2', 'groupId': 'OG000', 'lowerLimit': '26.6', 'upperLimit': '40.2'}, {'value': '27.5', 'groupId': 'OG001', 'lowerLimit': '20.0', 'upperLimit': '36.0'}]}]}, {'title': 'PMB2948 (B24) 36 months after Vacc 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '192', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '35.4', 'groupId': 'OG000', 'lowerLimit': '28.7', 'upperLimit': '42.6'}, {'value': '28.3', 'groupId': 'OG001', 'lowerLimit': '20.5', 'upperLimit': '37.3'}]}]}, {'title': 'PMB2948 (B24) 48 months after Vacc 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '36.6', 'groupId': 'OG000', 'lowerLimit': '28.7', 'upperLimit': '44.9'}, {'value': '26.5', 'groupId': 'OG001', 'lowerLimit': '18.1', 'upperLimit': '36.4'}]}]}, {'title': 'PMB2707 (B44) 12 months after Vacc 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.7', 'groupId': 'OG000', 'lowerLimit': '13.1', 'upperLimit': '25.4'}, {'value': '15.3', 'groupId': 'OG001', 'lowerLimit': '8.4', 'upperLimit': '24.7'}]}]}, {'title': 'PMB2707 (B44) 24 months after Vacc 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '200', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.0', 'groupId': 'OG000', 'lowerLimit': '12.9', 'upperLimit': '24.0'}, {'value': '18.2', 'groupId': 'OG001', 'lowerLimit': '12.0', 'upperLimit': '25.8'}]}]}, {'title': 'PMB2707 (B44) 36 months after Vacc 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '193', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.2', 'groupId': 'OG000', 'lowerLimit': '14.8', 'upperLimit': '26.6'}, {'value': '19.8', 'groupId': 'OG001', 'lowerLimit': '13.1', 'upperLimit': '28.1'}]}]}, {'title': 'PMB2707 (B44) 48 months after Vacc 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.2', 'groupId': 'OG000', 'lowerLimit': '12.4', 'upperLimit': '25.4'}, {'value': '16.2', 'groupId': 'OG001', 'lowerLimit': '9.5', 'upperLimit': '24.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12, 24, 36 and 48 months after Vaccination 2 (Vacc 2)', 'description': 'Percentage of participants who achieved an hSBA titer \\>=LLOQ for all 4 primary MenB test strains (LLOQ was 1:16 for A22 and 1:8 for A56, B24, and B44) was reported in this outcome measure.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Stage 2 mITT population analyzed. "Overall Number of Participants Analyzed": participants who were measured and analyzed for the outcome measure and \'Number Analyzed\' signifies number of participants with valid and determinate hSBA results on all 4 strains at the given time point. Analysis planned for combined Group 1 and 3, and Group 1 and 4.'}, {'type': 'SECONDARY', 'title': 'Stage2: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:8 (or >=LLOQ if Higher) for ACWY Test Strains 1 Month After Booster Vaccination: Groups 1 and 3 (Separately)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenABCWY + Saline (ACWY-Naive)', 'description': 'Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}, {'id': 'OG001', 'title': 'Group 3: MenABCWY + Saline (ACWY-Experienced)', 'description': 'Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}], 'classes': [{'title': 'MenA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '94.0', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '89.4', 'upperLimit': '100.0'}]}]}, {'title': 'MenC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '94.0', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '94.9', 'upperLimit': '100.0'}]}]}, {'title': 'MenW', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '94.0', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '89.4', 'upperLimit': '100.0'}]}]}, {'title': 'MenY', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '94.0', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '89.4', 'upperLimit': '100.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month after booster vaccination', 'description': 'Percentage of participants who achieved an hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY titer \\>=LLOQ for ACWY test strains (LLOQ = 1:8 for all MenA, MenC, MenW, and MenY strains) was reported in this outcome measure. Analysis was planned for Group 1 and 3 separately.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Booster EIP=participants who were eligible(met Stage \\[S\\] 1 eligibility criteria, continually met S 2 eligibility criteria), received booster dose (BD) as intended (same vaccine as received in S 1), had blood drawn for assay testing in required time frame at Month 55, had valid and determinate (VAD) MenB or MenA/C/W/Y assay result after BD, no major protocol violations determined by medical monitor. 'Number Analyzed': participants with VAD hSBA results for ACWY test strains at given time point."}, {'type': 'SECONDARY', 'title': 'Stage2: Percentage of Participants With hSBA Titer Level >=LLOQ for 4 Primary MenB Test Strains 1 Month After Booster Vaccination (Group 1 and 3 Combined; Group 2 and 4 Combined)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1+3 Combined (MenABCWY + Saline)', 'description': 'Stage 1: ACWY-naive and experienced participants who received an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}, {'id': 'OG001', 'title': 'Groups 2+4 Combined (Bivalent rLP2086 + MenACWY-CRM)', 'description': 'Stage 1: ACWY-naive and experienced participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received an intramuscular injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL MenACWY-CRM vaccine at Month 54.'}], 'classes': [{'title': 'PMB80 (A22)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '95.1', 'groupId': 'OG000', 'lowerLimit': '89.6', 'upperLimit': '98.2'}, {'value': '93.8', 'groupId': 'OG001', 'lowerLimit': '86.2', 'upperLimit': '98.0'}]}]}, {'title': 'PMB2001 (A56)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '97.1', 'upperLimit': '100.0'}, {'value': '98.8', 'groupId': 'OG001', 'lowerLimit': '93.7', 'upperLimit': '100.0'}]}]}, {'title': 'PMB2948 (B24)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '123', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '95.1', 'groupId': 'OG000', 'lowerLimit': '89.7', 'upperLimit': '98.2'}, {'value': '95.2', 'groupId': 'OG001', 'lowerLimit': '88.3', 'upperLimit': '98.7'}]}]}, {'title': 'PMB2707 (B44)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '99.2', 'groupId': 'OG000', 'lowerLimit': '95.7', 'upperLimit': '100.0'}, {'value': '98.8', 'groupId': 'OG001', 'lowerLimit': '93.7', 'upperLimit': '100.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month after booster vaccination', 'description': 'Percentage of participants who achieved an hSBA titer \\>=LLOQ for all 4 primary MenB test strains (LLOQ was 1:16 for A22 and 1:8 for A56, B24, and B44) was reported in this outcome measure.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Booster EIP analyzed. Here, "Overall Number of Participants analyzed" signifies number of participants who were measured and analyzed for this outcome measure. \'Number Analyzed\'=number of participants with VAD hSBA results for ACWY test strains at given time point. Analysis was planned for combined Group 1 and 3 and combined Group 2 and 4.'}, {'type': 'SECONDARY', 'title': 'Stage1: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1: Group 1 and Group 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '269', 'groupId': 'OG000'}, {'value': '269', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenABCWY + Saline (ACWY-Naive)', 'description': 'Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}, {'id': 'OG001', 'title': 'Group 3: MenABCWY + Saline (ACWY-Experienced)', 'description': 'Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}], 'classes': [{'title': 'Redness: Any', 'denoms': [{'units': 'Participants', 'counts': [{'value': '269', 'groupId': 'OG000'}, {'value': '269', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19.7', 'groupId': 'OG000', 'lowerLimit': '15.1', 'upperLimit': '25.0'}, {'value': '14.9', 'groupId': 'OG001', 'lowerLimit': '10.8', 'upperLimit': '19.7'}]}]}, {'title': 'Redness: Mild', 'denoms': [{'units': 'Participants', 'counts': [{'value': '269', 'groupId': 'OG000'}, {'value': '269', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.4', 'groupId': 'OG000', 'lowerLimit': '4.6', 'upperLimit': '11.2'}, {'value': '5.6', 'groupId': 'OG001', 'lowerLimit': '3.2', 'upperLimit': '9.0'}]}]}, {'title': 'Redness: Moderate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '269', 'groupId': 'OG000'}, {'value': '269', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000', 'lowerLimit': '6.7', 'upperLimit': '14.3'}, {'value': '7.4', 'groupId': 'OG001', 'lowerLimit': '4.6', 'upperLimit': '11.2'}]}]}, {'title': 'Redness: Severe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '269', 'groupId': 'OG000'}, {'value': '269', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000', 'lowerLimit': '0.8', 'upperLimit': '4.8'}, {'value': '1.9', 'groupId': 'OG001', 'lowerLimit': '0.6', 'upperLimit': '4.3'}]}]}, {'title': 'Swelling: Any', 'denoms': [{'units': 'Participants', 'counts': [{'value': '269', 'groupId': 'OG000'}, {'value': '269', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.8', 'groupId': 'OG000', 'lowerLimit': '16.1', 'upperLimit': '26.2'}, {'value': '17.5', 'groupId': 'OG001', 'lowerLimit': '13.1', 'upperLimit': '22.5'}]}]}, {'title': 'Swelling: Mild', 'denoms': [{'units': 'Participants', 'counts': [{'value': '269', 'groupId': 'OG000'}, {'value': '269', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.3', 'groupId': 'OG000', 'lowerLimit': '6.1', 'upperLimit': '13.4'}, {'value': '8.6', 'groupId': 'OG001', 'lowerLimit': '5.5', 'upperLimit': '12.6'}]}]}, {'title': 'Swelling: Moderate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '269', 'groupId': 'OG000'}, {'value': '269', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.4', 'groupId': 'OG000', 'lowerLimit': '7.0', 'upperLimit': '14.7'}, {'value': '8.6', 'groupId': 'OG001', 'lowerLimit': '5.5', 'upperLimit': '12.6'}]}]}, {'title': 'Swelling: Severe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '269', 'groupId': 'OG000'}, {'value': '269', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '3.2'}, {'value': '0.4', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.1'}]}]}, {'title': 'Pain at injection site: Any', 'denoms': [{'units': 'Participants', 'counts': [{'value': '269', 'groupId': 'OG000'}, {'value': '269', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '89.2', 'groupId': 'OG000', 'lowerLimit': '84.9', 'upperLimit': '92.7'}, {'value': '90.3', 'groupId': 'OG001', 'lowerLimit': '86.2', 'upperLimit': '93.6'}]}]}, {'title': 'Pain at injection site: Mild', 'denoms': [{'units': 'Participants', 'counts': [{'value': '269', 'groupId': 'OG000'}, {'value': '269', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '37.2', 'groupId': 'OG000', 'lowerLimit': '31.4', 'upperLimit': '43.3'}, {'value': '45.4', 'groupId': 'OG001', 'lowerLimit': '39.3', 'upperLimit': '51.5'}]}]}, {'title': 'Pain at injection site: Moderate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '269', 'groupId': 'OG000'}, {'value': '269', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '45.7', 'groupId': 'OG000', 'lowerLimit': '39.7', 'upperLimit': '51.9'}, {'value': '40.1', 'groupId': 'OG001', 'lowerLimit': '34.2', 'upperLimit': '46.3'}]}]}, {'title': 'Pain at injection site: Severe', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'OG000'}, {'value': '233', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.3', 'groupId': 'OG000', 'lowerLimit': '3.7', 'upperLimit': '9.9'}, {'value': '4.8', 'groupId': 'OG001', 'lowerLimit': '2.6', 'upperLimit': '8.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '7 days after Vaccination 1 (Vacc 1)', 'description': 'Local reactions (redness, swelling, and pain) at the site of investigational product administration were recorded in e-diary. Redness and swelling were measured and recorded in caliper units. Each caliper unit represented 0.5 cm. Redness and swelling were graded as mild (\\>2.0 to 5.0 cm), moderate (\\>5.0 to 10.0 cm) and severe (\\>10.0 cm). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity).', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Vaccination 1 safety population included participants who received the first dose of investigational product (MenABCWY+saline or bivalent rLP2086+MenACWY-CRM) at Visit 1 (Month 0), and for whom safety information from Visit 1 (Month 0) to prior to Visit 3 (Month 6) was available. Here, 'Number of Participants Analyzed' signifies number of participants measured and analyzed for this outcome measure. Analysis was planned for Group 1 and 3 separately."}, {'type': 'SECONDARY', 'title': 'Stage1: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2: Group 1 and Group 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'OG000'}, {'value': '233', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenABCWY + Saline (ACWY-Naive)', 'description': 'Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}, {'id': 'OG001', 'title': 'Group 3: MenABCWY + Saline (ACWY-Experienced)', 'description': 'Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}], 'classes': [{'title': 'Redness: Any', 'categories': [{'measurements': [{'value': '23.0', 'groupId': 'OG000', 'lowerLimit': '17.8', 'upperLimit': '29.0'}, {'value': '19.3', 'groupId': 'OG001', 'lowerLimit': '14.4', 'upperLimit': '25.0'}]}]}, {'title': 'Redness: Mild', 'categories': [{'measurements': [{'value': '7.0', 'groupId': 'OG000', 'lowerLimit': '4.0', 'upperLimit': '11.1'}, {'value': '6.9', 'groupId': 'OG001', 'lowerLimit': '4.0', 'upperLimit': '10.9'}]}]}, {'title': 'Redness: Moderate', 'categories': [{'measurements': [{'value': '11.7', 'groupId': 'OG000', 'lowerLimit': '7.9', 'upperLimit': '16.6'}, {'value': '9.0', 'groupId': 'OG001', 'lowerLimit': '5.7', 'upperLimit': '13.4'}]}]}, {'title': 'Redness: Severe', 'categories': [{'measurements': [{'value': '4.3', 'groupId': 'OG000', 'lowerLimit': '2.1', 'upperLimit': '7.9'}, {'value': '3.4', 'groupId': 'OG001', 'lowerLimit': '1.5', 'upperLimit': '6.7'}]}]}, {'title': 'Swelling: Any', 'categories': [{'measurements': [{'value': '19.1', 'groupId': 'OG000', 'lowerLimit': '14.3', 'upperLimit': '24.8'}, {'value': '18.0', 'groupId': 'OG001', 'lowerLimit': '13.3', 'upperLimit': '23.6'}]}]}, {'title': 'Swelling: Mild', 'categories': [{'measurements': [{'value': '8.7', 'groupId': 'OG000', 'lowerLimit': '5.4', 'upperLimit': '13.1'}, {'value': '5.6', 'groupId': 'OG001', 'lowerLimit': '3.0', 'upperLimit': '9.4'}]}]}, {'title': 'Swelling: Moderate', 'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000', 'lowerLimit': '6.4', 'upperLimit': '14.6'}, {'value': '11.2', 'groupId': 'OG001', 'lowerLimit': '7.4', 'upperLimit': '15.9'}]}]}, {'title': 'Swelling: Severe', 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.4'}, {'value': '1.3', 'groupId': 'OG001', 'lowerLimit': '0.3', 'upperLimit': '3.7'}]}]}, {'title': 'Pain at injection site: Any', 'categories': [{'measurements': [{'value': '85.2', 'groupId': 'OG000', 'lowerLimit': '80.0', 'upperLimit': '89.5'}, {'value': '83.7', 'groupId': 'OG001', 'lowerLimit': '78.3', 'upperLimit': '88.2'}]}]}, {'title': 'Pain at injection site: Mild', 'categories': [{'measurements': [{'value': '34.3', 'groupId': 'OG000', 'lowerLimit': '28.2', 'upperLimit': '40.9'}, {'value': '37.8', 'groupId': 'OG001', 'lowerLimit': '31.5', 'upperLimit': '44.3'}]}]}, {'title': 'Pain at injection site: Moderate', 'categories': [{'measurements': [{'value': '47.0', 'groupId': 'OG000', 'lowerLimit': '40.4', 'upperLimit': '53.6'}, {'value': '38.2', 'groupId': 'OG001', 'lowerLimit': '31.9', 'upperLimit': '44.8'}]}]}, {'title': 'Pain at injection site: Severe', 'categories': [{'measurements': [{'value': '3.9', 'groupId': 'OG000', 'lowerLimit': '1.8', 'upperLimit': '7.3'}, {'value': '7.7', 'groupId': 'OG001', 'lowerLimit': '4.6', 'upperLimit': '11.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '7 days after Vaccination 2 (Vacc 2)', 'description': 'Local reactions (redness, swelling, and pain) at the site of investigational product administration were recorded in e-diary. Redness and swelling were measured and recorded in caliper units. Each caliper unit represented 0.5 cm. Redness and swelling were graded as mild (\\>2.0 to 5.0 cm), moderate (\\>5.0 to 10.0 cm) and severe (\\>10.0 cm). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity).', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Vaccination 2 safety population included participants who received the second dose of investigational product (MenABCWY or bivalent rLP2086) at Visit 3 (Month 6), and for whom safety information from Visit 3 (Month 6) up to and including Visit 4 (month 7) was available. Here, 'Number of Participants Analyzed' signifies number of participants measured and analyzed for this outcome measure. Analysis was planned for Group 1 and 3 separately."}, {'type': 'SECONDARY', 'title': 'Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1: Group 1 and Group 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '269', 'groupId': 'OG000'}, {'value': '269', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenABCWY + Saline (ACWY-Naive)', 'description': 'Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}, {'id': 'OG001', 'title': 'Group 3: MenABCWY + Saline (ACWY-Experienced)', 'description': 'Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}], 'classes': [{'title': 'Fever: >= 38.0 degree C', 'categories': [{'measurements': [{'value': '7.4', 'groupId': 'OG000', 'lowerLimit': '4.6', 'upperLimit': '11.2'}, {'value': '5.2', 'groupId': 'OG001', 'lowerLimit': '2.9', 'upperLimit': '8.6'}]}]}, {'title': 'Fever: 38.0 to 38.4 degree C', 'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000', 'lowerLimit': '2.1', 'upperLimit': '7.2'}, {'value': '4.1', 'groupId': 'OG001', 'lowerLimit': '2.1', 'upperLimit': '7.2'}]}]}, {'title': 'Fever: 38.4 to 38.9 degree C', 'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000', 'lowerLimit': '0.8', 'upperLimit': '4.8'}, {'value': '0.7', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '2.7'}]}]}, {'title': 'Fever: 38.9 to 40.0 degree C', 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '3.2'}, {'value': '0.4', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.1'}]}]}, {'title': 'Fever: > 40.0 degree C', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.4'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.4'}]}]}, {'title': 'Fatigue: Any', 'categories': [{'measurements': [{'value': '56.5', 'groupId': 'OG000', 'lowerLimit': '50.4', 'upperLimit': '62.5'}, {'value': '49.1', 'groupId': 'OG001', 'lowerLimit': '42.9', 'upperLimit': '55.2'}]}]}, {'title': 'Fatigue: Mild', 'categories': [{'measurements': [{'value': '26.8', 'groupId': 'OG000', 'lowerLimit': '21.6', 'upperLimit': '32.5'}, {'value': '27.9', 'groupId': 'OG001', 'lowerLimit': '22.6', 'upperLimit': '33.6'}]}]}, {'title': 'Fatigue: Moderate', 'categories': [{'measurements': [{'value': '25.3', 'groupId': 'OG000', 'lowerLimit': '20.2', 'upperLimit': '30.9'}, {'value': '17.5', 'groupId': 'OG001', 'lowerLimit': '13.1', 'upperLimit': '22.5'}]}]}, {'title': 'Fatigue: Severe', 'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000', 'lowerLimit': '2.3', 'upperLimit': '7.7'}, {'value': '3.7', 'groupId': 'OG001', 'lowerLimit': '1.8', 'upperLimit': '6.7'}]}]}, {'title': 'Headache: Any', 'categories': [{'measurements': [{'value': '48.3', 'groupId': 'OG000', 'lowerLimit': '42.2', 'upperLimit': '54.5'}, {'value': '45.0', 'groupId': 'OG001', 'lowerLimit': '38.9', 'upperLimit': '51.1'}]}]}, {'title': 'Headache: Mild', 'categories': [{'measurements': [{'value': '27.1', 'groupId': 'OG000', 'lowerLimit': '21.9', 'upperLimit': '32.9'}, {'value': '29.4', 'groupId': 'OG001', 'lowerLimit': '24.0', 'upperLimit': '35.2'}]}]}, {'title': 'Headache: Moderate', 'categories': [{'measurements': [{'value': '19.3', 'groupId': 'OG000', 'lowerLimit': '14.8', 'upperLimit': '24.6'}, {'value': '14.1', 'groupId': 'OG001', 'lowerLimit': '10.2', 'upperLimit': '18.9'}]}]}, {'title': 'Headache: Severe', 'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000', 'lowerLimit': '0.6', 'upperLimit': '4.3'}, {'value': '1.5', 'groupId': 'OG001', 'lowerLimit': '0.4', 'upperLimit': '3.8'}]}]}, {'title': 'Chills: Any', 'categories': [{'measurements': [{'value': '20.1', 'groupId': 'OG000', 'lowerLimit': '15.5', 'upperLimit': '25.4'}, {'value': '14.9', 'groupId': 'OG001', 'lowerLimit': '10.8', 'upperLimit': '19.7'}]}]}, {'title': 'Chills: Mild', 'categories': [{'measurements': [{'value': '14.5', 'groupId': 'OG000', 'lowerLimit': '10.5', 'upperLimit': '19.3'}, {'value': '9.3', 'groupId': 'OG001', 'lowerLimit': '6.1', 'upperLimit': '13.4'}]}]}, {'title': 'Chills: Moderate', 'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000', 'lowerLimit': '2.3', 'upperLimit': '7.7'}, {'value': '4.8', 'groupId': 'OG001', 'lowerLimit': '2.6', 'upperLimit': '8.1'}]}]}, {'title': 'Chills: Severe', 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '3.2'}, {'value': '0.7', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '2.7'}]}]}, {'title': 'Vomiting: Any', 'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000', 'lowerLimit': '1.1', 'upperLimit': '5.3'}, {'value': '1.9', 'groupId': 'OG001', 'lowerLimit': '0.6', 'upperLimit': '4.3'}]}]}, {'title': 'Vomiting: Mild', 'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000', 'lowerLimit': '0.8', 'upperLimit': '4.8'}, {'value': '1.9', 'groupId': 'OG001', 'lowerLimit': '0.6', 'upperLimit': '4.3'}]}]}, {'title': 'Vomiting: Moderate', 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.1'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.4'}]}]}, {'title': 'Vomiting: severe', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.4'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.4'}]}]}, {'title': 'Diarrhea: Any', 'categories': [{'measurements': [{'value': '12.3', 'groupId': 'OG000', 'lowerLimit': '8.6', 'upperLimit': '16.8'}, {'value': '15.2', 'groupId': 'OG001', 'lowerLimit': '11.2', 'upperLimit': '20.1'}]}]}, {'title': 'Diarrhea: Mild', 'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000', 'lowerLimit': '6.7', 'upperLimit': '14.3'}, {'value': '10.8', 'groupId': 'OG001', 'lowerLimit': '7.3', 'upperLimit': '15.1'}]}]}, {'title': 'Diarrhea: Moderate', 'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000', 'lowerLimit': '0.8', 'upperLimit': '4.8'}, {'value': '4.5', 'groupId': 'OG001', 'lowerLimit': '2.3', 'upperLimit': '7.7'}]}]}, {'title': 'Diarrhea: Severe', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.4'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.4'}]}]}, {'title': 'Muscle pain: Any', 'categories': [{'measurements': [{'value': '29.0', 'groupId': 'OG000', 'lowerLimit': '23.6', 'upperLimit': '34.8'}, {'value': '22.7', 'groupId': 'OG001', 'lowerLimit': '17.8', 'upperLimit': '28.2'}]}]}, {'title': 'Muscle pain: Mild', 'categories': [{'measurements': [{'value': '17.1', 'groupId': 'OG000', 'lowerLimit': '12.8', 'upperLimit': '22.1'}, {'value': '14.5', 'groupId': 'OG001', 'lowerLimit': '10.5', 'upperLimit': '19.3'}]}]}, {'title': 'Muscle pain: Moderate', 'categories': [{'measurements': [{'value': '10.4', 'groupId': 'OG000', 'lowerLimit': '7.0', 'upperLimit': '14.7'}, {'value': '7.1', 'groupId': 'OG001', 'lowerLimit': '4.3', 'upperLimit': '10.8'}]}]}, {'title': 'Muscle pain: Severe', 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000', 'lowerLimit': '0.4', 'upperLimit': '3.8'}, {'value': '1.1', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '3.2'}]}]}, {'title': 'Joint pain: Any', 'categories': [{'measurements': [{'value': '20.8', 'groupId': 'OG000', 'lowerLimit': '16.1', 'upperLimit': '26.2'}, {'value': '18.2', 'groupId': 'OG001', 'lowerLimit': '13.8', 'upperLimit': '23.4'}]}]}, {'title': 'Joint pain: Mild', 'categories': [{'measurements': [{'value': '13.0', 'groupId': 'OG000', 'lowerLimit': '9.2', 'upperLimit': '17.6'}, {'value': '10.8', 'groupId': 'OG001', 'lowerLimit': '7.3', 'upperLimit': '15.1'}]}]}, {'title': 'Joint pain: Moderate', 'categories': [{'measurements': [{'value': '7.8', 'groupId': 'OG000', 'lowerLimit': '4.9', 'upperLimit': '11.7'}, {'value': '6.7', 'groupId': 'OG001', 'lowerLimit': '4.0', 'upperLimit': '10.4'}]}]}, {'title': 'Joint pain: Severe', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.4'}, {'value': '0.7', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '2.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '7 days after Vaccination 1 (Vacc 1)', 'description': 'Systemic events fever, vomiting, diarrhea, headache, fatigue, chills, muscle pain and joint pain were recorded in an e-diary. Fever was defined as \\>=38.0 degree C and categorized to 38.0 to 38.4 degree C, 38.5 to 38.9 degree C, 39.0 to 40.0 degree C and \\>40.0 degree C. Headache, fatigue, chills, muscle pain and joint pain were graded as mild (did not interfere with activity), moderate (some interference with activity) and severe (prevented daily activity). Vomiting was graded as mild (1-2 times in 24 hours), moderate (\\>2 times in 24 hours) and severe (required IV hydration). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours) and severe (\\>=6 in 24 hours).', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Vaccination 1 safety population included participants who received the first dose of investigational product (MenABCWY+saline or bivalent rLP2086+MenACWY-CRM) at Visit 1 (Month 0), and for whom safety information from Visit 1 (Month 0) to prior to Visit 3 (Month 6) was available. Here, 'Number of Participants Analyzed' signifies number of participants measured and analyzed for this outcome measure. Analysis was planned for Group 1 and 3 separately."}, {'type': 'SECONDARY', 'title': 'Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2: Group 1 and Group 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'OG000'}, {'value': '233', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenABCWY + Saline (ACWY-Naive)', 'description': 'Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}, {'id': 'OG001', 'title': 'Group 3: MenABCWY + Saline (ACWY-Experienced)', 'description': 'Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}], 'classes': [{'title': 'Fever: >= 38.0 degree C', 'categories': [{'measurements': [{'value': '3.5', 'groupId': 'OG000', 'lowerLimit': '1.5', 'upperLimit': '6.7'}, {'value': '1.7', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '4.3'}]}]}, {'title': 'Fever: 38.0 to 38.4°C', 'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000', 'lowerLimit': '0.7', 'upperLimit': '5.0'}, {'value': '0.9', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '3.1'}]}]}, {'title': 'Fever: 38.5 to 38.9°C', 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '3.8'}, {'value': '0.9', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '3.1'}]}]}, {'title': 'Fever: 39.0 to 40.0°C', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.6'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.6'}]}]}, {'title': 'Fever: > 40.0°C', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.6'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.6'}]}]}, {'title': 'Fatigue: Any', 'categories': [{'measurements': [{'value': '49.6', 'groupId': 'OG000', 'lowerLimit': '42.9', 'upperLimit': '56.2'}, {'value': '47.6', 'groupId': 'OG001', 'lowerLimit': '41.1', 'upperLimit': '54.3'}]}]}, {'title': 'Fatigue: Mild', 'categories': [{'measurements': [{'value': '20.9', 'groupId': 'OG000', 'lowerLimit': '15.8', 'upperLimit': '26.7'}, {'value': '26.2', 'groupId': 'OG001', 'lowerLimit': '20.7', 'upperLimit': '32.3'}]}]}, {'title': 'Fatigue: Moderate', 'categories': [{'measurements': [{'value': '26.1', 'groupId': 'OG000', 'lowerLimit': '20.5', 'upperLimit': '32.3'}, {'value': '18.9', 'groupId': 'OG001', 'lowerLimit': '14.1', 'upperLimit': '24.5'}]}]}, {'title': 'Fatigue: Severe', 'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '5.6'}, {'value': '2.6', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '5.5'}]}]}, {'title': 'Headache: Any', 'categories': [{'measurements': [{'value': '41.7', 'groupId': 'OG000', 'lowerLimit': '35.3', 'upperLimit': '48.4'}, {'value': '43.8', 'groupId': 'OG001', 'lowerLimit': '37.3', 'upperLimit': '50.4'}]}]}, {'title': 'Headache: Mild', 'categories': [{'measurements': [{'value': '22.6', 'groupId': 'OG000', 'lowerLimit': '17.4', 'upperLimit': '28.6'}, {'value': '26.6', 'groupId': 'OG001', 'lowerLimit': '21.1', 'upperLimit': '32.8'}]}]}, {'title': 'Headache: Moderate', 'categories': [{'measurements': [{'value': '17.8', 'groupId': 'OG000', 'lowerLimit': '13.1', 'upperLimit': '23.4'}, {'value': '13.3', 'groupId': 'OG001', 'lowerLimit': '9.2', 'upperLimit': '18.4'}]}]}, {'title': 'Headache: Severe', 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000', 'lowerLimit': '0.3', 'upperLimit': '3.8'}, {'value': '3.9', 'groupId': 'OG001', 'lowerLimit': '1.8', 'upperLimit': '7.2'}]}]}, {'title': 'Chills: Any', 'categories': [{'measurements': [{'value': '20.9', 'groupId': 'OG000', 'lowerLimit': '15.8', 'upperLimit': '26.7'}, {'value': '19.3', 'groupId': 'OG001', 'lowerLimit': '14.4', 'upperLimit': '25.0'}]}]}, {'title': 'Chills: Mild', 'categories': [{'measurements': [{'value': '16.1', 'groupId': 'OG000', 'lowerLimit': '11.6', 'upperLimit': '21.5'}, {'value': '11.6', 'groupId': 'OG001', 'lowerLimit': '7.8', 'upperLimit': '16.4'}]}]}, {'title': 'Chills: Moderate', 'categories': [{'measurements': [{'value': '3.9', 'groupId': 'OG000', 'lowerLimit': '1.8', 'upperLimit': '7.3'}, {'value': '5.2', 'groupId': 'OG001', 'lowerLimit': '2.7', 'upperLimit': '8.8'}]}]}, {'title': 'Chills: Severe', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '3.1'}, {'value': '2.6', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '5.5'}]}]}, {'title': 'Vomiting: Any', 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '4.4'}, {'value': '3.9', 'groupId': 'OG001', 'lowerLimit': '1.8', 'upperLimit': '7.2'}]}]}, {'title': 'Vomiting: Mild', 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '4.4'}, {'value': '3.4', 'groupId': 'OG001', 'lowerLimit': '1.5', 'upperLimit': '6.7'}]}]}, {'title': 'Vomiting: Moderate', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.6'}, {'value': '0.4', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.4'}]}]}, {'title': 'Vomiting: Severe', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.6'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.6'}]}]}, {'title': 'Diarrhea: Any', 'categories': [{'measurements': [{'value': '13.5', 'groupId': 'OG000', 'lowerLimit': '9.3', 'upperLimit': '18.6'}, {'value': '8.2', 'groupId': 'OG001', 'lowerLimit': '5.0', 'upperLimit': '12.4'}]}]}, {'title': 'Diarrhea: Mild', 'categories': [{'measurements': [{'value': '9.6', 'groupId': 'OG000', 'lowerLimit': '6.1', 'upperLimit': '14.1'}, {'value': '5.2', 'groupId': 'OG001', 'lowerLimit': '2.7', 'upperLimit': '8.8'}]}]}, {'title': 'Diarrhea: Moderate', 'categories': [{'measurements': [{'value': '3.9', 'groupId': 'OG000', 'lowerLimit': '1.8', 'upperLimit': '7.3'}, {'value': '2.6', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '5.5'}]}]}, {'title': 'Diarrhea: Severe', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.6'}, {'value': '0.4', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.4'}]}]}, {'title': 'Muscle pain: Any', 'categories': [{'measurements': [{'value': '24.8', 'groupId': 'OG000', 'lowerLimit': '19.3', 'upperLimit': '30.9'}, {'value': '19.3', 'groupId': 'OG001', 'lowerLimit': '14.4', 'upperLimit': '25.0'}]}]}, {'title': 'Muscle pain: Mild', 'categories': [{'measurements': [{'value': '13.0', 'groupId': 'OG000', 'lowerLimit': '9.0', 'upperLimit': '18.1'}, {'value': '8.6', 'groupId': 'OG001', 'lowerLimit': '5.3', 'upperLimit': '12.9'}]}]}, {'title': 'Muscle pain: Moderate', 'categories': [{'measurements': [{'value': '10.9', 'groupId': 'OG000', 'lowerLimit': '7.2', 'upperLimit': '15.6'}, {'value': '9.9', 'groupId': 'OG001', 'lowerLimit': '6.4', 'upperLimit': '14.4'}]}]}, {'title': 'Muscle pain: Severe', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '3.1'}, {'value': '0.9', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '3.1'}]}]}, {'title': 'Joint pain: Any', 'categories': [{'measurements': [{'value': '18.7', 'groupId': 'OG000', 'lowerLimit': '13.9', 'upperLimit': '24.3'}, {'value': '18.0', 'groupId': 'OG001', 'lowerLimit': '13.3', 'upperLimit': '23.6'}]}]}, {'title': 'Joint pain: Mild', 'categories': [{'measurements': [{'value': '9.1', 'groupId': 'OG000', 'lowerLimit': '5.7', 'upperLimit': '13.6'}, {'value': '10.7', 'groupId': 'OG001', 'lowerLimit': '7.1', 'upperLimit': '15.4'}]}]}, {'title': 'Joint pain: Moderate', 'categories': [{'measurements': [{'value': '9.1', 'groupId': 'OG000', 'lowerLimit': '5.7', 'upperLimit': '13.6'}, {'value': '6.4', 'groupId': 'OG001', 'lowerLimit': '3.6', 'upperLimit': '10.4'}]}]}, {'title': 'Joint pain: Severe', 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.4'}, {'value': '0.9', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '3.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '7 days after Vaccination 2 (Vacc 2)', 'description': 'Systemic events fever, vomiting, diarrhea, headache, fatigue, chills, muscle pain and joint pain were recorded in an e-diary. Fever was defined as \\>=38.0 degree C and categorized to 38.0 to 38.4 degree C, 38.5 to 38.9 degree C, 39.0 to 40.0 degree C and \\>40.0 degree C. Headache, fatigue, chills, muscle pain and joint pain were graded as mild (did not interfere with activity), moderate (some interference with activity) and severe (prevented daily activity). Vomiting was graded as mild (1-2 times in 24 hours), moderate (\\>2 times in 24 hours) and severe (required IV hydration). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours) and severe (\\>=6 in 24 hours).', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Vaccination 2 safety population included participants who received the second dose of investigational product (MenABCWY or bivalent rLP2086) at Visit 3 (Month 6), and for whom safety information from Visit 3 (Month 6) up to and including Visit 4 (month 7) was available. Here, 'Number of Participants Analyzed' signifies number of participants measured and analyzed for this outcome measure. Analysis was planned for Group 1 and 3 separately."}, {'type': 'SECONDARY', 'title': 'Stage1: Percentage of Participants With Antipyretic Medication Use 30 Days After Vaccination 1: Group 1 and Group 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '269', 'groupId': 'OG000'}, {'value': '269', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenABCWY + Saline (ACWY-Naive)', 'description': 'Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}, {'id': 'OG001', 'title': 'Group 3: MenABCWY + Saline (ACWY-Experienced)', 'description': 'Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.8', 'groupId': 'OG000', 'lowerLimit': '16.1', 'upperLimit': '26.2'}, {'value': '13.8', 'groupId': 'OG001', 'lowerLimit': '9.9', 'upperLimit': '18.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days after Vaccination 1', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Vaccination 1 safety population included participants who received the first dose of investigational product (MenABCWY+saline or bivalent rLP2086+MenACWY-CRM) at Visit 1 (Month 0), and for whom safety information from Visit 1 (Month 0) to prior to Visit 3 (Month 6) was available. Here, 'Number of Participants Analyzed' signifies number of participants measured and analyzed for this outcome measure. Analysis was planned for Group 1 and Group 3 separately."}, {'type': 'SECONDARY', 'title': 'Stage1: Percentage of Participants With Antipyretic Medication Use 30 Days After Vaccination 2: Group 1 and Group 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'OG000'}, {'value': '233', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenABCWY + Saline (ACWY-Naive)', 'description': 'Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}, {'id': 'OG001', 'title': 'Group 3: MenABCWY + Saline (ACWY-Experienced)', 'description': 'Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.8', 'groupId': 'OG000', 'lowerLimit': '13.1', 'upperLimit': '23.4'}, {'value': '13.3', 'groupId': 'OG001', 'lowerLimit': '9.2', 'upperLimit': '18.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days after Vaccination 2', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "Vaccination 2 safety population included participants who received the second dose of investigational product (MenABCWY or bivalent rLP2086) at Visit 3 (Month 6), and for whom safety information from Visit 3 (Month 6) up to and including Visit 4 (month 7) was available. Here, 'Number of Participants Analyzed' signifies number of participants measured and analyzed for this outcome measure. Analysis was planned for Group 1 and Group 3 separately."}, {'type': 'SECONDARY', 'title': 'Stage1: Percentage of Participants With at Least 1 SAE Within 30 Days After Vaccination 1: Group 1 and Group 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenABCWY + Saline (ACWY-Naive)', 'description': 'Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}, {'id': 'OG001', 'title': 'Group 3: MenABCWY + Saline (ACWY-Experienced)', 'description': 'Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.3'}, {'value': '0.7', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '2.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days after Vaccination 1', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Vaccination 1 safety population included participants who received the first dose of investigational product (MenABCWY+saline or bivalent rLP2086+MenACWY-CRM) at Visit 1 (Month 0), and for whom safety information from Visit 1 (Month 0) to prior to Visit 3 (Month 6) was available. Analysis was planned for Group 1 and Group 3 separately.'}, {'type': 'SECONDARY', 'title': 'Stage1: Percentage of Participants With at Least 1 SAE Within 30 Days After Vaccination 2: Group 1 and Group 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '242', 'groupId': 'OG000'}, {'value': '244', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenABCWY + Saline (ACWY-Naive)', 'description': 'Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}, {'id': 'OG001', 'title': 'Group 3: MenABCWY + Saline (ACWY-Experienced)', 'description': 'Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.3'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days after Vaccination 2', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Vaccination 2 safety population included participants who received the second dose of investigational product (MenABCWY or bivalent rLP2086) at Visit 3 (Month 6), and for whom safety information from Visit 3 (Month 6) up to and including Visit 4 (month 7) was available. Analysis was planned for Group 1 and Group 3 separately.'}, {'type': 'SECONDARY', 'title': 'Stage1: Percentage of Participants With at Least 1 SAE Within 30 Days After Any Vaccination: Group 1 and Group 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenABCWY + Saline (ACWY-Naive)', 'description': 'Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}, {'id': 'OG001', 'title': 'Group 3: MenABCWY + Saline (ACWY-Experienced)', 'description': 'Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.0'}, {'value': '0.7', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '2.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days after any vaccination', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population for Stage 1 included participants who had received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Analysis was planned for Group 1 and Group 3 separately.'}, {'type': 'SECONDARY', 'title': 'Stage1: Percentage of Participants With at Least 1 SAE During the Vaccination Phase: Group 1 and Group 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenABCWY + Saline (ACWY-Naive)', 'description': 'Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}, {'id': 'OG001', 'title': 'Group 3: MenABCWY + Saline (ACWY-Experienced)', 'description': 'Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.0'}, {'value': '1.8', 'groupId': 'OG001', 'lowerLimit': '0.6', 'upperLimit': '4.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Stage 1 Vaccination Phase: From Vaccination 1 through 1 month after Vaccination 2 (7 Months)', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Stage 1 safety population: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Analysis was planned for Group 1 and 3 separately.'}, {'type': 'SECONDARY', 'title': 'Stage1: Percentage of Participants With at Least 1 SAE During the Stage 1 Follow-up Phase: Group 1 and Group 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '239', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenABCWY + Saline (ACWY-Naive)', 'description': 'Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}, {'id': 'OG001', 'title': 'Group 3: MenABCWY + Saline (ACWY-Experienced)', 'description': 'Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '3.0'}, {'value': '0.4', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Stage 1 Follow-up phase: From 1 month after Vaccination 2 through 6 months after Vaccination 2 (5 Months)', 'description': "An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event. There was one participant who did not meet criteria for Stage 1 follow-up safety population. The subject's SAE happened in the follow-up phase but was not included in the follow-up safety population for Stage 1 (but in the safety population for Stage 1). Therefore, the SAE was not included in the follow-up table but in the broadly defined throughout Stage 1 table.", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Stage 1 Follow-up Safety population: participants who received at least 1 dose of investigational product and for whom safety information was available from after Visit 4 (Month 7) up to and including Visit 5 (Month 12). Analysis was planned for Group 1 and 3 separately. Overall number of participants analysed included only those participants who met criteria for Stage 1 follow-up safety population.'}, {'type': 'SECONDARY', 'title': 'Stage1: Percentage of Participants With at Least 1 SAE Throughout the Stage 1: Group 1 and Group 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenABCWY + Saline (ACWY-Naive)', 'description': 'Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}, {'id': 'OG001', 'title': 'Group 3: MenABCWY + Saline (ACWY-Experienced)', 'description': 'Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000', 'lowerLimit': '0.4', 'upperLimit': '3.7'}, {'value': '2.2', 'groupId': 'OG001', 'lowerLimit': '0.8', 'upperLimit': '4.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Throughout Stage 1: From the Vaccination 1 through 6 months after Vaccination 2 (12 Months)', 'description': "An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event. There was one participant who did not meet criteria for Stage 1 follow-up safety population. The subject's SAE happened in the follow-up phase but was not included in the follow-up safety population for Stage 1 (but in the safety population for Stage 1). Therefore, the SAE was not included in the follow-up table but in the broadly defined throughout Stage 1 table.", 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Stage 1 safety population: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Analysis was planned for Group 1 and 3 separately. Here overall number of participants analysed included those participants who met criteria for Stage 1 safety population.'}, {'type': 'SECONDARY', 'title': 'Stage1: Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Vaccination 1: Group 1 and Group 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenABCWY + Saline (ACWY-Naive)', 'description': 'Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}, {'id': 'OG001', 'title': 'Group 3: MenABCWY + Saline (ACWY-Experienced)', 'description': 'Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.8', 'groupId': 'OG000', 'lowerLimit': '2.6', 'upperLimit': '8.0'}, {'value': '5.9', 'groupId': 'OG001', 'lowerLimit': '3.4', 'upperLimit': '9.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days after vaccination 1', 'description': 'Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Vaccination 1 safety population included participants who received the first dose of investigational product (MenABCWY+saline or bivalent rLP2086+MenACWY-CRM) at Visit 1 (Month 0), and for whom safety information from Visit 1 (Month 0) to prior to Visit 3 (Month 6) was available. Analysis was planned for Group 1 and Group 3 separately.'}, {'type': 'SECONDARY', 'title': 'Stage1: Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Vaccination 2: Group 1 and Group 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '242', 'groupId': 'OG000'}, {'value': '244', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenABCWY + Saline (ACWY-Naive)', 'description': 'Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}, {'id': 'OG001', 'title': 'Group 3: MenABCWY + Saline (ACWY-Experienced)', 'description': 'Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.8', 'groupId': 'OG000', 'lowerLimit': '3.2', 'upperLimit': '9.5'}, {'value': '9.0', 'groupId': 'OG001', 'lowerLimit': '5.7', 'upperLimit': '13.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days after vaccination 2', 'description': 'Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Vaccination 2 safety population included participants who received the second dose of investigational product (MenABCWY or bivalent rLP2086) at Visit 3 (Month 6), and for whom safety information from Visit 3 (Month 6) up to and including Visit 4 (month 7) was available. Analysis was planned for Group 1 and Group 3 separately.'}, {'type': 'SECONDARY', 'title': 'Stage1: Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Any Vaccination: Group 1 and Group 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenABCWY + Saline (ACWY-Naive)', 'description': 'Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}, {'id': 'OG001', 'title': 'Group 3: MenABCWY + Saline (ACWY-Experienced)', 'description': 'Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.6', 'groupId': 'OG000', 'lowerLimit': '6.3', 'upperLimit': '13.7'}, {'value': '13.3', 'groupId': 'OG001', 'lowerLimit': '9.5', 'upperLimit': '17.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days after any vaccination', 'description': 'Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Stage 1 safety population: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Analysis was planned for Group 1 and Group 3 separately.'}, {'type': 'SECONDARY', 'title': 'Stage1: Percentage of Participants With at Least 1 Medically Attended AE During the Stage 1 Vaccination Phase: Group 1 and Group 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenABCWY + Saline (ACWY-Naive)', 'description': 'Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}, {'id': 'OG001', 'title': 'Group 3: MenABCWY + Saline (ACWY-Experienced)', 'description': 'Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}], 'classes': [{'categories': [{'measurements': [{'value': '23.9', 'groupId': 'OG000', 'lowerLimit': '19.0', 'upperLimit': '29.4'}, {'value': '28.4', 'groupId': 'OG001', 'lowerLimit': '23.1', 'upperLimit': '34.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Stage 1 Vaccination Phase: From Vaccination 1 through 1 month after Vaccination 2 (7 Months)', 'description': 'Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Stage 1 safety population: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Analysis was planned for Group 1 and 3 separately.'}, {'type': 'SECONDARY', 'title': 'Stage1: Percentage of Participants With at Least 1 Medically Attended AE During the Stage 1 Follow-up Phase: Group 1 and Group 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '239', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenABCWY + Saline (ACWY-Naive)', 'description': 'Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}, {'id': 'OG001', 'title': 'Group 3: MenABCWY + Saline (ACWY-Experienced)', 'description': 'Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.8', 'groupId': 'OG000', 'lowerLimit': '9.7', 'upperLimit': '18.8'}, {'value': '18.8', 'groupId': 'OG001', 'lowerLimit': '14.1', 'upperLimit': '24.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Stage 1 Follow-up phase: From 1 month after Vaccination 2 through 6 months after Vaccination 2 (5 Months)', 'description': 'Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Stage 1 Follow-up Safety population: participants who received at least 1 dose of investigational product and for whom safety information was available from after Visit 4 (Month 7) up to and including Visit 5 (Month 12). Analysis was planned for Group 1 and 3 separately.'}, {'type': 'SECONDARY', 'title': 'Stage1: Percentage of Participants With at Least 1 Medically Attended AE Throughout the Stage 1: Group 1 and Group 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenABCWY + Saline (ACWY-Naive)', 'description': 'Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}, {'id': 'OG001', 'title': 'Group 3: MenABCWY + Saline (ACWY-Experienced)', 'description': 'Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}], 'classes': [{'categories': [{'measurements': [{'value': '30.9', 'groupId': 'OG000', 'lowerLimit': '25.4', 'upperLimit': '36.7'}, {'value': '35.1', 'groupId': 'OG001', 'lowerLimit': '29.4', 'upperLimit': '41.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Throughout Stage 1: From the Vaccination 1 through 6 months after Vaccination 2 (12 Months)', 'description': 'Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Stage 1 safety population: Participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Analysis was planned for Group 1 and 3 separately.'}, {'type': 'SECONDARY', 'title': 'Stage1: Percentage of Participants With at Least 1 NDCMC Within 30 Days After Vaccination 1: Group 1 and Group 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenABCWY + Saline (ACWY-Naive)', 'description': 'Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}, {'id': 'OG001', 'title': 'Group 3: MenABCWY + Saline (ACWY-Experienced)', 'description': 'Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.3'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days after vaccination 1', 'description': 'A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Vaccination 1 safety population included participants who received the first dose of investigational product (MenABCWY+saline or bivalent rLP2086+MenACWY-CRM) at Visit 1 (Month 0), and for whom safety information from Visit 1 (Month 0) to prior to Visit 3 (Month 6) was available. Analysis was planned for Group 1 and Group 3 separately.'}, {'type': 'SECONDARY', 'title': 'Stage1: Percentage of Participants With at Least 1 NDCMC Within 30 Days After Vaccination 2: Group 1 and Group 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '242', 'groupId': 'OG000'}, {'value': '244', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenABCWY + Saline (ACWY-Naive)', 'description': 'Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}, {'id': 'OG001', 'title': 'Group 3: MenABCWY + Saline (ACWY-Experienced)', 'description': 'Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.5'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days after vaccination 2', 'description': 'A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Vaccination 2 safety population included participants who received the second dose of investigational product (MenABCWY or bivalent rLP2086) at Visit 3 (Month 6), and for whom safety information from Visit 3 (Month 6) up to and including Visit 4 (month 7) was available. Analysis was planned for Group 1 and Group 3 separately.'}, {'type': 'SECONDARY', 'title': 'Stage1: Percentage of Participants With at Least 1 NDCMC Within 30 Days After Any Vaccination: Group 1 and Group 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenABCWY + Saline (ACWY-Naive)', 'description': 'Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}, {'id': 'OG001', 'title': 'Group 3: MenABCWY + Saline (ACWY-Experienced)', 'description': 'Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.3'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days after any vaccination', 'description': 'A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Stage 1 safety population: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Analysis was planned for Group 1 and Group 3 separately.'}, {'type': 'SECONDARY', 'title': 'Stage1: Percentage of Participants With at Least 1 NDCMC During the Stage 1 Vaccination Phase: Group 1 and Group 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenABCWY + Saline (ACWY-Naive)', 'description': 'Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}, {'id': 'OG001', 'title': 'Group 3: MenABCWY + Saline (ACWY-Experienced)', 'description': 'Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '2.6'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Stage 1 Vaccination Phase: From Vaccination 1 through 1 month after Vaccination 2 (7 Months)', 'description': 'A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Stage 1 safety population: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Analysis was planned for Group 1 and Group 3 separately.'}, {'type': 'SECONDARY', 'title': 'Stage1: Percentage of Participants With at Least 1 NDCMC During the Stage 1 Follow-up Phase: Group 1 and Group 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '239', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenABCWY + Saline (ACWY-Naive)', 'description': 'Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}, {'id': 'OG001', 'title': 'Group 3: MenABCWY + Saline (ACWY-Experienced)', 'description': 'Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.3'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Stage 1 Follow-up phase: From 1 month after Vaccination 2 through 6 months after Vaccination 2 (5 Months)', 'description': 'A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Stage 1 Follow-up Safety population: participants who received at least 1 dose of investigational product and for whom safety information was available from after Visit 4 (Month 7) up to and including Visit 5 (Month 12). Analysis was planned for Group 1 and Group 3 separately.'}, {'type': 'SECONDARY', 'title': 'Stage1: Percentage of Participants With at Least 1 NDCMC Throughout the Stage 1: Group 1 and Group 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenABCWY + Saline (ACWY-Naive)', 'description': 'Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}, {'id': 'OG001', 'title': 'Group 3: MenABCWY + Saline (ACWY-Experienced)', 'description': 'Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '3.2'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Throughout Stage 1: From the Vaccination 1 through 6 months after Vaccination 2 (12 Months)', 'description': 'A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Stage 1 safety population: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Analysis was planned for Group 1 and Group 3 separately.'}, {'type': 'SECONDARY', 'title': 'Stage1: Percentage of Participants With at Least 1 AE Within 30 Days After Vaccination 1: Group 1 and Group 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenABCWY + Saline (ACWY-Naive)', 'description': 'Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}, {'id': 'OG001', 'title': 'Group 3: MenABCWY + Saline (ACWY-Experienced)', 'description': 'Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.1', 'groupId': 'OG000', 'lowerLimit': '11.0', 'upperLimit': '19.9'}, {'value': '11.1', 'groupId': 'OG001', 'lowerLimit': '7.6', 'upperLimit': '15.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days after vaccination 1', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs did not include local reaction and systemic events collected by systematic approach.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Vaccination 1 safety population included participants who received the first dose of investigational product (MenABCWY+saline or bivalent rLP2086+MenACWY-CRM) at Visit 1 (Month 0), and for whom safety information from Visit 1 (Month 0) to prior to Visit 3 (Month 6) was available. Analysis was planned for Group 1 and Group 3 separately.'}, {'type': 'SECONDARY', 'title': 'Stage1: Percentage of Participants With at Least 1 AE Within 30 Days After Vaccination 2: Group 1 and Group 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '242', 'groupId': 'OG000'}, {'value': '244', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenABCWY + Saline (ACWY-Naive)', 'description': 'Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}, {'id': 'OG001', 'title': 'Group 3: MenABCWY + Saline (ACWY-Experienced)', 'description': 'Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.1', 'groupId': 'OG000', 'lowerLimit': '11.7', 'upperLimit': '21.4'}, {'value': '12.3', 'groupId': 'OG001', 'lowerLimit': '8.5', 'upperLimit': '17.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days after vaccination 2', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs did not include local reaction and systemic events collected by systematic approach.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Vaccination 2 safety population included participants who received the second dose of investigational product (MenABCWY or bivalent rLP2086) at Visit 3 (Month 6), and for whom safety information from Visit 3 (Month 6) up to and including Visit 4 (month 7) was available. Analysis was planned for Group 1 and Group 3 separately.'}, {'type': 'SECONDARY', 'title': 'Stage1: Percentage of Participants With at Least 1 AE Within 30 Days After Vaccination Any Vaccination: Group 1 and Group 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenABCWY + Saline (ACWY-Naive)', 'description': 'Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}, {'id': 'OG001', 'title': 'Group 3: MenABCWY + Saline (ACWY-Experienced)', 'description': 'Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}], 'classes': [{'categories': [{'measurements': [{'value': '25.7', 'groupId': 'OG000', 'lowerLimit': '20.6', 'upperLimit': '31.4'}, {'value': '19.9', 'groupId': 'OG001', 'lowerLimit': '15.3', 'upperLimit': '25.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 days after any vaccination', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs did not include local reaction and systemic events collected by systematic approach.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Stage 1 safety population: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Analysis was planned for Group 1 and Group 3 separately.'}, {'type': 'SECONDARY', 'title': 'Stage1: Percentage of Participants With at Least 1 AE During the Stage 1 Vaccination Phase: Group 1 and Group 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenABCWY + Saline (ACWY-Naive)', 'description': 'Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}, {'id': 'OG001', 'title': 'Group 3: MenABCWY + Saline (ACWY-Experienced)', 'description': 'Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}], 'classes': [{'categories': [{'measurements': [{'value': '41.5', 'groupId': 'OG000', 'lowerLimit': '35.6', 'upperLimit': '47.6'}, {'value': '36.9', 'groupId': 'OG001', 'lowerLimit': '31.1', 'upperLimit': '42.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Stage 1 Vaccination Phase: From Vaccination 1 through 1 month after Vaccination 2 (7 Months)', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs did not include local reaction and systemic events collected by systematic approach.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Stage 1 safety population: participants who received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Analysis was planned for Group 1 and Group 3 separately.'}, {'type': 'SECONDARY', 'title': 'Stage1: Percentage of Participants With at Least 1 Immediate AE After Vaccination 1: Group 1 and Group 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenABCWY + Saline (ACWY-Naive)', 'description': 'Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}, {'id': 'OG001', 'title': 'Group 3: MenABCWY + Saline (ACWY-Experienced)', 'description': 'Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.3'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 minutes after Vaccination 1', 'description': 'Immediate AE was defined as AE occurring within the first 30 minutes after investigational product administration.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Vaccination 1 safety population included participants who received the first dose of investigational product (MenABCWY+saline or bivalent rLP2086+MenACWY-CRM) at Visit 1 (Month 0), and for whom safety information from Visit 1 (Month 0) to prior to Visit 3 (Month 6) was available. Analysis was planned for Group 1 and 3 separately.'}, {'type': 'SECONDARY', 'title': 'Stage1: Percentage of Participants With at Least 1 Immediate AE After Vaccination 2: Group 1 and Group 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '242', 'groupId': 'OG000'}, {'value': '244', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenABCWY + Saline (ACWY-Naive)', 'description': 'Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}, {'id': 'OG001', 'title': 'Group 3: MenABCWY + Saline (ACWY-Experienced)', 'description': 'Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '1.5'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '1.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 minutes after Vaccination 2', 'description': 'Immediate AE was defined as AE occurring within the first 30 minutes after investigational product administration.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Vaccination 2 safety population included participants who received the second dose of investigational product (MenABCWY or bivalent rLP2086) at Visit 3 (Month 6), and for whom safety information from Visit 3 (Month 6) up to and including Visit 4 (month 7) was available. Analysis was planned for Group 1 and 3 separately.'}, {'type': 'SECONDARY', 'title': 'Stage1: Number of Participants Who Missed School/Work Due to AE During the Stage 1 Vaccination Phase: Group 1 and Group 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'OG000'}, {'value': '271', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: MenABCWY + Saline (ACWY-Naive)', 'description': 'Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}, {'id': 'OG001', 'title': 'Group 3: MenABCWY + Saline (ACWY-Experienced)', 'description': 'Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54.'}], 'classes': [{'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Stage 1 Vaccination Phase: From Vaccination 1 through 1 month after Vaccination 2 (7 Months)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population for Stage 1 included participants who had received at least 1 dose of investigational product during Stage 1 and for whom safety data were available. Analysis was planned for Group 1 and Group 3 separately.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group 1: MenABCWY + Saline (ACWY-Naive)', 'description': 'Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants had blood drawn for antibody persistence at Month 18, 30, 42. There was a blood draw at Month 0, Month 6 and Month 54 before Vaccination 1, 2 and Booster vaccination. Post vaccination blood draw happened at 1 month after Vaccination 1, 2 and Booster vaccination. Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54. There was a safety follow-up 6 months after Vaccination 2 in Stage 1 (Visit 5) and 6 months after Booster Vaccination in Stage 2 (Visit 12).'}, {'id': 'FG001', 'title': 'Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive)', 'description': 'Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants had blood drawn for antibody persistence at Month 18, 30, 42. There was a blood draw at Month 0, Month 6 and Month 54 before Vaccination 1, 2 and Booster vaccination. Post vaccination blood draw happened at 1 month after Vaccination 1, 2 and Booster vaccination. Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54. There was a safety follow-up 6 months after Vaccination 2 in Stage 1 (Visit 5) and 6 months after Booster Vaccination in Stage 2 (Visit 12).'}, {'id': 'FG002', 'title': 'Group 3: MenABCWY + Saline (ACWY-Experienced)', 'description': 'Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants had blood drawn for antibody persistence at Month 18, 30, 42. There was a blood draw at Month 0, Month 6 and Month 54 before Vaccination 1, 2 and Booster vaccination. Post vaccination blood draw happened at 1 month after Vaccination 1, 2 and Booster vaccination. Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54. There was a safety follow-up 6 months after Vaccination 2 in Stage 1 (Visit 5) and 6 months after Booster Vaccination in Stage 2 (Visit 12).'}, {'id': 'FG003', 'title': 'Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced)', 'description': 'Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants had blood drawn for antibody persistence at Month 18, 30, 42. There was a blood draw at Month 0, Month 6 and Month 54 before Vaccination 1, 2 and Booster vaccination. Post vaccination blood draw happened at 1 month after Vaccination 1, 2 and Booster vaccination. Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54. There was a safety follow-up 6 months after Vaccination 2 in Stage 1 (Visit 5) and 6 months after Booster Vaccination in Stage 2 (Visit 12).'}], 'periods': [{'title': 'Stage 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '272'}, {'groupId': 'FG001', 'numSubjects': '537'}, {'groupId': 'FG002', 'numSubjects': '272'}, {'groupId': 'FG003', 'numSubjects': '529'}]}, {'type': 'Vaccination 1 at Month 0', 'achievements': [{'groupId': 'FG000', 'numSubjects': '272'}, {'groupId': 'FG001', 'numSubjects': '534'}, {'groupId': 'FG002', 'numSubjects': '271'}, {'groupId': 'FG003', 'numSubjects': '523'}]}, {'type': 'Vaccination 2 at Month 6', 'achievements': [{'groupId': 'FG000', 'numSubjects': '242'}, {'groupId': 'FG001', 'numSubjects': '469'}, {'groupId': 'FG002', 'numSubjects': '244'}, {'groupId': 'FG003', 'numSubjects': '477'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Completed Vaccination', 'groupId': 'FG000', 'numSubjects': '233'}, {'comment': 'Completed Vaccination', 'groupId': 'FG001', 'numSubjects': '462'}, {'comment': 'Completed Vaccination', 'groupId': 'FG002', 'numSubjects': '232'}, {'comment': 'Completed Vaccination', 'groupId': 'FG003', 'numSubjects': '463'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '75'}, {'groupId': 'FG002', 'numSubjects': '40'}, {'groupId': 'FG003', 'numSubjects': '66'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '24'}, {'groupId': 'FG002', 'numSubjects': '21'}, {'groupId': 'FG003', 'numSubjects': '38'}]}, {'type': 'No longer met eligibility criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Withdrawal by parent/guardian', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '22'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '10'}]}, {'type': 'Randomized but not Vaccinated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '6'}]}]}, {'title': 'Stage 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Eligible participants entered Stage 2.', 'groupId': 'FG000', 'numSubjects': '114'}, {'comment': 'Eligible participants entered Stage 2.', 'groupId': 'FG001', 'numSubjects': '65'}, {'comment': 'Eligible participants entered Stage 2.', 'groupId': 'FG002', 'numSubjects': '101'}, {'comment': 'Eligible participants entered Stage 2.', 'groupId': 'FG003', 'numSubjects': '73'}]}, {'type': 'Antibody Persistence: Blood Draw Month18', 'achievements': [{'groupId': 'FG000', 'numSubjects': '114'}, {'groupId': 'FG001', 'numSubjects': '63'}, {'groupId': 'FG002', 'numSubjects': '53'}, {'groupId': 'FG003', 'numSubjects': '23'}]}, {'type': 'Antibody Persistence: Blood Draw Month 30', 'achievements': [{'groupId': 'FG000', 'numSubjects': '104'}, {'groupId': 'FG001', 'numSubjects': '61'}, {'groupId': 'FG002', 'numSubjects': '96'}, {'groupId': 'FG003', 'numSubjects': '71'}]}, {'type': 'Antibody Persistence: Blood Draw Month 42', 'achievements': [{'groupId': 'FG000', 'numSubjects': '97'}, {'groupId': 'FG001', 'numSubjects': '55'}, {'groupId': 'FG002', 'numSubjects': '97'}, {'groupId': 'FG003', 'numSubjects': '68'}]}, {'type': 'Received Booster Vaccination', 'achievements': [{'groupId': 'FG000', 'numSubjects': '67'}, {'groupId': 'FG001', 'numSubjects': '40'}, {'groupId': 'FG002', 'numSubjects': '77'}, {'comment': 'Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized).', 'groupId': 'FG003', 'numSubjects': '58'}]}, {'type': 'COMPLETED', 'comment': 'Completed Stage 2', 'achievements': [{'comment': 'Completed Stage 2', 'groupId': 'FG000', 'numSubjects': '67'}, {'comment': 'Completed Stage 2', 'groupId': 'FG001', 'numSubjects': '38'}, {'comment': 'Completed Stage 2', 'groupId': 'FG002', 'numSubjects': '77'}, {'comment': 'Completed Stage 2', 'groupId': 'FG003', 'numSubjects': '58'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '27'}, {'groupId': 'FG002', 'numSubjects': '24'}, {'groupId': 'FG003', 'numSubjects': '15'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawn Before Booster Vaccination', 'reasons': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '24'}, {'groupId': 'FG002', 'numSubjects': '24'}, {'groupId': 'FG003', 'numSubjects': '15'}]}, {'type': 'Did not receive Booster Vaccination', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The study had 2 stages: 1 and 2. Study was conducted at 68 sites in Stage 1, with 39 of those sites participating in Stage 2. Participants were randomized as ACWY-naive and ACWY-experienced (received 1 prior dose of a vaccine containing 1 or more ACWY groups greater than or equal to \\[\\>=\\] 4 years prior to randomization).', 'preAssignmentDetails': 'A total of 1610 participants were randomized in this study, out of which 10 withdrew before vaccination.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'BG000'}, {'value': '534', 'groupId': 'BG001'}, {'value': '271', 'groupId': 'BG002'}, {'value': '523', 'groupId': 'BG003'}, {'value': '1600', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Group 1: MenABCWY + Saline (ACWY-Naive)', 'description': 'Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants had blood drawn for antibody persistence at Month 18, 30, 42. There was a blood draw at Month 0, Month 6 and Month 54 before Vaccination 1, 2 and Booster vaccination. Post vaccination blood draw happened at 1 month after Vaccination 1, 2 and Booster vaccination. Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54. There was a safety follow-up 6 months after Vaccination 2 in Stage 1 (Visit 5) and 6 months after Booster Vaccination in Stage 2 (Visit 12).'}, {'id': 'BG001', 'title': 'Group 2: Bivalent rLP2086 + MenACWY-CRM (ACWY-Naive)', 'description': 'Stage 1: ACWY-naive participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants had blood drawn for antibody persistence at Month 18, 30, 42. There was a blood draw at Month 0, Month 6 and Month 54 before Vaccination 1, 2 and Booster vaccination. Post vaccination blood draw happened at 1 month after Vaccination 1, 2 and Booster vaccination. Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54. There was a safety follow-up 6 months after Vaccination 2 in Stage 1 (Visit 5) and 6 months after Booster Vaccination in Stage 2 (Visit 12).'}, {'id': 'BG002', 'title': 'Group 3: MenABCWY + Saline (ACWY-Experienced)', 'description': 'Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 milliliter (mL) of Neisseria meningitidis groups A, B, C, W, and Y vaccine (MenABCWY) and 0.5 mL of saline at Month 0, participants received 0.5 mL of MenABCWY vaccine intramuscularly at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants had blood drawn for antibody persistence at Month 18, 30, 42. There was a blood draw at Month 0, Month 6 and Month 54 before Vaccination 1, 2 and Booster vaccination. Post vaccination blood draw happened at 1 month after Vaccination 1, 2 and Booster vaccination. Participants received 0.5 mL of MenABCWY vaccine (booster vaccination) intramuscularly at Month 54. There was a safety follow-up 6 months after Vaccination 2 in Stage 1 (Visit 5) and 6 months after Booster Vaccination in Stage 2 (Visit 12).'}, {'id': 'BG003', 'title': 'Group 4: Bivalent rLP2086 + MenACWY-CRM (ACWY-Experienced)', 'description': 'Stage 1: ACWY-experienced participants were randomized to receive an intramuscular injection of 0.5 mL bivalent recombinant lipoprotein 2086 (rLP2086) vaccine and 0.5 mL of meningococcal group A, C, W-135, and Y conjugate vaccine (MenACWY-CRM) at Month 0. Participants received 0.5 mL of bivalent rLP2086 vaccine at Month 6. Stage 1 was followed by Stage 2. Stage 2: Participants had blood drawn for antibody persistence at Month 18, 30, 42. There was a blood draw at Month 0, Month 6 and Month 54 before Vaccination 1, 2 and Booster vaccination. Post vaccination blood draw happened at 1 month after Vaccination 1, 2 and Booster vaccination. Participants received intramuscularly injection of 0.5 mL of bivalent rLP2086 vaccine and 0.5 mL of MenACWY-CRM vaccine (booster vaccination) at Month 54. There was a safety follow-up 6 months after Vaccination 2 in Stage 1 (Visit 5) and 6 months after Booster Vaccination in Stage 2 (Visit 12).'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'Stage 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'BG000'}, {'value': '534', 'groupId': 'BG001'}, {'value': '271', 'groupId': 'BG002'}, {'value': '523', 'groupId': 'BG003'}, {'value': '1600', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '16.0', 'spread': '5.67', 'groupId': 'BG000'}, {'value': '16.5', 'spread': '5.81', 'groupId': 'BG001'}, {'value': '17.7', 'spread': '3.57', 'groupId': 'BG002'}, {'value': '17.8', 'spread': '3.66', 'groupId': 'BG003'}, {'value': '17.1', 'spread': '4.87', 'groupId': 'BG004'}]}]}, {'title': 'Stage 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}, {'value': '56', 'groupId': 'BG003'}, {'value': '240', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '19.1', 'spread': '5.36', 'groupId': 'BG000'}, {'value': '18.5', 'spread': '5.51', 'groupId': 'BG001'}, {'value': '20.8', 'spread': '3.73', 'groupId': 'BG002'}, {'value': '21.1', 'spread': '4.11', 'groupId': 'BG003'}, {'value': '20.4', 'spread': '4.72', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': "Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized)."}, {'title': 'Sex: Female, Male', 'classes': [{'title': 'Stage 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'BG000'}, {'value': '534', 'groupId': 'BG001'}, {'value': '271', 'groupId': 'BG002'}, {'value': '523', 'groupId': 'BG003'}, {'value': '1600', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '144', 'groupId': 'BG000'}, {'value': '333', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}, {'value': '289', 'groupId': 'BG003'}, {'value': '918', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '128', 'groupId': 'BG000'}, {'value': '201', 'groupId': 'BG001'}, {'value': '119', 'groupId': 'BG002'}, {'value': '234', 'groupId': 'BG003'}, {'value': '682', 'groupId': 'BG004'}]}]}, {'title': 'Stage 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}, {'value': '56', 'groupId': 'BG003'}, {'value': '240', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}, {'value': '130', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}, {'value': '110', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': "Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized)."}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'title': 'Stage 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'BG000'}, {'value': '534', 'groupId': 'BG001'}, {'value': '271', 'groupId': 'BG002'}, {'value': '523', 'groupId': 'BG003'}, {'value': '1600', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '61', 'groupId': 'BG003'}, {'value': '193', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '236', 'groupId': 'BG000'}, {'value': '461', 'groupId': 'BG001'}, {'value': '246', 'groupId': 'BG002'}, {'value': '461', 'groupId': 'BG003'}, {'value': '1404', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}]}, {'title': 'Stage 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}, {'value': '56', 'groupId': 'BG003'}, {'value': '240', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}, {'value': '55', 'groupId': 'BG003'}, {'value': '227', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': "Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized)."}, {'title': 'Race (NIH/OMB)', 'classes': [{'title': 'Stage 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '272', 'groupId': 'BG000'}, {'value': '534', 'groupId': 'BG001'}, {'value': '271', 'groupId': 'BG002'}, {'value': '523', 'groupId': 'BG003'}, {'value': '1600', 'groupId': 'BG004'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '49', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}, {'value': '165', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '234', 'groupId': 'BG000'}, {'value': '464', 'groupId': 'BG001'}, {'value': '237', 'groupId': 'BG002'}, {'value': '435', 'groupId': 'BG003'}, {'value': '1370', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}, {'title': 'Stage 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}, {'value': '56', 'groupId': 'BG003'}, {'value': '240', 'groupId': 'BG004'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}, {'value': '53', 'groupId': 'BG003'}, {'value': '221', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': "Stage 1 safety population and Booster safety population were evaluated for baseline characteristics for Stage 1 and Stage 2, respectively. 'Number Analyzed' signifies number of participants evaluable for the respective stages. Two participants were not included in summary of demographics (safety population) for stage 2 since they were of mixed regimen (received MenABCWY at the booster vaccination instead of bivalent rLP2086 + MenACWY-CRM as randomized)."}], 'populationDescription': 'The safety population for Stage 1 included participants who had received at least 1 dose of investigational product during Stage 1 and for whom safety data were available.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-07-09', 'size': 2655288, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-06-20T12:09', 'hasProtocol': True}, {'date': '2022-02-28', 'size': 7194100, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-06-20T12:09', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1610}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2022-10-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-04', 'studyFirstSubmitDate': '2017-04-26', 'resultsFirstSubmitDate': '2023-06-20', 'studyFirstSubmitQcDate': '2017-04-26', 'lastUpdatePostDateStruct': {'date': '2023-08-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-08-04', 'studyFirstPostDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-08-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stage1: Percentage of Participants Achieving Serum Bactericidal Assay Using Human Complement (hSBA) Titer Level >= Lower Limit of Quantitation (LLOQ) for All 4 Primary Test Strains Combined 1 Month After Vaccination 2 (Group 2 and 4 Combined)', 'timeFrame': '1 month after Vaccination 2', 'description': 'Percentage of participants who achieved an hSBA titer \\>= LLOQ for all 4 primary MenB test strains combined (LLOQ was 1:16 for A22 and 1:8 for A56, B24, and B44) was reported in this outcome. Analysis for this outcome measure was planned for combined Group 2 and 4.'}, {'measure': 'Stage1: Percentage of Participants With Fold Rise >=4 in hSBA for Each of the 4 Primary MenB Test Strains From Baseline to 1 Month After Vaccination 2 (Group 2 and 4 Combined)', 'timeFrame': 'From Baseline (blood draw prior to Vaccination 1) to 1 month after Vaccination 2', 'description': 'The 4-fold increase: a) participants with baseline hSBA titer below limit of detection (LOD or an hSBA titer \\<1:4), response was defined as hSBA titer \\>=1:16 or LLOQ (whichever titer is higher); b) Participants with baseline hSBA titer \\>= LOD and \\< LLOQ, response was defined as hSBA titer \\>= 4 times the LLOQ; c) participants with baseline hSBA titer \\>= LLOQ, response was defined as hSBA titer \\>=4 times baseline titer. Four primary MenB test strains were PMB80 (A22), PMB2001 (A56), PMB2948 (B24) and PMB2707 (B44). Analysis for this outcome measure was planned for combined Group 2 and 4.'}, {'measure': 'Stage1: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 (Group 2 and 4 Combined)', 'timeFrame': '7 days after Vaccination 1', 'description': 'Local reactions (redness, swelling, and pain) at the site of investigational product administration were recorded in e-diary. Redness and swelling were measured and recorded in caliper units. Each caliper unit represented 0.5 cm. Redness and swelling were graded as mild (\\>2.0 to 5.0 cm), moderate (\\>5.0 to 10.0 cm) and severe (\\>10.0 cm). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity).'}, {'measure': 'Stage1: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 (Group 2 and 4 Combined)', 'timeFrame': '7 days after Vaccination 2', 'description': 'Local reactions (redness, swelling, and pain) at the site of investigational product administration were recorded in e-diary. Redness and swelling were measured and recorded in caliper units. Each caliper unit represented 0.5 cm. Redness and swelling were graded as mild (\\>2.0 to 5.0 cm), moderate (\\>5.0 to 10.0 cm) and severe (\\>10.0 cm). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity).'}, {'measure': 'Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 (Group 2 and 4 Combined)', 'timeFrame': '7 days after Vaccination 1', 'description': 'Systemic events fever, vomiting, diarrhea, headache, fatigue, chills, muscle pain other than muscle pain at the injection site, and joint pain were recorded by using an e-diary. Fever was defined as \\>=38.0 degree Celsius (C) and categorized to 38.0 to 38.4 degree C, 38.5 to 38.9 degree C, 39.0 to 40.0 degree C and \\>40.0 degree C. Headache, fatigue, chills, muscle pain and joint pain were graded as mild (did not interfere with activity), moderate (some interference with activity) and severe (prevented daily activity). Vomiting was graded as mild (1-2 times in 24 hours), moderate (\\>2 times in 24 hours) and severe (required IV hydration). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours) and severe (\\>=6 in 24 hours).'}, {'measure': 'Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 (Group 2 and 4 Combined)', 'timeFrame': '7 days after Vaccination 2', 'description': 'Systemic events fever, vomiting, diarrhea, headache, fatigue, chills, muscle pain other than muscle pain at the injection site, and joint pain were recorded by using an e-diary. Fever was defined as \\>=38.0 degree C and categorized to 38.0 to 38.4 degree C, 38.5 to 38.9 degree C, 39.0 to 40.0 degree C and \\>40.0 degree C. Headache, fatigue, chills, muscle pain and joint pain were graded as mild (did not interfere with activity), moderate (some interference with activity) and severe (prevented daily activity). Vomiting was graded as mild (1-2 times in 24 hours), moderate (\\>2 times in 24 hours) and severe (required IV hydration). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours) and severe (\\>=6 in 24 hours).'}, {'measure': 'Stage1: Percentage of Participants With Antipyretic Medication Use Within 7 Days After Vaccination 1 (Group 2 and 4 Combined)', 'timeFrame': '7 days after Vaccination 1'}, {'measure': 'Stage1: Percentage of Participants With Antipyretic Medication Use Within 7 Days After Vaccination 2 (Group 2 and 4 Combined)', 'timeFrame': '7 days after Vaccination 2'}, {'measure': 'Stage1: Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Vaccination 1 (Group 2 and 4 Combined)', 'timeFrame': '30 days after Vaccination 1', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event.'}, {'measure': 'Stage1: Percentage of Participants With at Least 1 Serious Adverse Event (SAE) Within 30 Days After Vaccination 2 (Group 2 and 4 Combined)', 'timeFrame': '30 days after Vaccination 2', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event.'}, {'measure': 'Stage1: Percentage of Participants With at Least 1 SAE Within 30 Days After Any Vaccination (Group 2 and 4 Combined)', 'timeFrame': '30 days after any vaccination', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event.'}, {'measure': 'Stage1: Percentage of Participants With at Least 1 SAE During the Stage 1 Vaccination Phase (Group 2 and 4 Combined)', 'timeFrame': 'Stage 1 Vaccination Phase: From Vaccination 1 through 1 month after Vaccination 2 (7 Months)', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event.'}, {'measure': 'Stage1: Percentage of Participants With at Least 1 SAE During the Stage 1 Follow-up Phase (Group 2 and 4 Combined)', 'timeFrame': 'Stage 1 Follow-up phase: From 1 month after Vaccination 2 through 6 months after Vaccination 2 (5 Months)', 'description': "An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event. There was one participant who did not meet criteria for Stage 1 follow-up safety population. The subject's SAE happened in the follow-up phase but was not included in the follow-up safety population for Stage 1 (but in the safety population for Stage 1). Therefore, the SAE was not included in the follow-up table but in the broadly defined throughout Stage 1 table."}, {'measure': 'Stage1: Percentage of Participants With at Least 1 SAE Throughout the Stage 1 (Group 2 and 4 Combined)', 'timeFrame': 'Throughout Stage 1: From the Vaccination 1 through 6 months after Vaccination 2 (12 Months)', 'description': "An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event. There was one participant who did not meet criteria for Stage 1 follow-up safety population. The subject's SAE happened in the follow-up phase but was not included in the follow-up safety population for Stage 1 (but in the safety population for Stage 1). Therefore, the SAE was not included in the follow-up table but in the broadly defined throughout Stage 1 table."}, {'measure': 'Stage1: Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Vaccination 1 (Group 2 and 4 Combined)', 'timeFrame': '30 days after Vaccination 1', 'description': 'Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility.'}, {'measure': 'Stage1: Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Vaccination 2 (Group 2 and 4 Combined)', 'timeFrame': '30 days after Vaccination 2', 'description': 'Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility.'}, {'measure': 'Stage1: Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Any Vaccination (Group 2 and 4 Combined)', 'timeFrame': '30 days after any vaccination', 'description': 'Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility.'}, {'measure': 'Stage1: Percentage of Participants With at Least 1 Medically Attended AE During the Stage 1 Vaccination Phase (Group 2 and 4 Combined)', 'timeFrame': 'Stage 1 Vaccination Phase: From Vaccination 1 through 1 month after Vaccination 2 (7 Months)', 'description': 'Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility.'}, {'measure': 'Stage1: Percentage of Participants With at Least 1 Medically Attended AE During the Stage 1 Follow-up Phase (Group 2 and 4 Combined)', 'timeFrame': 'Stage 1 Follow-up phase: From 1 month after Vaccination 2 through 6 months after Vaccination 2 (5 Months)', 'description': 'Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility.'}, {'measure': 'Stage1: Percentage of Participants With at Least 1 Medically Attended AE Throughout the Stage 1 (Group 2 and 4 Combined)', 'timeFrame': 'Throughout Stage 1: From the Vaccination 1 through 6 months after Vaccination 2 (12 Months)', 'description': 'Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility.'}, {'measure': 'Stage1: Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition (NDCMC) Within 30 Days After Vaccination 1 (Group 2 and 4 Combined)', 'timeFrame': '30 days after Vaccination 1', 'description': 'A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.'}, {'measure': 'Stage1: Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition (NDCMC) Within 30 Days After Vaccination 2 (Group 2 and 4 Combined)', 'timeFrame': '30 days after Vaccination 2', 'description': 'A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.'}, {'measure': 'Stage1: Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition (NDCMC) Within 30 Days After Any Vaccination (Group 2 and 4 Combined)', 'timeFrame': '30 days after any Vaccination', 'description': 'A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.'}, {'measure': 'Stage1: Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition (NDCMC) During the Stage 1 Vaccination Phase (Group 2 and 4 Combined)', 'timeFrame': 'Stage 1 Vaccination Phase: From Vaccination 1 through 1 month after Vaccination 2 (7 Months)', 'description': 'A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.'}, {'measure': 'Stage1: Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition (NDCMC) During the Stage 1 Follow-up Phase (Group 2 and 4 Combined)', 'timeFrame': 'Stage 1 Follow-up phase: From 1 month after Vaccination 2 through 6 months after Vaccination 2 (5 Months)', 'description': 'A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.'}, {'measure': 'Stage1: Percentage of Participants With at Least 1 Newly Diagnosed Chronic Medical Condition (NDCMC) Throughout the Stage 1 (Group 2 and 4)', 'timeFrame': 'Throughout Stage 1: From the Vaccination 1 through 6 months after Vaccination 2 (12 Months)', 'description': 'A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.'}, {'measure': 'Stage1: Percentage of Participants With at Least 1 AE Within 30 Days After Vaccination 1 (Group 2 and 4 Combined)', 'timeFrame': '30 days after Vaccination 1', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs did not include local reaction and systemic events collected by systematic approach.'}, {'measure': 'Stage1: Percentage of Participants With at Least 1 AE Within 30 Days After Vaccination 2 (Group 2 and 4 Combined)', 'timeFrame': '30 days after Vaccination 2', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs did not include local reaction and systemic events collected by systematic approach.'}, {'measure': 'Stage1: Percentage of Participants With at Least 1 AE Within 30 Days After Any Vaccination (Group 2 and 4 Combined)', 'timeFrame': '30 days after any vaccination', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs did not include local reaction and systemic events collected by systematic approach.'}, {'measure': 'Stage1: Percentage of Participants With at Least 1 AE During Vaccination Phase (Group 2 and 4 Combined)', 'timeFrame': 'Stage 1 Vaccination Phase: From Vaccination 1 through 1 month after Vaccination 2 (7 Months)', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs did not include local reaction and systemic events collected by systematic approach.'}, {'measure': 'Stage1: Percentage of Participants With at Least 1 Immediate AE After Vaccination 1 (Group 2 and 4 Combined)', 'timeFrame': '30 minutes after Vaccination 1', 'description': 'Immediate AE was defined as AE occurring within the first 30 minutes after investigational product administration.'}, {'measure': 'Stage1: Percentage of Participants With at Least 1 Immediate AE After Vaccination 2 (Group 2 and 4 Combined)', 'timeFrame': '30 minutes after Vaccination 2', 'description': 'Immediate AE was defined as AE occurring within the first 30 minutes after investigational product administration.'}, {'measure': 'Stage1: Number of Participants Who Missed School/Work Due to AE During the Stage 1 Vaccination Phase (Group 2 and 4 Combined)', 'timeFrame': 'Stage 1 Vaccination Phase: From Vaccination 1 through 1 month after Vaccination 2 (7 Months)'}, {'measure': 'Stage2: Percentage of Participants With Local Reactions Within 7 Days After Booster Vaccination: Group 1 Through Group 4', 'timeFrame': '7 days after booster vaccination', 'description': 'Local reactions (redness, swelling, and pain) at the site of investigational product administration were recorded in e-diary. Redness and swelling were measured and recorded in caliper units. Each caliper unit represented 0.5 cm. Redness and swelling were graded as mild (\\>2.0 to 5.0 cm), moderate (\\>5.0 to 10.0 cm) and severe (\\>10.0 cm). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity).'}, {'measure': 'Stage2: Percentage of Participants With Systemic Events Within 7 Days After Booster Vaccination: Group 1 Through Group 4', 'timeFrame': '7 days after booster vaccination', 'description': 'Systemic events fever, vomiting, diarrhea, headache, fatigue, chills, muscle pain and joint pain were recorded in an e-diary. Fever was defined as \\>=38.0 degree Celsius (C) and categorized to 38.0 to 38.4 degree C, 38.5 to 38.9 degree C, 39.0 to 40.0 degree C and \\>40.0 degree C. Headache, fatigue, chills, muscle pain and joint pain were graded as mild (did not interfere with activity), moderate (some interference with activity) and severe (prevented daily activity). Vomiting was graded as mild (1-2 times in 24 hours), moderate (\\>2 times in 24 hours) and severe (required IV hydration). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours) and severe (\\>=6 in 24 hours).'}, {'measure': 'Stage2: Percentage of Participants With Antipyretic Medication Use Within 7 Days After Booster Vaccination: Group 1 Through Group 4', 'timeFrame': '7 days after booster vaccination'}, {'measure': 'Stage2: Percentage of Participants With at Least 1 SAE During Booster Vaccination Phase: Group 1 Through Group 4', 'timeFrame': 'Booster vaccination phase: From booster vaccination through 1 month after booster vaccination', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event. SAE of "pregnancy" for one participant during the booster vaccination phase was recorded erroneously and hence it was included in results of Group 4.'}, {'measure': 'Stage2: Percentage of Participants With at Least 1 SAE During the Booster Follow-up Phase: Group 1 Through Group 4', 'timeFrame': 'Booster follow-up phase: From 1 month after booster vaccination through 6 months after booster vaccination (up to 5 months)', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event.'}, {'measure': 'Stage2: Percentage of Participants With at Least 1 SAE Throughout Booster Phase: Group 1 Through Group 4', 'timeFrame': 'Throughout Booster phase: From booster vaccination through 6 months after booster vaccination', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event. SAE of "pregnancy" for one participant during the booster vaccination phase was recorded erroneously and hence it was reported in result of outcome measure 37 for Group 4. Subsequently correction was made by the trial site and not included in subsequent phase/results. Hence, that 1 participant is not included in results of Group 4 here.'}, {'measure': 'Stage2: Percentage of Participants With at Least 1 Medically Attended AE During Booster Vaccination Phase: Group 1 Through Group 4', 'timeFrame': 'Booster vaccination phase: From booster vaccination through 1 month after booster vaccination', 'description': 'Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility.'}, {'measure': 'Stage2: Percentage of Participants With at Least 1 Medically Attended AE During the Booster Follow-up Phase: Group 1 Through Group 4', 'timeFrame': 'Booster Follow-up Phase: From 1 month after booster vaccination through 6 months after booster vaccination (up to 5 months)', 'description': 'Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility.'}, {'measure': 'Stage2: Percentage of Participants With at Least 1 Medically Attended AE Throughout Booster Phase: Group 1 Through Group 4', 'timeFrame': 'Throughout Booster Phase: From booster vaccination through 6 months after booster vaccination', 'description': 'Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility.'}, {'measure': 'Stage2: Percentage of Participants With at Least 1 NDCMC During Booster Vaccination Phase: Group 1 Through Group 4', 'timeFrame': 'Booster Vaccination Phase: From booster vaccination through 1 month after booster vaccination', 'description': 'A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.'}, {'measure': 'Stage2: Percentage of Participants With at Least 1 NDCMC During the Booster Follow-up Phase: Group 1 Through Group 4', 'timeFrame': 'Booster Follow-up Phase: From 1 month after booster vaccination through 6 months after booster vaccination (up to 5 months)', 'description': 'A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.'}, {'measure': 'Stage2: Percentage of Participants With at Least 1 NDCMC Throughout Booster Phase: Group 1 Through Group 4', 'timeFrame': 'Throughout Booster Phase: From booster vaccination through 6 months after booster vaccination', 'description': 'A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.'}, {'measure': 'Stage2: Percentage of Participants With at Least 1 AE During Booster Vaccination Phase: Group 1 Through Group 4', 'timeFrame': 'Booster Vaccination Phase: From booster vaccination through 1 month after booster vaccination', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs did not include local reaction and systemic events collected by systematic approach.'}, {'measure': 'Stage2: Percentage of Participants With at Least 1 Immediate AE After Booster Vaccination: Group 1 Through Group 4', 'timeFrame': '30 minutes after booster vaccination', 'description': 'Immediate AE was defined as AE occurring within the first 30 minutes after investigational product administration.'}, {'measure': 'Stage2: Number of Participants Who Missed School/Work Due to AE After Booster Vaccination: Group 1 Through Group 4', 'timeFrame': 'Booster Vaccination Phase: From booster vaccination through 1 month after booster vaccination'}], 'secondaryOutcomes': [{'measure': 'Stage1: Percentage of Participants With hSBA Titer Level >= LLOQ for 4 Primary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined)', 'timeFrame': '1 month after Vaccination 2', 'description': 'Percentage of participants who achieved an hSBA titer \\>= LLOQ for all 4 primary MenB test strains combined (LLOQ was 1:16 for A22 and 1:8 for A56, B24, and B44) was reported in this outcome measure. Four primary MenB test strains were PMB80 (A22), PMB2001 (A56), PMB2948 (B24) and PMB2707 (B44).'}, {'measure': 'Stage1: Percentage of Participants With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for All 4 Primary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined)', 'timeFrame': '1 month after Vaccination 2 (Vacc 2)', 'description': 'Percentage of participants who achieved an hSBA titer \\>= 1:4, \\>= 1:8, \\>= 1:16, \\>= 1:32, \\>= 1:64, \\>= 1:128 for all 4 primary MenB test strains was reported in this outcome measure. Four primary MenB test strains were PMB80 (A22), PMB2001 (A56), PMB2948 (B24) and PMB2707 (B44).'}, {'measure': 'Stage1: hSBA Geometric Mean Titers (GMTs) for All 4 Primary MenB Test Strains Combined 1 Month After Vaccination 2 (Group 2 and 4 Combined)', 'timeFrame': '1 month after Vaccination 2 (Vacc 2)', 'description': 'GMTs were calculated using all participants with valid and determinate hSBA titers at the given time point. LLOQ = 1:16 for A22; 1:8 for A56, B24, and B44. Titers below the LLOQ were set to 0.5 \\* LLOQ for analysis. Four primary MenB test strains were PMB80 (A22), PMB2001 (A56), PMB2948 (B24) and PMB2707 (B44).'}, {'measure': 'Stage1: Percentage of Participants With hSBA Titer Level >= LLOQ for 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined)', 'timeFrame': '1 month after Vaccination 2 (Vacc 2)', 'description': 'Percentage of participants who achieved an hSBA titer greater than or equal to LLOQ for 10 Secondary MenB test strains combined (LLOQ = 1:16 for A06, A12, and A19; 1:8 for A07, A15, A29, B03, B09, B15, and B16) was reported in this outcome measure.'}, {'measure': 'Stage1: Percentage of Participants With hSBA Titer Level >= 1:4, >= 1:8, >= 1:16, >= 1:32, >= 1:64, >= 1:128 for Each of the 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined)', 'timeFrame': '1 month after Vaccination 2 (Vacc 2)', 'description': 'Percentage of participants who achieved an hSBA titer \\>= 1:4, \\>= 1:8, \\>= 1:16, \\>= 1:32, \\>= 1:64, \\>= 1:128 for each of the 10 secondary MenB test strains was reported in this outcome measure. 10 secondary MenB test strains were PMB3175 (A29), PMB3010 (A06), PMB824 (A12), PMB3040 (A07), PMB1672 (A15), PMB1989 (A19), PMB648 (B16), PMB866 (B09), PMB1256 (B03) and PMB431 (B15).'}, {'measure': 'Stage1: hSBA Geometric Mean Titers (GMTs) for Each of the 10 Secondary MenB Test Strains 1 Month After Vaccination 2 (Group 2 and 4 Combined)', 'timeFrame': '1 month after Vaccination 2 (Vacc 2)', 'description': 'GMTs were calculated using all participants with valid and determinate hSBA titers at the given time point. LLOQ = 1:16 for A06, A12, and A19; 1:8 for A07, A15, A29, B03, B09, B15, and B16. Titers below the LLOQ were set to 0.5\\*LLOQ for analysis.'}, {'measure': 'Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=LLOQ for ACWY Test Strains 1 Month After the Vaccination 1: Groups 1, 2, 3 and 4', 'timeFrame': '1 month after Vaccination 1', 'description': 'Percentage of participants who achieved an hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY titer \\>=LLOQ for ACWY test strains (LLOQ = 1:8 for all MenA, MenC, MenW, and MenY strains) was reported in this outcome measure.'}, {'measure': 'Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for ACWY Test Strains 1 Month After the Vaccination 1: Groups 1, 2, 3 and 4', 'timeFrame': '1 month after Vaccination 1', 'description': 'Percentage of participants who achieved an hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY titer \\>=1:4, \\>=1:8, \\>=1:16, \\>=1:32, \\>=1:64, \\>=1:128 for ACWY test strains was reported in this outcome measure.'}, {'measure': 'Stage1: hSBA Geometric Mean Titers (GMTs) for ACWY Test Strains 1 Month After Vaccination 1: Groups 1, 2, 3 and 4', 'timeFrame': '1 month after Vaccination 1', 'description': 'GMTs were calculated using all participants with valid and determinate hSBA titers at the given time point. LLOQ = 1:8 for all MenA, MenC, MenW, and MenY. Titers below the LLOQ were set to 0.5\\*LLOQ for analysis.'}, {'measure': 'Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:8 (or LLOQ, Whichever is Higher) for ACWY Test Strains 1 Month After the Vaccination 1 in Groups 2 and 4, and 1 Month After Vaccination 2 in Groups 1 and 3', 'timeFrame': 'For Group 2 and 4: 1 month after Vaccination 1; For Group 1 and 3: 1 month after Vaccination 2', 'description': 'Percentage of participants who achieved an hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY titer \\>= LLOQ for ACWY test strains (LLOQ = 1:8 for all MenA, MenC, MenW, and MenY strains) was reported in this outcome measure.'}, {'measure': 'Stage1: Percentage of Participants With MenA, MenC, MenW, and MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and, >=1:128 for ACWY Test Strains 1 Month After Vaccination 1 in Groups 2 and 4, and 1 Month After Vaccination 2 in Groups 1 and 3', 'timeFrame': 'For Group 2 and 4: 1 month after Vaccination 1; For Group 1 and 3: 1 month after Vaccination 2', 'description': 'Percentage of participants who achieved an hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY titer \\>=1:4, \\>=1:8, \\>=1:16, \\>=1:32, \\>=1:64, \\>=1:128 for ACWY test strains was reported in this outcome measure.'}, {'measure': 'Stage1: hSBA GMTs for ACWY Test Strains 1 Month After Vaccination 1 in Groups 2 and 4 and 1 Month After Vaccination 2 in Groups 1 and 3', 'timeFrame': 'For Group 2 and 4: 1 month after Vaccination 1; For Group 1 and 3: 1 month after Vaccination 2', 'description': 'GMTs were calculated using all participants with valid and determinate hSBA titers at the given time point. LLOQ = 1:8 for all MenA, MenC, MenW, and MenY. Titers below the LLOQ were set to 0.5\\*LLOQ for analysis.'}, {'measure': 'Stage1: Percentage of Participants With hSBA Titer Level >= LLOQ for 4 Primary MenB Test Strains 1 Month After Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined)', 'timeFrame': '1 month after Vaccination 2 (Vacc 2)', 'description': 'Percentage of participants who achieved an hSBA titer \\>=LLOQ for all 4 primary MenB test strains (LLOQ was 1:16 for A22 and 1:8 for A56, B24, and B44) was reported in this outcome measure.'}, {'measure': 'Stage1: Percentage of Participants With >=4 Fold Rise in hSBA for 4 Primary MenB Strains and Composite Response (hSBA >=LLOQ for All 4 Primary MenB Strains Combined) From Baseline-1 Month After Vaccination 2 (Group 1 and 3 Combined;Group 2 and 4 Combined)', 'timeFrame': 'Baseline to 1 month after Vaccination 2', 'description': 'Percentage of participants who achieved an hSBA titer greater than or equal to LLOQ for all 4 primary MenB test strains combined (LLOQ was 1:16 for A22 and 1:8 for A56, B24, and B44) was reported in this outcome measure.'}, {'measure': 'Stage1: Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for Each of the 4 Primary MenB Test Strains From 1 Month After Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined)', 'timeFrame': '1 month after Vaccination 2', 'description': 'Percentage of participants who achieved an hSBA titer \\>=1:4, \\>=1:8, \\>=1:16, \\>=1:32, \\>=1:64, and \\>=1:128 for all 4 primary MenB test strains was reported in this outcome measure.'}, {'measure': 'Stage1: hSBA GMTs for Each of the 4 Primary MenB Test Strains 1 Month After Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined)', 'timeFrame': '1 month after Vaccination 2', 'description': 'GMTs were calculated using all participants with valid and determinate hSBA titers at the given time point. LLOQ =1:16 for A22; 1:8 for A56, B24, and B44. Titers below the LLOQ were set to 0.5\\*LLOQ for analysis.'}, {'measure': 'Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW and hSBA-MenY Titers >=1:8 (or LLOQ) for ACWY Test Strains Before Vaccination 1 and Before Vaccination 2: Groups 1, 2, 3 and 4', 'timeFrame': 'Before Vaccination 1 (Vacc 1) [Day 1], Before Vaccination 2 (Vacc 2) [173 to 194 Days After Visit 1]', 'description': 'Percentage of participants who achieved an hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY titer \\>=LLOQ for ACWY test strains (LLOQ = 1:8 for all MenA, MenC, MenW, and MenY strains) was reported in this outcome measure.'}, {'measure': 'Stage1: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for ACWY Test Strains Before Vaccination 1 and Before Vaccination 2: Groups 1, 2, 3 and 4', 'timeFrame': 'Before Vaccination 1 (Vacc 1) [Day 1], Before Vaccination 2 (Vacc 2) [173 to 194 Days After Visit 1]', 'description': 'Percentage of participants who achieved an hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY titer \\>=1:4, \\>= :8, \\>=1:16, \\>=1:32, \\>=1:64, \\>=1:128 for ACWY test strains was reported in this outcome measure.'}, {'measure': 'Stage1: hSBA GMTs for ACWY Test Strains Before Vaccination 1 and Before Vaccination 2: Groups 1, 2, 3 and 4', 'timeFrame': 'Before Vaccination 1 (Vacc 1) [Day 1], Before Vaccination 2 (Vacc 2) [173 to 194 Days After Visit 1]', 'description': 'GMTs were calculated using all participants with valid and determinate hSBA titers at the given time point. LLOQ = 1:8 for all MenA, MenC, MenW, and MenY strains. Titers below the LLOQ were set to 0.5\\*LLOQ for analysis. Confidence intervals were back transformations of confidence levels based on the Student t distribution for the mean logarithm of the concentrations, or the mean of the ratio.'}, {'measure': 'Stage1: Percentage of Participants With hSBA Titer Level >=LLOQ for 4 Primary MenB Test Strains Before Vaccination 1 and Before Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined)', 'timeFrame': 'Before Vaccination 1 (Vacc 1) [Day 1], Before Vaccination 2 (Vacc 2) [173 to 194 Days After Visit 1]', 'description': 'Percentage of participants who achieved an hSBA titer \\>=LLOQ for all 4 primary MenB test strains (LLOQ was 1:16 for A22 and 1:8 for A56, B24, and B44) was reported in this outcome measure.'}, {'measure': 'Stage1: Percentage of Participants With hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64, and >=1:128 for Each of the 4 Primary MenB Test Strains Before Vaccination 1 and Before Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined)', 'timeFrame': 'Before Vaccination 1 (Vacc 1) [Day 1], Before Vaccination 2 (Vacc 2) [173 to 194 Days After Visit 1]', 'description': 'Percentage of participants who achieved an hSBA titer \\>=1:4, \\>=1:8, \\>=1:16, \\>=1:32, \\>=1:64, and \\>=1:128 for each of the 4 primary MenB test strains was reported in this outcome measure.'}, {'measure': 'Stage1: hSBA GMTs for Each of the 4 Primary MenB Test Strains Before Vaccination 1 and Before Vaccination 2 (Group 1 and 3 Combined; Group 2 and 4 Combined)', 'timeFrame': 'Before Vaccination 1 (Vacc 1) [Day 1], Before Vaccination 2 (Vacc 2) [173 to 194 Days After Visit 1]', 'description': 'GMTs were calculated using all participants with valid and determinate hSBA titers at the given time point. LLOQ =1:16 for A22; 1:8 for A56, B24, and B44. Titers below the LLOQ were set to 0.5\\*LLOQ for analysis. CIs were back transformations of confidence levels based on the Student t distribution for the mean logarithm of the hSBA titers.'}, {'measure': 'Stage2: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:8 (or LLOQ if Higher) for ACWY Test Strains During Persistence Phase: Groups 1, 2, 3 and 4', 'timeFrame': '12, 24, 36 and 48 months after Vaccination 2 (Vacc 2)', 'description': 'Percentage of participants who achieved an hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY titer \\>=LLOQ for ACWY Test Strains (LLOQ = 1:8 for all MenA, MenC, MenW, and MenY strains) was reported in this outcome measure.'}, {'measure': 'Stage2: Percentage of Participants With hSBA Titer Level >=LLOQ for 4 Primary MenB Test Strains During Persistence Phase (Group 1 and 3 Combined; Group 2 and 4 Combined)', 'timeFrame': '12, 24, 36 and 48 months after Vaccination 2 (Vacc 2)', 'description': 'Percentage of participants who achieved an hSBA titer \\>=LLOQ for all 4 primary MenB test strains (LLOQ was 1:16 for A22 and 1:8 for A56, B24, and B44) was reported in this outcome measure.'}, {'measure': 'Stage2: Percentage of Participants With hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY Titers >=1:8 (or >=LLOQ if Higher) for ACWY Test Strains 1 Month After Booster Vaccination: Groups 1 and 3 (Separately)', 'timeFrame': '1 month after booster vaccination', 'description': 'Percentage of participants who achieved an hSBA-MenA, hSBA-MenC, hSBA-MenW, and hSBA-MenY titer \\>=LLOQ for ACWY test strains (LLOQ = 1:8 for all MenA, MenC, MenW, and MenY strains) was reported in this outcome measure. Analysis was planned for Group 1 and 3 separately.'}, {'measure': 'Stage2: Percentage of Participants With hSBA Titer Level >=LLOQ for 4 Primary MenB Test Strains 1 Month After Booster Vaccination (Group 1 and 3 Combined; Group 2 and 4 Combined)', 'timeFrame': '1 month after booster vaccination', 'description': 'Percentage of participants who achieved an hSBA titer \\>=LLOQ for all 4 primary MenB test strains (LLOQ was 1:16 for A22 and 1:8 for A56, B24, and B44) was reported in this outcome measure.'}, {'measure': 'Stage1: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1: Group 1 and Group 3', 'timeFrame': '7 days after Vaccination 1 (Vacc 1)', 'description': 'Local reactions (redness, swelling, and pain) at the site of investigational product administration were recorded in e-diary. Redness and swelling were measured and recorded in caliper units. Each caliper unit represented 0.5 cm. Redness and swelling were graded as mild (\\>2.0 to 5.0 cm), moderate (\\>5.0 to 10.0 cm) and severe (\\>10.0 cm). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity).'}, {'measure': 'Stage1: Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2: Group 1 and Group 3', 'timeFrame': '7 days after Vaccination 2 (Vacc 2)', 'description': 'Local reactions (redness, swelling, and pain) at the site of investigational product administration were recorded in e-diary. Redness and swelling were measured and recorded in caliper units. Each caliper unit represented 0.5 cm. Redness and swelling were graded as mild (\\>2.0 to 5.0 cm), moderate (\\>5.0 to 10.0 cm) and severe (\\>10.0 cm). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity).'}, {'measure': 'Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1: Group 1 and Group 3', 'timeFrame': '7 days after Vaccination 1 (Vacc 1)', 'description': 'Systemic events fever, vomiting, diarrhea, headache, fatigue, chills, muscle pain and joint pain were recorded in an e-diary. Fever was defined as \\>=38.0 degree C and categorized to 38.0 to 38.4 degree C, 38.5 to 38.9 degree C, 39.0 to 40.0 degree C and \\>40.0 degree C. Headache, fatigue, chills, muscle pain and joint pain were graded as mild (did not interfere with activity), moderate (some interference with activity) and severe (prevented daily activity). Vomiting was graded as mild (1-2 times in 24 hours), moderate (\\>2 times in 24 hours) and severe (required IV hydration). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours) and severe (\\>=6 in 24 hours).'}, {'measure': 'Stage1: Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2: Group 1 and Group 3', 'timeFrame': '7 days after Vaccination 2 (Vacc 2)', 'description': 'Systemic events fever, vomiting, diarrhea, headache, fatigue, chills, muscle pain and joint pain were recorded in an e-diary. Fever was defined as \\>=38.0 degree C and categorized to 38.0 to 38.4 degree C, 38.5 to 38.9 degree C, 39.0 to 40.0 degree C and \\>40.0 degree C. Headache, fatigue, chills, muscle pain and joint pain were graded as mild (did not interfere with activity), moderate (some interference with activity) and severe (prevented daily activity). Vomiting was graded as mild (1-2 times in 24 hours), moderate (\\>2 times in 24 hours) and severe (required IV hydration). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours) and severe (\\>=6 in 24 hours).'}, {'measure': 'Stage1: Percentage of Participants With Antipyretic Medication Use 30 Days After Vaccination 1: Group 1 and Group 3', 'timeFrame': '30 days after Vaccination 1'}, {'measure': 'Stage1: Percentage of Participants With Antipyretic Medication Use 30 Days After Vaccination 2: Group 1 and Group 3', 'timeFrame': '30 days after Vaccination 2'}, {'measure': 'Stage1: Percentage of Participants With at Least 1 SAE Within 30 Days After Vaccination 1: Group 1 and Group 3', 'timeFrame': '30 days after Vaccination 1', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event.'}, {'measure': 'Stage1: Percentage of Participants With at Least 1 SAE Within 30 Days After Vaccination 2: Group 1 and Group 3', 'timeFrame': '30 days after Vaccination 2', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event.'}, {'measure': 'Stage1: Percentage of Participants With at Least 1 SAE Within 30 Days After Any Vaccination: Group 1 and Group 3', 'timeFrame': '30 days after any vaccination', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event.'}, {'measure': 'Stage1: Percentage of Participants With at Least 1 SAE During the Vaccination Phase: Group 1 and Group 3', 'timeFrame': 'Stage 1 Vaccination Phase: From Vaccination 1 through 1 month after Vaccination 2 (7 Months)', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event.'}, {'measure': 'Stage1: Percentage of Participants With at Least 1 SAE During the Stage 1 Follow-up Phase: Group 1 and Group 3', 'timeFrame': 'Stage 1 Follow-up phase: From 1 month after Vaccination 2 through 6 months after Vaccination 2 (5 Months)', 'description': "An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event. There was one participant who did not meet criteria for Stage 1 follow-up safety population. The subject's SAE happened in the follow-up phase but was not included in the follow-up safety population for Stage 1 (but in the safety population for Stage 1). Therefore, the SAE was not included in the follow-up table but in the broadly defined throughout Stage 1 table."}, {'measure': 'Stage1: Percentage of Participants With at Least 1 SAE Throughout the Stage 1: Group 1 and Group 3', 'timeFrame': 'Throughout Stage 1: From the Vaccination 1 through 6 months after Vaccination 2 (12 Months)', 'description': "An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Or that was considered to be an important medical event. There was one participant who did not meet criteria for Stage 1 follow-up safety population. The subject's SAE happened in the follow-up phase but was not included in the follow-up safety population for Stage 1 (but in the safety population for Stage 1). Therefore, the SAE was not included in the follow-up table but in the broadly defined throughout Stage 1 table."}, {'measure': 'Stage1: Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Vaccination 1: Group 1 and Group 3', 'timeFrame': '30 days after vaccination 1', 'description': 'Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility.'}, {'measure': 'Stage1: Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Vaccination 2: Group 1 and Group 3', 'timeFrame': '30 days after vaccination 2', 'description': 'Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility.'}, {'measure': 'Stage1: Percentage of Participants With at Least 1 Medically Attended AE Within 30 Days After Any Vaccination: Group 1 and Group 3', 'timeFrame': '30 days after any vaccination', 'description': 'Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility.'}, {'measure': 'Stage1: Percentage of Participants With at Least 1 Medically Attended AE During the Stage 1 Vaccination Phase: Group 1 and Group 3', 'timeFrame': 'Stage 1 Vaccination Phase: From Vaccination 1 through 1 month after Vaccination 2 (7 Months)', 'description': 'Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility.'}, {'measure': 'Stage1: Percentage of Participants With at Least 1 Medically Attended AE During the Stage 1 Follow-up Phase: Group 1 and Group 3', 'timeFrame': 'Stage 1 Follow-up phase: From 1 month after Vaccination 2 through 6 months after Vaccination 2 (5 Months)', 'description': 'Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility.'}, {'measure': 'Stage1: Percentage of Participants With at Least 1 Medically Attended AE Throughout the Stage 1: Group 1 and Group 3', 'timeFrame': 'Throughout Stage 1: From the Vaccination 1 through 6 months after Vaccination 2 (12 Months)', 'description': 'Medically attended AE was defined as a nonserious AE that resulted in an evaluation at a medical facility.'}, {'measure': 'Stage1: Percentage of Participants With at Least 1 NDCMC Within 30 Days After Vaccination 1: Group 1 and Group 3', 'timeFrame': '30 days after vaccination 1', 'description': 'A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.'}, {'measure': 'Stage1: Percentage of Participants With at Least 1 NDCMC Within 30 Days After Vaccination 2: Group 1 and Group 3', 'timeFrame': '30 days after vaccination 2', 'description': 'A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.'}, {'measure': 'Stage1: Percentage of Participants With at Least 1 NDCMC Within 30 Days After Any Vaccination: Group 1 and Group 3', 'timeFrame': '30 days after any vaccination', 'description': 'A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.'}, {'measure': 'Stage1: Percentage of Participants With at Least 1 NDCMC During the Stage 1 Vaccination Phase: Group 1 and Group 3', 'timeFrame': 'Stage 1 Vaccination Phase: From Vaccination 1 through 1 month after Vaccination 2 (7 Months)', 'description': 'A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.'}, {'measure': 'Stage1: Percentage of Participants With at Least 1 NDCMC During the Stage 1 Follow-up Phase: Group 1 and Group 3', 'timeFrame': 'Stage 1 Follow-up phase: From 1 month after Vaccination 2 through 6 months after Vaccination 2 (5 Months)', 'description': 'A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.'}, {'measure': 'Stage1: Percentage of Participants With at Least 1 NDCMC Throughout the Stage 1: Group 1 and Group 3', 'timeFrame': 'Throughout Stage 1: From the Vaccination 1 through 6 months after Vaccination 2 (12 Months)', 'description': 'A NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.'}, {'measure': 'Stage1: Percentage of Participants With at Least 1 AE Within 30 Days After Vaccination 1: Group 1 and Group 3', 'timeFrame': '30 days after vaccination 1', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs did not include local reaction and systemic events collected by systematic approach.'}, {'measure': 'Stage1: Percentage of Participants With at Least 1 AE Within 30 Days After Vaccination 2: Group 1 and Group 3', 'timeFrame': '30 days after vaccination 2', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs did not include local reaction and systemic events collected by systematic approach.'}, {'measure': 'Stage1: Percentage of Participants With at Least 1 AE Within 30 Days After Vaccination Any Vaccination: Group 1 and Group 3', 'timeFrame': '30 days after any vaccination', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs did not include local reaction and systemic events collected by systematic approach.'}, {'measure': 'Stage1: Percentage of Participants With at Least 1 AE During the Stage 1 Vaccination Phase: Group 1 and Group 3', 'timeFrame': 'Stage 1 Vaccination Phase: From Vaccination 1 through 1 month after Vaccination 2 (7 Months)', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs did not include local reaction and systemic events collected by systematic approach.'}, {'measure': 'Stage1: Percentage of Participants With at Least 1 Immediate AE After Vaccination 1: Group 1 and Group 3', 'timeFrame': '30 minutes after Vaccination 1', 'description': 'Immediate AE was defined as AE occurring within the first 30 minutes after investigational product administration.'}, {'measure': 'Stage1: Percentage of Participants With at Least 1 Immediate AE After Vaccination 2: Group 1 and Group 3', 'timeFrame': '30 minutes after Vaccination 2', 'description': 'Immediate AE was defined as AE occurring within the first 30 minutes after investigational product administration.'}, {'measure': 'Stage1: Number of Participants Who Missed School/Work Due to AE During the Stage 1 Vaccination Phase: Group 1 and Group 3', 'timeFrame': 'Stage 1 Vaccination Phase: From Vaccination 1 through 1 month after Vaccination 2 (7 Months)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Meningococcal Vaccine']}, 'referencesModule': {'references': [{'pmid': '39520893', 'type': 'DERIVED', 'citation': "Peterson J, Drazan D, Moughan B, Maguire JD, Zolotas L, Maansson R, O'Neill R, Peyrani P, Jodar L, Gruber WC, Anderson AS, Beeslaar J. Randomized trial showing persistence of hSBA titers elicited by a pentavalent meningococcal MenABCWY vaccine for up to 4 years following a primary series and safety and immunogenicity of a booster dose. Vaccine. 2025 Jan 1;43(Pt 1):126469. doi: 10.1016/j.vaccine.2024.126469. Epub 2024 Nov 8."}, {'pmid': '37579773', 'type': 'DERIVED', 'citation': "Peterson J, Drazan D, Czajka H, Maguire J, Pregaldien JL, Seppa I, Maansson R, O'Neill R, Balmer P, Jodar L, Jansen KU, Anderson AS, Perez JL, Beeslaar J. Immunogenicity and safety of a pentavalent meningococcal ABCWY vaccine in adolescents and young adults: an observer-blind, active-controlled, randomised trial. Lancet Infect Dis. 2023 Dec;23(12):1370-1382. doi: 10.1016/S1473-3099(23)00191-3. Epub 2023 Aug 11."}], 'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=B1971057', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'This study is examining safety and immunogenicity of 2 doses of Trumenba administered on a 0-,6- month schedule. This trial is also studying safety and immunogenicity of a meningococcal pentavalent vaccine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '10 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female subject aged \\>=10 and \\<26 years at the time of enrollment.\n* Healthy subject as determined by medical history, physical examination, and judgment of the investigator.\n* Negative urine pregnancy test for all female subjects.\n* Subjects who have not received, or who have received no more than 1 prior dose within the past 4 years, of a vaccine containing 1 or more ACWY serogroup\n\nExclusion Criteria:\n\n* Previous vaccination with any meningococcal serogroup B or purely polysaccharide (nonconjugate) meningococcal vaccine.\n* Subjects receiving any allergen immunotherapy with a nonlicensed product or receiving allergen immunotherapy with a licensed product and are not on stable maintenance doses.\n* A known or suspected defect of the immune system that would prevent an immune response to the vaccine, such as subjects with congenital or acquired defects in B cell function, those receiving chronic systemic (oral, intravenous, or intramuscular) corticosteroid therapy, or those receiving immunosuppressive therapy. Subjects in the United States with terminal complement deficiency are excluded from participation in this study.\n* Significant neurological disorder or history of seizure (excluding simple febrile seizure).\n* Current chronic use of systemic antibiotics.\n* Received any investigational vaccines, drugs, or devices within 28 days before administration of the first study vaccination.\n* Any neuroinflammatory or autoimmune condition, including, but not limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.'}, 'identificationModule': {'nctId': 'NCT03135834', 'briefTitle': 'A Trial to Describe the Immunogenicity and Safety of 2 Doses of Bivalent rLP2086 (Trumenba) and a Pentavalent Meningococcal Vaccine in Healthy Subjects >=10 to <26 Years of Age.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A PHASE 3, RANDOMIZED, ACTIVE-CONTROLLED, OBSERVER-BLINDED STUDY TO ASSESS THE IMMUNOGENICITY, SAFETY, AND TOLERABILITY OF BIVALENT RLP2086 WHEN ADMINISTERED AS A 2-DOSE REGIMEN AND A FIRST-IN-HUMAN STUDY TO DESCRIBE THE IMMUNOGENICITY, SAFETY, AND TOLERABILITY OF A BIVALENT RLP2086-CONTAINING PENTAVALENT VACCINE (MENABCWY) IN HEALTHY SUBJECTS>=10 TO <26 YEARS OF AGE', 'orgStudyIdInfo': {'id': 'B1971057'}, 'secondaryIdInfos': [{'id': '2016-004421-17', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1 (ACWY Naive subjects, MenABCWY/Saline)', 'description': 'ACWY Naive subjects, MenABCWY/Saline', 'interventionNames': ['Biological: MenABCWY', 'Biological: Saline']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2 (ACWY Naive subjects, rLP2086/MenACWY-CRM)', 'description': 'ACWY Naive subjects, rLP2086/MenACWY-CRM', 'interventionNames': ['Biological: rLP2086', 'Biological: MenACWY-CRM']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3 (ACWY Experienced subjects, MenABCWY/Saline)', 'description': 'ACWY Experienced subjects, MenABCWY/Saline', 'interventionNames': ['Biological: MenABCWY', 'Biological: Saline']}, {'type': 'EXPERIMENTAL', 'label': 'Group 4 (ACWY Experienced subjects, rLP2086/MenACWY-CRM)', 'description': 'ACWY Experienced subjects, rLP2086/MenACWY-CRM', 'interventionNames': ['Biological: rLP2086', 'Biological: MenACWY-CRM']}], 'interventions': [{'name': 'MenABCWY', 'type': 'BIOLOGICAL', 'description': 'N meningitidis group A, B, C, W, and Y vaccine', 'armGroupLabels': ['Group 1 (ACWY Naive subjects, MenABCWY/Saline)', 'Group 3 (ACWY Experienced subjects, MenABCWY/Saline)']}, {'name': 'Saline', 'type': 'BIOLOGICAL', 'description': 'Placebo', 'armGroupLabels': ['Group 1 (ACWY Naive subjects, MenABCWY/Saline)', 'Group 3 (ACWY Experienced subjects, MenABCWY/Saline)']}, {'name': 'rLP2086', 'type': 'BIOLOGICAL', 'description': 'Bivalent recombinant lipoprotein 2086 vaccine', 'armGroupLabels': ['Group 2 (ACWY Naive subjects, rLP2086/MenACWY-CRM)', 'Group 4 (ACWY Experienced subjects, rLP2086/MenACWY-CRM)']}, {'name': 'MenACWY-CRM', 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