Viewing Study NCT02534935


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Study NCT ID: NCT02534935
Status: COMPLETED
Last Update Posted: 2021-09-27
First Post: 2015-02-23
Is Gene Therapy: True
Has Adverse Events: True

Brief Title: Immunogenicity, Safety and Tolerability of a Neisseria Meningitidis Serogroup B Bivalent Recominant Lipoprotein 2086 Vaccine (Bivalent rLP2086) in Healthy Toddlers.
Sponsor:
Organization:

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, '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 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': 'The immunogenicity data at 36 and 48 months after vaccination 3 was not collected due to change in planned analysis as per latest protocol amendment, according to which blood draw of participants at 36 and 48 months after Vaccination 3 was removed.'}}, 'adverseEventsModule': {'timeFrame': 'Stage 1: SAEs:Recorded from Vaccination(Vacc) 1 through 6 months after Vacc. 3 (Month 12). Local reactions and systemic events in e-diary: 7 days after Vacc 1, 2 and 3. NSAEs: Vaccination 1 through 1 month after Vacc 3 (Month 7). Stage 2 Follow up phase: Month 24 visit (up to 30 days). Stage 2 Booster phase: SAEs: From booster vacc up to 6 months after booster vacc NSAEs: From booster vacc up to 1 month after booster vacc. Local reactions and systemic events in e-diary: 7 days after booster vacc', 'description': 'SAEs and AEs were grouped by system organ class and preferred term. AEs included AEs collected in the e-diary (local and systemic reactions; systematic assessment) and AEs collected on the case report form at each visit (nonsystematic assessment).', 'eventGroups': [{'id': 'EG000', 'title': 'Group 1: 60- Microgram (mcg) Bivalent rLP2086 (>=12 Months to <24 Months): Stage 1', 'description': 'Participants from greater than or equal to (\\>=) 12 months to less than (\\<) 24 months of age, received intramuscular injection of 60 mcg of bivalent rLP2086 vaccine on months 0 (visit 1, vaccination1), 2 (visit 4, vaccination 2), and 6 (visit 6, vaccination 3).', 'otherNumAtRisk': 44, 'deathsNumAtRisk': 44, 'otherNumAffected': 43, 'seriousNumAtRisk': 44, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Group 2: 120-mcg Bivalent rLP2086 (>=12 Months to <24 Months):Stage 1', 'description': 'Participants from \\>=12 months to \\<24 months of age, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine on months 0 (visit 1, vaccination1), 2 (visit 4, vaccination 2), and 6 (visit 6, vaccination 3). All eligible participants (who received 3 doses of bivalent rLP2086 in stage 1 at the 120 mcg dose level) received intramuscular injection of single booster dose of 120 mcg of bivalent rLP2086 after 23 months of vaccination 3 (visit 12) in stage 2. Participants were followed up approximately 6 months after the booster vaccination.', 'otherNumAtRisk': 220, 'deathsNumAtRisk': 220, 'otherNumAffected': 209, 'seriousNumAtRisk': 220, 'deathsNumAffected': 0, 'seriousNumAffected': 19}, {'id': 'EG002', 'title': 'Group 3: HAV/Saline (>=12 Months to <24 Months): Stage 1', 'description': 'Participants from \\>=12 months to \\<24 months of age, received intramuscular injection of saline on 2 month and HAV vaccine on a 0, 6 month schedule.', 'otherNumAtRisk': 132, 'deathsNumAtRisk': 132, 'otherNumAffected': 113, 'seriousNumAtRisk': 132, 'deathsNumAffected': 0, 'seriousNumAffected': 8}, {'id': 'EG003', 'title': '120-mcg Bivalent rLP2086: Stage 2 Booster Phase', 'description': 'Participants who were randomly assigned to bivalent rLP2086 (irrespective of dose level) were eligible for booster vaccination. Participants received intramuscular injection of 120-mcg of bivalent rLP2086 vaccine after 23 months of visit 3.', 'otherNumAtRisk': 147, 'deathsNumAtRisk': 147, 'otherNumAffected': 121, 'seriousNumAtRisk': 147, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG004', 'title': 'Group 1: 60-mcg Bivalent rLP2086 (>=12 Months to <24 Months): Follow up', 'description': 'Participants from \\>=12 months to \\<24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on months 0 (visit 1, vaccination1), 2 (visit 4, vaccination 2), and 6 (visit 6, vaccination 3).', 'otherNumAtRisk': 44, 'deathsNumAtRisk': 44, 'otherNumAffected': 0, 'seriousNumAtRisk': 44, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Group 2: 120-mcg Bivalent rLP2086 (>=12 Months to <24 Months): Follow up', 'description': 'Participants from \\>=12 months to \\<24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on months 0 (visit 1, vaccination1), 2 (visit 4, vaccination 2), and 6 (visit 6, vaccination 3).', 'otherNumAtRisk': 220, 'deathsNumAtRisk': 220, 'otherNumAffected': 0, 'seriousNumAtRisk': 220, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG006', 'title': 'Group 3: HAV/Saline (>=12 Months to <24 Months): Follow up', 'description': 'Participants from \\>=12 months to \\<24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on months 0 (visit 1, vaccination1), 2 (visit 4, vaccination 2), and 6 (visit 6, vaccination 3).', 'otherNumAtRisk': 132, 'deathsNumAtRisk': 132, 'otherNumAffected': 0, 'seriousNumAtRisk': 132, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Eustachian tube disorder', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Middle ear effusion', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Anisometropia', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Astigmatism', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Conjunctivitis allergic', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypermetropia', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Aphthous ulcer', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhoea', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Enteritis', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Flatulence', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Teething', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Chills', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site erythema (redness)', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 137}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 28}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 71}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site erythema', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site pain (tenderness at injection site)', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 160}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 41}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site pain', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site swelling (swelling)', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 103}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 49}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pyrexia (fever)', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 82}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 15}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pyrexia', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vaccination site pain', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vessel puncture site bruise', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Food allergy', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bronchiolitis', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bronchitis', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cellulitis', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Conjunctivitis', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Croup infectious', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Enterobiasis', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Exanthema subitum', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastroenteritis viral', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastroenteritis', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hand-foot-and-mouth disease', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Impetigo', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Infected bite', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Laryngitis', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Lower respiratory tract infection', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Molluscum contagiosum', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasopharyngitis', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Otitis externa', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Otitis media acute', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Otitis media', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pharyngitis streptococcal', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pharyngitis', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 15}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pharyngotonsillitis', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory tract infection viral', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory tract infection', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Rhinitis', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin candida', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Tonsillitis', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Tracheitis', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper respiratory tract infection', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 58}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 34}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary tract infection', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Varicella', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Viral infection', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Viral pharyngitis', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Viral tonsillitis', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Viral upper respiratory tract infection', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 45}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 23}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Arthropod bite', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Arthropod sting', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Concussion', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Contusion', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Craniocerebral injury', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Excoriation', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Face injury', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fall', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hand fracture', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Laceration', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Lip injury', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Decreased appetite (loss of appetite)', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 142}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 50}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Decreased appetite', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Synovitis', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Somnolence (drowsiness)', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 127}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 40}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Somnolence', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Irritability', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cough', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Rhinitis allergic', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Rhinorrhoea', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dermatitis allergic', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dermatitis contact', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dermatitis diaper', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Eczema', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Miliaria', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash generalised', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urticaria', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Irritability', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 176}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 69}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dermatitis', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 68}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site pain', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 103}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arthralgia', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 15}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Myalgia', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 24}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 28}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhoea', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Eyelid ptosis', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Enteritis', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrooesophageal reflux disease', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Inguinal hernia', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Crying', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pyrexia', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bronchiolitis', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Bronchitis', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Croup infectious', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Enterovirus infection', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastroenteritis', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Otitis media', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Otitis media chronic', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia respiratory syncytial viral', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory tract infection viral', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Tonsillitis', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary tract infection', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Viral tonsillitis', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Viral upper respiratory tract infection', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Accidental exposure to product', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Head injury', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Balance disorder', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cerebellar ataxia', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Irritability', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Polydipsia psychogenic', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Adenoidal hypertrophy', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Rhinovirus infection', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cellulitis', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Sleep apnoea syndrome', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Influenza', 'notes': 'MedDRA v20.0 for Group 1: 60mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 2: 120mcg bivalent rLP2086 (\\>=12 months to \\<24 months), Group 3: HAV/Saline (\\>=12 months to \\<24 months); MedDRA v23.0 for booster stage and safety follow up groups.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 220, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 132, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 147, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 220, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 132, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Neisseria Meningitidis Serogroup B (MnB) Test Strains 1 Month After Vaccination 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}, {'value': '30', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <18 Months)', 'description': 'Participants from \\>=12 months to \\<18 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.'}, {'id': 'OG001', 'title': 'Group 1: 60-µg Bivalent rLP2086 (>=18 Months to <24 Months)', 'description': 'Participants from \\>=18 months to \\<24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.'}, {'id': 'OG002', 'title': 'Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <18 Months)', 'description': 'Participants from \\>=12 months to \\<18 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.'}, {'id': 'OG003', 'title': 'Group 2: 120-µg Bivalent rLP2086 (>=18 Months to <24 Months)', 'description': 'Participants from \\>=18 months to \\<24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.'}, {'id': 'OG004', 'title': 'Group 3: HAV/Saline (>=12 Months to <18 Months)', 'description': 'Participants from \\>=12 months to \\<18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.'}, {'id': 'OG005', 'title': 'Group 3: HAV/Saline (>=18 Months to <24 Months)', 'description': 'Participants from \\>=18 months to \\<24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.'}], 'classes': [{'title': 'PMB80 [A22]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}, {'value': '29', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '88.9', 'groupId': 'OG000', 'lowerLimit': '51.8', 'upperLimit': '99.7'}, {'value': '90.9', 'groupId': 'OG001', 'lowerLimit': '58.7', 'upperLimit': '99.8'}, {'value': '91.1', 'groupId': 'OG002', 'lowerLimit': '78.8', 'upperLimit': '97.5'}, {'value': '88.2', 'groupId': 'OG003', 'lowerLimit': '76.1', 'upperLimit': '95.6'}, {'value': '3.2', 'groupId': 'OG004', 'lowerLimit': '0.1', 'upperLimit': '16.7'}, {'value': '6.9', 'groupId': 'OG005', 'lowerLimit': '0.8', 'upperLimit': '22.8'}]}]}, {'title': 'PMB2001 [A56]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}, {'value': '30', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '66.4', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '69.2', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG002', 'lowerLimit': '92.5', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG003', 'lowerLimit': '92.6', 'upperLimit': '100.0'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '14.2'}, {'value': '3.3', 'groupId': 'OG005', 'lowerLimit': '0.1', 'upperLimit': '17.2'}]}]}, {'title': 'PMB2948 [B24]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}, {'value': '29', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '88.9', 'groupId': 'OG000', 'lowerLimit': '51.8', 'upperLimit': '99.7'}, {'value': '81.8', 'groupId': 'OG001', 'lowerLimit': '48.2', 'upperLimit': '97.7'}, {'value': '71.1', 'groupId': 'OG002', 'lowerLimit': '55.7', 'upperLimit': '83.6'}, {'value': '72.0', 'groupId': 'OG003', 'lowerLimit': '57.5', 'upperLimit': '83.8'}, {'value': '3.2', 'groupId': 'OG004', 'lowerLimit': '0.1', 'upperLimit': '16.7'}, {'value': '6.9', 'groupId': 'OG005', 'lowerLimit': '0.8', 'upperLimit': '22.8'}]}]}, {'title': 'PMB2707 [B44]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}, {'value': '30', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '88.9', 'groupId': 'OG000', 'lowerLimit': '51.8', 'upperLimit': '99.7'}, {'value': '90.0', 'groupId': 'OG001', 'lowerLimit': '55.5', 'upperLimit': '99.7'}, {'value': '87.2', 'groupId': 'OG002', 'lowerLimit': '74.3', 'upperLimit': '95.2'}, {'value': '85.1', 'groupId': 'OG003', 'lowerLimit': '71.7', 'upperLimit': '93.8'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '14.2'}, {'value': '0.0', 'groupId': 'OG005', 'lowerLimit': '0.0', 'upperLimit': '11.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month after Vaccination 3', 'description': 'Percentage of participants achieving hSBA titer \\>= LLOQ were computed along with corresponding 2-sided 95 percent (%) confidence interval (CIs). LLOQ was 1:16 for PMB80 (A22) and 1:8 for PMB2001 (A56), PMB2948 (B24) and PMB2707 (B44).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All eligible participants randomized to study received,scheduled investigational products, had pre and post vaccination blood drawn with valid and determinate assay results and had no important protocol deviation. Here,overall number of participants analyzed (N) signifies number of participants evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '110', 'groupId': 'OG003'}, {'value': '110', 'groupId': 'OG004'}, {'value': '220', 'groupId': 'OG005'}, {'value': '66', 'groupId': 'OG006'}, {'value': '66', 'groupId': 'OG007'}, {'value': '132', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <18 Months)', 'description': 'Participants from \\>=12 months to \\<18 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.'}, {'id': 'OG001', 'title': 'Group 1: 60-µg Bivalent rLP2086 (>=18 Months to <24 Months)', 'description': 'Participants from \\>=18 months to \\<24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.'}, {'id': 'OG002', 'title': 'Group 1: 60- mcg Bivalent rLP2086 (>=12 Months to <24 Months)', 'description': 'Participants from greater than or equal to (\\>=) 12 months to less than (\\<) 24 months of age, received intramuscular injection of 60 mcg of bivalent rLP2086 vaccine on months 0 vaccine on a 0, 2, 6 month schedule.'}, {'id': 'OG003', 'title': 'Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <18 Months)', 'description': 'Participants from \\>=12 months to \\<18 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.'}, {'id': 'OG004', 'title': 'Group 2: 120-µg Bivalent rLP2086 (>=18 Months to <24 Months)', 'description': 'Participants from \\>=18 months to \\<24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.'}, {'id': 'OG005', 'title': 'Group 2: 120-mcg Bivalent rLP2086 (>=12 Months to <24 Months)', 'description': 'Participants from \\>=12 months to \\<24 months of age, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine on a 0, 2, 6 month schedule. All participants who received 3 doses of 120 mcg bivalent rLP2086 in Stage 1 and gave consent for booster vaccination, received intramuscular injection of single booster dose of 120 mcg of bivalent rLP2086 after 23 to 24 months of Vaccination 3, in Stage 2. Participants were followed up approximately 6 months after the booster vaccination.'}, {'id': 'OG006', 'title': 'Group 3: HAV/Saline (>=12 Months to <18 Months)', 'description': 'Participants from \\>=12 months to \\<18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.'}, {'id': 'OG007', 'title': 'Group 3: HAV/Saline (>=18 Months to <24 Months)', 'description': 'Participants from \\>=18 months to \\<24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.'}, {'id': 'OG008', 'title': 'Group 3: HAV/Saline (>=12 Months to <24 Months): Stage 1', 'description': 'Participants from \\>=12 months to \\<24 months of age, received intramuscular injection of saline on 2 month and HAV vaccine on a 0, 6 month schedule.'}], 'classes': [{'title': 'Tenderness at injection site: Any', 'categories': [{'measurements': [{'value': '68.2', 'groupId': 'OG000', 'lowerLimit': '45.1', 'upperLimit': '86.1'}, {'value': '50.0', 'groupId': 'OG001', 'lowerLimit': '28.2', 'upperLimit': '71.8'}, {'value': '59.1', 'groupId': 'OG002', 'lowerLimit': '43.2', 'upperLimit': '73.7'}, {'value': '50.9', 'groupId': 'OG003', 'lowerLimit': '41.2', 'upperLimit': '60.6'}, {'value': '64.5', 'groupId': 'OG004', 'lowerLimit': '54.9', 'upperLimit': '73.4'}, {'value': '57.7', 'groupId': 'OG005', 'lowerLimit': '50.9', 'upperLimit': '64.3'}, {'value': '15.2', 'groupId': 'OG006', 'lowerLimit': '7.5', 'upperLimit': '26.1'}, {'value': '19.7', 'groupId': 'OG007', 'lowerLimit': '10.9', 'upperLimit': '31.3'}, {'value': '17.4', 'groupId': 'OG008', 'lowerLimit': '11.4', 'upperLimit': '25.0'}]}]}, {'title': 'Tenderness at injection site: Mild', 'categories': [{'measurements': [{'value': '45.5', 'groupId': 'OG000', 'lowerLimit': '24.4', 'upperLimit': '67.8'}, {'value': '27.3', 'groupId': 'OG001', 'lowerLimit': '10.7', 'upperLimit': '50.2'}, {'value': '36.4', 'groupId': 'OG002', 'lowerLimit': '22.4', 'upperLimit': '52.2'}, {'value': '27.3', 'groupId': 'OG003', 'lowerLimit': '19.2', 'upperLimit': '36.6'}, {'value': '34.5', 'groupId': 'OG004', 'lowerLimit': '25.7', 'upperLimit': '44.2'}, {'value': '30.9', 'groupId': 'OG005', 'lowerLimit': '24.9', 'upperLimit': '37.5'}, {'value': '12.1', 'groupId': 'OG006', 'lowerLimit': '5.4', 'upperLimit': '22.5'}, {'value': '19.7', 'groupId': 'OG007', 'lowerLimit': '10.9', 'upperLimit': '31.3'}, {'value': '15.9', 'groupId': 'OG008', 'lowerLimit': '10.1', 'upperLimit': '23.3'}]}]}, {'title': 'Tenderness at injection site: Moderate', 'categories': [{'measurements': [{'value': '22.7', 'groupId': 'OG000', 'lowerLimit': '7.8', 'upperLimit': '45.4'}, {'value': '18.2', 'groupId': 'OG001', 'lowerLimit': '5.2', 'upperLimit': '40.3'}, {'value': '20.5', 'groupId': 'OG002', 'lowerLimit': '9.8', 'upperLimit': '35.3'}, {'value': '20.9', 'groupId': 'OG003', 'lowerLimit': '13.7', 'upperLimit': '29.7'}, {'value': '24.5', 'groupId': 'OG004', 'lowerLimit': '16.8', 'upperLimit': '33.7'}, {'value': '22.7', 'groupId': 'OG005', 'lowerLimit': '17.4', 'upperLimit': '28.8'}, {'value': '3.0', 'groupId': 'OG006', 'lowerLimit': '0.4', 'upperLimit': '10.5'}, {'value': '0.0', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '5.4'}, {'value': '1.5', 'groupId': 'OG008', 'lowerLimit': '0.2', 'upperLimit': '5.4'}]}]}, {'title': 'Tenderness at injection site: Severe', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '15.4'}, {'value': '4.5', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '22.8'}, {'value': '2.3', 'groupId': 'OG002', 'lowerLimit': '0.1', 'upperLimit': '12.0'}, {'value': '2.7', 'groupId': 'OG003', 'lowerLimit': '0.6', 'upperLimit': '7.8'}, {'value': '5.5', 'groupId': 'OG004', 'lowerLimit': '2.0', 'upperLimit': '11.5'}, {'value': '4.1', 'groupId': 'OG005', 'lowerLimit': '1.9', 'upperLimit': '7.6'}, {'value': '0.0', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '5.4'}, {'value': '0.0', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '5.4'}, {'value': '0.0', 'groupId': 'OG008', 'lowerLimit': '0.0', 'upperLimit': '2.8'}]}]}, {'title': 'Redness: Any', 'categories': [{'measurements': [{'value': '68.2', 'groupId': 'OG000', 'lowerLimit': '45.1', 'upperLimit': '86.1'}, {'value': '40.9', 'groupId': 'OG001', 'lowerLimit': '20.7', 'upperLimit': '63.6'}, {'value': '54.5', 'groupId': 'OG002', 'lowerLimit': '38.8', 'upperLimit': '69.6'}, {'value': '50.9', 'groupId': 'OG003', 'lowerLimit': '41.2', 'upperLimit': '60.6'}, {'value': '42.7', 'groupId': 'OG004', 'lowerLimit': '33.3', 'upperLimit': '52.5'}, {'value': '46.8', 'groupId': 'OG005', 'lowerLimit': '40.1', 'upperLimit': '53.6'}, {'value': '13.6', 'groupId': 'OG006', 'lowerLimit': '6.4', 'upperLimit': '24.3'}, {'value': '16.7', 'groupId': 'OG007', 'lowerLimit': '8.6', 'upperLimit': '27.9'}, {'value': '15.2', 'groupId': 'OG008', 'lowerLimit': '9.5', 'upperLimit': '22.4'}]}]}, {'title': 'Redness: Mild', 'categories': [{'measurements': [{'value': '40.9', 'groupId': 'OG000', 'lowerLimit': '20.7', 'upperLimit': '63.6'}, {'value': '27.3', 'groupId': 'OG001', 'lowerLimit': '10.7', 'upperLimit': '50.2'}, {'value': '34.1', 'groupId': 'OG002', 'lowerLimit': '20.5', 'upperLimit': '49.9'}, {'value': '35.5', 'groupId': 'OG003', 'lowerLimit': '26.6', 'upperLimit': '45.1'}, {'value': '21.8', 'groupId': 'OG004', 'lowerLimit': '14.5', 'upperLimit': '30.7'}, {'value': '28.6', 'groupId': 'OG005', 'lowerLimit': '22.8', 'upperLimit': '35.1'}, {'value': '13.6', 'groupId': 'OG006', 'lowerLimit': '6.4', 'upperLimit': '24.3'}, {'value': '16.7', 'groupId': 'OG007', 'lowerLimit': '8.6', 'upperLimit': '27.9'}, {'value': '15.2', 'groupId': 'OG008', 'lowerLimit': '9.5', 'upperLimit': '22.4'}]}]}, {'title': 'Redness: Moderate', 'categories': [{'measurements': [{'value': '27.3', 'groupId': 'OG000', 'lowerLimit': '10.7', 'upperLimit': '50.2'}, {'value': '13.6', 'groupId': 'OG001', 'lowerLimit': '2.9', 'upperLimit': '34.9'}, {'value': '20.5', 'groupId': 'OG002', 'lowerLimit': '9.8', 'upperLimit': '35.3'}, {'value': '14.5', 'groupId': 'OG003', 'lowerLimit': '8.5', 'upperLimit': '22.5'}, {'value': '19.1', 'groupId': 'OG004', 'lowerLimit': '12.2', 'upperLimit': '27.7'}, {'value': '16.8', 'groupId': 'OG005', 'lowerLimit': '12.1', 'upperLimit': '22.4'}, {'value': '0.0', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '5.4'}, {'value': '0.0', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '5.4'}, {'value': '0.0', 'groupId': 'OG008', 'lowerLimit': '0.0', 'upperLimit': '2.8'}]}]}, {'title': 'Redness: Severe', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '15.4'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '15.4'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '8.0'}, {'value': '0.9', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '5.0'}, {'value': '1.8', 'groupId': 'OG004', 'lowerLimit': '0.2', 'upperLimit': '6.4'}, {'value': '1.4', 'groupId': 'OG005', 'lowerLimit': '0.3', 'upperLimit': '3.9'}, {'value': '0.0', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '5.4'}, {'value': '0.0', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '5.4'}, {'value': '0.0', 'groupId': 'OG008', 'lowerLimit': '0.0', 'upperLimit': '2.8'}]}]}, {'title': 'Swelling: Any', 'categories': [{'measurements': [{'value': '36.4', 'groupId': 'OG000', 'lowerLimit': '17.2', 'upperLimit': '59.3'}, {'value': '22.7', 'groupId': 'OG001', 'lowerLimit': '7.8', 'upperLimit': '45.4'}, {'value': '29.5', 'groupId': 'OG002', 'lowerLimit': '16.8', 'upperLimit': '45.2'}, {'value': '30.0', 'groupId': 'OG003', 'lowerLimit': '21.6', 'upperLimit': '39.5'}, {'value': '27.3', 'groupId': 'OG004', 'lowerLimit': '19.2', 'upperLimit': '36.6'}, {'value': '28.6', 'groupId': 'OG005', 'lowerLimit': '22.8', 'upperLimit': '35.1'}, {'value': '7.6', 'groupId': 'OG006', 'lowerLimit': '2.5', 'upperLimit': '16.8'}, {'value': '12.1', 'groupId': 'OG007', 'lowerLimit': '5.4', 'upperLimit': '22.5'}, {'value': '9.8', 'groupId': 'OG008', 'lowerLimit': '5.3', 'upperLimit': '16.3'}]}]}, {'title': 'Swelling: Mild', 'categories': [{'measurements': [{'value': '22.7', 'groupId': 'OG000', 'lowerLimit': '7.8', 'upperLimit': '45.4'}, {'value': '13.6', 'groupId': 'OG001', 'lowerLimit': '2.9', 'upperLimit': '34.9'}, {'value': '18.2', 'groupId': 'OG002', 'lowerLimit': '8.2', 'upperLimit': '32.7'}, {'value': '15.5', 'groupId': 'OG003', 'lowerLimit': '9.3', 'upperLimit': '23.6'}, {'value': '19.1', 'groupId': 'OG004', 'lowerLimit': '12.2', 'upperLimit': '27.7'}, {'value': '17.3', 'groupId': 'OG005', 'lowerLimit': '12.5', 'upperLimit': '22.9'}, {'value': '7.6', 'groupId': 'OG006', 'lowerLimit': '2.5', 'upperLimit': '16.8'}, {'value': '12.1', 'groupId': 'OG007', 'lowerLimit': '5.4', 'upperLimit': '22.5'}, {'value': '9.8', 'groupId': 'OG008', 'lowerLimit': '5.3', 'upperLimit': '16.3'}]}]}, {'title': 'Swelling: Moderate', 'categories': [{'measurements': [{'value': '13.6', 'groupId': 'OG000', 'lowerLimit': '2.9', 'upperLimit': '34.9'}, {'value': '9.1', 'groupId': 'OG001', 'lowerLimit': '1.1', 'upperLimit': '29.2'}, {'value': '11.4', 'groupId': 'OG002', 'lowerLimit': '3.8', 'upperLimit': '24.6'}, {'value': '13.6', 'groupId': 'OG003', 'lowerLimit': '7.8', 'upperLimit': '21.5'}, {'value': '8.2', 'groupId': 'OG004', 'lowerLimit': '3.8', 'upperLimit': '15.0'}, {'value': '10.9', 'groupId': 'OG005', 'lowerLimit': '7.1', 'upperLimit': '15.8'}, {'value': '0.0', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '5.4'}, {'value': '0.0', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '5.4'}, {'value': '0.0', 'groupId': 'OG008', 'lowerLimit': '0.0', 'upperLimit': '2.8'}]}]}, {'title': 'Swelling: Severe', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '15.4'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '15.4'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '8.0'}, {'value': '0.9', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '5.0'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '3.3'}, {'value': '0.5', 'groupId': 'OG005', 'lowerLimit': '0.0', 'upperLimit': '2.5'}, {'value': '0.0', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '5.4'}, {'value': '0.0', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '5.4'}, {'value': '0.0', 'groupId': 'OG008', 'lowerLimit': '0.0', 'upperLimit': '2.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'within 7 Days after Vaccination 1', 'description': 'Local reactions included tenderness at injection site, swelling and redness collected by using an electronic diary (e-diary). Tenderness was graded as: mild (hurted if gently touched), moderate (hurted if gently touched with crying) and severe (caused limitation of limb movement). Redness and swelling were graded as: mild (0.5-2.0 centimeter \\[cm\\]), moderate (2.5 to 7.0 cm) and severe (\\>7.0 cm).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population: all participants who received at least 1 dose of an investigational product (rLP2086 or HAV vaccine) and had safety data available.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '105', 'groupId': 'OG003'}, {'value': '107', 'groupId': 'OG004'}, {'value': '212', 'groupId': 'OG005'}, {'value': '63', 'groupId': 'OG006'}, {'value': '65', 'groupId': 'OG007'}, {'value': '128', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <18 Months)', 'description': 'Participants from \\>=12 months to \\<18 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.'}, {'id': 'OG001', 'title': 'Group 1: 60-µg Bivalent rLP2086 (>=18 Months to <24 Months)', 'description': 'Participants from \\>=18 months to \\<24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.'}, {'id': 'OG002', 'title': 'Group 1: 60- mcg Bivalent rLP2086 (>=12 Months to <24 Months)', 'description': 'Participants from greater than or equal to (\\>=) 12 months to less than (\\<) 24 months of age, received intramuscular injection of 60 mcg of bivalent rLP2086 vaccine on months 0 vaccine on a 0, 2, 6 month schedule.'}, {'id': 'OG003', 'title': 'Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <18 Months)', 'description': 'Participants from \\>=12 months to \\<18 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.'}, {'id': 'OG004', 'title': 'Group 2: 120-µg Bivalent rLP2086 (>=18 Months to <24 Months)', 'description': 'Participants from \\>=18 months to \\<24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.'}, {'id': 'OG005', 'title': 'Group 2: 120-mcg Bivalent rLP2086 (>=12 Months to <24 Months)', 'description': 'Participants from \\>=12 months to \\<24 months of age, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine on a 0, 2, 6 month schedule. All participants who received 3 doses of 120 mcg bivalent rLP2086 in Stage 1 and gave consent for booster vaccination, received intramuscular injection of single booster dose of 120 mcg of bivalent rLP2086 after 23 to 24 months of Vaccination 3, in Stage 2. Participants were followed up approximately 6 months after the booster vaccination.'}, {'id': 'OG006', 'title': 'Group 3: HAV/Saline (>=12 Months to <18 Months)', 'description': 'Participants from \\>=12 months to \\<18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.'}, {'id': 'OG007', 'title': 'Group 3: HAV/Saline (>=18 Months to <24 Months)', 'description': 'Participants from \\>=18 months to \\<24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.'}, {'id': 'OG008', 'title': 'Group 3: HAV/Saline (>=12 Months to <24 Months): Stage 1', 'description': 'Participants from \\>=12 months to \\<24 months of age, received intramuscular injection of saline on 2 month and HAV vaccine on a 0, 6 month schedule.'}], 'classes': [{'title': 'Tenderness at injection site: Any', 'categories': [{'measurements': [{'value': '45.5', 'groupId': 'OG000', 'lowerLimit': '24.4', 'upperLimit': '67.8'}, {'value': '50.0', 'groupId': 'OG001', 'lowerLimit': '28.2', 'upperLimit': '71.8'}, {'value': '47.7', 'groupId': 'OG002', 'lowerLimit': '32.5', 'upperLimit': '63.3'}, {'value': '45.7', 'groupId': 'OG003', 'lowerLimit': '36.0', 'upperLimit': '55.7'}, {'value': '60.7', 'groupId': 'OG004', 'lowerLimit': '50.8', 'upperLimit': '70.0'}, {'value': '53.3', 'groupId': 'OG005', 'lowerLimit': '46.3', 'upperLimit': '60.2'}, {'value': '14.3', 'groupId': 'OG006', 'lowerLimit': '6.7', 'upperLimit': '25.4'}, {'value': '15.4', 'groupId': 'OG007', 'lowerLimit': '7.6', 'upperLimit': '26.5'}, {'value': '14.8', 'groupId': 'OG008', 'lowerLimit': '9.2', 'upperLimit': '22.2'}]}]}, {'title': 'Tenderness at injection site: Mild', 'categories': [{'measurements': [{'value': '31.8', 'groupId': 'OG000', 'lowerLimit': '13.9', 'upperLimit': '54.9'}, {'value': '40.9', 'groupId': 'OG001', 'lowerLimit': '20.7', 'upperLimit': '63.6'}, {'value': '36.4', 'groupId': 'OG002', 'lowerLimit': '22.4', 'upperLimit': '52.2'}, {'value': '31.4', 'groupId': 'OG003', 'lowerLimit': '22.7', 'upperLimit': '41.2'}, {'value': '32.7', 'groupId': 'OG004', 'lowerLimit': '24.0', 'upperLimit': '42.5'}, {'value': '32.1', 'groupId': 'OG005', 'lowerLimit': '25.8', 'upperLimit': '38.8'}, {'value': '12.7', 'groupId': 'OG006', 'lowerLimit': '5.6', 'upperLimit': '23.5'}, {'value': '15.4', 'groupId': 'OG007', 'lowerLimit': '7.6', 'upperLimit': '26.5'}, {'value': '14.1', 'groupId': 'OG008', 'lowerLimit': '8.6', 'upperLimit': '21.3'}]}]}, {'title': 'Tenderness at injection site: Moderate', 'categories': [{'measurements': [{'value': '13.6', 'groupId': 'OG000', 'lowerLimit': '2.9', 'upperLimit': '34.9'}, {'value': '9.1', 'groupId': 'OG001', 'lowerLimit': '1.1', 'upperLimit': '29.2'}, {'value': '11.4', 'groupId': 'OG002', 'lowerLimit': '3.8', 'upperLimit': '24.6'}, {'value': '12.4', 'groupId': 'OG003', 'lowerLimit': '6.8', 'upperLimit': '20.2'}, {'value': '24.3', 'groupId': 'OG004', 'lowerLimit': '16.5', 'upperLimit': '33.5'}, {'value': '18.4', 'groupId': 'OG005', 'lowerLimit': '13.4', 'upperLimit': '24.3'}, {'value': '1.6', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '8.5'}, {'value': '0.0', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '5.5'}, {'value': '0.8', 'groupId': 'OG008', 'lowerLimit': '0.0', 'upperLimit': '4.3'}]}]}, {'title': 'Tenderness at injection site: Severe', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '15.4'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '15.4'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '8.0'}, {'value': '1.9', 'groupId': 'OG003', 'lowerLimit': '0.2', 'upperLimit': '6.7'}, {'value': '3.7', 'groupId': 'OG004', 'lowerLimit': '1.0', 'upperLimit': '9.3'}, {'value': '2.8', 'groupId': 'OG005', 'lowerLimit': '1.0', 'upperLimit': '6.1'}, {'value': '0.0', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '5.7'}, {'value': '0.0', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '5.5'}, {'value': '0.0', 'groupId': 'OG008', 'lowerLimit': '0.0', 'upperLimit': '2.8'}]}]}, {'title': 'Redness: Any', 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000', 'lowerLimit': '28.2', 'upperLimit': '71.8'}, {'value': '31.8', 'groupId': 'OG001', 'lowerLimit': '13.9', 'upperLimit': '54.9'}, {'value': '40.9', 'groupId': 'OG002', 'lowerLimit': '26.3', 'upperLimit': '56.8'}, {'value': '33.3', 'groupId': 'OG003', 'lowerLimit': '24.4', 'upperLimit': '43.2'}, {'value': '38.3', 'groupId': 'OG004', 'lowerLimit': '29.1', 'upperLimit': '48.2'}, {'value': '35.8', 'groupId': 'OG005', 'lowerLimit': '29.4', 'upperLimit': '42.7'}, {'value': '6.3', 'groupId': 'OG006', 'lowerLimit': '1.8', 'upperLimit': '15.5'}, {'value': '9.2', 'groupId': 'OG007', 'lowerLimit': '3.5', 'upperLimit': '19.0'}, {'value': '7.8', 'groupId': 'OG008', 'lowerLimit': '3.8', 'upperLimit': '13.9'}]}]}, {'title': 'Redness: Mild', 'categories': [{'measurements': [{'value': '40.9', 'groupId': 'OG000', 'lowerLimit': '20.7', 'upperLimit': '63.6'}, {'value': '27.3', 'groupId': 'OG001', 'lowerLimit': '10.7', 'upperLimit': '50.2'}, {'value': '34.1', 'groupId': 'OG002', 'lowerLimit': '20.5', 'upperLimit': '49.9'}, {'value': '21.9', 'groupId': 'OG003', 'lowerLimit': '14.4', 'upperLimit': '31.0'}, {'value': '23.4', 'groupId': 'OG004', 'lowerLimit': '15.7', 'upperLimit': '32.5'}, {'value': '22.6', 'groupId': 'OG005', 'lowerLimit': '17.2', 'upperLimit': '28.9'}, {'value': '6.3', 'groupId': 'OG006', 'lowerLimit': '1.8', 'upperLimit': '15.5'}, {'value': '9.2', 'groupId': 'OG007', 'lowerLimit': '3.5', 'upperLimit': '19.0'}, {'value': '7.8', 'groupId': 'OG008', 'lowerLimit': '3.8', 'upperLimit': '13.9'}]}]}, {'title': 'Redness: Moderate', 'categories': [{'measurements': [{'value': '9.1', 'groupId': 'OG000', 'lowerLimit': '1.1', 'upperLimit': '29.2'}, {'value': '4.5', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '22.8'}, {'value': '6.8', 'groupId': 'OG002', 'lowerLimit': '1.4', 'upperLimit': '18.7'}, {'value': '11.4', 'groupId': 'OG003', 'lowerLimit': '6.0', 'upperLimit': '19.1'}, {'value': '15.0', 'groupId': 'OG004', 'lowerLimit': '8.8', 'upperLimit': '23.1'}, {'value': '13.2', 'groupId': 'OG005', 'lowerLimit': '9.0', 'upperLimit': '18.5'}, {'value': '0.0', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '5.7'}, {'value': '0.0', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '5.5'}, {'value': '0.0', 'groupId': 'OG008', 'lowerLimit': '0.0', 'upperLimit': '2.8'}]}]}, {'title': 'Redness: Severe', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '15.4'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '15.4'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '8.0'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '3.5'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '3.4'}, {'value': '0.0', 'groupId': 'OG005', 'lowerLimit': '0.0', 'upperLimit': '1.7'}, {'value': '0.0', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '5.7'}, {'value': '0.0', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '5.5'}, {'value': '0.0', 'groupId': 'OG008', 'lowerLimit': '0.0', 'upperLimit': '2.8'}]}]}, {'title': 'Swelling: Any', 'categories': [{'measurements': [{'value': '18.2', 'groupId': 'OG000', 'lowerLimit': '5.2', 'upperLimit': '40.3'}, {'value': '27.3', 'groupId': 'OG001', 'lowerLimit': '10.7', 'upperLimit': '50.2'}, {'value': '22.7', 'groupId': 'OG002', 'lowerLimit': '11.5', 'upperLimit': '37.8'}, {'value': '21.0', 'groupId': 'OG003', 'lowerLimit': '13.6', 'upperLimit': '30.0'}, {'value': '19.6', 'groupId': 'OG004', 'lowerLimit': '12.6', 'upperLimit': '28.4'}, {'value': '20.3', 'groupId': 'OG005', 'lowerLimit': '15.1', 'upperLimit': '26.3'}, {'value': '1.6', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '8.5'}, {'value': '7.7', 'groupId': 'OG007', 'lowerLimit': '2.5', 'upperLimit': '17.0'}, {'value': '4.7', 'groupId': 'OG008', 'lowerLimit': '1.7', 'upperLimit': '9.9'}]}]}, {'title': 'Swelling: Mild', 'categories': [{'measurements': [{'value': '18.2', 'groupId': 'OG000', 'lowerLimit': '5.2', 'upperLimit': '40.3'}, {'value': '13.6', 'groupId': 'OG001', 'lowerLimit': '2.9', 'upperLimit': '34.9'}, {'value': '15.9', 'groupId': 'OG002', 'lowerLimit': '6.6', 'upperLimit': '30.1'}, {'value': '14.3', 'groupId': 'OG003', 'lowerLimit': '8.2', 'upperLimit': '22.5'}, {'value': '13.1', 'groupId': 'OG004', 'lowerLimit': '7.3', 'upperLimit': '21.0'}, {'value': '13.7', 'groupId': 'OG005', 'lowerLimit': '9.4', 'upperLimit': '19.1'}, {'value': '1.6', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '8.5'}, {'value': '7.7', 'groupId': 'OG007', 'lowerLimit': '2.5', 'upperLimit': '17.0'}, {'value': '4.7', 'groupId': 'OG008', 'lowerLimit': '1.7', 'upperLimit': '9.9'}]}]}, {'title': 'Swelling: Moderate', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '15.4'}, {'value': '13.6', 'groupId': 'OG001', 'lowerLimit': '2.9', 'upperLimit': '34.9'}, {'value': '6.8', 'groupId': 'OG002', 'lowerLimit': '1.4', 'upperLimit': '18.7'}, {'value': '6.7', 'groupId': 'OG003', 'lowerLimit': '2.7', 'upperLimit': '13.3'}, {'value': '5.6', 'groupId': 'OG004', 'lowerLimit': '2.1', 'upperLimit': '11.8'}, {'value': '6.1', 'groupId': 'OG005', 'lowerLimit': '3.3', 'upperLimit': '10.3'}, {'value': '0.0', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '5.7'}, {'value': '0.0', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '5.5'}, {'value': '0.0', 'groupId': 'OG008', 'lowerLimit': '0.0', 'upperLimit': '2.8'}]}]}, {'title': 'Swelling: Severe', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '15.4'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '15.4'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '8.0'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '3.5'}, {'value': '0.9', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '5.1'}, {'value': '0.5', 'groupId': 'OG005', 'lowerLimit': '0.0', 'upperLimit': '2.6'}, {'value': '0.0', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '5.7'}, {'value': '0.0', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '5.5'}, {'value': '0.0', 'groupId': 'OG008', 'lowerLimit': '0.0', 'upperLimit': '2.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'within 7 Days after Vaccination 2', 'description': 'Local reactions included tenderness at injection site, swelling and redness collected by using an e-diary. Tenderness was graded as: mild (hurted if gently touched), moderate (hurted if gently touched with crying) and severe (caused limitation of limb movement). Redness and swelling were graded as: mild (0.5-2.0 cm), moderate (2.5 to 7.0 cm) and severe (\\>7.0 cm).', 'unitOfMeasure': 'percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population: all participants who received at least 1 dose of an investigational product (rLP2086 or HAV vaccine) and had safety data available. Here, N signifies number of participants evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '104', 'groupId': 'OG003'}, {'value': '108', 'groupId': 'OG004'}, {'value': '212', 'groupId': 'OG005'}, {'value': '65', 'groupId': 'OG006'}, {'value': '63', 'groupId': 'OG007'}, {'value': '128', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <18 Months)', 'description': 'Participants from \\>=12 months to \\<18 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.'}, {'id': 'OG001', 'title': 'Group 1: 60-µg Bivalent rLP2086 (>=18 Months to <24 Months)', 'description': 'Participants from \\>=18 months to \\<24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.'}, {'id': 'OG002', 'title': 'Group 1: 60- mcg Bivalent rLP2086 (>=12 Months to <24 Months)', 'description': 'Participants from greater than or equal to (\\>=) 12 months to less than (\\<) 24 months of age, received intramuscular injection of 60 mcg of bivalent rLP2086 vaccine on months 0 vaccine on a 0, 2, 6 month schedule.'}, {'id': 'OG003', 'title': 'Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <18 Months)', 'description': 'Participants from \\>=12 months to \\<18 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.'}, {'id': 'OG004', 'title': 'Group 2: 120-µg Bivalent rLP2086 (>=18 Months to <24 Months)', 'description': 'Participants from \\>=18 months to \\<24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.'}, {'id': 'OG005', 'title': 'Group 2: 120-mcg Bivalent rLP2086 (>=12 Months to <24 Months)', 'description': 'Participants from \\>=12 months to \\<24 months of age, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine on a 0, 2, 6 month schedule. All participants who received 3 doses of 120 mcg bivalent rLP2086 in Stage 1 and gave consent for booster vaccination, received intramuscular injection of single booster dose of 120 mcg of bivalent rLP2086 after 23 to 24 months of Vaccination 3, in Stage 2. Participants were followed up approximately 6 months after the booster vaccination.'}, {'id': 'OG006', 'title': 'Group 3: HAV/Saline (>=12 Months to <18 Months)', 'description': 'Participants from \\>=12 months to \\<18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.'}, {'id': 'OG007', 'title': 'Group 3: HAV/Saline (>=18 Months to <24 Months)', 'description': 'Participants from \\>=18 months to \\<24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.'}, {'id': 'OG008', 'title': 'Group 3: HAV/Saline (>=12 Months to <24 Months): Stage 1', 'description': 'Participants from \\>=12 months to \\<24 months of age, received intramuscular injection of saline on 2 month and HAV vaccine on a 0, 6 month schedule.'}], 'classes': [{'title': 'Tenderness at injection site: Any', 'categories': [{'measurements': [{'value': '54.5', 'groupId': 'OG000', 'lowerLimit': '32.2', 'upperLimit': '75.6'}, {'value': '59.1', 'groupId': 'OG001', 'lowerLimit': '36.4', 'upperLimit': '79.3'}, {'value': '56.8', 'groupId': 'OG002', 'lowerLimit': '41.0', 'upperLimit': '71.7'}, {'value': '51.9', 'groupId': 'OG003', 'lowerLimit': '41.9', 'upperLimit': '61.8'}, {'value': '62.0', 'groupId': 'OG004', 'lowerLimit': '52.2', 'upperLimit': '71.2'}, {'value': '57.1', 'groupId': 'OG005', 'lowerLimit': '50.1', 'upperLimit': '63.8'}, {'value': '16.9', 'groupId': 'OG006', 'lowerLimit': '8.8', 'upperLimit': '28.3'}, {'value': '14.3', 'groupId': 'OG007', 'lowerLimit': '6.7', 'upperLimit': '25.4'}, {'value': '15.6', 'groupId': 'OG008', 'lowerLimit': '9.8', 'upperLimit': '23.1'}]}]}, {'title': 'Tenderness at injection site: Mild', 'categories': [{'measurements': [{'value': '22.7', 'groupId': 'OG000', 'lowerLimit': '7.8', 'upperLimit': '45.4'}, {'value': '40.9', 'groupId': 'OG001', 'lowerLimit': '20.7', 'upperLimit': '63.6'}, {'value': '31.8', 'groupId': 'OG002', 'lowerLimit': '18.6', 'upperLimit': '47.6'}, {'value': '29.8', 'groupId': 'OG003', 'lowerLimit': '21.2', 'upperLimit': '39.6'}, {'value': '34.3', 'groupId': 'OG004', 'lowerLimit': '25.4', 'upperLimit': '44.0'}, {'value': '32.1', 'groupId': 'OG005', 'lowerLimit': '25.8', 'upperLimit': '38.8'}, {'value': '12.3', 'groupId': 'OG006', 'lowerLimit': '5.5', 'upperLimit': '22.8'}, {'value': '12.7', 'groupId': 'OG007', 'lowerLimit': '5.6', 'upperLimit': '23.5'}, {'value': '12.5', 'groupId': 'OG008', 'lowerLimit': '7.3', 'upperLimit': '19.5'}]}]}, {'title': 'Tenderness at injection site: Moderate', 'categories': [{'measurements': [{'value': '31.8', 'groupId': 'OG000', 'lowerLimit': '13.9', 'upperLimit': '54.9'}, {'value': '18.2', 'groupId': 'OG001', 'lowerLimit': '5.2', 'upperLimit': '40.3'}, {'value': '25.0', 'groupId': 'OG002', 'lowerLimit': '13.2', 'upperLimit': '40.3'}, {'value': '17.3', 'groupId': 'OG003', 'lowerLimit': '10.6', 'upperLimit': '26.0'}, {'value': '22.2', 'groupId': 'OG004', 'lowerLimit': '14.8', 'upperLimit': '31.2'}, {'value': '19.8', 'groupId': 'OG005', 'lowerLimit': '14.7', 'upperLimit': '25.8'}, {'value': '4.6', 'groupId': 'OG006', 'lowerLimit': '1.0', 'upperLimit': '12.9'}, {'value': '1.6', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '8.5'}, {'value': '3.1', 'groupId': 'OG008', 'lowerLimit': '0.9', 'upperLimit': '7.8'}]}]}, {'title': 'Tenderness at injection site: Severe', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '15.4'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '15.4'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '8.0'}, {'value': '4.8', 'groupId': 'OG003', 'lowerLimit': '1.6', 'upperLimit': '10.9'}, {'value': '5.6', 'groupId': 'OG004', 'lowerLimit': '2.1', 'upperLimit': '11.7'}, {'value': '5.2', 'groupId': 'OG005', 'lowerLimit': '2.6', 'upperLimit': '9.1'}, {'value': '0.0', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '5.5'}, {'value': '0.0', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '5.7'}, {'value': '0.0', 'groupId': 'OG008', 'lowerLimit': '0.0', 'upperLimit': '2.8'}]}]}, {'title': 'Redness: Any', 'categories': [{'measurements': [{'value': '40.9', 'groupId': 'OG000', 'lowerLimit': '20.7', 'upperLimit': '63.6'}, {'value': '36.4', 'groupId': 'OG001', 'lowerLimit': '17.2', 'upperLimit': '59.3'}, {'value': '38.6', 'groupId': 'OG002', 'lowerLimit': '24.4', 'upperLimit': '54.5'}, {'value': '32.7', 'groupId': 'OG003', 'lowerLimit': '23.8', 'upperLimit': '42.6'}, {'value': '33.3', 'groupId': 'OG004', 'lowerLimit': '24.6', 'upperLimit': '43.1'}, {'value': '33.0', 'groupId': 'OG005', 'lowerLimit': '26.7', 'upperLimit': '39.8'}, {'value': '7.7', 'groupId': 'OG006', 'lowerLimit': '2.5', 'upperLimit': '17.0'}, {'value': '7.9', 'groupId': 'OG007', 'lowerLimit': '2.6', 'upperLimit': '17.6'}, {'value': '7.8', 'groupId': 'OG008', 'lowerLimit': '3.8', 'upperLimit': '13.9'}]}]}, {'title': 'Redness: Mild', 'categories': [{'measurements': [{'value': '31.8', 'groupId': 'OG000', 'lowerLimit': '13.9', 'upperLimit': '54.9'}, {'value': '27.3', 'groupId': 'OG001', 'lowerLimit': '10.7', 'upperLimit': '50.2'}, {'value': '29.5', 'groupId': 'OG002', 'lowerLimit': '16.8', 'upperLimit': '45.2'}, {'value': '23.1', 'groupId': 'OG003', 'lowerLimit': '15.4', 'upperLimit': '32.4'}, {'value': '18.5', 'groupId': 'OG004', 'lowerLimit': '11.7', 'upperLimit': '27.1'}, {'value': '20.8', 'groupId': 'OG005', 'lowerLimit': '15.5', 'upperLimit': '26.8'}, {'value': '6.2', 'groupId': 'OG006', 'lowerLimit': '1.7', 'upperLimit': '15.0'}, {'value': '7.9', 'groupId': 'OG007', 'lowerLimit': '2.6', 'upperLimit': '17.6'}, {'value': '7.0', 'groupId': 'OG008', 'lowerLimit': '3.3', 'upperLimit': '12.9'}]}]}, {'title': 'Redness: Moderate', 'categories': [{'measurements': [{'value': '9.1', 'groupId': 'OG000', 'lowerLimit': '1.1', 'upperLimit': '29.2'}, {'value': '9.1', 'groupId': 'OG001', 'lowerLimit': '1.1', 'upperLimit': '29.2'}, {'value': '9.1', 'groupId': 'OG002', 'lowerLimit': '2.5', 'upperLimit': '21.7'}, {'value': '8.7', 'groupId': 'OG003', 'lowerLimit': '4.0', 'upperLimit': '15.8'}, {'value': '14.8', 'groupId': 'OG004', 'lowerLimit': '8.7', 'upperLimit': '22.9'}, {'value': '11.8', 'groupId': 'OG005', 'lowerLimit': '7.8', 'upperLimit': '16.9'}, {'value': '1.5', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '8.3'}, {'value': '0.0', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '5.7'}, {'value': '0.8', 'groupId': 'OG008', 'lowerLimit': '0.0', 'upperLimit': '4.3'}]}]}, {'title': 'Redness: Severe', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '15.4'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '15.4'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '8.0'}, {'value': '1.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '5.2'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '3.4'}, {'value': '0.5', 'groupId': 'OG005', 'lowerLimit': '0.0', 'upperLimit': '2.6'}, {'value': '0.0', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '5.5'}, {'value': '0.0', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '5.7'}, {'value': '0.0', 'groupId': 'OG008', 'lowerLimit': '0.0', 'upperLimit': '2.8'}]}]}, {'title': 'Swelling: Any', 'categories': [{'measurements': [{'value': '18.2', 'groupId': 'OG000', 'lowerLimit': '5.2', 'upperLimit': '40.3'}, {'value': '27.3', 'groupId': 'OG001', 'lowerLimit': '10.7', 'upperLimit': '50.2'}, {'value': '22.7', 'groupId': 'OG002', 'lowerLimit': '11.5', 'upperLimit': '37.8'}, {'value': '23.1', 'groupId': 'OG003', 'lowerLimit': '15.4', 'upperLimit': '32.4'}, {'value': '22.2', 'groupId': 'OG004', 'lowerLimit': '14.8', 'upperLimit': '31.2'}, {'value': '22.6', 'groupId': 'OG005', 'lowerLimit': '17.2', 'upperLimit': '28.9'}, {'value': '4.6', 'groupId': 'OG006', 'lowerLimit': '1.0', 'upperLimit': '12.9'}, {'value': '6.3', 'groupId': 'OG007', 'lowerLimit': '1.8', 'upperLimit': '15.5'}, {'value': '5.5', 'groupId': 'OG008', 'lowerLimit': '2.2', 'upperLimit': '10.9'}]}]}, {'title': 'Swelling: Mild', 'categories': [{'measurements': [{'value': '9.1', 'groupId': 'OG000', 'lowerLimit': '1.1', 'upperLimit': '29.2'}, {'value': '13.6', 'groupId': 'OG001', 'lowerLimit': '2.9', 'upperLimit': '34.9'}, {'value': '11.4', 'groupId': 'OG002', 'lowerLimit': '3.8', 'upperLimit': '24.6'}, {'value': '16.3', 'groupId': 'OG003', 'lowerLimit': '9.8', 'upperLimit': '24.9'}, {'value': '11.1', 'groupId': 'OG004', 'lowerLimit': '5.9', 'upperLimit': '18.6'}, {'value': '13.7', 'groupId': 'OG005', 'lowerLimit': '9.4', 'upperLimit': '19.1'}, {'value': '4.6', 'groupId': 'OG006', 'lowerLimit': '1.0', 'upperLimit': '12.9'}, {'value': '4.8', 'groupId': 'OG007', 'lowerLimit': '1.0', 'upperLimit': '13.3'}, {'value': '4.7', 'groupId': 'OG008', 'lowerLimit': '1.7', 'upperLimit': '9.9'}]}]}, {'title': 'Swelling: Moderate', 'categories': [{'measurements': [{'value': '9.1', 'groupId': 'OG000', 'lowerLimit': '1.1', 'upperLimit': '29.2'}, {'value': '13.6', 'groupId': 'OG001', 'lowerLimit': '2.9', 'upperLimit': '34.9'}, {'value': '11.4', 'groupId': 'OG002', 'lowerLimit': '3.8', 'upperLimit': '24.6'}, {'value': '5.8', 'groupId': 'OG003', 'lowerLimit': '2.1', 'upperLimit': '12.1'}, {'value': '11.1', 'groupId': 'OG004', 'lowerLimit': '5.9', 'upperLimit': '18.6'}, {'value': '8.5', 'groupId': 'OG005', 'lowerLimit': '5.1', 'upperLimit': '13.1'}, {'value': '0.0', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '5.5'}, {'value': '1.6', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '8.5'}, {'value': '0.8', 'groupId': 'OG008', 'lowerLimit': '0.0', 'upperLimit': '4.3'}]}]}, {'title': 'Swelling: Severe', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '15.4'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '15.4'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '8.0'}, {'value': '1.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '5.2'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '3.4'}, {'value': '0.5', 'groupId': 'OG005', 'lowerLimit': '0.0', 'upperLimit': '2.6'}, {'value': '0.0', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '5.5'}, {'value': '0.0', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '5.7'}, {'value': '0.0', 'groupId': 'OG008', 'lowerLimit': '0.0', 'upperLimit': '2.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'within 7 Days after Vaccination 3', 'description': 'Local reactions included tenderness at injection site, swelling and redness collected by using an e-diary. Tenderness was graded as: mild (hurted if gently touched), moderate (hurted if gently touched with crying) and severe (caused limitation of limb movement). Redness and swelling were graded as: mild (0.5-2.0 cm), moderate (2.5 to 7.0 cm) and severe (\\>7.0 cm).', 'unitOfMeasure': 'percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population: all participants who received at least 1 dose of an investigational product (rLP2086 or HAV vaccine) and had safety data available. Here, N signifies number of participants evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '110', 'groupId': 'OG003'}, {'value': '110', 'groupId': 'OG004'}, {'value': '220', 'groupId': 'OG005'}, {'value': '66', 'groupId': 'OG006'}, {'value': '66', 'groupId': 'OG007'}, {'value': '132', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <18 Months)', 'description': 'Participants from \\>=12 months to \\<18 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.'}, {'id': 'OG001', 'title': 'Group 1: 60-µg Bivalent rLP2086 (>=18 Months to <24 Months)', 'description': 'Participants from \\>=18 months to \\<24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.'}, {'id': 'OG002', 'title': 'Group 1: 60- mcg Bivalent rLP2086 (>=12 Months to <24 Months)', 'description': 'Participants from greater than or equal to (\\>=) 12 months to less than (\\<) 24 months of age, received intramuscular injection of 60 mcg of bivalent rLP2086 vaccine on months 0 vaccine on a 0, 2, 6 month schedule.'}, {'id': 'OG003', 'title': 'Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <18 Months)', 'description': 'Participants from \\>=12 months to \\<18 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.'}, {'id': 'OG004', 'title': 'Group 2: 120-µg Bivalent rLP2086 (>=18 Months to <24 Months)', 'description': 'Participants from \\>=18 months to \\<24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.'}, {'id': 'OG005', 'title': 'Group 2: 120-mcg Bivalent rLP2086 (>=12 Months to <24 Months)', 'description': 'Participants from \\>=12 months to \\<24 months of age, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine on a 0, 2, 6 month schedule. All participants who received 3 doses of 120 mcg bivalent rLP2086 in Stage 1 and gave consent for booster vaccination, received intramuscular injection of single booster dose of 120 mcg of bivalent rLP2086 after 23 to 24 months of Vaccination 3, in Stage 2. Participants were followed up approximately 6 months after the booster vaccination.'}, {'id': 'OG006', 'title': 'Group 3: HAV/Saline (>=12 Months to <18 Months)', 'description': 'Participants from \\>=12 months to \\<18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.'}, {'id': 'OG007', 'title': 'Group 3: HAV/Saline (>=18 Months to <24 Months)', 'description': 'Participants from \\>=18 months to \\<24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.'}, {'id': 'OG008', 'title': 'Group 3: HAV/Saline (>=12 Months to <24 Months): Stage 1', 'description': 'Participants from \\>=12 months to \\<24 months of age, received intramuscular injection of saline on 2 month and HAV vaccine on a 0, 6 month schedule.'}], 'classes': [{'title': 'Fever >=38 degrees C', 'categories': [{'measurements': [{'value': '40.9', 'groupId': 'OG000', 'lowerLimit': '20.7', 'upperLimit': '63.6'}, {'value': '31.8', 'groupId': 'OG001', 'lowerLimit': '13.9', 'upperLimit': '54.9'}, {'value': '36.4', 'groupId': 'OG002', 'lowerLimit': '22.4', 'upperLimit': '52.2'}, {'value': '28.2', 'groupId': 'OG003', 'lowerLimit': '20.0', 'upperLimit': '37.6'}, {'value': '27.3', 'groupId': 'OG004', 'lowerLimit': '19.2', 'upperLimit': '36.6'}, {'value': '27.7', 'groupId': 'OG005', 'lowerLimit': '21.9', 'upperLimit': '34.1'}, {'value': '10.6', 'groupId': 'OG006', 'lowerLimit': '4.4', 'upperLimit': '20.6'}, {'value': '1.5', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '8.2'}, {'value': '6.1', 'groupId': 'OG008', 'lowerLimit': '2.7', 'upperLimit': '11.6'}]}]}, {'title': 'Fever 38 to <38.5 degrees C', 'categories': [{'measurements': [{'value': '22.7', 'groupId': 'OG000', 'lowerLimit': '7.8', 'upperLimit': '45.4'}, {'value': '18.2', 'groupId': 'OG001', 'lowerLimit': '5.2', 'upperLimit': '40.3'}, {'value': '20.5', 'groupId': 'OG002', 'lowerLimit': '9.8', 'upperLimit': '35.3'}, {'value': '7.3', 'groupId': 'OG003', 'lowerLimit': '3.2', 'upperLimit': '13.8'}, {'value': '7.3', 'groupId': 'OG004', 'lowerLimit': '3.2', 'upperLimit': '13.8'}, {'value': '7.3', 'groupId': 'OG005', 'lowerLimit': '4.2', 'upperLimit': '11.5'}, {'value': '6.1', 'groupId': 'OG006', 'lowerLimit': '1.7', 'upperLimit': '14.8'}, {'value': '1.5', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '8.2'}, {'value': '3.8', 'groupId': 'OG008', 'lowerLimit': '1.2', 'upperLimit': '8.6'}]}]}, {'title': 'Fever 38.5 to <39 degrees C', 'categories': [{'measurements': [{'value': '13.6', 'groupId': 'OG000', 'lowerLimit': '2.9', 'upperLimit': '34.9'}, {'value': '9.1', 'groupId': 'OG001', 'lowerLimit': '1.1', 'upperLimit': '29.2'}, {'value': '11.4', 'groupId': 'OG002', 'lowerLimit': '3.8', 'upperLimit': '24.6'}, {'value': '14.5', 'groupId': 'OG003', 'lowerLimit': '8.5', 'upperLimit': '22.5'}, {'value': '13.6', 'groupId': 'OG004', 'lowerLimit': '7.8', 'upperLimit': '21.5'}, {'value': '14.1', 'groupId': 'OG005', 'lowerLimit': '9.8', 'upperLimit': '19.4'}, {'value': '1.5', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '8.2'}, {'value': '0.0', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '5.4'}, {'value': '0.8', 'groupId': 'OG008', 'lowerLimit': '0.0', 'upperLimit': '4.1'}]}]}, {'title': 'Fever 39 to <39.5 degrees C', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '15.4'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '15.4'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '8.0'}, {'value': '4.5', 'groupId': 'OG003', 'lowerLimit': '1.5', 'upperLimit': '10.3'}, {'value': '3.6', 'groupId': 'OG004', 'lowerLimit': '1.0', 'upperLimit': '9.0'}, {'value': '4.1', 'groupId': 'OG005', 'lowerLimit': '1.9', 'upperLimit': '7.6'}, {'value': '3.0', 'groupId': 'OG006', 'lowerLimit': '0.4', 'upperLimit': '10.5'}, {'value': '0.0', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '5.4'}, {'value': '1.5', 'groupId': 'OG008', 'lowerLimit': '0.2', 'upperLimit': '5.4'}]}]}, {'title': 'Fever 39.5 to <=40 degrees C', 'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '22.8'}, {'value': '4.5', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '22.8'}, {'value': '4.5', 'groupId': 'OG002', 'lowerLimit': '0.6', 'upperLimit': '15.5'}, {'value': '1.8', 'groupId': 'OG003', 'lowerLimit': '0.2', 'upperLimit': '6.4'}, {'value': '1.8', 'groupId': 'OG004', 'lowerLimit': '0.2', 'upperLimit': '6.4'}, {'value': '1.8', 'groupId': 'OG005', 'lowerLimit': '0.5', 'upperLimit': '4.6'}, {'value': '0.0', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '5.4'}, {'value': '0.0', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '5.4'}, {'value': '0.0', 'groupId': 'OG008', 'lowerLimit': '0.0', 'upperLimit': '2.8'}]}]}, {'title': 'Fever >40 degrees C', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '15.4'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '15.4'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '8.0'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '3.3'}, {'value': '0.9', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '5.0'}, {'value': '0.5', 'groupId': 'OG005', 'lowerLimit': '0.0', 'upperLimit': '2.5'}, {'value': '0.0', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '5.4'}, {'value': '0.0', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '5.4'}, {'value': '0.0', 'groupId': 'OG008', 'lowerLimit': '0.0', 'upperLimit': '2.8'}]}]}, {'title': 'Irritability: Any', 'categories': [{'measurements': [{'value': '63.6', 'groupId': 'OG000', 'lowerLimit': '40.7', 'upperLimit': '82.8'}, {'value': '50.0', 'groupId': 'OG001', 'lowerLimit': '28.2', 'upperLimit': '71.8'}, {'value': '56.8', 'groupId': 'OG002', 'lowerLimit': '41.0', 'upperLimit': '71.7'}, {'value': '71.8', 'groupId': 'OG003', 'lowerLimit': '62.4', 'upperLimit': '80.0'}, {'value': '60.9', 'groupId': 'OG004', 'lowerLimit': '51.1', 'upperLimit': '70.1'}, {'value': '66.4', 'groupId': 'OG005', 'lowerLimit': '59.7', 'upperLimit': '72.6'}, {'value': '40.9', 'groupId': 'OG006', 'lowerLimit': '29.0', 'upperLimit': '53.7'}, {'value': '33.3', 'groupId': 'OG007', 'lowerLimit': '22.2', 'upperLimit': '46.0'}, {'value': '37.1', 'groupId': 'OG008', 'lowerLimit': '28.9', 'upperLimit': '46.0'}]}]}, {'title': 'Irritability: Mild', 'categories': [{'measurements': [{'value': '27.3', 'groupId': 'OG000', 'lowerLimit': '10.7', 'upperLimit': '50.2'}, {'value': '9.1', 'groupId': 'OG001', 'lowerLimit': '1.1', 'upperLimit': '29.2'}, {'value': '18.2', 'groupId': 'OG002', 'lowerLimit': '8.2', 'upperLimit': '32.7'}, {'value': '19.1', 'groupId': 'OG003', 'lowerLimit': '12.2', 'upperLimit': '27.7'}, {'value': '16.4', 'groupId': 'OG004', 'lowerLimit': '10.0', 'upperLimit': '24.6'}, {'value': '17.7', 'groupId': 'OG005', 'lowerLimit': '12.9', 'upperLimit': '23.4'}, {'value': '10.6', 'groupId': 'OG006', 'lowerLimit': '4.4', 'upperLimit': '20.6'}, {'value': '13.6', 'groupId': 'OG007', 'lowerLimit': '6.4', 'upperLimit': '24.3'}, {'value': '12.1', 'groupId': 'OG008', 'lowerLimit': '7.1', 'upperLimit': '18.9'}]}]}, {'title': 'Irritability: Moderate', 'categories': [{'measurements': [{'value': '31.8', 'groupId': 'OG000', 'lowerLimit': '13.9', 'upperLimit': '54.9'}, {'value': '40.9', 'groupId': 'OG001', 'lowerLimit': '20.7', 'upperLimit': '63.6'}, {'value': '36.4', 'groupId': 'OG002', 'lowerLimit': '22.4', 'upperLimit': '52.2'}, {'value': '46.4', 'groupId': 'OG003', 'lowerLimit': '36.8', 'upperLimit': '56.1'}, {'value': '39.1', 'groupId': 'OG004', 'lowerLimit': '29.9', 'upperLimit': '48.9'}, {'value': '42.7', 'groupId': 'OG005', 'lowerLimit': '36.1', 'upperLimit': '49.6'}, {'value': '30.3', 'groupId': 'OG006', 'lowerLimit': '19.6', 'upperLimit': '42.9'}, {'value': '16.7', 'groupId': 'OG007', 'lowerLimit': '8.6', 'upperLimit': '27.9'}, {'value': '23.5', 'groupId': 'OG008', 'lowerLimit': '16.5', 'upperLimit': '31.6'}]}]}, {'title': 'Irritability: Severe', 'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '22.8'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '15.4'}, {'value': '2.3', 'groupId': 'OG002', 'lowerLimit': '0.1', 'upperLimit': '12.0'}, {'value': '6.4', 'groupId': 'OG003', 'lowerLimit': '2.6', 'upperLimit': '12.7'}, {'value': '5.5', 'groupId': 'OG004', 'lowerLimit': '2.0', 'upperLimit': '11.5'}, {'value': '5.9', 'groupId': 'OG005', 'lowerLimit': '3.2', 'upperLimit': '9.9'}, {'value': '0.0', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '5.4'}, {'value': '3.0', 'groupId': 'OG007', 'lowerLimit': '0.4', 'upperLimit': '10.5'}, {'value': '1.5', 'groupId': 'OG008', 'lowerLimit': '0.2', 'upperLimit': '5.4'}]}]}, {'title': 'Drowsiness: Any', 'categories': [{'measurements': [{'value': '45.5', 'groupId': 'OG000', 'lowerLimit': '24.4', 'upperLimit': '67.8'}, {'value': '40.9', 'groupId': 'OG001', 'lowerLimit': '20.7', 'upperLimit': '63.6'}, {'value': '43.2', 'groupId': 'OG002', 'lowerLimit': '28.3', 'upperLimit': '59.0'}, {'value': '45.5', 'groupId': 'OG003', 'lowerLimit': '35.9', 'upperLimit': '55.2'}, {'value': '42.7', 'groupId': 'OG004', 'lowerLimit': '33.3', 'upperLimit': '52.5'}, {'value': '44.1', 'groupId': 'OG005', 'lowerLimit': '37.4', 'upperLimit': '50.9'}, {'value': '25.8', 'groupId': 'OG006', 'lowerLimit': '15.8', 'upperLimit': '38.0'}, {'value': '10.6', 'groupId': 'OG007', 'lowerLimit': '4.4', 'upperLimit': '20.6'}, {'value': '18.2', 'groupId': 'OG008', 'lowerLimit': '12.0', 'upperLimit': '25.8'}]}]}, {'title': 'Drowsiness: Mild', 'categories': [{'measurements': [{'value': '36.4', 'groupId': 'OG000', 'lowerLimit': '17.2', 'upperLimit': '59.3'}, {'value': '31.8', 'groupId': 'OG001', 'lowerLimit': '13.9', 'upperLimit': '54.9'}, {'value': '34.1', 'groupId': 'OG002', 'lowerLimit': '20.5', 'upperLimit': '49.9'}, {'value': '28.2', 'groupId': 'OG003', 'lowerLimit': '20.0', 'upperLimit': '37.6'}, {'value': '24.5', 'groupId': 'OG004', 'lowerLimit': '16.8', 'upperLimit': '33.7'}, {'value': '26.4', 'groupId': 'OG005', 'lowerLimit': '20.7', 'upperLimit': '32.7'}, {'value': '16.7', 'groupId': 'OG006', 'lowerLimit': '8.6', 'upperLimit': '27.9'}, {'value': '6.1', 'groupId': 'OG007', 'lowerLimit': '1.7', 'upperLimit': '14.8'}, {'value': '11.4', 'groupId': 'OG008', 'lowerLimit': '6.5', 'upperLimit': '18.0'}]}]}, {'title': 'Drowsiness: Moderate', 'categories': [{'measurements': [{'value': '9.1', 'groupId': 'OG000', 'lowerLimit': '1.1', 'upperLimit': '29.2'}, {'value': '9.1', 'groupId': 'OG001', 'lowerLimit': '1.1', 'upperLimit': '29.2'}, {'value': '9.1', 'groupId': 'OG002', 'lowerLimit': '2.5', 'upperLimit': '21.7'}, {'value': '11.8', 'groupId': 'OG003', 'lowerLimit': '6.4', 'upperLimit': '19.4'}, {'value': '15.5', 'groupId': 'OG004', 'lowerLimit': '9.3', 'upperLimit': '23.6'}, {'value': '13.6', 'groupId': 'OG005', 'lowerLimit': '9.4', 'upperLimit': '18.9'}, {'value': '7.6', 'groupId': 'OG006', 'lowerLimit': '2.5', 'upperLimit': '16.8'}, {'value': '4.5', 'groupId': 'OG007', 'lowerLimit': '0.9', 'upperLimit': '12.7'}, {'value': '6.1', 'groupId': 'OG008', 'lowerLimit': '2.7', 'upperLimit': '11.6'}]}]}, {'title': 'Drowsiness: Severe', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '15.4'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '15.4'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '8.0'}, {'value': '5.5', 'groupId': 'OG003', 'lowerLimit': '2.0', 'upperLimit': '11.5'}, {'value': '2.7', 'groupId': 'OG004', 'lowerLimit': '0.6', 'upperLimit': '7.8'}, {'value': '4.1', 'groupId': 'OG005', 'lowerLimit': '1.9', 'upperLimit': '7.6'}, {'value': '1.5', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '8.2'}, {'value': '0.0', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '15.4'}, {'value': '0.8', 'groupId': 'OG008', 'lowerLimit': '0.0', 'upperLimit': '4.1'}]}]}, {'title': 'Loss of or decrease appetite: Any', 'categories': [{'measurements': [{'value': '36.4', 'groupId': 'OG000', 'lowerLimit': '17.2', 'upperLimit': '59.3'}, {'value': '36.4', 'groupId': 'OG001', 'lowerLimit': '17.2', 'upperLimit': '59.3'}, {'value': '36.4', 'groupId': 'OG002', 'lowerLimit': '22.4', 'upperLimit': '52.2'}, {'value': '44.5', 'groupId': 'OG003', 'lowerLimit': '35.1', 'upperLimit': '54.3'}, {'value': '46.4', 'groupId': 'OG004', 'lowerLimit': '36.8', 'upperLimit': '56.1'}, {'value': '45.5', 'groupId': 'OG005', 'lowerLimit': '38.7', 'upperLimit': '52.3'}, {'value': '34.8', 'groupId': 'OG006', 'lowerLimit': '23.5', 'upperLimit': '47.6'}, {'value': '10.6', 'groupId': 'OG007', 'lowerLimit': '4.4', 'upperLimit': '20.6'}, {'value': '22.7', 'groupId': 'OG008', 'lowerLimit': '15.9', 'upperLimit': '30.8'}]}]}, {'title': 'Loss of or decrease appetite: Mild', 'categories': [{'measurements': [{'value': '22.7', 'groupId': 'OG000', 'lowerLimit': '7.8', 'upperLimit': '45.4'}, {'value': '18.2', 'groupId': 'OG001', 'lowerLimit': '5.2', 'upperLimit': '40.3'}, {'value': '20.5', 'groupId': 'OG002', 'lowerLimit': '9.8', 'upperLimit': '35.3'}, {'value': '16.4', 'groupId': 'OG003', 'lowerLimit': '10.0', 'upperLimit': '24.6'}, {'value': '24.5', 'groupId': 'OG004', 'lowerLimit': '16.8', 'upperLimit': '33.7'}, {'value': '20.5', 'groupId': 'OG005', 'lowerLimit': '15.3', 'upperLimit': '26.4'}, {'value': '13.6', 'groupId': 'OG006', 'lowerLimit': '6.4', 'upperLimit': '24.3'}, {'value': '7.6', 'groupId': 'OG007', 'lowerLimit': '2.5', 'upperLimit': '16.8'}, {'value': '10.6', 'groupId': 'OG008', 'lowerLimit': '5.9', 'upperLimit': '17.2'}]}]}, {'title': 'Loss of or decrease appetite: Moderate', 'categories': [{'measurements': [{'value': '13.6', 'groupId': 'OG000', 'lowerLimit': '2.9', 'upperLimit': '34.9'}, {'value': '9.1', 'groupId': 'OG001', 'lowerLimit': '1.1', 'upperLimit': '29.2'}, {'value': '11.4', 'groupId': 'OG002', 'lowerLimit': '3.8', 'upperLimit': '24.6'}, {'value': '25.5', 'groupId': 'OG003', 'lowerLimit': '17.6', 'upperLimit': '34.6'}, {'value': '14.5', 'groupId': 'OG004', 'lowerLimit': '8.5', 'upperLimit': '22.5'}, {'value': '20.0', 'groupId': 'OG005', 'lowerLimit': '14.9', 'upperLimit': '25.9'}, {'value': '18.2', 'groupId': 'OG006', 'lowerLimit': '9.8', 'upperLimit': '29.6'}, {'value': '1.5', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '8.2'}, {'value': '9.8', 'groupId': 'OG008', 'lowerLimit': '5.3', 'upperLimit': '16.3'}]}]}, {'title': 'Loss of or decrease appetite: Severe', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '15.4'}, {'value': '9.1', 'groupId': 'OG001', 'lowerLimit': '1.1', 'upperLimit': '29.2'}, {'value': '4.5', 'groupId': 'OG002', 'lowerLimit': '0.6', 'upperLimit': '15.5'}, {'value': '2.7', 'groupId': 'OG003', 'lowerLimit': '0.6', 'upperLimit': '7.8'}, {'value': '7.3', 'groupId': 'OG004', 'lowerLimit': '3.2', 'upperLimit': '13.8'}, {'value': '5.0', 'groupId': 'OG005', 'lowerLimit': '2.5', 'upperLimit': '8.8'}, {'value': '3.0', 'groupId': 'OG006', 'lowerLimit': '0.4', 'upperLimit': '10.5'}, {'value': '1.5', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '8.2'}, {'value': '2.3', 'groupId': 'OG008', 'lowerLimit': '0.5', 'upperLimit': '6.5'}]}]}, {'title': 'Antipyretic medication use', 'categories': [{'measurements': [{'value': '45.5', 'groupId': 'OG000', 'lowerLimit': '24.4', 'upperLimit': '67.8'}, {'value': '59.1', 'groupId': 'OG001', 'lowerLimit': '36.4', 'upperLimit': '79.3'}, {'value': '52.3', 'groupId': 'OG002', 'lowerLimit': '36.7', 'upperLimit': '67.5'}, {'value': '52.7', 'groupId': 'OG003', 'lowerLimit': '43.0', 'upperLimit': '62.3'}, {'value': '40.9', 'groupId': 'OG004', 'lowerLimit': '31.6', 'upperLimit': '50.7'}, {'value': '46.8', 'groupId': 'OG005', 'lowerLimit': '40.1', 'upperLimit': '53.6'}, {'value': '24.2', 'groupId': 'OG006', 'lowerLimit': '14.5', 'upperLimit': '36.4'}, {'value': '15.2', 'groupId': 'OG007', 'lowerLimit': '7.5', 'upperLimit': '26.1'}, {'value': '19.7', 'groupId': 'OG008', 'lowerLimit': '13.3', 'upperLimit': '27.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'within 7 Days after Vaccination 1', 'description': 'Systemic reactions included fever, irritability, drowsiness, loss of or decreased appetite and were recorded by using an e-diary. Fever was graded as 38.0 to 38.4 degree Celsius (C), 38.5 to 38.9 degree C, 39.0 to 39.4 degree C, \\>39.5 to 40.0 degree C and \\>40.0 degree C. Irritability was graded as mild (easily consolable), moderate (requiring increased attention) and severe (inconsolable). Drowsiness was graded as mild (Increased or prolonged sleeping bouts), moderate (slightly subdued interfering with daily activity) and severe (disabling not interested in usual daily activity). Loss of or decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed).', 'unitOfMeasure': 'percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population: all participants who received at least 1 dose of an investigational product (rLP2086 or HAV vaccine) and had safety data available.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '105', 'groupId': 'OG003'}, {'value': '107', 'groupId': 'OG004'}, {'value': '212', 'groupId': 'OG005'}, {'value': '63', 'groupId': 'OG006'}, {'value': '65', 'groupId': 'OG007'}, {'value': '128', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <18 Months)', 'description': 'Participants from \\>=12 months to \\<18 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.'}, {'id': 'OG001', 'title': 'Group 1: 60-µg Bivalent rLP2086 (>=18 Months to <24 Months)', 'description': 'Participants from \\>=18 months to \\<24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.'}, {'id': 'OG002', 'title': 'Group 1: 60- mcg Bivalent rLP2086 (>=12 Months to <24 Months)', 'description': 'Participants from greater than or equal to (\\>=) 12 months to less than (\\<) 24 months of age, received intramuscular injection of 60 mcg of bivalent rLP2086 vaccine on months 0 vaccine on a 0, 2, 6 month schedule.'}, {'id': 'OG003', 'title': 'Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <18 Months)', 'description': 'Participants from \\>=12 months to \\<18 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.'}, {'id': 'OG004', 'title': 'Group 2: 120-µg Bivalent rLP2086 (>=18 Months to <24 Months)', 'description': 'Participants from \\>=18 months to \\<24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.'}, {'id': 'OG005', 'title': 'Group 2: 120-mcg Bivalent rLP2086 (>=12 Months to <24 Months)', 'description': 'Participants from \\>=12 months to \\<24 months of age, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine on a 0, 2, 6 month schedule. All participants who received 3 doses of 120 mcg bivalent rLP2086 in Stage 1 and gave consent for booster vaccination, received intramuscular injection of single booster dose of 120 mcg of bivalent rLP2086 after 23 to 24 months of Vaccination 3, in Stage 2. Participants were followed up approximately 6 months after the booster vaccination.'}, {'id': 'OG006', 'title': 'Group 3: HAV/Saline (>=12 Months to <18 Months)', 'description': 'Participants from \\>=12 months to \\<18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.'}, {'id': 'OG007', 'title': 'Group 3: HAV/Saline (>=18 Months to <24 Months)', 'description': 'Participants from \\>=18 months to \\<24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.'}, {'id': 'OG008', 'title': 'Group 3: HAV/Saline (>=12 Months to <24 Months): Stage 1', 'description': 'Participants from \\>=12 months to \\<24 months of age, received intramuscular injection of saline on 2 month and HAV vaccine on a 0, 6 month schedule.'}], 'classes': [{'title': 'Fever >=38 degrees C', 'categories': [{'measurements': [{'value': '13.6', 'groupId': 'OG000', 'lowerLimit': '2.9', 'upperLimit': '34.9'}, {'value': '9.1', 'groupId': 'OG001', 'lowerLimit': '1.1', 'upperLimit': '29.2'}, {'value': '11.4', 'groupId': 'OG002', 'lowerLimit': '3.8', 'upperLimit': '24.6'}, {'value': '14.3', 'groupId': 'OG003', 'lowerLimit': '8.2', 'upperLimit': '22.5'}, {'value': '14.0', 'groupId': 'OG004', 'lowerLimit': '8.1', 'upperLimit': '22.1'}, {'value': '14.2', 'groupId': 'OG005', 'lowerLimit': '9.8', 'upperLimit': '19.6'}, {'value': '6.3', 'groupId': 'OG006', 'lowerLimit': '1.8', 'upperLimit': '15.5'}, {'value': '3.1', 'groupId': 'OG007', 'lowerLimit': '0.4', 'upperLimit': '10.7'}, {'value': '4.7', 'groupId': 'OG008', 'lowerLimit': '1.7', 'upperLimit': '9.9'}]}]}, {'title': 'Fever 38 to <38.5 degrees C', 'categories': [{'measurements': [{'value': '13.6', 'groupId': 'OG000', 'lowerLimit': '2.9', 'upperLimit': '34.9'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '15.4'}, {'value': '6.8', 'groupId': 'OG002', 'lowerLimit': '1.4', 'upperLimit': '18.7'}, {'value': '4.8', 'groupId': 'OG003', 'lowerLimit': '1.6', 'upperLimit': '10.8'}, {'value': '8.4', 'groupId': 'OG004', 'lowerLimit': '3.9', 'upperLimit': '15.4'}, {'value': '6.6', 'groupId': 'OG005', 'lowerLimit': '3.7', 'upperLimit': '10.8'}, {'value': '4.8', 'groupId': 'OG006', 'lowerLimit': '1.0', 'upperLimit': '13.3'}, {'value': '3.1', 'groupId': 'OG007', 'lowerLimit': '0.4', 'upperLimit': '10.7'}, {'value': '3.9', 'groupId': 'OG008', 'lowerLimit': '1.3', 'upperLimit': '8.9'}]}]}, {'title': 'Fever 38.5 to <39 degrees C', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '15.4'}, {'value': '4.5', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '22.8'}, {'value': '2.3', 'groupId': 'OG002', 'lowerLimit': '0.1', 'upperLimit': '12.0'}, {'value': '6.7', 'groupId': 'OG003', 'lowerLimit': '2.7', 'upperLimit': '13.3'}, {'value': '2.8', 'groupId': 'OG004', 'lowerLimit': '0.6', 'upperLimit': '8.0'}, {'value': '4.7', 'groupId': 'OG005', 'lowerLimit': '2.3', 'upperLimit': '8.5'}, {'value': '1.6', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '8.5'}, {'value': '0.0', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '5.5'}, {'value': '0.8', 'groupId': 'OG008', 'lowerLimit': '0.0', 'upperLimit': '4.3'}]}]}, {'title': 'Fever 39 to <39.5 degrees C', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '15.4'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '15.4'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '8.0'}, {'value': '1.9', 'groupId': 'OG003', 'lowerLimit': '0.2', 'upperLimit': '6.7'}, {'value': '1.9', 'groupId': 'OG004', 'lowerLimit': '0.2', 'upperLimit': '6.6'}, {'value': '1.9', 'groupId': 'OG005', 'lowerLimit': '0.5', 'upperLimit': '4.8'}, {'value': '0.0', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '5.7'}, {'value': '0.0', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '5.5'}, {'value': '0.0', 'groupId': 'OG008', 'lowerLimit': '0.0', 'upperLimit': '2.8'}]}]}, {'title': 'Fever 39.5 to <=40 degrees C', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '15.4'}, {'value': '4.5', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '22.8'}, {'value': '2.3', 'groupId': 'OG002', 'lowerLimit': '0.1', 'upperLimit': '12.0'}, {'value': '1.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '5.2'}, {'value': '0.9', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '5.1'}, {'value': '0.9', 'groupId': 'OG005', 'lowerLimit': '0.1', 'upperLimit': '3.4'}, {'value': '0.0', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '5.7'}, {'value': '0.0', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '5.5'}, {'value': '0.0', 'groupId': 'OG008', 'lowerLimit': '0.0', 'upperLimit': '2.8'}]}]}, {'title': 'Fever >40 degrees C', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '15.4'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '15.4'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '8.0'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '3.5'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '3.4'}, {'value': '0.0', 'groupId': 'OG005', 'lowerLimit': '0.0', 'upperLimit': '1.7'}, {'value': '0.0', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '5.7'}, {'value': '0.0', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '5.5'}, {'value': '0.0', 'groupId': 'OG008', 'lowerLimit': '0.0', 'upperLimit': '2.8'}]}]}, {'title': 'Irritability: Any', 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000', 'lowerLimit': '28.2', 'upperLimit': '71.8'}, {'value': '40.9', 'groupId': 'OG001', 'lowerLimit': '20.7', 'upperLimit': '63.6'}, {'value': '45.5', 'groupId': 'OG002', 'lowerLimit': '30.4', 'upperLimit': '61.2'}, {'value': '54.3', 'groupId': 'OG003', 'lowerLimit': '44.3', 'upperLimit': '64.0'}, {'value': '55.1', 'groupId': 'OG004', 'lowerLimit': '45.2', 'upperLimit': '64.8'}, {'value': '54.7', 'groupId': 'OG005', 'lowerLimit': '47.8', 'upperLimit': '61.5'}, {'value': '31.7', 'groupId': 'OG006', 'lowerLimit': '20.6', 'upperLimit': '44.7'}, {'value': '18.5', 'groupId': 'OG007', 'lowerLimit': '9.9', 'upperLimit': '30.0'}, {'value': '25.0', 'groupId': 'OG008', 'lowerLimit': '17.8', 'upperLimit': '33.4'}]}]}, {'title': 'Irritability: Mild', 'categories': [{'measurements': [{'value': '40.9', 'groupId': 'OG000', 'lowerLimit': '20.7', 'upperLimit': '63.6'}, {'value': '18.2', 'groupId': 'OG001', 'lowerLimit': '5.2', 'upperLimit': '40.3'}, {'value': '29.5', 'groupId': 'OG002', 'lowerLimit': '16.8', 'upperLimit': '45.2'}, {'value': '19.0', 'groupId': 'OG003', 'lowerLimit': '12.0', 'upperLimit': '27.9'}, {'value': '18.7', 'groupId': 'OG004', 'lowerLimit': '11.8', 'upperLimit': '27.4'}, {'value': '18.9', 'groupId': 'OG005', 'lowerLimit': '13.8', 'upperLimit': '24.8'}, {'value': '7.9', 'groupId': 'OG006', 'lowerLimit': '2.6', 'upperLimit': '17.6'}, {'value': '6.2', 'groupId': 'OG007', 'lowerLimit': '1.7', 'upperLimit': '15.0'}, {'value': '7.0', 'groupId': 'OG008', 'lowerLimit': '3.3', 'upperLimit': '12.9'}]}]}, {'title': 'Irritability: Moderate', 'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '22.8'}, {'value': '22.7', 'groupId': 'OG001', 'lowerLimit': '7.8', 'upperLimit': '45.4'}, {'value': '13.6', 'groupId': 'OG002', 'lowerLimit': '5.2', 'upperLimit': '27.4'}, {'value': '31.4', 'groupId': 'OG003', 'lowerLimit': '22.7', 'upperLimit': '41.2'}, {'value': '34.6', 'groupId': 'OG004', 'lowerLimit': '25.6', 'upperLimit': '44.4'}, {'value': '33.0', 'groupId': 'OG005', 'lowerLimit': '26.7', 'upperLimit': '39.8'}, {'value': '22.2', 'groupId': 'OG006', 'lowerLimit': '12.7', 'upperLimit': '34.5'}, {'value': '9.2', 'groupId': 'OG007', 'lowerLimit': '3.5', 'upperLimit': '19.0'}, {'value': '15.6', 'groupId': 'OG008', 'lowerLimit': '9.8', 'upperLimit': '23.1'}]}]}, {'title': 'Irritability: Severe', 'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '22.8'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '15.4'}, {'value': '2.3', 'groupId': 'OG002', 'lowerLimit': '0.1', 'upperLimit': '12.0'}, {'value': '3.8', 'groupId': 'OG003', 'lowerLimit': '1.0', 'upperLimit': '9.5'}, {'value': '1.9', 'groupId': 'OG004', 'lowerLimit': '0.2', 'upperLimit': '6.6'}, {'value': '2.8', 'groupId': 'OG005', 'lowerLimit': '1.0', 'upperLimit': '6.1'}, {'value': '1.6', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '8.5'}, {'value': '3.1', 'groupId': 'OG007', 'lowerLimit': '0.4', 'upperLimit': '10.7'}, {'value': '2.3', 'groupId': 'OG008', 'lowerLimit': '0.5', 'upperLimit': '6.7'}]}]}, {'title': 'Drowsiness: Any', 'categories': [{'measurements': [{'value': '13.6', 'groupId': 'OG000', 'lowerLimit': '2.9', 'upperLimit': '34.9'}, {'value': '18.2', 'groupId': 'OG001', 'lowerLimit': '5.2', 'upperLimit': '40.3'}, {'value': '15.9', 'groupId': 'OG002', 'lowerLimit': '6.6', 'upperLimit': '30.1'}, {'value': '37.1', 'groupId': 'OG003', 'lowerLimit': '27.9', 'upperLimit': '47.1'}, {'value': '24.3', 'groupId': 'OG004', 'lowerLimit': '16.5', 'upperLimit': '33.5'}, {'value': '30.7', 'groupId': 'OG005', 'lowerLimit': '24.5', 'upperLimit': '37.3'}, {'value': '19.0', 'groupId': 'OG006', 'lowerLimit': '10.2', 'upperLimit': '30.9'}, {'value': '4.6', 'groupId': 'OG007', 'lowerLimit': '1.0', 'upperLimit': '12.9'}, {'value': '11.7', 'groupId': 'OG008', 'lowerLimit': '6.7', 'upperLimit': '18.6'}]}]}, {'title': 'Drowsiness: Mild', 'categories': [{'measurements': [{'value': '9.1', 'groupId': 'OG000', 'lowerLimit': '1.1', 'upperLimit': '29.2'}, {'value': '18.2', 'groupId': 'OG001', 'lowerLimit': '5.2', 'upperLimit': '40.3'}, {'value': '13.6', 'groupId': 'OG002', 'lowerLimit': '5.2', 'upperLimit': '27.4'}, {'value': '22.9', 'groupId': 'OG003', 'lowerLimit': '15.2', 'upperLimit': '32.1'}, {'value': '14.0', 'groupId': 'OG004', 'lowerLimit': '8.1', 'upperLimit': '22.1'}, {'value': '18.4', 'groupId': 'OG005', 'lowerLimit': '13.4', 'upperLimit': '24.3'}, {'value': '9.5', 'groupId': 'OG006', 'lowerLimit': '3.6', 'upperLimit': '19.6'}, {'value': '4.6', 'groupId': 'OG007', 'lowerLimit': '1.0', 'upperLimit': '12.9'}, {'value': '7.0', 'groupId': 'OG008', 'lowerLimit': '3.3', 'upperLimit': '12.9'}]}]}, {'title': 'Drowsiness: Moderate', 'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '22.8'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '15.4'}, {'value': '2.3', 'groupId': 'OG002', 'lowerLimit': '0.1', 'upperLimit': '12.0'}, {'value': '13.3', 'groupId': 'OG003', 'lowerLimit': '7.5', 'upperLimit': '21.4'}, {'value': '8.4', 'groupId': 'OG004', 'lowerLimit': '3.9', 'upperLimit': '15.4'}, {'value': '10.8', 'groupId': 'OG005', 'lowerLimit': '7.0', 'upperLimit': '15.8'}, {'value': '7.9', 'groupId': 'OG006', 'lowerLimit': '2.6', 'upperLimit': '17.6'}, {'value': '0.0', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '5.5'}, {'value': '3.9', 'groupId': 'OG008', 'lowerLimit': '1.3', 'upperLimit': '8.9'}]}]}, {'title': 'Drowsiness: Severe', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '15.4'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '15.4'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '8.0'}, {'value': '1.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '5.2'}, {'value': '1.9', 'groupId': 'OG004', 'lowerLimit': '0.2', 'upperLimit': '6.6'}, {'value': '1.4', 'groupId': 'OG005', 'lowerLimit': '0.3', 'upperLimit': '4.1'}, {'value': '1.6', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '8.5'}, {'value': '0.0', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '5.5'}, {'value': '0.8', 'groupId': 'OG008', 'lowerLimit': '0.0', 'upperLimit': '4.3'}]}]}, {'title': 'Loss of or decreased appetite: Any', 'categories': [{'measurements': [{'value': '31.8', 'groupId': 'OG000', 'lowerLimit': '13.9', 'upperLimit': '54.9'}, {'value': '18.2', 'groupId': 'OG001', 'lowerLimit': '5.2', 'upperLimit': '40.3'}, {'value': '25.0', 'groupId': 'OG002', 'lowerLimit': '13.2', 'upperLimit': '40.3'}, {'value': '41.0', 'groupId': 'OG003', 'lowerLimit': '31.5', 'upperLimit': '51.0'}, {'value': '31.8', 'groupId': 'OG004', 'lowerLimit': '23.1', 'upperLimit': '41.5'}, {'value': '36.3', 'groupId': 'OG005', 'lowerLimit': '29.8', 'upperLimit': '43.2'}, {'value': '22.2', 'groupId': 'OG006', 'lowerLimit': '12.7', 'upperLimit': '34.5'}, {'value': '13.8', 'groupId': 'OG007', 'lowerLimit': '6.5', 'upperLimit': '24.7'}, {'value': '18.0', 'groupId': 'OG008', 'lowerLimit': '11.7', 'upperLimit': '25.7'}]}]}, {'title': 'Loss of or decreased appetite: Mild', 'categories': [{'measurements': [{'value': '27.3', 'groupId': 'OG000', 'lowerLimit': '10.7', 'upperLimit': '50.2'}, {'value': '18.2', 'groupId': 'OG001', 'lowerLimit': '5.2', 'upperLimit': '40.3'}, {'value': '22.7', 'groupId': 'OG002', 'lowerLimit': '11.5', 'upperLimit': '37.8'}, {'value': '19.0', 'groupId': 'OG003', 'lowerLimit': '12.0', 'upperLimit': '27.9'}, {'value': '19.6', 'groupId': 'OG004', 'lowerLimit': '12.6', 'upperLimit': '28.4'}, {'value': '19.3', 'groupId': 'OG005', 'lowerLimit': '14.3', 'upperLimit': '25.3'}, {'value': '11.1', 'groupId': 'OG006', 'lowerLimit': '4.6', 'upperLimit': '21.6'}, {'value': '7.7', 'groupId': 'OG007', 'lowerLimit': '2.5', 'upperLimit': '17.0'}, {'value': '9.4', 'groupId': 'OG008', 'lowerLimit': '4.9', 'upperLimit': '15.8'}]}]}, {'title': 'Loss of or decreased appetite: Moderate', 'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '22.8'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '15.4'}, {'value': '2.3', 'groupId': 'OG002', 'lowerLimit': '0.1', 'upperLimit': '12.0'}, {'value': '17.1', 'groupId': 'OG003', 'lowerLimit': '10.5', 'upperLimit': '25.7'}, {'value': '7.5', 'groupId': 'OG004', 'lowerLimit': '3.3', 'upperLimit': '14.2'}, {'value': '12.3', 'groupId': 'OG005', 'lowerLimit': '8.2', 'upperLimit': '17.5'}, {'value': '9.5', 'groupId': 'OG006', 'lowerLimit': '3.6', 'upperLimit': '19.6'}, {'value': '6.2', 'groupId': 'OG007', 'lowerLimit': '1.7', 'upperLimit': '15.0'}, {'value': '7.8', 'groupId': 'OG008', 'lowerLimit': '3.8', 'upperLimit': '13.9'}]}]}, {'title': 'Loss of or decreased appetite: Severe', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '15.4'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '15.4'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '8.0'}, {'value': '4.8', 'groupId': 'OG003', 'lowerLimit': '1.6', 'upperLimit': '10.8'}, {'value': '4.7', 'groupId': 'OG004', 'lowerLimit': '1.5', 'upperLimit': '10.6'}, {'value': '4.7', 'groupId': 'OG005', 'lowerLimit': '2.3', 'upperLimit': '8.5'}, {'value': '1.6', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '8.5'}, {'value': '0.0', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '5.5'}, {'value': '0.8', 'groupId': 'OG008', 'lowerLimit': '0.0', 'upperLimit': '4.3'}]}]}, {'title': 'Antipyretic medication use', 'categories': [{'measurements': [{'value': '45.5', 'groupId': 'OG000', 'lowerLimit': '24.4', 'upperLimit': '67.8'}, {'value': '27.3', 'groupId': 'OG001', 'lowerLimit': '10.7', 'upperLimit': '50.2'}, {'value': '36.4', 'groupId': 'OG002', 'lowerLimit': '22.4', 'upperLimit': '52.2'}, {'value': '35.2', 'groupId': 'OG003', 'lowerLimit': '26.2', 'upperLimit': '45.2'}, {'value': '31.8', 'groupId': 'OG004', 'lowerLimit': '23.1', 'upperLimit': '41.5'}, {'value': '33.5', 'groupId': 'OG005', 'lowerLimit': '27.2', 'upperLimit': '40.3'}, {'value': '19.0', 'groupId': 'OG006', 'lowerLimit': '10.2', 'upperLimit': '30.9'}, {'value': '10.8', 'groupId': 'OG007', 'lowerLimit': '4.4', 'upperLimit': '20.9'}, {'value': '14.8', 'groupId': 'OG008', 'lowerLimit': '9.2', 'upperLimit': '22.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'within 7 Days after Vaccination 2', 'description': 'Systemic reactions included fever, irritability, drowsiness, loss of or decreased appetite and were recorded by using an e-diary. Fever was graded as 38.0 to 38.4 degree C, 38.5 to 38.9 degree C, 39.0 to 39.4 degree C, \\>39.5 to 40.0 degree C and \\>40.0 degree C. Irritability was graded as mild (easily consolable), moderate (requiring increased attention) and severe (inconsolable). Drowsiness was graded as mild (Increased or prolonged sleeping bouts), moderate (slightly subdued interfering with daily activity) and severe (disabling not interested in usual daily activity). Loss of or decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed).', 'unitOfMeasure': 'percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population: all participants who received at least 1 dose of an investigational product (rLP2086 or HAV vaccine) and had safety data available. Here, N signifies number of participants evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '104', 'groupId': 'OG003'}, {'value': '108', 'groupId': 'OG004'}, {'value': '212', 'groupId': 'OG005'}, {'value': '65', 'groupId': 'OG006'}, {'value': '63', 'groupId': 'OG007'}, {'value': '128', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <18 Months)', 'description': 'Participants from \\>=12 months to \\<18 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.'}, {'id': 'OG001', 'title': 'Group 1: 60-µg Bivalent rLP2086 (>=18 Months to <24 Months)', 'description': 'Participants from \\>=18 months to \\<24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.'}, {'id': 'OG002', 'title': 'Group 1: 60- mcg Bivalent rLP2086 (>=12 Months to <24 Months)', 'description': 'Participants from greater than or equal to (\\>=) 12 months to less than (\\<) 24 months of age, received intramuscular injection of 60 mcg of bivalent rLP2086 vaccine on months 0 vaccine on a 0, 2, 6 month schedule.'}, {'id': 'OG003', 'title': 'Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <18 Months)', 'description': 'Participants from \\>=12 months to \\<18 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.'}, {'id': 'OG004', 'title': 'Group 2: 120-µg Bivalent rLP2086 (>=18 Months to <24 Months)', 'description': 'Participants from \\>=18 months to \\<24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.'}, {'id': 'OG005', 'title': 'Group 2: 120-mcg Bivalent rLP2086 (>=12 Months to <24 Months)', 'description': 'Participants from \\>=12 months to \\<24 months of age, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine on a 0, 2, 6 month schedule. All participants who received 3 doses of 120 mcg bivalent rLP2086 in Stage 1 and gave consent for booster vaccination, received intramuscular injection of single booster dose of 120 mcg of bivalent rLP2086 after 23 to 24 months of Vaccination 3, in Stage 2. Participants were followed up approximately 6 months after the booster vaccination.'}, {'id': 'OG006', 'title': 'Group 3: HAV/Saline (>=12 Months to <18 Months)', 'description': 'Participants from \\>=12 months to \\<18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.'}, {'id': 'OG007', 'title': 'Group 3: HAV/Saline (>=18 Months to <24 Months)', 'description': 'Participants from \\>=18 months to \\<24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.'}, {'id': 'OG008', 'title': 'Group 3: HAV/Saline (>=12 Months to <24 Months): Stage 1', 'description': 'Participants from \\>=12 months to \\<24 months of age, received intramuscular injection of saline on 2 month and HAV vaccine on a 0, 6 month schedule.'}], 'classes': [{'title': 'Fever >=38 degrees C', 'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '22.8'}, {'value': '4.5', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '22.8'}, {'value': '4.5', 'groupId': 'OG002', 'lowerLimit': '0.6', 'upperLimit': '15.5'}, {'value': '10.6', 'groupId': 'OG003', 'lowerLimit': '5.4', 'upperLimit': '18.1'}, {'value': '14.8', 'groupId': 'OG004', 'lowerLimit': '8.7', 'upperLimit': '22.9'}, {'value': '12.7', 'groupId': 'OG005', 'lowerLimit': '8.6', 'upperLimit': '18.0'}, {'value': '4.6', 'groupId': 'OG006', 'lowerLimit': '1.0', 'upperLimit': '12.9'}, {'value': '7.9', 'groupId': 'OG007', 'lowerLimit': '2.6', 'upperLimit': '17.6'}, {'value': '6.3', 'groupId': 'OG008', 'lowerLimit': '2.7', 'upperLimit': '11.9'}]}]}, {'title': 'Fever 38 to <38.5 degrees C', 'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '22.8'}, {'value': '4.5', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '22.8'}, {'value': '4.5', 'groupId': 'OG002', 'lowerLimit': '0.6', 'upperLimit': '15.5'}, {'value': '6.7', 'groupId': 'OG003', 'lowerLimit': '2.7', 'upperLimit': '13.4'}, {'value': '6.5', 'groupId': 'OG004', 'lowerLimit': '2.6', 'upperLimit': '12.9'}, {'value': '6.6', 'groupId': 'OG005', 'lowerLimit': '3.7', 'upperLimit': '10.8'}, {'value': '3.1', 'groupId': 'OG006', 'lowerLimit': '0.4', 'upperLimit': '10.7'}, {'value': '4.8', 'groupId': 'OG007', 'lowerLimit': '1.0', 'upperLimit': '13.3'}, {'value': '3.9', 'groupId': 'OG008', 'lowerLimit': '1.3', 'upperLimit': '8.9'}]}]}, {'title': 'Fever 38.5 to <39 degrees C', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '15.4'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '15.4'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '8.0'}, {'value': '2.9', 'groupId': 'OG003', 'lowerLimit': '0.6', 'upperLimit': '8.2'}, {'value': '1.9', 'groupId': 'OG004', 'lowerLimit': '0.2', 'upperLimit': '6.5'}, {'value': '2.4', 'groupId': 'OG005', 'lowerLimit': '0.8', 'upperLimit': '5.4'}, {'value': '1.5', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '8.3'}, {'value': '1.6', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '8.5'}, {'value': '1.6', 'groupId': 'OG008', 'lowerLimit': '0.2', 'upperLimit': '5.5'}]}]}, {'title': 'Fever 39 to <39.5 degrees C', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '15.4'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '15.4'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '8.0'}, {'value': '1.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '5.2'}, {'value': '3.7', 'groupId': 'OG004', 'lowerLimit': '1.0', 'upperLimit': '9.2'}, {'value': '2.4', 'groupId': 'OG005', 'lowerLimit': '0.8', 'upperLimit': '5.4'}, {'value': '0.0', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '5.5'}, {'value': '1.6', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '8.5'}, {'value': '0.8', 'groupId': 'OG008', 'lowerLimit': '0.0', 'upperLimit': '4.3'}]}]}, {'title': 'Fever 39.5 to <=40 degrees C', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '15.4'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '15.4'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '8.0'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '3.5'}, {'value': '2.8', 'groupId': 'OG004', 'lowerLimit': '0.6', 'upperLimit': '7.9'}, {'value': '1.4', 'groupId': 'OG005', 'lowerLimit': '0.3', 'upperLimit': '4.1'}, {'value': '0.0', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '5.5'}, {'value': '0.0', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '5.7'}, {'value': '0.0', 'groupId': 'OG008', 'lowerLimit': '0.0', 'upperLimit': '2.8'}]}]}, {'title': 'Fever >40 degrees C', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '15.4'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '15.4'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '8.0'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '3.5'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '3.4'}, {'value': '0.0', 'groupId': 'OG005', 'lowerLimit': '0.0', 'upperLimit': '1.7'}, {'value': '0.0', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '5.5'}, {'value': '0.0', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '5.7'}, {'value': '0.0', 'groupId': 'OG008', 'lowerLimit': '0.0', 'upperLimit': '2.8'}]}]}, {'title': 'Irritability: Any', 'categories': [{'measurements': [{'value': '36.4', 'groupId': 'OG000', 'lowerLimit': '17.2', 'upperLimit': '59.3'}, {'value': '36.4', 'groupId': 'OG001', 'lowerLimit': '17.2', 'upperLimit': '59.3'}, {'value': '36.4', 'groupId': 'OG002', 'lowerLimit': '22.4', 'upperLimit': '52.2'}, {'value': '56.7', 'groupId': 'OG003', 'lowerLimit': '46.7', 'upperLimit': '66.4'}, {'value': '44.4', 'groupId': 'OG004', 'lowerLimit': '34.9', 'upperLimit': '54.3'}, {'value': '50.5', 'groupId': 'OG005', 'lowerLimit': '43.5', 'upperLimit': '57.4'}, {'value': '24.6', 'groupId': 'OG006', 'lowerLimit': '14.8', 'upperLimit': '36.9'}, {'value': '30.2', 'groupId': 'OG007', 'lowerLimit': '19.2', 'upperLimit': '43.0'}, {'value': '27.3', 'groupId': 'OG008', 'lowerLimit': '19.8', 'upperLimit': '35.9'}]}]}, {'title': 'Irritability: Mild', 'categories': [{'measurements': [{'value': '22.7', 'groupId': 'OG000', 'lowerLimit': '7.8', 'upperLimit': '45.4'}, {'value': '18.2', 'groupId': 'OG001', 'lowerLimit': '5.2', 'upperLimit': '40.3'}, {'value': '20.5', 'groupId': 'OG002', 'lowerLimit': '9.8', 'upperLimit': '35.3'}, {'value': '27.9', 'groupId': 'OG003', 'lowerLimit': '19.5', 'upperLimit': '37.5'}, {'value': '19.4', 'groupId': 'OG004', 'lowerLimit': '12.5', 'upperLimit': '28.2'}, {'value': '23.6', 'groupId': 'OG005', 'lowerLimit': '18.0', 'upperLimit': '29.9'}, {'value': '9.2', 'groupId': 'OG006', 'lowerLimit': '3.5', 'upperLimit': '19.0'}, {'value': '15.9', 'groupId': 'OG007', 'lowerLimit': '7.9', 'upperLimit': '27.3'}, {'value': '12.5', 'groupId': 'OG008', 'lowerLimit': '7.3', 'upperLimit': '19.5'}]}]}, {'title': 'Irritability: Moderate', 'categories': [{'measurements': [{'value': '13.6', 'groupId': 'OG000', 'lowerLimit': '2.9', 'upperLimit': '34.9'}, {'value': '18.2', 'groupId': 'OG001', 'lowerLimit': '5.2', 'upperLimit': '40.3'}, {'value': '15.9', 'groupId': 'OG002', 'lowerLimit': '6.6', 'upperLimit': '30.1'}, {'value': '26.0', 'groupId': 'OG003', 'lowerLimit': '17.9', 'upperLimit': '35.5'}, {'value': '24.1', 'groupId': 'OG004', 'lowerLimit': '16.4', 'upperLimit': '33.3'}, {'value': '25.0', 'groupId': 'OG005', 'lowerLimit': '19.3', 'upperLimit': '31.4'}, {'value': '13.8', 'groupId': 'OG006', 'lowerLimit': '6.5', 'upperLimit': '24.7'}, {'value': '12.7', 'groupId': 'OG007', 'lowerLimit': '5.6', 'upperLimit': '23.5'}, {'value': '13.3', 'groupId': 'OG008', 'lowerLimit': '7.9', 'upperLimit': '20.4'}]}]}, {'title': 'Irritability: Severe', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '15.4'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '15.4'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '8.0'}, {'value': '2.9', 'groupId': 'OG003', 'lowerLimit': '0.6', 'upperLimit': '8.2'}, {'value': '0.9', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '5.1'}, {'value': '1.9', 'groupId': 'OG005', 'lowerLimit': '0.5', 'upperLimit': '4.8'}, {'value': '1.5', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '8.3'}, {'value': '1.6', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '8.5'}, {'value': '1.6', 'groupId': 'OG008', 'lowerLimit': '0.2', 'upperLimit': '5.5'}]}]}, {'title': 'Drowsiness: Any', 'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '22.8'}, {'value': '22.7', 'groupId': 'OG001', 'lowerLimit': '7.8', 'upperLimit': '45.4'}, {'value': '13.6', 'groupId': 'OG002', 'lowerLimit': '5.2', 'upperLimit': '27.4'}, {'value': '37.5', 'groupId': 'OG003', 'lowerLimit': '28.2', 'upperLimit': '47.5'}, {'value': '30.6', 'groupId': 'OG004', 'lowerLimit': '22.1', 'upperLimit': '40.2'}, {'value': '34.0', 'groupId': 'OG005', 'lowerLimit': '27.6', 'upperLimit': '40.8'}, {'value': '13.8', 'groupId': 'OG006', 'lowerLimit': '6.5', 'upperLimit': '24.7'}, {'value': '12.7', 'groupId': 'OG007', 'lowerLimit': '5.6', 'upperLimit': '23.5'}, {'value': '13.3', 'groupId': 'OG008', 'lowerLimit': '7.9', 'upperLimit': '20.4'}]}]}, {'title': 'Drowsiness: Mild', 'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '22.8'}, {'value': '22.7', 'groupId': 'OG001', 'lowerLimit': '7.8', 'upperLimit': '45.4'}, {'value': '13.6', 'groupId': 'OG002', 'lowerLimit': '5.2', 'upperLimit': '27.4'}, {'value': '24.0', 'groupId': 'OG003', 'lowerLimit': '16.2', 'upperLimit': '33.4'}, {'value': '23.1', 'groupId': 'OG004', 'lowerLimit': '15.6', 'upperLimit': '32.2'}, {'value': '23.6', 'groupId': 'OG005', 'lowerLimit': '18.0', 'upperLimit': '29.9'}, {'value': '10.8', 'groupId': 'OG006', 'lowerLimit': '4.4', 'upperLimit': '20.9'}, {'value': '9.5', 'groupId': 'OG007', 'lowerLimit': '3.6', 'upperLimit': '19.6'}, {'value': '10.2', 'groupId': 'OG008', 'lowerLimit': '5.5', 'upperLimit': '16.7'}]}]}, {'title': 'Drowsiness: Moderate', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '15.4'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '15.4'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '8.0'}, {'value': '10.6', 'groupId': 'OG003', 'lowerLimit': '5.4', 'upperLimit': '18.1'}, {'value': '6.5', 'groupId': 'OG004', 'lowerLimit': '2.6', 'upperLimit': '12.9'}, {'value': '8.5', 'groupId': 'OG005', 'lowerLimit': '5.1', 'upperLimit': '13.1'}, {'value': '3.1', 'groupId': 'OG006', 'lowerLimit': '0.4', 'upperLimit': '10.7'}, {'value': '1.6', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '8.5'}, {'value': '2.3', 'groupId': 'OG008', 'lowerLimit': '0.5', 'upperLimit': '6.7'}]}]}, {'title': 'Drowsiness: Severe', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '15.4'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '15.4'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '8.0'}, {'value': '2.9', 'groupId': 'OG003', 'lowerLimit': '0.6', 'upperLimit': '8.2'}, {'value': '0.9', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '5.1'}, {'value': '1.9', 'groupId': 'OG005', 'lowerLimit': '0.5', 'upperLimit': '4.8'}, {'value': '0.0', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '5.5'}, {'value': '1.6', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '8.5'}, {'value': '0.8', 'groupId': 'OG008', 'lowerLimit': '0.0', 'upperLimit': '4.3'}]}]}, {'title': 'Loss of or decreased appetite: Any', 'categories': [{'measurements': [{'value': '13.6', 'groupId': 'OG000', 'lowerLimit': '2.9', 'upperLimit': '34.9'}, {'value': '22.7', 'groupId': 'OG001', 'lowerLimit': '7.8', 'upperLimit': '45.4'}, {'value': '18.2', 'groupId': 'OG002', 'lowerLimit': '8.2', 'upperLimit': '32.7'}, {'value': '33.7', 'groupId': 'OG003', 'lowerLimit': '24.7', 'upperLimit': '43.6'}, {'value': '35.2', 'groupId': 'OG004', 'lowerLimit': '26.2', 'upperLimit': '45.0'}, {'value': '34.4', 'groupId': 'OG005', 'lowerLimit': '28.1', 'upperLimit': '41.2'}, {'value': '16.9', 'groupId': 'OG006', 'lowerLimit': '8.8', 'upperLimit': '28.3'}, {'value': '19.0', 'groupId': 'OG007', 'lowerLimit': '10.2', 'upperLimit': '30.9'}, {'value': '18.0', 'groupId': 'OG008', 'lowerLimit': '11.7', 'upperLimit': '25.7'}]}]}, {'title': 'Loss of or decreased appetite: Mild', 'categories': [{'measurements': [{'value': '13.6', 'groupId': 'OG000', 'lowerLimit': '2.9', 'upperLimit': '34.9'}, {'value': '22.7', 'groupId': 'OG001', 'lowerLimit': '7.8', 'upperLimit': '45.4'}, {'value': '15.9', 'groupId': 'OG002', 'lowerLimit': '6.6', 'upperLimit': '30.1'}, {'value': '15.4', 'groupId': 'OG003', 'lowerLimit': '9.1', 'upperLimit': '23.8'}, {'value': '18.5', 'groupId': 'OG004', 'lowerLimit': '11.7', 'upperLimit': '27.1'}, {'value': '17.0', 'groupId': 'OG005', 'lowerLimit': '12.2', 'upperLimit': '22.7'}, {'value': '9.2', 'groupId': 'OG006', 'lowerLimit': '3.5', 'upperLimit': '19.0'}, {'value': '15.9', 'groupId': 'OG007', 'lowerLimit': '7.9', 'upperLimit': '27.3'}, {'value': '12.5', 'groupId': 'OG008', 'lowerLimit': '7.3', 'upperLimit': '19.5'}]}]}, {'title': 'Loss of or decreased appetite: Moderate', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '15.4'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '15.4'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '8.0'}, {'value': '14.4', 'groupId': 'OG003', 'lowerLimit': '8.3', 'upperLimit': '22.7'}, {'value': '14.8', 'groupId': 'OG004', 'lowerLimit': '8.7', 'upperLimit': '22.9'}, {'value': '14.6', 'groupId': 'OG005', 'lowerLimit': '10.2', 'upperLimit': '20.1'}, {'value': '7.7', 'groupId': 'OG006', 'lowerLimit': '2.5', 'upperLimit': '17.0'}, {'value': '1.6', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '8.5'}, {'value': '4.7', 'groupId': 'OG008', 'lowerLimit': '1.7', 'upperLimit': '9.9'}]}]}, {'title': 'Loss of or decreased appetite: Severe', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '15.4'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '15.4'}, {'value': '2.3', 'groupId': 'OG002', 'lowerLimit': '0.1', 'upperLimit': '12.0'}, {'value': '3.8', 'groupId': 'OG003', 'lowerLimit': '1.1', 'upperLimit': '9.6'}, {'value': '1.9', 'groupId': 'OG004', 'lowerLimit': '0.2', 'upperLimit': '6.5'}, {'value': '2.8', 'groupId': 'OG005', 'lowerLimit': '1.0', 'upperLimit': '6.1'}, {'value': '0.0', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '5.5'}, {'value': '1.6', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '8.5'}, {'value': '0.8', 'groupId': 'OG008', 'lowerLimit': '0.0', 'upperLimit': '4.3'}]}]}, {'title': 'Antipyretic medication use', 'categories': [{'measurements': [{'value': '18.2', 'groupId': 'OG000', 'lowerLimit': '5.2', 'upperLimit': '40.3'}, {'value': '18.2', 'groupId': 'OG001', 'lowerLimit': '5.2', 'upperLimit': '40.3'}, {'value': '18.2', 'groupId': 'OG002', 'lowerLimit': '8.2', 'upperLimit': '32.7'}, {'value': '34.6', 'groupId': 'OG003', 'lowerLimit': '25.6', 'upperLimit': '44.6'}, {'value': '33.3', 'groupId': 'OG004', 'lowerLimit': '24.6', 'upperLimit': '43.1'}, {'value': '34.0', 'groupId': 'OG005', 'lowerLimit': '27.6', 'upperLimit': '40.8'}, {'value': '13.8', 'groupId': 'OG006', 'lowerLimit': '6.5', 'upperLimit': '24.7'}, {'value': '15.9', 'groupId': 'OG007', 'lowerLimit': '7.9', 'upperLimit': '27.3'}, {'value': '14.8', 'groupId': 'OG008', 'lowerLimit': '9.2', 'upperLimit': '22.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'within 7 Days after Vaccination 3', 'description': 'Systemic reactions included fever, irritability, drowsiness, loss of or decreased appetite and were recorded by using an e-diary. Fever was graded as 38.0 to 38.4 degree C, 38.5 to 38.9 degree C, 39.0 to 39.4 degree C, \\>39.5 to 40.0 degree C and \\>40.0 degree C. Irritability was graded as mild (easily consolable), moderate (requiring increased attention) and severe (inconsolable). Drowsiness was graded as mild (Increased or prolonged sleeping bouts), moderate (slightly subdued interfering with daily activity) and severe (disabling not interested in usual daily activity). Loss of or decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed).', 'unitOfMeasure': 'percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population: all participants who received at least 1 dose of an investigational product (rLP2086 or HAV vaccine) and had safety data available. Here, N signifies number of participants evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE), Newly Diagnosed Chronic Medical Condition (NDCMC) and Immediate Adverse Event (IAE) Within 30 Days After Vaccination 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '110', 'groupId': 'OG003'}, {'value': '110', 'groupId': 'OG004'}, {'value': '220', 'groupId': 'OG005'}, {'value': '66', 'groupId': 'OG006'}, {'value': '66', 'groupId': 'OG007'}, {'value': '132', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <18 Months)', 'description': 'Participants from \\>=12 months to \\<18 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.'}, {'id': 'OG001', 'title': 'Group 1: 60-µg Bivalent rLP2086 (>=18 Months to <24 Months)', 'description': 'Participants from \\>=18 months to \\<24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.'}, {'id': 'OG002', 'title': 'Group 1: 60- mcg Bivalent rLP2086 (>=12 Months to <24 Months)', 'description': 'Participants from greater than or equal to (\\>=) 12 months to less than (\\<) 24 months of age, received intramuscular injection of 60 mcg of bivalent rLP2086 vaccine on months 0 vaccine on a 0, 2, 6 month schedule.'}, {'id': 'OG003', 'title': 'Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <18 Months)', 'description': 'Participants from \\>=12 months to \\<18 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.'}, {'id': 'OG004', 'title': 'Group 2: 120-µg Bivalent rLP2086 (>=18 Months to <24 Months)', 'description': 'Participants from \\>=18 months to \\<24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.'}, {'id': 'OG005', 'title': 'Group 2: 120-mcg Bivalent rLP2086 (>=12 Months to <24 Months)', 'description': 'Participants from \\>=12 months to \\<24 months of age, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine on a 0, 2, 6 month schedule. All participants who received 3 doses of 120 mcg bivalent rLP2086 in Stage 1 and gave consent for booster vaccination, received intramuscular injection of single booster dose of 120 mcg of bivalent rLP2086 after 23 to 24 months of Vaccination 3, in Stage 2. Participants were followed up approximately 6 months after the booster vaccination.'}, {'id': 'OG006', 'title': 'Group 3: HAV/Saline (>=12 Months to <18 Months)', 'description': 'Participants from \\>=12 months to \\<18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.'}, {'id': 'OG007', 'title': 'Group 3: HAV/Saline (>=18 Months to <24 Months)', 'description': 'Participants from \\>=18 months to \\<24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.'}, {'id': 'OG008', 'title': 'Group 3: HAV/Saline (>=12 Months to <24 Months): Stage 1', 'description': 'Participants from \\>=12 months to \\<24 months of age, received intramuscular injection of saline on 2 month and HAV vaccine on a 0, 6 month schedule.'}], 'classes': [{'title': 'AE', 'categories': [{'measurements': [{'value': '18.2', 'groupId': 'OG000', 'lowerLimit': '5.2', 'upperLimit': '40.3'}, {'value': '45.5', 'groupId': 'OG001', 'lowerLimit': '24.4', 'upperLimit': '67.8'}, {'value': '31.8', 'groupId': 'OG002', 'lowerLimit': '18.6', 'upperLimit': '47.6'}, {'value': '38.2', 'groupId': 'OG003', 'lowerLimit': '29.1', 'upperLimit': '47.9'}, {'value': '41.8', 'groupId': 'OG004', 'lowerLimit': '32.5', 'upperLimit': '51.6'}, {'value': '40.0', 'groupId': 'OG005', 'lowerLimit': '33.5', 'upperLimit': '46.8'}, {'value': '33.3', 'groupId': 'OG006', 'lowerLimit': '22.2', 'upperLimit': '46.0'}, {'value': '27.3', 'groupId': 'OG007', 'lowerLimit': '17.0', 'upperLimit': '39.6'}, {'value': '30.3', 'groupId': 'OG008', 'lowerLimit': '22.6', 'upperLimit': '38.9'}]}]}, {'title': 'SAE', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '15.4'}, {'value': '4.5', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '22.8'}, {'value': '2.3', 'groupId': 'OG002', 'lowerLimit': '0.1', 'upperLimit': '12.0'}, {'value': '0.9', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '5.0'}, {'value': '1.8', 'groupId': 'OG004', 'lowerLimit': '0.2', 'upperLimit': '6.4'}, {'value': '1.4', 'groupId': 'OG005', 'lowerLimit': '0.3', 'upperLimit': '3.9'}, {'value': '1.5', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '8.2'}, {'value': '1.5', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '8.2'}, {'value': '1.5', 'groupId': 'OG008', 'lowerLimit': '0.2', 'upperLimit': '5.4'}]}]}, {'title': 'MAE', 'categories': [{'measurements': [{'value': '9.1', 'groupId': 'OG000', 'lowerLimit': '1.1', 'upperLimit': '29.2'}, {'value': '13.6', 'groupId': 'OG001', 'lowerLimit': '2.9', 'upperLimit': '34.9'}, {'value': '11.4', 'groupId': 'OG002', 'lowerLimit': '3.8', 'upperLimit': '24.6'}, {'value': '18.2', 'groupId': 'OG003', 'lowerLimit': '11.5', 'upperLimit': '26.7'}, {'value': '19.1', 'groupId': 'OG004', 'lowerLimit': '12.2', 'upperLimit': '27.7'}, {'value': '18.6', 'groupId': 'OG005', 'lowerLimit': '13.7', 'upperLimit': '24.4'}, {'value': '18.2', 'groupId': 'OG006', 'lowerLimit': '9.8', 'upperLimit': '29.6'}, {'value': '16.7', 'groupId': 'OG007', 'lowerLimit': '8.6', 'upperLimit': '27.9'}, {'value': '17.4', 'groupId': 'OG008', 'lowerLimit': '11.4', 'upperLimit': '25.0'}]}]}, {'title': 'NDCMC', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '15.4'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '15.4'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '8.0'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '3.3'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '3.3'}, {'value': '0.0', 'groupId': 'OG005', 'lowerLimit': '0.0', 'upperLimit': '1.7'}, {'value': '0.0', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '5.4'}, {'value': '0.0', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '5.4'}, {'value': '0.0', 'groupId': 'OG008', 'lowerLimit': '0.0', 'upperLimit': '2.8'}]}]}, {'title': 'IAE', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '15.4'}, {'value': '4.5', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '22.8'}, {'value': '2.3', 'groupId': 'OG002', 'lowerLimit': '0.1', 'upperLimit': '12.0'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '3.3'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '3.3'}, {'value': '0.0', 'groupId': 'OG005', 'lowerLimit': '0.0', 'upperLimit': '1.7'}, {'value': '0.0', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '5.4'}, {'value': '0.0', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '5.4'}, {'value': '0.0', 'groupId': 'OG008', 'lowerLimit': '0.0', 'upperLimit': '2.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'within 30 Days after Vaccination 1', 'description': 'An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; lack of efficacy in an approved indication; important medical event. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects. Immediate AE was defined as AEs occurring within the first 30 minutes after investigational product administration.', 'unitOfMeasure': 'percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population: all participants who received at least 1 dose of an investigational product (rLP2086 or HAV vaccine) and had safety data available.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE), Newly Diagnosed Chronic Medical Condition (NDCMC) and Immediate Adverse Event (IAE) Within 30 Days After Vaccination 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '105', 'groupId': 'OG003'}, {'value': '108', 'groupId': 'OG004'}, {'value': '213', 'groupId': 'OG005'}, {'value': '66', 'groupId': 'OG006'}, {'value': '65', 'groupId': 'OG007'}, {'value': '131', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <18 Months)', 'description': 'Participants from \\>=12 months to \\<18 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.'}, {'id': 'OG001', 'title': 'Group 1: 60-µg Bivalent rLP2086 (>=18 Months to <24 Months)', 'description': 'Participants from \\>=18 months to \\<24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.'}, {'id': 'OG002', 'title': 'Group 1: 60- mcg Bivalent rLP2086 (>=12 Months to <24 Months)', 'description': 'Participants from greater than or equal to (\\>=) 12 months to less than (\\<) 24 months of age, received intramuscular injection of 60 mcg of bivalent rLP2086 vaccine on months 0 vaccine on a 0, 2, 6 month schedule.'}, {'id': 'OG003', 'title': 'Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <18 Months)', 'description': 'Participants from \\>=12 months to \\<18 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.'}, {'id': 'OG004', 'title': 'Group 2: 120-µg Bivalent rLP2086 (>=18 Months to <24 Months)', 'description': 'Participants from \\>=18 months to \\<24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.'}, {'id': 'OG005', 'title': 'Group 2: 120-mcg Bivalent rLP2086 (>=12 Months to <24 Months)', 'description': 'Participants from \\>=12 months to \\<24 months of age, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine on a 0, 2, 6 month schedule. All participants who received 3 doses of 120 mcg bivalent rLP2086 in Stage 1 and gave consent for booster vaccination, received intramuscular injection of single booster dose of 120 mcg of bivalent rLP2086 after 23 to 24 months of Vaccination 3, in Stage 2. Participants were followed up approximately 6 months after the booster vaccination.'}, {'id': 'OG006', 'title': 'Group 3: HAV/Saline (>=12 Months to <18 Months)', 'description': 'Participants from \\>=12 months to \\<18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.'}, {'id': 'OG007', 'title': 'Group 3: HAV/Saline (>=18 Months to <24 Months)', 'description': 'Participants from \\>=18 months to \\<24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.'}, {'id': 'OG008', 'title': 'Group 3: HAV/Saline (>=12 Months to <24 Months): Stage 1', 'description': 'Participants from \\>=12 months to \\<24 months of age, received intramuscular injection of saline on 2 month and HAV vaccine on a 0, 6 month schedule.'}], 'classes': [{'title': 'AE', 'categories': [{'measurements': [{'value': '18.2', 'groupId': 'OG000', 'lowerLimit': '5.2', 'upperLimit': '40.3'}, {'value': '27.3', 'groupId': 'OG001', 'lowerLimit': '10.7', 'upperLimit': '50.2'}, {'value': '22.7', 'groupId': 'OG002', 'lowerLimit': '11.5', 'upperLimit': '37.8'}, {'value': '34.3', 'groupId': 'OG003', 'lowerLimit': '25.3', 'upperLimit': '44.2'}, {'value': '34.3', 'groupId': 'OG004', 'lowerLimit': '25.4', 'upperLimit': '44.0'}, {'value': '34.3', 'groupId': 'OG005', 'lowerLimit': '27.9', 'upperLimit': '41.1'}, {'value': '24.2', 'groupId': 'OG006', 'lowerLimit': '14.5', 'upperLimit': '36.4'}, {'value': '32.3', 'groupId': 'OG007', 'lowerLimit': '21.2', 'upperLimit': '45.1'}, {'value': '28.2', 'groupId': 'OG008', 'lowerLimit': '20.7', 'upperLimit': '36.8'}]}]}, {'title': 'SAE', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '15.4'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '15.4'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '8.0'}, {'value': '3.8', 'groupId': 'OG003', 'lowerLimit': '1.0', 'upperLimit': '9.5'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '3.4'}, {'value': '1.9', 'groupId': 'OG005', 'lowerLimit': '0.5', 'upperLimit': '4.7'}, {'value': '1.5', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '8.2'}, {'value': '0.0', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '5.5'}, {'value': '0.8', 'groupId': 'OG008', 'lowerLimit': '0.0', 'upperLimit': '4.2'}]}]}, {'title': 'MAE', 'categories': [{'measurements': [{'value': '13.6', 'groupId': 'OG000', 'lowerLimit': '2.9', 'upperLimit': '34.9'}, {'value': '9.1', 'groupId': 'OG001', 'lowerLimit': '1.1', 'upperLimit': '29.2'}, {'value': '11.4', 'groupId': 'OG002', 'lowerLimit': '3.8', 'upperLimit': '24.6'}, {'value': '16.2', 'groupId': 'OG003', 'lowerLimit': '9.7', 'upperLimit': '24.7'}, {'value': '18.5', 'groupId': 'OG004', 'lowerLimit': '11.7', 'upperLimit': '27.1'}, {'value': '17.4', 'groupId': 'OG005', 'lowerLimit': '12.5', 'upperLimit': '23.1'}, {'value': '13.6', 'groupId': 'OG006', 'lowerLimit': '6.4', 'upperLimit': '24.3'}, {'value': '23.1', 'groupId': 'OG007', 'lowerLimit': '13.5', 'upperLimit': '35.2'}, {'value': '18.3', 'groupId': 'OG008', 'lowerLimit': '12.1', 'upperLimit': '26.0'}]}]}, {'title': 'NDCMC', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '15.4'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '15.4'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '8.0'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '3.5'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '3.4'}, {'value': '0.0', 'groupId': 'OG005', 'lowerLimit': '0.0', 'upperLimit': '1.7'}, {'value': '0.0', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '5.4'}, {'value': '0.0', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '5.5'}, {'value': '0.0', 'groupId': 'OG008', 'lowerLimit': '0.0', 'upperLimit': '2.8'}]}]}, {'title': 'IAE', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '15.4'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '15.4'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '8.0'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '5.2'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '3.4'}, {'value': '0.5', 'groupId': 'OG005', 'lowerLimit': '0.0', 'upperLimit': '2.6'}, {'value': '0.0', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '5.4'}, {'value': '0.0', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '5.5'}, {'value': '0.0', 'groupId': 'OG008', 'lowerLimit': '0.0', 'upperLimit': '2.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'within 30 Days after Vaccination 2', 'description': 'An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; lack of efficacy in an approved indication; important medical event. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects. Immediate AE was defined as AEs occurring within the first 30 minutes after investigational product administration.', 'unitOfMeasure': 'percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population: all participants who received at least 1 dose of an investigational product (rLP2086 or HAV vaccine) and had safety data available. Here, N signifies number of participants evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE), Newly Diagnosed Chronic Medical Condition (NDCMC) and Immediate Adverse Event (IAE) Within 30 Days After Vaccination 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '104', 'groupId': 'OG003'}, {'value': '108', 'groupId': 'OG004'}, {'value': '212', 'groupId': 'OG005'}, {'value': '65', 'groupId': 'OG006'}, {'value': '64', 'groupId': 'OG007'}, {'value': '129', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <18 Months)', 'description': 'Participants from \\>=12 months to \\<18 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.'}, {'id': 'OG001', 'title': 'Group 1: 60-µg Bivalent rLP2086 (>=18 Months to <24 Months)', 'description': 'Participants from \\>=18 months to \\<24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.'}, {'id': 'OG002', 'title': 'Group 1: 60- mcg Bivalent rLP2086 (>=12 Months to <24 Months)', 'description': 'Participants from greater than or equal to (\\>=) 12 months to less than (\\<) 24 months of age, received intramuscular injection of 60 mcg of bivalent rLP2086 vaccine on months 0 vaccine on a 0, 2, 6 month schedule.'}, {'id': 'OG003', 'title': 'Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <18 Months)', 'description': 'Participants from \\>=12 months to \\<18 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.'}, {'id': 'OG004', 'title': 'Group 2: 120-µg Bivalent rLP2086 (>=18 Months to <24 Months)', 'description': 'Participants from \\>=18 months to \\<24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.'}, {'id': 'OG005', 'title': 'Group 2: 120-mcg Bivalent rLP2086 (>=12 Months to <24 Months)', 'description': 'Participants from \\>=12 months to \\<24 months of age, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine on a 0, 2, 6 month schedule. All participants who received 3 doses of 120 mcg bivalent rLP2086 in Stage 1 and gave consent for booster vaccination, received intramuscular injection of single booster dose of 120 mcg of bivalent rLP2086 after 23 to 24 months of Vaccination 3, in Stage 2. Participants were followed up approximately 6 months after the booster vaccination.'}, {'id': 'OG006', 'title': 'Group 3: HAV/Saline (>=12 Months to <18 Months)', 'description': 'Participants from \\>=12 months to \\<18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.'}, {'id': 'OG007', 'title': 'Group 3: HAV/Saline (>=18 Months to <24 Months)', 'description': 'Participants from \\>=18 months to \\<24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.'}, {'id': 'OG008', 'title': 'Group 3: HAV/Saline (>=12 Months to <24 Months): Stage 1', 'description': 'Participants from \\>=12 months to \\<24 months of age, received intramuscular injection of saline on 2 month and HAV vaccine on a 0, 6 month schedule.'}], 'classes': [{'title': 'AE', 'categories': [{'measurements': [{'value': '18.2', 'groupId': 'OG000', 'lowerLimit': '5.2', 'upperLimit': '40.3'}, {'value': '40.9', 'groupId': 'OG001', 'lowerLimit': '20.7', 'upperLimit': '63.6'}, {'value': '29.5', 'groupId': 'OG002', 'lowerLimit': '16.8', 'upperLimit': '45.2'}, {'value': '25.0', 'groupId': 'OG003', 'lowerLimit': '17.0', 'upperLimit': '34.4'}, {'value': '30.6', 'groupId': 'OG004', 'lowerLimit': '22.1', 'upperLimit': '40.2'}, {'value': '27.8', 'groupId': 'OG005', 'lowerLimit': '21.9', 'upperLimit': '34.4'}, {'value': '24.6', 'groupId': 'OG006', 'lowerLimit': '14.8', 'upperLimit': '36.9'}, {'value': '28.1', 'groupId': 'OG007', 'lowerLimit': '17.6', 'upperLimit': '40.8'}, {'value': '26.4', 'groupId': 'OG008', 'lowerLimit': '19.0', 'upperLimit': '34.8'}]}]}, {'title': 'SAE', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '15.4'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '15.4'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '8.0'}, {'value': '1.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '5.2'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '3.4'}, {'value': '0.5', 'groupId': 'OG005', 'lowerLimit': '0.0', 'upperLimit': '2.6'}, {'value': '1.5', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '8.3'}, {'value': '0.0', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '5.6'}, {'value': '0.8', 'groupId': 'OG008', 'lowerLimit': '0.0', 'upperLimit': '4.2'}]}]}, {'title': 'MAE', 'categories': [{'measurements': [{'value': '9.1', 'groupId': 'OG000', 'lowerLimit': '1.1', 'upperLimit': '29.2'}, {'value': '27.3', 'groupId': 'OG001', 'lowerLimit': '10.7', 'upperLimit': '50.2'}, {'value': '18.2', 'groupId': 'OG002', 'lowerLimit': '8.2', 'upperLimit': '32.7'}, {'value': '13.5', 'groupId': 'OG003', 'lowerLimit': '7.6', 'upperLimit': '21.6'}, {'value': '16.7', 'groupId': 'OG004', 'lowerLimit': '10.2', 'upperLimit': '25.1'}, {'value': '15.1', 'groupId': 'OG005', 'lowerLimit': '10.6', 'upperLimit': '20.6'}, {'value': '12.3', 'groupId': 'OG006', 'lowerLimit': '5.5', 'upperLimit': '22.8'}, {'value': '20.3', 'groupId': 'OG007', 'lowerLimit': '11.3', 'upperLimit': '32.2'}, {'value': '16.3', 'groupId': 'OG008', 'lowerLimit': '10.4', 'upperLimit': '23.8'}]}]}, {'title': 'NDCMC', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '15.4'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '15.4'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '8.0'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '3.5'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '3.4'}, {'value': '0.0', 'groupId': 'OG005', 'lowerLimit': '0.0', 'upperLimit': '1.7'}, {'value': '0.0', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '5.5'}, {'value': '0.0', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '5.6'}, {'value': '0.0', 'groupId': 'OG008', 'lowerLimit': '0.0', 'upperLimit': '2.8'}]}]}, {'title': 'IAE', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '15.4'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '15.4'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '8.0'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '3.5'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '5.1'}, {'value': '0.5', 'groupId': 'OG005', 'lowerLimit': '0.0', 'upperLimit': '2.6'}, {'value': '0.0', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '5.5'}, {'value': '0.0', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '5.6'}, {'value': '0.0', 'groupId': 'OG008', 'lowerLimit': '0.0', 'upperLimit': '2.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'within 30 Days after Vaccination 3', 'description': 'An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; lack of efficacy in an approved indication; important medical event. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects. Immediate AE was defined as AEs occurring within the first 30 minutes after investigational product administration.', 'unitOfMeasure': 'percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population: all participants who received at least 1 dose of an investigational product (rLP2086 or HAV vaccine) and had safety data available. Here, N signifies number of participants evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE) and Newly Diagnosed Chronic Medical Condition (NDCMC) Within 30 Days After Any Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '110', 'groupId': 'OG003'}, {'value': '110', 'groupId': 'OG004'}, {'value': '220', 'groupId': 'OG005'}, {'value': '66', 'groupId': 'OG006'}, {'value': '66', 'groupId': 'OG007'}, {'value': '132', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <18 Months)', 'description': 'Participants from \\>=12 months to \\<18 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.'}, {'id': 'OG001', 'title': 'Group 1: 60-µg Bivalent rLP2086 (>=18 Months to <24 Months)', 'description': 'Participants from \\>=18 months to \\<24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.'}, {'id': 'OG002', 'title': 'Group 1: 60- mcg Bivalent rLP2086 (>=12 Months to <24 Months)', 'description': 'Participants from greater than or equal to (\\>=) 12 months to less than (\\<) 24 months of age, received intramuscular injection of 60 mcg of bivalent rLP2086 vaccine on months 0 vaccine on a 0, 2, 6 month schedule.'}, {'id': 'OG003', 'title': 'Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <18 Months)', 'description': 'Participants from \\>=12 months to \\<18 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.'}, {'id': 'OG004', 'title': 'Group 2: 120-µg Bivalent rLP2086 (>=18 Months to <24 Months)', 'description': 'Participants from \\>=18 months to \\<24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.'}, {'id': 'OG005', 'title': 'Group 2: 120-mcg Bivalent rLP2086 (>=12 Months to <24 Months)', 'description': 'Participants from \\>=12 months to \\<24 months of age, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine on a 0, 2, 6 month schedule. All participants who received 3 doses of 120 mcg bivalent rLP2086 in Stage 1 and gave consent for booster vaccination, received intramuscular injection of single booster dose of 120 mcg of bivalent rLP2086 after 23 to 24 months of Vaccination 3, in Stage 2. Participants were followed up approximately 6 months after the booster vaccination.'}, {'id': 'OG006', 'title': 'Group 3: HAV/Saline (>=12 Months to <18 Months)', 'description': 'Participants from \\>=12 months to \\<18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.'}, {'id': 'OG007', 'title': 'Group 3: HAV/Saline (>=18 Months to <24 Months)', 'description': 'Participants from \\>=18 months to \\<24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.'}, {'id': 'OG008', 'title': 'Group 3: HAV/Saline (>=12 Months to <24 Months): Stage 1', 'description': 'Participants from \\>=12 months to \\<24 months of age, received intramuscular injection of saline on 2 month and HAV vaccine on a 0, 6 month schedule.'}], 'classes': [{'title': 'AE', 'categories': [{'measurements': [{'value': '36.4', 'groupId': 'OG000', 'lowerLimit': '17.2', 'upperLimit': '59.3'}, {'value': '63.6', 'groupId': 'OG001', 'lowerLimit': '40.7', 'upperLimit': '82.8'}, {'value': '50.0', 'groupId': 'OG002', 'lowerLimit': '34.6', 'upperLimit': '65.4'}, {'value': '54.5', 'groupId': 'OG003', 'lowerLimit': '44.8', 'upperLimit': '64.1'}, {'value': '61.8', 'groupId': 'OG004', 'lowerLimit': '52.1', 'upperLimit': '70.9'}, {'value': '58.2', 'groupId': 'OG005', 'lowerLimit': '51.4', 'upperLimit': '64.8'}, {'value': '53.0', 'groupId': 'OG006', 'lowerLimit': '40.3', 'upperLimit': '65.4'}, {'value': '54.5', 'groupId': 'OG007', 'lowerLimit': '41.8', 'upperLimit': '66.9'}, {'value': '53.8', 'groupId': 'OG008', 'lowerLimit': '44.9', 'upperLimit': '62.5'}]}]}, {'title': 'SAE', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '15.4'}, {'value': '4.5', 'groupId': 'OG001', 'lowerLimit': '0.1', 'upperLimit': '22.8'}, {'value': '2.3', 'groupId': 'OG002', 'lowerLimit': '0.1', 'upperLimit': '12.0'}, {'value': '5.5', 'groupId': 'OG003', 'lowerLimit': '2.0', 'upperLimit': '11.5'}, {'value': '1.8', 'groupId': 'OG004', 'lowerLimit': '0.2', 'upperLimit': '6.4'}, {'value': '3.6', 'groupId': 'OG005', 'lowerLimit': '1.6', 'upperLimit': '7.0'}, {'value': '4.5', 'groupId': 'OG006', 'lowerLimit': '0.9', 'upperLimit': '12.7'}, {'value': '1.5', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '8.2'}, {'value': '3.0', 'groupId': 'OG008', 'lowerLimit': '0.8', 'upperLimit': '7.6'}]}]}, {'title': 'MAE', 'categories': [{'measurements': [{'value': '22.7', 'groupId': 'OG000', 'lowerLimit': '7.8', 'upperLimit': '45.4'}, {'value': '40.9', 'groupId': 'OG001', 'lowerLimit': '20.7', 'upperLimit': '63.6'}, {'value': '31.8', 'groupId': 'OG002', 'lowerLimit': '18.6', 'upperLimit': '47.6'}, {'value': '32.7', 'groupId': 'OG003', 'lowerLimit': '24.1', 'upperLimit': '42.3'}, {'value': '40.0', 'groupId': 'OG004', 'lowerLimit': '30.8', 'upperLimit': '49.8'}, {'value': '36.4', 'groupId': 'OG005', 'lowerLimit': '30.0', 'upperLimit': '43.1'}, {'value': '31.8', 'groupId': 'OG006', 'lowerLimit': '20.9', 'upperLimit': '44.4'}, {'value': '39.4', 'groupId': 'OG007', 'lowerLimit': '27.6', 'upperLimit': '52.2'}, {'value': '35.6', 'groupId': 'OG008', 'lowerLimit': '27.5', 'upperLimit': '44.4'}]}]}, {'title': 'NDCMC', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '15.4'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '15.4'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '8.0'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '3.3'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '3.3'}, {'value': '0.0', 'groupId': 'OG005', 'lowerLimit': '0.0', 'upperLimit': '1.7'}, {'value': '0.0', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '5.4'}, {'value': '0.0', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '5.4'}, {'value': '0.0', 'groupId': 'OG008', 'lowerLimit': '0.0', 'upperLimit': '2.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'within 30 Days after any Vaccination', 'description': 'An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; lack of efficacy in an approved indication; important medical event. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition that was not identified prior to study start and 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: all participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE) and Newly Diagnosed Chronic Medical Condition (NDCMC) During the Vaccination Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '110', 'groupId': 'OG003'}, {'value': '110', 'groupId': 'OG004'}, {'value': '220', 'groupId': 'OG005'}, {'value': '66', 'groupId': 'OG006'}, {'value': '66', 'groupId': 'OG007'}, {'value': '132', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <18 Months)', 'description': 'Participants from \\>=12 months to \\<18 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.'}, {'id': 'OG001', 'title': 'Group 1: 60-µg Bivalent rLP2086 (>=18 Months to <24 Months)', 'description': 'Participants from \\>=18 months to \\<24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.'}, {'id': 'OG002', 'title': 'Group 1: 60- mcg Bivalent rLP2086 (>=12 Months to <24 Months)', 'description': 'Participants from greater than or equal to (\\>=) 12 months to less than (\\<) 24 months of age, received intramuscular injection of 60 mcg of bivalent rLP2086 vaccine on months 0 vaccine on a 0, 2, 6 month schedule.'}, {'id': 'OG003', 'title': 'Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <18 Months)', 'description': 'Participants from \\>=12 months to \\<18 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.'}, {'id': 'OG004', 'title': 'Group 2: 120-µg Bivalent rLP2086 (>=18 Months to <24 Months)', 'description': 'Participants from \\>=18 months to \\<24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.'}, {'id': 'OG005', 'title': 'Group 2: 120-mcg Bivalent rLP2086 (>=12 Months to <24 Months)', 'description': 'Participants from \\>=12 months to \\<24 months of age, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine on a 0, 2, 6 month schedule. All participants who received 3 doses of 120 mcg bivalent rLP2086 in Stage 1 and gave consent for booster vaccination, received intramuscular injection of single booster dose of 120 mcg of bivalent rLP2086 after 23 to 24 months of Vaccination 3, in Stage 2. Participants were followed up approximately 6 months after the booster vaccination.'}, {'id': 'OG006', 'title': 'Group 3: HAV/Saline (>=12 Months to <18 Months)', 'description': 'Participants from \\>=12 months to \\<18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.'}, {'id': 'OG007', 'title': 'Group 3: HAV/Saline (>=18 Months to <24 Months)', 'description': 'Participants from \\>=18 months to \\<24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.'}, {'id': 'OG008', 'title': 'Group 3: HAV/Saline (>=12 Months to <24 Months): Stage 1', 'description': 'Participants from \\>=12 months to \\<24 months of age, received intramuscular injection of saline on 2 month and HAV vaccine on a 0, 6 month schedule.'}], 'classes': [{'title': 'AE', 'categories': [{'measurements': [{'value': '54.5', 'groupId': 'OG000', 'lowerLimit': '32.2', 'upperLimit': '75.6'}, {'value': '77.3', 'groupId': 'OG001', 'lowerLimit': '54.6', 'upperLimit': '92.2'}, {'value': '65.9', 'groupId': 'OG002', 'lowerLimit': '50.1', 'upperLimit': '79.5'}, {'value': '68.2', 'groupId': 'OG003', 'lowerLimit': '58.6', 'upperLimit': '76.7'}, {'value': '71.8', 'groupId': 'OG004', 'lowerLimit': '62.4', 'upperLimit': '80.0'}, {'value': '70.0', 'groupId': 'OG005', 'lowerLimit': '63.5', 'upperLimit': '76.0'}, {'value': '65.2', 'groupId': 'OG006', 'lowerLimit': '52.4', 'upperLimit': '76.5'}, {'value': '63.6', 'groupId': 'OG007', 'lowerLimit': '50.9', 'upperLimit': '75.1'}, {'value': '64.4', 'groupId': 'OG008', 'lowerLimit': '55.6', 'upperLimit': '72.5'}]}]}, {'title': 'SAE', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '15.4'}, {'value': '9.1', 'groupId': 'OG001', 'lowerLimit': '1.1', 'upperLimit': '29.2'}, {'value': '4.5', 'groupId': 'OG002', 'lowerLimit': '0.6', 'upperLimit': '15.5'}, {'value': '10.9', 'groupId': 'OG003', 'lowerLimit': '5.8', 'upperLimit': '18.3'}, {'value': '3.6', 'groupId': 'OG004', 'lowerLimit': '1.0', 'upperLimit': '9.0'}, {'value': '7.3', 'groupId': 'OG005', 'lowerLimit': '4.2', 'upperLimit': '11.5'}, {'value': '4.5', 'groupId': 'OG006', 'lowerLimit': '0.9', 'upperLimit': '12.7'}, {'value': '6.1', 'groupId': 'OG007', 'lowerLimit': '1.7', 'upperLimit': '14.8'}, {'value': '5.3', 'groupId': 'OG008', 'lowerLimit': '2.2', 'upperLimit': '10.6'}]}]}, {'title': 'MAE', 'categories': [{'measurements': [{'value': '36.4', 'groupId': 'OG000', 'lowerLimit': '17.2', 'upperLimit': '59.3'}, {'value': '45.5', 'groupId': 'OG001', 'lowerLimit': '24.4', 'upperLimit': '67.8'}, {'value': '40.9', 'groupId': 'OG002', 'lowerLimit': '26.3', 'upperLimit': '56.8'}, {'value': '47.3', 'groupId': 'OG003', 'lowerLimit': '37.7', 'upperLimit': '57.0'}, {'value': '54.5', 'groupId': 'OG004', 'lowerLimit': '44.8', 'upperLimit': '64.1'}, {'value': '50.9', 'groupId': 'OG005', 'lowerLimit': '44.1', 'upperLimit': '57.7'}, {'value': '42.4', 'groupId': 'OG006', 'lowerLimit': '30.3', 'upperLimit': '55.2'}, {'value': '43.9', 'groupId': 'OG007', 'lowerLimit': '31.7', 'upperLimit': '56.7'}, {'value': '43.2', 'groupId': 'OG008', 'lowerLimit': '34.6', 'upperLimit': '52.1'}]}]}, {'title': 'NDCMC', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '15.4'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '15.4'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '8.0'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '3.3'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '5.0'}, {'value': '0.5', 'groupId': 'OG005', 'lowerLimit': '0.0', 'upperLimit': '2.5'}, {'value': '0.0', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '5.4'}, {'value': '0.0', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '5.4'}, {'value': '0.0', 'groupId': 'OG008', 'lowerLimit': '0.0', 'upperLimit': '2.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the Vaccination 1 up to 1 month after Vaccination 3', 'description': 'An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; lack of efficacy in an approved indication; important medical event. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition that was not identified prior to study start and 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: all participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With at Least 1 Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE) and Newly Diagnosed Chronic Medical Condition (NDCMC) During the Follow up Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '108', 'groupId': 'OG003'}, {'value': '107', 'groupId': 'OG004'}, {'value': '215', 'groupId': 'OG005'}, {'value': '65', 'groupId': 'OG006'}, {'value': '63', 'groupId': 'OG007'}, {'value': '128', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <18 Months)', 'description': 'Participants from \\>=12 months to \\<18 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.'}, {'id': 'OG001', 'title': 'Group 1: 60-µg Bivalent rLP2086 (>=18 Months to <24 Months)', 'description': 'Participants from \\>=18 months to \\<24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.'}, {'id': 'OG002', 'title': 'Group 1: 60- mcg Bivalent rLP2086 (>=12 Months to <24 Months)', 'description': 'Participants from greater than or equal to (\\>=) 12 months to less than (\\<) 24 months of age, received intramuscular injection of 60 mcg of bivalent rLP2086 vaccine on months 0 vaccine on a 0, 2, 6 month schedule.'}, {'id': 'OG003', 'title': 'Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <18 Months)', 'description': 'Participants from \\>=12 months to \\<18 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.'}, {'id': 'OG004', 'title': 'Group 2: 120-µg Bivalent rLP2086 (>=18 Months to <24 Months)', 'description': 'Participants from \\>=18 months to \\<24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.'}, {'id': 'OG005', 'title': 'Group 2: 120-mcg Bivalent rLP2086 (>=12 Months to <24 Months)', 'description': 'Participants from \\>=12 months to \\<24 months of age, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine on a 0, 2, 6 month schedule. All participants who received 3 doses of 120 mcg bivalent rLP2086 in Stage 1 and gave consent for booster vaccination, received intramuscular injection of single booster dose of 120 mcg of bivalent rLP2086 after 23 to 24 months of Vaccination 3, in Stage 2. Participants were followed up approximately 6 months after the booster vaccination.'}, {'id': 'OG006', 'title': 'Group 3: HAV/Saline (>=12 Months to <18 Months)', 'description': 'Participants from \\>=12 months to \\<18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.'}, {'id': 'OG007', 'title': 'Group 3: HAV/Saline (>=18 Months to <24 Months)', 'description': 'Participants from \\>=18 months to \\<24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.'}, {'id': 'OG008', 'title': 'Group 3: HAV/Saline (>=12 Months to <24 Months): Stage 1', 'description': 'Participants from \\>=12 months to \\<24 months of age, received intramuscular injection of saline on 2 month and HAV vaccine on a 0, 6 month schedule.'}], 'classes': [{'title': 'SAE', 'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '22.8'}, {'value': '9.1', 'groupId': 'OG001', 'lowerLimit': '1.1', 'upperLimit': '29.2'}, {'value': '6.8', 'groupId': 'OG002', 'lowerLimit': '1.4', 'upperLimit': '18.7'}, {'value': '0.9', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '5.1'}, {'value': '3.7', 'groupId': 'OG004', 'lowerLimit': '1.0', 'upperLimit': '9.3'}, {'value': '2.3', 'groupId': 'OG005', 'lowerLimit': '0.8', 'upperLimit': '5.3'}, {'value': '1.5', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '8.3'}, {'value': '1.6', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '8.5'}, {'value': '1.6', 'groupId': 'OG008', 'lowerLimit': '0.2', 'upperLimit': '5.5'}]}]}, {'title': 'MAE', 'categories': [{'measurements': [{'value': '22.7', 'groupId': 'OG000', 'lowerLimit': '7.8', 'upperLimit': '45.4'}, {'value': '40.9', 'groupId': 'OG001', 'lowerLimit': '20.7', 'upperLimit': '63.6'}, {'value': '31.8', 'groupId': 'OG002', 'lowerLimit': '18.6', 'upperLimit': '47.6'}, {'value': '29.6', 'groupId': 'OG003', 'lowerLimit': '21.2', 'upperLimit': '39.2'}, {'value': '32.7', 'groupId': 'OG004', 'lowerLimit': '24.0', 'upperLimit': '42.5'}, {'value': '31.2', 'groupId': 'OG005', 'lowerLimit': '25.0', 'upperLimit': '37.8'}, {'value': '30.8', 'groupId': 'OG006', 'lowerLimit': '19.9', 'upperLimit': '43.4'}, {'value': '28.6', 'groupId': 'OG007', 'lowerLimit': '17.9', 'upperLimit': '41.3'}, {'value': '29.7', 'groupId': 'OG008', 'lowerLimit': '21.9', 'upperLimit': '38.4'}]}]}, {'title': 'NDCMC', 'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '22.8'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '15.4'}, {'value': '2.3', 'groupId': 'OG002', 'lowerLimit': '0.1', 'upperLimit': '12.0'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '3.4'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '3.4'}, {'value': '0.0', 'groupId': 'OG005', 'lowerLimit': '0.0', 'upperLimit': '1.7'}, {'value': '0.0', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '5.5'}, {'value': '0.0', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '5.7'}, {'value': '0.0', 'groupId': 'OG008', 'lowerLimit': '0.0', 'upperLimit': '2.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From 1 month after Vaccination 3 up to 6 months after Vaccination 3', 'description': 'An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; lack of efficacy in an approved indication; important medical event. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition that was not identified prior to study start and 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: all participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available. Here "N" signifies number of participants evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With at Least 1 Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE) and Newly Diagnosed Chronic Medical Condition (NDCMC) From Vaccination 1 up to 6 Months After Vaccination 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '110', 'groupId': 'OG003'}, {'value': '110', 'groupId': 'OG004'}, {'value': '220', 'groupId': 'OG005'}, {'value': '66', 'groupId': 'OG006'}, {'value': '66', 'groupId': 'OG007'}, {'value': '132', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <18 Months)', 'description': 'Participants from \\>=12 months to \\<18 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.'}, {'id': 'OG001', 'title': 'Group 1: 60-µg Bivalent rLP2086 (>=18 Months to <24 Months)', 'description': 'Participants from \\>=18 months to \\<24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.'}, {'id': 'OG002', 'title': 'Group 1: 60- mcg Bivalent rLP2086 (>=12 Months to <24 Months)', 'description': 'Participants from greater than or equal to (\\>=) 12 months to less than (\\<) 24 months of age, received intramuscular injection of 60 mcg of bivalent rLP2086 vaccine on months 0 vaccine on a 0, 2, 6 month schedule.'}, {'id': 'OG003', 'title': 'Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <18 Months)', 'description': 'Participants from \\>=12 months to \\<18 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.'}, {'id': 'OG004', 'title': 'Group 2: 120-µg Bivalent rLP2086 (>=18 Months to <24 Months)', 'description': 'Participants from \\>=18 months to \\<24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.'}, {'id': 'OG005', 'title': 'Group 2: 120-mcg Bivalent rLP2086 (>=12 Months to <24 Months)', 'description': 'Participants from \\>=12 months to \\<24 months of age, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine on a 0, 2, 6 month schedule. All participants who received 3 doses of 120 mcg bivalent rLP2086 in Stage 1 and gave consent for booster vaccination, received intramuscular injection of single booster dose of 120 mcg of bivalent rLP2086 after 23 to 24 months of Vaccination 3, in Stage 2. Participants were followed up approximately 6 months after the booster vaccination.'}, {'id': 'OG006', 'title': 'Group 3: HAV/Saline (>=12 Months to <18 Months)', 'description': 'Participants from \\>=12 months to \\<18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.'}, {'id': 'OG007', 'title': 'Group 3: HAV/Saline (>=18 Months to <24 Months)', 'description': 'Participants from \\>=18 months to \\<24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.'}, {'id': 'OG008', 'title': 'Group 3: HAV/Saline (>=12 Months to <24 Months): Stage 1', 'description': 'Participants from \\>=12 months to \\<24 months of age, received intramuscular injection of saline on 2 month and HAV vaccine on a 0, 6 month schedule.'}], 'classes': [{'title': 'SAE', 'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '22.8'}, {'value': '13.6', 'groupId': 'OG001', 'lowerLimit': '2.9', 'upperLimit': '34.9'}, {'value': '9.1', 'groupId': 'OG002', 'lowerLimit': '2.5', 'upperLimit': '21.7'}, {'value': '10.9', 'groupId': 'OG003', 'lowerLimit': '5.8', 'upperLimit': '18.3'}, {'value': '6.4', 'groupId': 'OG004', 'lowerLimit': '2.6', 'upperLimit': '12.7'}, {'value': '8.6', 'groupId': 'OG005', 'lowerLimit': '5.3', 'upperLimit': '13.2'}, {'value': '6.1', 'groupId': 'OG006', 'lowerLimit': '1.7', 'upperLimit': '14.8'}, {'value': '6.1', 'groupId': 'OG007', 'lowerLimit': '1.7', 'upperLimit': '14.8'}, {'value': '6.1', 'groupId': 'OG008', 'lowerLimit': '2.7', 'upperLimit': '11.6'}]}]}, {'title': 'MAE', 'categories': [{'measurements': [{'value': '54.5', 'groupId': 'OG000', 'lowerLimit': '32.2', 'upperLimit': '75.6'}, {'value': '68.2', 'groupId': 'OG001', 'lowerLimit': '45.1', 'upperLimit': '86.1'}, {'value': '61.4', 'groupId': 'OG002', 'lowerLimit': '45.5', 'upperLimit': '75.6'}, {'value': '54.5', 'groupId': 'OG003', 'lowerLimit': '44.8', 'upperLimit': '64.1'}, {'value': '62.7', 'groupId': 'OG004', 'lowerLimit': '53.0', 'upperLimit': '71.8'}, {'value': '58.6', 'groupId': 'OG005', 'lowerLimit': '51.8', 'upperLimit': '65.2'}, {'value': '59.1', 'groupId': 'OG006', 'lowerLimit': '46.3', 'upperLimit': '71.0'}, {'value': '53.0', 'groupId': 'OG007', 'lowerLimit': '40.3', 'upperLimit': '65.4'}, {'value': '56.1', 'groupId': 'OG008', 'lowerLimit': '42.7', 'upperLimit': '64.7'}]}]}, {'title': 'NDCMC', 'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '22.8'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '15.4'}, {'value': '2.3', 'groupId': 'OG002', 'lowerLimit': '0.1', 'upperLimit': '12.0'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '3.3'}, {'value': '0.9', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '5.0'}, {'value': '0.5', 'groupId': 'OG005', 'lowerLimit': '0.0', 'upperLimit': '2.5'}, {'value': '0.0', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '5.4'}, {'value': '0.0', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '5.4'}, {'value': '0.0', 'groupId': 'OG008', 'lowerLimit': '0.0', 'upperLimit': '2.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Vaccination 1 up to 6 months after Vaccination 3', 'description': 'An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; lack of efficacy in an approved indication; important medical event. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition that was not identified prior to study start and 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: all participants who received at least 1 dose of the investigational product (rLP2086 or HAV/saline) and had safety data available.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With hSBA Titer Between 12 Months to Less Than (<) 24 Months >= LLOQ for Each of the 4 Primary MnB Test Strains at 1, 6, 12, and 24 Months After Vaccination 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: 60- mcg Bivalent rLP2086 (>=12 Months to <24 Months)', 'description': 'Participants from greater than or equal to (\\>=) 12 months to less than (\\<) 24 months of age, received intramuscular injection of 60 mcg of bivalent rLP2086 vaccine on months 0 vaccine on a 0, 2, 6 month schedule.'}, {'id': 'OG001', 'title': 'Group 2: 120-mcg Bivalent rLP2086 (>=12 Months to <24 Months)', 'description': 'Participants from \\>=12 months to \\<24 months of age, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine on a 0, 2, 6 month schedule. All participants who received 3 doses of 120 mcg bivalent rLP2086 in Stage 1 and gave consent for booster vaccination, received intramuscular injection of single booster dose of 120 mcg of bivalent rLP2086 after 23 to 24 months of Vaccination 3, in Stage 2. Participants were followed up approximately 6 months after the booster vaccination.'}, {'id': 'OG002', 'title': 'Group 3: HAV/Saline (>=12 Months to <24 Months): Stage 1', 'description': 'Participants from \\>=12 months to \\<24 months of age, received intramuscular injection of saline on 2 month and HAV vaccine on a 0, 6 month schedule.'}], 'classes': [{'title': 'PMB80 (A22) 1 Month after Vaccination 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '90.0', 'groupId': 'OG000', 'lowerLimit': '68.3', 'upperLimit': '98.8'}, {'value': '89.6', 'groupId': 'OG001', 'lowerLimit': '81.7', 'upperLimit': '94.9'}, {'value': '5.0', 'groupId': 'OG002', 'lowerLimit': '1.0', 'upperLimit': '13.9'}]}]}, {'title': 'PMB80 (A22): 6 Months after Vaccination 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '10.0', 'groupId': 'OG000', 'lowerLimit': '1.2', 'upperLimit': '31.7'}, {'value': '12.4', 'groupId': 'OG001', 'lowerLimit': '6.6', 'upperLimit': '20.6'}, {'value': '3.4', 'groupId': 'OG002', 'lowerLimit': '0.4', 'upperLimit': '11.9'}]}]}, {'title': 'PMB80 (A22): 12 Months after Vaccination 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '14.3', 'groupId': 'OG000', 'lowerLimit': '3.0', 'upperLimit': '36.3'}, {'value': '6.3', 'groupId': 'OG001', 'lowerLimit': '2.4', 'upperLimit': '13.2'}, {'value': '1.8', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '9.7'}]}]}, {'title': 'PMB80 (A22): 24 Months after Vaccination 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '17.6'}, {'value': '3.7', 'groupId': 'OG001', 'lowerLimit': '0.8', 'upperLimit': '10.4'}]}]}, {'title': 'PMB2001 (A56): 1 Month after Vaccination 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '82.4', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG001', 'lowerLimit': '96.2', 'upperLimit': '100.0'}, {'value': '1.9', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '9.9'}]}]}, {'title': 'PMB2001 (A56): 6 months after Vaccination 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '61.1', 'groupId': 'OG000', 'lowerLimit': '35.7', 'upperLimit': '82.7'}, {'value': '59.1', 'groupId': 'OG001', 'lowerLimit': '48.1', 'upperLimit': '69.5'}, {'value': '3.8', 'groupId': 'OG002', 'lowerLimit': '0.5', 'upperLimit': '13.2'}]}]}, {'title': 'PMB2001 (A56): 12 months after Vaccination 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '56.3', 'groupId': 'OG000', 'lowerLimit': '29.9', 'upperLimit': '80.2'}, {'value': '38.7', 'groupId': 'OG001', 'lowerLimit': '28.8', 'upperLimit': '49.4'}, {'value': '5.7', 'groupId': 'OG002', 'lowerLimit': '1.2', 'upperLimit': '15.7'}]}]}, {'title': 'PMB2001 (A56): 24 months after Vaccination 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '41.2', 'groupId': 'OG000', 'lowerLimit': '18.4', 'upperLimit': '67.1'}, {'value': '22.8', 'groupId': 'OG001', 'lowerLimit': '14.1', 'upperLimit': '33.6'}]}]}, {'title': 'PMB2948 (B24): 1 Month after Vaccination 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '85.0', 'groupId': 'OG000', 'lowerLimit': '62.1', 'upperLimit': '96.8'}, {'value': '71.6', 'groupId': 'OG001', 'lowerLimit': '61.4', 'upperLimit': '80.4'}, {'value': '5.0', 'groupId': 'OG002', 'lowerLimit': '1.0', 'upperLimit': '13.9'}]}]}, {'title': 'PMB2948 (B24): 6 month after Vaccination 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '15.0', 'groupId': 'OG000', 'lowerLimit': '3.2', 'upperLimit': '37.9'}, {'value': '10.3', 'groupId': 'OG001', 'lowerLimit': '5.1', 'upperLimit': '18.1'}, {'value': '3.4', 'groupId': 'OG002', 'lowerLimit': '0.4', 'upperLimit': '11.9'}]}]}, {'title': 'PMB2948 (B24): 12 month after Vaccination 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '9.5', 'groupId': 'OG000', 'lowerLimit': '1.2', 'upperLimit': '30.4'}, {'value': '3.2', 'groupId': 'OG001', 'lowerLimit': '0.7', 'upperLimit': '9.1'}, {'value': '3.6', 'groupId': 'OG002', 'lowerLimit': '0.4', 'upperLimit': '12.5'}]}]}, {'title': 'PMB2948 (B24): 24 month after Vaccination 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.3', 'groupId': 'OG000', 'lowerLimit': '0.1', 'upperLimit': '26.0'}, {'value': '3.7', 'groupId': 'OG001', 'lowerLimit': '0.8', 'upperLimit': '10.3'}]}]}, {'title': 'PMB2707 (B44): 1 Month after Vaccination 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '89.5', 'groupId': 'OG000', 'lowerLimit': '66.9', 'upperLimit': '98.7'}, {'value': '86.2', 'groupId': 'OG001', 'lowerLimit': '77.5', 'upperLimit': '92.4'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '6.6'}]}]}, {'title': 'PMB2707 (B44): 6 month after Vaccination 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000', 'lowerLimit': '7.3', 'upperLimit': '52.4'}, {'value': '40.4', 'groupId': 'OG001', 'lowerLimit': '30.2', 'upperLimit': '51.4'}, {'value': '1.9', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '10.1'}]}]}, {'title': 'PMB2707 (B44): 12 month after Vaccination 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '12.5', 'groupId': 'OG000', 'lowerLimit': '1.6', 'upperLimit': '38.3'}, {'value': '17.8', 'groupId': 'OG001', 'lowerLimit': '10.5', 'upperLimit': '27.3'}, {'value': '2.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '10.4'}]}]}, {'title': 'PMB2707 (B44): 24 month after Vaccination 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '11.8', 'groupId': 'OG000', 'lowerLimit': '1.5', 'upperLimit': '36.4'}, {'value': '12.5', 'groupId': 'OG001', 'lowerLimit': '6.2', 'upperLimit': '21.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1, 6, 12, 24 months after Vaccination 3', 'description': 'Percentage of participants achieving hSBA titer \\>= LLOQ were computed along with corresponding 2-sided 95% CIs. LLOQ was 1:16 for PMB80 (A22) and 1:8 for PMB2001 (A56), PMB2948 (B24), and PMB2707 (B44).', 'unitOfMeasure': 'percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable immunogenicity population: all eligible participants randomized to study, received scheduled investigational products, had pre and post vaccination blood drawn with valid and determinate assay results and had no important protocol deviation. Here N signifies number of participants evaluable for this outcome measure and "number analyzed" (n) signifies participants evaluable at specific rows.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With hSBA Titer >= LLOQ for Each of the 4 Primary MnB Test Strains 1 Month After Vaccination 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}, {'value': '50', 'groupId': 'OG004'}, {'value': '95', 'groupId': 'OG005'}, {'value': '30', 'groupId': 'OG006'}, {'value': '29', 'groupId': 'OG007'}, {'value': '59', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <18 Months)', 'description': 'Participants from \\>=12 months to \\<18 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.'}, {'id': 'OG001', 'title': 'Group 1: 60-µg Bivalent rLP2086 (>=18 Months to <24 Months)', 'description': 'Participants from \\>=18 months to \\<24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.'}, {'id': 'OG002', 'title': 'Group 1: 60- mcg Bivalent rLP2086 (>=12 Months to <24 Months)', 'description': 'Participants from greater than or equal to (\\>=) 12 months to less than (\\<) 24 months of age, received intramuscular injection of 60 mcg of bivalent rLP2086 vaccine on months 0 vaccine on a 0, 2, 6 month schedule.'}, {'id': 'OG003', 'title': 'Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <18 Months)', 'description': 'Participants from \\>=12 months to \\<18 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.'}, {'id': 'OG004', 'title': 'Group 2: 120-µg Bivalent rLP2086 (>=18 Months to <24 Months)', 'description': 'Participants from \\>=18 months to \\<24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.'}, {'id': 'OG005', 'title': 'Group 2: 120-mcg Bivalent rLP2086 (>=12 Months to <24 Months)', 'description': 'Participants from \\>=12 months to \\<24 months of age, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine on a 0, 2, 6 month schedule. All participants who received 3 doses of 120 mcg bivalent rLP2086 in Stage 1 and gave consent for booster vaccination, received intramuscular injection of single booster dose of 120 mcg of bivalent rLP2086 after 23 to 24 months of Vaccination 3, in Stage 2. Participants were followed up approximately 6 months after the booster vaccination.'}, {'id': 'OG006', 'title': 'Group 3: HAV/Saline (>=12 Months to <18 Months)', 'description': 'Participants from \\>=12 months to \\<18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.'}, {'id': 'OG007', 'title': 'Group 3: HAV/Saline (>=18 Months to <24 Months)', 'description': 'Participants from \\>=18 months to \\<24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.'}, {'id': 'OG008', 'title': 'Group 3: HAV/Saline (>=12 Months to <24 Months): Stage 1', 'description': 'Participants from \\>=12 months to \\<24 months of age, received intramuscular injection of saline on 2 month and HAV vaccine on a 0, 6 month schedule.'}], 'classes': [{'title': '1 Mon after Vac2: PMB80[A22]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}, {'value': '50', 'groupId': 'OG004'}, {'value': '95', 'groupId': 'OG005'}, {'value': '30', 'groupId': 'OG006'}, {'value': '29', 'groupId': 'OG007'}, {'value': '59', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '90.0', 'groupId': 'OG000', 'lowerLimit': '55.5', 'upperLimit': '99.7'}, {'value': '66.7', 'groupId': 'OG001', 'lowerLimit': '29.9', 'upperLimit': '92.5'}, {'value': '78.9', 'groupId': 'OG002', 'lowerLimit': '54.4', 'upperLimit': '93.9'}, {'value': '64.4', 'groupId': 'OG003', 'lowerLimit': '48.8', 'upperLimit': '78.1'}, {'value': '84.0', 'groupId': 'OG004', 'lowerLimit': '70.9', 'upperLimit': '92.8'}, {'value': '74.7', 'groupId': 'OG005', 'lowerLimit': '64.8', 'upperLimit': '83.1'}, {'value': '0.0', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '11.6'}, {'value': '3.4', 'groupId': 'OG007', 'lowerLimit': '0.1', 'upperLimit': '17.8'}, {'value': '1.7', 'groupId': 'OG008', 'lowerLimit': '0.0', 'upperLimit': '9.1'}]}]}, {'title': '1Mon after Vac2:PMB2001[A56]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}, {'value': '48', 'groupId': 'OG004'}, {'value': '95', 'groupId': 'OG005'}, {'value': '23', 'groupId': 'OG006'}, {'value': '29', 'groupId': 'OG007'}, {'value': '52', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '66.4', 'upperLimit': '100.0'}, {'value': '90.0', 'groupId': 'OG001', 'lowerLimit': '55.5', 'upperLimit': '99.7'}, {'value': '94.7', 'groupId': 'OG002', 'lowerLimit': '74.0', 'upperLimit': '99.9'}, {'value': '100.0', 'groupId': 'OG003', 'lowerLimit': '92.5', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG004', 'lowerLimit': '92.6', 'upperLimit': '100.0'}, {'value': '100.0', 'groupId': 'OG005', 'lowerLimit': '96.2', 'upperLimit': '100.0'}, {'value': '0.0', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '14.8'}, {'value': '0.0', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '11.9'}, {'value': '0.0', 'groupId': 'OG008', 'lowerLimit': '0.0', 'upperLimit': '6.8'}]}]}, {'title': '1Mon after Vac2:PMB2948[B24]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}, {'value': '86', 'groupId': 'OG005'}, {'value': '30', 'groupId': 'OG006'}, {'value': '29', 'groupId': 'OG007'}, {'value': '59', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '70.0', 'groupId': 'OG000', 'lowerLimit': '34.8', 'upperLimit': '93.3'}, {'value': '44.4', 'groupId': 'OG001', 'lowerLimit': '13.7', 'upperLimit': '78.8'}, {'value': '57.9', 'groupId': 'OG002', 'lowerLimit': '33.5', 'upperLimit': '79.7'}, {'value': '23.8', 'groupId': 'OG003', 'lowerLimit': '12.1', 'upperLimit': '39.5'}, {'value': '43.2', 'groupId': 'OG004', 'lowerLimit': '28.3', 'upperLimit': '59.0'}, {'value': '33.7', 'groupId': 'OG005', 'lowerLimit': '23.9', 'upperLimit': '44.7'}, {'value': '0.0', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '11.6'}, {'value': '3.4', 'groupId': 'OG007', 'lowerLimit': '0.1', 'upperLimit': '17.8'}, {'value': '1.7', 'groupId': 'OG008', 'lowerLimit': '0.0', 'upperLimit': '9.1'}]}]}, {'title': '1Mon after Vac2:PMB2707[B44]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}, {'value': '47', 'groupId': 'OG004'}, {'value': '94', 'groupId': 'OG005'}, {'value': '23', 'groupId': 'OG006'}, {'value': '29', 'groupId': 'OG007'}, {'value': '52', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '77.8', 'groupId': 'OG000', 'lowerLimit': '40.0', 'upperLimit': '97.2'}, {'value': '60.0', 'groupId': 'OG001', 'lowerLimit': '26.2', 'upperLimit': '87.8'}, {'value': '68.4', 'groupId': 'OG002', 'lowerLimit': '43.4', 'upperLimit': '87.4'}, {'value': '72.3', 'groupId': 'OG003', 'lowerLimit': '57.4', 'upperLimit': '84.4'}, {'value': '63.8', 'groupId': 'OG004', 'lowerLimit': '48.5', 'upperLimit': '77.3'}, {'value': '68.1', 'groupId': 'OG005', 'lowerLimit': '57.7', 'upperLimit': '77.3'}, {'value': '0.0', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '14.8'}, {'value': '0.0', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '11.9'}, {'value': '0.0', 'groupId': 'OG008', 'lowerLimit': '0.0', 'upperLimit': '6.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month (Mon) after Vaccination (Vac) 2', 'description': 'Percentage of participants achieving hSBA titer \\>= LLOQ were computed along with corresponding 2-sided 95% CIs. LLOQ was 1:16 for PMB80 (A22) and 1:8 for PMB2001 (A56), PMB2948 (B24), and PMB2707 (B44).', 'unitOfMeasure': 'percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable immunogenicity population: all eligible participants randomized to study, received scheduled investigational products, had pre and post vaccination blood drawn with valid and determinate assay results and had no important protocol deviation. Here "N" signifies number of participants evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}, {'value': '97', 'groupId': 'OG005'}, {'value': '31', 'groupId': 'OG006'}, {'value': '30', 'groupId': 'OG007'}, {'value': '61', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <18 Months)', 'description': 'Participants from \\>=12 months to \\<18 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.'}, {'id': 'OG001', 'title': 'Group 1: 60-µg Bivalent rLP2086 (>=18 Months to <24 Months)', 'description': 'Participants from \\>=18 months to \\<24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.'}, {'id': 'OG002', 'title': 'Group 1: 60- mcg Bivalent rLP2086 (>=12 Months to <24 Months)', 'description': 'Participants from greater than or equal to (\\>=) 12 months to less than (\\<) 24 months of age, received intramuscular injection of 60 mcg of bivalent rLP2086 vaccine on months 0 vaccine on a 0, 2, 6 month schedule.'}, {'id': 'OG003', 'title': 'Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <18 Months)', 'description': 'Participants from \\>=12 months to \\<18 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.'}, {'id': 'OG004', 'title': 'Group 2: 120-µg Bivalent rLP2086 (>=18 Months to <24 Months)', 'description': 'Participants from \\>=18 months to \\<24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.'}, {'id': 'OG005', 'title': 'Group 2: 120-mcg Bivalent rLP2086 (>=12 Months to <24 Months)', 'description': 'Participants from \\>=12 months to \\<24 months of age, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine on a 0, 2, 6 month schedule. All participants who received 3 doses of 120 mcg bivalent rLP2086 in Stage 1 and gave consent for booster vaccination, received intramuscular injection of single booster dose of 120 mcg of bivalent rLP2086 after 23 to 24 months of Vaccination 3, in Stage 2. Participants were followed up approximately 6 months after the booster vaccination.'}, {'id': 'OG006', 'title': 'Group 3: HAV/Saline (>=12 Months to <18 Months)', 'description': 'Participants from \\>=12 months to \\<18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.'}, {'id': 'OG007', 'title': 'Group 3: HAV/Saline (>=18 Months to <24 Months)', 'description': 'Participants from \\>=18 months to \\<24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.'}, {'id': 'OG008', 'title': 'Group 3: HAV/Saline (>=12 Months to <24 Months): Stage 1', 'description': 'Participants from \\>=12 months to \\<24 months of age, received intramuscular injection of saline on 2 month and HAV vaccine on a 0, 6 month schedule.'}], 'classes': [{'title': 'T1: PMB80 [A22] - 1:4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}, {'value': '97', 'groupId': 'OG005'}, {'value': '31', 'groupId': 'OG006'}, {'value': '30', 'groupId': 'OG007'}, {'value': '61', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '33.6'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '28.5'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '16.8'}, {'value': '4.3', 'groupId': 'OG003', 'lowerLimit': '0.5', 'upperLimit': '14.8'}, {'value': '3.9', 'groupId': 'OG004', 'lowerLimit': '0.5', 'upperLimit': '13.5'}, {'value': '4.1', 'groupId': 'OG005', 'lowerLimit': '1.1', 'upperLimit': '10.2'}, {'value': '0.0', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '11.2'}, {'value': '3.3', 'groupId': 'OG007', 'lowerLimit': '0.1', 'upperLimit': '17.2'}, {'value': '1.6', 'groupId': 'OG008', 'lowerLimit': '0.0', 'upperLimit': '8.8'}]}]}, {'title': 'T1: PMB80 [A22] - 1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}, {'value': '97', 'groupId': 'OG005'}, {'value': '31', 'groupId': 'OG006'}, {'value': '30', 'groupId': 'OG007'}, {'value': '61', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '33.6'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '28.5'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '16.8'}, {'value': '2.2', 'groupId': 'OG003', 'lowerLimit': '0.1', 'upperLimit': '11.5'}, {'value': '3.9', 'groupId': 'OG004', 'lowerLimit': '0.5', 'upperLimit': '13.5'}, {'value': '3.1', 'groupId': 'OG005', 'lowerLimit': '0.6', 'upperLimit': '8.8'}, {'value': '0.0', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '11.2'}, {'value': '3.3', 'groupId': 'OG007', 'lowerLimit': '0.1', 'upperLimit': '17.2'}, {'value': '1.6', 'groupId': 'OG008', 'lowerLimit': '0.0', 'upperLimit': '8.8'}]}]}, {'title': 'T1: PMB80 [A22] - 1:16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}, {'value': '97', 'groupId': 'OG005'}, {'value': '31', 'groupId': 'OG006'}, {'value': '30', 'groupId': 'OG007'}, {'value': '61', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '33.6'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '28.5'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '16.8'}, {'value': '2.2', 'groupId': 'OG003', 'lowerLimit': '0.1', 'upperLimit': '11.5'}, {'value': '3.9', 'groupId': 'OG004', 'lowerLimit': '0.5', 'upperLimit': '13.5'}, {'value': '3.1', 'groupId': 'OG005', 'lowerLimit': '0.6', 'upperLimit': '8.8'}, {'value': '0.0', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '11.2'}, {'value': '3.3', 'groupId': 'OG007', 'lowerLimit': '0.1', 'upperLimit': '17.2'}, {'value': '1.6', 'groupId': 'OG008', 'lowerLimit': '0.0', 'upperLimit': '8.8'}]}]}, {'title': 'T1: PMB80 [A22] - 1:32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}, {'value': '97', 'groupId': 'OG005'}, {'value': '31', 'groupId': 'OG006'}, {'value': '30', 'groupId': 'OG007'}, {'value': '61', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '33.6'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '28.5'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '16.8'}, {'value': '2.2', 'groupId': 'OG003', 'lowerLimit': '0.1', 'upperLimit': '11.5'}, {'value': '2.0', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '10.4'}, {'value': '2.1', 'groupId': 'OG005', 'lowerLimit': '0.3', 'upperLimit': '7.3'}, {'value': '0.0', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '11.2'}, {'value': '0.0', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '11.6'}, {'value': '0.0', 'groupId': 'OG008', 'lowerLimit': '0.0', 'upperLimit': '5.9'}]}]}, {'title': 'T1: PMB80 [A22] - 1:64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}, {'value': '97', 'groupId': 'OG005'}, {'value': '31', 'groupId': 'OG006'}, {'value': '30', 'groupId': 'OG007'}, {'value': '61', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '33.6'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '28.5'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '16.8'}, {'value': '2.2', 'groupId': 'OG003', 'lowerLimit': '0.1', 'upperLimit': '11.5'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '7.0'}, {'value': '1.0', 'groupId': 'OG005', 'lowerLimit': '0.0', 'upperLimit': '5.6'}, {'value': '0.0', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '11.2'}, {'value': '0.0', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '11.6'}, {'value': '0.0', 'groupId': 'OG008', 'lowerLimit': '0.0', 'upperLimit': '5.9'}]}]}, {'title': 'T1: PMB80 [A22] - 1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}, {'value': '97', 'groupId': 'OG005'}, {'value': '31', 'groupId': 'OG006'}, {'value': '30', 'groupId': 'OG007'}, {'value': '61', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '33.6'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '28.5'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '16.8'}, {'value': '2.2', 'groupId': 'OG003', 'lowerLimit': '0.1', 'upperLimit': '11.5'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '7.0'}, {'value': '1.0', 'groupId': 'OG005', 'lowerLimit': '0.0', 'upperLimit': '5.6'}, {'value': '0.0', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '11.2'}, {'value': '0.0', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '11.6'}, {'value': '0.0', 'groupId': 'OG008', 'lowerLimit': '0.0', 'upperLimit': '5.9'}]}]}, {'title': 'T1: PMB2001 (A56)-1:4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}, {'value': '95', 'groupId': 'OG005'}, {'value': '24', 'groupId': 'OG006'}, {'value': '29', 'groupId': 'OG007'}, {'value': '53', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '33.6'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '30.8'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '17.6'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '7.7'}, {'value': '4.1', 'groupId': 'OG004', 'lowerLimit': '0.5', 'upperLimit': '14.0'}, {'value': '2.1', 'groupId': 'OG005', 'lowerLimit': '0.3', 'upperLimit': '7.4'}, {'value': '4.2', 'groupId': 'OG006', 'lowerLimit': '0.1', 'upperLimit': '21.1'}, {'value': '0.0', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '11.9'}, {'value': '1.9', 'groupId': 'OG008', 'lowerLimit': '0.0', 'upperLimit': '10.1'}]}]}, {'title': 'T1: PMB2001 (A56)-1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}, {'value': '95', 'groupId': 'OG005'}, {'value': '24', 'groupId': 'OG006'}, {'value': '29', 'groupId': 'OG007'}, {'value': '53', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '33.6'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '30.8'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '17.6'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '7.7'}, {'value': '2.0', 'groupId': 'OG004', 'lowerLimit': '0.1', 'upperLimit': '10.9'}, {'value': '1.1', 'groupId': 'OG005', 'lowerLimit': '0.0', 'upperLimit': '5.7'}, {'value': '0.0', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '14.2'}, {'value': '0.0', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '11.9'}, {'value': '0.0', 'groupId': 'OG008', 'lowerLimit': '0.0', 'upperLimit': '6.7'}]}]}, {'title': 'T1: PMB2001 (A56)-1:16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}, {'value': '95', 'groupId': 'OG005'}, {'value': '24', 'groupId': 'OG006'}, {'value': '29', 'groupId': 'OG007'}, {'value': '53', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '33.6'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '30.8'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '17.6'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '7.7'}, {'value': '2.0', 'groupId': 'OG004', 'lowerLimit': '0.1', 'upperLimit': '10.9'}, {'value': '1.1', 'groupId': 'OG005', 'lowerLimit': '0.0', 'upperLimit': '5.7'}, {'value': '0.0', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '14.2'}, {'value': '0.0', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '11.9'}, {'value': '0.0', 'groupId': 'OG008', 'lowerLimit': '0.0', 'upperLimit': '6.7'}]}]}, {'title': 'T1: PMB2001 (A56)-1:32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}, {'value': '95', 'groupId': 'OG005'}, {'value': '24', 'groupId': 'OG006'}, {'value': '29', 'groupId': 'OG007'}, {'value': '53', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '33.6'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '30.8'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '17.6'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '7.7'}, {'value': '2.0', 'groupId': 'OG004', 'lowerLimit': '0.1', 'upperLimit': '10.9'}, {'value': '1.1', 'groupId': 'OG005', 'lowerLimit': '0.0', 'upperLimit': '5.7'}, {'value': '0.0', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '14.2'}, {'value': '0.0', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '11.9'}, {'value': '0.0', 'groupId': 'OG008', 'lowerLimit': '0.0', 'upperLimit': '6.7'}]}]}, {'title': 'T1: PMB2001 (A56)-1:64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}, {'value': '95', 'groupId': 'OG005'}, {'value': '24', 'groupId': 'OG006'}, {'value': '29', 'groupId': 'OG007'}, {'value': '53', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '33.6'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '30.8'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '17.6'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '7.7'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '7.3'}, {'value': '0.0', 'groupId': 'OG005', 'lowerLimit': '0.0', 'upperLimit': '3.8'}, {'value': '0.0', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '14.2'}, {'value': '0.0', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '11.9'}, {'value': '0.0', 'groupId': 'OG008', 'lowerLimit': '0.0', 'upperLimit': '6.7'}]}]}, {'title': 'T1: PMB2001 (A56)-1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}, {'value': '95', 'groupId': 'OG005'}, {'value': '24', 'groupId': 'OG006'}, {'value': '29', 'groupId': 'OG007'}, {'value': '53', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '33.6'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '30.8'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '17.6'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '7.7'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '7.3'}, {'value': '0.0', 'groupId': 'OG005', 'lowerLimit': '0.0', 'upperLimit': '3.8'}, {'value': '0.0', 'groupId': 'OG006', 'lowerLimit': '0.0', 'upperLimit': '14.2'}, {'value': '0.0', 'groupId': 'OG007', 'lowerLimit': '0.0', 'upperLimit': '11.9'}, 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'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}, {'value': '48', 'groupId': 'OG004'}, {'value': '82', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '30.8'}, {'value': '11.1', 'groupId': 'OG001', 'lowerLimit': '0.3', 'upperLimit': '48.2'}, {'value': '5.3', 'groupId': 'OG002', 'lowerLimit': '0.1', 'upperLimit': '26.0'}, {'value': '8.8', 'groupId': 'OG003', 'lowerLimit': '1.9', 'upperLimit': '23.7'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '7.4'}, {'value': '3.7', 'groupId': 'OG005', 'lowerLimit': '0.8', 'upperLimit': '10.3'}]}]}, {'title': 'T6: PMB2948 (B24): 1: 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}, {'value': '48', 'groupId': 'OG004'}, {'value': '82', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '30.8'}, {'value': '11.1', 'groupId': 'OG001', 'lowerLimit': '0.3', 'upperLimit': '48.2'}, {'value': '5.3', 'groupId': 'OG002', 'lowerLimit': '0.1', 'upperLimit': '26.0'}, {'value': '5.9', 'groupId': 'OG003', 'lowerLimit': '0.7', 'upperLimit': '19.7'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '7.4'}, {'value': '2.4', 'groupId': 'OG005', 'lowerLimit': '0.3', 'upperLimit': '8.5'}]}]}, {'title': 'T6: PMB2948 (B24): 1: 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}, {'value': '48', 'groupId': 'OG004'}, {'value': '82', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '30.8'}, {'value': '11.1', 'groupId': 'OG001', 'lowerLimit': '0.3', 'upperLimit': '48.2'}, {'value': '5.3', 'groupId': 'OG002', 'lowerLimit': '0.1', 'upperLimit': '26.0'}, {'value': '5.9', 'groupId': 'OG003', 'lowerLimit': '0.7', 'upperLimit': '19.7'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '7.4'}, {'value': '2.4', 'groupId': 'OG005', 'lowerLimit': '0.3', 'upperLimit': '8.5'}]}]}, {'title': 'T6: PMB2948 (B24): 1: 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}, {'value': '48', 'groupId': 'OG004'}, {'value': '82', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '30.8'}, {'value': '11.1', 'groupId': 'OG001', 'lowerLimit': '0.3', 'upperLimit': '48.2'}, {'value': '5.3', 'groupId': 'OG002', 'lowerLimit': '0.1', 'upperLimit': '26.0'}, {'value': '5.9', 'groupId': 'OG003', 'lowerLimit': '0.7', 'upperLimit': '19.7'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '7.4'}, {'value': '2.4', 'groupId': 'OG005', 'lowerLimit': '0.3', 'upperLimit': '8.5'}]}]}, {'title': 'T6: PMB2948 (B24): 1: 128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}, {'value': '48', 'groupId': 'OG004'}, {'value': '82', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '30.8'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '33.6'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '17.6'}, {'value': '2.9', 'groupId': 'OG003', 'lowerLimit': '0.1', 'upperLimit': '15.3'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '0.0', 'upperLimit': '7.4'}, {'value': '1.2', 'groupId': 'OG005', 'lowerLimit': '0.0', 'upperLimit': '6.6'}]}]}, {'title': 'T6: PMB2707 (B44): 1: 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '41', 'groupId': 'OG004'}, {'value': '80', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '33.6'}, {'value': '25.0', 'groupId': 'OG001', 'lowerLimit': '3.2', 'upperLimit': '65.1'}, {'value': '11.8', 'groupId': 'OG002', 'lowerLimit': '1.5', 'upperLimit': '36.4'}, {'value': '15.4', 'groupId': 'OG003', 'lowerLimit': '5.9', 'upperLimit': '30.5'}, {'value': '12.2', 'groupId': 'OG004', 'lowerLimit': '4.1', 'upperLimit': '26.2'}, {'value': '13.8', 'groupId': 'OG005', 'lowerLimit': '7.1', 'upperLimit': '23.3'}]}]}, {'title': 'T6: PMB2707 (B44): 1: 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '41', 'groupId': 'OG004'}, {'value': '80', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '33.6'}, {'value': '25.0', 'groupId': 'OG001', 'lowerLimit': '3.2', 'upperLimit': '65.1'}, {'value': '11.8', 'groupId': 'OG002', 'lowerLimit': '1.5', 'upperLimit': '36.4'}, {'value': '12.8', 'groupId': 'OG003', 'lowerLimit': '4.3', 'upperLimit': '27.4'}, {'value': '12.2', 'groupId': 'OG004', 'lowerLimit': '4.1', 'upperLimit': '26.2'}, {'value': '12.5', 'groupId': 'OG005', 'lowerLimit': '6.2', 'upperLimit': '21.8'}]}]}, {'title': 'T6: PMB2707 (B44): 1: 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '41', 'groupId': 'OG004'}, {'value': '80', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 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'0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '36.9'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '19.5'}, {'value': '5.1', 'groupId': 'OG003', 'lowerLimit': '0.6', 'upperLimit': '17.3'}, {'value': '2.4', 'groupId': 'OG004', 'lowerLimit': '0.1', 'upperLimit': '12.9'}, {'value': '3.8', 'groupId': 'OG005', 'lowerLimit': '0.8', 'upperLimit': '10.6'}]}]}, {'title': 'T6: PMB2707 (B44): 1: 64', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '41', 'groupId': 'OG004'}, {'value': '80', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '33.6'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '36.9'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '19.5'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '9.0'}, {'value': '2.4', 'groupId': 'OG004', 'lowerLimit': '0.1', 'upperLimit': '12.9'}, {'value': '1.3', 'groupId': 'OG005', 'lowerLimit': '0.0', 'upperLimit': '6.8'}]}]}, {'title': 'T6: PMB2707 (B44): 1: 128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '41', 'groupId': 'OG004'}, {'value': '80', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '33.6'}, {'value': '0.0', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '36.9'}, {'value': '0.0', 'groupId': 'OG002', 'lowerLimit': '0.0', 'upperLimit': '19.5'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '9.0'}, {'value': '2.4', 'groupId': 'OG004', 'lowerLimit': '0.1', 'upperLimit': '12.9'}, {'value': '1.3', 'groupId': 'OG005', 'lowerLimit': '0.0', 'upperLimit': '6.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Before Vaccination 1 (T1), 1 month after Vaccination 2 (T2), 1 month after Vaccination 3 (T3), 6 months after Vaccination 3 (T4), 12 months after Vaccination 3 (T5) and 24 months after Vaccination 3 (T6)', 'unitOfMeasure': 'percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable immunogenicity population: all eligible participants randomized to study, received scheduled investigational products, had pre and post vaccination blood drawn with valid and determinate assay results and had no important protocol deviation. Here N signifies number of participants evaluable for this outcome measure and n signifies participants evaluable at specific rows.'}, {'type': 'SECONDARY', 'title': 'Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs) for Each of the 4 Primary Test Strains', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}, {'value': '97', 'groupId': 'OG005'}, {'value': '31', 'groupId': 'OG006'}, {'value': '30', 'groupId': 'OG007'}, {'value': '61', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: 60-µg Bivalent rLP2086 (>=12 Months to <18 Months)', 'description': 'Participants from \\>=12 months to \\<18 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.'}, {'id': 'OG001', 'title': 'Group 1: 60-µg Bivalent rLP2086 (>=18 Months to <24 Months)', 'description': 'Participants from \\>=18 months to \\<24 months of age, received intramuscular injection of 60 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.'}, {'id': 'OG002', 'title': 'Group 1: 60- mcg Bivalent rLP2086 (>=12 Months to <24 Months)', 'description': 'Participants from greater than or equal to (\\>=) 12 months to less than (\\<) 24 months of age, received intramuscular injection of 60 mcg of bivalent rLP2086 vaccine on months 0 vaccine on a 0, 2, 6 month schedule.'}, {'id': 'OG003', 'title': 'Group 2: 120-µg Bivalent rLP2086 (>=12 Months to <18 Months)', 'description': 'Participants from \\>=12 months to \\<18 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.'}, {'id': 'OG004', 'title': 'Group 2: 120-µg Bivalent rLP2086 (>=18 Months to <24 Months)', 'description': 'Participants from \\>=18 months to \\<24 months of age, received intramuscular injection of 120 µg of bivalent rLP2086 vaccine on a 0-, 2-, 6- month schedule.'}, {'id': 'OG005', 'title': 'Group 2: 120-mcg Bivalent rLP2086 (>=12 Months to <24 Months)', 'description': 'Participants from \\>=12 months to \\<24 months of age, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine on a 0, 2, 6 month schedule. All participants who received 3 doses of 120 mcg bivalent rLP2086 in Stage 1 and gave consent for booster vaccination, received intramuscular injection of single booster dose of 120 mcg of bivalent rLP2086 after 23 to 24 months of Vaccination 3, in Stage 2. Participants were followed up approximately 6 months after the booster vaccination.'}, {'id': 'OG006', 'title': 'Group 3: HAV/Saline (>=12 Months to <18 Months)', 'description': 'Participants from \\>=12 months to \\<18 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.'}, {'id': 'OG007', 'title': 'Group 3: HAV/Saline (>=18 Months to <24 Months)', 'description': 'Participants from \\>=18 months to \\<24 months of age, received intramuscular injection of saline on 2- month and HAV vaccine on a 0-, 6- month schedule.'}, {'id': 'OG008', 'title': 'Group 3: HAV/Saline (>=12 Months to <24 Months): Stage 1', 'description': 'Participants from \\>=12 months to \\<24 months of age, received intramuscular injection of saline on 2 month and HAV vaccine on a 0, 6 month schedule.'}], 'classes': [{'title': 'T1:PMB80 (A22)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}, {'value': '97', 'groupId': 'OG005'}, {'value': '31', 'groupId': 'OG006'}, {'value': '30', 'groupId': 'OG007'}, {'value': '61', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '8.0', 'comment': 'CI was not estimable due to the lack of variability of geometric means.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '8.0', 'comment': 'CI was not estimable due to the lack of variability of geometric means.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '8.0', 'comment': 'CI was not estimable due to the lack of variability of geometric means.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '8.5', 'groupId': 'OG003', 'lowerLimit': '7.5', 'upperLimit': '9.6'}, {'value': '8.3', 'groupId': 'OG004', 'lowerLimit': '7.8', 'upperLimit': '8.9'}, {'value': '8.4', 'groupId': 'OG005', 'lowerLimit': '7.9', 'upperLimit': '9.0'}, {'value': '8.0', 'comment': 'CI was not estimable due to the lack of variability of geometric means.', 'groupId': 'OG006', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '8.2', 'groupId': 'OG007', 'lowerLimit': '7.8', 'upperLimit': '8.6'}, {'value': '8.1', 'groupId': 'OG008', 'lowerLimit': '7.9', 'upperLimit': '8.3'}]}]}, {'title': 'T1: PMB2001 (A56)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}, {'value': '95', 'groupId': 'OG005'}, {'value': '24', 'groupId': 'OG006'}, {'value': '29', 'groupId': 'OG007'}, {'value': '53', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '4.0', 'comment': 'CI was not estimable due to the lack of variability of geometric means.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '4.0', 'comment': 'CI was not estimable due to the lack of variability of geometric means.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '4.0', 'comment': 'CI was not estimable due to the lack of variability of geometric means.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '4.0', 'comment': 'CI was not estimable due to the lack of variability of geometric means.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '4.2', 'groupId': 'OG004', 'lowerLimit': '3.8', 'upperLimit': '4.5'}, {'value': '4.1', 'groupId': 'OG005', 'lowerLimit': '3.9', 'upperLimit': '4.3'}, {'value': '4.0', 'comment': 'CI was not estimable due to the lack of variability of geometric means.', 'groupId': 'OG006', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '4.0', 'comment': 'CI was not estimable due to the lack of variability of geometric means.', 'groupId': 'OG007', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '4.0', 'comment': 'CI was not estimable due to the lack of variability of geometric means.', 'groupId': 'OG008', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'T1: PMB2948 (B24)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}, {'value': '97', 'groupId': 'OG005'}, {'value': '31', 'groupId': 'OG006'}, {'value': '30', 'groupId': 'OG007'}, {'value': '61', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '4.0', 'comment': 'CI was not estimable due to the lack of variability of geometric means.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '4.8', 'groupId': 'OG001', 'lowerLimit': '3.2', 'upperLimit': '7.4'}, {'value': '4.4', 'groupId': 'OG002', 'lowerLimit': '3.6', 'upperLimit': '5.4'}, {'value': '4.1', 'groupId': 'OG003', 'lowerLimit': '3.9', 'upperLimit': '4.4'}, {'value': '4.1', 'groupId': 'OG004', 'lowerLimit': '3.9', 'upperLimit': '4.3'}, {'value': '4.1', 'groupId': 'OG005', 'lowerLimit': '4.0', 'upperLimit': '4.3'}, {'value': '4.0', 'comment': 'CI was not estimable due to the lack of variability of geometric means.', 'groupId': 'OG006', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '4.4', 'groupId': 'OG007', 'lowerLimit': '3.6', 'upperLimit': '5.3'}, {'value': '4.2', 'groupId': 'OG008', 'lowerLimit': '3.8', 'upperLimit': '4.6'}]}]}, {'title': 'T1: PMB2707 (B44)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}, {'value': '95', 'groupId': 'OG005'}, {'value': '24', 'groupId': 'OG006'}, {'value': '30', 'groupId': 'OG007'}, {'value': '54', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '4.0', 'comment': 'CI was not estimable due to the lack of variability of geometric means.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '4.0', 'comment': 'CI was not estimable due to the lack of variability of geometric means.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '4.0', 'comment': 'CI was not estimable due to the lack of variability of geometric means.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '4.1', 'groupId': 'OG003', 'lowerLimit': '3.9', 'upperLimit': '4.2'}, {'value': '4.0', 'comment': 'CI was not estimable due to the lack of variability of geometric means.', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '4.0', 'groupId': 'OG005', 'lowerLimit': '4.0', 'upperLimit': '4.1'}, {'value': '4.0', 'comment': 'CI was not estimable due to the lack of variability of geometric means.', 'groupId': 'OG006', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '4.0', 'comment': 'CI was not estimable due to the lack of variability of geometric means.', 'groupId': 'OG007', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '4.0', 'comment': 'CI was not estimable due to the lack of variability of geometric means.', 'groupId': 'OG008', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'T2: PMB80 (A22)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}, {'value': '50', 'groupId': 'OG004'}, {'value': '95', 'groupId': 'OG005'}, {'value': '30', 'groupId': 'OG006'}, {'value': '29', 'groupId': 'OG007'}, {'value': '59', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '42.2', 'groupId': 'OG000', 'lowerLimit': '22.6', 'upperLimit': '79.1'}, {'value': '23.5', 'groupId': 'OG001', 'lowerLimit': '10.1', 'upperLimit': '54.9'}, {'value': '32.0', 'groupId': 'OG002', 'lowerLimit': '19.7', 'upperLimit': '52.0'}, {'value': '24.6', 'groupId': 'OG003', 'lowerLimit': '17.8', 'upperLimit': '34.2'}, {'value': '36.8', 'groupId': 'OG004', 'lowerLimit': '26.9', 'upperLimit': '50.3'}, {'value': '30.4', 'groupId': 'OG005', 'lowerLimit': '24.3', 'upperLimit': '38.1'}, {'value': '8.0', 'comment': 'CI was not estimable due to the lack of variability of geometric means.', 'groupId': 'OG006', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '8.6', 'groupId': 'OG007', 'lowerLimit': '7.4', 'upperLimit': '10.0'}, {'value': '8.3', 'groupId': 'OG008', 'lowerLimit': '7.7', 'upperLimit': '8.9'}]}]}, {'title': 'T2: PMB2001 (A56)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}, {'value': '48', 'groupId': 'OG004'}, {'value': '95', 'groupId': 'OG005'}, {'value': '23', 'groupId': 'OG006'}, {'value': '29', 'groupId': 'OG007'}, {'value': '52', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '101.6', 'groupId': 'OG000', 'lowerLimit': '64.0', 'upperLimit': '161.2'}, {'value': '68.6', 'groupId': 'OG001', 'lowerLimit': '28.2', 'upperLimit': '166.8'}, {'value': '82.6', 'groupId': 'OG002', 'lowerLimit': '51.4', 'upperLimit': '129.9'}, {'value': '117.2', 'groupId': 'OG003', 'lowerLimit': '89.7', 'upperLimit': '153.0'}, {'value': '104.6', 'groupId': 'OG004', 'lowerLimit': '80.4', 'upperLimit': '136.0'}, {'value': '110.6', 'groupId': 'OG005', 'lowerLimit': '92.0', 'upperLimit': '133.0'}, {'value': '4.0', 'comment': 'CI was not estimable due to the lack of variability of geometric means.', 'groupId': 'OG006', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '4.0', 'comment': 'CI was not estimable due to the lack of variability of geometric means.', 'groupId': 'OG007', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '4.0', 'comment': 'CI was not estimable due to the lack of variability of geometric means.', 'groupId': 'OG008', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'T2: PMB2948 (B24)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}, {'value': '86', 'groupId': 'OG005'}, {'value': '30', 'groupId': 'OG006'}, {'value': '29', 'groupId': 'OG007'}, {'value': '59', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '10.6', 'groupId': 'OG000', 'lowerLimit': '6.2', 'upperLimit': '18.0'}, {'value': '6.9', 'groupId': 'OG001', 'lowerLimit': '4.1', 'upperLimit': '11.5'}, {'value': '8.6', 'groupId': 'OG002', 'lowerLimit': '6.1', 'upperLimit': '12.2'}, {'value': '6.0', 'groupId': 'OG003', 'lowerLimit': '4.7', 'upperLimit': '7.8'}, {'value': '8.5', 'groupId': 'OG004', 'lowerLimit': '6.4', 'upperLimit': '11.3'}, {'value': '7.2', 'groupId': 'OG005', 'lowerLimit': '5.9', 'upperLimit': '8.7'}, {'value': '4.0', 'comment': 'CI was not estimable due to the lack of variability of geometric means.', 'groupId': 'OG006', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '4.3', 'groupId': 'OG007', 'lowerLimit': '3.7', 'upperLimit': '5.0'}, {'value': '4.1', 'groupId': 'OG008', 'lowerLimit': '3.9', 'upperLimit': '4.4'}]}]}, {'title': 'T2: PMB2707 (B44)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}, {'value': '47', 'groupId': 'OG004'}, {'value': '94', 'groupId': 'OG005'}, {'value': '23', 'groupId': 'OG006'}, {'value': '29', 'groupId': 'OG007'}, {'value': '52', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '23.5', 'groupId': 'OG000', 'lowerLimit': '9.3', 'upperLimit': '59.4'}, {'value': '21.1', 'groupId': 'OG001', 'lowerLimit': '6.5', 'upperLimit': '68.3'}, {'value': '22.2', 'groupId': 'OG002', 'lowerLimit': '11.2', 'upperLimit': '43.9'}, {'value': '22.1', 'groupId': 'OG003', 'lowerLimit': '15.5', 'upperLimit': '31.6'}, {'value': '17.0', 'groupId': 'OG004', 'lowerLimit': '11.8', 'upperLimit': '24.4'}, {'value': '19.4', 'groupId': 'OG005', 'lowerLimit': '15.1', 'upperLimit': '24.9'}, {'value': '4.0', 'comment': 'CI was not estimable due to the lack of variability of geometric means.', 'groupId': 'OG006', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '4.0', 'comment': 'CI was not estimable due to the lack of variability of geometric means.', 'groupId': 'OG007', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '40', 'comment': 'CI was not estimable due to the lack of variability of geometric means.', 'groupId': 'OG008', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'T3: PMB80 (A22)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}, {'value': '96', 'groupId': 'OG005'}, {'value': '31', 'groupId': 'OG006'}, {'value': '29', 'groupId': 'OG007'}, {'value': '60', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '80.6', 'groupId': 'OG000', 'lowerLimit': '30.9', 'upperLimit': '210.7'}, {'value': '82.3', 'groupId': 'OG001', 'lowerLimit': '36.5', 'upperLimit': '185.8'}, {'value': '81.6', 'groupId': 'OG002', 'lowerLimit': '46.6', 'upperLimit': '142.8'}, {'value': '63.0', 'groupId': 'OG003', 'lowerLimit': '44.5', 'upperLimit': '89.3'}, {'value': '71.4', 'groupId': 'OG004', 'lowerLimit': '52.7', 'upperLimit': '96.6'}, {'value': '67.3', 'groupId': 'OG005', 'lowerLimit': '53.7', 'upperLimit': '84.3'}, {'value': '8.6', 'groupId': 'OG006', 'lowerLimit': '7.5', 'upperLimit': '9.8'}, {'value': '8.6', 'groupId': 'OG007', 'lowerLimit': '7.7', 'upperLimit': '9.6'}, {'value': '8.6', 'groupId': 'OG008', 'lowerLimit': '7.9', 'upperLimit': '9.3'}]}]}, {'title': 'T3: PMB2001 (A56)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}, {'value': '48', 'groupId': 'OG004'}, {'value': '95', 'groupId': 'OG005'}, {'value': '24', 'groupId': 'OG006'}, {'value': '30', 'groupId': 'OG007'}, {'value': '54', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '109.7', 'groupId': 'OG000', 'lowerLimit': '70.4', 'upperLimit': '171.1'}, {'value': '181.0', 'groupId': 'OG001', 'lowerLimit': '68.6', 'upperLimit': '477.9'}, {'value': '142.8', 'groupId': 'OG002', 'lowerLimit': '85.5', 'upperLimit': '238.6'}, {'value': '190.6', 'groupId': 'OG003', 'lowerLimit': '146.9', 'upperLimit': '247.4'}, {'value': '154.4', 'groupId': 'OG004', 'lowerLimit': '116.3', 'upperLimit': '205.1'}, {'value': '171.4', 'groupId': 'OG005', 'lowerLimit': '141.6', 'upperLimit': '207.4'}, {'value': '4.0', 'comment': 'CI was not estimable due to the lack of variability of geometric means.', 'groupId': 'OG006', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '4.3', 'groupId': 'OG007', 'lowerLimit': '3.7', 'upperLimit': '4.9'}, {'value': '4.2', 'groupId': 'OG008', 'lowerLimit': '3.8', 'upperLimit': '4.5'}]}]}, {'title': 'T3: PMB2948 (B24)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}, {'value': '50', 'groupId': 'OG004'}, {'value': '95', 'groupId': 'OG005'}, {'value': '31', 'groupId': 'OG006'}, {'value': '29', 'groupId': 'OG007'}, {'value': '60', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '20.2', 'groupId': 'OG000', 'lowerLimit': '11.1', 'upperLimit': '36.6'}, {'value': '17.0', 'groupId': 'OG001', 'lowerLimit': '8.2', 'upperLimit': '35.5'}, {'value': '18.4', 'groupId': 'OG002', 'lowerLimit': '11.8', 'upperLimit': '28.6'}, {'value': '15.8', 'groupId': 'OG003', 'lowerLimit': '11.4', 'upperLimit': '21.8'}, {'value': '14.5', 'groupId': 'OG004', 'lowerLimit': '11.1', 'upperLimit': '19.1'}, {'value': '15.1', 'groupId': 'OG005', 'lowerLimit': '12.3', 'upperLimit': '18.6'}, {'value': '4.3', 'groupId': 'OG006', 'lowerLimit': '3.7', 'upperLimit': '4.9'}, {'value': '4.4', 'groupId': 'OG007', 'lowerLimit': '3.8', 'upperLimit': '5.0'}, {'value': '4.3', 'groupId': 'OG008', 'lowerLimit': '3.9', 'upperLimit': '4.8'}]}]}, {'title': 'T3: PMB2707 (B44)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}, {'value': '47', 'groupId': 'OG004'}, {'value': '94', 'groupId': 'OG005'}, {'value': '24', 'groupId': 'OG006'}, {'value': '30', 'groupId': 'OG007'}, {'value': '54', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '29.6', 'groupId': 'OG000', 'lowerLimit': '11.6', 'upperLimit': '75.8'}, {'value': '34.3', 'groupId': 'OG001', 'lowerLimit': '15.0', 'upperLimit': '78.2'}, {'value': '32.0', 'groupId': 'OG002', 'lowerLimit': '18.3', 'upperLimit': '55.8'}, {'value': '46.3', 'groupId': 'OG003', 'lowerLimit': '31.6', 'upperLimit': '67.8'}, {'value': '44.9', 'groupId': 'OG004', 'lowerLimit': '31.3', 'upperLimit': '64.5'}, {'value': '45.6', 'groupId': 'OG005', 'lowerLimit': '35.2', 'upperLimit': '59.0'}, {'value': '4.0', 'comment': 'CI was not estimable due to the lack of variability of geometric means.', 'groupId': 'OG006', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '4.0', 'comment': 'CI was not estimable due to the lack of variability of geometric means.', 'groupId': 'OG007', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '4.0', 'comment': 'CI was not estimable due to the lack of variability of geometric means.', 'groupId': 'OG008', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'T4: PMB80 (A22)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}, {'value': '97', 'groupId': 'OG005'}, {'value': '30', 'groupId': 'OG006'}, {'value': '28', 'groupId': 'OG007'}, {'value': '58', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '10.6', 'groupId': 'OG000', 'lowerLimit': '6.5', 'upperLimit': '17.0'}, {'value': '8.0', 'comment': 'CI was not estimable due to the lack of variability of geometric means.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '9.2', 'groupId': 'OG002', 'lowerLimit': '7.3', 'upperLimit': '11.5'}, {'value': '10.8', 'groupId': 'OG003', 'lowerLimit': '8.7', 'upperLimit': '13.5'}, {'value': '9.0', 'groupId': 'OG004', 'lowerLimit': '7.9', 'upperLimit': '10.2'}, {'value': '9.8', 'groupId': 'OG005', 'lowerLimit': '8.7', 'upperLimit': '11.1'}, {'value': '8.0', 'comment': 'CI was not estimable due to the lack of variability of geometric means.', 'groupId': 'OG006', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '8.8', 'groupId': 'OG007', 'lowerLimit': '7.5', 'upperLimit': '10.4'}, {'value': '8.4', 'groupId': 'OG008', 'lowerLimit': '7.8', 'upperLimit': '9.0'}]}]}, {'title': 'T4: PMB2001 (A56)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}, {'value': '47', 'groupId': 'OG004'}, {'value': '88', 'groupId': 'OG005'}, {'value': '24', 'groupId': 'OG006'}, {'value': '28', 'groupId': 'OG007'}, {'value': '52', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '7.3', 'groupId': 'OG000', 'lowerLimit': '3.3', 'upperLimit': '16.1'}, {'value': '27.9', 'groupId': 'OG001', 'lowerLimit': '11.3', 'upperLimit': '68.5'}, {'value': '15.4', 'groupId': 'OG002', 'lowerLimit': '8.1', 'upperLimit': '29.3'}, {'value': '13.7', 'groupId': 'OG003', 'lowerLimit': '9.4', 'upperLimit': '20.1'}, {'value': '12.5', 'groupId': 'OG004', 'lowerLimit': '8.7', 'upperLimit': '17.9'}, {'value': '13.0', 'groupId': 'OG005', 'lowerLimit': '10.1', 'upperLimit': '16.9'}, {'value': '4.1', 'groupId': 'OG006', 'lowerLimit': '3.9', 'upperLimit': '4.4'}, {'value': '4.6', 'groupId': 'OG007', 'lowerLimit': '3.4', 'upperLimit': '6.3'}, {'value': '4.4', 'groupId': 'OG008', 'lowerLimit': '3.7', 'upperLimit': '5.2'}]}]}, {'title': 'T4: PMB2948 (B24)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}, {'value': '97', 'groupId': 'OG005'}, {'value': '30', 'groupId': 'OG006'}, {'value': '28', 'groupId': 'OG007'}, {'value': '58', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '4.9', 'groupId': 'OG000', 'lowerLimit': '3.5', 'upperLimit': '6.9'}, {'value': '4.6', 'groupId': 'OG001', 'lowerLimit': '3.4', 'upperLimit': '6.3'}, {'value': '4.8', 'groupId': 'OG002', 'lowerLimit': '3.9', 'upperLimit': '5.9'}, {'value': '4.4', 'groupId': 'OG003', 'lowerLimit': '4.0', 'upperLimit': '4.9'}, {'value': '4.9', 'groupId': 'OG004', 'lowerLimit': '4.2', 'upperLimit': '5.8'}, {'value': '4.7', 'groupId': 'OG005', 'lowerLimit': '4.2', 'upperLimit': '5.2'}, {'value': '4.1', 'groupId': 'OG006', 'lowerLimit': '3.9', 'upperLimit': '4.3'}, {'value': '4.3', 'groupId': 'OG007', 'lowerLimit': '3.7', 'upperLimit': '5.0'}, {'value': '4.2', 'groupId': 'OG008', 'lowerLimit': '3.9', 'upperLimit': '4.5'}]}]}, {'title': 'T4: PMB2707 (B44)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '46', 'groupId': 'OG004'}, {'value': '89', 'groupId': 'OG005'}, {'value': '24', 'groupId': 'OG006'}, {'value': '29', 'groupId': 'OG007'}, {'value': '53', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '4.8', 'groupId': 'OG000', 'lowerLimit': '3.2', 'upperLimit': '7.2'}, {'value': '8.7', 'groupId': 'OG001', 'lowerLimit': '2.6', 'upperLimit': '29.5'}, {'value': '6.4', 'groupId': 'OG002', 'lowerLimit': '3.6', 'upperLimit': '11.5'}, {'value': '7.9', 'groupId': 'OG003', 'lowerLimit': '5.8', 'upperLimit': '10.6'}, {'value': '7.3', 'groupId': 'OG004', 'lowerLimit': '5.7', 'upperLimit': '9.3'}, {'value': '7.6', 'groupId': 'OG005', 'lowerLimit': '6.3', 'upperLimit': '9.1'}, {'value': '4.1', 'groupId': 'OG006', 'lowerLimit': '3.9', 'upperLimit': '4.4'}, {'value': '4.0', 'comment': 'CI was not estimable due to the lack of variability of geometric means.', 'groupId': 'OG007', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '4.1', 'groupId': 'OG008', 'lowerLimit': '3.9', 'upperLimit': '4.2'}]}]}, {'title': 'T5: PMB80 (A22)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}, {'value': '50', 'groupId': 'OG004'}, {'value': '95', 'groupId': 'OG005'}, {'value': '27', 'groupId': 'OG006'}, {'value': '28', 'groupId': 'OG007'}, {'value': '55', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '8.6', 'groupId': 'OG000', 'lowerLimit': '7.3', 'upperLimit': '10.0'}, {'value': '9.7', 'groupId': 'OG001', 'lowerLimit': '7.2', 'upperLimit': '13.1'}, {'value': '9.1', 'groupId': 'OG002', 'lowerLimit': '7.8', 'upperLimit': '10.7'}, {'value': '8.9', 'groupId': 'OG003', 'lowerLimit': '7.9', 'upperLimit': '10.0'}, {'value': '8.6', 'groupId': 'OG004', 'lowerLimit': '7.8', 'upperLimit': '9.5'}, {'value': '8.7', 'groupId': 'OG005', 'lowerLimit': '8.1', 'upperLimit': '9.4'}, {'value': '8.2', 'groupId': 'OG006', 'lowerLimit': '7.8', 'upperLimit': '8.7'}, {'value': '8.0', 'comment': 'CI was not estimable due to the lack of variability of geometric means.', 'groupId': 'OG007', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '8.1', 'groupId': 'OG008', 'lowerLimit': '7.9', 'upperLimit': '8.3'}]}]}, {'title': 'T5: PMB2001 (A56)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}, {'value': '48', 'groupId': 'OG004'}, {'value': '93', 'groupId': 'OG005'}, {'value': '23', 'groupId': 'OG006'}, {'value': '30', 'groupId': 'OG007'}, {'value': '53', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '8.6', 'groupId': 'OG000', 'lowerLimit': '3.4', 'upperLimit': '22.1'}, {'value': '35.3', 'groupId': 'OG001', 'lowerLimit': '11.3', 'upperLimit': '110.1'}, {'value': '16.0', 'groupId': 'OG002', 'lowerLimit': '7.6', 'upperLimit': '33.5'}, {'value': '7.9', 'groupId': 'OG003', 'lowerLimit': '5.8', 'upperLimit': '10.7'}, {'value': '8.1', 'groupId': 'OG004', 'lowerLimit': '6.0', 'upperLimit': '11.0'}, {'value': '8.0', 'groupId': 'OG005', 'lowerLimit': '6.5', 'upperLimit': '9.9'}, {'value': '4.0', 'comment': 'CI was not estimable due to the lack of variability of geometric means.', 'groupId': 'OG006', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '5.3', 'groupId': 'OG007', 'lowerLimit': '3.8', 'upperLimit': '7.3'}, {'value': '4.7', 'groupId': 'OG008', 'lowerLimit': '3.9', 'upperLimit': '5.6'}]}]}, {'title': 'T5: PMB2948 (B24)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}, {'value': '93', 'groupId': 'OG005'}, {'value': '27', 'groupId': 'OG006'}, {'value': '28', 'groupId': 'OG007'}, {'value': '55', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '4.0', 'comment': 'CI was not estimable due to the lack of variability of geometric means.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '5.1', 'groupId': 'OG001', 'lowerLimit': '3.5', 'upperLimit': '7.5'}, {'value': '4.6', 'groupId': 'OG002', 'lowerLimit': '3.8', 'upperLimit': '5.5'}, {'value': '4.1', 'groupId': 'OG003', 'lowerLimit': '3.9', 'upperLimit': '4.2'}, {'value': '4.4', 'groupId': 'OG004', 'lowerLimit': '3.8', 'upperLimit': '5.0'}, {'value': '4.2', 'groupId': 'OG005', 'lowerLimit': '3.9', 'upperLimit': '4.5'}, {'value': '4.0', 'comment': 'CI was not estimable due to the lack of variability of geometric means.', 'groupId': 'OG006', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '4.6', 'groupId': 'OG007', 'lowerLimit': '3.7', 'upperLimit': '5.8'}, {'value': '4.3', 'groupId': 'OG008', 'lowerLimit': '3.9', 'upperLimit': '4.8'}]}]}, {'title': 'T5: PMB2707 (B44)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}, {'value': '47', 'groupId': 'OG004'}, {'value': '90', 'groupId': 'OG005'}, {'value': '22', 'groupId': 'OG006'}, {'value': '29', 'groupId': 'OG007'}, {'value': '51', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '4.3', 'groupId': 'OG000', 'lowerLimit': '3.6', 'upperLimit': '5.2'}, {'value': '4.9', 'groupId': 'OG001', 'lowerLimit': '3.0', 'upperLimit': '7.9'}, {'value': '4.6', 'groupId': 'OG002', 'lowerLimit': '3.7', 'upperLimit': '5.6'}, {'value': '5.3', 'groupId': 'OG003', 'lowerLimit': '4.4', 'upperLimit': '6.6'}, {'value': '5.0', 'groupId': 'OG004', 'lowerLimit': '4.2', 'upperLimit': '5.9'}, {'value': '5.2', 'groupId': 'OG005', 'lowerLimit': '4.5', 'upperLimit': '5.9'}, {'value': '4.0', 'comment': 'CI was not estimable due to the lack of variability of geometric means.', 'groupId': 'OG006', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '4.1', 'groupId': 'OG007', 'lowerLimit': '3.9', 'upperLimit': '4.3'}, {'value': '4.1', 'groupId': 'OG008', 'lowerLimit': '3.9', 'upperLimit': '4.2'}]}]}, {'title': 'T6: PMB80 (A22)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}, {'value': '47', 'groupId': 'OG004'}, {'value': '81', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '8.0', 'comment': 'CI was not estimable due to the lack of variability of geometric means.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '8.0', 'comment': 'CI was not estimable due to the lack of variability of geometric means.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '8.0', 'comment': 'CI was not estimable due to the lack of variability of geometric means.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '8.9', 'groupId': 'OG003', 'lowerLimit': '7.6', 'upperLimit': '10.3'}, {'value': '8.4', 'groupId': 'OG004', 'lowerLimit': '7.6', 'upperLimit': '9.1'}, {'value': '8.6', 'groupId': 'OG005', 'lowerLimit': '7.9', 'upperLimit': '9.3'}]}]}, {'title': 'T6: PMB2001 (A56)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}, {'value': '79', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '6.9', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '23.8'}, {'value': '16.0', 'groupId': 'OG001', 'lowerLimit': '7.5', 'upperLimit': '34.2'}, {'value': '10.2', 'groupId': 'OG002', 'lowerLimit': '5.1', 'upperLimit': '20.6'}, {'value': '5.1', 'groupId': 'OG003', 'lowerLimit': '4.0', 'upperLimit': '6.6'}, {'value': '7.3', 'groupId': 'OG004', 'lowerLimit': '5.1', 'upperLimit': '10.5'}, {'value': '6.1', 'groupId': 'OG005', 'lowerLimit': '4.9', 'upperLimit': '7.6'}]}]}, {'title': 'T6: PMB2948 (B24)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}, {'value': '48', 'groupId': 'OG004'}, {'value': '82', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '4.0', 'comment': 'CI was not estimable due to the lack of variability of geometric means.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '5.4', 'groupId': 'OG001', 'lowerLimit': '2.7', 'upperLimit': '11.1'}, {'value': '4.6', 'groupId': 'OG002', 'lowerLimit': '3.4', 'upperLimit': '6.3'}, {'value': '4.9', 'groupId': 'OG003', 'lowerLimit': '3.8', 'upperLimit': '6.4'}, {'value': '4.0', 'comment': 'CI was not estimable due to the lack of variability of geometric means.', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '4.4', 'groupId': 'OG005', 'lowerLimit': '3.9', 'upperLimit': '4.8'}]}]}, {'title': 'T6: PMB2707 (B44)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '41', 'groupId': 'OG004'}, {'value': '80', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}]}], 'categories': [{'measurements': [{'value': '4.0', 'comment': 'CI was not estimable due to the lack of variability of geometric means.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '5.2', 'groupId': 'OG001', 'lowerLimit': '3.4', 'upperLimit': '8.0'}, {'value': '4.5', 'groupId': 'OG002', 'lowerLimit': '3.7', 'upperLimit': '5.5'}, {'value': '4.8', 'groupId': 'OG003', 'lowerLimit': '4.0', 'upperLimit': '5.7'}, {'value': '5.0', 'groupId': 'OG004', 'lowerLimit': '4.0', 'upperLimit': '6.3'}, {'value': '4.9', 'groupId': 'OG005', 'lowerLimit': '4.2', 'upperLimit': '5.6'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Before Vaccination 1 (T1), 1 month after Vaccination 2 (T2), 1 month after Vaccination 3 (T3), 6 months after Vaccination 3 (T4), 12 months after Vaccination 3 (T5) and 24 months after Vaccination 3 (T6)', 'unitOfMeasure': 'titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Evaluable immunogenicity population: all eligible participants randomized to study, received scheduled investigational products, had pre and post vaccination blood drawn with valid and determinate assay results and had no important protocol deviation. Here N signifies number of participants evaluable for this outcome measure and n signifies participants evaluable at specific rows.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Booster Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '120-mcg Bivalent rLP2086: Stage 2 Booster Phase', 'description': 'Participants who were randomly assigned to bivalent rLP2086 (irrespective of dose level) were eligible for booster vaccination. Participants received intramuscular injection of 120-mcg of bivalent rLP2086 vaccine after 23 months of visit 3.'}], 'classes': [{'title': 'Pain at injection site: mild', 'categories': [{'measurements': [{'value': '30.6', 'groupId': 'OG000', 'lowerLimit': '23.3', 'upperLimit': '38.7'}]}]}, {'title': 'Pain at injection site: moderate', 'categories': [{'measurements': [{'value': '29.3', 'groupId': 'OG000', 'lowerLimit': '22.0', 'upperLimit': '37.3'}]}]}, {'title': 'Pain at injection site: severe', 'categories': [{'measurements': [{'value': '10.2', 'groupId': 'OG000', 'lowerLimit': '5.8', 'upperLimit': '16.3'}]}]}, {'title': 'Redness: mild', 'categories': [{'measurements': [{'value': '22.4', 'groupId': 'OG000', 'lowerLimit': '16.0', 'upperLimit': '30.1'}]}]}, {'title': 'Redness: moderate', 'categories': [{'measurements': [{'value': '21.1', 'groupId': 'OG000', 'lowerLimit': '14.8', 'upperLimit': '28.6'}]}]}, {'title': 'Redness: severe', 'categories': [{'measurements': [{'value': '4.8', 'groupId': 'OG000', 'lowerLimit': '1.9', 'upperLimit': '9.6'}]}]}, {'title': 'Swelling: mild', 'categories': [{'measurements': [{'value': '18.4', 'groupId': 'OG000', 'lowerLimit': '12.5', 'upperLimit': '25.6'}]}]}, {'title': 'Swelling: moderate', 'categories': [{'measurements': [{'value': '15.0', 'groupId': 'OG000', 'lowerLimit': '9.6', 'upperLimit': '21.8'}]}]}, {'title': 'Swelling: severe', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 7 days after booster vaccination', 'description': 'Local reactions included pain at injection site, swelling and redness collected by using an e-diary. Pain at injection site was graded as: mild (does not interfere with activity), moderate (interferes with activity) and severe (prevents daily activity). A caliper was used to measure the redness or swelling area. Caliper units were converted to centimeters (cm) according to 1 caliper unit = 0.5 cm. Redness and swelling were graded as: none (0 cm) mild (0.5-2.0 cm), moderate (\\>=2.0 to 7.0 cm) and severe (\\>7.0 cm).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Booster safety population included all participants who received the booster dose at 23 months after vaccination 3 (Visit 12), and for whom safety information was available.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '120-mcg Bivalent rLP2086: Stage 2 Booster Phase', 'description': 'Participants who were randomly assigned to bivalent rLP2086 (irrespective of dose level) were eligible for booster vaccination. Participants received intramuscular injection of 120-mcg of bivalent rLP2086 vaccine after 23 months of visit 3.'}], 'classes': [{'title': 'Fever >=38 degree C', 'categories': [{'measurements': [{'value': '10.2', 'groupId': 'OG000', 'lowerLimit': '5.8', 'upperLimit': '16.3'}]}]}, {'title': 'Fever 38 to <38.5 degree C', 'categories': [{'measurements': [{'value': '6.1', 'groupId': 'OG000', 'lowerLimit': '2.8', 'upperLimit': '11.3'}]}]}, {'title': 'Fever 38.5 to <39 degree C', 'categories': [{'measurements': [{'value': '3.4', 'groupId': 'OG000', 'lowerLimit': '1.1', 'upperLimit': '7.8'}]}]}, {'title': 'Fever 39 to <39.5 degree C', 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '3.7'}]}]}, {'title': 'Fever 39.5 to <=40 degree C', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.5'}]}]}, {'title': 'Fever >40 degree C', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.5'}]}]}, {'title': 'Vomiting: mild', 'categories': [{'measurements': [{'value': '4.8', 'groupId': 'OG000', 'lowerLimit': '1.9', 'upperLimit': '9.6'}]}]}, {'title': 'Vomiting: moderate', 'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '4.8'}]}]}, {'title': 'Vomiting: severe', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.5'}]}]}, {'title': 'Diarrhea: mild', 'categories': [{'measurements': [{'value': '4.8', 'groupId': 'OG000', 'lowerLimit': '1.9', 'upperLimit': '9.6'}]}]}, {'title': 'Diarrhea: moderate', 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '3.7'}]}]}, {'title': 'Diarrhea: severe', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.5'}]}]}, {'title': 'Headache: mild', 'categories': [{'measurements': [{'value': '7.5', 'groupId': 'OG000', 'lowerLimit': '3.8', 'upperLimit': '13.0'}]}]}, {'title': 'Headache: moderate', 'categories': [{'measurements': [{'value': '10.2', 'groupId': 'OG000', 'lowerLimit': '5.8', 'upperLimit': '16.3'}]}]}, {'title': 'Headache: severe', 'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '4.8'}]}]}, {'title': 'Fatigue: mild', 'categories': [{'measurements': [{'value': '17.0', 'groupId': 'OG000', 'lowerLimit': '11.3', 'upperLimit': '24.1'}]}]}, {'title': 'Fatigue: moderate', 'categories': [{'measurements': [{'value': '22.4', 'groupId': 'OG000', 'lowerLimit': '16.0', 'upperLimit': '30.1'}]}]}, {'title': 'Fatigue: severe', 'categories': [{'measurements': [{'value': '6.8', 'groupId': 'OG000', 'lowerLimit': '3.3', 'upperLimit': '12.2'}]}]}, {'title': 'Muscle pain : mild', 'categories': [{'measurements': [{'value': '6.1', 'groupId': 'OG000', 'lowerLimit': '2.8', 'upperLimit': '11.3'}]}]}, {'title': 'Muscle pain : moderate', 'categories': [{'measurements': [{'value': '8.2', 'groupId': 'OG000', 'lowerLimit': '4.3', 'upperLimit': '13.8'}]}]}, {'title': 'Muscle pain : severe', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000', 'lowerLimit': '0.4', 'upperLimit': '5.4'}]}]}, {'title': 'Joint pain: mild', 'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000', 'lowerLimit': '1.5', 'upperLimit': '8.7'}]}]}, {'title': 'Joint pain: moderate', 'categories': [{'measurements': [{'value': '6.1', 'groupId': 'OG000', 'lowerLimit': '2.8', 'upperLimit': '11.3'}]}]}, {'title': 'Joint pain: severe', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.5'}]}]}, {'title': 'Antipyretic medication use', 'categories': [{'measurements': [{'value': '34.7', 'groupId': 'OG000', 'lowerLimit': '27.0', 'upperLimit': '43.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 7 days after booster vaccination', 'description': 'Systemic reactions included fever, vomiting, diarrhea, headache, fatigue, muscle pain and joint pain were recorded by using an e-diary. Fever was defined as a temperature of greater than or equal to (\\>=) 38.0 degree Celsius and was graded as 38.0 degree Celsius (C) to 38.4 degree C, 38.5 degree C to 38.9 degree C, 39.0 degree C to 39.4 degree C, 39.5 degree C to 40.0 degree C, \\>40.0 degree C. Vomiting was graded as mild (1 to 2 times in 24 hours), moderate (\\>2 times in 24 hours) and severe (requires IV hydration). Diarrhea was graded as mild (2 to 3 loose stools in 24 hours), moderate (4 to 5 loose stools in 24 hours), and severe (6 or more loose stools in 24 hours). Fatigue, headache, muscle pain and joint pain were graded as: mild (did not interfere with activity), moderate (some interference with activity) and severe (prevented daily routine activity). The use and type of antipyretic medication was also recorded in the e-diary daily.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Booster safety population included all participants who received the booster dose at 23 months after Vaccination 3 (Visit 12), and for whom safety information was available.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With SAE, MAE, NDCMC From Booster Vaccination to 1 Month After Booster Vaccination, 1 Month After Booster Vaccination to 6 Months After Booster Vaccination and Booster Vaccination Through 6 Months After Booster Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '120-mcg Bivalent rLP2086: Stage 2 Booster Phase', 'description': 'Participants who were randomly assigned to bivalent rLP2086 (irrespective of dose level) were eligible for booster vaccination. Participants received intramuscular injection of 120-mcg of bivalent rLP2086 vaccine after 23 months of visit 3.'}], 'classes': [{'title': 'SAE: T1', 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '3.7'}]}]}, {'title': 'SAE: T2', 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '3.7'}]}]}, {'title': 'SAE: T3', 'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '4.8'}]}]}, {'title': 'MAE: T1', 'categories': [{'measurements': [{'value': '4.8', 'groupId': 'OG000', 'lowerLimit': '1.9', 'upperLimit': '9.6'}]}]}, {'title': 'MAE: T2', 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000', 'lowerLimit': '0.7', 'upperLimit': '6.8'}]}]}, {'title': 'MAE: T3', 'categories': [{'measurements': [{'value': '7.5', 'groupId': 'OG000', 'lowerLimit': '3.8', 'upperLimit': '13.0'}]}]}, {'title': 'NDCMC: T1', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.5'}]}]}, {'title': 'NDCMC: T2', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.5'}]}]}, {'title': 'NDCMC: T3', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Booster vaccination to 1 month after booster vaccination (T1), 1 month after booster vaccination to 6 months after booster vaccination (T2) and booster vaccination through 6 months after booster vaccination (T3)', 'description': 'SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; lack of efficacy in an approved indication; important medical event. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition that was not identified prior to study start and 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 all participants who received the booster dose at 23 months after Vaccination 3 (Visit 12), and for whom safety information was available.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With at Least 1 Adverse Event (AE) From Booster Vaccination to 1 Month After Booster Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '120-mcg Bivalent rLP2086: Stage 2 Booster Phase', 'description': 'Participants who were randomly assigned to bivalent rLP2086 (irrespective of dose level) were eligible for booster vaccination. Participants received intramuscular injection of 120-mcg of bivalent rLP2086 vaccine after 23 months of visit 3.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.6', 'groupId': 'OG000', 'lowerLimit': '8.5', 'upperLimit': '20.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Booster vaccination up to 1 month after booster vaccination', 'description': 'An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Booster safety population included all participants who received the booster dose at 23 months after Vaccination 3 (Visit 12), and for whom safety information was available.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Immediate Adverse Event (IAE) After Booster Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '120-mcg Bivalent rLP2086: Stage 2 Booster Phase', 'description': 'Participants who were randomly assigned to bivalent rLP2086 (irrespective of dose level) were eligible for booster vaccination. Participants received intramuscular injection of 120-mcg of bivalent rLP2086 vaccine after 23 months of visit 3.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 30 minutes after booster vaccination', 'description': 'Immediate AE was defined as AEs occurring within the first 30 minutes after investigational product administration.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Booster safety population included all participants who received the booster dose at 23 months after vaccination 3 (Visit 12), and for whom safety information was available.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With hSBA Titer >=LLOQ >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains Before Booster Vaccination, and 1 Month After Booster Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '120-mcg Bivalent rLP2086: Stage 2 Booster Phase', 'description': 'Participants who were randomly assigned to bivalent rLP2086 (irrespective of dose level) were eligible for booster vaccination. Participants received intramuscular injection of 120-mcg of bivalent rLP2086 vaccine after 23 months of visit 3.'}], 'classes': [{'title': 'PMB80 (A22): before booster vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000', 'lowerLimit': '0.4', 'upperLimit': '10.1'}]}]}, {'title': 'PMB80 (A22):1 month after booster vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '92.6', 'groupId': 'OG000', 'lowerLimit': '83.7', 'upperLimit': '97.6'}]}]}, {'title': 'PMB2001 (A56):before booster vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '15.2', 'groupId': 'OG000', 'lowerLimit': '7.5', 'upperLimit': '26.1'}]}]}, {'title': 'PMB2001 (A56):1 month after booster vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '94.7', 'upperLimit': '100.0'}]}]}, {'title': 'PMB2948 (B24): before booster vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.2', 'groupId': 'OG000', 'lowerLimit': '2.4', 'upperLimit': '16.1'}]}]}, {'title': 'PMB2948 (B24):1 month after booster vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '92.8', 'groupId': 'OG000', 'lowerLimit': '83.9', 'upperLimit': '97.6'}]}]}, {'title': 'PMB2707 (B44): before booster vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.0', 'groupId': 'OG000', 'lowerLimit': '3.4', 'upperLimit': '18.5'}]}]}, {'title': 'PMB2707 (B44): 1 month after booster vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '95.7', 'groupId': 'OG000', 'lowerLimit': '87.8', 'upperLimit': '99.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Before booster vaccination and 1 month after booster vaccination', 'description': 'Percentage of participants achieving hSBA titer \\>= LLOQ were computed along with corresponding 2-sided 95 % CIs. The LLOQ was 1:16 for A22 and 1:8 for A56, B24, and B44.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Booster evaluable immunogenicity population: participants eligible for study, randomized to 120 mcg bivalent rLP2086 during stage 1, received scheduled investigational products, had blood drawn prior to booster vaccination dose and post-booster vaccination blood drawn (Visit 13) within 28-42 days from booster vaccination (Visit 12) and had no important protocol deviation. N=number of participants evaluable for this outcome measure and number analyzed=participants evaluable at specific rows.'}, {'type': 'SECONDARY', 'title': 'Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs) for Each of the 4 MnB Primary Test Strains at Before Booster Vaccination and 1 Month After Booster Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '120-mcg Bivalent rLP2086: Stage 2 Booster Phase', 'description': 'Participants who were randomly assigned to bivalent rLP2086 (irrespective of dose level) were eligible for booster vaccination. Participants received intramuscular injection of 120-mcg of bivalent rLP2086 vaccine after 23 months of visit 3.'}], 'classes': [{'title': 'PMB80 (A22): before booster vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.4', 'groupId': 'OG000', 'lowerLimit': '7.8', 'upperLimit': '9.0'}]}]}, {'title': 'PMB80 (A22):1 month after booster vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '112.1', 'groupId': 'OG000', 'lowerLimit': '87.2', 'upperLimit': '144.2'}]}]}, {'title': 'PMB2001 (A56):before booster vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.2', 'groupId': 'OG000', 'lowerLimit': '4.4', 'upperLimit': '6.2'}]}]}, {'title': 'PMB2001 (A56):1 month after booster vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '248.3', 'groupId': 'OG000', 'lowerLimit': '192.7', 'upperLimit': '319.9'}]}]}, {'title': 'PMB2948 (B24): before booster vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000', 'lowerLimit': '4.0', 'upperLimit': '5.1'}]}]}, {'title': 'PMB2948 (B24):1 month after booster vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '48.3', 'groupId': 'OG000', 'lowerLimit': '37.6', 'upperLimit': '62.0'}]}]}, {'title': 'PMB2707 (B44): before booster vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.4', 'groupId': 'OG000', 'lowerLimit': '4.1', 'upperLimit': '4.9'}]}]}, {'title': 'PMB2707 (B44): 1 month after booster vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '98.6', 'groupId': 'OG000', 'lowerLimit': '71.4', 'upperLimit': '136.2'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Before booster vaccination and 1 month after booster vaccination', 'description': 'The LLOQ was 1:16 for A22, 1:8 for A56, B24, and B44. Titers below the LLOQ were set to 0.5\\*LLOQ for analysis. Titers were expressed in terms of 1/dilution.', 'unitOfMeasure': 'titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Booster evaluable immunogenicity population: participants eligible for study, randomized to 120 mcg bivalent rLP2086 during stage 1, received scheduled investigational products, had blood drawn prior to booster vaccination dose and post-booster vaccination blood drawn (Visit 13) within 28-42 days from booster vaccination (Visit 12) and had no important protocol deviation. N=number of participants evaluable for this outcome measure and number analyzed=participants evaluable at specific rows.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group 1: 60- mcg Bivalent rLP2086 (>=12 Months to <24 Months)', 'description': 'Participants from greater than or equal to (\\>=) 12 months to less than (\\<) 24 months of age, received intramuscular injection of 60 mcg of bivalent rLP2086 vaccine on months 0 vaccine on a 0, 2, 6 month schedule.'}, {'id': 'FG001', 'title': 'Group 2: 120-mcg Bivalent rLP2086 (>=12 Months to <24 Months)', 'description': 'Participants from \\>=12 months to \\<24 months of age, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine on a 0, 2, 6 month schedule. All participants who received 3 doses of 120 mcg bivalent rLP2086 in Stage 1 and gave consent for booster vaccination, received intramuscular injection of single booster dose of 120 mcg of bivalent rLP2086 after 23 to 24 months of Vaccination 3, in Stage 2. Participants were followed up approximately 6 months after the booster vaccination.'}, {'id': 'FG002', 'title': 'Group 3: HAV/Saline (>=12 Months to <24 Months): Stage 1', 'description': 'Participants from \\>=12 months to \\<24 months of age, received intramuscular injection of saline on 2 month and HAV vaccine on a 0, 6 month schedule.'}], 'periods': [{'title': 'Stage 1: 24 Months', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '220'}, {'groupId': 'FG002', 'numSubjects': '132'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '210'}, {'groupId': 'FG002', 'numSubjects': '127'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'No longer willing to participate in study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'No longer meets eligibility criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Stage 2: 8 Months', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Participants entered into Stage 2.', 'groupId': 'FG000', 'numSubjects': '40'}, {'comment': 'Participants who received all 3 doses and entered Stage 2.', 'groupId': 'FG001', 'numSubjects': '174'}, {'comment': 'Participants of HAV/Saline were not eligible for Stage 2.', 'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '170'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Moved away/parents resigned from study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Stage 2: Booster Phase (6 Months)', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Participants were not eligible for Booster vaccination in Stage 2.', 'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'Participants who received 3 doses of bivalent rLP2086 in Stage 1 and gave consent for booster vaccination.', 'groupId': 'FG001', 'numSubjects': '148'}, {'comment': 'Participants of HAV/Saline were not eligible for Stage 2.', 'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '147'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Not received booster vaccination', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'In Stage 1, participants received 60 or 120 microgram (mcg) of bivalent rLP2086 vaccine or HAV/saline at Month 1, 2 and 6, and then followed up for 24 months. In Stage 2, participants who received bivalent rLP2086 during Stage 1 had a follow up visit at Month 24. Further participants who received 120 mcg bivalent rLP2086 during Stage 1 were eligible for receiving booster vaccination 6 months after Month 24 visit.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'BG000'}, {'value': '220', 'groupId': 'BG001'}, {'value': '132', 'groupId': 'BG002'}, {'value': '396', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Group 1: 60- mcg Bivalent rLP2086 (>=12 Months to <24 Months)', 'description': 'Participants from greater than or equal to (\\>=) 12 months to less than (\\<) 24 months of age, received intramuscular injection of 60 mcg of bivalent rLP2086 vaccine on months 0 vaccine on a 0, 2, 6 month schedule.'}, {'id': 'BG001', 'title': 'Group 2: 120-mcg Bivalent rLP2086 (>=12 Months to <24 Months)', 'description': 'Participants from \\>=12 months to \\<24 months of age, received intramuscular injection of 120 mcg of bivalent rLP2086 vaccine on a 0, 2, 6 month schedule. All participants who received 3 doses of 120 mcg bivalent rLP2086 in Stage 1 and gave consent for booster vaccination, received intramuscular injection of single booster dose of 120 mcg of bivalent rLP2086 after 23 to 24 months of Vaccination 3, in Stage 2. Participants were followed up approximately 6 months after the booster vaccination.'}, {'id': 'BG002', 'title': 'Group 3: HAV/Saline (>=12 Months to <24 Months): Stage 1', 'description': 'Participants from \\>=12 months to \\<24 months of age, received intramuscular injection of saline on 2 month and HAV vaccine on a 0, 6 month schedule.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '16.9', 'spread': '4.08', 'groupId': 'BG000'}, {'value': '17.4', 'spread': '3.54', 'groupId': 'BG001'}, {'value': '17.3', 'spread': '3.58', 'groupId': 'BG002'}, {'value': '17.3', 'spread': '3.61', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '114', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}, {'value': '209', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '106', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '187', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race: White', 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '210', 'groupId': 'BG001'}, {'value': '127', 'groupId': 'BG002'}, {'value': '374', 'groupId': 'BG003'}]}]}, {'title': 'Race: Asian', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}]}, {'title': 'Race: Other', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Ethnicity: Hispanic', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}, {'title': 'Ethnicity: Non-Hispanic', 'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '218', 'groupId': 'BG001'}, {'value': '132', 'groupId': 'BG002'}, {'value': '394', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety population included all participants who received at least 1 dose of the investigational product (rLP2086, HAV vaccine or saline) and had safety data available.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-04-19', 'size': 2764249, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-02-19T11:18', 'hasProtocol': True}, {'date': '2017-07-13', 'size': 1539739, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-02-19T11:18', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 396}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2020-03-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-30', 'studyFirstSubmitDate': '2015-02-23', 'resultsFirstSubmitDate': '2018-02-19', 'studyFirstSubmitQcDate': '2015-08-25', 'lastUpdatePostDateStruct': {'date': '2021-09-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-03-16', 'studyFirstPostDateStruct': {'date': '2015-08-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-04-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of the 4 Primary Neisseria Meningitidis Serogroup B (MnB) Test Strains 1 Month After Vaccination 3', 'timeFrame': '1 month after Vaccination 3', 'description': 'Percentage of participants achieving hSBA titer \\>= LLOQ were computed along with corresponding 2-sided 95 percent (%) confidence interval (CIs). LLOQ was 1:16 for PMB80 (A22) and 1:8 for PMB2001 (A56), PMB2948 (B24) and PMB2707 (B44).'}, {'measure': 'Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 1', 'timeFrame': 'within 7 Days after Vaccination 1', 'description': 'Local reactions included tenderness at injection site, swelling and redness collected by using an electronic diary (e-diary). Tenderness was graded as: mild (hurted if gently touched), moderate (hurted if gently touched with crying) and severe (caused limitation of limb movement). Redness and swelling were graded as: mild (0.5-2.0 centimeter \\[cm\\]), moderate (2.5 to 7.0 cm) and severe (\\>7.0 cm).'}, {'measure': 'Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 2', 'timeFrame': 'within 7 Days after Vaccination 2', 'description': 'Local reactions included tenderness at injection site, swelling and redness collected by using an e-diary. Tenderness was graded as: mild (hurted if gently touched), moderate (hurted if gently touched with crying) and severe (caused limitation of limb movement). Redness and swelling were graded as: mild (0.5-2.0 cm), moderate (2.5 to 7.0 cm) and severe (\\>7.0 cm).'}, {'measure': 'Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Vaccination 3', 'timeFrame': 'within 7 Days after Vaccination 3', 'description': 'Local reactions included tenderness at injection site, swelling and redness collected by using an e-diary. Tenderness was graded as: mild (hurted if gently touched), moderate (hurted if gently touched with crying) and severe (caused limitation of limb movement). Redness and swelling were graded as: mild (0.5-2.0 cm), moderate (2.5 to 7.0 cm) and severe (\\>7.0 cm).'}, {'measure': 'Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 1', 'timeFrame': 'within 7 Days after Vaccination 1', 'description': 'Systemic reactions included fever, irritability, drowsiness, loss of or decreased appetite and were recorded by using an e-diary. Fever was graded as 38.0 to 38.4 degree Celsius (C), 38.5 to 38.9 degree C, 39.0 to 39.4 degree C, \\>39.5 to 40.0 degree C and \\>40.0 degree C. Irritability was graded as mild (easily consolable), moderate (requiring increased attention) and severe (inconsolable). Drowsiness was graded as mild (Increased or prolonged sleeping bouts), moderate (slightly subdued interfering with daily activity) and severe (disabling not interested in usual daily activity). Loss of or decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed).'}, {'measure': 'Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 2', 'timeFrame': 'within 7 Days after Vaccination 2', 'description': 'Systemic reactions included fever, irritability, drowsiness, loss of or decreased appetite and were recorded by using an e-diary. Fever was graded as 38.0 to 38.4 degree C, 38.5 to 38.9 degree C, 39.0 to 39.4 degree C, \\>39.5 to 40.0 degree C and \\>40.0 degree C. Irritability was graded as mild (easily consolable), moderate (requiring increased attention) and severe (inconsolable). Drowsiness was graded as mild (Increased or prolonged sleeping bouts), moderate (slightly subdued interfering with daily activity) and severe (disabling not interested in usual daily activity). Loss of or decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed).'}, {'measure': 'Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Vaccination 3', 'timeFrame': 'within 7 Days after Vaccination 3', 'description': 'Systemic reactions included fever, irritability, drowsiness, loss of or decreased appetite and were recorded by using an e-diary. Fever was graded as 38.0 to 38.4 degree C, 38.5 to 38.9 degree C, 39.0 to 39.4 degree C, \\>39.5 to 40.0 degree C and \\>40.0 degree C. Irritability was graded as mild (easily consolable), moderate (requiring increased attention) and severe (inconsolable). Drowsiness was graded as mild (Increased or prolonged sleeping bouts), moderate (slightly subdued interfering with daily activity) and severe (disabling not interested in usual daily activity). Loss of or decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed).'}, {'measure': 'Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE), Newly Diagnosed Chronic Medical Condition (NDCMC) and Immediate Adverse Event (IAE) Within 30 Days After Vaccination 1', 'timeFrame': 'within 30 Days after Vaccination 1', 'description': 'An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; lack of efficacy in an approved indication; important medical event. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects. Immediate AE was defined as AEs occurring within the first 30 minutes after investigational product administration.'}, {'measure': 'Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE), Newly Diagnosed Chronic Medical Condition (NDCMC) and Immediate Adverse Event (IAE) Within 30 Days After Vaccination 2', 'timeFrame': 'within 30 Days after Vaccination 2', 'description': 'An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; lack of efficacy in an approved indication; important medical event. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects. Immediate AE was defined as AEs occurring within the first 30 minutes after investigational product administration.'}, {'measure': 'Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE), Newly Diagnosed Chronic Medical Condition (NDCMC) and Immediate Adverse Event (IAE) Within 30 Days After Vaccination 3', 'timeFrame': 'within 30 Days after Vaccination 3', 'description': 'An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; lack of efficacy in an approved indication; important medical event. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects. Immediate AE was defined as AEs occurring within the first 30 minutes after investigational product administration.'}, {'measure': 'Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE) and Newly Diagnosed Chronic Medical Condition (NDCMC) Within 30 Days After Any Vaccination', 'timeFrame': 'within 30 Days after any Vaccination', 'description': 'An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; lack of efficacy in an approved indication; important medical event. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects.'}, {'measure': 'Percentage of Participants With at Least 1 Adverse Event (AE), Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE) and Newly Diagnosed Chronic Medical Condition (NDCMC) During the Vaccination Phase', 'timeFrame': 'From the Vaccination 1 up to 1 month after Vaccination 3', 'description': 'An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; lack of efficacy in an approved indication; important medical event. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects.'}, {'measure': 'Percentage of Participants With at Least 1 Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE) and Newly Diagnosed Chronic Medical Condition (NDCMC) During the Follow up Phase', 'timeFrame': 'From 1 month after Vaccination 3 up to 6 months after Vaccination 3', 'description': 'An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; lack of efficacy in an approved indication; important medical event. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects.'}, {'measure': 'Percentage of Participants With at Least 1 Serious Adverse Event (SAE), Medically Attended Adverse Event (MAE) and Newly Diagnosed Chronic Medical Condition (NDCMC) From Vaccination 1 up to 6 Months After Vaccination 3', 'timeFrame': 'From Vaccination 1 up to 6 months after Vaccination 3', 'description': 'An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; lack of efficacy in an approved indication; important medical event. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With hSBA Titer Between 12 Months to Less Than (<) 24 Months >= LLOQ for Each of the 4 Primary MnB Test Strains at 1, 6, 12, and 24 Months After Vaccination 3', 'timeFrame': '1, 6, 12, 24 months after Vaccination 3', 'description': 'Percentage of participants achieving hSBA titer \\>= LLOQ were computed along with corresponding 2-sided 95% CIs. LLOQ was 1:16 for PMB80 (A22) and 1:8 for PMB2001 (A56), PMB2948 (B24), and PMB2707 (B44).'}, {'measure': 'Percentage of Participants With hSBA Titer >= LLOQ for Each of the 4 Primary MnB Test Strains 1 Month After Vaccination 2', 'timeFrame': '1 month (Mon) after Vaccination (Vac) 2', 'description': 'Percentage of participants achieving hSBA titer \\>= LLOQ were computed along with corresponding 2-sided 95% CIs. LLOQ was 1:16 for PMB80 (A22) and 1:8 for PMB2001 (A56), PMB2948 (B24), and PMB2707 (B44).'}, {'measure': 'Percentage of Participants With Serum Bactericidal Assay Using hSBA Titers >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains', 'timeFrame': 'Before Vaccination 1 (T1), 1 month after Vaccination 2 (T2), 1 month after Vaccination 3 (T3), 6 months after Vaccination 3 (T4), 12 months after Vaccination 3 (T5) and 24 months after Vaccination 3 (T6)'}, {'measure': 'Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs) for Each of the 4 Primary Test Strains', 'timeFrame': 'Before Vaccination 1 (T1), 1 month after Vaccination 2 (T2), 1 month after Vaccination 3 (T3), 6 months after Vaccination 3 (T4), 12 months after Vaccination 3 (T5) and 24 months after Vaccination 3 (T6)'}, {'measure': 'Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days After Booster Vaccination', 'timeFrame': 'Within 7 days after booster vaccination', 'description': 'Local reactions included pain at injection site, swelling and redness collected by using an e-diary. Pain at injection site was graded as: mild (does not interfere with activity), moderate (interferes with activity) and severe (prevents daily activity). A caliper was used to measure the redness or swelling area. Caliper units were converted to centimeters (cm) according to 1 caliper unit = 0.5 cm. Redness and swelling were graded as: none (0 cm) mild (0.5-2.0 cm), moderate (\\>=2.0 to 7.0 cm) and severe (\\>7.0 cm).'}, {'measure': 'Percentage of Participants Reporting Systemic Events and Antipyretic Use Within 7 Days After Booster Vaccination', 'timeFrame': 'Within 7 days after booster vaccination', 'description': 'Systemic reactions included fever, vomiting, diarrhea, headache, fatigue, muscle pain and joint pain were recorded by using an e-diary. Fever was defined as a temperature of greater than or equal to (\\>=) 38.0 degree Celsius and was graded as 38.0 degree Celsius (C) to 38.4 degree C, 38.5 degree C to 38.9 degree C, 39.0 degree C to 39.4 degree C, 39.5 degree C to 40.0 degree C, \\>40.0 degree C. Vomiting was graded as mild (1 to 2 times in 24 hours), moderate (\\>2 times in 24 hours) and severe (requires IV hydration). Diarrhea was graded as mild (2 to 3 loose stools in 24 hours), moderate (4 to 5 loose stools in 24 hours), and severe (6 or more loose stools in 24 hours). Fatigue, headache, muscle pain and joint pain were graded as: mild (did not interfere with activity), moderate (some interference with activity) and severe (prevented daily routine activity). The use and type of antipyretic medication was also recorded in the e-diary daily.'}, {'measure': 'Percentage of Participants With SAE, MAE, NDCMC From Booster Vaccination to 1 Month After Booster Vaccination, 1 Month After Booster Vaccination to 6 Months After Booster Vaccination and Booster Vaccination Through 6 Months After Booster Vaccination', 'timeFrame': 'Booster vaccination to 1 month after booster vaccination (T1), 1 month after booster vaccination to 6 months after booster vaccination (T2) and booster vaccination through 6 months after booster vaccination (T3)', 'description': 'SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; lack of efficacy in an approved indication; important medical event. A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. An NDCMC was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects.'}, {'measure': 'Percentage of Participants With at Least 1 Adverse Event (AE) From Booster Vaccination to 1 Month After Booster Vaccination', 'timeFrame': 'Booster vaccination up to 1 month after booster vaccination', 'description': 'An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship.'}, {'measure': 'Percentage of Participants With Immediate Adverse Event (IAE) After Booster Vaccination', 'timeFrame': 'Within 30 minutes after booster vaccination', 'description': 'Immediate AE was defined as AEs occurring within the first 30 minutes after investigational product administration.'}, {'measure': 'Percentage of Participants With hSBA Titer >=LLOQ >=1:4, >=1:8, >=1:16, >=1:32, >=1:64 and >=1:128 for Each of the 4 Primary Test Strains Before Booster Vaccination, and 1 Month After Booster Vaccination', 'timeFrame': 'Before booster vaccination and 1 month after booster vaccination', 'description': 'Percentage of participants achieving hSBA titer \\>= LLOQ were computed along with corresponding 2-sided 95 % CIs. The LLOQ was 1:16 for A22 and 1:8 for A56, B24, and B44.'}, {'measure': 'Serum Bactericidal Assay Using Human Complement (hSBA) Geometric Mean Titers (GMTs) for Each of the 4 MnB Primary Test Strains at Before Booster Vaccination and 1 Month After Booster Vaccination', 'timeFrame': 'Before booster vaccination and 1 month after booster vaccination', 'description': 'The LLOQ was 1:16 for A22, 1:8 for A56, B24, and B44. Titers below the LLOQ were set to 0.5\\*LLOQ for analysis. Titers were expressed in terms of 1/dilution.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Phase 2 Immunogenicity', 'Safety', 'Tolerability Study', 'rLP2086 Vaccine', 'Healthy Toddlers', 'Neisseria meningitidis', 'Duration of Immunogenicity'], 'conditions': ['Meningococcal B Disease']}, 'referencesModule': {'references': [{'pmid': '36087588', 'type': 'DERIVED', 'citation': "Marshall HS, Vesikari T, Richmond PC, Wysocki J, Szenborn L, Beeslaar J, Maguire JD, Balmer P, O'Neill R, Anderson AS, Pregaldien JL, Maansson R, Jiang HQ, Perez JL. Safety and immunogenicity of a primary series and booster dose of the meningococcal serogroup B-factor H binding protein vaccine (MenB-FHbp) in healthy children aged 1-9 years: two phase 2 randomised, controlled, observer-blinded studies. Lancet Infect Dis. 2023 Jan;23(1):103-116. doi: 10.1016/S1473-3099(22)00424-8. Epub 2022 Sep 7."}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1971035&StudyName=Immunogenicity%2C%20Safety%20and%20Tolerability%20of%20Meningococcal%20B%20Vaccine%20in%20Healthy%20Toddlers.%20', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the immunogenicity, safety and tolerability of a new vaccine that might prevent meningococcal B disease. The study will be conducted in healthy toddlers aged between 12 and 24 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '24 Months', 'minimumAge': '12 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female subject aged 12 to \\<15 months or 18 to \\<24 months during sentinel-cohort enrollment, Or,12 to \\<24 months during expanded-cohort enrollment.\n* Subjects must have received all vaccinations in the relevant National Immunization Program (NIP) for their age group.\n* Subject is determined to be in good health by medical history, physical examination, and judgment of the investigator.\n\nExclusion Criteria:\n\n* Previous vaccination with any meningococcal serogroup B vaccine.\n* Previous vaccination with HAV vaccine, or requirement to receive nonstudy HAV vaccine during Stage 1 of the study.\n* Contraindication to vaccination with any HAV vaccine or known latex allergy.\n* A previous anaphylactic reaction to any vaccine or vaccine-related component.\n* Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.\n* A known or suspected disorder 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 or those receiving systemic immunosuppressive therapy. Subjects with terminal complement deficiency may be included.\n* History of microbiologically proven disease caused by N meningitidis or Neisseria gonorrhoeae.\n* Significant neurologic disorder or history of seizure (excluding simple febrile seizure).\n* Receipt of any blood products, including immunoglobulin, within 6 months before the first study vaccination until the end of Stage 1.\n* Current chronic use of systemic antibiotics.\n* Received any investigational drugs, vaccines or devices within 28 days before administration of the first study vaccination and/or during study participation.\n* Any neuroinflammatory or autoimmune condition, including but not limited to transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.'}, 'identificationModule': {'nctId': 'NCT02534935', 'briefTitle': 'Immunogenicity, Safety and Tolerability of a Neisseria Meningitidis Serogroup B Bivalent Recominant Lipoprotein 2086 Vaccine (Bivalent rLP2086) in Healthy Toddlers.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A PHASE 2, RANDOMIZED, CONTROLLED, OBSERVER-BLINDED STUDY CONDUCTED TO DESCRIBE THE IMMUNOGENICITY, SAFETY, AND TOLERABILITY OF A NEISSERIA MENINGITIDIS SEROGROUP B BIVALENT RECOMBINANT LIPOPROTEIN 2086 VACCINE (BIVALENT RLP2086) WHEN ADMINISTERED TO HEALTHY TODDLERS AGED 12 TO <18 MONTHS OR 18 TO <24 MONTHS, AND THE SAFETY AND IMMUNOGENICITY OF A BOOSTER DOSE OF BIVALENT RLP2086', 'orgStudyIdInfo': {'id': 'B1971035'}, 'secondaryIdInfos': [{'id': '2011-004400-38', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'rLP2086 vaccine', 'description': 'Arm stratified by age:\n\n≥12 to \\<18 months and ≥18 to \\<24 months', 'interventionNames': ['Biological: rLP2086 vaccine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Arm stratified by age:\n\n≥12 to \\<18 months and ≥18 to \\<24 months', 'interventionNames': ['Biological: Pediatric HAV vaccine']}], 'interventions': [{'name': 'rLP2086 vaccine', 'type': 'BIOLOGICAL', 'description': '60 mcg or 120mcg at 0, 2 and 6 months', 'armGroupLabels': ['rLP2086 vaccine']}, {'name': 'Pediatric HAV vaccine', 'type': 'BIOLOGICAL', 'description': '0.5-mL dose at months 0 and 6. Normal saline at month 2.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2605', 'city': 'Canberra, Garran', 'state': 'Australian Capital Territory', 'country': 'Australia', 'facility': 'The Canberra Hospital'}, {'zip': '2035', 'city': 'Maroubra', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Australian Clinical Research Network (ACRN)', 'geoPoint': {'lat': -33.95, 'lon': 151.23333}}, {'zip': '2035', 'city': 'Maroubra', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Maroubra Medical Centre', 'geoPoint': {'lat': -33.95, 'lon': 151.23333}}, {'zip': '5006', 'city': 'North Adelaide', 'state': 'South Australia', 'country': 'Australia', 'facility': "Women's And Children's Hospital", 'geoPoint': {'lat': -34.90733, 'lon': 138.59141}}, {'zip': '3052', 'city': 'Parkville', 'state': 'Victoria', 'country': 'Australia', 'facility': "Murdoch Children's Research Institute", 'geoPoint': {'lat': -37.78333, 'lon': 144.95}}, {'zip': '6009', 'city': 'Nedlands', 'state': 'Western Australia', 'country': 'Australia', 'facility': "Vaccine Trials Group, Telethon Kids Institute, Perth Children's Hospital", 'geoPoint': {'lat': -31.98184, 'lon': 115.8073}}, {'zip': '377 01', 'city': 'Jindřichův Hradec', 'country': 'Czechia', 'facility': 'Ordinace praktickeho lekare pro deti a dorost', 'geoPoint': {'lat': 49.14404, 'lon': 15.00301}}, {'zip': '377 01', 'city': 'Jindřichův Hradec', 'country': 'Czechia', 'facility': 'Samostatna ordinace praktickeho lekare pro deti a dorost', 'geoPoint': {'lat': 49.14404, 'lon': 15.00301}}, {'zip': '160 00', 'city': 'Praha 6 - Vokovice', 'country': 'Czechia', 'facility': 'Medicentrum 6 s.r.o'}, {'zip': '257 41', 'city': 'Týnec nad Sázavou', 'country': 'Czechia', 'facility': 'Prakticky Lekar Pro Deti A Mladez', 'geoPoint': {'lat': 49.83348, 'lon': 14.58983}}, {'zip': '02230', 'city': 'Espoo', 'country': 'Finland', 'facility': 'Espoo Vaccine Research Clinic', 'geoPoint': {'lat': 60.2052, 'lon': 24.6522}}, {'zip': '00100', 'city': 'Helsinki', 'country': 'Finland', 'facility': 'Helsinki South Vaccine Research Clinic', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'zip': '00930', 'city': 'Helsinki', 'country': 'Finland', 'facility': 'Helsinki East Vaccine Research Clinic', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'zip': '04400', 'city': 'Järvenpää', 'country': 'Finland', 'facility': 'Jarvenpaa Vaccine Research Center', 'geoPoint': {'lat': 60.47369, 'lon': 25.08992}}, {'zip': '28100', 'city': 'Pori', 'country': 'Finland', 'facility': 'Pori Vaccine Research Clinic', 'geoPoint': {'lat': 61.48072, 'lon': 21.78518}}, {'zip': '33100', 'city': 'Tampere', 'country': 'Finland', 'facility': 'Tampere Vaccine Research Clinic', 'geoPoint': {'lat': 61.49911, 'lon': 23.78712}}, {'zip': '20520', 'city': 'Turku', 'country': 'Finland', 'facility': 'Turku Vaccine Research Clinic', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}, {'zip': '85-079', 'city': 'Bydgoszcz', 'country': 'Poland', 'facility': 'NZOZ Vitamed', 'geoPoint': {'lat': 53.1235, 'lon': 18.00762}}, {'zip': '39-200', 'city': 'Dębica', 'country': 'Poland', 'facility': 'Prywatny Gabinet Lekarski dr n. med. Jerzy Brzostek', 'geoPoint': {'lat': 50.05146, 'lon': 21.41141}}, {'zip': '31-302', 'city': 'Krakow', 'country': 'Poland', 'facility': 'Indywidualna Specjalistyczna Praktyka Lekarska Hanna Czajka', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '91-347', 'city': 'Lodz', 'country': 'Poland', 'facility': 'Specjalistyczna Praktyka Lekarska GRAVITA', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'zip': '20-044', 'city': 'Lublin', 'country': 'Poland', 'facility': 'NZOZ Praktyka Lekarza Rodzinnego Eskulap sp. z o.o', 'geoPoint': {'lat': 51.25058, 'lon': 22.57009}}, {'zip': '41-103', 'city': 'Siemianowice Śląskie', 'country': 'Poland', 'facility': 'Niepubliczny Zaklad Lecznictwa Ambulatoryjnego Michalkowice Jarosz i Partnerzy Spolka Lekarska', 'geoPoint': {'lat': 50.32738, 'lon': 19.02901}}, {'zip': '55-100', 'city': 'Trzebnica', 'country': 'Poland', 'facility': 'Szpital im. Sw. Jadwigi Slaskiej w Trzebnicy Oddzial Pediatryczny', 'geoPoint': {'lat': 51.31076, 'lon': 17.06331}}, {'zip': '50-368', 'city': 'Wroclaw', 'country': 'Poland', 'facility': 'Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego we Wroclawiu Klinika Pediatrii i Chorob', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'url': 'https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests', 'ipdSharing': 'YES', 'description': "Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\\_trials/trial\\_data\\_and\\_results/data\\_requests."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}