Ignite Creation Date:
2025-12-25 @ 12:24 AM
Ignite Modification Date:
2025-12-25 @ 10:28 PM
Study NCT ID:
NCT01939158
Status:
COMPLETED
Last Update Posted:
2021-10-05
First Post:
2013-08-29
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Immunogenicity and Safety Study of 1 and 2 Doses of GlaxoSmithKline (GSK) Biologicals' Meningococcal Vaccine MenACWY-TT (GSK134612) in Toddlers, Persistence up to 5 Years After Vaccination and Co-administration With Pfizer's Prevenar 13™Vaccine
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008589', 'term': 'Meningococcal Infections'}], 'ancestors': [{'id': 'D016870', 'term': 'Neisseriaceae Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C538862', 'term': '13-valent pneumococcal vaccine'}]}}, '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}}, 'adverseEventsModule': {'timeFrame': 'AE data were collected from Baseline up to end of study (up to 5 years). Solicited local and general reactions was collected within 4 days post vaccination.', 'description': 'Same event may appear as both an adverse event and serious adverse events. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event.', 'eventGroups': [{'id': 'EG000', 'title': 'ACWY1d Group', 'description': 'Participants received single dose of meningococcal polysaccharide groups A, C, W-135, and Y tetanus toxoid conjugate (MenACWY-TT) vaccine administered intramuscularly at Month 0.', 'otherNumAtRisk': 203, 'deathsNumAtRisk': 203, 'otherNumAffected': 199, 'seriousNumAtRisk': 203, 'deathsNumAffected': 0, 'seriousNumAffected': 12}, {'id': 'EG001', 'title': 'ACWY2d Group', 'description': 'Participants received two doses of MenACWY-TT vaccine administered intramuscularly at Month 0 and Month 2.', 'otherNumAtRisk': 197, 'deathsNumAtRisk': 197, 'otherNumAffected': 196, 'seriousNumAtRisk': 197, 'deathsNumAffected': 0, 'seriousNumAffected': 11}, {'id': 'EG002', 'title': 'Co-ad Group', 'description': 'Participants received single dose of MenACWY-TT vaccine and single dose of Prevnar 13 administered intramuscularly at Month 0.', 'otherNumAtRisk': 201, 'deathsNumAtRisk': 201, 'otherNumAffected': 197, 'seriousNumAtRisk': 201, 'deathsNumAffected': 1, 'seriousNumAffected': 13}, {'id': 'EG003', 'title': 'PCV13 Group', 'description': 'Participants received single dose of Prevnar 13 at Month 0 and single dose of MenACWY-TT administered intramuscularly at Month 2.', 'otherNumAtRisk': 201, 'deathsNumAtRisk': 201, 'otherNumAffected': 197, 'seriousNumAtRisk': 201, 'deathsNumAffected': 1, 'seriousNumAffected': 16}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Ear disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Corneal erosion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Eye inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Ocular hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Abnormal faeces', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Aphthous ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Coeliac disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 23}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Enteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Faeces soft', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Mouth ulceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Teething', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Tooth disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Crying', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Gait disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Injection site bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Injection site mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Swelling face', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Vaccination site bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Vaccination site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Food allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Immunisation reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Coxsackie viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Croup infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Dermatitis infected', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Loss Of Appetite', 'notes': 'Number of participants evaluable for this general reaction.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 199, 'numAffected': 56}, {'groupId': 'EG001', 'numAtRisk': 196, 'numAffected': 78}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 54}, {'groupId': 'EG003', 'numAtRisk': 197, 'numAffected': 83}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Temperature/(Rectal) (°C)', 'notes': 'Number of participants evaluable for this general reaction.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 199, 'numAffected': 26}, {'groupId': 'EG001', 'numAtRisk': 196, 'numAffected': 46}, {'groupId': 'EG002', 'numAtRisk': 197, 'numAffected': 34}, {'groupId': 'EG003', 'numAtRisk': 197, 'numAffected': 63}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}], 'seriousEvents': [{'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Anaphylactic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Abscess limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Bronchitis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Croup infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Encephalitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Gastroenteritis rotavirus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Gastroenteritis salmonella', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Laryngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Meningitis aseptic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Myringitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Pneumonia pneumococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Pneumonia viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Staphylococcal scalded skin syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Burns first degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Burns second 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201, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Petroleum distillate poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Skin laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Soft tissue injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Diabetes mellitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Failure to thrive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Marasmus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Brain neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Febrile convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Adenoidal hypertrophy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Asphyxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Bronchospasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}, {'term': 'Dermatitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 203, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 197, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 201, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 201, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v23.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Serum Bactericidal Assay Using Rabbit Complement Antibody (rSBA) Titers >=1:8 at 1 Month After Administration of 1 Dose of MenACWY-TT in the ACWY1d, ACWY2d and Co-ad Groups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}, {'value': '178', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ACWY1d Group', 'description': 'Participants received single dose of meningococcal polysaccharide groups A, C, W-135, and Y tetanus toxoid conjugate (MenACWY-TT) vaccine administered intramuscularly at Month 0.'}, {'id': 'OG001', 'title': 'ACWY2d Group', 'description': 'Participants received two doses of MenACWY-TT vaccine administered intramuscularly at Month 0 and Month 2.'}, {'id': 'OG002', 'title': 'Co-ad Group', 'description': 'Participants received single dose of MenACWY-TT vaccine and single dose of Prevnar 13 administered intramuscularly at Month 0.'}], 'classes': [{'title': 'rSBA-MenA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}, {'value': '178', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '97.8', 'groupId': 'OG000', 'lowerLimit': '94.4', 'upperLimit': '99.4'}, {'value': '96.8', 'groupId': 'OG001', 'lowerLimit': '92.8', 'upperLimit': '99.0'}, {'value': '94.9', 'groupId': 'OG002', 'lowerLimit': '90.6', 'upperLimit': '97.7'}]}]}, {'title': 'rSBA-MenC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}, {'value': '157', 'groupId': 'OG001'}, {'value': '176', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '95.0', 'groupId': 'OG000', 'lowerLimit': '90.7', 'upperLimit': '97.7'}, {'value': '95.5', 'groupId': 'OG001', 'lowerLimit': '91.0', 'upperLimit': '98.2'}, {'value': '96.0', 'groupId': 'OG002', 'lowerLimit': '92.0', 'upperLimit': '98.4'}]}]}, {'title': 'rSBA-MenW-135', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}, {'value': '177', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '95.0', 'groupId': 'OG000', 'lowerLimit': '90.7', 'upperLimit': '97.7'}, {'value': '94.9', 'groupId': 'OG001', 'lowerLimit': '90.3', 'upperLimit': '97.8'}, {'value': '93.2', 'groupId': 'OG002', 'lowerLimit': '88.5', 'upperLimit': '96.4'}]}]}, {'title': 'rSBA-MenY', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '157', 'groupId': 'OG001'}, {'value': '177', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '92.8', 'groupId': 'OG000', 'lowerLimit': '88.0', 'upperLimit': '96.1'}, {'value': '93.6', 'groupId': 'OG001', 'lowerLimit': '88.6', 'upperLimit': '96.9'}, {'value': '89.8', 'groupId': 'OG002', 'lowerLimit': '84.4', 'upperLimit': '93.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month after administration of 1st dose of MenACWY-TT (i.e. at Month 1)', 'description': 'Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). Percentage of participants with rSBA titers \\>=1:8 against each serogroup at 1 month after administration of MenACWY-TT are reported. According-to-protocol (ATP) cohort for persistence Year 1 population included all participants who met all eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present with a medical condition or received product leading to exclusion or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyzed on ATP cohort for persistence Year 1 population. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure and \'number analyzed\' signifies participants evaluable for each specified category. Data for this outcome measure was not planned to be collected and analyzed for PCV13 reporting group.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With rSBA Titers >=1:8 at 1 Month After Administration of 2 Doses of MenACWY-TT in the ACWY2d Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ACWY2d Group', 'description': 'Participants received two doses of MenACWY-TT vaccine administered intramuscularly at Month 0 and Month 2.'}], 'classes': [{'title': 'rSBA-MenA', 'categories': [{'measurements': [{'value': '98.0', 'groupId': 'OG000', 'lowerLimit': '94.3', 'upperLimit': '99.6'}]}]}, {'title': 'rSBA-MenC', 'categories': [{'measurements': [{'value': '98.7', 'groupId': 'OG000', 'lowerLimit': '95.3', 'upperLimit': '99.8'}]}]}, {'title': 'rSBA-MenW-135', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '97.6', 'upperLimit': '100.0'}]}]}, {'title': 'rSBA-MenY', 'categories': [{'measurements': [{'value': '99.3', 'groupId': 'OG000', 'lowerLimit': '96.3', 'upperLimit': '100.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month after administration of 2nd dose of MenACWY-TT (i.e. at Month 3)', 'description': 'Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). Percentage of participants with rSBA titers \\>=1:8 against each serogroup at 1 month after administration of 2 doses of MenACWY-TT are reported. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyzed on ATP cohort for persistence Year 1 population. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure. Data for this outcome measure was not planned to be collected and analyzed for ACWY1d, Co-ad and PCV13 reporting groups.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at Year 1 in the ACWY1d and ACWY2d Groups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ACWY1d Group', 'description': 'Participants received single dose of meningococcal polysaccharide groups A, C, W-135, and Y tetanus toxoid conjugate (MenACWY-TT) vaccine administered intramuscularly at Month 0.'}, {'id': 'OG001', 'title': 'ACWY2d Group', 'description': 'Participants received two doses of MenACWY-TT vaccine administered intramuscularly at Month 0 and Month 2.'}], 'classes': [{'title': 'rSBA-MenA: >=1:8', 'categories': [{'measurements': [{'value': '63.5', 'groupId': 'OG000', 'lowerLimit': '55.7', 'upperLimit': '70.8'}, {'value': '70.6', 'groupId': 'OG001', 'lowerLimit': '62.4', 'upperLimit': '77.9'}]}]}, {'title': 'rSBA-MenC: >=1:8', 'categories': [{'measurements': [{'value': '49.1', 'groupId': 'OG000', 'lowerLimit': '41.3', 'upperLimit': '56.9'}, {'value': '55.2', 'groupId': 'OG001', 'lowerLimit': '46.7', 'upperLimit': '63.6'}]}]}, {'title': 'rSBA-MenW-135: >=1:8', 'categories': [{'measurements': [{'value': '65.3', 'groupId': 'OG000', 'lowerLimit': '57.5', 'upperLimit': '72.5'}, {'value': '77.6', 'groupId': 'OG001', 'lowerLimit': '69.9', 'upperLimit': '84.2'}]}]}, {'title': 'rSBA-MenY: >=1:8', 'categories': [{'measurements': [{'value': '73.1', 'groupId': 'OG000', 'lowerLimit': '65.7', 'upperLimit': '79.6'}, {'value': '79.7', 'groupId': 'OG001', 'lowerLimit': '72.2', 'upperLimit': '86.0'}]}]}, {'title': 'rSBA-MenA: >=1:128', 'categories': [{'measurements': [{'value': '44.9', 'groupId': 'OG000', 'lowerLimit': '37.2', 'upperLimit': '52.8'}, {'value': '50.3', 'groupId': 'OG001', 'lowerLimit': '41.9', 'upperLimit': '58.8'}]}]}, {'title': 'rSBA-MenC: >=1:128', 'categories': [{'measurements': [{'value': '21.0', 'groupId': 'OG000', 'lowerLimit': '15.1', 'upperLimit': '27.9'}, {'value': '27.3', 'groupId': 'OG001', 'lowerLimit': '20.2', 'upperLimit': '35.3'}]}]}, {'title': 'rSBA-MenW-135: >=1:128', 'categories': [{'measurements': [{'value': '46.7', 'groupId': 'OG000', 'lowerLimit': '39.0', 'upperLimit': '54.6'}, {'value': '60.1', 'groupId': 'OG001', 'lowerLimit': '51.6', 'upperLimit': '68.2'}]}]}, {'title': 'rSBA-MenY: >=1:128', 'categories': [{'measurements': [{'value': '52.1', 'groupId': 'OG000', 'lowerLimit': '44.2', 'upperLimit': '59.9'}, {'value': '60.8', 'groupId': 'OG001', 'lowerLimit': '52.3', 'upperLimit': '68.9'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Year 1', 'description': 'Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). Percentage of participants with rSBA titers \\>=1:8 and \\>=1:128 against each serogroup at Year 1 after administration of MenACWY-TT are reported. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyzed on ATP cohort for persistence Year 1 population. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure. Data for this outcome measure was not planned to be collected and analyzed for Co-ad and PCV13 reporting groups.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at Year 1 in the ACWY1d and ACWY2d Groups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '167', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ACWY1d Group', 'description': 'Participants received single dose of meningococcal polysaccharide groups A, C, W-135, and Y tetanus toxoid conjugate (MenACWY-TT) vaccine administered intramuscularly at Month 0.'}, {'id': 'OG001', 'title': 'ACWY2d Group', 'description': 'Participants received two doses of MenACWY-TT vaccine administered intramuscularly at Month 0 and Month 2.'}], 'classes': [{'title': 'rSBA-MenA', 'categories': [{'measurements': [{'value': '62.7', 'groupId': 'OG000', 'lowerLimit': '42.6', 'upperLimit': '92.2'}, {'value': '76.6', 'groupId': 'OG001', 'lowerLimit': '50.7', 'upperLimit': '115.7'}]}]}, {'title': 'rSBA-MenC', 'categories': [{'measurements': [{'value': '16.2', 'groupId': 'OG000', 'lowerLimit': '12.4', 'upperLimit': '21.1'}, {'value': '21.2', 'groupId': 'OG001', 'lowerLimit': '15.6', 'upperLimit': '28.9'}]}]}, {'title': 'rSBA-MenW-135', 'categories': [{'measurements': [{'value': '57.2', 'groupId': 'OG000', 'lowerLimit': '39.9', 'upperLimit': '82.0'}, {'value': '123.1', 'groupId': 'OG001', 'lowerLimit': '82.7', 'upperLimit': '183.4'}]}]}, {'title': 'rSBA-MenY', 'categories': [{'measurements': [{'value': '76.8', 'groupId': 'OG000', 'lowerLimit': '54.2', 'upperLimit': '109.0'}, {'value': '112.3', 'groupId': 'OG001', 'lowerLimit': '77.5', 'upperLimit': '162.8'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Year 1', 'description': 'Geometric mean titers of antibodies against each serogroup were assessed using rSBA. Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). rSBA titers are expressed as 1/dilution. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.', 'unitOfMeasure': 'titers (1/dilution)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyzed on ATP cohort for persistence Year 1 population. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure. Data for this outcome measure was not planned to be collected and analyzed for Co-ad and PCV13 reporting groups.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at Year 3 in the ACWY1d and ACWY2d Groups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ACWY1d Group', 'description': 'Participants received single dose of meningococcal polysaccharide groups A, C, W-135, and Y tetanus toxoid conjugate (MenACWY-TT) vaccine administered intramuscularly at Month 0.'}, {'id': 'OG001', 'title': 'ACWY2d Group', 'description': 'Participants received two doses of MenACWY-TT vaccine administered intramuscularly at Month 0 and Month 2.'}], 'classes': [{'title': 'rSBA-MenA: >=1:8', 'categories': [{'measurements': [{'value': '46.9', 'groupId': 'OG000', 'lowerLimit': '38.7', 'upperLimit': '55.3'}, {'value': '54.5', 'groupId': 'OG001', 'lowerLimit': '45.2', 'upperLimit': '63.6'}]}]}, {'title': 'rSBA-MenC: >=1:8', 'categories': [{'measurements': [{'value': '35.4', 'groupId': 'OG000', 'lowerLimit': '27.7', 'upperLimit': '43.7'}, {'value': '33.9', 'groupId': 'OG001', 'lowerLimit': '25.5', 'upperLimit': '43.0'}]}]}, {'title': 'rSBA-MenW-135: >=1:8', 'categories': [{'measurements': [{'value': '59.2', 'groupId': 'OG000', 'lowerLimit': '50.8', 'upperLimit': '67.2'}, {'value': '72.7', 'groupId': 'OG001', 'lowerLimit': '63.9', 'upperLimit': '80.4'}]}]}, {'title': 'rSBA-MenY: >=1:8', 'categories': [{'measurements': [{'value': '61.9', 'groupId': 'OG000', 'lowerLimit': '53.5', 'upperLimit': '69.8'}, {'value': '68.6', 'groupId': 'OG001', 'lowerLimit': '59.5', 'upperLimit': '76.7'}]}]}, {'title': 'rSBA-MenA: >=1:128', 'categories': [{'measurements': [{'value': '34.0', 'groupId': 'OG000', 'lowerLimit': '26.4', 'upperLimit': '42.3'}, {'value': '31.4', 'groupId': 'OG001', 'lowerLimit': '23.3', 'upperLimit': '40.5'}]}]}, {'title': 'rSBA-MenC: >=1:128', 'categories': [{'measurements': [{'value': '9.5', 'groupId': 'OG000', 'lowerLimit': '5.3', 'upperLimit': '15.5'}, {'value': '15.7', 'groupId': 'OG001', 'lowerLimit': '9.7', 'upperLimit': '23.4'}]}]}, {'title': 'rSBA-MenW-135: >=1:128', 'categories': [{'measurements': [{'value': '42.9', 'groupId': 'OG000', 'lowerLimit': '34.7', 'upperLimit': '51.3'}, {'value': '52.9', 'groupId': 'OG001', 'lowerLimit': '43.6', 'upperLimit': '62.0'}]}]}, {'title': 'rSBA-MenY: >=1:128', 'categories': [{'measurements': [{'value': '49.0', 'groupId': 'OG000', 'lowerLimit': '40.7', 'upperLimit': '57.3'}, {'value': '53.7', 'groupId': 'OG001', 'lowerLimit': '44.4', 'upperLimit': '62.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Year 3', 'description': 'Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). Percentage of participants with rSBA titers \\>=1:8 and \\>=1:128 against each serogroup at Year 3 after administration of MenACWY-TT are reported. ATP cohort for persistence Year 3 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyzed on ATP cohort for persistence Year 3 population. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure. Data for this outcome measure was not planned to be collected and analyzed for Co-ad and PCV13 reporting groups.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at Year 3 in the ACWY1d and ACWY2d Groups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ACWY1d Group', 'description': 'Participants received single dose of meningococcal polysaccharide groups A, C, W-135, and Y tetanus toxoid conjugate (MenACWY-TT) vaccine administered intramuscularly at Month 0.'}, {'id': 'OG001', 'title': 'ACWY2d Group', 'description': 'Participants received two doses of MenACWY-TT vaccine administered intramuscularly at Month 0 and Month 2.'}], 'classes': [{'title': 'rSBA-MenA', 'categories': [{'measurements': [{'value': '29.7', 'groupId': 'OG000', 'lowerLimit': '19.8', 'upperLimit': '44.5'}, {'value': '28.5', 'groupId': 'OG001', 'lowerLimit': '18.7', 'upperLimit': '43.6'}]}]}, {'title': 'rSBA-MenC', 'categories': [{'measurements': [{'value': '9.8', 'groupId': 'OG000', 'lowerLimit': '7.6', 'upperLimit': '12.7'}, {'value': '11.5', 'groupId': 'OG001', 'lowerLimit': '8.4', 'upperLimit': '15.8'}]}]}, {'title': 'rSBA-MenW-135', 'categories': [{'measurements': [{'value': '42.5', 'groupId': 'OG000', 'lowerLimit': '29.2', 'upperLimit': '61.8'}, {'value': '92.9', 'groupId': 'OG001', 'lowerLimit': '59.9', 'upperLimit': '143.9'}]}]}, {'title': 'rSBA-MenY', 'categories': [{'measurements': [{'value': '58.0', 'groupId': 'OG000', 'lowerLimit': '39.1', 'upperLimit': '86.0'}, {'value': '75.1', 'groupId': 'OG001', 'lowerLimit': '48.7', 'upperLimit': '115.9'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Year 3', 'description': 'Geometric mean titers of antibodies against each serogroup were assessed using rSBA. Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). rSBA titers are expressed as 1/dilution. ATP cohort for persistence Year 3 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.', 'unitOfMeasure': 'titers (1/dilution)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyzed on ATP cohort for persistence Year 3 population. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure. Data for this outcome measure was not planned to be collected and analyzed for Co-ad and PCV13 reporting groups.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at Year 5 in the ACWY1d and ACWY2d Groups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ACWY1d Group', 'description': 'Participants received single dose of meningococcal polysaccharide groups A, C, W-135, and Y tetanus toxoid conjugate (MenACWY-TT) vaccine administered intramuscularly at Month 0.'}, {'id': 'OG001', 'title': 'ACWY2d Group', 'description': 'Participants received two doses of MenACWY-TT vaccine administered intramuscularly at Month 0 and Month 2.'}], 'classes': [{'title': 'rSBA-MenA: >=1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '58.6', 'groupId': 'OG000', 'lowerLimit': '49.8', 'upperLimit': '67.1'}, {'value': '65.8', 'groupId': 'OG001', 'lowerLimit': '56.5', 'upperLimit': '74.3'}]}]}, {'title': 'rSBA-MenC: >=1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.5', 'groupId': 'OG000', 'lowerLimit': '13.9', 'upperLimit': '28.3'}, {'value': '28.4', 'groupId': 'OG001', 'lowerLimit': '20.5', 'upperLimit': '37.6'}]}]}, {'title': 'rSBA-MenW-135: >=1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '44.4', 'groupId': 'OG000', 'lowerLimit': '35.8', 'upperLimit': '53.2'}, {'value': '50.4', 'groupId': 'OG001', 'lowerLimit': '41.0', 'upperLimit': '59.8'}]}]}, {'title': 'rSBA-MenY: >=1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '47.4', 'groupId': 'OG000', 'lowerLimit': '38.7', 'upperLimit': '56.2'}, {'value': '58.1', 'groupId': 'OG001', 'lowerLimit': '48.6', 'upperLimit': '67.2'}]}]}, {'title': 'rSBA-MenA: >=1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '43.6', 'groupId': 'OG000', 'lowerLimit': '35.0', 'upperLimit': '52.5'}, {'value': '53.0', 'groupId': 'OG001', 'lowerLimit': '43.5', 'upperLimit': '62.3'}]}]}, {'title': 'rSBA-MenC: >=1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.1', 'groupId': 'OG000', 'lowerLimit': '2.7', 'upperLimit': '11.6'}, {'value': '10.3', 'groupId': 'OG001', 'lowerLimit': '5.5', 'upperLimit': '17.4'}]}]}, {'title': 'rSBA-MenW-135: >=1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '32.3', 'groupId': 'OG000', 'lowerLimit': '24.5', 'upperLimit': '41.0'}, {'value': '39.3', 'groupId': 'OG001', 'lowerLimit': '30.4', 'upperLimit': '48.8'}]}]}, {'title': 'rSBA-MenY: >=1:128', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '39.8', 'groupId': 'OG000', 'lowerLimit': '31.5', 'upperLimit': '48.7'}, {'value': '52.1', 'groupId': 'OG001', 'lowerLimit': '42.7', 'upperLimit': '61.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Year 5', 'description': 'Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). Percentage of participants with rSBA titers \\>=1:8 and \\>=1:128 against each serogroup at Year 5 after administration of MenACWY-TT are reported. ATP cohort for persistence Year 5 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyzed on ATP cohort for persistence Year 5 population. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure and \'number analyzed\' signifies participants evaluable for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Co-ad and PCV13 reporting groups.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at Year 5 in the ACWY1d and ACWY2d Groups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ACWY1d Group', 'description': 'Participants received single dose of meningococcal polysaccharide groups A, C, W-135, and Y tetanus toxoid conjugate (MenACWY-TT) vaccine administered intramuscularly at Month 0.'}, {'id': 'OG001', 'title': 'ACWY2d Group', 'description': 'Participants received two doses of MenACWY-TT vaccine administered intramuscularly at Month 0 and Month 2.'}], 'classes': [{'title': 'rSBA-MenA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '46.8', 'groupId': 'OG000', 'lowerLimit': '30.7', 'upperLimit': '71.5'}, {'value': '69.9', 'groupId': 'OG001', 'lowerLimit': '44.7', 'upperLimit': '109.3'}]}]}, {'title': 'rSBA-MenC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.6', 'groupId': 'OG000', 'lowerLimit': '5.3', 'upperLimit': '8.2'}, {'value': '8.5', 'groupId': 'OG001', 'lowerLimit': '6.4', 'upperLimit': '11.2'}]}]}, {'title': 'rSBA-MenW-135', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25.0', 'groupId': 'OG000', 'lowerLimit': '16.7', 'upperLimit': '37.6'}, {'value': '37.1', 'groupId': 'OG001', 'lowerLimit': '23.3', 'upperLimit': '59.0'}]}]}, {'title': 'rSBA-MenY', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '36.5', 'groupId': 'OG000', 'lowerLimit': '23.6', 'upperLimit': '56.2'}, {'value': '55.8', 'groupId': 'OG001', 'lowerLimit': '35.7', 'upperLimit': '87.5'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Year 5', 'description': 'Geometric mean titers of antibodies against each serogroup were assessed using rSBA. Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). rSBA titers are expressed as 1/dilution. ATP cohort for persistence Year 5 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.', 'unitOfMeasure': 'titers (1/dilution)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyzed on ATP cohort for persistence Year 5 population. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure and \'number analyzed\' signifies participants evaluable for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Co-ad and PCV13 reporting groups.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Concentrations (GMCs) of Antibodies for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Co-ad Group', 'description': 'Participants received single dose of MenACWY-TT vaccine and single dose of Prevnar 13 administered intramuscularly at Month 0.'}, {'id': 'OG001', 'title': 'PCV13 Group', 'description': 'Participants received single dose of Prevnar 13 at Month 0 and single dose of MenACWY-TT administered intramuscularly at Month 2.'}], 'classes': [{'title': 'anti-1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.94', 'groupId': 'OG000', 'lowerLimit': '2.56', 'upperLimit': '3.36'}, {'value': '2.62', 'groupId': 'OG001', 'lowerLimit': '2.27', 'upperLimit': '3.01'}]}]}, {'title': 'anti-3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.80', 'groupId': 'OG000', 'lowerLimit': '0.69', 'upperLimit': '0.91'}, {'value': '0.71', 'groupId': 'OG001', 'lowerLimit': '0.62', 'upperLimit': '0.81'}]}]}, {'title': 'anti-4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.46', 'groupId': 'OG000', 'lowerLimit': '2.14', 'upperLimit': '2.83'}, {'value': '1.96', 'groupId': 'OG001', 'lowerLimit': '1.69', 'upperLimit': '2.26'}]}]}, {'title': 'anti-5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.09', 'groupId': 'OG000', 'lowerLimit': '1.84', 'upperLimit': '2.37'}, {'value': '1.67', 'groupId': 'OG001', 'lowerLimit': '1.46', 'upperLimit': '1.91'}]}]}, {'title': 'anti-6A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.59', 'groupId': 'OG000', 'lowerLimit': '7.50', 'upperLimit': '9.85'}, {'value': '7.28', 'groupId': 'OG001', 'lowerLimit': '6.33', 'upperLimit': '8.37'}]}]}, {'title': 'anti-6B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.36', 'groupId': 'OG000', 'lowerLimit': '6.33', 'upperLimit': '8.55'}, {'value': '6.68', 'groupId': 'OG001', 'lowerLimit': '5.70', 'upperLimit': '7.83'}]}]}, {'title': 'anti-7F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.14', 'groupId': 'OG000', 'lowerLimit': '4.49', 'upperLimit': '5.88'}, {'value': '4.81', 'groupId': 'OG001', 'lowerLimit': '4.23', 'upperLimit': '5.47'}]}]}, {'title': 'anti-9V', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.03', 'groupId': 'OG000', 'lowerLimit': '1.78', 'upperLimit': '2.30'}, {'value': '1.79', 'groupId': 'OG001', 'lowerLimit': '1.59', 'upperLimit': '2.03'}]}]}, {'title': 'anti-14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.1', 'groupId': 'OG000', 'lowerLimit': '11.38', 'upperLimit': '15.07'}, {'value': '11.94', 'groupId': 'OG001', 'lowerLimit': '10.43', 'upperLimit': '13.66'}]}]}, {'title': 'anti-18C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.53', 'groupId': 'OG000', 'lowerLimit': '2.19', 'upperLimit': '2.92'}, {'value': '2.13', 'groupId': 'OG001', 'lowerLimit': '1.84', 'upperLimit': '2.47'}]}]}, {'title': 'anti-19A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.60', 'groupId': 'OG000', 'lowerLimit': '8.41', 'upperLimit': '10.97'}, {'value': '8.62', 'groupId': 'OG001', 'lowerLimit': '7.53', 'upperLimit': '9.87'}]}]}, {'title': 'anti-19F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.40', 'groupId': 'OG000', 'lowerLimit': '7.33', 'upperLimit': '9.62'}, {'value': '7.98', 'groupId': 'OG001', 'lowerLimit': '6.96', 'upperLimit': '9.15'}]}]}, {'title': 'anti-23F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.33', 'groupId': 'OG000', 'lowerLimit': '4.57', 'upperLimit': '6.21'}, {'value': '4.47', 'groupId': 'OG001', 'lowerLimit': '3.83', 'upperLimit': '5.23'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 month after administration of Prevnar 13 (i.e. at Month 1)', 'description': 'GMCs for anti-pneumococcal antibodies (anti-1, anti-3, anti-4, anti-5, anti-6A, anti-6B, anti-7F, anti-9V, anti-14, anti-18C, anti-19A, anti-19F and anti-23F) were measured in microgram per milliliter (mcg/mL). ATP cohort for immunogenicity post dose 1 included all evaluable participants who met eligibility criteria, complied with the procedures defined in the protocol and with no elimination criteria during the study from the ATP cohort for safety, received all study vaccines at Month 0, had assay results available for antibodies against at least one study vaccine antigen component at Visit 2 (Month 1), and had available blood sample at Visit 2 (Month 1) for PCV13 group.', 'unitOfMeasure': 'mcg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyzed on ATP cohort for immunogenicity post dose 1 population. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure and \'number analyzed\' signifies participants evaluable for each specified category. Data for this outcome measure was not planned to be collected and analyzed for ACWY1d and ACWY2d reporting groups.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >=1:4 and >=1:8 at 1 Month After Administration of 1 Dose of MenACWY-TT in the ACWY1d and ACWY2d Groups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ACWY1d Group', 'description': 'Participants received single dose of meningococcal polysaccharide groups A, C, W-135, and Y tetanus toxoid conjugate (MenACWY-TT) vaccine administered intramuscularly at Month 0.'}, {'id': 'OG001', 'title': 'ACWY2d Group', 'description': 'Participants received two doses of MenACWY-TT vaccine administered intramuscularly at Month 0 and Month 2.'}], 'classes': [{'title': 'hSBA-MenA: >=1:4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '95.9', 'groupId': 'OG000', 'lowerLimit': '88.6', 'upperLimit': '99.2'}, {'value': '97.0', 'groupId': 'OG001', 'lowerLimit': '89.5', 'upperLimit': '99.6'}]}]}, {'title': 'hSBA-MenC: >=1:4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '98.7', 'groupId': 'OG000', 'lowerLimit': '93.1', 'upperLimit': '100.0'}, {'value': '97.1', 'groupId': 'OG001', 'lowerLimit': '90.1', 'upperLimit': '99.7'}]}]}, {'title': 'hSBA-MenW-135: >=1:4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '62.5', 'groupId': 'OG000', 'lowerLimit': '50.3', 'upperLimit': '73.6'}, {'value': '68.9', 'groupId': 'OG001', 'lowerLimit': '55.7', 'upperLimit': '80.1'}]}]}, {'title': 'hSBA-MenY: >=1:4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '67.6', 'groupId': 'OG000', 'lowerLimit': '55.5', 'upperLimit': '78.2'}, {'value': '64.3', 'groupId': 'OG001', 'lowerLimit': '50.4', 'upperLimit': '76.6'}]}]}, {'title': 'hSBA-MenA: >=1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '95.9', 'groupId': 'OG000', 'lowerLimit': '88.6', 'upperLimit': '99.2'}, {'value': '97.0', 'groupId': 'OG001', 'lowerLimit': '89.5', 'upperLimit': '99.6'}]}]}, {'title': 'hSBA-MenC: >=1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '98.7', 'groupId': 'OG000', 'lowerLimit': '93.1', 'upperLimit': '100.0'}, {'value': '95.7', 'groupId': 'OG001', 'lowerLimit': '88.0', 'upperLimit': '99.1'}]}]}, {'title': 'hSBA-MenW-135: >=1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '62.5', 'groupId': 'OG000', 'lowerLimit': '50.3', 'upperLimit': '73.6'}, {'value': '68.9', 'groupId': 'OG001', 'lowerLimit': '55.7', 'upperLimit': '80.1'}]}]}, {'title': 'hSBA-MenY: >=1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '67.6', 'groupId': 'OG000', 'lowerLimit': '55.5', 'upperLimit': '78.2'}, {'value': '64.3', 'groupId': 'OG001', 'lowerLimit': '50.4', 'upperLimit': '76.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month after administration of 1st dose of MenACWY-TT (i.e. at Month 1)', 'description': 'Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). Percentage of participants with hSBA titers \\>=1:4 and \\>=1:8 against each serogroup at 1 month after administration of MenACWY-TT are reported. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyzed on ATP cohort for persistence Year 1 population. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure and \'number analyzed\' signifies participants evaluable for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Co-ad and PCV13 reporting groups.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With hSBA Titers >=1:4 and >=1:8 at 1 Month After Administration of 2 Doses of MenACWY-TT in the ACWY2d Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ACWY2d Group', 'description': 'Participants received two doses of MenACWY-TT vaccine administered intramuscularly at Month 0 and Month 2.'}], 'classes': [{'title': 'hSBA-MenA: >=1:4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '97.0', 'groupId': 'OG000', 'lowerLimit': '89.5', 'upperLimit': '99.6'}]}]}, {'title': 'hSBA-MenC: >=1:4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '94.8', 'upperLimit': '100.0'}]}]}, {'title': 'hSBA-MenW-135: >=1:4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '97.1', 'groupId': 'OG000', 'lowerLimit': '90.1', 'upperLimit': '99.7'}]}]}, {'title': 'hSBA-MenY: >=1:4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '95.3', 'groupId': 'OG000', 'lowerLimit': '86.9', 'upperLimit': '99.0'}]}]}, {'title': 'hSBA-MenA: >=1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '97.0', 'groupId': 'OG000', 'lowerLimit': '89.5', 'upperLimit': '99.6'}]}]}, {'title': 'hSBA-MenC: >=1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000', 'lowerLimit': '94.8', 'upperLimit': '100.0'}]}]}, {'title': 'hSBA-MenW-135: >=1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '97.1', 'groupId': 'OG000', 'lowerLimit': '90.1', 'upperLimit': '99.7'}]}]}, {'title': 'hSBA-MenY: >=1:8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '95.3', 'groupId': 'OG000', 'lowerLimit': '86.9', 'upperLimit': '99.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month after administration of 2nd dose of MenACWY-TT (i.e. at Month 3)', 'description': 'Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). Percentage of participants with hSBA titers \\>=1:4 and \\>=1:8 against each serogroup at 1 month after administration of 2 doses of MenACWY-TT are reported. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyzed on ATP cohort for persistence Year 1 population. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure and \'number analyzed\' signifies participants evaluable for each specified category. Data for this outcome measure was not planned to be collected and analyzed for ACWY1d, Co-ad and PCV13 reporting groups.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Titers (GMTs) With hSBA for Each of the 4 Serogroups Following Vaccination at 1 Month After Administration of 1 Dose of MenACWY-TT in the ACWY1d and ACWY2d Groups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ACWY1d Group', 'description': 'Participants received single dose of meningococcal polysaccharide groups A, C, W-135, and Y tetanus toxoid conjugate (MenACWY-TT) vaccine administered intramuscularly at Month 0.'}, {'id': 'OG001', 'title': 'ACWY2d Group', 'description': 'Participants received two doses of MenACWY-TT vaccine administered intramuscularly at Month 0 and Month 2.'}], 'classes': [{'title': 'hSBA-MenA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '118.0', 'groupId': 'OG000', 'lowerLimit': '86.8', 'upperLimit': '160.5'}, {'value': '132.9', 'groupId': 'OG001', 'lowerLimit': '98.1', 'upperLimit': '180.1'}]}]}, {'title': 'hSBA-MenC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '151.9', 'groupId': 'OG000', 'lowerLimit': '104.8', 'upperLimit': '220.4'}, {'value': '160.8', 'groupId': 'OG001', 'lowerLimit': '109.8', 'upperLimit': '235.5'}]}]}, {'title': 'hSBA-MenW-135', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27.5', 'groupId': 'OG000', 'lowerLimit': '16.1', 'upperLimit': '46.8'}, {'value': '26.2', 'groupId': 'OG001', 'lowerLimit': '16.0', 'upperLimit': '43.0'}]}]}, {'title': 'hSBA-MenY', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '41.2', 'groupId': 'OG000', 'lowerLimit': '23.7', 'upperLimit': '71.5'}, {'value': '31.9', 'groupId': 'OG001', 'lowerLimit': '17.6', 'upperLimit': '57.9'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 month after administration of 1st dose of MenACWY-TT (i.e. at Month 1)', 'description': 'Geometric mean titers of antibodies against each serogroup were assessed using hSBA. Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). hSBA titers are expressed as 1/dilution. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.', 'unitOfMeasure': 'titers (1/dilution)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyzed on ATP cohort for persistence Year 1 population. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure and \'number analyzed\' signifies participants evaluable for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Co-ad and PCV13 reporting groups.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Titers (GMTs) With hSBA for Each of the 4 Serogroups Following Vaccination at 1 Month After Administration of 2 Doses of MenACWY-TT in the ACWY2d Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ACWY2d Group', 'description': 'Participants received two doses of MenACWY-TT vaccine administered intramuscularly at Month 0 and Month 2.'}], 'classes': [{'title': 'hSBA-MenA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '170.5', 'groupId': 'OG000', 'lowerLimit': '126.2', 'upperLimit': '230.2'}]}]}, {'title': 'hSBA-MenC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1753.3', 'groupId': 'OG000', 'lowerLimit': '1278.7', 'upperLimit': '2404.2'}]}]}, {'title': 'hSBA-MenW-135', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '756.8', 'groupId': 'OG000', 'lowerLimit': '550.1', 'upperLimit': '1041.3'}]}]}, {'title': 'hSBA-MenY', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '513.0', 'groupId': 'OG000', 'lowerLimit': '339.4', 'upperLimit': '775.4'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 month after administration of 2nd dose of MenACWY-TT (i.e. at Month 3)', 'description': 'Geometric mean titers of antibodies against each serogroup were assessed using hSBA. Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). hSBA titers are expressed as 1/dilution. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.', 'unitOfMeasure': 'titers (1/dilution)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyzed on ATP cohort for persistence Year 1 population. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure and \'number analyzed\' signifies participants evaluable for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Co-ad and PCV13 reporting groups.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at 1 Month After Administration of 1 Dose of MenACWY-TT in the PCV-13 Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PCV13 Group', 'description': 'Participants received single dose of Prevnar 13 at Month 0 and single dose of MenACWY-TT administered intramuscularly at Month 2.'}], 'classes': [{'title': 'rSBA-MenA: >=1:8', 'categories': [{'measurements': [{'value': '96.4', 'groupId': 'OG000', 'lowerLimit': '92.4', 'upperLimit': '98.7'}]}]}, {'title': 'rSBA-MenC: >=1:8', 'categories': [{'measurements': [{'value': '95.3', 'groupId': 'OG000', 'lowerLimit': '90.9', 'upperLimit': '97.9'}]}]}, {'title': 'rSBA-MenW-135: >=1:8', 'categories': [{'measurements': [{'value': '96.4', 'groupId': 'OG000', 'lowerLimit': '92.4', 'upperLimit': '98.7'}]}]}, {'title': 'rSBA-MenY: >=1:8', 'categories': [{'measurements': [{'value': '97.0', 'groupId': 'OG000', 'lowerLimit': '93.2', 'upperLimit': '99.0'}]}]}, {'title': 'rSBA-MenA: >=1:128', 'categories': [{'measurements': [{'value': '95.9', 'groupId': 'OG000', 'lowerLimit': '91.7', 'upperLimit': '98.3'}]}]}, {'title': 'rSBA-MenC: >=1:128', 'categories': [{'measurements': [{'value': '85.8', 'groupId': 'OG000', 'lowerLimit': '79.6', 'upperLimit': '90.7'}]}]}, {'title': 'rSBA-MenW-135: >=1:128', 'categories': [{'measurements': [{'value': '96.4', 'groupId': 'OG000', 'lowerLimit': '92.4', 'upperLimit': '98.7'}]}]}, {'title': 'rSBA-MenY: >=1:128', 'categories': [{'measurements': [{'value': '97.0', 'groupId': 'OG000', 'lowerLimit': '93.2', 'upperLimit': '99.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month after administration of 1st dose of MenACWY-TT (i.e. at Month 3)', 'description': 'Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). Percentage of participants with rSBA titers \\>=1:8 and \\>=1:128 against each serogroup at 1 month after administration of MenACWY-TT are reported. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyzed on ATP cohort for persistence Year 1 population. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure. Data for this outcome measure was not planned to be collected and analyzed for ACWY1d, ACWY2d and Co-ad reporting groups.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Titers (GMTs) With rSBA Titers for Each of the 4 Serogroups Following Vaccination at 1 Month After Administration of 1 Dose of MenACWY-TT in the PCV-13 Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'PCV13 Group', 'description': 'Participants received single dose of Prevnar 13 at Month 0 and single dose of MenACWY-TT administered intramuscularly at Month 2.'}], 'classes': [{'title': 'rSBA-MenA', 'categories': [{'measurements': [{'value': '1957.7', 'groupId': 'OG000', 'lowerLimit': '1513.4', 'upperLimit': '2532.3'}]}]}, {'title': 'rSBA-MenC', 'categories': [{'measurements': [{'value': '376.4', 'groupId': 'OG000', 'lowerLimit': '284.7', 'upperLimit': '497.6'}]}]}, {'title': 'rSBA-MenW-135', 'categories': [{'measurements': [{'value': '3490.5', 'groupId': 'OG000', 'lowerLimit': '2643.3', 'upperLimit': '4609.3'}]}]}, {'title': 'rSBA-MenY', 'categories': [{'measurements': [{'value': '1481.2', 'groupId': 'OG000', 'lowerLimit': '1158.4', 'upperLimit': '1893.9'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 month after administration of 1st dose of MenACWY-TT (i.e. at Month 3)', 'description': 'Geometric mean titers of antibodies against each serogroup were assessed using rSBA. Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). rSBA titers are expressed as 1/dilution. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.', 'unitOfMeasure': 'titers (1/dilution)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyzed on ATP cohort for persistence Year 1 population. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure. Data for this outcome measure was not planned to be collected and analyzed for ACWY1d, ACWY2d and Co-ad reporting groups.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With rSBA Titers >=1:128 at 1 Month After Administration of 1 Dose of MenACWY-TT in the ACWY1d, ACWY2d and Co-ad Groups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}, {'value': '178', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ACWY1d Group', 'description': 'Participants received single dose of meningococcal polysaccharide groups A, C, W-135, and Y tetanus toxoid conjugate (MenACWY-TT) vaccine administered intramuscularly at Month 0.'}, {'id': 'OG001', 'title': 'ACWY2d Group', 'description': 'Participants received two doses of MenACWY-TT vaccine administered intramuscularly at Month 0 and Month 2.'}, {'id': 'OG002', 'title': 'Co-ad Group', 'description': 'Participants received single dose of MenACWY-TT vaccine and single dose of Prevnar 13 administered intramuscularly at Month 0.'}], 'classes': [{'title': 'rSBA-MenA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}, {'value': '178', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '94.4', 'groupId': 'OG000', 'lowerLimit': '90.0', 'upperLimit': '97.3'}, {'value': '95.6', 'groupId': 'OG001', 'lowerLimit': '91.1', 'upperLimit': '98.2'}, {'value': '93.8', 'groupId': 'OG002', 'lowerLimit': '89.2', 'upperLimit': '96.9'}]}]}, {'title': 'rSBA-MenC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}, {'value': '157', 'groupId': 'OG001'}, {'value': '176', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '85.5', 'groupId': 'OG000', 'lowerLimit': '79.4', 'upperLimit': '90.3'}, {'value': '85.4', 'groupId': 'OG001', 'lowerLimit': '78.8', 'upperLimit': '90.5'}, {'value': '88.1', 'groupId': 'OG002', 'lowerLimit': '82.3', 'upperLimit': '92.5'}]}]}, {'title': 'rSBA-MenW-135', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}, {'value': '177', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '95.0', 'groupId': 'OG000', 'lowerLimit': '90.7', 'upperLimit': '97.7'}, {'value': '94.3', 'groupId': 'OG001', 'lowerLimit': '89.5', 'upperLimit': '97.4'}, {'value': '92.7', 'groupId': 'OG002', 'lowerLimit': '87.8', 'upperLimit': '96.0'}]}]}, {'title': 'rSBA-MenY', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '157', 'groupId': 'OG001'}, {'value': '177', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '90.6', 'groupId': 'OG000', 'lowerLimit': '85.3', 'upperLimit': '94.4'}, {'value': '91.7', 'groupId': 'OG001', 'lowerLimit': '86.3', 'upperLimit': '95.5'}, {'value': '89.3', 'groupId': 'OG002', 'lowerLimit': '83.7', 'upperLimit': '93.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month after administration of 1st dose of MenACWY-TT (i.e. at Month 1)', 'description': 'Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). Percentage of participants with rSBA titers \\>=1:128 against each serogroup at 1 month after administration of MenACWY-TT are reported. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyzed on ATP cohort for persistence Year 1 population. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure and \'number analyzed\' signifies participants evaluable for each specified category. Data for this outcome measure was not planned to be collected and analyzed for PCV13 reporting group.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at 1 Month After Administration of 1 Dose of MenACWY-TT in ACWY1d, ACWY2d and Co-ad Groups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}, {'value': '178', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ACWY1d Group', 'description': 'Participants received single dose of meningococcal polysaccharide groups A, C, W-135, and Y tetanus toxoid conjugate (MenACWY-TT) vaccine administered intramuscularly at Month 0.'}, {'id': 'OG001', 'title': 'ACWY2d Group', 'description': 'Participants received two doses of MenACWY-TT vaccine administered intramuscularly at Month 0 and Month 2.'}, {'id': 'OG002', 'title': 'Co-ad Group', 'description': 'Participants received single dose of MenACWY-TT vaccine and single dose of Prevnar 13 administered intramuscularly at Month 0.'}], 'classes': [{'title': 'rSBA-MenA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}, {'value': '178', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1437.0', 'groupId': 'OG000', 'lowerLimit': '1118.3', 'upperLimit': '1846.6'}, {'value': '1275.2', 'groupId': 'OG001', 'lowerLimit': '970.5', 'upperLimit': '1675.4'}, {'value': '1146.4', 'groupId': 'OG002', 'lowerLimit': '867.9', 'upperLimit': '1514.3'}]}]}, {'title': 'rSBA-MenC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}, {'value': '157', 'groupId': 'OG001'}, {'value': '176', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '452.3', 'groupId': 'OG000', 'lowerLimit': '345.6', 'upperLimit': '591.9'}, {'value': '369.3', 'groupId': 'OG001', 'lowerLimit': '280.9', 'upperLimit': '485.5'}, {'value': '337.3', 'groupId': 'OG002', 'lowerLimit': '263.8', 'upperLimit': '431.1'}]}]}, {'title': 'rSBA-MenW-135', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '158', 'groupId': 'OG001'}, {'value': '177', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2120.2', 'groupId': 'OG000', 'lowerLimit': '1601.0', 'upperLimit': '2807.8'}, {'value': '2030.1', 'groupId': 'OG001', 'lowerLimit': '1510.7', 'upperLimit': '2728.2'}, {'value': '1550.9', 'groupId': 'OG002', 'lowerLimit': '1137.4', 'upperLimit': '2114.7'}]}]}, {'title': 'rSBA-MenY', 'denoms': [{'units': 'Participants', 'counts': [{'value': '180', 'groupId': 'OG000'}, {'value': '157', 'groupId': 'OG001'}, {'value': '177', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '951.8', 'groupId': 'OG000', 'lowerLimit': '705.0', 'upperLimit': '1284.9'}, {'value': '933.3', 'groupId': 'OG001', 'lowerLimit': '692.3', 'upperLimit': '1258.3'}, {'value': '778.5', 'groupId': 'OG002', 'lowerLimit': '566.2', 'upperLimit': '1070.4'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 month after administration of 1st dose of MenACWY-TT (i.e. at Month 1)', 'description': 'Geometric mean titers of antibodies against each serogroup were assessed using rSBA. Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). rSBA titers are expressed as 1/dilution. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.', 'unitOfMeasure': 'titers (1/dilution)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyzed on ATP cohort for persistence Year 1 population. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure and \'number analyzed\' signifies participants evaluable for each specified category. Data for this outcome measure was not planned to be collected and analyzed for PCV13 reporting group.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With hSBA Titers >=1:4 and >=1:8 at Year 1, 3 and 5 in the ACWY1d and ACWY2d Groups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ACWY1d Group', 'description': 'Participants received single dose of meningococcal polysaccharide groups A, C, W-135, and Y tetanus toxoid conjugate (MenACWY-TT) vaccine administered intramuscularly at Month 0.'}, {'id': 'OG001', 'title': 'ACWY2d Group', 'description': 'Participants received two doses of MenACWY-TT vaccine administered intramuscularly at Month 0 and Month 2.'}], 'classes': [{'title': 'hSBA-MenA: >=1:4 (Year 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '37.1', 'groupId': 'OG000', 'lowerLimit': '25.9', 'upperLimit': '49.5'}, {'value': '35.5', 'groupId': 'OG001', 'lowerLimit': '23.7', 'upperLimit': '48.7'}]}]}, {'title': 'hSBA-MenC: >=1:4 (Year 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '81.7', 'groupId': 'OG000', 'lowerLimit': '70.7', 'upperLimit': '89.9'}, {'value': '93.7', 'groupId': 'OG001', 'lowerLimit': '84.5', 'upperLimit': '98.2'}]}]}, {'title': 'hSBA-MenW-135: >=1:4 (Year 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '95.8', 'groupId': 'OG000', 'lowerLimit': '88.3', 'upperLimit': '99.1'}, {'value': '98.5', 'groupId': 'OG001', 'lowerLimit': '91.7', 'upperLimit': '100.0'}]}]}, {'title': 'hSBA-MenY: >=1:4 (Year 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '91.9', 'groupId': 'OG000', 'lowerLimit': '82.2', 'upperLimit': '97.3'}, {'value': '87.9', 'groupId': 'OG001', 'lowerLimit': '76.7', 'upperLimit': '95.0'}]}]}, {'title': 'hSBA-MenA: >=1:8 (Year 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '35.7', 'groupId': 'OG000', 'lowerLimit': '24.6', 'upperLimit': '48.1'}, {'value': '35.5', 'groupId': 'OG001', 'lowerLimit': '23.7', 'upperLimit': '48.7'}]}]}, {'title': 'hSBA-MenC: >=1:8 (Year 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '80.3', 'groupId': 'OG000', 'lowerLimit': '69.1', 'upperLimit': '88.8'}, {'value': '90.5', 'groupId': 'OG001', 'lowerLimit': '80.4', 'upperLimit': '96.4'}]}]}, {'title': 'hSBA-MenW-135: >=1:8 (Year 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '95.8', 'groupId': 'OG000', 'lowerLimit': '88.3', 'upperLimit': '99.1'}, {'value': '98.5', 'groupId': 'OG001', 'lowerLimit': '91.7', 'upperLimit': '100.0'}]}]}, {'title': 'hSBA-MenY: >=1:8 (Year 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '91.9', 'groupId': 'OG000', 'lowerLimit': '82.2', 'upperLimit': '97.3'}, {'value': '87.9', 'groupId': 'OG001', 'lowerLimit': '76.7', 'upperLimit': '95.0'}]}]}, {'title': 'hSBA-MenA: >=1:4 (Year 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '36.4', 'groupId': 'OG000', 'lowerLimit': '23.8', 'upperLimit': '50.4'}, {'value': '36.0', 'groupId': 'OG001', 'lowerLimit': '22.9', 'upperLimit': '50.8'}]}]}, {'title': 'hSBA-MenC: >=1:4 (Year 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '65.6', 'groupId': 'OG000', 'lowerLimit': '52.3', 'upperLimit': '77.3'}, {'value': '67.9', 'groupId': 'OG001', 'lowerLimit': '54.0', 'upperLimit': '79.7'}]}]}, {'title': 'hSBA-MenW-135: >=1:4 (Year 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '71.6', 'groupId': 'OG000', 'lowerLimit': '59.3', 'upperLimit': '82.0'}, {'value': '87.0', 'groupId': 'OG001', 'lowerLimit': '75.1', 'upperLimit': '94.6'}]}]}, {'title': 'hSBA-MenY: >=1:4 (Year 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '53.1', 'groupId': 'OG000', 'lowerLimit': '40.2', 'upperLimit': '65.7'}, {'value': '61.5', 'groupId': 'OG001', 'lowerLimit': '47.0', 'upperLimit': '74.7'}]}]}, {'title': 'hSBA-MenA: >=1:8 (Year 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '36.4', 'groupId': 'OG000', 'lowerLimit': '23.8', 'upperLimit': '50.4'}, {'value': '36.0', 'groupId': 'OG001', 'lowerLimit': '22.9', 'upperLimit': '50.8'}]}]}, {'title': 'hSBA-MenC: >=1:8 (Year 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '65.6', 'groupId': 'OG000', 'lowerLimit': '52.3', 'upperLimit': '77.3'}, {'value': '67.9', 'groupId': 'OG001', 'lowerLimit': '54.0', 'upperLimit': '79.7'}]}]}, {'title': 'hSBA-MenW-135: >=1:8 (Year 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '71.6', 'groupId': 'OG000', 'lowerLimit': '59.3', 'upperLimit': '82.0'}, {'value': '87.0', 'groupId': 'OG001', 'lowerLimit': '75.1', 'upperLimit': '94.6'}]}]}, {'title': 'hSBA-MenY: >=1:8 (Year 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '53.1', 'groupId': 'OG000', 'lowerLimit': '40.2', 'upperLimit': '65.7'}, {'value': '61.5', 'groupId': 'OG001', 'lowerLimit': '47.0', 'upperLimit': '74.7'}]}]}, {'title': 'hSBA-MenA: >=1:4 (Year 5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27.9', 'groupId': 'OG000', 'lowerLimit': '17.1', 'upperLimit': '40.8'}, {'value': '17.9', 'groupId': 'OG001', 'lowerLimit': '8.9', 'upperLimit': '30.4'}]}]}, {'title': 'hSBA-MenC: >=1:4 (Year 5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '60.7', 'groupId': 'OG000', 'lowerLimit': '47.3', 'upperLimit': '72.9'}, {'value': '67.8', 'groupId': 'OG001', 'lowerLimit': '54.4', 'upperLimit': '79.4'}]}]}, {'title': 'hSBA-MenW-135: >=1:4 (Year 5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '58.9', 'groupId': 'OG000', 'lowerLimit': '45.0', 'upperLimit': '71.9'}, {'value': '63.6', 'groupId': 'OG001', 'lowerLimit': '47.8', 'upperLimit': '77.6'}]}]}, {'title': 'hSBA-MenY: >=1:4 (Year 5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '61.5', 'groupId': 'OG000', 'lowerLimit': '48.6', 'upperLimit': '73.3'}, {'value': '54.2', 'groupId': 'OG001', 'lowerLimit': '39.2', 'upperLimit': '68.6'}]}]}, {'title': 'hSBA-MenA: >=1:8 (Year 5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27.9', 'groupId': 'OG000', 'lowerLimit': '17.1', 'upperLimit': '40.8'}, {'value': '17.9', 'groupId': 'OG001', 'lowerLimit': '8.9', 'upperLimit': '30.4'}]}]}, {'title': 'hSBA-MenC: >=1:8 (Year 5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '60.7', 'groupId': 'OG000', 'lowerLimit': '47.3', 'upperLimit': '72.9'}, {'value': '67.8', 'groupId': 'OG001', 'lowerLimit': '54.4', 'upperLimit': '79.4'}]}]}, {'title': 'hSBA-MenW-135: >=1:8 (Year 5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '58.9', 'groupId': 'OG000', 'lowerLimit': '45.0', 'upperLimit': '71.9'}, {'value': '63.6', 'groupId': 'OG001', 'lowerLimit': '47.8', 'upperLimit': '77.6'}]}]}, {'title': 'hSBA-MenY: >=1:8 (Year 5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '61.5', 'groupId': 'OG000', 'lowerLimit': '48.6', 'upperLimit': '73.3'}, {'value': '54.2', 'groupId': 'OG001', 'lowerLimit': '39.2', 'upperLimit': '68.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Year 1, Year 3, Year 5', 'description': 'Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). Percentage of participants with hSBA titers \\>=1:4 and \\>=1:8 against each serogroup at Year 1, 3 and 5 after administration of MenACWY-TT are reported. ATP cohort for persistence Year 1, 3 and 5 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyzed on ATP cohort for persistence Year 1, 3 and 5 population. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure and \'number analyzed\' signifies participants evaluable for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Co-ad and PCV13 reporting groups.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Titers (GMTs) With hSBA for Each of the 4 Serogroups Following Vaccination at Year 1, 3 and 5 in the ACWY1d and ACWY2d Groups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ACWY1d Group', 'description': 'Participants received single dose of meningococcal polysaccharide groups A, C, W-135, and Y tetanus toxoid conjugate (MenACWY-TT) vaccine administered intramuscularly at Month 0.'}, {'id': 'OG001', 'title': 'ACWY2d Group', 'description': 'Participants received two doses of MenACWY-TT vaccine administered intramuscularly at Month 0 and Month 2.'}], 'classes': [{'title': 'hSBA-MenA (Year 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.1', 'groupId': 'OG000', 'lowerLimit': '4.1', 'upperLimit': '8.9'}, {'value': '6.4', 'groupId': 'OG001', 'lowerLimit': '4.2', 'upperLimit': '10.0'}]}]}, {'title': 'hSBA-MenC (Year 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '35.2', 'groupId': 'OG000', 'lowerLimit': '22.5', 'upperLimit': '55.2'}, {'value': '73.4', 'groupId': 'OG001', 'lowerLimit': '47.5', 'upperLimit': '113.4'}]}]}, {'title': 'hSBA-MenW-135 (Year 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '72', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '209.0', 'groupId': 'OG000', 'lowerLimit': '149.9', 'upperLimit': '291.4'}, {'value': '232.6', 'groupId': 'OG001', 'lowerLimit': '168.3', 'upperLimit': '321.4'}]}]}, {'title': 'hSBA-MenY (Year 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '144.4', 'groupId': 'OG000', 'lowerLimit': '97.2', 'upperLimit': '214.5'}, {'value': '143.9', 'groupId': 'OG001', 'lowerLimit': '88.5', 'upperLimit': '233.8'}]}]}, {'title': 'hSBA-MenA (Year 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.8', 'groupId': 'OG000', 'lowerLimit': '3.8', 'upperLimit': '8.9'}, {'value': '5.4', 'groupId': 'OG001', 'lowerLimit': '3.6', 'upperLimit': '8.0'}]}]}, {'title': 'hSBA-MenC (Year 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23.6', 'groupId': 'OG000', 'lowerLimit': '13.9', 'upperLimit': '40.2'}, {'value': '27.0', 'groupId': 'OG001', 'lowerLimit': '15.6', 'upperLimit': '46.8'}]}]}, {'title': 'hSBA-MenW-135 (Year 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '67', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30.5', 'groupId': 'OG000', 'lowerLimit': '18.7', 'upperLimit': '49.6'}, {'value': '55.5', 'groupId': 'OG001', 'lowerLimit': '35.3', 'upperLimit': '87.1'}]}]}, {'title': 'hSBA-MenY (Year 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.3', 'groupId': 'OG000', 'lowerLimit': '10.1', 'upperLimit': '29.6'}, {'value': '24.1', 'groupId': 'OG001', 'lowerLimit': '13.3', 'upperLimit': '43.8'}]}]}, {'title': 'hSBA-MenA (Year 5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.4', 'groupId': 'OG000', 'lowerLimit': '3.1', 'upperLimit': '6.2'}, {'value': '3.1', 'groupId': 'OG001', 'lowerLimit': '2.4', 'upperLimit': '4.0'}]}]}, {'title': 'hSBA-MenC (Year 5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.1', 'groupId': 'OG000', 'lowerLimit': '10.9', 'upperLimit': '30.0'}, {'value': '29.4', 'groupId': 'OG001', 'lowerLimit': '16.3', 'upperLimit': '52.9'}]}]}, {'title': 'hSBA-MenW-135 (Year 5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '56', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.8', 'groupId': 'OG000', 'lowerLimit': '11.6', 'upperLimit': '37.1'}, {'value': '19.5', 'groupId': 'OG001', 'lowerLimit': '10.7', 'upperLimit': '35.2'}]}]}, {'title': 'hSBA-MenY (Year 5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24.3', 'groupId': 'OG000', 'lowerLimit': '14.3', 'upperLimit': '41.1'}, {'value': '16.8', 'groupId': 'OG001', 'lowerLimit': '9.0', 'upperLimit': '31.3'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Year 1, Year 3, Year 5', 'description': 'Geometric mean titers of antibodies against each serogroup were assessed using hSBA. Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). hSBA titers are expressed as 1/dilution. ATP cohort for persistence Year 1, 3 and 5 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.', 'unitOfMeasure': 'titers (1/dilution)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyzed on ATP cohort for persistence Year 1, 3 and 5 population. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure and \'number analyzed\' signifies participants evaluable for each specified category. Data for this outcome measure was not planned to be collected and analyzed for Co-ad and PCV13 reporting groups.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at Year 1, 3 and 5 in the Co-ad and PCV-13 Groups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Co-ad Group', 'description': 'Participants received single dose of MenACWY-TT vaccine and single dose of Prevnar 13 administered intramuscularly at Month 0.'}, {'id': 'OG001', 'title': 'PCV13 Group', 'description': 'Participants received single dose of Prevnar 13 at Month 0 and single dose of MenACWY-TT administered intramuscularly at Month 2.'}], 'classes': [{'title': 'rSBA-MenA: >=1:8 (Year 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '66.5', 'groupId': 'OG000', 'lowerLimit': '58.9', 'upperLimit': '73.5'}, {'value': '70.4', 'groupId': 'OG001', 'lowerLimit': '62.9', 'upperLimit': '77.2'}]}]}, {'title': 'rSBA-MenC: >=1:8 (Year 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '42.7', 'groupId': 'OG000', 'lowerLimit': '35.2', 'upperLimit': '50.5'}, {'value': '50.3', 'groupId': 'OG001', 'lowerLimit': '42.5', 'upperLimit': '58.1'}]}]}, {'title': 'rSBA-MenW-135: >=1:8 (Year 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '60.2', 'groupId': 'OG000', 'lowerLimit': '52.5', 'upperLimit': '67.6'}, {'value': '72.8', 'groupId': 'OG001', 'lowerLimit': '65.4', 'upperLimit': '79.3'}]}]}, {'title': 'rSBA-MenY: >=1:8 (Year 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '67.1', 'groupId': 'OG000', 'lowerLimit': '59.5', 'upperLimit': '74.0'}, {'value': '80.5', 'groupId': 'OG001', 'lowerLimit': '73.7', 'upperLimit': '86.2'}]}]}, {'title': 'rSBA-MenA: >=1:128 (Year 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '42.8', 'groupId': 'OG000', 'lowerLimit': '35.3', 'upperLimit': '50.5'}, {'value': '56.2', 'groupId': 'OG001', 'lowerLimit': '48.4', 'upperLimit': '63.8'}]}]}, {'title': 'rSBA-MenC: >=1:128 (Year 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.8', 'groupId': 'OG000', 'lowerLimit': '10.7', 'upperLimit': '22.1'}, {'value': '20.1', 'groupId': 'OG001', 'lowerLimit': '14.4', 'upperLimit': '27.0'}]}]}, {'title': 'rSBA-MenW-135: >=1:128 (Year 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '42.7', 'groupId': 'OG000', 'lowerLimit': '35.2', 'upperLimit': '50.5'}, {'value': '58.0', 'groupId': 'OG001', 'lowerLimit': '50.2', 'upperLimit': '65.5'}]}]}, {'title': 'rSBA-MenY: >=1:128 (Year 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '53.8', 'groupId': 'OG000', 'lowerLimit': '46.0', 'upperLimit': '61.4'}, {'value': '69.2', 'groupId': 'OG001', 'lowerLimit': '61.7', 'upperLimit': '76.1'}]}]}, {'title': 'rSBA-MenA: >=1:8 (Year 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '51.0', 'groupId': 'OG000', 'lowerLimit': '42.7', 'upperLimit': '59.2'}, {'value': '53.8', 'groupId': 'OG001', 'lowerLimit': '44.9', 'upperLimit': '62.5'}]}]}, {'title': 'rSBA-MenC: >=1:8 (Year 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28.5', 'groupId': 'OG000', 'lowerLimit': '21.4', 'upperLimit': '36.4'}, {'value': '31.8', 'groupId': 'OG001', 'lowerLimit': '24.0', 'upperLimit': '40.5'}]}]}, {'title': 'rSBA-MenW-135: >=1:8 (Year 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '53.0', 'groupId': 'OG000', 'lowerLimit': '44.7', 'upperLimit': '61.1'}, {'value': '56.8', 'groupId': 'OG001', 'lowerLimit': '47.9', 'upperLimit': '65.4'}]}]}, {'title': 'rSBA-MenY: >=1:8 (Year 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '62.9', 'groupId': 'OG000', 'lowerLimit': '54.7', 'upperLimit': '70.6'}, {'value': '73.5', 'groupId': 'OG001', 'lowerLimit': '65.1', 'upperLimit': '80.8'}]}]}, {'title': 'rSBA-MenA: >=1:128 (Year 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '39.1', 'groupId': 'OG000', 'lowerLimit': '31.2', 'upperLimit': '47.3'}, {'value': '40.2', 'groupId': 'OG001', 'lowerLimit': '31.7', 'upperLimit': '49.0'}]}]}, {'title': 'rSBA-MenC: >=1:128 (Year 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.6', 'groupId': 'OG000', 'lowerLimit': '9.4', 'upperLimit': '21.2'}, {'value': '10.6', 'groupId': 'OG001', 'lowerLimit': '5.9', 'upperLimit': '17.2'}]}]}, {'title': 'rSBA-MenW-135: >=1:128 (Year 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '39.1', 'groupId': 'OG000', 'lowerLimit': '31.2', 'upperLimit': '47.3'}, {'value': '42.4', 'groupId': 'OG001', 'lowerLimit': '33.9', 'upperLimit': '51.3'}]}]}, {'title': 'rSBA-MenY: >=1:128 (Year 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '53.0', 'groupId': 'OG000', 'lowerLimit': '44.7', 'upperLimit': '61.1'}, {'value': '59.8', 'groupId': 'OG001', 'lowerLimit': '51.0', 'upperLimit': '68.3'}]}]}, {'title': 'rSBA-MenA: >=1:8 (Year 5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '45.8', 'groupId': 'OG000', 'lowerLimit': '37.4', 'upperLimit': '54.3'}, {'value': '47.3', 'groupId': 'OG001', 'lowerLimit': '38.4', 'upperLimit': '56.3'}]}]}, {'title': 'rSBA-MenC: >=1:8 (Year 5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23.9', 'groupId': 'OG000', 'lowerLimit': '17.2', 'upperLimit': '31.8'}, {'value': '19.4', 'groupId': 'OG001', 'lowerLimit': '13.0', 'upperLimit': '27.3'}]}]}, {'title': 'rSBA-MenW-135: >=1:8 (Year 5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '43.0', 'groupId': 'OG000', 'lowerLimit': '34.7', 'upperLimit': '51.5'}, {'value': '45.0', 'groupId': 'OG001', 'lowerLimit': '36.2', 'upperLimit': '54.0'}]}]}, {'title': 'rSBA-MenY: >=1:8 (Year 5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '52.8', 'groupId': 'OG000', 'lowerLimit': '44.3', 'upperLimit': '61.2'}, {'value': '55.8', 'groupId': 'OG001', 'lowerLimit': '46.8', 'upperLimit': '64.5'}]}]}, {'title': 'rSBA-MenA: >=1:128 (Year 5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '19.0', 'groupId': 'OG000', 'lowerLimit': '12.9', 'upperLimit': '26.4'}, {'value': '36.4', 'groupId': 'OG001', 'lowerLimit': '28.1', 'upperLimit': '45.4'}]}]}, {'title': 'rSBA-MenC: >=1:128 (Year 5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.0', 'groupId': 'OG000', 'lowerLimit': '7.1', 'upperLimit': '18.5'}, {'value': '7.8', 'groupId': 'OG001', 'lowerLimit': '3.8', 'upperLimit': '13.8'}]}]}, {'title': 'rSBA-MenW-135: >=1:128 (Year 5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33.8', 'groupId': 'OG000', 'lowerLimit': '26.1', 'upperLimit': '42.2'}, {'value': '35.7', 'groupId': 'OG001', 'lowerLimit': '27.4', 'upperLimit': '44.6'}]}]}, {'title': 'rSBA-MenY: >=1:128 (Year 5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '42.3', 'groupId': 'OG000', 'lowerLimit': '34.0', 'upperLimit': '50.8'}, {'value': '48.1', 'groupId': 'OG001', 'lowerLimit': '39.2', 'upperLimit': '57.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Year 1, Year 3, Year 5', 'description': 'Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). Percentage of participants with rSBA titers \\>=1:8 and \\>=1:128 against each serogroup at Year 1, 3 and 5 after administration of MenACWY-TT are reported. ATP cohort for persistence Year 1, 3 and 5 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyzed on ATP cohort for persistence Year 1, 3 and 5 population. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure and \'number analyzed\' signifies participants evaluable for each specified category. Data for this outcome measure was not planned to be collected and analyzed for ACWY1d and ACWY2d reporting groups.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at Year 1, 3 and 5 in the Co-ad and PCV-13 Groups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Co-ad Group', 'description': 'Participants received single dose of MenACWY-TT vaccine and single dose of Prevnar 13 administered intramuscularly at Month 0.'}, {'id': 'OG001', 'title': 'PCV13 Group', 'description': 'Participants received single dose of Prevnar 13 at Month 0 and single dose of MenACWY-TT administered intramuscularly at Month 2.'}], 'classes': [{'title': 'rSBA-MenA (Year 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '59.5', 'groupId': 'OG000', 'lowerLimit': '40.7', 'upperLimit': '87.2'}, {'value': '119.4', 'groupId': 'OG001', 'lowerLimit': '79.5', 'upperLimit': '179.3'}]}]}, {'title': 'rSBA-MenC (Year 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.6', 'groupId': 'OG000', 'lowerLimit': '10.0', 'upperLimit': '16.0'}, {'value': '16.0', 'groupId': 'OG001', 'lowerLimit': '12.2', 'upperLimit': '20.9'}]}]}, {'title': 'rSBA-MenW-135 (Year 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '171', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '52.0', 'groupId': 'OG000', 'lowerLimit': '35.5', 'upperLimit': '76.4'}, {'value': '109.5', 'groupId': 'OG001', 'lowerLimit': '75.0', 'upperLimit': '160.0'}]}]}, {'title': 'rSBA-MenY (Year 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '173', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '70.7', 'groupId': 'OG000', 'lowerLimit': '49.0', 'upperLimit': '102.1'}, {'value': '169.2', 'groupId': 'OG001', 'lowerLimit': '119.2', 'upperLimit': '240.1'}]}]}, {'title': 'rSBA-MenA (Year 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '38.6', 'groupId': 'OG000', 'lowerLimit': '25.4', 'upperLimit': '58.8'}, {'value': '42.3', 'groupId': 'OG001', 'lowerLimit': '27.2', 'upperLimit': '65.6'}]}]}, {'title': 'rSBA-MenC (Year 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.1', 'groupId': 'OG000', 'lowerLimit': '7.1', 'upperLimit': '11.6'}, {'value': '9.3', 'groupId': 'OG001', 'lowerLimit': '7.1', 'upperLimit': '12.1'}]}]}, {'title': 'rSBA-MenW-135 (Year 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '34.4', 'groupId': 'OG000', 'lowerLimit': '23.4', 'upperLimit': '50.6'}, {'value': '44.5', 'groupId': 'OG001', 'lowerLimit': '28.9', 'upperLimit': '68.7'}]}]}, {'title': 'rSBA-MenY (Year 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '132', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '67.6', 'groupId': 'OG000', 'lowerLimit': '45.6', 'upperLimit': '100.3'}, {'value': '106.0', 'groupId': 'OG001', 'lowerLimit': '70.2', 'upperLimit': '160.0'}]}]}, {'title': 'rSBA-MenA (Year 5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.4', 'groupId': 'OG000', 'lowerLimit': '11.1', 'upperLimit': '21.3'}, {'value': '28.3', 'groupId': 'OG001', 'lowerLimit': '18.5', 'upperLimit': '43.2'}]}]}, {'title': 'rSBA-MenC (Year 5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.9', 'groupId': 'OG000', 'lowerLimit': '6.2', 'upperLimit': '10.0'}, {'value': '7.0', 'groupId': 'OG001', 'lowerLimit': '5.5', 'upperLimit': '8.8'}]}]}, {'title': 'rSBA-MenW-135 (Year 5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26.2', 'groupId': 'OG000', 'lowerLimit': '17.6', 'upperLimit': '39.0'}, {'value': '31.7', 'groupId': 'OG001', 'lowerLimit': '20.2', 'upperLimit': '49.6'}]}]}, {'title': 'rSBA-MenY (Year 5)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '43.3', 'groupId': 'OG000', 'lowerLimit': '28.3', 'upperLimit': '66.2'}, {'value': '53.9', 'groupId': 'OG001', 'lowerLimit': '34.5', 'upperLimit': '84.2'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Year 1, Year 3, Year 5', 'description': 'Geometric mean titers of antibodies against each serogroup were assessed using rSBA. Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). rSBA titers are expressed as 1/dilution. ATP cohort for persistence Year 1, 3 and 5 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.', 'unitOfMeasure': 'titers (1/dilution)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyzed on ATP cohort for persistence Year 1, 3 and 5 population. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure and \'number analyzed\' signifies participants evaluable for each specified category. Data for this outcome measure was not planned to be collected and analyzed for ACWY1d and ACWY2d reporting groups.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Antibody Concentrations >=0.15 mcg/mL, >=0.26 mcg/mL and >=0.35 mcg/mL for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Co-ad Group', 'description': 'Participants received single dose of MenACWY-TT vaccine and single dose of Prevnar 13 administered intramuscularly at Month 0.'}, {'id': 'OG001', 'title': 'PCV13 Group', 'description': 'Participants received single dose of Prevnar 13 at Month 0 and single dose of MenACWY-TT administered intramuscularly at Month 2.'}], 'classes': [{'title': 'anti-1 (>=0.15 mcg/mL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '97.7', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '97.9', 'upperLimit': '100'}]}]}, {'title': 'anti-3 (>=0.15 mcg/mL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '99.3', 'groupId': 'OG000', 'lowerLimit': '96.4', 'upperLimit': '100'}, {'value': '97.5', 'groupId': 'OG001', 'lowerLimit': '93.8', 'upperLimit': '99.3'}]}]}, {'title': 'anti-4 (>=0.15 mcg/mL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '97.8', 'upperLimit': '100'}, {'value': '99.4', 'groupId': 'OG001', 'lowerLimit': '96.8', 'upperLimit': '100'}]}]}, {'title': 'anti-5 (>=0.15 mcg/mL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '97.8', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '97.9', 'upperLimit': '100'}]}]}, {'title': 'anti-6A (>=0.15 mcg/mL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '97.8', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '97.9', 'upperLimit': '100'}]}]}, {'title': 'anti-6B (>=0.15 mcg/mL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '97.7', 'upperLimit': '100'}, {'value': '99.4', 'groupId': 'OG001', 'lowerLimit': '96.8', 'upperLimit': '100'}]}]}, {'title': 'anti-7F (>=0.15 mcg/mL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '97.8', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '97.9', 'upperLimit': '100'}]}]}, {'title': 'anti-9V (>=0.15 mcg/mL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '99.4', 'groupId': 'OG000', 'lowerLimit': '96.6', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '97.9', 'upperLimit': '100'}]}]}, {'title': 'anti-14 (>=0.15 mcg/mL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '97.7', 'upperLimit': '100'}, {'value': '99.4', 'groupId': 'OG001', 'lowerLimit': '96.8', 'upperLimit': '100'}]}]}, {'title': 'anti-18C (>=0.15 mcg/mL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '97.8', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '97.9', 'upperLimit': '100'}]}]}, {'title': 'anti-19A (>=0.15 mcg/mL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '97.7', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '97.9', 'upperLimit': '100'}]}]}, {'title': 'anti-19F (>=0.15 mcg/mL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '97.7', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '97.9', 'upperLimit': '100'}]}]}, {'title': 'anti-23F (>=0.15 mcg/mL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '97.7', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '97.8', 'upperLimit': '100'}]}]}, {'title': 'anti-1 (>=0.26 mcg/mL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '99.4', 'groupId': 'OG000', 'lowerLimit': '96.6', 'upperLimit': '100'}, {'value': '99.4', 'groupId': 'OG001', 'lowerLimit': '96.8', 'upperLimit': '100'}]}]}, {'title': 'anti-3 (>=0.26 mcg/mL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '94.0', 'groupId': 'OG000', 'lowerLimit': '89.0', 'upperLimit': '97.2'}, {'value': '88.3', 'groupId': 'OG001', 'lowerLimit': '82.3', 'upperLimit': '92.8'}]}]}, {'title': 'anti-4 (>=0.26 mcg/mL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '98.8', 'groupId': 'OG000', 'lowerLimit': '95.6', 'upperLimit': '99.9'}, {'value': '98.3', 'groupId': 'OG001', 'lowerLimit': '95.0', 'upperLimit': '99.6'}]}]}, {'title': 'anti-5 (>=0.26 mcg/mL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '99.4', 'groupId': 'OG000', 'lowerLimit': '96.6', 'upperLimit': '100'}, {'value': '98.8', 'groupId': 'OG001', 'lowerLimit': '95.9', 'upperLimit': '99.9'}]}]}, {'title': 'anti-6A (>=0.26 mcg/mL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '97.8', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '97.9', 'upperLimit': '100'}]}]}, {'title': 'anti-6B (>=0.26 mcg/mL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '97.7', 'upperLimit': '100'}, {'value': '99.4', 'groupId': 'OG001', 'lowerLimit': '96.8', 'upperLimit': '100'}]}]}, {'title': 'anti-7F (>=0.26 mcg/mL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '97.8', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '97.9', 'upperLimit': '100'}]}]}, {'title': 'anti-9V (>=0.26 mcg/mL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '99.4', 'groupId': 'OG000', 'lowerLimit': '96.6', 'upperLimit': '100'}, {'value': '98.8', 'groupId': 'OG001', 'lowerLimit': '95.9', 'upperLimit': '99.9'}]}]}, {'title': 'anti-14 (>=0.26 mcg/mL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '97.7', 'upperLimit': '100'}, {'value': '99.4', 'groupId': 'OG001', 'lowerLimit': '96.8', 'upperLimit': '100'}]}]}, {'title': 'anti-18C (>=0.26 mcg/mL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '98.8', 'groupId': 'OG000', 'lowerLimit': '95.6', 'upperLimit': '99.9'}, {'value': '99.4', 'groupId': 'OG001', 'lowerLimit': '96.8', 'upperLimit': '100'}]}]}, {'title': 'anti-19A (>=0.26 mcg/mL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '97.7', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '97.9', 'upperLimit': '100'}]}]}, {'title': 'anti-19F (>=0.26 mcg/mL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '97.7', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '97.9', 'upperLimit': '100'}]}]}, {'title': 'anti-23F (>=0.26 mcg/mL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '99.4', 'groupId': 'OG000', 'lowerLimit': '96.6', 'upperLimit': '100'}, {'value': '99.4', 'groupId': 'OG001', 'lowerLimit': '96.7', 'upperLimit': '100'}]}]}, {'title': 'anti-1 (>=0.35 mcg/mL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '99.4', 'groupId': 'OG000', 'lowerLimit': '96.6', 'upperLimit': '100'}, {'value': '98.2', 'groupId': 'OG001', 'lowerLimit': '95.0', 'upperLimit': '99.6'}]}]}, {'title': 'anti-3 (>=0.35 mcg/mL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '83.4', 'groupId': 'OG000', 'lowerLimit': '76.5', 'upperLimit': '89.0'}, {'value': '79.0', 'groupId': 'OG001', 'lowerLimit': '71.9', 'upperLimit': '85.0'}]}]}, {'title': 'anti-4 (>=0.35 mcg/mL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '96.9', 'groupId': 'OG000', 'lowerLimit': '93.0', 'upperLimit': '99.0'}, {'value': '97.1', 'groupId': 'OG001', 'lowerLimit': '93.3', 'upperLimit': '99.0'}]}]}, {'title': 'anti-5 (>=0.35 mcg/mL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '98.8', 'groupId': 'OG000', 'lowerLimit': '95.6', 'upperLimit': '99.9'}, {'value': '94.8', 'groupId': 'OG001', 'lowerLimit': '90.3', 'upperLimit': '97.6'}]}]}, {'title': 'anti-6A (>=0.35 mcg/mL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '99.4', 'groupId': 'OG000', 'lowerLimit': '96.6', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '97.9', 'upperLimit': '100'}]}]}, {'title': 'anti-6B (>=0.35 mcg/mL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '99.4', 'groupId': 'OG000', 'lowerLimit': '96.6', 'upperLimit': '100'}, {'value': '99.4', 'groupId': 'OG001', 'lowerLimit': '96.8', 'upperLimit': '100'}]}]}, {'title': 'anti-7F (>=0.35 mcg/mL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '99.4', 'groupId': 'OG000', 'lowerLimit': '96.6', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '97.9', 'upperLimit': '100'}]}]}, {'title': 'anti-9V (>=0.35 mcg/mL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '99.4', 'groupId': 'OG000', 'lowerLimit': '96.6', 'upperLimit': '100'}, {'value': '97.7', 'groupId': 'OG001', 'lowerLimit': '94.2', 'upperLimit': '99.4'}]}]}, {'title': 'anti-14 (>=0.35 mcg/mL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '97.7', 'upperLimit': '100'}, {'value': '99.4', 'groupId': 'OG001', 'lowerLimit': '96.8', 'upperLimit': '100'}]}]}, {'title': 'anti-18C (>=0.35 mcg/mL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '98.8', 'groupId': 'OG000', 'lowerLimit': '95.6', 'upperLimit': '99.9'}, {'value': '99.4', 'groupId': 'OG001', 'lowerLimit': '96.8', 'upperLimit': '100'}]}]}, {'title': 'anti-19A (>=0.35 mcg/mL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '170', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '97.7', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '97.9', 'upperLimit': '100'}]}]}, {'title': 'anti-19F (>=0.35 mcg/mL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '97.7', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '97.9', 'upperLimit': '100'}]}]}, {'title': 'anti-23F (>=0.35 mcg/mL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}, {'value': '169', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '99.4', 'groupId': 'OG000', 'lowerLimit': '96.6', 'upperLimit': '100'}, {'value': '99.4', 'groupId': 'OG001', 'lowerLimit': '96.7', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month after administration of Prevnar 13 (i.e. at Month 1)', 'description': 'Antibody concentrations were determined for anti-pneumococcal antibodies: anti-1, anti-3, anti-4, anti-5, anti-6A, anti-6B, anti-7F, anti-9V, anti-14, anti-18C, anti-19A, anti-19F and anti-23F. Percentage of participants with antibody concentrations \\>=0.15 mcg/mL, \\>=0.26 mcg/mL and \\>=0.35 mcg/mL against each serogroup at 1 month after administration of Prevnar 13 are reported. ATP cohort for immunogenicity post dose 1 included all evaluable participants who met eligibility criteria, complied with the procedures defined in the protocol and with no elimination criteria during the study from the ATP cohort for safety, received all study vaccines at Month 0, had assay results available for antibodies against at least one study vaccine antigen component at Visit 2, those with available blood sample at Visit 2 for PCV13 group.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyzed on ATP cohort for immunogenicity post dose 1 population. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure and \'number analyzed\' signifies participants evaluable for each specified category. Data for this outcome measure was not planned to be collected and analyzed for ACWY1d and ACWY2d reporting groups.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >=1:8 for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Co-ad Group', 'description': 'Participants received single dose of MenACWY-TT vaccine and single dose of Prevnar 13 administered intramuscularly at Month 0.'}, {'id': 'OG001', 'title': 'PCV13 Group', 'description': 'Participants received single dose of Prevnar 13 at Month 0 and single dose of MenACWY-TT administered intramuscularly at Month 2.'}], 'classes': [{'title': 'OPSONO-1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '93.8', 'groupId': 'OG000', 'lowerLimit': '86.2', 'upperLimit': '98.0'}, {'value': '90.7', 'groupId': 'OG001', 'lowerLimit': '82.5', 'upperLimit': '95.9'}]}]}, {'title': 'OPSONO-3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '98.7', 'groupId': 'OG000', 'lowerLimit': '92.9', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '95.5', 'upperLimit': '100'}]}]}, {'title': 'OPSONO-4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '95.3', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '95.5', 'upperLimit': '100'}]}]}, {'title': 'OPSONO-5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '95.5', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '95.8', 'upperLimit': '100'}]}]}, {'title': 'OPSONO-6A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '95.5', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '95.9', 'upperLimit': '100'}]}]}, {'title': 'OPSONO-6B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '95.2', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '95.4', 'upperLimit': '100'}]}]}, {'title': 'OPSONO-7F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '95.5', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '95.8', 'upperLimit': '100'}]}]}, {'title': 'OPSONO-9V', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '95.5', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '95.9', 'upperLimit': '100'}]}]}, {'title': 'OPSONO-14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '95.1', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '95.4', 'upperLimit': '100'}]}]}, {'title': 'OPSONO-18C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '95.5', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '95.9', 'upperLimit': '100'}]}]}, {'title': 'OPSONO-19A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '95.5', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '95.9', 'upperLimit': '100'}]}]}, {'title': 'OPSONO-19F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '98.8', 'groupId': 'OG000', 'lowerLimit': '93.3', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '95.9', 'upperLimit': '100'}]}]}, {'title': 'OPSONO-23F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '98.7', 'groupId': 'OG000', 'lowerLimit': '93.0', 'upperLimit': '100'}, {'value': '98.8', 'groupId': 'OG001', 'lowerLimit': '93.2', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month after administration of Prevnar 13 (i.e. at Month 1)', 'description': 'OPA titers were determined for anti-pneumococcal serotypes: OPSONO-1, OPSONO-3, OPSONO-4, OPSONO-5, OPSONO-6A, OPSONO-6B, OPSONO-7F, OPSONO-9V, OPSONO-14, OPSONO-18C, OPSONO-19A, OPSONO-19F and OPSONO-23F. Percentage of participants with OPA titers \\>=1:8 against each serogroup at 1 month after administration of Prevnar 13 are reported. ATP cohort for immunogenicity post dose 1 included all evaluable participants who met eligibility criteria, complied with the procedures defined in the protocol and with no elimination criteria during the study from the ATP cohort for safety, received all study vaccines at Month 0, had assay results available for antibodies against at least one study vaccine antigen component at Visit 2, those with available blood sample at Visit 2 for PCV13 group.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyzed on ATP cohort for immunogenicity post dose 1 population. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure and \'number analyzed\' signifies participants evaluable for each specified category. Data for this outcome measure was not planned to be collected and analyzed for ACWY1d and ACWY2d reporting groups.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Titers (GMTs) With OPA for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Co-ad Group', 'description': 'Participants received single dose of MenACWY-TT vaccine and single dose of Prevnar 13 administered intramuscularly at Month 0.'}, {'id': 'OG001', 'title': 'PCV13 Group', 'description': 'Participants received single dose of Prevnar 13 at Month 0 and single dose of MenACWY-TT administered intramuscularly at Month 2.'}], 'classes': [{'title': 'OPSONO-1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '116.1', 'groupId': 'OG000', 'lowerLimit': '83.8', 'upperLimit': '160.7'}, {'value': '106.1', 'groupId': 'OG001', 'lowerLimit': '77.0', 'upperLimit': '146.2'}]}]}, {'title': 'OPSONO-3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '137.6', 'groupId': 'OG000', 'lowerLimit': '106.4', 'upperLimit': '178.0'}, {'value': '122.0', 'groupId': 'OG001', 'lowerLimit': '100.6', 'upperLimit': '147.9'}]}]}, {'title': 'OPSONO-4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2194.8', 'groupId': 'OG000', 'lowerLimit': '1660.0', 'upperLimit': '2901.9'}, {'value': '2210.1', 'groupId': 'OG001', 'lowerLimit': '1735.0', 'upperLimit': '2815.2'}]}]}, {'title': 'OPSONO-5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '452.3', 'groupId': 'OG000', 'lowerLimit': '360.4', 'upperLimit': '567.5'}, {'value': '404.6', 'groupId': 'OG001', 'lowerLimit': '319.1', 'upperLimit': '512.9'}]}]}, {'title': 'OPSONO-6A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10177.2', 'groupId': 'OG000', 'lowerLimit': '7784.7', 'upperLimit': '13305.1'}, {'value': '7354.2', 'groupId': 'OG001', 'lowerLimit': '5707.4', 'upperLimit': '9476.1'}]}]}, {'title': 'OPSONO-6B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '75', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4952.3', 'groupId': 'OG000', 'lowerLimit': '3734.4', 'upperLimit': '6567.4'}, {'value': '3881.5', 'groupId': 'OG001', 'lowerLimit': '3055.8', 'upperLimit': '4930.2'}]}]}, {'title': 'OPSONO-7F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8957.4', 'groupId': 'OG000', 'lowerLimit': '7306.4', 'upperLimit': '10981.5'}, {'value': '8526.5', 'groupId': 'OG001', 'lowerLimit': '6926.2', 'upperLimit': '10496.7'}]}]}, {'title': 'OPSONO-9V', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3375.5', 'groupId': 'OG000', 'lowerLimit': '2539.6', 'upperLimit': '4486.6'}, {'value': '2332.3', 'groupId': 'OG001', 'lowerLimit': '1766.1', 'upperLimit': '3080.1'}]}]}, {'title': 'OPSONO-14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3443.7', 'groupId': 'OG000', 'lowerLimit': '2453.5', 'upperLimit': '4833.5'}, {'value': '3157.8', 'groupId': 'OG001', 'lowerLimit': '2445.4', 'upperLimit': '4077.8'}]}]}, {'title': 'OPSONO-18C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3881.0', 'groupId': 'OG000', 'lowerLimit': '2947.2', 'upperLimit': '5110.7'}, {'value': '3289.8', 'groupId': 'OG001', 'lowerLimit': '2513.7', 'upperLimit': '4305.5'}]}]}, {'title': 'OPSONO-19A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3362.5', 'groupId': 'OG000', 'lowerLimit': '2639.6', 'upperLimit': '4283.4'}, {'value': '2494.3', 'groupId': 'OG001', 'lowerLimit': '1986.7', 'upperLimit': '3131.6'}]}]}, {'title': 'OPSONO-19F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1795.5', 'groupId': 'OG000', 'lowerLimit': '1305.6', 'upperLimit': '2469.2'}, {'value': '1647.6', 'groupId': 'OG001', 'lowerLimit': '1287.6', 'upperLimit': '2108.3'}]}]}, {'title': 'OPSONO-23F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7755.7', 'groupId': 'OG000', 'lowerLimit': '5450.9', 'upperLimit': '11034.9'}, {'value': '5677.4', 'groupId': 'OG001', 'lowerLimit': '4255.0', 'upperLimit': '7575.3'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 month after administration of Prevnar 13 (i.e. at Month 1)', 'description': 'OPA titers were determined for anti-pneumococcal serotypes: OPSONO-1, OPSONO-3, OPSONO-4, OPSONO-5, OPSONO-6A, OPSONO-6B, OPSONO-7F, OPSONO-9V, OPSONO-14, OPSONO-18C, OPSONO-19A, OPSONO-19F and OPSONO-23F. OPA titers are expressed as 1/dilution. ATP cohort for immunogenicity post dose 1 included all evaluable participants who met eligibility criteria, complied with the procedures defined in the protocol and with no elimination criteria during the study from the ATP cohort for safety, received all study vaccines at Month 0, had assay results available for antibodies against at least one study vaccine antigen component at Visit 2, those with available blood sample at Visit 2 for PCV13 group.', 'unitOfMeasure': 'titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analyzed on ATP cohort for immunogenicity post dose 1 population. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure and \'number analyzed\' signifies participants evaluable for each specified category. Data for this outcome measure was not planned to be collected and analyzed for ACWY1d and ACWY2d reporting groups.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Solicited Local Reactions Within 4 Days Post Each Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}, {'value': '197', 'groupId': 'OG002'}, {'value': '197', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'ACWY1d Group', 'description': 'Participants received single dose of meningococcal polysaccharide groups A, C, W-135, and Y tetanus toxoid conjugate (MenACWY-TT) vaccine administered intramuscularly at Month 0.'}, {'id': 'OG001', 'title': 'ACWY2d Group', 'description': 'Participants received two doses of MenACWY-TT vaccine administered intramuscularly at Month 0 and Month 2.'}, {'id': 'OG002', 'title': 'Co-ad Group', 'description': 'Participants received single dose of MenACWY-TT vaccine and single dose of Prevnar 13 administered intramuscularly at Month 0.'}, {'id': 'OG003', 'title': 'PCV13 Group', 'description': 'Participants received single dose of Prevnar 13 at Month 0 and single dose of MenACWY-TT administered intramuscularly at Month 2.'}], 'classes': [{'title': 'Pain: Post MenACWY-TT Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '195', 'groupId': 'OG001'}, {'value': '197', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}]}, {'title': 'Pain: Post Prevenar 13 Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '196', 'groupId': 'OG002'}, {'value': '196', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '85', 'groupId': 'OG002'}, {'value': '72', 'groupId': 'OG003'}]}]}, {'title': 'Pain: Post MenACWY-TT Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '191', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG003'}]}]}, {'title': 'Redness: Post MenACWY-TT Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '195', 'groupId': 'OG001'}, {'value': '197', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}]}, {'title': 'Redness: Post Prevenar 13 Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '196', 'groupId': 'OG002'}, {'value': '196', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '87', 'groupId': 'OG002'}, {'value': '90', 'groupId': 'OG003'}]}]}, {'title': 'Redness: Post MenACWY-TT Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '191', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG003'}]}]}, {'title': 'Swelling: Post MenACWY-TT Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '195', 'groupId': 'OG001'}, {'value': '197', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}]}]}, {'title': 'Swelling: Post Prevenar 13 Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '196', 'groupId': 'OG002'}, {'value': '196', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG002'}, {'value': '63', 'groupId': 'OG003'}]}]}, {'title': 'Swelling: Post MenACWY-TT Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '191', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 4 days post each vaccination (vaccination 1 [at Month 0] and vaccination 2 [at Month 2])', 'description': "Solicited local reactions included pain, redness and swelling. Here, '0' in the number analyzed field signifies that no vaccine was administered in the specified group for the specified category.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The total vaccinated cohort (TVC) included all participants vaccinated with at least 1 dose of study vaccine. The analysis was performed per vaccine actually administered at Dose 1. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure and \'number analyzed\' signifies participants evaluable for each specified category.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Solicited General Reactions Within 4 Days Post Each Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '196', 'groupId': 'OG001'}, {'value': '197', 'groupId': 'OG002'}, {'value': '197', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'ACWY1d Group', 'description': 'Participants received single dose of meningococcal polysaccharide groups A, C, W-135, and Y tetanus toxoid conjugate (MenACWY-TT) vaccine administered intramuscularly at Month 0.'}, {'id': 'OG001', 'title': 'ACWY2d Group', 'description': 'Participants received two doses of MenACWY-TT vaccine administered intramuscularly at Month 0 and Month 2.'}, {'id': 'OG002', 'title': 'Co-ad Group', 'description': 'Participants received single dose of MenACWY-TT vaccine and single dose of Prevnar 13 administered intramuscularly at Month 0.'}, {'id': 'OG003', 'title': 'PCV13 Group', 'description': 'Participants received single dose of Prevnar 13 at Month 0 and single dose of MenACWY-TT administered intramuscularly at Month 2.'}], 'classes': [{'title': 'Drowsiness: Post Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '195', 'groupId': 'OG001'}, {'value': '197', 'groupId': 'OG002'}, {'value': '196', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}, {'value': '72', 'groupId': 'OG003'}]}]}, {'title': 'Drowsiness: Post Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '191', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG003'}]}]}, {'title': 'Irritability/Fussiness: Post Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '195', 'groupId': 'OG001'}, {'value': '197', 'groupId': 'OG002'}, {'value': '196', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '107', 'groupId': 'OG002'}, {'value': '85', 'groupId': 'OG003'}]}]}, {'title': 'Irritability/Fussiness: Post Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '191', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG001'}, {'value': '67', 'groupId': 'OG003'}]}]}, {'title': 'Loss of Appetite: Post Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '195', 'groupId': 'OG001'}, {'value': '197', 'groupId': 'OG002'}, {'value': '196', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '58', 'groupId': 'OG003'}]}]}, {'title': 'Loss of Appetite: Post Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '191', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG003'}]}]}, {'title': 'Fever: Post Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '195', 'groupId': 'OG001'}, {'value': '197', 'groupId': 'OG002'}, {'value': '196', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}]}]}, {'title': 'Fever: Post Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '189', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '191', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 4 days post each vaccination (vaccination 1 [Dose 1] and vaccination 2 [Dose 2])', 'description': "Solicited general reactions included drowsiness, irritability/fussiness, loss of appetite and fever. Here, '0' in the number analyzed field signifies that no vaccine was administered in the specified group for the specified category. Post dose 1 for ACWY1d and Co-ad group included reactions occurred after dosing of both MenACWY-TT and Prevenar 13 for Co-ad group and data was collected and summarized collectively.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The total vaccinated cohort (TVC) included all participants vaccinated with at least 1 dose of study vaccine. The analysis was performed per vaccine actually administered at Dose 1. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure and \'number analyzed\' signifies participants evaluable for each specified category.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Unsolicited Adverse Events Within 31 Days Post Any Study Vaccination, Classified According to Medical Dictionary for Regulatory Activities (MedDRA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}, {'value': '201', 'groupId': 'OG002'}, {'value': '201', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'ACWY1d Group', 'description': 'Participants received single dose of meningococcal polysaccharide groups A, C, W-135, and Y tetanus toxoid conjugate (MenACWY-TT) vaccine administered intramuscularly at Month 0.'}, {'id': 'OG001', 'title': 'ACWY2d Group', 'description': 'Participants received two doses of MenACWY-TT vaccine administered intramuscularly at Month 0 and Month 2.'}, {'id': 'OG002', 'title': 'Co-ad Group', 'description': 'Participants received single dose of MenACWY-TT vaccine and single dose of Prevnar 13 administered intramuscularly at Month 0.'}, {'id': 'OG003', 'title': 'PCV13 Group', 'description': 'Participants received single dose of Prevnar 13 at Month 0 and single dose of MenACWY-TT administered intramuscularly at Month 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 31 days post any vaccination', 'description': 'An adverse event was any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An unsolicited adverse event was an observed adverse event that did not fulfill the conditions prelisted in the case report book (CRB) in terms of symptom and/or onset post-vaccination.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The total vaccinated cohort (TVC) included all participants vaccinated with at least 1 dose of study vaccine. The analysis was performed per vaccine actually administered at Dose 1.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Serious Adverse Events From Month 0 to Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}, {'value': '201', 'groupId': 'OG002'}, {'value': '201', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'ACWY1d Group', 'description': 'Participants received single dose of meningococcal polysaccharide groups A, C, W-135, and Y tetanus toxoid conjugate (MenACWY-TT) vaccine administered intramuscularly at Month 0.'}, {'id': 'OG001', 'title': 'ACWY2d Group', 'description': 'Participants received two doses of MenACWY-TT vaccine administered intramuscularly at Month 0 and Month 2.'}, {'id': 'OG002', 'title': 'Co-ad Group', 'description': 'Participants received single dose of MenACWY-TT vaccine and single dose of Prevnar 13 administered intramuscularly at Month 0.'}, {'id': 'OG003', 'title': 'PCV13 Group', 'description': 'Participants received single dose of Prevnar 13 at Month 0 and single dose of MenACWY-TT administered intramuscularly at Month 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Month 0 to Month 9', 'description': 'An adverse event was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The total vaccinated cohort (TVC) included all participants vaccinated with at least 1 dose of study vaccine. The analysis was performed per vaccine actually administered at Dose 1.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Serious Adverse Events Related to Study Vaccination From First Dose of Study Drug up to End of Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}, {'value': '201', 'groupId': 'OG002'}, {'value': '201', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'ACWY1d Group', 'description': 'Participants received single dose of meningococcal polysaccharide groups A, C, W-135, and Y tetanus toxoid conjugate (MenACWY-TT) vaccine administered intramuscularly at Month 0.'}, {'id': 'OG001', 'title': 'ACWY2d Group', 'description': 'Participants received two doses of MenACWY-TT vaccine administered intramuscularly at Month 0 and Month 2.'}, {'id': 'OG002', 'title': 'Co-ad Group', 'description': 'Participants received single dose of MenACWY-TT vaccine and single dose of Prevnar 13 administered intramuscularly at Month 0.'}, {'id': 'OG003', 'title': 'PCV13 Group', 'description': 'Participants received single dose of Prevnar 13 at Month 0 and single dose of MenACWY-TT administered intramuscularly at Month 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to end of study (up to 5 years)', 'description': 'An adverse event was any untoward medical occurrence in a participant who received study drug. Serious adverse event was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Related adverse events were those adverse events who were related to the vaccination as judged by the investigator.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The total vaccinated cohort (TVC) included all participants vaccinated with at least 1 dose of study vaccine. The analysis was performed per vaccine actually administered at Dose 1.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Any New Onset of Chronic Illnesses (NOCIs) From Month 0 to Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'OG000'}, {'value': '197', 'groupId': 'OG001'}, {'value': '201', 'groupId': 'OG002'}, {'value': '201', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'ACWY1d Group', 'description': 'Participants received single dose of meningococcal polysaccharide groups A, C, W-135, and Y tetanus toxoid conjugate (MenACWY-TT) vaccine administered intramuscularly at Month 0.'}, {'id': 'OG001', 'title': 'ACWY2d Group', 'description': 'Participants received two doses of MenACWY-TT vaccine administered intramuscularly at Month 0 and Month 2.'}, {'id': 'OG002', 'title': 'Co-ad Group', 'description': 'Participants received single dose of MenACWY-TT vaccine and single dose of Prevnar 13 administered intramuscularly at Month 0.'}, {'id': 'OG003', 'title': 'PCV13 Group', 'description': 'Participants received single dose of Prevnar 13 at Month 0 and single dose of MenACWY-TT administered intramuscularly at Month 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Month 0 to Month 9', 'description': 'New onset chronic illness included autoimmune disorders, asthma, type I diabetes and allergies.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The total vaccinated cohort (TVC) included all participants vaccinated with at least 1 dose of study vaccine. The analysis was performed per vaccine actually administered at Dose 1.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ACWY1d Group', 'description': 'Participants received single dose of meningococcal polysaccharide groups A, C, W-135, and Y tetanus toxoid conjugate (MenACWY-TT) vaccine administered intramuscularly at Month 0.'}, {'id': 'FG001', 'title': 'ACWY2d Group', 'description': 'Participants received two doses of MenACWY-TT vaccine administered intramuscularly at Month 0 and Month 2.'}, {'id': 'FG002', 'title': 'Co-ad Group', 'description': 'Participants received single dose of MenACWY-TT vaccine and single dose of Prevnar 13 administered intramuscularly at Month 0.'}, {'id': 'FG003', 'title': 'PCV13 Group', 'description': 'Participants received single dose of Prevnar 13 at Month 0 and single dose of MenACWY-TT administered intramuscularly at Month 2.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '203'}, {'groupId': 'FG001', 'numSubjects': '198'}, {'groupId': 'FG002', 'numSubjects': '201'}, {'groupId': 'FG003', 'numSubjects': '201'}]}, {'type': 'Vaccinated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '203'}, {'groupId': 'FG001', 'numSubjects': '197'}, {'groupId': 'FG002', 'numSubjects': '201'}, {'groupId': 'FG003', 'numSubjects': '201'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '156'}, {'groupId': 'FG001', 'numSubjects': '146'}, {'groupId': 'FG002', 'numSubjects': '160'}, {'groupId': 'FG003', 'numSubjects': '157'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '52'}, {'groupId': 'FG002', 'numSubjects': '41'}, {'groupId': 'FG003', 'numSubjects': '44'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '15'}, {'groupId': 'FG003', 'numSubjects': '17'}]}, {'type': 'Migrated/moved from study area', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '6'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '17'}, {'groupId': 'FG003', 'numSubjects': '17'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'No longer meets eligibility criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'Study was conducted from 2 October 2013 to 5 December 2019.', 'preAssignmentDetails': 'A total of 803 participants were enrolled and were randomized in 1:1:1:1 ratio to either ACWY1d, ACWY2d, Co-ad and PCV13 groups.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '203', 'groupId': 'BG000'}, {'value': '197', 'groupId': 'BG001'}, {'value': '201', 'groupId': 'BG002'}, {'value': '201', 'groupId': 'BG003'}, {'value': '802', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'ACWY1d Group', 'description': 'Participants received single dose of meningococcal polysaccharide groups A, C, W-135, and Y tetanus toxoid conjugate (MenACWY-TT) vaccine administered intramuscularly at Month 0.'}, {'id': 'BG001', 'title': 'ACWY2d Group', 'description': 'Participants received two doses of MenACWY-TT vaccine administered intramuscularly at Month 0 and Month 2.'}, {'id': 'BG002', 'title': 'Co-ad Group', 'description': 'Participants received single dose of MenACWY-TT vaccine and single dose of Prevnar 13 administered intramuscularly at Month 0.'}, {'id': 'BG003', 'title': 'PCV13 Group', 'description': 'Participants received single dose of Prevnar 13 at Month 0 and single dose of MenACWY-TT administered intramuscularly at Month 2.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '12.8', 'spread': '0.9', 'groupId': 'BG000'}, {'value': '12.8', 'spread': '0.9', 'groupId': 'BG001'}, {'value': '12.8', 'spread': '0.9', 'groupId': 'BG002'}, {'value': '12.7', 'spread': '0.9', 'groupId': 'BG003'}, {'value': '12.8', 'spread': '0.9', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '94', 'groupId': 'BG000'}, {'value': '85', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}, {'value': '98', 'groupId': 'BG003'}, {'value': '375', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '109', 'groupId': 'BG000'}, {'value': '112', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}, {'value': '103', 'groupId': 'BG003'}, {'value': '427', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '31', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '195', 'groupId': 'BG000'}, {'value': '189', 'groupId': 'BG001'}, {'value': '194', 'groupId': 'BG002'}, {'value': '193', 'groupId': 'BG003'}, {'value': '771', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}, {'value': '127', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '135', 'groupId': 'BG000'}, {'value': '127', 'groupId': 'BG001'}, {'value': '137', 'groupId': 'BG002'}, {'value': '134', 'groupId': 'BG003'}, {'value': '533', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}, {'value': '130', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Analysis was performed on participants, who received at least one dose of study drug.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-05-09', 'size': 4770141, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-09-07T12:49', 'hasProtocol': True}, {'date': '2016-11-11', 'size': 1966065, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-09-07T12:49', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 803}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'dispFirstSubmitDate': '2020-09-23', 'completionDateStruct': {'date': '2019-12-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-07', 'studyFirstSubmitDate': '2013-08-29', 'dispFirstSubmitQcDate': '2020-09-23', 'resultsFirstSubmitDate': '2021-09-07', 'studyFirstSubmitQcDate': '2013-09-05', 'dispFirstPostDateStruct': {'date': '2020-09-30', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2021-10-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-09-07', 'studyFirstPostDateStruct': {'date': '2013-09-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-10-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Serum Bactericidal Assay Using Rabbit Complement Antibody (rSBA) Titers >=1:8 at 1 Month After Administration of 1 Dose of MenACWY-TT in the ACWY1d, ACWY2d and Co-ad Groups', 'timeFrame': '1 month after administration of 1st dose of MenACWY-TT (i.e. at Month 1)', 'description': 'Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). Percentage of participants with rSBA titers \\>=1:8 against each serogroup at 1 month after administration of MenACWY-TT are reported. According-to-protocol (ATP) cohort for persistence Year 1 population included all participants who met all eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present with a medical condition or received product leading to exclusion or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.'}, {'measure': 'Percentage of Participants With rSBA Titers >=1:8 at 1 Month After Administration of 2 Doses of MenACWY-TT in the ACWY2d Group', 'timeFrame': '1 month after administration of 2nd dose of MenACWY-TT (i.e. at Month 3)', 'description': 'Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). Percentage of participants with rSBA titers \\>=1:8 against each serogroup at 1 month after administration of 2 doses of MenACWY-TT are reported. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.'}, {'measure': 'Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at Year 1 in the ACWY1d and ACWY2d Groups', 'timeFrame': 'At Year 1', 'description': 'Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). Percentage of participants with rSBA titers \\>=1:8 and \\>=1:128 against each serogroup at Year 1 after administration of MenACWY-TT are reported. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.'}, {'measure': 'Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at Year 1 in the ACWY1d and ACWY2d Groups', 'timeFrame': 'At Year 1', 'description': 'Geometric mean titers of antibodies against each serogroup were assessed using rSBA. Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). rSBA titers are expressed as 1/dilution. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.'}, {'measure': 'Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at Year 3 in the ACWY1d and ACWY2d Groups', 'timeFrame': 'At Year 3', 'description': 'Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). Percentage of participants with rSBA titers \\>=1:8 and \\>=1:128 against each serogroup at Year 3 after administration of MenACWY-TT are reported. ATP cohort for persistence Year 3 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.'}, {'measure': 'Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at Year 3 in the ACWY1d and ACWY2d Groups', 'timeFrame': 'At Year 3', 'description': 'Geometric mean titers of antibodies against each serogroup were assessed using rSBA. Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). rSBA titers are expressed as 1/dilution. ATP cohort for persistence Year 3 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.'}, {'measure': 'Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at Year 5 in the ACWY1d and ACWY2d Groups', 'timeFrame': 'At Year 5', 'description': 'Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). Percentage of participants with rSBA titers \\>=1:8 and \\>=1:128 against each serogroup at Year 5 after administration of MenACWY-TT are reported. ATP cohort for persistence Year 5 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.'}, {'measure': 'Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at Year 5 in the ACWY1d and ACWY2d Groups', 'timeFrame': 'At Year 5', 'description': 'Geometric mean titers of antibodies against each serogroup were assessed using rSBA. Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). rSBA titers are expressed as 1/dilution. ATP cohort for persistence Year 5 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.'}, {'measure': 'Geometric Mean Concentrations (GMCs) of Antibodies for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups', 'timeFrame': '1 month after administration of Prevnar 13 (i.e. at Month 1)', 'description': 'GMCs for anti-pneumococcal antibodies (anti-1, anti-3, anti-4, anti-5, anti-6A, anti-6B, anti-7F, anti-9V, anti-14, anti-18C, anti-19A, anti-19F and anti-23F) were measured in microgram per milliliter (mcg/mL). ATP cohort for immunogenicity post dose 1 included all evaluable participants who met eligibility criteria, complied with the procedures defined in the protocol and with no elimination criteria during the study from the ATP cohort for safety, received all study vaccines at Month 0, had assay results available for antibodies against at least one study vaccine antigen component at Visit 2 (Month 1), and had available blood sample at Visit 2 (Month 1) for PCV13 group.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Serum Bactericidal Assay Using Human Complement (hSBA) Titers >=1:4 and >=1:8 at 1 Month After Administration of 1 Dose of MenACWY-TT in the ACWY1d and ACWY2d Groups', 'timeFrame': '1 month after administration of 1st dose of MenACWY-TT (i.e. at Month 1)', 'description': 'Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). Percentage of participants with hSBA titers \\>=1:4 and \\>=1:8 against each serogroup at 1 month after administration of MenACWY-TT are reported. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.'}, {'measure': 'Percentage of Participants With hSBA Titers >=1:4 and >=1:8 at 1 Month After Administration of 2 Doses of MenACWY-TT in the ACWY2d Group', 'timeFrame': '1 month after administration of 2nd dose of MenACWY-TT (i.e. at Month 3)', 'description': 'Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). Percentage of participants with hSBA titers \\>=1:4 and \\>=1:8 against each serogroup at 1 month after administration of 2 doses of MenACWY-TT are reported. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.'}, {'measure': 'Geometric Mean Titers (GMTs) With hSBA for Each of the 4 Serogroups Following Vaccination at 1 Month After Administration of 1 Dose of MenACWY-TT in the ACWY1d and ACWY2d Groups', 'timeFrame': '1 month after administration of 1st dose of MenACWY-TT (i.e. at Month 1)', 'description': 'Geometric mean titers of antibodies against each serogroup were assessed using hSBA. Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). hSBA titers are expressed as 1/dilution. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.'}, {'measure': 'Geometric Mean Titers (GMTs) With hSBA for Each of the 4 Serogroups Following Vaccination at 1 Month After Administration of 2 Doses of MenACWY-TT in the ACWY2d Group', 'timeFrame': '1 month after administration of 2nd dose of MenACWY-TT (i.e. at Month 3)', 'description': 'Geometric mean titers of antibodies against each serogroup were assessed using hSBA. Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). hSBA titers are expressed as 1/dilution. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.'}, {'measure': 'Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at 1 Month After Administration of 1 Dose of MenACWY-TT in the PCV-13 Group', 'timeFrame': '1 month after administration of 1st dose of MenACWY-TT (i.e. at Month 3)', 'description': 'Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). Percentage of participants with rSBA titers \\>=1:8 and \\>=1:128 against each serogroup at 1 month after administration of MenACWY-TT are reported. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.'}, {'measure': 'Geometric Mean Titers (GMTs) With rSBA Titers for Each of the 4 Serogroups Following Vaccination at 1 Month After Administration of 1 Dose of MenACWY-TT in the PCV-13 Group', 'timeFrame': '1 month after administration of 1st dose of MenACWY-TT (i.e. at Month 3)', 'description': 'Geometric mean titers of antibodies against each serogroup were assessed using rSBA. Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). rSBA titers are expressed as 1/dilution. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.'}, {'measure': 'Percentage of Participants With rSBA Titers >=1:128 at 1 Month After Administration of 1 Dose of MenACWY-TT in the ACWY1d, ACWY2d and Co-ad Groups', 'timeFrame': '1 month after administration of 1st dose of MenACWY-TT (i.e. at Month 1)', 'description': 'Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). Percentage of participants with rSBA titers \\>=1:128 against each serogroup at 1 month after administration of MenACWY-TT are reported. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.'}, {'measure': 'Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at 1 Month After Administration of 1 Dose of MenACWY-TT in ACWY1d, ACWY2d and Co-ad Groups', 'timeFrame': '1 month after administration of 1st dose of MenACWY-TT (i.e. at Month 1)', 'description': 'Geometric mean titers of antibodies against each serogroup were assessed using rSBA. Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). rSBA titers are expressed as 1/dilution. ATP cohort for persistence Year 1 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.'}, {'measure': 'Percentage of Participants With hSBA Titers >=1:4 and >=1:8 at Year 1, 3 and 5 in the ACWY1d and ACWY2d Groups', 'timeFrame': 'At Year 1, Year 3, Year 5', 'description': 'Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). Percentage of participants with hSBA titers \\>=1:4 and \\>=1:8 against each serogroup at Year 1, 3 and 5 after administration of MenACWY-TT are reported. ATP cohort for persistence Year 1, 3 and 5 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.'}, {'measure': 'Geometric Mean Titers (GMTs) With hSBA for Each of the 4 Serogroups Following Vaccination at Year 1, 3 and 5 in the ACWY1d and ACWY2d Groups', 'timeFrame': 'At Year 1, Year 3, Year 5', 'description': 'Geometric mean titers of antibodies against each serogroup were assessed using hSBA. Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). hSBA titers are expressed as 1/dilution. ATP cohort for persistence Year 1, 3 and 5 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.'}, {'measure': 'Percentage of Participants With rSBA Titers >=1:8 and >=1:128 at Year 1, 3 and 5 in the Co-ad and PCV-13 Groups', 'timeFrame': 'At Year 1, Year 3, Year 5', 'description': 'Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). Percentage of participants with rSBA titers \\>=1:8 and \\>=1:128 against each serogroup at Year 1, 3 and 5 after administration of MenACWY-TT are reported. ATP cohort for persistence Year 1, 3 and 5 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.'}, {'measure': 'Geometric Mean Titers (GMTs) With rSBA for Each of the 4 Serogroups Following Vaccination at Year 1, 3 and 5 in the Co-ad and PCV-13 Groups', 'timeFrame': 'At Year 1, Year 3, Year 5', 'description': 'Geometric mean titers of antibodies against each serogroup were assessed using rSBA. Serogroups included neisseria meningitidis serogroup A (MenA), Neisseria meningitidis serogroup C (MenC), Neisseria meningitidis serogroup W-135 (MenW-135) and Neisseria meningitidis serogroup Y (MenY). rSBA titers are expressed as 1/dilution. ATP cohort for persistence Year 1, 3 and 5 included all participants who met eligibility criteria, received complete primary vaccination series, had assay results available for at least 1 antigen tested, complied with procedures and intervals in protocol, did not present medical condition, received product or were non-compliant with protocol-defined serum sampling windows or lack of availability of immunogenicity results at the previous time point.'}, {'measure': 'Percentage of Participants With Antibody Concentrations >=0.15 mcg/mL, >=0.26 mcg/mL and >=0.35 mcg/mL for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups', 'timeFrame': '1 month after administration of Prevnar 13 (i.e. at Month 1)', 'description': 'Antibody concentrations were determined for anti-pneumococcal antibodies: anti-1, anti-3, anti-4, anti-5, anti-6A, anti-6B, anti-7F, anti-9V, anti-14, anti-18C, anti-19A, anti-19F and anti-23F. Percentage of participants with antibody concentrations \\>=0.15 mcg/mL, \\>=0.26 mcg/mL and \\>=0.35 mcg/mL against each serogroup at 1 month after administration of Prevnar 13 are reported. ATP cohort for immunogenicity post dose 1 included all evaluable participants who met eligibility criteria, complied with the procedures defined in the protocol and with no elimination criteria during the study from the ATP cohort for safety, received all study vaccines at Month 0, had assay results available for antibodies against at least one study vaccine antigen component at Visit 2, those with available blood sample at Visit 2 for PCV13 group.'}, {'measure': 'Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >=1:8 for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups', 'timeFrame': '1 month after administration of Prevnar 13 (i.e. at Month 1)', 'description': 'OPA titers were determined for anti-pneumococcal serotypes: OPSONO-1, OPSONO-3, OPSONO-4, OPSONO-5, OPSONO-6A, OPSONO-6B, OPSONO-7F, OPSONO-9V, OPSONO-14, OPSONO-18C, OPSONO-19A, OPSONO-19F and OPSONO-23F. Percentage of participants with OPA titers \\>=1:8 against each serogroup at 1 month after administration of Prevnar 13 are reported. ATP cohort for immunogenicity post dose 1 included all evaluable participants who met eligibility criteria, complied with the procedures defined in the protocol and with no elimination criteria during the study from the ATP cohort for safety, received all study vaccines at Month 0, had assay results available for antibodies against at least one study vaccine antigen component at Visit 2, those with available blood sample at Visit 2 for PCV13 group.'}, {'measure': 'Geometric Mean Titers (GMTs) With OPA for Each of the Anti-pneumococcal Serotypes at 1 Month After Administration of Prevnar 13 in the Co-ad and PCV-13 Groups', 'timeFrame': '1 month after administration of Prevnar 13 (i.e. at Month 1)', 'description': 'OPA titers were determined for anti-pneumococcal serotypes: OPSONO-1, OPSONO-3, OPSONO-4, OPSONO-5, OPSONO-6A, OPSONO-6B, OPSONO-7F, OPSONO-9V, OPSONO-14, OPSONO-18C, OPSONO-19A, OPSONO-19F and OPSONO-23F. OPA titers are expressed as 1/dilution. ATP cohort for immunogenicity post dose 1 included all evaluable participants who met eligibility criteria, complied with the procedures defined in the protocol and with no elimination criteria during the study from the ATP cohort for safety, received all study vaccines at Month 0, had assay results available for antibodies against at least one study vaccine antigen component at Visit 2, those with available blood sample at Visit 2 for PCV13 group.'}, {'measure': 'Number of Participants With Solicited Local Reactions Within 4 Days Post Each Vaccination', 'timeFrame': 'Within 4 days post each vaccination (vaccination 1 [at Month 0] and vaccination 2 [at Month 2])', 'description': "Solicited local reactions included pain, redness and swelling. Here, '0' in the number analyzed field signifies that no vaccine was administered in the specified group for the specified category."}, {'measure': 'Number of Participants With Solicited General Reactions Within 4 Days Post Each Vaccination', 'timeFrame': 'Within 4 days post each vaccination (vaccination 1 [Dose 1] and vaccination 2 [Dose 2])', 'description': "Solicited general reactions included drowsiness, irritability/fussiness, loss of appetite and fever. Here, '0' in the number analyzed field signifies that no vaccine was administered in the specified group for the specified category. Post dose 1 for ACWY1d and Co-ad group included reactions occurred after dosing of both MenACWY-TT and Prevenar 13 for Co-ad group and data was collected and summarized collectively."}, {'measure': 'Number of Participants With Unsolicited Adverse Events Within 31 Days Post Any Study Vaccination, Classified According to Medical Dictionary for Regulatory Activities (MedDRA)', 'timeFrame': 'Within 31 days post any vaccination', 'description': 'An adverse event was any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An unsolicited adverse event was an observed adverse event that did not fulfill the conditions prelisted in the case report book (CRB) in terms of symptom and/or onset post-vaccination.'}, {'measure': 'Number of Participants With Serious Adverse Events From Month 0 to Month 9', 'timeFrame': 'Month 0 to Month 9', 'description': 'An adverse event was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect.'}, {'measure': 'Number of Participants With Serious Adverse Events Related to Study Vaccination From First Dose of Study Drug up to End of Study', 'timeFrame': 'Baseline up to end of study (up to 5 years)', 'description': 'An adverse event was any untoward medical occurrence in a participant who received study drug. Serious adverse event was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Related adverse events were those adverse events who were related to the vaccination as judged by the investigator.'}, {'measure': 'Number of Participants With Any New Onset of Chronic Illnesses (NOCIs) From Month 0 to Month 9', 'timeFrame': 'Month 0 to Month 9', 'description': 'New onset chronic illness included autoimmune disorders, asthma, type I diabetes and allergies.'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Co-administration', 'Safety', 'Persistence', 'Immunogenicity', 'Prevenar 13', 'Meningococcal vaccine', 'Toddlers', '5 years'], 'conditions': ['Infections, Meningococcal']}, 'referencesModule': {'references': [{'pmid': '36621408', 'type': 'DERIVED', 'citation': 'Cutland CL, Peyrani P, Webber C, Newton R, Cutler M, Perez JL. A phase 3, randomized, controlled, open-label study to evaluate the persistence up to 5 years of 1 or 2 doses of meningococcal conjugate vaccine MenACWY-TT given with or without 13-valent pneumococcal conjugate vaccine in 12-14-month-old children. Vaccine. 2023 Jan 27;41(5):1153-1160. doi: 10.1016/j.vaccine.2022.11.048. Epub 2023 Jan 6.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=MENACWY-TT-104&StudyName=A+Phase+Iii%2C+Randomised%2C+Open%2C+Controlled%2C+Multicentre%2C+Primary+Vaccination+Study+To+Evaluate+The+Immunogenicity+And+Persistence+Of+1+And+2+Doses+Of+Meningococcal+Conjugate+Vaccine+Menacwy-tt+In+Toddlers+%28after+1+Month+And+Up+To+5+Years%29+And+To+Demonstrate+Non-inferiority+Of+Co-administration+Of+Menacwy-tt+And+13-valent+Pneumococcal+Conjugate+Vaccine+Prevenar+13%28registered%29+Versus+Separate+Administration+Of+The+2+Vaccines', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to compare the immediate and long term (up to 5 years) immunogenicity and safety of GSK Biologicals' MenACWY-TT vaccine when given as a single dose or as 2 doses to toddlers aged 12 to 14 months. Also, this study will also assess if co-administration of GSK Biologicals' MenACWY-TT with the booster dose of Pfizer's Prevenar 13 adversely impacts the immunogenicity of either of the vaccines.", 'detailedDescription': 'The Medicines Control Council (MCC) authorities requested that subjects be screened for HIV testing prior to study enrolment in South Africa to ensure that only HIV negative participants are enrolled. As such, HIV rapid test was added at Visit 1 only for subjects in South Africa. Subjects previously screened HIV positive will be excluded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Months', 'minimumAge': '12 Months', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects' parent(s)/Legally Acceptable Representative(s) \\[LAR(s)\\] who, in the opinion of the investigator, can and will comply with the requirements of the protocol.\n* A male or female between, and including, 12 and 14 months of age at the time of the first vaccination.\n* Written informed consent obtained from the parent(s)/LAR(s) of the subject.\n* Healthy subjects as established by medical history and clinical examination before entering into the study.\n* Vaccination records showing the completion of the full primary vaccination schedule with Prevenar 13 and Diphtheria, Tetanus and Pertussis (DTP) containing vaccine according to local recommendations at least 5 months before the study entry.\n\nExclusion Criteria:\n\n* Child in care.\n* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine or planned use during the study period.\n* Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. For corticosteroids, this will mean prednisone 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.\n* Planned administration/administration of a vaccine not foreseen by the study protocol within the period starting 30 days before and ending 30 days after the dose of vaccines, with the exception of a licensed inactivated influenza vaccine. Measles, Mumps Rubella (MMR) vaccine or Measles Mumps Rubella and Varicella (MMRV) vaccine can be co-administered with MenACWY-TT and/or Prevenar 13. A DTPa containing vaccine can be administered after the last blood sampling (at Visit 2 or 4 depending on the group).\n* Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product (pharmaceutical product or device).\n* Previous vaccination against Neisseria meningitidis.\n* Previous booster vaccination against Streptococcus pneumoniae.\n* Previous booster vaccination against Corynebacterium diphtheriae, Clostridium tetani and Bordetella pertussis.\n* History of meningococcal disease.\n* Any confirmed or suspected immunosuppressive or immunodeficient condition (congenital or secondary), including human immunodeficiency virus (HIV) infection, based on medical history and physical examination (no laboratory testing required)\\*\n\n * Note: With the exception of HIV rapid testing which will be done for subjects in South Africa.\n* Family history of congenital or hereditary immunodeficiency.\n* History of any reaction or hypersensitivity, including to diphtheria toxoid, likely to be exacerbated by any component of the vaccines.\n* Major congenital defects or serious chronic illness.\n* History of any neurological disorders or seizures, including Guillain-Barré syndrome (GBS). History of a simple, single febrile seizure is permitted.\n* Acute disease and/or fever at the time of enrollment.\n* Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period."}, 'identificationModule': {'nctId': 'NCT01939158', 'briefTitle': "Immunogenicity and Safety Study of 1 and 2 Doses of GlaxoSmithKline (GSK) Biologicals' Meningococcal Vaccine MenACWY-TT (GSK134612) in Toddlers, Persistence up to 5 Years After Vaccination and Co-administration With Pfizer's Prevenar 13™Vaccine", 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A PHASE III, RANDOMISED, OPEN, CONTROLLED, MULTICENTRE, PRIMARY VACCINATION STUDY TO EVALUATE THE IMMUNOGENICITY AND PERSISTENCE OF 1 AND 2 DOSES OF MENINGOCOCCAL CONJUGATE VACCINE MENACWY-TT IN TODDLERS (AFTER 1 MONTH AND UP TO 5 YEARS) AND TO DEMONSTRATE NON-INFERIORITY OF CO-ADMINISTRATION OF MENACWY-TT AND 13-VALENT PNEUMOCOCCAL CONJUGATE VACCINE PREVENAR 13(REGISTERED) VERSUS SEPARATE ADMINISTRATION OF THE 2 VACCINES', 'orgStudyIdInfo': {'id': 'MENACWY-TT-104'}, 'secondaryIdInfos': [{'id': 'C0921003', 'type': 'OTHER', 'domain': 'Alias Study Number'}, {'id': '2013-001083-28', 'type': 'EUDRACT_NUMBER'}, {'id': '116892', 'type': 'OTHER', 'domain': 'Alias Study Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ACWY1d group', 'description': 'Subjects will receive 1 dose of the MenACWY-TT vaccine', 'interventionNames': ['Biological: Meningococcal vaccine GSK134612']}, {'type': 'EXPERIMENTAL', 'label': 'ACWY2d group', 'description': 'Subjects will receive 2 doses of the MenACWY-TT vaccine 2 months apart', 'interventionNames': ['Biological: Meningococcal vaccine GSK134612']}, {'type': 'EXPERIMENTAL', 'label': 'Co-ad group', 'description': 'Subjects will receive 1 dose of the MenACWY-TT vaccine co-administered with Prevenar 13™', 'interventionNames': ['Biological: Meningococcal vaccine GSK134612', 'Biological: Prevenar 13™']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PCV-13 group', 'description': 'Subjects will receive 1 dose of Prevenar 13™ and 1 dose of the MenACWY-TT vaccine 2 months later', 'interventionNames': ['Biological: Meningococcal vaccine GSK134612', 'Biological: Prevenar 13™']}], 'interventions': [{'name': 'Meningococcal vaccine GSK134612', 'type': 'BIOLOGICAL', 'description': '1 or 2 doses administered intramuscularly in the left anterolateral thigh or deltoid region', 'armGroupLabels': ['ACWY1d group', 'ACWY2d group', 'Co-ad group', 'PCV-13 group']}, {'name': 'Prevenar 13™', 'type': 'BIOLOGICAL', 'description': '1 dose administered intramuscularly in the right anterolateral thigh or deltoid region', 'armGroupLabels': ['Co-ad group', 'PCV-13 group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2605', 'city': 'Garran', 'state': 'Australian Capital Territory', 'country': 'Australia', 'facility': 'Canberra Hospital', 'geoPoint': {'lat': -35.34206, 'lon': 149.10846}}, {'zip': '2145', 'city': 'Westmead', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'The Childrens Hospital at Westmead', 'geoPoint': {'lat': -33.80383, 'lon': 150.98768}}, {'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': '3010', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Vaccine and Immunization Research Group', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'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': 'R3E 3P4', 'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'facility': "The Clinical Research Unit; Children's Hospital Research Institute of Manitoba [CHRIM]", 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}, {'zip': 'B3K 6R8', 'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'Canadian Center for Vaccinology - IWK Health Centre', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'zip': 'P3A 1W8', 'city': 'Greater Sudbury', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Medicor Research Inc.', 'geoPoint': {'lat': 46.49, 'lon': -80.99001}}, {'zip': 'L8L 5G8', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Dr. Allen Greenspoon Medicine Professional Corporation', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'G1E 7G9', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'CHU de Quebec-Universite Laval', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': '160 00', 'city': 'Prague', 'state': 'Vokovice', 'country': 'Czechia', 'facility': 'Medicentrum 6 s.r.o', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, 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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. 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