Ignite Creation Date:
2025-12-25 @ 1:00 AM
Ignite Modification Date:
2025-12-25 @ 11:13 PM
Study NCT ID:
NCT04502693
Status:
COMPLETED
Last Update Posted:
2024-03-05
First Post:
2020-08-04
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Effectiveness of GlaxoSmithKline Biologicals S.A's Meningococcal Group B and Combined ABCWY Vaccines in Healthy Adolescents and Young Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-01-18', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D008589', 'term': 'Meningococcal Infections'}, {'id': 'D008581', 'term': 'Meningitis'}], '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'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C570015', 'term': '4CMenB vaccine'}, {'id': 'C525703', 'term': 'MenACWY'}, {'id': 'D022401', 'term': 'Meningococcal Vaccines'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D001428', 'term': 'Bacterial Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'GSKClinicalSupportHD@gsk.com', 'phone': '8664357343', 'title': 'GSK Response Center', 'organization': 'GlaxoSmithKline'}, 'certainAgreement': {'otherDetails': 'GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'SAEs and Non-serious AEs (Other AEs) were collected through the entire period of the study (from Day 1 up to study end [Day 361])', 'eventGroups': [{'id': 'EG000', 'title': 'MenB_0_2_6 Group', 'description': 'Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.', 'otherNumAtRisk': 897, 'deathsNumAtRisk': 897, 'otherNumAffected': 876, 'seriousNumAtRisk': 897, 'deathsNumAffected': 1, 'seriousNumAffected': 20}, {'id': 'EG001', 'title': 'MenB_0_6 Group', 'description': 'Participants received 2 doses of rMenB+OMV NZ vaccine on Day 1, and Day 181, 1 dose of MenACWY vaccine on Day 61. Participants received 1 dose of Placebo on Day 211 to maintain blinding.', 'otherNumAtRisk': 906, 'deathsNumAtRisk': 906, 'otherNumAffected': 872, 'seriousNumAtRisk': 906, 'deathsNumAffected': 1, 'seriousNumAffected': 22}, {'id': 'EG002', 'title': 'ACWY Group', 'description': 'Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.', 'otherNumAtRisk': 178, 'deathsNumAtRisk': 178, 'otherNumAffected': 173, 'seriousNumAtRisk': 178, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG003', 'title': 'ABCWY-1 Group', 'description': 'Participants received 2 doses of MenABCWY lot 1 vaccine at Day 1 and Day 181 and 2 doses of placebo at Day 61 and Day 211.', 'otherNumAtRisk': 549, 'deathsNumAtRisk': 549, 'otherNumAffected': 529, 'seriousNumAtRisk': 549, 'deathsNumAffected': 0, 'seriousNumAffected': 8}, {'id': 'EG004', 'title': 'ABCWY-2 Group', 'description': 'Participants received 2 doses of MenABCWY lot 2 vaccine at Day 1 and Day 181 and 2 doses of placebo at Day 61 and Day 211', 'otherNumAtRisk': 554, 'deathsNumAtRisk': 554, 'otherNumAffected': 537, 'seriousNumAtRisk': 554, 'deathsNumAffected': 0, 'seriousNumAffected': 9}, {'id': 'EG005', 'title': 'ABCWY-3 Group', 'description': 'Participants received 2 doses of MenABCWY lot 3 vaccine at Day 1 and Day 181 and 2 doses of placebo at Day 61 and Day 211.', 'otherNumAtRisk': 554, 'deathsNumAtRisk': 554, 'otherNumAffected': 544, 'seriousNumAtRisk': 554, 'deathsNumAffected': 0, 'seriousNumAffected': 8}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 897, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 906, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 549, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 554, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Coagulopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 897, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 906, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 549, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 554, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Increased tendency to bruise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 897, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 906, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 549, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 554, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 897, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 906, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 549, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 554, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Lymphadenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 897, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 906, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 549, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 897, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 906, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 549, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 554, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 554, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 897, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 906, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 549, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 554, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 554, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 897, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 906, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 549, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 897, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 906, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 549, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 554, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Tachycardia paroxysmal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 897, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 906, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 540, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Dermoid cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 897, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 906, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 549, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 554, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Familial mediterranean fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 897, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 906, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 549, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Multiple endocrine neoplasia Type 1', 'stats': [{'groupId': 'EG000', 'numAtRisk': 897, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 906, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 549, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Pectus excavatum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 897, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 906, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 549, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': "Rathke's cleft cyst", 'stats': [{'groupId': 'EG000', 'numAtRisk': 897, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 906, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 549, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Type V hyperlipidaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 897, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 906, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 549, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Cerumen impaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 897, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 906, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 549, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 554, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Ear discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 897, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 906, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 549, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 897, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 906, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 549, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 554, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 554, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Eustachian tube dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 897, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 906, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 549, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Excessive cerumen production', 'stats': [{'groupId': 'EG000', 'numAtRisk': 897, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 906, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 549, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 554, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'External ear inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 897, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 906, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 549, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Hypoacusis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 897, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 906, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 549, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Motion sickness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 897, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 906, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 549, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 897, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 906, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 549, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Tympanic membrane perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 897, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 906, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 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'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Vancomycin infusion reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 897, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 906, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 549, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 897, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 906, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 178, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 549, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 554, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic US N. Meningitidis Serogroup B Strains at 1 Month After the 3-dose (0,2,6-M), 2-dose(0,6-M) Vaccination Schedule of rMenB+OMV and 1 Dose of MenACWY', 'denoms': [{'units': 'Participants', 'counts': [{'value': '740', 'groupId': 'OG000'}, {'value': '751', 'groupId': 'OG001'}, {'value': '147', 'groupId': 'OG002'}]}, {'units': 'Samples', 'counts': [{'value': '25596', 'groupId': 'OG000'}, {'value': '26142', 'groupId': 'OG001'}, {'value': '4374', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'MenB_0_2_6 Group', 'description': 'Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.'}, {'id': 'OG001', 'title': 'MenB_0_6 Group', 'description': 'Participants received 2 doses of rMenB+OMV NZ vaccine on Day 1, and Day 181, 1 dose of MenACWY vaccine on Day 61. Participants received 1 dose of Placebo on Day 211 to maintain blinding.'}, {'id': 'OG002', 'title': 'ACWY Group', 'description': 'Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.3', 'groupId': 'OG000'}, {'value': '14.4', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'VE (Vaccine Effectiveness)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '83.2', 'ciLowerLimit': '81.9', 'ciUpperLimit': '84.4', 'groupDescription': 'To demonstrate the effectiveness of the rMenB+OMV NZ vaccine against a randomly selected panel of endemic US N. meningitidis serogroup B invasive disease strains as measured by bactericidal activity using enc-hSBA at 1 month after the 3-dose (0,2,6-months) schedule in MenB\\_0\\_2\\_6 group when compared to 1 month after the MenACWY dose in the ACWY group.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Effectiveness of rMenB+OMV NZ vaccine is demonstrated if the LL of the 2-sided 97.5% CI for Vaccine Effectiveness (VE) against the selected strain panel between the MenB\\_0\\_2\\_6 and the ACWY groups is above 65%. VE is defined as 1- Risk Ratio (RR) = (1- percentage of samples without bactericidal serum activity at 1:4 dilution in MenB group / percentage of samples without bactericidal serum activity at 1:4 dilution in the ACWY group) x100 percentage.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'VE', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '81.8', 'ciLowerLimit': '80.4', 'ciUpperLimit': '83.1', 'groupDescription': 'To demonstrate the effectiveness of the rMenB+OMV NZ vaccine against a randomly selected panel of endemic US N. meningitidis serogroup B invasive disease strains as measured by bactericidal activity using enc-hSBA at 1 month after the 2-dose (0,6-M) schedule in MenB\\_0\\_6 group when compared to 1 month after the MenACWY dose in the ACWY group.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Effectiveness of rMenB+OMV NZ vaccine is demonstrated if the LL of the 2-sided 97.5% CI for VE against the selected strain panel between the MenB\\_0\\_ 6 and the ACWY groups is above 65%.\n\nVE is defined as 1- RR = (1- percentage of samples without bactericidal serum activity at 1:4 dilution in MenB group / percentage of samples without bactericidal serum activity at 1:4 dilution in the ACWY group) x100 percentage.'}], 'paramType': 'NUMBER', 'timeFrame': 'At 1 month after vaccination schedule (i.e., Day 211 for MenB_0_2_6 group [3-dose schedule] and MenB_0_6 group, and Day 31 for ACWY group)', 'description': 'The effectiveness (test-based) of rMenB+OMV vaccine at 1 month after the 3 doses in MenB\\_0\\_2\\_6 group and 1 month after the 2 dose schedule in MenB\\_0\\_6 group when compared to one dose of MenACWY vaccination in ACWY group, against a panel of N. meningitidis serogroup B strains was measured in terms of percentage of samples without bactericidal activity using endogenous complement human Serum Bactericidal Assay (enc-hSBA), which provides a qualitative assessment (yes/no) of the presence of sufficient bactericidal antibodies in human sera to kill a meningococcal strain at a specific dilution of 1:4.\n\nParticipants were randomly selected for testing against each strain therefore only a subset of participants were tested for each of the strains.', 'unitOfMeasure': 'Percentage of blood samples', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Samples', 'denomUnitsSelected': 'Samples', 'populationDescription': 'Analysis was performed on blood samples collected from Per Protocol Set (PPS) ,which included participants who received at least 1 dose of the study treatment to which they were randomized and have post-vaccination data for the specified analysis at the specified timepoints and did not have any protocol deviations that lead to exclusion from the PPS.\n\nNumber of Participants analyzed = Total number of participants included in PPS.'}, {'type': 'PRIMARY', 'title': 'Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic US N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose (0,2-M) Vaccination Schedule of rMenB+OMV and 1 Dose of MenACWY', 'denoms': [{'units': 'Participants', 'counts': [{'value': '740', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}, {'units': 'Samples', 'counts': [{'value': '27569', 'groupId': 'OG000'}, {'value': '4374', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MenB_0_2_6 Group', 'description': 'Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.'}, {'id': 'OG001', 'title': 'ACWY Group', 'description': 'Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.8', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'VE', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '97.5', 'paramValue': '78.7', 'ciLowerLimit': '77.2', 'ciUpperLimit': '80.1', 'groupDescription': 'To demonstrate the effectiveness of the rMenB+OMV NZ vaccine against a randomly selected panel of endemic US N. meningitidis serogroup B invasive disease strains as measured by bactericidal activity using enc-hSBA at 1 month after the 2-dose (0,2-M) schedule in MenB\\_0\\_2\\_6 group when compared to 1 month after the MenACWY dose in the ACWY group.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Effectiveness of rMenB+OMV NZ vaccine is demonstrated if the LL of the 2-sided 97.5% CI for VE against the selected strain panel between the MenB\\_0\\_2\\_6 and the ACWY groups is above 65%. VE is defined as 1- RR = (1- percentage of samples without bactericidal serum activity at 1:4 dilution in MenB group / percentage of samples without bactericidal serum activity at 1:4 dilution in the ACWY group) x100 percentage.'}], 'paramType': 'NUMBER', 'timeFrame': 'At 1 month after vaccination schedule (i.e., Day 91 for the MenB_0_2_6 group [2-dose schedule] and Day 31 for ACWY group)', 'description': 'The effectiveness (test-based) of rMenB+OMV vaccine at 1 month after the 2 doses in MenB\\_0\\_2\\_6 group when compared to one dose of MenACWY vaccination in ACWY group, against a panel of N. meningitidis serogroup B strains was measured in terms of percentage of samples without bactericidal activity using endogenous complement human Serum Bactericidal Assay (enc-hSBA), which provides a qualitative assessment (yes/no) of the presence of sufficient bactericidal antibodies in human sera to kill a meningococcal strain at a specific dilution of 1:4.\n\nParticipants were randomly selected for testing against each strain therefore only a subset of participants were tested for each of the strains.', 'unitOfMeasure': 'Percentage of blood samples', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Samples', 'denomUnitsSelected': 'Samples', 'populationDescription': 'Analysis was performed on blood samples collected from Per Protocol Set (PPS) ,which included participants who received at least 1 dose of the study treatment to which they were randomized and have post-vaccination data for the specific analysis at specified timepoints and did not have any protocol deviations that lead to exclusion from the PPS.\n\nNumber of Participants analyzed = Total number of participants included in PPS.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Whose Sera Kill Greater Than or Equal to (>=) 70% of the Strains Tested Using Enc-hSBA at 1 Month After the 3-dose (0,2,6-M) Schedule of rMenB+OMV and 2-dose(0,6-M) Schedule of rMenB+OMV', 'denoms': [{'units': 'Participants', 'counts': [{'value': '790', 'groupId': 'OG000'}, {'value': '813', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MenB_0_2_6 Group', 'description': 'Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.'}, {'id': 'OG001', 'title': 'MenB_0_6 Group', 'description': 'Participants received 2 doses of rMenB+OMV NZ vaccine on Day 1, and Day 181, 1 dose of MenACWY vaccine on Day 61. Participants received 1 dose of Placebo on Day 211 to maintain blinding.'}], 'classes': [{'categories': [{'measurements': [{'value': '93.4', 'spread': '91.2', 'groupId': 'OG000', 'lowerLimit': '91.2', 'upperLimit': '95.2'}, {'value': '89.8', 'spread': '87.2', 'groupId': 'OG001', 'lowerLimit': '87.2', 'upperLimit': '92'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 1 month after vaccination schedule (i.e., Day 211 for MenB_0_2_6 group [3-dose schedule] and MenB_0_6 group)', 'description': 'The effectiveness (responder-based) of the rMenB+OMV NZ vaccine was measured in terms of percentage of participants whose sera kill \\>=70% of the strains tested using enc-hSBA, calculated based on Clopper Pearson method. Effectiveness is demonstrated if Lower Limit (LL) of the two-sided 97.5% CI for the percentages of participants whose sera kill ≥70% of strains is above 65%.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '97.5% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Full Analysis Set, which included participants who were randomized, received at least 1 dose of the study treatment and had post-vaccination effectiveness available for the specified analysis at the specified timepoint.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Whose Sera Kill >=70% of the Strains Tested Using Enc-hSBA at 1 Month After the 2-dose (0,2-M) Schedule of rMenB+OMV', 'denoms': [{'units': 'Participants', 'counts': [{'value': '831', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MenB_0_2_6 Group', 'description': 'Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '84.8', 'spread': '81.8', 'groupId': 'OG000', 'lowerLimit': '81.8', 'upperLimit': '87.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 1 month after vaccination schedule (i.e., Day 91 for the MenB_0_2_6 group [2-dose schedule])', 'description': 'The effectiveness (responder-based) of the rMenB+OMV NZ vaccine was measured in terms of percentage of participants whose sera kill \\>=70% of the strains tested using enc-hSBA, calculated based on Clopper Pearson method. Effectiveness is demonstrated if Lower Limit (LL) of the two-sided 97.5% CI for the percentages of participants whose sera kill ≥70% of strains is above 65%.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '97.5% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Full Analysis Set, which included participants who were randomized, received at least 1 dose of the study treatment and had post-vaccination effectiveness available for the specified analysis at the specified timepoint.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Titers (GMTs) Against Serogroups A, C, W and Y for Each Lot (ABCWY-1 Group, ABCWY-2 Group and ABCWY-3 Group) at 1 Month After the Last Vaccination of MenABCWY', 'denoms': [{'units': 'Participants', 'counts': [{'value': '452', 'groupId': 'OG000'}, {'value': '449', 'groupId': 'OG001'}, {'value': '458', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'ABCWY-1 Group', 'description': 'Participants received 2 doses of MenABCWY lot 1 vaccine at Day 1 and Day 181 and 2 doses of placebo at Day 61 and Day 211.'}, {'id': 'OG001', 'title': 'ABCWY-2 Group', 'description': 'Participants received 2 doses of MenABCWY lot 2 vaccine at Day 1 and Day 181 and 2 doses of placebo at Day 61 and Day 211.'}, {'id': 'OG002', 'title': 'ABCWY-3 Group', 'description': 'Participants received 2 doses of MenABCWY lot 3 vaccine at Day 1 and Day 181 and 2 doses of placebo at Day 61 and Day 211.'}], 'classes': [{'title': 'Men A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}, {'value': '443', 'groupId': 'OG001'}, {'value': '454', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '336.4', 'groupId': 'OG000', 'lowerLimit': '299.3', 'upperLimit': '378.0'}, {'value': '349.9', 'groupId': 'OG001', 'lowerLimit': '311.5', 'upperLimit': '393.0'}, {'value': '390.4', 'groupId': 'OG002', 'lowerLimit': '347.4', 'upperLimit': '438.8'}]}]}, {'title': 'Men C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '448', 'groupId': 'OG000'}, {'value': '449', 'groupId': 'OG001'}, {'value': '456', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1036.7', 'groupId': 'OG000', 'lowerLimit': '877.6', 'upperLimit': '1224.5'}, {'value': '1130.2', 'groupId': 'OG001', 'lowerLimit': '958.1', 'upperLimit': '1333.4'}, {'value': '888.4', 'groupId': 'OG002', 'lowerLimit': '752.1', 'upperLimit': '1049.2'}]}]}, {'title': 'Men W', 'denoms': [{'units': 'Participants', 'counts': [{'value': '452', 'groupId': 'OG000'}, {'value': '449', 'groupId': 'OG001'}, {'value': '458', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '564.5', 'groupId': 'OG000', 'lowerLimit': '497.9', 'upperLimit': '639.9'}, {'value': '635.5', 'groupId': 'OG001', 'lowerLimit': '561.0', 'upperLimit': '719.9'}, {'value': '640.1', 'groupId': 'OG002', 'lowerLimit': '564.6', 'upperLimit': '725.6'}]}]}, {'title': 'Men Y', 'denoms': [{'units': 'Participants', 'counts': [{'value': '451', 'groupId': 'OG000'}, {'value': '449', 'groupId': 'OG001'}, {'value': '457', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '536.7', 'groupId': 'OG000', 'lowerLimit': '464.5', 'upperLimit': '620.2'}, {'value': '623.9', 'groupId': 'OG001', 'lowerLimit': '540.4', 'upperLimit': '720.2'}, {'value': '644.3', 'groupId': 'OG002', 'lowerLimit': '557.6', 'upperLimit': '744.6'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.96', 'ciLowerLimit': '0.84', 'ciUpperLimit': '1.10', 'groupDescription': 'To demonstrate lot-to-lot consistency of the immune responses of ABCWY-1 and ABCWY-2 lots of the MenACWY component of the MenABCWY vaccine, as measured by hSBA GMTs directed against serogroup A at 1 month after last vaccination (Day 211).', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Lot-to-lot consistency is claimed if the 2-sided 95% CIs for the ratio of hSBA GMTs of antibodies against each of the serogroups A, C, W and Y are within the \\[0.5;2.0\\] equivalence interval for each pair of lots.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'GMT ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.86', 'ciLowerLimit': '0.75', 'ciUpperLimit': '0.98', 'groupDescription': 'To demonstrate lot-to-lot consistency of the immune responses of ABCWY-1 and ABCWY-3 lots of the MenACWY component of the MenABCWY vaccine, as measured by hSBA GMTs directed against serogroup A at 1 month after last vaccination (Day 211).', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Lot-to-lot consistency is claimed if the 2-sided 95% CIs for the ratio of hSBA GMTs of antibodies against each of the serogroups A, C, W and Y is within the \\[0.5;2.0\\] equivalence interval for each pair of lots.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'GMT ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.90', 'ciLowerLimit': '0.78', 'ciUpperLimit': '1.02', 'groupDescription': 'To demonstrate lot-to-lot consistency of the immune responses of ABCWY-2 and ABCWY-3 lots of the MenACWY component of the MenABCWY vaccine, as measured by hSBA GMTs directed against serogroup A at 1 month after last vaccination (Day 211).', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Lot-to-lot consistency is claimed if the 2-sided 95% CIs for the ratio of hSBA GMTs of antibodies against each of the serogroups A, C, W and Y is within the \\[0.5;2.0\\] equivalence interval for each pair of lots.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.92', 'ciLowerLimit': '0.76', 'ciUpperLimit': '1.11', 'groupDescription': 'To demonstrate lot-to-lot consistency of the immune responses of ABCWY-1 and ABCWY-2 lots of the MenACWY component of the MenABCWY vaccine, as measured by hSBA GMTs directed against serogroup C at 1 month after last vaccination (Day 211).', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Lot-to-lot consistency is claimed if the 2-sided 95% CIs for the ratio of hSBA GMTs of antibodies against each of the serogroups A, C, W and Y are within the \\[0.5;2.0\\] equivalence interval for each pair of lots.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'GMT ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.17', 'ciLowerLimit': '0.97', 'ciUpperLimit': '1.41', 'groupDescription': 'To demonstrate lot-to-lot consistency of the immune responses of ABCWY-1 and ABCWY-3 lots of the MenACWY component of the MenABCWY vaccine, as measured by hSBA GMTs directed against serogroup C at 1 month after last vaccination (Day 211).', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Lot-to-lot consistency is claimed if the 2-sided 95% CIs for the ratio of hSBA GMTs of antibodies against each of the serogroups A, C, W and Y is within the \\[0.5;2.0\\] equivalence interval for each pair of lots.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'GMT ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.27', 'ciLowerLimit': '1.05', 'ciUpperLimit': '1.54', 'groupDescription': 'To demonstrate lot-to-lot consistency of the immune responses of ABCWY-2 and ABCWY-3 lots of the MenACWY component of the MenABCWY vaccine, as measured by hSBA GMTs directed against serogroup C at 1 month after last vaccination (Day 211).', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Lot-to-lot consistency is claimed if the 2-sided 95% CIs for the ratio of hSBA GMTs of antibodies against each of the serogroups A, C, W and Y is within the \\[0.5;2.0\\] equivalence interval for each pair of lots.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.89', 'ciLowerLimit': '0.77', 'ciUpperLimit': '1.02', 'groupDescription': 'To demonstrate lot-to-lot consistency of the immune responses of ABCWY-1 and ABCWY-2 lots of the MenACWY component of the MenABCWY vaccine, as measured by hSBA GMTs directed against serogroup W at 1 month after last vaccination (Day 211).', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Lot-to-lot consistency is claimed if the 2-sided 95% CIs for the ratio of hSBA GMTs of antibodies against each of the serogroups A, C, W and Y are within the \\[0.5;2.0\\] equivalence interval for each pair of lots.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'GMT ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.88', 'ciLowerLimit': '0.77', 'ciUpperLimit': '1.02', 'groupDescription': 'To demonstrate lot-to-lot consistency of the immune responses of ABCWY-1 and ABCWY-3 lots of the MenACWY component of the MenABCWY vaccine, as measured by hSBA GMTs directed against serogroup W at 1 month after last vaccination (Day 211).', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Lot-to-lot consistency is claimed if the 2-sided 95% CIs for the ratio of hSBA GMTs of antibodies against each of the serogroups A, C, W and Y is within the \\[0.5;2.0\\] equivalence interval for each pair of lots.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'GMT ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.99', 'ciLowerLimit': '0.86', 'ciUpperLimit': '1.14', 'groupDescription': 'To demonstrate lot-to-lot consistency of the immune responses of ABCWY-2 and ABCWY-3 lots of the MenACWY component of the MenABCWY vaccine, as measured by hSBA GMTs directed against serogroup W at 1 month after last vaccination (Day 211).', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Lot-to-lot consistency is claimed if the 2-sided 95% CIs for the ratio of hSBA GMTs of antibodies against each of the serogroups A, C, W and Y is within the \\[0.5;2.0\\] equivalence interval for each pair of lots.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.86', 'ciLowerLimit': '0.73', 'ciUpperLimit': '1.01', 'groupDescription': 'To demonstrate lot-to-lot consistency of the immune responses of ABCWY-1 and ABCWY-2 lots of the MenACWY component of the MenABCWY vaccine, as measured by hSBA GMTs directed against serogroup Y at 1 month after last vaccination (Day 211).', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Lot-to-lot consistency is claimed if the 2-sided 95% CIs for the ratio of hSBA GMTs of antibodies against each of the serogroups A, C, W and Y are within the \\[0.5;2.0\\] equivalence interval for each pair of lots.'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'GMT ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.83', 'ciLowerLimit': '0.71', 'ciUpperLimit': '0.98', 'groupDescription': 'To demonstrate lot-to-lot consistency of the immune responses of ABCWY-1 and ABCWY-3 lots of the MenACWY component of the MenABCWY vaccine, as measured by hSBA GMTs directed against serogroup Y at 1 month after last vaccination (Day 211).', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Lot-to-lot consistency is claimed if the 2-sided 95% CIs for the ratio of hSBA GMTs of antibodies against each of the serogroups A, C, W and Y is within the \\[0.5;2.0\\] equivalence interval for each pair of lots.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'GMT ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.97', 'ciLowerLimit': '0.82', 'ciUpperLimit': '1.14', 'groupDescription': 'To demonstrate lot-to-lot consistency of the immune responses of ABCWY-2 and ABCWY-3 lots of the MenACWY component of the MenABCWY vaccine, as measured by hSBA GMTs directed against serogroup Y at 1 month after last vaccination (Day 211).', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Lot-to-lot consistency is claimed if the 2-sided 95% CIs for the ratio of hSBA GMTs of antibodies against each of the serogroups A, C, W and Y is within the \\[0.5;2.0\\] equivalence interval for each pair of lots.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At 1 month after the last vaccination of MenABCWY (Day 211)', 'description': 'Immune response was measured in terms of hSBA GMTs directed against serogroups A, C, W and Y. As pre-specified in the protocol, the data reported in this outcome measures data were presented for individual lots to demonstrate the consistency of the immune response of 3 lots (ABCWY- 1 Group, ABCWY-2 Group, and ABCWY-3 Group) of the ACWY component of the MenABCWY vaccine.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on Per Protocol Set (PPS), which included participants who received at least 1 dose of the study treatment to which they were randomized and have post-vaccination data for the specified analysis at specified timepoints and did not have any protocol deviations that lead to exclusion from the PPS.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With 4-fold Rise in hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y at 1 Month After Last MenABCWY Vaccination (Pooled Lots) and MenACWY Vaccination (for the ACWY Group), Relative to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1196', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABCWY_Pooled', 'description': 'Participants received 2 doses of either MenABCWY Lot 1, Lot 2, or Lot 3 vaccine on Day 1 and Day 181 and 1 dose of placebo on Day 61. Participants received 1 dose of placebo on Day 211 to maintain blinding.\n\nTo evaluate the effectiveness of 2 doses of the MenABCWY vaccines against rMenB+OMV and MenACWY vaccines, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.'}, {'id': 'OG001', 'title': 'ACWY Group', 'description': 'Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.'}], 'classes': [{'title': 'Men A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1170', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '97.0', 'groupId': 'OG000', 'lowerLimit': '95.9', 'upperLimit': '97.9'}, {'value': '85.7', 'groupId': 'OG001', 'lowerLimit': '77.8', 'upperLimit': '91.6'}]}]}, {'title': 'Men C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1189', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '97.2', 'groupId': 'OG000', 'lowerLimit': '96.1', 'upperLimit': '98.1'}, {'value': '50.0', 'groupId': 'OG001', 'lowerLimit': '40.5', 'upperLimit': '59.5'}]}]}, {'title': 'Men W', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1185', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '97.0', 'groupId': 'OG000', 'lowerLimit': '95.9', 'upperLimit': '97.9'}, {'value': '61.7', 'groupId': 'OG001', 'lowerLimit': '52.2', 'upperLimit': '70.6'}]}]}, {'title': 'Men Y', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1196', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '96.7', 'groupId': 'OG000', 'lowerLimit': '95.6', 'upperLimit': '97.7'}, {'value': '69.7', 'groupId': 'OG001', 'lowerLimit': '60.7', 'upperLimit': '77.8'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage of participants', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.29', 'ciLowerLimit': '5.88', 'ciUpperLimit': '19.01', 'groupDescription': 'To demonstrate the immunological non-inferiority of the MenABCWY vaccine compared to the MenACWY vaccine in participants without a previous MenACWY vaccination (unprimed) as measured by the percentages of participants, achieving a 4-fold rise in hSBA titers against N. meningitidis serogroup A at 1 month after the last MenABCWY vaccination (Day 211) and 1 month after the MenACWY vaccination.', 'statisticalMethod': 'Difference in percentage of participants', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority of MenABCWY vaccine is demonstrated if the LL of the 2-sided 95% CI for the difference in percentage of participants with 4-fold rise between the 2 groups is above -10%.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage of participants', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '47.22', 'ciLowerLimit': '38.14', 'ciUpperLimit': '56.30', 'groupDescription': 'To demonstrate the immunological non-inferiority of the MenABCWY vaccine compared to the MenACWY vaccine in participants without a previous MenACWY vaccination (unprimed) as measured by the percentages of participants, achieving a 4-fold rise in hSBA titers against N. meningitidis serogroup C at 1 month after the last MenABCWY vaccination (Day 211) and 1 month after the MenACWY vaccination.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority of MenABCWY vaccine is demonstrated if the LL of the 2-sided 95% CI for the difference in percentage of participants with 4-fold rise between the 2 groups is above -10%.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage of participants', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '35.31', 'ciLowerLimit': '26.88', 'ciUpperLimit': '44.49', 'groupDescription': 'To demonstrate the immunological non-inferiority of the MenABCWY vaccine compared to the MenACWY vaccine in participants without a previous MenACWY vaccination (unprimed) as measured by the percentages of participants, achieving a 4-fold rise in hSBA titers against N. meningitidis serogroup W at 1 month after the last MenABCWY vaccination (Day 211) and 1 month after the MenACWY vaccination.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority of MenABCWY vaccine is demonstrated if the LL of the 2-sided 95% CI for the difference in percentage of participants with 4-fold rise between the 2 groups is above -10%.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage of participants', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '26.99', 'ciLowerLimit': '19.38', 'ciUpperLimit': '35.81', 'groupDescription': 'To demonstrate the immunological non-inferiority of the MenABCWY vaccine compared to the MenACWY vaccine in participants without a previous MenACWY vaccination (unprimed) as measured by the percentages of participants, achieving a 4-fold rise in hSBA titers against N. meningitidis serogroup Y at 1 month after the last MenABCWY vaccination (Day 211) and 1 month after the MenACWY vaccination.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority of MenABCWY vaccine is demonstrated if the LL of the 2-sided 95% CI for the difference in percentage of participants with 4-fold rise between the 2 groups is above -10%.'}], 'paramType': 'NUMBER', 'timeFrame': 'At 1 month after vaccination schedule (i.e., Day 211 for the ABCWY_Pooled group and Day 31 for the ACWY Group) compared to Day 1 (baseline)', 'description': 'Four-fold rise is defined as: If the pre-vaccination hSBA titer is \\< 4, then post-vaccination hSBA titer should be \\>= 16 . If the pre-vaccination hSBA titer is \\>= limit of detection (LOD) but \\< LL of quantification (LLOQ), then post-vaccination hSBA titer should be \\>= 4 times the LLOQ. If the pre-vaccination hSBA titer is \\>= LLOQ, then post-vaccination hSBA titer should be \\>= 4 times the pre-vaccination hSBA titer.\n\nAs pre-specified in the protocol, data reported in this outcome measure were presented for ACWY group, ABCWY pooled group to evaluate the immunological non-inferiority of 2 doses of the MenABCWY vaccines against MenACWY vaccines, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on Per Protocol Set, which included participants who received at least 1 dose of the study treatment to which they were randomized and have post-vaccination data for the specified analysis at specified timepoints and did not have any protocol deviations that lead to exclusion from the PPS.'}, {'type': 'PRIMARY', 'title': 'Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After Last MenABCWY Vaccination (Pooled Lots) and MenACWY Vaccination (for the ACWY Group)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1356', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}, {'units': 'Samples', 'counts': [{'value': '25715', 'groupId': 'OG000'}, {'value': '4374', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABCWY_Pooled', 'description': 'Participants received 2 doses of either MenABCWY Lot 1, Lot 2, or Lot 3 vaccine on Day 1 and Day 181 and 1 dose of placebo on Day 61. Participants received 1 dose of placebo on Day 211 to maintain blinding.\n\nTo evaluate the effectiveness of 2 doses of the MenABCWY vaccines against rMenB+OMV and MenACWY vaccines, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.'}, {'id': 'OG001', 'title': 'ACWY Group', 'description': 'Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.4', 'groupId': 'OG000'}, {'value': '79', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'VE', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '77.9', 'ciLowerLimit': '76.6', 'ciUpperLimit': '79.2', 'groupDescription': 'To demonstrate the effectiveness of the MenABCWY vaccine against a randomly selected panel of endemic US N. meningitidis serogroup B invasive disease strains as measured by enc-hSBA at 1 month after the last MenABCWY vaccination (Day 211) when compared to 1 month after the MenACWY vaccination.', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Effectiveness of MenABCWY vaccine is demonstrated if the LL of the 2-sided 95% CI for VE against the selected strain panel between the ABCWY and the ACWY groups is above 65%. VE is defined as 1- RR = (1- percentage of samples without bactericidal serum activity at 1:4 dilution in ABCWY\\_Pooled group / percentage of samples without bactericidal serum activity at 1:4 dilution in the ACWY group) x100 percentage.'}], 'paramType': 'NUMBER', 'timeFrame': 'At 1 month after the vaccination schedule (i.e., Day 211 for the ABCWY_Pooled group and Day 31 for the ACWY group)', 'description': 'The effectiveness (test-based) of 2 doses of MenABCWY vaccine when compared to 1 dose of MenACWY vaccine, against a panel of N. meningitidis serogroup B strains was measured in terms of percentage of samples without bactericidal activity using enc-hSBA, which provides a qualitative assessment (yes/no) of the presence of sufficient bactericidal antibodies in human sera to kill a meningococcal strain at a specific dilution of 1:4.\n\nAs pre-specified in the protocol, data reported in this outcome measure were presented for ACWY group and ABCWY pooled group to evaluate the effectiveness of 2 doses of the MenABCWY vaccines against MenACWY vaccines, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.', 'unitOfMeasure': 'Percentage of blood samples', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Samples', 'denomUnitsSelected': 'Samples', 'populationDescription': 'Analysis was performed on blood samples collected from Per Protocol Set (PPS), which included participants who received at least 1 dose of the study treatment to which they were randomized and have post-vaccination data for the specified analysis at specified timepoints and did not have any protocol deviations that lead to exclusion from the PPS.'}, {'type': 'PRIMARY', 'title': 'Percentage of Blood Samples With Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose (Pooled Lots) and 2-dose(0,2-M) Schedule of rMenB+OMV', 'denoms': [{'units': 'Participants', 'counts': [{'value': '740', 'groupId': 'OG000'}, {'value': '1356', 'groupId': 'OG001'}]}, {'units': 'Samples', 'counts': [{'value': '27569', 'groupId': 'OG000'}, {'value': '25715', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MenB_0_2_6 Group', 'description': 'Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.'}, {'id': 'OG001', 'title': 'ABCWY_Pooled', 'description': 'Participants received 2 doses of either MenABCWY Lot 1, Lot 2, or Lot 3 vaccine on Day 1 and Day 181 and 1 dose of placebo on Day 61. Participants received 1 dose of placebo on Day 211 to maintain blinding.\n\nTo evaluate the effectiveness of 2 doses of the MenABCWY vaccines against rMenB+OMV and MenACWY vaccines, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.'}], 'classes': [{'categories': [{'measurements': [{'value': '83.1', 'groupId': 'OG000'}, {'value': '82.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentage of participants', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.61', 'ciLowerLimit': '-1.25', 'ciUpperLimit': '0.03', 'groupDescription': 'To demonstrate the non-inferiority of the effectiveness of the MenABCWY vaccine (0,6-months schedule) compared to the rMenB+OMV NZ vaccine (0,2-months) in terms of percentage of samples with bactericidal serum activity using enc-hSBA against a randomly selected panel of endemic US N. meningitidis serogroup B invasive disease strains.', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-inferiority of MenABCWY to rMenB+OMV NZ is demonstrated if LL of the 2-sided 95% CI for the difference in percentages of samples with bactericidal serum activity at 1:4 dilution is above -5%.'}], 'paramType': 'NUMBER', 'timeFrame': 'At 1 month after the vaccination schedule (i.e., Day 211 for the ABCWY_Pooled group and Day 91 for the MenB_0_2_6 Group [2-dose schedule])', 'description': 'The effectiveness was measured in terms of percentage of samples with bactericidal activity using enc-hSBA, which provides a qualitative assessment (yes/no) of the presence of sufficient bactericidal antibodies in human sera to kill a meningococcal strain at a specific dilution of 1:4. As pre-specified in the protocol, data reported in this outcome measure were presented for MenB\\_0\\_2\\_6 Group and ABCWY pooled group to evaluate the effectiveness of 2 doses of the MenABCWY vaccines against MenACWY vaccines, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.', 'unitOfMeasure': 'Percentage of blood samples', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Samples', 'denomUnitsSelected': 'Samples', 'populationDescription': 'Analysis was performed on blood samples collected from PPS, which included participants who received at least 1 dose of the study treatment to which they were randomized and have post-vaccination data for the specified analysis at specified timepoints and did not have any protocol deviations that lead to exclusion from the PPS.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Whose Sera Kill >=70% of the Strains Tested Using Enc-hSBA at 1 Month After the Last Vaccination in the ABCWY Group (Pooled Lots)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '817', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ABCWY_Pooled', 'description': 'Participants received 2 doses of either MenABCWY Lot 1, Lot 2, or Lot 3 vaccine on Day 1 and Day 181 and 1 dose of placebo on Day 61. Participants received 1 dose of placebo on Day 211 to maintain blinding.\n\nTo evaluate the effectiveness of 2 doses of the MenABCWY vaccines against rMenB+OMV and MenACWY vaccines, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.'}], 'classes': [{'categories': [{'measurements': [{'value': '84.1', 'spread': '81.4', 'groupId': 'OG000', 'lowerLimit': '81.4', 'upperLimit': '86.5'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 1 month after the last vaccination of MenABCWY (Day 211)', 'description': 'The effectiveness (responder-based) of the MenABCWY vaccine is measured in terms of percentage of participants whose sera kill \\>=70% of the strains tested using enc-hSBA, being calculated based on Clopper Pearson method. Effectiveness is demonstrated Lower Limit (LL) of the two-sided 97.5% CI for the percentages of participants whose sera kill ≥70% of strains tested for MenABCWY is above 65%.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the FAS, which included all participants who were randomized, received at least 1 dose of the study treatment, and had post-vaccination effectiveness data available for the specified analysis at the specified time points.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Any Solicited Local Adverse Events (AEs) After the First Study Intervention Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '885', 'groupId': 'OG000'}, {'value': '894', 'groupId': 'OG001'}, {'value': '1638', 'groupId': 'OG002'}, {'value': '178', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MenB_0_2_6 Group', 'description': 'Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.'}, {'id': 'OG001', 'title': 'MenB_0_6 Group', 'description': 'Participants received 2 doses of rMenB+OMV NZ vaccine on Day 1, and Day 181, 1 dose of MenACWY vaccine on Day 61. Participants received 1 dose of Placebo on Day 211 to maintain blinding.'}, {'id': 'OG002', 'title': 'ABCWY_Pooled', 'description': 'Participants received 2 doses of either MenABCWY Lot 1, Lot 2, or Lot 3 vaccine on Day 1 and Day 181 and 1 dose of placebo on Day 61. Participants received 1 dose of placebo on Day 211 to maintain blinding.\n\nTo evaluate the effectiveness of 2 doses of the MenABCWY vaccines against rMenB+OMV and MenACWY vaccines, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.'}, {'id': 'OG003', 'title': 'ACWY Group', 'description': 'Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.'}], 'classes': [{'title': 'Pain', 'categories': [{'measurements': [{'value': '807', 'groupId': 'OG000'}, {'value': '819', 'groupId': 'OG001'}, {'value': '1503', 'groupId': 'OG002'}, {'value': '67', 'groupId': 'OG003'}]}]}, {'title': 'Erythema', 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '216', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}]}, {'title': 'Swelling', 'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '217', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}]}, {'title': 'Induration', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During 7 days after the first study intervention administration occurring at Day 1', 'description': 'Assessed solicited local adverse events were injection or administration site = pain, erythema, swelling, induration. Any = occurrence of the adverse event regardless of intensity grade. Any erythema and swelling = adverse event reported with a surface diameter greater than 0 millimeters. No solicited AEs were collected after vaccination on Day 211 because these vaccines were administered as part of standard of care and to maintain blinding. As pre- specified in the protocol, data reported in this outcome measure were presented for MenB\\_0\\_2\\_6 group, MenB\\_0\\_6 group, ACWY group, ABCWY pooled group.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Solicited Safety Set (SSS), which included participants who received at least 1 dose of the study treatment and had solicited safety data during the specified period.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Any Solicited Local Adverse Events (AEs) After the Second Study Intervention Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '823', 'groupId': 'OG000'}, {'value': '813', 'groupId': 'OG001'}, {'value': '1511', 'groupId': 'OG002'}, {'value': '161', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MenB_0_2_6 Group', 'description': 'Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.'}, {'id': 'OG001', 'title': 'MenB_0_6 Group', 'description': 'Participants received 2 doses of rMenB+OMV NZ vaccine on Day 1, and Day 181, 1 dose of MenACWY vaccine on Day 61. Participants received 1 dose of Placebo on Day 211 to maintain blinding.'}, {'id': 'OG002', 'title': 'ABCWY_Pooled', 'description': 'Participants received 2 doses of either MenABCWY Lot 1, Lot 2, or Lot 3 vaccine on Day 1 and Day 181 and 1 dose of placebo on Day 61. Participants received 1 dose of placebo on Day 211 to maintain blinding.\n\nTo evaluate the effectiveness of 2 doses of the MenABCWY vaccines against rMenB+OMV and MenACWY vaccines, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.'}, {'id': 'OG003', 'title': 'ACWY Group', 'description': 'Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.'}], 'classes': [{'title': 'Pain', 'categories': [{'measurements': [{'value': '714', 'groupId': 'OG000'}, {'value': '224', 'groupId': 'OG001'}, {'value': '205', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}]}, {'title': 'Erythema', 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Swelling', 'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Induration', 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During 7 days after the second study intervention administration occurring at Day 61', 'description': 'Assessed solicited local adverse events were injection or administration site pain, erythema, swelling, induration. Any = occurrence of the adverse event regardless of intensity grade. Any erythema and swelling = adverse event reported with a surface diameter greater than 0 millimeters. No solicited AEs were collected after vaccination on Day 211 because these vaccines were administered as part of standard of care and to maintain blinding. As pre- specified in the protocol, data reported in this outcome measure were presented for MenB\\_0\\_2\\_6 group, MenB\\_0\\_6 group, ACWY group, ABCWY pooled group.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Solicited Safety Set (SSS), which included participants who received at least 1 dose of the study treatment and had solicited safety data during the specified period.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Any Solicited Local Adverse Events (AEs) After the Third Study Intervention Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '765', 'groupId': 'OG000'}, {'value': '759', 'groupId': 'OG001'}, {'value': '1428', 'groupId': 'OG002'}, {'value': '148', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MenB_0_2_6 Group', 'description': 'Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.'}, {'id': 'OG001', 'title': 'MenB_0_6 Group', 'description': 'Participants received 2 doses of rMenB+OMV NZ vaccine on Day 1, and Day 181, 1 dose of MenACWY vaccine on Day 61. Participants received 1 dose of Placebo on Day 211 to maintain blinding.'}, {'id': 'OG002', 'title': 'ABCWY_Pooled', 'description': 'Participants received 2 doses of either MenABCWY Lot 1, Lot 2, or Lot 3 vaccine on Day 1 and Day 181 and 1 dose of placebo on Day 61. Participants received 1 dose of placebo on Day 211 to maintain blinding.\n\nTo evaluate the effectiveness of 2 doses of the MenABCWY vaccines against rMenB+OMV and MenACWY vaccines, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.'}, {'id': 'OG003', 'title': 'ACWY Group', 'description': 'Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.'}], 'classes': [{'title': 'Pain', 'categories': [{'measurements': [{'value': '677', 'groupId': 'OG000'}, {'value': '676', 'groupId': 'OG001'}, {'value': '1258', 'groupId': 'OG002'}, {'value': '126', 'groupId': 'OG003'}]}]}, {'title': 'Erythema', 'categories': [{'measurements': [{'value': '118', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '168', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}]}, {'title': 'Swelling', 'categories': [{'measurements': [{'value': '107', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '176', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}]}, {'title': 'Induration', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '114', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During 7 days after the third study intervention administration occurring at Day 181', 'description': 'Assessed solicited local adverse events were injection or administration site pain, erythema, swelling, induration. Any = occurrence of the adverse event regardless of intensity grade. Any erythema and swelling = adverse event reported with a surface diameter greater than 0 millimeters. No solicited AEs were collected after vaccination on Day 211 because these vaccines were administered as part of standard of care and to maintain blinding. As pre- specified in the protocol, data reported in this outcome measure were presented for MenB\\_0\\_2\\_6 group, MenB\\_0\\_6 group, ACWY group, ABCWY pooled group.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Solicited Safety Set (SSS), which included participants who received at least 1 dose of the study treatment and had solicited safety data during the specified period.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Any Solicited Systemic AEs After the First Study Intervention Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '885', 'groupId': 'OG000'}, {'value': '894', 'groupId': 'OG001'}, {'value': '1638', 'groupId': 'OG002'}, {'value': '178', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MenB_0_2_6 Group', 'description': 'Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.'}, {'id': 'OG001', 'title': 'MenB_0_6 Group', 'description': 'Participants received 2 doses of rMenB+OMV NZ vaccine on Day 1, and Day 181, 1 dose of MenACWY vaccine on Day 61. Participants received 1 dose of Placebo on Day 211 to maintain blinding.'}, {'id': 'OG002', 'title': 'ABCWY_Pooled', 'description': 'Participants received 2 doses of either MenABCWY Lot 1, Lot 2, or Lot 3 vaccine on Day 1 and Day 181 and 1 dose of placebo on Day 61. Participants received 1 dose of placebo on Day 211 to maintain blinding.\n\nTo evaluate the effectiveness of 2 doses of the MenABCWY vaccines against rMenB+OMV and MenACWY vaccines, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.'}, {'id': 'OG003', 'title': 'ACWY Group', 'description': 'Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.'}], 'classes': [{'title': 'Fatigue', 'categories': [{'measurements': [{'value': '423', 'groupId': 'OG000'}, {'value': '414', 'groupId': 'OG001'}, {'value': '828', 'groupId': 'OG002'}, {'value': '78', 'groupId': 'OG003'}]}]}, {'title': 'Nausea', 'categories': [{'measurements': [{'value': '112', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}, {'value': '242', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}]}, {'title': 'Myalgia', 'categories': [{'measurements': [{'value': '92', 'groupId': 'OG000'}, {'value': '106', 'groupId': 'OG001'}, {'value': '242', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}]}, {'title': 'Arthralgia', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '133', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}]}, {'title': 'Headache', 'categories': [{'measurements': [{'value': '358', 'groupId': 'OG000'}, {'value': '330', 'groupId': 'OG001'}, {'value': '681', 'groupId': 'OG002'}, {'value': '69', 'groupId': 'OG003'}]}]}, {'title': 'Fever (C)', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During 7 days after the first study intervention administration occurring at Day 1', 'description': 'Assessed solicited systemic AEs were fatigue, nausea, myalgia, arthralgia, headache and fever \\[temperature \\>= 38.0°C\\]. Any = occurrence of the adverse event regardless of intensity grade or relation to study vaccination. No solicited AEs were collected after vaccination on Day 211 because these vaccines were administered as part of standard of care and to maintain blinding. As pre- specified in the protocol, data reported in this outcome measure were presented for MenB\\_0\\_2\\_6 group, MenB\\_0\\_6 group, ACWY group, ABCWY pooled group.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Solicited Safety Set (SSS), which included participants who receive at least 1 dose of the study treatment and had solicited safety data during the specified period.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Any Solicited Systemic AEs After the Second Study Intervention Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '823', 'groupId': 'OG000'}, {'value': '813', 'groupId': 'OG001'}, {'value': '1511', 'groupId': 'OG002'}, {'value': '161', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MenB_0_2_6 Group', 'description': 'Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.'}, {'id': 'OG001', 'title': 'MenB_0_6 Group', 'description': 'Participants received 2 doses of rMenB+OMV NZ vaccine on Day 1, and Day 181, 1 dose of MenACWY vaccine on Day 61. Participants received 1 dose of Placebo on Day 211 to maintain blinding.'}, {'id': 'OG002', 'title': 'ABCWY_Pooled', 'description': 'Participants received 2 doses of either MenABCWY Lot 1, Lot 2, or Lot 3 vaccine on Day 1 and Day 181 and 1 dose of placebo on Day 61. Participants received 1 dose of placebo on Day 211 to maintain blinding.\n\nTo evaluate the effectiveness of 2 doses of the MenABCWY vaccines against rMenB+OMV and MenACWY vaccines, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.'}, {'id': 'OG003', 'title': 'ACWY Group', 'description': 'Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.'}], 'classes': [{'title': 'Fatigue', 'categories': [{'measurements': [{'value': '372', 'groupId': 'OG000'}, {'value': '228', 'groupId': 'OG001'}, {'value': '345', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}]}]}, {'title': 'Nausea', 'categories': [{'measurements': [{'value': '104', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}]}, {'title': 'Myalgia', 'categories': [{'measurements': [{'value': '110', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Arthralgia', 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000'}, {'value': '332.0', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': 'Headache', 'categories': [{'measurements': [{'value': '301', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}, {'value': '332', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}]}, {'title': 'Fever (C)', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During 7 days after the second study intervention administration occurring at Day 61', 'description': 'Assessed solicited systemic AEs were fatigue, nausea, myalgia, arthralgia, headache and fever \\[temperature \\>= 38.0°C\\]. Any = occurrence of the adverse event regardless of intensity grade or relation to study vaccination. No solicited AEs were collected after vaccination on Day 211 because these vaccines were administered as part of standard of care and to maintain blinding. As pre- specified in the protocol, data reported in this outcome measure were presented for MenB\\_0\\_2\\_6 group, MenB\\_0\\_6 group, ACWY group, ABCWY pooled group.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Solicited Safety Set (SSS), which included participants who receive at least 1 dose of the study treatment and had solicited safety data during the specified period.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Any Solicited Systemic AEs After the Third Study Intervention Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '765', 'groupId': 'OG000'}, {'value': '759', 'groupId': 'OG001'}, {'value': '1428', 'groupId': 'OG002'}, {'value': '148', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MenB_0_2_6 Group', 'description': 'Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.'}, {'id': 'OG001', 'title': 'MenB_0_6 Group', 'description': 'Participants received 2 doses of rMenB+OMV NZ vaccine on Day 1, and Day 181, 1 dose of MenACWY vaccine on Day 61. Participants received 1 dose of Placebo on Day 211 to maintain blinding.'}, {'id': 'OG002', 'title': 'ABCWY_Pooled', 'description': 'Participants received 2 doses of either MenABCWY Lot 1, Lot 2, or Lot 3 vaccine on Day 1 and Day 181 and 1 dose of placebo on Day 61. Participants received 1 dose of placebo on Day 211 to maintain blinding.\n\nTo evaluate the effectiveness of 2 doses of the MenABCWY vaccines against rMenB+OMV and MenACWY vaccines, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.'}, {'id': 'OG003', 'title': 'ACWY Group', 'description': 'Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.'}], 'classes': [{'title': 'Fatigue', 'categories': [{'measurements': [{'value': '374', 'groupId': 'OG000'}, {'value': '341', 'groupId': 'OG001'}, {'value': '602', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}]}]}, {'title': 'Nausea', 'categories': [{'measurements': [{'value': '94', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '147', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}]}, {'title': 'Myalgia', 'categories': [{'measurements': [{'value': '106', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}, {'value': '168', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}]}, {'title': 'Arthralgia', 'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '104', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}, {'title': 'Headache', 'categories': [{'measurements': [{'value': '302', 'groupId': 'OG000'}, {'value': '284', 'groupId': 'OG001'}, {'value': '509', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}]}]}, {'title': 'Fever (C)', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During 7 days after the third study intervention administration occurring at Day 181', 'description': 'Assessed solicited systemic AEs were fatigue, nausea, myalgia, arthralgia, headache and fever \\[temperature \\>= 38.0°C\\]. Any = occurrence of the adverse event regardless of intensity grade or relation to study vaccination. No solicited AEs were collected after vaccination on Day 211 because these vaccines were administered as part of standard of care and to maintain blinding. As pre- specified in the protocol, data reported in this outcome measure were presented for MenB\\_0\\_2\\_6 group, MenB\\_0\\_6 group, ACWY group, ABCWY pooled group.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Solicited Safety Set (SSS), which included participants who receive at least 1 dose of the study treatment and had solicited safety data during the specified period.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Any Unsolicited AEs After the First Study Intervention Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '893', 'groupId': 'OG000'}, {'value': '900', 'groupId': 'OG001'}, {'value': '1648', 'groupId': 'OG002'}, {'value': '178', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MenB_0_2_6 Group', 'description': 'Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.'}, {'id': 'OG001', 'title': 'MenB_0_6 Group', 'description': 'Participants received 2 doses of rMenB+OMV NZ vaccine on Day 1, and Day 181, 1 dose of MenACWY vaccine on Day 61. Participants received 1 dose of Placebo on Day 211 to maintain blinding.'}, {'id': 'OG002', 'title': 'ABCWY_Pooled', 'description': 'Participants received 2 doses of either MenABCWY Lot 1, Lot 2, or Lot 3 vaccine on Day 1 and Day 181 and 1 dose of placebo on Day 61. Participants received 1 dose of placebo on Day 211 to maintain blinding.\n\nTo evaluate the effectiveness of 2 doses of the MenABCWY vaccines against rMenB+OMV and MenACWY vaccines, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.'}, {'id': 'OG003', 'title': 'ACWY Group', 'description': 'Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}, {'value': '217', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 30 days after the first study intervention administration occurring at Day 1', 'description': "Unsolicited AEs are defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms were reported as an unsolicited AE. Any Unsolicited AEs (including Serious adverse events (SAEs), AEs leading to withdrawal, Adverse event of special interest (AESIs) and medically attended AEs were collected during 30 days after vaccination 1-3. For vaccination on Day 211 (Vaccination 4), conducted as part of standard of care and to maintain blinding, no eDiary data or all unsolicited AEs were collected for the 30 days following vaccination. However, SAEs, AEs leading to withdrawal, AESIs and medically attended AEs were collected throughout study duration. As pre-specified in the protocol, data reported in this outcome measure were presented for MenB\\_0\\_2\\_6 group, MenB\\_0\\_6 group, ACWY group, ABCWY pooled group.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Unsolicited Safety Set (USS), which included participants who received at least 1 dose of the study treatment and had Unsolicited safety data during the specified period.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Any Unsolicited AEs After the Second Study Intervention Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '851', 'groupId': 'OG000'}, {'value': '855', 'groupId': 'OG001'}, {'value': '1579', 'groupId': 'OG002'}, {'value': '170', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MenB_0_2_6 Group', 'description': 'Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.'}, {'id': 'OG001', 'title': 'MenB_0_6 Group', 'description': 'Participants received 2 doses of rMenB+OMV NZ vaccine on Day 1, and Day 181, 1 dose of MenACWY vaccine on Day 61. Participants received 1 dose of Placebo on Day 211 to maintain blinding.'}, {'id': 'OG002', 'title': 'ABCWY_Pooled', 'description': 'Participants received 2 doses of either MenABCWY Lot 1, Lot 2, or Lot 3 vaccine on Day 1 and Day 181 and 1 dose of placebo on Day 61. Participants received 1 dose of placebo on Day 211 to maintain blinding.\n\nTo evaluate the effectiveness of 2 doses of the MenABCWY vaccines against rMenB+OMV and MenACWY vaccines, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.'}, {'id': 'OG003', 'title': 'ACWY Group', 'description': 'Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '106', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '160', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 30 days after the second study intervention administration occurring at Day 61', 'description': "Unsolicited AEs are defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms were reported as an unsolicited AE. Any Unsolicited AEs (including Serious adverse events (SAEs), AEs leading to withdrawal, Adverse event of special interest (AESIs) and medically attended AEs were collected during 30 days after vaccination 1-3. For vaccination on Day 211 (Vaccination 4), conducted as part of standard of care and to maintain blinding, no eDiary data or all unsolicited AEs were collected for the 30 days following vaccination. However, SAEs, AEs leading to withdrawal, AESIs and medically attended AEs were collected throughout study duration. As pre-specified in the protocol, data reported in this outcome measure were presented for MenB\\_0\\_2\\_6 group, MenB\\_0\\_6 group, ACWY group, ABCWY pooled group.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Unsolicited Safety Set (USS), which included participants who received at least 1 dose of the study treatment and had Unsolicited safety data during the specified period.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Any Unsolicited AEs After the Third Study Intervention Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '815', 'groupId': 'OG000'}, {'value': '823', 'groupId': 'OG001'}, {'value': '1521', 'groupId': 'OG002'}, {'value': '166', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MenB_0_2_6 Group', 'description': 'Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.'}, {'id': 'OG001', 'title': 'MenB_0_6 Group', 'description': 'Participants received 2 doses of rMenB+OMV NZ vaccine on Day 1, and Day 181, 1 dose of MenACWY vaccine on Day 61. Participants received 1 dose of Placebo on Day 211 to maintain blinding.'}, {'id': 'OG002', 'title': 'ABCWY_Pooled', 'description': 'Participants received 2 doses of either MenABCWY Lot 1, Lot 2, or Lot 3 vaccine on Day 1 and Day 181 and 1 dose of placebo on Day 61. Participants received 1 dose of placebo on Day 211 to maintain blinding.\n\nTo evaluate the effectiveness of 2 doses of the MenABCWY vaccines against rMenB+OMV and MenACWY vaccines, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.'}, {'id': 'OG003', 'title': 'ACWY Group', 'description': 'Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '183', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the 30 days after the third study intervention administration occurring at Day 181', 'description': "Unsolicited AEs are defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms were reported as an unsolicited AE. Any Unsolicited AEs (including Serious adverse events (SAEs), AEs leading to withdrawal, Adverse event of special interest (AESIs) and medically attended AEs were collected during 30 days after vaccination 1-3. For vaccination on Day 211 (Vaccination 4), conducted as part of standard of care and to maintain blinding, no eDiary data or all unsolicited AEs were collected for the 30 days following vaccination. However, SAEs, AEs leading to withdrawal, AESIs and medically attended AEs were collected throughout study duration. As pre-specified in the protocol, data reported in this outcome measure were presented for MenB\\_0\\_2\\_6 group, MenB\\_0\\_6 group, ACWY group, ABCWY pooled group.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Unsolicited Safety Set (USS), which included all participants who received at least 1 dose of the study treatment and had Unsolicited safety data during the specified period.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With SAEs, AEs Leading to Withdrawal, AESIs and Medically Attended AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '893', 'groupId': 'OG000'}, {'value': '900', 'groupId': 'OG001'}, {'value': '1648', 'groupId': 'OG002'}, {'value': '178', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MenB_0_2_6 Group', 'description': 'Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.'}, {'id': 'OG001', 'title': 'MenB_0_6 Group', 'description': 'Participants received 2 doses of rMenB+OMV NZ vaccine on Day 1, and Day 181, 1 dose of MenACWY vaccine on Day 61. Participants received 1 dose of Placebo on Day 211 to maintain blinding.'}, {'id': 'OG002', 'title': 'ABCWY_Pooled', 'description': 'Participants received 2 doses of either MenABCWY Lot 1, Lot 2, or Lot 3 vaccine on Day 1 and Day 181 and 1 dose of placebo on Day 61. Participants received 1 dose of placebo on Day 211 to maintain blinding.\n\nTo evaluate the effectiveness of 2 doses of the MenABCWY vaccines against rMenB+OMV and MenACWY vaccines, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.'}, {'id': 'OG003', 'title': 'ACWY Group', 'description': 'Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.'}], 'classes': [{'title': 'SAEs', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}, {'title': 'AEs leading to withdrawal', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'AESIs', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'medically attended AEs', 'categories': [{'measurements': [{'value': '238', 'groupId': 'OG000'}, {'value': '288', 'groupId': 'OG001'}, {'value': '479', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Throughout the study period (Day 1 to Day 361)', 'description': 'A SAEs is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity and is a congenital anomaly/birth defect in the offspring of a study subject. AESIs are predefined (serious or non-serious) AEs of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation to characterize and understand it. Medically attended AEs are symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a health care provider. As pre-specified in the protocol, data reported in this outcome measure were presented for MenB\\_0\\_2\\_6 group, MenB\\_0\\_6 group, ACWY group, ABCWY pooled group.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Unsolicited Safety Set (USS), which included participants who received at least 1 dose of the study treatment and report unsolicited AEs/report not having unsolicited AEs.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With 4-fold Rise in hSBA Titers Against N.Meningitidis Group B Strains at 1 Month After Last MenABCWY Dose(ABCWY Group-pooled Lots) and 1 Month After 2-dose(0,2-M) Schedule of rMenB+OMV NZ Relative to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '719', 'groupId': 'OG000'}, {'value': '678', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MenB_0_2_6 Group', 'description': 'Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.'}, {'id': 'OG001', 'title': 'ABCWY_Pooled', 'description': 'Participants received 2 doses of either MenABCWY Lot 1, Lot 2, or Lot 3 vaccine on Day 1 and Day 181 and 1 dose of placebo on Day 61. Participants received 1 dose of placebo on Day 211 to maintain blinding.\n\nTo evaluate the effectiveness of 2 doses of the MenABCWY vaccines against rMenB+OMV and MenACWY vaccines, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.'}], 'classes': [{'title': 'fHbp (M14459) Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '719', 'groupId': 'OG000'}, {'value': '675', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '74.7', 'groupId': 'OG000', 'lowerLimit': '71.3', 'upperLimit': '77.8'}, {'value': '79.7', 'groupId': 'OG001', 'lowerLimit': '76.5', 'upperLimit': '82.7'}]}]}, {'title': 'NadA (96217) Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '717', 'groupId': 'OG000'}, {'value': '671', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '96.4', 'groupId': 'OG000', 'lowerLimit': '94.7', 'upperLimit': '97.6'}, {'value': '92.7', 'groupId': 'OG001', 'lowerLimit': '90.5', 'upperLimit': '94.5'}]}]}, {'title': 'NHBA (M13520) Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '718', 'groupId': 'OG000'}, {'value': '678', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '58.6', 'groupId': 'OG000', 'lowerLimit': '54.9', 'upperLimit': '62.3'}, {'value': '61.9', 'groupId': 'OG001', 'lowerLimit': '58.2', 'upperLimit': '65.6'}]}]}, {'title': 'PorA (NZ98/254) Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '704', 'groupId': 'OG000'}, {'value': '642', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '53.3', 'groupId': 'OG000', 'lowerLimit': '49.5', 'upperLimit': '57.0'}, {'value': '42.2', 'groupId': 'OG001', 'lowerLimit': '38.4', 'upperLimit': '46.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 1 month after the vaccination schedule (i.e., Day 211 for the ABCWY_Pooled group and Day 91 for the MenB_0_2_6 Group [2-dose schedule]) compared to Day 1 (Baseline)', 'description': 'The immunogenicity is measured as percentage of participants achieving a 4-fold rise in hSBA titers against N. meningitidis serogroup B indicator strains (M14459, 96217, M13520 and NZ98/254 for fHbp, NadA, NHBA and PorA P1.4 antigens, respectively). 4-fold rise per each indicator strain was defined as a post-vaccination hSBA titre ≥16 for participants with a pre-vaccination hSBA titre \\<4; a post-vaccination hSBA titre ≥4 times the LLOQ for participants with a pre-vaccination hSBA titre ≥LOD and \\<LLOQ; a post-vaccination hSBA titre ≥4 times the pre-vaccination hSBA titre for participants with a pre-vaccination hSBA titre ≥ LLOQ. As pre-specified in the protocol, data reported in this outcome measure were presented for MenB\\_0\\_2\\_6 Group and ABCWY pooled group to evaluate the effectiveness of 2 doses of the MenABCWY vaccines against MenACWY vaccines, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on Per Protocol Set, which included participants who received at least 1 dose of the study treatment to which they were randomized and have post-vaccination data for the specified analysis at specified timepoints and did not have any protocol deviations that lead to exclusion from the PPS.'}, {'type': 'SECONDARY', 'title': 'Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY', 'denoms': [{'units': 'Participants', 'counts': [{'value': '790', 'groupId': 'OG000'}, {'value': '813', 'groupId': 'OG001'}, {'value': '817', 'groupId': 'OG002'}, {'value': '136', 'groupId': 'OG003'}]}, {'units': 'Samples', 'counts': [{'value': '281', 'groupId': 'OG000'}, {'value': '282', 'groupId': 'OG001'}, {'value': '288', 'groupId': 'OG002'}, {'value': '58', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MenB_0_2_6 Group', 'description': 'Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.'}, {'id': 'OG001', 'title': 'MenB_0_6 Group', 'description': 'Participants received 2 doses of rMenB+OMV NZ vaccine on Day 1, and Day 181, 1 dose of MenACWY vaccine on Day 61. Participants received 1 dose of Placebo on Day 211 to maintain blinding.'}, {'id': 'OG002', 'title': 'ABCWY_Pooled', 'description': 'Participants received 2 doses of either MenABCWY Lot 1, Lot 2, or Lot 3 vaccine on Day 1 and Day 181 and 1 dose of placebo on Day 61. Participants received 1 dose of placebo on Day 211 to maintain blinding.\n\nTo evaluate the effectiveness of 2 doses of the MenABCWY vaccines against rMenB+OMV and MenACWY vaccines, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.'}, {'id': 'OG003', 'title': 'ACWY Group', 'description': 'Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.'}], 'classes': [{'title': 'Meningitis B M10713 Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '790', 'groupId': 'OG000'}, {'value': '813', 'groupId': 'OG001'}, {'value': '817', 'groupId': 'OG002'}, {'value': '136', 'groupId': 'OG003'}]}, {'units': 'Samples', 'counts': [{'value': '252', 'groupId': 'OG000'}, {'value': '247', 'groupId': 'OG001'}, {'value': '251', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}, {'value': '0.4', 'groupId': 'OG001'}, {'value': '1.2', 'groupId': 'OG002'}, {'value': '15.6', 'groupId': 'OG003'}]}]}, {'title': 'Meningitis B M08641 Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '790', 'groupId': 'OG000'}, {'value': '813', 'groupId': 'OG001'}, {'value': '817', 'groupId': 'OG002'}, {'value': '136', 'groupId': 'OG003'}]}, {'units': 'Samples', 'counts': [{'value': '229', 'groupId': 'OG000'}, {'value': '259', 'groupId': 'OG001'}, {'value': '237', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6.6', 'groupId': 'OG000'}, {'value': '6.2', 'groupId': 'OG001'}, {'value': '8.0', 'groupId': 'OG002'}, {'value': '96.6', 'groupId': 'OG003'}]}]}, {'title': 'Meningitis B M12898 Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '790', 'groupId': 'OG000'}, {'value': '813', 'groupId': 'OG001'}, {'value': '817', 'groupId': 'OG002'}, {'value': '136', 'groupId': 'OG003'}]}, {'units': 'Samples', 'counts': [{'value': '242', 'groupId': 'OG000'}, {'value': '265', 'groupId': 'OG001'}, {'value': '249', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '8.4', 'groupId': 'OG000'}, {'value': '11.4', 'groupId': 'OG001'}, {'value': '12.1', 'groupId': 'OG002'}, {'value': '68.1', 'groupId': 'OG003'}]}]}, {'title': 'Meningitis B M09150 Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '790', 'groupId': 'OG000'}, {'value': '813', 'groupId': 'OG001'}, {'value': '817', 'groupId': 'OG002'}, {'value': '136', 'groupId': 'OG003'}]}, {'units': 'Samples', 'counts': [{'value': '249', 'groupId': 'OG000'}, {'value': '222', 'groupId': 'OG001'}, {'value': '273', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5.2', 'groupId': 'OG000'}, {'value': '8.5', 'groupId': 'OG001'}, {'value': '12.6', 'groupId': 'OG002'}, {'value': '73.0', 'groupId': 'OG003'}]}]}, {'title': 'Meningitis B M09401 Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '790', 'groupId': 'OG000'}, {'value': '813', 'groupId': 'OG001'}, {'value': '817', 'groupId': 'OG002'}, {'value': '136', 'groupId': 'OG003'}]}, {'units': 'Samples', 'counts': [{'value': '243', 'groupId': 'OG000'}, {'value': '275', 'groupId': 'OG001'}, {'value': '288', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '50.2', 'groupId': 'OG000'}, {'value': '46.5', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '98.0', 'groupId': 'OG003'}]}]}, {'title': 'Meningitis B M07463 Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '790', 'groupId': 'OG000'}, {'value': '813', 'groupId': 'OG001'}, {'value': '817', 'groupId': 'OG002'}, {'value': '136', 'groupId': 'OG003'}]}, {'units': 'Samples', 'counts': [{'value': '259', 'groupId': 'OG000'}, {'value': '274', 'groupId': 'OG001'}, {'value': '256', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000'}, {'value': '1.8', 'groupId': 'OG001'}, {'value': '3.5', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}]}, {'title': 'Meningitis B M10496 Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '790', 'groupId': 'OG000'}, {'value': '813', 'groupId': 'OG001'}, {'value': '817', 'groupId': 'OG002'}, {'value': '136', 'groupId': 'OG003'}]}, {'units': 'Samples', 'counts': [{'value': '263', 'groupId': 'OG000'}, {'value': '261', 'groupId': 'OG001'}, {'value': '257', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '54.4', 'groupId': 'OG000'}, {'value': '47.9', 'groupId': 'OG001'}, {'value': '68.9', 'groupId': 'OG002'}, {'value': '100.0', 'groupId': 'OG003'}]}]}, {'title': 'Meningitis B M14530 Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '790', 'groupId': 'OG000'}, {'value': '813', 'groupId': 'OG001'}, {'value': '817', 'groupId': 'OG002'}, {'value': '136', 'groupId': 'OG003'}]}, {'units': 'Samples', 'counts': [{'value': '241', 'groupId': 'OG000'}, {'value': '257', 'groupId': 'OG001'}, {'value': '284', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000'}, {'value': '1.6', 'groupId': 'OG001'}, {'value': '3.2', 'groupId': 'OG002'}, {'value': '100.0', 'groupId': 'OG003'}]}]}, {'title': 'Meningitis B M15668 Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '790', 'groupId': 'OG000'}, {'value': '813', 'groupId': 'OG001'}, {'value': '817', 'groupId': 'OG002'}, {'value': '136', 'groupId': 'OG003'}]}, {'units': 'Samples', 'counts': [{'value': '237', 'groupId': 'OG000'}, {'value': '270', 'groupId': 'OG001'}, {'value': '262', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000'}, {'value': '2.2', 'groupId': 'OG001'}, {'value': '0.8', 'groupId': 'OG002'}, {'value': '87.8', 'groupId': 'OG003'}]}]}, {'title': 'Meningitis B M14028 Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '790', 'groupId': 'OG000'}, {'value': '813', 'groupId': 'OG001'}, {'value': '817', 'groupId': 'OG002'}, {'value': '136', 'groupId': 'OG003'}]}, {'units': 'Samples', 'counts': [{'value': '246', 'groupId': 'OG000'}, {'value': '282', 'groupId': 'OG001'}, {'value': '283', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.8', 'groupId': 'OG000'}, {'value': '5.7', 'groupId': 'OG001'}, {'value': '4.9', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}]}, {'title': 'Meningitis B M09909 Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '790', 'groupId': 'OG000'}, {'value': '813', 'groupId': 'OG001'}, {'value': '817', 'groupId': 'OG002'}, {'value': '136', 'groupId': 'OG003'}]}, {'units': 'Samples', 'counts': [{'value': '244', 'groupId': 'OG000'}, {'value': '265', 'groupId': 'OG001'}, {'value': '261', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '79.1', 'groupId': 'OG000'}, {'value': '83.4', 'groupId': 'OG001'}, {'value': '86.2', 'groupId': 'OG002'}, {'value': '100.0', 'groupId': 'OG003'}]}]}, {'title': 'Meningitis B M14385 Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '790', 'groupId': 'OG000'}, {'value': '813', 'groupId': 'OG001'}, {'value': '817', 'groupId': 'OG002'}, {'value': '136', 'groupId': 'OG003'}]}, {'units': 'Samples', 'counts': [{'value': '235', 'groupId': 'OG000'}, {'value': '237', 'groupId': 'OG001'}, {'value': '259', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '0.8', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}, {'value': '16.3', 'groupId': 'OG003'}]}]}, {'title': 'Meningitis B M07992 Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '790', 'groupId': 'OG000'}, {'value': '813', 'groupId': 'OG001'}, {'value': '817', 'groupId': 'OG002'}, {'value': '136', 'groupId': 'OG003'}]}, {'units': 'Samples', 'counts': [{'value': '237', 'groupId': 'OG000'}, {'value': '252', 'groupId': 'OG001'}, {'value': '274', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}, {'value': '0.4', 'groupId': 'OG002'}, {'value': '0.0', 'groupId': 'OG003'}]}]}, {'title': 'Meningitis B M09155 Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '790', 'groupId': 'OG000'}, {'value': '813', 'groupId': 'OG001'}, {'value': '817', 'groupId': 'OG002'}, {'value': '136', 'groupId': 'OG003'}]}, {'units': 'Samples', 'counts': [{'value': '234', 'groupId': 'OG000'}, {'value': '255', 'groupId': 'OG001'}, {'value': '230', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000'}, {'value': '2.0', 'groupId': 'OG001'}, {'value': '1.3', 'groupId': 'OG002'}, {'value': '97.8', 'groupId': 'OG003'}]}]}, {'title': 'Meningitis B M13085 Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '790', 'groupId': 'OG000'}, {'value': '813', 'groupId': 'OG001'}, {'value': '817', 'groupId': 'OG002'}, {'value': '136', 'groupId': 'OG003'}]}, {'units': 'Samples', 'counts': [{'value': '256', 'groupId': 'OG000'}, {'value': '253', 'groupId': 'OG001'}, {'value': '255', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '13.5', 'groupId': 'OG000'}, {'value': '27.5', 'groupId': 'OG001'}, {'value': '26.6', 'groupId': 'OG002'}, {'value': '69.3', 'groupId': 'OG003'}]}]}, {'title': 'Meningitis B M18303 Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '790', 'groupId': 'OG000'}, {'value': '813', 'groupId': 'OG001'}, {'value': '817', 'groupId': 'OG002'}, {'value': '136', 'groupId': 'OG003'}]}, {'units': 'Samples', 'counts': [{'value': '241', 'groupId': 'OG000'}, {'value': '252', 'groupId': 'OG001'}, {'value': '264', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000'}, {'value': '4.0', 'groupId': 'OG001'}, {'value': '9.5', 'groupId': 'OG002'}, {'value': '100.0', 'groupId': 'OG003'}]}]}, {'title': 'Meningitis B M18711 Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '790', 'groupId': 'OG000'}, {'value': '813', 'groupId': 'OG001'}, {'value': '817', 'groupId': 'OG002'}, {'value': '136', 'groupId': 'OG003'}]}, {'units': 'Samples', 'counts': [{'value': '252', 'groupId': 'OG000'}, {'value': '237', 'groupId': 'OG001'}, {'value': '262', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5.2', 'groupId': 'OG000'}, {'value': '4.2', 'groupId': 'OG001'}, {'value': '9.5', 'groupId': 'OG002'}, {'value': '75.8', 'groupId': 'OG003'}]}]}, {'title': 'Meningitis B M15009 Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '790', 'groupId': 'OG000'}, {'value': '813', 'groupId': 'OG001'}, {'value': '817', 'groupId': 'OG002'}, {'value': '136', 'groupId': 'OG003'}]}, {'units': 'Samples', 'counts': [{'value': '262', 'groupId': 'OG000'}, {'value': '254', 'groupId': 'OG001'}, {'value': '242', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '11.8', 'groupId': 'OG000'}, {'value': '20.5', 'groupId': 'OG001'}, {'value': '31.8', 'groupId': 'OG002'}, {'value': '86.5', 'groupId': 'OG003'}]}]}, {'title': 'Meningitis B M07773 Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '790', 'groupId': 'OG000'}, {'value': '813', 'groupId': 'OG001'}, {'value': '817', 'groupId': 'OG002'}, {'value': '136', 'groupId': 'OG003'}]}, {'units': 'Samples', 'counts': [{'value': '269', 'groupId': 'OG000'}, {'value': '262', 'groupId': 'OG001'}, {'value': '251', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000'}, {'value': '0.4', 'groupId': 'OG001'}, {'value': '0.4', 'groupId': 'OG002'}, {'value': '74.3', 'groupId': 'OG003'}]}]}, {'title': 'Meningitis B M09662 Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '790', 'groupId': 'OG000'}, {'value': '813', 'groupId': 'OG001'}, {'value': '817', 'groupId': 'OG002'}, {'value': '136', 'groupId': 'OG003'}]}, {'units': 'Samples', 'counts': [{'value': '267', 'groupId': 'OG000'}, {'value': '266', 'groupId': 'OG001'}, {'value': '255', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '61.4', 'groupId': 'OG000'}, {'value': '50.8', 'groupId': 'OG001'}, {'value': '66.3', 'groupId': 'OG002'}, {'value': '95.8', 'groupId': 'OG003'}]}]}, {'title': 'Meningitis B M18483 Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '790', 'groupId': 'OG000'}, {'value': '813', 'groupId': 'OG001'}, {'value': '817', 'groupId': 'OG002'}, {'value': '136', 'groupId': 'OG003'}]}, {'units': 'Samples', 'counts': [{'value': '228', 'groupId': 'OG000'}, {'value': '233', 'groupId': 'OG001'}, {'value': '222', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000'}, {'value': '5.1', 'groupId': 'OG001'}, {'value': '3.7', 'groupId': 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[{'units': 'Participants', 'counts': [{'value': '790', 'groupId': 'OG000'}, {'value': '813', 'groupId': 'OG001'}, {'value': '817', 'groupId': 'OG002'}, {'value': '136', 'groupId': 'OG003'}]}, {'units': 'Samples', 'counts': [{'value': '228', 'groupId': 'OG000'}, {'value': '255', 'groupId': 'OG001'}, {'value': '264', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '15.4', 'groupId': 'OG000'}, {'value': '21.2', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}]}, {'title': 'Meningitis B M08389 Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '790', 'groupId': 'OG000'}, {'value': '813', 'groupId': 'OG001'}, {'value': '817', 'groupId': 'OG002'}, {'value': '136', 'groupId': 'OG003'}]}, {'units': 'Samples', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '259', 'groupId': 'OG001'}, {'value': '250', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '10.7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '11.7', 'groupId': 'OG002'}, {'value': '87.2', 'groupId': 'OG003'}]}]}, {'title': 'Meningitis B M16822 Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '790', 'groupId': 'OG000'}, {'value': '813', 'groupId': 'OG001'}, {'value': '817', 'groupId': 'OG002'}, {'value': '136', 'groupId': 'OG003'}]}, {'units': 'Samples', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '233', 'groupId': 'OG001'}, {'value': '264', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '67.8', 'groupId': 'OG000'}, {'value': '76.4', 'groupId': 'OG001'}, {'value': '82.2', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}]}, {'title': 'Meningitis B M10995 Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '790', 'groupId': 'OG000'}, {'value': '813', 'groupId': 'OG001'}, {'value': '817', 'groupId': 'OG002'}, {'value': '136', 'groupId': 'OG003'}]}, {'units': 'Samples', 'counts': [{'value': '268', 'groupId': 'OG000'}, {'value': '258', 'groupId': 'OG001'}, {'value': '239', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5.2', 'groupId': 'OG000'}, {'value': '17.8', 'groupId': 'OG001'}, {'value': '30.6', 'groupId': 'OG002'}, {'value': '85.1', 'groupId': 'OG003'}]}]}, {'title': 'Meningitis B M08780 Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '790', 'groupId': 'OG000'}, {'value': '813', 'groupId': 'OG001'}, {'value': '817', 'groupId': 'OG002'}, {'value': '136', 'groupId': 'OG003'}]}, {'units': 'Samples', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '259', 'groupId': 'OG001'}, {'value': '260', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000'}, {'value': '0.8', 'groupId': 'OG001'}, {'value': '1.5', 'groupId': 'OG002'}, {'value': '92.5', 'groupId': 'OG003'}]}]}, {'title': 'Meningitis B M09910 Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '790', 'groupId': 'OG000'}, {'value': '813', 'groupId': 'OG001'}, {'value': '817', 'groupId': 'OG002'}, {'value': '136', 'groupId': 'OG003'}]}, {'units': 'Samples', 'counts': [{'value': '247', 'groupId': 'OG000'}, {'value': '246', 'groupId': 'OG001'}, {'value': '257', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000'}, {'value': '1.2', 'groupId': 'OG001'}, {'value': '1.2', 'groupId': 'OG002'}, {'value': '93', 'groupId': 'OG003'}]}]}, {'title': 'Meningitis B M08320 Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '790', 'groupId': 'OG000'}, {'value': '813', 'groupId': 'OG001'}, {'value': '817', 'groupId': 'OG002'}, {'value': '136', 'groupId': 'OG003'}]}, {'units': 'Samples', 'counts': [{'value': '262', 'groupId': 'OG000'}, {'value': '238', 'groupId': 'OG001'}, {'value': '253', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '33.6', 'groupId': 'OG000'}, {'value': '39.7', 'groupId': 'OG001'}, {'value': '43.3', 'groupId': 'OG002'}, {'value': '87', 'groupId': 'OG003'}]}]}, {'title': 'Meningitis B M14879 Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '790', 'groupId': 'OG000'}, {'value': '813', 'groupId': 'OG001'}, {'value': '817', 'groupId': 'OG002'}, {'value': '136', 'groupId': 'OG003'}]}, {'units': 'Samples', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '242', 'groupId': 'OG001'}, {'value': '247', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000'}, {'value': '2.1', 'groupId': 'OG001'}, {'value': '6.1', 'groupId': 'OG002'}, {'value': '21.3', 'groupId': 'OG003'}]}]}, {'title': 'Meningitis B M09345 Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '790', 'groupId': 'OG000'}, {'value': '813', 'groupId': 'OG001'}, {'value': '817', 'groupId': 'OG002'}, {'value': '136', 'groupId': 'OG003'}]}, {'units': 'Samples', 'counts': [{'value': '251', 'groupId': 'OG000'}, {'value': '257', 'groupId': 'OG001'}, {'value': '282', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '19.3', 'groupId': 'OG000'}, {'value': '20.1', 'groupId': 'OG001'}, {'value': '33.4', 'groupId': 'OG002'}, {'value': '81.2', 'groupId': 'OG003'}]}]}, {'title': 'Meningitis B M14594 Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '790', 'groupId': 'OG000'}, {'value': '813', 'groupId': 'OG001'}, {'value': '817', 'groupId': 'OG002'}, {'value': '136', 'groupId': 'OG003'}]}, {'units': 'Samples', 'counts': [{'value': '245', 'groupId': 'OG000'}, {'value': '241', 'groupId': 'OG001'}, {'value': '238', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '20.8', 'groupId': 'OG000'}, {'value': '27.4', 'groupId': 'OG001'}, {'value': '41.2', 'groupId': 'OG002'}, {'value': '97.7', 'groupId': 'OG003'}]}]}, {'title': 'Meningitis B M07621 Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '790', 'groupId': 'OG000'}, {'value': '813', 'groupId': 'OG001'}, {'value': '817', 'groupId': 'OG002'}, {'value': '136', 'groupId': 'OG003'}]}, {'units': 'Samples', 'counts': [{'value': '251', 'groupId': 'OG000'}, {'value': '260', 'groupId': 'OG001'}, {'value': '263', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000'}, {'value': '1.2', 'groupId': 'OG001'}, {'value': '1.1', 'groupId': 'OG002'}, {'value': '77.5', 'groupId': 'OG003'}]}]}, {'title': 'Meningitis B M13568 Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '790', 'groupId': 'OG000'}, {'value': '813', 'groupId': 'OG001'}, {'value': '817', 'groupId': 'OG002'}, {'value': '136', 'groupId': 'OG003'}]}, {'units': 'Samples', 'counts': [{'value': '261', 'groupId': 'OG000'}, {'value': '264', 'groupId': 'OG001'}, {'value': '253', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5.4', 'groupId': 'OG000'}, {'value': '3.8', 'groupId': 'OG001'}, {'value': '3.9', 'groupId': 'OG002'}, {'value': '95', 'groupId': 'OG003'}]}]}, {'title': 'Meningitis B M18017 Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '790', 'groupId': 'OG000'}, {'value': '813', 'groupId': 'OG001'}, {'value': '817', 'groupId': 'OG002'}, {'value': '136', 'groupId': 'OG003'}]}, {'units': 'Samples', 'counts': [{'value': '246', 'groupId': 'OG000'}, {'value': '247', 'groupId': 'OG001'}, {'value': '258', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1.6', 'groupId': 'OG002'}, {'value': '96.8', 'groupId': 'OG003'}]}]}, {'title': 'Meningitis B M08420 Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '790', 'groupId': 'OG000'}, {'value': '813', 'groupId': 'OG001'}, {'value': '817', 'groupId': 'OG002'}, {'value': '136', 'groupId': 'OG003'}]}, {'units': 'Samples', 'counts': [{'value': '243', 'groupId': 'OG000'}, {'value': '255', 'groupId': 'OG001'}, {'value': '256', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000'}, {'value': '0.4', 'groupId': 'OG001'}, {'value': '1.6', 'groupId': 'OG002'}, {'value': '95', 'groupId': 'OG003'}]}]}, {'title': 'Meningitis B M07959 Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '790', 'groupId': 'OG000'}, {'value': '813', 'groupId': 'OG001'}, {'value': '817', 'groupId': 'OG002'}, {'value': '136', 'groupId': 'OG003'}]}, {'units': 'Samples', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '237', 'groupId': 'OG001'}, {'value': '254', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.7', 'groupId': 'OG000'}, {'value': '2.5', 'groupId': 'OG001'}, {'value': '1.7', 'groupId': 'OG002'}, {'value': '97.1', 'groupId': 'OG003'}]}]}, {'title': 'Meningitis B M06970 Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '790', 'groupId': 'OG000'}, {'value': '813', 'groupId': 'OG001'}, {'value': '817', 'groupId': 'OG002'}, {'value': '136', 'groupId': 'OG003'}]}, {'units': 'Samples', 'counts': [{'value': '236', 'groupId': 'OG000'}, {'value': '261', 'groupId': 'OG001'}, {'value': '253', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '19.6', 'groupId': 'OG000'}, {'value': '17.6', 'groupId': 'OG001'}, {'value': '30.2', 'groupId': 'OG002'}, {'value': '85.7', 'groupId': 'OG003'}]}]}, {'title': 'Meningitis B M10491 Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '790', 'groupId': 'OG000'}, {'value': '813', 'groupId': 'OG001'}, {'value': '817', 'groupId': 'OG002'}, {'value': '136', 'groupId': 'OG003'}]}, {'units': 'Samples', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '262', 'groupId': 'OG001'}, {'value': '227', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5.4', 'groupId': 'OG000'}, {'value': '8.4', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '82.1', 'groupId': 'OG003'}]}]}, {'title': 'Meningitis B M13569 Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '790', 'groupId': 'OG000'}, {'value': '813', 'groupId': 'OG001'}, {'value': '817', 'groupId': 'OG002'}, {'value': '136', 'groupId': 'OG003'}]}, {'units': 'Samples', 'counts': [{'value': '221', 'groupId': 'OG000'}, {'value': '243', 'groupId': 'OG001'}, {'value': '247', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '2.9', 'groupId': 'OG001'}, {'value': '1.2', 'groupId': 'OG002'}, {'value': '96.8', 'groupId': 'OG003'}]}]}, {'title': 'Meningitis B M10182 Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '790', 'groupId': 'OG000'}, {'value': '813', 'groupId': 'OG001'}, {'value': '817', 'groupId': 'OG002'}, {'value': '136', 'groupId': 'OG003'}]}, {'units': 'Samples', 'counts': [{'value': '229', 'groupId': 'OG000'}, {'value': '234', 'groupId': 'OG001'}, {'value': '256', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Meningitis B M13547 Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '790', 'groupId': 'OG000'}, {'value': '813', 'groupId': 'OG001'}, {'value': '817', 'groupId': 'OG002'}, {'value': '136', 'groupId': 'OG003'}]}, {'units': 'Samples', 'counts': [{'value': '251', 'groupId': 'OG000'}, {'value': '258', 'groupId': 'OG001'}, {'value': '238', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2.4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4.7', 'groupId': 'OG002'}, {'value': '47.7', 'groupId': 'OG003'}]}]}, {'title': 'Meningitis B M15276 Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '790', 'groupId': 'OG000'}, {'value': '813', 'groupId': 'OG001'}, {'value': '817', 'groupId': 'OG002'}, {'value': '136', 'groupId': 'OG003'}]}, {'units': 'Samples', 'counts': [{'value': '231', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}, {'value': '259', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1.5', 'groupId': 'OG002'}, {'value': '87.8', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 1 month after the vaccination schedule (i.e., Day 211 for the MenB_0_2_6 group [3 dose schedule], MenB_0_6 group, ABCWY_Pooled group and Day 31 for the MenACWY group)', 'description': 'The effectiveness of the 3 dose (0,2,6-M) and 2 dose (0,6-M ) schedule of rMenB+OMV NZ vaccine and 2 doses of MenABCWY vaccine when compared to 1 month after the MenACWY vaccination (Day 31), against a panel of N. meningitidis serogroup B strains is measured in terms of percentage of samples without bactericidal activity using enc-hSBA, which provides a qualitative assessment (yes/no) of the presence of sufficient bactericidal antibodies in human sera to kill a meningococcal strain at a specific dilution of 1:4. As pre-specified in the protocol, data reported in this outcome measure were presented for the MenB\\_0\\_2\\_6 group, MenB\\_0\\_6 group,ACWY group and ABCWY pooled group, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.', 'unitOfMeasure': 'Percentage of blood samples', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Samples', 'denomUnitsSelected': 'Samples', 'populationDescription': 'Analysis was performed on blood samples collected from FAS, which included participants who were randomized, received at least one dose of the study treatment, and had post-vaccination effectiveness data available for the specified analysis at the specified time points. Participants were randomly selected for testing against each strain therefore only a subset of participants were tested for each of the strains.\n\nNumber of Participants analyzed = Total number of participants included in FAS.'}, {'type': 'SECONDARY', 'title': 'Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY', 'denoms': [{'units': 'Participants', 'counts': [{'value': '893', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}, {'units': 'Samples', 'counts': [{'value': '293', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MenB_0_2_6 Group', 'description': 'Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.'}, {'id': 'OG001', 'title': 'ACWY Group', 'description': 'Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.'}], 'classes': [{'title': 'Meningitis B M10713 Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '893', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}, {'units': 'Samples', 'counts': [{'value': '266', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000'}, {'value': '15.6', 'groupId': 'OG001'}]}]}, {'title': 'Meningitis B M08641 Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '893', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}, {'units': 'Samples', 'counts': [{'value': '250', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.2', 'groupId': 'OG000'}, {'value': '96.6', 'groupId': 'OG001'}]}]}, {'title': 'Meningitis B M12898 Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '893', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}, {'units': 'Samples', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.4', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}]}, {'title': 'Meningitis B M09150 Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '893', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}, {'units': 'Samples', 'counts': [{'value': '250', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.3', 'groupId': 'OG000'}, {'value': '68.6', 'groupId': 'OG001'}]}]}, {'title': 'Meningitis B M09401 Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '893', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}, {'units': 'Samples', 'counts': [{'value': '253', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}]}, {'title': 'Meningitis B M07463 Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '893', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}, {'units': 'Samples', 'counts': [{'value': '265', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}]}, {'title': 'Meningitis B M10496 Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '893', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}, {'units': 'Samples', 'counts': [{'value': '277', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '50.5', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Meningitis B M14530 Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '893', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}, {'units': 'Samples', 'counts': 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'OG000'}, {'value': '173', 'groupId': 'OG001'}]}, {'units': 'Samples', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '63.7', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}]}, {'title': 'Meningitis B M11290 Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '893', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}, {'units': 'Samples', 'counts': [{'value': '278', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '70.5', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Meningitis B M14988 Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '893', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}, {'units': 'Samples', 'counts': [{'value': '251', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}]}, {'title': 'Meningitis B M10536 Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '893', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}, {'units': 'Samples', 'counts': [{'value': '241', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23.2', 'groupId': 'OG000'}, {'value': '91.7', 'groupId': 'OG001'}]}]}, {'title': 'Meningitis B M08959 Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '893', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}, {'units': 'Samples', 'counts': [{'value': '267', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}, {'value': '85.1', 'groupId': 'OG001'}]}]}, {'title': 'Meningitis B M08785 Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '893', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}, {'units': 'Samples', 'counts': [{'value': '262', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}, {'value': '53.8', 'groupId': 'OG001'}]}]}, {'title': 'Meningitis B M07245 Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '893', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}, {'units': 'Samples', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '23.3', 'groupId': 'OG001'}]}]}, {'title': 'Meningitis B M19315 Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '893', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}, {'units': 'Samples', 'counts': [{'value': '270', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.3', 'groupId': 'OG000'}, {'value': '79.4', 'groupId': 'OG001'}]}]}, {'title': 'Meningitis B M14376 Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '893', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}, {'units': 'Samples', 'counts': [{'value': '269', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '92.7', 'groupId': 'OG001'}]}]}, {'title': 'Meningitis B M08994 Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '893', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}, {'units': 'Samples', 'counts': [{'value': '233', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.9', 'groupId': 'OG000'}, {'value': '55.7', 'groupId': 'OG001'}]}]}, {'title': 'Meningitis B M11646 Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '893', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}, {'units': 'Samples', 'counts': [{'value': '252', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000'}, {'value': '83.3', 'groupId': 'OG001'}]}]}, {'title': 'Meningitis B M13362 Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '893', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}, {'units': 'Samples', 'counts': [{'value': '272', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000'}, {'value': '81.6', 'groupId': 'OG001'}]}]}, {'title': 'Meningitis B M08080 Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '893', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}, {'units': 'Samples', 'counts': [{'value': '244', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '46.8', 'groupId': 'OG000'}, {'value': '87.1', 'groupId': 'OG001'}]}]}, {'title': 'Meningitis B M08370 Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '893', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}, {'units': 'Samples', 'counts': [{'value': '280', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.9', 'groupId': 'OG000'}, {'value': '97.7', 'groupId': 'OG001'}]}]}, {'title': 'Meningitis B M08129 Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '893', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}, {'units': 'Samples', 'counts': [{'value': '242', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.4', 'groupId': 'OG000'}, {'value': '71.4', 'groupId': 'OG001'}]}]}, {'title': 'Meningitis B M07111 Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '893', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}, {'units': 'Samples', 'counts': [{'value': '244', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}, {'value': '90.9', 'groupId': 'OG001'}]}]}, {'title': 'Meningitis B M07537 Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '893', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}, {'units': 'Samples', 'counts': [{'value': '253', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '96.4', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Meningitis B M13438 Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '893', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}, {'units': 'Samples', 'counts': [{'value': '263', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'Meningitis B M10661 Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '893', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}, {'units': 'Samples', 'counts': [{'value': '259', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}]}]}, {'title': 'Meningitis B M10920 Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '893', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}, {'units': 'Samples', 'counts': [{'value': '259', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '50.2', 'groupId': 'OG000'}, {'value': '91.2', 'groupId': 'OG001'}]}]}, {'title': 'Meningitis B M15564 Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '893', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}, {'units': 'Samples', 'counts': [{'value': '258', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000'}, {'value': '77.5', 'groupId': 'OG001'}]}]}, {'title': 'Meningitis B M10934 Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '893', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}, {'units': 'Samples', 'counts': [{'value': '286', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Meningitis B M09400 Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '893', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}, {'units': 'Samples', 'counts': [{'value': '261', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000'}, {'value': '97.4', 'groupId': 'OG001'}]}]}, {'title': 'Meningitis B M08781 Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '893', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}, {'units': 'Samples', 'counts': [{'value': '223', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '75.8', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Meningitis B M09173 Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '893', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}, {'units': 'Samples', 'counts': [{'value': '244', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '95.2', 'groupId': 'OG001'}]}]}, {'title': 'Meningitis B M14113 Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '893', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}, {'units': 'Samples', 'counts': [{'value': '244', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28.3', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Meningitis B M08389 Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '893', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}, {'units': 'Samples', 'counts': [{'value': '258', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000'}, {'value': '86.7', 'groupId': 'OG001'}]}]}, {'title': 'Meningitis B M16822 Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '893', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}, {'units': 'Samples', 'counts': [{'value': '240', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}]}, {'title': 'Meningitis B M10995 Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '893', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}, {'units': 'Samples', 'counts': [{'value': '282', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.3', 'groupId': 'OG000'}, {'value': '85.1', 'groupId': 'OG001'}]}]}, {'title': 'Meningitis B M08780 Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '893', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}, {'units': 'Samples', 'counts': [{'value': '241', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000'}, {'value': '92.5', 'groupId': 'OG001'}]}]}, {'title': 'Meningitis B M09910 Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '893', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}, {'units': 'Samples', 'counts': [{'value': '256', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}]}]}, {'title': 'Meningitis B M08320 Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '893', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}, {'units': 'Samples', 'counts': [{'value': '277', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '45.1', 'groupId': 'OG000'}, {'value': '86.8', 'groupId': 'OG001'}]}]}, {'title': 'Meningitis B M14879 Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '893', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}, {'units': 'Samples', 'counts': [{'value': '252', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000'}, {'value': '23.2', 'groupId': 'OG001'}]}]}, {'title': 'Meningitis B M09345 Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '893', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}, {'units': 'Samples', 'counts': [{'value': '263', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '32.3', 'groupId': 'OG000'}, {'value': '74.9', 'groupId': 'OG001'}]}]}, {'title': 'Meningitis B M14594 Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '893', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}, {'units': 'Samples', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '35.8', 'groupId': 'OG000'}, {'value': '97.7', 'groupId': 'OG001'}]}]}, {'title': 'Meningitis B M07621 Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '893', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}, {'units': 'Samples', 'counts': [{'value': '259', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}, {'value': '77.5', 'groupId': 'OG001'}]}]}, {'title': 'Meningitis B M13568 Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '893', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}, {'units': 'Samples', 'counts': [{'value': '268', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.7', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}]}, {'title': 'Meningitis B M18017 Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '893', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}, {'units': 'Samples', 'counts': [{'value': '262', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '96.8', 'groupId': 'OG001'}]}]}, {'title': 'Meningitis B M08420 Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '893', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}, {'units': 'Samples', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}]}, {'title': 'Meningitis B M07959 Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '893', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}, {'units': 'Samples', 'counts': [{'value': '243', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.2', 'groupId': 'OG000'}, {'value': '97.1', 'groupId': 'OG001'}]}]}, {'title': 'Meningitis B M06970 Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '893', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}, {'units': 'Samples', 'counts': [{'value': '243', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28.8', 'groupId': 'OG000'}, {'value': '90.6', 'groupId': 'OG001'}]}]}, {'title': 'Meningitis B M10491 Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '893', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}, {'units': 'Samples', 'counts': [{'value': '254', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.1', 'groupId': 'OG000'}, {'value': '82.1', 'groupId': 'OG001'}]}]}, {'title': 'Meningitis B M13569 Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '893', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}, {'units': 'Samples', 'counts': [{'value': '233', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}, {'value': '96.8', 'groupId': 'OG001'}]}]}, {'title': 'Meningitis B M10182 Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '893', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}, {'units': 'Samples', 'counts': [{'value': '251', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Meningitis B M13547 Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '893', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}, {'units': 'Samples', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '47.7', 'groupId': 'OG001'}]}]}, {'title': 'Meningitis B M15276 Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '893', 'groupId': 'OG000'}, {'value': '173', 'groupId': 'OG001'}]}, {'units': 'Samples', 'counts': [{'value': '238', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}, {'value': '87.8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 1 month after the vaccination schedule (i.e., Day 91 for the MenB_0_2_6 group [2 dose schedule] and Day 31 for the MenACWY group)', 'description': 'The effectiveness of the 2 dose (0,2-M) schedule of rMenB+OMV NZ vaccine when compared to 1 month after the MenACWY vaccination (Day 31), against a panel of N. meningitidis serogroup B strains is measured in terms of percentage of samples without bactericidal activity using enc-hSBA, which provides a qualitative assessment (yes/no) of the presence of sufficient bactericidal antibodies in human sera to kill a meningococcal strain at a specific dilution of 1:4.', 'unitOfMeasure': 'Percentage of blood samples', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Samples', 'denomUnitsSelected': 'Samples', 'populationDescription': 'Analysis was performed on blood samples collected from FAS , which included all participants who were randomized, received at least 1 dose of the study treatment and had post-vaccination effectiveness data available for the specified analysis at the specified time points.\n\nParticipants were randomly selected for testing against each strain therefore only a subset of participants were tested for each of the strains.\n\nNumber of Participants analyzed = Total number of participants included in FAS.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Classified by Percentage of Serogroup B Invasive Disease Strains Killed Using Enc-hSBA in Each Subject at 1 Month After Vaccination Schedule for the MenB_0_2_6 Group [3 Dose], MenB_0_6 Group and Last MenABCWY Dose (Pooled Lots)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '790', 'groupId': 'OG000'}, {'value': '813', 'groupId': 'OG001'}, {'value': '817', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'MenB_0_2_6 Group', 'description': 'Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.'}, {'id': 'OG001', 'title': 'MenB_0_6 Group', 'description': 'Participants received 2 doses of rMenB+OMV NZ vaccine on Day 1, and Day 181, 1 dose of MenACWY vaccine on Day 61. Participants received 1 dose of Placebo on Day 211 to maintain blinding.'}, {'id': 'OG002', 'title': 'ABCWY_Pooled', 'description': 'Participants received 2 doses of either MenABCWY Lot 1, Lot 2, or Lot 3 vaccine on Day 1 and Day 181 and 1 dose of placebo on Day 61. Participants received 1 dose of placebo on Day 211 to maintain blinding.\n\nTo evaluate the effectiveness of 2 doses of the MenABCWY vaccines against rMenB+OMV and MenACWY vaccines, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.'}], 'classes': [{'title': '>=50% killed strains', 'categories': [{'measurements': [{'value': '98.7', 'spread': '97.7', 'groupId': 'OG000', 'lowerLimit': '97.7', 'upperLimit': '99.4'}, {'value': '98.5', 'spread': '97.4', 'groupId': 'OG001', 'lowerLimit': '97.4', 'upperLimit': '99.2'}, {'value': '98', 'spread': '96.8', 'groupId': 'OG002', 'lowerLimit': '96.8', 'upperLimit': '98.9'}]}]}, {'title': '>=55% killed strains', 'categories': [{'measurements': [{'value': '98.4', 'spread': '97.2', 'groupId': 'OG000', 'lowerLimit': '97.2', 'upperLimit': '99.1'}, {'value': '97.4', 'spread': '96.1', 'groupId': 'OG001', 'lowerLimit': '96.1', 'upperLimit': '98.4'}, {'value': '96.8', 'spread': '95.4', 'groupId': 'OG002', 'lowerLimit': '95.4', 'upperLimit': '97.9'}]}]}, {'title': '>=60% killed strains', 'categories': [{'measurements': [{'value': '97.8', 'spread': '96.6', 'groupId': 'OG000', 'lowerLimit': '96.6', 'upperLimit': '98.7'}, {'value': '96.8', 'spread': '95.3', 'groupId': 'OG001', 'lowerLimit': '95.3', 'upperLimit': '97.9'}, {'value': '95.2', 'spread': '93.5', 'groupId': 'OG002', 'lowerLimit': '93.5', 'upperLimit': '96.6'}]}]}, {'title': '>=65% killed strains', 'categories': [{'measurements': [{'value': '96.5', 'spread': '94.9', 'groupId': 'OG000', 'lowerLimit': '94.9', 'upperLimit': '97.6'}, {'value': '93.6', 'spread': '91.7', 'groupId': 'OG001', 'lowerLimit': '91.7', 'upperLimit': '95.2'}, {'value': '90.1', 'spread': '87.8', 'groupId': 'OG002', 'lowerLimit': '87.8', 'upperLimit': '92'}]}]}, {'title': '>=70% killed strains', 'categories': [{'measurements': [{'value': '93.4', 'spread': '91.5', 'groupId': 'OG000', 'lowerLimit': '91.5', 'upperLimit': '95'}, {'value': '89.8', 'spread': '87.5', 'groupId': 'OG001', 'lowerLimit': '87.5', 'upperLimit': '91.8'}, {'value': '84.1', 'spread': '81.4', 'groupId': 'OG002', 'lowerLimit': '81.4', 'upperLimit': '86.5'}]}]}, {'title': '>=75% killed strains', 'categories': [{'measurements': [{'value': '86.8', 'spread': '84.3', 'groupId': 'OG000', 'lowerLimit': '84.3', 'upperLimit': '89.1'}, {'value': '82.2', 'spread': '79.4', 'groupId': 'OG001', 'lowerLimit': '79.4', 'upperLimit': '84.7'}, {'value': '74.7', 'spread': '71.5', 'groupId': 'OG002', 'lowerLimit': '71.5', 'upperLimit': '77.6'}]}]}, {'title': '>=80% killed strains', 'categories': [{'measurements': [{'value': '79.2', 'spread': '76.2', 'groupId': 'OG000', 'lowerLimit': '76.2', 'upperLimit': '82'}, {'value': '75.5', 'spread': '72.4', 'groupId': 'OG001', 'lowerLimit': '72.4', 'upperLimit': '78.4'}, {'value': '66', 'spread': '62.6', 'groupId': 'OG002', 'lowerLimit': '62.6', 'upperLimit': '69.2'}]}]}, {'title': '>=85% killed strains', 'categories': [{'measurements': [{'value': '62.8', 'spread': '59.3', 'groupId': 'OG000', 'lowerLimit': '59.3', 'upperLimit': '66.2'}, {'value': '60.4', 'spread': '56.9', 'groupId': 'OG001', 'lowerLimit': '56.9', 'upperLimit': '63.8'}, {'value': '50.1', 'spread': '46.6', 'groupId': 'OG002', 'lowerLimit': '46.6', 'upperLimit': '53.5'}]}]}, {'title': '>=90% killed strains', 'categories': [{'measurements': [{'value': '43.7', 'spread': '40.2', 'groupId': 'OG000', 'lowerLimit': '40.2', 'upperLimit': '47.2'}, {'value': '41.3', 'spread': '37.9', 'groupId': 'OG001', 'lowerLimit': '37.9', 'upperLimit': '44.8'}, {'value': '32.1', 'spread': '28.9', 'groupId': 'OG002', 'lowerLimit': '28.9', 'upperLimit': '35.4'}]}]}, {'title': '>=95% killed strains', 'categories': [{'measurements': [{'value': '22.5', 'spread': '19.7', 'groupId': 'OG000', 'lowerLimit': '19.7', 'upperLimit': '25.6'}, {'value': '21', 'spread': '18.3', 'groupId': 'OG001', 'lowerLimit': '18.3', 'upperLimit': '24'}, {'value': '13.7', 'spread': '11.4', 'groupId': 'OG002', 'lowerLimit': '11.4', 'upperLimit': '16.3'}]}]}, {'title': '100% killed strains', 'categories': [{'measurements': [{'value': '10', 'spread': '8', 'groupId': 'OG000', 'lowerLimit': '8', 'upperLimit': '12.3'}, {'value': '8.4', 'spread': '6.6', 'groupId': 'OG001', 'lowerLimit': '6.6', 'upperLimit': '10.5'}, {'value': '6.1', 'spread': '4.6', 'groupId': 'OG002', 'lowerLimit': '4.6', 'upperLimit': '8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 1 month after the vaccination schedule (Day 211 for MenB_0_2_6 group (3 dose schedule), MenB_0_6 group and ABCWY_Pooled group)', 'description': 'The percentage of participants classified by percentage of N.meningitidis serogroup B invasive strains killed using enc-hSBA and the corresponding 2- sided 95% CI based on Clopper-Pearson method is calculated for each vaccine group. As pre-specified in the protocol, data reported in this outcome measure were presented for the MenB\\_0\\_2\\_6 group, MenB\\_0\\_6 group and ABCWY pooled group, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the FAS, which included participants who were randomized, received at least 1 dose of the study treatment and had post-vaccination effectiveness data available for the specified analysis at the specified time points.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Classified by Percentage of Serogroup B Invasive Disease Strains Killed Using Enc-hSBA in Each Subject at 1 Month After Vaccination With rMenB+OMV NZ (0,2-months)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '831', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MenB_0_2_6 Group', 'description': 'Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.'}], 'classes': [{'title': '>=50% killed strains', 'categories': [{'measurements': [{'value': '98.6', 'spread': '97.5', 'groupId': 'OG000', 'lowerLimit': '97.5', 'upperLimit': '99.3'}]}]}, {'title': '>=55% killed strains', 'categories': [{'measurements': [{'value': '97.7', 'spread': '96.5', 'groupId': 'OG000', 'lowerLimit': '96.5', 'upperLimit': '98.6'}]}]}, {'title': '>=60% killed strains', 'categories': [{'measurements': [{'value': '96.5', 'spread': '95', 'groupId': 'OG000', 'lowerLimit': '95', 'upperLimit': '97.7'}]}]}, {'title': '>=65% killed strains', 'categories': [{'measurements': [{'value': '92.2', 'spread': '90.1', 'groupId': 'OG000', 'lowerLimit': '90.1', 'upperLimit': '93.9'}]}]}, {'title': '>=70% killed strains', 'categories': [{'measurements': [{'value': '84.8', 'spread': '82.2', 'groupId': 'OG000', 'lowerLimit': '82.2', 'upperLimit': '87.2'}]}]}, {'title': '>=75% killed strains', 'categories': [{'measurements': [{'value': '75.7', 'spread': '72.6', 'groupId': 'OG000', 'lowerLimit': '72.6', 'upperLimit': '78.6'}]}]}, {'title': '>=80% killed strains', 'categories': [{'measurements': [{'value': '66.7', 'spread': '63.3', 'groupId': 'OG000', 'lowerLimit': '63.3', 'upperLimit': '69.9'}]}]}, {'title': '>=85% killed strains', 'categories': [{'measurements': [{'value': '49.7', 'spread': '46.2', 'groupId': 'OG000', 'lowerLimit': '46.2', 'upperLimit': '53.2'}]}]}, {'title': '>=90% killed strains', 'categories': [{'measurements': [{'value': '33.8', 'spread': '30.6', 'groupId': 'OG000', 'lowerLimit': '30.6', 'upperLimit': '37.1'}]}]}, {'title': '>=95% killed strains', 'categories': [{'measurements': [{'value': '16.2', 'spread': '13.8', 'groupId': 'OG000', 'lowerLimit': '13.8', 'upperLimit': '18.9'}]}]}, {'title': '100% killed strains', 'categories': [{'measurements': [{'value': '7.7', 'spread': '6', 'groupId': 'OG000', 'lowerLimit': '6', 'upperLimit': '9.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 1 month after the vaccination schedule (Day 91 for MenB_0_2_6 group [2 dose schedule])', 'description': 'The percentage of participants classified by percentage of N.meningitidis serogroup B invasive strains killed using enc-hSBA and the corresponding 2- sided 95% CI based on Clopper-Pearson method is calculated for each vaccine group.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the FAS, which included participants who were randomized, received at least 1 dose of the study treatment, and had post-vaccination effectiveness data available for the specified analysis at the specified time points.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With hSBA Titers >= LLOQ for Each and All Serogroup B Indicator Strains at Day 1 and at 1 Month After Vaccination With rMenB+OMV NZ (0,2,6-months and 0,6-months) and Last Dose of MenABCWY (ABCWY Group-pooled Lots)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '749', 'groupId': 'OG000'}, {'value': '731', 'groupId': 'OG001'}, {'value': '780', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'MenB_0_2_6 Group', 'description': 'Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.'}, {'id': 'OG001', 'title': 'MenB_0_6 Group', 'description': 'Participants received 2 doses of rMenB+OMV NZ vaccine on Day 1, and Day 181, 1 dose of MenACWY vaccine on Day 61. Participants received 1 dose of Placebo on Day 211 to maintain blinding.'}, {'id': 'OG002', 'title': 'ABCWY_Pooled', 'description': 'Participants received 2 doses of either MenABCWY Lot 1, Lot 2, or Lot 3 vaccine on Day 1 and Day 181 and 1 dose of placebo on Day 61. Participants received 1 dose of placebo on Day 211 to maintain blinding.\n\nTo evaluate the effectiveness of 2 doses of the MenABCWY vaccines against rMenB+OMV and MenACWY vaccines, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.'}], 'classes': [{'title': 'fHbp (M14459) Ab, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '749', 'groupId': 'OG000'}, {'value': '730', 'groupId': 'OG001'}, {'value': '762', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.9', 'groupId': 'OG000', 'lowerLimit': '3.5', 'upperLimit': '6.7'}, {'value': '3.4', 'groupId': 'OG001', 'lowerLimit': '2.2', 'upperLimit': '5'}, {'value': '5.4', 'groupId': 'OG002', 'lowerLimit': '3.9', 'upperLimit': '7.2'}]}]}, {'title': 'fHbp (M14459) Ab, Day 211', 'denoms': [{'units': 'Participants', 'counts': [{'value': '690', 'groupId': 'OG000'}, {'value': '707', 'groupId': 'OG001'}, {'value': '738', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '97.4', 'groupId': 'OG000', 'lowerLimit': '95.9', 'upperLimit': '98.4'}, {'value': '94.6', 'groupId': 'OG001', 'lowerLimit': '92.7', 'upperLimit': '96.2'}, {'value': '95.9', 'groupId': 'OG002', 'lowerLimit': '94.2', 'upperLimit': '97.2'}]}]}, {'title': 'NadA (96217) Ab, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '744', 'groupId': 'OG000'}, {'value': '731', 'groupId': 'OG001'}, {'value': '780', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6.2', 'groupId': 'OG000', 'lowerLimit': '4.6', 'upperLimit': '8.2'}, {'value': '4.4', 'groupId': 'OG001', 'lowerLimit': '3.0', 'upperLimit': '6.1'}, {'value': '6.2', 'groupId': 'OG002', 'lowerLimit': '4.6', 'upperLimit': '8.1'}]}]}, {'title': 'NadA (96217) Ab, Day 211', 'denoms': [{'units': 'Participants', 'counts': [{'value': '691', 'groupId': 'OG000'}, {'value': '707', 'groupId': 'OG001'}, {'value': '734', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '99.5', 'upperLimit': '100'}, {'value': '98', 'groupId': 'OG001', 'lowerLimit': '96.7', 'upperLimit': '98.9'}, {'value': '96.2', 'groupId': 'OG002', 'lowerLimit': '94.5', 'upperLimit': '97.5'}]}]}, {'title': 'NHBA (M13520) Ab, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '749', 'groupId': 'OG000'}, {'value': '731', 'groupId': 'OG001'}, {'value': '764', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '23.2', 'groupId': 'OG000', 'lowerLimit': '20.3', 'upperLimit': '26.4'}, {'value': '20.9', 'groupId': 'OG001', 'lowerLimit': '18', 'upperLimit': '24.1'}, {'value': '18.5', 'groupId': 'OG002', 'lowerLimit': '15.8', 'upperLimit': '21.4'}]}]}, {'title': 'NHBA (M13520) Ab, Day 211', 'denoms': [{'units': 'Participants', 'counts': [{'value': '695', 'groupId': 'OG000'}, {'value': '711', 'groupId': 'OG001'}, {'value': '738', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '97.0', 'groupId': 'OG000', 'lowerLimit': '95.4', 'upperLimit': '98.1'}, {'value': '97.5', 'groupId': 'OG001', 'lowerLimit': '96.0', 'upperLimit': '98.5'}, {'value': '95.3', 'groupId': 'OG002', 'lowerLimit': '93.5', 'upperLimit': '96.7'}]}]}, {'title': 'PorA (NZ98/254) Ab, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '738', 'groupId': 'OG000'}, {'value': '716', 'groupId': 'OG001'}, {'value': '751', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.3', 'groupId': 'OG000', 'lowerLimit': '1.3', 'upperLimit': '3.7'}, {'value': '1.4', 'groupId': 'OG001', 'lowerLimit': '0.7', 'upperLimit': '2.6'}, {'value': '2.1', 'groupId': 'OG002', 'lowerLimit': '1.2', 'upperLimit': '3.4'}]}]}, {'title': 'PorA (NZ98/254) Ab, Day 211', 'denoms': [{'units': 'Participants', 'counts': [{'value': '657', 'groupId': 'OG000'}, {'value': '684', 'groupId': 'OG001'}, {'value': '709', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '85.8', 'groupId': 'OG000', 'lowerLimit': '82.9', 'upperLimit': '88.4'}, {'value': '82.6', 'groupId': 'OG001', 'lowerLimit': '79.5', 'upperLimit': '85.4'}, {'value': '75.3', 'groupId': 'OG002', 'lowerLimit': '72.0', 'upperLimit': '78.5'}]}]}, {'title': 'Composite Response, Day=1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '727', 'groupId': 'OG000'}, {'value': '708', 'groupId': 'OG001'}, {'value': '747', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '2.2'}, {'value': '0.6', 'groupId': 'OG001', 'lowerLimit': '0.2', 'upperLimit': '1.4'}, {'value': '1.1', 'groupId': 'OG002', 'lowerLimit': '0.5', 'upperLimit': '2.1'}]}]}, {'title': 'Composite Response, Day=211', 'denoms': [{'units': 'Participants', 'counts': [{'value': '654', 'groupId': 'OG000'}, {'value': '683', 'groupId': 'OG001'}, {'value': '707', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '83.3', 'groupId': 'OG000', 'lowerLimit': '80.3', 'upperLimit': '86.1'}, {'value': '80.7', 'groupId': 'OG001', 'lowerLimit': '77.5', 'upperLimit': '83.6'}, {'value': '71.4', 'groupId': 'OG002', 'lowerLimit': '67.9', 'upperLimit': '74.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Day 1 (pre-vaccination) and1 month after the vaccination schedule (i.e., Day 211 for MenB_0_2_6 group [3 dose schedule], MenB_0_6 group and ABCWY_Pooled group)', 'description': 'The immune response to rMenB+OMV NZ and MenABCWY vaccine is evaluated by measuring bactericidal activity against each (individual response) and all (composite response) N. meningitidis serogroup B indicator strains(M14459, 96217, M13520 and NZ98/254 for fHbp, NadA, NHBA and PorA P1.4 antigens, respectively). As pre-specified in the protocol, data reported in this outcome measure were presented for the MenB\\_0\\_2\\_6 group, MenB\\_0\\_6 group and ABCWY pooled group, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Full Analysis Set, which included participants who were randomized, received at least 1 dose of the study treatment, and had post-vaccination effectiveness data available for the specified analysis at the specified time point.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With hSBA Titers >= LLOQ for Each and All Serogroup B Indicator Strains at Day 1 and at 1 Month After Vaccination With rMenB+OMV NZ (0,2-months)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '753', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MenB_0_2_6 Group', 'description': 'Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.'}], 'classes': [{'title': 'fHbp (M14459) Ab, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '749', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.9', 'groupId': 'OG000', 'lowerLimit': '3.5', 'upperLimit': '6.7'}]}]}, {'title': 'fHbp (M14459) Ab, Day 91', 'denoms': [{'units': 'Participants', 'counts': [{'value': '750', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '92.9', 'groupId': 'OG000', 'lowerLimit': '90.9', 'upperLimit': '94.7'}]}]}, {'title': 'NadA (96217) Ab, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '744', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.2', 'groupId': 'OG000', 'lowerLimit': '4.6', 'upperLimit': '8.2'}]}]}, {'title': 'NadA (96217) Ab, Day 91', 'denoms': [{'units': 'Participants', 'counts': [{'value': '753', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '99.5', 'groupId': 'OG000', 'lowerLimit': '98.6', 'upperLimit': '99.9'}]}]}, {'title': 'NHBA, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '749', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '23.2', 'groupId': 'OG000', 'lowerLimit': '20.3', 'upperLimit': '26.4'}]}]}, {'title': 'NHBA (M13520) Ab, Day 91', 'denoms': [{'units': 'Participants', 'counts': [{'value': '750', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '96.1', 'groupId': 'OG000', 'lowerLimit': '94.5', 'upperLimit': '97.4'}]}]}, {'title': 'PorA N (NZ98/254) Ab, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '738', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.3', 'groupId': 'OG000', 'lowerLimit': '1.3', 'upperLimit': '3.7'}]}]}, {'title': 'PorA N (NZ98/254) Ab, Day 91', 'denoms': [{'units': 'Participants', 'counts': [{'value': '745', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000', 'lowerLimit': '76.9', 'upperLimit': '82.8'}]}]}, {'title': 'Composite Response, Day=1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '727', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '2.2'}]}]}, {'title': 'Composite Response, Day=91', 'denoms': [{'units': 'Participants', 'counts': [{'value': '744', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '75.5', 'groupId': 'OG000', 'lowerLimit': '72.3', 'upperLimit': '78.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Day 1 (pre-vaccination) and1 month after the vaccination schedule (i.e., Day 91 for MenB_0_2_6 group [2 dose schedule])', 'description': 'The immune response to rMenB+OMV NZ is evaluated by measuring bactericidal activity against each (individual response) and all (composite response) N. meningitidis serogroup B indicator strains (M14459, 96217, M13520 and NZ98/254 for fHbp, NadA, NHBA and PorA P1.4 antigens, respectively).', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Full Analysis Set, which included participants who were randomized, received at least 1 dose of the study treatment, and had post-vaccination effectiveness data available for the specified analysis at the specified time points.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With 4-fold Rise in hSBA Titers for Each of the Serogroup B Strains at 1 Month After Vaccination With rMenB+OMV NZ (0,2,6-months and 0,6-months) and Last Dose of MenABCWY (ABCWY Group-pooled Lots)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '685', 'groupId': 'OG000'}, {'value': '704', 'groupId': 'OG001'}, {'value': '731', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'MenB_0_2_6 Group', 'description': 'Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.'}, {'id': 'OG001', 'title': 'MenB_0_6 Group', 'description': 'Participants received 2 doses of rMenB+OMV NZ vaccine on Day 1, and Day 181, 1 dose of MenACWY vaccine on Day 61. Participants received 1 dose of Placebo on Day 211 to maintain blinding.'}, {'id': 'OG002', 'title': 'ABCWY_Pooled', 'description': 'Participants received 2 doses of either MenABCWY Lot 1, Lot 2, or Lot 3 vaccine on Day 1 and Day 181 and 1 dose of placebo on Day 61. Participants received 1 dose of placebo on Day 211 to maintain blinding.\n\nTo evaluate the effectiveness of 2 doses of the MenABCWY vaccines against rMenB+OMV and MenACWY vaccines, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.'}], 'classes': [{'title': 'fHbp (M14459) Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '679', 'groupId': 'OG000'}, {'value': '699', 'groupId': 'OG001'}, {'value': '729', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '86.7', 'groupId': 'OG000', 'lowerLimit': '84.0', 'upperLimit': '89.2'}, {'value': '82.4', 'groupId': 'OG001', 'lowerLimit': '79.4', 'upperLimit': '85.2'}, {'value': '78.9', 'groupId': 'OG002', 'lowerLimit': '75.7', 'upperLimit': '81.8'}]}]}, {'title': 'NadA (96217) Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '679', 'groupId': 'OG000'}, {'value': '700', 'groupId': 'OG001'}, {'value': '725', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '98.7', 'groupId': 'OG000', 'lowerLimit': '97.5', 'upperLimit': '99.4'}, {'value': '95.3', 'groupId': 'OG001', 'lowerLimit': '93.4', 'upperLimit': '96.7'}, {'value': '92.3', 'groupId': 'OG002', 'lowerLimit': '90.1', 'upperLimit': '94.1'}]}]}, {'title': 'NHBA (M13520) Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '685', 'groupId': 'OG000'}, {'value': '704', 'groupId': 'OG001'}, {'value': '731', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '66.9', 'groupId': 'OG000', 'lowerLimit': '63.2', 'upperLimit': '70.4'}, {'value': '69.5', 'groupId': 'OG001', 'lowerLimit': '65.9', 'upperLimit': '72.8'}, {'value': '61.1', 'groupId': 'OG002', 'lowerLimit': '57.5', 'upperLimit': '64.7'}]}]}, {'title': 'PorA (NZ98/254) Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '637', 'groupId': 'OG000'}, {'value': '664', 'groupId': 'OG001'}, {'value': '693', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '56.5', 'groupId': 'OG000', 'lowerLimit': '52.6', 'upperLimit': '60.4'}, {'value': '57.2', 'groupId': 'OG001', 'lowerLimit': '53.4', 'upperLimit': '61.0'}, {'value': '42.4', 'groupId': 'OG002', 'lowerLimit': '38.7', 'upperLimit': '46.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 1 month after the vaccination schedule (i.e., Day 211 for MenB_0_2_6 group [3 dose schedule], MenB_0_6 group and ABCWY_Pooled group) compared to Day 1 (baseline)', 'description': 'The immune response to 3 dose (0,2,6-M), 2 dose (0,6-M) schedule of rMenB+OMV NZ and 2 doses of MenABCWY vaccine was evaluated by measuring bactericidal activity against each of the N. meningitidis serogroup B test strains- M14459, 96217, NZ98/254 and M13520 for fHbp, NadA, NHBA and PorA P1.4 antigens, respectively compared to baseline. Four-fold rise per each indicator strain was defined as a post-vaccination hSBA titre ≥16 for subjects with a pre-vaccination hSBA titre \\<4 a post-vaccination hSBA titer ≥4 times the LLOQ for subjects with a pre-vaccination hSBA titre ≥LOD and \\<LLOQ a post-vaccination hSBA titre ≥4 times the pre-vaccination hSBA titre for participants with a pre-vaccination hSBA titre ≥ LLOQ. As pre-specified in the protocol, data reported in this outcome measure were presented for the MenB\\_0\\_2\\_6 group, MenB\\_0\\_6 group and ABCWY pooled group, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Full Analysis Set, which included participants who were randomized, received at least 1 dose of the study treatment, and had post-vaccination effectiveness data available for the specified analysis at the specified time points.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With 4-fold Rise in hSBA Titers for Each of the Serogroup B Strains at 1 Month After Vaccination With rMenB+OMV NZ (0,2 Months)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '739', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MenB_0_2_6 Group', 'description': 'Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.'}], 'classes': [{'title': 'fHbp (M14459) Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '739', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '74.6', 'groupId': 'OG000', 'lowerLimit': '71.3', 'upperLimit': '77.7'}]}]}, {'title': 'NadA (96217) Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '738', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '96.3', 'groupId': 'OG000', 'lowerLimit': '94.7', 'upperLimit': '97.6'}]}]}, {'title': 'NHBA (M13520) Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '739', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '58.5', 'groupId': 'OG000', 'lowerLimit': '54.8', 'upperLimit': '62.0'}]}]}, {'title': 'PorA (NZ98/254) Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '724', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '53.5', 'groupId': 'OG000', 'lowerLimit': '49.7', 'upperLimit': '57.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 1 month after the vaccination schedule (i.e., Day 91 for MenB_0_2_6 [2-dose schedule]) compared to Day 1 (baseline)', 'description': 'The immune response to 2 dose (0,2-M) is evaluated by measuring bactericidal activity against each of the N. meningitidis serogroup B test strains- M14459, 96217, NZ98/254 and M13520 for fHbp, NadA, NHBA and PorA P1.4 antigens, respectively compared to baseline. Four-fold rise per each indicator strain was defined as a post-vaccination hSBA titre ≥16 for participants with a pre-vaccination hSBA titre \\<4 a post-vaccination hSBA titre ≥4 times the LLOQ for subjects with a pre-vaccination hSBA titre ≥LOD and \\<LLOQ a post-vaccination hSBA titre ≥4 times the pre-vaccination hSBA titre for subjects with a pre-vaccination hSBA titre ≥ LLOQ.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Full Analysis Set, which included participants who were randomized, received at least 1 dose of the study treatment, and had post-vaccination effectiveness data available for the specified analysis at the specified time points.'}, {'type': 'SECONDARY', 'title': 'hSBA Geometric Mean Titres (GMTs) Against Each of the N. Meningitidis Serogroup B Strains at Day 1 and at 1 Month After Vaccination With rMenB+OMV NZ (0,2,6-months, 0,6-months) and Last Dose of MenABCWY (ABCWY Group-pooled Lots)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '749', 'groupId': 'OG000'}, {'value': '731', 'groupId': 'OG001'}, {'value': '780', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'MenB_0_2_6 Group', 'description': 'Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.'}, {'id': 'OG001', 'title': 'MenB_0_6 Group', 'description': 'Participants received 2 doses of rMenB+OMV NZ vaccine on Day 1, and Day 181, 1 dose of MenACWY vaccine on Day 61. Participants received 1 dose of Placebo on Day 211 to maintain blinding.'}, {'id': 'OG002', 'title': 'ABCWY_Pooled', 'description': 'Participants received 2 doses of either MenABCWY Lot 1, Lot 2, or Lot 3 vaccine on Day 1 and Day 181 and 1 dose of placebo on Day 61. Participants received 1 dose of placebo on Day 211 to maintain blinding.\n\nTo evaluate the effectiveness of 2 doses of the MenABCWY vaccines against rMenB+OMV and MenACWY vaccines, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.'}], 'classes': [{'title': 'fHbp (M14459) Ab, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '749', 'groupId': 'OG000'}, {'value': '730', 'groupId': 'OG001'}, {'value': '762', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.8', 'groupId': 'OG000', 'lowerLimit': '2.7', 'upperLimit': '2.8'}, {'value': '2.7', 'groupId': 'OG001', 'lowerLimit': '2.6', 'upperLimit': '2.8'}, {'value': '2.8', 'groupId': 'OG002', 'lowerLimit': '2.7', 'upperLimit': '2.9'}]}]}, {'title': 'fHbp (M14459) Ab, Day 211', 'denoms': [{'units': 'Participants', 'counts': [{'value': '690', 'groupId': 'OG000'}, {'value': '707', 'groupId': 'OG001'}, {'value': '738', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '30.8', 'groupId': 'OG000', 'lowerLimit': '28.3', 'upperLimit': '33.5'}, {'value': '28.1', 'groupId': 'OG001', 'lowerLimit': '25.9', 'upperLimit': '30.6'}, {'value': '25', 'groupId': 'OG002', 'lowerLimit': '23', 'upperLimit': '27.1'}]}]}, {'title': 'NadA (96217) Ab, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '744', 'groupId': 'OG000'}, {'value': '731', 'groupId': 'OG001'}, {'value': '780', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8.4', 'groupId': 'OG000', 'lowerLimit': '8.1', 'upperLimit': '8.6'}, {'value': '8.3', 'groupId': 'OG001', 'lowerLimit': '8', 'upperLimit': '8.6'}, {'value': '8.5', 'groupId': 'OG002', 'lowerLimit': '8.2', 'upperLimit': '8.8'}]}]}, {'title': 'NadA (96217) Ab, Day 211', 'denoms': [{'units': 'Participants', 'counts': [{'value': '691', 'groupId': 'OG000'}, {'value': '707', 'groupId': 'OG001'}, {'value': '734', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '267.2', 'groupId': 'OG000', 'lowerLimit': '243.7', 'upperLimit': '293'}, {'value': '215.1', 'groupId': 'OG001', 'lowerLimit': '196.2', 'upperLimit': '235.9'}, {'value': '150.6', 'groupId': 'OG002', 'lowerLimit': '137.3', 'upperLimit': '165.2'}]}]}, {'title': 'NHBA (M13520) Ab, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '749', 'groupId': 'OG000'}, {'value': '731', 'groupId': 'OG001'}, {'value': '764', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.4', 'groupId': 'OG000', 'lowerLimit': '3.1', 'upperLimit': '3.7'}, {'value': '3.2', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '3.5'}, {'value': '3.1', 'groupId': 'OG002', 'lowerLimit': '2.8', 'upperLimit': '3.4'}]}]}, {'title': 'NHBA (M13520) Ab, Day 211', 'denoms': [{'units': 'Participants', 'counts': [{'value': '695', 'groupId': 'OG000'}, {'value': '711', 'groupId': 'OG001'}, {'value': '738', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '30.6', 'groupId': 'OG000', 'lowerLimit': '27.7', 'upperLimit': '33.7'}, {'value': '33.2', 'groupId': 'OG001', 'lowerLimit': '30.2', 'upperLimit': '36.6'}, {'value': '25.2', 'groupId': 'OG002', 'lowerLimit': '22.9', 'upperLimit': '27.8'}]}]}, {'title': 'PorA (NZ98/254) Ab, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '738', 'groupId': 'OG000'}, {'value': '716', 'groupId': 'OG001'}, {'value': '751', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.2', 'groupId': 'OG000', 'lowerLimit': '3.1', 'upperLimit': '3.2'}, {'value': '3.1', 'groupId': 'OG001', 'lowerLimit': '3', 'upperLimit': '3.2'}, {'value': '3.1', 'groupId': 'OG002', 'lowerLimit': '3.1', 'upperLimit': '3.2'}]}]}, {'title': 'PorA (NZ98/254) Ab, Day 211', 'denoms': [{'units': 'Participants', 'counts': [{'value': '657', 'groupId': 'OG000'}, {'value': '684', 'groupId': 'OG001'}, {'value': '709', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '18.1', 'groupId': 'OG000', 'lowerLimit': '16.3', 'upperLimit': '20.1'}, {'value': '17.7', 'groupId': 'OG001', 'lowerLimit': '15.9', 'upperLimit': '19.6'}, {'value': '12.9', 'groupId': 'OG002', 'lowerLimit': '11.6', 'upperLimit': '14.4'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Day 1 (pre-vaccination) and at 1 month after the vaccination schedule (i.e., Day 211 for MenB_0_2_6 group (3 dose schedule), MenB_0_6 group and ABCWY_Pooled group)', 'description': 'The immune response to rMenB+OMV NZ and MenABCWY vaccine was evaluated by measuring bactericidal activity against N. meningitidis serogroup B test strains in terms of GMTs after vaccination compared to baseline (Day 1). For each N. meningitidis serogroup B test strain (M14459, M13520, 96217 and NZ98/254 for fHbp, NadA, NHBA and PorA P1.4 antigens, respectively), The GMTs (After vaccination/baseline) are calculated, with their associated 2-sided 95% CIs. As pre-specified in the protocol, data reported in this outcome measure were presented for the MenB\\_0\\_2\\_6 group, MenB\\_0\\_6 group and ABCWY pooled group, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Full Analysis Set, which included participants who were randomized, received at least 1 dose of the study treatment, and had post-vaccination effectiveness data available for the specified analysis at the specified time points.'}, {'type': 'SECONDARY', 'title': 'hSBA GMTs Against Each of the N. Meningitidis Serogroup B Strains at Day 1 and at 1 Month After Vaccination With rMenB+OMV NZ (0,2-months)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '753', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MenB_0_2_6 Group', 'description': 'Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.'}], 'classes': [{'title': 'fHbp (M14459) Ab, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '749', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.8', 'groupId': 'OG000', 'lowerLimit': '2.7', 'upperLimit': '2.8'}]}]}, {'title': 'fHbp (M14459) Ab, Day 91', 'denoms': [{'units': 'Participants', 'counts': [{'value': '750', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '20.9', 'groupId': 'OG000', 'lowerLimit': '18.9', 'upperLimit': '23.1'}]}]}, {'title': 'NadA (96217) Ab, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '744', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.4', 'groupId': 'OG000', 'lowerLimit': '8.1', 'upperLimit': '8.6'}]}]}, {'title': 'NadA (96217) Ab, Day 91', 'denoms': [{'units': 'Participants', 'counts': [{'value': '753', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '178.5', 'groupId': 'OG000', 'lowerLimit': '161.7', 'upperLimit': '197.2'}]}]}, {'title': 'NHBA (M13520) Ab, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '749', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.4', 'groupId': 'OG000', 'lowerLimit': '3.1', 'upperLimit': '3.7'}]}]}, {'title': 'NHBA (M13520) Ab, Day 91', 'denoms': [{'units': 'Participants', 'counts': [{'value': '750', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '27.2', 'groupId': 'OG000', 'lowerLimit': '24.1', 'upperLimit': '30.6'}]}]}, {'title': 'PorA (NZ98/254) Ab, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '738', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.2', 'groupId': 'OG000', 'lowerLimit': '3.1', 'upperLimit': '3.2'}]}]}, {'title': 'PorA (NZ98/254) Ab, Day 91', 'denoms': [{'units': 'Participants', 'counts': [{'value': '745', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '17.1', 'groupId': 'OG000', 'lowerLimit': '15.2', 'upperLimit': '19.3'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Day 1 (pre-vaccination) and at 1 month after the vaccination schedule (i.e., Day 91 for MenB_0_2_6 group[2-dose schedule])', 'description': 'The immune response to rMenB+OMV NZ and MenABCWY vaccine was evaluated by measuring bactericidal activity against N. meningitidis serogroup B test strains in terms of GMTs after vaccination compared to baseline (Day 1). For each N. meningitidis serogroup B test strain (M14459, M13520, 96217 and NZ98/254 for fHbp, NadA, NHBA and PorA P1.4 antigens, respectively), The GMTs (After vaccination/baseline) were calculated, with their associated 2-sided 95% CIs.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Full Analysis Set, which included all participants who were randomized, received at least 1 dose of the study treatment, and had post-vaccination effectiveness data available for the specified analysis at the specified time points.'}, {'type': 'SECONDARY', 'title': 'hSBA Geometric Mean Ratios (GMRs) for Each of the N. Meningitidis Serogroup B Strains at 1 Month After Vaccination With rMenB+OMV NZ (0,2,6-months, 0,6-months) and Last Dose of MenABCWY (ABCWY Group-pooled Lots)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '685', 'groupId': 'OG000'}, {'value': '704', 'groupId': 'OG001'}, {'value': '731', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'MenB_0_2_6 Group', 'description': 'Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.'}, {'id': 'OG001', 'title': 'MenB_0_6 Group', 'description': 'Participants received 2 doses of rMenB+OMV NZ vaccine on Day 1, and Day 181, 1 dose of MenACWY vaccine on Day 61. Participants received 1 dose of Placebo on Day 211 to maintain blinding.'}, {'id': 'OG002', 'title': 'ABCWY_Pooled', 'description': 'Participants received 2 doses of either MenABCWY Lot 1, Lot 2, or Lot 3 vaccine on Day 1 and Day 181 and 1 dose of placebo on Day 61. Participants received 1 dose of placebo on Day 211 to maintain blinding.\n\nTo evaluate the effectiveness of 2 doses of the MenABCWY vaccines against rMenB+OMV and MenACWY vaccines, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.'}], 'classes': [{'title': 'fHbp (M14459) Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '679', 'groupId': 'OG000'}, {'value': '699', 'groupId': 'OG001'}, {'value': '729', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '11.2', 'groupId': 'OG000', 'lowerLimit': '10.3', 'upperLimit': '12.2'}, {'value': '10.5', 'groupId': 'OG001', 'lowerLimit': '9.6', 'upperLimit': '11.4'}, {'value': '9', 'groupId': 'OG002', 'lowerLimit': '8.2', 'upperLimit': '9.8'}]}]}, {'title': 'NadA (96217) Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '679', 'groupId': 'OG000'}, {'value': '700', 'groupId': 'OG001'}, {'value': '725', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '32.1', 'groupId': 'OG000', 'lowerLimit': '29.1', 'upperLimit': '35.3'}, {'value': '25.8', 'groupId': 'OG001', 'lowerLimit': '23.5', 'upperLimit': '28.4'}, {'value': '17.7', 'groupId': 'OG002', 'lowerLimit': '16', 'upperLimit': '19.4'}]}]}, {'title': 'NHBA (M13520) Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '685', 'groupId': 'OG000'}, {'value': '704', 'groupId': 'OG001'}, {'value': '731', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '9.1', 'groupId': 'OG000', 'lowerLimit': '8.2', 'upperLimit': '10.1'}, {'value': '10.6', 'groupId': 'OG001', 'lowerLimit': '9.5', 'upperLimit': '11.7'}, {'value': '8.2', 'groupId': 'OG002', 'lowerLimit': '7.4', 'upperLimit': '9.1'}]}]}, {'title': 'PorA (NZ98/254) Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '637', 'groupId': 'OG000'}, {'value': '664', 'groupId': 'OG001'}, {'value': '693', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.8', 'groupId': 'OG000', 'lowerLimit': '5.2', 'upperLimit': '6.5'}, {'value': '5.8', 'groupId': 'OG001', 'lowerLimit': '5.2', 'upperLimit': '6.4'}, {'value': '4.1', 'groupId': 'OG002', 'lowerLimit': '3.7', 'upperLimit': '4.6'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At 1 month after the vaccination schedule (i.e., Day 211 for MenB_0_2_6 group (3 dose schedule), MenB_0_6 group and ABCWY_Pooled group) compared to Day 1 (baseline)', 'description': 'The immune response to rMenB+OMV NZ vaccine was evaluated by measuring bactericidal activity against N. meningitidis serogroup B test strains after vaccination compared to baseline (Day 1). For each N. meningitidis serogroup B test strain (M14459, M13520, 96217 and NZ98/254 for fHbp, NadA, NHBA and PorA P1.4 antigens, respectively), the GMRs (after vaccination/baseline) are calculated, with their associated 2-sided 95% CIs. As pre-specified in the protocol, data reported in this outcome measure were presented for the MenB\\_0\\_2\\_6 group, MenB\\_0\\_6 group and ABCWY pooled group, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.', 'unitOfMeasure': 'Ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Full Analysis Set, which included participants who were randomized, received at least 1 dose of the study treatment, and had post-vaccination effectiveness data available for the specified analysis at the specified time points.'}, {'type': 'SECONDARY', 'title': 'hSBA GMRs for Each of the N. Meningitidis Serogroup B Strains at 1 Month After Vaccination With rMenB+OMV NZ (0,2-months)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '739', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MenB_0_2_6 Group', 'description': 'Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.'}], 'classes': [{'title': 'fHbp (M14459) Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '739', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.7', 'groupId': 'OG000', 'lowerLimit': '6.9', 'upperLimit': '8.5'}]}]}, {'title': 'NadA (96217) Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '738', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '21.7', 'groupId': 'OG000', 'lowerLimit': '19.5', 'upperLimit': '24'}]}]}, {'title': 'NHBA (M13520) Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '739', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '7.1', 'upperLimit': '9'}]}]}, {'title': 'PorA (NZ98/254) Ab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '724', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.5', 'groupId': 'OG000', 'lowerLimit': '4.9', 'upperLimit': '6.2'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At 1 month after the vaccination schedule (i.e., Day 91 for MenB_0_2_6 group [2-dose schedule]) compared to Day 1 (baseline)', 'description': 'The immune response to rMenB+OMV NZ vaccine was evaluated by measuring bactericidal activity against N. meningitidis serogroup B test strains after vaccination compared to baseline (Day 1). For each N. meningitidis serogroup B test strain (M14459, M13520, 96217 and NZ98/254 for fHbp, NadA, NHBA and PorA P1.4 antigens, respectively), the GMRs (after vaccination/baseline) are calculated, with their associated 2-sided 95% CIs.', 'unitOfMeasure': 'Ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Full Analysis Set, which included participants who were randomized, received at least 1 dose of the study treatment, and had post-vaccination effectiveness data available for the specified analysis at the specified time points.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With hSBA Titers >= LLOQ for Each of the N. Meningitidis Serogroups A,C,W,Y at Day 1 and at 1 Month After the First and the Last MenABCWY Vaccination for ABCWY_Pooled Group and 1 Month After the MenACWY Vaccine for ACWY Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1489', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABCWY_Pooled', 'description': 'Participants received 2 doses of either MenABCWY Lot 1, Lot 2, or Lot 3 vaccine on Day 1 and Day 181 and 1 dose of placebo on Day 61. Participants received 1 dose of placebo on Day 211 to maintain blinding.\n\nTo evaluate the effectiveness of 2 doses of the MenABCWY vaccines against rMenB+OMV and MenACWY vaccines, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.'}, {'id': 'OG001', 'title': 'ACWY Group', 'description': 'Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.'}], 'classes': [{'title': 'Men A, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1452', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.2', 'groupId': 'OG000', 'lowerLimit': '7.7', 'upperLimit': '10.8'}, {'value': '11.7', 'groupId': 'OG001', 'lowerLimit': '6.8', 'upperLimit': '18.3'}]}]}, {'title': 'Men A, Day 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '79.5', 'groupId': 'OG000', 'lowerLimit': '71.7', 'upperLimit': '86.1'}, {'value': '90.2', 'groupId': 'OG001', 'lowerLimit': '83.9', 'upperLimit': '94.7'}]}]}, {'title': 'Men A, Day 211', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1446', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '98.6', 'groupId': 'OG000', 'lowerLimit': '97.9', 'upperLimit': '99.2'}]}]}, {'title': 'Men C, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1487', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29.8', 'groupId': 'OG000', 'lowerLimit': '27.5', 'upperLimit': '32.2'}, {'value': '28.8', 'groupId': 'OG001', 'lowerLimit': '21.4', 'upperLimit': '37.1'}]}]}, {'title': 'Men C, Day 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '74.8', 'groupId': 'OG000', 'lowerLimit': '66.8', 'upperLimit': '81.8'}, {'value': '64.0', 'groupId': 'OG001', 'lowerLimit': '55.3', 'upperLimit': '72.0'}]}]}, {'title': 'Men C, Day 211', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1457', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '99.6', 'groupId': 'OG000', 'lowerLimit': '99.1', 'upperLimit': '99.8'}]}]}, {'title': 'Men W, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1473', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.6', 'groupId': 'OG000', 'lowerLimit': '10.9', 'upperLimit': '14.4'}, {'value': '12.9', 'groupId': 'OG001', 'lowerLimit': '7.8', 'upperLimit': '19.6'}]}]}, {'title': 'Men W, Day 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '80.3', 'groupId': 'OG000', 'lowerLimit': '72.8', 'upperLimit': '86.5'}, {'value': '69.3', 'groupId': 'OG001', 'lowerLimit': '60.9', 'upperLimit': '76.9'}]}]}, {'title': 'Men W, Day 211', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1463', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '99.2', 'groupId': 'OG000', 'lowerLimit': '98.7', 'upperLimit': '99.6'}]}]}, {'title': 'Men Y, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1489', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.2', 'groupId': 'OG000', 'lowerLimit': '10.6', 'upperLimit': '14.0'}, {'value': '13.5', 'groupId': 'OG001', 'lowerLimit': '8.3', 'upperLimit': '20.2'}]}]}, {'title': 'Men Y, Day 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '82.2', 'groupId': 'OG000', 'lowerLimit': '75.0', 'upperLimit': '88.0'}, {'value': '80.0', 'groupId': 'OG001', 'lowerLimit': '72.4', 'upperLimit': '86.3'}]}]}, {'title': 'Men Y, Day 211', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1461', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '99.2', 'groupId': 'OG000', 'lowerLimit': '98.7', 'upperLimit': '99.6'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At Day 1, and 1 month after vaccination schedule (i.e, at Day 31 for ABCWY group [pooled lots -first dose] and for ACWY Group, and at Day 211 for ABCWY group [pooled lots - second dose])', 'description': 'The immune responses to MenABCWY and MenACWY vaccines were evaluated by measuring bactericidal activity against N. meningitidis serogroups A, C, W and Y after vaccination compared to baseline (Day 1) and expressed as the percentage of participants with hSBA titers \\>= LLOQ for serogroups A, C, W and Y at baseline and 1 month after vaccination schedule of MenABCWY and MenACWY vaccines. As pre-specified in the protocol, data reported in this outcome measure were presented for the ACWY group and ABCWY pooled group, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Full Analysis Set, which included participants who were randomized, received at least 1 dose of the study treatment, and had post-vaccination effectiveness data available for the specified analysis at the specified time points.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With 4-fold Rise in hSBA Titers for Each of the N. Meningitidis Serogroups A, C, W and Y at 1 Month After the First MenABCWY Dose for ABCWY_Pooled Group Compared to the MenACWY Vaccine for ACWY Group Relative to Baseline (Day 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABCWY_Pooled', 'description': 'Participants received 2 doses of either MenABCWY Lot 1, Lot 2, or Lot 3 vaccine on Day 1 and Day 181 and 1 dose of placebo on Day 61. Participants received 1 dose of placebo on Day 211 to maintain blinding.\n\nTo evaluate the effectiveness of 2 doses of the MenABCWY vaccines against rMenB+OMV and MenACWY vaccines, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.'}, {'id': 'OG001', 'title': 'ACWY Group', 'description': 'Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.'}], 'classes': [{'title': 'Men A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '74.0', 'groupId': 'OG000', 'lowerLimit': '65.5', 'upperLimit': '81.4'}, {'value': '86.0', 'groupId': 'OG001', 'lowerLimit': '78.8', 'upperLimit': '91.5'}]}]}, {'title': 'Men C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '66.9', 'groupId': 'OG000', 'lowerLimit': '58.4', 'upperLimit': '74.6'}, {'value': '56.7', 'groupId': 'OG001', 'lowerLimit': '47.9', 'upperLimit': '65.2'}]}]}, {'title': 'Men W', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '74.1', 'groupId': 'OG000', 'lowerLimit': '66.0', 'upperLimit': '81.2'}, {'value': '66.2', 'groupId': 'OG001', 'lowerLimit': '57.6', 'upperLimit': '74.1'}]}]}, {'title': 'Men Y', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '76.0', 'groupId': 'OG000', 'lowerLimit': '68.3', 'upperLimit': '82.7'}, {'value': '72.1', 'groupId': 'OG001', 'lowerLimit': '63.9', 'upperLimit': '79.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 1 month after vaccination schedule (i.e, at Day 31 for ABCWY group [pooled group] and for ACWY Group) relative to baseline (Day 1)', 'description': 'The immune response to MenABCWY vaccine compared to MenACWY vaccine was evaluated by measuring bactericidal activity against each of the N. meningitidis serogroups A, C, W and Y at Day 31 compared to baseline (Day 1).\n\nFour-fold rise is defined as:\n\n\\- If the pre-vaccination hSBA titer is \\< 4, then post-vaccination hSBA titer should be ≥ 16. - If the pre-vaccination hSBA titer is ≥ LOD but \\< LLOQ, then post-vaccination hSBA titer should be ≥ 4 times the LLOQ. - If the pre-vaccination hSBA titer is ≥ LLOQ, then post-vaccination hSBA titer should be ≥ 4 times the pre-vaccination hSBA titer. The corresponding 2- sided 95% CI based on Clopper-Pearson method is calculated for each vaccine group. As pre-specified in the protocol, data reported in this outcome measure were presented for the ACWY group and ABCWY pooled group, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Full Analysis Set, which included participants who were randomized, received at least 1 dose of the study treatment, and had post-vaccination effectiveness available for the specified analysis at the specified time points.'}, {'type': 'SECONDARY', 'title': 'hSBA GMTs Against Each of the N. Meningitidis Serogroups A, C, W and Y at Day 1 and 1 Month After the First and the Last MenABCWY Vaccination for the ABCWY_Pooled Group and at 1 Month After the MenACWY Vaccination for ACWY Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1489', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABCWY_Pooled', 'description': 'Participants received 2 doses of either MenABCWY Lot 1, Lot 2, or Lot 3 vaccine on Day 1 and Day 181 and 1 dose of placebo on Day 61. Participants received 1 dose of placebo on Day 211 to maintain blinding.\n\nTo evaluate the effectiveness of 2 doses of the MenABCWY vaccines against rMenB+OMV and MenACWY vaccines, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.'}, {'id': 'OG001', 'title': 'ACWY Group', 'description': 'Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.'}], 'classes': [{'title': 'Men A, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1452', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.1', 'groupId': 'OG000', 'lowerLimit': '10.3', 'upperLimit': '11.9'}, {'value': '12.7', 'groupId': 'OG001', 'lowerLimit': '10.9', 'upperLimit': '14.8'}]}]}, {'title': 'Men A, Day 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '175.3', 'groupId': 'OG000', 'lowerLimit': '121.2', 'upperLimit': '253.3'}, {'value': '474.8', 'groupId': 'OG001', 'lowerLimit': '331.3', 'upperLimit': '680.3'}]}]}, {'title': 'Men A, Day 211', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1446', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '352.0', 'groupId': 'OG000', 'lowerLimit': '322.0', 'upperLimit': '384.7'}]}]}, {'title': 'Men C, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1487', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.0', 'groupId': 'OG000', 'lowerLimit': '10.9', 'upperLimit': '13.3'}, {'value': '11.4', 'groupId': 'OG001', 'lowerLimit': '9.1', 'upperLimit': '14.3'}]}]}, {'title': 'Men C, Day 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '674.8', 'groupId': 'OG000', 'lowerLimit': '355.9', 'upperLimit': '1279.4'}, {'value': '379.0', 'groupId': 'OG001', 'lowerLimit': '204.4', 'upperLimit': '703.0'}]}]}, {'title': 'Men C, Day 211', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1457', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1162.5', 'groupId': 'OG000', 'lowerLimit': '1015.7', 'upperLimit': '1330.5'}]}]}, {'title': 'Men W, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1473', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.0', 'groupId': 'OG000', 'lowerLimit': '7.4', 'upperLimit': '8.7'}, {'value': '7.4', 'groupId': 'OG001', 'lowerLimit': '6.2', 'upperLimit': '8.9'}]}]}, {'title': 'Men W, Day 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '374.0', 'groupId': 'OG000', 'lowerLimit': '243.4', 'upperLimit': '574.8'}, {'value': '194.3', 'groupId': 'OG001', 'lowerLimit': '128.3', 'upperLimit': '294.2'}]}]}, {'title': 'Men W, Day 211', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1463', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '666.5', 'groupId': 'OG000', 'lowerLimit': '603.2', 'upperLimit': '736.3'}]}]}, {'title': 'Men Y, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1489', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.3', 'groupId': 'OG000', 'lowerLimit': '8.7', 'upperLimit': '10.0'}, {'value': '9.9', 'groupId': 'OG001', 'lowerLimit': '8.6', 'upperLimit': '11.5'}]}]}, {'title': 'Men Y, Day 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '375.4', 'groupId': 'OG000', 'lowerLimit': '246.9', 'upperLimit': '570.7'}, {'value': '320.9', 'groupId': 'OG001', 'lowerLimit': '213.8', 'upperLimit': '481.7'}]}]}, {'title': 'Men Y, Day 211', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1461', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '655.9', 'groupId': 'OG000', 'lowerLimit': '587.0', 'upperLimit': '733.0'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Day 1, and 1 month after vaccination schedule (i.e, at Day 31 for ABCWY group [pooled lots -first dose] and for ACWY Group, and at Day 211 for ABCWY group [pooled lots - second dose])', 'description': 'The immune responses to MenABCWY and MenACWY vaccines are evaluated by measuring bactericidal activity against N. meningitidis serogroups A, C, W and Y in terms of GMTs after vaccination compared to baseline (Day 1). For each N. meningitidis serogroups A, C, W and Y, the GMTs (after vaccination/baseline) are calculated, with their associated 2-sided 95% CIs. As pre-specified in the protocol, data reported in this outcome measure were presented for the ACWY group and ABCWY pooled group, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Full Analysis Set, which included participants who were randomized, received at least 1 dose of the study treatment, and had post-vaccination effectiveness data available for the specified analysis at the specified time points.'}, {'type': 'SECONDARY', 'title': 'GMRs for Each of the N. Meningitidis Serogroups A, C, W and Y at 1 Month After the First and the Last MenABCWY Vaccination for the ABCWY _Pooled Group and at 1 Month After the MenACWY Vaccination for ACWY Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1446', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ABCWY_Pooled', 'description': 'Participants received 2 doses of either MenABCWY Lot 1, Lot 2, or Lot 3 vaccine on Day 1 and Day 181 and 1 dose of placebo on Day 61. Participants received 1 dose of placebo on Day 211 to maintain blinding.\n\nTo evaluate the effectiveness of 2 doses of the MenABCWY vaccines against rMenB+OMV and MenACWY vaccines, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.'}, {'id': 'OG001', 'title': 'ACWY Group', 'description': 'Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.'}], 'classes': [{'title': 'Men A, Day 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '129', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.8', 'groupId': 'OG000', 'lowerLimit': '7.9', 'upperLimit': '17.7'}, {'value': '31.8', 'groupId': 'OG001', 'lowerLimit': '21.4', 'upperLimit': '47.1'}]}]}, {'title': 'Men A, Day 211', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1397', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '31.2', 'groupId': 'OG000', 'lowerLimit': '28.3', 'upperLimit': '34.5'}]}]}, {'title': 'Men C, Day 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30.9', 'groupId': 'OG000', 'lowerLimit': '16.9', 'upperLimit': '56.2'}, {'value': '22.9', 'groupId': 'OG001', 'lowerLimit': '12.8', 'upperLimit': '41.1'}]}]}, {'title': 'Men C, Day 211', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1439', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '96.9', 'groupId': 'OG000', 'lowerLimit': '84.5', 'upperLimit': '111.1'}]}]}, {'title': 'Men W, Day 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '32.9', 'groupId': 'OG000', 'lowerLimit': '21.7', 'upperLimit': '50.0'}, {'value': '23.2', 'groupId': 'OG001', 'lowerLimit': '15.5', 'upperLimit': '34.7'}]}]}, {'title': 'Men W, Day 211', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1432', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '83.8', 'groupId': 'OG000', 'lowerLimit': '74.9', 'upperLimit': '93.8'}]}]}, {'title': 'Men Y, Day 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28.1', 'groupId': 'OG000', 'lowerLimit': '18.3', 'upperLimit': '43.2'}, {'value': '25.6', 'groupId': 'OG001', 'lowerLimit': '16.9', 'upperLimit': '38.8'}]}]}, {'title': 'Men Y, Day 211', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1446', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '70.2', 'groupId': 'OG000', 'lowerLimit': '62.3', 'upperLimit': '79.1'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 month after vaccination schedule (i.e, at Day 31 for ABCWY group [pooled lots -first dose] and for ACWY Group, and at Day 211 for ABCWY group [pooled lots - second dose]) compared to baseline (Day 1)', 'description': 'The immune responses to MenABCWY and MenACWY vaccines are evaluated by measuring bactericidal activity against N. meningitidis serogroups A, C, W and Y. For each N. meningitidis serogroups A, C, W and Y, the GMRs (after vaccination/baseline) are calculated, with their associated 2-sided 95% CIs. As pre-specified in the protocol, data reported in this outcome measure were presented for the ACWY group and ABCWY pooled group, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.', 'unitOfMeasure': 'Ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Full Analysis Set, which included participants who were randomized, received at least 1 dose of the study treatment, and had post-vaccination effectiveness data available for the specified analysis at the specified time points.'}, {'type': 'SECONDARY', 'title': 'Total Immunoglobulin G (IgG) Antibodies Concentrations Against N. Meningitidis Serogroups A, C, W and Y at Day 1 and 1 Month After the First and the Last MenABCWY Vaccination for ABCWY _Pooled Group and 1 Month After the MenACWY Vaccination for ACWY Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '179', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ACWY Group', 'description': 'Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.'}, {'id': 'OG001', 'title': 'ABCWY_Pooled', 'description': 'Participants received 2 doses of either MenABCWY Lot 1, Lot 2, or Lot 3 vaccine on Day 1 and Day 181 and 1 dose of placebo on Day 61. Participants received 1 dose of placebo on Day 211 to maintain blinding.\n\nTo evaluate the effectiveness of 2 doses of the MenABCWY vaccines against rMenB+OMV and MenACWY vaccines, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.'}], 'classes': [{'title': 'Men A, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}, {'value': '179', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.3', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '2.7'}, {'value': '1.9', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '2.2'}]}]}, {'title': 'Men A, Day 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '177', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '53.7', 'groupId': 'OG000', 'lowerLimit': '40.8', 'upperLimit': '70.7'}, {'value': '18.1', 'groupId': 'OG001', 'lowerLimit': '13.8', 'upperLimit': '23.8'}]}]}, {'title': 'Men A, Day 211', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30.2', 'groupId': 'OG001', 'lowerLimit': '23.3', 'upperLimit': '39.2'}]}]}, {'title': 'Men C, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}, {'value': '179', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000', 'lowerLimit': '0.7', 'upperLimit': '1.0'}, {'value': '0.7', 'groupId': 'OG001', 'lowerLimit': '0.6', 'upperLimit': '0.8'}]}]}, {'title': 'Men C, Day 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}, {'value': '175', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.8', 'groupId': 'OG000', 'lowerLimit': '10.4', 'upperLimit': '18.4'}, {'value': '15.5', 'groupId': 'OG001', 'lowerLimit': '11.6', 'upperLimit': '20.7'}]}]}, {'title': 'Men C, Day 211', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.0', 'groupId': 'OG001', 'lowerLimit': '13.1', 'upperLimit': '22.0'}]}]}, {'title': 'Men W, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}, {'value': '179', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '0.7'}, {'value': '0.5', 'groupId': 'OG001', 'lowerLimit': '0.4', 'upperLimit': '0.6'}]}]}, {'title': 'Men W, Day 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.4', 'groupId': 'OG000', 'lowerLimit': '6.0', 'upperLimit': '11.6'}, {'value': '9.1', 'groupId': 'OG001', 'lowerLimit': '6.5', 'upperLimit': '12.8'}]}]}, {'title': 'Men W, Day 211', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.7', 'groupId': 'OG001', 'lowerLimit': '16.0', 'upperLimit': '29.5'}]}]}, {'title': 'Men Y, Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}, {'value': '179', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000', 'lowerLimit': '0.8', 'upperLimit': '1.0'}, {'value': '0.9', 'groupId': 'OG001', 'lowerLimit': '0.7', 'upperLimit': '1.0'}]}]}, {'title': 'Men Y, Day 31', 'denoms': [{'units': 'Participants', 'counts': [{'value': '172', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.3', 'groupId': 'OG000', 'lowerLimit': '10.2', 'upperLimit': '19.8'}, {'value': '12.9', 'groupId': 'OG001', 'lowerLimit': '9.2', 'upperLimit': '18.0'}]}]}, {'title': 'Men Y, Day 211', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '164', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26.3', 'groupId': 'OG001', 'lowerLimit': '19.6', 'upperLimit': '35.4'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At Day 1, and 1 month after vaccination schedule (i.e, at Day 31 for ABCWY group [pooled lots -first dose] and for ACWY Group, and at Day 211 for ABCWY group [pooled lots - second dose])', 'description': 'The immune responses to MenABCWY and MenACWY vaccines were evaluated by measuring the total IgG in terms of electrochemiluminescence-based multiplex (ECL) geometric mean concentrations (GMCs) which was an alternative assay to Enzyme-Linked Immunosorbent Assay (ELISA). ECL (validated assay) was used because ELISA is not validated. As pre- specified in the protocol, data reported in this outcome measure were presented for the ACWY group and ABCWY pooled group, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.', 'unitOfMeasure': 'microgram per milliliter(µg/mL)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was performed on the Full Analysis Set, which included participants who were randomized, received at least 1 dose of the study treatment, and had post-vaccination effectiveness data available for the specified analysis at the specified time points.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MenB_0_2_6 Group', 'description': 'Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.'}, {'id': 'FG001', 'title': 'MenB_0_6 Group', 'description': 'Participants received 2 doses of rMenB+OMV NZ vaccine on Day 1, and Day 181, 1 dose of MenACWY vaccine on Day 61. Participants received 1 dose of Placebo on Day 211 to maintain blinding.'}, {'id': 'FG002', 'title': 'ABCWY_Pooled', 'description': 'Participants received 2 doses of either MenABCWY Lot 1, Lot 2, or Lot 3 vaccine on Day 1 and Day 181 and 1 dose of placebo on Day 61. Participants received 1 dose of placebo on Day 211 to maintain blinding.\n\nTo evaluate the effectiveness of 2 doses of the MenABCWY vaccines against rMenB+OMV and MenACWY vaccines, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.'}, {'id': 'FG003', 'title': 'ACWY Group', 'description': 'Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '897'}, {'groupId': 'FG001', 'numSubjects': '906'}, {'groupId': 'FG002', 'numSubjects': '1657'}, {'groupId': 'FG003', 'numSubjects': '178'}]}, {'type': 'ABCWY-1 Group', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '549'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'ABCWY-2 Group', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '554'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'ABCWY-3 Group', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '554'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '797'}, {'groupId': 'FG001', 'numSubjects': '811'}, {'groupId': 'FG002', 'numSubjects': '1497'}, {'groupId': 'FG003', 'numSubjects': '163'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '100'}, {'groupId': 'FG001', 'numSubjects': '95'}, {'groupId': 'FG002', 'numSubjects': '160'}, {'groupId': 'FG003', 'numSubjects': '15'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '36'}, {'groupId': 'FG002', 'numSubjects': '69'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '16'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '38'}, {'groupId': 'FG002', 'numSubjects': '54'}, {'groupId': 'FG003', 'numSubjects': '7'}]}, {'type': 'MIGRATED / MOVED FROM THE STUDY AREA', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'As pre-specified in protocol:\n\n* Participant flow, Baseline characteristics, Effectiveness and immunogenicity data are presented for MenB\\_0\\_2\\_6 group, MenB\\_0\\_6 group, ACWY group, ABCWY pooled group.\n* Lot-to-lot consistency analysis data are presented for individual ABCWY lot groups (ABCWY-1, ABCWY-2 and ABCWY-3) as Lot-to-Lot assessment was limited to the objective on lot-to-lot consistency only.', 'preAssignmentDetails': 'Out of 3657 participants enrolled,19 participants did not receive vaccination as they did not meet the eligibility criteria, therefore only 3638 participants were included in the Exposed Set and started the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '897', 'groupId': 'BG000'}, {'value': '906', 'groupId': 'BG001'}, {'value': '1657', 'groupId': 'BG002'}, {'value': '178', 'groupId': 'BG003'}, {'value': '3638', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'MenB_0_2_6 Group', 'description': 'Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.'}, {'id': 'BG001', 'title': 'MenB_0_6 Group', 'description': 'Participants received 2 doses of rMenB+OMV NZ vaccine on Day 1, and Day 181, 1 dose of MenACWY vaccine on Day 61. Participants received 1 dose of Placebo on Day 211 to maintain blinding.'}, {'id': 'BG002', 'title': 'ABCWY_Pooled', 'description': 'Participants received 2 doses of either MenABCWY Lot 1, Lot 2, or Lot 3 vaccine on Day 1 and Day 181 and 1 dose of placebo on Day 61. Participants received 1 dose of placebo on Day 211 to maintain blinding.\n\nTo evaluate the effectiveness of 2 doses of the MenABCWY vaccines against rMenB+OMV and MenACWY vaccines, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.'}, {'id': 'BG003', 'title': 'ACWY Group', 'description': 'Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '16.5', 'spread': '4.7', 'groupId': 'BG000'}, {'value': '16.5', 'spread': '4.7', 'groupId': 'BG001'}, {'value': '16.5', 'spread': '4.7', 'groupId': 'BG002'}, {'value': '16.9', 'spread': '4.6', 'groupId': 'BG003'}, {'value': '16.5', 'spread': '4.7', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '464', 'groupId': 'BG000'}, {'value': '446', 'groupId': 'BG001'}, {'value': '933', 'groupId': 'BG002'}, {'value': '100', 'groupId': 'BG003'}, {'value': '1943', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '433', 'groupId': 'BG000'}, {'value': '460', 'groupId': 'BG001'}, {'value': '724', 'groupId': 'BG002'}, {'value': '78', 'groupId': 'BG003'}, {'value': '1695', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '183', 'groupId': 'BG004'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '127', 'groupId': 'BG004'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '796', 'groupId': 'BG000'}, {'value': '791', 'groupId': 'BG001'}, {'value': '1492', 'groupId': 'BG002'}, {'value': '162', 'groupId': 'BG003'}, {'value': '3241', 'groupId': 'BG004'}]}]}, {'title': 'Other, Unspecified', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '67', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'As pre-specified in the protocol, data reported in the Baseline characteristics are presented for MenB\\_0\\_2\\_6 group, MenB\\_0\\_6 group, ACWY group, ABCWY pooled group.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-05-12', 'size': 3284119, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-12-21T04:38', 'hasProtocol': True}, {'date': '2023-09-06', 'size': 4722314, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-02-09T10:08', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Observer-blinded study. Recipients \\& study evaluators will be unaware of vaccine administered.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3657}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'dispFirstSubmitDate': '2023-09-04', 'completionDateStruct': {'date': '2022-09-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-09', 'studyFirstSubmitDate': '2020-08-04', 'resultsFirstSubmitDate': '2023-12-21', 'studyFirstSubmitQcDate': '2020-08-04', 'dispFirstPostDateStruct': {'date': '2024-03-05', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2024-03-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-02-09', 'studyFirstPostDateStruct': {'date': '2020-08-06', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic US N. Meningitidis Serogroup B Strains at 1 Month After the 3-dose (0,2,6-M), 2-dose(0,6-M) Vaccination Schedule of rMenB+OMV and 1 Dose of MenACWY', 'timeFrame': 'At 1 month after vaccination schedule (i.e., Day 211 for MenB_0_2_6 group [3-dose schedule] and MenB_0_6 group, and Day 31 for ACWY group)', 'description': 'The effectiveness (test-based) of rMenB+OMV vaccine at 1 month after the 3 doses in MenB\\_0\\_2\\_6 group and 1 month after the 2 dose schedule in MenB\\_0\\_6 group when compared to one dose of MenACWY vaccination in ACWY group, against a panel of N. meningitidis serogroup B strains was measured in terms of percentage of samples without bactericidal activity using endogenous complement human Serum Bactericidal Assay (enc-hSBA), which provides a qualitative assessment (yes/no) of the presence of sufficient bactericidal antibodies in human sera to kill a meningococcal strain at a specific dilution of 1:4.\n\nParticipants were randomly selected for testing against each strain therefore only a subset of participants were tested for each of the strains.'}, {'measure': 'Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic US N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose (0,2-M) Vaccination Schedule of rMenB+OMV and 1 Dose of MenACWY', 'timeFrame': 'At 1 month after vaccination schedule (i.e., Day 91 for the MenB_0_2_6 group [2-dose schedule] and Day 31 for ACWY group)', 'description': 'The effectiveness (test-based) of rMenB+OMV vaccine at 1 month after the 2 doses in MenB\\_0\\_2\\_6 group when compared to one dose of MenACWY vaccination in ACWY group, against a panel of N. meningitidis serogroup B strains was measured in terms of percentage of samples without bactericidal activity using endogenous complement human Serum Bactericidal Assay (enc-hSBA), which provides a qualitative assessment (yes/no) of the presence of sufficient bactericidal antibodies in human sera to kill a meningococcal strain at a specific dilution of 1:4.\n\nParticipants were randomly selected for testing against each strain therefore only a subset of participants were tested for each of the strains.'}, {'measure': 'Percentage of Participants Whose Sera Kill Greater Than or Equal to (>=) 70% of the Strains Tested Using Enc-hSBA at 1 Month After the 3-dose (0,2,6-M) Schedule of rMenB+OMV and 2-dose(0,6-M) Schedule of rMenB+OMV', 'timeFrame': 'At 1 month after vaccination schedule (i.e., Day 211 for MenB_0_2_6 group [3-dose schedule] and MenB_0_6 group)', 'description': 'The effectiveness (responder-based) of the rMenB+OMV NZ vaccine was measured in terms of percentage of participants whose sera kill \\>=70% of the strains tested using enc-hSBA, calculated based on Clopper Pearson method. Effectiveness is demonstrated if Lower Limit (LL) of the two-sided 97.5% CI for the percentages of participants whose sera kill ≥70% of strains is above 65%.'}, {'measure': 'Percentage of Participants Whose Sera Kill >=70% of the Strains Tested Using Enc-hSBA at 1 Month After the 2-dose (0,2-M) Schedule of rMenB+OMV', 'timeFrame': 'At 1 month after vaccination schedule (i.e., Day 91 for the MenB_0_2_6 group [2-dose schedule])', 'description': 'The effectiveness (responder-based) of the rMenB+OMV NZ vaccine was measured in terms of percentage of participants whose sera kill \\>=70% of the strains tested using enc-hSBA, calculated based on Clopper Pearson method. Effectiveness is demonstrated if Lower Limit (LL) of the two-sided 97.5% CI for the percentages of participants whose sera kill ≥70% of strains is above 65%.'}, {'measure': 'Geometric Mean Titers (GMTs) Against Serogroups A, C, W and Y for Each Lot (ABCWY-1 Group, ABCWY-2 Group and ABCWY-3 Group) at 1 Month After the Last Vaccination of MenABCWY', 'timeFrame': 'At 1 month after the last vaccination of MenABCWY (Day 211)', 'description': 'Immune response was measured in terms of hSBA GMTs directed against serogroups A, C, W and Y. As pre-specified in the protocol, the data reported in this outcome measures data were presented for individual lots to demonstrate the consistency of the immune response of 3 lots (ABCWY- 1 Group, ABCWY-2 Group, and ABCWY-3 Group) of the ACWY component of the MenABCWY vaccine.'}, {'measure': 'Percentage of Participants With 4-fold Rise in hSBA Titers Against N. Meningitidis Serogroups A, C, W and Y at 1 Month After Last MenABCWY Vaccination (Pooled Lots) and MenACWY Vaccination (for the ACWY Group), Relative to Baseline', 'timeFrame': 'At 1 month after vaccination schedule (i.e., Day 211 for the ABCWY_Pooled group and Day 31 for the ACWY Group) compared to Day 1 (baseline)', 'description': 'Four-fold rise is defined as: If the pre-vaccination hSBA titer is \\< 4, then post-vaccination hSBA titer should be \\>= 16 . If the pre-vaccination hSBA titer is \\>= limit of detection (LOD) but \\< LL of quantification (LLOQ), then post-vaccination hSBA titer should be \\>= 4 times the LLOQ. If the pre-vaccination hSBA titer is \\>= LLOQ, then post-vaccination hSBA titer should be \\>= 4 times the pre-vaccination hSBA titer.\n\nAs pre-specified in the protocol, data reported in this outcome measure were presented for ACWY group, ABCWY pooled group to evaluate the immunological non-inferiority of 2 doses of the MenABCWY vaccines against MenACWY vaccines, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.'}, {'measure': 'Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After Last MenABCWY Vaccination (Pooled Lots) and MenACWY Vaccination (for the ACWY Group)', 'timeFrame': 'At 1 month after the vaccination schedule (i.e., Day 211 for the ABCWY_Pooled group and Day 31 for the ACWY group)', 'description': 'The effectiveness (test-based) of 2 doses of MenABCWY vaccine when compared to 1 dose of MenACWY vaccine, against a panel of N. meningitidis serogroup B strains was measured in terms of percentage of samples without bactericidal activity using enc-hSBA, which provides a qualitative assessment (yes/no) of the presence of sufficient bactericidal antibodies in human sera to kill a meningococcal strain at a specific dilution of 1:4.\n\nAs pre-specified in the protocol, data reported in this outcome measure were presented for ACWY group and ABCWY pooled group to evaluate the effectiveness of 2 doses of the MenABCWY vaccines against MenACWY vaccines, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.'}, {'measure': 'Percentage of Blood Samples With Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose (Pooled Lots) and 2-dose(0,2-M) Schedule of rMenB+OMV', 'timeFrame': 'At 1 month after the vaccination schedule (i.e., Day 211 for the ABCWY_Pooled group and Day 91 for the MenB_0_2_6 Group [2-dose schedule])', 'description': 'The effectiveness was measured in terms of percentage of samples with bactericidal activity using enc-hSBA, which provides a qualitative assessment (yes/no) of the presence of sufficient bactericidal antibodies in human sera to kill a meningococcal strain at a specific dilution of 1:4. As pre-specified in the protocol, data reported in this outcome measure were presented for MenB\\_0\\_2\\_6 Group and ABCWY pooled group to evaluate the effectiveness of 2 doses of the MenABCWY vaccines against MenACWY vaccines, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.'}, {'measure': 'Percentage of Participants Whose Sera Kill >=70% of the Strains Tested Using Enc-hSBA at 1 Month After the Last Vaccination in the ABCWY Group (Pooled Lots)', 'timeFrame': 'At 1 month after the last vaccination of MenABCWY (Day 211)', 'description': 'The effectiveness (responder-based) of the MenABCWY vaccine is measured in terms of percentage of participants whose sera kill \\>=70% of the strains tested using enc-hSBA, being calculated based on Clopper Pearson method. Effectiveness is demonstrated Lower Limit (LL) of the two-sided 97.5% CI for the percentages of participants whose sera kill ≥70% of strains tested for MenABCWY is above 65%.'}, {'measure': 'Number of Participants With Any Solicited Local Adverse Events (AEs) After the First Study Intervention Administration', 'timeFrame': 'During 7 days after the first study intervention administration occurring at Day 1', 'description': 'Assessed solicited local adverse events were injection or administration site = pain, erythema, swelling, induration. Any = occurrence of the adverse event regardless of intensity grade. Any erythema and swelling = adverse event reported with a surface diameter greater than 0 millimeters. No solicited AEs were collected after vaccination on Day 211 because these vaccines were administered as part of standard of care and to maintain blinding. As pre- specified in the protocol, data reported in this outcome measure were presented for MenB\\_0\\_2\\_6 group, MenB\\_0\\_6 group, ACWY group, ABCWY pooled group.'}, {'measure': 'Number of Participants With Any Solicited Local Adverse Events (AEs) After the Second Study Intervention Administration', 'timeFrame': 'During 7 days after the second study intervention administration occurring at Day 61', 'description': 'Assessed solicited local adverse events were injection or administration site pain, erythema, swelling, induration. Any = occurrence of the adverse event regardless of intensity grade. Any erythema and swelling = adverse event reported with a surface diameter greater than 0 millimeters. No solicited AEs were collected after vaccination on Day 211 because these vaccines were administered as part of standard of care and to maintain blinding. As pre- specified in the protocol, data reported in this outcome measure were presented for MenB\\_0\\_2\\_6 group, MenB\\_0\\_6 group, ACWY group, ABCWY pooled group.'}, {'measure': 'Number of Participants With Any Solicited Local Adverse Events (AEs) After the Third Study Intervention Administration', 'timeFrame': 'During 7 days after the third study intervention administration occurring at Day 181', 'description': 'Assessed solicited local adverse events were injection or administration site pain, erythema, swelling, induration. Any = occurrence of the adverse event regardless of intensity grade. Any erythema and swelling = adverse event reported with a surface diameter greater than 0 millimeters. No solicited AEs were collected after vaccination on Day 211 because these vaccines were administered as part of standard of care and to maintain blinding. As pre- specified in the protocol, data reported in this outcome measure were presented for MenB\\_0\\_2\\_6 group, MenB\\_0\\_6 group, ACWY group, ABCWY pooled group.'}, {'measure': 'Number of Participants With Any Solicited Systemic AEs After the First Study Intervention Administration', 'timeFrame': 'During 7 days after the first study intervention administration occurring at Day 1', 'description': 'Assessed solicited systemic AEs were fatigue, nausea, myalgia, arthralgia, headache and fever \\[temperature \\>= 38.0°C\\]. Any = occurrence of the adverse event regardless of intensity grade or relation to study vaccination. No solicited AEs were collected after vaccination on Day 211 because these vaccines were administered as part of standard of care and to maintain blinding. As pre- specified in the protocol, data reported in this outcome measure were presented for MenB\\_0\\_2\\_6 group, MenB\\_0\\_6 group, ACWY group, ABCWY pooled group.'}, {'measure': 'Number of Participants With Any Solicited Systemic AEs After the Second Study Intervention Administration', 'timeFrame': 'During 7 days after the second study intervention administration occurring at Day 61', 'description': 'Assessed solicited systemic AEs were fatigue, nausea, myalgia, arthralgia, headache and fever \\[temperature \\>= 38.0°C\\]. Any = occurrence of the adverse event regardless of intensity grade or relation to study vaccination. No solicited AEs were collected after vaccination on Day 211 because these vaccines were administered as part of standard of care and to maintain blinding. As pre- specified in the protocol, data reported in this outcome measure were presented for MenB\\_0\\_2\\_6 group, MenB\\_0\\_6 group, ACWY group, ABCWY pooled group.'}, {'measure': 'Number of Participants With Any Solicited Systemic AEs After the Third Study Intervention Administration', 'timeFrame': 'During 7 days after the third study intervention administration occurring at Day 181', 'description': 'Assessed solicited systemic AEs were fatigue, nausea, myalgia, arthralgia, headache and fever \\[temperature \\>= 38.0°C\\]. Any = occurrence of the adverse event regardless of intensity grade or relation to study vaccination. No solicited AEs were collected after vaccination on Day 211 because these vaccines were administered as part of standard of care and to maintain blinding. As pre- specified in the protocol, data reported in this outcome measure were presented for MenB\\_0\\_2\\_6 group, MenB\\_0\\_6 group, ACWY group, ABCWY pooled group.'}, {'measure': 'Number of Participants With Any Unsolicited AEs After the First Study Intervention Administration', 'timeFrame': 'During the 30 days after the first study intervention administration occurring at Day 1', 'description': "Unsolicited AEs are defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms were reported as an unsolicited AE. Any Unsolicited AEs (including Serious adverse events (SAEs), AEs leading to withdrawal, Adverse event of special interest (AESIs) and medically attended AEs were collected during 30 days after vaccination 1-3. For vaccination on Day 211 (Vaccination 4), conducted as part of standard of care and to maintain blinding, no eDiary data or all unsolicited AEs were collected for the 30 days following vaccination. However, SAEs, AEs leading to withdrawal, AESIs and medically attended AEs were collected throughout study duration. As pre-specified in the protocol, data reported in this outcome measure were presented for MenB\\_0\\_2\\_6 group, MenB\\_0\\_6 group, ACWY group, ABCWY pooled group."}, {'measure': 'Number of Participants With Any Unsolicited AEs After the Second Study Intervention Administration', 'timeFrame': 'During the 30 days after the second study intervention administration occurring at Day 61', 'description': "Unsolicited AEs are defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms were reported as an unsolicited AE. Any Unsolicited AEs (including Serious adverse events (SAEs), AEs leading to withdrawal, Adverse event of special interest (AESIs) and medically attended AEs were collected during 30 days after vaccination 1-3. For vaccination on Day 211 (Vaccination 4), conducted as part of standard of care and to maintain blinding, no eDiary data or all unsolicited AEs were collected for the 30 days following vaccination. However, SAEs, AEs leading to withdrawal, AESIs and medically attended AEs were collected throughout study duration. As pre-specified in the protocol, data reported in this outcome measure were presented for MenB\\_0\\_2\\_6 group, MenB\\_0\\_6 group, ACWY group, ABCWY pooled group."}, {'measure': 'Number of Participants With Any Unsolicited AEs After the Third Study Intervention Administration', 'timeFrame': 'During the 30 days after the third study intervention administration occurring at Day 181', 'description': "Unsolicited AEs are defined as any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms were reported as an unsolicited AE. Any Unsolicited AEs (including Serious adverse events (SAEs), AEs leading to withdrawal, Adverse event of special interest (AESIs) and medically attended AEs were collected during 30 days after vaccination 1-3. For vaccination on Day 211 (Vaccination 4), conducted as part of standard of care and to maintain blinding, no eDiary data or all unsolicited AEs were collected for the 30 days following vaccination. However, SAEs, AEs leading to withdrawal, AESIs and medically attended AEs were collected throughout study duration. As pre-specified in the protocol, data reported in this outcome measure were presented for MenB\\_0\\_2\\_6 group, MenB\\_0\\_6 group, ACWY group, ABCWY pooled group."}, {'measure': 'Number of Participants With SAEs, AEs Leading to Withdrawal, AESIs and Medically Attended AEs', 'timeFrame': 'Throughout the study period (Day 1 to Day 361)', 'description': 'A SAEs is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity and is a congenital anomaly/birth defect in the offspring of a study subject. AESIs are predefined (serious or non-serious) AEs of scientific and medical concern specific to the product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate, because such an event might warrant further investigation to characterize and understand it. Medically attended AEs are symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a health care provider. As pre-specified in the protocol, data reported in this outcome measure were presented for MenB\\_0\\_2\\_6 group, MenB\\_0\\_6 group, ACWY group, ABCWY pooled group.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With 4-fold Rise in hSBA Titers Against N.Meningitidis Group B Strains at 1 Month After Last MenABCWY Dose(ABCWY Group-pooled Lots) and 1 Month After 2-dose(0,2-M) Schedule of rMenB+OMV NZ Relative to Baseline', 'timeFrame': 'At 1 month after the vaccination schedule (i.e., Day 211 for the ABCWY_Pooled group and Day 91 for the MenB_0_2_6 Group [2-dose schedule]) compared to Day 1 (Baseline)', 'description': 'The immunogenicity is measured as percentage of participants achieving a 4-fold rise in hSBA titers against N. meningitidis serogroup B indicator strains (M14459, 96217, M13520 and NZ98/254 for fHbp, NadA, NHBA and PorA P1.4 antigens, respectively). 4-fold rise per each indicator strain was defined as a post-vaccination hSBA titre ≥16 for participants with a pre-vaccination hSBA titre \\<4; a post-vaccination hSBA titre ≥4 times the LLOQ for participants with a pre-vaccination hSBA titre ≥LOD and \\<LLOQ; a post-vaccination hSBA titre ≥4 times the pre-vaccination hSBA titre for participants with a pre-vaccination hSBA titre ≥ LLOQ. As pre-specified in the protocol, data reported in this outcome measure were presented for MenB\\_0\\_2\\_6 Group and ABCWY pooled group to evaluate the effectiveness of 2 doses of the MenABCWY vaccines against MenACWY vaccines, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.'}, {'measure': 'Percentage of Blood Samples Without Bactericidal Serum Activity Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the Last MenABCWY Dose and 3-dose (0,2,6-M), 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY', 'timeFrame': 'At 1 month after the vaccination schedule (i.e., Day 211 for the MenB_0_2_6 group [3 dose schedule], MenB_0_6 group, ABCWY_Pooled group and Day 31 for the MenACWY group)', 'description': 'The effectiveness of the 3 dose (0,2,6-M) and 2 dose (0,6-M ) schedule of rMenB+OMV NZ vaccine and 2 doses of MenABCWY vaccine when compared to 1 month after the MenACWY vaccination (Day 31), against a panel of N. meningitidis serogroup B strains is measured in terms of percentage of samples without bactericidal activity using enc-hSBA, which provides a qualitative assessment (yes/no) of the presence of sufficient bactericidal antibodies in human sera to kill a meningococcal strain at a specific dilution of 1:4. As pre-specified in the protocol, data reported in this outcome measure were presented for the MenB\\_0\\_2\\_6 group, MenB\\_0\\_6 group,ACWY group and ABCWY pooled group, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.'}, {'measure': 'Percentage of Blood Samples Without Bactericidal Serum Activity Using Enc-hSBA Against Each of the Endemic U.S N. Meningitidis Serogroup B Strains at 1 Month After the 2-dose(0,6-M) Schedule of rMenB+OMV and 1 Dose of MenACWY', 'timeFrame': 'At 1 month after the vaccination schedule (i.e., Day 91 for the MenB_0_2_6 group [2 dose schedule] and Day 31 for the MenACWY group)', 'description': 'The effectiveness of the 2 dose (0,2-M) schedule of rMenB+OMV NZ vaccine when compared to 1 month after the MenACWY vaccination (Day 31), against a panel of N. meningitidis serogroup B strains is measured in terms of percentage of samples without bactericidal activity using enc-hSBA, which provides a qualitative assessment (yes/no) of the presence of sufficient bactericidal antibodies in human sera to kill a meningococcal strain at a specific dilution of 1:4.'}, {'measure': 'Percentage of Participants Classified by Percentage of Serogroup B Invasive Disease Strains Killed Using Enc-hSBA in Each Subject at 1 Month After Vaccination Schedule for the MenB_0_2_6 Group [3 Dose], MenB_0_6 Group and Last MenABCWY Dose (Pooled Lots)', 'timeFrame': 'At 1 month after the vaccination schedule (Day 211 for MenB_0_2_6 group (3 dose schedule), MenB_0_6 group and ABCWY_Pooled group)', 'description': 'The percentage of participants classified by percentage of N.meningitidis serogroup B invasive strains killed using enc-hSBA and the corresponding 2- sided 95% CI based on Clopper-Pearson method is calculated for each vaccine group. As pre-specified in the protocol, data reported in this outcome measure were presented for the MenB\\_0\\_2\\_6 group, MenB\\_0\\_6 group and ABCWY pooled group, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.'}, {'measure': 'Percentage of Participants Classified by Percentage of Serogroup B Invasive Disease Strains Killed Using Enc-hSBA in Each Subject at 1 Month After Vaccination With rMenB+OMV NZ (0,2-months)', 'timeFrame': 'At 1 month after the vaccination schedule (Day 91 for MenB_0_2_6 group [2 dose schedule])', 'description': 'The percentage of participants classified by percentage of N.meningitidis serogroup B invasive strains killed using enc-hSBA and the corresponding 2- sided 95% CI based on Clopper-Pearson method is calculated for each vaccine group.'}, {'measure': 'Percentage of Participants With hSBA Titers >= LLOQ for Each and All Serogroup B Indicator Strains at Day 1 and at 1 Month After Vaccination With rMenB+OMV NZ (0,2,6-months and 0,6-months) and Last Dose of MenABCWY (ABCWY Group-pooled Lots)', 'timeFrame': 'At Day 1 (pre-vaccination) and1 month after the vaccination schedule (i.e., Day 211 for MenB_0_2_6 group [3 dose schedule], MenB_0_6 group and ABCWY_Pooled group)', 'description': 'The immune response to rMenB+OMV NZ and MenABCWY vaccine is evaluated by measuring bactericidal activity against each (individual response) and all (composite response) N. meningitidis serogroup B indicator strains(M14459, 96217, M13520 and NZ98/254 for fHbp, NadA, NHBA and PorA P1.4 antigens, respectively). As pre-specified in the protocol, data reported in this outcome measure were presented for the MenB\\_0\\_2\\_6 group, MenB\\_0\\_6 group and ABCWY pooled group, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.'}, {'measure': 'Percentage of Participants With hSBA Titers >= LLOQ for Each and All Serogroup B Indicator Strains at Day 1 and at 1 Month After Vaccination With rMenB+OMV NZ (0,2-months)', 'timeFrame': 'At Day 1 (pre-vaccination) and1 month after the vaccination schedule (i.e., Day 91 for MenB_0_2_6 group [2 dose schedule])', 'description': 'The immune response to rMenB+OMV NZ is evaluated by measuring bactericidal activity against each (individual response) and all (composite response) N. meningitidis serogroup B indicator strains (M14459, 96217, M13520 and NZ98/254 for fHbp, NadA, NHBA and PorA P1.4 antigens, respectively).'}, {'measure': 'Percentage of Participants With 4-fold Rise in hSBA Titers for Each of the Serogroup B Strains at 1 Month After Vaccination With rMenB+OMV NZ (0,2,6-months and 0,6-months) and Last Dose of MenABCWY (ABCWY Group-pooled Lots)', 'timeFrame': 'At 1 month after the vaccination schedule (i.e., Day 211 for MenB_0_2_6 group [3 dose schedule], MenB_0_6 group and ABCWY_Pooled group) compared to Day 1 (baseline)', 'description': 'The immune response to 3 dose (0,2,6-M), 2 dose (0,6-M) schedule of rMenB+OMV NZ and 2 doses of MenABCWY vaccine was evaluated by measuring bactericidal activity against each of the N. meningitidis serogroup B test strains- M14459, 96217, NZ98/254 and M13520 for fHbp, NadA, NHBA and PorA P1.4 antigens, respectively compared to baseline. Four-fold rise per each indicator strain was defined as a post-vaccination hSBA titre ≥16 for subjects with a pre-vaccination hSBA titre \\<4 a post-vaccination hSBA titer ≥4 times the LLOQ for subjects with a pre-vaccination hSBA titre ≥LOD and \\<LLOQ a post-vaccination hSBA titre ≥4 times the pre-vaccination hSBA titre for participants with a pre-vaccination hSBA titre ≥ LLOQ. As pre-specified in the protocol, data reported in this outcome measure were presented for the MenB\\_0\\_2\\_6 group, MenB\\_0\\_6 group and ABCWY pooled group, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.'}, {'measure': 'Percentage of Participants With 4-fold Rise in hSBA Titers for Each of the Serogroup B Strains at 1 Month After Vaccination With rMenB+OMV NZ (0,2 Months)', 'timeFrame': 'At 1 month after the vaccination schedule (i.e., Day 91 for MenB_0_2_6 [2-dose schedule]) compared to Day 1 (baseline)', 'description': 'The immune response to 2 dose (0,2-M) is evaluated by measuring bactericidal activity against each of the N. meningitidis serogroup B test strains- M14459, 96217, NZ98/254 and M13520 for fHbp, NadA, NHBA and PorA P1.4 antigens, respectively compared to baseline. Four-fold rise per each indicator strain was defined as a post-vaccination hSBA titre ≥16 for participants with a pre-vaccination hSBA titre \\<4 a post-vaccination hSBA titre ≥4 times the LLOQ for subjects with a pre-vaccination hSBA titre ≥LOD and \\<LLOQ a post-vaccination hSBA titre ≥4 times the pre-vaccination hSBA titre for subjects with a pre-vaccination hSBA titre ≥ LLOQ.'}, {'measure': 'hSBA Geometric Mean Titres (GMTs) Against Each of the N. Meningitidis Serogroup B Strains at Day 1 and at 1 Month After Vaccination With rMenB+OMV NZ (0,2,6-months, 0,6-months) and Last Dose of MenABCWY (ABCWY Group-pooled Lots)', 'timeFrame': 'At Day 1 (pre-vaccination) and at 1 month after the vaccination schedule (i.e., Day 211 for MenB_0_2_6 group (3 dose schedule), MenB_0_6 group and ABCWY_Pooled group)', 'description': 'The immune response to rMenB+OMV NZ and MenABCWY vaccine was evaluated by measuring bactericidal activity against N. meningitidis serogroup B test strains in terms of GMTs after vaccination compared to baseline (Day 1). For each N. meningitidis serogroup B test strain (M14459, M13520, 96217 and NZ98/254 for fHbp, NadA, NHBA and PorA P1.4 antigens, respectively), The GMTs (After vaccination/baseline) are calculated, with their associated 2-sided 95% CIs. As pre-specified in the protocol, data reported in this outcome measure were presented for the MenB\\_0\\_2\\_6 group, MenB\\_0\\_6 group and ABCWY pooled group, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.'}, {'measure': 'hSBA GMTs Against Each of the N. Meningitidis Serogroup B Strains at Day 1 and at 1 Month After Vaccination With rMenB+OMV NZ (0,2-months)', 'timeFrame': 'At Day 1 (pre-vaccination) and at 1 month after the vaccination schedule (i.e., Day 91 for MenB_0_2_6 group[2-dose schedule])', 'description': 'The immune response to rMenB+OMV NZ and MenABCWY vaccine was evaluated by measuring bactericidal activity against N. meningitidis serogroup B test strains in terms of GMTs after vaccination compared to baseline (Day 1). For each N. meningitidis serogroup B test strain (M14459, M13520, 96217 and NZ98/254 for fHbp, NadA, NHBA and PorA P1.4 antigens, respectively), The GMTs (After vaccination/baseline) were calculated, with their associated 2-sided 95% CIs.'}, {'measure': 'hSBA Geometric Mean Ratios (GMRs) for Each of the N. Meningitidis Serogroup B Strains at 1 Month After Vaccination With rMenB+OMV NZ (0,2,6-months, 0,6-months) and Last Dose of MenABCWY (ABCWY Group-pooled Lots)', 'timeFrame': 'At 1 month after the vaccination schedule (i.e., Day 211 for MenB_0_2_6 group (3 dose schedule), MenB_0_6 group and ABCWY_Pooled group) compared to Day 1 (baseline)', 'description': 'The immune response to rMenB+OMV NZ vaccine was evaluated by measuring bactericidal activity against N. meningitidis serogroup B test strains after vaccination compared to baseline (Day 1). For each N. meningitidis serogroup B test strain (M14459, M13520, 96217 and NZ98/254 for fHbp, NadA, NHBA and PorA P1.4 antigens, respectively), the GMRs (after vaccination/baseline) are calculated, with their associated 2-sided 95% CIs. As pre-specified in the protocol, data reported in this outcome measure were presented for the MenB\\_0\\_2\\_6 group, MenB\\_0\\_6 group and ABCWY pooled group, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.'}, {'measure': 'hSBA GMRs for Each of the N. Meningitidis Serogroup B Strains at 1 Month After Vaccination With rMenB+OMV NZ (0,2-months)', 'timeFrame': 'At 1 month after the vaccination schedule (i.e., Day 91 for MenB_0_2_6 group [2-dose schedule]) compared to Day 1 (baseline)', 'description': 'The immune response to rMenB+OMV NZ vaccine was evaluated by measuring bactericidal activity against N. meningitidis serogroup B test strains after vaccination compared to baseline (Day 1). For each N. meningitidis serogroup B test strain (M14459, M13520, 96217 and NZ98/254 for fHbp, NadA, NHBA and PorA P1.4 antigens, respectively), the GMRs (after vaccination/baseline) are calculated, with their associated 2-sided 95% CIs.'}, {'measure': 'Percentage of Participants With hSBA Titers >= LLOQ for Each of the N. Meningitidis Serogroups A,C,W,Y at Day 1 and at 1 Month After the First and the Last MenABCWY Vaccination for ABCWY_Pooled Group and 1 Month After the MenACWY Vaccine for ACWY Group', 'timeFrame': 'At Day 1, and 1 month after vaccination schedule (i.e, at Day 31 for ABCWY group [pooled lots -first dose] and for ACWY Group, and at Day 211 for ABCWY group [pooled lots - second dose])', 'description': 'The immune responses to MenABCWY and MenACWY vaccines were evaluated by measuring bactericidal activity against N. meningitidis serogroups A, C, W and Y after vaccination compared to baseline (Day 1) and expressed as the percentage of participants with hSBA titers \\>= LLOQ for serogroups A, C, W and Y at baseline and 1 month after vaccination schedule of MenABCWY and MenACWY vaccines. As pre-specified in the protocol, data reported in this outcome measure were presented for the ACWY group and ABCWY pooled group, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.'}, {'measure': 'Percentage of Participants With 4-fold Rise in hSBA Titers for Each of the N. Meningitidis Serogroups A, C, W and Y at 1 Month After the First MenABCWY Dose for ABCWY_Pooled Group Compared to the MenACWY Vaccine for ACWY Group Relative to Baseline (Day 1)', 'timeFrame': 'At 1 month after vaccination schedule (i.e, at Day 31 for ABCWY group [pooled group] and for ACWY Group) relative to baseline (Day 1)', 'description': 'The immune response to MenABCWY vaccine compared to MenACWY vaccine was evaluated by measuring bactericidal activity against each of the N. meningitidis serogroups A, C, W and Y at Day 31 compared to baseline (Day 1).\n\nFour-fold rise is defined as:\n\n\\- If the pre-vaccination hSBA titer is \\< 4, then post-vaccination hSBA titer should be ≥ 16. - If the pre-vaccination hSBA titer is ≥ LOD but \\< LLOQ, then post-vaccination hSBA titer should be ≥ 4 times the LLOQ. - If the pre-vaccination hSBA titer is ≥ LLOQ, then post-vaccination hSBA titer should be ≥ 4 times the pre-vaccination hSBA titer. The corresponding 2- sided 95% CI based on Clopper-Pearson method is calculated for each vaccine group. As pre-specified in the protocol, data reported in this outcome measure were presented for the ACWY group and ABCWY pooled group, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.'}, {'measure': 'hSBA GMTs Against Each of the N. Meningitidis Serogroups A, C, W and Y at Day 1 and 1 Month After the First and the Last MenABCWY Vaccination for the ABCWY_Pooled Group and at 1 Month After the MenACWY Vaccination for ACWY Group', 'timeFrame': 'At Day 1, and 1 month after vaccination schedule (i.e, at Day 31 for ABCWY group [pooled lots -first dose] and for ACWY Group, and at Day 211 for ABCWY group [pooled lots - second dose])', 'description': 'The immune responses to MenABCWY and MenACWY vaccines are evaluated by measuring bactericidal activity against N. meningitidis serogroups A, C, W and Y in terms of GMTs after vaccination compared to baseline (Day 1). For each N. meningitidis serogroups A, C, W and Y, the GMTs (after vaccination/baseline) are calculated, with their associated 2-sided 95% CIs. As pre-specified in the protocol, data reported in this outcome measure were presented for the ACWY group and ABCWY pooled group, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.'}, {'measure': 'GMRs for Each of the N. Meningitidis Serogroups A, C, W and Y at 1 Month After the First and the Last MenABCWY Vaccination for the ABCWY _Pooled Group and at 1 Month After the MenACWY Vaccination for ACWY Group', 'timeFrame': '1 month after vaccination schedule (i.e, at Day 31 for ABCWY group [pooled lots -first dose] and for ACWY Group, and at Day 211 for ABCWY group [pooled lots - second dose]) compared to baseline (Day 1)', 'description': 'The immune responses to MenABCWY and MenACWY vaccines are evaluated by measuring bactericidal activity against N. meningitidis serogroups A, C, W and Y. For each N. meningitidis serogroups A, C, W and Y, the GMRs (after vaccination/baseline) are calculated, with their associated 2-sided 95% CIs. As pre-specified in the protocol, data reported in this outcome measure were presented for the ACWY group and ABCWY pooled group, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.'}, {'measure': 'Total Immunoglobulin G (IgG) Antibodies Concentrations Against N. Meningitidis Serogroups A, C, W and Y at Day 1 and 1 Month After the First and the Last MenABCWY Vaccination for ABCWY _Pooled Group and 1 Month After the MenACWY Vaccination for ACWY Group', 'timeFrame': 'At Day 1, and 1 month after vaccination schedule (i.e, at Day 31 for ABCWY group [pooled lots -first dose] and for ACWY Group, and at Day 211 for ABCWY group [pooled lots - second dose])', 'description': 'The immune responses to MenABCWY and MenACWY vaccines were evaluated by measuring the total IgG in terms of electrochemiluminescence-based multiplex (ECL) geometric mean concentrations (GMCs) which was an alternative assay to Enzyme-Linked Immunosorbent Assay (ELISA). ECL (validated assay) was used because ELISA is not validated. As pre- specified in the protocol, data reported in this outcome measure were presented for the ACWY group and ABCWY pooled group, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bexsero', 'Menveo', 'MenABCWY', 'Effectiveness', 'Invasive meningococcal disease', 'Meningitis'], 'conditions': ['Infections, Meningococcal']}, 'referencesModule': {'references': [{'pmid': '39647494', 'type': 'DERIVED', 'citation': 'Nolan T, Bhusal C, Beran J, Bloch M, Cetin BS, Dinleyici EC, Drazan D, Kokko S, Koski S, Laajalahti O, Langley JM, Ramet M, Richmond PC, Silas P, Tapiero B, Tiong F, Tipton M, Ukkonen B, Ulukol B, Lattanzi M, Trapani M, Willemsen A, Toneatto D; QUINTET study group. Breadth of immune response, immunogenicity, reactogenicity, and safety for a pentavalent meningococcal ABCWY vaccine in healthy adolescents and young adults: results from a phase 3, randomised, controlled observer-blinded trial. Lancet Infect Dis. 2025 May;25(5):560-573. doi: 10.1016/S1473-3099(24)00667-4. Epub 2024 Dec 5.'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study was to evaluate the effectiveness of 2 doses or 3 doses of GSK's licenced meningococcal group B Bexsero (rMenB+OMV NZ) vaccine and of 2 doses of GSK's investigational combined meningococcal (MenABCWY) vaccine (GSK3536819A) in healthy adolescents and young adults. The immunogenicity and safety were evaluated in the study.", 'detailedDescription': "As per the feedback from the Center for Biologics Evaluation and Research (CBER), the scope of this post-marketing commitment study was extended to demonstrate the effectiveness, immunogenicity, and safety of GSK's investigational combined meningococcal ABCWY vaccine along with the rMenB+OMV NZ vaccine. Note that the rMenB+OMV and MenACWY vaccines provided to the MenB\\_0\\_2\\_6, MenB\\_0\\_6 group, and MenACWY group, respectively, at day 211 were only as part of the standard care of treatment and to maintain blinding. These vaccination schedules were not considered for any endpoint evaluations."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '10 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects or/and 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* Written or witnessed/thumb printed informed consent obtained from the subject/parent(s)/LAR(s) of the subject prior to performance of any study specific procedure.\n* Written informed assent obtained from the subject (if applicable) prior to performing any study specific procedure.\n* A male or female between, and including, 10 and 25 years of age (i.e. 25 years + 364 days) at the time of the first vaccination.\n* Healthy subjects as established by medical history physical examination and clinical judgment of the investigator before entering into the study.\n* Subjects who are either unvaccinated with MenACWY vaccine or have received a single previous dose of MenACWY vaccine can participate in the study, if they have received it at least 4 years prior to informed consent and assent as applicable (with the exception of meningococcal C vaccination, if the last dose of MenC was received at ≤24 months of age).\n* Female subjects of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as pre-menarche, current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy or post-menopause\\*.\n* Female subjects of childbearing potential may be enrolled in the study, if the subject:\n\n * has practiced adequate contraception for 30 days prior to vaccination, and\n * has a negative pregnancy test on the day of vaccination, and\n * has agreed to continue adequate contraception until 30 days after completion of Visit 6.\n\n * A female is considered to be of non-childbearing potential prior to menarche and after natural or induced menopause. Natural menopause is recognized to have occurred after 12 consecutive months of amenorrhea for which there is no other obvious pathological or physiological cause. Induced menopause is recognized to have occurred after hysterectomy, after bilateral oophorectomy, or iatrogenic ablation of ovarian function.\n\nExclusion Criteria:\n\nMedical conditions\n\n* Current or previous, confirmed or suspected disease caused by N. meningitidis.\n* Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis infection within 60 days of enrolment.\n* Progressive, unstable or uncontrolled clinical conditions.\n* Clinical conditions representing a contraindication to intramuscular vaccination and blood draws.\n* Any neuroinflammatory, congenital neurological conditions, encephalopathies, seizures. History of febrile convulsions should not lead to exclusion.\n* History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s)/product(s).\n\n * Hypersensitivity, including allergy, to any component of vaccines, including diphtheria toxoid (CRM 197) and latex medicinal products or medical equipment whose use is foreseen in this study.\n* Abnormal function or modification of the immune system resulting from:\n\n * Autoimmune disorders or immunodeficiency syndromes.\n * Systemic administration of corticosteroids (PO/IV/IM) for more than 14 consecutive days within 90 days prior to study vaccination until the post-vaccination 3 blood sample (Visit 6). This will mean prednisone - ≥20 mg/day (for adult subjects) or ≥0.5 mg/kg/day (for paediatric subjects), or equivalent. Inhaled and topical steroids are allowed.\n * Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to study vaccination.\n * Administration of long-acting immune-modifying drugs at any time during the study period (e.g. infliximab).\n* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.\n\nPrior/Concomitant therapy\n\n* Use of any investigational or non-registered product other than the study vaccine(s)/product(s) during the period starting 30 days before the first dose of study vaccine(s)/product(s) (Day -29 to Day 1), or planned use during the study period.\n* Previous vaccination against any group B meningococcal vaccine at any time prior to informed consent and assent as applicable.\n* Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 90 days before the first dose of study vaccine/ product or planned administration during the study period until the post-vaccination 3 blood sample (Visit 6).\n* Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 90 days prior to the vaccine/product dose(s) until the post-vaccination 3 blood sample (Visit 6). For corticosteroids, this will mean prednisone ≥20 mg/day (for adult subjects) or ≥0.5 mg/kg/day (for paediatric subjects), or equivalent. Inhaled and topical steroids are allowed.\n\nPrior/Concurrent clinical study experience\n\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.\n\nOther exclusions\n\n* Child in care.\n* Pregnant or lactating female.\n* Female planning to become pregnant or planning to discontinue contraceptive precautions.\n* History of /current chronic alcohol abuse and/or drug abuse as determined by the investigator.\n* Any study personnel or immediate dependants, family, or household member."}, 'identificationModule': {'nctId': 'NCT04502693', 'briefTitle': "Effectiveness of GlaxoSmithKline Biologicals S.A's Meningococcal Group B and Combined ABCWY Vaccines in Healthy Adolescents and Young Adults", 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': "A Phase III, Randomized, Controlled, Observer-blind Study to Demonstrate Effectiveness, Immunogenicity and Safety of GSK's Meningococcal Group B and Combined ABCWY Vaccines When Administered to Healthy Adolescents and Young Adults", 'orgStudyIdInfo': {'id': '205416'}, 'secondaryIdInfos': [{'id': '2019-001666-15', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MenB_0_2_6 Group', 'description': 'Participants received 3 doses of rMenB+OMV NZ vaccine on Day 1, Day 61 and Day 181. Participants received 1 dose of MenACWY vaccine at Day 211 as a standard of care.', 'interventionNames': ['Combination Product: rMenB+OMV NZ vaccine', 'Biological: Meningococcal Groups A, C, W and Y Conjugate Vaccine (MenACWY)']}, {'type': 'EXPERIMENTAL', 'label': 'MenB_0_6 Group', 'description': 'Participants received 2 doses of rMenB+OMV NZ vaccine on Day 1, and Day 181, 1 dose of MenACWY vaccine on Day 61. Participants received 1 dose of Placebo on Day 211 to maintain blinding.', 'interventionNames': ['Combination Product: rMenB+OMV NZ vaccine', 'Biological: Meningococcal Groups A, C, W and Y Conjugate Vaccine (MenACWY)', 'Combination Product: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'ABCWY-1 Group', 'description': 'Participants received 2 doses of MenABCWY lot 1 vaccine at Day 1 and Day 181 and 2 doses of placebo at Day 61 and Day 211.', 'interventionNames': ['Combination Product: Placebo', 'Combination Product: MenABCWY-1']}, {'type': 'EXPERIMENTAL', 'label': 'ABCWY-2 Group', 'description': 'Participants received 2 doses of MenABCWY lot 2 vaccine at Day 1 and Day 181 and 2 doses of placebo at Day 61 and Day 211.', 'interventionNames': ['Combination Product: Placebo', 'Combination Product: MenABCWY-2']}, {'type': 'EXPERIMENTAL', 'label': 'ABCWY-3 Group', 'description': 'Participants received 2 doses of MenABCWY lot 3 vaccine at Day 1 and Day 181 and 2 doses of placebo at Day 61 and Day 211.', 'interventionNames': ['Combination Product: Placebo', 'Combination Product: MenABCWY-3']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ACWY Group', 'description': 'Participants received 1 dose of MenACWY vaccine at Day 1,1 dose of placebo at Day 61 and 1 dose of rMenB+OMV NZ vaccine on Day 181. Participants received 1 dose of rMenB+OMV NZ vaccine on Day 211 as standard of care.', 'interventionNames': ['Combination Product: rMenB+OMV NZ vaccine', 'Biological: Meningococcal Groups A, C, W and Y Conjugate Vaccine (MenACWY)', 'Combination Product: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'ABCWY_Pooled', 'description': 'Participants received 2 doses of either MenABCWY Lot 1, Lot 2, or Lot 3 vaccine on Day 1 and Day 181 and 1 dose of placebo on Day 61. Participants received 1 dose of placebo on Day 211 to maintain blinding.\n\nTo evaluate the effectiveness of 2 doses of the MenABCWY vaccines against rMenB+OMV and MenACWY vaccines, participants from the ABCWY-1, ABCWY-2, and ABCWY-3 groups were pooled into a single group.', 'interventionNames': ['Combination Product: MenABCWY-1', 'Combination Product: MenABCWY-2', 'Combination Product: MenABCWY-3']}], 'interventions': [{'name': 'rMenB+OMV NZ vaccine', 'type': 'COMBINATION_PRODUCT', 'otherNames': ['Bexsero'], 'description': 'rMenB+OMV NZ vaccine was administered intramuscularly.', 'armGroupLabels': ['ACWY Group', 'MenB_0_2_6 Group', 'MenB_0_6 Group']}, {'name': 'Meningococcal Groups A, C, W and Y Conjugate Vaccine (MenACWY)', 'type': 'BIOLOGICAL', 'otherNames': ['Menveo'], 'description': 'MenACWY vaccine was administered intramuscularly.', 'armGroupLabels': ['ACWY Group', 'MenB_0_2_6 Group', 'MenB_0_6 Group']}, {'name': 'Placebo', 'type': 'COMBINATION_PRODUCT', 'otherNames': ['NaCl, saline solution'], 'description': 'Placebo was administered intramuscularly.', 'armGroupLabels': ['ABCWY-1 Group', 'ABCWY-2 Group', 'ABCWY-3 Group', 'ACWY Group', 'MenB_0_6 Group']}, {'name': 'MenABCWY-1', 'type': 'COMBINATION_PRODUCT', 'description': 'Lot 1 of the MenABCWY vaccine was administered intramuscularly.', 'armGroupLabels': ['ABCWY-1 Group', 'ABCWY_Pooled']}, {'name': 'MenABCWY-2', 'type': 'COMBINATION_PRODUCT', 'description': 'Lot 2 of the MenABCWY vaccine was administered intramuscularly.', 'armGroupLabels': ['ABCWY-2 Group', 'ABCWY_Pooled']}, {'name': 'MenABCWY-3', 'type': 'COMBINATION_PRODUCT', 'description': 'Lot 3 of the MenABCWY vaccine was administered intramuscularly.', 'armGroupLabels': ['ABCWY-3 Group', 'ABCWY_Pooled']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85286', 'city': 'Chandler', 'state': 'Arizona', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 33.30616, 'lon': -111.84125}}, {'zip': '85308', 'city': 'Glendale', 'state': 'Arizona', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 33.53865, 'lon': -112.18599}}, {'zip': '72401', 'city': 'Jonesboro', 'state': 'Arkansas', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.8423, 'lon': -90.70428}}, {'zip': '90201', 'city': 'Bell Gardens', 'state': 'California', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 33.96529, 'lon': -118.15146}}, {'zip': '91304', 'city': 'Canoga Park', 'state': 'California', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 34.20112, 'lon': -118.59814}}, {'zip': '92840', 'city': 'Garden Grove', 'state': 'California', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 33.77391, 'lon': -117.94145}}, {'zip': '90301', 'city': 'Inglewood', 'state': 'California', 'country': 'United States', 'facility': 'GSK Investigational 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