Viewing Study NCT00944034

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Ignite Creation Date: 2025-12-25 @ 2:23 AM
Ignite Modification Date: 2025-12-28 @ 12:07 AM
Study NCT ID: NCT00944034
Status: COMPLETED
Last Update Posted: 2017-08-14
First Post: 2009-07-21
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Safety, Tolerability and Immunogenicity of Meningococcal B Recombinant Vaccine Administered as Booster Dose at 12, 18 or 24 Months of Age in Toddlers (12-24 Months) Primed With a Three-Dose Immunization Series as Infants in Study V72P12
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008589', 'term': 'Meningococcal Infections'}, {'id': 'D008585', 'term': 'Meningitis, Meningococcal'}], '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': 'D016920', 'term': 'Meningitis, Bacterial'}, {'id': 'D020806', 'term': 'Central Nervous System Bacterial Infections'}, {'id': 'D002494', 'term': 'Central Nervous System Infections'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D008581', 'term': 'Meningitis'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'anh.phung@novartis.com', 'phone': '+39 0577 245863', 'title': 'Posting Director', 'organization': 'Novartis Vaccines'}, 'certainAgreement': {'otherDetails': "The terms and conditions of Novartis' agreement with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publications of the pooled data (i.e., data from all sites) in the clinical trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'None reported'}}, 'adverseEventsModule': {'timeFrame': 'From day 1 to day 7 after vaccination', 'description': 'Of the 1588 subjects enrolled into this study, 1519 were vaccinated and included in the safety analysis.', 'eventGroups': [{'id': 'EG000', 'title': 'B+R246_12', 'description': 'Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.', 'otherNumAtRisk': 185, 'otherNumAffected': 180, 'seriousNumAtRisk': 185, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'B+R246_18', 'description': 'Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.', 'otherNumAtRisk': 152, 'otherNumAffected': 147, 'seriousNumAtRisk': 152, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'B+R246_24', 'description': 'Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.', 'otherNumAtRisk': 144, 'otherNumAffected': 140, 'seriousNumAtRisk': 144, 'seriousNumAffected': 6}, {'id': 'EG003', 'title': 'B246_12', 'description': 'Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.', 'otherNumAtRisk': 170, 'otherNumAffected': 163, 'seriousNumAtRisk': 170, 'seriousNumAffected': 6}, {'id': 'EG004', 'title': 'B246_18', 'description': 'Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age.', 'otherNumAtRisk': 153, 'otherNumAffected': 139, 'seriousNumAtRisk': 153, 'seriousNumAffected': 7}, {'id': 'EG005', 'title': 'B246_24', 'description': 'Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age.', 'otherNumAtRisk': 126, 'otherNumAffected': 116, 'seriousNumAtRisk': 126, 'seriousNumAffected': 1}, {'id': 'EG006', 'title': 'B+R234_12', 'description': 'Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12 months of age.', 'otherNumAtRisk': 104, 'otherNumAffected': 102, 'seriousNumAtRisk': 104, 'seriousNumAffected': 5}, {'id': 'EG007', 'title': 'B+R234_18', 'description': 'Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.', 'otherNumAtRisk': 74, 'otherNumAffected': 73, 'seriousNumAtRisk': 74, 'seriousNumAffected': 5}, {'id': 'EG008', 'title': 'B+R234_24', 'description': 'Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.', 'otherNumAtRisk': 66, 'otherNumAffected': 62, 'seriousNumAtRisk': 66, 'seriousNumAffected': 3}, {'id': 'EG009', 'title': 'B12 14', 'description': 'Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 and14 months of age.', 'otherNumAtRisk': 239, 'otherNumAffected': 230, 'seriousNumAtRisk': 239, 'seriousNumAffected': 16}, {'id': 'EG010', 'title': 'B18 20', 'description': 'Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 and 20 months of age.', 'otherNumAtRisk': 51, 'otherNumAffected': 50, 'seriousNumAtRisk': 51, 'seriousNumAffected': 0}, {'id': 'EG011', 'title': 'B24 26', 'description': 'Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 and 26 months of age.', 'otherNumAtRisk': 55, 'otherNumAffected': 54, 'seriousNumAtRisk': 55, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 185, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 144, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 170, 'numAffected': 13}, {'groupId': 'EG004', 'numAtRisk': 153, 'numAffected': 8}, {'groupId': 'EG005', 'numAtRisk': 126, 'numAffected': 7}, {'groupId': 'EG006', 'numAtRisk': 104, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 74, 'numAffected': 4}, {'groupId': 'EG008', 'numAtRisk': 66, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 239, 'numAffected': 24}, {'groupId': 'EG010', 'numAtRisk': 51, 'numAffected': 6}, {'groupId': 'EG011', 'numAtRisk': 55, 'numAffected': 8}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 185, 'numAffected': 72}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 61}, {'groupId': 'EG002', 'numAtRisk': 144, 'numAffected': 72}, {'groupId': 'EG003', 'numAtRisk': 170, 'numAffected': 63}, {'groupId': 'EG004', 'numAtRisk': 153, 'numAffected': 56}, {'groupId': 'EG005', 'numAtRisk': 126, 'numAffected': 52}, {'groupId': 'EG006', 'numAtRisk': 104, 'numAffected': 50}, {'groupId': 'EG007', 'numAtRisk': 74, 'numAffected': 33}, {'groupId': 'EG008', 'numAtRisk': 66, 'numAffected': 27}, {'groupId': 'EG009', 'numAtRisk': 239, 'numAffected': 129}, {'groupId': 'EG010', 'numAtRisk': 51, 'numAffected': 25}, {'groupId': 'EG011', 'numAtRisk': 55, 'numAffected': 28}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Crying', 'stats': [{'groupId': 'EG000', 'numAtRisk': 185, 'numAffected': 56}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 43}, {'groupId': 'EG002', 'numAtRisk': 144, 'numAffected': 46}, {'groupId': 'EG003', 'numAtRisk': 170, 'numAffected': 52}, {'groupId': 'EG004', 'numAtRisk': 153, 'numAffected': 51}, {'groupId': 'EG005', 'numAtRisk': 126, 'numAffected': 40}, {'groupId': 'EG006', 'numAtRisk': 104, 'numAffected': 41}, {'groupId': 'EG007', 'numAtRisk': 74, 'numAffected': 18}, {'groupId': 'EG008', 'numAtRisk': 66, 'numAffected': 22}, {'groupId': 'EG009', 'numAtRisk': 239, 'numAffected': 105}, {'groupId': 'EG010', 'numAtRisk': 51, 'numAffected': 17}, {'groupId': 'EG011', 'numAtRisk': 55, 'numAffected': 25}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 185, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 144, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 170, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 153, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 126, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 104, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 239, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 55, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 185, 'numAffected': 127}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 100}, {'groupId': 'EG002', 'numAtRisk': 144, 'numAffected': 109}, {'groupId': 'EG003', 'numAtRisk': 170, 'numAffected': 117}, {'groupId': 'EG004', 'numAtRisk': 153, 'numAffected': 94}, {'groupId': 'EG005', 'numAtRisk': 126, 'numAffected': 94}, {'groupId': 'EG006', 'numAtRisk': 104, 'numAffected': 76}, {'groupId': 'EG007', 'numAtRisk': 74, 'numAffected': 52}, {'groupId': 'EG008', 'numAtRisk': 66, 'numAffected': 49}, {'groupId': 'EG009', 'numAtRisk': 239, 'numAffected': 179}, {'groupId': 'EG010', 'numAtRisk': 51, 'numAffected': 38}, {'groupId': 'EG011', 'numAtRisk': 55, 'numAffected': 41}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Injection site induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 185, 'numAffected': 101}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 74}, {'groupId': 'EG002', 'numAtRisk': 144, 'numAffected': 76}, {'groupId': 'EG003', 'numAtRisk': 170, 'numAffected': 93}, {'groupId': 'EG004', 'numAtRisk': 153, 'numAffected': 62}, {'groupId': 'EG005', 'numAtRisk': 126, 'numAffected': 73}, {'groupId': 'EG006', 'numAtRisk': 104, 'numAffected': 52}, {'groupId': 'EG007', 'numAtRisk': 74, 'numAffected': 41}, {'groupId': 'EG008', 'numAtRisk': 66, 'numAffected': 35}, {'groupId': 'EG009', 'numAtRisk': 239, 'numAffected': 148}, {'groupId': 'EG010', 'numAtRisk': 51, 'numAffected': 27}, {'groupId': 'EG011', 'numAtRisk': 55, 'numAffected': 33}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 185, 'numAffected': 107}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 114}, {'groupId': 'EG002', 'numAtRisk': 144, 'numAffected': 118}, {'groupId': 'EG003', 'numAtRisk': 170, 'numAffected': 104}, {'groupId': 'EG004', 'numAtRisk': 153, 'numAffected': 104}, {'groupId': 'EG005', 'numAtRisk': 126, 'numAffected': 105}, {'groupId': 'EG006', 'numAtRisk': 104, 'numAffected': 70}, {'groupId': 'EG007', 'numAtRisk': 74, 'numAffected': 56}, {'groupId': 'EG008', 'numAtRisk': 66, 'numAffected': 51}, {'groupId': 'EG009', 'numAtRisk': 239, 'numAffected': 187}, {'groupId': 'EG010', 'numAtRisk': 51, 'numAffected': 41}, {'groupId': 'EG011', 'numAtRisk': 55, 'numAffected': 51}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 185, 'numAffected': 73}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 53}, {'groupId': 'EG002', 'numAtRisk': 144, 'numAffected': 63}, {'groupId': 'EG003', 'numAtRisk': 170, 'numAffected': 57}, {'groupId': 'EG004', 'numAtRisk': 153, 'numAffected': 52}, {'groupId': 'EG005', 'numAtRisk': 126, 'numAffected': 50}, {'groupId': 'EG006', 'numAtRisk': 104, 'numAffected': 32}, {'groupId': 'EG007', 'numAtRisk': 74, 'numAffected': 36}, {'groupId': 'EG008', 'numAtRisk': 66, 'numAffected': 25}, {'groupId': 'EG009', 'numAtRisk': 239, 'numAffected': 107}, {'groupId': 'EG010', 'numAtRisk': 51, 'numAffected': 21}, {'groupId': 'EG011', 'numAtRisk': 55, 'numAffected': 24}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 185, 'numAffected': 78}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 57}, {'groupId': 'EG002', 'numAtRisk': 144, 'numAffected': 50}, {'groupId': 'EG003', 'numAtRisk': 170, 'numAffected': 60}, {'groupId': 'EG004', 'numAtRisk': 153, 'numAffected': 59}, {'groupId': 'EG005', 'numAtRisk': 126, 'numAffected': 32}, {'groupId': 'EG006', 'numAtRisk': 104, 'numAffected': 53}, {'groupId': 'EG007', 'numAtRisk': 74, 'numAffected': 28}, {'groupId': 'EG008', 'numAtRisk': 66, 'numAffected': 27}, {'groupId': 'EG009', 'numAtRisk': 239, 'numAffected': 133}, {'groupId': 'EG010', 'numAtRisk': 51, 'numAffected': 24}, {'groupId': 'EG011', 'numAtRisk': 55, 'numAffected': 22}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 144, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 153, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 126, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 239, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 55, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Eating disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 185, 'numAffected': 64}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 70}, {'groupId': 'EG002', 'numAtRisk': 144, 'numAffected': 68}, {'groupId': 'EG003', 'numAtRisk': 170, 'numAffected': 66}, {'groupId': 'EG004', 'numAtRisk': 153, 'numAffected': 59}, {'groupId': 'EG005', 'numAtRisk': 126, 'numAffected': 51}, {'groupId': 'EG006', 'numAtRisk': 104, 'numAffected': 41}, {'groupId': 'EG007', 'numAtRisk': 74, 'numAffected': 29}, {'groupId': 'EG008', 'numAtRisk': 66, 'numAffected': 28}, {'groupId': 'EG009', 'numAtRisk': 239, 'numAffected': 126}, {'groupId': 'EG010', 'numAtRisk': 51, 'numAffected': 21}, {'groupId': 'EG011', 'numAtRisk': 55, 'numAffected': 34}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 185, 'numAffected': 110}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 100}, {'groupId': 'EG002', 'numAtRisk': 144, 'numAffected': 92}, {'groupId': 'EG003', 'numAtRisk': 170, 'numAffected': 104}, {'groupId': 'EG004', 'numAtRisk': 153, 'numAffected': 91}, {'groupId': 'EG005', 'numAtRisk': 126, 'numAffected': 83}, {'groupId': 'EG006', 'numAtRisk': 104, 'numAffected': 72}, {'groupId': 'EG007', 'numAtRisk': 74, 'numAffected': 53}, {'groupId': 'EG008', 'numAtRisk': 66, 'numAffected': 44}, {'groupId': 'EG009', 'numAtRisk': 239, 'numAffected': 177}, {'groupId': 'EG010', 'numAtRisk': 51, 'numAffected': 32}, {'groupId': 'EG011', 'numAtRisk': 55, 'numAffected': 35}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 185, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 144, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 170, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 153, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 126, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 239, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 51, 'numAffected': 3}, {'groupId': 'EG011', 'numAtRisk': 55, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 185, 'numAffected': 39}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 144, 'numAffected': 32}, {'groupId': 'EG003', 'numAtRisk': 170, 'numAffected': 40}, {'groupId': 'EG004', 'numAtRisk': 153, 'numAffected': 27}, {'groupId': 'EG005', 'numAtRisk': 126, 'numAffected': 27}, {'groupId': 'EG006', 'numAtRisk': 104, 'numAffected': 21}, {'groupId': 'EG007', 'numAtRisk': 74, 'numAffected': 18}, {'groupId': 'EG008', 'numAtRisk': 66, 'numAffected': 13}, {'groupId': 'EG009', 'numAtRisk': 239, 'numAffected': 72}, {'groupId': 'EG010', 'numAtRisk': 51, 'numAffected': 16}, {'groupId': 'EG011', 'numAtRisk': 55, 'numAffected': 21}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Enteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 185, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 144, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 170, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 153, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 126, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 104, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 66, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 239, 'numAffected': 4}, {'groupId': 'EG010', 'numAtRisk': 51, 'numAffected': 3}, {'groupId': 'EG011', 'numAtRisk': 55, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Teething', 'stats': [{'groupId': 'EG000', 'numAtRisk': 185, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 144, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 170, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 104, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 74, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 239, 'numAffected': 15}, {'groupId': 'EG010', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 185, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 144, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 170, 'numAffected': 13}, {'groupId': 'EG004', 'numAtRisk': 153, 'numAffected': 12}, {'groupId': 'EG005', 'numAtRisk': 126, 'numAffected': 10}, {'groupId': 'EG006', 'numAtRisk': 104, 'numAffected': 15}, {'groupId': 'EG007', 'numAtRisk': 74, 'numAffected': 8}, {'groupId': 'EG008', 'numAtRisk': 66, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 239, 'numAffected': 41}, {'groupId': 'EG010', 'numAtRisk': 51, 'numAffected': 7}, {'groupId': 'EG011', 'numAtRisk': 55, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Dermatitis diaper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 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'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Escherichia urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 185, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 153, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 239, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 185, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 153, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 74, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 239, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 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'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 153, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 239, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 185, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 239, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 185, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 144, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 239, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Respiratory syncytial virus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 239, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 185, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 66, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 239, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Eczema herpeticum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 185, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 104, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 239, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 185, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 239, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Periorbital cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 185, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 239, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Pneumonia respiratory syncytial viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 185, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 239, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Superinfection bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 185, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 239, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 185, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 153, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 239, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 185, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 170, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 239, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}, {'term': 'Accidental exposure to product', 'stats': [{'groupId': 'EG000', 'numAtRisk': 185, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 152, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 144, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 170, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 104, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 66, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 239, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 55, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Receiving a Fourth (Booster) Dose of rMenB+OMV NZ Vaccination in Subjects Who Previously Received 3 Doses of rMenB+OMV NZ and Routine Vaccines at 2, 4 and 6 Months of Age.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}, {'value': '108', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'B+R246_12', 'description': 'Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.'}, {'id': 'OG001', 'title': 'B+R246_18', 'description': 'Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.'}, {'id': 'OG002', 'title': 'B+R246_24', 'description': 'Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.'}], 'classes': [{'title': 'hSBA≥ 1: 5 (H44/76 strain)(N = 158,116,101)', 'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000', 'lowerLimit': '93', 'upperLimit': '99'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '96', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG002', 'lowerLimit': '95', 'upperLimit': '100'}]}]}, {'title': 'hSBA≥ 1: 5 (5/99 strain)(N= 156,118,100)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '97', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '96', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG002', 'lowerLimit': '95', 'upperLimit': '100'}]}]}, {'title': 'hSBA≥ 1: 5 (NZ 98/254 strain)(N= 159,118,103)', 'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000', 'lowerLimit': '89', 'upperLimit': '98'}, {'value': '77', 'groupId': 'OG001', 'lowerLimit': '67', 'upperLimit': '86'}, {'value': '84', 'groupId': 'OG002', 'lowerLimit': '74', 'upperLimit': '92'}]}]}, {'title': 'hSBA≥ 1: 5 (M10713 strain)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'In this group exploratory analyses was not performed', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'In this group exploratory analyses was not performed', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'In this group exploratory analyses was not performed', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month after booster', 'description': 'Immunogenicity was assessed in terms of percentage of subjects with serum bactericidal antibody (SBA) titers ≥1:5 (98.3% CI) against N.meningitidis serogroup reference strains H44/76, NZ98/254 and 5/99, one month after the fourth (booster) dose of meningococcal B vaccine at 12 or 18 or24 months of age who were previously vaccinated with 3 doses of rMenB+OMV NZ and routine vaccines at 2, 4 and 6 months of age.', 'unitOfMeasure': 'percentage of subjects', 'dispersionType': '98.3% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the per-protocol population. This outcome measure was assessed only for the strains H44/76, NZ98/254 and 5/99. As exploratory analyses were performed on the M10713 strain, no endpoints were considered for this strain.'}, {'type': 'SECONDARY', 'title': 'Percentages of Subjects With SBA Titers ≥1:5 After Receiving a Fourth (Booster) Dose of rMenB+OMV NZ Vaccination in Subjects Who Previously Received 3 Doses of rMenB+OMV NZ at 2, 4 and 6 Months of Age and Routine Vaccines at 3, 5 and 7 Months of Age.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '145', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'B246_12', 'description': 'Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.'}, {'id': 'OG001', 'title': 'B246_18', 'description': 'Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age.'}, {'id': 'OG002', 'title': 'B246_24', 'description': 'Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age.'}], 'classes': [{'title': 'hSBA≥ 1: 5 (H44/76 strain)(N= 138,111,93)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '97', 'upperLimit': '100'}, {'value': '99', 'groupId': 'OG001', 'lowerLimit': '94', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG002', 'lowerLimit': '95', 'upperLimit': '100'}]}]}, {'title': 'hSBA≥ 1: 5 (5/99 strain)(N= 142,110,92)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '97', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '96', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG002', 'lowerLimit': '95', 'upperLimit': '100'}]}]}, {'title': 'hSBA≥ 1: 5 (NZ 98/254 strain)(N= 142,111,95)', 'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000', 'lowerLimit': '90', 'upperLimit': '99'}, {'value': '86', 'groupId': 'OG001', 'lowerLimit': '76', 'upperLimit': '93'}, {'value': '89', 'groupId': 'OG002', 'lowerLimit': '80', 'upperLimit': '96'}]}]}, {'title': 'hSBA≥ 1: 5 (M10713 strain)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'In this group exploratory analyses was not performed', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'In this group exploratory analyses was not performed', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'In this group exploratory analyses was not performed', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month after booster', 'description': 'Immunogenicity was assessed in terms of Percentages of Subjects With SBA Titers ≥1:5 (98.3% CI), After Receiving a Fourth (Booster) Dose of rMenB+OMV NZ Vaccination in subjects who previously received 3 doses of rMenB+OMV NZ at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age.', 'unitOfMeasure': 'percentage of subjects', 'dispersionType': '98.3% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on per-protocol population. This outcome measure was assessed only against H44/76, NZ98/254 and 5/99 strains. As exploratory analyses were performed on the M10713 strain, no endpoints were considered for this strain.'}, {'type': 'SECONDARY', 'title': 'Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Receiving a Fourth (Booster) Dose of rMenB+OMV NZ Vaccination in Subjects Who Previously Received 3 Doses of rMenB+OMV NZ and Routine Vaccines at 2, 3 and 4 Months of Age.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'B+R234_12', 'description': 'Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12 months of age.'}, {'id': 'OG001', 'title': 'B+R234_18', 'description': 'Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.'}, {'id': 'OG002', 'title': 'B+R234_24', 'description': 'Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.'}], 'classes': [{'title': 'hSBA≥ 1: 5 (H44/76 strain)(N= 83,56,48 )', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '94', 'upperLimit': '100'}, {'value': '98', 'groupId': 'OG001', 'lowerLimit': '88', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG002', 'lowerLimit': '91', 'upperLimit': '100'}]}]}, {'title': 'hSBA≥ 1: 5 (5/99 strain)(N= 84,56,46)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '94', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '92', 'upperLimit': '100'}, {'value': '100', 'groupId': 'OG002', 'lowerLimit': '90', 'upperLimit': '100'}]}]}, {'title': 'hSBA≥ 1: 5 (NZ 98/254 strain)(N= 83,56,48)', 'categories': [{'measurements': [{'value': '97', 'groupId': 'OG000', 'lowerLimit': '89', 'upperLimit': '100'}, {'value': '80', 'groupId': 'OG001', 'lowerLimit': '65', 'upperLimit': '91'}, {'value': '96', 'groupId': 'OG002', 'lowerLimit': '83', 'upperLimit': '100'}]}]}, {'title': 'hSBA≥ 1: 5 (M10713 strain)(N= 67,50,41)', 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000', 'lowerLimit': '62', 'upperLimit': '87'}, {'value': '74', 'groupId': 'OG001', 'lowerLimit': '57', 'upperLimit': '87'}, {'value': '95', 'groupId': 'OG002', 'lowerLimit': '81', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month after booster', 'description': 'Immunogenicity was assessed in terms of percentage of subjects with serum bactericidal antibody (SBA) titers ≥1:5 (98.3% CI) against N.meningitidis serogroup reference strains H44/76, NZ98/254 and 5/99, one month after the fourth (booster) dose of meningococcal B vaccine at 12 or 18 or24 months of age who were previously vaccinated with 3 doses of rMenB+OMV NZ and routine vaccines at 2, 3 and 4 months of age.', 'unitOfMeasure': 'percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the per-protocol population'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Titers (GMTs) in Subjects One Month After Receiving a Fourth (Booster) Dose of rMenB+OMV NZ Vaccination in Subjects at 12 18 or 24 Months of Age Who Previously Received 3 Doses of rMenB+OMV NZ at 2, 3 and 4 or 2, 4 and 6 Months of Age.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '120', 'groupId': 'OG001'}, {'value': '108', 'groupId': 'OG002'}, {'value': '145', 'groupId': 'OG003'}, {'value': '114', 'groupId': 'OG004'}, {'value': '98', 'groupId': 'OG005'}, {'value': '86', 'groupId': 'OG006'}, {'value': '58', 'groupId': 'OG007'}, {'value': '48', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'B+R246_12', 'description': 'Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.'}, {'id': 'OG001', 'title': 'B+R246_18', 'description': 'Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.'}, {'id': 'OG002', 'title': 'B+R246_24', 'description': 'Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.'}, {'id': 'OG003', 'title': 'B246_12', 'description': 'Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.'}, {'id': 'OG004', 'title': 'B246_18', 'description': 'Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age.'}, {'id': 'OG005', 'title': 'B246_24', 'description': 'Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age.'}, {'id': 'OG006', 'title': 'B+R234_12', 'description': 'Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12 months of age.'}, {'id': 'OG007', 'title': 'B+R234_18', 'description': 'Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.'}, {'id': 'OG008', 'title': 'B+R234_24', 'description': 'Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.'}], 'classes': [{'title': 'hSBA≥ 1: 5 (H44/76 strain)', 'categories': [{'measurements': [{'value': '125', 'groupId': 'OG000', 'lowerLimit': '106', 'upperLimit': '148'}, {'value': '123', 'groupId': 'OG001', 'lowerLimit': '101', 'upperLimit': '149'}, {'value': '108', 'groupId': 'OG002', 'lowerLimit': '88', 'upperLimit': '133'}, {'value': '178', 'groupId': 'OG003', 'lowerLimit': '149', 'upperLimit': '213'}, {'value': '164', 'groupId': 'OG004', 'lowerLimit': '135', 'upperLimit': '200'}, {'value': '152', 'groupId': 'OG005', 'lowerLimit': '122', 'upperLimit': '188'}, {'value': '135', 'groupId': 'OG006', 'lowerLimit': '108', 'upperLimit': '170'}, {'value': '92', 'groupId': 'OG007', 'lowerLimit': '70', 'upperLimit': '121'}, {'value': '128', 'groupId': 'OG008', 'lowerLimit': '95', 'upperLimit': '172'}]}]}, {'title': 'hSBA≥ 1: 5 (5/99 strain)', 'categories': [{'measurements': [{'value': '1276', 'groupId': 'OG000', 'lowerLimit': '1092', 'upperLimit': '1491'}, {'value': '2183', 'groupId': 'OG001', 'lowerLimit': '1824', 'upperLimit': '2611'}, {'value': '1820', 'groupId': 'OG002', 'lowerLimit': '1497', 'upperLimit': '2212'}, {'value': '1713', 'groupId': 'OG003', 'lowerLimit': '1454', 'upperLimit': '2020'}, {'value': '2058', 'groupId': 'OG004', 'lowerLimit': '1710', 'upperLimit': '2476'}, {'value': '2739', 'groupId': 'OG005', 'lowerLimit': '2233', 'upperLimit': '3361'}, {'value': '1558', 'groupId': 'OG006', 'lowerLimit': '1262', 'upperLimit': '1923'}, {'value': '1486', 'groupId': 'OG007', 'lowerLimit': '1148', 'upperLimit': '1924'}, {'value': '2081', 'groupId': 'OG008', 'lowerLimit': '1564', 'upperLimit': '2771'}]}]}, {'title': 'hSBA≥ 1: 5 (NZ 98/254 strain)', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000', 'lowerLimit': '29', 'upperLimit': '44'}, {'value': '15', 'groupId': 'OG001', 'lowerLimit': '12', 'upperLimit': '19'}, {'value': '17', 'groupId': 'OG002', 'lowerLimit': '14', 'upperLimit': '22'}, {'value': '34', 'groupId': 'OG003', 'lowerLimit': '27', 'upperLimit': '42'}, {'value': '17', 'groupId': 'OG004', 'lowerLimit': '14', 'upperLimit': '22'}, {'value': '19', 'groupId': 'OG005', 'lowerLimit': '15', 'upperLimit': '25'}, {'value': '47', 'groupId': 'OG006', 'lowerLimit': '36', 'upperLimit': '62'}, {'value': '17', 'groupId': 'OG007', 'lowerLimit': '12', 'upperLimit': '24'}, {'value': '33', 'groupId': 'OG008', 'lowerLimit': '23', 'upperLimit': '47'}]}]}, {'title': 'hSBA≥ 1: 5 (M10713 strain)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'In this group exploratory analyses was not performed.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'In this group exploratory analyses was not performed.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'In this group exploratory analyses was not performed.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'In this group exploratory analyses was not performed.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'In this group exploratory analyses was not performed.', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'In this group exploratory analyses was not performed.', 'groupId': 'OG005', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '12', 'groupId': 'OG006', 'lowerLimit': '8.52', 'upperLimit': '17'}, {'value': '15', 'groupId': 'OG007', 'lowerLimit': '10', 'upperLimit': '23'}, {'value': '26', 'groupId': 'OG008', 'lowerLimit': '17', 'upperLimit': '41'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 month after booster', 'description': 'The serum antibody titers one month after the fourth (booster) dose of meningococcal B vaccine at 12 or 18 or24 months of age who were previously vaccinated with 3 doses of rMenB+OMV NZ at 2, 3 and 4 or 2, 4 and 6 months of age, are reported as geometric mean titers (GMTs) against N.meningitidis serogroup reference strains H44/76, NZ98/254 and 5/99.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the per-protocol population. For hSBA≥ 1: 5 (H44/76 strain) (N=158 116 101 138 111 93 83 56 48) For hSBA≥ 1: 5 (5/99 strain) (N=156 118 100 142 110 92 84 56 46) For hSBA≥ 1: 5 (NZ 98/254 strain) (N=159 118 103 142 111 95 86 56 48) For hSBA≥ 1: 5 (M10713 strain) (N=0 0 0 0 0 0 67 50 41)'}, {'type': 'SECONDARY', 'title': 'GMTs in Subjects One Month After the Fourth (Booster) Dose of Meningococcal B Vaccine at 12 Months of Age Previously Vaccinated With 3 Doses of rMenB+OMV NZ at 2, 3 and 4 or 2, 4 and 6 Months of Age and Single Dose of rMenB+OMV NZ Given at Same Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}, {'value': '86', 'groupId': 'OG002'}, {'value': '239', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'B+R246_12', 'description': 'Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.'}, {'id': 'OG001', 'title': 'B246_12', 'description': 'Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.'}, {'id': 'OG002', 'title': 'B+R234_12', 'description': 'Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12 months of age.'}, {'id': 'OG003', 'title': 'B12 14', 'description': 'Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 and14 months of age.'}], 'classes': [{'title': 'hSBA≥ 1: 5 (H44/76 strain)(N= 158,138,83,217)', 'categories': [{'measurements': [{'value': '125', 'groupId': 'OG000', 'lowerLimit': '102', 'upperLimit': '154'}, {'value': '179', 'groupId': 'OG001', 'lowerLimit': '144', 'upperLimit': '223'}, {'value': '137', 'groupId': 'OG002', 'lowerLimit': '104', 'upperLimit': '181'}, {'value': '18', 'groupId': 'OG003', 'lowerLimit': '15', 'upperLimit': '21'}]}]}, {'title': 'hSBA≥ 1: 5 (5/99 strain)(N= 156,142,84,216)', 'categories': [{'measurements': [{'value': '1301', 'groupId': 'OG000', 'lowerLimit': '1076', 'upperLimit': '1573'}, {'value': '1763', 'groupId': 'OG001', 'lowerLimit': '1441', 'upperLimit': '2157'}, {'value': '1607', 'groupId': 'OG002', 'lowerLimit': '1243', 'upperLimit': '2077'}, {'value': '49', 'groupId': 'OG003', 'lowerLimit': '42', 'upperLimit': '58'}]}]}, {'title': 'hSBA≥ 1: 5 (NZ 98/254 strain)(N= 159,142,86,220)', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000', 'lowerLimit': '29', 'upperLimit': '46'}, {'value': '35', 'groupId': 'OG001', 'lowerLimit': '27', 'upperLimit': '44'}, {'value': '48', 'groupId': 'OG002', 'lowerLimit': '36', 'upperLimit': '65'}, {'value': '3.71', 'groupId': 'OG003', 'lowerLimit': '3.06', 'upperLimit': '4.5'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 month after booster', 'description': 'Characterization of immunological memory by serum antibody titers (98.3% CI) one month after the fourth (booster) dose of meningococcal B vaccine at 12 months of age who were previously vaccinated with 3 doses of rMenB+OMV NZ at 2, 3 and 4 or 2, 4 and 6 months of age and single dose of rMenB+OMV NZ given at same ages, are reported as geometric mean titers (GMTs) against N.meningitidis serogroup reference strains H44/76, NZ98/254 and 5/99.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the per-protocol population'}, {'type': 'SECONDARY', 'title': 'GMTs in Subjects One Month After the Fourth (Booster) Dose of Meningococcal B Vaccine at 18 and 24months of Age, Previously Vaccinated With 3 Doses of rMenB+OMV NZ at 2, 3 and 4 or 2, 4 and 6 Months of Age and Single Dose of rMenB+OMV NZ Given at Same Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '114', 'groupId': 'OG002'}, {'value': '98', 'groupId': 'OG003'}, {'value': '58', 'groupId': 'OG004'}, {'value': '48', 'groupId': 'OG005'}, {'value': '47', 'groupId': 'OG006'}, {'value': '53', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'B+R246_18', 'description': 'Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.'}, {'id': 'OG001', 'title': 'B+R246_24', 'description': 'Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.'}, {'id': 'OG002', 'title': 'B246_18', 'description': 'Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age.'}, {'id': 'OG003', 'title': 'B246_24', 'description': 'Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age.'}, {'id': 'OG004', 'title': 'B+R234_18', 'description': 'Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.'}, {'id': 'OG005', 'title': 'B+R234_24', 'description': 'Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.'}, {'id': 'OG006', 'title': 'B18 20', 'description': 'Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 and 20 months of age.'}, {'id': 'OG007', 'title': 'B24 26', 'description': 'Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 and 26 months of age.'}], 'classes': [{'title': 'hSBA≥ 1: 5 (H44/76 strain)', 'categories': [{'measurements': [{'value': '126', 'groupId': 'OG000', 'lowerLimit': '104', 'upperLimit': '154'}, {'value': '110', 'groupId': 'OG001', 'lowerLimit': '89', 'upperLimit': '136'}, {'value': '162', 'groupId': 'OG002', 'lowerLimit': '132', 'upperLimit': '198'}, {'value': '155', 'groupId': 'OG003', 'lowerLimit': '124', 'upperLimit': '193'}, {'value': '93', 'groupId': 'OG004', 'lowerLimit': '70', 'upperLimit': '123'}, {'value': '132', 'groupId': 'OG005', 'lowerLimit': '97', 'upperLimit': '180'}, {'value': '18', 'groupId': 'OG006', 'lowerLimit': '13', 'upperLimit': '25'}, {'value': '14', 'groupId': 'OG007', 'lowerLimit': '10', 'upperLimit': '19'}]}]}, {'title': 'hSBA≥ 1: 5 (5/99 strain)', 'categories': [{'measurements': [{'value': '2195', 'groupId': 'OG000', 'lowerLimit': '1790', 'upperLimit': '2691'}, {'value': '1811', 'groupId': 'OG001', 'lowerLimit': '1449', 'upperLimit': '2262'}, {'value': '2034', 'groupId': 'OG002', 'lowerLimit': '1648', 'upperLimit': '2511'}, {'value': '2735', 'groupId': 'OG003', 'lowerLimit': '2166', 'upperLimit': '3455'}, {'value': '1483', 'groupId': 'OG004', 'lowerLimit': '1107', 'upperLimit': '1986'}, {'value': '2087', 'groupId': 'OG005', 'lowerLimit': '1508', 'upperLimit': '2889'}, {'value': '41', 'groupId': 'OG006', 'lowerLimit': '30', 'upperLimit': '56'}, {'value': '30', 'groupId': 'OG007', 'lowerLimit': '22', 'upperLimit': '41'}]}]}, {'title': 'hSBA≥ 1: 5 (NZ 98/254 strain)', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000', 'lowerLimit': '12', 'upperLimit': '20'}, {'value': '18', 'groupId': 'OG001', 'lowerLimit': '14', 'upperLimit': '23'}, {'value': '17', 'groupId': 'OG002', 'lowerLimit': '14', 'upperLimit': '22'}, {'value': '20', 'groupId': 'OG003', 'lowerLimit': '15', 'upperLimit': '26'}, {'value': '17', 'groupId': 'OG004', 'lowerLimit': '12', 'upperLimit': '25'}, {'value': '34', 'groupId': 'OG005', 'lowerLimit': '23', 'upperLimit': '49'}, {'value': '2.76', 'groupId': 'OG006', 'lowerLimit': '1.87', 'upperLimit': '4.08'}, {'value': '2.1', 'groupId': 'OG007', 'lowerLimit': '1.44', 'upperLimit': '3.07'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 month after booster', 'description': 'Characterization of immunological memory by serum antibody titers one month after the fourth (booster) dose of meningococcal B vaccine at 18 and 24months of age who were previously vaccinated with 3 doses of rMenB+OMV NZ at 2, 3 and 4 or 2, 4 and 6 months of age and single dose of rMenB+OMV NZ given at same ages, are reported as geometric mean titers (GMTs) against N.meningitidis serogroup reference strains H44/76, NZ98/254 and 5/99.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the per-protocol population. For hSBA≥ 1: 5 (H44/76 strain)(N=116 101 111 93 56 48 46 52), hSBA≥ 1: 5 (5/99 strain) (N=118 100 110 92 56 46 48 50), hSBA≥ 1: 5 (NZ 98/254 strain) (N=118 103 111 95 56 48 47 50)'}, {'type': 'SECONDARY', 'title': 'Two-dose Catch-up Regimen of rMenB+OMV NZ in Unprimed Toddlers Aged 12, 18 or 24 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '189', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'B12 14', 'description': 'Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 and14 months of age.'}, {'id': 'OG001', 'title': 'B18 20', 'description': 'Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 and 20 months of age.'}, {'id': 'OG002', 'title': 'B24 26', 'description': 'Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 and 26 months of age.'}], 'classes': [{'title': 'hSBA≥ 1: 5 (H44/76 strain)(N= 156,42,45)', 'categories': [{'measurements': [{'value': '188', 'groupId': 'OG000', 'lowerLimit': '164', 'upperLimit': '216'}, {'value': '171', 'groupId': 'OG001', 'lowerLimit': '130', 'upperLimit': '224'}, {'value': '177', 'groupId': 'OG002', 'lowerLimit': '136', 'upperLimit': '231'}]}]}, {'title': 'hSBA≥ 1: 5 (5/99 strain)(N= 177, 40,46)', 'categories': [{'measurements': [{'value': '635', 'groupId': 'OG000', 'lowerLimit': '548', 'upperLimit': '735'}, {'value': '491', 'groupId': 'OG001', 'lowerLimit': '359', 'upperLimit': '672'}, {'value': '559', 'groupId': 'OG002', 'lowerLimit': '417', 'upperLimit': '749'}]}]}, {'title': 'hSBA≥ 1: 5 (NZ 98/254 strain)(N = 179,44,45)', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000', 'lowerLimit': '35', 'upperLimit': '47'}, {'value': '23', 'groupId': 'OG001', 'lowerLimit': '17', 'upperLimit': '30'}, {'value': '24', 'groupId': 'OG002', 'lowerLimit': '18', 'upperLimit': '32'}]}]}, {'title': 'hSBA≥ 1: 5 (M10713 strain)(N= 0,34,37)', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'In this group exploratory analyses was not performed.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '14', 'groupId': 'OG001', 'lowerLimit': '8.02', 'upperLimit': '23'}, {'value': '18', 'groupId': 'OG002', 'lowerLimit': '11', 'upperLimit': '29'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 month after second vaccination', 'description': 'Immunogenicity evaluation of a two-dose catch-up regimen of rMenB+OMV NZ in unprimed toddlers aged 12, 18 or 24 months as measured by serum antibody titers one month after the second vaccination f meningococcal B vaccine at 18 and 24months of age who were previously vaccinated with 3 doses of rMenB+OMV NZ reported as geometric mean titers (GMTs) against N.meningitidis serogroup reference strains H44/76, NZ98/254 and 5/99.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the per-protocol population'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Concentrations Against Vaccine Antigen 287- 953 One Month After Fourth Booster Dose to Previously Primed Toddlers at 12, 18 or 24 Months of Age.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '108', 'groupId': 'OG002'}, {'value': '145', 'groupId': 'OG003'}, {'value': '114', 'groupId': 'OG004'}, {'value': '98', 'groupId': 'OG005'}, {'value': '86', 'groupId': 'OG006'}, {'value': '58', 'groupId': 'OG007'}, {'value': '48', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'B+R246_12', 'description': 'Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.'}, {'id': 'OG001', 'title': 'B+R246_18', 'description': 'Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.'}, {'id': 'OG002', 'title': 'B+R246_24', 'description': 'Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.'}, {'id': 'OG003', 'title': 'B246_12', 'description': 'Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.'}, {'id': 'OG004', 'title': 'B246_18', 'description': 'Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age.'}, {'id': 'OG005', 'title': 'B246_24', 'description': 'Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age.'}, {'id': 'OG006', 'title': 'B+R234_12', 'description': 'Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12 months of age.'}, {'id': 'OG007', 'title': 'B+R234_18', 'description': 'Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.'}, {'id': 'OG008', 'title': 'B+R234_24', 'description': 'Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '5334', 'groupId': 'OG000', 'lowerLimit': '4670', 'upperLimit': '6093'}, {'value': '6395', 'groupId': 'OG001', 'lowerLimit': '5474', 'upperLimit': '7470'}, {'value': '6864', 'groupId': 'OG002', 'lowerLimit': '5826', 'upperLimit': '8087'}, {'value': '6605', 'groupId': 'OG003', 'lowerLimit': '5733', 'upperLimit': '7609'}, {'value': '6418', 'groupId': 'OG004', 'lowerLimit': '5477', 'upperLimit': '7520'}, {'value': '8120', 'groupId': 'OG005', 'lowerLimit': '6833', 'upperLimit': '9649'}, {'value': '6125', 'groupId': 'OG006', 'lowerLimit': '5110', 'upperLimit': '7342'}, {'value': '5952', 'groupId': 'OG007', 'lowerLimit': '4771', 'upperLimit': '7426'}, {'value': '6774', 'groupId': 'OG008', 'lowerLimit': '5305', 'upperLimit': '8649'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 month after booster vaccination', 'description': 'Immunogenicity evaluation against vaccine antigen 287-953 one month after fourth booster dose to previously primed toddlers at 12, 18 or 24 months measured by ELISA.', 'unitOfMeasure': 'IU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the per-protocol population'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Concentrations Against Vaccine Antigen 287- 953 One Month After Booster Given After a Two-dose Catch-up Regimen in Toddlers Starting at 12, 18 or 24 Months of Age.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'B12 14', 'description': 'Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 and14 months of age.'}, {'id': 'OG001', 'title': 'B18 20', 'description': 'Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 and 20 months of age.'}, {'id': 'OG002', 'title': 'B24 26', 'description': 'Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 and 26 months of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '122', 'groupId': 'OG000', 'lowerLimit': '101', 'upperLimit': '147'}, {'value': '121', 'groupId': 'OG001', 'lowerLimit': '84', 'upperLimit': '176'}, {'value': '100', 'groupId': 'OG002', 'lowerLimit': '69', 'upperLimit': '144'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 month after booster vaccination', 'description': 'Immunogenicity evaluation against vaccine antigen 287-953 one month after booster given after a two-dose catch-up regimen in toddlers starting at 12, 18 or 24 months of age.one month after fourth booster dose to previously primed toddlers at 12, 18 or 24 months of age measured by ELISA', 'unitOfMeasure': 'IU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the per-protocol population'}, {'type': 'SECONDARY', 'title': 'Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving a Fourth Booster Dose of rMenB+OMV NZ Vaccine at 12, 18 or 24 Months of Age.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}, {'value': '126', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'B246_12', 'description': 'Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.'}, {'id': 'OG001', 'title': 'B246_18', 'description': 'Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age.'}, {'id': 'OG002', 'title': 'B246_24', 'description': 'Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age.'}], 'classes': [{'title': 'Any', 'categories': [{'measurements': [{'value': '156', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}, {'value': '116', 'groupId': 'OG002'}]}]}, {'title': 'Any Local', 'categories': [{'measurements': [{'value': '137', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '113', 'groupId': 'OG002'}]}]}, {'title': 'Injection site Tenderness', 'categories': [{'measurements': [{'value': '104', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}, {'value': '105', 'groupId': 'OG002'}]}]}, {'title': 'Injection site Erythema', 'categories': [{'measurements': [{'value': '117', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '94', 'groupId': 'OG002'}]}]}, {'title': 'Injection site Induration', 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}]}]}, {'title': 'Injection site Swelling', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}]}, {'title': 'Any Systemic', 'categories': [{'measurements': [{'value': '134', 'groupId': 'OG000'}, {'value': '118', 'groupId': 'OG001'}, {'value': '101', 'groupId': 'OG002'}]}]}, {'title': 'ChangeEat.Habits', 'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}]}]}, {'title': 'Sleepiness', 'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}]}]}, {'title': 'Vomiting', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': 'Diarrhea', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}]}, {'title': 'Irritbility', 'categories': [{'measurements': [{'value': '104', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}, {'value': '83', 'groupId': 'OG002'}]}]}, {'title': 'Unusual Crying', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}]}, {'title': 'Rash', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'Fever ( >= 38C )', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}]}, {'title': 'Any Ohter', 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}]}]}, {'title': 'Body Temp. <38 C', 'categories': [{'measurements': [{'value': '118', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}]}]}, {'title': 'Medical Attend. Fever', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Antipyretic prophylactic', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}]}, {'title': 'Antipyretic therapeutic', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From day 1 to day 7 after vaccination', 'description': 'The safety and tolerability of the 4th booster dose rMenB+OMV NZ vaccine in children (12, 18 or 24 months age) is reported as number of subjects with solicited local and systemic adverse events.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on the Safety Population.'}, {'type': 'SECONDARY', 'title': 'Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving a Two-dose Catch-up Regimen of rMenB+OMV NZ Vaccine at 12, 18 or 24 Months of Age.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '239', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'B12 14', 'description': 'Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 and14 months of age.'}, {'id': 'OG001', 'title': 'B18 20', 'description': 'Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 and 20 months of age.'}, {'id': 'OG002', 'title': 'B24 26', 'description': 'Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 and 26 months of age.'}], 'classes': [{'title': 'Injection site Tenderness (vaccination 1)', 'categories': [{'measurements': [{'value': '151', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}]}, {'title': 'Injection site Tenderness (vaccination 2)', 'categories': [{'measurements': [{'value': '143', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}]}, {'title': 'Injection site Erythema (vaccination 1)', 'categories': [{'measurements': [{'value': '151', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}]}, {'title': 'Injection site Erythema (vaccination 2)', 'categories': [{'measurements': [{'value': '148', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}]}, {'title': 'Injection site Induration (vaccination 1)', 'categories': [{'measurements': [{'value': '112', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}]}, {'title': 'Injection site Induration (vaccination 2)', 'categories': [{'measurements': [{'value': '101', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}]}, {'title': 'Injection site Swelling (vaccination 1)', 'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}]}, {'title': 'Injection site Swelling (vaccination 2)', 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}]}, {'title': 'Change in Eating habits (vaccination 1)', 'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}]}, {'title': 'Change in Eating habits (vaccination 2)', 'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}]}, {'title': 'Sleepiness (vaccination 1)', 'categories': [{'measurements': [{'value': '106', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}]}, {'title': 'Sleepiness (vaccination 2)', 'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}]}, {'title': 'Vomiting (vaccination 1)', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Vomiting (vaccination 2)', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Diarrhea (vaccination 1)', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}]}]}, {'title': 'Diarrhea (vaccination 2)', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'Irritability (vaccination 1)', 'categories': [{'measurements': [{'value': '156', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}]}, {'title': 'Irritability (vaccination 2)', 'categories': [{'measurements': [{'value': '126', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}]}, {'title': 'Unusual Crying (vaccination 1)', 'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}]}, {'title': 'Unusual Crying (vaccination 2)', 'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}]}, {'title': 'Rash (vaccination 1)', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Rash (vaccination 2)', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Fever ( >= 38C ) (vaccination 1)', 'categories': [{'measurements': [{'value': '83', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}]}, {'title': 'Fever ( >= 38C ) (vaccination 2)', 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}, {'title': 'Body Temp.<38 C (vaccination 1)', 'categories': [{'measurements': [{'value': '156', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}]}, {'title': 'Body Temp.<38 C (vaccination 2)', 'categories': [{'measurements': [{'value': '163', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}]}, {'title': 'Medical Attend. Fever (vaccination 1)', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Medical Attend. Fever (vaccination 2)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Antipyretic prophylactic (vaccination 1)', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}]}, {'title': 'Antipyretic prophylactic (vaccination 2)', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': 'Antipyretic therapeutic (vaccination 1)', 'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': 'Antipyretic therapeutic (vaccination 2)', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'day 1 to day 7 after vaccination', 'description': 'The safety and tolerability of the two-dose catch-up regimen of rMenB+OMV NZ vaccine in children (12, 18 or 24 months age) is reported as number of subjects with solicited local and systemic adverse events.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was done on safety population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'B+R246_12', 'description': 'Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.age'}, {'id': 'FG001', 'title': 'B+R246_18', 'description': 'Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.'}, {'id': 'FG002', 'title': 'B+R246_24', 'description': 'Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.'}, {'id': 'FG003', 'title': 'B246_12', 'description': 'Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.'}, {'id': 'FG004', 'title': 'B246_18', 'description': 'Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age.'}, {'id': 'FG005', 'title': 'B246_24', 'description': 'Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age.'}, {'id': 'FG006', 'title': 'B+R234_12', 'description': 'Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12 months of age.'}, {'id': 'FG007', 'title': 'B+R234_18', 'description': 'Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.'}, {'id': 'FG008', 'title': 'B+R234_24', 'description': 'Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.'}, {'id': 'FG009', 'title': 'B12 14', 'description': 'Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 and14 months of age.'}, {'id': 'FG010', 'title': 'B18 20', 'description': 'Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 and 20 months of age.'}, {'id': 'FG011', 'title': 'B24 26', 'description': 'Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 and 26 months of age.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '188'}, {'groupId': 'FG001', 'numSubjects': '157'}, {'groupId': 'FG002', 'numSubjects': '152'}, {'groupId': 'FG003', 'numSubjects': '174'}, {'groupId': 'FG004', 'numSubjects': '164'}, {'groupId': 'FG005', 'numSubjects': '143'}, {'groupId': 'FG006', 'numSubjects': '106'}, {'groupId': 'FG007', 'numSubjects': '78'}, {'groupId': 'FG008', 'numSubjects': '73'}, {'groupId': 'FG009', 'numSubjects': '246'}, {'groupId': 'FG010', 'numSubjects': '51'}, {'groupId': 'FG011', 'numSubjects': '56'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '183'}, {'groupId': 'FG001', 'numSubjects': '150'}, {'groupId': 'FG002', 'numSubjects': '143'}, {'groupId': 'FG003', 'numSubjects': '170'}, {'groupId': 'FG004', 'numSubjects': '150'}, {'groupId': 'FG005', 'numSubjects': '123'}, {'groupId': 'FG006', 'numSubjects': '102'}, {'groupId': 'FG007', 'numSubjects': '73'}, {'groupId': 'FG008', 'numSubjects': '63'}, {'groupId': 'FG009', 'numSubjects': '236'}, {'groupId': 'FG010', 'numSubjects': '50'}, {'groupId': 'FG011', 'numSubjects': '52'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '14'}, {'groupId': 'FG005', 'numSubjects': '20'}, {'groupId': 'FG006', 'numSubjects': '4'}, {'groupId': 'FG007', 'numSubjects': '5'}, {'groupId': 'FG008', 'numSubjects': '10'}, {'groupId': 'FG009', 'numSubjects': '10'}, {'groupId': 'FG010', 'numSubjects': '1'}, {'groupId': 'FG011', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Inappropriate enrollment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '1'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '8'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '2'}, {'groupId': 'FG008', 'numSubjects': '3'}, {'groupId': 'FG009', 'numSubjects': '4'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '7'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '5'}, {'groupId': 'FG009', 'numSubjects': '1'}, {'groupId': 'FG010', 'numSubjects': '1'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '4'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'type': 'Unable to classify', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'type': 'Administrative reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Subjects were enrolled from 6 centres in Belgium, 4 in Czech, 24 in Germany, 5 in Italy, 16 in Spain and 4 in UK who had previously participated in and completed the study V72P12.', 'preAssignmentDetails': 'All enrolled subjects were included in the trial.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '188', 'groupId': 'BG000'}, {'value': '157', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}, {'value': '174', 'groupId': 'BG003'}, {'value': '164', 'groupId': 'BG004'}, {'value': '143', 'groupId': 'BG005'}, {'value': '106', 'groupId': 'BG006'}, {'value': '78', 'groupId': 'BG007'}, {'value': '73', 'groupId': 'BG008'}, {'value': '246', 'groupId': 'BG009'}, {'value': '51', 'groupId': 'BG010'}, {'value': '56', 'groupId': 'BG011'}, {'value': '1588', 'groupId': 'BG012'}]}], 'groups': [{'id': 'BG000', 'title': 'B+R246_12', 'description': 'Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.'}, {'id': 'BG001', 'title': 'B+R246_18', 'description': 'Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.'}, {'id': 'BG002', 'title': 'B+R246_24', 'description': 'Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.'}, {'id': 'BG003', 'title': 'B246_12', 'description': 'Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.'}, {'id': 'BG004', 'title': 'B246_18', 'description': 'Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age.'}, {'id': 'BG005', 'title': 'B246_24', 'description': 'Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age.'}, {'id': 'BG006', 'title': 'B+R234_12', 'description': 'Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12 months of age.'}, {'id': 'BG007', 'title': 'B+R234_18', 'description': 'Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.'}, {'id': 'BG008', 'title': 'B+R234_24', 'description': 'Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.'}, {'id': 'BG009', 'title': 'B12 14', 'description': 'Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 and14 months of age.'}, {'id': 'BG010', 'title': 'B18 20', 'description': 'Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 and 20 months of age.'}, {'id': 'BG011', 'title': 'B24 26', 'description': 'Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 and 26 months of age.'}, {'id': 'BG012', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '188', 'groupId': 'BG000'}, {'value': '157', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}, {'value': '174', 'groupId': 'BG003'}, {'value': '164', 'groupId': 'BG004'}, {'value': '143', 'groupId': 'BG005'}, {'value': '106', 'groupId': 'BG006'}, {'value': '78', 'groupId': 'BG007'}, {'value': '73', 'groupId': 'BG008'}, {'value': '246', 'groupId': 'BG009'}, {'value': '51', 'groupId': 'BG010'}, {'value': '56', 'groupId': 'BG011'}, {'value': '1588', 'groupId': 'BG012'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '12.6', 'spread': '1.2', 'groupId': 'BG000'}, {'value': '18.1', 'spread': '0.6', 'groupId': 'BG001'}, {'value': '24', 'spread': '0.4', 'groupId': 'BG002'}, {'value': '12.7', 'spread': '0.9', 'groupId': 'BG003'}, {'value': '18.1', 'spread': '0.5', 'groupId': 'BG004'}, {'value': '24', 'spread': '0.3', 'groupId': 'BG005'}, {'value': '12.8', 'spread': '1.4', 'groupId': 'BG006'}, {'value': '18', 'spread': '0.4', 'groupId': 'BG007'}, {'value': '24', 'spread': '0.5', 'groupId': 'BG008'}, {'value': '12.6', 'spread': '1.3', 'groupId': 'BG009'}, {'value': '18', 'spread': '0.2', 'groupId': 'BG010'}, {'value': '24', 'spread': '0.2', 'groupId': 'BG011'}, {'value': '17.1', 'spread': '4.7', 'groupId': 'BG012'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '78', 'groupId': 'BG000'}, {'value': '73', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}, {'value': '81', 'groupId': 'BG003'}, {'value': '80', 'groupId': 'BG004'}, {'value': '75', 'groupId': 'BG005'}, {'value': '62', 'groupId': 'BG006'}, {'value': '41', 'groupId': 'BG007'}, {'value': '34', 'groupId': 'BG008'}, {'value': '115', 'groupId': 'BG009'}, {'value': '23', 'groupId': 'BG010'}, {'value': '23', 'groupId': 'BG011'}, {'value': '762', 'groupId': 'BG012'}]}, {'title': 'Male', 'measurements': [{'value': '110', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}, {'value': '93', 'groupId': 'BG003'}, {'value': '84', 'groupId': 'BG004'}, {'value': '68', 'groupId': 'BG005'}, {'value': '44', 'groupId': 'BG006'}, {'value': '37', 'groupId': 'BG007'}, {'value': '39', 'groupId': 'BG008'}, {'value': '131', 'groupId': 'BG009'}, {'value': '28', 'groupId': 'BG010'}, {'value': '33', 'groupId': 'BG011'}, {'value': '826', 'groupId': 'BG012'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1588}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-12', 'studyFirstSubmitDate': '2009-07-21', 'resultsFirstSubmitDate': '2015-02-16', 'studyFirstSubmitQcDate': '2009-07-21', 'lastUpdatePostDateStruct': {'date': '2017-08-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-10-07', 'studyFirstPostDateStruct': {'date': '2009-07-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-11-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Receiving a Fourth (Booster) Dose of rMenB+OMV NZ Vaccination in Subjects Who Previously Received 3 Doses of rMenB+OMV NZ and Routine Vaccines at 2, 4 and 6 Months of Age.', 'timeFrame': '1 month after booster', 'description': 'Immunogenicity was assessed in terms of percentage of subjects with serum bactericidal antibody (SBA) titers ≥1:5 (98.3% CI) against N.meningitidis serogroup reference strains H44/76, NZ98/254 and 5/99, one month after the fourth (booster) dose of meningococcal B vaccine at 12 or 18 or24 months of age who were previously vaccinated with 3 doses of rMenB+OMV NZ and routine vaccines at 2, 4 and 6 months of age.'}], 'secondaryOutcomes': [{'measure': 'Percentages of Subjects With SBA Titers ≥1:5 After Receiving a Fourth (Booster) Dose of rMenB+OMV NZ Vaccination in Subjects Who Previously Received 3 Doses of rMenB+OMV NZ at 2, 4 and 6 Months of Age and Routine Vaccines at 3, 5 and 7 Months of Age.', 'timeFrame': '1 month after booster', 'description': 'Immunogenicity was assessed in terms of Percentages of Subjects With SBA Titers ≥1:5 (98.3% CI), After Receiving a Fourth (Booster) Dose of rMenB+OMV NZ Vaccination in subjects who previously received 3 doses of rMenB+OMV NZ at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age.'}, {'measure': 'Percentages of Subjects With Serum Bactericidal Antibody Titers ≥1:5 After Receiving a Fourth (Booster) Dose of rMenB+OMV NZ Vaccination in Subjects Who Previously Received 3 Doses of rMenB+OMV NZ and Routine Vaccines at 2, 3 and 4 Months of Age.', 'timeFrame': '1 month after booster', 'description': 'Immunogenicity was assessed in terms of percentage of subjects with serum bactericidal antibody (SBA) titers ≥1:5 (98.3% CI) against N.meningitidis serogroup reference strains H44/76, NZ98/254 and 5/99, one month after the fourth (booster) dose of meningococcal B vaccine at 12 or 18 or24 months of age who were previously vaccinated with 3 doses of rMenB+OMV NZ and routine vaccines at 2, 3 and 4 months of age.'}, {'measure': 'Geometric Mean Titers (GMTs) in Subjects One Month After Receiving a Fourth (Booster) Dose of rMenB+OMV NZ Vaccination in Subjects at 12 18 or 24 Months of Age Who Previously Received 3 Doses of rMenB+OMV NZ at 2, 3 and 4 or 2, 4 and 6 Months of Age.', 'timeFrame': '1 month after booster', 'description': 'The serum antibody titers one month after the fourth (booster) dose of meningococcal B vaccine at 12 or 18 or24 months of age who were previously vaccinated with 3 doses of rMenB+OMV NZ at 2, 3 and 4 or 2, 4 and 6 months of age, are reported as geometric mean titers (GMTs) against N.meningitidis serogroup reference strains H44/76, NZ98/254 and 5/99.'}, {'measure': 'GMTs in Subjects One Month After the Fourth (Booster) Dose of Meningococcal B Vaccine at 12 Months of Age Previously Vaccinated With 3 Doses of rMenB+OMV NZ at 2, 3 and 4 or 2, 4 and 6 Months of Age and Single Dose of rMenB+OMV NZ Given at Same Age', 'timeFrame': '1 month after booster', 'description': 'Characterization of immunological memory by serum antibody titers (98.3% CI) one month after the fourth (booster) dose of meningococcal B vaccine at 12 months of age who were previously vaccinated with 3 doses of rMenB+OMV NZ at 2, 3 and 4 or 2, 4 and 6 months of age and single dose of rMenB+OMV NZ given at same ages, are reported as geometric mean titers (GMTs) against N.meningitidis serogroup reference strains H44/76, NZ98/254 and 5/99.'}, {'measure': 'GMTs in Subjects One Month After the Fourth (Booster) Dose of Meningococcal B Vaccine at 18 and 24months of Age, Previously Vaccinated With 3 Doses of rMenB+OMV NZ at 2, 3 and 4 or 2, 4 and 6 Months of Age and Single Dose of rMenB+OMV NZ Given at Same Age', 'timeFrame': '1 month after booster', 'description': 'Characterization of immunological memory by serum antibody titers one month after the fourth (booster) dose of meningococcal B vaccine at 18 and 24months of age who were previously vaccinated with 3 doses of rMenB+OMV NZ at 2, 3 and 4 or 2, 4 and 6 months of age and single dose of rMenB+OMV NZ given at same ages, are reported as geometric mean titers (GMTs) against N.meningitidis serogroup reference strains H44/76, NZ98/254 and 5/99.'}, {'measure': 'Two-dose Catch-up Regimen of rMenB+OMV NZ in Unprimed Toddlers Aged 12, 18 or 24 Months', 'timeFrame': '1 month after second vaccination', 'description': 'Immunogenicity evaluation of a two-dose catch-up regimen of rMenB+OMV NZ in unprimed toddlers aged 12, 18 or 24 months as measured by serum antibody titers one month after the second vaccination f meningococcal B vaccine at 18 and 24months of age who were previously vaccinated with 3 doses of rMenB+OMV NZ reported as geometric mean titers (GMTs) against N.meningitidis serogroup reference strains H44/76, NZ98/254 and 5/99.'}, {'measure': 'Geometric Mean Concentrations Against Vaccine Antigen 287- 953 One Month After Fourth Booster Dose to Previously Primed Toddlers at 12, 18 or 24 Months of Age.', 'timeFrame': '1 month after booster vaccination', 'description': 'Immunogenicity evaluation against vaccine antigen 287-953 one month after fourth booster dose to previously primed toddlers at 12, 18 or 24 months measured by ELISA.'}, {'measure': 'Geometric Mean Concentrations Against Vaccine Antigen 287- 953 One Month After Booster Given After a Two-dose Catch-up Regimen in Toddlers Starting at 12, 18 or 24 Months of Age.', 'timeFrame': '1 month after booster vaccination', 'description': 'Immunogenicity evaluation against vaccine antigen 287-953 one month after booster given after a two-dose catch-up regimen in toddlers starting at 12, 18 or 24 months of age.one month after fourth booster dose to previously primed toddlers at 12, 18 or 24 months of age measured by ELISA'}, {'measure': 'Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving a Fourth Booster Dose of rMenB+OMV NZ Vaccine at 12, 18 or 24 Months of Age.', 'timeFrame': 'From day 1 to day 7 after vaccination', 'description': 'The safety and tolerability of the 4th booster dose rMenB+OMV NZ vaccine in children (12, 18 or 24 months age) is reported as number of subjects with solicited local and systemic adverse events.'}, {'measure': 'Number of Children Reporting Solicited Local and Systemic Adverse Events After Receiving a Two-dose Catch-up Regimen of rMenB+OMV NZ Vaccine at 12, 18 or 24 Months of Age.', 'timeFrame': 'day 1 to day 7 after vaccination', 'description': 'The safety and tolerability of the two-dose catch-up regimen of rMenB+OMV NZ vaccine in children (12, 18 or 24 months age) is reported as number of subjects with solicited local and systemic adverse events.'}]}, 'conditionsModule': {'keywords': ['Meningococcal meningitis', 'prevention', 'vaccination', 'toddler'], 'conditions': ['Meningococcal Disease', 'Meningococcal Meningitis']}, 'referencesModule': {'references': [{'pmid': '33020485', 'type': 'DERIVED', 'citation': 'Bartolini E, Borgogni E, Bruttini M, Muzzi A, Giuliani M, Iozzi S, Petracca R, Martinelli M, Bonacci S, Marchi S, Brettoni C, Donati C, Torricelli G, Guidotti S, Domina M, Beninati C, Teti G, Felici F, Rappuoli R, Castellino F, Del Giudice G, Masignani V, Pizza M, Maione D. Immunological fingerprint of 4CMenB recombinant antigens via protein microarray reveals key immunosignatures correlating with bactericidal activity. Nat Commun. 2020 Oct 5;11(1):4994. doi: 10.1038/s41467-020-18791-0.'}, {'pmid': '26756390', 'type': 'DERIVED', 'citation': 'Snape MD, Voysey M, Finn A, Bona G, Esposito S, Principi N, Diez-Domingo J, Sokal E, Kieninger D, Prymula R, Dull PM, Kohl I, Barone M, Wang H, Toneatto D, Pollard AJ; European MenB Vaccine Study Group. Persistence of Bactericidal Antibodies After Infant Serogroup B Meningococcal Immunization and Booster Dose Response at 12, 18 or 24 Months of Age. Pediatr Infect Dis J. 2016 Apr;35(4):e113-23. doi: 10.1097/INF.0000000000001056.'}]}, 'descriptionModule': {'briefSummary': 'This extension study V72P12E1 will investigate the safety, tolerability and immunogenicity of a fourth (booster) dose of rMenB+OMV NZ at 12, 18 and 24 months of age in subjects previously primed with rMenB+OMV NZ according to two different three-dose immunization schedules in infancy (2, 4 and 6 or 2, 3 and 4 months of age in the parent study V72P12). The study will also explore the bactericidal antibody persistence at 12, 18 and 24 months of age, following the two different immunization schedules, in order to identify the optimal timing for boosting. Two catch-up rMenB+OMV NZ doses will be given to unprimed, naïve toddlers at 12 (subjects enrolled in the control group of V72P12), 18 and 24 months of age (two new cohort of subjects enrolled). These subjects will generate data for assessing the safety and immunogenicity of a two-dose catch-up regimen at these ages, but will also serve as controls for a descriptive comparison of antibody persistence and booster responses for the other groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '24 Months', 'minimumAge': '12 Months', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nFollow-on participants of V72P12:\n\nHealthy toddlers who completed Study V72P12, aged:\n\n* 12 months or older - Groups 1a, 2a, 3a, 4\n* 18 months (0/ +29 days window) - Groups 1b, 2b, 3b\n* 24 months (0/ +29 days window) - Groups 1c, 2c, 3c\n\nNaive subjects newly enrolled:\n\n* Group 5: healthy 18-month-old toddlers (0/ +29 days window)\n* Group 6: healthy 24-month-old toddlers (0/ +29 days window)\n\nExclusion Criteria:\n\n* History of any meningococcal B vaccine administration (only for groups 5 and 6);\n* Previous ascertained or suspected disease caused by N. meningitidis;\n* History of severe allergic reaction after previous vaccinations or hypersensitivity to any vaccine component;\n* Significant acute or chronic infection within the previous 7 days or axillary temperature major or equal to 38 degrees within the previous day\n* Antibiotics within 6 days prior to enrollment;\n* Any serious chronic or progressive disease;\n* Known or suspected impairment or alteration of the immune system;\n* Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation.'}, 'identificationModule': {'nctId': 'NCT00944034', 'briefTitle': 'Safety, Tolerability and Immunogenicity of Meningococcal B Recombinant Vaccine Administered as Booster Dose at 12, 18 or 24 Months of Age in Toddlers (12-24 Months) Primed With a Three-Dose Immunization Series as Infants in Study V72P12', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Phase 2b, Open Label, Multi-Center, Extension Study to Evaluate the Safety, Tolerability and Immunogenicity of a Booster Dose of Novartis Meningococcal B Recombinant Vaccine Administered at 12, 18 or 24 Months of Age in Subjects Who Previously Received a Three-Dose Primary Series of the Novartis Meningococcal B Recombinant Vaccine as Infants in Study V72P12', 'orgStudyIdInfo': {'id': 'V72P12E1'}, 'secondaryIdInfos': [{'id': '2009-011676-30'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'B+R246_12', 'description': 'Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.', 'interventionNames': ['Biological: rMenB+OMV NZ with routine vaccinations']}, {'type': 'EXPERIMENTAL', 'label': 'B+R246_18', 'description': 'Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.', 'interventionNames': ['Biological: rMenB+OMV NZ with routine vaccinations']}, {'type': 'EXPERIMENTAL', 'label': 'B+R246_24', 'description': 'Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.', 'interventionNames': ['Biological: rMenB+OMV NZ with routine vaccinations']}, {'type': 'EXPERIMENTAL', 'label': 'B246_12', 'description': 'Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.', 'interventionNames': ['Biological: rMenB+OMV NZ']}, {'type': 'EXPERIMENTAL', 'label': 'B246_18', 'description': 'Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age.', 'interventionNames': ['Biological: rMenB+OMV NZ']}, {'type': 'EXPERIMENTAL', 'label': 'B246_24', 'description': 'Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age.', 'interventionNames': ['Biological: rMenB+OMV NZ']}, {'type': 'EXPERIMENTAL', 'label': 'B+R234_12', 'description': 'Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12 months of age.', 'interventionNames': ['Biological: rMenB+OMV NZ with routine vaccinations']}, {'type': 'EXPERIMENTAL', 'label': 'B+R234_18', 'description': 'Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.', 'interventionNames': ['Biological: rMenB+OMV NZ with routine vaccinations']}, {'type': 'EXPERIMENTAL', 'label': 'B+R234_24', 'description': 'Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.', 'interventionNames': ['Biological: rMenB+OMV NZ with routine vaccinations']}, {'type': 'EXPERIMENTAL', 'label': 'B12 14', 'description': 'Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 and14 months of age.', 'interventionNames': ['Biological: two doses of rMenB+OMV NZ']}, {'type': 'EXPERIMENTAL', 'label': 'B18 20', 'description': 'Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 and 20 months of age.', 'interventionNames': ['Biological: two doses of rMenB+OMV NZ']}, {'type': 'EXPERIMENTAL', 'label': 'B24 26', 'description': 'Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 and 26 months of age.', 'interventionNames': ['Biological: two doses of rMenB+OMV NZ']}], 'interventions': [{'name': 'rMenB+OMV NZ with routine vaccinations', 'type': 'BIOLOGICAL', 'description': 'rMenB+OMV NZ with routine 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