Ignite Creation Date:
2025-12-26 @ 11:13 AM
Ignite Modification Date:
2025-12-31 @ 6:39 PM
Study NCT ID:
NCT00262028
Status:
COMPLETED
Last Update Posted:
2016-02-11
First Post:
2005-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of the Safety and Immune Response of a Meningococcal Vaccine Administered to Healthy Children
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C556088', 'term': 'MenACWY-CRM vaccine'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'RegistryContactVaccinesUS@novartis.com', 'title': 'Posting Director', 'organization': 'Novartis Vaccines and Diagnostics'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Serious Adverse Events (SAEs), AEs leading to premature withdrawal and any medically significant AEs were collected from Day 1 to 360', 'eventGroups': [{'id': 'EG000', 'title': 'MenACWY (2-5 Years Old)', 'description': 'Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine.', 'otherNumAtRisk': 151, 'otherNumAffected': 82, 'seriousNumAtRisk': 151, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'MenACWY-PS (2-5 Years Old)', 'description': 'Subjects received one dose of the licensed MenACWY-polysaccharide vaccine.', 'otherNumAtRisk': 153, 'otherNumAffected': 69, 'seriousNumAtRisk': 153, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'MenACWY (6-10 Years Old)', 'description': 'Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine.', 'otherNumAtRisk': 157, 'otherNumAffected': 81, 'seriousNumAtRisk': 157, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'MenACWY-PS (6-10 Years Old)', 'description': 'Subjects received one dose of the licensed MenACWY-CRM polysaccharide vaccine.', 'otherNumAtRisk': 157, 'otherNumAffected': 64, 'seriousNumAtRisk': 157, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'MenACWY (12-15 Months Old)', 'description': 'Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine.', 'otherNumAtRisk': 74, 'otherNumAffected': 64, 'seriousNumAtRisk': 74, 'seriousNumAffected': 2}, {'id': 'EG005', 'title': 'MenACWY-PnC (12-15 Months Old)', 'description': 'Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine administered concomitantly with pneumococcal conjugate vaccine.', 'otherNumAtRisk': 71, 'otherNumAffected': 61, 'seriousNumAtRisk': 71, 'seriousNumAffected': 3}, {'id': 'EG006', 'title': 'MenACWY (16-23 Months Old)', 'description': 'Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine.', 'otherNumAtRisk': 71, 'otherNumAffected': 62, 'seriousNumAtRisk': 71, 'seriousNumAffected': 3}, {'id': 'EG007', 'title': 'MenACWY+DTaP (16-23 Months Old)', 'description': 'Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine administered concomitantly with DTaP vaccine.', 'otherNumAtRisk': 73, 'otherNumAffected': 59, 'seriousNumAtRisk': 73, 'seriousNumAffected': 2}, {'id': 'EG008', 'title': 'MenACWY-PS (3-5 Years Old)', 'description': 'Children aged 3 to 5 years receiving MenACWY-PS from the first part of the study (Menomune not licensed in US in children under 2 years of ages) served as controls for the 12-23-months-old part two toddlers.', 'otherNumAtRisk': 100, 'otherNumAffected': 40, 'seriousNumAtRisk': 100, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 74, 'numAffected': 10}, {'groupId': 'EG005', 'numAtRisk': 71, 'numAffected': 12}, {'groupId': 'EG006', 'numAtRisk': 71, 'numAffected': 20}, {'groupId': 'EG007', 'numAtRisk': 73, 'numAffected': 17}, {'groupId': 'EG008', 'numAtRisk': 100, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'TEETHING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 74, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 71, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 73, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 100, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'VOMITING', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 157, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 71, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 71, 'numAffected': 5}, 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{'term': 'INJECTION SITE PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 157, 'numAffected': 57}, {'groupId': 'EG003', 'numAtRisk': 157, 'numAffected': 43}, {'groupId': 'EG004', 'numAtRisk': 74, 'numAffected': 15}, {'groupId': 'EG005', 'numAtRisk': 71, 'numAffected': 18}, {'groupId': 'EG006', 'numAtRisk': 71, 'numAffected': 19}, {'groupId': 'EG007', 'numAtRisk': 73, 'numAffected': 18}, {'groupId': 'EG008', 'numAtRisk': 100, 'numAffected': 22}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'MALAISE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 157, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 157, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 74, 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73, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 100, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'LOBAR PNEUMONIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 100, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'ORAL HERPES', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 100, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'PERITONITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 100, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'PNEUMONIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 100, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'DEHYDRATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 100, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'FEBRILE CONVULSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 100, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'ASTHMA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 74, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 100, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'BRONCHIAL HYPERREACTIVITY', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 100, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'HYPOXIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 100, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'PLEURAL EFFUSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 100, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'PNEUMOTHORAX', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 100, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}, {'term': 'SLEEP APNOEA SYNDROME', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 153, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 157, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 74, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 71, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 71, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 100, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (Unspecified)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Subjects (2-10 Years of Age) With Human Serum Bactericidal Activity (hSBA) Titers ≥1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '284', 'groupId': 'OG000'}, {'value': '285', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MenACWY-CRM (2-10 Years Old)', 'description': 'Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine'}, {'id': 'OG001', 'title': 'MenACWY-PS (2-10 Years)', 'description': 'Subjects received one dose of the licensed MenACWY-PS vaccine'}], 'classes': [{'title': 'Serogroup A (Day 1), N=280, 281', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Serogroup A (Day 29), N=280, 281', 'categories': [{'measurements': [{'value': '228', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}]}, {'title': 'Serogroup C (Day 1)', 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}, {'value': '81', 'groupId': 'OG001'}]}]}, {'title': 'Serogroup C (Day 29)', 'categories': [{'measurements': [{'value': '232', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}]}]}, {'title': 'Serogroup W (Day 1), N=279, 282', 'categories': [{'measurements': [{'value': '111', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}]}, {'title': 'Serogroup W (Day 29), N=279, 282', 'categories': [{'measurements': [{'value': '263', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}]}]}, {'title': 'Serogroup Y (Day 1), N=280, 282', 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}]}, {'title': 'Serogroup Y (Day 29), N=280, 282', 'categories': [{'measurements': [{'value': '254', 'groupId': 'OG000'}, {'value': '167', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Vaccine group difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '37', 'ciLowerLimit': '29', 'ciUpperLimit': '44', 'groupDescription': 'Noninferiority of immune responses of MenACWY-CRM to licensed comparator against serogroup A', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'MenACWY-CRM was considered to be noninferior to the licensed comparator if the lower limit (LL) of the 95% confidence intervals (CI) of the difference (MenACWY minus licensed comparator)in the percentage of the subjects with hSBA titer ≥ 1:4 at one month post vaccination was \\> -10% against each serogroup'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Vaccine group difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '19', 'ciLowerLimit': '12', 'ciUpperLimit': '26', 'groupDescription': 'Noninferiority of immune responses of MenACWY-CRM to licensed comparator against serogroup C', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'MenACWY-CRM was considered to be noninferior to the licensed comparator if the lower LL of the 95% CI of the difference (MenACWY minus licensed comparator)in the percentage of the subjects with hSBA titer ≥ 1:4 at one month post vaccination was \\> -10% against each serogroup'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Vaccine group difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '23', 'ciLowerLimit': '17', 'ciUpperLimit': '29', 'groupDescription': 'Noninferiority of immune responses of MenACWY-CRM to licensed comparator against serogroup W', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'MenACWY-CRM was considered to be noninferior to the licensed comparator if the LL of the 95% CI of the difference (MenACWY minus licensed comparator)in the percentage of the subjects with hSBA titer ≥ 1:4 at one month post vaccination was \\> -10% against each serogroup'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Vaccine group difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '31', 'ciLowerLimit': '25', 'ciUpperLimit': '38', 'groupDescription': 'No inferiority of immune responses of MenACWY-CRM to licensed comparator against serogroup Y', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'MenACWY-CRM was considered to be noninferior to the licensed comparator if the LL of the 95% CI of the difference (MenACWY minus licensed comparator)in the percentage of the subjects with hSBA titer ≥ 1:4 at one month post vaccination was \\> -10% against each serogroup'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Vaccine group difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '37', 'ciLowerLimit': '29', 'ciUpperLimit': '44', 'groupDescription': 'Superiority of immune responses of MenACWY-CRM to licensed comparator against serogroup A\n\nMenACWY-CRM was considered to be superior to the licensed comparator if the LL of the 95% CI of the difference (MenACWY minus licensed comparator) in the percentage of the subjects with hSBA titer ≥ 1:4 at one month post vaccination was \\> 0% against each serogroup', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Vaccine group difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '19', 'ciLowerLimit': '12', 'ciUpperLimit': '26', 'groupDescription': 'Superiority of immune responses of MenACWY-CRM to licensed comparator against serogroup C\n\nMenACWY-CRM was considered to be superior to the licensed comparator if the LL of the 95% CI of the difference (MenACWY minus licensed comparator) in the percentage of the subjects with hSBA titer ≥ 1:4 at one month post vaccination was \\> 0% against each serogroup', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Vaccine group difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '23', 'ciLowerLimit': '17', 'ciUpperLimit': '29', 'groupDescription': 'Superiority of immune responses of MenACWY-CRM to licensed comparator against serogroup W\n\nMenACWY-CRM was considered to be superior to the licensed comparator if the LL of the 95% CI of the difference (MenACWY minus licensed comparator) in the percentage of the subjects with hSBA titer ≥ 1:4 at one month post vaccination was \\> 0% against each serogroup', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Vaccine group difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '31', 'ciLowerLimit': '25', 'ciUpperLimit': '38', 'groupDescription': 'Superiority of immune responses of MenACWY-CRM to licensed comparator against serogroup Y\n\nMenACWY-CRM was considered to be superior to the licensed comparator if the LL of the 95% CI of the difference (MenACWY minus licensed comparator) in the percentage of the subjects with hSBA titer ≥ 1:4 at one month post vaccination was \\> 0% against each serogroup', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '1 month post vaccination (Day 29)', 'description': 'Number of subjects (2-10 years of age) achieving with hSBA titers ≥1:4 against Neisseria meningitidis serogroups A,C,W and Y, one month after receiving one dose of either MenACWY-CRM vaccine or MenACWY-PS vaccine.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on per protocol population i.e. all subjects who received one dose of vaccine and provided serum samples at the relevant time points (day 1, day 29 and day 360) and had no major protocol deviation.'}, {'type': 'SECONDARY', 'title': 'Percentages of Subjects (2-5 Years of Age and 6-10 Years of Age) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}, {'value': '147', 'groupId': 'OG002'}, {'value': '145', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MenACWY-CRM (2-5 Years Old)', 'description': 'Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine'}, {'id': 'OG001', 'title': 'MenACWY-PS (2-5 Years Old)', 'description': 'Subjects received one dose of the licensed MenACWY-PS vaccine'}, {'id': 'OG002', 'title': 'MenACWY-CRM (6-10 Years Old)', 'description': 'Subjects received one dose of investigational MenACWY-CRM vaccine'}, {'id': 'OG003', 'title': 'MenACWY-PS (6-10 Years Old)', 'description': 'Subjects received one dose of licensed MenACWY-PS vaccine'}], 'classes': [{'title': 'Serogroup A (Day 1), N=133,138,147,143', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '5'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '3'}, {'value': '3', 'groupId': 'OG002', 'lowerLimit': '1', 'upperLimit': '7'}, {'value': '1', 'groupId': 'OG003', 'lowerLimit': '0.018', 'upperLimit': '4'}]}]}, {'title': 'Serogroup A (Day 29), N=133,138,147,143', 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000', 'lowerLimit': '72', 'upperLimit': '86'}, {'value': '43', 'groupId': 'OG001', 'lowerLimit': '34', 'upperLimit': '51'}, {'value': '83', 'groupId': 'OG002', 'lowerLimit': '76', 'upperLimit': '89'}, {'value': '46', 'groupId': 'OG003', 'lowerLimit': '38', 'upperLimit': '55'}]}]}, {'title': 'Serogroup C (Day 1), N=135,138,146,145', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000', 'lowerLimit': '16', 'upperLimit': '31'}, {'value': '11', 'groupId': 'OG001', 'lowerLimit': '6', 'upperLimit': '17'}, {'value': '34', 'groupId': 'OG002', 'lowerLimit': '26', 'upperLimit': '42'}, {'value': '46', 'groupId': 'OG003', 'lowerLimit': '37', 'upperLimit': '54'}]}]}, {'title': 'Serogroup C (Day 29), N=135,138,146,145', 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000', 'lowerLimit': '68', 'upperLimit': '83'}, {'value': '45', 'groupId': 'OG001', 'lowerLimit': '36', 'upperLimit': '54'}, {'value': '88', 'groupId': 'OG002', 'lowerLimit': '82', 'upperLimit': '93'}, {'value': '82', 'groupId': 'OG003', 'lowerLimit': '75', 'upperLimit': '88'}]}]}, {'title': 'Serogroup W (Day 1), N=135,138,144,144', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000', 'lowerLimit': '24', 'upperLimit': '40'}, {'value': '22', 'groupId': 'OG001', 'lowerLimit': '16', 'upperLimit': '30'}, {'value': '47', 'groupId': 'OG002', 'lowerLimit': '39', 'upperLimit': '56'}, {'value': '53', 'groupId': 'OG003', 'lowerLimit': '45', 'upperLimit': '62'}]}]}, {'title': 'Serogroup W (Day 29), N=135,138,144,144', 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000', 'lowerLimit': '84', 'upperLimit': '95'}, {'value': '55', 'groupId': 'OG001', 'lowerLimit': '46', 'upperLimit': '64'}, {'value': '98', 'groupId': 'OG002', 'lowerLimit': '94', 'upperLimit': '100'}, {'value': '88', 'groupId': 'OG003', 'lowerLimit': '81', 'upperLimit': '92'}]}]}, {'title': 'Serogroup Y (Day 1), N=134,138,146,144', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '12', 'upperLimit': '25'}, {'value': '13', 'groupId': 'OG001', 'lowerLimit': '8', 'upperLimit': '20'}, {'value': '25', 'groupId': 'OG002', 'lowerLimit': '19', 'upperLimit': '33'}, {'value': '35', 'groupId': 'OG003', 'lowerLimit': '27', 'upperLimit': '43'}]}]}, {'title': 'Serogroup Y (Day 29), N=134,138,146,144', 'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000', 'lowerLimit': '80', 'upperLimit': '92'}, {'value': '49', 'groupId': 'OG001', 'lowerLimit': '40', 'upperLimit': '57'}, {'value': '95', 'groupId': 'OG002', 'lowerLimit': '89', 'upperLimit': '98'}, {'value': '69', 'groupId': 'OG003', 'lowerLimit': '61', 'upperLimit': '77'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month post vaccination (Day 29)', 'description': 'Percentages of subjects (2-5 years of age and 6-10 years of age) with hSBA ≥ 1:4 directed against N. meningitidis serogroups A, C, W and Y, one month after receiving one dose of either MenACWY-CRM vaccine or MenACWY-PS vaccine.', 'unitOfMeasure': 'Percentages of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on per protocol population. The total number of participants analyzed in the MenACWY-CRM (2-10 Years Old) group (282), is different respect with that reported in the Outcome Measure 1 (281). There, the largest number for each group across the 4 strains was reported (not all strains had a result from the lab-i.e. C strain).'}, {'type': 'SECONDARY', 'title': 'Percentages of Subjects (12-23 Months Old) With hSBA Titer ≥ 1:4 After Receiving MenACWY-CRM Vaccine Compared With Percentage of Subjects (3-5 Years Old) With hSBA Titer ≥ 1:4 After Receiving MenACWY-PS Vaccine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '241', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MenACWY-CRM (12-23 Months Old)', 'description': 'Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine'}, {'id': 'OG001', 'title': 'MenACWY-PS (3-5 Years Old)', 'description': 'Subjects received one dose of the licensed MenACWY-PS vaccine. This group was a subset of the licensed comparator (2-5 years old) cohort that received one dose of licensed MenACWY-PS vaccine'}], 'classes': [{'title': 'Serogroup A (Day 1), N=240,91', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '4'}]}]}, {'title': 'Serogroup A (Day 29), N=240,91', 'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000', 'lowerLimit': '76', 'upperLimit': '86'}, {'value': '51', 'groupId': 'OG001', 'lowerLimit': '40', 'upperLimit': '61'}]}]}, {'title': 'Serogroup C (Day 1), N=241,91', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '6'}, {'value': '12', 'groupId': 'OG001', 'lowerLimit': '6', 'upperLimit': '21'}]}]}, {'title': 'Serogroup C (Day 29), N=241,91', 'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000', 'lowerLimit': '86', 'upperLimit': '94'}, {'value': '42', 'groupId': 'OG001', 'lowerLimit': '32', 'upperLimit': '53'}]}]}, {'title': 'Serogroup W (Day 1), N=240,91', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '6'}, {'value': '24', 'groupId': 'OG001', 'lowerLimit': '16', 'upperLimit': '34'}]}]}, {'title': 'Serogroup W (Day 29), N=240,91', 'categories': [{'measurements': [{'value': '86', 'groupId': 'OG000', 'lowerLimit': '81', 'upperLimit': '90'}, {'value': '63', 'groupId': 'OG001', 'lowerLimit': '52', 'upperLimit': '73'}]}]}, {'title': 'Serogroup Y (Day 1), N=238,91', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '5'}, {'value': '15', 'groupId': 'OG001', 'lowerLimit': '9', 'upperLimit': '24'}]}]}, {'title': 'Serogroup Y (Day 29), N=238,91', 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000', 'lowerLimit': '58', 'upperLimit': '70'}, {'value': '51', 'groupId': 'OG001', 'lowerLimit': '40', 'upperLimit': '61'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 month post vaccination (Day 29)', 'description': 'Percentage of subjects (12-23 months old) with hSBA ≥ 1:4 directed against N. meningitidis serogroups A, C, W and Y after receiving one dose of MenACWY-CRM vaccine compared with percentage of subjects (3-5 years old) with hSBA ≥ 1:4 after one dose of licensed MenACWY-PS vaccine.', 'unitOfMeasure': 'Percentages of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on per protocol population.'}, {'type': 'SECONDARY', 'title': 'hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years of Age) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '281', 'groupId': 'OG000'}, {'value': '283', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MenACWY-CRM (2-10 Years Old)', 'description': 'Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine'}, {'id': 'OG001', 'title': 'MenACWY-PS (2-10 Years)', 'description': 'Subjects received one dose of the licensed MenACWY-PS vaccine'}], 'classes': [{'title': 'Serogroup A (Day 1), N=280, 281', 'categories': [{'measurements': [{'value': '2.06', 'groupId': 'OG000', 'lowerLimit': '2.02', 'upperLimit': '2.1'}, {'value': '2.02', 'groupId': 'OG001', 'lowerLimit': '1.98', 'upperLimit': '2.06'}]}]}, {'title': 'Serogroup A (Day 29), N=280, 281', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000', 'lowerLimit': '30', 'upperLimit': '44'}, {'value': '6.31', 'groupId': 'OG001', 'lowerLimit': '5.21', 'upperLimit': '7.64'}]}]}, {'title': 'Serogroup C (Day 1)', 'categories': [{'measurements': [{'value': '3.07', 'groupId': 'OG000', 'lowerLimit': '2.77', 'upperLimit': '3.4'}, {'value': '3.33', 'groupId': 'OG001', 'lowerLimit': '3.01', 'upperLimit': '3.68'}]}]}, {'title': 'Serogroup C (Day 29)', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000', 'lowerLimit': '21', 'upperLimit': '34'}, {'value': '15', 'groupId': 'OG001', 'lowerLimit': '12', 'upperLimit': '20'}]}]}, {'title': 'Serogroup W (Day 1), N=279, 282', 'categories': [{'measurements': [{'value': '5.74', 'groupId': 'OG000', 'lowerLimit': '4.86', 'upperLimit': '6.78'}, {'value': '5.63', 'groupId': 'OG001', 'lowerLimit': '4.77', 'upperLimit': '6.65'}]}]}, {'title': 'Serogroup W (Day 29), N=279, 282', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000', 'lowerLimit': '50', 'upperLimit': '71'}, {'value': '14', 'groupId': 'OG001', 'lowerLimit': '12', 'upperLimit': '17'}]}]}, {'title': 'Serogroup Y (Day 1), N=280, 282', 'categories': [{'measurements': [{'value': '3.32', 'groupId': 'OG000', 'lowerLimit': '2.95', 'upperLimit': '3.73'}, {'value': '3.34', 'groupId': 'OG001', 'lowerLimit': '2.97', 'upperLimit': '3.76'}]}]}, {'title': 'Serogroup Y (Day 29), N=280, 282', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000', 'lowerLimit': '44', 'upperLimit': '66'}, {'value': '11', 'groupId': 'OG001', 'lowerLimit': '9.29', 'upperLimit': '14'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 month post vaccination (Day 29)', 'description': 'hSBA GMT against N. meningitidis serogroups A, C, W, and Y, in subjects (2-10 years of age), one month after receiving one dose of either MenACWY-CRM vaccine or the licensed MenACWY-PS vaccine.', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on per protocol population.'}, {'type': 'SECONDARY', 'title': 'hSBA GMT in Subjects (2-5 Years of Age and 6-10 Years of Age) Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '135', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}, {'value': '147', 'groupId': 'OG002'}, {'value': '145', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MenACWY-CRM (2-5 Years Old)', 'description': 'Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine'}, {'id': 'OG001', 'title': 'MenACWY-PS (2-5 Years Old)', 'description': 'Subjects received one dose of the MenACWY-PS vaccine'}, {'id': 'OG002', 'title': 'MenACWY-CRM (6-10 Years Old)', 'description': 'Subjects received one dose of MenACWY-CRM conjugate vaccine'}, {'id': 'OG003', 'title': 'MenACWY-PS (6-10 Years Old)', 'description': 'Subjects received one dose of MenACWY-PS vaccine'}], 'classes': [{'title': 'Serogroup A (Day 1), N=133,138,147,143', 'categories': [{'measurements': [{'value': '2.04', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '2.07'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '1.97', 'upperLimit': '2.03'}, {'value': '2.08', 'groupId': 'OG002', 'lowerLimit': '2.01', 'upperLimit': '2.15'}, {'value': '2.03', 'groupId': 'OG003', 'lowerLimit': '1.96', 'upperLimit': '2.11'}]}]}, {'title': 'Serogroup A (Day 29), N=133,138,147,143', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000', 'lowerLimit': '22', 'upperLimit': '37'}, {'value': '5.8', 'groupId': 'OG001', 'lowerLimit': '4.49', 'upperLimit': '7.5'}, {'value': '45', 'groupId': 'OG002', 'lowerLimit': '34', 'upperLimit': '60'}, {'value': '6.84', 'groupId': 'OG003', 'lowerLimit': '5.17', 'upperLimit': '9.06'}]}]}, {'title': 'Serogroup C (Day 1), N=135,138,146,145', 'categories': [{'measurements': [{'value': '2.81', 'groupId': 'OG000', 'lowerLimit': '2.52', 'upperLimit': '3.13'}, {'value': '2.38', 'groupId': 'OG001', 'lowerLimit': '2.14', 'upperLimit': '2.65'}, {'value': '3.33', 'groupId': 'OG002', 'lowerLimit': '2.84', 'upperLimit': '3.9'}, {'value': '4.58', 'groupId': 'OG003', 'lowerLimit': '3.91', 'upperLimit': '5.38'}]}]}, {'title': 'Serogroup C (Day 29), N=135,138,146,145', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000', 'lowerLimit': '11', 'upperLimit': '19'}, {'value': '6.93', 'groupId': 'OG001', 'lowerLimit': '5.22', 'upperLimit': '9.18'}, {'value': 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N=134,138,146,144', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '2.61', 'upperLimit': '3.44'}, {'value': '2.57', 'groupId': 'OG001', 'lowerLimit': '2.24', 'upperLimit': '2.95'}, {'value': '3.65', 'groupId': 'OG002', 'lowerLimit': '3.03', 'upperLimit': '4.38'}, {'value': '4.3', 'groupId': 'OG003', 'lowerLimit': '3.58', 'upperLimit': '5.18'}]}]}, {'title': 'Serogroup Y (Day 29), N=134,138,146,144', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000', 'lowerLimit': '31', 'upperLimit': '56'}, {'value': '7.17', 'groupId': 'OG001', 'lowerLimit': '5.37', 'upperLimit': '9.58'}, {'value': '68', 'groupId': 'OG002', 'lowerLimit': '51', 'upperLimit': '90'}, {'value': '18', 'groupId': 'OG003', 'lowerLimit': '13', 'upperLimit': '24'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 month post vaccination (Day 29)', 'description': 'hSBA GMT against N. meningitidis serogroups A, C, W, and Y, in subjects (2-5 years of age and 6-10 years of age), one month after receiving one dose of either MenACWY-CRM vaccine or licensed MenACWY-PS vaccine.', 'unitOfMeasure': 'Titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on per protocol population.'}, {'type': 'SECONDARY', 'title': 'hSBA Geometric Mean Titer (GMT) in Subjects (12-23 Months Old) After Receiving MenACWY-CRM Vaccine Compared With hSBA GMT in 3-5 Year Old Subjects After Receiving MenACWY-PS Vaccine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '241', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MenACWY-CRM (12-23 Months Old)', 'description': 'Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine'}, {'id': 'OG001', 'title': 'MenACWY-PS (3-5 Years Old)', 'description': 'Subjects received one dose of the licensed MenACWY-PS vaccine This group was a subset of the Licensed comparator (2-5 year old) cohort that received one dose of licensed MenACWY-PS vaccine.'}], 'classes': [{'title': 'Serogroup A (Day 1), N=240,91', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '2'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '2'}]}]}, {'title': 'Serogroup A (Day 29), N=240,91', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '15', 'upperLimit': '21'}, {'value': '7.18', 'groupId': 'OG001', 'lowerLimit': '5.34', 'upperLimit': '9.64'}]}]}, {'title': 'Serogroup C (Day 1), N=241,91', 'categories': [{'measurements': [{'value': '2.13', 'groupId': 'OG000', 'lowerLimit': '2.02', 'upperLimit': '2.25'}, {'value': '2.44', 'groupId': 'OG001', 'lowerLimit': '2.23', 'upperLimit': '2.68'}]}]}, {'title': 'Serogroup C (Day 29), N=241,91', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000', 'lowerLimit': '18', 'upperLimit': '26'}, {'value': '7.09', 'groupId': 'OG001', 'lowerLimit': '5.29', 'upperLimit': '9.5'}]}]}, {'title': 'Serogroup W (Day 1), N=240,91', 'categories': [{'measurements': [{'value': '2.13', 'groupId': 'OG000', 'lowerLimit': '1.94', 'upperLimit': '2.33'}, {'value': '3.91', 'groupId': 'OG001', 'lowerLimit': '3.36', 'upperLimit': '4.55'}]}]}, {'title': 'Serogroup W (Day 29), N=240,91', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '15', 'upperLimit': '21'}, {'value': '9.52', 'groupId': 'OG001', 'lowerLimit': '7.21', 'upperLimit': '13'}]}]}, {'title': 'Serogroup Y (Day 1), N=238,91', 'categories': [{'measurements': [{'value': '2.11', 'groupId': 'OG000', 'lowerLimit': '1.97', 'upperLimit': '2.25'}, {'value': '2.69', 'groupId': 'OG001', 'lowerLimit': '2.42', 'upperLimit': '3'}]}]}, {'title': 'Serogroup Y (Day 29), N=238,91', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000', 'lowerLimit': '8.91', 'upperLimit': '14'}, {'value': '8.48', 'groupId': 'OG001', 'lowerLimit': '6.01', 'upperLimit': '12'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 month post vaccination (Day 29)', 'description': 'hSBA GMT against N. meningitidis serogroups A, C, W, and Y, in subjects (12-23 months old), one month after receiving one dose of MenACWY-CRM vaccine compared with hSBA GMT in 3-5 year old subjects after receiving one dose of licensed MenACWY-PS vaccine.', 'unitOfMeasure': 'Titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on per protocol population.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'OG000'}, {'value': '240', 'groupId': 'OG001'}, {'value': '119', 'groupId': 'OG002'}, {'value': '114', 'groupId': 'OG003'}, {'value': '134', 'groupId': 'OG004'}, {'value': '126', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'MenACWY-CRM (2-10 Years Old)', 'description': 'Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine'}, {'id': 'OG001', 'title': 'MenACWY-PS (2-10 Years)', 'description': 'Subjects received one dose of the licensed MenACWY-PS vaccine'}, {'id': 'OG002', 'title': 'MenACWY-CRM (2-5 Years)', 'description': 'Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine'}, {'id': 'OG003', 'title': 'MenACWY-PS (2-5 Years)', 'description': 'Subjects received one dose of the licensed MenACWY-PS vaccine'}, {'id': 'OG004', 'title': 'MenACWY-CRM (6-10 Years)', 'description': 'Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine'}, {'id': 'OG005', 'title': 'MenACWY-PS (6-10 Years)', 'description': 'Subjects received one dose of the licensed MenACWY-PS vaccine'}], 'classes': [{'title': 'Serogroup A (Day 1), N=253,238,119,114,134,124', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}, {'title': 'Serogroup A (Day 360), N=253,238,119,114,134,124', 'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}, {'value': '29', 'groupId': 'OG005'}]}]}, {'title': 'Serogroup C (Day 1), N=252,240,119,114,133,126', 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}, {'value': '60', 'groupId': 'OG005'}]}]}, {'title': 'Serogroup C (Day 360), N=252,240,119,114,133,126', 'categories': [{'measurements': [{'value': '172', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}, {'value': '95', 'groupId': 'OG004'}, {'value': '85', 'groupId': 'OG005'}]}]}, {'title': 'Serogroup W (Day 1), N=249,237,119,113,130,124', 'categories': [{'measurements': [{'value': '96', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}, {'value': '61', 'groupId': 'OG004'}, {'value': '64', 'groupId': 'OG005'}]}]}, {'title': 'Serogroup W (Day 360), N=249,237,119,113,130,124', 'categories': [{'measurements': [{'value': '234', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}, {'value': '108', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}, {'value': '126', 'groupId': 'OG004'}, {'value': '78', 'groupId': 'OG005'}]}]}, {'title': 'Serogroup Y (Day 1), N=250,239,118,113,132,126', 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}, {'value': '45', 'groupId': 'OG005'}]}]}, {'title': 'Serogroup Y (Day 360), N=250,239,118,113,132,126', 'categories': [{'measurements': [{'value': '215', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '101', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '114', 'groupId': 'OG004'}, {'value': '64', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months post vaccination (Day 360)', 'description': 'Number of subjects (2-10 years, 2-5 years and 6-10 years old subjects) with hSBA ≥ 1:4 directed against N. meningitidis serogroups A, C, W and Y, 12 months after receiving one dose of either MenACWY-CRM vaccine or MenACWY-PS vaccine.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on per protocol population.'}, {'type': 'SECONDARY', 'title': 'hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '253', 'groupId': 'OG000'}, {'value': '240', 'groupId': 'OG001'}, {'value': '119', 'groupId': 'OG002'}, {'value': '114', 'groupId': 'OG003'}, {'value': '134', 'groupId': 'OG004'}, {'value': '126', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'MenACWY-CRM (2-10 Years Old)', 'description': 'Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine'}, {'id': 'OG001', 'title': 'MenACWY-PS (2-10 Years Old)', 'description': 'Subjects received one dose of the licensed MenACWY-PS vaccine'}, {'id': 'OG002', 'title': 'MenACWY-CRM (2-5 Years Old)', 'description': 'Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine'}, {'id': 'OG003', 'title': 'MenACWY-PS (2-5 Years Old)', 'description': 'Subjects received one dose of the licensed MenACWY-PS vaccine'}, {'id': 'OG004', 'title': 'MenACWY-CRM (6-10 Years Old)', 'description': 'Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine'}, {'id': 'OG005', 'title': 'MenACWY-PS (6-10 Years Old)', 'description': 'Subjects received one dose of the licensed MenACWY-PS vaccine'}], 'classes': [{'title': 'Serogroup A (Day 1), N=253,238,119,114,134,124', 'categories': [{'measurements': [{'value': '2.06', 'groupId': 'OG000', 'lowerLimit': '2.02', 'upperLimit': '2.11'}, {'value': '2.02', 'groupId': 'OG001', 'lowerLimit': '1.97', 'upperLimit': '2.07'}, {'value': '2.04', 'groupId': 'OG002', 'lowerLimit': '2', 'upperLimit': '2.08'}, {'value': '2', 'groupId': 'OG003', 'lowerLimit': '1.96', 'upperLimit': '2.04'}, {'value': '2.09', 'groupId': 'OG004', 'lowerLimit': '2', 'upperLimit': '2.17'}, {'value': '2.04', 'groupId': 'OG005', 'lowerLimit': '1.95', 'upperLimit': '2.12'}]}]}, {'title': 'Serogroup A (Day 360), N=253,238,119114,134,124', 'categories': [{'measurements': [{'value': '3.88', 'groupId': 'OG000', 'lowerLimit': 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'lowerLimit': '4.01', 'upperLimit': '5.67'}]}]}, {'title': 'Serogroup C (Day 360), N=252,240,119,114,133,126', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000', 'lowerLimit': '8.64', 'upperLimit': '13'}, {'value': '9.02', 'groupId': 'OG001', 'lowerLimit': '7.23', 'upperLimit': '11'}, {'value': '7.53', 'groupId': 'OG002', 'lowerLimit': '5.93', 'upperLimit': '9.55'}, {'value': '4.71', 'groupId': 'OG003', 'lowerLimit': '3.69', 'upperLimit': '6.01'}, {'value': '15', 'groupId': 'OG004', 'lowerLimit': '11', 'upperLimit': '21'}, {'value': '16', 'groupId': 'OG005', 'lowerLimit': '12', 'upperLimit': '23'}]}]}, {'title': 'Serogroup W (Day 1), N=249,237,119,113,130,124', 'categories': [{'measurements': [{'value': '5.5', 'groupId': 'OG000', 'lowerLimit': '4.62', 'upperLimit': '6.55'}, {'value': '5.38', 'groupId': 'OG001', 'lowerLimit': '4.5', 'upperLimit': '6.44'}, {'value': '4.4', 'groupId': 'OG002', 'lowerLimit': '3.52', 'upperLimit': '5.51'}, {'value': '3.43', 'groupId': 'OG003', 'lowerLimit': '2.73', 'upperLimit': '4.32'}, {'value': '6.75', 'groupId': 'OG004', 'lowerLimit': '5.23', 'upperLimit': '8.7'}, {'value': '8.1', 'groupId': 'OG005', 'lowerLimit': '6.25', 'upperLimit': '11'}]}]}, {'title': 'Serogroup W (Day 360), N=249,237,119,113,130,124', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000', 'lowerLimit': '35', 'upperLimit': '50'}, {'value': '7.57', 'groupId': 'OG001', 'lowerLimit': '6.33', 'upperLimit': '9.07'}, {'value': '36', 'groupId': 'OG002', 'lowerLimit': '28', 'upperLimit': '46'}, {'value': '4.95', 'groupId': 'OG003', 'lowerLimit': '3.83', 'upperLimit': '6.4'}, {'value': '49', 'groupId': 'OG004', 'lowerLimit': '38', 'upperLimit': '62'}, {'value': '11', 'groupId': 'OG005', 'lowerLimit': '8.75', 'upperLimit': '14'}]}]}, {'title': 'Serogroup Y (Day 1), N=250,239,118,113,132,126', 'categories': [{'measurements': [{'value': '3.29', 'groupId': 'OG000', 'lowerLimit': '2.9', 'upperLimit': '3.73'}, {'value': '3.4', 'groupId': 'OG001', 'lowerLimit': '2.99', 'upperLimit': '3.87'}, {'value': '3.04', 'groupId': 'OG002', 'lowerLimit': '2.62', 'upperLimit': '3.53'}, {'value': '2.56', 'groupId': 'OG003', 'lowerLimit': '2.2', 'upperLimit': '2.98'}, {'value': '3.53', 'groupId': 'OG004', 'lowerLimit': '2.91', 'upperLimit': '4.27'}, {'value': '4.39', 'groupId': 'OG005', 'lowerLimit': '3.61', 'upperLimit': '5.35'}]}]}, {'title': 'Serogroup Y (Day 360), N=250,239,118,113,132,126', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000', 'lowerLimit': '22', 'upperLimit': '33'}, {'value': '5.29', 'groupId': 'OG001', 'lowerLimit': '4.34', 'upperLimit': '6.45'}, {'value': '24', 'groupId': 'OG002', 'lowerLimit': '19', 'upperLimit': '31'}, {'value': '3.42', 'groupId': 'OG003', 'lowerLimit': '2.65', 'upperLimit': '4.43'}, {'value': '30', 'groupId': 'OG004', 'lowerLimit': '23', 'upperLimit': '40'}, {'value': '7.82', 'groupId': 'OG005', 'lowerLimit': '5.86', 'upperLimit': '10'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '12 months post vaccination (Day 360)', 'description': 'hSBA GMT against N. meningitidis serogroups A, C, W, and Y, in subjects (2-10 years, 2-5 years and 6-10 years old), twelve months after receiving one dose of either MenACWY-CRM vaccine or MenACWY-PS vaccine.', 'unitOfMeasure': 'Titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on per protocol population.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}, {'value': '157', 'groupId': 'OG002'}, {'value': '157', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MenACWY-CRM (2-5 Years Old)', 'description': 'Subjects received one dose of investigational MenACWY-CRM conjugate vaccine'}, {'id': 'OG001', 'title': 'MenACWY-PS (2-5 Years Old)', 'description': 'Subjects received one dose of licensed MenACWY-PS vaccine'}, {'id': 'OG002', 'title': 'MenACWY-CRM (6-10 Years Old)', 'description': 'Subjects received one dose of investigational MenACWY-CRM conjugate vaccine'}, {'id': 'OG003', 'title': 'MenACWY-PS (6-10 Years Old)', 'description': 'Subjects received one dose of licensed MenACWY-PS vaccine'}], 'classes': [{'title': 'Local reactions', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '70', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}]}, {'title': 'Injection site pain', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}]}]}, {'title': 'Injection site erythema', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}, {'title': 'Injection site induration', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': 'Systemic reactions', 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}]}, {'title': 'Change in eating habits, N=145,150', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': 'NA', 'groupId': 'OG002'}, {'value': 'NA', 'groupId': 'OG003'}]}]}, {'title': 'Sleepiness', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': 'NA', 'groupId': 'OG002'}, {'value': 'NA', 'groupId': 'OG003'}]}]}, {'title': 'Irritability', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': 'NA', 'groupId': 'OG002'}, {'value': 'NA', 'groupId': 'OG003'}]}]}, {'title': 'Vomiting', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': 'NA', 'groupId': 'OG002'}, {'value': 'NA', 'groupId': 'OG003'}]}]}, {'title': 'Diarrhea', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': 'NA', 'groupId': 'OG002'}, {'value': 'NA', 'groupId': 'OG003'}]}]}, {'title': 'Chills, N=156, 157', 'categories': [{'measurements': [{'value': 'NA', 'groupId': 'OG000'}, {'value': 'NA', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}, {'title': 'Nausea, N=156, 157', 'categories': [{'measurements': [{'value': 'NA', 'groupId': 'OG000'}, {'value': 'NA', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': 'Malaise, N=156, 157', 'categories': [{'measurements': [{'value': 'NA', 'groupId': 'OG000'}, {'value': 'NA', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}, {'title': 'Myalgia, N=156, 157', 'categories': [{'measurements': [{'value': 'NA', 'groupId': 'OG000'}, {'value': 'NA', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'Arthralgia, N=151,153,156,157', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Headache, N=151,153,156,157', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}]}, {'title': 'Stayed at home due to reactions, N=146,151,154,156', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Analg./antipyr. med. used, N=150,152,157,157', 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 to 7 post vaccination', 'description': 'Safety and tolerability of a single dose of MenACWY-CRM conjugate vaccine compared to the safety and tolerability of a single dose of licensed MenACWY-PS vaccine when administered to healthy children 2 to 10 years of age.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on safety population i.e. all randomized subjects who received a vaccination and who had follow up safety data.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MenACWY-CRM (12-15 Months)', 'description': 'Subjects received one dose of investigational MenACWY-CRM conjugate vaccine'}, {'id': 'OG001', 'title': 'MenACWY-CRM + PnC (12-15 Months)', 'description': 'Subjects received one dose of investigational MenACWY-CRM conjugate vaccine concomitantly with PnC'}, {'id': 'OG002', 'title': 'MenACWY-CRM (16-23 Months)', 'description': 'Subjects received one dose of investigational MenACWY-CRM conjugate vaccine'}, {'id': 'OG003', 'title': 'MenACWY-CRM + DTaP (16-23 Months)', 'description': 'Subjects received one dose of investigational MenACWY-CRM conjugate vaccine concomitantly with DTaP'}], 'classes': [{'title': 'Local reactions', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '35', 'groupId': 'OG003'}]}]}, {'title': 'Injection site reaction tenderness', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}]}, {'title': 'Injection site reaction erythema', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}]}]}, {'title': 'Injection site reaction induration', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}]}, {'title': 'Systemic reactions', 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}]}, {'title': 'Change in eating habits, N=74,70,71,72', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}]}, {'title': 'Sleepiness', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}]}]}, {'title': 'Persistent crying, N=74,70,71,72', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'Irritability', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}]}]}, {'title': 'Vomiting', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}, {'title': 'Diarrhea', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}]}]}, {'title': 'Analgesic/antipyretic medicine used', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 to 7 post vaccination', 'description': 'Safety and tolerability of a single dose of MenACWY-CRM conjugate vaccine when administered in healthy toddlers (12-15 months old), alone or concomitantly with PnC and when administered in healthy toddlers (16-23 months old), alone or concomitantly with DTaP.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on safety population.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Unsolicited Adverse Events (AEs) After Vaccination in Children Aged 2 to 10 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '153', 'groupId': 'OG001'}, {'value': '157', 'groupId': 'OG002'}, {'value': '157', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MenACWY-CRM (2-5 Years Old)', 'description': 'Subjects received one dose of investigational MenACWY-CRM conjugate vaccine'}, {'id': 'OG001', 'title': 'MenACWY-PS (2-5 Years Old)', 'description': 'Subjects received one dose of licensed MenACWY-PS vaccine'}, {'id': 'OG002', 'title': 'MenACWY-CRM (6-10 Years Old)', 'description': 'Subjects received one dose of investigational MenACWY-CRM conjugate vaccine'}, {'id': 'OG003', 'title': 'MenACWY-PS (6-10 Years Old)', 'description': 'Subjects received one dose of licensed MenACWY-PS vaccine'}], 'classes': [{'title': 'Any AE', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}]}]}, {'title': 'Possibly or probably related AEs', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'AEs leading to premature withdrawal', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1- Day 360 (throughout the study)', 'description': 'Safety and tolerability of a single dose of MenACWY-CRM conjugate vaccine compared to the safety and tolerability of a single dose of licensed MenACWY-PS vaccine when administered to healthy children 2 to 10 years of age.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on safety population.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Unsolicited Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}, {'value': '73', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MenACWY-CRM (12-15 Months Old)', 'description': 'Subjects received one dose of investigational MenACWY-CRM conjugate vaccine'}, {'id': 'OG001', 'title': 'MenACWY-CRM + PnC (12-15 Months Old)', 'description': 'Subjects received one dose of investigational MenACWY-CRM conjugate vaccine in concomitant with PnC'}, {'id': 'OG002', 'title': 'MenACWY-CRM (16-23 Months)', 'description': 'Subjects received one dose of investigational MenACWY-CRM conjugate vaccine'}, {'id': 'OG003', 'title': 'MenACWY-CRM + DTaP (16-23 Months)', 'description': 'Subjects received one dose of investigational MenACWY-CRM conjugate vaccine in concomitant with DTaP'}], 'classes': [{'title': 'Any AE', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}]}, {'title': 'Possibly or probably related AEs', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'AEs leading to premature withdrawal', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1- Day 360 (Throughout the study)', 'description': 'Safety and tolerability of a single dose of MenACWY-CRM conjugate vaccine when administered in healthy toddlers (12-15 months old), alone or concomitantly with PnC and when administered in healthy toddlers (16-23 months old), alone or concomitantly with DTaP.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on safety population.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MenACWY (2-5 Years Old)', 'description': 'Subjects received one dose of the investigational MenACWY-cross-reactive material (CRM) conjugate vaccine.'}, {'id': 'FG001', 'title': 'MenACWY-PS (2-5 Years Old)', 'description': 'Subjects received one dose of the licensed MenACWY-polysaccharide vaccine.'}, {'id': 'FG002', 'title': 'MenACWY (6-10 Years Old)', 'description': 'Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine.'}, {'id': 'FG003', 'title': 'MenACWY-PS (6-10 Years Old)', 'description': 'Subjects received one dose of the licensed MenACWY-polysaccharide vaccine.'}, {'id': 'FG004', 'title': 'MenACWY (12-15 Months Old)', 'description': 'Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine.'}, {'id': 'FG005', 'title': 'MenACWY+PnC (12-15 Months)', 'description': 'Subjects received one dose of the MenACWY-CRM conjugate vaccine administered concomitantly with pneumococcal conjugate vaccine (PnC).'}, {'id': 'FG006', 'title': 'MenACWY (16-23 Months)', 'description': 'Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine.'}, {'id': 'FG007', 'title': 'MenACWY+DTaP (16-23 Months)', 'description': 'Subjects received one dose of the MenACWY-CRM conjugate vaccine administered concomitantly with diphtheria-tetanus-acellular pertussis (DTaP) vaccine.'}, {'id': 'FG008', 'title': 'MenACWY-PS (3-5 Years Old)', 'description': 'Children aged 3 to 5 years receiving MenACWY- polysaccharide (PS) vaccine from the first part of the study (Menomune, not licensed in US in children under 2 years of age) were used as controls for the 12-23-months-old part two toddlers.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '152'}, {'groupId': 'FG001', 'numSubjects': '153'}, {'groupId': 'FG002', 'numSubjects': '157'}, {'groupId': 'FG003', 'numSubjects': '157'}, {'groupId': 'FG004', 'numSubjects': '74'}, {'groupId': 'FG005', 'numSubjects': '73'}, {'groupId': 'FG006', 'numSubjects': '71'}, {'groupId': 'FG007', 'numSubjects': '73'}, {'groupId': 'FG008', 'numSubjects': '100'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '128'}, {'groupId': 'FG001', 'numSubjects': '126'}, {'groupId': 'FG002', 'numSubjects': '137'}, {'groupId': 'FG003', 'numSubjects': '134'}, {'groupId': 'FG004', 'numSubjects': '62'}, {'groupId': 'FG005', 'numSubjects': '60'}, {'groupId': 'FG006', 'numSubjects': '59'}, {'groupId': 'FG007', 'numSubjects': '55'}, {'groupId': 'FG008', 'numSubjects': '81'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '27'}, {'groupId': 'FG002', 'numSubjects': '20'}, {'groupId': 'FG003', 'numSubjects': '23'}, {'groupId': 'FG004', 'numSubjects': '12'}, {'groupId': 'FG005', 'numSubjects': '13'}, {'groupId': 'FG006', 'numSubjects': '12'}, {'groupId': 'FG007', 'numSubjects': '18'}, {'groupId': 'FG008', 'numSubjects': '19'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '5'}, {'groupId': 'FG007', 'numSubjects': '7'}, {'groupId': 'FG008', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'groupId': 'FG007', 'numSubjects': '5'}, {'groupId': 'FG008', 'numSubjects': '6'}]}, {'type': 'Administrative Reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '12'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '7'}, {'groupId': 'FG006', 'numSubjects': '4'}, {'groupId': 'FG007', 'numSubjects': '6'}, {'groupId': 'FG008', 'numSubjects': '10'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}]}, {'type': 'Unable to classify', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Subjects were recruited from a single center.', 'preAssignmentDetails': 'All enrolled subjects participated in this study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'BG000'}, {'value': '153', 'groupId': 'BG001'}, {'value': '157', 'groupId': 'BG002'}, {'value': '157', 'groupId': 'BG003'}, {'value': '74', 'groupId': 'BG004'}, {'value': '73', 'groupId': 'BG005'}, {'value': '71', 'groupId': 'BG006'}, {'value': '73', 'groupId': 'BG007'}, {'value': '100', 'groupId': 'BG008'}, {'value': '1010', 'groupId': 'BG009'}]}], 'groups': [{'id': 'BG000', 'title': 'MenACWY (2-5 Years Old)', 'description': 'Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine.'}, {'id': 'BG001', 'title': 'MenACWY-PS (2-5 Years Old)', 'description': 'Subjects received one dose of the licensed MenACWY-polysaccharide vaccine.'}, {'id': 'BG002', 'title': 'MenACWY (6-10 Years Old)', 'description': 'Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine'}, {'id': 'BG003', 'title': 'MenACWY-PS (6-10 Years Old)', 'description': 'Subjects received one dose of the licensed MenACWY-polysaccharide vaccine.'}, {'id': 'BG004', 'title': 'MenACWY (12-15 Months Old)', 'description': 'Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine.'}, {'id': 'BG005', 'title': 'MenACWY-PnC (12-15 Months Old)', 'description': 'Subjects received one dose of the MenACWY-CRM conjugate vaccine administered concomitantly with pneumococcal conjugate vaccine.'}, {'id': 'BG006', 'title': 'MenACWY (16-23 Months Old)', 'description': 'Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine.'}, {'id': 'BG007', 'title': 'MenACWY+DTaP (16-23 Months Old)', 'description': 'Subjects received one dose of the MenACWY-CRM conjugate vaccine administered concomitantly with DTaP vaccine.'}, {'id': 'BG008', 'title': 'MenACWY+PS (3-5 YearsOld)', 'description': 'Children aged 3 to 5 years receiving MenACWY-PS from the first part of the study (Menomune, not licensed in US in children under 2 years of age) were used as controls for the 12-23-months-old part two toddlers.'}, {'id': 'BG009', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '3.3', 'spread': '1.2', 'groupId': 'BG000'}, {'value': '3.3', 'spread': '1.2', 'groupId': 'BG001'}, {'value': '8.0', 'spread': '1.5', 'groupId': 'BG002'}, {'value': '8.0', 'spread': '1.4', 'groupId': 'BG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data are reported in a separate table', 'groupId': 'BG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data are reported in a separate table', 'groupId': 'BG005'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data are reported in a separate table', 'groupId': 'BG006'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data are reported in a separate table', 'groupId': 'BG007'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data are reported in a separate table', 'groupId': 'BG008'}, {'value': '5.7', 'spread': '2.7', 'groupId': 'BG009'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Data are reported in the previous table', 'groupId': 'BG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data are reported in the previous table', 'groupId': 'BG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data are reported in the previous table', 'groupId': 'BG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Data are reported in the previous table', 'groupId': 'BG003'}, {'value': '12.2', 'spread': '0.5', 'groupId': 'BG004'}, {'value': '12.2', 'spread': '0.5', 'groupId': 'BG005'}, {'value': '18.2', 'spread': '1.3', 'groupId': 'BG006'}, {'value': '18.2', 'spread': '1.4', 'groupId': 'BG007'}, {'value': '52.6', 'spread': '11.4', 'groupId': 'BG008'}, {'value': '24.7', 'spread': '17.5', 'groupId': 'BG009'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '79', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}, {'value': '78', 'groupId': 'BG003'}, {'value': 'NA', 'comment': 'Data are reported in a separate table', 'groupId': 'BG004'}, {'value': 'NA', 'comment': 'reported in a separate table', 'groupId': 'BG005'}, {'value': 'NA', 'comment': 'reported in a separate table', 'groupId': 'BG006'}, {'value': 'NA', 'comment': 'reported in a separate table', 'groupId': 'BG007'}, {'value': 'NA', 'comment': 'reported in a separate table', 'groupId': 'BG008'}, {'value': 'NA', 'comment': 'Total not calculated because data are not available (NA) in one or more arms.', 'groupId': 'BG009'}]}, {'title': 'Male', 'measurements': [{'value': '86', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}, {'value': '79', 'groupId': 'BG003'}, {'value': 'NA', 'comment': 'reported in a separate table', 'groupId': 'BG004'}, {'value': 'NA', 'comment': 'reported in a separate table', 'groupId': 'BG005'}, {'value': 'NA', 'comment': 'reported in a separate table', 'groupId': 'BG006'}, {'value': 'NA', 'comment': 'reported in a separate table', 'groupId': 'BG007'}, {'value': 'NA', 'comment': 'reported in a separate table', 'groupId': 'BG008'}, {'value': 'NA', 'comment': 'Total not calculated because data are not available (NA) in one or more arms.', 'groupId': 'BG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': 'NA', 'comment': 'Data are reported in the previous table', 'groupId': 'BG000'}, {'value': 'NA', 'comment': 'Data are reported in the previous table', 'groupId': 'BG001'}, {'value': 'NA', 'comment': 'Data are reported in the previous table', 'groupId': 'BG002'}, {'value': 'NA', 'comment': 'Data are reported in the previous table', 'groupId': 'BG003'}, {'value': '30', 'groupId': 'BG004'}, {'value': '29', 'groupId': 'BG005'}, {'value': '31', 'groupId': 'BG006'}, {'value': '36', 'groupId': 'BG007'}, {'value': '51', 'groupId': 'BG008'}, {'value': 'NA', 'comment': 'Total not calculated because data are not available (NA) in one or more arms.', 'groupId': 'BG009'}]}, {'title': 'Male', 'measurements': [{'value': 'NA', 'comment': 'Data are reported in the previous table', 'groupId': 'BG000'}, {'value': 'NA', 'comment': 'Data are reported in the previous table', 'groupId': 'BG001'}, {'value': 'NA', 'comment': 'Data are reported in the previous table', 'groupId': 'BG002'}, {'value': 'NA', 'comment': 'Data are reported in the previous table', 'groupId': 'BG003'}, {'value': '44', 'groupId': 'BG004'}, {'value': '44', 'groupId': 'BG005'}, {'value': '40', 'groupId': 'BG006'}, {'value': '37', 'groupId': 'BG007'}, {'value': '49', 'groupId': 'BG008'}, {'value': 'NA', 'comment': 'Total not calculated because data are not available (NA) in one or more arms.', 'groupId': 'BG009'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 910}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2006-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-12', 'studyFirstSubmitDate': '2005-12-02', 'resultsFirstSubmitDate': '2013-08-30', 'studyFirstSubmitQcDate': '2005-12-02', 'lastUpdatePostDateStruct': {'date': '2016-02-11', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-01-12', 'studyFirstPostDateStruct': {'date': '2005-12-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-02-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Subjects (2-10 Years of Age) With Human Serum Bactericidal Activity (hSBA) Titers ≥1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine', 'timeFrame': '1 month post vaccination (Day 29)', 'description': 'Number of subjects (2-10 years of age) achieving with hSBA titers ≥1:4 against Neisseria meningitidis serogroups A,C,W and Y, one month after receiving one dose of either MenACWY-CRM vaccine or MenACWY-PS vaccine.'}], 'secondaryOutcomes': [{'measure': 'Percentages of Subjects (2-5 Years of Age and 6-10 Years of Age) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM or MenACWY-PS Vaccine', 'timeFrame': '1 month post vaccination (Day 29)', 'description': 'Percentages of subjects (2-5 years of age and 6-10 years of age) with hSBA ≥ 1:4 directed against N. meningitidis serogroups A, C, W and Y, one month after receiving one dose of either MenACWY-CRM vaccine or MenACWY-PS vaccine.'}, {'measure': 'Percentages of Subjects (12-23 Months Old) With hSBA Titer ≥ 1:4 After Receiving MenACWY-CRM Vaccine Compared With Percentage of Subjects (3-5 Years Old) With hSBA Titer ≥ 1:4 After Receiving MenACWY-PS Vaccine', 'timeFrame': '1 month post vaccination (Day 29)', 'description': 'Percentage of subjects (12-23 months old) with hSBA ≥ 1:4 directed against N. meningitidis serogroups A, C, W and Y after receiving one dose of MenACWY-CRM vaccine compared with percentage of subjects (3-5 years old) with hSBA ≥ 1:4 after one dose of licensed MenACWY-PS vaccine.'}, {'measure': 'hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years of Age) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine', 'timeFrame': '1 month post vaccination (Day 29)', 'description': 'hSBA GMT against N. meningitidis serogroups A, C, W, and Y, in subjects (2-10 years of age), one month after receiving one dose of either MenACWY-CRM vaccine or the licensed MenACWY-PS vaccine.'}, {'measure': 'hSBA GMT in Subjects (2-5 Years of Age and 6-10 Years of Age) Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine', 'timeFrame': '1 month post vaccination (Day 29)', 'description': 'hSBA GMT against N. meningitidis serogroups A, C, W, and Y, in subjects (2-5 years of age and 6-10 years of age), one month after receiving one dose of either MenACWY-CRM vaccine or licensed MenACWY-PS vaccine.'}, {'measure': 'hSBA Geometric Mean Titer (GMT) in Subjects (12-23 Months Old) After Receiving MenACWY-CRM Vaccine Compared With hSBA GMT in 3-5 Year Old Subjects After Receiving MenACWY-PS Vaccine', 'timeFrame': '1 month post vaccination (Day 29)', 'description': 'hSBA GMT against N. meningitidis serogroups A, C, W, and Y, in subjects (12-23 months old), one month after receiving one dose of MenACWY-CRM vaccine compared with hSBA GMT in 3-5 year old subjects after receiving one dose of licensed MenACWY-PS vaccine.'}, {'measure': 'Number of Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) With hSBA ≥ 1:4 After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine', 'timeFrame': '12 months post vaccination (Day 360)', 'description': 'Number of subjects (2-10 years, 2-5 years and 6-10 years old subjects) with hSBA ≥ 1:4 directed against N. meningitidis serogroups A, C, W and Y, 12 months after receiving one dose of either MenACWY-CRM vaccine or MenACWY-PS vaccine.'}, {'measure': 'hSBA Geometric Mean Titer (GMT) in Subjects (2-10 Years, 2-5 Years and 6-10 Years Old) After Receiving Either MenACWY-CRM Vaccine or MenACWY-PS Vaccine', 'timeFrame': '12 months post vaccination (Day 360)', 'description': 'hSBA GMT against N. meningitidis serogroups A, C, W, and Y, in subjects (2-10 years, 2-5 years and 6-10 years old), twelve months after receiving one dose of either MenACWY-CRM vaccine or MenACWY-PS vaccine.'}, {'measure': 'Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Children Aged 2 to 10 Years', 'timeFrame': 'Day 1 to 7 post vaccination', 'description': 'Safety and tolerability of a single dose of MenACWY-CRM conjugate vaccine compared to the safety and tolerability of a single dose of licensed MenACWY-PS vaccine when administered to healthy children 2 to 10 years of age.'}, {'measure': 'Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months', 'timeFrame': 'Day 1 to 7 post vaccination', 'description': 'Safety and tolerability of a single dose of MenACWY-CRM conjugate vaccine when administered in healthy toddlers (12-15 months old), alone or concomitantly with PnC and when administered in healthy toddlers (16-23 months old), alone or concomitantly with DTaP.'}, {'measure': 'Number of Subjects Reporting Unsolicited Adverse Events (AEs) After Vaccination in Children Aged 2 to 10 Years', 'timeFrame': 'Day 1- Day 360 (throughout the study)', 'description': 'Safety and tolerability of a single dose of MenACWY-CRM conjugate vaccine compared to the safety and tolerability of a single dose of licensed MenACWY-PS vaccine when administered to healthy children 2 to 10 years of age.'}, {'measure': 'Number of Subjects Reporting Unsolicited Adverse Events After Vaccination in Toddlers Aged 12 to 23 Months', 'timeFrame': 'Day 1- Day 360 (Throughout the study)', 'description': 'Safety and tolerability of a single dose of MenACWY-CRM conjugate vaccine when administered in healthy toddlers (12-15 months old), alone or concomitantly with PnC and when administered in healthy toddlers (16-23 months old), alone or concomitantly with DTaP.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Prevention of Meningococcal Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and immunogenicity of Novartis (formerly Chiron) Meningococcal ACWY Conjugate Vaccine administered to healthy children ages 1 - 10 years'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Years', 'minimumAge': '12 Months', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Group 1: Healthy children 2-10 years of age;\n* Group 2: Healthy toddlers 12-23 months of age; who are up to date with age appropriate immunizations for diphtheria, tetanus, pertussis, polio, hepatitis B, Hemophilus influenzae type b, and pneumococcus.\n\nExclusion Criteria:\n\n* Group 1: Subjects with a previous or suspected disease caused by N. meningitidis; or previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s); Any serious acute, chronic or progressive disease.\n* Group 2: Subjects with a previous or suspected disease caused by N. meningitidis or previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s); Any serious acute, chronic or progressive disease.'}, 'identificationModule': {'nctId': 'NCT00262028', 'briefTitle': 'Study of the Safety and Immune Response of a Meningococcal Vaccine Administered to Healthy Children', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Phase 2, Randomized, Single-blind, Controlled, Single-Center Study to Compare the Safety and Immunogenicity of One Dose of Chiron Meningococcal ACWY Conjugate Vaccine With One Dose of Licensed Meningococcal ACWY Polysaccharide Vaccine Administered to Healthy Children 2-10 Years of Age and an Open-label Study to Assess the Safety and Immunogenicity of One Dose of Chiron Meningococcal ACWY Conjugate Vaccine Administered to Healthy Toddlers 12-23 Months of Age', 'orgStudyIdInfo': {'id': 'V59P8'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MenACWY-CRM (2-10 years)', 'description': 'Subjects received one dose of investigational MenACWY-CRM conjugate vaccine', 'interventionNames': ['Biological: MenACWY-CRM Vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'MenACWY-CRM (12-23 months)', 'description': 'Subjects received one dose of investigational MenACWY-CRM conjugate vaccine', 'interventionNames': ['Biological: MenACWY-CRM Vaccine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'MenACWY-PS (2-10 years)', 'description': 'Subjects received one dose of licensed comparator MenACWY polysaccharide (MenACWY-PS) vaccine', 'interventionNames': ['Biological: MenACWY-PS Vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'MenACWY-CRM+PnC (12-15 months)', 'description': 'Subjects received one dose of MenACWY-CRM vaccine alone or concomitantly with PnC', 'interventionNames': ['Biological: MenACWY-CRM Vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'MenACWY-CRM+DTaP (16-23 months)', 'description': 'Subjects received one dose of MenACWY-CRM vaccine alone or concomitantly with DTaP', 'interventionNames': ['Biological: MenACWY-CRM Vaccine']}], 'interventions': [{'name': 'MenACWY-CRM Vaccine', 'type': 'BIOLOGICAL', 'armGroupLabels': ['MenACWY-CRM (12-23 months)', 'MenACWY-CRM (2-10 years)', 'MenACWY-CRM+DTaP (16-23 months)', 'MenACWY-CRM+PnC (12-15 months)']}, {'name': 'MenACWY-PS Vaccine', 'type': 'BIOLOGICAL', 'armGroupLabels': ['MenACWY-PS (2-10 years)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94612', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Vaccine Study Center', 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}], 'overallOfficials': [{'name': 'Novartis Vaccines', 'role': 'STUDY_CHAIR', 'affiliation': 'Novartis Vaccines & Diagnostics'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Vaccines', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}