Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-30 @ 11:44 AM
Study NCT ID:
NCT00310856
Status:
COMPLETED
Last Update Posted:
2018-10-09
First Post:
2006-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Immunogenicity and Safety of MenACWY in Infants (6 & 12 Months)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008585', 'term': 'Meningitis, Meningococcal'}, {'id': 'D008581', 'term': 'Meningitis'}], 'ancestors': [{'id': 'D016920', 'term': 'Meningitis, Bacterial'}, {'id': 'D020806', 'term': 'Central Nervous System Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D008589', 'term': 'Meningococcal Infections'}, {'id': 'D016870', 'term': 'Neisseriaceae Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D002494', 'term': 'Central Nervous System Infections'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C556088', 'term': 'MenACWY-CRM vaccine'}, {'id': 'C000625559', 'term': 'MenC-CRM vaccine'}, {'id': 'C410218', 'term': 'serogroup C meningococcal conjugate vaccine'}, {'id': 'C541234', 'term': 'diphtheria-tetanus-five component acellular pertussis-inactivated poliomyelitis -Haemophilus influenzae type b conjugate vaccine'}, {'id': 'D013745', 'term': 'Tetanus Toxoid'}, {'id': 'C512971', 'term': 'pentacel'}, {'id': 'D000069443', 'term': 'Heptavalent Pneumococcal Conjugate Vaccine'}], 'ancestors': [{'id': 'D014121', 'term': 'Toxoids'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D022242', 'term': 'Pneumococcal Vaccines'}, {'id': 'D022541', 'term': 'Streptococcal Vaccines'}, {'id': 'D001428', 'term': 'Bacterial Vaccines'}, {'id': 'D017778', 'term': 'Vaccines, Combined'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'RegistryContactVaccinesUS@novartis.com', 'title': 'Posting Director', 'organization': 'Novartis Vaccines and Diagnostics'}, 'certainAgreement': {'otherDetails': "The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigators from publishing. Any publications from a single site are postponed until the publication of the pool data (i.e., data from all sites) in the clinical trial.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events (AEs) and serious adverse events (SAEs) were reported throughout the study (day 1 through day 336)', 'eventGroups': [{'id': 'EG000', 'title': 'MenACWY-CRM_6-12M', 'description': 'Subjects received 2 doses of MenACWY-CRM at 6 and 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months)', 'otherNumAtRisk': 64, 'otherNumAffected': 62, 'seriousNumAtRisk': 64, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'MenACWY-CRM_12M', 'description': 'Subjects received 1 dose of MenACWY-CRM at 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months)', 'otherNumAtRisk': 61, 'otherNumAffected': 58, 'seriousNumAtRisk': 61, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'MenC-CRM_12M_MenACWY-CRM_18M', 'description': 'Subjects received 1 dose each of MenC-CRM (at 12 months) and MenACWY-CRM (at 12 months). Subjects also received routine vaccines: 1 dose each of PC7 (at 12 months), MMR+Varicella (at 13 months) and DTaP-Hib- IPV (at 18 months)', 'otherNumAtRisk': 50, 'otherNumAffected': 50, 'seriousNumAtRisk': 50, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 33}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 39}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Injection site induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 35}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 31}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 35}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 34}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 45}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 38}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 32}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 22}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Eating disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 21}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Infectious mononucleosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Respiratory syncytial virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Lethargy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 64, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 61, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Subjects With hSBA Titers ≥1:4 Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MenACWY-CRM_6-12 M', 'description': 'Subjects received 2 doses of MenACWY-CRM at 6 and 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months).'}, {'id': 'OG001', 'title': 'MenACWY-CRM_12 M', 'description': 'Subjects received 1 dose of MenACWY-CRM at 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months).'}], 'classes': [{'title': 'Serogroup A - Prevaccination (N=50,53)', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '22'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '7'}]}]}, {'title': 'Serogroup A - Postvaccination (N=50,53)', 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000', 'lowerLimit': '76', 'upperLimit': '95'}, {'value': '74', 'groupId': 'OG001', 'lowerLimit': '60', 'upperLimit': '85'}]}]}, {'title': 'Serogroup C - Prevaccination', 'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000', 'lowerLimit': '73', 'upperLimit': '94'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '0.047', 'upperLimit': '10'}]}]}, {'title': 'Serogroup C - Postvaccination', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '94', 'upperLimit': '100'}, {'value': '96', 'groupId': 'OG001', 'lowerLimit': '87', 'upperLimit': '100'}]}]}, {'title': 'Serogroup W - Prevaccination (N=40,41)', 'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000', 'lowerLimit': '70', 'upperLimit': '94'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '0.062', 'upperLimit': '13'}]}]}, {'title': 'Serogroup W - Postvaccination (N=40,41)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '91', 'upperLimit': '100'}, {'value': '95', 'groupId': 'OG001', 'lowerLimit': '83', 'upperLimit': '99'}]}]}, {'title': 'Serogroup Y - Prevaccination (N=53,54)', 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000', 'lowerLimit': '58', 'upperLimit': '83'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '7'}]}]}, {'title': 'Serogroup Y - Postvaccination (N=53,54)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '93', 'upperLimit': '100'}, {'value': '78', 'groupId': 'OG001', 'lowerLimit': '64', 'upperLimit': '88'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Before and 1 month after 2-dose or 1-dose schedule', 'description': 'Immunogenicity was measured as the percentage of subjects with hSBA titers ≥1:4 against meningococcal serogroups A, C, W and Y, evaluated by serum bactericidal assay using human complement (hSBA), before vaccination and 1 month after 2-dose schedule of MenACWY-CRM administered at 6 and 12 months of age (MenACWY-CRM\\_6-12 M group) or 1-dose schedule administered at 12 months (MenACWY-CRM\\_12 M group)', 'unitOfMeasure': 'Percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on per protocol (PP) population, i.e subjects in the exposed population who received all the relevant doses of vaccines correctly; and provided evaluable serum samples at the relevant time points; and had no major protocol violation as defined prior to unblinding.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean hSBA Titers Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MenACWY-CRM_6-12 M', 'description': 'Subjects received 2 doses of MenACWY-CRM at 6 and 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months).'}, {'id': 'OG001', 'title': 'MenACWY-CRM_12 M', 'description': 'Subjects received 1 dose of MenACWY-CRM at 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months).'}], 'classes': [{'title': 'Serogroup A - Prevaccination (N=50,53)', 'categories': [{'measurements': [{'value': '2.41', 'groupId': 'OG000', 'lowerLimit': '2.18', 'upperLimit': '2.65'}, {'value': '1.99', 'groupId': 'OG001', 'lowerLimit': '1.81', 'upperLimit': '2.19'}]}]}, {'title': 'Serogroup A - Postvaccination (N=50,53)', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000', 'lowerLimit': '29', 'upperLimit': '65'}, {'value': '11', 'groupId': 'OG001', 'lowerLimit': '7.55', 'upperLimit': '16'}]}]}, {'title': 'Serogroup C - Prevaccination', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '25'}, {'value': '2.06', 'groupId': 'OG001', 'lowerLimit': '1.54', 'upperLimit': '2.77'}]}]}, {'title': 'Serogroup C - Postvaccination', 'categories': [{'measurements': [{'value': '302', 'groupId': 'OG000', 'lowerLimit': '224', 'upperLimit': '405'}, {'value': '40', 'groupId': 'OG001', 'lowerLimit': '30', 'upperLimit': '54'}]}]}, {'title': 'Serogroup W - Prevaccination (N=40,41)', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000', 'lowerLimit': '12', 'upperLimit': '19'}, {'value': '2.09', 'groupId': 'OG001', 'lowerLimit': '1.68', 'upperLimit': '2.6'}]}]}, {'title': 'Serogroup W-Postvaccination (N=40,41)', 'categories': [{'measurements': [{'value': '220', 'groupId': 'OG000', 'lowerLimit': '155', 'upperLimit': '313'}, {'value': '30', 'groupId': 'OG001', 'lowerLimit': '21', 'upperLimit': '43'}]}]}, {'title': 'Serogroup Y - Prevaccination', 'categories': [{'measurements': [{'value': '7.91', 'groupId': 'OG000', 'lowerLimit': '6.64', 'upperLimit': '9.43'}, {'value': '2.02', 'groupId': 'OG001', 'lowerLimit': '1.7', 'upperLimit': '2.4'}]}]}, {'title': 'Serogroup Y - Postvaccination', 'categories': [{'measurements': [{'value': '136', 'groupId': 'OG000', 'lowerLimit': '100', 'upperLimit': '185'}, {'value': '10', 'groupId': 'OG001', 'lowerLimit': '7.68', 'upperLimit': '14'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Before and 1 month after 2-dose or 1-dose schedule', 'description': 'The immune response was measured as the hSBA geometric mean titers (GMTs) against meningococcal serogroups A, C, W and Y, before vaccination and 1 month after 2-dose schedule of MenACWY-CRM administered at 6 and 12 months of age (MenACWY-CRM\\_6-12 M group) or 1-dose schedule administered at 12 months of age (MenACWY-CRM\\_12 M group)', 'unitOfMeasure': 'Geometric mean titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on PP population.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With hSBA Titers ≥1:8 Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MenACWY-CRM_6-12 M', 'description': 'Subjects received 2 doses of MenACWY-CRM at 6 and 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months).'}, {'id': 'OG001', 'title': 'MenACWY-CRM_12 M', 'description': 'Subjects received 1 dose of MenACWY-CRM at 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months).'}], 'classes': [{'title': 'Serogroup A - Prevaccination (N=50,53)', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '19'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '7'}]}]}, {'title': 'Serogroup A - Postvaccination (N=50,53)', 'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000', 'lowerLimit': '71', 'upperLimit': '93'}, {'value': '60', 'groupId': 'OG001', 'lowerLimit': '46', 'upperLimit': '74'}]}]}, {'title': 'Serogroup C - Prevaccination', 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000', 'lowerLimit': '61', 'upperLimit': '85'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '0.047', 'upperLimit': '10'}]}]}, {'title': 'Serogroup C - Postvaccination', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '94', 'upperLimit': '100'}, {'value': '93', 'groupId': 'OG001', 'lowerLimit': '82', 'upperLimit': '98'}]}]}, {'title': 'Serogroup W - Prevaccination (N=40,41)', 'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000', 'lowerLimit': '56', 'upperLimit': '85'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '0.062', 'upperLimit': '13'}]}]}, {'title': 'Serogroup W - Postvaccination (N=40,41)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '91', 'upperLimit': '100'}, {'value': '93', 'groupId': 'OG001', 'lowerLimit': '80', 'upperLimit': '98'}]}]}, {'title': 'Serogroup Y - Prevaccination (N=53,54)', 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000', 'lowerLimit': '40', 'upperLimit': '68'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '7'}]}]}, {'title': 'Serogroup Y - Postvaccination (N=53,54)', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '93', 'upperLimit': '100'}, {'value': '67', 'groupId': 'OG001', 'lowerLimit': '53', 'upperLimit': '79'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Before and 1 month after 2-dose or 1-dose schedule', 'description': 'Immunogenicity was measured as the percentage of subjects with hSBA titers ≥1:8 against meningococcal serogroups A, C, W and Y, before vaccination and 1 month after 2-dose schedule of MenACWY-CRM administered at 6 and 12 months of age (MenACWY-CRM\\_6-12 M group) or 1-dose schedule administered at 12 months of age (MenACWY-CRM\\_12 M)', 'unitOfMeasure': 'Percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on PP population.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With hSBA Titers ≥1:4 or ≥1:8 Against Meningococcal Serogroup C After One Vaccination of MenC-CRM Administered at 12 Months of Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MenC-CRM_12 M_MenACWY-CRM_18 M', 'description': 'Subjects received 1 dose each of MenC-CRM (at 12 months) and MenACWY-CRM (at 12 months).\n\nSubjects also received routine vaccines: 1 dose each of PC7 (at 12 months), MMR+Varicella (at 13 months) and DTaP-Hib-IPV (at 18 months).'}], 'classes': [{'title': 'hSBA titers ≥1:4 - Prevaccination', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '9'}]}]}, {'title': 'hSBA titers ≥1:4 - Postvaccination', 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000', 'lowerLimit': '80', 'upperLimit': '98'}]}]}, {'title': 'hSBA titers ≥1:8 - Prevaccination', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '9'}]}]}, {'title': 'hSBA titers ≥1:8 - Postvaccination', 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000', 'lowerLimit': '73', 'upperLimit': '96'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Before and 1 month after MenC-CRM vaccination at 12 months', 'description': 'Immunogenicity was measured as the percentage of subjects who achieved hSBA titers ≥1:4 or ≥1:8 against meningococcal serogroup C, before and 1 month after one vaccination of MenC-CRM administered concomitantly with Prevnar at 12 months of age', 'unitOfMeasure': 'Percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on PP population.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean hSBA Titers Against Meningococcal Serogroup C After One Vaccination of MenC-CRM Administered at 12 Months of Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MenC-CRM_12 M_MenACWY-CRM_18 M', 'description': 'Subjects received 1 dose each of MenC-CRM (at 12 months) and MenACWY-CRM (at 12 months).\n\nSubjects also received routine vaccines: 1 dose each of PC7 (at 12 months), MMR+Varicella (at 13 months) and DTaP-Hib-IPV (at 18 months).'}], 'classes': [{'title': 'hSBA GMTs - Prevaccination', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '1.81', 'upperLimit': '2.21'}]}]}, {'title': 'hSBA GMTs - Postvaccination', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000', 'lowerLimit': '29', 'upperLimit': '52'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Before and 1 month after MenC-CRM vaccination at 12 months', 'description': 'The immune response was measured as the hSBA GMT against meningococcal serogroup C, before and 1 month after one vaccination of MenC-CRM administered concomitantly with Prevnar at 12 months of age', 'unitOfMeasure': 'Geometric mean titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on PP population.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With hSBA Titers ≥1:4 or ≥1:8 Against Meningococcal Serogroup A, W and Y After One Vaccination of MenACWY-CRM Administered at 18 Months of Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MenC-CRM_12 M_MenACWY-CRM_18 M', 'description': 'Subjects received 1 dose each of MenC-CRM (at 12 months) and MenACWY-CRM (at 12 months).\n\nSubjects also received routine vaccines: 1 dose each of PC7 (at 12 months), MMR+Varicella (at 13 months) and DTaP-Hib-IPV (at 18 months).'}], 'classes': [{'title': 'Serogroup A - hSBA ≥1:4 - Prevaccination', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '9'}]}]}, {'title': 'Serogroup A - hSBA ≥1:4 - Postvaccination', 'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000', 'lowerLimit': '46', 'upperLimit': '78'}]}]}, {'title': 'Serogroup W - hSBA ≥1:4 - Prevaccination (N=37)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '0.068', 'upperLimit': '14'}]}]}, {'title': 'Serogroup W - hSBA ≥1:4 - Postvaccination (N=37)', 'categories': [{'measurements': [{'value': '81', 'groupId': 'OG000', 'lowerLimit': '65', 'upperLimit': '92'}]}]}, {'title': 'Serogroup Y - hSBA ≥1:4 - Prevaccination', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '9'}]}]}, {'title': 'Serogroup Y - hSBA ≥1:4 - Postvaccination', 'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000', 'lowerLimit': '63', 'upperLimit': '90'}]}]}, {'title': 'Serogroup A - hSBA ≥1:8 - Prevaccination', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '9'}]}]}, {'title': 'Serogroup A - hSBA ≥1:8 - Postvaccination', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000', 'lowerLimit': '33', 'upperLimit': '67'}]}]}, {'title': 'Serogroup W - hSBA ≥1:8 - Prevaccination (N=37)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '0.068', 'upperLimit': '14'}]}]}, {'title': 'Serogroup W - hSBA ≥1:8 - Postvaccination (N=37)', 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000', 'lowerLimit': '59', 'upperLimit': '88'}]}]}, {'title': 'Serogroup Y - hSBA ≥1:8 - Prevaccination', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '9'}]}]}, {'title': 'Serogroup Y - hSBA ≥1:8 - Postvaccination', 'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000', 'lowerLimit': '46', 'upperLimit': '78'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Before and 1 month after MenACWY-CRM vaccination at 18 months', 'description': 'Immunogenicity was measured as the percentage of subjects who achieved hSBA titers ≥1:4 or ≥1:8 against meningococcal serogroups A, W and Y, before and 1 month after one vaccination of MenACWY-CRM administered concomitantly with Pentacel at 18 months of age', 'unitOfMeasure': 'Percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on PP population.'}, {'type': 'SECONDARY', 'title': 'hSBA GMTs Against Meningococcal Serogroups A, W and Y After One Vaccination of MenACWY-CRM Administered at 18 Months of Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MenC-CRM_12 M_MenACWY-CRM_18 M', 'description': 'Subjects received 1 dose each of MenC-CRM (at 12 months) and MenACWY-CRM (at 12 months).\n\nSubjects also received routine vaccines: 1 dose each of PC7 (at 12 months), MMR+Varicella (at 13 months) and DTaP-Hib-IPV (at 18 months).'}], 'classes': [{'title': 'Serogroup A - Prevaccination', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '1.78', 'upperLimit': '2.24'}]}]}, {'title': 'Serogroup A - Postvaccination', 'categories': [{'measurements': [{'value': '8.05', 'groupId': 'OG000', 'lowerLimit': '5.11', 'upperLimit': '13'}]}]}, {'title': 'Serogroup W - Prevaccination (N=37)', 'categories': [{'measurements': [{'value': '2.09', 'groupId': 'OG000', 'lowerLimit': '1.66', 'upperLimit': '2.64'}]}]}, {'title': 'Serogroup W - Postvaccination (N=37)', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000', 'lowerLimit': '12', 'upperLimit': '24'}]}]}, {'title': 'Serogroup Y - Prevaccination', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '1.62', 'upperLimit': '2.45'}]}]}, {'title': 'Serogroup Y - Postvaccination', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000', 'lowerLimit': '8.78', 'upperLimit': '18'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Before and 1 month after MenACWY-CRM vaccination at 18 months', 'description': 'The immune response was measured as the hSBA GMTs against meningococcal serogroups A, W and Y, before and 1 month after one vaccination of MenACWY-CRM administered concomitantly with Pentacel at 18 months of age', 'unitOfMeasure': 'Geometric mean titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on PP population.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With hSBA Titers ≥1:4 or ≥1:8 Against Meningococcal Serogroup C After MenACWY-CRM Vaccination Administered at 18 Months of Age, Following One Vaccination of MenC-CRM at 12 Months of Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MenC-CRM_12 M_MenACWY-CRM_18 M', 'description': 'Subjects received 1 dose each of MenC-CRM (at 12 months) and MenACWY-CRM (at 12 months).\n\nSubjects also received routine vaccines: 1 dose each of PC7 (at 12 months), MMR+Varicella (at 13 months) and DTaP-Hib-IPV (at 18 months).'}], 'classes': [{'title': 'hSBA ≥1:4 - Prevaccination', 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG000', 'lowerLimit': '75', 'upperLimit': '97'}]}]}, {'title': 'hSBA ≥1:4 - Postvaccination', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '91', 'upperLimit': '100'}]}]}, {'title': 'hSBA ≥1:8 - Prevaccination', 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000', 'lowerLimit': '66', 'upperLimit': '92'}]}]}, {'title': 'hSBA ≥1:8 - Postvaccination', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000', 'lowerLimit': '91', 'upperLimit': '100'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Before and 1 month after MenACWY-CRM vaccination at 18 months', 'description': 'Booster response was measured as the percentage of subjects who achieved hSBA titers ≥1:4 or ≥1:8 against meningococcal serogroup C, before and 1 month after MenACWY-CRM vaccination administered at 18 months of age, following one vaccination of MenC-CRM at 12 months of age', 'unitOfMeasure': 'Percentage of subjects', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on PP population.'}, {'type': 'SECONDARY', 'title': 'hSBA GMT Against Meningococcal Serogroup C After MenACWY-CRM Vaccination Administered at 18 Months of Age, Following One Vaccination of MenC-CRM at 12 Months of Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MenC-CRM_12 M_MenACWY-CRM_18 M', 'description': 'Subjects received 1 dose each of MenC-CRM (at 12 months) and MenACWY-CRM (at 12 months).\n\nSubjects also received routine vaccines: 1 dose each of PC7 (at 12 months), MMR+Varicella (at 13 months) and DTaP-Hib-IPV (at 18 months).'}], 'classes': [{'title': 'hSBA GMTs - Prevaccination', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000', 'lowerLimit': '20', 'upperLimit': '41'}]}]}, {'title': 'hSBA GMTs - Postvaccination', 'categories': [{'measurements': [{'value': '667', 'groupId': 'OG000', 'lowerLimit': '467', 'upperLimit': '952'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Before and 1 month after MenACWY-CRM vaccination at 18 months', 'description': 'Booster response was measured as the hSBA GMT against meningococcal serogroup C, before and 1 month after MenACWY-CRM vaccination administered at 18 months of age, following one vaccination of MenC-CRM at 12 months of age', 'unitOfMeasure': 'Geometric mean titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on PP population.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Who Reported Solicited Local and Systemic Reactions After Any MenACWY-CRM, MenC-CRM and Concomitant Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'MenACWY-CRM_6-12 M', 'description': 'Subjects received 2 doses of MenACWY-CRM at 6 and 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months).'}, {'id': 'OG001', 'title': 'MenACWY-CRM_12 M', 'description': 'Subjects received 1 dose of MenACWY-CRM at 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months).'}, {'id': 'OG002', 'title': 'MenC-CRM_12 M_MenACWY-CRM_18 M', 'description': 'Subjects received 1 dose each of MenC-CRM (at 12 months) and MenACWY-CRM (at 12 months).\n\nSubjects also received routine vaccines: 1 dose each of PC7 (at 12 months), MMR+Varicella (at 13 months) and DTaP-Hib-IPV (at 18 months).'}], 'classes': [{'title': 'Any local reactions', 'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}]}, {'title': 'MenACWY MenC Tenderness (N=64,56,50)', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}]}, {'title': 'MenACWY MenC Erythema (N=64,56,50)', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}]}, {'title': 'MenACWY MenC Induration (N=64,56,50)', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}]}, {'title': 'DTaP-Hib-IPV Tenderness (N=64,61,44)', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}]}]}, {'title': 'DTaP-Hib-IPV Erythema (N=64,61,44)', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}]}, {'title': 'DTaP-Hib-IPV Induration (N=64,61,44)', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}]}, {'title': 'PCV7 Tenderness', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}]}, {'title': 'PC7 Erythema', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}]}, {'title': 'PC7 Induration', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}]}, {'title': 'Any systemic reactions', 'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}]}]}, {'title': 'Change in eating habits (N=62,60,50)', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}]}, {'title': 'Sleepiness', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}]}, {'title': 'Irritability', 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}]}, {'title': 'Vomiting', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'Diarrhea', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': 'Fever (≥38 °C)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}]}, {'title': 'Analgesic Antipyretic Medicines Used', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From day 1 through day 7 after any vaccination', 'description': 'The safety was assessed as the number of subjects who reported solicited local and systemic reactions from day 1 through day 7 following any vaccination of MenACWY-CRM, MenC-CRM and concomitant vaccination', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis was done on the safety population, i.e. all subjects who had at least one vaccination and some postbaseline safety data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MenACWY-CRM_6-12 M', 'description': 'Subjects received 2 doses of MenACWY-CRM (1 dose at 6 and 12 months of age). Subjects also received routine vaccines: 2 doses of PC7 (1 dose at 6 and 12 months of age), 1 dose of DTaP-Hib-IPV (at 6 months of age) and 1 dose of MMR+Varicella (at 13 months of age).'}, {'id': 'FG001', 'title': 'MenACWY-CRM_12 M', 'description': 'Subjects received 1 dose of MenACWY-CRM at 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (1 dose at 6 and 12 months of age), 1 dose of DTaP-Hib-IPV (at 6 months of age) and 1 dose of MMR+Varicella (at 13 months of age).'}, {'id': 'FG002', 'title': 'MenC-CRM_12 M_MenACWY-CRM_18 M', 'description': 'Subjects received 1 dose of MenC-CRM (at 12 months of age) and 1 dose of MenACWY-CRM (at 18 months of age).\n\nSubjects also received routine vaccines: 1 dose of PCV7 (at 12 months), MMR+Varicella (at 13 months) and DTaP-Hib-IPV (at 18 months).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '64'}, {'groupId': 'FG001', 'numSubjects': '61'}, {'groupId': 'FG002', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '56'}, {'groupId': 'FG002', 'numSubjects': '42'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'Inappropriate enrollment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Unable to classify', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Subjects were enrolled at three sites in Canada.', 'preAssignmentDetails': 'All enrolled subjects were included in the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '175', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'MenACWY-CRM_6-12 M', 'description': 'Subjects received 2 doses of MenACWY-CRM at 6 and 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months).'}, {'id': 'BG001', 'title': 'MenACWY-CRM_12 M', 'description': 'Subjects received 1 dose of MenACWY-CRM at 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months).'}, {'id': 'BG002', 'title': 'MenC-CRM_12 M_MenACWY-CRM_18 M', 'description': 'Subjects received 1 dose each of MenC-CRM (at 12 months) and MenACWY-CRM (at 12 months).\n\nSubjects also received routine vaccines: 1 dose each of PC7 (at 12 months), MMR+Varicella (at 13 months) and DTaP-Hib-IPV (at 18 months).'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '6.0', 'spread': '0.2', 'groupId': 'BG000'}, {'value': '6.0', 'spread': '0.0', 'groupId': 'BG001'}, {'value': '12.1', 'spread': '0.2', 'groupId': 'BG002'}, {'value': '7.7', 'spread': '2.8', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '77', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '98', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Analysis was done for all enrolled subjects.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 175}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2006-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-10', 'studyFirstSubmitDate': '2006-04-03', 'resultsFirstSubmitDate': '2013-08-29', 'studyFirstSubmitQcDate': '2006-04-03', 'lastUpdatePostDateStruct': {'date': '2018-10-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-08-29', 'studyFirstPostDateStruct': {'date': '2006-04-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-11-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Subjects With hSBA Titers ≥1:4 Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule', 'timeFrame': 'Before and 1 month after 2-dose or 1-dose schedule', 'description': 'Immunogenicity was measured as the percentage of subjects with hSBA titers ≥1:4 against meningococcal serogroups A, C, W and Y, evaluated by serum bactericidal assay using human complement (hSBA), before vaccination and 1 month after 2-dose schedule of MenACWY-CRM administered at 6 and 12 months of age (MenACWY-CRM\\_6-12 M group) or 1-dose schedule administered at 12 months (MenACWY-CRM\\_12 M group)'}], 'secondaryOutcomes': [{'measure': 'Geometric Mean hSBA Titers Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule', 'timeFrame': 'Before and 1 month after 2-dose or 1-dose schedule', 'description': 'The immune response was measured as the hSBA geometric mean titers (GMTs) against meningococcal serogroups A, C, W and Y, before vaccination and 1 month after 2-dose schedule of MenACWY-CRM administered at 6 and 12 months of age (MenACWY-CRM\\_6-12 M group) or 1-dose schedule administered at 12 months of age (MenACWY-CRM\\_12 M group)'}, {'measure': 'Percentage of Subjects With hSBA Titers ≥1:8 Against Each of 4 Meningococcal Serogroups After MenACWY-CRM Vaccination Administered as 2-Dose or 1-Dose Schedule', 'timeFrame': 'Before and 1 month after 2-dose or 1-dose schedule', 'description': 'Immunogenicity was measured as the percentage of subjects with hSBA titers ≥1:8 against meningococcal serogroups A, C, W and Y, before vaccination and 1 month after 2-dose schedule of MenACWY-CRM administered at 6 and 12 months of age (MenACWY-CRM\\_6-12 M group) or 1-dose schedule administered at 12 months of age (MenACWY-CRM\\_12 M)'}, {'measure': 'Percentage of Subjects With hSBA Titers ≥1:4 or ≥1:8 Against Meningococcal Serogroup C After One Vaccination of MenC-CRM Administered at 12 Months of Age', 'timeFrame': 'Before and 1 month after MenC-CRM vaccination at 12 months', 'description': 'Immunogenicity was measured as the percentage of subjects who achieved hSBA titers ≥1:4 or ≥1:8 against meningococcal serogroup C, before and 1 month after one vaccination of MenC-CRM administered concomitantly with Prevnar at 12 months of age'}, {'measure': 'Geometric Mean hSBA Titers Against Meningococcal Serogroup C After One Vaccination of MenC-CRM Administered at 12 Months of Age', 'timeFrame': 'Before and 1 month after MenC-CRM vaccination at 12 months', 'description': 'The immune response was measured as the hSBA GMT against meningococcal serogroup C, before and 1 month after one vaccination of MenC-CRM administered concomitantly with Prevnar at 12 months of age'}, {'measure': 'Percentage of Subjects With hSBA Titers ≥1:4 or ≥1:8 Against Meningococcal Serogroup A, W and Y After One Vaccination of MenACWY-CRM Administered at 18 Months of Age', 'timeFrame': 'Before and 1 month after MenACWY-CRM vaccination at 18 months', 'description': 'Immunogenicity was measured as the percentage of subjects who achieved hSBA titers ≥1:4 or ≥1:8 against meningococcal serogroups A, W and Y, before and 1 month after one vaccination of MenACWY-CRM administered concomitantly with Pentacel at 18 months of age'}, {'measure': 'hSBA GMTs Against Meningococcal Serogroups A, W and Y After One Vaccination of MenACWY-CRM Administered at 18 Months of Age', 'timeFrame': 'Before and 1 month after MenACWY-CRM vaccination at 18 months', 'description': 'The immune response was measured as the hSBA GMTs against meningococcal serogroups A, W and Y, before and 1 month after one vaccination of MenACWY-CRM administered concomitantly with Pentacel at 18 months of age'}, {'measure': 'Percentage of Subjects With hSBA Titers ≥1:4 or ≥1:8 Against Meningococcal Serogroup C After MenACWY-CRM Vaccination Administered at 18 Months of Age, Following One Vaccination of MenC-CRM at 12 Months of Age', 'timeFrame': 'Before and 1 month after MenACWY-CRM vaccination at 18 months', 'description': 'Booster response was measured as the percentage of subjects who achieved hSBA titers ≥1:4 or ≥1:8 against meningococcal serogroup C, before and 1 month after MenACWY-CRM vaccination administered at 18 months of age, following one vaccination of MenC-CRM at 12 months of age'}, {'measure': 'hSBA GMT Against Meningococcal Serogroup C After MenACWY-CRM Vaccination Administered at 18 Months of Age, Following One Vaccination of MenC-CRM at 12 Months of Age', 'timeFrame': 'Before and 1 month after MenACWY-CRM vaccination at 18 months', 'description': 'Booster response was measured as the hSBA GMT against meningococcal serogroup C, before and 1 month after MenACWY-CRM vaccination administered at 18 months of age, following one vaccination of MenC-CRM at 12 months of age'}, {'measure': 'Number of Subjects Who Reported Solicited Local and Systemic Reactions After Any MenACWY-CRM, MenC-CRM and Concomitant Vaccination', 'timeFrame': 'From day 1 through day 7 after any vaccination', 'description': 'The safety was assessed as the number of subjects who reported solicited local and systemic reactions from day 1 through day 7 following any vaccination of MenACWY-CRM, MenC-CRM and concomitant vaccination'}]}, 'conditionsModule': {'keywords': ['meningitis', 'children', 'vaccine'], 'conditions': ['Meningococcal Meningitis']}, 'descriptionModule': {'briefSummary': 'To assess the immunogenicity of Novartis (formerly Chiron) Meningococcal ACWY conjugate vaccine (MenACWY) when administered as a two-dose schedule at 6 and 12 months of age.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Months', 'minimumAge': '6 Months', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nInclusion criteria for Groups I (MenACWY-CRM\\_6-12 M) and II (MenACWY-CRM\\_12 M)\n\nSubjects eligible for enrollment in the study were healthy infants:\n\n1. who were 6 months old and who were born after full-term pregnancy with an estimated gestational age of 37 weeks or greater and a birth weight 2.5 kg or greater;\n2. who previously received two doses of PC7 and DTaP-Hib-IPV vaccines;\n3. for whom a parent/legal guardian gave written informed consent, after the nature of the study was explained;\n4. who were available for all the visits scheduled in the study;\n5. who were in good health as determined by medical history, physical examination, and clinical judgment of the investigator.\n\nInclusion criteria for Group III (MenC-CRM\\_12 M\\_MenACWY-CRM\\_18 M)\n\nSubjects eligible for enrollment in the study were healthy infants:\n\n1. who were 12 months old;\n2. who previously received three doses of DTaP-Hib-IPV (Pentacel) vaccines;\n3. for whom a parent/legal guardian gave written informed consent, after the nature of the study was explained;\n4. who were available for all the visits scheduled in the study;\n5. who were in good health as determined by medical history, physical examination, and clinical judgment of the investigator.\n\nExclusion criteria:\n\nSubjects were not to be included in this study if:\n\n1. their parents/legal guardians were unwilling or unable to give written informed consent to participate in the study;\n2. they previously received any meningococcal vaccine;\n3. they had a previously ascertained or suspected disease caused by Neisseria meningitidis (N meningitidis);\n4. they had a history of any anaphylactic shock, asthma, urticaria, or other allergic reaction after previous vaccinations or known hypersensitivity to any vaccine component;\n5. they had experienced significant acute or chronic infection within the previous 7 days or had experienced fever (38.0ºC or greater) within the previous 3 days;\n6. they had any present or suspected serious acute disease (e.g., leukemia, lymphomas), or chronic disease (e.g., with signs of cardiac failure, renal failure, severe malnutrition, or insulin-dependent diabetes), or progressive neurological disease, or a genetic anomaly/known cytogenic disorders (e.g., Down's syndrome), or who had a diagnosed cardiac defect or abnormality of hemodynamic significance (e.g., ventricular septal defect, patent ductus arteriosus, or atrial septal defect);\n7. they had a known or suspected autoimmune disease or impairment /alteration of immune function resulting from use of (for example):\n\n * any immunosuppressive therapy since birth;\n * immunostimulants since birth;\n * any systemic corticosteroid administered for more than 5 days or in a daily dose of greater than 1 mg/kg/day prednisone or equivalent for 5 days or less in the previous 30 days;\n8. they had a suspected or known HIV infection or HIV-related disease;\n9. they had received parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within the past 90 days and were expected to receive it for the full length of the study;\n10. they had a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time;\n11. they had a history of seizure disorder:\n\n * febrile seizure;\n * any other seizure disorder;\n12. they had taken systemic antibiotics (either oral or parenteral) within the previous 14 days (EXCEPTION: subjects who had received an oral or parenteral β-lactam antibiotic \\[e.g.: penicillin, amoxicillin, ceftriaxone, cefuroxime or cephalexin\\] could have been enrolled 7 days following the last dose);\n13. their parents/legal guardians were planning to leave the area of the study center before the end of the study period;\n14. they had any condition which, in the opinion of the investigator, might have interfered with the evaluation of the study objectives."}, 'identificationModule': {'nctId': 'NCT00310856', 'briefTitle': 'Immunogenicity and Safety of MenACWY in Infants (6 & 12 Months)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Phase 2, Partially Randomized, Open Label, Multicenter Study to Evaluate the Safety and Immunogenicity After One or Two Doses of Novartis (Formerly Chiron) Meningococcal ACWY Conjugate Vaccine Administered to Healthy Infants and Young Children', 'orgStudyIdInfo': {'id': 'V59P9'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MenACWY-CRM_6-12 M', 'description': 'Subjects received 2 doses of MenACWY-CRM (1 dose at 6 and 12 months of age). Subjects also received routine vaccines: 2 doses of PC7 (1 dose at 6 and 12 months of age), 1 dose of DTaP-Hib-IPV (at 6 months of age) and 1 dose of MMR+Varicella (at 13 months of age)', 'interventionNames': ['Biological: MenACWY-CRM', 'Biological: DTaP-Hib-IPV', 'Biological: PC7', 'Biological: MMR', 'Biological: Varicella']}, {'type': 'EXPERIMENTAL', 'label': 'MenACWY-CRM_12 M', 'description': 'Subjects received 1 dose of MenACWY-CRM at 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (1 dose at 6 and 12 months of age), 1 dose of DTaP-Hib-IPV (at 6 months of age) and 1 dose of MMR+Varicella (at 13 months of age)', 'interventionNames': ['Biological: MenACWY-CRM', 'Biological: DTaP-Hib-IPV', 'Biological: PC7', 'Biological: MMR', 'Biological: Varicella']}, {'type': 'EXPERIMENTAL', 'label': 'MenC-CRM_12 M_MenACWY-CRM_18 M', 'description': 'Subjects received 1 dose of MenC-CRM (at 12 months of age) and 1 dose of MenACWY-CRM (at 18 months of age).\n\nSubjects also received routine vaccines: 1 dose of PCV7 (at 12 months), MMR+Varicella (at 13 months) and DTaP-Hib-IPV (at 18 months)', 'interventionNames': ['Biological: MenACWY-CRM', 'Biological: MenC-CRM', 'Biological: DTaP-Hib-IPV', 'Biological: PC7', 'Biological: MMR', 'Biological: Varicella']}], 'interventions': [{'name': 'MenACWY-CRM', 'type': 'BIOLOGICAL', 'otherNames': ['Meningococcal ACWY conjugate vaccine'], 'description': 'Subjects received the full dose (0.5 mL) of MenACWY-CRM, obtained by extemporaneous mixing of lyophilized MenA powder component and the MenCWY suspension, administered by IM injection into the anterolateral area of the right thigh.', 'armGroupLabels': ['MenACWY-CRM_12 M', 'MenACWY-CRM_6-12 M', 'MenC-CRM_12 M_MenACWY-CRM_18 M']}, {'name': 'MenC-CRM', 'type': 'BIOLOGICAL', 'otherNames': ['Meningococcal C conjugate vaccine'], 'description': 'One dose (0.5 mL) of MenC-CRM was obtained by extemporaneous mixing just before injection of the lyophilized MenC component and a saline solvent, administered by IM injection into the arm region.', 'armGroupLabels': ['MenC-CRM_12 M_MenACWY-CRM_18 M']}, {'name': 'DTaP-Hib-IPV', 'type': 'BIOLOGICAL', 'otherNames': ['Combined vaccine containing diphtheria, tetanus, pertussis, Haemophilus influenzae type B and inactivated polio virus; Pentacel'], 'armGroupLabels': ['MenACWY-CRM_12 M', 'MenACWY-CRM_6-12 M', 'MenC-CRM_12 M_MenACWY-CRM_18 M']}, {'name': 'PC7', 'type': 'BIOLOGICAL', 'otherNames': ['Heptavalent conjugate pneumococcal; Prevnar'], 'description': 'One dose (0.5 mL) of PC7, supplied in pre-filled syringe, administered by IM injection into the anterolateral area of the left thigh.', 'armGroupLabels': ['MenACWY-CRM_12 M', 'MenACWY-CRM_6-12 M', 'MenC-CRM_12 M_MenACWY-CRM_18 M']}, {'name': 'MMR', 'type': 'BIOLOGICAL', 'otherNames': ['Measles, mumps and rubella'], 'armGroupLabels': ['MenACWY-CRM_12 M', 'MenACWY-CRM_6-12 M', 'MenC-CRM_12 M_MenACWY-CRM_18 M']}, {'name': 'Varicella', 'type': 'BIOLOGICAL', 'armGroupLabels': ['MenACWY-CRM_12 M', 'MenACWY-CRM_6-12 M', 'MenC-CRM_12 M_MenACWY-CRM_18 M']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'K1H 8L1', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': "Children's Hospital of Eastern Ontario Research Institute", 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'K1S 0G8', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Herridge Community Health Clinic', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'B3K 6R8', 'city': 'Halifax', 'country': 'Canada', 'facility': 'Clinical Trials Research Center, Department of Pediatrics, Dalhousie University, IWK Health Center', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}], 'overallOfficials': [{'name': 'Scott Halperin, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Novartis Vaccines & Diagnostics'}, {'name': 'Francisco Diaz-Mitoma, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Novartis Vaccines'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Vaccines', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}