Ignite Creation Date:
2025-12-24 @ 3:18 PM
Ignite Modification Date:
2026-01-02 @ 5:15 AM
Study NCT ID:
NCT00422292
Status:
COMPLETED
Last Update Posted:
2016-04-14
First Post:
2007-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Immunogenicity and Safety of Pediatric Vaccines When Administered With Menactra® in Healthy Toddlers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008585', 'term': 'Meningitis, Meningococcal'}, {'id': 'D008457', 'term': 'Measles'}, {'id': 'D009107', 'term': 'Mumps'}, {'id': 'D012409', 'term': 'Rubella'}, {'id': 'D002644', 'term': 'Chickenpox'}, {'id': 'D006192', 'term': 'Haemophilus Infections'}], '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': 'D008581', 'term': 'Meningitis'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}, {'id': 'D018185', 'term': 'Morbillivirus Infections'}, {'id': 'D018184', 'term': 'Paramyxoviridae Infections'}, {'id': 'D018701', 'term': 'Mononegavirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D019351', 'term': 'Rubulavirus Infections'}, {'id': 'D010309', 'term': 'Parotitis'}, {'id': 'D010305', 'term': 'Parotid Diseases'}, {'id': 'D012466', 'term': 'Salivary Gland Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D018355', 'term': 'Rubivirus Infections'}, {'id': 'D014036', 'term': 'Togaviridae Infections'}, {'id': 'D000073618', 'term': 'Varicella Zoster Virus Infection'}, {'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D016871', 'term': 'Pasteurellaceae Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D022401', 'term': 'Meningococcal Vaccines'}, {'id': 'C050102', 'term': 'measles, mumps, rubella, varicella vaccine'}], 'ancestors': [{'id': 'D001428', 'term': 'Bacterial Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'RegistryContactUs@sanofipasteur.com', 'title': 'Medical Director', 'organization': 'Sanofi Pasteur Inc.'}, 'certainAgreement': {'otherDetails': 'Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events data were collected for 6 months after the last vaccination.', 'eventGroups': [{'id': 'EG000', 'title': 'Group 1: Menactra® at 9 and 12 Months', 'description': 'Participants who received only Menactra® vaccination at 9 and 12 months of age', 'otherNumAtRisk': 257, 'otherNumAffected': 91, 'seriousNumAtRisk': 257, 'seriousNumAffected': 14}, {'id': 'EG001', 'title': 'Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Month', 'description': 'Participants who received Menactra® at 9 months of age and Menactra® plus measles, mumps, rubella, varicella (MMRV or MMR+V) vaccine at 12 months of age', 'otherNumAtRisk': 664, 'otherNumAffected': 185, 'seriousNumAtRisk': 616, 'seriousNumAffected': 24}, {'id': 'EG002', 'title': 'Group 3: Menactra® at 12 Months; Menactra® + PCV at 12 Months', 'description': 'Participants who received Menactra® at 9 months of age and Menactra® plus pneumococcal conjugate vaccine (PCV) at 12 months of age', 'otherNumAtRisk': 246, 'otherNumAffected': 77, 'seriousNumAtRisk': 246, 'seriousNumAffected': 10}, {'id': 'EG003', 'title': 'Group 4: MMRV + PCV at 12 Months', 'description': 'Participants who received no vaccination at 9 months of age and measles, mumps, rubella, varicella (MMRV) vaccine plus pneumococcal conjugate vaccine (PCV) at 12 months of age', 'otherNumAtRisk': 476, 'otherNumAffected': 148, 'seriousNumAtRisk': 476, 'seriousNumAffected': 17}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 21, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 664, 'numEvents': 42, 'numAffected': 38}, {'groupId': 'EG002', 'numAtRisk': 246, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 476, 'numEvents': 33, 'numAffected': 29}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Teething', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 16, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 664, 'numEvents': 32, 'numAffected': 27}, {'groupId': 'EG002', 'numAtRisk': 246, 'numEvents': 20, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 476, 'numEvents': 17, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 664, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 246, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 476, 'numEvents': 51, 'numAffected': 48}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 664, 'numEvents': 18, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 246, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 476, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 25, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 664, 'numEvents': 52, 'numAffected': 52}, {'groupId': 'EG002', 'numAtRisk': 246, 'numEvents': 22, 'numAffected': 22}, {'groupId': 'EG003', 'numAtRisk': 476, 'numEvents': 20, 'numAffected': 20}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 22, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 664, 'numEvents': 51, 'numAffected': 50}, {'groupId': 'EG002', 'numAtRisk': 246, 'numEvents': 26, 'numAffected': 25}, {'groupId': 'EG003', 'numAtRisk': 476, 'numEvents': 19, 'numAffected': 19}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 664, 'numEvents': 29, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 246, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 476, 'numEvents': 16, 'numAffected': 16}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 664, 'numEvents': 27, 'numAffected': 25}, {'groupId': 'EG002', 'numAtRisk': 246, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 476, 'numEvents': 22, 'numAffected': 22}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}], 'seriousEvents': [{'term': 'Congenital spinal cord anomaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 476, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 476, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Intussusception', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 476, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Melaena', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 476, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Bacterial sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 476, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 476, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Croup infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 246, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 476, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Febrile infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 476, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 246, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 476, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 476, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Infected Cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 476, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': "Kawasaki's diseas", 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 476, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Lobar pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 476, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Otitis media acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 246, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 476, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Periorbital cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 476, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Periumbilical abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 476, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 476, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Pneumonia respiratory syncytial viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 476, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Respiratory syncytial virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 476, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Respiratory tract infection viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 246, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 476, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Staphylococcal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 246, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 476, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Staphylococcal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 246, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 476, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Streptococcal bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 476, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Subcutaneous abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 246, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 476, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 476, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Accidental overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 476, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Closed head injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 476, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Foreign body trauma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 476, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 476, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Failure to thrive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 476, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Craniosynostosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 476, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Autism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 476, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 476, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Febrile convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 246, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 476, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Myoclonic epilepsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 246, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 476, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 476, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}, {'term': 'Bronchial hyperactivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 257, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 616, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 246, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 476, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.0'}], 'frequencyThreshold': '5.0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Measles, Mumps, Rubella, and Varicella (MMRV) Antibody Values in Participants Who Received MMRV Vaccine (Groups 2 and 4 Only)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '498', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '399', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Menactra® at 9 and 12 Months', 'description': 'Participants who received only Menactra® vaccination at 9 and 12 months of age'}, {'id': 'OG001', 'title': 'Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months', 'description': 'Participants who received Menactra® at 9 months of age and Menactra® plus measles, mumps, rubella, varicella (MMRV or MMR+V) vaccine at 12 months of age'}, {'id': 'OG002', 'title': 'Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months', 'description': 'Participants who received Menactra® at 9 months of age and Menactra® plus pneumococcal conjugate vaccine (PCV) at 12 months of age'}, {'id': 'OG003', 'title': 'Group 4: MMRV + PCV at 12 Months', 'description': 'Participants who received no vaccination at 9 months of age and measles, mumps, rubella, varicella (MMRV) vaccine plus pneumococcal conjugate vaccine (PCV) at 12 months of age'}], 'classes': [{'title': 'Measles', 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG003'}]}]}, {'title': 'Mumps', 'categories': [{'measurements': [{'value': '95', 'groupId': 'OG001'}, {'value': '95', 'groupId': 'OG003'}]}]}, {'title': 'Rubella', 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG001'}, {'value': '88', 'groupId': 'OG003'}]}]}, {'title': 'Varicella', 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG001'}, {'value': '87', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 30 after the 12-month vaccination', 'description': 'Percentage of participants who had a concentration of ≥ 300 mIU/mL in the enzyme-linked immunosorbent assay (ELISA) or ≥ 120 mIU/mL in the neutralization when the ELISA concentration was less than 300 mIU/mL - for measles; ≥ 500 U/mL (ELISA) or ≥ 60 (1/dil) in the neutralization assay when the ELISA concentration was less than 500 mIU/mL - for mumps; ≥ 10 IU/mL (ELISA) - for Rubella; and ≥ 300 mIU/mL (ELISA) or ≥ 4 (1/dil) Fluorescent antibody to membrane antigen (FAMA) when the ELISA concentration was less than 300 mIU/mL - for varicella.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Antibody responses were evaluated in the per-protocol population.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Concentrations (GMCs) of Anti-Pneumococcal Antibodies After Pneumococcal Conjugated Vaccine (PCV) in Groups 3 and 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '191', 'groupId': 'OG002'}, {'value': '399', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Menactra® at 9 and 12 Months', 'description': 'Participants who received only Menactra® vaccination at 9 and 12 months of age'}, {'id': 'OG001', 'title': 'Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months', 'description': 'Participants who received Menactra® at 9 months of age and Menactra® plus measles, mumps, rubella, varicella (MMRV or MMR+V) vaccine at 12 months of age'}, {'id': 'OG002', 'title': 'Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months', 'description': 'Participants who received Menactra® at 9 months of age and Menactra® plus pneumococcal conjugate vaccine (PCV) at 12 months of age'}, {'id': 'OG003', 'title': 'Group 4: MMRV + PCV at 12 Months', 'description': 'Participants who received no vaccination at 9 months of age and measles, mumps, rubella, varicella (MMRV) vaccine plus pneumococcal conjugate vaccine (PCV) at 12 months of age'}], 'classes': [{'title': 'Serotype 4', 'categories': [{'measurements': [{'value': '1.82', 'groupId': 'OG002', 'lowerLimit': '1.62', 'upperLimit': '2.05'}, {'value': '3.33', 'groupId': 'OG003', 'lowerLimit': '3.06', 'upperLimit': '3.62'}]}]}, {'title': 'Serotype 6B', 'categories': [{'measurements': [{'value': '5.40', 'groupId': 'OG002', 'lowerLimit': '4.79', 'upperLimit': '6.09'}, {'value': '10.8', 'groupId': 'OG003', 'lowerLimit': '9.89', 'upperLimit': '11.7'}]}]}, {'title': 'Serotype 9V', 'categories': [{'measurements': [{'value': '2.06', 'groupId': 'OG002', 'lowerLimit': '1.84', 'upperLimit': '2.30'}, {'value': '3.57', 'groupId': 'OG003', 'lowerLimit': '3.29', 'upperLimit': '3.88'}]}]}, {'title': 'Serotype 14', 'categories': [{'measurements': [{'value': '6.73', 'groupId': 'OG002', 'lowerLimit': '5.95', 'upperLimit': '7.60'}, {'value': '10.5', 'groupId': 'OG003', 'lowerLimit': '9.65', 'upperLimit': '11.3'}]}]}, {'title': 'Serotype 18C', 'categories': [{'measurements': [{'value': '1.58', 'groupId': 'OG002', 'lowerLimit': '1.43', 'upperLimit': '1.75'}, {'value': '2.91', 'groupId': 'OG003', 'lowerLimit': '2.66', 'upperLimit': '3.18'}]}]}, {'title': 'Serotype 19F', 'categories': [{'measurements': [{'value': '2.50', 'groupId': 'OG002', 'lowerLimit': '2.24', 'upperLimit': '2.78'}, {'value': '4.03', 'groupId': 'OG003', 'lowerLimit': '3.74', 'upperLimit': '4.34'}]}]}, {'title': 'Serotype 23F', 'categories': [{'measurements': [{'value': '4.62', 'groupId': 'OG002', 'lowerLimit': '4.06', 'upperLimit': '5.25'}, {'value': '7.03', 'groupId': 'OG003', 'lowerLimit': '6.39', 'upperLimit': '7.73'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 30 after the 12-month vaccination', 'unitOfMeasure': 'Titers', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Geometric Mean Concentrations (GMCs) were determined in the per-protocol population Group 3 and Group 4.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With Anti-Pneumococcal Concentrations ≥ 0.35 μg/mL After Pneumococcal Conjugate Vaccine (PCV) in Group 3 and Group 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '191', 'groupId': 'OG002'}, {'value': '399', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Menactra® at 9 and 12 Months', 'description': 'Participants who received only Menactra® vaccination at 9 and 12 months of age'}, {'id': 'OG001', 'title': 'Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months', 'description': 'Participants who received Menactra® at 9 months of age and Menactra® plus measles, mumps, rubella, varicella (MMRV or MMR+V) vaccine at 12 months of age'}, {'id': 'OG002', 'title': 'Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months', 'description': 'Participants who received Menactra® at 9 months of age and Menactra® plus pneumococcal conjugate vaccine (PCV) at 12 months of age'}, {'id': 'OG003', 'title': 'Group 4: MMRV + PCV at 12 Months', 'description': 'Participants who received no vaccination at 9 months of age and measles, mumps, rubella, varicella (MMRV) vaccine plus pneumococcal conjugate vaccine (PCV) at 12 months of age'}], 'classes': [{'title': 'Serotype 4', 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG002'}, {'value': '99', 'groupId': 'OG003'}]}]}, {'title': 'Serotype 6B', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}]}, {'title': 'Serotype 9V', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}]}, {'title': 'Serotype 14', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}]}, {'title': 'Serotype18C', 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG002'}, {'value': '99', 'groupId': 'OG003'}]}]}, {'title': 'Serotype 19F', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}]}, {'title': 'Serotype 23F', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG002'}, {'value': '100', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 30 after 12-month vaccination', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'OG000'}, {'value': '616', 'groupId': 'OG001'}, {'value': '246', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Menactra® at 9 and 12 Months', 'description': 'Participants who received only Menactra® vaccination at 9 and 12 months of age'}, {'id': 'OG001', 'title': 'Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months', 'description': 'Participants who received Menactra® at 9 months of age and Menactra® plus measles, mumps, rubella, varicella (MMRV or MMR+V) vaccine at 12 months of age'}, {'id': 'OG002', 'title': 'Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months', 'description': 'Participants who received Menactra® at 9 months of age and Menactra® plus pneumococcal conjugate vaccine (PCV) at 12 months of age'}, {'id': 'OG003', 'title': 'Group 4: MMRV + PCV at 12 Months', 'description': 'Participants who received no vaccination at 9 months of age and measles, mumps, rubella, varicella (MMRV) vaccine plus pneumococcal conjugate vaccine (PCV) at 12 months of age'}], 'classes': [{'title': 'Any Solicited Injection Site Reacton', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}]}]}, {'title': 'Any Tenderness', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Tenderness (Cries when limb is moved)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Any Erythema', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Erythema (≥ 2.0 in)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Any Swelling', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Swelling (≥ 2.0 in)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Any Solicited Systemic Reaction', 'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}]}]}, {'title': 'Any Fever', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Fever (> 103.1 ºF or > 39.5 ºC)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Any Vomiting', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Vomiting', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Any Crying Abnormal', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Crying Abnormal (> 3 hours)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Any Irritability', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Irritability (Inconsolable)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Any Drowsiness', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Drowsiness (Sleeps most of time)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Any Appetite Lost', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}]}, {'title': 'Grade 3 Appetite Lost (Refuses ≥ 3 feeds/meals)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 0 to 7 after vaccination', 'description': 'Solicited injection site reactions: Injection site tenderness, injection site erythema, and injection site swelling.\n\nSolicited systemic reactions: Fever (temperature), vomiting, crying abnormal, drowsiness, appetite lost, and irritability.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'OG000'}, {'value': '572', 'groupId': 'OG001'}, {'value': '246', 'groupId': 'OG002'}, {'value': '476', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Group 1: Menactra® at 9 and 12 Months', 'description': 'Participants who received only Menactra® vaccination at 9 and 12 months of age'}, {'id': 'OG001', 'title': 'Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months', 'description': 'Participants who received Menactra® at 9 months of age and Menactra® plus measles, mumps, rubella, varicella (MMRV or MMR+V) vaccine at 12 months of age'}, {'id': 'OG002', 'title': 'Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months', 'description': 'Participants who received Menactra® at 9 months of age and Menactra® plus pneumococcal conjugate vaccine (PCV) at 12 months of age'}, {'id': 'OG003', 'title': 'Group 4: MMRV + PCV at 12 Months', 'description': 'Participants who received no vaccination at 9 months of age and measles, mumps, rubella, varicella (MMRV) vaccine plus pneumococcal conjugate vaccine (PCV) at 12 months of age'}], 'classes': [{'title': 'Any Solicited Injection Site Reaction - Menactra', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Any Tenderness', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '51', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Tenderness (Cries when limb is moved)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Any Erythema', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Erythema (≥ 2.0 in)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Any Swelling', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Swelling (≥ 2.0 in)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Any Solicited Injection Site Reaction - MMRV', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}]}, {'title': 'Any Tenderness', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Tenderness (Cries when limb is moved)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Any Erythema', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Erythema (≥ 2.0 in)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Any Swelling', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Swelling (≥ 2.0 in)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Any Solicited Injection Site Reaction - PCV', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}]}, {'title': 'Any Tenderness', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Tenderness (Cries when limb is moved)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Any Erythema', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Erythema (≥ 2.0 in)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Any Swelling', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Swelling (≥ 2.0 in)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Any Solicited Systemic Reaction', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}, {'value': '77', 'groupId': 'OG003'}]}]}, {'title': 'Any Fever', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Fever (> 103.1 ºF or > 39.5 ºC)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Any Vomiting', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Vomiting', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Any Crying Abnormal', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Crying Abnormal (> 3 hours)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Any Irritability', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '62', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Irritability (Inconsolable)', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'Any Drowsiness', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Drowsiness (Sleeps most of time)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Any Appetite Lost', 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}]}, {'title': 'Grade 3 Appetite Lost (Refuses ≥ 3 feeds/meals)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 0 to 7 after vaccination', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Solicited Injection Site and Systemic Reactions were assessed in the intend-to-treat population.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group 1: Menactra® at 9 and 12 Months', 'description': 'Participants who received only Menactra® vaccination at 9 and 12 months of age'}, {'id': 'FG001', 'title': 'Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months', 'description': 'Participants who received Menactra® at 9 months of age and Menactra® plus measles, mumps, rubella, varicella (MMRV or MMR+V) vaccine at 12 months of age'}, {'id': 'FG002', 'title': 'Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months', 'description': 'Participants who received Menactra® at 9 months of age and Menactra® plus pneumococcal conjugate vaccine (PCV) at 12 months of age'}, {'id': 'FG003', 'title': 'Group 4: MMRV + PCV at 12 Months', 'description': 'Participants who received no vaccination at 9 months of age and measles, mumps, rubella, varicella (MMRV) vaccine plus pneumococcal conjugate vaccine (PCV) at 12 months of age'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '257'}, {'groupId': 'FG001', 'numSubjects': '664'}, {'groupId': 'FG002', 'numSubjects': '246'}, {'groupId': 'FG003', 'numSubjects': '476'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '239'}, {'groupId': 'FG001', 'numSubjects': '598'}, {'groupId': 'FG002', 'numSubjects': '224'}, {'groupId': 'FG003', 'numSubjects': '452'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '66'}, {'groupId': 'FG002', 'numSubjects': '22'}, {'groupId': 'FG003', 'numSubjects': '24'}]}], 'dropWithdraws': [{'type': 'Serious adverse events', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '13'}]}]}], 'recruitmentDetails': 'Participants were enrolled from 15 January 2007 to 16 March 2008 in 92 clinical centers in the US.', 'preAssignmentDetails': 'A total of 2289 participants who met the inclusion and exclusion criteria were enrolled and vaccinated; 1643 were included in the final analyses presented.\n\n625 participants that got ActHIB as part of their 12 month study vaccinations prior to Protocol Amendment 2 approval were excluded from all analyses and presented in a separate report.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '257', 'groupId': 'BG000'}, {'value': '664', 'groupId': 'BG001'}, {'value': '246', 'groupId': 'BG002'}, {'value': '476', 'groupId': 'BG003'}, {'value': '1643', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Group 1: Menactra® at 9 and 12 Months', 'description': 'Participants who received only Menactra® vaccination at 9 and 12 months of age'}, {'id': 'BG001', 'title': 'Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months', 'description': 'Participants who received Menactra® at 9 months of age and Menactra® plus measles, mumps, rubella, varicella (MMRV or MMR+V) vaccine at 12 months of age'}, {'id': 'BG002', 'title': 'Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months', 'description': 'Participants who received Menactra® at 9 months of age and Menactra® plus pneumococcal conjugate vaccine (PCV) at 12 months of age'}, {'id': 'BG003', 'title': 'Group 4: MMRV + PCV at 12 Months', 'description': 'Participants who received no vaccination at 9 months of age and measles, mumps, rubella, varicella (MMRV) vaccine plus pneumococcal conjugate vaccine (PCV) at 12 months of age'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '257', 'groupId': 'BG000'}, {'value': '664', 'groupId': 'BG001'}, {'value': '246', 'groupId': 'BG002'}, {'value': '476', 'groupId': 'BG003'}, {'value': '1643', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '283.4', 'spread': '11.3', 'groupId': 'BG000'}, {'value': '283.0', 'spread': '11.3', 'groupId': 'BG001'}, {'value': '282.8', 'spread': '10.3', 'groupId': 'BG002'}, {'value': '374.8', 'spread': '8.6', 'groupId': 'BG003'}, {'value': '283.4', 'spread': '11.3', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Days', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '119', 'groupId': 'BG000'}, {'value': '349', 'groupId': 'BG001'}, {'value': '118', 'groupId': 'BG002'}, {'value': '231', 'groupId': 'BG003'}, {'value': '817', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '138', 'groupId': 'BG000'}, {'value': '315', 'groupId': 'BG001'}, {'value': '128', 'groupId': 'BG002'}, {'value': '245', 'groupId': 'BG003'}, {'value': '826', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '257', 'groupId': 'BG000'}, {'value': '664', 'groupId': 'BG001'}, {'value': '246', 'groupId': 'BG002'}, {'value': '476', 'groupId': 'BG003'}, {'value': '1643', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1664}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'dispFirstSubmitDate': '2010-03-31', 'completionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-12', 'studyFirstSubmitDate': '2007-01-12', 'dispFirstSubmitQcDate': '2010-03-31', 'resultsFirstSubmitDate': '2011-05-10', 'studyFirstSubmitQcDate': '2007-01-12', 'dispFirstPostDateStruct': {'date': '2010-04-02', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2016-04-14', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-05-10', 'studyFirstPostDateStruct': {'date': '2007-01-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-06-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Percentage of Participants With Anti-Pneumococcal Concentrations ≥ 0.35 μg/mL After Pneumococcal Conjugate Vaccine (PCV) in Group 3 and Group 4', 'timeFrame': 'Day 30 after 12-month vaccination'}, {'measure': 'Percentage of Participants Reporting a Solicited Injection Site and Systemic Reactions After Menactra® Vaccination at 9 Months of Age', 'timeFrame': 'Days 0 to 7 after vaccination', 'description': 'Solicited injection site reactions: Injection site tenderness, injection site erythema, and injection site swelling.\n\nSolicited systemic reactions: Fever (temperature), vomiting, crying abnormal, drowsiness, appetite lost, and irritability.'}, {'measure': 'Percentage of Participants With Solicited Injection Site and Systemic Reactions After Vaccination at 12 Months of Age', 'timeFrame': 'Days 0 to 7 after vaccination'}], 'primaryOutcomes': [{'measure': 'Measles, Mumps, Rubella, and Varicella (MMRV) Antibody Values in Participants Who Received MMRV Vaccine (Groups 2 and 4 Only)', 'timeFrame': 'Day 30 after the 12-month vaccination', 'description': 'Percentage of participants who had a concentration of ≥ 300 mIU/mL in the enzyme-linked immunosorbent assay (ELISA) or ≥ 120 mIU/mL in the neutralization when the ELISA concentration was less than 300 mIU/mL - for measles; ≥ 500 U/mL (ELISA) or ≥ 60 (1/dil) in the neutralization assay when the ELISA concentration was less than 500 mIU/mL - for mumps; ≥ 10 IU/mL (ELISA) - for Rubella; and ≥ 300 mIU/mL (ELISA) or ≥ 4 (1/dil) Fluorescent antibody to membrane antigen (FAMA) when the ELISA concentration was less than 300 mIU/mL - for varicella.'}, {'measure': 'Geometric Mean Concentrations (GMCs) of Anti-Pneumococcal Antibodies After Pneumococcal Conjugated Vaccine (PCV) in Groups 3 and 4', 'timeFrame': 'Day 30 after the 12-month vaccination'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Menactra vaccine', 'Meningococcal meningitis', 'Measles', 'Mumps', 'Rubella', 'Varicella vaccines', 'Haemophilus influenzae type b', 'Pneumococcal conjugate vaccine'], 'conditions': ['Meningococcal Meningitis', 'Measles', 'Mumps', 'Rubella', 'Varicella']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.sanofipasteur.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This is a modified single-blind, randomized, parallel-group, comparative, multicenter study to test Menactra vaccine in toddlers.\n\nPrimary Objectives:\n\n* To evaluate the antibody responses induced by Measles, Mumps, Rubella, and Varicella (MMRV) vaccine when administered alone or concomitantly with Menactra vaccine.\n* To evaluate the antibody responses induced by Pneumococcal Conjugated Vaccine (PCV) when administered alone or concomitantly with Menactra vaccine.\n\nObservational Objectives:\n\nSafety - To describe the safety profile throughout the course of the study from Day 0 up to 6 months after the last study vaccination\\[s\\]) in subjects in the study groups.\n\nImmunogenicity:\n\n\\- To describe the antibody responses to meningococcal serogroups A, C, Y, and W-135, 30 days after the first and second Menactra vaccine administration in a subset of subjects in the first study group.', 'detailedDescription': 'No meningococcal vaccine is presently licensed for the population aged \\< 2 years in the US, establishing the effectiveness of a quadrivalent polysaccharide conjugate vaccine against invasive meningococcal disease in children aged \\< 2 years would address this important, currently unmet public health need.\n\nAt enrollment, each 9-month old subject will be randomly assigned to a study group and vaccinated. A second vaccination will be administered at 12 months of age. Subjects will provide one blood sample during the trial.\n\nTwelve-month old subjects will also be vaccinated with routine pediatric vaccines and provide one blood sample 30 days after vaccinations in the control group'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Months', 'minimumAge': '9 Months', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria :\n\n* Healthy, as determined by medical history and physical examination\n* Aged 9 months (249 to 291 days) for Groups 1, 2, and 3 or aged 12 months (365 to 386 days) for Group 4 at the time of enrollment\n* The parent or legal guardian has signed and dated the Institutional Review Board (IRB)-approved informed consent form.\n\nExclusion Criteria :\n\n* Serious acute or chronic disease (e.g., cardiac, renal, metabolic, rheumatologic, psychiatric, hematologic, autoimmune disorders, diabetes, atopic conditions, congenital defects, convulsions, encephalopathy, blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic system, acute untreated tuberculosis) that could interfere with trial conduct or completion\n* Known or suspected impairment of immunologic function\n* Acute medical illness within the last 72 hours or a temperature ≥ 100.4ºF (≥38.0ºC) at the time of enrollment.\n* History of documented invasive meningococcal disease or previous meningococcal vaccination.\n* Known human immunodeficiency virus (HIV), hepatitis B, or hepatitis C seropositivity as reported by the parent or legal guardian\n* Received either immune globulin or other blood products within the last 3 months, or received injected or oral corticosteroids, or other immunomodulator therapy within 6 weeks of the study vaccines. Individuals on a tapering dose schedule of oral steroids lasting \\< 7 days and individuals (e.g., asthmatics) on a short schedule of oral steroids lasting 3 to 4 days may be included in the trial as long as they have not received more than one course within the last two weeks prior to enrollment. Topical steroids are not included in this exclusion criterion.\n* Anticipated to receive oral or injected antibiotic therapy within the 72 hours prior to any blood draw. Topical antibiotics and antibiotic drops are not included in this exclusion criterion.\n* Suspected or known hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the study vaccines or a vaccine containing the same substances. For ProQuad vaccine recipients, this includes a hypersensitivity to gelatin or a history of anaphylactic reactions to neomycin.\n* Thrombocytopenia or a bleeding disorder contraindicating intramuscular (IM) vaccination.\n* Parent or legal guardian unable or unwilling to comply with the study procedures\n* Participation in another interventional clinical trial in the 30 days preceding enrollment or planned participation in another clinical trial involving the investigation of a drug, vaccine, medical procedure, or medical device during the subject's trial period.\n* Diagnosed with any condition, which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine\n* Received any vaccine in the 30-day period prior to receipt of the study vaccines, or scheduled to receive any vaccination other than influenza vaccination and hyposensitization therapy in the 30-day period after receipt of the study vaccines. Hyposensitization therapy and influenza vaccination may be received up to two weeks before or two weeks after receiving the study vaccines. Subjects should not have received their fourth dose of Pneumococcal conjugate vaccine (PCV) or Haemophilus influenzae type b (Hib) vaccine or their first dose of Measles, mumps, rubella, varicella (MMRV) vaccine before enrollment or been scheduled to receive these vaccines outside of the study-specified visits.\n* Personal or family history of Guillain-Barré Syndrome (GBS)\n* History of seizures, including febrile seizures, or any other neurologic disorder\n* Known hypersensitivity to dry natural rubber latex."}, 'identificationModule': {'nctId': 'NCT00422292', 'briefTitle': 'Immunogenicity and Safety of Pediatric Vaccines When Administered With Menactra® in Healthy Toddlers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'An Immunogenicity, Safety, and Non-Interference Evaluation of Pediatric Vaccines Administered Concomitantly With Menactra® (Meningococcal [Groups A, C, Y and W-135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine) to Healthy Toddlers', 'orgStudyIdInfo': {'id': 'MTA37'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Menactra® at 9 and 12 Months', 'description': 'Participants will received Menactra® vaccination at 9 and 12 months of age.', 'interventionNames': ['Biological: Meningococcal Polysaccharide Diphtheria Conjugate Vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'Menactra® at 9 Months and Menactra® + MMRV at 12 Months', 'description': 'Participants will receive Menactra® at 9 months of age and Menactra® plus measles, mumps, rubella, varicella (MMRV) vaccine at 12 months of age', 'interventionNames': ['Biological: Meningococcal Polysaccharide Diphtheria Conjugate Vaccine']}, {'type': 'EXPERIMENTAL', 'label': 'Menactra® at 9 Months and Menactra® + PCV at 12 Months', 'description': 'Participants will receive Menactra® at 9 months of age and Menactra® plus pneumococcal conjugate vaccine (PCV) at 12 months of age', 'interventionNames': ['Biological: Meningococcal Polysaccharide Diphtheria Conjugate Vaccine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'MMRV + PCV at 12 Months', 'description': 'Participants who received no vaccination at 9 months of age and measles, mumps, rubella, varicella (MMRV) vaccine plus pneumococcal conjugate vaccine (PCV) at 12 months of age', 'interventionNames': ['Biological: Measles, Mumps, Rubella and Varicella']}], 'interventions': [{'name': 'Meningococcal Polysaccharide Diphtheria Conjugate Vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['Menactra®'], 'description': '0.5 mL dose, intramuscular (IM)', 'armGroupLabels': ['Menactra® at 9 and 12 Months']}, {'name': 'Meningococcal Polysaccharide Diphtheria Conjugate Vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['Menactra®'], 'description': '0.5 mL dose, IM', 'armGroupLabels': ['Menactra® at 9 Months and Menactra® + MMRV at 12 Months']}, {'name': 'Meningococcal Polysaccharide Diphtheria Conjugate Vaccine', 'type': 'BIOLOGICAL', 'otherNames': ['Menactra®'], 'description': 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