Ignite Creation Date:
2025-12-25 @ 12:41 AM
Ignite Modification Date:
2025-12-27 @ 11:02 AM
Study NCT ID:
NCT01337167
Status:
COMPLETED
Last Update Posted:
2018-11-15
First Post:
2011-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety, Tolerability, and Immunogenicity of V419 Given Concomitantly With Prevnar 13™ and RotaTeq™ (V419-005)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D004165', 'term': 'Diphtheria'}, {'id': 'D013742', 'term': 'Tetanus'}, {'id': 'D014917', 'term': 'Whooping Cough'}, {'id': 'D011051', 'term': 'Poliomyelitis'}, {'id': 'D006509', 'term': 'Hepatitis B'}, {'id': 'D006192', 'term': 'Haemophilus Infections'}], 'ancestors': [{'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D003354', 'term': 'Corynebacterium Infections'}, {'id': 'D000193', 'term': 'Actinomycetales Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D003015', 'term': 'Clostridium Infections'}, {'id': 'D001885', 'term': 'Bordetella Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D009187', 'term': 'Myelitis'}, {'id': 'D002494', 'term': 'Central Nervous System Infections'}, {'id': 'D004769', 'term': 'Enterovirus Infections'}, {'id': 'D010850', 'term': 'Picornaviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D000090862', 'term': 'Neuroinflammatory Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D018347', 'term': 'Hepadnaviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D016871', 'term': 'Pasteurellaceae Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D022681', 'term': 'Diphtheria-Tetanus-acellular Pertussis Vaccines'}, {'id': 'C061964', 'term': 'Haemophilus influenzae-type b polysaccharide-Neisseria meningitidis outer membrane protein conjugate vaccine'}, {'id': 'C538862', 'term': '13-valent pneumococcal vaccine'}, {'id': 'C492535', 'term': 'RotaTeq'}, {'id': 'D022243', 'term': 'Rotavirus Vaccines'}, {'id': 'C512971', 'term': 'pentacel'}, {'id': 'C055753', 'term': 'Haemophilus influenza type b polysaccharide vaccine-tetanus toxin conjugate'}], 'ancestors': [{'id': 'D010567', 'term': 'Pertussis Vaccine'}, {'id': 'D001428', 'term': 'Bacterial Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D004168', 'term': 'Diphtheria Toxoid'}, {'id': 'D014121', 'term': 'Toxoids'}, {'id': 'D013745', 'term': 'Tetanus Toxoid'}, {'id': 'D017778', 'term': 'Vaccines, Combined'}, {'id': 'D022282', 'term': 'Vaccines, Acellular'}, {'id': 'D022223', 'term': 'Vaccines, Subunit'}, {'id': 'D014765', 'term': 'Viral Vaccines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp.'}, 'certainAgreement': {'otherDetails': 'The sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/ presentation. Any information identified by the sponsor as confidential must be deleted prior to submission.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'SAEs: up to 6 months after vaccination 3 (the last infant vaccination) and up to 15 days after vaccination 4 (the toddler vaccination); Vaccine-related SAEs and deaths: up to Month 16 (duration of the study); Other AEs: up to 15 days after any vaccination', 'description': 'The All Subjects as Treated population included all randomized participants who received at least one dose of study vaccine and had safety follow-up', 'eventGroups': [{'id': 'EG000', 'title': 'V419', 'description': 'V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.', 'otherNumAtRisk': 980, 'otherNumAffected': 939, 'seriousNumAtRisk': 980, 'seriousNumAffected': 58}, {'id': 'EG001', 'title': 'Control', 'description': 'Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.', 'otherNumAtRisk': 483, 'otherNumAffected': 458, 'seriousNumAtRisk': 483, 'seriousNumAffected': 32}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 980, 'numEvents': 68, 'numAffected': 61}, {'groupId': 'EG001', 'numAtRisk': 483, 'numEvents': 25, 'numAffected': 22}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 980, 'numEvents': 432, 'numAffected': 282}, {'groupId': 'EG001', 'numAtRisk': 483, 'numEvents': 186, 'numAffected': 125}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Crying', 'stats': [{'groupId': 'EG000', 'numAtRisk': 980, 'numEvents': 1933, 'numAffected': 788}, {'groupId': 'EG001', 'numAtRisk': 483, 'numEvents': 857, 'numAffected': 370}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 980, 'numEvents': 2389, 'numAffected': 853}, {'groupId': 'EG001', 'numAtRisk': 483, 'numEvents': 1109, 'numAffected': 415}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 980, 'numEvents': 1014, 'numAffected': 560}, {'groupId': 'EG001', 'numAtRisk': 483, 'numEvents': 356, 'numAffected': 216}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 980, 'numEvents': 76, 'numAffected': 69}, {'groupId': 'EG001', 'numAtRisk': 483, 'numEvents': 28, 'numAffected': 26}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 980, 'numEvents': 108, 'numAffected': 100}, {'groupId': 'EG001', 'numAtRisk': 483, 'numEvents': 41, 'numAffected': 40}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 980, 'numEvents': 1087, 'numAffected': 577}, {'groupId': 'EG001', 'numAtRisk': 483, 'numEvents': 469, 'numAffected': 271}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 980, 'numEvents': 1863, 'numAffected': 755}, {'groupId': 'EG001', 'numAtRisk': 483, 'numEvents': 887, 'numAffected': 369}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Injection-site bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 980, 'numEvents': 103, 'numAffected': 62}, {'groupId': 'EG001', 'numAtRisk': 483, 'numEvents': 61, 'numAffected': 36}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Injection-site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 980, 'numEvents': 2665, 'numAffected': 597}, {'groupId': 'EG001', 'numAtRisk': 483, 'numEvents': 1365, 'numAffected': 277}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Injection-site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 980, 'numEvents': 4276, 'numAffected': 826}, {'groupId': 'EG001', 'numAtRisk': 483, 'numEvents': 2234, 'numAffected': 391}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Injection-site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 980, 'numEvents': 1974, 'numAffected': 513}, {'groupId': 'EG001', 'numAtRisk': 483, 'numEvents': 989, 'numAffected': 219}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}], 'seriousEvents': [{'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 980, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 483, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Lymphadenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 980, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 483, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 980, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 483, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pyloric stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 980, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 483, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Anal fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 980, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 483, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 980, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 483, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 980, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 483, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Device expulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 980, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 483, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 980, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 483, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 980, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 483, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 980, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 483, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Bronchopneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 980, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 483, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Croup infectious', 'stats': [{'groupId': 'EG000', 'numAtRisk': 980, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 483, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Gastritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 980, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 483, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 980, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 483, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Gastroenteritis salmonella', 'stats': [{'groupId': 'EG000', 'numAtRisk': 980, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 483, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 980, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 483, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Human herpesvirus 6 infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 980, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 483, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 980, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 483, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Meningitis enteroviral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 980, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 483, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Meningitis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 980, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 483, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 980, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 483, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 980, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 483, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 980, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 483, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Respiratory syncytial virus bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 980, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 483, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Respiratory syncytial virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 980, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 483, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Roseola', 'stats': [{'groupId': 'EG000', 'numAtRisk': 980, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 483, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Subcutaneous abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 980, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 483, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 980, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 483, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 980, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 483, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 980, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 483, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Vulval abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 980, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 483, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Wound infection staphylococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 980, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 483, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Accidental overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 980, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 483, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Foreign body', 'stats': [{'groupId': 'EG000', 'numAtRisk': 980, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 483, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 980, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 483, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Post concussion syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 980, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 483, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Skull fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 980, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 483, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Skull fracture base', 'stats': [{'groupId': 'EG000', 'numAtRisk': 980, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 483, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Tibia fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 980, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 483, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Urine output decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 980, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 483, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Abnormal weight gain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 980, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 483, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 980, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 483, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Failure to thrive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 980, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 483, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 980, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 483, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 980, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 483, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Dyskinesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 980, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 483, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Dystonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 980, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 483, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Febrile convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 980, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 483, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Movement disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 980, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 483, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Tonic convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 980, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 483, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 980, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 483, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Apparent life threatening event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 980, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 483, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Asphyxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 980, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 483, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 980, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 483, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 980, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 483, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Bronchial hyperreactivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 980, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 483, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 980, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 483, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 980, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 483, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Infantile apnoeic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 980, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 483, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 980, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 483, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 980, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 483, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 980, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 483, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 980, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 483, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': "Kawasaki's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 980, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 483, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Responding to Polyribosylribitol Phosphate Antigen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '765', 'groupId': 'OG000'}, {'value': '382', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V419', 'description': 'V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.'}], 'classes': [{'title': 'Titer >=1.0 μg/mL', 'categories': [{'measurements': [{'value': '84.97', 'groupId': 'OG000', 'lowerLimit': '82.24', 'upperLimit': '87.43'}, {'value': '75.39', 'groupId': 'OG001', 'lowerLimit': '70.76', 'upperLimit': '79.63'}]}]}, {'title': 'Titer >=0.15 μg/mL', 'categories': [{'measurements': [{'value': '97.25', 'groupId': 'OG000', 'lowerLimit': '95.83', 'upperLimit': '98.29'}, {'value': '92.41', 'groupId': 'OG001', 'lowerLimit': '89.28', 'upperLimit': '94.86'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Response Rate Difference (V419 - Ctrl)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.68', 'ciLowerLimit': '4.83', 'ciUpperLimit': '14.83', 'groupDescription': 'Non-inferiority for titer \\>=1.0 μg/mL', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine', 'nonInferiorityComment': 'Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \\>= -10%'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Response Rate Difference (V419 - Ctrl)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.87', 'ciLowerLimit': '2.23', 'ciUpperLimit': '8.14', 'groupDescription': 'Non-inferiority for titer \\>=0.15 μg/mL', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine', 'nonInferiorityComment': 'Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \\>= -5%'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Response Rate Difference (V419-Ctrl)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.87', 'ciLowerLimit': '2.23', 'ciUpperLimit': '8.14', 'groupDescription': 'Secondary Analysis: Non-inferiority for titer \\>=0.15 μg/mL', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine', 'nonInferiorityComment': 'Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \\>= -10%'}], 'paramType': 'NUMBER', 'timeFrame': 'Postdose 3 (Month 7)', 'description': 'Participant serum samples were collected for testing with a radioimmunoassay for antibodies to Haemophilus influenza type b capsular polysaccharide polyribosylribitol phosphate. Response was evaluated for titer \\>=0.15 μg/mL and \\>=1.0 μg/mL.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Responding to Hepatitis B Surface Antigen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '688', 'groupId': 'OG000'}, {'value': '353', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V419', 'description': 'V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '99.42', 'groupId': 'OG000', 'lowerLimit': '98.52', 'upperLimit': '99.84'}, {'value': '98.58', 'groupId': 'OG001', 'lowerLimit': '96.73', 'upperLimit': '99.54'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Response Rate Difference (V419 - Ctrl)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.84', 'ciLowerLimit': '-0.35', 'ciUpperLimit': '2.74', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine', 'nonInferiorityComment': 'Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \\>= -10%'}], 'paramType': 'NUMBER', 'timeFrame': 'Postdose 3 (Month 7)', 'description': 'Participant serum samples were collected for testing with an enhanced chemiluminescence assay for antibodies to Hepatitis B Surface Antigen. Response was defined as a titer \\>=10 milli International units (mIU)/mL.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Responding to Diphtheria Toxin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '786', 'groupId': 'OG000'}, {'value': '393', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V419', 'description': 'V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '82.44', 'groupId': 'OG000', 'lowerLimit': '79.60', 'upperLimit': '85.04'}, {'value': '86.26', 'groupId': 'OG001', 'lowerLimit': '82.45', 'upperLimit': '89.51'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Response Rate Difference (V419 - Ctrl)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.84', 'ciLowerLimit': '-8.02', 'ciUpperLimit': '0.66', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine', 'nonInferiorityComment': 'Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \\>= -10%'}], 'paramType': 'NUMBER', 'timeFrame': 'Postdose 3 (Month 7)', 'description': 'Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to diphtheria toxin. Response was defined as a titer \\>=0.1 International unit (IU)/mL.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Responding to Tetanus Toxin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '787', 'groupId': 'OG000'}, {'value': '390', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V419', 'description': 'V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '99.87', 'groupId': 'OG000', 'lowerLimit': '99.29', 'upperLimit': '100.00'}, {'value': '99.49', 'groupId': 'OG001', 'lowerLimit': '98.16', 'upperLimit': '99.94'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Response Rate Difference (V419 - Ctrl)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.39', 'ciLowerLimit': '-0.28', 'ciUpperLimit': '1.74', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine', 'nonInferiorityComment': 'Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \\>= -5%'}], 'paramType': 'NUMBER', 'timeFrame': 'Postdose 3 (Month 7)', 'description': 'Participant serum samples were collected for testing with an ELISA for anti-tetanus antibodies. Response was defined as a titer \\>=0.1 IU/mL.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Responding to Pertussis Toxin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '796', 'groupId': 'OG000'}, {'value': '391', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V419', 'description': 'V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '98.12', 'groupId': 'OG000', 'lowerLimit': '96.91', 'upperLimit': '98.94'}, {'value': '98.47', 'groupId': 'OG001', 'lowerLimit': '96.69', 'upperLimit': '99.43'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Response Rate Difference (V419 - Ctrl)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.33', 'ciLowerLimit': '-1.80', 'ciUpperLimit': '1.60', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine', 'nonInferiorityComment': 'Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \\>= -10%'}], 'paramType': 'NUMBER', 'timeFrame': 'Postdose 3 (Month 7)', 'description': 'Participant serum samples were collected for testing with an Enzyme-linked Immunosorbent Assay (ELISA) for antibodies to pertussis toxin. Response was defined as follows: 1) if the predose titer was \\<4 times the lower limit of quantitation (4X LLOQ) then the postdose titer was \\>=4X LLOQ; 2) if the predose titer was \\>=4X LLOQ then the postdose titer was \\>= the predose titer.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Responding to Pertussis Filamentous Hemagglutinin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '796', 'groupId': 'OG000'}, {'value': '391', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V419', 'description': 'V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '87.31', 'groupId': 'OG000', 'lowerLimit': '84.80', 'upperLimit': '89.55'}, {'value': '92.07', 'groupId': 'OG001', 'lowerLimit': '88.93', 'upperLimit': '94.55'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Response Rate Difference (V419 - Ctrl)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.70', 'ciLowerLimit': '-8.14', 'ciUpperLimit': '-0.97', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine', 'nonInferiorityComment': 'Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \\>= -10%'}], 'paramType': 'NUMBER', 'timeFrame': 'Postdose 3 (Month 7)', 'description': 'Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin. Response was defined as follows: 1) if the predose titer was \\<4X LLOQ then the postdose titer was \\>=4X LLOQ; 2) if the predose titer was \\>=4X LLOQ then the postdose titer was \\>= the predose titer.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Responding to Pertussis Pertactin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '794', 'groupId': 'OG000'}, {'value': '390', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V419', 'description': 'V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '79.35', 'groupId': 'OG000', 'lowerLimit': '76.36', 'upperLimit': '82.11'}, {'value': '82.05', 'groupId': 'OG001', 'lowerLimit': '77.88', 'upperLimit': '85.73'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Response Rate Difference (V419 - Ctrl)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.67', 'ciLowerLimit': '-7.27', 'ciUpperLimit': '2.23', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine', 'nonInferiorityComment': 'Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \\>= -10%'}], 'paramType': 'NUMBER', 'timeFrame': 'Postdose 3 (Month 7)', 'description': 'Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin. Response was defined as follows: 1) if the predose titer was \\<4X LLOQ then the postdose titer was \\>=4X LLOQ; 2) if the predose titer was \\>=4X LLOQ then the postdose titer was \\>= the predose titer.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Responding to Pertussis Fimbriae', 'denoms': [{'units': 'Participants', 'counts': [{'value': '796', 'groupId': 'OG000'}, {'value': '391', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V419', 'description': 'V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '90.20', 'groupId': 'OG000', 'lowerLimit': '87.92', 'upperLimit': '92.18'}, {'value': '86.19', 'groupId': 'OG001', 'lowerLimit': '82.37', 'upperLimit': '89.45'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Response Rate Difference (V419 - Ctrl)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.05', 'ciLowerLimit': '0.23', 'ciUpperLimit': '8.28', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine', 'nonInferiorityComment': 'Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \\>= -10%'}], 'paramType': 'NUMBER', 'timeFrame': 'Postdose 3 (Month 7)', 'description': 'Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae. Response was defined as follows: 1) if the predose titer was \\<4X LLOQ then the postdose titer was \\>=4X LLOQ; 2) if the predose titer was \\>=4X LLOQ then the postdose titer was \\>= the predose titer.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Responding to Poliovirus Type 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '806', 'groupId': 'OG000'}, {'value': '398', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V419', 'description': 'V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '100.00', 'groupId': 'OG000', 'lowerLimit': '99.54', 'upperLimit': '100.00'}, {'value': '98.24', 'groupId': 'OG001', 'lowerLimit': '96.41', 'upperLimit': '99.29'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Response Rate Difference (V419 - Ctrl)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.76', 'ciLowerLimit': '0.85', 'ciUpperLimit': '3.59', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine', 'nonInferiorityComment': 'Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \\>= -5%'}, {'pValue': '<0.001', 'groupIds': ['OG000'], 'paramType': 'Response Rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '100.00', 'ciLowerLimit': '99.54', 'ciUpperLimit': '100.00', 'statisticalMethod': 'Clopper and Pearson', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Acceptability requires that the lower bound of the 2-sided 95% CI of the response rate is \\>=90'}], 'paramType': 'NUMBER', 'timeFrame': 'Postdose 3 (Month 7)', 'description': 'Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 1. Response is defined as a titer \\>=8.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Responding to Poliovirus Type 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '801', 'groupId': 'OG000'}, {'value': '399', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V419', 'description': 'V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '100.00', 'groupId': 'OG000', 'lowerLimit': '99.54', 'upperLimit': '100.00'}, {'value': '99.75', 'groupId': 'OG001', 'lowerLimit': '98.61', 'upperLimit': '99.99'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Response Rate Difference (V419 - Ctrl)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.26', 'ciLowerLimit': '-0.22', 'ciUpperLimit': '1.42', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine', 'nonInferiorityComment': 'Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \\>= -5%'}, {'pValue': '<0.001', 'groupIds': ['OG000'], 'paramType': 'Response Rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '100.00', 'ciLowerLimit': '99.54', 'ciUpperLimit': '100.00', 'statisticalMethod': 'Clopper and Pearson', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Acceptability requires that the lower bound of the 2-sided 95% CI of the response rate is \\>=90'}], 'paramType': 'NUMBER', 'timeFrame': 'Postdose 3 (Month 7)', 'description': 'Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 2. Response is defined as a titer \\>=8.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Responding to Poliovirus Type 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '790', 'groupId': 'OG000'}, {'value': '396', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V419', 'description': 'V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '100.00', 'groupId': 'OG000', 'lowerLimit': '99.53', 'upperLimit': '100.00'}, {'value': '99.75', 'groupId': 'OG001', 'lowerLimit': '98.60', 'upperLimit': '99.99'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Response Rate Difference (V419 - Ctrl)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.25', 'ciLowerLimit': '-0.24', 'ciUpperLimit': '1.41', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine', 'nonInferiorityComment': 'Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \\>= -5%'}, {'pValue': '<0.001', 'groupIds': ['OG000'], 'paramType': 'Response Rate', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '100.00', 'ciLowerLimit': '99.53', 'ciUpperLimit': '100.00', 'statisticalMethod': 'Clopper and Pearson', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Acceptability requires that the lower bound of the 2-sided 95% CI of the response rate is \\>=90'}], 'paramType': 'NUMBER', 'timeFrame': 'Postdose 3 (Month 7)', 'description': 'Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 3. Response is defined as a titer \\>=8.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Concentration of Antibodies to Pertussis Toxin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '810', 'groupId': 'OG000'}, {'value': '400', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V419', 'description': 'V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '110.40', 'groupId': 'OG000', 'lowerLimit': '105.78', 'upperLimit': '115.21'}, {'value': '86.54', 'groupId': 'OG001', 'lowerLimit': '81.87', 'upperLimit': '91.48'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio (V419/Control)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.28', 'ciLowerLimit': '1.20', 'ciUpperLimit': '1.38', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine', 'nonInferiorityComment': 'Non-inferiority requires that the lower limit of the 2-sided 95% CI of the Geometric Mean Concentration (GMC) ratio is \\>=0.67'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Postdose 3 (Month 7)', 'description': 'Participant serum samples were collected for testing with an ELISA for antibodies to pertussis toxin. The unit of measure is ELISA units/mL (EU/mL).', 'unitOfMeasure': 'EU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Concentration of Antibodies to Pertussis Filamentous Hemagglutinin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '810', 'groupId': 'OG000'}, {'value': '400', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V419', 'description': 'V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '48.17', 'groupId': 'OG000', 'lowerLimit': '45.68', 'upperLimit': '50.80'}, {'value': '74.44', 'groupId': 'OG001', 'lowerLimit': '68.99', 'upperLimit': '80.33'}]}]}], 'analyses': [{'pValue': '0.786', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio (V419/Control)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.64', 'ciLowerLimit': '0.59', 'ciUpperLimit': '0.70', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine', 'nonInferiorityComment': 'Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \\>=0.67'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Postdose 3 (Month 7)', 'description': 'Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin.', 'unitOfMeasure': 'EU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Concentration of Antibodies to Pertussis Pertactin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '808', 'groupId': 'OG000'}, {'value': '400', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V419', 'description': 'V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '56.22', 'groupId': 'OG000', 'lowerLimit': '51.93', 'upperLimit': '60.85'}, {'value': '66.16', 'groupId': 'OG001', 'lowerLimit': '59.50', 'upperLimit': '73.57'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio (V419/Control)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.83', 'ciLowerLimit': '0.73', 'ciUpperLimit': '0.95', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine', 'nonInferiorityComment': 'Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \\>=0.67'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Postdose 3 (Month 7)', 'description': 'Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin.', 'unitOfMeasure': 'EU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Concentration of Antibodies to Pertussis Fimbriae', 'denoms': [{'units': 'Participants', 'counts': [{'value': '809', 'groupId': 'OG000'}, {'value': '400', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V419', 'description': 'V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '235.62', 'groupId': 'OG000', 'lowerLimit': '221.43', 'upperLimit': '250.73'}, {'value': '185.54', 'groupId': 'OG001', 'lowerLimit': '169.33', 'upperLimit': '203.31'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio (V419/Control)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.28', 'ciLowerLimit': '1.15', 'ciUpperLimit': '1.42', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine', 'nonInferiorityComment': 'Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \\>=0.67'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Postdose 3 (Month 7)', 'description': 'Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae.', 'unitOfMeasure': 'EU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Responding to Pertussis Toxin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '701', 'groupId': 'OG000'}, {'value': '349', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V419', 'description': 'V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '99.29', 'groupId': 'OG000', 'lowerLimit': '98.34', 'upperLimit': '99.77'}, {'value': '97.42', 'groupId': 'OG001', 'lowerLimit': '95.16', 'upperLimit': '98.81'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Response Rate Difference (V419 - Ctrl)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.88', 'ciLowerLimit': '0.39', 'ciUpperLimit': '4.18', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine', 'nonInferiorityComment': 'Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \\>= -10%'}], 'paramType': 'NUMBER', 'timeFrame': 'Postdose 4 (Month 16)', 'description': 'Participant serum samples were collected for testing with an ELISA for antibodies to pertussis toxin. Response was defined as follows: 1) if the predose titer was \\<4 times the lower limit of quantitation (4X LLOQ) then the postdose titer was \\>=4X LLOQ; 2) if the predose titer was \\>=4X LLOQ then the postdose titer was \\>= the predose titer.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 4.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Responding to Pertussis Filamentous Hemagglutinin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '699', 'groupId': 'OG000'}, {'value': '350', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V419', 'description': 'V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '94.42', 'groupId': 'OG000', 'lowerLimit': '92.45', 'upperLimit': '96.00'}, {'value': '93.14', 'groupId': 'OG001', 'lowerLimit': '89.97', 'upperLimit': '95.56'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Response Rate Difference (V419 - Ctrl)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.30', 'ciLowerLimit': '-1.67', 'ciUpperLimit': '4.78', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine', 'nonInferiorityComment': 'Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \\>= -10%'}], 'paramType': 'NUMBER', 'timeFrame': 'Postdose 4 (Month 16)', 'description': 'Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin. Response was defined as follows: 1) if the predose titer was \\<4 times the lower limit of quantitation (4X LLOQ) then the postdose titer was \\>=4X LLOQ; 2) if the predose titer was \\>=4X LLOQ then the postdose titer was \\>= the predose titer.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 4.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Responding to Pertussis Pertactin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '701', 'groupId': 'OG000'}, {'value': '351', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V419', 'description': 'V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '93.01', 'groupId': 'OG000', 'lowerLimit': '90.86', 'upperLimit': '94.78'}, {'value': '93.45', 'groupId': 'OG001', 'lowerLimit': '90.33', 'upperLimit': '95.80'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Response Rate Difference (V419 - Ctrl)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.41', 'ciLowerLimit': '-3.46', 'ciUpperLimit': '3.10', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine', 'nonInferiorityComment': 'Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \\>= -10%'}], 'paramType': 'NUMBER', 'timeFrame': 'Postdose 4 (Month 16)', 'description': 'Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin. Response was defined as follows: 1) if the predose titer was \\<4 times the lower limit of quantitation (4X LLOQ) then the postdose titer was \\>=4X LLOQ; 2) if the predose titer was \\>=4X LLOQ then the postdose titer was \\>= the predose titer.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 4.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Responding to Pertussis Fimbriae', 'denoms': [{'units': 'Participants', 'counts': [{'value': '700', 'groupId': 'OG000'}, {'value': '351', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V419', 'description': 'V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '97.29', 'groupId': 'OG000', 'lowerLimit': '95.79', 'upperLimit': '98.36'}, {'value': '91.17', 'groupId': 'OG001', 'lowerLimit': '87.70', 'upperLimit': '93.92'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Response Rate Difference (V419 - Ctrl)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.18', 'ciLowerLimit': '3.26', 'ciUpperLimit': '9.78', 'statisticalMethod': 'Miettinen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Response rate, response rate difference and p-value were stratified by brand of birth dose of Hepatitis B vaccine', 'nonInferiorityComment': 'Non-inferiority requires that the lower limit of the 95% CI of the response rate difference is \\>= -10%'}], 'paramType': 'NUMBER', 'timeFrame': 'Postdose 4 (Month 16)', 'description': 'Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae. Response was defined as follows: 1) if the predose titer was \\<4 times the lower limit of quantitation (4X LLOQ) then the postdose titer was \\>=4X LLOQ; 2) if the predose titer was \\>=4X LLOQ then the postdose titer was \\>= the predose titer.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included participants who met the inclusion criteria, were not protocol violators, had a vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 4.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Concentration of Antibodies to Pertussis Toxin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '713', 'groupId': 'OG000'}, {'value': '356', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V419', 'description': 'V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '127.22', 'groupId': 'OG000', 'lowerLimit': '121.17', 'upperLimit': '133.57'}, {'value': '91.31', 'groupId': 'OG001', 'lowerLimit': '85.09', 'upperLimit': '97.98'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio (V419/Control)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.40', 'ciLowerLimit': '1.28', 'ciUpperLimit': '1.52', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine', 'nonInferiorityComment': 'Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \\>=0.67'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Postdose 4 (Month 16)', 'description': 'Participant serum samples were collected for testing with an ELISA for antibodies to pertussis toxin.', 'unitOfMeasure': 'EU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 4.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Concentration of Antibodies to Pertussis Filamentous Hemagglutinin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '710', 'groupId': 'OG000'}, {'value': '357', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V419', 'description': 'V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '88.92', 'groupId': 'OG000', 'lowerLimit': '84.06', 'upperLimit': '94.05'}, {'value': '89.18', 'groupId': 'OG001', 'lowerLimit': '82.54', 'upperLimit': '96.35'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio (V419/Control)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.00', 'ciLowerLimit': '0.91', 'ciUpperLimit': '1.10', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine', 'nonInferiorityComment': 'Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \\>=0.67'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Postdose 4 (Month 16)', 'description': 'Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin.', 'unitOfMeasure': 'EU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 4.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Concentration of Antibodies to Pertussis Pertactin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '713', 'groupId': 'OG000'}, {'value': '358', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V419', 'description': 'V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '108.05', 'groupId': 'OG000', 'lowerLimit': '99.88', 'upperLimit': '116.90'}, {'value': '139.35', 'groupId': 'OG001', 'lowerLimit': '124.81', 'upperLimit': '155.58'}]}]}], 'analyses': [{'pValue': '0.014', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio (V419/Control)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.78', 'ciLowerLimit': '0.68', 'ciUpperLimit': '0.89', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine', 'nonInferiorityComment': 'Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \\>=0.67'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Postdose 4 (Month 16)', 'description': 'Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin.', 'unitOfMeasure': 'EU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 4.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Concentration of Antibodies to Pertussis Fimbriae', 'denoms': [{'units': 'Participants', 'counts': [{'value': '713', 'groupId': 'OG000'}, {'value': '358', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V419', 'description': 'V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '658.50', 'groupId': 'OG000', 'lowerLimit': '617.53', 'upperLimit': '702.20'}, {'value': '414.66', 'groupId': 'OG001', 'lowerLimit': '371.41', 'upperLimit': '462.94'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio (V419/Control)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.58', 'ciLowerLimit': '1.41', 'ciUpperLimit': '1.78', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine', 'nonInferiorityComment': 'Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \\>=0.67'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Postdose 4 (Month 16)', 'description': 'Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae.', 'unitOfMeasure': 'EU/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 4.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Concentration of Antibodies to Polyribosylribitol Phosphate Antigen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '765', 'groupId': 'OG000'}, {'value': '382', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V419', 'description': 'V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.11', 'groupId': 'OG000', 'lowerLimit': '4.55', 'upperLimit': '5.73'}, {'value': '3.18', 'groupId': 'OG001', 'lowerLimit': '2.66', 'upperLimit': '3.81'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio (V419/Control)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.62', 'ciLowerLimit': '1.32', 'ciUpperLimit': '1.98', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine', 'nonInferiorityComment': 'Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \\>=0.67'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Postdose 3 (Month 7)', 'description': 'Participant serum samples were collected for testing with a radioimmunoassay for antibodies to Haemophilus influenza type b capsular polysaccharide polyribosylribitol phosphate.', 'unitOfMeasure': 'μg/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Concentration of Immunoglobulin A (IgA) Antibodies to Rotavirus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '522', 'groupId': 'OG000'}, {'value': '274', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V419', 'description': 'V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '278.19', 'groupId': 'OG000', 'lowerLimit': '246.99', 'upperLimit': '313.32'}, {'value': '274.46', 'groupId': 'OG001', 'lowerLimit': '232.83', 'upperLimit': '323.52'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMC Ratio (V419/Control)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.02', 'ciLowerLimit': '0.83', 'ciUpperLimit': '1.24', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'GMC, GMC ratio, and p-value were adjusted for post- and prevaccination titer, vaccination group, and brand of birth dose of Hepatitis B vaccine', 'nonInferiorityComment': 'Non-inferiority requires that the lower limit of the 2-sided 95% CI of the GMC ratio is \\>=0.67'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Postdose 3 (Month 7)', 'description': 'Participant serum samples were collected for testing with an Enzyme-linked Immunosorbent assay for IgA antibodies to rotavirus.', 'unitOfMeasure': 'units/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population included participants who met the inclusion criteria, were not protocol violators, had an infant vaccination window of 42 to 84 days after the previous dose, and a blood draw sample window for the endpoint of 28 to 51 days after dose 3.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '981', 'groupId': 'OG000'}, {'value': '484', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V419', 'description': 'V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.'}], 'classes': [{'title': 'Any injection-site pain', 'categories': [{'measurements': [{'value': '73.4', 'groupId': 'OG000'}, {'value': '71.8', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 injection-site pain', 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000'}, {'value': '4.6', 'groupId': 'OG001'}]}]}, {'title': 'Any injection-site erythema', 'categories': [{'measurements': [{'value': '48.8', 'groupId': 'OG000'}, {'value': '42.2', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 injection-site erythema', 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000'}, {'value': '0.6', 'groupId': 'OG001'}]}]}, {'title': 'Any injection-site swelling', 'categories': [{'measurements': [{'value': '40.1', 'groupId': 'OG000'}, {'value': '34.8', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 injection-site swelling', 'categories': [{'measurements': [{'value': '0.3', 'groupId': 'OG000'}, {'value': '0.4', 'groupId': 'OG001'}]}]}, {'title': 'Any pyrexia', 'categories': [{'measurements': [{'value': '47.4', 'groupId': 'OG000'}, {'value': '34.4', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 pyrexia', 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000'}, {'value': '1.2', 'groupId': 'OG001'}]}]}, {'title': 'Any vomiting', 'categories': [{'measurements': [{'value': '25.7', 'groupId': 'OG000'}, {'value': '21.5', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 vomiting', 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}, {'value': '0.6', 'groupId': 'OG001'}]}]}, {'title': 'Any crying abnormal', 'categories': [{'measurements': [{'value': '74.8', 'groupId': 'OG000'}, {'value': '72.3', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 crying abnormal', 'categories': [{'measurements': [{'value': '7.9', 'groupId': 'OG000'}, {'value': '8.3', 'groupId': 'OG001'}]}]}, {'title': 'Any somnolence', 'categories': [{'measurements': [{'value': '74.1', 'groupId': 'OG000'}, {'value': '71.6', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 somnolence', 'categories': [{'measurements': [{'value': '3.5', 'groupId': 'OG000'}, {'value': '2.9', 'groupId': 'OG001'}]}]}, {'title': 'Any decreased appetite', 'categories': [{'measurements': [{'value': '48.9', 'groupId': 'OG000'}, {'value': '43.3', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 decreased appetite', 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000'}, {'value': '0.4', 'groupId': 'OG001'}]}]}, {'title': 'Any irritability', 'categories': [{'measurements': [{'value': '83.1', 'groupId': 'OG000'}, {'value': '81.8', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3 irritability', 'categories': [{'measurements': [{'value': '7.7', 'groupId': 'OG000'}, {'value': '5.8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 5 days after any infant vaccination (up to 6 months)', 'description': 'Solicited injection-site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Pyrexia, Vomiting, Crying abnormal, Somnolence, Decreased appetite, and Irritability. Grade 3 Solicited injection site reaction: Pain, Cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling, \\>5 cm. Grade 3 Solicited systemic reactions: Pyrexia, \\>=39.5°C (\\>=103.1°F) rectal; Vomiting, \\>=6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal, \\>3 hours; Somnolence, Sleeping most of the time or difficult to wake up; Decreased appetite, Refuses \\>=3 feeds or refuses most feeds; Irritability, Inconsolable.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants included in these analyses were All Subjects as Treated population and were defined as all vaccinated participants with safety follow up.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug', 'denoms': [{'units': 'Participants', 'counts': [{'value': '981', 'groupId': 'OG000'}, {'value': '484', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V419', 'description': 'V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.'}], 'classes': [{'title': 'Any pyrexia', 'categories': [{'measurements': [{'value': '45.1', 'groupId': 'OG000'}, {'value': '32.1', 'groupId': 'OG001'}]}]}, {'title': 'Any vomiting', 'categories': [{'measurements': [{'value': '20.8', 'groupId': 'OG000'}, {'value': '16.4', 'groupId': 'OG001'}]}]}, {'title': 'Any crying abnormal', 'categories': [{'measurements': [{'value': '71.4', 'groupId': 'OG000'}, {'value': '68.5', 'groupId': 'OG001'}]}]}, {'title': 'Any somnolence', 'categories': [{'measurements': [{'value': '68.5', 'groupId': 'OG000'}, {'value': '66.7', 'groupId': 'OG001'}]}]}, {'title': 'Any decreased appetite', 'categories': [{'measurements': [{'value': '45.7', 'groupId': 'OG000'}, {'value': '40.2', 'groupId': 'OG001'}]}]}, {'title': 'Any irritability', 'categories': [{'measurements': [{'value': '79.6', 'groupId': 'OG000'}, {'value': '77.4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 5 days after any infant vaccination (up to 6 months)', 'description': 'Solicited systemic adverse events: pyrexia, vomiting, crying abnormal, somnolence, decreased appetite, and irritability. Adverse events deemed related to study drug were those judged to be definitely related, probably related, or possibly related by the investigator.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants included in this analyses were All Subjects as Treated population and were defined as all vaccinated participants with safety follow up.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug', 'denoms': [{'units': 'Participants', 'counts': [{'value': '981', 'groupId': 'OG000'}, {'value': '484', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V419', 'description': 'V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.'}], 'classes': [{'title': 'Any pyrexia, vaccination 1', 'categories': [{'measurements': [{'value': '16.1', 'groupId': 'OG000'}, {'value': '12.6', 'groupId': 'OG001'}]}]}, {'title': 'Any pyrexia, vaccination 2 (N=950, 472)', 'categories': [{'measurements': [{'value': '26.6', 'groupId': 'OG000'}, {'value': '16.4', 'groupId': 'OG001'}]}]}, {'title': 'Any pyrexia, vaccination 3 (N=924, 460)', 'categories': [{'measurements': [{'value': '26.6', 'groupId': 'OG000'}, {'value': '16.2', 'groupId': 'OG001'}]}]}, {'title': 'Any vomiting, vaccination 1', 'categories': [{'measurements': [{'value': '11.2', 'groupId': 'OG000'}, {'value': '7.9', 'groupId': 'OG001'}]}]}, {'title': 'Any vomiting, vaccination 2 (N=950, 472)', 'categories': [{'measurements': [{'value': '10.2', 'groupId': 'OG000'}, {'value': '8.5', 'groupId': 'OG001'}]}]}, {'title': 'Any vomiting, vaccination 3 (N=924, 460)', 'categories': [{'measurements': [{'value': '8.0', 'groupId': 'OG000'}, {'value': '4.6', 'groupId': 'OG001'}]}]}, {'title': 'Any crying abnormal, vaccination 1', 'categories': [{'measurements': [{'value': '50.9', 'groupId': 'OG000'}, {'value': '48.7', 'groupId': 'OG001'}]}]}, {'title': 'Any crying abnormal, vaccination 2 (N=950, 472)', 'categories': [{'measurements': [{'value': '48.4', 'groupId': 'OG000'}, {'value': '42.9', 'groupId': 'OG001'}]}]}, {'title': 'Any crying abnormal, vaccination 3 (N=924, 460)', 'categories': [{'measurements': [{'value': '42.0', 'groupId': 'OG000'}, {'value': '36.1', 'groupId': 'OG001'}]}]}, {'title': 'Any somnolence, vaccination 1', 'categories': [{'measurements': [{'value': '54.6', 'groupId': 'OG000'}, {'value': '54.0', 'groupId': 'OG001'}]}]}, {'title': 'Any somnolence, vaccination 2 (N=950, 472)', 'categories': [{'measurements': [{'value': '42.9', 'groupId': 'OG000'}, {'value': '41.4', 'groupId': 'OG001'}]}]}, {'title': 'Any somnolence, vaccination 3 (N=924, 460)', 'categories': [{'measurements': [{'value': '38.3', 'groupId': 'OG000'}, {'value': '35.0', 'groupId': 'OG001'}]}]}, {'title': 'Any decreased appetite, vaccination 1', 'categories': [{'measurements': [{'value': '27.4', 'groupId': 'OG000'}, {'value': '24.0', 'groupId': 'OG001'}]}]}, {'title': 'Any decreased appetite, vaccination 2 (N=950, 472)', 'categories': [{'measurements': [{'value': '24.1', 'groupId': 'OG000'}, {'value': '19.8', 'groupId': 'OG001'}]}]}, {'title': 'Any decreased appetite, vaccination 3 (N=924, 460)', 'categories': [{'measurements': [{'value': '20.9', 'groupId': 'OG000'}, {'value': '17.3', 'groupId': 'OG001'}]}]}, {'title': 'Any irritability, vaccination 1', 'categories': [{'measurements': [{'value': '63.2', 'groupId': 'OG000'}, {'value': '60.5', 'groupId': 'OG001'}]}]}, {'title': 'Any irritability, vaccination 2 (N=950, 472)', 'categories': [{'measurements': [{'value': '56.6', 'groupId': 'OG000'}, {'value': '52.7', 'groupId': 'OG001'}]}]}, {'title': 'Any irritability, vaccination 3 (N=924, 460)', 'categories': [{'measurements': [{'value': '52.7', 'groupId': 'OG000'}, {'value': '48.8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 5 days after each infant vaccination (up to 6 months)', 'description': 'Solicited systemic adverse events: pyrexia, vomiting, crying abnormal, somnolence, decreased appetite, and irritability. Adverse events deemed related to study drug were those judged to be definitely related, probably related, or possibly related by the investigator.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants included in this analyses were All Subjects as Treated population and were defined as all vaccinated participants with safety follow up.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Elevated Temperature by Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '981', 'groupId': 'OG000'}, {'value': '484', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V419', 'description': 'V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.'}], 'classes': [{'title': 'All routes <38.0°C', 'categories': [{'measurements': [{'value': '51.1', 'groupId': 'OG000'}, {'value': '64.3', 'groupId': 'OG001'}]}]}, {'title': 'All routes >=38.0°C and <38.5°C, mild', 'categories': [{'measurements': [{'value': '24.2', 'groupId': 'OG000'}, {'value': '19.1', 'groupId': 'OG001'}]}]}, {'title': 'All routes >=38.5°C and <39.5°C, moderate', 'categories': [{'measurements': [{'value': '22.7', 'groupId': 'OG000'}, {'value': '15.5', 'groupId': 'OG001'}]}]}, {'title': 'All routes >=39.5°C, severe', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000'}, {'value': '1.1', 'groupId': 'OG001'}]}]}, {'title': 'Rectal <38.0°C', 'categories': [{'measurements': [{'value': '44.5', 'groupId': 'OG000'}, {'value': '57.7', 'groupId': 'OG001'}]}]}, {'title': 'Rectal >=38.0°C and <38.5°C, mild', 'categories': [{'measurements': [{'value': '24.3', 'groupId': 'OG000'}, {'value': '17.9', 'groupId': 'OG001'}]}]}, {'title': 'Rectal >=38.5°C and <39.5°C, moderate', 'categories': [{'measurements': [{'value': '21.6', 'groupId': 'OG000'}, {'value': '14.9', 'groupId': 'OG001'}]}]}, {'title': 'Rectal >=39.5°C, severe', 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000'}, {'value': '0.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-13.1', 'ciLowerLimit': '-18.4', 'ciUpperLimit': '-7.7', 'estimateComment': 'Mean Difference is V419 - Control. The 95% confidence intervals were based on the unstratified Miettinen and Nurminen method.', 'groupDescription': 'Estimated difference, all routes \\<38°C', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.1', 'ciLowerLimit': '0.5', 'ciUpperLimit': '9.5', 'estimateComment': 'Mean Difference is V419 - Control. The 95% confidence intervals were based on the unstratified Miettinen and Nurminen method.', 'groupDescription': 'Estimated difference, all routes \\>=38°C and \\<38.5°C', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.1', 'ciLowerLimit': '2.8', 'ciUpperLimit': '11.2', 'estimateComment': 'Mean Difference is V419 - Control. The 95% confidence intervals were based on the unstratified Miettinen and Nurminen method.', 'groupDescription': 'Estimated difference, all routes \\>=38.5°C and \\<39.5°C', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.9', 'ciLowerLimit': '-0.6', 'ciUpperLimit': '2.2', 'estimateComment': 'Mean Difference is V419 - Control. The 95% confidence intervals were based on the unstratified Miettinen and Nurminen method.', 'groupDescription': 'Estimated difference, all routes \\>=39.5°C', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-13.2', 'ciLowerLimit': '-18.6', 'ciUpperLimit': '-7.7', 'estimateComment': 'Mean Difference is V419 - Control. The 95% confidence intervals were based on the unstratified Miettinen and Nurminen method.', 'groupDescription': 'Estimated difference, rectal \\<38°C', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.5', 'ciLowerLimit': '1.9', 'ciUpperLimit': '10.8', 'estimateComment': 'Mean Difference is V419 - Control. The 95% confidence intervals were based on the unstratified Miettinen and Nurminen method.', 'groupDescription': 'Estimated difference, rectal \\>=38°C and \\<38.5°C', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.7', 'ciLowerLimit': '2.4', 'ciUpperLimit': '10.7', 'estimateComment': 'Mean Difference is V419 - Control. The 95% confidence intervals were based on the unstratified Miettinen and Nurminen method.', 'groupDescription': 'Estimated difference, rectal \\>=38.5°C and \\<39.5°C', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.2', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '2.4', 'estimateComment': 'Mean Difference is V419 - Control. The 95% confidence intervals were based on the unstratified Miettinen and Nurminen method.', 'groupDescription': 'Estimated difference, rectal \\>=39.5°C', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 5 days after any infant vaccination (up to 6 months)', 'description': 'Maximum temperature (all routes) was based on actual temperatures recorded with no adjustments to the measurement route. Maximum temperature (rectal) was required of all participants if the reading by another method was \\>=38.0°C.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants included in this analyses were All Subjects as Treated population and were defined as all vaccinated participants with safety follow up and temperature data.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Pyrexia, Febrile Convulsion, or Convulsion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '981', 'groupId': 'OG000'}, {'value': '484', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V419', 'description': 'V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.'}], 'classes': [{'title': 'Pyrexia AEs', 'categories': [{'measurements': [{'value': '49.3', 'groupId': 'OG000'}, {'value': '35.6', 'groupId': 'OG001'}]}]}, {'title': 'Febrile convulsion AEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Convulsion AEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Pyrexia SAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Febrile convulsion SAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Convulsion SAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 15 days after any infant vaccination (up to 6 months)', 'description': 'The percentage of participants with one or more adverse events (AE), serious adverse events (SAE), and vaccine-related SAE (pyrexia, febrile convulsion, and convulsion) is reported.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants included in this analyses were All Subjects as Treated population and were defined as all vaccinated participants with safety follow up.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Pyrexia, Febrile Convulsion, or Convulsion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '981', 'groupId': 'OG000'}, {'value': '484', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'V419', 'description': 'V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.'}], 'classes': [{'title': 'Pyrexia SAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0.2', 'groupId': 'OG001'}]}]}, {'title': 'Febrile convulsion SAEs', 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Convulsion SAEs', 'categories': [{'measurements': [{'value': '0.1', 'groupId': 'OG000'}, {'value': '0.4', 'groupId': 'OG001'}]}]}, {'title': 'Pyrexia vaccine-related SAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Febrile convulsion vaccine-related SAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Convulsion vaccine-related SAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 181 days after any infant vaccination (up to 12 months)', 'description': 'The percentage of participants with one or more adverse events (AE), serious adverse events (SAE), and vaccine-related SAE (pyrexia, febrile convulsion, and convulsion) is reported.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants included in this analyses were All Subjects as Treated population and were defined as all vaccinated participants with safety follow up.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'V419', 'description': 'V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.'}, {'id': 'FG001', 'title': 'Control', 'description': 'Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.'}], 'periods': [{'title': 'Infant Series', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '986'}, {'groupId': 'FG001', 'numSubjects': '487'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '924'}, {'groupId': 'FG001', 'numSubjects': '460'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '62'}, {'groupId': 'FG001', 'numSubjects': '27'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Non-compliance with study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Randomized but not vaccinated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}, {'title': 'Interim Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '924'}, {'groupId': 'FG001', 'numSubjects': '460'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '843'}, {'groupId': 'FG001', 'numSubjects': '420'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '81'}, {'groupId': 'FG001', 'numSubjects': '40'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '51'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'Non-compliance with study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Other protocol criterion not met', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Toddler Vaccinations', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '843'}, {'groupId': 'FG001', 'numSubjects': '420'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '829'}, {'groupId': 'FG001', 'numSubjects': '407'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '13'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '12'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'The infant series of vaccinations were those administered at 2, 4, and 6 months of age; the toddler vaccinations were those administered at 15 months of age. The Interim Period is the time between the last vaccination of the infant series and the time of administration of the toddler vaccination.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '986', 'groupId': 'BG000'}, {'value': '487', 'groupId': 'BG001'}, {'value': '1473', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'V419', 'description': 'V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.'}, {'id': 'BG001', 'title': 'Control', 'description': 'Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65.6', 'spread': '7.5', 'groupId': 'BG000'}, {'value': '65.0', 'spread': '6.9', 'groupId': 'BG001'}, {'value': '65.4', 'spread': '7.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Days', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '479', 'groupId': 'BG000'}, {'value': '214', 'groupId': 'BG001'}, {'value': '693', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '507', 'groupId': 'BG000'}, {'value': '273', 'groupId': 'BG001'}, {'value': '780', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1473}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2013-05-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-19', 'studyFirstSubmitDate': '2011-04-15', 'resultsFirstSubmitDate': '2016-02-18', 'studyFirstSubmitQcDate': '2011-04-15', 'lastUpdatePostDateStruct': {'date': '2018-11-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-02-18', 'studyFirstPostDateStruct': {'date': '2011-04-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-03-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Responding to Polyribosylribitol Phosphate Antigen', 'timeFrame': 'Postdose 3 (Month 7)', 'description': 'Participant serum samples were collected for testing with a radioimmunoassay for antibodies to Haemophilus influenza type b capsular polysaccharide polyribosylribitol phosphate. Response was evaluated for titer \\>=0.15 μg/mL and \\>=1.0 μg/mL.'}, {'measure': 'Percentage of Participants Responding to Hepatitis B Surface Antigen', 'timeFrame': 'Postdose 3 (Month 7)', 'description': 'Participant serum samples were collected for testing with an enhanced chemiluminescence assay for antibodies to Hepatitis B Surface Antigen. Response was defined as a titer \\>=10 milli International units (mIU)/mL.'}, {'measure': 'Percentage of Participants Responding to Diphtheria Toxin', 'timeFrame': 'Postdose 3 (Month 7)', 'description': 'Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to diphtheria toxin. Response was defined as a titer \\>=0.1 International unit (IU)/mL.'}, {'measure': 'Percentage of Participants Responding to Tetanus Toxin', 'timeFrame': 'Postdose 3 (Month 7)', 'description': 'Participant serum samples were collected for testing with an ELISA for anti-tetanus antibodies. Response was defined as a titer \\>=0.1 IU/mL.'}, {'measure': 'Percentage of Participants Responding to Pertussis Toxin', 'timeFrame': 'Postdose 3 (Month 7)', 'description': 'Participant serum samples were collected for testing with an Enzyme-linked Immunosorbent Assay (ELISA) for antibodies to pertussis toxin. Response was defined as follows: 1) if the predose titer was \\<4 times the lower limit of quantitation (4X LLOQ) then the postdose titer was \\>=4X LLOQ; 2) if the predose titer was \\>=4X LLOQ then the postdose titer was \\>= the predose titer.'}, {'measure': 'Percentage of Participants Responding to Pertussis Filamentous Hemagglutinin', 'timeFrame': 'Postdose 3 (Month 7)', 'description': 'Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin. Response was defined as follows: 1) if the predose titer was \\<4X LLOQ then the postdose titer was \\>=4X LLOQ; 2) if the predose titer was \\>=4X LLOQ then the postdose titer was \\>= the predose titer.'}, {'measure': 'Percentage of Participants Responding to Pertussis Pertactin', 'timeFrame': 'Postdose 3 (Month 7)', 'description': 'Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin. Response was defined as follows: 1) if the predose titer was \\<4X LLOQ then the postdose titer was \\>=4X LLOQ; 2) if the predose titer was \\>=4X LLOQ then the postdose titer was \\>= the predose titer.'}, {'measure': 'Percentage of Participants Responding to Pertussis Fimbriae', 'timeFrame': 'Postdose 3 (Month 7)', 'description': 'Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae. Response was defined as follows: 1) if the predose titer was \\<4X LLOQ then the postdose titer was \\>=4X LLOQ; 2) if the predose titer was \\>=4X LLOQ then the postdose titer was \\>= the predose titer.'}, {'measure': 'Percentage of Participants Responding to Poliovirus Type 1', 'timeFrame': 'Postdose 3 (Month 7)', 'description': 'Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 1. Response is defined as a titer \\>=8.'}, {'measure': 'Percentage of Participants Responding to Poliovirus Type 2', 'timeFrame': 'Postdose 3 (Month 7)', 'description': 'Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 2. Response is defined as a titer \\>=8.'}, {'measure': 'Percentage of Participants Responding to Poliovirus Type 3', 'timeFrame': 'Postdose 3 (Month 7)', 'description': 'Participant serum samples were collected for testing with a Micrometabolic Inhibition Test for neutralizing antibodies to Poliovirus Type 3. Response is defined as a titer \\>=8.'}, {'measure': 'Geometric Mean Concentration of Antibodies to Pertussis Toxin', 'timeFrame': 'Postdose 3 (Month 7)', 'description': 'Participant serum samples were collected for testing with an ELISA for antibodies to pertussis toxin. The unit of measure is ELISA units/mL (EU/mL).'}, {'measure': 'Geometric Mean Concentration of Antibodies to Pertussis Filamentous Hemagglutinin', 'timeFrame': 'Postdose 3 (Month 7)', 'description': 'Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin.'}, {'measure': 'Geometric Mean Concentration of Antibodies to Pertussis Pertactin', 'timeFrame': 'Postdose 3 (Month 7)', 'description': 'Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin.'}, {'measure': 'Geometric Mean Concentration of Antibodies to Pertussis Fimbriae', 'timeFrame': 'Postdose 3 (Month 7)', 'description': 'Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae.'}, {'measure': 'Percentage of Participants Responding to Pertussis Toxin', 'timeFrame': 'Postdose 4 (Month 16)', 'description': 'Participant serum samples were collected for testing with an ELISA for antibodies to pertussis toxin. Response was defined as follows: 1) if the predose titer was \\<4 times the lower limit of quantitation (4X LLOQ) then the postdose titer was \\>=4X LLOQ; 2) if the predose titer was \\>=4X LLOQ then the postdose titer was \\>= the predose titer.'}, {'measure': 'Percentage of Participants Responding to Pertussis Filamentous Hemagglutinin', 'timeFrame': 'Postdose 4 (Month 16)', 'description': 'Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin. Response was defined as follows: 1) if the predose titer was \\<4 times the lower limit of quantitation (4X LLOQ) then the postdose titer was \\>=4X LLOQ; 2) if the predose titer was \\>=4X LLOQ then the postdose titer was \\>= the predose titer.'}, {'measure': 'Percentage of Participants Responding to Pertussis Pertactin', 'timeFrame': 'Postdose 4 (Month 16)', 'description': 'Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin. Response was defined as follows: 1) if the predose titer was \\<4 times the lower limit of quantitation (4X LLOQ) then the postdose titer was \\>=4X LLOQ; 2) if the predose titer was \\>=4X LLOQ then the postdose titer was \\>= the predose titer.'}, {'measure': 'Percentage of Participants Responding to Pertussis Fimbriae', 'timeFrame': 'Postdose 4 (Month 16)', 'description': 'Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae. Response was defined as follows: 1) if the predose titer was \\<4 times the lower limit of quantitation (4X LLOQ) then the postdose titer was \\>=4X LLOQ; 2) if the predose titer was \\>=4X LLOQ then the postdose titer was \\>= the predose titer.'}, {'measure': 'Geometric Mean Concentration of Antibodies to Pertussis Toxin', 'timeFrame': 'Postdose 4 (Month 16)', 'description': 'Participant serum samples were collected for testing with an ELISA for antibodies to pertussis toxin.'}, {'measure': 'Geometric Mean Concentration of Antibodies to Pertussis Filamentous Hemagglutinin', 'timeFrame': 'Postdose 4 (Month 16)', 'description': 'Participant serum samples were collected for testing with an ELISA for antibodies to pertussis filamentous hemagglutinin.'}, {'measure': 'Geometric Mean Concentration of Antibodies to Pertussis Pertactin', 'timeFrame': 'Postdose 4 (Month 16)', 'description': 'Participant serum samples were collected for testing with an ELISA for antibodies to pertussis pertactin.'}, {'measure': 'Geometric Mean Concentration of Antibodies to Pertussis Fimbriae', 'timeFrame': 'Postdose 4 (Month 16)', 'description': 'Participant serum samples were collected for testing with an ELISA for antibodies to pertussis fimbriae.'}], 'secondaryOutcomes': [{'measure': 'Geometric Mean Concentration of Antibodies to Polyribosylribitol Phosphate Antigen', 'timeFrame': 'Postdose 3 (Month 7)', 'description': 'Participant serum samples were collected for testing with a radioimmunoassay for antibodies to Haemophilus influenza type b capsular polysaccharide polyribosylribitol phosphate.'}, {'measure': 'Geometric Mean Concentration of Immunoglobulin A (IgA) Antibodies to Rotavirus', 'timeFrame': 'Postdose 3 (Month 7)', 'description': 'Participant serum samples were collected for testing with an Enzyme-linked Immunosorbent assay for IgA antibodies to rotavirus.'}, {'measure': 'Percentage of Participants Reporting Solicited Injection-site or Systemic Reactions', 'timeFrame': 'Up to 5 days after any infant vaccination (up to 6 months)', 'description': 'Solicited injection-site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Pyrexia, Vomiting, Crying abnormal, Somnolence, Decreased appetite, and Irritability. Grade 3 Solicited injection site reaction: Pain, Cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling, \\>5 cm. Grade 3 Solicited systemic reactions: Pyrexia, \\>=39.5°C (\\>=103.1°F) rectal; Vomiting, \\>=6 episodes per 24 hours or requiring parenteral hydration; Crying abnormal, \\>3 hours; Somnolence, Sleeping most of the time or difficult to wake up; Decreased appetite, Refuses \\>=3 feeds or refuses most feeds; Irritability, Inconsolable.'}, {'measure': 'Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug', 'timeFrame': 'Up to 5 days after any infant vaccination (up to 6 months)', 'description': 'Solicited systemic adverse events: pyrexia, vomiting, crying abnormal, somnolence, decreased appetite, and irritability. Adverse events deemed related to study drug were those judged to be definitely related, probably related, or possibly related by the investigator.'}, {'measure': 'Percentage of Participants Reporting One or More Solicited Adverse Events Related to Study Drug', 'timeFrame': 'Up to 5 days after each infant vaccination (up to 6 months)', 'description': 'Solicited systemic adverse events: pyrexia, vomiting, crying abnormal, somnolence, decreased appetite, and irritability. Adverse events deemed related to study drug were those judged to be definitely related, probably related, or possibly related by the investigator.'}, {'measure': 'Percentage of Participants With Elevated Temperature by Severity', 'timeFrame': 'Up to 5 days after any infant vaccination (up to 6 months)', 'description': 'Maximum temperature (all routes) was based on actual temperatures recorded with no adjustments to the measurement route. Maximum temperature (rectal) was required of all participants if the reading by another method was \\>=38.0°C.'}, {'measure': 'Percentage of Participants With Pyrexia, Febrile Convulsion, or Convulsion', 'timeFrame': 'Up to 15 days after any infant vaccination (up to 6 months)', 'description': 'The percentage of participants with one or more adverse events (AE), serious adverse events (SAE), and vaccine-related SAE (pyrexia, febrile convulsion, and convulsion) is reported.'}, {'measure': 'Percentage of Participants With Pyrexia, Febrile Convulsion, or Convulsion', 'timeFrame': 'Up to 181 days after any infant vaccination (up to 12 months)', 'description': 'The percentage of participants with one or more adverse events (AE), serious adverse events (SAE), and vaccine-related SAE (pyrexia, febrile convulsion, and convulsion) is reported.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Diphtheria', 'Tetanus', 'Whooping Cough (pertussis)', 'Poliomyelitis', 'Hepatitis B infection', 'Haemophilus influenzae type b infection'], 'conditions': ['Bacterial Infections', 'Virus Diseases']}, 'referencesModule': {'references': [{'pmid': '26216331', 'type': 'BACKGROUND', 'citation': 'Marshall GS, Adams GL, Leonardi ML, Petrecz M, Flores SA, Ngai AL, Xu J, Liu G, Stek JE, Foglia G, Lee AW. Immunogenicity, Safety, and Tolerability of a Hexavalent Vaccine in Infants. Pediatrics. 2015 Aug;136(2):e323-32. doi: 10.1542/peds.2014-4102.'}]}, 'descriptionModule': {'briefSummary': 'This is a study to assess the safety, tolerability, and immunogenicity of V419 (PR5I) when administered as an infant series at 2, 4, and 6 months of age followed by a toddler dose of DAPTACEL™, Prevnar 13™ and PedvaxHIB™ at 15 months of age. The study will determine whether subjects who receive V419 have a similar immune response to the vaccine compared to subjects who receive licensed component vaccine controls.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '89 Days', 'minimumAge': '46 Days', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria :\n\n* Participant is a healthy infant\n* Participant has received one dose of monovalent hepatitis B vaccine prior to or at 1 month of age\n\nExclusion Criteria :\n\n* Participant has received more than one dose of monovalent hepatitis B vaccine or hepatitis B based combination vaccine prior to study entry\n* Participant has been vaccinated with any acellular pertussis or whole cell pertussis based combination vaccines, haemophilus influenzae type b conjugate, poliovirus, pneumococcal conjugate or pneumococcal polysaccharide, rotavirus, or any combination of the above\n* Participant has had a fever ≥38.0°C (≥110.4°F) within 24 hours of study enrollment\n* Participant was vaccinated with any non-study vaccine (i.e., inactivated, conjugated, live virus vaccine) within 30 days prior to study enrollment, except for inactivated influenza vaccine which will be permitted 15 days or more prior to enrollment\n* Participant has hepatitis B surface antigen (HBsAg) seropositivity (by medical history)\n* Participant has a history of haemophilus influenzae type B, hepatitis B, diphtheria, tetanus, pertussis, poliomyelitis, rotavirus, or pneumococcal infection'}, 'identificationModule': {'nctId': 'NCT01337167', 'briefTitle': 'Safety, Tolerability, and Immunogenicity of V419 Given Concomitantly With Prevnar 13™ and RotaTeq™ (V419-005)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Phase III Randomized, Open-Label, Active-Comparator Controlled Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V419 in Infants When Given at 2, 4, and 6 Months Concomitantly With Prevnar 13™ and RotaTeq™', 'orgStudyIdInfo': {'id': 'V419-005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'V419', 'description': 'V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.', 'interventionNames': ['Biological: V419', 'Biological: DAPTACEL™', 'Biological: PedvaxHIB™', 'Biological: Prevnar 13™', 'Biological: RotaTeq™']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.', 'interventionNames': ['Biological: DAPTACEL™', 'Biological: Prevnar 13™', 'Biological: RotaTeq™', 'Biological: PENTACEL™', 'Biological: Recombivax HB vaccine', 'Biological: ActHIB™']}], 'interventions': [{'name': 'V419', 'type': 'BIOLOGICAL', 'description': 'V419 (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate \\[Meningococcal Outer Membrane Protein Complex\\], and Hepatitis B \\[Recombinant\\] Vaccine) 0.5 mL intramuscular injection at 2, 4, and 6 months of age', 'armGroupLabels': ['V419']}, {'name': 'DAPTACEL™', 'type': 'BIOLOGICAL', 'description': 'DAPTACEL™ 0.5 mL intramuscular injection at 15 months of age', 'armGroupLabels': ['Control', 'V419']}, {'name': 'PedvaxHIB™', 'type': 'BIOLOGICAL', 'description': 'PedvaxHIB™ 0.5 mL intramuscular injection at 15 months of age', 'armGroupLabels': ['V419']}, {'name': 'Prevnar 13™', 'type': 'BIOLOGICAL', 'description': 'Prevnar 13™ 0.5 mL intramuscular injection at 2, 4, 6, and 15 months of age', 'armGroupLabels': ['Control', 'V419']}, {'name': 'RotaTeq™', 'type': 'BIOLOGICAL', 'otherNames': ['V260'], 'description': 'RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age', 'armGroupLabels': ['Control', 'V419']}, {'name': 'PENTACEL™', 'type': 'BIOLOGICAL', 'description': 'PENTACEL™ 0.5 mL intramuscular injection at 2, 4, and 6 months of age', 'armGroupLabels': ['Control']}, {'name': 'Recombivax HB vaccine', 'type': 'BIOLOGICAL', 'description': 'Recombivax HB vaccine 0.5 mL intramuscular injection at 2 and 6 months of age', 'armGroupLabels': ['Control']}, {'name': 'ActHIB™', 'type': 'BIOLOGICAL', 'description': 'ActHIB™ 0.5 mL intramuscular injection at 15 months of age', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'ipdSharingStatementModule': {'url': 'http://engagezone.msd.com/ds_documentation.php', 'ipdSharing': 'YES', 'description': 'https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'MCM Vaccines B.V.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}