Viewing Study NCT01480258

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Ignite Creation Date: 2025-12-25 @ 12:05 AM
Ignite Modification Date: 2025-12-25 @ 10:03 PM
Study NCT ID: NCT01480258
Status: COMPLETED
Last Update Posted: 2019-04-02
First Post: 2011-11-23
Is NOT Gene Therapy: False
Has Adverse Events: True
Brief Title: Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 4, and 11 to 12 Months (V419-008)
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Finland', 'Italy', 'Sweden']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D004165', 'term': 'Diphtheria'}, {'id': 'D014917', 'term': 'Whooping Cough'}, {'id': 'D013742', 'term': 'Tetanus'}, {'id': 'D006509', 'term': 'Hepatitis B'}, {'id': 'D006192', 'term': 'Haemophilus Infections'}, {'id': 'D011051', 'term': 'Poliomyelitis'}], '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': 'D001885', 'term': 'Bordetella Infections'}, {'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D003015', 'term': 'Clostridium Infections'}, {'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'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000617220', 'term': 'Vaxelis'}, {'id': 'D022243', 'term': 'Rotavirus Vaccines'}, {'id': 'C538862', 'term': '13-valent pneumococcal vaccine'}], 'ancestors': [{'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, '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 and Sponsor representative 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 or Sponsor representative as confidential must be deleted prior to submission.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to approximately 11 months (serious AEs and deaths were collected for the duration of the study; unsolicited adverse events were collected from D1 to D15 after each hexavalent vaccination, solicited adverse events were collected D1 to D5 after each hexavalent vaccination)', 'description': 'Analysis population includes all randomised participants who received at least 1 vaccination and had safety follow-up.', 'eventGroups': [{'id': 'EG000', 'title': 'PR5I', 'description': 'Infant series: PR5I 0.5 mL injection + Prevenar 13™ 0.5 mL injection administered at 2 and 4 months of age, and rotavirus vaccine (either Rotarix™ 1.5 mL oral dose at 2 and 4 months of age \\[subset 1\\] or RotaTeq™ 2 mL oral dose at 2, 4 and 5 months of age \\[subset 2\\]). Toddler dose: PR5I 0.5 mL injection + Prevenar 13™ 0.5 mL injection administered at 11 to 12 months of age.', 'otherNumAtRisk': 653, 'deathsNumAtRisk': 653, 'otherNumAffected': 650, 'seriousNumAtRisk': 653, 'deathsNumAffected': 0, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': 'INFANRIX™ Hexa', 'description': 'Infant series: INFANRIX™ hexa 0.5 mL injection + Prevenar 13™ 0.5 mL injection administered at 2 and 4 months of age, and rotavirus vaccine (either Rotarix™ 1.5 mL oral dose at 2 and 4 months of age \\[subset 1\\] or RotaTeq™ 2 mL oral dose at 2, 4 and 5 months of age \\[subset 2\\]). Toddler dose: INFANRIX™ hexa 0.5 mL injection + Prevenar 13™ 0.5 mL injection administered at 11 to 12 months of age.', 'otherNumAtRisk': 659, 'deathsNumAtRisk': 659, 'otherNumAffected': 653, 'seriousNumAtRisk': 659, 'deathsNumAffected': 0, 'seriousNumAffected': 10}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 653, 'numEvents': 23, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 659, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 653, 'numEvents': 25, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 659, 'numEvents': 18, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 653, 'numEvents': 95, 'numAffected': 76}, {'groupId': 'EG001', 'numAtRisk': 659, 'numEvents': 84, 'numAffected': 70}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 653, 'numEvents': 32, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 659, 'numEvents': 29, 'numAffected': 25}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 653, 'numEvents': 324, 'numAffected': 220}, {'groupId': 'EG001', 'numAtRisk': 659, 'numEvents': 319, 'numAffected': 211}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Crying', 'stats': [{'groupId': 'EG000', 'numAtRisk': 653, 'numEvents': 1422, 'numAffected': 583}, {'groupId': 'EG001', 'numAtRisk': 659, 'numEvents': 1305, 'numAffected': 574}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Injection site bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 653, 'numEvents': 15, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 659, 'numEvents': 24, 'numAffected': 23}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Injection site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 653, 'numEvents': 1625, 'numAffected': 485}, {'groupId': 'EG001', 'numAtRisk': 659, 'numEvents': 1490, 'numAffected': 450}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Injection site haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 653, 'numEvents': 21, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 659, 'numEvents': 20, 'numAffected': 17}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Injection site induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 653, 'numEvents': 266, 'numAffected': 119}, {'groupId': 'EG001', 'numAtRisk': 659, 'numEvents': 246, 'numAffected': 107}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 653, 'numEvents': 1778, 'numAffected': 496}, {'groupId': 'EG001', 'numAtRisk': 659, 'numEvents': 1656, 'numAffected': 493}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 653, 'numEvents': 1179, 'numAffected': 406}, {'groupId': 'EG001', 'numAtRisk': 659, 'numEvents': 1083, 'numAffected': 373}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 653, 'numEvents': 1518, 'numAffected': 598}, {'groupId': 'EG001', 'numAtRisk': 659, 'numEvents': 1446, 'numAffected': 589}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 653, 'numEvents': 875, 'numAffected': 490}, {'groupId': 'EG001', 'numAtRisk': 659, 'numEvents': 768, 'numAffected': 452}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 653, 'numEvents': 39, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 659, 'numEvents': 39, 'numAffected': 36}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 653, 'numEvents': 26, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 659, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 653, 'numEvents': 39, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 659, 'numEvents': 44, 'numAffected': 41}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 653, 'numEvents': 45, 'numAffected': 41}, {'groupId': 'EG001', 'numAtRisk': 659, 'numEvents': 48, 'numAffected': 43}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 653, 'numEvents': 731, 'numAffected': 431}, {'groupId': 'EG001', 'numAtRisk': 659, 'numEvents': 694, 'numAffected': 411}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 653, 'numEvents': 1168, 'numAffected': 562}, {'groupId': 'EG001', 'numAtRisk': 659, 'numEvents': 1118, 'numAffected': 529}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 653, 'numEvents': 31, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 659, 'numEvents': 29, 'numAffected': 24}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}], 'seriousEvents': [{'term': 'Idiopathic thrombocytopenic purpura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 653, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 659, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Heart disease congenital', 'stats': [{'groupId': 'EG000', 'numAtRisk': 653, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 659, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Vitello-intestinal duct remnant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 653, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 659, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 653, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 659, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 653, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 659, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Injection site abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 653, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 659, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pneumonia respiratory syncytial viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 653, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 659, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 653, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 659, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Pyelonephritis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 653, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 659, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Respiratory syncytial virus bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 653, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 659, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Streptococcal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 653, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 659, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 653, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 659, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 653, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 659, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 653, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 659, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 653, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 659, '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': 653, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 659, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}], 'frequencyThreshold': '2.5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Acceptability of Antibody (Ab) Response or Seroresponse Rates to All Antigens Contained in PR5I Vaccine One Month After the Toddler Dose of PR5I (11 to 12 Months of Age)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '638', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PR5I', 'description': 'Infant series: PR5I 0.5 mL injection + Prevenar 13™ 0.5 mL injection administered at 2 and 4 months of age, and rotavirus vaccine (either Rotarix™ 1.5 mL oral dose at 2 and 4 months of age \\[subset 1\\] or RotaTeq™ 2 mL oral dose at 2, 4 and 5 months of age \\[subset 2\\]). Toddler dose: PR5I 0.5 mL injection + Prevenar 13™ 0.5 mL injection administered at 11 to 12 months of age.'}, {'id': 'OG001', 'title': 'INFANRIX™ Hexa', 'description': 'Infant series: INFANRIX™ hexa 0.5 mL injection + Prevenar 13™ 0.5 mL injection administered at 2 and 4 months of age, and rotavirus vaccine (either Rotarix™ 1.5 mL oral dose at 2 and 4 months of age \\[subset 1\\] or RotaTeq™ 2 mL oral dose at 2, 4 and 5 months of age \\[subset 2\\]). Toddler dose: INFANRIX™ hexa 0.5 mL injection + Prevenar 13™ 0.5 mL injection administered at 11 to 12 months of age.'}], 'classes': [{'title': 'Anti-PRP ≥1.0 μg/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '454', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '89.87', 'groupId': 'OG000', 'lowerLimit': '86.72', 'upperLimit': '92.49'}]}]}, {'title': 'Anti-HBsAg ≥10 mIU/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '377', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '98.14', 'groupId': 'OG000', 'lowerLimit': '96.21', 'upperLimit': '99.25'}]}]}, {'title': 'Anti-Diphtheria ≥0.1 IU/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '590', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '98.64', 'groupId': 'OG000', 'lowerLimit': '97.35', 'upperLimit': '99.41'}]}]}, {'title': 'Anti-Tetanus ≥0.1 IU/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '589', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '99.83', 'groupId': 'OG000', 'lowerLimit': '99.06', 'upperLimit': '100.00'}]}]}, {'title': 'Anti-PT seroresponse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '566', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '99.12', 'groupId': 'OG000', 'lowerLimit': '97.95', 'upperLimit': '99.71'}]}]}, {'title': 'Anti-FHA seroresponse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '582', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '97.42', 'groupId': 'OG000', 'lowerLimit': '95.78', 'upperLimit': '98.55'}]}]}, {'title': 'Anti-FIM seroresponse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '581', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '98.28', 'groupId': 'OG000', 'lowerLimit': '96.86', 'upperLimit': '99.17'}]}]}, {'title': 'Anti-PRN seroresponse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '582', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '96.91', 'groupId': 'OG000', 'lowerLimit': '95.16', 'upperLimit': '98.16'}]}]}, {'title': 'Anti-IPV1 ≥1:8 dilution', 'denoms': [{'units': 'Participants', 'counts': [{'value': '591', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '99.32', 'groupId': 'OG000', 'lowerLimit': '98.28', 'upperLimit': '99.82'}]}]}, {'title': 'Anti-IPV2 ≥1:8 dilution', 'denoms': [{'units': 'Participants', 'counts': [{'value': '591', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '99.83', 'groupId': 'OG000', 'lowerLimit': '99.06', 'upperLimit': '100.00'}]}]}, {'title': 'Anti-IPV3 ≥1:8 dilution', 'denoms': [{'units': 'Participants', 'counts': [{'value': '590', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '99.49', 'groupId': 'OG000', 'lowerLimit': '98.52', 'upperLimit': '99.90'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'pValueComment': 'One-sided p-value', 'groupDescription': 'Anti-PRP ≥ 1.0 μg/mL', 'statisticalMethod': 'Clopper and Pearson', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than 75%.'}, {'pValue': '<0.001', 'groupIds': ['OG000'], 'pValueComment': 'One-sided p-value', 'groupDescription': 'Anti-HBsAg ≥10 mIU/mL', 'statisticalMethod': 'Clopper and Pearson', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than 75%.'}, {'pValue': '<0.001', 'groupIds': ['OG000'], 'pValueComment': 'One-sided p-value', 'groupDescription': 'Anti-Diphtheria ≥0.1 IU/mL', 'statisticalMethod': 'Clopper and Pearson', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than 75%.'}, {'pValue': '<0.001', 'groupIds': ['OG000'], 'pValueComment': 'One-sided p-value', 'groupDescription': 'Anti-Tetanus ≥0.1 IU/mL', 'statisticalMethod': 'Clopper and Pearson', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than 75%.'}, {'pValue': '<0.001', 'groupIds': ['OG000'], 'pValueComment': 'One-sided p-value', 'groupDescription': 'Anti-PT seroresponse', 'statisticalMethod': 'Clopper and Pearson', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than 75%.'}, {'pValue': '<0.001', 'groupIds': ['OG000'], 'pValueComment': 'One-sided p-value', 'groupDescription': 'Anti-FHA seroresponse', 'statisticalMethod': 'Clopper and Pearson', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than 75%.'}, {'pValue': '<0.001', 'groupIds': ['OG000'], 'pValueComment': 'One-sided p-value', 'groupDescription': 'Anti-FIM seroresponse', 'statisticalMethod': 'Clopper and Pearson', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than 75%.'}, {'pValue': '<0.001', 'groupIds': ['OG000'], 'pValueComment': 'One-sided p-value', 'groupDescription': 'Anti-PRN seroresponse', 'statisticalMethod': 'Clopper and Pearson', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than 75%.'}, {'pValue': '<0.001', 'groupIds': ['OG000'], 'pValueComment': 'One-sided p-value', 'groupDescription': 'Anti-IPV1 ≥1:8 dilution', 'statisticalMethod': 'Clopper and Pearson', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than 75%.'}, {'pValue': '<0.001', 'groupIds': ['OG000'], 'pValueComment': 'One-sided p-value', 'groupDescription': 'Anti-IPV2 ≥1:8 dilution', 'statisticalMethod': 'Clopper and Pearson', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than 75%.'}, {'pValue': '<0.001', 'groupIds': ['OG000'], 'pValueComment': 'One-sided p-value', 'groupDescription': 'Anti-IPV3 ≥1:8 dilution', 'statisticalMethod': 'Clopper and Pearson', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than 75%.'}], 'paramType': 'NUMBER', 'timeFrame': '1 month after Toddler dose of PR51 (post-toddler dose)', 'description': 'Acceptability response rates were defined as Ab titre ≥1.0 μg/mL for Haemophilus influenzae type b (Hib) (polyribosylribitol phosphate, PRP); ≥10 mIU/mL for Hepatitis (HBsAg); ≥0.1 IU/mL for diphtheria and tetanus; ≥8 (1/dil) for inactive poliovirus type (IPV) 1, 2 \\& 3, and percentage of pertussis seroresponder participants (Pertussis toxoid \\[PT\\], Filamentous haemagglutinin \\[FHA\\], Fimbriae types 2 \\& 3 \\[FIM\\] and Pertactin \\[PRN\\]) 1 month Post-Toddler dose of PR5I. Seroresponse was defined: (1) If pre-Dose 1 Ab concentration (cc) was \\<LLOQ (lower limit of quantitation), postvaccination Ab cc was ≥LLOQ, (2) If pre-Dose 1 Ab cc was ≥LLOQ, postvaccination Ab cc was ≥prevaccination levels. Due to the timing of the occurrence of protocol violation or the availability of each antigen serology testing result, the analysis populations may not have been identical for each antigen-specific analysis at each post-vaccination visit.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who met the inclusion criteria, were not protocol violators, received PR51 vaccinations within acceptable day ranges, and had a blood draw sample window of Days 28 to 51 following the Toddler dose. Participants receiving INFANRIX™ hexa were excluded from the acceptability analyses.'}, {'type': 'SECONDARY', 'title': 'Non-inferiority of Antibody (Ab) Response Rate to Haemophilus Influenzae Type b (PRP) One Month After the 2nd Dose of PR5I (4 Months of Age) as Compared With INFANRIX Hexa', 'denoms': [{'units': 'Participants', 'counts': [{'value': '609', 'groupId': 'OG000'}, {'value': '592', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PR5I', 'description': 'Infant series: PR5I 0.5 mL injection + Prevenar 13™ 0.5 mL injection administered at 2 and 4 months of age, and rotavirus vaccine (either Rotarix™ 1.5 mL oral dose at 2 and 4 months of age \\[subset 1\\] or RotaTeq™ 2 mL oral dose at 2, 4 and 5 months of age \\[subset 2\\]). Toddler dose: PR5I 0.5 mL injection + Prevenar 13™ 0.5 mL injection administered at 11 to 12 months of age.'}, {'id': 'OG001', 'title': 'INFANRIX™ Hexa', 'description': 'Infant series: INFANRIX™ hexa 0.5 mL injection + Prevenar 13™ 0.5 mL injection administered at 2 and 4 months of age, and rotavirus vaccine (either Rotarix™ 1.5 mL oral dose at 2 and 4 months of age \\[subset 1\\] or RotaTeq™ 2 mL oral dose at 2, 4 and 5 months of age \\[subset 2\\]). Toddler dose: INFANRIX™ hexa 0.5 mL injection + Prevenar 13™ 0.5 mL injection administered at 11 to 12 months of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '72.86', 'groupId': 'OG000'}, {'value': '26.66', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '46.20', 'ciLowerLimit': '41.05', 'ciUpperLimit': '51.06', 'pValueComment': 'Stratification by country.', 'statisticalMethod': 'Miettinen & Nurminen', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'If the lower bound of the 95% confidence interval (CI) was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.'}], 'paramType': 'NUMBER', 'timeFrame': '1 month after the 2nd dose (post-infant dose 2)', 'description': 'Percentage of participants with an Ab titre ≥1.0 μg/mL for Hib (polyribosylribitol phosphate, PRP) measured by radioimmunoassay (RIA) 1 month post-infant dose 2 of PR5I or INFANRIX hexa.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received 2nd dose in the Infant series and had a blood draw sample window of Days 28 to 51 post-infant dose 2.'}, {'type': 'SECONDARY', 'title': 'Superiority of Antibody (Ab) Response Rates to Haemophilus Influenzae Type b (PRP) One Month After the 2nd Dose of PR5I (4 Months of Age) as Compared With INFANRIX Hexa', 'denoms': [{'units': 'Participants', 'counts': [{'value': '609', 'groupId': 'OG000'}, {'value': '592', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PR5I', 'description': 'Infant series: PR5I 0.5 mL injection + Prevenar 13™ 0.5 mL injection administered at 2 and 4 months of age, and rotavirus vaccine (either Rotarix™ 1.5 mL oral dose at 2 and 4 months of age \\[subset 1\\] or RotaTeq™ 2 mL oral dose at 2, 4 and 5 months of age \\[subset 2\\]). Toddler dose: PR5I 0.5 mL injection + Prevenar 13™ 0.5 mL injection administered at 11 to 12 months of age.'}, {'id': 'OG001', 'title': 'INFANRIX™ Hexa', 'description': 'Infant series: INFANRIX™ hexa 0.5 mL injection + Prevenar 13™ 0.5 mL injection administered at 2 and 4 months of age, and rotavirus vaccine (either Rotarix™ 1.5 mL oral dose at 2 and 4 months of age \\[subset 1\\] or RotaTeq™ 2 mL oral dose at 2, 4 and 5 months of age \\[subset 2\\]). Toddler dose: INFANRIX™ hexa 0.5 mL injection + Prevenar 13™ 0.5 mL injection administered at 11 to 12 months of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '72.86', 'groupId': 'OG000'}, {'value': '26.66', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '46.20', 'ciLowerLimit': '41.05', 'ciUpperLimit': '51.06', 'statisticalMethod': 'Miettinen & Nurminen', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratification by country.', 'nonInferiorityComment': 'If the lower bound of the 95% CI was greater than 0, it was concluded that PR5I group response rate was superior to INFANRIX hexa group response rate.'}], 'paramType': 'NUMBER', 'timeFrame': '1 month after the 2nd dose (post-infant dose 2)', 'description': 'Percentage of participants with an Ab titre ≥1.0 μg/mL for Hib (polyribosylribitol phosphate, PRP) measured by RIA 1 month post-infant dose 2 of PR5I or INFANRIX hexa.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received 2nd dose in the Infant series and had a blood draw sample window of Days 28 to 51 post-infant dose 2.'}, {'type': 'SECONDARY', 'title': 'Non-inferiority Ab Response Rates to PR5I Antigens One Month After the Toddler Dose of PR5I (11 to 12 Months of Age) as Compared With INFANRIX Hexa', 'denoms': [{'units': 'Participants', 'counts': [{'value': '638', 'groupId': 'OG000'}, {'value': '642', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PR5I', 'description': 'Infant series: PR5I 0.5 mL injection + Prevenar 13™ 0.5 mL injection administered at 2 and 4 months of age, and rotavirus vaccine (either Rotarix™ 1.5 mL oral dose at 2 and 4 months of age \\[subset 1\\] or RotaTeq™ 2 mL oral dose at 2, 4 and 5 months of age \\[subset 2\\]). Toddler dose: PR5I 0.5 mL injection + Prevenar 13™ 0.5 mL injection administered at 11 to 12 months of age.'}, {'id': 'OG001', 'title': 'INFANRIX™ Hexa', 'description': 'Infant series: INFANRIX™ hexa 0.5 mL injection + Prevenar 13™ 0.5 mL injection administered at 2 and 4 months of age, and rotavirus vaccine (either Rotarix™ 1.5 mL oral dose at 2 and 4 months of age \\[subset 1\\] or RotaTeq™ 2 mL oral dose at 2, 4 and 5 months of age \\[subset 2\\]). Toddler dose: INFANRIX™ hexa 0.5 mL injection + Prevenar 13™ 0.5 mL injection administered at 11 to 12 months of age.'}], 'classes': [{'title': 'Anti-PRP ≥1.0 μg/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '454', 'groupId': 'OG000'}, {'value': '478', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '89.80', 'groupId': 'OG000'}, {'value': '91.06', 'groupId': 'OG001'}]}]}, {'title': 'Anti-HBsAg ≥10 mIU/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '377', 'groupId': 'OG000'}, {'value': '391', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '98.14', 'groupId': 'OG000'}, {'value': '98.73', 'groupId': 'OG001'}]}]}, {'title': 'Anti-Diphtheria ≥0.1 IU/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '590', 'groupId': 'OG000'}, {'value': '578', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '98.62', 'groupId': 'OG000'}, {'value': '99.83', 'groupId': 'OG001'}]}]}, {'title': 'Anti-Tetanus ≥0.1 IU/mL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '589', 'groupId': 'OG000'}, {'value': '577', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '99.83', 'groupId': 'OG000'}, {'value': '100.00', 'groupId': 'OG001'}]}]}, {'title': 'Anti-PT seroresponse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '566', 'groupId': 'OG000'}, {'value': '561', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '99.11', 'groupId': 'OG000'}, {'value': '99.64', 'groupId': 'OG001'}]}]}, {'title': 'Anti-FHA seroresponse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '582', 'groupId': 'OG000'}, {'value': '571', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '97.40', 'groupId': 'OG000'}, {'value': '99.13', 'groupId': 'OG001'}]}]}, {'title': 'Anti-PRN seroresponse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '582', 'groupId': 'OG000'}, {'value': '572', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '96.86', 'groupId': 'OG000'}, {'value': '98.28', 'groupId': 'OG001'}]}]}, {'title': 'Anti-IPV1 ≥1:8 dilution', 'denoms': [{'units': 'Participants', 'counts': [{'value': '591', 'groupId': 'OG000'}, {'value': '580', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '99.32', 'groupId': 'OG000'}, {'value': '99.83', 'groupId': 'OG001'}]}]}, {'title': 'Anti-IPV2 ≥1:8 dilution', 'denoms': [{'units': 'Participants', 'counts': [{'value': '591', 'groupId': 'OG000'}, {'value': '579', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '99.83', 'groupId': 'OG000'}, {'value': '100.00', 'groupId': 'OG001'}]}]}, {'title': 'Anti-IPV3 ≥1:8 dilution', 'denoms': [{'units': 'Participants', 'counts': [{'value': '590', 'groupId': 'OG000'}, {'value': '579', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '99.49', 'groupId': 'OG000'}, {'value': '99.65', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.27', 'ciLowerLimit': '-5.13', 'ciUpperLimit': '2.52', 'groupDescription': 'Non-inferiority for PRP', 'statisticalMethod': 'Miettinen & Nurminen with stratification', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'Statistical analysis was based on the Miettinen \\& Nurminen method stratified by country.', 'nonInferiorityComment': 'The estimate of the difference between PR5I \\& INFANRIX hexa groups in PRP response rate (based on Ab titre ≥1.0 μg/mL) was calculated with its 1-sided P-value \\& 2-sided 95% CI. If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'ifference in percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.59', 'ciLowerLimit': '-2.66', 'ciUpperLimit': '1.35', 'groupDescription': 'Non-Inferiority for HBsAg', 'statisticalMethod': 'Miettinen & Nurminen with stratification', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'Statistical analysis was based on the Miettinen \\& Nurminen method stratified by country.', 'nonInferiorityComment': 'The estimate of the difference between PR5I \\& INFANRIX hexa groups in HBsAg response rate (based on Ab titre ≥10 mIU/mL) was calculated with its 1-sided P-value \\& 2-sided 95% CI. If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.21', 'ciLowerLimit': '-2.54', 'ciUpperLimit': '-0.22', 'groupDescription': 'Non-Inferiority for Diptheria', 'statisticalMethod': 'Miettinen & Nurminen with stratification', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'Statistical analysis was based on the Miettinen \\& Nurminen method stratified by country.', 'nonInferiorityComment': 'The estimate of the difference between PR5I \\& INFANRIX hexa groups in Diphtheria response rate (based on Ab titre ≥0.1 IU/mL) was calculated with its 1-sided P-value \\& 2-sided 95% CI. If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.17', 'ciLowerLimit': '-0.95', 'ciUpperLimit': '0.50', 'groupDescription': 'Non-Inferiority for Tetanus', 'statisticalMethod': 'Miettinen & Nurminen with stratification', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'Statistical analysis was based on the Miettinen \\& Nurminen method stratified by country.', 'nonInferiorityComment': 'The estimate of the difference between PR5I \\& INFANRIX hexa groups in Tetanus response rate (based on Ab titre ≥0.1 IU/mL) was calculated with its 1-sided P-value \\& 2-sided 95% CI. If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.54', 'ciLowerLimit': '-1.75', 'ciUpperLimit': '0.49', 'groupDescription': 'Non-Inferiority for PT', 'statisticalMethod': 'Miettinen & Nurminen with stratification', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'Statistical analysis was based on the Miettinen \\& Nurminen method stratified by country.', 'nonInferiorityComment': 'The estimate of the difference between PR5I \\& INFANRIX hexa groups in the percentage of seroresponder participants for PT was calculated with its 1-sided P-value \\& 2-sided 95% CI. If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.73', 'ciLowerLimit': '-3.47', 'ciUpperLimit': '-0.26', 'groupDescription': 'Non-Inferiority for FHA', 'statisticalMethod': 'Miettinen & Nurminen with stratification', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'Statistical analysis was based on the Miettinen \\& Nurminen method stratified by country.', 'nonInferiorityComment': 'The estimate of the difference between PR5I \\& INFANRIX hexa groups in the percentage of seroresponder participants for FHA was calculated with its 1-sided P-value \\& 2-sided 95% CI. If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.42', 'ciLowerLimit': '-3.42', 'ciUpperLimit': '0.39', 'groupDescription': 'Non-Inferiority for PRN', 'statisticalMethod': 'Miettinen & Nurminen with stratification', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'Statistical analysis was based on the Miettinen \\& Nurminen method stratified by country.', 'nonInferiorityComment': 'The estimate of the difference between PR5I \\& INFANRIX hexa groups in the percentage of seroresponder participants for PRN was calculated with its 1-sided P-value \\& 2-sided 95% CI. If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.51', 'ciLowerLimit': '-1.59', 'ciUpperLimit': '0.34', 'groupDescription': 'Non-Inferiority for IPV1', 'statisticalMethod': 'Miettinen & Nurminen with stratification', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'Statistical analysis was based on the Miettinen \\& Nurminen method stratified by country.', 'nonInferiorityComment': 'The estimate of the difference between PR5I \\& INFANRIX hexa groups in IPV1 response rate (based on Ab titre ≥8 (1/dil)) was calculated with its 1-sided P-value \\& 2-sided 95% CI. If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.17', 'ciLowerLimit': '-0.96', 'ciUpperLimit': '0.49', 'groupDescription': 'Non-Inferiority for IPV2', 'statisticalMethod': 'Miettinen & Nurminen with stratification', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'Statistical analysis was based on the Miettinen \\& Nurminen method stratified by country.', 'nonInferiorityComment': 'The estimate of the difference between PR5I \\& INFANRIX hexa groups in IPV2 response rate (based on Ab titre ≥8 (1/dil)) was calculated with its 1-sided P-value \\& 2-sided 95% CI. If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.16', 'ciLowerLimit': '-1.20', 'ciUpperLimit': '0.82', 'groupDescription': 'Non-Inferiority for IPV3', 'statisticalMethod': 'Miettinen & Nurminen with stratification', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'Statistical analysis was based on the Miettinen \\& Nurminen method stratified by country.', 'nonInferiorityComment': 'The estimate of the difference between PR5I \\& INFANRIX hexa groups in IPV3 response rate (based on Ab titre ≥8 (1/dil)) was calculated with its 1-sided P-value \\& 2-sided 95% CI. If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate.'}], 'paramType': 'NUMBER', 'timeFrame': '1 month after Toddler dose (post-toddler dose)', 'description': 'Percentage of participants with pre-specified Ab titre for PRP, HBsAg, diphtheria, tetanus, IPV1, 2 \\& 3, and percentage of pertussis seroresponder participants (PT, FHA, FIM and PRN) 1 month post-toddler dose were calculated based on the method by Miettinen and Nurminen stratified by country. Seroresponse was defined: (1) If pre-Dose 1 Ab cc was \\<LLOQ, post-vaccination Ab cc was ≥LLOQ, (2) If pre-Dose 1 Ab cc was ≥LLOQ, post-vaccination Ab cc was ≥pre-vaccination levels. Due to the timing of the occurrence of protocol violation or the availability of each antigen serology testing result, the analysis populations may not have been identical for each antigen-specific analysis at each post-vaccination visit.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who met the inclusion criteria, were not protocol violators, received vaccinations within acceptable day ranges, and had a blood draw sample window of Days 28 to 51 following the Toddler dose.'}, {'type': 'SECONDARY', 'title': 'Non-inferiority of Rotavirus Response (Geometric Mean Titer, GMT) One Month After the 2nd Dose of Rotarix (4 Months of Age) Administered Concomitantly With PR5I Versus INFANRIX Hexa', 'denoms': [{'units': 'Participants', 'counts': [{'value': '160', 'groupId': 'OG000'}, {'value': '171', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PR5I', 'description': 'Infant series: PR5I 0.5 mL injection + Prevenar 13™ 0.5 mL injection administered at 2 and 4 months of age, and rotavirus vaccine (either Rotarix™ 1.5 mL oral dose at 2 and 4 months of age \\[subset 1\\] or RotaTeq™ 2 mL oral dose at 2, 4 and 5 months of age \\[subset 2\\]). Toddler dose: PR5I 0.5 mL injection + Prevenar 13™ 0.5 mL injection administered at 11 to 12 months of age.'}, {'id': 'OG001', 'title': 'INFANRIX™ Hexa', 'description': 'Infant series: INFANRIX™ hexa 0.5 mL injection + Prevenar 13™ 0.5 mL injection administered at 2 and 4 months of age, and rotavirus vaccine (either Rotarix™ 1.5 mL oral dose at 2 and 4 months of age \\[subset 1\\] or RotaTeq™ 2 mL oral dose at 2, 4 and 5 months of age \\[subset 2\\]). Toddler dose: INFANRIX™ hexa 0.5 mL injection + Prevenar 13™ 0.5 mL injection administered at 11 to 12 months of age.'}], 'classes': [{'categories': [{'measurements': [{'value': '96.41', 'groupId': 'OG000', 'lowerLimit': '71.69', 'upperLimit': '129.65'}, {'value': '122.24', 'groupId': 'OG001', 'lowerLimit': '92.48', 'upperLimit': '161.58'}]}]}], 'analyses': [{'pValue': '0.011', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Mean Titre (GMT) ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.80', 'ciLowerLimit': '0.54', 'ciUpperLimit': '1.20', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'The estimate for anti-rotavirus IgA GMT ratio (PR5I group/INFANRIX hexa group) was calculated with its 1-sided P-value and 2-sided 95% CI. If the lower bound of the 95% CI for GMT ratio was greater than 0.50 (non-inferiority margin), it was concluded that the Rotarix antigen response in the PR5I group was not inferior to the Rotarix antigen response in the INFANRIX hexa group.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 month after the 2nd dose of Rotarix, administered concomitantly with PR5I or INFANRIX hexa (Post-Dose 2)', 'description': 'Antibody titres expressed in units/mL were measured for Rotavirus IgA by Enzyme Immunoassay (EIA), 1 month after the 2nd dose of Rotarix, administered concomitantly with PR5I or INFANRIX hexa (Post-Dose 2). The 95% CI for GMT was based on the t-distribution of the natural log-transformed antibody titer.', 'unitOfMeasure': 'Titre (units/mL)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received dose 2 of Rotarix.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Who Experienced an Adverse Event (AE) From Day 1 to Day 15 After Any Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '653', 'groupId': 'OG000'}, {'value': '659', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PR5I', 'description': 'Infant series: PR5I 0.5 mL injection + Prevenar 13™ 0.5 mL injection administered at 2 and 4 months of age, and rotavirus vaccine (either Rotarix™ 1.5 mL oral dose at 2 and 4 months of age \\[subset 1\\] or RotaTeq™ 2 mL oral dose at 2, 4 and 5 months of age \\[subset 2\\]). Toddler dose: PR5I 0.5 mL injection + Prevenar 13™ 0.5 mL injection administered at 11 to 12 months of age.'}, {'id': 'OG001', 'title': 'INFANRIX™ Hexa', 'description': 'Infant series: INFANRIX™ hexa 0.5 mL injection + Prevenar 13™ 0.5 mL injection administered at 2 and 4 months of age, and rotavirus vaccine (either Rotarix™ 1.5 mL oral dose at 2 and 4 months of age \\[subset 1\\] or RotaTeq™ 2 mL oral dose at 2, 4 and 5 months of age \\[subset 2\\]). Toddler dose: INFANRIX™ hexa 0.5 mL injection + Prevenar 13™ 0.5 mL injection administered at 11 to 12 months of age.'}], 'classes': [{'title': 'At least 1 ISR or systemic AE (D1-D15)', 'categories': [{'measurements': [{'value': '99.5', 'groupId': 'OG000'}, {'value': '99.2', 'groupId': 'OG001'}]}]}, {'title': 'At least 1 ISR or V-related systemic AE (D1-D15)', 'categories': [{'measurements': [{'value': '99.5', 'groupId': 'OG000'}, {'value': '98.8', 'groupId': 'OG001'}]}]}, {'title': 'At least 1 ISR (D1-D15)', 'categories': [{'measurements': [{'value': '90.8', 'groupId': 'OG000'}, {'value': '88.2', 'groupId': 'OG001'}]}]}, {'title': 'At least 1 solicited ISR (D1-D5)', 'categories': [{'measurements': [{'value': '90.4', 'groupId': 'OG000'}, {'value': '87.9', 'groupId': 'OG001'}]}]}, {'title': 'At least 1 systemic AE (D1-D15)', 'categories': [{'measurements': [{'value': '99.1', 'groupId': 'OG000'}, {'value': '98.9', 'groupId': 'OG001'}]}]}, {'title': 'At least 1 V-related systemic AE (D1-D15)', 'categories': [{'measurements': [{'value': '99.1', 'groupId': 'OG000'}, {'value': '98.3', 'groupId': 'OG001'}]}]}, {'title': 'At least 1 solicited systemic AE (D1-D5)', 'categories': [{'measurements': [{'value': '99.1', 'groupId': 'OG000'}, {'value': '98.3', 'groupId': 'OG001'}]}]}, {'title': 'At least 1 V-related solicited systemic AE (D1-D5)', 'categories': [{'measurements': [{'value': '99.1', 'groupId': 'OG000'}, {'value': '98.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-0.7', 'ciUpperLimit': '1.4', 'groupDescription': 'ISR or systemic AE', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \\& Nurminen method. The aim of the 95% CI was to investigate an overall trend and not any specific difference. If 0.0 was excluded from the 95% CI, the trend could not be ruled out.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciPctValue': '95', 'paramValue': '0.8', 'ciLowerLimit': '-0.3', 'ciUpperLimit': '2.0', 'groupDescription': 'ISR or V-related systemic AE', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \\& Nurminen method. The aim of the 95% CI was to investigate an overall trend and not any specific difference. If 0.0 was excluded from the 95% CI, the trend could not be ruled out.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.6', 'ciLowerLimit': '-0.7', 'ciUpperLimit': '6.0', 'groupDescription': 'At least 1 ISR', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \\& Nurminen method. The aim of the 95% CI was to investigate an overall trend and not any specific difference. If 0.0 was excluded from the 95% CI, the trend could not be ruled out.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.5', 'ciLowerLimit': '-0.9', 'ciUpperLimit': '5.9', 'groupDescription': 'At least 1 solicited ISR', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \\& Nurminen method. The aim of the 95% CI was to investigate an overall trend and not any specific difference. If 0.0 was excluded from the 95% CI, the trend could not be ruled out.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-1.1', 'ciUpperLimit': '1.4', 'groupDescription': 'At least 1 systemic AE', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \\& Nurminen method. The aim of the 95% CI was to investigate an overall trend and not any specific difference. If 0.0 was excluded from the 95% CI, the trend could not be ruled out.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8', 'ciLowerLimit': '-0.5', 'ciUpperLimit': '2.2', 'groupDescription': 'At least 1 vaccine-related systemic AE', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \\& Nurminen method. The aim of the 95% CI was to investigate an overall trend and not any specific difference. If 0.0 was excluded from the 95% CI, the trend could not be ruled out.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.8', 'ciLowerLimit': '-0.5', 'ciUpperLimit': '2.2', 'groupDescription': 'At least 1 solicited systemic AE', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \\& Nurminen method. The aim of the 95% CI was to investigate an overall trend and not any specific difference. If 0.0 was excluded from the 95% CI, the trend could not be ruled out.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciPctValue': '95', 'paramValue': '0.9', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '2.3', 'groupDescription': 'At least 1 vaccine-related solicited systemic AE', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \\& Nurminen method. The aim of the 95% CI was to investigate an overall trend and not any specific difference. If 0.0 was excluded from the 95% CI, the trend could not be ruled out.'}], 'paramType': 'NUMBER', 'timeFrame': 'Solicited AEs: up to 5 days (Days 1-5 after any vaccination); unsolicited AEs: up to 15 days (Day 1-15 after any vaccination)', 'description': 'Injection-site and systemic AEs were reported daily on the Vaccination Report Card (VRC) by the parent(s) or legal representative from Day 1 (D1) to D15 after each vaccination. Solicited injection site and systemic AEs were reported daily from D1 to D5 after each vaccination. AEs at injection sites were always considered as vaccine-related (V-related) (Injection-Site Reactions \\[ISRs\\]). The investigator had to assess whether systemic AEs were related or not to the vaccine. All AEs (related and unrelated) are displayed here.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized participants who received at least 1 vaccination and who had safety follow-up.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Reporting Solicited ISRs From D1 to D5 After Any Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '653', 'groupId': 'OG000'}, {'value': '659', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PR5I', 'description': 'Infant series: PR5I 0.5 mL injection + Prevenar 13™ 0.5 mL injection administered at 2 and 4 months of age, and rotavirus vaccine (either Rotarix™ 1.5 mL oral dose at 2 and 4 months of age \\[subset 1\\] or RotaTeq™ 2 mL oral dose at 2, 4 and 5 months of age \\[subset 2\\]). Toddler dose: PR5I 0.5 mL injection + Prevenar 13™ 0.5 mL injection administered at 11 to 12 months of age.'}, {'id': 'OG001', 'title': 'INFANRIX™ Hexa', 'description': 'Infant series: INFANRIX™ hexa 0.5 mL injection + Prevenar 13™ 0.5 mL injection administered at 2 and 4 months of age, and rotavirus vaccine (either Rotarix™ 1.5 mL oral dose at 2 and 4 months of age \\[subset 1\\] or RotaTeq™ 2 mL oral dose at 2, 4 and 5 months of age \\[subset 2\\]). Toddler dose: INFANRIX™ hexa 0.5 mL injection + Prevenar 13™ 0.5 mL injection administered at 11 to 12 months of age.'}], 'classes': [{'title': 'Injection-site erythema', 'categories': [{'measurements': [{'value': '68.6', 'groupId': 'OG000'}, {'value': '60.4', 'groupId': 'OG001'}]}]}, {'title': 'Injection-site pain', 'categories': [{'measurements': [{'value': '73.4', 'groupId': 'OG000'}, {'value': '70.0', 'groupId': 'OG001'}]}]}, {'title': 'Injection-site swelling', 'categories': [{'measurements': [{'value': '56.8', 'groupId': 'OG000'}, {'value': '49.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.2', 'ciLowerLimit': '3.0', 'ciUpperLimit': '13.3', 'groupDescription': 'Injection-site erythema', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \\& Nurminen method. The aim of the 95% CI was to investigate whether an overall trend of risk differences existed. If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.4', 'ciLowerLimit': '-1.5', 'ciUpperLimit': '8.3', 'groupDescription': 'Injection-site pain', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \\& Nurminen method. The aim of the 95% CI was to investigate whether an overall trend of risk differences existed. If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciPctValue': '95', 'paramValue': '7.5', 'ciLowerLimit': '2.1', 'ciUpperLimit': '12.9', 'groupDescription': 'Injection-site swelling', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \\& Nurminen method. The aim of the 95% CI was to investigate whether an overall trend of risk differences existed. If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 5 days (Day 1 to Day 5 following vaccination)', 'description': 'Adverse events at injection sites were always considered as related to vaccine (Injection-Site Reactions \\[ISRs\\]). Solicited ISRs were defined as injection-site erythema, injection-site pain, and injection-site swelling occurring from D1 to D5 after vaccination.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomised participants who received at least 1 vaccination and who had safety follow-up.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Reporting Unsolicited ISRs From D1 to D15 After Any Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '653', 'groupId': 'OG000'}, {'value': '659', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PR5I', 'description': 'Infant series: PR5I 0.5 mL injection + Prevenar 13™ 0.5 mL injection administered at 2 and 4 months of age, and rotavirus vaccine (either Rotarix™ 1.5 mL oral dose at 2 and 4 months of age \\[subset 1\\] or RotaTeq™ 2 mL oral dose at 2, 4 and 5 months of age \\[subset 2\\]). Toddler dose: PR5I 0.5 mL injection + Prevenar 13™ 0.5 mL injection administered at 11 to 12 months of age.'}, {'id': 'OG001', 'title': 'INFANRIX™ Hexa', 'description': 'Infant series: INFANRIX™ hexa 0.5 mL injection + Prevenar 13™ 0.5 mL injection administered at 2 and 4 months of age, and rotavirus vaccine (either Rotarix™ 1.5 mL oral dose at 2 and 4 months of age \\[subset 1\\] or RotaTeq™ 2 mL oral dose at 2, 4 and 5 months of age \\[subset 2\\]). Toddler dose: INFANRIX™ hexa 0.5 mL injection + Prevenar 13™ 0.5 mL injection administered at 11 to 12 months of age.'}], 'classes': [{'title': 'Injection-site bruising', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': '2.0', 'groupId': 'OG001'}]}]}, {'title': 'Injection-site haemorrhage', 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}, {'value': '1.8', 'groupId': 'OG001'}]}]}, {'title': 'Injection-site induration', 'categories': [{'measurements': [{'value': '15.8', 'groupId': 'OG000'}, {'value': '13.2', 'groupId': 'OG001'}]}]}, {'title': 'Injection-site nodule', 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000'}, {'value': '0.8', 'groupId': 'OG001'}]}]}, {'title': 'Injection-site warmth', 'categories': [{'measurements': [{'value': '2.3', 'groupId': 'OG000'}, {'value': '1.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.1', 'ciLowerLimit': '-2.5', 'ciUpperLimit': '0.3', 'groupDescription': 'Injection-site bruising', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \\& Nurminen method. The aim of the 95% CI was to investigate an overall trend and not any specific difference. If 0.0 was excluded from the 95% CI, the trend could not be ruled out.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-1.5', 'ciUpperLimit': '1.6', 'groupDescription': 'Injection-site haemorrhage', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \\& Nurminen method. The aim of the 95% CI was to investigate an overall trend and not any specific difference. If 0.0 was excluded from the 95% CI, the trend could not be ruled out.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.6', 'ciLowerLimit': '-1.2', 'ciUpperLimit': '6.4', 'groupDescription': 'Injection-site induration', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.3', 'ciLowerLimit': '-0.8', 'ciUpperLimit': '1.5', 'groupDescription': 'Injection-site nodule', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \\& Nurminen method. The aim of the 95% CI was to investigate an overall trend and not any specific difference. If 0.0 was excluded from the 95% CI, the trend could not be ruled out.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciPctValue': '95', 'paramValue': '1.1', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '2.7', 'groupDescription': 'Injection-site warmth', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \\& Nurminen method. The aim of the 95% CI was to investigate an overall trend and not any specific difference. If 0.0 was excluded from the 95% CI, the trend could not be ruled out.'}], 'paramType': 'NUMBER', 'timeFrame': 'From D1 to D15 after any vaccination', 'description': 'Adverse events at injection sites were always considered as related to vaccine (Injection-Site Reactions {ISRs\\]). Unsolicited ISRs occurring from Day 1 (D1) to D15 after any vaccination were reported daily on the VRC by the parent(s) or legal representative. Unsolicited ISRs with incidence ≥1% are reported below.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomised participants who received at least 1 vaccination and who had safety follow-up.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Reporting Solicited Adverse Events (AEs) From D1 to D5 After Any Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '653', 'groupId': 'OG000'}, {'value': '659', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PR5I', 'description': 'Infant series: PR5I 0.5 mL injection + Prevenar 13™ 0.5 mL injection administered at 2 and 4 months of age, and rotavirus vaccine (either Rotarix™ 1.5 mL oral dose at 2 and 4 months of age \\[subset 1\\] or RotaTeq™ 2 mL oral dose at 2, 4 and 5 months of age \\[subset 2\\]). Toddler dose: PR5I 0.5 mL injection + Prevenar 13™ 0.5 mL injection administered at 11 to 12 months of age.'}, {'id': 'OG001', 'title': 'INFANRIX™ Hexa', 'description': 'Infant series: INFANRIX™ hexa 0.5 mL injection + Prevenar 13™ 0.5 mL injection administered at 2 and 4 months of age, and rotavirus vaccine (either Rotarix™ 1.5 mL oral dose at 2 and 4 months of age \\[subset 1\\] or RotaTeq™ 2 mL oral dose at 2, 4 and 5 months of age \\[subset 2\\]). Toddler dose: INFANRIX™ hexa 0.5 mL injection + Prevenar 13™ 0.5 mL injection administered at 11 to 12 months of age.'}], 'classes': [{'title': 'Crying', 'categories': [{'measurements': [{'value': '89.3', 'groupId': 'OG000'}, {'value': '87.1', 'groupId': 'OG001'}]}]}, {'title': 'Decreased appetite', 'categories': [{'measurements': [{'value': '65.8', 'groupId': 'OG000'}, {'value': '62.2', 'groupId': 'OG001'}]}]}, {'title': 'Irritability', 'categories': [{'measurements': [{'value': '91.6', 'groupId': 'OG000'}, {'value': '89.4', 'groupId': 'OG001'}]}]}, {'title': 'Pyrexia', 'categories': [{'measurements': [{'value': '73.8', 'groupId': 'OG000'}, {'value': '67.4', 'groupId': 'OG001'}]}]}, {'title': 'Somnolence', 'categories': [{'measurements': [{'value': '86.1', 'groupId': 'OG000'}, {'value': '80.3', 'groupId': 'OG001'}]}]}, {'title': 'Vomiting', 'categories': [{'measurements': [{'value': '32.8', 'groupId': 'OG000'}, {'value': '31.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.2', 'ciLowerLimit': '-1.3', 'ciUpperLimit': '5.7', 'groupDescription': 'Crying', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \\& Nurminen method. The aim of the 95% CI was to investigate whether an overall trend of risk differences existed. If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.6', 'ciLowerLimit': '-1.6', 'ciUpperLimit': '8.8', 'groupDescription': 'Decreased appetite', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \\& Nurminen method. If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.2', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '5.4', 'groupDescription': 'Irritability', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \\& Nurminen method. If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.4', 'ciLowerLimit': '1.5', 'ciUpperLimit': '11.3', 'groupDescription': 'Pyrexia', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \\& Nurminen method. If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.8', 'ciLowerLimit': '1.7', 'ciUpperLimit': '9.8', 'groupDescription': 'Somnolence', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \\& Nurminen method. The aim of the 95% CI was to investigate an overall trend and not any specific difference. If 0.0 was excluded from the 95% CI, the trend could not be ruled out.'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.8', 'ciLowerLimit': '-3.2', 'ciUpperLimit': '6.9', 'groupDescription': 'Vomiting', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'The risk differences between groups (PR5I group - INFANRIX hexa group) and their 2-sided 95% CI were calculated for the above criteria based on the unstratified Miettinen \\& Nurminen method. If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant.'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 5 days (from D1 to D5 after any vaccination)', 'description': 'Solicited systemic AEs were defined as crying, decreased appetite, irritability, pyrexia (rectal temperature ≥38.0°C), somnolence, and vomiting occurring from D1 to D5 after vaccination. The investigator had to assess whether these systemic AEs were related or not to the vaccines. All (related and unrelated) are displayed here.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomised participants who received at least 1 vaccination and who had safety follow-up.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PR5I', 'description': 'Infant series: PR5I 0.5 mL injection + Prevenar 13™ 0.5 mL injection administered at 2 and 4 months of age, and rotavirus vaccine (either Rotarix™ 1.5 mL oral dose at 2 and 4 months of age \\[subset 1\\] or RotaTeq™ 2 mL oral dose at 2, 4 and 5 months of age \\[subset 2\\]). Toddler dose: PR5I 0.5 mL injection + Prevenar 13™ 0.5 mL injection administered at 11 to 12 months of age.'}, {'id': 'FG001', 'title': 'INFANRIX™ Hexa', 'description': 'Infant series: INFANRIX™ hexa 0.5 mL injection + Prevenar 13™ 0.5 mL injection administered at 2 and 4 months of age, and rotavirus vaccine (either Rotarix™ 1.5 mL oral dose at 2 and 4 months of age \\[subset 1\\] or RotaTeq™ 2 mL oral dose at 2, 4 and 5 months of age \\[subset 2\\]). Toddler dose: INFANRIX™ hexa 0.5 mL injection + Prevenar 13™ 0.5 mL injection administered at 11 to 12 months of age.'}], 'periods': [{'title': 'Infant Series', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '656'}, {'groupId': 'FG001', 'numSubjects': '659'}]}, {'type': 'Vaccinated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '653'}, {'groupId': 'FG001', 'numSubjects': '659'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '649'}, {'groupId': 'FG001', 'numSubjects': '651'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '8'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Not Vaccinated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}, {'title': 'Interim Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '649'}, {'groupId': 'FG001', 'numSubjects': '651'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '639'}, {'groupId': 'FG001', 'numSubjects': '642'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}, {'title': 'Toddler Dose', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '639'}, {'groupId': 'FG001', 'numSubjects': '642'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '639'}, {'groupId': 'FG001', 'numSubjects': '642'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants from Italy and Sweden were randomized to Rotavirus Vaccine Subset 1 (Rotarix™). Participants from Finland were randomized to Rotavirus Vaccine Subset 2 (RotaTeq™).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '656', 'groupId': 'BG000'}, {'value': '659', 'groupId': 'BG001'}, {'value': '1315', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'PR5I', 'description': 'Infant series: PR5I 0.5 mL injection + Prevenar 13™ 0.5 mL injection administered at 2 and 4 months of age, and rotavirus vaccine (either Rotarix™ 1.5 mL oral dose at 2 and 4 months of age \\[subset 1\\] or RotaTeq™ 2 mL oral dose at 2, 4 and 5 months of age \\[subset 2\\]). Toddler dose: PR5I 0.5 mL injection + Prevenar 13™ 0.5 mL injection administered at 11 to 12 months of age.'}, {'id': 'BG001', 'title': 'INFANRIX™ Hexa', 'description': 'Infant series: INFANRIX™ hexa 0.5 mL injection + Prevenar 13™ 0.5 mL injection administered at 2 and 4 months of age, and rotavirus vaccine (either Rotarix™ 1.5 mL oral dose at 2 and 4 months of age \\[subset 1\\] or RotaTeq™ 2 mL oral dose at 2, 4 and 5 months of age \\[subset 2\\]). Toddler dose: INFANRIX™ hexa 0.5 mL injection + Prevenar 13™ 0.5 mL injection administered at 11 to 12 months of age.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68', 'spread': '10.3', 'groupId': 'BG000'}, {'value': '68.1', 'spread': '10.5', 'groupId': 'BG001'}, {'value': '68.1', 'spread': '10.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Days', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '323', 'groupId': 'BG000'}, {'value': '313', 'groupId': 'BG001'}, {'value': '636', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '333', 'groupId': 'BG000'}, {'value': '346', 'groupId': 'BG001'}, {'value': '679', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Finland', 'categories': [{'measurements': [{'value': '459', 'groupId': 'BG000'}, {'value': '460', 'groupId': 'BG001'}, {'value': '919', 'groupId': 'BG002'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '132', 'groupId': 'BG000'}, {'value': '132', 'groupId': 'BG001'}, {'value': '264', 'groupId': 'BG002'}]}]}, {'title': 'Sweden', 'categories': [{'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '132', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1315}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2013-10-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-11', 'studyFirstSubmitDate': '2011-11-23', 'resultsFirstSubmitDate': '2019-03-11', 'studyFirstSubmitQcDate': '2011-11-23', 'lastUpdatePostDateStruct': {'date': '2019-04-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-03-11', 'studyFirstPostDateStruct': {'date': '2011-11-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-04-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-10-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acceptability of Antibody (Ab) Response or Seroresponse Rates to All Antigens Contained in PR5I Vaccine One Month After the Toddler Dose of PR5I (11 to 12 Months of Age)', 'timeFrame': '1 month after Toddler dose of PR51 (post-toddler dose)', 'description': 'Acceptability response rates were defined as Ab titre ≥1.0 μg/mL for Haemophilus influenzae type b (Hib) (polyribosylribitol phosphate, PRP); ≥10 mIU/mL for Hepatitis (HBsAg); ≥0.1 IU/mL for diphtheria and tetanus; ≥8 (1/dil) for inactive poliovirus type (IPV) 1, 2 \\& 3, and percentage of pertussis seroresponder participants (Pertussis toxoid \\[PT\\], Filamentous haemagglutinin \\[FHA\\], Fimbriae types 2 \\& 3 \\[FIM\\] and Pertactin \\[PRN\\]) 1 month Post-Toddler dose of PR5I. Seroresponse was defined: (1) If pre-Dose 1 Ab concentration (cc) was \\<LLOQ (lower limit of quantitation), postvaccination Ab cc was ≥LLOQ, (2) If pre-Dose 1 Ab cc was ≥LLOQ, postvaccination Ab cc was ≥prevaccination levels. Due to the timing of the occurrence of protocol violation or the availability of each antigen serology testing result, the analysis populations may not have been identical for each antigen-specific analysis at each post-vaccination visit.'}], 'secondaryOutcomes': [{'measure': 'Non-inferiority of Antibody (Ab) Response Rate to Haemophilus Influenzae Type b (PRP) One Month After the 2nd Dose of PR5I (4 Months of Age) as Compared With INFANRIX Hexa', 'timeFrame': '1 month after the 2nd dose (post-infant dose 2)', 'description': 'Percentage of participants with an Ab titre ≥1.0 μg/mL for Hib (polyribosylribitol phosphate, PRP) measured by radioimmunoassay (RIA) 1 month post-infant dose 2 of PR5I or INFANRIX hexa.'}, {'measure': 'Superiority of Antibody (Ab) Response Rates to Haemophilus Influenzae Type b (PRP) One Month After the 2nd Dose of PR5I (4 Months of Age) as Compared With INFANRIX Hexa', 'timeFrame': '1 month after the 2nd dose (post-infant dose 2)', 'description': 'Percentage of participants with an Ab titre ≥1.0 μg/mL for Hib (polyribosylribitol phosphate, PRP) measured by RIA 1 month post-infant dose 2 of PR5I or INFANRIX hexa.'}, {'measure': 'Non-inferiority Ab Response Rates to PR5I Antigens One Month After the Toddler Dose of PR5I (11 to 12 Months of Age) as Compared With INFANRIX Hexa', 'timeFrame': '1 month after Toddler dose (post-toddler dose)', 'description': 'Percentage of participants with pre-specified Ab titre for PRP, HBsAg, diphtheria, tetanus, IPV1, 2 \\& 3, and percentage of pertussis seroresponder participants (PT, FHA, FIM and PRN) 1 month post-toddler dose were calculated based on the method by Miettinen and Nurminen stratified by country. Seroresponse was defined: (1) If pre-Dose 1 Ab cc was \\<LLOQ, post-vaccination Ab cc was ≥LLOQ, (2) If pre-Dose 1 Ab cc was ≥LLOQ, post-vaccination Ab cc was ≥pre-vaccination levels. Due to the timing of the occurrence of protocol violation or the availability of each antigen serology testing result, the analysis populations may not have been identical for each antigen-specific analysis at each post-vaccination visit.'}, {'measure': 'Non-inferiority of Rotavirus Response (Geometric Mean Titer, GMT) One Month After the 2nd Dose of Rotarix (4 Months of Age) Administered Concomitantly With PR5I Versus INFANRIX Hexa', 'timeFrame': '1 month after the 2nd dose of Rotarix, administered concomitantly with PR5I or INFANRIX hexa (Post-Dose 2)', 'description': 'Antibody titres expressed in units/mL were measured for Rotavirus IgA by Enzyme Immunoassay (EIA), 1 month after the 2nd dose of Rotarix, administered concomitantly with PR5I or INFANRIX hexa (Post-Dose 2). The 95% CI for GMT was based on the t-distribution of the natural log-transformed antibody titer.'}, {'measure': 'Number of Participants Who Experienced an Adverse Event (AE) From Day 1 to Day 15 After Any Vaccination', 'timeFrame': 'Solicited AEs: up to 5 days (Days 1-5 after any vaccination); unsolicited AEs: up to 15 days (Day 1-15 after any vaccination)', 'description': 'Injection-site and systemic AEs were reported daily on the Vaccination Report Card (VRC) by the parent(s) or legal representative from Day 1 (D1) to D15 after each vaccination. Solicited injection site and systemic AEs were reported daily from D1 to D5 after each vaccination. AEs at injection sites were always considered as vaccine-related (V-related) (Injection-Site Reactions \\[ISRs\\]). The investigator had to assess whether systemic AEs were related or not to the vaccine. All AEs (related and unrelated) are displayed here.'}, {'measure': 'Percentage of Participants Reporting Solicited ISRs From D1 to D5 After Any Vaccination', 'timeFrame': 'Up to 5 days (Day 1 to Day 5 following vaccination)', 'description': 'Adverse events at injection sites were always considered as related to vaccine (Injection-Site Reactions \\[ISRs\\]). Solicited ISRs were defined as injection-site erythema, injection-site pain, and injection-site swelling occurring from D1 to D5 after vaccination.'}, {'measure': 'Percentage of Participants Reporting Unsolicited ISRs From D1 to D15 After Any Vaccination', 'timeFrame': 'From D1 to D15 after any vaccination', 'description': 'Adverse events at injection sites were always considered as related to vaccine (Injection-Site Reactions {ISRs\\]). Unsolicited ISRs occurring from Day 1 (D1) to D15 after any vaccination were reported daily on the VRC by the parent(s) or legal representative. Unsolicited ISRs with incidence ≥1% are reported below.'}, {'measure': 'Percentage of Participants Reporting Solicited Adverse Events (AEs) From D1 to D5 After Any Vaccination', 'timeFrame': 'Up to 5 days (from D1 to D5 after any vaccination)', 'description': 'Solicited systemic AEs were defined as crying, decreased appetite, irritability, pyrexia (rectal temperature ≥38.0°C), somnolence, and vomiting occurring from D1 to D5 after vaccination. The investigator had to assess whether these systemic AEs were related or not to the vaccines. All (related and unrelated) are displayed here.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['combination vaccine', 'diphtheria', 'pertussis', 'tetanus', 'hepatitis B', 'Hep B', 'Haemophilus influenzae b', 'Hib', 'polio', 'poliovirus'], 'conditions': ['Bacterial Infections', 'Virus Diseases']}, 'referencesModule': {'references': [{'pmid': '27288217', 'type': 'DERIVED', 'citation': 'Silfverdal SA, Icardi G, Vesikari T, Flores SA, Pagnoni MF, Xu J, Liu GF, Stek JE, Boisnard F, Thomas S, Ziani E, Lee AW. A Phase III randomized, double-blind, clinical trial of an investigational hexavalent vaccine given at 2, 4, and 11-12 months. Vaccine. 2016 Jul 19;34(33):3810-6. doi: 10.1016/j.vaccine.2016.05.054. Epub 2016 Jun 18.'}]}, 'descriptionModule': {'briefSummary': 'This study will determine whether participants who receive V419 (PR5I) at 2, 4, and 11 to 12 months of age have an acceptable response to the vaccine. This study will also determine whether the immune response to V419 is similar to that of participants who received a licensed vaccine control. The primary hypothesis is that participants who receive PR5I at 2, 4, and 11 to 12 months have an acceptable response rate to all PR5I-contained antigens at one month after the Toddler dose of PR5I.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '89 Days', 'minimumAge': '46 Days', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy infant able to attend all study visits\n* Parent(s)/legal representative are able to read, understand, and complete study questionnaires\n\nExclusion Criteria:\n\n* History of congenital or acquired immunodeficiency\n* Received or is expected to receive immunosuppressive agents or systemic immunomodulatory steroids\n* History of leukemia, lymphoma, malignant melanoma, or myeloproliferative disorder\n* Hypersensitivity to any of the vaccine components or history of a life-threatening reaction to a vaccine containing the same substances as the study vaccines or concomitant study vaccines\n* Has any chronic illness that could interfere with study conduct or completion\n* Received any immune globulin, blood, or blood-derived products since birth\n* Received a dose of hepatitis B vaccine prior to study entry\n* Vaccinated with any acellular pertussis or whole cell pertussis based combination vaccines, Haemophilus influenzae type b conjugate, poliovirus, pneumococcal conjugate or pneumococcal polysaccharide, rotavirus vaccine, or combination thereof\n* Fever within 24 hours prior to enrollment\n* Received any non-study vaccine within 30 days prior to enrollment, except for inactivated influenza vaccine, which is permitted 14 days or more prior to enrolment\n* Has a coagulation disorder\n* Has developmental delay or neurological disorder\n* Participant or his/her mother has a medical history of hepatitis B surface antigens (HBsAg) seropositivity\n* History of Haemophilus influenzae type b, hepatitis B, diphtheria, tetanus, pertussis, poliomyelitis, rotavirus gastroenteritis, or invasive pneumococcal infection'}, 'identificationModule': {'nctId': 'NCT01480258', 'briefTitle': 'Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 4, and 11 to 12 Months (V419-008)', 'organization': {'class': 'INDUSTRY', 'fullName': 'MCM Vaccines B.V.'}, 'officialTitle': 'A Phase III Randomized, Double-Blind, Active-Comparator Controlled Clinical Trial to Study the Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 4, and 11 to 12 Months', 'orgStudyIdInfo': {'id': 'V419-008'}, 'secondaryIdInfos': [{'id': '2010-021491-28', 'type': 'EUDRACT_NUMBER'}, {'id': 'V419-008', 'type': 'OTHER', 'domain': 'Merck'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PR5I', 'description': 'Infant series: PR5I 0.5 mL injection + Prevenar 13™ 0.5 mL injection administered at 2 and 4 months of age, and rotavirus vaccine (either Rotarix™ 1.5 mL oral dose at 2 and 4 months of age \\[subset 1\\] or RotaTeq™ 2 mL oral dose at 2, 4 and 5 months of age \\[subset 2\\]).\n\nToddler dose: PR5I 0.5 mL injection + Prevenar 13™ 0.5 mL injection administered at 11 to 12 months of age.', 'interventionNames': ['Biological: PR5I', 'Biological: Rotavirus vaccine', 'Biological: Prevenar 13™']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'INFANRIX™ hexa', 'description': 'Infant series: INFANRIX™ hexa 0.5 mL injection + Prevenar 13™ 0.5 mL injection administered at 2 and 4 months of age, and rotavirus vaccine (either Rotarix™ 1.5 mL oral dose at 2 and 4 months of age \\[subset 1\\] or RotaTeq™ 2 mL oral dose at 2, 4 and 5 months of age \\[subset 2\\]).\n\nToddler dose: INFANRIX™ hexa 0.5 mL injection + Prevenar 13™ 0.5 mL injection administered at 11 to 12 months of age.', 'interventionNames': ['Biological: Rotavirus vaccine', 'Biological: Prevenar 13™', 'Biological: INFANRIX™ hexa']}], 'interventions': [{'name': 'PR5I', 'type': 'BIOLOGICAL', 'otherNames': ['V419', 'Vaxelis®'], 'description': 'DTaP-HB-IPV-Hib (Diphtheria, tetanus, pertussis \\[acellular, component\\], hepatitis B \\[recombinant DNA\\], polio virus \\[inactivated\\], and Haemophilus influenza type b conjugate vaccine \\[adsorbed\\]) Vaccine 0.5 mL intramuscular injection at 2, 4, and 11 to 12 months of age. Injection is to be administered in the upper anterolateral thigh, separate limb from the concomitant vaccine. PR5I is a liquid suspension hexavalent vaccine.', 'armGroupLabels': ['PR5I']}, {'name': 'Rotavirus vaccine', 'type': 'BIOLOGICAL', 'description': 'Rotarix™ 1.5 mL oral dose at 2 and 4 months of age (subset 1, Italy and Sweden) or RotaTeq™ 2 mL oral dose at 2, 4 and 5 months of age (subset 2, Finland)', 'armGroupLabels': ['INFANRIX™ hexa', 'PR5I']}, {'name': 'Prevenar 13™', 'type': 'BIOLOGICAL', 'description': 'Prevenar 13™ 0.5 mL intramuscular injection at 2, 4, and 11 to 12 months of age. Injection is to be administered in the upper anterolateral thigh, separate limb from the concomitant vaccine.', 'armGroupLabels': ['INFANRIX™ hexa', 'PR5I']}, {'name': 'INFANRIX™ hexa', 'type': 'BIOLOGICAL', 'description': 'Combined Diphtheria-Tetanus-acellular Pertussis \\[DTaP\\], Hepatitis B \\[HepB\\], Poliovirus \\[IPV\\] and Haemophilus influenzae type b \\[Hib\\] Vaccine 0.5 mL intramuscular injection at 2, 4 and 11 to 12 months of age. Injection is to be administered in the upper anterolateral thigh, separate limb from the concomitant vaccine. INFANRIX™ hexa is provided as 2 components (lyophilized Hib and liquid DTaP, IPV, and HepB). Prior to administration, the vaccine must be reconstituted by adding the liquid DTaP-HepB-IPV component to the vial containing the Hib pellet.', 'armGroupLabels': ['INFANRIX™ hexa']}]}, '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': 'http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MCM Vaccines B.V.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}