Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2025-12-27 @ 12:17 PM
Study NCT ID:
NCT01600092
Status:
COMPLETED
Last Update Posted:
2018-11-14
First Post:
2012-05-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of the Immunogenicity, Tolerability, and Safety of a New Formulation of RotaTeq™ in Infants (V260-035)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Canada', 'Czechia', 'Denmark', 'Finland', 'Israel', 'Mexico', 'Poland', 'Spain', 'Sweden', 'United States']}, 'interventionBrowseModule': {'meshes': [{'id': 'D022243', 'term': 'Rotavirus Vaccines'}], '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 must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All adverse events: up to 42 days after any vaccination; serious adverse events, deaths, and intussusception: up to Day 185', 'description': 'The participants at risk includes participants who received at least one dose of study vaccine and had follow-up', 'eventGroups': [{'id': 'EG000', 'title': 'RotaTeq™ Experimental Formulation', 'description': 'Three 2.0 mL oral doses of RotaTeq™ experimental formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).', 'otherNumAtRisk': 508, 'otherNumAffected': 398, 'seriousNumAtRisk': 508, 'seriousNumAffected': 20}, {'id': 'EG001', 'title': 'RotaTeq™ Existing Formulation', 'description': 'Three 2.0 mL oral doses of RotaTeq™ existing formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).', 'otherNumAtRisk': 499, 'otherNumAffected': 385, 'seriousNumAtRisk': 499, 'seriousNumAffected': 12}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 33, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 499, 'numEvents': 29, 'numAffected': 22}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 307, 'numAffected': 173}, {'groupId': 'EG001', 'numAtRisk': 499, 'numEvents': 276, 'numAffected': 156}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 175, 'numAffected': 102}, {'groupId': 'EG001', 'numAtRisk': 499, 'numEvents': 180, 'numAffected': 107}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 211, 'numAffected': 151}, {'groupId': 'EG001', 'numAtRisk': 499, 'numEvents': 231, 'numAffected': 152}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 35, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 499, 'numEvents': 25, 'numAffected': 25}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 106, 'numAffected': 79}, {'groupId': 'EG001', 'numAtRisk': 499, 'numEvents': 113, 'numAffected': 83}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 26, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 499, 'numEvents': 33, 'numAffected': 29}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 53, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 499, 'numEvents': 56, 'numAffected': 40}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 97, 'numAffected': 78}, {'groupId': 'EG001', 'numAtRisk': 499, 'numEvents': 87, 'numAffected': 67}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 98, 'numAffected': 65}, {'groupId': 'EG001', 'numAtRisk': 499, 'numEvents': 113, 'numAffected': 77}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 39, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 499, 'numEvents': 50, 'numAffected': 44}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}], 'seriousEvents': [{'term': 'Intussusception', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 499, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Umbilical hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 499, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 499, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Anal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 499, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 499, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 499, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 499, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 499, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Laryngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 499, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Parainfluenzae virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 499, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 499, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 499, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Pyelonephritis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 499, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Respiratory syncytial virus bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 499, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Respiratory tract infection viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 499, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 499, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 499, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 499, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 499, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Head injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 499, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Subcutaneous haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 499, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Hypersomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 499, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Loss of consciousness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 499, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Restlessness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 508, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 499, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Geometric Mean Titer of Serum Neutralizing Antibody Response to Human Rotavirus Serotypes G1, G2, G3, G4, and P1A[8]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '480', 'groupId': 'OG000'}, {'value': '482', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RotaTeq™ Experimental Formulation', 'description': 'Three 2.0 mL oral doses of RotaTeq™ experimental formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).'}, {'id': 'OG001', 'title': 'RotaTeq™ Existing Formulation', 'description': 'Three 2.0 mL oral doses of RotaTeq™ existing formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).'}], 'classes': [{'title': 'Serotype G1', 'categories': [{'measurements': [{'value': '99.8', 'groupId': 'OG000', 'lowerLimit': '89.7', 'upperLimit': '111.1'}, {'value': '106.1', 'groupId': 'OG001', 'lowerLimit': '94.6', 'upperLimit': '119.0'}]}]}, {'title': 'Serotype G2', 'categories': [{'measurements': [{'value': '30.0', 'groupId': 'OG000', 'lowerLimit': '27.0', 'upperLimit': '33.3'}, {'value': '26.3', 'groupId': 'OG001', 'lowerLimit': '23.7', 'upperLimit': '29.1'}]}]}, {'title': 'Serotype G3', 'categories': [{'measurements': [{'value': '82.8', 'groupId': 'OG000', 'lowerLimit': '74.2', 'upperLimit': '92.5'}, {'value': '25.2', 'groupId': 'OG001', 'lowerLimit': '22.6', 'upperLimit': '28.1'}]}]}, {'title': 'Serotype G4', 'categories': [{'measurements': [{'value': '78.9', 'groupId': 'OG000', 'lowerLimit': '72.3', 'upperLimit': '86.1'}, {'value': '71.5', 'groupId': 'OG001', 'lowerLimit': '65.4', 'upperLimit': '78.1'}]}]}, {'title': 'Serotype P1A[8]', 'categories': [{'measurements': [{'value': '106.9', 'groupId': 'OG000', 'lowerLimit': '96.5', 'upperLimit': '118.4'}, {'value': '90.1', 'groupId': 'OG001', 'lowerLimit': '80.2', 'upperLimit': '101.2'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio (Experimental/Existing)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.92', 'ciLowerLimit': '0.79', 'ciUpperLimit': '1.07', 'estimateComment': 'GMTs and GMT ratio were based on a model with terms for treatment and country, with the constraint that the mean baseline value is the same for both treatment groups', 'groupDescription': 'Serotype G1', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority required that the lower bound of the 2-sided 95% confidence interval of the GMT ratio is \\>0.67'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio (Experimental/Existing)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.15', 'ciLowerLimit': '0.99', 'ciUpperLimit': '1.33', 'estimateComment': 'GMTs and GMT ratio were based on a model with terms for treatment and country, with the constraint that the mean baseline value is the same for both treatment groups', 'groupDescription': 'Serotype G2', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority required that the lower bound of the 2-sided 95% confidence interval of the GMT ratio is \\>0.67'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio (Experimental/Existing)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.20', 'ciLowerLimit': '2.75', 'ciUpperLimit': '3.74', 'estimateComment': 'GMTs and GMT ratio were based on a model with terms for treatment and country, with the constraint that the mean baseline value is the same for both treatment groups', 'groupDescription': 'Serotype G3', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority required that the lower bound of the 2-sided 95% confidence interval of the GMT ratio is \\>0.67'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio (Experimental/Existing)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.06', 'ciLowerLimit': '0.94', 'ciUpperLimit': '1.20', 'estimateComment': 'GMTs and GMT ratio were based on a model with terms for treatment and country, with the constraint that the mean baseline value is the same for both treatment groups', 'groupDescription': 'Serotype G4', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority required that the lower bound of the 2-sided 95% confidence interval of the GMT ratio is \\>0.67'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'GMT Ratio (Experimental/Existing)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.16', 'ciLowerLimit': '1.00', 'ciUpperLimit': '1.35', 'estimateComment': 'GMTs and GMT ratio were based on a model with terms for treatment and country, with the constraint that the mean baseline value is the same for both treatment groups', 'groupDescription': 'Serotype P1A\\[8\\]', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'nonInferiorityComment': 'Non-inferiority required that the lower bound of the 2-sided 95% confidence interval of the GMT ratio is \\>0.67'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '42 days after vaccination 3 (up to 185 days)', 'unitOfMeasure': 'Titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received the 3 scheduled doses of study vaccine, did not have important protocol deviations, and had follow-up results for the endpoint'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Tier-1 Adverse Events: Diarrhea, Vomiting, Elevated Temperature, and Irritability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '509', 'groupId': 'OG000'}, {'value': '505', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RotaTeq™ Experimental Formulation', 'description': 'Three 2.0 mL oral doses of RotaTeq™ experimental formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).'}, {'id': 'OG001', 'title': 'RotaTeq™ Existing Formulation', 'description': 'Three 2.0 mL oral doses of RotaTeq™ existing formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).'}], 'classes': [{'title': 'Diarrhea', 'categories': [{'measurements': [{'value': '144', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}]}, {'title': 'Vomiting', 'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}]}, {'title': 'Elevated temperature', 'categories': [{'measurements': [{'value': '217', 'groupId': 'OG000'}, {'value': '223', 'groupId': 'OG001'}]}]}, {'title': 'Irritability', 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 7 days after any vaccination (up to 147 days)', 'description': 'An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse event. Protocol-defined Tier-1 adverse events to be collected up to 7 days after any vaccination were diarrhea, vomiting, elevated temperature (rectal \\>=38.1° C, \\>=100.5° F), and irritability.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least one dose of study vaccine. Participants were assigned to treatment groups based on the vaccine received as the first dose.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Tier-1 Adverse Events: Intussusception', 'denoms': [{'units': 'Participants', 'counts': [{'value': '509', 'groupId': 'OG000'}, {'value': '505', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RotaTeq™ Experimental Formulation', 'description': 'Three 2.0 mL oral doses of RotaTeq™ experimental formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).'}, {'id': 'OG001', 'title': 'RotaTeq™ Existing Formulation', 'description': 'Three 2.0 mL oral doses of RotaTeq™ existing formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Day 185', 'description': 'The protocol-defined Tier-1 adverse event to be collected for the duration of the study (up to Day 185) was intussusception', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received at least one dose of study vaccine. Participants were assigned to treatment groups based on the vaccine received as the first dose.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Titer of Serum Anti-Rotavirus Immunoglobulin A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '474', 'groupId': 'OG000'}, {'value': '474', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RotaTeq™ Experimental Formulation', 'description': 'Three 2.0 mL oral doses of RotaTeq™ experimental formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).'}, {'id': 'OG001', 'title': 'RotaTeq™ Existing Formulation', 'description': 'Three 2.0 mL oral doses of RotaTeq™ existing formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).'}], 'classes': [{'categories': [{'measurements': [{'value': '240.5', 'groupId': 'OG000', 'lowerLimit': '210.4', 'upperLimit': '274.8'}, {'value': '235.5', 'groupId': 'OG001', 'lowerLimit': '204.1', 'upperLimit': '271.8'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '42 days after vaccination 3 (up to 185 days)', 'unitOfMeasure': 'Titer', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received the 3 scheduled doses of study vaccine, did not have important protocol deviations, and had follow-up results for the endpoint'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With >=3-fold Rise From Baseline in GMT of Serum Neutralizing Antibody to Human Rotavirus Serotypes G1, G2, G3, G4, and P1A[8]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '480', 'groupId': 'OG000'}, {'value': '481', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RotaTeq™ Experimental Formulation', 'description': 'Three 2.0 mL oral doses of RotaTeq™ experimental formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).'}, {'id': 'OG001', 'title': 'RotaTeq™ Existing Formulation', 'description': 'Three 2.0 mL oral doses of RotaTeq™ existing formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).'}], 'classes': [{'title': 'Serotype G1', 'categories': [{'measurements': [{'value': '56.0', 'groupId': 'OG000', 'lowerLimit': '51.5', 'upperLimit': '60.5'}, {'value': '53.8', 'groupId': 'OG001', 'lowerLimit': '49.3', 'upperLimit': '58.4'}]}]}, {'title': 'Serotype G2', 'categories': [{'measurements': [{'value': '30.4', 'groupId': 'OG000', 'lowerLimit': '26.3', 'upperLimit': '34.7'}, {'value': '26.8', 'groupId': 'OG001', 'lowerLimit': '22.9', 'upperLimit': '31.0'}]}]}, {'title': 'Serotype G3', 'categories': [{'measurements': [{'value': '65.8', 'groupId': 'OG000', 'lowerLimit': '61.4', 'upperLimit': '70.1'}, {'value': '33.3', 'groupId': 'OG001', 'lowerLimit': '29.1', 'upperLimit': '37.7'}]}]}, {'title': 'Serotype G4', 'categories': [{'measurements': [{'value': '58.3', 'groupId': 'OG000', 'lowerLimit': '53.8', 'upperLimit': '62.8'}, {'value': '49.7', 'groupId': 'OG001', 'lowerLimit': '45.1', 'upperLimit': '54.3'}]}]}, {'title': 'Serotype P1A[8]', 'categories': [{'measurements': [{'value': '49.6', 'groupId': 'OG000', 'lowerLimit': '45.0', 'upperLimit': '54.2'}, {'value': '42.6', 'groupId': 'OG001', 'lowerLimit': '38.2', 'upperLimit': '47.2'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and 42 days after vaccination 3 (up to 185 days)', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received the 3 scheduled doses of study vaccine, did not have important protocol deviations, and had baseline and follow-up results for the endpoint'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'RotaTeq™ Experimental Formulation', 'description': 'Three 2.0 mL oral doses of RotaTeq™ experimental formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).'}, {'id': 'FG001', 'title': 'RotaTeq™ Existing Formulation', 'description': 'Three 2.0 mL oral doses of RotaTeq™ existing formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '513'}, {'groupId': 'FG001', 'numSubjects': '507'}]}, {'type': 'Received at Least 1 Vaccination', 'achievements': [{'comment': '1 participant received RotaTeq™ existing formulation as their first vaccination', 'groupId': 'FG000', 'numSubjects': '510'}, {'groupId': 'FG001', 'numSubjects': '504'}]}, {'type': 'Received All 3 Vaccinations', 'achievements': [{'groupId': 'FG000', 'numSubjects': '500'}, {'groupId': 'FG001', 'numSubjects': '494'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '495'}, {'groupId': 'FG001', 'numSubjects': '491'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '16'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Withdrawal by parent/guardian', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Randomized but not vaccinated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'preAssignmentDetails': 'A total of 1039 participants were screened'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '513', 'groupId': 'BG000'}, {'value': '507', 'groupId': 'BG001'}, {'value': '1020', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'RotaTeq™ Experimental Formulation', 'description': 'Three 2.0 mL oral doses of RotaTeq™ experimental formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).'}, {'id': 'BG001', 'title': 'RotaTeq™ Existing Formulation', 'description': 'Three 2.0 mL oral doses of RotaTeq™ existing formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '8.4', 'spread': '1.4', 'groupId': 'BG000'}, {'value': '8.3', 'spread': '1.4', 'groupId': 'BG001'}, {'value': '8.3', 'spread': '1.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Weeks', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '232', 'groupId': 'BG000'}, {'value': '240', 'groupId': 'BG001'}, {'value': '472', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '281', 'groupId': 'BG000'}, {'value': '267', 'groupId': 'BG001'}, {'value': '548', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1020}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2014-03-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-19', 'studyFirstSubmitDate': '2012-05-14', 'resultsFirstSubmitDate': '2015-03-09', 'studyFirstSubmitQcDate': '2012-05-14', 'lastUpdatePostDateStruct': {'date': '2018-11-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-03-09', 'studyFirstPostDateStruct': {'date': '2012-05-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-03-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Geometric Mean Titer of Serum Neutralizing Antibody Response to Human Rotavirus Serotypes G1, G2, G3, G4, and P1A[8]', 'timeFrame': '42 days after vaccination 3 (up to 185 days)'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Tier-1 Adverse Events: Diarrhea, Vomiting, Elevated Temperature, and Irritability', 'timeFrame': 'Up to 7 days after any vaccination (up to 147 days)', 'description': 'An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse event. Protocol-defined Tier-1 adverse events to be collected up to 7 days after any vaccination were diarrhea, vomiting, elevated temperature (rectal \\>=38.1° C, \\>=100.5° F), and irritability.'}, {'measure': 'Number of Participants With Tier-1 Adverse Events: Intussusception', 'timeFrame': 'Up to Day 185', 'description': 'The protocol-defined Tier-1 adverse event to be collected for the duration of the study (up to Day 185) was intussusception'}, {'measure': 'Geometric Mean Titer of Serum Anti-Rotavirus Immunoglobulin A', 'timeFrame': '42 days after vaccination 3 (up to 185 days)'}, {'measure': 'Percentage of Participants With >=3-fold Rise From Baseline in GMT of Serum Neutralizing Antibody to Human Rotavirus Serotypes G1, G2, G3, G4, and P1A[8]', 'timeFrame': 'Baseline and 42 days after vaccination 3 (up to 185 days)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Rotavirus Gastroenteritis']}, 'referencesModule': {'availIpds': [{'url': 'http://www.merck.com/clinical-trials/study.html?id=V260-035&kw=V260-035&tab=access', 'type': 'CSR Synopsis'}], 'references': [{'pmid': '28141698', 'type': 'RESULT', 'citation': 'Martinon-Torres F, Greenberg D, Varman M, Killar JA, Hille D, Strable EL, Stek JE, Kaplan SS. Safety, Tolerability and Immunogenicity of Pentavalent Rotavirus Vaccine Manufactured by a Modified Process. Pediatr Infect Dis J. 2017 Apr;36(4):417-422. doi: 10.1097/INF.0000000000001511.'}]}, 'descriptionModule': {'briefSummary': 'A study to compare safety, tolerability, and immunogenicity of a new formulation of RotaTeq™ with the existing formulation in infants. The primary hypothesis of the study is that the new formulation will be noninferior to the existing formulation on the basis of immunogenicity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Weeks', 'minimumAge': '6 Weeks', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Parent or legal guardian agrees to have infant participate by giving written informed consent\n\nExclusion Criteria:\n\n* History of congenital abdominal disorders, prior rotavirus gastroenteritis, chronic diarrhea, failure to thrive, or abdominal surgery\n* History of intussusception\n* Known or suspected impairment of immunological function, including Severe\n\nCombined Immunodeficiency (SCID)\n\n* Prior administration of any rotavirus vaccine\n* Clinical evidence of active gastrointestinal illness, with the exception of well-controlled gastroesophageal reflux disease (GERD)\n* Receipt of 1) systemic corticosteroids (≥ 2mg/kg total daily dose of prednisone or equivalent) for 14 consecutive days or more since birth, or 2) systemic corticosteroids ≥ 2mg/kg/dose within 7 days prior to the administration of the first dose of study vaccine. Participant using non-systemic corticosteroids will be eligible for vaccination.\n* Residing in a household with an immunocompromised person\n* Prior receipt of a blood transfusion or blood products, including immunoglobulins\n* Participation in another interventional study within 14 days prior to the first study vaccination or expected anytime during the study\n* Receipt of investigational inactivated vaccines within 14 days or investigational live vaccines within 28 days prior to the first study vaccination or expected anytime during the study'}, 'identificationModule': {'nctId': 'NCT01600092', 'briefTitle': 'A Study of the Immunogenicity, Tolerability, and Safety of a New Formulation of RotaTeq™ in Infants (V260-035)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Double-blind, Randomized, Controlled, Multicenter Study to Evaluate the Safety, Tolerability, and Immunogenicity of a New Formulation of RotaTeq™', 'orgStudyIdInfo': {'id': 'V260-035'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RotaTeq™ Experimental Formulation', 'description': 'Three 2.0 mL oral doses of RotaTeq™ experimental formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days)', 'interventionNames': ['Biological: RotaTeq™ experimental formulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'RotaTeq™ Existing Formulation', 'description': 'Three 2.0 mL oral doses of RotaTeq™ existing formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).', 'interventionNames': ['Biological: RotaTeq™ existing formulation']}], 'interventions': [{'name': 'RotaTeq™ experimental formulation', 'type': 'BIOLOGICAL', 'otherNames': ['V260'], 'armGroupLabels': ['RotaTeq™ Experimental Formulation']}, {'name': 'RotaTeq™ existing formulation', 'type': 'BIOLOGICAL', 'otherNames': ['V260'], 'armGroupLabels': ['RotaTeq™ Existing Formulation']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'ipdSharingStatementModule': {'url': 'http://engagezone.msd.com/ds_documentation.php', 'ipdSharing': 'YES', 'description': 'https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}