Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2026-03-06 @ 11:58 AM
Study NCT ID:
NCT00090233
Status:
COMPLETED
Last Update Posted:
2015-10-05
First Post:
2004-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Rotavirus Efficacy and Safety Trial (REST)(V260-006)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Puerto Rico', 'United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D012400', 'term': 'Rotavirus Infections'}], 'ancestors': [{'id': 'D012088', 'term': 'Reoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C492535', 'term': 'RotaTeq'}, {'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': {'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp'}, 'certainAgreement': {'otherDetails': 'Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': '70,301 participants randomized, 69,274 evaluated, when DSMB first recommended ending enrollment.'}}, 'adverseEventsModule': {'timeFrame': 'Participants in this study were followed for all serious adverse events (SAEs) and other adverse events (AEs), for up to 42 days following each study vaccination', 'description': 'Participants listed in SAE tables (34904-RotaTeq; 34862-Placebo) are those who received study treatment. Other AEs were reported for a pre-defined subset who received ≥1 dose (4808-RotaTeq; 4796-Placebo). Although a participant may have had ≥ 2 AEs they are counted only once in a category. The same participant may appear in different categories.', 'eventGroups': [{'id': 'EG000', 'title': 'RotaTeq™', 'description': 'Three oral doses (\\~6.5x10\\^7 to \\~1.2x10\\^8 IU/dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.\n\nThe Not Completed total includes participants discontinued at any time before the completion of the third study vaccination and/or the 42-day safety follow-up period post vaccination 3.', 'otherNumAtRisk': 4800, 'otherNumAffected': 4000, 'seriousNumAtRisk': 34904, 'seriousNumAffected': 863}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.\n\nThe Not Completed total includes participants discontinued at any time before the completion of the third study vaccination and/or the 42-day safety follow-up period post vaccination 3.', 'otherNumAtRisk': 4787, 'otherNumAffected': 4047, 'seriousNumAtRisk': 34862, 'seriousNumAffected': 955}], 'otherEvents': [{'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4800, 'numAffected': 315}, {'groupId': 'EG001', 'numAtRisk': 4787, 'numAffected': 339}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4800, 'numAffected': 53}, {'groupId': 'EG001', 'numAtRisk': 4787, 'numAffected': 40}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4800, 'numAffected': 188}, {'groupId': 'EG001', 'numAtRisk': 4787, 'numAffected': 214}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4800, 'numAffected': 1047}, {'groupId': 'EG001', 'numAtRisk': 4787, 'numAffected': 1022}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4800, 'numAffected': 273}, {'groupId': 'EG001', 'numAtRisk': 4787, 'numAffected': 282}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4800, 'numAffected': 62}, {'groupId': 'EG001', 'numAtRisk': 4787, 'numAffected': 59}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Infantile colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4800, 'numAffected': 70}, {'groupId': 'EG001', 'numAtRisk': 4787, 'numAffected': 65}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Regurgitation of food', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4800, 'numAffected': 175}, {'groupId': 'EG001', 'numAtRisk': 4787, 'numAffected': 183}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Teething', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4800, 'numAffected': 196}, {'groupId': 'EG001', 'numAtRisk': 4787, 'numAffected': 165}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4800, 'numAffected': 613}, {'groupId': 'EG001', 'numAtRisk': 4787, 'numAffected': 644}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4800, 'numAffected': 216}, {'groupId': 'EG001', 'numAtRisk': 4787, 'numAffected': 228}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4800, 'numAffected': 881}, {'groupId': 'EG001', 'numAtRisk': 4787, 'numAffected': 862}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4800, 'numAffected': 1970}, {'groupId': 'EG001', 'numAtRisk': 4787, 'numAffected': 2056}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4800, 'numAffected': 200}, {'groupId': 'EG001', 'numAtRisk': 4787, 'numAffected': 185}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4800, 'numAffected': 79}, {'groupId': 'EG001', 'numAtRisk': 4787, 'numAffected': 73}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Candida nappy rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4800, 'numAffected': 46}, {'groupId': 'EG001', 'numAtRisk': 4787, 'numAffected': 51}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4800, 'numAffected': 94}, {'groupId': 'EG001', 'numAtRisk': 4787, 'numAffected': 107}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4800, 'numAffected': 447}, {'groupId': 'EG001', 'numAtRisk': 4787, 'numAffected': 454}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4800, 'numAffected': 89}, {'groupId': 'EG001', 'numAtRisk': 4787, 'numAffected': 72}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4800, 'numAffected': 276}, {'groupId': 'EG001', 'numAtRisk': 4787, 'numAffected': 277}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Oral candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4800, 'numAffected': 185}, {'groupId': 'EG001', 'numAtRisk': 4787, 'numAffected': 188}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4800, 'numAffected': 624}, {'groupId': 'EG001', 'numAtRisk': 4787, 'numAffected': 602}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4800, 'numAffected': 60}, {'groupId': 'EG001', 'numAtRisk': 4787, 'numAffected': 57}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4800, 'numAffected': 97}, {'groupId': 'EG001', 'numAtRisk': 4787, 'numAffected': 83}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4800, 'numAffected': 348}, {'groupId': 'EG001', 'numAtRisk': 4787, 'numAffected': 337}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4800, 'numAffected': 1230}, {'groupId': 'EG001', 'numAtRisk': 4787, 'numAffected': 1279}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4800, 'numAffected': 105}, {'groupId': 'EG001', 'numAtRisk': 4787, 'numAffected': 121}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4800, 'numAffected': 68}, {'groupId': 'EG001', 'numAtRisk': 4787, 'numAffected': 67}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4800, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 4787, 'numAffected': 46}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4800, 'numAffected': 215}, {'groupId': 'EG001', 'numAtRisk': 4787, 'numAffected': 180}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Crying', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4800, 'numAffected': 160}, {'groupId': 'EG001', 'numAtRisk': 4787, 'numAffected': 190}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Restlessness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4800, 'numAffected': 63}, {'groupId': 'EG001', 'numAtRisk': 4787, 'numAffected': 69}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4800, 'numAffected': 471}, {'groupId': 'EG001', 'numAtRisk': 4787, 'numAffected': 456}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4800, 'numAffected': 293}, {'groupId': 'EG001', 'numAtRisk': 4787, 'numAffected': 294}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4800, 'numAffected': 222}, {'groupId': 'EG001', 'numAtRisk': 4787, 'numAffected': 254}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4800, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 4787, 'numAffected': 51}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4800, 'numAffected': 47}, {'groupId': 'EG001', 'numAtRisk': 4787, 'numAffected': 25}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Dermatitis diaper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4800, 'numAffected': 106}, {'groupId': 'EG001', 'numAtRisk': 4787, 'numAffected': 120}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4800, 'numAffected': 129}, {'groupId': 'EG001', 'numAtRisk': 4787, 'numAffected': 110}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4800, 'numAffected': 167}, {'groupId': 'EG001', 'numAtRisk': 4787, 'numAffected': 153}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34904, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 34862, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Idiopathic thrombocytopenic purpura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34904, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34862, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Lymphadenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34904, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 34862, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34904, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34862, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34904, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34862, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34904, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34862, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34904, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34862, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34904, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 34862, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Cardio-respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34904, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34862, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Cardiopulmonary failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34904, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34862, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Cyanosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34904, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 34862, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Atrial septal defect', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34904, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34862, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Cerebral palsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34904, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34862, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Coarctation of the aorta', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34904, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34862, 'numAffected': 2}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Congenital cystic kidney disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34904, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34862, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Congenital intestinal malformation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34904, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34862, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Cryptorchism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34904, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34862, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Cystic fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34904, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34862, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Developmental glaucoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34904, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34862, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Glycogen storage disease type ib', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34904, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34862, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Hip dysplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34904, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 34862, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Hydrocele', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34904, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34862, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Kidney malformation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34904, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34862, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Polycystic liver disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34904, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34862, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Pulmonary artery stenosis congenital', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34904, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34862, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Pyloric stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34904, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34862, 'numAffected': 2}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Retinoblastoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34904, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34862, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Ventricular septal defect', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34904, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34862, 'numAffected': 2}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Chalazion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34904, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34862, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34904, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34862, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34904, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 34862, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34904, 'numAffected': 5}, 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'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Status asthmaticus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34904, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34862, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Tachypnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34904, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34862, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Tracheomalacia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34904, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34862, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34904, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 34862, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Dermatitis allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34904, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34862, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Dermatitis atopic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34904, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 34862, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34904, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34862, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Eczema infantile', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34904, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34862, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Lichen sclerosus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34904, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34862, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Psoriasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34904, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34862, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Purpura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34904, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34862, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34904, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34862, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Seborrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34904, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34862, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34904, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 34862, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Urticaria pigmentosa', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34904, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34862, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Child abuse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34904, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34862, 'numAffected': 1}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Child neglect', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34904, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34862, 'numAffected': 1}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Overfeeding of infant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34904, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34862, 'numAffected': 0}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Circulatory collapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34904, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 34862, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34904, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34862, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34904, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34862, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Pallor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34904, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34862, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Vasculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34904, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 34862, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Intussusception Within 42 Days Following Any Dose of RotaTeq™/Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34002', 'groupId': 'OG000'}, {'value': '33969', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RotaTeq™', 'description': 'Three oral doses (\\~6.5x10\\^7 to \\~1.2x10\\^8 IU/dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.006', 'groupIds': ['OG000', 'OG001'], 'paramType': 'relative risk', 'ciPctValue': '95', 'paramValue': '1.6', 'ciLowerLimit': '0.4', 'ciUpperLimit': '6.4', 'pValueComment': 'p≤ 10/11, where p is proportion of participants with intussusception in vaccine group relative to total number of participants with intussusception. Based on conditional binomial approach.\n\nAdjusted for group-sequential design.', 'statisticalMethod': 'Exact binomial test', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'Exact binomial test adjusted for group-sequential design.', 'testedNonInferiority': True, 'nonInferiorityComment': 'Relative Risk ≤10.0 (non-inferiority margin).'}], 'paramType': 'NUMBER', 'timeFrame': 'Within 42 days following any dose of RotaTeq™/placebo', 'description': 'Number of participants with confirmed intussusception within 42 days after each vaccination with RotaTeq™/placebo.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants in the study were followed for potential cases of intussusception.'}, {'type': 'SECONDARY', 'title': 'G1 Serum Neutralizing Antibody (SNA) Responses Against Rotavirus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RotaTeq™', 'description': 'Participants randomized to treatment with RotaTeq™ tested with data available for analysis excluding protocol violators, participants with invalid data based on laboratory determinations, participants with wildtype rotavirus detected in the stool, or with samples taken outside the range of 9 to 33 days postdose 3.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Participants randomized to treatment with Placebo tested with data available for analysis excluding protocol violators, participants with invalid data based on laboratory determinations, participants with wildtype rotavirus detected in the stool, or with samples taken outside the range of 9 to 33 days postdose 3.'}], 'classes': [{'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'paramType': 'Proportion', 'ciPctValue': '95', 'paramValue': '81.2', 'ciLowerLimit': '72.9', 'ciUpperLimit': '87.8', 'pValueComment': 'p≥42%, where p is proportion of participants with ≥3-fold rise in antibody titer from Predose 1 to Postdose 3 in vaccine group. Based on binomial approach.', 'statisticalMethod': 'Exact binomial test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '14 days following the 3rd vaccination', 'description': 'Number of participants with a 3-fold rise or greater in G1 Serum neutralizing antibody (SNA) responses against rotavirus from baseline to postdose 3.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Population among participants in Finland using Per-Protocol Case Definition'}, {'type': 'PRIMARY', 'title': 'Occurrence of Rotavirus Disease Caused by Serotypes G1, G2, G3 and G4 That Occurs 14 Days Following the 3rd Vaccination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2207', 'groupId': 'OG000'}, {'value': '2305', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RotaTeq™', 'description': 'The number of participants randomized to treatment with RotaTeq™ is different from the number analyzed because some participants were excluded due to protocol violations and/or participants without follow-up and/or participants classified as unevaluable due to detection of wildtype rotavirus in the stool prior to 14 days Postdose 3; incomplete clinical and/or laboratory results; or stool samples collected out of day range.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'The number of participants randomized to treatment with Placebo is different from the number analyzed because some participants were excluded due to protocol violations and/or participants without follow-up and/or participants classified as unevaluable due to detection of wildtype rotavirus in the stool prior to 14 days Postdose 3; incomplete clinical and/or laboratory results; or stool samples collected out of day range.'}], 'classes': [{'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}, {'value': '315', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Efficacy=1-Relative Risk', 'ciPctValue': '95', 'paramValue': '74.0', 'ciLowerLimit': '66.8', 'ciUpperLimit': '79.9', 'pValueComment': 'Efficacy≥35%. Based on p≤.65/(.65+k), where p is proportion of participants with outcome in vaccine group relative to total number of participants with outcome, k is ratio of follow-up time; placebo/vaccine.\n\nBased on conditional binomial approach.', 'estimateComment': 'Efficacy = 1-RR, expressed as a percentage; the RR is the incidence in the vaccine group / the incidence in the placebo group.', 'statisticalMethod': 'Exact binomial test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Exact binomial test.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'At least 14 days following the 3rd vaccination through the first full rotavirus season', 'description': 'Rotavirus gastroenteritis cases consist of all participants with one or more episodes classified as positive. Multiple positive episodes for one participant are counted as a single case.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Population Using Per-Protocol Case Definition'}, {'type': 'SECONDARY', 'title': 'Occurrence of Hospital Admissions and Visits to Emergency Departments (or the Equivalent at International Sites) for Rotavirus Disease Associated With Serotypes G1, G2, G3, or G4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28646', 'groupId': 'OG000'}, {'value': '28488', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RotaTeq™', 'description': 'Three oral doses (\\~6.5x10\\^7 to \\~1.2x10\\^8 IU/dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.'}], 'classes': [{'title': 'Hospital admissions', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}]}]}, {'title': 'Emergency department visits', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '213', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciPctValue': '95', 'paramValue': '94.5', 'ciLowerLimit': '91.2', 'ciUpperLimit': '96.6', 'pValueComment': 'Rate Reduction\\>0%', 'estimateComment': 'Risk ratio of rate of hospitalizations and emergency department visits between treatment groups. Reported here are results after 12 additional emergency department visits were identified among placebo recipients and data were re-analyzed.', 'statisticalMethod': 'Poisson regression', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': "Poisson regression with generalized estimating equations.\n\nValidated with Van Elteren's extension of Wilcoxon Rank Sum test.", 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'At least 14 days following the 3rd vaccination', 'description': 'Health Outcomes Substudy - Occurrence of hospital admissions and emergency department visits for episode(s) of rotavirus gastroenteritis associated with serotypes G1, G2, G3, or G4 by treatment group. Occurrence was expressed as the annual number of events per 1000 person-years.', 'unitOfMeasure': 'Annual # of events per 1000 person-years', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Population Using Per-Protocol Case Definition'}, {'type': 'SECONDARY', 'title': 'Efficacy of a 3-dose Regimen of RotaTeq™ Against Moderate-to-severe Rotavirus Disease (Clinical Score >8) Caused by Serotypes G1, G2, G3, and G4 Occurring at Least 14 Days Following the Third Dose.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2201', 'groupId': 'OG000'}, {'value': '2292', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RotaTeq™', 'description': 'Three oral doses (\\~6.5x10\\^7 to \\~1.2x10\\^8 IU/dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.'}], 'classes': [{'title': 'First episode scores', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '262', 'groupId': 'OG001'}]}]}, {'title': 'Worst episode scores', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '265', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Efficacy=1-Relative Risk', 'ciPctValue': '95', 'paramValue': '81.5', 'ciLowerLimit': '74.9', 'ciUpperLimit': '86.7', 'pValueComment': 'Efficacy\\>0%. Based on p\\< 1/(1+k), where p is proportion of participants with outcome in vaccine group relative to total number of participants with outcome, and k is ratio of follow-up time; placebo / vaccine. Based on conditional binomial approach.', 'estimateComment': 'Estimated value is based on the worst episode scores.', 'statisticalMethod': 'Exact binomial test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'At least 14 days following the 3rd vaccination through the first rotavirus season', 'description': 'Number of participants with rotavirus gastroenteritis whose clinical score was \\>8 for the first episode and for the worst episode. Scores evaluated the intensity and duration of diarrhea, vomiting, fever, and behavioral symptoms. The total score for an episode is equal to the sum of the scores for each of the symptoms \\[range: total score 0 (best) to 24 (worst)\\].', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Population Using Per-Protocol Case Definition'}, {'type': 'SECONDARY', 'title': 'Efficacy of a 3-dose Regimen of RotaTeq™ Against Severe Rotavirus Disease (Clinical Score > 16) Caused by Serotypes G1, G2, G3, and G4 Occurring at Least 14 Days Following the Third Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2198', 'groupId': 'OG000'}, {'value': '2271', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RotaTeq™', 'description': 'Three oral doses (\\~6.5x10\\^7 to \\~1.2x10\\^8 IU/dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.'}], 'classes': [{'title': 'First episode scores', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}, {'title': 'Worst episode scores', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Efficacy=1-Relative Risk', 'ciPctValue': '95', 'paramValue': '98.0', 'ciLowerLimit': '88.3', 'ciUpperLimit': '100', 'pValueComment': 'Efficacy\\>0%. Based on p\\< 1/(1+k), where p is proportion of participants with outcome in vaccine group relative to total number of participants with outcome, and k is ratio of follow-up time; placebo/vaccine. Based on conditional binomial approach.', 'statisticalMethod': 'Exact binomial test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'At least 14 days following the 3rd vaccination through the first rotavirus season', 'description': 'Number of participants with rotavirus gastroenteritis whose clinical score was \\>16 for the first episode and for the worst episode. Scores evaluated the intensity and duration of diarrhea, vomiting, fever, and behavioral symptoms. The total score for an episode is equal to the sum of the scores for each of the symptoms \\[range: total score 0 (best) to 24 (worst)\\].', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Population Using Per-Protocol Case Definition'}, {'type': 'SECONDARY', 'title': 'Seroprotection/Seroconversion for Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus, & Polio Types 1,2,& 3 Who Received COMVAX™, INFANRIX™, IPOL™ & PREVNAR™ Concomitantly With RotaTeq™ Versus Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '558', 'groupId': 'OG000'}, {'value': '592', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RotaTeq™', 'description': 'Three oral doses (\\~6.5x10\\^7 to \\~1.2x10\\^8 IU/dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.'}], 'classes': [{'title': 'Hepatitis B (N=202, N=214)', 'categories': [{'measurements': [{'value': '197', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}]}]}, {'title': 'Haemophilus influenzae type b (N=558, N=592)', 'categories': [{'measurements': [{'value': '417', 'groupId': 'OG000'}, {'value': '426', 'groupId': 'OG001'}]}]}, {'title': 'Diphtheria (N=136, N=144)', 'categories': [{'measurements': [{'value': '136', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}]}]}, {'title': 'Tetanus (N=132, N=140)', 'categories': [{'measurements': [{'value': '132', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}]}]}, {'title': 'Polio type 1 (N=341, N=360)', 'categories': [{'measurements': [{'value': '328', 'groupId': 'OG000'}, {'value': '349', 'groupId': 'OG001'}]}]}, {'title': 'Polio type 2 (N=341, N=359)', 'categories': [{'measurements': [{'value': '311', 'groupId': 'OG000'}, {'value': '326', 'groupId': 'OG001'}]}]}, {'title': 'Polio type 3 (N=341, N=359)', 'categories': [{'measurements': [{'value': '324', 'groupId': 'OG000'}, {'value': '343', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'pValueComment': 'p\\<0.001 was obtained for all comparisons. pv - pp ≥-.10, where p is proportion of participants who achieved seroprotection in the vaccine and placebo groups, respectively.', 'statisticalMethod': 'Miettenen and Nurminen', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Difference (vaccine-placebo) in seroprotection rates was greater than -.10 (non-inferiority margin).'}], 'paramType': 'NUMBER', 'timeFrame': '42 days following third dose', 'description': 'The number of participants who achieved seroprotection/seroconversion to hepatitis B, Haemophilus influenzae type b, diphtheria, tetanus, \\& polio types 1, 2, \\& 3, per established criteria.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Population'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Antibody Titer(s) (GMT) to Pertussis Toxin (PT), Pertussis Filamentous Haemagglutinin (FHA), and Pertussis Pertactin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RotaTeq™', 'description': 'Three oral doses (\\~6.5x10\\^7 to \\~1.2x10\\^8 IU/dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.'}], 'classes': [{'title': 'Pertussis PT', 'categories': [{'measurements': [{'value': '20.18', 'groupId': 'OG000', 'lowerLimit': '17.10', 'upperLimit': '23.81'}, {'value': '22.73', 'groupId': 'OG001', 'lowerLimit': '19.59', 'upperLimit': '26.37'}]}]}, {'title': 'Pertussis FHA', 'categories': [{'measurements': [{'value': '55.69', 'groupId': 'OG000', 'lowerLimit': '48.01', 'upperLimit': '64.59'}, {'value': '64.33', 'groupId': 'OG001', 'lowerLimit': '55.41', 'upperLimit': '74.69'}]}]}, {'title': 'Pertussis Pertactin', 'categories': [{'measurements': [{'value': '34.77', 'groupId': 'OG000', 'lowerLimit': '26.46', 'upperLimit': '45.70'}, {'value': '59.17', 'groupId': 'OG001', 'lowerLimit': '46.21', 'upperLimit': '75.76'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMTR for Pertussis PT', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.9', 'ciLowerLimit': '0.7', 'ciUpperLimit': '1.1', 'groupDescription': 'The GMT Ratio between RotaTeq™ and Placebo (GMTR) for Pertussis PT was used for analysis.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 't-test on natural log of titers', 'testedNonInferiority': True, 'nonInferiorityComment': 'GMTR was greater than 0.5 (non-inferiority margin).'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMTR for Pertussis FHA', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.9', 'ciLowerLimit': '0.7', 'ciUpperLimit': '1.1', 'groupDescription': 'The GMT Ratio between RotaTeq™ and Placebo (GMTR) for Pertussis FHA was used for analysis.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 't-test on natural log of titers', 'testedNonInferiority': True, 'nonInferiorityComment': 'GMTR was greater than 0.5 (non-inferiority margin).'}, {'pValue': '0.193', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMTR for Pertussis Pertactin', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.6', 'ciLowerLimit': '0.4', 'ciUpperLimit': '0.8', 'groupDescription': 'The GMT Ratio between RotaTeq™ and Placebo (GMTR) for Pertussis Pertactin was used for analysis.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 't-test on natural log of titers', 'testedNonInferiority': True, 'nonInferiorityComment': 'GMTR was greater than 0.5 (non-inferiority margin).'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '42 days following third dose', 'description': 'Measurement of immune response in the group that received RotaTeq™ and the group that received placebo was performed by determining geometric mean antibody titers to Pertussis Toxin (PT), Pertussis Filamentous Haemagglutinin (FHA), and Pertussis Pertactin. Antibody titers were measured with an indirect, non-competitive, enzyme immunoassay (EIA).', 'unitOfMeasure': 'ELISA units/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Population; excluding protocol violators and participants with invalid data based on laboratory determinations.'}, {'type': 'SECONDARY', 'title': 'Geometric Mean Antibody Titer(s) (GMT) to Pneumococcal Serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RotaTeq™', 'description': 'Three oral doses (\\~6.5x10\\^7 to \\~1.2x10\\^8 IU/dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.'}], 'classes': [{'title': 'Pneumococcal serotype 4 (N=181, N=196)', 'categories': [{'measurements': [{'value': '1.13', 'groupId': 'OG000', 'lowerLimit': '0.99', 'upperLimit': '1.29'}, {'value': '0.96', 'groupId': 'OG001', 'lowerLimit': '0.84', 'upperLimit': '1.09'}]}]}, {'title': 'Pneumococcal serotype 6B (N=185, N=198)', 'categories': [{'measurements': [{'value': '2.39', 'groupId': 'OG000', 'lowerLimit': '1.93', 'upperLimit': '2.95'}, {'value': '1.72', 'groupId': 'OG001', 'lowerLimit': '1.38', 'upperLimit': '2.13'}]}]}, {'title': 'Pneumococcal serotype 9V (N=166, N=181)', 'categories': [{'measurements': [{'value': '1.90', 'groupId': 'OG000', 'lowerLimit': '1.66', 'upperLimit': '2.19'}, {'value': '1.78', 'groupId': 'OG001', 'lowerLimit': '1.55', 'upperLimit': '2.04'}]}]}, {'title': 'Pneumococcal serotype 14 (N=178, N=198)', 'categories': [{'measurements': [{'value': '4.24', 'groupId': 'OG000', 'lowerLimit': '3.39', 'upperLimit': '5.29'}, {'value': '4.33', 'groupId': 'OG001', 'lowerLimit': '3.55', 'upperLimit': '5.28'}]}]}, {'title': 'Pneumococcal serotype 18C (N=166, N=180)', 'categories': [{'measurements': [{'value': '2.60', 'groupId': 'OG000', 'lowerLimit': '2.30', 'upperLimit': '2.94'}, {'value': '2.02', 'groupId': 'OG001', 'lowerLimit': '1.76', 'upperLimit': '2.32'}]}]}, {'title': 'Pneumococcal serotype 19F (N=180, N=196)', 'categories': [{'measurements': [{'value': '1.97', 'groupId': 'OG000', 'lowerLimit': '1.61', 'upperLimit': '2.42'}, {'value': '1.84', 'groupId': 'OG001', 'lowerLimit': '1.55', 'upperLimit': '2.20'}]}]}, {'title': 'Pneumococcal serotype 23F (N=185, N=198)', 'categories': [{'measurements': [{'value': '1.71', 'groupId': 'OG000', 'lowerLimit': '1.41', 'upperLimit': '2.07'}, {'value': '1.50', 'groupId': 'OG001', 'lowerLimit': '1.24', 'upperLimit': '1.80'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMTR for pneumococcal serotype 4', 'ciPctValue': '95', 'paramValue': '1.2', 'ciLowerLimit': '1.0', 'ciUpperLimit': '1.4', 'groupDescription': 'The GMT Ratio between RotaTeq™ and Placebo (GMTR) for pneumococcal serotype 4 was used for analysis.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 't-test on natural log of titers', 'testedNonInferiority': True, 'nonInferiorityComment': 'GMTR was greater than 0.5 (non-inferiority margin).'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMTR for pneumococcal serotype 6B', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.4', 'ciLowerLimit': '1.0', 'ciUpperLimit': '1.9', 'groupDescription': 'The GMT Ratio between RotaTeq™ and Placebo (GMTR) for pneumococcal serotype 6B was used for analysis.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 't-test on natural log of titers', 'testedNonInferiority': True, 'nonInferiorityComment': 'GMTR was greater than 0.5 (non-inferiority margin).'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMTR for pneumococcal serotype 9V', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.1', 'ciLowerLimit': '0.9', 'ciUpperLimit': '1.3', 'groupDescription': 'The GMT Ratio between RotaTeq™ and Placebo (GMTR) for pneumococcal serotype 9V was used for analysis.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 't-test on natural log of titers', 'testedNonInferiority': True, 'nonInferiorityComment': 'GMTR was greater than 0.5 (non-inferiority margin).'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMTR for pneumococcal serotype 14', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.0', 'ciLowerLimit': '0.7', 'ciUpperLimit': '1.3', 'groupDescription': 'The GMT Ratio between RotaTeq™ and Placebo (GMTR) for pneumococcal serotype 14 was used for analysis.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 't-test on natural log of titers', 'testedNonInferiority': True, 'nonInferiorityComment': 'GMTR was greater than 0.5 (non-inferiority margin).'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMTR for pneumococcal serotype 18C', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.3', 'ciLowerLimit': '1.1', 'ciUpperLimit': '1.6', 'groupDescription': 'The GMT Ratio between RotaTeq™ and Placebo (GMTR) for pneumococcal serotype 18C was used for analysis.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 't-test on natural log of titers', 'testedNonInferiority': True, 'nonInferiorityComment': 'GMTR was greater than 0.5 (non-inferiority margin).'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMTR for pneumococcal serotype 19F', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.1', 'ciLowerLimit': '0.8', 'ciUpperLimit': '1.4', 'groupDescription': 'The GMT Ratio between RotaTeq™ and Placebo (GMTR) for pneumococcal serotype 19F was used for analysis.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 't-test on natural log of titers', 'testedNonInferiority': True, 'nonInferiorityComment': 'GMTR was greater than 0.5 (non-inferiority margin).'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'GMTR for pneumococcal serotype 23F', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.1', 'ciLowerLimit': '0.9', 'ciUpperLimit': '1.5', 'groupDescription': 'The GMT Ratio between RotaTeq™ and Placebo (GMTR) for pneumococcal serotype 23F was used for analysis.', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 't-test on natural log of titers', 'testedNonInferiority': True, 'nonInferiorityComment': 'GMTR was greater than 0.5 (non-inferiority margin).'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '42 days following third dose', 'description': 'Measurement of immune response in the group that received RotaTeq™ and the group that received placebo was performed by determining geometric mean antibody titers to pneumococcal serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F. Serum antibody titers to type-specific pneumococcal polysaccharides were determined by an EIA.', 'unitOfMeasure': 'micrograms/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Population; excluding protocol violators and participants with invalid data based on laboratory determinations.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'RotaTeq™', 'description': 'Three oral doses (\\~6.5x10\\^7 to \\~1.2x10\\^8 IU/dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) through the first rotavirus season postvaccination. The rotavirus season for each site was prospectively determined using historical epidemiologic data.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) through the first rotavirus season postvaccination. The rotavirus season for each site was prospectively determined using historical epidemiologic data.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Evaluated by data safety monitoring board (DSMB) when they recommended stopping enrollment', 'groupId': 'FG000', 'numSubjects': '34644'}, {'comment': 'Evaluated by data safety monitoring board when they recommended stopping enrollment', 'groupId': 'FG001', 'numSubjects': '34630'}]}, {'type': 'Vaccinated at Visit 1', 'achievements': [{'comment': 'Randomized Not vaccinated 609', 'groupId': 'FG000', 'numSubjects': '34035'}, {'comment': 'Randomized Not vaccinated 627', 'groupId': 'FG001', 'numSubjects': '34003'}]}, {'type': 'Vaccinated at Visit 2', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31052'}, {'groupId': 'FG001', 'numSubjects': '31066'}]}, {'type': 'Vaccinated at Visit 3', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29667'}, {'groupId': 'FG001', 'numSubjects': '29598'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Does not include participants who discontinued prior to the 42 day safety follow-up', 'groupId': 'FG000', 'numSubjects': '29645'}, {'comment': 'Does not include participants who discontinued prior to the 42 day safety follow-up', 'groupId': 'FG001', 'numSubjects': '29565'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4999'}, {'groupId': 'FG001', 'numSubjects': '5065'}]}], 'dropWithdraws': [{'type': 'Randomized Not Vaccinated (Visit 1)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '609'}, {'groupId': 'FG001', 'numSubjects': '627'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '214'}, {'groupId': 'FG001', 'numSubjects': '198'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '68'}, {'groupId': 'FG001', 'numSubjects': '95'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '960'}, {'groupId': 'FG001', 'numSubjects': '1022'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '182'}, {'groupId': 'FG001', 'numSubjects': '211'}]}, {'type': 'Moved', 'reasons': [{'groupId': 'FG000', 'numSubjects': '203'}, {'groupId': 'FG001', 'numSubjects': '189'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1211'}, {'groupId': 'FG001', 'numSubjects': '1160'}]}, {'type': 'Data not available at data cut-off point', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1552'}, {'groupId': 'FG001', 'numSubjects': '1563'}]}]}], 'recruitmentDetails': 'Participants were recruited at 356 sites in Belgium, Costa Rica, Finland, Germany, Guatemala, Italy, Jamaica, Mexico, Puerto Rico, Sweden, Taiwan, and the United States from 12 Jan 2001 first patient in (FPI) to 06 Oct 2004 last patient in (LPI).', 'preAssignmentDetails': 'Participants with: history of congenital abdominal disorders, intussusception, or abdominal surgery; history of\n\nknown prior rotavirus disease, chronic diarrhea, or failure to thrive were excluded from the trial before\n\nassignment to groups.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '34644', 'groupId': 'BG000'}, {'value': '34630', 'groupId': 'BG001'}, {'value': '69274', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'RotaTeq™', 'description': 'Three oral doses (\\~6.5x10\\^7 to \\~1.2x10\\^8 IU/dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '5 Weeks of Age and Under', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': '6 to 12 Weeks of Age', 'categories': [{'measurements': [{'value': '34551', 'groupId': 'BG000'}, {'value': '34527', 'groupId': 'BG001'}, {'value': '69078', 'groupId': 'BG002'}]}]}, {'title': 'Over 12 Weeks of Age', 'categories': [{'measurements': [{'value': '92', 'groupId': 'BG000'}, {'value': '99', 'groupId': 'BG001'}, {'value': '191', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'The eligibility for this study was to enroll infants 6-12 weeks of age; however infants that were 5 weeks and under, and infants who were 12 weeks and over were inadvertently enrolled outside these ranges. Those infants who received at least 1 dose of study vaccine, were followed for safety.', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17058', 'groupId': 'BG000'}, {'value': '17101', 'groupId': 'BG001'}, {'value': '34159', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '17586', 'groupId': 'BG000'}, {'value': '17529', 'groupId': 'BG001'}, {'value': '35115', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '23772', 'groupId': 'BG000'}, {'value': '23788', 'groupId': 'BG001'}, {'value': '47560', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic American', 'categories': [{'measurements': [{'value': '4963', 'groupId': 'BG000'}, {'value': '4911', 'groupId': 'BG001'}, {'value': '9874', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '2908', 'groupId': 'BG000'}, {'value': '2941', 'groupId': 'BG001'}, {'value': '5849', 'groupId': 'BG002'}]}]}, {'title': 'Multi Racial', 'categories': [{'measurements': [{'value': '1815', 'groupId': 'BG000'}, {'value': '1817', 'groupId': 'BG001'}, {'value': '3632', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '536', 'groupId': 'BG000'}, {'value': '552', 'groupId': 'BG001'}, {'value': '1088', 'groupId': 'BG002'}]}]}, {'title': 'Native American', 'categories': [{'measurements': [{'value': '531', 'groupId': 'BG000'}, {'value': '514', 'groupId': 'BG001'}, {'value': '1045', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '119', 'groupId': 'BG000'}, {'value': '107', 'groupId': 'BG001'}, {'value': '226', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 69274}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2004-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-18', 'studyFirstSubmitDate': '2004-08-25', 'resultsFirstSubmitDate': '2009-06-29', 'studyFirstSubmitQcDate': '2004-08-26', 'lastUpdatePostDateStruct': {'date': '2015-10-05', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-04-06', 'studyFirstPostDateStruct': {'date': '2004-08-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-05-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intussusception Within 42 Days Following Any Dose of RotaTeq™/Placebo', 'timeFrame': 'Within 42 days following any dose of RotaTeq™/placebo', 'description': 'Number of participants with confirmed intussusception within 42 days after each vaccination with RotaTeq™/placebo.'}, {'measure': 'Occurrence of Rotavirus Disease Caused by Serotypes G1, G2, G3 and G4 That Occurs 14 Days Following the 3rd Vaccination', 'timeFrame': 'At least 14 days following the 3rd vaccination through the first full rotavirus season', 'description': 'Rotavirus gastroenteritis cases consist of all participants with one or more episodes classified as positive. Multiple positive episodes for one participant are counted as a single case.'}], 'secondaryOutcomes': [{'measure': 'G1 Serum Neutralizing Antibody (SNA) Responses Against Rotavirus', 'timeFrame': '14 days following the 3rd vaccination', 'description': 'Number of participants with a 3-fold rise or greater in G1 Serum neutralizing antibody (SNA) responses against rotavirus from baseline to postdose 3.'}, {'measure': 'Occurrence of Hospital Admissions and Visits to Emergency Departments (or the Equivalent at International Sites) for Rotavirus Disease Associated With Serotypes G1, G2, G3, or G4', 'timeFrame': 'At least 14 days following the 3rd vaccination', 'description': 'Health Outcomes Substudy - Occurrence of hospital admissions and emergency department visits for episode(s) of rotavirus gastroenteritis associated with serotypes G1, G2, G3, or G4 by treatment group. Occurrence was expressed as the annual number of events per 1000 person-years.'}, {'measure': 'Efficacy of a 3-dose Regimen of RotaTeq™ Against Moderate-to-severe Rotavirus Disease (Clinical Score >8) Caused by Serotypes G1, G2, G3, and G4 Occurring at Least 14 Days Following the Third Dose.', 'timeFrame': 'At least 14 days following the 3rd vaccination through the first rotavirus season', 'description': 'Number of participants with rotavirus gastroenteritis whose clinical score was \\>8 for the first episode and for the worst episode. Scores evaluated the intensity and duration of diarrhea, vomiting, fever, and behavioral symptoms. The total score for an episode is equal to the sum of the scores for each of the symptoms \\[range: total score 0 (best) to 24 (worst)\\].'}, {'measure': 'Efficacy of a 3-dose Regimen of RotaTeq™ Against Severe Rotavirus Disease (Clinical Score > 16) Caused by Serotypes G1, G2, G3, and G4 Occurring at Least 14 Days Following the Third Dose', 'timeFrame': 'At least 14 days following the 3rd vaccination through the first rotavirus season', 'description': 'Number of participants with rotavirus gastroenteritis whose clinical score was \\>16 for the first episode and for the worst episode. Scores evaluated the intensity and duration of diarrhea, vomiting, fever, and behavioral symptoms. The total score for an episode is equal to the sum of the scores for each of the symptoms \\[range: total score 0 (best) to 24 (worst)\\].'}, {'measure': 'Seroprotection/Seroconversion for Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus, & Polio Types 1,2,& 3 Who Received COMVAX™, INFANRIX™, IPOL™ & PREVNAR™ Concomitantly With RotaTeq™ Versus Placebo', 'timeFrame': '42 days following third dose', 'description': 'The number of participants who achieved seroprotection/seroconversion to hepatitis B, Haemophilus influenzae type b, diphtheria, tetanus, \\& polio types 1, 2, \\& 3, per established criteria.'}, {'measure': 'Geometric Mean Antibody Titer(s) (GMT) to Pertussis Toxin (PT), Pertussis Filamentous Haemagglutinin (FHA), and Pertussis Pertactin', 'timeFrame': '42 days following third dose', 'description': 'Measurement of immune response in the group that received RotaTeq™ and the group that received placebo was performed by determining geometric mean antibody titers to Pertussis Toxin (PT), Pertussis Filamentous Haemagglutinin (FHA), and Pertussis Pertactin. Antibody titers were measured with an indirect, non-competitive, enzyme immunoassay (EIA).'}, {'measure': 'Geometric Mean Antibody Titer(s) (GMT) to Pneumococcal Serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F', 'timeFrame': '42 days following third dose', 'description': 'Measurement of immune response in the group that received RotaTeq™ and the group that received placebo was performed by determining geometric mean antibody titers to pneumococcal serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F. Serum antibody titers to type-specific pneumococcal polysaccharides were determined by an EIA.'}]}, 'conditionsModule': {'conditions': ['Rotavirus Infections']}, 'referencesModule': {'references': [{'pmid': '16394299', 'type': 'RESULT', 'citation': "Vesikari T, Matson DO, Dennehy P, Van Damme P, Santosham M, Rodriguez Z, Dallas MJ, Heyse JF, Goveia MG, Black SB, Shinefield HR, Christie CD, Ylitalo S, Itzler RF, Coia ML, Onorato MT, Adeyi BA, Marshall GS, Gothefors L, Campens D, Karvonen A, Watt JP, O'Brien KL, DiNubile MJ, Clark HF, Boslego JW, Offit PA, Heaton PM; Rotavirus Efficacy and Safety Trial (REST) Study Team. Safety and efficacy of a pentavalent human-bovine (WC3) reassortant rotavirus vaccine. N Engl J Med. 2006 Jan 5;354(1):23-33. doi: 10.1056/NEJMoa052664."}, {'pmid': '20540778', 'type': 'DERIVED', 'citation': 'Itzler R, Koch G, Matson DO, Gothefors L, Van Damme P, Dinubile MJ, Heaton PM. Robustness of the healthcare utilization results from the Rotavirus Efficacy and Safety Trial (REST) evaluating the human-bovine (WC3) reassortant pentavalent rotavirus vaccine (RV5). BMC Pediatr. 2010 Jun 11;10:42. doi: 10.1186/1471-2431-10-42.'}]}, 'descriptionModule': {'briefSummary': 'This study was designed to evaluate the safety of the investigational rotavirus vaccine and the efficacy to prevent rotavirus gastroenteritis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Weeks', 'minimumAge': '6 Weeks', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy infants\n\nExclusion Criteria:\n\n* None Specified'}, 'identificationModule': {'nctId': 'NCT00090233', 'briefTitle': 'Rotavirus Efficacy and Safety Trial (REST)(V260-006)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'Safety and Efficacy of Pentavalent (G1, G2, G3, G4 , and P1) Human-Bovine Reassortant Rotavirus Vaccine in Healthy Infants', 'orgStudyIdInfo': {'id': 'V260-006'}, 'secondaryIdInfos': [{'id': '2004_012'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'RotaTeq', 'interventionNames': ['Biological: Rotateq™']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Placebo', 'interventionNames': ['Biological: Comparator: Placebo']}], 'interventions': [{'name': 'Rotateq™', 'type': 'BIOLOGICAL', 'otherNames': ['V260'], 'description': '3 doses of 2.0 mL RotaTeq administered orally. Dose 1 will be given at study entry, Dose 2 will be given 4-10 weeks after Dose 1, Dose 3 will be given 4-10 weeks after Dose 2.', 'armGroupLabels': ['1']}, {'name': 'Comparator: Placebo', 'type': 'BIOLOGICAL', 'description': '3 doses of 2.0 mL Placebo to RotaTeq administered orally. Dose 1 will be given at study entry, Dose 2 will be given 4-10 weeks after Dose 1, Dose 3 will be given 4-10 weeks after Dose 2.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}