Ignite Creation Date:
2025-12-24 @ 4:32 PM
Ignite Modification Date:
2026-01-01 @ 10:58 PM
Study NCT ID:
NCT00353366
Status:
COMPLETED
Last Update Posted:
2021-03-16
First Post:
2006-07-17
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
To Evaluate Safety & Reactogenicity of GSK Bio's Human Rotavirus (HRV) Vaccine in Filipino Infants at Least 6 Weeks of Age at First Vaccination
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012400', 'term': 'Rotavirus Infections'}, {'id': 'D005759', 'term': 'Gastroenteritis'}], 'ancestors': [{'id': 'D012088', 'term': 'Reoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C492457', 'term': 'RIX4414 vaccine'}, {'id': 'D003625', 'term': 'Data Collection'}], 'ancestors': [{'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'GSKClinicalSupportHD@gsk.com', 'phone': '866-435-7343', 'title': 'GSK Response Center', 'organization': 'GlaxoSmithKline'}, 'certainAgreement': {'otherDetails': 'GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK 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}}, 'adverseEventsModule': {'timeFrame': 'Serious Adverse Events: during the entire study period; Solicited local and general symptoms: During the 15-day (Days 0-14) post-vaccination period; Unsolicited symptoms: During the 31-day (Days 0-30) post-vaccination period.', 'eventGroups': [{'id': 'EG000', 'title': 'Rotarix Group', 'description': 'Subjects received 2 doses of Rotarix administered at an interval of not less than 4 weeks between the doses. The first dose was administered at the age of 6 weeks and the vaccination course completed by the age of 24 weeks.', 'otherNumAtRisk': 1439, 'deathsNumAtRisk': 1439, 'otherNumAffected': 827, 'seriousNumAtRisk': 1439, 'deathsNumAffected': 0, 'seriousNumAffected': 33}], 'otherEvents': [{'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1439, 'numAffected': 443}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1439, 'numAffected': 93}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1439, 'numAffected': 226}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1439, 'numAffected': 545}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Loss of appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1439, 'numAffected': 351}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1439, 'numAffected': 240}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}], 'seriousEvents': [{'term': 'Bronchopneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1439, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1439, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Amoebic dysentery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1439, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1439, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Amoebiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1439, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1439, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Bronchiolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1439, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1439, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1439, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Diarrhoea infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1439, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Exanthema subitum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1439, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1439, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hypersomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1439, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Hypophagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1439, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Intussusception', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1439, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Milk anyergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1439, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pneumonia aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1439, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Pneumonia bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1439, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Roseola', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1439, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Urinary tract infection enterococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1439, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}, {'term': 'Viral rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1439, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Subjects Reporting Grade 2 or 3 Symptoms (Fever, Vomiting or Diarrhea).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1439', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rotarix Group', 'description': 'Subjects received 2 doses of Rotarix administered at an interval of not less than 4 weeks between the doses. The first dose was administered at the age of 6 weeks and the vaccination course completed by the age of 24 weeks.'}], 'classes': [{'title': 'Grade 2/3;Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1439', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '147', 'groupId': 'OG000'}]}]}, {'title': 'Grade 2/3; Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1304', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '98', 'groupId': 'OG000'}]}]}, {'title': 'Grade 2/3; Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1439', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '212', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During the 15-day (Days 0-14) solicited follow-up period after each vaccine dose (Dose 1 and Dose 2).', 'description': 'Grade 2 or 3 symptoms assessed include fever, vomiting and diarrhea. Grade 2 fever was defined as axillary temperature above 38.0 degrees Celsius (°C) and below or equal to 39.0°C or rectal temperature above 38.5°C and below or equal to 39.5°C. Grade 3 fever was defined as axillary temperature above 39.0°C. Grade 2 vomiting was defined as 2 episodes of vomiting per day. Grade 3 vomiting was defined as at least 3 episodes of vomiting per day. Grade 2 diarrhea was defined as 4-5 looser than normal stools per day. Grade 3 diarrhea was defined as at least 6 looser than normal stools per day.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort which included all vaccinated subjects with at least one dose of the Rotarix vaccine administration documented.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1439', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rotarix Group', 'description': 'Subjects received 2 doses of Rotarix administered at an interval of not less than 4 weeks between the doses. The first dose was administered at the age of 6 weeks and the vaccination course completed by the age of 24 weeks.'}], 'classes': [{'title': 'Any Cough; Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1439', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '311', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 Cough; Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1439', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'Related Cough; Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1439', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'Any Diarrhea; Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1439', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 Diarrhea; Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1439', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'Related Diarrhea; Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1439', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}]}]}, {'title': 'Any Temperature; Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1439', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '130', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 Temperature; Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1439', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Related Temperature; Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1439', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}]}]}, {'title': 'Any Irritability; Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1439', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '464', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 Irritability; Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1439', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}]}]}, {'title': 'Related Irritability; Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1439', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}, {'title': 'Any Loss of appetite; Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1439', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '269', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 Loss of appetite; Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1439', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Related Loss of appetite; Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1439', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}]}]}, {'title': 'Any Vomiting; Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1439', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '190', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 Vomiting; Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1439', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}]}]}, {'title': 'Related Vomiting; Dose 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1439', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}]}]}, {'title': 'Any Cough; Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1439', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '256', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 Cough; Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1304', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Related Cough; Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1304', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}]}]}, {'title': 'Any Diarrhea; Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1304', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 Diarrhea; Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1304', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Related Diarrhea; Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1304', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'Any Temperature; Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1304', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '130', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 Temperature; Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1304', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Related Temperature; Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1304', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}, {'title': 'Any Irritability; Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1304', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '307', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 Irritability; Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1304', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}, {'title': 'Related Irritability; Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1304', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000'}]}]}, {'title': 'Any Loss of appetite; Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1304', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '193', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 Loss of appetite; Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1304', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Related Loss of appetite; Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1304', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}]}]}, {'title': 'Any Vomiting; Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1304', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '113', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 Vomiting; Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1304', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'Related Vomiting; Dose 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1304', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}, {'title': 'Any Cough; Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1439', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '443', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 Cough; Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1439', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}, {'title': 'Related Cough; Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1439', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}]}]}, {'title': 'Any Diarrhea; Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1439', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 Diarrhea; Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1439', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}, {'title': 'Related Diarrhea; Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1439', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}]}]}, {'title': 'Any Temperature; Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1439', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '226', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 Temperature; Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1439', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Related Temperature; Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1439', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}]}]}, {'title': 'Any Irritability; Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1439', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '545', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 Irritability; Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1439', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}]}]}, {'title': 'Related Irritability; Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1439', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '130', 'groupId': 'OG000'}]}]}, {'title': 'Any Loss of appetite; Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1439', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '351', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 Loss of appetite; Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1439', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Related Loss of appetite; Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1439', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000'}]}]}, {'title': 'Any Vomiting; Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1439', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '240', 'groupId': 'OG000'}]}]}, {'title': 'Grade 3 Vomiting; Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1439', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}]}]}, {'title': 'Related Vomiting; Across Doses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1439', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During the 15-day solicited follow-up period (Day 0 to Day 14) after each vaccine dose (Dose 1 and Dose 2).', 'description': 'Solicited symptoms assessed included cough, diarrhea, fever, irritability, loss of appetite and vomiting. Any = Any reports of the specified symptom irrespective of intensity grade and relationship to vaccination. Grade 3 symptom: symptom that prevented normal activity. Grade 3 loss of appetite = not eating at all, grade 3 fever = axillary temperature \\> 39.0°C, grade 3 vomiting = ≥ 3 episodes of vomiting/day and grade 3 diarrhea = ≥ 6 looser than normal stools/day. Related = symptom assessed by the investigator as causally related to the vaccination regardless of intensity grade.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort , which included all vaccinated subjects with at least one dose of the Rotarix vaccine administration documented.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Unsolicited Adverse Events (AE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1439', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rotarix Group', 'description': 'Subjects received 2 doses of Rotarix administered at an interval of not less than 4 weeks between the doses. The first dose was administered at the age of 6 weeks and the vaccination course completed by the age of 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '352', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During the 31-day follow-up period (Day 0 to Day 30) after any vaccine dose.', 'description': 'An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined as an adverse event (AE) reported in addition to those solicited during the clinical study. Any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one dose of the Rotarix vaccine administration documented.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Reporting Serious Adverse Events (SAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1439', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Rotarix Group', 'description': 'Subjects received 2 doses of Rotarix administered at an interval of not less than 4 weeks between the doses. The first dose was administered at the age of 6 weeks and the vaccination course completed by the age of 24 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Throughout the study period (Day 0 to one month post-Dose 2).', 'description': 'Serious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with at least one dose of the Rotarix vaccine administration documented.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Rotarix Group', 'description': 'Subjects received 2 doses of Rotarix administered at an interval of not less than 4 weeks between the doses. The first dose was administered at the age of 6 weeks and the vaccination course completed by the age of 24 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1439'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1296'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '143'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '92'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1439', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Rotarix Group', 'description': 'Subjects received 2 doses of Rotarix administered at an interval of not less than 4 weeks between the doses. The first dose was administered at the age of 6 weeks and the vaccination course completed by the age of 24 weeks.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '11.2', 'spread': '3.88', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Weeks', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '692', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '747', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1439}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-11-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2010-07-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-23', 'studyFirstSubmitDate': '2006-07-17', 'resultsFirstSubmitDate': '2011-07-07', 'studyFirstSubmitQcDate': '2006-07-17', 'lastUpdatePostDateStruct': {'date': '2021-03-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2011-07-07', 'studyFirstPostDateStruct': {'date': '2006-07-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-08-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Subjects Reporting Grade 2 or 3 Symptoms (Fever, Vomiting or Diarrhea).', 'timeFrame': 'During the 15-day (Days 0-14) solicited follow-up period after each vaccine dose (Dose 1 and Dose 2).', 'description': 'Grade 2 or 3 symptoms assessed include fever, vomiting and diarrhea. Grade 2 fever was defined as axillary temperature above 38.0 degrees Celsius (°C) and below or equal to 39.0°C or rectal temperature above 38.5°C and below or equal to 39.5°C. Grade 3 fever was defined as axillary temperature above 39.0°C. Grade 2 vomiting was defined as 2 episodes of vomiting per day. Grade 3 vomiting was defined as at least 3 episodes of vomiting per day. Grade 2 diarrhea was defined as 4-5 looser than normal stools per day. Grade 3 diarrhea was defined as at least 6 looser than normal stools per day.'}], 'secondaryOutcomes': [{'measure': 'Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.', 'timeFrame': 'During the 15-day solicited follow-up period (Day 0 to Day 14) after each vaccine dose (Dose 1 and Dose 2).', 'description': 'Solicited symptoms assessed included cough, diarrhea, fever, irritability, loss of appetite and vomiting. Any = Any reports of the specified symptom irrespective of intensity grade and relationship to vaccination. Grade 3 symptom: symptom that prevented normal activity. Grade 3 loss of appetite = not eating at all, grade 3 fever = axillary temperature \\> 39.0°C, grade 3 vomiting = ≥ 3 episodes of vomiting/day and grade 3 diarrhea = ≥ 6 looser than normal stools/day. Related = symptom assessed by the investigator as causally related to the vaccination regardless of intensity grade.'}, {'measure': 'Number of Subjects Reporting Unsolicited Adverse Events (AE)', 'timeFrame': 'During the 31-day follow-up period (Day 0 to Day 30) after any vaccine dose.', 'description': 'An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined as an adverse event (AE) reported in addition to those solicited during the clinical study. Any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.'}, {'measure': 'Number of Subjects Reporting Serious Adverse Events (SAE)', 'timeFrame': 'Throughout the study period (Day 0 to one month post-Dose 2).', 'description': 'Serious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.'}]}, 'conditionsModule': {'keywords': ['safety', 'Post-marketing surveillance (PMS)', 'Rotarix', 'oral', 'Filipino', 'Rotavirus', 'Gastroenteritis', 'Human Rotavirus (HRV) vaccine'], 'conditions': ['Infections, Rotavirus', 'Rotavirus Vaccines']}, 'referencesModule': {'references': [{'pmid': '25424932', 'type': 'BACKGROUND', 'citation': 'Bravo L, Chitraka A, Liu A, Choudhury J, Kumar K, Berezo L, Cimafranca L, Chatterjee P, Garg P, Siriwardene P, Bernardo R, Mehta S, Balasubramanian S, Karkada N, Htay Han H. Reactogenicity and safety of the human rotavirus vaccine, Rotarix in The Philippines, Sri Lanka, and India: a post-marketing surveillance study. Hum Vaccin Immunother. 2014;10(8):2276-83. doi: 10.4161/hv.29280.'}]}, 'descriptionModule': {'briefSummary': 'GSK has submitted a registration file for its live attenuated oral human rotavirus (HRV) vaccine in several countries. In view of its registration in the Philippines, the present study will collect data on the safety of the vaccine in the local target population as per the Bureau of Food and Drugs Directive.', 'detailedDescription': 'The protocol was amended to reflect a change in the prescribing information. The age of the infants was changed from 6 - 14 weeks to at least 6 weeks at the time of the first vaccination. This protocol posting has been amended in order to comply with FDA AA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '24 Weeks', 'minimumAge': '6 Weeks', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Filipino subjects aged at least 6 weeks at the time of first vaccination', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits) should be enrolled in the study.\n* A Filipino male or female aged at least 6 weeks at the time of the first vaccination.\n* Written informed consent obtained from the parent or guardian of the subject.\n\nExclusion Criteria:\n\n* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.\n* Any history of chronic gastrointestinal disease including any uncorrected congenital malformation of the GI tract.\n* Any contraindications as stated in the Prescribing Information.'}, 'identificationModule': {'nctId': 'NCT00353366', 'briefTitle': "To Evaluate Safety & Reactogenicity of GSK Bio's Human Rotavirus (HRV) Vaccine in Filipino Infants at Least 6 Weeks of Age at First Vaccination", 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': "Open, Multicentric, Post-marketing Surveillance Study to Evaluate Safety and Reactogenicity of GSK Bio's Live Attenuated Oral Human Rotavirus (HRV) Vaccine, Rotarix When Administered According to Prescribing Information, in Filipino Subjects Aged at Least 6 Weeks of Age at the Time of First Vaccination", 'orgStudyIdInfo': {'id': '103366'}, 'secondaryIdInfos': [{'id': '2012-004039-21', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort Group', 'description': 'Subjects received two oral doses of the Rotarix vaccine at the age of 6 weeks', 'interventionNames': ['Biological: Rotarix', 'Other: Data collection']}], 'interventions': [{'name': 'Rotarix', 'type': 'BIOLOGICAL', 'description': 'Two doses of the oral vaccine', 'armGroupLabels': ['Cohort Group']}, {'name': 'Data collection', 'type': 'OTHER', 'description': 'Safety evaluation: recording of adverse events by using diary cards and by non-leading questioning.', 'armGroupLabels': ['Cohort Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1780', 'city': 'Alabang, Muntinlupa City', 'country': 'Philippines', 'facility': 'GSK Investigational Site'}, {'city': 'Binangonan, Rizal', 'country': 'Philippines', 'facility': 'GSK Investigational Site'}, {'city': 'Cainta, Rizal', 'country': 'Philippines', 'facility': 'GSK Investigational Site'}, {'zip': '1780', 'city': 'City of Muntinlupa', 'country': 'Philippines', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 14.39028, 'lon': 121.0475}}, {'city': 'Gen. Trias, Cavite', 'country': 'Philippines', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 15.67785, 'lon': 120.76978}}, {'city': 'Imus, Cavite', 'country': 'Philippines', 'facility': 'GSK Investigational Site'}, {'zip': '4027', 'city': 'Los Banos, Laguna', 'country': 'Philippines', 'facility': 'GSK Investigational Site'}, {'city': 'Makati City', 'country': 'Philippines', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 14.55027, 'lon': 121.03269}}, {'zip': '1000', 'city': 'Manila', 'country': 'Philippines', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 14.6042, 'lon': 120.9822}}, {'city': 'Manila', 'country': 'Philippines', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 14.6042, 'lon': 120.9822}}, {'city': 'Maybunga, Pasig City', 'country': 'Philippines', 'facility': 'GSK Investigational Site'}, {'city': 'Pasay', 'country': 'Philippines', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 14.53748, 'lon': 121.00144}}, {'zip': '1600', 'city': 'Pasig City, Metro Manila', 'country': 'Philippines', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 14.58691, 'lon': 121.0614}}, {'zip': '1102', 'city': 'Quezon City', 'country': 'Philippines', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 14.6488, 'lon': 121.0509}}, {'zip': '1113', 'city': 'Quezon City', 'country': 'Philippines', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 14.6488, 'lon': 121.0509}}, {'city': 'Quezon City', 'country': 'Philippines', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 14.6488, 'lon': 121.0509}}, {'city': 'Talaba IV, Bacoor, Cavite', 'country': 'Philippines', 'facility': 'GSK Investigational Site'}, {'city': 'Taytay, Rizal', 'country': 'Philippines', 'facility': 'GSK Investigational Site'}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}