Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2025-12-25 @ 11:21 PM
Study NCT ID:
NCT01636193
Status:
COMPLETED
Last Update Posted:
2015-08-17
First Post:
2012-06-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Drug Use Investigation for ROTARIX®
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1607}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-13', 'studyFirstSubmitDate': '2012-06-25', 'studyFirstSubmitQcDate': '2012-07-05', 'lastUpdatePostDateStruct': {'date': '2015-08-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of Adverse events under clinical practice.', 'timeFrame': 'During the 31-day observation period after each vaccination.'}, {'measure': 'Occurrence of typical symptoms of intussusceptions and bloody stool.', 'timeFrame': 'During the 31-day observation period after each vaccination.'}]}, 'conditionsModule': {'keywords': ['Rotavirus', 'Rotarix', 'Drug Use Investigation', 'Safety'], 'conditions': ['Infections, Rotavirus']}, 'descriptionModule': {'briefSummary': 'This study aims to assess the safety of Oral Rotarix® under clinical practice; and collect information regarding typical symptoms of intussusceptions and bloody stool in Japan.', 'detailedDescription': 'This is non-interventional study conducted in one group received Oral Rotarix®. This surveillance is abbreviated as SMILER (Surveillance and Monitoring In Living clinical Experience for Rotarix).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Infants who receive Rotarix for the first time to prevent rotavirus gastroenteritis as part of routine immunisation programme.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• Infants who receive Rotarix for the first time to prevent rotavirus gastroenteritis, an indication of Rotarix, will be included in the investigation.\n\nExclusion Criteria:\n\n• All infants included in the special drug use investigation of Oral Rotarix will be excluded.'}, 'identificationModule': {'nctId': 'NCT01636193', 'briefTitle': 'Drug Use Investigation for ROTARIX®', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'Drug Use Investigation for ROTARIX', 'orgStudyIdInfo': {'id': '115926'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Rota Group', 'description': 'Subjects will receive Rotarix® as per routine practice.', 'interventionNames': ['Biological: Oral Rotarix®', 'Other: Data collection']}], 'interventions': [{'name': 'Oral Rotarix®', 'type': 'BIOLOGICAL', 'description': '2 doses administered orally.', 'armGroupLabels': ['Rota Group']}, {'name': 'Data collection', 'type': 'OTHER', 'description': "Safety data will be collected through the check of health observation diary and interview of vaccinee's parent.", 'armGroupLabels': ['Rota Group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}