Ignite Creation Date:
2025-12-24 @ 3:50 PM
Ignite Modification Date:
2025-12-26 @ 9:28 AM
Study NCT ID:
NCT00346892
Status:
COMPLETED
Last Update Posted:
2016-09-09
First Post:
2006-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Evaluate 2 Doses of GSK Biologicals' Oral Live Attenuated Human HRV Vaccine Co-administered With Either OPV or IPV
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': 'D022243', 'term': 'Rotavirus Vaccines'}], 'ancestors': [{'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 450}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'lastUpdateSubmitDate': '2016-09-08', 'studyFirstSubmitDate': '2006-02-03', 'studyFirstSubmitQcDate': '2006-06-29', 'lastUpdatePostDateStruct': {'date': '2016-09-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-06-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Seroprotection for each polio serotype 1 month after the 3rd dose.'}], 'secondaryOutcomes': [{'measure': 'Proportion of subjects with vaccine take 1 month after each dose of study vaccine, viral shedding in a subset of subjects, presence of RV in diarrheal stools, anti-rota IgA antibody seroconversion rate and serum anti-rota IgA antibody concent'}]}, 'conditionsModule': {'keywords': ['Prophylaxis rotavirus'], 'conditions': ['Rotavirus Infections']}, 'referencesModule': {'availIpds': [{'id': '444563/014', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Clinical Study Report', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '444563/014', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Dataset Specification', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '444563/014', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Statistical Analysis Plan', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '444563/014', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Individual Participant Data Set', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '444563/014', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Informed Consent Form', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '444563/014', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Study Protocol', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}], 'seeAlsoLinks': [{'url': 'https://www.clinicalstudydatarequest.com', 'label': 'Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.'}]}, 'descriptionModule': {'briefSummary': '"The primary objective of this study was to demonstrate that co-administering HRV vaccine with OPV does not induce a significant decrease in poliovirus immune response one month after the third dose of combined vaccines.\n\nThe primary objective was reached if one month after the third dose of polio vaccine, upper limit of the 95% CI for the difference in Seroprotection rate between the group B and C pooled and (minus) the group A was below 10% for each polio serotype."', 'detailedDescription': 'The study had three groups: Group A: HRV + OPV + DTPa/Hib; Group B: HRV + placebo OPV + DTPa-IPV/Hib; Group C: HRV Placebo + OPV + DTPa/Hib. Two cohorts: Subjects enrolled before the 2002 RV season were to receive two doses of HRV or placebo at approximately 6 and 10 weeks of age (first cohort) and subjects enrolled after the 2002 RV season received vaccinations at approximately 10 and 14 weeks of age (second cohort). Routine EPI vaccinations were to be administered concomitantly with the study vaccines.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Weeks', 'minimumAge': '5 Weeks', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion criteria: Healthy infants between 5 and 10 weeks of age at first study vaccination with (after the 2002 RV season) confirmed negative HIV status of the subject's mother during pregnancy or thereafter. Exclusion criteria: History of allergic disease, any confirmed or suspected immunosuppressive or immunodeficient condition, clinically significant history of chronic gastrointestinal disease or other serious medical condition as determined by the investigator or had not received treatment prohibited by the protocol."}, 'identificationModule': {'nctId': 'NCT00346892', 'briefTitle': "To Evaluate 2 Doses of GSK Biologicals' Oral Live Attenuated Human HRV Vaccine Co-administered With Either OPV or IPV", 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': "Reactogenicity & Immunogenicity Study of Two Doses of GSK Biologicals' Oral Live Attenuated HRV Vaccine Co-administered With Either OPV or IPV in Healthy Infants (Approximately 5-10 Weeks Old) in South Africa", 'orgStudyIdInfo': {'id': '444563/014'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Rotavirus (vaccine)', 'type': 'BIOLOGICAL'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Pretoria', 'country': 'South Africa', 'geoPoint': {'lat': -25.74486, 'lon': 28.18783}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}