Ignite Creation Date:
2025-12-24 @ 3:37 PM
Ignite Modification Date:
2025-12-27 @ 12:03 PM
Study NCT ID:
NCT00263692
Status:
COMPLETED
Last Update Posted:
2016-09-15
First Post:
2005-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of GSK Biologicals' DTaP-IPV Candidate Vaccine to DTaP and IPV Separately Administered Vaccines in Terms of Immune Response and Safety
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004165', 'term': 'Diphtheria'}, {'id': 'D013742', 'term': 'Tetanus'}], 'ancestors': [{'id': 'D003354', 'term': 'Corynebacterium Infections'}, {'id': 'D000193', 'term': 'Actinomycetales Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D003015', 'term': 'Clostridium Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013745', 'term': 'Tetanus Toxoid'}], 'ancestors': [{'id': 'D014121', 'term': 'Toxoids'}, {'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': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 401}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2004-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-14', 'studyFirstSubmitDate': '2005-12-08', 'studyFirstSubmitQcDate': '2005-12-08', 'lastUpdatePostDateStruct': {'date': '2016-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Immunogenicity after vaccination.'}], 'secondaryOutcomes': [{'measure': 'Immunogenicity and safety after vaccination.'}]}, 'conditionsModule': {'conditions': ['Diphtheria', 'Acellular Pertussis', 'Tetanus']}, 'referencesModule': {'availIpds': [{'id': '213503/047', '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': '213503/047', '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': '213503/047', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Dataset Specification', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '213503/047', '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': '213503/047', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Study Protocol', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': '213503/047', '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'}], 'references': [{'pmid': '16759769', 'type': 'BACKGROUND', 'citation': 'Black S, Friedland LR, Schuind A, Howe B; GlaxoSmithKline DTaP-IPV Vaccine Study Group. Immunogenicity and safety of a combined DTaP-IPV vaccine compared with separate DTaP and IPV vaccines when administered as pre-school booster doses with a second dose of MMR vaccine to healthy children aged 4-6 years. Vaccine. 2006 Aug 28;24(35-36):6163-71. doi: 10.1016/j.vaccine.2006.04.001. Epub 2006 Apr 21.'}, {'pmid': '18980534', 'type': 'BACKGROUND', 'citation': 'Weston WM, Klein NP. Kinrix: a new combination DTaP-IPV vaccine for children aged 4-6 years. Expert Rev Vaccines. 2008 Nov;7(9):1309-20. doi: 10.1586/14760584.7.9.1309.'}], '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 aims of this study are to compare the immunogenicity and safety of the GSK Biologicals' combined DTaP-IPV vaccine with separate administration of DTaP and IPV vaccines, when administered as a fifth dose of acellular pertussis vaccine to children aged 4 to 6 years when co-administered with MMR vaccine in subjects who had previously received four doses of Infanrix, three doses of poliovirus-containing vaccine and MMR vaccination."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '4 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy children between and including 4 and 6 years of age.\n* Previously received 4 doses of GSK Biologicals' DTaP, 3 doses of IPV vaccine and 1 dose of measles, mumps, and rubella vaccine.\n\nExclusion Criteria:\n\n* Use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding the administration of study vaccines, or planned use during the study period.\n* Chronic administration or planned administration of immunosuppressants or other immune modifying drugs within six months prior to study vaccination or planned administration during the study period\n* Administration of immunoglobulins and/or blood products within 3 months prior to vaccination."}, 'identificationModule': {'nctId': 'NCT00263692', 'briefTitle': "Comparison of GSK Biologicals' DTaP-IPV Candidate Vaccine to DTaP and IPV Separately Administered Vaccines in Terms of Immune Response and Safety", 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': "Open, Randomized, Phase II, Clinical Trial to Compare the Immunogenicity and Safety of a Booster Dose of GSK Biologicals' DTaP-IPV Vaccine (Infanrix®-IPV) Co-administered With a Booster Dose of Merck and Company's M-M-R®II, to That of Separate Injections of GSK Biologicals' DTaP Vaccine (Infanrix®), Aventis Pasteur's IPV (IPOL®) and M-M-R®II Administered as Booster Doses to Healthy Children 4 to 6 Years of Age.", 'orgStudyIdInfo': {'id': '213503/047'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Prophylaxis: Diphtheria, tetanus, pertussis, poliovirus type 1, type 2 and type 3', 'type': 'BIOLOGICAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '72401', 'city': 'Jonesboro', 'state': 'Arkansas', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.8423, 'lon': -90.70428}}, {'zip': '92708', 'city': 'Fountain Valley', 'state': 'California', 'country': 'United States', 'facility': 'GSK Investigational Site', 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'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '71270', 'city': 'Ruston', 'state': 'Louisiana', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 32.52321, 'lon': -92.63793}}, {'zip': '08009', 'city': 'Berlin', 'state': 'New Jersey', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 39.79123, 'lon': -74.92905}}, {'zip': '08889', 'city': 'Whitehouse Station', 'state': 'New Jersey', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 40.61538, 'lon': -74.77044}}, {'zip': '13760', 'city': 'Endwell', 'state': 'New York', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 42.11285, 'lon': -76.02103}}, {'zip': '11794', 'city': 'Stony Brook', 'state': 'New York', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 40.92565, 'lon': -73.14094}}, {'zip': '15241', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '23111', 'city': 'Mechanicsville', 'state': 'Virginia', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 37.60876, 'lon': -77.37331}}], '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'}}}}