Ignite Creation Date:
2025-12-25 @ 3:25 AM
Ignite Modification Date:
2026-03-03 @ 6:05 PM
Study NCT ID:
NCT01294605
Status:
COMPLETED
Last Update Posted:
2016-09-15
First Post:
2011-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immunogenicity and Reactogenicity Study of BoostrixTM (dTpa) and Boostrix-IPV (dTpa-IPV)
Sponsor:
Organization:
Raw JSON
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Primary vaccination of adults with reduced antigen-content diphtheria-tetanus-acellular pertussis or dTpa-inactivated poliovirus vaccines compared to diphtheria-tetanus-toxoid vaccines. Curr Med Res Opin. 2007 Nov;23(11):2729-39. doi: 10.1185/03007x233034.'}, {'pmid': '21718738', 'type': 'BACKGROUND', 'citation': 'Van Damme P, McIntyre P, Grimprel E, Kuriyakose S, Jacquet JM, Hardt K, Messier M, Van Der Meeren O. Immunogenicity of the reduced-antigen-content dTpa vaccine (Boostrix((R))) in adults 55 years of age and over: a sub-analysis of four trials. Vaccine. 2011 Aug 11;29(35):5932-9. doi: 10.1016/j.vaccine.2011.06.049. Epub 2011 Jun 28.'}, {'type': 'BACKGROUND', 'citation': 'Van Damme P et al. Primary vaccination of adults with reduced antigen content diphtheria-tetanus-acellular pertussis (dTpa) vaccines. Abstract presented at the 27th Annual Meeting of European Society for Paediatric Infectious Diseases (ESPID), Brussels, Belgium. 09-13 June 2009.'}], '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': 'This purpose of the study is to evaluate the immunogenicity and reactogenicity of Boostrix™ (when used in a primary schedule (0, 1, 6-month) or a single dose of Boostrix-IPV followed by two doses of Td vaccines (DitanrixTM Adult, TedivaxTM), as compared to three doses of licensed Td vaccines in adults.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Only subjects for whom the investigator believes the requirements of the protocol will be complied with will be enrolled in the study\n* A male or female adult \\>= 40 years of age\n* Written informed consent to be obtained from the subject prior to study entry\n* No history of diphtheria or tetanus toxoid containing vaccination in the last 20 years, including those who have never been vaccinated and those with an unknown vaccination status.\n* Free of obvious health problems as established by medical history and clinical examination before entering into the study.\n* subject should not be pregnant or plan to become pregnant.\n\nExclusion Criteria:\n\n* Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period\n* Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.\n* Major congenital defects or serious chronic illness.\n* History of any neurologic disorders or seizures\n* Acute disease at the time of enrolment.\n* Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.\n* Pregnant or lactating female\n* Female planning to become pregnant or planning to discontinue contraceptive precautions\n* Previous vaccination with a meningococcal-conjugate vaccine, Prevenar™ or other experimental conjugated pneumococcal vaccines\n* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).\n* Any confirmed or suspected immunosuppressive or immunodeficient condition'}, 'identificationModule': {'nctId': 'NCT01294605', 'briefTitle': 'Immunogenicity and Reactogenicity Study of BoostrixTM (dTpa) and Boostrix-IPV (dTpa-IPV)', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'Double-blind, Randomized, Phase III Clinical Trial to Evaluate the Immunogenicity and Reactogenicity of Three Consecutive Doses of dTpa, or of dTpa-IPV Followed by Two Doses of Td Vaccine , and Compared to Three Consecutive Doses of Td Vaccine Administered to Healthy Adults in a 0,1,6-month Schedule', 'orgStudyIdInfo': {'id': '263855/034'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'interventionNames': ['Biological: Boostrix™ (dTpa)']}, {'type': 'EXPERIMENTAL', 'label': 'Group B', 'interventionNames': ["Biological: GSK Biologicals' reduced-antigen-content combined diphtheria, tetanus, acellular pertussis and inactivated polio vaccine (dTpa-IPV; BoostrixTM)", 'Biological: Ditanrix™ Adult, TedivaxTM (Td)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group C', 'interventionNames': ['Biological: Ditanrix™ Adult, TedivaxTM (Td)']}], 'interventions': [{'name': 'Boostrix™ (dTpa)', 'type': 'BIOLOGICAL', 'description': 'Intramuscular, 3 doses', 'armGroupLabels': ['Group A']}, {'name': "GSK Biologicals' reduced-antigen-content combined diphtheria, tetanus, acellular pertussis and inactivated polio vaccine (dTpa-IPV; BoostrixTM)", 'type': 'BIOLOGICAL', 'description': 'Intramuscular, single dose', 'armGroupLabels': ['Group B']}, {'name': 'Ditanrix™ Adult, TedivaxTM (Td)', 'type': 'BIOLOGICAL', 'description': 'Intramuscular, 2 doses', 'armGroupLabels': ['Group B']}, {'name': 'Ditanrix™ Adult, TedivaxTM (Td)', 'type': 'BIOLOGICAL', 'description': 'Intramuscular, 3 doses', 'armGroupLabels': ['Group C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Bruges', 'country': 'Belgium', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.20892, 'lon': 3.22424}}, {'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '2610', 'city': 'Wilrijk', 'country': 'Belgium', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.16734, 'lon': 4.39513}}, {'zip': '3015 GE', 'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'zip': '3584 CJ', 'city': 'Utrecht', 'country': 'Netherlands', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}, {'zip': '46600', 'city': 'Alzira', 'country': 'Spain', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 39.15, 'lon': -0.43333}}, {'zip': '08035', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08036', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '8025', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Centelles', 'country': 'Spain', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 41.79746, 'lon': 2.21902}}, {'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '08100', 'city': 'Mollet del Vallès', 'country': 'Spain', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 41.54026, 'lon': 2.21306}}, {'zip': '28500', 'city': 'Vic', 'country': 'Spain', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 41.93012, 'lon': 2.25486}}], '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'}}}}