Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2025-12-25 @ 9:25 PM
Study NCT ID:
NCT00297856
Status:
COMPLETED
Last Update Posted:
2014-01-13
First Post:
2006-02-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Post-marketing Safety Study of GSK Biologicals' Boostrix® Vaccine
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': 'C505143', 'term': 'Boostrix'}, {'id': 'D014612', 'term': 'Vaccines'}], 'ancestors': [{'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-09', 'studyFirstSubmitDate': '2006-02-28', 'studyFirstSubmitQcDate': '2006-02-28', 'lastUpdatePostDateStruct': {'date': '2014-01-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-03-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of medically-attended neurological events.', 'timeFrame': '30 days following vaccination with Boostrix.'}], 'secondaryOutcomes': [{'measure': 'Occurrence of medically-attended hematologic events', 'timeFrame': '30 days following vaccination with Boostrix'}, {'measure': 'Occurrence of allergic reactions.', 'timeFrame': '30 days following vaccination with Boostrix'}, {'measure': 'Occurrence of new onset chronic illnesses', 'timeFrame': '6-month period following vaccination with Boostrix'}, {'measure': 'Occurrence of neurological and hematological events and allergic reactions', 'timeFrame': 'Within the second 30-day period following vaccination with Boostrix'}, {'measure': 'Occurrence of chronic illnesses in an historical control cohort of subjects vaccinated with Td vaccine'}]}, 'conditionsModule': {'keywords': ['Boostrix'], 'conditions': ['Diphtheria', 'Tetanus', 'Acellular Pertussis']}, 'referencesModule': {'references': [{'pmid': '20190673', 'type': 'BACKGROUND', 'citation': 'Klein NP, Hansen J, Lewis E, Lyon L, Nguyen B, Black S, Weston WM, Wu S, Li P, Howe B, Friedland LR. Post-marketing safety evaluation of a tetanus toxoid, reduced diphtheria toxoid and 3-component acellular pertussis vaccine administered to a cohort of adolescents in a United States health maintenance organization. Pediatr Infect Dis J. 2010 Jul;29(7):613-7. doi: 10.1097/INF.0b013e3181d581f9.'}]}, 'descriptionModule': {'briefSummary': "Pre-licensure studies of GSK Biologicals' Boostrix® have shown it to be generally safe and well-tolerated. This post-licensure study is designed to evaluate relatively uncommon/rare outcomes in a large population cohort. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.", 'detailedDescription': 'Data collection through utilization of automated databases at the study site. The collaborator is Kaiser Permanente Vaccine Study Center.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '10 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects enrolled in the Northern California Kaiser-Permanente Health Care Plan', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects between the age of 10 and 18 years (inclusive) who received a dose of Boostrix and who have safety follow-up information available'}, 'identificationModule': {'nctId': 'NCT00297856', 'briefTitle': "Post-marketing Safety Study of GSK Biologicals' Boostrix® Vaccine", 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': "Open, Prospective Study of the Safety of GSK Biologicals' Boostrix® (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed) Administered to a Cohort of Adolescents in a US Health Maintenance Organization (HMO)", 'orgStudyIdInfo': {'id': '104154'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Boostrix cohort', 'interventionNames': ['Biological: Boostrix®']}, {'label': 'Historical Td cohort', 'interventionNames': ['Biological: Td (Tetanus diphtheria) vaccine']}], 'interventions': [{'name': 'Boostrix®', 'type': 'BIOLOGICAL', 'description': 'Single dose', 'armGroupLabels': ['Boostrix cohort']}, {'name': 'Td (Tetanus diphtheria) vaccine', 'type': 'BIOLOGICAL', 'description': 'Single dose', 'armGroupLabels': ['Historical Td cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94612', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}