Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2026-02-24 @ 2:06 PM
Study NCT ID:
NCT00508833
Status:
COMPLETED
Last Update Posted:
2007-07-30
First Post:
2007-07-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of SmithKline Beecham (GlaxoSmithKline [GSK]) Biologicals' Candidate Adjuvanted Vaccines (287615)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-07', 'lastUpdateSubmitDate': '2007-07-27', 'studyFirstSubmitDate': '2007-07-27', 'studyFirstSubmitQcDate': '2007-07-27', 'lastUpdatePostDateStruct': {'date': '2007-07-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-07-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intensity of the CTL response at Week 6'}], 'secondaryOutcomes': [{'measure': 'Solicited symptoms (7 days), other AEs (up to 6 mths), SAEs (entire study), intensity of CTL response at Week 46, 48, 78; anti-HBs response up to week 78'}]}, 'conditionsModule': {'keywords': ['Adjuvants', 'HBsAg'], 'conditions': ['Hepatitis B Disease']}, 'descriptionModule': {'briefSummary': 'This study was done to evaluate the effect of various adjuvants in combination with HBsAg as a model antigen on the induction of immune responses, mainly cytotoxic T lymphocytes (CTL) in healthy volunteers. The study was also done to evaluate the safety and reactogenicity of the various adjuvanted vaccines.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy volunteers between 18 and 40 years of age\n* Written informed consent obtained from subject\n* Female of non-childbearing potential\n\nExclusion Criteria:\n\n* Any hepatitis B vaccination.\n* Positive HBV serological markers: anti-HBs, anti-HBc, and/ or HBsAg\n* Pregnancy or lactating female\n* Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days or 7 half-lives (whichever is the longer) preceding the first vaccine administration'}, 'identificationModule': {'nctId': 'NCT00508833', 'briefTitle': "Safety and Efficacy of SmithKline Beecham (GlaxoSmithKline [GSK]) Biologicals' Candidate Adjuvanted Vaccines (287615)", 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': "Safety and the Efficacy of GSK Biologicals' Candidate Adjuvanted Vaccines (287615) Containing HBsAg With Various Adjuvants to Induce Cytotoxic T Lymphocytes (CTL) in Healthy Adult Volunteers", 'orgStudyIdInfo': {'id': '287615/005'}}, 'armsInterventionsModule': {'interventions': [{'name': '287615 containing HBsAg with adjuvants', 'type': 'BIOLOGICAL'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ghent', 'country': 'Belgium', 'facility': 'GSK Clinical Trials Call Center', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}}}}