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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00697749 |
This study compares the immunogenicity and safety of the novel adjuvanted HBV vaccine and Engerix™-B administered to subjects who were positively identified as having the HLA-DQ2 genotype
Condition | Intervention | Phase |
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Hepatitis B |
Biological: HBV-MPL vaccine 208129 Biological: Engerix™-B |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Study to Compare the Immunogenicity and Safety of GSK Biologicals' Novel Adjuvanted HBV Vaccine (0, 6 Month Schedule) to Engerix™-B (0, 1, 6 Month Schedule) in Healthy (≥ 15 Years) Volunteers Positive for the HLA-DQ2 Genotype |
Enrollment: | 230 |
Study Start Date: | April 1999 |
Primary Completion Date: | January 2000 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Group A: Experimental |
Biological: HBV-MPL vaccine 208129
2-dose intramuscular injection
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Group B: Active Comparator |
Biological: Engerix™-B
3-dose intramuscular injection
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At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham
Ages Eligible for Study: | 15 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | GSK ( Isabelle Harpigny ) |
Study ID Numbers: | 208129/034 |
Study First Received: | June 11, 2008 |
Last Updated: | June 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00697749 |
Health Authority: | Belgium: Institutional Review Board |
Hepatitis B Adjuvanted hepatitis B vaccine Recombinant hepatitis B vaccine |
Virus Diseases Hepatitis Liver Diseases Digestive System Diseases |
Hepatitis B Hepatitis, Viral, Human DNA Virus Infections Healthy |
Hepadnaviridae Infections |