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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00697749 |
Purpose
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 |
|---|---|---|
|
Hepatitis B |
Biological: HBV-MPL vaccine 208129 Biological: Engerix™-B |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| 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 |
|---|---|
| Experimental: Group A |
Biological: HBV-MPL vaccine 208129
2-dose intramuscular injection
|
| Active Comparator: Group B |
Biological: Engerix™-B
3-dose intramuscular injection
|
At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham
Eligibility| Ages Eligible for Study: | 15 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Isabelle Harpigny, GSK |
| ClinicalTrials.gov Identifier: | NCT00697749 History of Changes |
| Other Study ID Numbers: | 208129/034 |
| Study First Received: | June 11, 2008 |
| Last Updated: | June 13, 2008 |
| Health Authority: | Belgium: Institutional Review Board |
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Hepatitis B Adjuvanted hepatitis B vaccine Recombinant hepatitis B vaccine |
|
Hepatitis Hepatitis A Hepatitis B Liver Diseases Digestive System Diseases Hepatitis, Viral, Human |
Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Hepadnaviridae Infections DNA Virus Infections |