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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00698555 |
This study will evaluate the immunogenicity and safety of different formulations of the candidate HBV-MPL vaccine administered according to a 2-dose schedule and compare it to that of Engerix™-B administered according to a 3-dose schedule in order to determine the optimal dose of each component of the candidate HBV-MPL vaccine when administered at 0 and 6 months
Condition | Intervention | Phase |
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Hepatitis B |
Biological: HBV-MPL vaccine Biological: Engerix™-B |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Parallel Assignment, Efficacy Study |
Official Title: | Study Comparing the Immunogenicity and Reactogenicity of Different Formulations of GSK Bio's HBV-MPL Vaccine Injected as a 0, 6 Months Schedule With That of Engerix™-B Injected as a 0, 1, 6 Months Schedule in Healthy Adults Aged 18-40 Years |
Enrollment: | 163 |
Study Start Date: | March 1997 |
Primary Completion Date: | May 1998 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Group A: Experimental |
Biological: HBV-MPL vaccine
5 different formulations, 2-dose intramuscular injection
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Group B: Experimental |
Biological: HBV-MPL vaccine
5 different formulations, 2-dose intramuscular injection
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Group C: Experimental |
Biological: HBV-MPL vaccine
5 different formulations, 2-dose intramuscular injection
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Group D: Experimental |
Biological: HBV-MPL vaccine
5 different formulations, 2-dose intramuscular injection
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Group E: Experimental |
Biological: HBV-MPL vaccine
5 different formulations, 2-dose intramuscular injection
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Group F: 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: | 18 Years to 40 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | GSK ( Isabelle Harpigny ) |
Study ID Numbers: | 208129/025 |
Study First Received: | June 13, 2008 |
Last Updated: | June 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00698555 |
Health Authority: | Belgium: Ministry of Social Affairs, Public Health and the Environment |
Hepatitis B HBV-MPL Recombinant hepatitis B vaccine |
Virus Diseases Hepatitis Liver Diseases Digestive System Diseases |
Hepatitis B Hepatitis, Viral, Human DNA Virus Infections Healthy |
Hepadnaviridae Infections |