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Tracking Information | |||||
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First Received Date † | June 13, 2008 | ||||
Last Updated Date | June 16, 2008 | ||||
Start Date † | March 1997 | ||||
Current Primary Outcome Measures † |
Anti-HBs antibody concentrations [ Time Frame: Month 7 ] | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00698555 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | Comparing Immunogenicity and Safety of Different Formulations of HBV-MPL Vaccine With Engerix™-B in Adults Aged 18-40 y | ||||
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 | ||||
Brief Summary | 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 |
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Detailed Description | At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham |
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Study Phase | Phase II | ||||
Study Type † | Interventional | ||||
Study Design † | Prevention, Randomized, Open Label, Parallel Assignment, Efficacy Study | ||||
Condition † | Hepatitis B | ||||
Intervention † |
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Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Completed | ||||
Enrollment † | 163 | ||||
Completion Date | |||||
Primary Completion Date | May 1998 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years to 40 Years | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts †† | |||||
Location Countries † | Belgium | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00698555 | ||||
Responsible Party | Isabelle Harpigny, GSK | ||||
Secondary IDs †† | |||||
Study Sponsor † | GlaxoSmithKline | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | GlaxoSmithKline | ||||
Verification Date | June 2008 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |