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Tracking Information | |||||
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First Received Date † | June 17, 2008 | ||||
Last Updated Date | June 18, 2008 | ||||
Start Date † | March 1996 | ||||
Current Primary Outcome Measures † |
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Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00699764 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | Safety of a Herpes Simplex Candidate Vaccine (gD2t) With MPL and Its Efficacy to Prevent Genital Herpes Disease | ||||
Official Title † | Safety of GSK Biologicals' (Previously Smith Kline Beecham Biologicals') Herpes Simplex Candidate Vaccine (gD2t) With Adjuvant & Its Efficacy to Prevent Genital Herpes Disease in HSV Positive or Negative Subjects With Genital Herpes Disease | ||||
Brief Summary | The purpose of the study is to evaluate the safety of Herpes Simplex candidate vaccine (gD2t) with adjuvant and its efficacy to prevent genital herpes disease in HSV positive or negative consorts of subjects with genital herpes disease. |
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Detailed Description | This study was monitored by a Data Safety Monitoring Board 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 III | ||||
Study Type † | Interventional | ||||
Study Design † | Prevention, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study | ||||
Condition † | Prophylaxis Herpes Simplex | ||||
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 † | 2491 | ||||
Completion Date | October 1999 | ||||
Primary Completion Date | October 1999 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years to 45 Years | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts †† | |||||
Location Countries † | United States, Australia, Canada, Italy, Puerto Rico | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00699764 | ||||
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. |