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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00698893 |
The purpose of the study is to evaluate the safety and reactogenicity of candidate gD vaccine, with or without MPL, in HSV-seropositive subjects. The immune response elicited in these subjects will also be evaluated.
Condition | Intervention | Phase |
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Prophylaxis Herpes Simplex |
Biological: Herpes simplex candidate (gD) vaccine GSK208141 |
Phase I |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | An Open Study in Healthy Herpes Simplex Virus (HSV)-Positive Adults to Evaluate the Safety of GSK Biologicals' Candidate gD Vaccine, With or Without MPL |
Enrollment: | 16 |
Study Start Date: | May 1992 |
Study Completion Date: | July 1992 |
Primary Completion Date: | July 1992 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Group A: Experimental |
Biological: Herpes simplex candidate (gD) vaccine GSK208141
Intramuscular injection, 2 doses, 2 different formulations (with and without MPL)
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Group B: Experimental |
Biological: Herpes simplex candidate (gD) vaccine GSK208141
Intramuscular injection, 2 doses, 2 different formulations (with and without MPL)
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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: | 208141/001 |
Study First Received: | June 13, 2008 |
Last Updated: | June 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00698893 History of Changes |
Health Authority: | Belgium: Institutional Review Board |
Herpes simplex Herpes simplex candidate (gD) vaccine |
Virus Diseases Herpes Simplex Skin Diseases, Infectious Skin Diseases |
DNA Virus Infections Healthy Herpesviridae Infections |
Skin Diseases, Viral Virus Diseases Herpes Simplex Skin Diseases, Infectious |
Skin Diseases DNA Virus Infections Herpesviridae Infections |