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NCT00224484 · ClinicalTrials.gov registry record · Phase 3
Safety Study of Herpes Simplex Vaccine in HSV Seronegative and Seropositive Females Between 10 and 17 Years Old
A Phase 3 study of Herpes Simplex, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 5,960
- Enrollment target
- 20
- Study locations
NCT00224484: Completed Phase 3 study of Herpes Simplex, sponsored by GlaxoSmithKline.
NCT00224484 is a Phase 3 study of Herpes Simplex that has completed, run by GlaxoSmithKline. The registered enrollment target is 5,960 participants, above the 234-participant average among 4 other Herpes Simplex trials with a reported enrollment target (2447% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00224484, a Phase 3 study of Herpes Simplex, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 5,960 participants
- Enrollment target
- 20
- Study locations
Study Summary
Main goal of this study is to compare the occurrence of serious adverse events (SAEs) between the herpes simplex (gD2-AS04) vaccine group and the Saline control group throughout the study period (up to month 12). The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Primary Outcome
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Conditions Studied
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL GSK208141
- BIOLOGICAL Havrix (investigational formulation)
Study Locations (20)
Arizona
- GSK Investigational Site - Chandler
- GSK Investigational Site - Mesa
- GSK Investigational Site - Mesa
- GSK Investigational Site - Tempe
- GSK Investigational Site - Tucson
Colorado
- GSK Investigational Site - Centennial
- GSK Investigational Site - Littleton
- GSK Investigational Site - Thornton
- GSK Investigational Site - Westminster
- GSK Investigational Site - Wheat Ridge
California
- GSK Investigational Site - Beverly Hills
- GSK Investigational Site - Fountain Valley
- GSK Investigational Site - Long Beach
- GSK Investigational Site - Rolling Hills Estates
Florida
- GSK Investigational Site - Clearwater
- GSK Investigational Site - Cocoa Beach
- GSK Investigational Site - Melbourne
Alabama
- GSK Investigational Site - Birmingham
- GSK Investigational Site - Birmingham
Connecticut
- GSK Investigational Site - Norwich
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5,960 participants |
| Start Date | 2004-04-07 |
| Est. Completion | 2007-07-24 |
| Phase | Phase 3 |
What the finished NCT00224484 record still lists
NCT00224484 is an interventional study that assigns participants to a tested intervention. Its 5,960 participants enrollment target places it among the larger protocols in the corpus, above the 234-participant average among 4 other Herpes Simplex trials with a reported enrollment target (2447% higher).
The record links to 1 condition, with Herpes Simplex appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT00224484 names 20 study sites across 6 states, led by Arizona, Colorado, California.
Frequently Asked Questions
What is clinical trial NCT00224484 about?
NCT00224484 is a clinical study titled "Safety Study of Herpes Simplex Vaccine in HSV Seronegative and Seropositive Females Between 10 and 17 Years Old". Main goal of this study is to compare the occurrence of serious adverse events (SAEs) between the herpes simplex (gD2-AS04) vaccine group and the Saline control group throughout the study period (up to month 12). The Protocol Posting has been updated in order to comply with the FDA Amendment Act, S...
What is the current status of trial NCT00224484?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 5,960 participants. The study started on 2004-04-07. Estimated completion is 2007-07-24.
What conditions does trial NCT00224484 study?
This clinical trial studies the following conditions: Herpes Simplex.
What interventions are being tested in trial NCT00224484?
The interventions under investigation include: Placebo (BIOLOGICAL), GSK208141 (BIOLOGICAL), Havrix (investigational formulation) (BIOLOGICAL).
Who is sponsoring clinical trial NCT00224484?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00224484 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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