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NCT00057330 · ClinicalTrials.gov registry record · Phase 3
HerpeVac Trial for Young Women
A Phase 3 study of Herpes Simplex Infection, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 8,323
- Enrollment target
- 20
- Study locations
NCT00057330: Completed Phase 3 study of Herpes Simplex Infection, sponsored by GlaxoSmithKline.
NCT00057330 is a Phase 3 study of Herpes Simplex Infection that has completed, run by GlaxoSmithKline. The registered enrollment target is 8,323 participants, above the 771-participant average among 15,282 other Phase 3 trials with a reported enrollment target (980% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00057330, a Phase 3 study of Herpes Simplex Infection, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 8,323 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary purpose of this study is to see if a herpes vaccine may prevent genital herpes disease in women who are not infected. The study will enroll approximately 7550 healthy women. These women will be randomly assigned to 1 of 2 possible study groups: herpes vaccine (experimental group) or hepatitis A vaccine (control group). Participants will receive their assigned vaccine at 0, 1, and 6 months. Participants will have 9 scheduled study visits and additional unscheduled visits for an evaluation of herpes if it is suspected. Participants will be involved in study related procedures for up to 20 months.
Primary Outcome
Genital herpes disease was defined as signs (swelling, papules, vesicles, ulcers, crusts, fissures, erythema, or vaginal discharge) and/or symptoms (pain, burning, itching, tingling, dysuria) which developed on the skin or mucosa of the anogenital region and/or buttocks and laboratory confirmation of Herpes Simplex Virus (HSV)-1 or 2 infection (either concomitant positive HSV culture or HSV seroconversion within 6 months after onset of signs and/or symptoms). Seroconversion to HSV-1 and/or HSV-2
Conditions Studied
Interventions
- BIOLOGICAL HSV vaccine or SB208141, GSK Biologicals' glycoprotein D (gD)-Alum/3-deacylated form of Monophosphoryl Lipid A (MPL) candidate genital herpes vaccine
- BIOLOGICAL Havrix™, GlaxoSmithKline (GSK) Biologicals' licensed Hepatitis A vaccine
Study Locations (20)
California
- GSK Investigational Site - Carson
- GSK Investigational Site - Long Beach
- GSK Investigational Site - Los Angeles
- GSK Investigational Site - San Diego
- GSK Investigational Site - San Diego
- GSK Investigational Site - San Francisco
- GSK Investigational Site - Torrance
- GSK Investigational Site - Vallejo
Arizona
- GSK Investigational Site - Chandler
- GSK Investigational Site - Mesa
- GSK Investigational Site - Mesa
- GSK Investigational Site - Phoenix
- GSK Investigational Site - Phoenix
- GSK Investigational Site - Tempe
Georgia
- GSK Investigational Site - Athens
- GSK Investigational Site - Atlanta
- GSK Investigational Site - Augusta
- GSK Investigational Site - Satesboro
Alabama
- GSK Investigational Site - Birmingham
Colorado
- GSK Investigational Site - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8,323 participants |
| Start Date | 2003-01-14 |
| Est. Completion | 2009-08-22 |
| Phase | Phase 3 |
What the finished NCT00057330 record still lists
NCT00057330 is an interventional study that assigns participants to a tested intervention. Its 8,323 participants enrollment target places it among the larger protocols in the corpus, above the 771-participant average among 15,282 other Phase 3 trials with a reported enrollment target (980% higher).
The record links to 1 condition, with Herpes Simplex Infection appearing as the primary indexed condition, and to 2 interventions - of which HSV vaccine or SB208141, GSK Biologicals' glycoprotein D (gD)-Alum/3-deacylated form of Monophosphoryl Lipid A (MPL) candidate genital herpes vaccine is the first listed.
NCT00057330 names 20 study sites across 5 states, led by California, Arizona, Georgia.
Frequently Asked Questions
What is clinical trial NCT00057330 about?
NCT00057330 is a clinical study titled "HerpeVac Trial for Young Women". The primary purpose of this study is to see if a herpes vaccine may prevent genital herpes disease in women who are not infected. The study will enroll approximately 7550 healthy women. These women will be randomly assigned to 1 of 2 possible study groups: herpes vaccine (experimental group) or hepa...
What is the current status of trial NCT00057330?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 8,323 participants. The study started on 2003-01-14. Estimated completion is 2009-08-22.
What conditions does trial NCT00057330 study?
This clinical trial studies the following conditions: Herpes Simplex Infection.
What interventions are being tested in trial NCT00057330?
The interventions under investigation include: HSV vaccine or SB208141, GSK Biologicals' glycoprotein D (gD)-Alum/3-deacylated form of Monophosphoryl Lipid A (MPL) candidate genital herpes vaccine (BIOLOGICAL), Havrix™, GlaxoSmithKline (GSK) Biologicals' licensed Hepatitis A vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT00057330?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00057330 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00057330's enrollment target sits among peer trials
8,323 32nd of 2000 higher than 1,969 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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