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NCT00224471 · ClinicalTrials.gov registry record · Phase 3
Study to Compare Safety and Immunogenicity of Commercial Scale Consistency Lots of Herpes Simplex Vaccine
A Phase 3 study of Herpes Simplex, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 671
- Enrollment target
- 13
- Study locations
NCT00224471: Completed Phase 3 study of Herpes Simplex, sponsored by GlaxoSmithKline.
NCT00224471 is a Phase 3 study of Herpes Simplex that has completed, run by GlaxoSmithKline. The registered enrollment target is 671 participants, below the 1,557-participant average among 4 other Herpes Simplex trials with a reported enrollment target (57% lower). The trial reports 13 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00224471, a Phase 3 study of Herpes Simplex, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 671 participants
- Enrollment target
- 13
- Study locations
Study Summary
Evaluate, one month after the third dose, the lot-to-lot consistency of 3 different commercial scale production lots of the candidate vaccine in healthy HSV 1-/2- females aged 10-17 years, determined by ELISA. Absence in significant variation for both parameters among the tested lots was hypothesized.
Conditions Studied
Interventions
- BIOLOGICAL GSK208141 vaccine
Study Locations (13)
Utah
- GSK Investigational Site - Salt Lake City
- GSK Investigational Site - Salt Lake City
Arizona
- GSK Investigational Site - Mesa
California
- GSK Investigational Site - Fountain Valley
Colorado
- GSK Investigational Site - Golden
Ohio
- GSK Investigational Site - Cincinnati
South Carolina
- GSK Investigational Site - Charleston
Texas
- GSK Investigational Site - Galveston
Washington
- GSK Investigational Site - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 671 participants |
| Start Date | 2003-12 |
| Est. Completion | 2006-01 |
| Phase | Phase 3 |
What the finished NCT00224471 record still lists
NCT00224471 is an interventional study that assigns participants to a tested intervention. The registered 671 participants enrollment target is mid-sized for trials with a published cap, below the 1,557-participant average among 4 other Herpes Simplex trials with a reported enrollment target (57% lower).
The record links to 1 condition, with Herpes Simplex appearing as the primary indexed condition, and to 1 intervention - of which GSK208141 vaccine is the first listed.
NCT00224471 lists 13 locations in 12 states (Utah, Arizona, California).
Frequently Asked Questions
What is clinical trial NCT00224471 about?
NCT00224471 is a clinical study titled "Study to Compare Safety and Immunogenicity of Commercial Scale Consistency Lots of Herpes Simplex Vaccine". Evaluate, one month after the third dose, the lot-to-lot consistency of 3 different commercial scale production lots of the candidate vaccine in healthy HSV 1-/2- females aged 10-17 years, determined by ELISA. Absence in significant variation for both parameters among the tested lots was hypothesize...
What is the current status of trial NCT00224471?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 671 participants. The study started on 2003-12. Estimated completion is 2006-01.
What conditions does trial NCT00224471 study?
This clinical trial studies the following conditions: Herpes Simplex.
What interventions are being tested in trial NCT00224471?
The interventions under investigation include: GSK208141 vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT00224471?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00224471 being conducted?
This trial has 13 study locations across Arizona, California, Colorado, Ohio, South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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