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NCT00799825 · ClinicalTrials.gov registry record · Phase 3
Safety Study of GSK Biologicals' Human Papillomavirus Vaccine in 580299/008 Subjects From Canada or the US
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 346
- Enrollment target
NCT00799825: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT00799825 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 346 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00799825, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 346 participants
- Enrollment target
Study Summary
This phase 3b study is designed to assess the safety of GlaxoSmithKline Biological's HPV vaccine GSK580299 in female subjects who took part in study 580299/008 and received the control vaccine (Hepatitis A vaccine).
Primary Outcome
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. Any = Occurrence of any SAE regardless of intensity grade or relation to vaccination. Grade 3 = SAE which prevented normal, everyday activities. Related = SAE assessed by the investigator as related to the vaccination.
Interventions
- BIOLOGICAL GSK Biological's HPV vaccine GSK580299 (Cervarix™)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 346 participants |
| Start Date | 2009-01-01 |
| Est. Completion | 2012-08-02 |
| Phase | Phase 3 |
What the finished NCT00799825 record still lists
NCT00799825 is an interventional study that assigns participants to a tested intervention. The registered 346 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 1 intervention - of which GSK Biological's HPV vaccine GSK580299 (Cervarix™) is the first listed.
NCT00799825 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00799825 about?
NCT00799825 is a clinical study titled "Safety Study of GSK Biologicals' Human Papillomavirus Vaccine in 580299/008 Subjects From Canada or the US". This phase 3b study is designed to assess the safety of GlaxoSmithKline Biological's HPV vaccine GSK580299 in female subjects who took part in study 580299/008 and received the control vaccine (Hepatitis A vaccine).
What is the current status of trial NCT00799825?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 346 participants. The study started on 2009-01-01. Estimated completion is 2012-08-02.
What interventions are being tested in trial NCT00799825?
The interventions under investigation include: GSK Biological's HPV vaccine GSK580299 (Cervarix™) (BIOLOGICAL).
Who is sponsoring clinical trial NCT00799825?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00799825's enrollment target sits among peer trials
346 1049th of 2000 higher than 951 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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