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NCT00369824 · ClinicalTrials.gov registry record · Phase 3
Evaluation of Safety and Immunogenicity of Co-administering HPV Vaccine With Other Vaccines in Healthy Female Subjects
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,330
- Enrollment target
NCT00369824: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT00369824 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 1,330 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00369824, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,330 participants
- Enrollment target
Study Summary
Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. Vaccination of pre-teens and adolescents, ideally before sexual debut and thus before exposure to oncogenic HPV, is a rational strategy for prevention of cervical cancer, and so HPV vaccination could complement the existing pre-adolescent/adolescents platform. Therefore, this Phase 3b study is designed to evaluate the safety and immunogenicity of co-administering Boostrix and/or Menactra with GSK Biologicals' HPV vaccine (580299) as compared to the administration of any of the vaccines alone. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Primary Outcome
Anti-D and anti-T antibodies cut-off values assessed include 1.0 international unit per milliliter (IU/mL)
Interventions
- BIOLOGICAL Different formulations of GSK Biologicals' HPV vaccine (580299)
- BIOLOGICAL Menactra TM
- BIOLOGICAL Boostrix TM
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,330 participants |
| Start Date | 2006-09-26 |
| Est. Completion | 2008-02-13 |
| Phase | Phase 3 |
What the finished NCT00369824 record still lists
NCT00369824 is an interventional study that assigns participants to a tested intervention. Its 1,330 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% higher).
The record links to 0 conditions, and to 3 interventions - of which Different formulations of GSK Biologicals' HPV vaccine (580299) is the first listed.
NCT00369824 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00369824 about?
NCT00369824 is a clinical study titled "Evaluation of Safety and Immunogenicity of Co-administering HPV Vaccine With Other Vaccines in Healthy Female Subjects". Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. Vaccination of pre-teens and adolescents, ideally before sexual debut and thus before exposure to oncogenic HPV, is a rational strategy for prevention of cervical cancer, and so HPV vaccin...
What is the current status of trial NCT00369824?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,330 participants. The study started on 2006-09-26. Estimated completion is 2008-02-13.
What interventions are being tested in trial NCT00369824?
The interventions under investigation include: Different formulations of GSK Biologicals' HPV vaccine (580299) (BIOLOGICAL), Menactra TM (BIOLOGICAL), Boostrix TM (BIOLOGICAL).
Who is sponsoring clinical trial NCT00369824?
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 NCT00369824's enrollment target sits among peer trials
1,330 183rd of 2000 higher than 1,818 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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