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NCT00546078 · ClinicalTrials.gov registry record · Phase 2
Follow-up Study to Evaluate the Safety and Immunogenicity of a HPV Vaccine (580299) in North America
A Phase 2 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 116
- Enrollment target
NCT00546078: Completed Phase 2 study, sponsored by GlaxoSmithKline.
NCT00546078 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 116 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (13% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00546078, a Phase 2 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 116 participants
- Enrollment target
Study Summary
Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. This study will further evaluate induction of immune memory and anamnestic responses in women who previously took part in the primary study (580299/001) and follow-up study (580299/007). Subjects were aged 15-25 yrs at the time of entry into the primary study and participation in the follow-up study lasted approximately 6 years. In the primary and follow-up studies, subjects were protected against HPV-16 and HPV-18 endpoints and had sustained antibody responses to both vaccine types over at least 5.5 years of follow-up. All subjects from North American study sites that completed the follow-up study will be invited to take part in the current study. The study will evaluate the safety and immunogenicity of a dose of GSK Biologicals HPV vaccine (580299) in women who had been immunologically primed in the primary study. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Primary Outcome
Cut-off values assessed include 8 Enzyme-linked immunosorbent assay units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.
Interventions
- BIOLOGICAL Cervarix™
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 116 participants |
| Start Date | 2008-01-14 |
| Est. Completion | 2009-12-01 |
| Phase | Phase 2 |
What the finished NCT00546078 record still lists
NCT00546078 is an interventional study that assigns participants to a tested intervention. The registered 116 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (13% lower).
The record links to 0 conditions, and to 1 intervention - of which Cervarix™ is the first listed.
NCT00546078 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00546078 about?
NCT00546078 is a clinical study titled "Follow-up Study to Evaluate the Safety and Immunogenicity of a HPV Vaccine (580299) in North America". Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. This study will further evaluate induction of immune memory and anamnestic responses in women who previously took part in the primary study (580299/001) and follow-up study (580299/007). S...
What is the current status of trial NCT00546078?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 116 participants. The study started on 2008-01-14. Estimated completion is 2009-12-01.
What interventions are being tested in trial NCT00546078?
The interventions under investigation include: Cervarix™ (BIOLOGICAL).
Who is sponsoring clinical trial NCT00546078?
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 NCT00546078's enrollment target sits among peer trials
116 623rd of 2000 higher than 1,375 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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