Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 116 participants.
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.
Interventions
- BIOLOGICAL Cervarix™
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 116 participants |
| Start Date | 2008-01-14 |
| Est. Completion | 2009-12-01 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00546078
The ClinicalTrials.gov registry entry for NCT00546078 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 116 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Cervarix™ is the first listed.
NCT00546078 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.