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NCT03051516 · ClinicalTrials.gov registry record · Phase 4
HPV Vaccine Therapy in Interrupting Progression in Patients With High-Grade Vulvar or Anal Lesions
A Phase 4 study, sponsored by Fred Hutchinson Cancer Center.
- Terminated
- Registry status
- Phase 4
- Development phase
- 188
- Enrollment target
NCT03051516: Clinical Trial Phase 4 study, sponsored by Fred Hutchinson Cancer Center.
NCT03051516 is a Phase 4 study that was terminated before completion, run by Fred Hutchinson Cancer Center. The registered enrollment target is 188 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (64% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03051516, a Phase 4 study, was terminated before completion, sponsored by Fred Hutchinson Cancer Center.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 188 participants
- Enrollment target
Study Summary
This phase IV trial studies how well human papillomavirus (HPV) vaccine therapy works in interrupting progression in patients with high-grade vulvar or anal lesions. Vaccines made from HPV peptides or antigens may help the body build an effective immune response to kill tumor cells and decrease the chance of vulvar or anal lesions to progress or come back.
Primary Outcome
Persistence will be measured as two or more consecutive polymerase chain reaction (PCR) positive swabs for the same human papillomavirus (HPV) genotype. Will use Chi-Square test to compare the number of participants with the persistent infection in the vaccinated to unvaccinated group.
Interventions
- OTHER Laboratory Biomarker Analysis
- OTHER Questionnaire Administration
- BIOLOGICAL Recombinant Human Papillomavirus Nonavalent Vaccine
- OTHER Placebo Administration
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 188 participants |
| Start Date | 2017-08-01 |
| Est. Completion | 2022-12-31 |
| Phase | Phase 4 |
Why NCT03051516 stopped before completion
NCT03051516 is an interventional study that assigns participants to a tested intervention. The registered 188 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (64% lower).
The record links to 0 conditions, and to 4 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT03051516 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03051516 about?
NCT03051516 is a clinical study titled "HPV Vaccine Therapy in Interrupting Progression in Patients With High-Grade Vulvar or Anal Lesions". This phase IV trial studies how well human papillomavirus (HPV) vaccine therapy works in interrupting progression in patients with high-grade vulvar or anal lesions. Vaccines made from HPV peptides or antigens may help the body build an effective immune response to kill tumor cells and decrease the ...
What is the current status of trial NCT03051516?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 188 participants. The study started on 2017-08-01. Estimated completion is 2022-12-31.
What interventions are being tested in trial NCT03051516?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Questionnaire Administration (OTHER), Recombinant Human Papillomavirus Nonavalent Vaccine (BIOLOGICAL), Placebo Administration (OTHER).
Who is sponsoring clinical trial NCT03051516?
This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03051516's enrollment target sits among peer trials
188 456th of 2000 higher than 1,542 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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