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NCT01461096 · ClinicalTrials.gov registry record · Phase 3
Quadrivalent HPV Vaccine to Prevent Anal HPV in HIV-infected Men and Women
A Phase 3 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 3
- Development phase
- 575
- Enrollment target
NCT01461096: Completed Phase 3 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT01461096 is a Phase 3 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 575 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (26% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01461096, a Phase 3 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 575 participants
- Enrollment target
Study Summary
Men who have sex with men (MSM) have an increased risk of developing anal human papillomavirus (HPV) infections, which can be a risk factor for anal cancer. HIV-infected women are also at risk of anal cancer. This study will evaluate the effectiveness of the Food and Drug Administration (FDA)-approved quadrivalent HPV vaccine, Gardasil, at preventing anal HPV infection in HIV-infected MSM and HIV-infected women.
Primary Outcome
The outcome for this evaluation was time to the first new persistent infection of any of HPV 6, 11, 16, or 18. Persistent infection was defined as an infection confirmed by positive anal HPV PCR results at 2 consecutive visits at least 16 weeks apart without an intervening negative result. A participant who had a positive measurement on his/her last measurement with no consecutive confirmatory measurement was considered as having a persistent infection. Participants with pre-existing HPV infecti
Interventions
- BIOLOGICAL Quadrivalent HPV Vaccine
- BIOLOGICAL Placebo Vaccine for Male Participants Only
- BIOLOGICAL Placebo Vaccine for Female Participants Only
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 575 participants |
| Start Date | 2012-03 |
| Est. Completion | 2016-01 |
| Phase | Phase 3 |
What the finished NCT01461096 record still lists
NCT01461096 is an interventional study that assigns participants to a tested intervention. The registered 575 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 (26% lower).
The record links to 0 conditions, and to 3 interventions - of which Quadrivalent HPV Vaccine is the first listed.
NCT01461096 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01461096 about?
NCT01461096 is a clinical study titled "Quadrivalent HPV Vaccine to Prevent Anal HPV in HIV-infected Men and Women". Men who have sex with men (MSM) have an increased risk of developing anal human papillomavirus (HPV) infections, which can be a risk factor for anal cancer. HIV-infected women are also at risk of anal cancer. This study will evaluate the effectiveness of the Food and Drug Administration (FDA)-approv...
What is the current status of trial NCT01461096?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 575 participants. The study started on 2012-03. Estimated completion is 2016-01.
What interventions are being tested in trial NCT01461096?
The interventions under investigation include: Quadrivalent HPV Vaccine (BIOLOGICAL), Placebo Vaccine for Male Participants Only (BIOLOGICAL), Placebo Vaccine for Female Participants Only (BIOLOGICAL).
Who is sponsoring clinical trial NCT01461096?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01461096's enrollment target sits among peer trials
575 661st of 2000 higher than 1,338 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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