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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01461096
The ClinicalTrials.gov registry entry for NCT01461096 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 575 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Quadrivalent HPV Vaccine is the first listed.
NCT01461096 reports 0 study locations.
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.
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