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NCT04199689 · ClinicalTrials.gov registry record · Phase 3
Efficacy Against Oral Persistent Infection, Immunogenicity and Safety of the 9-valent Human Papillomavirus Vaccine (9vHPV) in Men Aged 20-45 Years (V503-049)
A Phase 3 study of Papillomavirus Infections, sponsored by Merck Sharp & Dohme.
- Active
- Registry status
- Phase 3
- Development phase
- 6,033
- Enrollment target
- 20
- Study locations
NCT04199689 is a Phase 3 study of Papillomavirus Infections that is active but no longer recruiting, run by Merck Sharp & Dohme. The registered enrollment target is 6,033 participants, above the 260-participant average among 5 other Papillomavirus Infections trials with a reported enrollment target (2220% higher). The trial reports 20 study locations across 10 states.
The verdict
NCT04199689, a Phase 3 study of Papillomavirus Infections, is active but no longer recruiting, sponsored by Merck Sharp & Dohme.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 6,033 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the efficacy, immunogenicity and safety of the 9vHPV vaccine in men 20 to 45 years of age. The primary hypothesis tested after the primary database lock is that administration of a 3-dose regimen of 9vHPV vaccine will reduce the incidence of human papillomavirus (HPV) 16/18/31/33/45/52/58-related oral persistent infection (6 months or longer) compared with placebo. There will also be an Extension Study to offer an opportunity to complete the 3 dose regimen of 9vHPV vaccine for participants who received placebo in the Base Study, or received less than 3 doses of 9vHPV vaccine in the Base Study.
Conditions Studied
Interventions
- BIOLOGICAL 9vHPV Vaccine
- OTHER Placebo (Saline for Injection)
Study Locations (20)
California
- Valley Clinical Trials Inc. ( Site 0002) - Northridge
- Inland Empire Clinical Trials, LLC ( Site 0025) - Rialto
- Alta California Medical Group ( Site 0031) - Simi Valley
- Encompass Clinical Research ( Site 0028) - Spring Valley
- Diablo Clinical Research, Inc ( Site 0042) - Walnut Creek
New York
- Certified Research Associates ( Site 0041) - Cortland
- Laser Surgery Care ( Site 0018) - New York
- Weill Cornell Medicine ( Site 0046) - New York
- Rochester Clinical Research, Inc. ( Site 0008) - Rochester
Florida
- Clinical Research of South Florida ( Site 0036) - Coral Gables
- Acevedo Clinical Research Associates ( Site 0001) - Miami
- Moffitt Cancer Center ( Site 0017) - Tampa
Kansas
- Cotton-O'Neil Clinical Research Center ( Site 0044) - Topeka
- Heartland Research Associates, LLC ( Site 0034) - Wichita
Georgia
- Augusta University ( Site 0010) - Augusta
Idaho
- Solaris Clinical Research, LLC ( Site 0003) - Meridian
Kentucky
- Kentucky Pediatric/Adult Research Inc ( Site 0011) - Bardstown
Missouri
- Healthcare Research Network LLC ( Site 0035) - Hazelwood
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6,033 participants |
| Start Date | 2020-02-27 |
| Est. Completion | 2028-08-31 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04199689
The ClinicalTrials.gov registry entry for NCT04199689 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 6,033 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 260-participant average among 5 other Papillomavirus Infections trials with a reported enrollment target (2220% higher). The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Papillomavirus Infections appearing as the primary indexed condition, and to 2 interventions - of which 9vHPV Vaccine is the first listed.
NCT04199689 reports 20 study locations spanning 10 distinct geographic areas - top geographies include California, New York, Florida.
Frequently Asked Questions
What is clinical trial NCT04199689 about?
NCT04199689 is a clinical study titled "Efficacy Against Oral Persistent Infection, Immunogenicity and Safety of the 9-valent Human Papillomavirus Vaccine (9vHPV) in Men Aged 20-45 Years (V503-049)". The purpose of this study is to evaluate the efficacy, immunogenicity and safety of the 9vHPV vaccine in men 20 to 45 years of age. The primary hypothesis tested after the primary database lock is that administration of a 3-dose regimen of 9vHPV vaccine will reduce the incidence of human papillomavi...
What is the current status of trial NCT04199689?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 6,033 participants. The study started on 2020-02-27. Estimated completion is 2028-08-31.
What conditions does trial NCT04199689 study?
This clinical trial studies the following conditions: Papillomavirus Infections.
What interventions are being tested in trial NCT04199689?
The interventions under investigation include: 9vHPV Vaccine (BIOLOGICAL), Placebo (Saline for Injection) (OTHER).
Who is sponsoring clinical trial NCT04199689?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04199689 being conducted?
This trial has 20 study locations across California, Florida, Georgia, Idaho, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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