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Efficacy Against Oral Persistent Infection, Immunogenicity and Safety of the 9-valent Human Papillomavirus Vaccine (9vHPV) in Men Aged 20-45 Years (V503-049)
NCT04199689 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 6,033 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 741 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04199689 reports 20 study locations spanning 10 distinct geographic areas — top geographies include California, New York, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04199689?
The interventions under investigation include: 9vHPV Vaccine (BIOLOGICAL), Placebo (Saline for Injection) (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04199689?
This trial is sponsored by Merck Sharp & Dohme, which has 741 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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