Efficacy Against Oral Persistent Infection, Immunogenicity and Safety of the 9-valent Human Papillomavirus Vaccine (9vHPV) in Men Aged 20-45 Years (V503-049)
Public ClinicalTrials.gov record NCT04199689. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3, International, Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Trial to Study the Efficacy, Immunogenicity, and Safety of the 9vHPV Vaccine, a Multivalent L1 Virus-like Particle Vaccine, in the Prevention of Oral Persistent Infection With HPV Types 16, 18, 31, 33, 45, 52, or 58 in Adult Males, 20 to 45 Years of Age
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04199689
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 6,033 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 20 Years to 45 Years
- Sex
- Male
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 27, 2020 (Actual)
- Primary completion
- Jan 15, 2027 (Estimated)
- Completion
- Aug 13, 2027 (Estimated)
- Last update posted
- Oct 20, 2026
2020 – 2027
United States locations
- U.S. sites
- 32
- U.S. states
- 17
- U.S. cities
- 31
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Valley Clinical Trials Inc. ( Site 0002) | Northridge | California | 91325 | — |
| Inland Empire Clinical Trials, LLC ( Site 0025) | Rialto | California | 92377 | — |
| Alta California Medical Group ( Site 0031) | Simi Valley | California | 93065 | — |
| Encompass Clinical Research ( Site 0028) | Spring Valley | California | 91978 | — |
| Diablo Clinical Research, Inc ( Site 0042) | Walnut Creek | California | 94598 | — |
| Clinical Research of South Florida ( Site 0036) | Coral Gables | Florida | 33134 | — |
| Acevedo Clinical Research Associates ( Site 0001) | Miami | Florida | 33142 | — |
| Moffitt Cancer Center ( Site 0017) | Tampa | Florida | 33617 | — |
| Augusta University ( Site 0010) | Augusta | Georgia | 30912 | — |
| Solaris Clinical Research, LLC ( Site 0003) | Meridian | Idaho | 83646 | — |
| Cotton-O'Neil Clinical Research Center ( Site 0044) | Topeka | Kansas | 66606 | — |
| Heartland Research Associates, LLC ( Site 0034) | Wichita | Kansas | 67207 | — |
| Kentucky Pediatric/Adult Research Inc ( Site 0011) | Bardstown | Kentucky | 40004 | — |
| Healthcare Research Network LLC ( Site 0035) | Hazelwood | Missouri | 63042 | — |
| Alliance for Multispecialty Reseach, LLC ( Site 0021) | Las Vegas | Nevada | 89119 | — |
| Certified Research Associates ( Site 0041) | Cortland | New York | 13045 | — |
| Laser Surgery Care ( Site 0018) | New York | New York | 10011 | — |
| Weill Cornell Medicine ( Site 0046) | New York | New York | 10065 | — |
| Rochester Clinical Research, Inc. ( Site 0008) | Rochester | New York | 14609 | — |
| PMG Research of Salisbury ( Site 0009) | Salisbury | North Carolina | 28144 | — |
| Rapid Medical Research, Inc. ( Site 0037) | Cleveland | Ohio | 44122 | — |
| Preferred Primary Care Physicians ( Site 0032) | Pittsburgh | Pennsylvania | 15236 | — |
| Coastal Carolina Research Center ( Site 0043) | North Charleston | South Carolina | 29405 | — |
| Holston Medical Group ( Site 0030) | Kingsport | Tennessee | 37660 | — |
| University of Texas Medical Branch at Galveston ( Site 0038) | Galveston | Texas | 77555-1115 | — |
| Texas Center For Drug Development ( Site 0013) | Houston | Texas | 77081 | — |
| Crossroads Clinical Research LLC ( Site 0027) | Victoria | Texas | 77901 | — |
| J Lewis Research Inc/Foothill Family Clinic South ( Site 0006) | Salt Lake City | Utah | 84121 | — |
| J Lewis Research Inc/Jordan River Family Medicine ( Site 0023) | South Jordan | Utah | 84095 | — |
| Charlottesville Medical Research Center, LLC ( Site 0007) | Charlottesville | Virginia | 22911 | — |
| Health Research of Hampton Roads, Inc. ( Site 0015) | Newport News | Virginia | 23606 | — |
| Clinical Research Partners, LLC. ( Site 0004) | Richmond | Virginia | 23226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 71 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04199689, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 20, 2026 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04199689 live on ClinicalTrials.gov.