🏛️ Verified NIH Record • Updated 2025-03-21

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)

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

🔵 Active, Not Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: Merck Sharp & Dohme LLC

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: Valley Clinical Trials Inc. ( Site 0002) — Northridge, California

Age range: 20 Years to 45 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (103 Sites)

Showing the first 25 of 103 sites.

  • Valley Clinical Trials Inc. ( Site 0002) — Northridge, California
  • Inland Empire Clinical Trials, LLC ( Site 0025) — Rialto, California
  • Alta California Medical Group ( Site 0031) — Simi Valley, California
  • Encompass Clinical Research ( Site 0028) — Spring Valley, California
  • Diablo Clinical Research, Inc ( Site 0042) — Walnut Creek, California
  • Clinical Research of South Florida ( Site 0036) — Coral Gables, Florida
  • Acevedo Clinical Research Associates ( Site 0001) — Miami, Florida
  • Moffitt Cancer Center ( Site 0017) — Tampa, Florida
  • Augusta University ( Site 0010) — Augusta, Georgia
  • Solaris Clinical Research, LLC ( Site 0003) — Meridian, Idaho
  • Cotton-O'Neil Clinical Research Center ( Site 0044) — Topeka, Kansas
  • Heartland Research Associates, LLC ( Site 0034) — Wichita, Kansas
  • Kentucky Pediatric/Adult Research Inc ( Site 0011) — Bardstown, Kentucky
  • Healthcare Research Network LLC ( Site 0035) — Hazelwood, Missouri
  • Alliance for Multispecialty Reseach, LLC ( Site 0021) — Las Vegas, Nevada
  • Certified Research Associates ( Site 0041) — Cortland, New York
  • Laser Surgery Care ( Site 0018) — New York, New York
  • Weill Cornell Medicine ( Site 0046) — New York, New York
  • Rochester Clinical Research, Inc. ( Site 0008) — Rochester, New York
  • PMG Research of Salisbury ( Site 0009) — Salisbury, North Carolina
  • Rapid Medical Research, Inc. ( Site 0037) — Cleveland, Ohio
  • Preferred Primary Care Physicians ( Site 0032) — Pittsburgh, Pennsylvania
  • Coastal Carolina Research Center ( Site 0043) — North Charleston, South Carolina
  • Holston Medical Group ( Site 0030) — Kingsport, Tennessee
  • University of Texas Medical Branch at Galveston ( Site 0038) — Galveston, Texas

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗