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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

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Trial Profile

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

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 31 Mar 2025

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At a glance

  • Drugs V 503 (Primary)
  • Indications Human papillomavirus infections
  • Focus Adverse reactions; Registrational
  • Acronyms V503-049
  • Sponsors Merck Sharp & Dohme; Merck Sharp & Dohme Corp.

Most Recent Events

  • 25 Mar 2025 Planned End Date changed from 21 Sep 2026 to 31 Aug 2028.
  • 25 Mar 2025 Planned primary completion date changed from 21 Sep 2026 to 27 Aug 2027.
  • 06 Feb 2024 Planned End Date changed from 12 Aug 2026 to 21 Sep 2026.

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