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A Phase III Placebo-controlled Clinical Trial to Study the Tolerability, Immunogenicity and Efficacy of V501 in 16- to 26-year-old Japanese Men

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Trial Profile

A Phase III Placebo-controlled Clinical Trial to Study the Tolerability, Immunogenicity and Efficacy of V501 in 16- to 26-year-old Japanese Men

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 13 May 2022

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At a glance

  • Drugs Human papillomavirus vaccine recombinant quadrivalent Merck (Primary)
  • Indications Anal cancer; Anal intraepithelial neoplasia; Condylomata acuminata; Human papillomavirus infections; Penile cancer
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Sponsors Merck Sharp & Dohme Corp.

    • Most Recent Events

    • 20 Feb 2019 Primary endpoint (Combined Incidence of HPV Type 6, 11, 16, or 18-related Persistent Infection) has been met, according to the results published in the Vaccine
    • 20 Feb 2019 Results of the interim (database lock: April 24, 2017) and final analysis (database lock: February 5, 2018), published in the Vaccine
    • 05 Oct 2017 Status changed from active, no longer recruiting to completed.

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