A Phase III Clinical Trial to Study the Tolerability and Immunogenicity of 9vHPV (V503), a Multivalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine, in 16- to 26-Year-Old Men and 16- to 26-Year-Old Women

Trial Profile

A Phase III Clinical Trial to Study the Tolerability and Immunogenicity of 9vHPV (V503), a Multivalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine, in 16- to 26-Year-Old Men and 16- to 26-Year-Old Women

Completed
Phase of Trial: Phase III

Latest Information Update: 26 Apr 2017

At a glance

  • Drugs Human papillomavirus vaccine recombinant nonavalent Merck (Primary)
  • Indications Anal cancer; Human papillomavirus infections
  • Focus Adverse reactions; Pharmacodynamics; Registrational
  • Sponsors Merck Sharp & Dohme
  • Most Recent Events

    • 15 Dec 2015 According to a Merck & Co. media release, the US FDA has approved an expanded age indication for human papillomavirus 9-valent vaccine, recombinant (GARDASIL 9), the company's 9-valent HPV vaccine, to now include use in males 16 through 26 years of age, for the prevention of anal cancer caused by HPV types 16, 18, 31, 33, 45, 52 and 58, precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58, and genital warts caused by HPV types 6 and 1.
    • 15 Aug 2014 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov record.
    • 30 Jul 2013 Status changed from recruiting to active, no longer recruiting as reported by ClinicalTrials.gov.
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