Clinical Trial: Efficacy and Tolerability Study of V501 in Japanese Males (V501-122)
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: A Phase III Placebo-controlled Clinical Trial to Study the Tolerability, Immunogenicity and Efficacy of V501 in 16- to 26-year-old Japanese Men
Brief Summary: A study to evaluate the efficacy, immunogenicity, and tolerability of V501 (quadrivalent Human Papilloma Virus [HPV] [Type 6, 11, 16 and 18] L1 Virus-Like Particle vaccine, GARDASIL™) in healthy, 16- to 26-year old Japanese males. The hypotheses tested are: 1) V501 reduces the combined incidence of HPV 6-, 11-, 16-, or 18-related persistent infection compared with placebo, and 2) V501 reduces the combined incidence of HPV 6-, 11-, 16-, or 18-related persistent infection, condyloma acuminata, penile/perianal/perineal intraepithelial neoplasia, or penile, perianal, or perineal cancer compared with placebo.
Detailed Summary:
Sponsor: Merck Sharp & Dohme Corp.
Current Primary Outcome:
- Combined Incidence of HPV 6-, 11-, 16-, or 18-Related Persistent Infection [ Time Frame: Up to 36 months ]
- Percentage of Participants with an Adverse Event (AE) [ Time Frame: Up to 14 days after any vaccination ]
- Percentage of Participants with Vaccine-Related Serious Adverse Events (SAEs) [ Time Frame: Up to 36 Months ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Combined Incidence of HPV 6-, 11-, 16-, or 18-Related Persistent Infection, Condyloma Acuminata, Penile/Perianal/Perineal Intraepithelial Neoplasia, or Penile, Perianal, or Perineal Cancer [ Time Frame: Up to 36 months ]
Original Secondary Outcome: Same as current
Information By: Merck Sharp & Dohme Corp.
Dates:
Date Received: May 22, 2013
Date Started: June 27, 2013
Date Completion: September 26, 2017
Last Updated: May 12, 2017
Last Verified: May 2017
