Clinical Trial: An Investigational Study of Gardasil™ (qHPV, V501) Vaccine in Reducing the Incidence of Anogenital Warts in Young Men (V501-020)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: An Investigational Vaccine in Reducing the Incidence of Anogenital Warts in Young Men

Brief Summary: This study is to evaluate an investigational vaccine with the following objectives: to demonstrate that the vaccine is well tolerated in young men; to demonstrate that the vaccine reduces incidence of external genital lesions (Condylomata acuminata [anogenital warts], penile/perianal/perineal intraepithelial neoplasia [PIN], penile, perianal, perineal cancer) in young men; to demonstrate that the vaccine reduces the incidence of anal intraepithelial neoplasia (AIN) or anal cancer in men having sex with men (MSM); and to demonstrate that the vaccine reduces incidence of Human Papilloma Virus (HPV) infection in young men.

Detailed Summary:

The base study (V501-020) encompassed Day 1 through Month 7, during which time participants received randomly assigned Gardasil™ (qHPV vaccine) or placebo at Day 1, Month 2, and Month 6. Base study follow-up continued through Month 36.

The base study was extended in protocol V501-020-10 Extension 1 (EXT1). Participants who received placebo and participants who received only 1 dose of qHPV vaccine in the base study were offered a complete 3-dose qHPV vaccine regimen (administered at EXT1 Day 1, Month 2 and Month 6). Participants who received only 2 doses of qHPV vaccine in the base study were offered a single additional dose of qHPV vaccine (administered at EXT1 Day 1). Participants were followed to EXT1 Month 7.

A second extension study, V501-020-21 (EXT2), will estimate the long-term safety and effectiveness of qHPV vaccine during a period of 10 years following initial enrollment in the base study. Subjects who received at least one dose of qHPV vaccine in either the base study or EXT1 are eligible to enroll in EXT2.


Sponsor: Merck Sharp & Dohme Corp.

Current Primary Outcome:

  • Incidence of Human Papillomavirus (HPV) Related External Genital Warts, Perineal Intraepithelial Neoplasia (PIN), Penile, Perianal or Perineal Cancer [ Time Frame: Base study: through Month 36 ]
    Subjects with HPV 6/11/16/18-related external genital warts, PIN, penile, perianal or perineal cancer per 100 person-years of follow-up.
  • Number of Participants With Severe Injection Site Adverse Experiences (AEs) [ Time Frame: Base study: through Day 5 after any vaccination ]
  • Number of Participants With Vaccine-Related Serious Adverse Events (SAEs) [ Time Frame: Base study: through Month 36 ]


Original Primary Outcome:

Current Secondary Outcome:

  • Incidence of HPV 6/11/16/18-related Persistent Infection [ Time Frame: Base study: through Month 36 ]
    Subjects with HPV 6/11/16/18-related persistent infection per 100 person-years of follow-up.
  • Incidence of HPV 6/11/16/18-related Deoxyribonucleic Acid (DNA) Detection [ Time Frame: Base study: through Month 36 ]
    Subjects with HPV 6/11/16/18-related DNA detection per 100 person-years of follow-up.


Original Secondary Outcome:

Information By: Merck Sharp & Dohme Corp.

Dates:
Date Received: August 25, 2004
Date Started: September 24, 2004
Date Completion:
Last Updated: April 11, 2017
Last Verified: April 2017