Overview

This trial is active, not recruiting.

Condition condylomata acuminata
Treatments (gardasil™) human papillomavirus (types 6, 11, 16, 18) recombinant vaccine, comparator: placebo (unspecified)
Phase phase 3
Sponsor Merck Sharp & Dohme Corp.
Start date September 2004
End date July 2009
Trial size 4065 participants
Trial identifier NCT00090285, 2004_103, Formerly-0904HPVHMES, V501-020

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose prevention
Arm
(Experimental)
(gardasil™) human papillomavirus (types 6, 11, 16, 18) recombinant vaccine qHPV
Duration of Treatment: 6 months
(Placebo Comparator)
comparator: placebo (unspecified)
Duration of Treatment: 6 months

Primary Outcomes

Measure
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
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

Secondary Outcomes

Measure
Incidence of HPV 6/11/16/18-related Persistent Infection
time frame: Base study: through Month 36
Incidence of HPV 6/11/16/18-related Deoxyribonucleic Acid (DNA) Detection
time frame: Base study: through Month 36

Eligibility Criteria

Male participants from 16 years up to 26 years old.

Inclusion Criteria: - Healthy male between the ages of 16 years and 23 years and 364 days. For the MSM substudy, between the ages of 16 years and 26 years and 364 days. - No clinical evidence of genital lesions suggesting sexually-transmitted disease, and no history of anogenital warts - Additional criteria will be discussed with you by the physician Exclusion Criteria: - Concurrently enrolled in a clinical study involving collection of genital specimens - History of known prior vaccination with an HPV vaccine - Received an inactivated vaccine within 14 days or a live virus vaccine within 21 days prior to enrollment - History of a severe allergic reaction that required medical intervention - Received any immune globulin or blood-derived products within 6 months prior to the first study injection - History of splenectomy, immune disorders, or receiving immunosuppressives - Immunocompromised or diagnosed with HIV infection - Known thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections - History of recent or ongoing alcohol or drug abuse

Additional Information

Official title An Investigational Vaccine in Reducing the Incidence of Anogenital Warts in Young Men
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Merck Sharp & Dohme Corp..