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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00090285
First received: August 25, 2004
Last updated: April 11, 2017
Last verified: April 2017
History of Changes
August 25, 2004
April 11, 2017
September 24, 2004
July 31, 2009   (Final data collection date for primary outcome 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 ]
    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 ]
Not Provided
Complete list of historical versions of study NCT00090285 on ClinicalTrials.gov Archive Site
  • 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.
Not Provided
Substudy to Evaluate the Incidence of HPV 6/11/16/18-related Anal Intraepithelial Neoplasia (AIN) and Anal Cancer in Men Having Sex With Men (MSM) [ Time Frame: Base study: through Month 36 ]
Participants with HPV 6/11/16/18-related AIN or anal cancer per 100 person-years of follow-up
Not Provided
 
An Investigational Study of Gardasil™ (qHPV, V501) Vaccine in Reducing the Incidence of Anogenital Warts in Young Men (V501-020)
An Investigational Vaccine in Reducing the Incidence of Anogenital Warts in Young Men
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.

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.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condylomata Acuminata
  • Biological: (Gardasil™) human papillomavirus (types 6, 11, 16, 18) recombinant vaccine
    Duration of Treatment: 6 months
    Other Names:
    • qHPV
    • V501
  • Biological: Comparator: placebo (unspecified)
    Duration of Treatment: 6 months
  • Experimental: qHPV Vaccine
    Intervention: Biological: (Gardasil™) human papillomavirus (types 6, 11, 16, 18) recombinant vaccine
  • Placebo Comparator: Placebo
    Intervention: Biological: Comparator: placebo (unspecified)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4065
April 3, 2017
July 31, 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
16 Years to 26 Years   (Child, Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
Australia,   Brazil,   Canada,   Costa Rica,   Croatia,   Finland,   Germany,   Mexico,   Netherlands,   Norway,   Peru,   Philippines,   Portugal,   South Africa,   Spain,   Sweden,   Taiwan,   United States
 
NCT00090285
V501-020
Formerly-0904HPVHMES
2004_103
Not Provided
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP