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

Phase 3
16 Years
26 Years
Open (Enrolling)
Condylomata Acuminata

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Trial Information

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

The base study (V501-020) encompassed Day 1 through Month 7, during which time participants
received randomly assigned Gardasilâ„¢ (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.

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Outcome Measure:

Incidence of Human Papillomavirus (HPV) Related External Genital Warts, Perineal Intraepithelial Neoplasia (PIN), Penile, Perianal or Perineal Cancer

Outcome Description:

Subjects with HPV 6/11/16/18-related external genital warts, PIN, penile, perianal or perineal cancer per 100 person-years of follow-up.

Outcome Time Frame:

Base study: through Month 36

Safety Issue:


Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

September 2004

Completion Date:

December 2017

Related Keywords:

  • Condylomata Acuminata
  • anogenital warts
  • Condylomata Acuminata