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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

4065 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-03

Study Completion Date

2017-04-03

Brief Summary

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This study was conducted to demonstrate that Gardasil™ (quadrivalent human papillomavirus \[qHPV\] vaccine) 1) is well tolerated in young men, 2) reduces incidence of external genital lesions in young men, 3) reduces the incidence of anal intraepithelial neoplasia (AIN) or anal cancer in men having sex with men (MSM), and 4) reduces incidence of Human Papillomavirus (HPV) infection in young men. In the 7-month Base Study participants received randomly assigned qHPV vaccine or placebo at Day 1, Month 2, and Month 6. Base Study follow-up continued through Month 36. In Extension 1 (EXT1), participants who received placebo or an incomplete qHPV vaccine regimen in the Base Study were offered qHPV vaccine. Participants were followed in EXT1 for 7 months. In Extension 2 \[LTFU (EXT2)\], long-term effectiveness, immunogenicity, and safety of qHPV vaccine were followed up to 10 years following study enrollment. Participants who received ≥1 dose of qHPV vaccine in the Base Study or EXT1 were eligible to enroll in LTFU (EXT2).

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Detailed Description

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Conditions

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Condylomata Acuminata

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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qHPV Vaccine

The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6. Follow-up for the Base Study encompassed Month 7 through Month 36.

Group Type EXPERIMENTAL

(Gardasil™) human papillomavirus (types 6, 11, 16, 18) recombinant vaccine

Intervention Type BIOLOGICAL

0.5 mL intramuscular injection in the deltoid muscle at Day 1, Month 2, and Month 6 in the Base Study

Placebo

The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time participants received placebo at Day 1, Month 2 and Month 6. Follow-up for the Base Study encompassed Month 7 through Month 36.

Group Type PLACEBO_COMPARATOR

Comparator: placebo (unspecified)

Intervention Type BIOLOGICAL

0.5 mL intramuscular injection in the deltoid muscle at Day 1, Month 2, and Month 6 in the Base Study

Interventions

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(Gardasil™) human papillomavirus (types 6, 11, 16, 18) recombinant vaccine

0.5 mL intramuscular injection in the deltoid muscle at Day 1, Month 2, and Month 6 in the Base Study

Intervention Type BIOLOGICAL

Comparator: placebo (unspecified)

0.5 mL intramuscular injection in the deltoid muscle at Day 1, Month 2, and Month 6 in the Base Study

Intervention Type BIOLOGICAL

Other Intervention Names

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qHPV V501

Eligibility Criteria

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Inclusion Criteria

* Healthy heterosexual males between the ages of 16 years and 23 years and 364 days. Healthy men having sex with men (MSM) 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

Minimum Eligible Age

16 Years

Maximum Eligible Age

26 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes