Status:
COMPLETED
An Investigational Study of Gardasil™ (qHPV Vaccine) in Reducing the Incidence of Anogenital Warts in Young Men (V501-020)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Condylomata Acuminata
Eligibility:
MALE
16-26 years
Phase:
PHASE3
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 3 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 3 2017
Estimated Enrollment :
4065 Patients enrolled
Trial Details
Trial ID
NCT00090285
Start Date
September 3 2004
End Date
April 3 2017
Last Update
August 23 2018
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