Status:
COMPLETED
Efficacy and Tolerability Study of V501 in Japanese Males (V501-122)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Anogenital Human Papilloma Virus Infection
Condyloma Acuminata
Eligibility:
MALE
16-26 years
Phase:
PHASE3
Brief Summary
A study to evaluate the efficacy and tolerability of V501 (quadrivalent Human Papilloma Virus \[HPV\] \[Type 6, 11, 16 and 18\] L1 Virus-Like Particle vaccine, GARDASIL™) in healthy, 16- to 26-year ol...
Eligibility Criteria
Inclusion
- Japanese
- No clinical evidence of gross genital lesion suggesting sexually-transmitted disease and no clinically present external genital warts
- Other inclusion criteria will be discussed with the investigator during screening
Exclusion
- History of known prior vaccination with an HPV vaccine or plans to receive one outside the study
- History of external genital warts
- History of severe allergic reaction that required medical intervention
- Received immune globulin or blood-derived products in the past 6 months or plan to receive any before Month 7 of the study
- History of splenectomy, is currently immunocompromised, or has been diagnosed with immunodeficiency, Human Immunodeficiency Virus (HIV), lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other autoimmune condition
- Received immunosuppressive therapy in the past year, excluding inhaled, nasal, or topical corticosteroids and certain regimens of systemic corticosteroids
- Known thrombocytopenia or coagulation disorder that would contraindicate intramuscular injections
- Ongoing alcohol or drug abuse within the past 12 months
Key Trial Info
Start Date :
June 27 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2017
Estimated Enrollment :
1124 Patients enrolled
Trial Details
Trial ID
NCT01862874
Start Date
June 27 2013
End Date
August 30 2017
Last Update
April 2 2019
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