A Phase III Placebo-controlled Clinical Trial to Study the Tolerability, Immunogenicity and Efficacy of V501 in 16- to 26-year-old Japanese Men
Inclusion Criteria:
- 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 Criteria:
- 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