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, GARDASILâ„¢) in healthy, 16- to 26-year old Japanese males. The hypotheses tested are: 1) V501 reduces the combined incidence of HPV 6-, 11-, 16-, or 18-related persistent infection compared with placebo, and 2) V501 reduces the combined incidence of HPV 6-, 11-, 16-, or 18-related persistent infection, condyloma acuminata, penile/perianal/perineal intraepithelial neoplasia, or penile, perianal, or perineal cancer compared with placebo.
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Combined Incidence of HPV Type 6, 11, 16, or 18-related Persistent Infection
Timeframe: Up to Month 36
Percentage of Participants With Maximum Temperature ≥37.5°C Reported on the Vaccination Report Card
Timeframe: Up to 5 days after any vaccination
Percentage of Participants With an Injection-site Adverse Event Prompted on the Vaccination Report Card
Timeframe: Up to 5 days after any vaccination
Percentage of Participants With a Systemic Adverse Event
Timeframe: Up to 15 days after any vaccination
Percentage of Participants With a Vaccine-related Systemic Adverse Event
Timeframe: Up to 15 days after any vaccination