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 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.
Age range
16 Years – 26 Years
Sex
MALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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