The purposes of this phase 3, double-blind, placebo-controlled clinical study are to evaluate the efficacy of V503 (9-valent human papillomavirus \[9vHPV\] vaccine) in preventing human papillomavirus (HPV)-related anogenital persistent infection, and to evaluate the safety/tolerability of V503, in Japanese males who are 16 to 26 years of age. It is hypothesized that administration of a 3-dose regimen of V503 reduces the combined incidence of HPV 6/11/16/18-related anogenital persistent infection, as well as the combined incidence of HPV 31/33/45/52/58-related anogenital persistent infection, compared with placebo. The study includes a Base Study to assess efficacy and safety of V503, and an Extension Study. Participants who received placebo in the Base Study will be eligible to receive V503 vaccine on Day 1, Month 2, and Month 6 of the Extension Study. Participants who received less than 3 doses of V503 in the Base Study will be offered the opportunity to complete the 3-dose regimen in the Extension Study.
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Combined Incidence of Human Papillomavirus (HPV) 6/11/16/18-related Anogenital Persistent Infection
Timeframe: Up to approximately 36 Months
Percentage of Participants With Solicited Injection-site Adverse Events (AEs)
Timeframe: Up to 5 days after any vaccination
Percentage of Participants With ≥1 Systemic AE
Timeframe: Up to 15 days after any vaccination
Percentage of Participants With ≥1 Serious Adverse Events (SAEs)
Timeframe: Up to approximately 37 months
Number of Participants With Elevated Oral Body Temperature
Timeframe: Up to 5 days after any vaccination