This is a study of V501 \[quadrivalent Human Papillomavirus (HPV) (Type 6, 11, 16 and 18) L1 virus-like particle (VLP) vaccine\] in healthy Japanese boys. This study will consist of two periods. Period I of the study is to evaluate the immunogenicity and tolerability of V501 up to Month 7. Period II of the study is to evaluate the long-term immunogenicity and safety from Month 7 to Month 30. Two analyses are planned. The first analysis will be conducted when all subjects have completed their Month 7 visit or have been discontinued before that time. The second analysis will be conducted at the end of study. The primary hypothesis tested in this study is that seroconversion rates for the vaccine HPV types will be \>90% at 4 weeks postdose 3.
Age range
9 Years – 15 Years
Sex
MALE
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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.
Percentage of Participants With Seroconversion for HPV Types 6, 11, 16, and 18
Timeframe: Four weeks postdose 3 (Month 7)
Percentage of Participants With Elevated Oral Temperature (>=37.5° C)
Timeframe: Up to Day 5 after any vaccination
Percentage of Participants With an Injection-site Adverse Event
Timeframe: Up to Day 5 after any vaccination
Percentage of Participants With a Systemic Adverse Event
Timeframe: Up to Day 15 after any vaccination
Percentage of Participants With a Serious Adverse Event
Timeframe: Up to Day 15 after any vaccination
Percentage of Participants With a Vaccine-related Serious Adverse Event
Timeframe: Up to 30 months