Safety and Tolerability Study of V501 in Japanese Boys (V501-200)

A Phase III, Open-Label, Clinical Trial to Study the Safety and Immunogenicity of the Quadrivalent HPV (Types 6, 11, 16, 18) L1 VLP Particle (VLP) Vaccine in 9- to 15-Year-Old Japanese Boys

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.

Inclusion Criteria:

• Healthy Japanese male
• Have a legal representative who provides written informed consent for the trial on the participant's behalf
• Have a legal representative who is able to read, understand, and complete the vaccine report card
• Has not yet had coitarche and does not plan on becoming sexually active from Day 1 through Month 7 of the study
• Other inclusion criteria will be discussed with the investigator during screening

Exclusion Criteria:

• Currently enrolled in clinical studies of investigational agents
• History of known prior vaccination with an HPV vaccine or plans to receive one outside the study
• History of severe allergic reaction that required medical intervention
• Allergic to any vaccine component, including aluminum, yeast, or BENZONASE™
• Received immune globulin or blood-derived products in the past 6 months or plans 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) infection, 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
• Known thrombocytopenia or coagulation disorder that would contraindicate intramuscular injections
• Ongoing alcohol or drug abuse within the past 12 months
• History of genital warts or a positive test for HPV