Safety and Tolerability Study of V501 in Japanese Boys (V501-200)
Condition: Anogenital Human Papilloma Virus Infection; Condyloma Acuminata
MeSH terms: Papillomavirus Infections; Papilloma
Intervention: V501
Intervention description: Quadrivalent HPV [Type 6, 11, 16 and 18] L1 VLP vaccine), 0.5 mL intramuscular injection on Day 1, Month 2, and Month 6
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 101.0
Sex: Male
Minimum age: 9 Years
Maximum age: 15 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      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.
    

Eligibility criteria:

        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