A Study of the Safety, Tolerability, and Immunogenicity of a 9-valent Human Papillomavirus Vaccine ([9vHPV]; V503) Administered to 9- to 15-Year-Old Japanese Girls (V503-008).
Condition: Papillomavirus Infections
MeSH terms: Papillomavirus Infections
Intervention: V503
Intervention description: V503 0.5 mL intramuscular injection at 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: 100.0
Sex: Female
Minimum age: 9 Years
Maximum age: 15 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Papillomavirus vaccines; Uterine cervical cancer; Human Papilloma Virus infections

Summary:

      This study will evaluate the safety, tolerability, and immunogenicity of V503 in Japanese
      girls between the ages of 9 and 15 and will determine whether V503 induces an acceptable
      immune response to all human papillomavirus (HPV) strains contained in the vaccine. The
      success criterion for the primary analysis requires that point estimates for seroconversion
      rate be greater than 90% for all 9 HPV types.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant is in good physical health-

          -  Participant's parent/legal guardian is able to read, understand, and complete the
             vaccine report card

          -  Participant's parent/legal guardian agrees to provide a phone number for follow-up
             purposes

          -  Participant is not sexually active and does not plan to become sexually active during
             the time from Day 1 to Month 7 of the study

        Exclusion Criteria:

          -  Participant has a history of severe allergic reaction that required medical
             intervention

          -  Participant has thrombocytopenia or any coagulation disorder that would contraindicate
             intramuscular injection

          -  Participant is pregnant

          -  Participant intends to donate blood during the time from Day 1 to Month 7 of the study

          -  Participant is immunocompromised or has been diagnosed as having a congenital or
             acquired immunodeficiency, human immunodeficiency virus (HIV) infection, lymphoma,
             leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid
             arthritis, inflammatory bowel disease, or other autoimmune condition.

          -  Participant has had a splenectomy

          -  Participant has received any of the following immunosuppressive therapies in the year
             prior to enrollment: radiation therapy, cyclophosphamide, azathioprine, methotrexate,
             any chemotherapy, cyclosporin, leflunomide (Arava), tumor necrosis factor alpha
             (TNF-α) antagonists, monoclonal antibody therapies, antilymphocyte sera, or other
             therapy known to interfere with the immune response.

          -  Participant has received any immune globulin product or blood-derived product in the
             three months prior to the Day 1 vaccination, or plans to receive any such product
             through Month 7 of the study

          -  Participant has received any inactivated vaccines within 14 days of the Day 1
             vaccination or any live vaccines within 28 days of the Day 1 vaccination

          -  Participant has received a marketed HPV vaccine or has participated in an HPV vaccine
             clinical trial

          -  Participant has had a fever (oral temperature ≥37.8°C) within 24 hours of the Day 1
             vaccination

          -  Participant has a history of a positive test for HPV or history of genital warts