A Phase III Open-label, Safety, Tolerability and Immunogenicity Study of a 9-Valent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine Administered to 9- to 15-Year-Old Japanese Preadolescent and Adolescent Girls
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