Efficacy, Immunogenicity and Safety of V503 in Chinese Women Aged 20-45 Years (V503-023)

Inclusion Criteria

1. Healthy
2. Has not had sex with males or has had sex with males and used effective contraception with no failures since the first day of the participant's last menstrual period through Day 1
3. Agrees to use effective contraception if has sex with a male partner during study
4. Has had sexual intercourse with male partners, and has had 1 to 4 male and/or female sexual partners

Exclusion Criteria

1. History of a positive test for HPV
2. History of an abnormal Pap test result showing ASC-US, atypical squamous cells - cannot exclude HSIL (high grade squamous intraepithelial lesion [(ASC-H)], low-grade squamous intraepithelial lesion (LSIL), HSIL), or atypical glandular cells
3. History of an abnormal cervical biopsy result showing CIN, adenocarcinoma in situ or cervical cancer
4. History of or clinical evidence at the Day 1 gynecologic examination of HPV-related anogenital diseases (e.g., genital warts, VIN, VaIN, AIN, vulvular cancer, vaginal cancer or anal cancer
5. Does not have an intact cervix uteri or has more than one cervix uteri
6. Is pregnant
7. Known allergy to any vaccine component, including aluminum, yeast, or Benzonase™ (nuclease, Nycomed™ [used to remove residual nucleic acids from this and other vaccines])
8. History of severe allergic reaction (e.g., swelling of the mouth and throat, difficulty breathing, hypotension or shock) that required medical intervention
9. Has thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections
10. Currently immunocompromised or has been diagnosed as having a congenital or acquired immunodeficiency, human immunodeficiency virus (HIV) infection, lymphoma, leukemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis (JRA), inflammatory bowel disease, or other autoimmune condition
11. Has had a splenectomy
12. Is expecting to donate eggs during Day 1 through Month 7 of the study
13. Plans to receive during Day 1 through Month 7 of the study, is receiving or has received within 12 months prior to enrollment the following immunosuppressive therapies: radiation therapy, cyclophosphamide, azathioprine, methotrexate, any chemotherapy, cyclosporin, leflunomide (Arava™), tumor necrosis factor (TNF)-α antagonists, monocolonal antibody therapies (including rituximab [Rituxan™]), intravenous gamma globulin (IVIG), antilymphocyte sera, or other therapy known to interfere with the immune response. With regard to systemic corticosteroids, a participant will be excluded if she is currently receiving steroid therapy, has recently (defined as within 2 weeks of enrollment) received such therapy, or has received 2 or more courses of high dose corticosteroids (orally or parenterally) lasting at least 1 week within 12 months prior to enrollment. Participants using inhaled, nasal, or topical corticosteroids are considered eligible for the study.
14. Plans to receive during Day 1 through Month 7 of the study, is receiving or has received within the 6 months prior to the Day 1 vaccination any immune globulin product (including RhoGAM™) or blood derived product other than IVIG
15. Has received a marketed HPV vaccine, or has participated in an HPV vaccine clinical study and has received either active agent or placebo
16. Concurrently enrolled in clinical studies of investigational agents or studies involving collection of cervical specimens
17. User of recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence at the discretion of the investigator. Alcohol abusers are defined as those who drink despite recurrent social, interpersonal, and/or legal problems as a result of alcohol use