Efficacy, Immunogenicity and Safety of V503 in Chinese Women Aged 20-45 Years (V503-023)
Efficacy, Immunogenicity and Safety of V503 in Chinese Women Aged 20-45 Years (V503-023)
This study will evaluate the efficacy, immunogenicity and safety of 9-valent human
 papillomavirus (9vHPV; V503) vaccine in Chinese women 20 to 45 years of age. The primary
 hypotheses are: 9vHPV vaccine reduces the incidence of HPV 31-, 33-, 45-, 52-, and 58-related
 12-month persistent infection at least 1 month post Dose 3, compared with quadrivalent HPV
 (qHPV) vaccine in women 20 to 45 years of age who are seronegative at Day 1 and polymerase
 chain reaction (PCR) negative Day 1 through Month 7 to the relevant HPV type; and 9vHPV
 vaccine induces non-inferior competitive luminex immunoassay (cLIA) geometric mean titers
 (GMTs) for each of HPV 6, 11, 16, and 18 one month post Dose 3, compared with qHPV vaccine in
 women 20 to 45 years of age who are seronegative at Day 1 and PCR negative Day 1 through
 Month 7 to the relevant HPV type.
This study has two stages with the Stage I expected from Day 1 through Month 30, and the
 Stage II expected post-Month 30 to Month 90. The Stage I study is a case-driven study which
 aims to accrue at least 20 cases of HPV 31/33/45/52/58-related 12-month persistent infection
 and at least 39 cases of HPV 31/33/45/52/58-related 6-month persistent infection by
 completion of Month 30 visit. The Stage II study is a case-driven study which aims to accrue
 at least 12 cases of HPV 31/33/45/52/58-related cervical intraepithelial neoplasia grade 2 or
 3 (CIN 2/3), cervical adenocarcinoma in situ (AIS), and cervical cancer observed in both
 Stage I and Stage II, by completion of Month 90 visit.
Inclusion Criteria

 -  Healthy

 -  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

 -  Agrees to use effective contraception if has sex with a male partner during study

 -  Has had sexual intercourse with male partners, and has had 1 to 4 male and/or female
 sexual partners

 Exclusion Criteria

 -  History of a positive test for HPV

 -  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

 -  History of an abnormal cervical biopsy result showing CIN, adenocarcinoma in situ or
 cervical cancer

 -  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

 -  Does not have an intact cervix uteri or has more than one cervix uteri

 -  Is pregnant

 -  Known allergy to any vaccine component, including aluminum, yeast, or Benzonase™
 (nuclease, Nycomed™ [used to remove residual nucleic acids from this and other
 vaccines])

 -  History of severe allergic reaction (e.g., swelling of the mouth and throat,
 difficulty breathing, hypotension or shock) that required medical intervention

 -  Has thrombocytopenia or any coagulation disorder that would contraindicate
 intramuscular injections

 -  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

 -  Has had a splenectomy

 -  Is expecting to donate eggs during Day 1 through Month 7 of the study

 -  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.

 -  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

 -  Has received a marketed HPV vaccine, or has participated in an HPV vaccine clinical
 study and has received either active agent or placebo

 -  Concurrently enrolled in clinical studies of investigational agents or studies
 involving collection of cervical specimens

 -  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