Safety and Immunogenicity Study of V503 (GARDASIL™9, 9vHPV Vaccine) Administered to 9- to 26-Year-Old Females and Males in Vietnam (V503-017)
Safety and Immunogenicity Study of V503 (GARDASIL™9, 9vHPV Vaccine) Administered to 9- to 26-Year-Old Females and Males in Vietnam (V503-017)
This study will evaluate the safety and immunogenicity of V503 (GARDASIL™9, 9vHPV vaccine)
 administered to 9- to 26-year-old females and males in Vietnam. The study hypothesis states
 that V503 induces acceptable anti-human papillomavirus (HPV) 6, 11, 16, 18, 31, 33, 45, 52,
 and 58 seroconversion at 4 weeks postdose 3.
Inclusion Criteria:

 -  In good physical health

 -  Participants 9 to 15 years of age: has not had coitarche and do not plan on becoming
 sexually active during the study

 -  Participants 16 to 26 year of age: has never had Papanicolaou (Pap) testing or has had
 only normal Pap test results. Has a lifetime history of ≤4 male and/or female sexual
 partners.

 -  Female participants 16 to 26 years of age: has not had sex with males or has had sex
 with males and used effective contraception, and understands and agrees that during
 the study she should not have sexual intercourse with males without effective
 contraception (rhythm method, withdrawal, and emergency contraception are not
 acceptable methods of contraception per-protocol).

 Exclusion Criteria:

 -  Known allergy to any vaccine component, including aluminum, yeast, or BENZONASE™

 -  History of severe allergic reaction that required medical intervention

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

 -  Concurrently enrolled in clinical studies of investigational agents

 -  Immunocompromised or has been diagnosed with 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

 -  Had a splenectomy

 -  User of recreational or illicit drugs or has had a recent history (within the last
 year) of drug abuse or dependence. Alcohol abusers are defined as those who drink
 despite recurrent social, interpersonal, and/or legal problems as a result of alcohol
 use.

 -  History of a positive test for HPV

 -  Male participants 16 to 26 years of age: history of HPV-related external genital
 lesions (e.g., condyloma acuminata) or HPV-related anal lesions (e.g., condyloma
 acuminata, or anal intraepithelial neoplasia) or anal cancer.

 -  Female participants 16 to 26 years of age: history of an abnormal cervical biopsy
 result (showing cervical intraepithelial neoplasia or worse).

 -  Female participants 16 to 26 years of age: history of HPV-related external genital
 lesions (e.g., condyloma acuminata, or vulvar intraepithelial neoplasia) or external
 genital cancer, HPV-related vaginal lesions (e.g., condyloma acuminata, or vaginal
 intraepithelial neoplasia) or vaginal cancer, or HPV-related anal lesions (e.g.,
 condyloma acuminata, or anal intraepithelial neoplasia) or anal cancer.

 -  Female participants: pregnant as determined by a serum pregnancy test or urine
 pregnancy test that is sensitive to 25 mIU/mL beta human chorionic gonadotropin
 (β-hCG).

 -  Female participants: expecting to donate eggs during the study.

 -  Receiving or has received a prohibited immunosuppressive therapy in the year prior to
 the study

 -  Received any immune globulin product or blood-derived product within the 3 months
 prior to the Day 1 vaccination, or plans to receive any such product during the study

 -  Received inactivated or recombinant vaccines within 14 days prior to the Day 1
 vaccination or has received live vaccines within 21 days prior to the Day 1
 vaccination

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

 -  Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling or
 child) who is investigational site or sponsor staff directly involved with this study.