Safety and Immunogenicity Study of V503 (GARDASIL™9, 9vHPV Vaccine) Administered to 9- to 26-Year-Old Females and Males in Vietnam (V503-017)
Condition: Papillomavirus Infections; Uterine Cervical Neoplasms; Vulvar Neoplasms; Vaginal Neoplasms; Adenocarcinoma in Situ; Condylomata Acuminata
MeSH terms: Papillomavirus Infections; Neoplasms; Uterine Cervical Neoplasms; Vulvar Neoplasms; Adenocarcinoma in Situ; Vaginal Neoplasms
Intervention: 9vHPV vaccine
Intervention description: 9-valent HPV [Types 6, 11, 16, 18, 31, 33, 45, 52, and 58] L1 virus-like particle vaccine in a 0.5-mL intramuscular injection
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 201.0
Sex: All
Minimum age: 9 Years
Maximum age: 26 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      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.
    

Eligibility criteria:

        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.