A Study of V503 (A Multivalent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) in Preadolescents and Adolescents (V503-002)
Condition: Cervical Cancers; Vulvar Cancer; Vaginal Cancer; Genital Lesions; PAP Test Abnormalities; HPV Infections
MeSH terms: Papillomavirus Infections; Vulvar Neoplasms; Vaginal Neoplasms
Intervention: V503
Intervention description: Multivalent HPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lots 1, 2, or 3.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 3074.0
Sex: All
Minimum age: 9 Years
Maximum age: 26 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will evaluate the immunogenicity and tolerability of V503 (a multivalent human
      papillomavirus [HPV] L1 virus-like particle [VLP] vaccine) in preadolescent and adolescent
      participants between 9 and 15 years old and demonstrate the consistency of the manufactured
      vaccine through assessment of 3 different final manufacturing process lots of V503.

      The primary hypotheses are as follows:

        1. The 9-valent HPV L1 VLP vaccine when administered to preadolescent and adolescent boys
           and girls 9 to 15 years of age and young women 16 to 26 years of age is generally
           well-tolerated.

        2. 9-valent HPV L1 VLP vaccine induces non-inferior immune responses in preadolescent and
           adolescent girls 9 to 15 years of age who are seronegative at Day 1 to the relevant HPV
           type compared to young women 16 to 26 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,
           as measured by anti-HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58 geometric mean titers
           (GMTs) at 4 weeks post-dose 3.

        3. The 9-valent HPV L1 VLP vaccine induces non-inferior immune responses in preadolescent
           and adolescent boys 9 to 15 years of age who are seronegative at Day 1 to the relevant
           HPV type compared to young women 16 to 26 years of age who are seronegative at Day 1 and
           PCR-negative Day 1 through Month 7 to the relevant HPV type, as measured by anti-HPV 6,
           11, 16, 18, 31, 33, 45, 52, and 58 GMTs at 4 weeks post-dose 3.

        4. Three separate final manufacturing process (FMP) lots of the 9-valent HPV L1 VLP vaccine
           induce similar immune responses, as measured by anti-HPV types 6, 11, 16, 18, 31, 33,
           45, 52, and 58 GMTs at 4 weeks post-dose 3.
    

Eligibility criteria:

        Inclusion Criteria:

        Boys and Girls Age 9 to 15:

          -  Participant has not had sexual intercourse prior to the study and does not plan to
             become sexually active during the study period Day 1 to Month 7

        Women Age 16 to 26:

          -  Participant has never had Pap testing or has had only normal results

          -  Participant has had 0 to 4 sexual partners at the time of enrollment

        Exclusion Criteria:

        Boys and Girls Age 9 to 15:

          -  History of allergic reaction that required medical intervention

          -  Currently enrolled in any other clinical study

          -  Participant is pregnant

          -  Participant is immunocompromised or has taken immunosuppressants in the last year

          -  Participant has received a marketed HPV vaccine or participated in an HPV vaccine
             clinical trial

          -  Participant has a history of positive test for HPV

        Women Age 16 to 26:

          -  History of allergic reaction that required medical intervention

          -  Currently enrolled in any other clinical study

          -  Participant is pregnant

          -  Participant is immunocompromised or has taken immunosuppressants in the last year

          -  Participant has received a marketed HPV vaccine or participated in an HPV vaccine
             clinical trial

          -  Participant has a history of positive test for HPV

          -  Participant has a history of abnormal cervical biopsy result

          -  Participant has a history of external genital lesions