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
Study type: Interventional
Phase: Phase 3

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.
    

Detailed description: 
      The base study V503-002 was a 12-month study that collected immunogenicity data through Month
      7 and safety data through Month 12.

      An optional extension study (V503-002 EXT1) collected safety and immunogenicity information
      through Month 36. Participants enrolled in the 16- to 26-year-old cohort in the base study
      were not included in EXT1. Per protocol, EXT1 included immunogenicity data from a subset of
      9- to 15-year-old females and safety data from all 9- to 15-year-old females regardless of
      lot administered.

      An optional second extension study (V503-002 EXT2) collected long-term safety and
      immunogenicity information through approximately Month 126. No study vaccine was administered
      in the extension studies. Participants enrolled in the 16- to 26-year-old cohort in the base
      study were not included in EXT2. Per protocol, EXT2 included immunogenicity data from a
      subset of 9- to 15-year-old females and effectiveness and safety data from all 9- to
      15-year-old females regardless of lot administered.
    

Intervention name(s): V503
Intervention type(s): Biological
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention