• To demonstrate that administration of V503 induces non-inferior Geometric Mean Titers (GMTs) (for serum anti-HPV16 and anti-HPV18) compared to GARDASIL.
- To evaluate the tolerability of V503 in 9-15 year-old girls.
- To summarize humoral immune response (anti-HPV 6, 11, 16, 18) induced by V503 or GARDASIL.
|Human Papillomavirus||Biological: 1 dose at Day 1, 1 dose at Month 2 and 1 dose at Month 6||Phase III|
|Study Design:||Allocation: Randomized
Control: Active Control
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||A Randomized, Double-Blinded, Controlled With GARDASIL (Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, Adsorbed)), Phase III Clinical Trial to Study the Immunogenicity and Tolerability of V503 (9-Valent Human Papillomavirus (HPV) Vaccine) in Preadolescent and Adolescent Girls (9- to 15-year-old)|