A Phase III Clinical Trial to Study the Immunogenicity, Tolerability, and Manufacturing Consistency of V503 (A Multivalent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) in Preadolescents and Adolescents (9 to 15 Year Olds) With a Comparison to Young Women (16 to 26 Year Olds)
The base study V503-002 is a 12-month study that is collecting safety and immunogenicity
information for six months following the subjects' third dose of study vaccine and is
expected to conclude in 2011.
An optional extension study (V503-002 EXT1) will collect safety and immunogenicity
information through Month 36. No study vaccine will be administered in the extension study.
Subjects enrolled in the 16- to 26-year-old cohort in the base study will not be included in
An optional second extension study (V503-002 EXT2) will collect long-term safety and
immunogenicity information through approximately 10 years. No study vaccine will be
administered in the extension study. Subjects enrolled in the 16- to 26-year-old cohort in
the base study will not be included in EXT2.
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Number of subjects with injection site adverse experiences
Day 1 to 5 post-vaccination
United States: Food and Drug Administration