Papillomavirus Infections Clinical Trial
Official title:
A Safety and Immunogenicity Study of Quadrivalent HPV (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine in Preadolescents and Adolescents (Base Study). A Long Term Immunogenicity, Safety, and Effectiveness Study of GARDASIL (Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine) Among Adolescents Who Received GARDASIL at 9-18 Years of Age (Extension Study).
This study is to evaluate the safety, tolerability, and immune response of an investigational vaccine in preadolescent and adolescent boys and girls for the prevention of Human Papilloma Virus (HPV).
The original base protocol (V501-018)(NCT00092547) was extended in amendments V501-018-05 and
-06 to provide 37 months of follow-up. Additionally, subjects in the Placebo Group during the
base study were given 3 doses of open-label GARDASIL™ (V501) at Months 30, 32, and 36.
The study was extended again in amendment V501-018-10(NCT00092547), titled "A Long Term
Immunogenicity, Safety, and Effectiveness Study of GARDASIL (Human Papillomavirus [Types 6,
11, 16, 18] Recombinant Vaccine) Among Adolescents Who Received GARDASIL at 9-18 Years of
Age" to allow a follow-up period to Month 126.
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