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).
The original base protocol (V501-018)(NCT00092547) was extended in amendments 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.
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Number of Participants Reporting Serious Adverse Experiences (SAE) in the Vaccination and Follow-up Phases
Tolerability as assessed by the number of participants with clinical adverse experiences in the Vaccination and Follow-up Phases. A serious adverse event is any adverse event that results in death, is life threatening, results in a persistent or significant disability/incapacity, results in hospitalization or prolongs an existing hospitalization, is a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an "other important medical event" based on medical judgment.
Day 1 through Month 18
United States: Food and Drug Administration