Spots Global Cancer Trial Database for A Study of Gardasil (V501) in Preadolescents and Adolescents (V501-018)
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Trial Identification
Brief Title: A Study of Gardasil (V501) in Preadolescents and Adolescents (V501-018)
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).
Study ID: NCT00092547
Study Description
Brief Summary: 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).
Detailed Description: 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.
Keywords
Eligibility
Minimum Age: 9 Years
Eligible Ages: CHILD
Sex: ALL
Healthy Volunteers: Yes
Locations
Contact Details
Name: Medical Monitor
Affiliation: Merck Sharp & Dohme LLC
Role: STUDY_DIRECTOR
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