NCT00092547

A Study of Gardasil (V501) in Preadolescents and Adolescents (V501-018)

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).

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,781 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 9 Years – 15 Years
• Healthy volunteers: Accepted

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.

Conditions

• Human
• Papillomavirus Infections

Interventions

Type	Name	Description
BIOLOGICAL	V501	0.5 mL intramuscular injection of V501
BIOLOGICAL	Comparator: Placebo	0.5 mL intramuscular injection of placebo

Timeline

• Start date: 2003-10-08
• Primary completion: 2005-11-03
• Completion: 2015-06-01
• First posted: 2004-09-28
• Last updated: 2018-02-20
• Results posted: 2010-05-04