NCT00092482

Immunogenicity Bridge Between an Investigational Monovalent Vaccine and the Equivalent Component of Gardasil (V501) a Quadrivalent Vaccine (V501-012)(COMPLETED)

Immunogenicity and Safety of Gardasil (V501) Quadrivalent HPV (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine in Consistency Lots for 16- to 23-Year-Old Women With and Additional Immunogenicity Bridge to the Monovalent HPV 16 Vaccine Pilot Manufacturing Lot Study-The F.U.T.U.R.E. Study (Females United to Unilaterally Reduce Endo/Ectocervical Disease)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3,882 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: Female
• Age: 16 Years – 23 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to determine if an investigational vaccine with a single component develops an immune response that is similar to the equivalent investigational vaccine with four components to reduce cervical disease.

Conditions

• Cervical Cancer
• Genital Warts

Interventions

Type	Name	Description
BIOLOGICAL	V501, Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine / Duration of Treatment: 4 years

Timeline

• Start date: 2002-06-28
• Primary completion: 2004-06-30
• Completion: 2008-08-15
• First posted: 2004-09-27
• Last updated: 2017-03-22