NCT00551187

A Study to Evaluate Tolerability and Immunogenicity of V504 Administered Concomitantly With GARDASIL (V504-001)(COMPLETED)

A Randomized, Double-Blinded, Tolerability and Immunogenicity Study of a Multivalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine Administered Concomitantly With GARDASIL to 16- to 26- Year-Old Women

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 620 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: Female
• Age: 16 Years – 26 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate vaccine immunogenicity and how well the body tolerates V504 when given with Gardasil.

Conditions

• Cervical Cancer
• Vulvar Cancer
• Vaginal Cancer
• Genital Warts
• Human Papillomavirus Infection

Interventions

Type	Name	Description
BIOLOGICAL	V504	V504 0.5 ml injection in 3 dose regimen for 6 month treatment period.
BIOLOGICAL	Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine	Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine 0.5 ml injection in 3 dose regimen for 6 month treatment period.
BIOLOGICAL	Comparator: Placebo (unspecified)	V504 Placebo in 3 dose regimen for 6 month treatment period.

Timeline

• Start date: 2007-10-01
• Primary completion: 2009-05-01
• Completion: 2009-05-01
• First posted: 2007-10-30
• Last updated: 2015-06-08