NCT00520598

Broad Spectrum HPV (Human Papillomavirus) Vaccine in 16 to 26 Year Old Women (V505-001)

A Phase IIa Randomized, Double-Blind Controlled With Gardasil, Clinical Trial to Study theTolerability and Immunogenicity of V505 (a Multivalent Human Papilloma Virus [HPV] L1 Virus Like Particle [VLP] Vaccine) in Healthy 16 to 26 Year Old Women

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 511 (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 the safety and immunogenicity of V505 in comparison to GARDASIL (TM)

Conditions

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

Interventions

Type	Name	Description
BIOLOGICAL	Comparator: V505 formulation 1	0.5 ml injection of V505 formulation 1 as 3 dose regimen at Day 1, Month 2 and Month 6.
DRUG	Comparator: V505 formulation 2	0.5 ml injection of V505 formulation 2 as 3 dose regimen at Day 1, Month 2 and Month 6.
DRUG	Comparator: V505 formulation 2	0.5 ml injection of V505 formulation 2 as 2 dose regimen at Day 1 and Month 6.
BIOLOGICAL	Comparator: V505 formulation 3	0.5 ml injection of V505 formulation 3 as 2 dose regimen at Day 1 and Month 6.
BIOLOGICAL	Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant	0.5 ml injection of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine as 3 dose regimen at Day 1, Month 2 and Month 6.
BIOLOGICAL	Comparator: Placebo (unspecified)	0.5 ml injection of placebo to V505 as a 1 dose regimen at Month 2.

Timeline

• Start date: 2007-10-01
• Primary completion: 2011-05-01
• Completion: 2011-05-01
• First posted: 2007-08-24
• Last updated: 2015-11-26