NCT00365716

Dose-Ranging Study of Quadrivalent Human Papillomavirus (HPV) (Types 6,11,16,18) L1 Virus-Like Particle (VLP) Vaccine (V501-007)(COMPLETED)

A Placebo-Controlled, Dose-Ranging Study of Quadrivalent HPV Virus-Like Particle (VLP) Vaccine in 16- to 23-Year-Old Women

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1,158 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: Female
• Age: 16 Years – 23 Years
• Healthy volunteers: Accepted

Summary

This study was conducted in 2 parts. Part A was a randomized, double-blind, placebo-controlled, multicenter, sequential dose-escalating evaluation. Part B was a randomized, double-blind (operating under in-house blinding procedures), placebo-controlled, multicenter, dose-ranging study.

Conditions

• Papillomavirus Infections
• Genital Diseases, Female

Interventions

Type	Name	Description
BIOLOGICAL	Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 20/40/40/20	20/40/40/20 formulation of quadrivalent human papillomavirus (HPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.
BIOLOGICAL	Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 40/40/40/40	40/40/40/40 formulation of quadrivalent human papillomavirus (HPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.
BIOLOGICAL	Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 80/80/40/80	80/80/40/80 formulation of quadrivalent human papillomavirus (qHPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.
BIOLOGICAL	Placebo (mcg) (Aluminum Adjuvant)225	placebo containing 225 mcg of aluminum adjuvant per dose at Day 1, Month 2, and Month 6.
BIOLOGICAL	Placebo (mcg) (Aluminum Adjuvant) 450	placebo containing 450 mcg of aluminum adjuvant per dose at Day 1, Month 2, and Month 6.

Timeline

• Start date: 2000-05-01
• Primary completion: 2004-05-01
• Completion: 2009-09-01
• First posted: 2006-08-17
• Last updated: 2015-10-07
• Results posted: 2010-08-03