CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 1,158 enrolled
Drug / intervention
Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 20/40/40/20 +4 morebiological
Likely dose
Placebo (mcg) (Aluminum Adjuvant)225 225 mcgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00365716
NCT00365716Phase 2Completed
CompareCT.gov

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

Merck Sharp & Dohme LLC·interventional·Posted Aug 17, 2006·Updated Oct 7, 2015

In Brief

A Phase 2 clinical trial evaluating Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 20/40/40/20, Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 40/40/40/40, and 3 other interventions for Papillomavirus Infections and Genital Diseases, Female. Completed, enrolled 1,158 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPapillomavirus Infections, Genital Diseases, Female
Countries--
Collaborators--

Timeline

Phase 2CompletedFinished
2000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 17, 2006
Enrollment StartMay 1, 2000
Primary CompletionMay 1, 2004
Study CompletionSep 1, 2009
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 19.9 years ago

Interventions

Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 20/40/40/20biological

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.

Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 40/40/40/40biological

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.

Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 80/80/40/80biological

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.

Placebo (mcg) (Aluminum Adjuvant)225biological

placebo containing 225 mcg of aluminum adjuvant per dose at Day 1, Month 2, and Month 6.

Placebo (mcg) (Aluminum Adjuvant) 450biological

placebo containing 450 mcg of aluminum adjuvant per dose at Day 1, Month 2, and Month 6.