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

NCT00365716 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1158

Last updated 2015-10-07

Study results available
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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

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.

Sponsors & Collaborators

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
23 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2000-05-31
Primary Completion
2004-05-31
Completion
2009-09-30

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Entities

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00365716 on ClinicalTrials.gov