MedTrace Logo

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

NCT00551187 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 620

Last updated 2015-06-08

No results posted yet for this study

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

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.

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
26 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2009-05-31
Completion
2009-05-31

More Related Trials

Entities

Diseases
Companies

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 NCT00551187 on ClinicalTrials.gov