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Prevention of Human Papillomavirus (HPV) in 20 to 45 Year Old Chinese Women (V501-041)

NCT00834106 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3006

Last updated 2019-02-04

Study results available
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Summary

A study to test the safety and effectiveness of Quadrivalent HPV (types 6, 11, 16, 18) L1 VLP vaccine against combined incidence of HPV 6/11/16/18-related persistent infection and vaccine type-specific genital disease among Chinese females between the ages of 20 and 45.

Conditions

  • HPV Infections

Interventions

BIOLOGICAL

Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine

Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine injection at Day 1, Month 2, and Month 6.

BIOLOGICAL

Comparator: placebo (unspecified)

Aluminum-containing Vaccine placebo injection at Day 1, Month 2, and Month 6.

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2012-05-11
Completion
2016-09-30
FDA Drug
Yes

More Related Trials

Entities

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 NCT00834106 on ClinicalTrials.gov