Clinical Trials Directory

Trials / Completed

CompletedNCT00517309

Study to Test the Safety of HPV Vaccine in Women (V501-011)(COMPLETED)

Immunogenicity and Safety of Quadrivalent HPV L1 Virus-Like Particle (VLP) Vaccine in 16- to 23-Year-Old Women When Administered Alone or Concomitantly With Hepatitis B Vaccine (Recombinant)--the F.U.T.U.R.E. Study (Females United to Unilaterally Reduce Endo/Ectocervical Disease

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
1,877 (actual)
Sponsor
Merck Sharp & Dohme LLC · Industry
Sex
Female
Age
16 Years – 23 Years
Healthy volunteers
Accepted

Summary

The primary purpose of the study is to test the safety of HPV Vaccine in Women

Conditions

Interventions

TypeNameDescription
BIOLOGICALV501, Gardasil, Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine / Duration of Treatment : 4 Years
BIOLOGICALComparator: placebo (concomitant-vaccine matched) / Duration of Treatment : 4 Years

Timeline

Start date
2001-12-28
Primary completion
2004-06-08
Completion
2004-06-11
First posted
2007-08-16
Last updated
2017-03-22

Source: ClinicalTrials.gov record NCT00517309. Inclusion in this directory is not an endorsement.