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Clinical Trials/NCT00517309
NCT00517309
Completed
Phase 3

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

Merck Sharp & Dohme LLC0 sites1,877 target enrollmentDecember 28, 2001
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ConditionsCervical CancerGenital Warts

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Cervical Cancer
Sponsor
Merck Sharp & Dohme LLC
Enrollment
1877
Primary Endpoint
Quadrivalent HPV vaccine is generally well tolerated when administered alone or concomitantly with hepatitis B vaccine.
Status
Completed
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
December 28, 2001
End Date
June 11, 2004
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Females age 16 to 23 years old
  • •Must agree to refrain from sexual activity (vaginal or anal) for 48 hours prior to any scheduled visit

Exclusion Criteria

  • •History of vaccination with an HPV vaccine
  • •History of hepatitis B infection
  • •History of vaccination with hepatitis B vaccine
  • •History of genital warts or treatment for genital warts

Outcomes

Primary Outcomes

Quadrivalent HPV vaccine is generally well tolerated when administered alone or concomitantly with hepatitis B vaccine.

Secondary Outcomes

  • HPV vaccine is well tolerated in 16-23 year old females.

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