Immunogenicity Bridge Between an Investigational Monovalent Vaccine and the Equivalent Component of Gardasil (V501) a Quadrivalent Vaccine (V501-012)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00092482
First received: September 22, 2004
Last updated: May 29, 2014
Last verified: May 2014
  Purpose

The purpose of the study is to determine if an investigational vaccine with a single component develops an immune response that is similar to the equivalent investigational vaccine with four components to reduce cervical disease.


Condition Intervention Phase
Cervical Cancer
Genital Warts
Biological: V501, Gardasil, human papillomavirus (type 6, 11, 16, 18) recombinant vaccine / Duration of Treatment: 4 years
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety of Gardasil (V501) Quadrivalent HPV (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine in Consistency Lots for 16- to 23-Year-Old Women With and Additional Immunogenicity Bridge to the Monovalent HPV 16 Vaccine Pilot Manufacturing Lot Study-The F.U.T.U.R.E. Study (Females United to Unilaterally Reduce Endo/Ectocervical Disease)

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Tolerability and immune responses at week 4 post dose 3.

Enrollment: 3882
Study Start Date: June 2002
Study Completion Date: August 2008
Primary Completion Date: June 2004 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   16 Years to 23 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Female with an intact uterus with lifetime history of 0-4 sexual partners

Exclusion Criteria:

  • Prior Human Papillomavirus Vaccine (HPV) vaccination;
  • Prior abnormal paps;
  • Prior history of genital warts
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00092482

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00092482     History of Changes
Other Study ID Numbers: V501-012, 2004_080
Study First Received: September 22, 2004
Last Updated: May 29, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on October 01, 2014