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

This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: August 15, 2007
Last updated: June 4, 2015
Last verified: June 2015
The primary purpose of the study is to test the safety of HPV Vaccine in Women

Condition Intervention Phase
Cervical Cancer
Genital Warts
Biological: V501, Gardasil, Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine / Duration of Treatment : 4 Years
Biological: Comparator: placebo (concomitant-vaccine matched) / Duration of Treatment : 4 Years
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Quadrivalent HPV vaccine is generally well tolerated when administered alone or concomitantly with hepatitis B vaccine.

Secondary Outcome Measures:
  • HPV vaccine is well tolerated in 16-23 year old females.

Enrollment: 1877
Study Start Date: December 2001
Study Completion Date: June 2004
Primary Completion Date: June 2004 (Final data collection date for primary outcome measure)

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

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
  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 identifier: NCT00517309

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

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00517309     History of Changes
Other Study ID Numbers: V501-011  2007_576 
Study First Received: August 15, 2007
Last Updated: June 4, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis B
Uterine Cervical Neoplasms
DNA Virus Infections
Digestive System Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Hepadnaviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Neoplasms by Site
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Uterine Neoplasms
Virus Diseases
Immunologic Factors
Physiological Effects of Drugs processed this record on May 26, 2016