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Trial record 28 of 31 for:    Completed Studies | Gardasil | Phase 3

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00517309
Recruitment Status : Completed
First Posted : August 16, 2007
Last Update Posted : March 22, 2017
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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

Condition or disease Intervention/treatment 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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1877 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Actual Study Start Date : December 28, 2001
Actual Primary Completion Date : June 8, 2004
Actual Study Completion Date : June 11, 2004

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 23 Years   (Child, Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00517309

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
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Study Director: Medical Monitor Merck Sharp & Dohme Corp.
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Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00517309    
Other Study ID Numbers: V501-011
First Posted: August 16, 2007    Key Record Dates
Last Update Posted: March 22, 2017
Last Verified: March 2017
Additional relevant MeSH terms:
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Condylomata Acuminata
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Skin Diseases, Viral
Tumor Virus Infections
Skin Diseases, Infectious
Skin Diseases
Immunologic Factors
Physiological Effects of Drugs