A Study to Evaluate the Safety, Immune Response, and Efficacy of Gardasil (V501) in Women - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00090220

Purpose

This study is to assess the tolerability and efficacy of a vaccine being evaluated to reduce the incidence of human papillomavirus (HPV) infection and disease (external genital warts and vulvar, vaginal, and cervical cancer) in women.

Condition	Intervention	Phase
Healthy Papillomavirus Infection	Biological: V501, Gardasil, human papillomavirus (types 6,11,16,18) recombinant vaccine Biological: Comparator: placebo	Phase III

MedlinePlus related topics: Cancer Warts

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Safety, Immunogenicity, and Efficacy of Gardasil (V501 (Human Papilloma Virus [Types 6, 11, 16, 18] Recombinant Vaccine) in Mid-Adult Women - The FUTURE III (Females United to Unilaterally Reduce Endo/Ectocervical Cancer) Study

Further study details as provided by Merck:

Primary Outcome Measures:

Combined incidence of HPV6/11/16/18 related persistent infection, genital warts, VIN, VaIN, vulvar cancer, vaginal cancer, cervical dysplasia, cervical AIS, and cervical cancer through Month 7.

Estimated Enrollment:	3800
Study Start Date:	June 2004

Detailed Description:

The duration of treatment is 9 months.

Eligibility

Ages Eligible for Study:	24 Years to 45 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

No history of HPV infection, surgical treatment to the cervix, or genital warts

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00090220

Locations

United States, Alabama
Call for Information
Birmingham, Alabama, United States, 35233
United States, California
Call for Information
Davis, California, United States, 95616
Call for Information
Colton, California, United States, 92324
Call for Information
Fountain Valley, California, United States, 92708
United States, Colorado
Call for Information
Boulder, Colorado, United States, 80027
United States, Florida
Call for Information
Tampa, Florida, United States, 33607
United States, Georgia
Call for Information
Augusta, Georgia, United States, 30912
United States, Illinois
Call for Information
Champaign, Illinois, United States, 61820
United States, Indiana
Call for Information
Indianapolis, Indiana, United States, 46202-5124
United States, Kentucky
Call for Information
Bardstown, Kentucky, United States, 40004
United States, New York
Call for Information
Stony Brook, New York, United States, 11794-8091
United States, North Carolina
Call for Information
Chapel Hill, North Carolina, United States, 27514
United States, Pennsylvania
Call for International Site Information
Horsham, Pennsylvania, United States, 19044
Call for Information
Trexlertown, Pennsylvania, United States, 18087-0060
Call for Information
Philadelphia, Pennsylvania, United States, 19114
United States, Virginia
Call for Information
Richmond, Virginia, United States, 23226

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Study ID Numbers:	2004_013
Study First Received:	August 25, 2004
Last Updated:	July 12, 2006
ClinicalTrials.gov Identifier:	NCT00090220
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Virus Diseases
DNA Virus Infections
Papillomavirus Infections
Healthy
Papilloma

Additional relevant MeSH terms:

Tumor Virus Infections
Infection

ClinicalTrials.gov processed this record on January 14, 2009