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

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
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	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
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 September 04, 2008

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