Cervical Intraepithelial Neoplasm (CIN)-Warts Efficacy Trial in Women (Gardasil) - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00092521

Purpose

The primary purpose of the study is to determine if Gardasil (V501) with four components is able to prevent cervical cancer, cervical dysplasia, and genital warts.

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

MedlinePlus related topics: Cancer Genital Warts Warts

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	A Study to Evaluate the Efficacy of Gardasil (V501) Quadrivalent HPV (Types 6, 11, 16, and 18) L1 Virus-Like Particle (VLP) Vaccine in Reducing the Incidence of HPV 6/11-, 16-, and 18-Related CIN and VaIN, and HPV 6/11-, 16-, and 18-Related External Genital Warts and VI

Further study details as provided by Merck:

Primary Outcome Measures:

Vaccine type(s)-related external genital wart disease and/or CIN (any grade), AIS; vaccine HPV type related cervical, vulvar and vaginal cancer.

Secondary Outcome Measures:

Robust immune response

Estimated Enrollment:	5700
Study Start Date:	December 2001

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 Papilloma Virus (HPV) vaccination
Prior abnormal paps
History of genital warts

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00092521

Locations

United States, Pennsylvania
Call for Information
Horsham, Pennsylvania, United States, 19044

Sponsors and Collaborators

Merck

More Information

Publications indexed to this study:

Ault KA; Future II Study Group. Effect of prophylactic human papillomavirus L1 virus-like-particle vaccine on risk of cervical intraepithelial neoplasia grade 2, grade 3, and adenocarcinoma in situ: a combined analysis of four randomised clinical trials. Lancet. 2007 Jun 2;369(9576):1861-8.

Garland SM, Hernandez-Avila M, Wheeler CM, Perez G, Harper DM, Leodolter S, Tang GW, Ferris DG, Steben M, Bryan J, Taddeo FJ, Railkar R, Esser MT, Sings HL, Nelson M, Boslego J, Sattler C, Barr E, Koutsky LA; Females United to Unilaterally Reduce Endo/Ectocervical Disease (FUTURE) I Investigators. Quadrivalent vaccine against human papillomavirus to prevent anogenital diseases. N Engl J Med. 2007 May 10;356(19):1928-43.

Study ID Numbers:	2004_081
Study First Received:	September 23, 2004
Last Updated:	July 12, 2006
ClinicalTrials.gov Identifier:	NCT00092521
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Sexually Transmitted Diseases, Viral
Skin Diseases
Condyloma
Cervical Intraepithelial Neoplasia
Carcinoma
Virus Diseases
Skin Diseases, Infectious
Warts

Condyloma acuminatum
Cervical intraepithelial neoplasia
Condylomata Acuminata
Carcinoma in Situ
Sexually Transmitted Diseases
Papillomavirus Infections
DNA Virus Infections
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Skin Diseases, Viral
Neoplasms
Neoplasms by Histologic Type
Tumor Virus Infections

ClinicalTrials.gov processed this record on January 16, 2009