Immunogenicity Bridge Between an Investigational Monovalent Vaccine and the Equivalent Component of Gardasil (V501) a Quadrivalent Vaccine

This study has been completed.

First Received: September 22, 2004 Last Updated: May 17, 2007 History of Changes

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00092482

Purpose

The purpose of the study is to determine if an investigational vaccine with a single component develops an immune response that is similar to the equivalent investigational vaccine with four components to reduce cervical disease.

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

MedlinePlus related topics: Genital Warts Warts

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Immunogenicity and Safety of Gardasil (V501) Quadrivalent HPV (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine in Consistency Lots for 16- to 23-Year-Old Women With and Additional Immunogenicity Bridge to the Monovalent HPV 16 Vaccine Pilot Manufacturing Lot Study-The F.U.T.U.R.E. Study (Females United to Unilaterally Reduce Endo/Ectocervical Disease)

Further study details as provided by Merck:

Primary Outcome Measures:

Tolerability and immune responses at week 4 post dose 3.

Estimated Enrollment:	3900
Study Start Date:	April 2002

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 Papillomavirus Vaccine (HPV) vaccination;
Prior abnormal paps;
Prior history of genital warts

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00092482

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Publications:

Garland SM, Steben M, Hernandez-Avila M, Koutsky LA, Wheeler CM, Perez G, Harper DM, Leodolter S, Tang GW, Ferris DG, Esser MT, Vuocolo SC, Nelson M, Railkar R, Sattler C, Barr E. AN EVALUATION OF NON-INFERIORITY IN ANTIBODY RESPONSE TO HUMAN PAPILLOMAVIRUS (HPV) 16 IN SUBJECTS VACCINATED WITH MONOVALENT (HPV 16) AND QUADRIVALENT (HPV 6, 11, 16, 18) L1 VIRUS LIKE PARTICLE VACCINES. Clin Vaccine Immunol. 2007 Apr 11; [Epub ahead of print]

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Brown DR, Kjaer SK, Sigurdsson K, Iversen OE, Hernandez-Avila M, Wheeler CM, Perez G, Koutsky LA, Tay EH, Garcia P, Ault KA, Garland SM, Leodolter S, Olsson SE, Tang GW, Ferris DG, Paavonen J, Steben M, Bosch FX, Dillner J, Joura EA, Kurman RJ, Majewski S, Muñoz N, Myers ER, Villa LL, Taddeo FJ, Roberts C, Tadesse A, Bryan J, Lupinacci LC, Giacoletti KE, Sings HL, James M, Hesley TM, Barr E. The impact of quadrivalent human papillomavirus (HPV; types 6, 11, 16, and 18) L1 virus-like particle vaccine on infection and disease due to oncogenic nonvaccine HPV types in generally HPV-naive women aged 16-26 years. J Infect Dis. 2009 Apr 1;199(7):926-35.

Wheeler CM, Kjaer SK, Sigurdsson K, Iversen OE, Hernandez-Avila M, Perez G, Brown DR, Koutsky LA, Tay EH, García P, Ault KA, Garland SM, Leodolter S, Olsson SE, Tang GW, Ferris DG, Paavonen J, Steben M, Bosch FX, Dillner J, Joura EA, Kurman RJ, Majewski S, Muñoz N, Myers ER, Villa LL, Taddeo FJ, Roberts C, Tadesse A, Bryan J, Lupinacci LC, Giacoletti KE, James M, Vuocolo S, Hesley TM, Barr E. The impact of quadrivalent human papillomavirus (HPV; types 6, 11, 16, and 18) L1 virus-like particle vaccine on infection and disease due to oncogenic nonvaccine HPV types in sexually active women aged 16-26 years. J Infect Dis. 2009 Apr 1;199(7):936-44.

Study ID Numbers:	2004_080
Study First Received:	September 22, 2004
Last Updated:	May 17, 2007
ClinicalTrials.gov Identifier:	NCT00092482 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Virus Diseases
Skin Diseases, Infectious
Sexually Transmitted Diseases, Viral
Warts
Skin Diseases
Condylomata Acuminata

Condyloma Acuminatum
Sexually Transmitted Diseases
Condyloma
DNA Virus Infections
Papillomavirus Infections

Additional relevant MeSH terms:

Skin Diseases, Viral
Virus Diseases
Skin Diseases, Infectious
Sexually Transmitted Diseases, Viral
Warts
Skin Diseases

Condylomata Acuminata
Sexually Transmitted Diseases
Tumor Virus Infections
DNA Virus Infections
Papillomavirus Infections

ClinicalTrials.gov processed this record on May 07, 2009