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

Sponsor:	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: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine Biological: Comparator: Placebo	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Cervical Cancer Genital Warts Vaginal Cancer Vulvar Cancer Warts

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Combined Incidence of HPV 6/11/16/18 Related Persistent Infection, Genital Warts, Vulvar Intraepithelial Neoplasia (VIN), Vaginal Intraepithelial Neoplasia (VaIN), Vulvar Cancer, Vaginal Cancer, Cervical Dysplasia, AIS, and Cervical Cancer [ Time Frame: Day 1 to Month 48 ] [ Designated as safety issue: No ]
HPV 6/11/16/18: The four types of HPV (types 6/11/16/18) associated with the primary outcome measure were determined by polymerase chain reaction (PCR) testing.

Secondary Outcome Measures:

Combined Incidence of HPV 6/11 Related Persistent Infection, Genital Warts, VIN, VaIN, Vulvar Cancer, Vaginal Cancer, Cervical Dysplasia, Adenocarcinoma In Situ (AIS), and Cervical Cancer [ Time Frame: Day 1 to Month 48 ] [ Designated as safety issue: No ]
HPV 6/11: The two types of HPV (types 6/11) associated with the secondary outcome measure were determined by polymerase chain reaction (PCR) testing.
Combined Incidence of HPV 31/33/35/52/58 Related Persistent Infection, Genital Warts, VIN, VaIN, Vulvar Cancer, Vaginal Cancer, Cervical Dysplasia, Cervical AIS, and Cervical Cancer [ Time Frame: 48 months ] [ Designated as safety issue: No ]

Enrollment:	3819
Study Start Date:	June 2004
Estimated Study Completion Date:	April 2016
Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Gardasil	Biological: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine Gardasil intramuscular injection in three 0.5 mL doses over 6 months.
Placebo Comparator: 2 Placebo	Biological: Comparator: Placebo Placebo intramuscular injection in three 0.5 mL doses over 6 months.

Detailed Description:

The original base protocol was extended. Subjects in the placebo arm of the base study are to be given 3 doses of open-label GARDASIL™ (V501) at Extension Day 1, Extension Month 2 and Extension Month 6. Subjects were followed to Extension Month 7.

A Long Term Follow-Up (LTFU) extension study [(V501-019-20)(NCT00090220)] will observe the long term safety, effectiveness, and immunogenicity of GARDASIL™ in 1,600 women who participated in the base protocol in Colombia. Data will be collected over a period of 6-10 years following subjects' enrollment in the original base protocol.

Eligibility

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Subject is pregnant
Subject previously received any HPV vaccine

Contacts and Locations

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

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Publications:

Muñoz N, Manalastas R Jr, Pitisuttithum P, Tresukosol D, Monsonego J, Ault K, Clavel C, Luna J, Myers E, Hood S, Bautista O, Bryan J, Taddeo FJ, Esser MT, Vuocolo S, Haupt RM, Barr E, Saah A. Safety, immunogenicity, and efficacy of quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine in women aged 24-45 years: a randomised, double-blind trial. Lancet. 2009 Jun 6;373(9679):1949-57. Epub 2009 Jun 1.

Velicer C, Zhu X, Vuocolo S, Liaw KL, Saah A. Prevalence and Incidence of HPV Genital Infection in Women. Sex Transm Dis. 2009 Jul 31; [Epub ahead of print]

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Garland SM, Ault KA, Gall SA, Paavonen J, Sings HL, Ciprero KL, Saah A, Marino D, Ryan D, Radley D, Zhou H, Haupt RM, Garner EI; Quadrivalent Human Papillomavirus Vaccine Phase III Investigators. Pregnancy and infant outcomes in the clinical trials of a human papillomavirus type 6/11/16/18 vaccine: a combined analysis of five randomized controlled trials. Obstet Gynecol. 2009 Dec;114(6):1179-88.

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00090220 History of Changes
Other Study ID Numbers:	2004_013, V501-019
Study First Received:	August 25, 2004
Results First Received:	October 30, 2009
Last Updated:	June 14, 2010
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections

ClinicalTrials.gov processed this record on February 09, 2012