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

Sponsor:	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, including Cervical Intraepithelial Neoplasia (CIN)(Any Grade) and Adenocarcinoma In Situ (AIS), and genital warts.

Condition	Intervention	Phase
Cervical Cancer Genital Warts	Biological: V501 Biological: Comparator: Placebo Biological: Human Papillomavirus (HPV) 16 Monovalent	Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	A Study to Evaluate the Efficacy of Quadrivalent HPV Vaccine in Reducing the Incidence of HPV 6-, 11-, 16-, and 18-Related CIN, AIS, and Cervical Cancer, and HPV 6-, 11-, 16-, and 18-Related External Genital Warts, Vulvar Intraepithelial Neoplasia Vaginal Intraepithelial Neoplasia, Vulvar Cancer, and Vaginal Cancer in 16- to 23-Year-Old Women

Resource links provided by NLM:

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

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Incidence of HPV 6/11/16/18-related Cervical Intraepithelial Neoplasia (CIN)(Any Grade), Adenocarcinoma In Situ (AIS) or Cervical Cancer [ Time Frame: Follow-up through end of study (4 years) ] [ Designated as safety issue: No ]
Incidence of HPV 6/11/16/18-related External Genital Lesions (EGL) [Genital Warts, Vulvar/Vaginal Intraepithelial Neoplasia (Any Grade), Vulvar/Vaginal Cancer] [ Time Frame: Follow-up through end of study (4 years) ] [ Designated as safety issue: No ]

Enrollment:	5759
Study Start Date:	December 2001
Study Completion Date:	August 2008
Primary Completion Date:	July 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental V501	Biological: V501 Final Manufactured Product (FMP) quadrivalent HPV vaccine, a 0.5 mL intramuscular injection given at Day 1, Month 2 and Month 6.
2: Placebo Comparator Placebo	Biological: Comparator: Placebo a 0.5 mL intramuscular placebo injection given at Day 1, Month 2 and Month 6.
3: Experimental HPV 16 Monovalent Vaccine	Biological: Human Papillomavirus (HPV) 16 Monovalent HPV 16 Monovalent vaccine, a 0.5 mL intramuscular injection given at Day 1, Month 2 and Month 6.

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 (HPV) vaccination
Prior abnormal paps
History of genital warts

Contacts and Locations

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

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Publications:

Garland SM, Steben M, Sings HL, James M, Lu S, Railkar R, Barr E, Haupt RM, Joura EA. Natural History of Genital Warts: Analysis of the Placebo Arm of 2 Randomized Phase III Trials of a Quadrivalent Human Papillomavirus (Types 6, 11, 16, and 18) Vaccine. J Infect Dis. 2009 Jan 26; [Epub ahead of print]

Barr E, Gause CK, Bautista OM, Railkar RA, Lupinacci LC, Insinga RP, Sings HL, Haupt RM. Impact of a prophylactic quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 virus-like particle vaccine in a sexually active population of North American women. Am J Obstet Gynecol. 2008 Mar;198(3):261.e1-11.

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.

Joura EA, Leodolter S, Hernandez-Avila M, Wheeler CM, Perez G, Koutsky LA, Garland SM, Harper DM, Tang GW, Ferris DG, Steben M, Jones RW, Bryan J, Taddeo FJ, Bautista OM, Esser MT, Sings HL, Nelson M, Boslego JW, Sattler C, Barr E, Paavonen J. Efficacy of a quadrivalent prophylactic human papillomavirus (types 6, 11, 16, and 18) L1 virus-like-particle vaccine against high-grade vulval and vaginal lesions: a combined analysis of three randomised clinical trials. Lancet. 2007 May 19;369(9574):1693-702.

Insinga RP, Dasbach EJ, Allen SE, Carides GW, Myers ER. Reductions in Human Papillomavirus-Disease Resource Use and Costs with Quadrivalent Human Papillomavirus (Types 6, 11, 16, and 18) Recombinant Vaccination: The FUTURE Study Economic Evaluation. Value Health. 2008 May 16; [Epub ahead of print]

Perez G, Lazcano-Ponce E, Hernandez-Avila M, García PJ, Muñoz N, Villa LL, Bryan J, Taddeo FJ, Lu S, Esser MT, Vuocolo S, Sattler C, Barr E. Safety, immunogenicity, and efficacy of quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 virus-like-particle vaccine in Latin American women. Int J Cancer. 2008 Mar 15;122(6):1311-8.

FUTURE II Study Group. Prophylactic efficacy of a quadrivalent human papillomavirus (HPV) vaccine in women with virological evidence of HPV infection. J Infect Dis. 2007 Nov 15;196(10):1438-46. Epub 2007 Oct 31.

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.

Giuliano AR, Lazcano-Ponce E, Villa L, Nolan T, Marchant C, Radley D, Golm G, McCarroll K, Yu J, Esser MT, Vuocolo SC, Barr E. Impact of baseline covariates on the immunogenicity of a quadrivalent (types 6, 11, 16, and 18) human papillomavirus virus-like-particle vaccine. J Infect Dis. 2007 Oct 15;196(8):1153-62. Epub 2007 Sep 17.

Garland SM, Insinga RP, Sings HL, Haupt RM, Joura EA. Human papillomavirus infections and vulvar disease development. Cancer Epidemiol Biomarkers Prev. 2009 Jun;18(6):1777-84.

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

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.

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.

Six L, Leodolter S, Sings HL, Barr E, Haupt R, Joura EA. Prevalence of human papillomavirus types 6, 11, 16 and 18 in young Austrian women - baseline data of a phase III vaccine trial. Wien Klin Wochenschr. 2008;120(21-22):666-71.

Responsible Party:	Merck Sharp & Dohme Corp ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2004_081, V501-013
Study First Received:	September 23, 2004
Results First Received:	August 3, 2009
Last Updated:	January 21, 2010
ClinicalTrials.gov Identifier:	NCT00092521 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Sexually Transmitted Diseases, Viral
Tumor Virus Infections
Urogenital Neoplasms
Genital Diseases, Female
Uterine Cervical Neoplasms
Uterine Cervical Diseases
Neoplasms by Site
Carcinoma in Situ
Uterine Neoplasms
Neoplasms by Histologic Type
Skin Diseases
Genital Neoplasms, Female
Uterine Diseases

Cervical Intraepithelial Neoplasia
Carcinoma
Virus Diseases
Skin Diseases, Viral
Neoplasms
Skin Diseases, Infectious
Warts
Condylomata Acuminata
Sexually Transmitted Diseases
Papillomavirus Infections
DNA Virus Infections
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on February 08, 2010