Dose-Ranging Study of Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00365716

Purpose

This study was conducted in 2 parts. Part A was a randomized, double-blind, placebo-controlled, multicenter, sequential dose-escalating evaluation. Part B was a randomized, double-blind (operating under in-house blinding procedures), placebo-controlled, multicenter, dose-ranging study.

Condition	Intervention	Phase
Papillomavirus Infections Genital Diseases, Female	Biological: V501, /Duration of Treatment : 6 Months Biological: Comparator : placebo with adjuvant (unspecified) /Duration of Treatment : 6 Months	Phase II

MedlinePlus related topics: Reproductive Health

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Placebo-Controlled, Dose-Ranging Study of Quadrivalent HPV Virus-Like Particle (VLP) Vaccine in 16- to 23-Year-Old Women

Further study details as provided by Merck:

Primary Outcome Measures:

Safety and tolerability

Secondary Outcome Measures:

Through 36 Months: HPV PCR positivity; incidence of CIN, VIN, VaIN, AIS, cervical cancer, and genital warts

Estimated Enrollment:	1045
Study Start Date:	May 2000

Eligibility

Ages Eligible for Study:	16 Years to 23 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria :

Healthy females 16 to 23 years of age
Not pregnant at enrollment and must have agreed to use effective contraception through Month 7 of the study
Lifetime history of 0 to 4 male sexual partners (individuals with whom penetrative sexual intercourse occurred)

Exclusion Criteria :

No prior receipt of an HPV vaccine
No receipt of inactivated or recombinant vaccines within 14 days prior to enrollment or receipt of live vaccines within 21 days prior to enrollment
No prior abnormal Pap test showing SIL or biopsy showing CIN
No prior history of genital warts or treatment for genital warts

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00365716

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Publications:

Villa LL, Costa RL, Petta CA, Andrade RP, Ault KA, Giuliano AR, Wheeler CM, Koutsky LA, Malm C, Lehtinen M, Skjeldestad FE, Olsson SE, Steinwall M, Brown DR, Kurman RJ, Ronnett BM, Stoler MH, Ferenczy A, Harper DM, Tamms GM, Yu J, Lupinacci L, Railkar R, Taddeo FJ, Jansen KU, Esser MT, Sings HL, Saah AJ, Barr E. Prophylactic quadrivalent human papillomavirus (types 6, 11, 16, and 18) L1 virus-like particle vaccine in young women: a randomised double-blind placebo-controlled multicentre phase II efficacy trial. Lancet Oncol. 2005 May;6(5):271-8.

Villa LL, Ault KA, Giuliano AR, Costa RL, Petta CA, Andrade RP, Brown DR, Ferenczy A, Harper DM, Koutsky LA, Kurman RJ, Lehtinen M, Malm C, Olsson SE, Ronnett BM, Skjeldestad FE, Steinwall M, Stoler MH, Wheeler CM, Taddeo FJ, Yu J, Lupinacci L, Railkar R, Marchese R, Esser MT, Bryan J, Jansen KU, Sings HL, Tamms GM, Saah AJ, Barr E. Immunologic responses following administration of a vaccine targeting human papillomavirus Types 6, 11, 16, and 18. Vaccine. 2006 Jul 7;24(27-28):5571-83. Epub 2006 May 15.

Villa LL, Costa RL, Petta CA, Andrade RP, Paavonen J, Iversen OE, Olsson SE, Hoye J, Steinwall M, Riis-Johannessen G, Andersson-Ellstrom A, Elfgren K, Krogh G, Lehtinen M, Malm C, Tamms GM, Giacoletti K, Lupinacci L, Railkar R, Taddeo FJ, Bryan J, Esser MT, Sings HL, Saah AJ, Barr E. High sustained efficacy of a prophylactic quadrivalent human papillomavirus types 6/11/16/18 L1 virus-like particle vaccine through 5 years of follow-up. Br J Cancer. 2006 Dec 4;95(11):1459-66. Epub 2006 Nov 21.

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.

Study ID Numbers:	2006_516
Study First Received:	August 16, 2006
Last Updated:	October 9, 2007
ClinicalTrials.gov Identifier:	NCT00365716
Health Authority:	United States: Food and Drug Administration

Keywords provided by Merck:

HPV 6/11/16/18 infection and related genital disease

Study placed in the following topic categories:

Virus Diseases
Genital Diseases, Female
DNA Virus Infections
Papillomavirus Infections

Additional relevant MeSH terms:

Tumor Virus Infections
Infection

ClinicalTrials.gov processed this record on January 14, 2009