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

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

This study is ongoing, but not recruiting participants.
Information provided by Merck

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields
Brief Title ^†	Cervical Intraepithelial Neoplasm (CIN)-Warts Efficacy Trial in Women (Gardasil)
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
Brief Summary	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.
Detailed Description
Study Phase	Phase III
Study Type ^†	Interventional
Study Design ^†	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Primary Outcome Measure ^†	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 Measure ^†	Robust immune response
Condition ^†	Cervical Cancer Genital Warts
Intervention ^†	Biological: V501, Gardasil, human papillomavirus (types 6, 11, 16, 18) recombinant vaccine / Duration of Treatment: 4 years
MEDLINE PMIDs
Links

Recruitment Information Fields
Recruitment Status ^†	Active, not recruiting
Enrollment ^†	5700
Start Date ^†	December 2001
Completion Date
Eligibility 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
Gender	Female
Ages	16 Years to 23 Years
Accepts Healthy Volunteers	Yes
Contacts ^††
Location Countries ^†	United States

Administrative Information Fields
NCT ID ^†	NCT00092521
Organization ID	2004_081
Secondary IDs ^††
Study Sponsor ^†	Merck
Collaborators ^††
Investigators ^†
Information Provided By	Merck
Verification Date	September 2005
First Received Date ^†	September 23, 2004
Last Updated Date	July 12, 2006

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.