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

Tracking Information

First Received Date ^ICMJE

August 25, 2004

Last Updated Date

October 29, 2009

Start Date ^ICMJE

June 2004

Primary Completion Date

July 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Combined incidence of HPV6/11/16/18 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 ]

Original Primary Outcome Measures ^ICMJE

Combined incidence of HPV6/11/16/18 related persistent infection, genital warts, VIN, VaIN, vulvar cancer, vaginal cancer, cervical dysplasia, cervical AIS, and cervical cancer through Month 7.

Change History

Complete list of historical versions of study NCT00090220 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Combined incidence of HPV6/11 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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Healthy
Papillomavirus Infection

Intervention ^ICMJE

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

Study Arms / Comparison Groups

Experimental: Gardasil
Placebo Comparator: Placebo

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

3800

Estimated Completion Date

March 2011

Primary Completion Date

July 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

24 Years to 45 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00090220

Responsible Party

Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.

Study ID Numbers ^ICMJE

2004_013, V501-019

Study Sponsor ^ICMJE

Merck

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Medical Monitor

Merck

Information Provided By

Merck

Verification Date

October 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP