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

Home

Study Topics

Glossary


	Full Text View


	Tabular View


	Contacts and Locations


	No Study Results Posted


	Related Studies

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

This study is ongoing, but not recruiting participants.

Study NCT00090220. Last updated on July 12, 2006. Information provided by Merck

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

Descriptive Information Fields

Brief Title ^†

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

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

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

The duration of treatment is 9 months.

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Primary Outcome Measure ^†

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.

Secondary Outcome Measure ^†

Condition ^†

Healthy
Papillomavirus Infection

Intervention ^†

Biological: V501, Gardasil, human papillomavirus (types 6,11,16,18) recombinant vaccine
Biological: Comparator: placebo

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

3800

Start Date ^†

June 2004

Completion Date

Eligibility Criteria ^†

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

Gender

Female

Ages

24 Years to 45 Years

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00090220

Organization ID

2004_013

Secondary IDs ^††

Study Sponsor ^†

Merck

Collaborators ^††

Investigators ^†

Study Director:

Medical Monitor

Merck

Information Provided By

Merck

Verification Date

September 2005

First Received Date ^†

August 25, 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.