Broad Spectrum HPV Vaccine Tolerability, Immunogenicity, and Efficacy Study - Tabular View

Tracking Information

First Received Date ^ICMJE

August 16, 2006

Last Updated Date

March 19, 2007

Start Date ^ICMJE

October 2006

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Proprietary Information - Exploratory (Non-Confirmatory) Trial

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00365443 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Proprietary Information - Exploratory (Non-Confirmatory) Trial

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Broad Spectrum HPV Vaccine Tolerability, Immunogenicity, and Efficacy Study

Official Title ^ICMJE

Proprietary Information - Exploratory (Non-Confirmatory) Trial

Brief Summary

This study is to evaluate an investigational vaccine with the following objectives: (1) To demonstrate prevention of cervical, vulvar, and vaginal cancers and related precancers, external genital lesions, and persistent infection caused by the HPV types in the study vaccine, (2) To demonstrate that the vaccine is well-tolerated in women, (3) To evaluate vaccine immune responses in women.

This is an early phase trial and some specific protocol information is proprietary and not publicly available at this time. (Full information is available to trial participants).

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Cervical Cancer
Condylomata Acuminata

Intervention ^ICMJE

Biological: V502

Study Arms / Comparison Groups

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

Terminated

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Female, between the ages of 16 and 26

Exclusion Criteria:

History of an abnormal PAP test or abnormal cervical biopsy result
History of external genital/vaginal warts
History of positive HPV test
Currently a user of any illegal drugs or an alcohol abuser
Are pregnant
Currently enrolled in another clinical trial
Currently has or has a history of certain medical conditions or is currently taking or has taken certain medications (details will be discussed at the time of consent).

Gender

Female

Ages

16 Years to 26 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00365443

Responsible Party

Study ID Numbers ^ICMJE

2006_503

Study Sponsor ^ICMJE

Merck

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Medical Monitor

Merck

Information Provided By

Merck

Verification Date

March 2007

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