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Broad Spectrum HPV Vaccine Tolerability, Immunogenicity, and Efficacy Study
This study has been terminated.
Study NCT00365443   Information provided by Merck
First Received: August 16, 2006   Last Updated: March 19, 2007   History of Changes

August 16, 2006
March 19, 2007
October 2006
 
Proprietary Information - Exploratory (Non-Confirmatory) Trial
Same as current
Complete list of historical versions of study NCT00365443 on ClinicalTrials.gov Archive Site
Proprietary Information - Exploratory (Non-Confirmatory) Trial
Same as current
 
Broad Spectrum HPV Vaccine Tolerability, Immunogenicity, and Efficacy Study
Proprietary Information - Exploratory (Non-Confirmatory) Trial

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).

 
Phase II
Interventional
Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
  • Cervical Cancer
  • Condylomata Acuminata
Biological: V502
 
 

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

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).
Female
16 Years to 26 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00365443
 
2006_503
Merck
 
Study Director: Medical Monitor Merck
Merck
March 2007

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