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Broad Spectrum HPV Vaccine Tolerability, Immunogenicity, and Efficacy Study (V502-003)

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00365443
First received: August 16, 2006
Last updated: June 17, 2014
Last verified: June 2014

August 16, 2006
June 17, 2014
October 2006
Not Provided
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
Not Provided
Not Provided
 
Broad Spectrum HPV Vaccine Tolerability, Immunogenicity, and Efficacy Study (V502-003)
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).

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
  • Cervical Cancer
  • Condylomata Acuminata
Biological: V502
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
Not Provided
Not Provided

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
Not Provided
 
NCT00365443
V502-003, 2006_503
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
June 2014

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