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Broad Spectrum HPV Vaccine Tolerability, Immunogenicity, and Efficacy Study

This study has been terminated.

Sponsored by: Merck
Information provided by: Merck
ClinicalTrials.gov Identifier: NCT00365443
  Purpose

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).


Condition Intervention Phase
Cervical Cancer
Condylomata Acuminata
Biological: V502
Phase II

MedlinePlus related topics:   Cancer    Cervical Cancer    Genital Warts   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title:   Proprietary Information - Exploratory (Non-Confirmatory) Trial

Further study details as provided by Merck:

Primary Outcome Measures:
  • Proprietary Information - Exploratory (Non-Confirmatory) Trial

Secondary Outcome Measures:
  • Proprietary Information - Exploratory (Non-Confirmatory) Trial

Study Start Date:   October 2006

  Eligibility
Ages Eligible for Study:   16 Years to 26 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Criteria

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).
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00365443

Locations
United States, Ohio
Call for Information    
      Cleveland, Ohio, United States, 44122

Sponsors and Collaborators
Merck

Investigators
Study Director:     Medical Monitor     Merck    
  More Information

Study ID Numbers:   2006_503
First Received:   August 16, 2006
Last Updated:   March 19, 2007
ClinicalTrials.gov Identifier:   NCT00365443
Health Authority:   United States: Food and Drug Administration

Keywords provided by Merck:
anogenital warts  
premalignancy  
HPV  
Human papillomavirus  

Study placed in the following topic categories:
Sexually Transmitted Diseases, Viral
Skin Diseases
Condyloma
Genital Neoplasms, Female
Uterine Diseases
Urogenital Neoplasms
Uterine Cervical Neoplasms
Genital Diseases, Female
Virus Diseases
Skin Diseases, Infectious
Uterine Cervical Diseases
Warts
Condyloma acuminatum
Condylomata Acuminata
Sexually Transmitted Diseases
Uterine Neoplasms
Papillomavirus Infections
DNA Virus Infections

Additional relevant MeSH terms:
Skin Diseases, Viral
Neoplasms
Neoplasms by Site
Tumor Virus Infections

ClinicalTrials.gov processed this record on September 05, 2008




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