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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This study has been withdrawn prior to enrollment.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:
Merck
ClinicalTrials.gov Identifier:
NCT00365443
First received: August 16, 2006
Last updated: March 5, 2012
Last verified: March 2012
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Proprietary Information - Exploratory (Non-Confirmatory) Trial

Resource links provided by NLM:

U.S. FDA Resources

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

Enrollment: 0
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

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00365443     History of Changes
Other Study ID Numbers: 2006_503
Study First Received: August 16, 2006
Last Updated: March 5, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Merck:
anogenital warts
premalignancy
HPV
Human papillomavirus

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Condylomata Acuminata
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
 Warts
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Skin Diseases, Viral
Tumor Virus Infections
Skin Diseases, Infectious
Skin Diseases

ClinicalTrials.gov processed this record on May 23, 2013