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

This study has been withdrawn prior to enrollment.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: August 16, 2006
Last updated: June 18, 2015
Last verified: June 2015

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
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Proprietary Information - Exploratory (Non-Confirmatory) Trial

Further study details as provided by Merck Sharp & Dohme Corp.:

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

Ages Eligible for Study:   16 Years to 26 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00365443

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00365443     History of Changes
Other Study ID Numbers: V502-003
Study First Received: August 16, 2006
Last Updated: June 18, 2015

Keywords provided by Merck Sharp & Dohme Corp.:
anogenital warts
Human papillomavirus

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female processed this record on September 19, 2017