Broad Spectrum HPV Vaccine Tolerability, Immunogenicity, and Efficacy Study (V502-003)
Primary Purpose
Cervical Cancer, Condylomata Acuminata
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
V502
Sponsored by
About this trial
This is an interventional prevention trial for Cervical Cancer focused on measuring anogenital warts, premalignancy, HPV, Human papillomavirus
Eligibility 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).
Sites / Locations
Outcomes
Primary Outcome Measures
Proprietary Information - Exploratory (Non-Confirmatory) Trial
Secondary Outcome Measures
Proprietary Information - Exploratory (Non-Confirmatory) Trial
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00365443
Brief Title
Broad Spectrum HPV Vaccine Tolerability, Immunogenicity, and Efficacy Study (V502-003)
Official Title
Proprietary Information - Exploratory (Non-Confirmatory) Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Withdrawn
Study Start Date
October 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
Brief Summary
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer, Condylomata Acuminata
Keywords
anogenital warts, premalignancy, HPV, Human papillomavirus
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
V502
Primary Outcome Measure Information:
Title
Proprietary Information - Exploratory (Non-Confirmatory) Trial
Secondary Outcome Measure Information:
Title
Proprietary Information - Exploratory (Non-Confirmatory) Trial
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
26 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Broad Spectrum HPV Vaccine Tolerability, Immunogenicity, and Efficacy Study (V502-003)
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