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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Withdrawn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
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cervical Cancer focused on measuring anogenital warts, premalignancy, HPV, Human papillomavirus

Eligibility Criteria

16 Years - 26 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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

    First Posted
    August 16, 2006
    Last Updated
    June 18, 2015
    Sponsor
    Merck Sharp & Dohme LLC
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    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    Withdrawn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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