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Study to Test the Safety of HPV Vaccine in Women (V501-011)(COMPLETED) (FUTURE)

Primary Purpose

Cervical Cancer, Genital Warts

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
V501, Gardasil, Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine / Duration of Treatment : 4 Years
Comparator: placebo (concomitant-vaccine matched) / Duration of Treatment : 4 Years
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cervical Cancer

Eligibility Criteria

16 Years - 23 Years (Child, Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Females age 16 to 23 years old
  • Must agree to refrain from sexual activity (vaginal or anal) for 48 hours prior to any scheduled visit

Exclusion Criteria:

  • History of vaccination with an HPV vaccine
  • History of hepatitis B infection
  • History of vaccination with hepatitis B vaccine
  • History of genital warts or treatment for genital warts

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Quadrivalent HPV vaccine is generally well tolerated when administered alone or concomitantly with hepatitis B vaccine.

    Secondary Outcome Measures

    HPV vaccine is well tolerated in 16-23 year old females.

    Full Information

    First Posted
    August 15, 2007
    Last Updated
    March 20, 2017
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00517309
    Brief Title
    Study to Test the Safety of HPV Vaccine in Women (V501-011)(COMPLETED)
    Acronym
    FUTURE
    Official Title
    Immunogenicity and Safety of Quadrivalent HPV L1 Virus-Like Particle (VLP) Vaccine in 16- to 23-Year-Old Women When Administered Alone or Concomitantly With Hepatitis B Vaccine (Recombinant)--the F.U.T.U.R.E. Study (Females United to Unilaterally Reduce Endo/Ectocervical Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    December 28, 2001 (Actual)
    Primary Completion Date
    June 8, 2004 (Actual)
    Study Completion Date
    June 11, 2004 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck Sharp & Dohme LLC

    4. Oversight

    5. Study Description

    Brief Summary
    The primary purpose of the study is to test the safety of HPV Vaccine in Women

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cervical Cancer, Genital Warts

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    1877 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Biological
    Intervention Name(s)
    V501, Gardasil, Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine / Duration of Treatment : 4 Years
    Intervention Type
    Biological
    Intervention Name(s)
    Comparator: placebo (concomitant-vaccine matched) / Duration of Treatment : 4 Years
    Primary Outcome Measure Information:
    Title
    Quadrivalent HPV vaccine is generally well tolerated when administered alone or concomitantly with hepatitis B vaccine.
    Secondary Outcome Measure Information:
    Title
    HPV vaccine is well tolerated in 16-23 year old females.

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    16 Years
    Maximum Age & Unit of Time
    23 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Females age 16 to 23 years old Must agree to refrain from sexual activity (vaginal or anal) for 48 hours prior to any scheduled visit Exclusion Criteria: History of vaccination with an HPV vaccine History of hepatitis B infection History of vaccination with hepatitis B vaccine History of genital warts or treatment for genital warts
    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

    Citations:
    PubMed Identifier
    18164106
    Citation
    Wheeler CM, Bautista OM, Tomassini JE, Nelson M, Sattler CA, Barr E; Protocol 11 study Investigators. Safety and immunogenicity of co-administered quadrivalent human papillomavirus (HPV)-6/11/16/18 L1 virus-like particle (VLP) and hepatitis B (HBV) vaccines. Vaccine. 2008 Jan 30;26(5):686-96. doi: 10.1016/j.vaccine.2007.11.043. Epub 2007 Dec 5.
    Results Reference
    background
    PubMed Identifier
    17955433
    Citation
    Giuliano AR, Lazcano-Ponce E, Villa L, Nolan T, Marchant C, Radley D, Golm G, McCarroll K, Yu J, Esser MT, Vuocolo SC, Barr E. Impact of baseline covariates on the immunogenicity of a quadrivalent (types 6, 11, 16, and 18) human papillomavirus virus-like-particle vaccine. J Infect Dis. 2007 Oct 15;196(8):1153-62. doi: 10.1086/521679. Epub 2007 Sep 17.
    Results Reference
    background
    Available IPD and Supporting Information:
    Available IPD/Information Type
    CSR Synopsis
    Available IPD/Information URL
    http://www.merck.com/clinical-trials/policies-perspectives.html

    Learn more about this trial

    Study to Test the Safety of HPV Vaccine in Women (V501-011)(COMPLETED)

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