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Broad Spectrum HPV (Human Papillomavirus) Vaccine in 16 to 26 Year Old Women (V505-001)

Primary Purpose

Cervical Cancer, Vulvar Cancer, Vaginal Cancer

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Comparator: V505 formulation 1
Comparator: V505 formulation 2
Comparator: V505 formulation 2
Comparator: V505 formulation 3
Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant
Comparator: Placebo (unspecified)
Sponsored by
Merck Sharp & Dohme LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cervical Cancer

Eligibility Criteria

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

Inclusion Criteria:

  • Female between 16 to 26 years old
  • Has never had Pap testing or have only had normal Pap test results
  • Lifetime history of 0 to 4 sexual partners

Exclusion Criteria:

  • History of an abnormal cervical biopsy result; History of a positive test for HPV; History of external genital/vaginal warts; Currently a user of any illegal drugs or an alcohol abuser
  • History of severe allergic reaction that required medical attention
  • Are pregnant
  • Received a marketed HPV vaccine
  • Currently enrolled in a 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 time of consent)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm Type

    Active Comparator

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    1

    2

    3

    4

    5

    Arm Description

    Arm 1: 0.5 ml injection of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine as 3 dose regimen.

    Arm 2: 0.5 ml injection of V505 formulation 1 as 3 dose regimen.

    Arm 3: 0.5 ml injection of V505 formulation 2 as 3 dose regimen

    Arm 4: 0.5 ml injection of V505 formulation 2 as 2 dose regimen and 1 Pbo injection

    Arm 5: 0.5 ml injection of V505 formulation 3 as 2 dose regimen and 1 Pbo injection

    Outcomes

    Primary Outcome Measures

    Geometric mean titers (GMTs) to HPV types contained in the vaccines administered in a 3-dose regimen

    Secondary Outcome Measures

    Geometric mean titers (GMTs) to HPV types contained in the vaccines administered in a 2-dose regimen

    Full Information

    First Posted
    August 22, 2007
    Last Updated
    November 25, 2015
    Sponsor
    Merck Sharp & Dohme LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00520598
    Brief Title
    Broad Spectrum HPV (Human Papillomavirus) Vaccine in 16 to 26 Year Old Women (V505-001)
    Official Title
    A Phase IIa Randomized, Double-Blind Controlled With Gardasil, Clinical Trial to Study theTolerability and Immunogenicity of V505 (a Multivalent Human Papilloma Virus [HPV] L1 Virus Like Particle [VLP] Vaccine) in Healthy 16 to 26 Year Old Women
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2007 (undefined)
    Primary Completion Date
    May 2011 (Actual)
    Study Completion Date
    May 2011 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate the safety and immunogenicity of V505 in comparison to GARDASIL (TM)

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cervical Cancer, Vulvar Cancer, Vaginal Cancer, Genital Warts, Human Papillomavirus Infection

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    511 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Active Comparator
    Arm Description
    Arm 1: 0.5 ml injection of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine as 3 dose regimen.
    Arm Title
    2
    Arm Type
    Experimental
    Arm Description
    Arm 2: 0.5 ml injection of V505 formulation 1 as 3 dose regimen.
    Arm Title
    3
    Arm Type
    Experimental
    Arm Description
    Arm 3: 0.5 ml injection of V505 formulation 2 as 3 dose regimen
    Arm Title
    4
    Arm Type
    Experimental
    Arm Description
    Arm 4: 0.5 ml injection of V505 formulation 2 as 2 dose regimen and 1 Pbo injection
    Arm Title
    5
    Arm Type
    Experimental
    Arm Description
    Arm 5: 0.5 ml injection of V505 formulation 3 as 2 dose regimen and 1 Pbo injection
    Intervention Type
    Biological
    Intervention Name(s)
    Comparator: V505 formulation 1
    Intervention Description
    0.5 ml injection of V505 formulation 1 as 3 dose regimen at Day 1, Month 2 and Month 6.
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: V505 formulation 2
    Intervention Description
    0.5 ml injection of V505 formulation 2 as 3 dose regimen at Day 1, Month 2 and Month 6.
    Intervention Type
    Drug
    Intervention Name(s)
    Comparator: V505 formulation 2
    Intervention Description
    0.5 ml injection of V505 formulation 2 as 2 dose regimen at Day 1 and Month 6.
    Intervention Type
    Biological
    Intervention Name(s)
    Comparator: V505 formulation 3
    Intervention Description
    0.5 ml injection of V505 formulation 3 as 2 dose regimen at Day 1 and Month 6.
    Intervention Type
    Biological
    Intervention Name(s)
    Comparator: Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant
    Intervention Description
    0.5 ml injection of Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine as 3 dose regimen at Day 1, Month 2 and Month 6.
    Intervention Type
    Biological
    Intervention Name(s)
    Comparator: Placebo (unspecified)
    Intervention Description
    0.5 ml injection of placebo to V505 as a 1 dose regimen at Month 2.
    Primary Outcome Measure Information:
    Title
    Geometric mean titers (GMTs) to HPV types contained in the vaccines administered in a 3-dose regimen
    Time Frame
    4 weeks post dose 3
    Secondary Outcome Measure Information:
    Title
    Geometric mean titers (GMTs) to HPV types contained in the vaccines administered in a 2-dose regimen
    Time Frame
    4 weeks post dose 2

    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 16 to 26 years old Has never had Pap testing or have only had normal Pap test results Lifetime history of 0 to 4 sexual partners Exclusion Criteria: History of an abnormal cervical biopsy result; History of a positive test for HPV; History of external genital/vaginal warts; Currently a user of any illegal drugs or an alcohol abuser History of severe allergic reaction that required medical attention Are pregnant Received a marketed HPV vaccine Currently enrolled in a 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 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 (Human Papillomavirus) Vaccine in 16 to 26 Year Old Women (V505-001)

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