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Prevalence-based Health and Economic Model of the Bivalent Versus the Quadrivalent Human Papillomavirus (HPV) Vaccine

Primary Purpose

Human Papillomavirus Infection

Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Prevalence-based model
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an observational trial for Human Papillomavirus Infection focused on measuring Gardasil, Prevalence-model, Cervarix, economic, health

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Female subjects vaccinated with either HPV-1 or HPV-2 vaccines in Taiwan (hypothetical group).

Exclusion Criteria:

  • Not applicable.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Arm Label

    HPV-1 Group

    HPV-2 Group

    Arm Description

    Hypothetical group of women vaccinated with HPV-1 vaccine in Taiwan.

    Hypothetical group of women vaccinated with HPV-2 vaccine in Taiwan.

    Outcomes

    Primary Outcome Measures

    Annual number of lesions prevented by each vaccine
    Lesion related total cost averted by each vaccine
    Additional costs averted by HPV-1 vaccine compared to HPV-2 vaccine

    Secondary Outcome Measures

    Full Information

    First Posted
    September 27, 2012
    Last Updated
    October 4, 2012
    Sponsor
    GlaxoSmithKline
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01702337
    Brief Title
    Prevalence-based Health and Economic Model of the Bivalent Versus the Quadrivalent Human Papillomavirus (HPV) Vaccine
    Official Title
    Additional Health and Economic Impact of the Bivalent Versus the Quadrivalent HPV Vaccine in Taiwan: Results of a Prevalence-based Model
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    October 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2010 (undefined)
    Primary Completion Date
    February 2010 (Actual)
    Study Completion Date
    February 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    GlaxoSmithKline

    4. Oversight

    5. Study Description

    Brief Summary
    This study compares the health and economic impact of the bivalent HPV vaccine (HPV-1) and the quadrivalent HPV vaccine (HPV-2).
    Detailed Description
    This study uses a prevalence-based model (by using efficacy data from each vaccine's respective trials and published cost data for Taiwan) which estimates the differences in lesions, genital warts, cervical cancer and costs from a healthcare payer's perspective prevented between HPV-1 and HPV-2 vaccines during one year (when all women are vaccinated). It also analyses costs from a societal perspective.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Human Papillomavirus Infection
    Keywords
    Gardasil, Prevalence-model, Cervarix, economic, health

    7. Study Design

    Enrollment
    1 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    HPV-1 Group
    Arm Description
    Hypothetical group of women vaccinated with HPV-1 vaccine in Taiwan.
    Arm Title
    HPV-2 Group
    Arm Description
    Hypothetical group of women vaccinated with HPV-2 vaccine in Taiwan.
    Intervention Type
    Other
    Intervention Name(s)
    Prevalence-based model
    Intervention Description
    Static prevalence-based model to estimate vaccine effect over a one-year period at a steady state (when all women are fully vaccinated).
    Primary Outcome Measure Information:
    Title
    Annual number of lesions prevented by each vaccine
    Time Frame
    Over a one-year period
    Title
    Lesion related total cost averted by each vaccine
    Time Frame
    Over a one-year period
    Title
    Additional costs averted by HPV-1 vaccine compared to HPV-2 vaccine
    Time Frame
    Over a one-year period

    10. Eligibility

    Sex
    Female
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Female subjects vaccinated with either HPV-1 or HPV-2 vaccines in Taiwan (hypothetical group). Exclusion Criteria: Not applicable.
    Study Population Description
    Hypothetical group of women vaccinated with either HPV-1 or HPV-2 vaccines in Taiwan.
    Sampling Method
    Non-Probability Sample
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    GSK Clinical Trials
    Organizational Affiliation
    GlaxoSmithKline
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    Citation
    ADDITIONAL HEALTH AND ECONOMIC IMPACT OF THE BIVALENT VERSUS THE QUADRIVALENT HPV VACCINE IN TAIWAN: RESULTS OF A PREVALENCE-BASED MODEL, Ho. T.H., van Enckevort, P.J. & Demarteau, N. Poster presented at: ISPOR, 4th Asia-Pacific Conference, 5-7 September 2010, Phuket, Thailand.
    Results Reference
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    Learn more about this trial

    Prevalence-based Health and Economic Model of the Bivalent Versus the Quadrivalent Human Papillomavirus (HPV) Vaccine

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