<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01702337</url>
  </required_header>
  <id_info>
    <org_study_id>114420</org_study_id>
    <nct_id>NCT01702337</nct_id>
  </id_info>
  <brief_title>Prevalence-based Health and Economic Model of the Bivalent Versus the Quadrivalent Human Papillomavirus (HPV) Vaccine</brief_title>
  <official_title>Additional Health and Economic Impact of the Bivalent Versus the Quadrivalent HPV Vaccine in Taiwan: Results of a Prevalence-based Model</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GlaxoSmithKline</source>
  <brief_summary>
    <textblock>
      This study compares the health and economic impact of the bivalent HPV vaccine (HPV-1) and&#xD;
      the quadrivalent HPV vaccine (HPV-2).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study uses a prevalence-based model (by using efficacy data from each vaccine's&#xD;
      respective trials and published cost data for Taiwan) which estimates the differences in&#xD;
      lesions, genital warts, cervical cancer and costs from a healthcare payer's perspective&#xD;
      prevented between HPV-1 and HPV-2 vaccines during one year (when all women are vaccinated).&#xD;
      It also analyses costs from a societal perspective.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2010</start_date>
  <completion_date type="Actual">February 2010</completion_date>
  <primary_completion_date type="Actual">February 2010</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <primary_outcome>
    <measure>Annual number of lesions prevented by each vaccine</measure>
    <time_frame>Over a one-year period</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Lesion related total cost averted by each vaccine</measure>
    <time_frame>Over a one-year period</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Additional costs averted by HPV-1 vaccine compared to HPV-2 vaccine</measure>
    <time_frame>Over a one-year period</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">1</enrollment>
  <condition>Human Papillomavirus Infection</condition>
  <arm_group>
    <arm_group_label>HPV-1 Group</arm_group_label>
    <description>Hypothetical group of women vaccinated with HPV-1 vaccine in Taiwan.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HPV-2 Group</arm_group_label>
    <description>Hypothetical group of women vaccinated with HPV-2 vaccine in Taiwan.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Prevalence-based model</intervention_name>
    <description>Static prevalence-based model to estimate vaccine effect over a one-year period at a steady state (when all women are fully vaccinated).</description>
    <arm_group_label>HPV-1 Group</arm_group_label>
    <arm_group_label>HPV-2 Group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Hypothetical group of women vaccinated with either HPV-1 or HPV-2 vaccines in Taiwan.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female subjects vaccinated with either HPV-1 or HPV-2 vaccines in Taiwan (hypothetical&#xD;
             group).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not applicable.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>GSK Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>GlaxoSmithKline</affiliation>
  </overall_official>
  <reference>
    <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. &amp; Demarteau, N. Poster presented at: ISPOR, 4th Asia-Pacific Conference, 5-7 September 2010, Phuket, Thailand.</citation>
  </reference>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>September 27, 2012</study_first_submitted>
  <study_first_submitted_qc>October 4, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 8, 2012</study_first_posted>
  <last_update_submitted>October 4, 2012</last_update_submitted>
  <last_update_submitted_qc>October 4, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 8, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Gardasil</keyword>
  <keyword>Prevalence-model</keyword>
  <keyword>Cervarix</keyword>
  <keyword>economic</keyword>
  <keyword>health</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Papillomavirus Infections</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01702337
org study id: 114420
nct id: NCT01702337
lead sponsor: 
This study compares the health and economic impact of the bivalent HPV vaccine (HPV-1) and
      the quadrivalent HPV vaccine (HPV-2).
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.
measure: Annual number of lesions prevented by each vaccine
time frame: Over a one-year period
measure: Lesion related total cost averted by each vaccine
time frame: Over a one-year period
measure: Additional costs averted by HPV-1 vaccine compared to HPV-2 vaccine
time frame: Over a one-year period
arm group label: HPV-1 Group
description: Hypothetical group of women vaccinated with HPV-1 vaccine in Taiwan.
arm group label: HPV-2 Group
description: Hypothetical group of women vaccinated with HPV-2 vaccine in Taiwan.
intervention type: Other
intervention name: Prevalence-based model
description: Static prevalence-based model to estimate vaccine effect over a one-year period at a steady state (when all women are fully vaccinated).
arm group label: HPV-1 Group
arm group label: HPV-2 Group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: GSK Clinical Trials
role: Study Director
affiliation: GlaxoSmithKline
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.
responsible party type: Sponsor
mesh term: Papillomavirus Infections