<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/NCT01682005</url>
  </required_header>
  <id_info>
    <org_study_id>116829</org_study_id>
    <nct_id>NCT01682005</nct_id>
  </id_info>
  <brief_title>Study to Analyze the Clinical and Cost Impact of Complete and Incomplete Rotavirus (RV) Vaccination</brief_title>
  <official_title>Clinical and Cost Impact of Complete and Incomplete Rotavirus Vaccination</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GlaxoSmithKline</source>
  <brief_summary>
    <textblock>
      This study aims to estimate the clinical and cost impact of RV vaccinations (both Rotateq®&#xD;
      and Rotarix®) among children aged less than 5 years using insurance claims data from&#xD;
      commercial plans and Medicaid low-income population. The impact of incomplete and complete RV&#xD;
      vaccination will also be examined, overall and stratified by age (e.g., 6 weeks to 8 months,&#xD;
      8 months and onwards ) and calendar time of RV vaccination (e.g., 2006 onward).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Insurance claims data from the MarketScan Commercial Claims and Encounters Database&#xD;
      {MarketScan Commercial (2000-2011[Q2])} and the MarketScan Multi-State Medicaid Database&#xD;
      {Marketscan Medicaid (2002-2010)} will be analyzed separately; no merging of the databases&#xD;
      will occur.&#xD;
&#xD;
      The claims data extracts are fully de-identified and compliant with the Health Insurance&#xD;
      Portability and Accountability Act of 1996 (U.S.) (HIPAA).&#xD;
&#xD;
      For children who received at least 1 RV vaccine dose within the Advisory Committee on&#xD;
      Immunization Practices (ACIP)-specified vaccination window of 6 weeks to 8 months old, their&#xD;
      observation time will be divided into three RV-vaccinated cohorts: any RV vaccination before&#xD;
      8 months (i.e., during the vaccination window between 6 weeks and 8 months old); complete RV&#xD;
      vaccination (i.e., after 8 months old); and incomplete RV vaccination (i.e., after 8 months&#xD;
      old). For children who did not receive any RV vaccine dose within the vaccination window,&#xD;
      their observation time will be divided into four control cohorts: historical (i.e., before RV&#xD;
      vaccines were available) unvaccinated on/before 8 months old; contemporary (i.e., after RV&#xD;
      vaccines were available) unvaccinated on/before 8 months old; historical unvaccinated after 8&#xD;
      months old; and contemporary unvaccinated after 8 months old.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">August 2013</completion_date>
  <primary_completion_date type="Actual">August 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Estimation of the clinical impact of complete and incomplete RV vaccination among children less than 5 years of age by determining the incidence of first RV episode.</measure>
    <time_frame>During the study period (from January 2000 up to June 2011), an expected average of 1 year and 6 months.</time_frame>
    <description>Each RV episode will last from 14 days before the first RV-coded claim to 14 days after the last RV-coded claim, unless censored by birth at the start and/or by end of observation at the end. For each cohort, incidence rates will be calculated as the number of first RV episodes that occurred divided by the cohort's person-years of observation censored at the start of first RV episodes.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Estimation of the clinical impact of complete and incomplete RV vaccination among children less than 5 years of age by calculating the RV-related resource utilization.</measure>
    <time_frame>During the study period (from January 2000 up to June 2011), an expected average of 1 year and 6 months.</time_frame>
    <description>For each cohort, utilization rates will be calculated as the number of RV-related hospitalizations, ER visits, and outpatient visits utilized divided by the cohort's total person-years of observation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Estimation of the clinical impact of complete and incomplete RV vaccination among children less than 5 years of age by calculating the diarrhea-related resource utilization.</measure>
    <time_frame>During the study period (from January 2000 up to June 2011), an expected average of 1 year and 6 months.</time_frame>
    <description>For each cohort, utilization rates will be calculated as the number of diarrhea-related hospitalizations, ER visits, and outpatient visits utilized divided by the cohort's total person-years of observation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Estimation of the cost impact of complete and incomplete RV vaccination among children less than 5 years of age by determining the first RV episode costs.</measure>
    <time_frame>During the study period (from January 2000 up to June 2011), an expected average of 1 year and 6 months.</time_frame>
    <description>Costs will be reported on a per-patient per-month (PPPM) basis, using the episode duration in person-months as the weight. For each cohort, an average PPPM cost of first RV episodes will be calculated.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Estimation of the cost impact of complete and incomplete RV vaccination among children less than 5 years of age by calculating the RV-related healthcare costs.</measure>
    <time_frame>During the study period (from January 2000 up to June 2011), an expected average of 1 year and 6 months.</time_frame>
    <description>For each cohort, total RV-related per-patient per-year (PPPY) costs will be calculated as the total cost of RV-related hospitalizations, ER visits, and outpatient visits utilized divided by the cohort's total person-years of observation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Estimation of the cost impact of complete and incomplete RV vaccination among children less than 5 years of age by calculating the diarrhea-related healthcare costs.</measure>
    <time_frame>During the study period (from January 2000 up to June 2011), an expected average of 1 year and 6 months.</time_frame>
    <description>For each cohort, total diarrhea-related PPPY costs will be calculated as the total cost of diarrhea-related hospitalizations, ER visits, and outpatient visits utilized divided by the cohort's total person-years of observation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Estimation of the clinical impact of complete and incomplete RV vaccination among children less than 5 years of age by calculating the first diarrhea episode costs.</measure>
    <time_frame>During the study period (from 2000 up to June 2011).</time_frame>
  </primary_outcome>
  <number_of_groups>7</number_of_groups>
  <enrollment type="Actual">1</enrollment>
  <condition>Infections, Rotavirus</condition>
  <arm_group>
    <arm_group_label>Complete RV vaccination</arm_group_label>
    <description>Subjects had received 2 doses of Rotarix or 3 doses of Rotateq/mixed within the vaccination window and the observation time is from the end of the vaccination window (8 months old) to end of observation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Incomplete RV vaccination</arm_group_label>
    <description>Subjects received at least one vaccination but less than complete vaccination has been received within the vaccination window and the observation time from 8 months old (if still observed) to end of observation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Any RV vaccination before 8 months</arm_group_label>
    <description>Subjects received any vaccination within the vaccination window and the observation time from 6 weeks old to earliest of end of observation or 8 months old.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Historical unvaccinated on/before 8 months old</arm_group_label>
    <description>Subjects did not receive any RV vaccination within the vaccination window and the observation time is from 6 weeks old (if still observed and on/before 12/31/06) to earliest of: 12/31/2006, end of observation, or 8 months old.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Historical unvaccinated after 8 months old</arm_group_label>
    <description>Subjects did not receive any RV vaccination within the vaccination window and observation time is from 8 months old (if still observed and on/before 12/31/2006) to earliest of: 12/31/2006 or end of observation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Contemporary unvaccinated on/before 8 months old</arm_group_label>
    <description>Subjects did not receive any RV vaccination within the vaccination window and observation time is from 6 weeks old (if on/after 01/01/2007) to earliest of: end of observation, or 8 months old.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Contemporary unvaccinated after 8 months old</arm_group_label>
    <description>Subjects did not receive any RV vaccination within the vaccination window observation time is from 8 months old (if on/after 01/01/2007) to end of observation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Data interpretation</intervention_name>
    <description>The data collected for each group will be fully de-identified, interpreted and analysed separately for the 2 databases (MarketScan Commercial and MarketScan Medicaid).</description>
    <arm_group_label>Any RV vaccination before 8 months</arm_group_label>
    <arm_group_label>Complete RV vaccination</arm_group_label>
    <arm_group_label>Contemporary unvaccinated after 8 months old</arm_group_label>
    <arm_group_label>Contemporary unvaccinated on/before 8 months old</arm_group_label>
    <arm_group_label>Historical unvaccinated after 8 months old</arm_group_label>
    <arm_group_label>Historical unvaccinated on/before 8 months old</arm_group_label>
    <arm_group_label>Incomplete RV vaccination</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Children less than 5 years old continuously enrolled in commercial insurance or Medicaid&#xD;
        from birth, and received both medical and pharmacy benefits.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Continuously enrolled from birth. (Note: Due to the absence of birth dates in&#xD;
             insurance claims data, this inclusion criterion will be met if a child's year of first&#xD;
             enrollment and year of birth are the same. If so, then the date of first enrollment&#xD;
             will be used as proxy for date of birth.)&#xD;
&#xD;
          -  Received both medical and pharmacy benefits.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Enrolled in capitation-based health plans.&#xD;
&#xD;
          -  For MarketScan Commercial, residence in states with universal vaccination programs&#xD;
             that include the RV vaccine or where RV vaccine inclusion cannot be ascertained (i.e.,&#xD;
             Alaska, Idaho, Massachusetts, Maine, North Dakota, New Hampshire, New Mexico, Oregon,&#xD;
             Rhode Island, Vermont, Washington, Wisconsin, and Wyoming).&#xD;
&#xD;
          -  Lost to follow-up or had RV prior to 6 weeks of age.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>5 Years</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>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>September 6, 2012</study_first_submitted>
  <study_first_submitted_qc>September 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2012</study_first_posted>
  <last_update_submitted>August 28, 2014</last_update_submitted>
  <last_update_submitted_qc>August 28, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 1, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cost</keyword>
  <keyword>Children</keyword>
  <keyword>Rotavirus</keyword>
  <keyword>Rotavirus vaccination</keyword>
  <keyword>Clinical</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rotavirus 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/NCT01682005
org study id: 116829
nct id: NCT01682005
lead sponsor: 
This study aims to estimate the clinical and cost impact of RV vaccinations (both Rotateq®
      and Rotarix®) among children aged less than 5 years using insurance claims data from
      commercial plans and Medicaid low-income population. The impact of incomplete and complete RV
      vaccination will also be examined, overall and stratified by age (e.g., 6 weeks to 8 months,
      8 months and onwards ) and calendar time of RV vaccination (e.g., 2006 onward).
Insurance claims data from the MarketScan Commercial Claims and Encounters Database
      {MarketScan Commercial (2000-2011[Q2])} and the MarketScan Multi-State Medicaid Database
      {Marketscan Medicaid (2002-2010)} will be analyzed separately; no merging of the databases
      will occur.

      The claims data extracts are fully de-identified and compliant with the Health Insurance
      Portability and Accountability Act of 1996 (U.S.) (HIPAA).

      For children who received at least 1 RV vaccine dose within the Advisory Committee on
      Immunization Practices (ACIP)-specified vaccination window of 6 weeks to 8 months old, their
      observation time will be divided into three RV-vaccinated cohorts: any RV vaccination before
      8 months (i.e., during the vaccination window between 6 weeks and 8 months old); complete RV
      vaccination (i.e., after 8 months old); and incomplete RV vaccination (i.e., after 8 months
      old). For children who did not receive any RV vaccine dose within the vaccination window,
      their observation time will be divided into four control cohorts: historical (i.e., before RV
      vaccines were available) unvaccinated on/before 8 months old; contemporary (i.e., after RV
      vaccines were available) unvaccinated on/before 8 months old; historical unvaccinated after 8
      months old; and contemporary unvaccinated after 8 months old.
observational model: Cohort
time perspective: Retrospective
measure: Estimation of the clinical impact of complete and incomplete RV vaccination among children less than 5 years of age by determining the incidence of first RV episode.
time frame: During the study period (from January 2000 up to June 2011), an expected average of 1 year and 6 months.
description: Each RV episode will last from 14 days before the first RV-coded claim to 14 days after the last RV-coded claim, unless censored by birth at the start and/or by end of observation at the end. For each cohort, incidence rates will be calculated as the number of first RV episodes that occurred divided by the cohort's person-years of observation censored at the start of first RV episodes.
measure: Estimation of the clinical impact of complete and incomplete RV vaccination among children less than 5 years of age by calculating the RV-related resource utilization.
time frame: During the study period (from January 2000 up to June 2011), an expected average of 1 year and 6 months.
description: For each cohort, utilization rates will be calculated as the number of RV-related hospitalizations, ER visits, and outpatient visits utilized divided by the cohort's total person-years of observation.
measure: Estimation of the clinical impact of complete and incomplete RV vaccination among children less than 5 years of age by calculating the diarrhea-related resource utilization.
time frame: During the study period (from January 2000 up to June 2011), an expected average of 1 year and 6 months.
description: For each cohort, utilization rates will be calculated as the number of diarrhea-related hospitalizations, ER visits, and outpatient visits utilized divided by the cohort's total person-years of observation.
measure: Estimation of the cost impact of complete and incomplete RV vaccination among children less than 5 years of age by determining the first RV episode costs.
time frame: During the study period (from January 2000 up to June 2011), an expected average of 1 year and 6 months.
description: Costs will be reported on a per-patient per-month (PPPM) basis, using the episode duration in person-months as the weight. For each cohort, an average PPPM cost of first RV episodes will be calculated.
measure: Estimation of the cost impact of complete and incomplete RV vaccination among children less than 5 years of age by calculating the RV-related healthcare costs.
time frame: During the study period (from January 2000 up to June 2011), an expected average of 1 year and 6 months.
description: For each cohort, total RV-related per-patient per-year (PPPY) costs will be calculated as the total cost of RV-related hospitalizations, ER visits, and outpatient visits utilized divided by the cohort's total person-years of observation.
measure: Estimation of the cost impact of complete and incomplete RV vaccination among children less than 5 years of age by calculating the diarrhea-related healthcare costs.
time frame: During the study period (from January 2000 up to June 2011), an expected average of 1 year and 6 months.
description: For each cohort, total diarrhea-related PPPY costs will be calculated as the total cost of diarrhea-related hospitalizations, ER visits, and outpatient visits utilized divided by the cohort's total person-years of observation.
measure: Estimation of the clinical impact of complete and incomplete RV vaccination among children less than 5 years of age by calculating the first diarrhea episode costs.
time frame: During the study period (from 2000 up to June 2011).
arm group label: Complete RV vaccination
description: Subjects had received 2 doses of Rotarix or 3 doses of Rotateq/mixed within the vaccination window and the observation time is from the end of the vaccination window (8 months old) to end of observation.
arm group label: Incomplete RV vaccination
description: Subjects received at least one vaccination but less than complete vaccination has been received within the vaccination window and the observation time from 8 months old (if still observed) to end of observation.
arm group label: Any RV vaccination before 8 months
description: Subjects received any vaccination within the vaccination window and the observation time from 6 weeks old to earliest of end of observation or 8 months old.
arm group label: Historical unvaccinated on/before 8 months old
description: Subjects did not receive any RV vaccination within the vaccination window and the observation time is from 6 weeks old (if still observed and on/before 12/31/06) to earliest of: 12/31/2006, end of observation, or 8 months old.
arm group label: Historical unvaccinated after 8 months old
description: Subjects did not receive any RV vaccination within the vaccination window and observation time is from 8 months old (if still observed and on/before 12/31/2006) to earliest of: 12/31/2006 or end of observation.
arm group label: Contemporary unvaccinated on/before 8 months old
description: Subjects did not receive any RV vaccination within the vaccination window and observation time is from 6 weeks old (if on/after 01/01/2007) to earliest of: end of observation, or 8 months old.
arm group label: Contemporary unvaccinated after 8 months old
description: Subjects did not receive any RV vaccination within the vaccination window observation time is from 8 months old (if on/after 01/01/2007) to end of observation.
intervention type: Other
intervention name: Data interpretation
description: The data collected for each group will be fully de-identified, interpreted and analysed separately for the 2 databases (MarketScan Commercial and MarketScan Medicaid).
arm group label: Any RV vaccination before 8 months
arm group label: Complete RV vaccination
arm group label: Contemporary unvaccinated after 8 months old
arm group label: Contemporary unvaccinated on/before 8 months old
arm group label: Historical unvaccinated after 8 months old
arm group label: Historical unvaccinated on/before 8 months old
arm group label: Incomplete RV vaccination
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 5 Years
healthy volunteers: Accepts Healthy Volunteers
last name: GSK Clinical Trials
role: Study Director
affiliation: GlaxoSmithKline
responsible party type: Sponsor
mesh term: Rotavirus Infections