<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/NCT01706302</url>
  </required_header>
  <id_info>
    <org_study_id>116357</org_study_id>
    <nct_id>NCT01706302</nct_id>
  </id_info>
  <brief_title>Burden of Respiratory Syncytial Virus (RSV) in the United Kingdom From 1995 to 2009</brief_title>
  <official_title>Burden of Respiratory Syncytial Virus (RSV) in the United Kingdom, 1995 to 2009</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GlaxoSmithKline</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sage Analytica</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>GlaxoSmithKline</source>
  <brief_summary>
    <textblock>
      The study will assess the burden of RSV-attributable general practice consultations,&#xD;
      hosptializations, and deaths by age and risk group in in United Kingdom from 1995 to 2009.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This epidemiological study is based on an already existing database of time series regression&#xD;
      modeling outputs generated during the generated by EPI-FLU-018 BOD UK DB (116273) study,&#xD;
      which estimated the burden of influenza in terms of General Practitioner (GP) consultations,&#xD;
      hospitalizations, and deaths associated with various respiratory and non-respiratory&#xD;
      outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">November 2012</completion_date>
  <primary_completion_date type="Actual">November 2012</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Occurrence in the EPI-FLU-018 BOD UK DB results database of potentially RSV-attributable GP consultation, hospitalization or death associated with respiratory outcomes.</measure>
    <time_frame>From 1995 to 2009</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Occurrence in the EPI-FLU-018 BOD UK DB results database of potentially RSV-attributable GP consultation, hospitalization or death associated with non-respiratory outcomes.</measure>
    <time_frame>From 1995 to 2009</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence in the EPI-FLU-018 BOD UK DB results database of potentially RSV-attributable GP prescription of antibiotics relevant to respiratory disease, by age and risk group.</measure>
    <time_frame>From 1995 to 2009</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peak occurrence of potentially RSV-attributable hospitalizations and deaths in elderly and pediatric populations.</measure>
    <time_frame>From 1995 to 2009</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence of potentially RSV-attributable deaths among the total number of RSV-attributable hospitalizations and cases, by age and risk group.</measure>
    <time_frame>From 1995 to 2009</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1</enrollment>
  <condition>Respiratory Syncyctial Virus Vaccines</condition>
  <arm_group>
    <arm_group_label>Cohort Group</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Data collection</intervention_name>
    <description>The previous study has used four primary data sources: the General Practice Research Data (GPRD [recently re-named Clinical Practice Research Datalink (CPRD)], for mild outcomes), the Hospital Episode Statistics database (HES, for hospitalizations), the Office of National Statistics mortality database (ONS, for mortality), and weekly virology data from the Health Protection Agency (HPA). The extracted data are referred to as the EPI-FLU-018 BOD UK DB database. Weekly time series will be generated to estimate the RSV burden and characterize it in terms of incidence of GP consultations, hospitalizations and deaths for each of the respiratory and non-respiratory outcomes (including GP antibiotic prescriptions), stratified by age and risk group.</description>
    <arm_group_label>Cohort Group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects included in the 116273 study who were registered with an acceptable flag in the&#xD;
        CPRD, or with a potentially RSV-related event in the HES database or the ONS mortality&#xD;
        data.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        • Included in the EPI-FLU-018 BOD UK DB BOD UK DB (eTrack: 116273) study database. The&#xD;
        inclusion criterion for EPI-FLU-018 was registration with an acceptable flag in the CPRD,&#xD;
        or registration in the HES database or the ONS mortality data with a flu-related event.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        • Not Applicable&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>GSK Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>GlaxoSmithKline</affiliation>
  </overall_official>
  <verification_date>April 2013</verification_date>
  <study_first_submitted>October 11, 2012</study_first_submitted>
  <study_first_submitted_qc>October 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2012</study_first_posted>
  <last_update_submitted>April 25, 2013</last_update_submitted>
  <last_update_submitted_qc>April 25, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 29, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>General Practice Research Database</keyword>
  <keyword>Burden of Disease</keyword>
  <keyword>Clinical Practice Research Datalink</keyword>
  <keyword>Hospital Episode Statistics</keyword>
  <keyword>Office of National Statistics</keyword>
  <keyword>RSV</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Virus Diseases</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/NCT01706302
org study id: 116357
nct id: NCT01706302
lead sponsor: 
collaborator: 
The study will assess the burden of RSV-attributable general practice consultations,
      hosptializations, and deaths by age and risk group in in United Kingdom from 1995 to 2009.
This epidemiological study is based on an already existing database of time series regression
      modeling outputs generated during the generated by EPI-FLU-018 BOD UK DB (116273) study,
      which estimated the burden of influenza in terms of General Practitioner (GP) consultations,
      hospitalizations, and deaths associated with various respiratory and non-respiratory
      outcomes.
time perspective: Retrospective
measure: Occurrence in the EPI-FLU-018 BOD UK DB results database of potentially RSV-attributable GP consultation, hospitalization or death associated with respiratory outcomes.
time frame: From 1995 to 2009
measure: Occurrence in the EPI-FLU-018 BOD UK DB results database of potentially RSV-attributable GP consultation, hospitalization or death associated with non-respiratory outcomes.
time frame: From 1995 to 2009
measure: Occurrence in the EPI-FLU-018 BOD UK DB results database of potentially RSV-attributable GP prescription of antibiotics relevant to respiratory disease, by age and risk group.
time frame: From 1995 to 2009
measure: Peak occurrence of potentially RSV-attributable hospitalizations and deaths in elderly and pediatric populations.
time frame: From 1995 to 2009
measure: Occurrence of potentially RSV-attributable deaths among the total number of RSV-attributable hospitalizations and cases, by age and risk group.
time frame: From 1995 to 2009
arm group label: Cohort Group
intervention type: Other
intervention name: Data collection
description: The previous study has used four primary data sources: the General Practice Research Data (GPRD [recently re-named Clinical Practice Research Datalink (CPRD)], for mild outcomes), the Hospital Episode Statistics database (HES, for hospitalizations), the Office of National Statistics mortality database (ONS, for mortality), and weekly virology data from the Health Protection Agency (HPA). The extracted data are referred to as the EPI-FLU-018 BOD UK DB database. Weekly time series will be generated to estimate the RSV burden and characterize it in terms of incidence of GP consultations, hospitalizations and deaths for each of the respiratory and non-respiratory outcomes (including GP antibiotic prescriptions), stratified by age and risk group.
arm group label: Cohort Group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: GSK Clinical Trials
role: Study Director
affiliation: GlaxoSmithKline
responsible party type: Sponsor
mesh term: Virus Diseases