<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/NCT01715792</url>
  </required_header>
  <id_info>
    <org_study_id>116602</org_study_id>
    <nct_id>NCT01715792</nct_id>
  </id_info>
  <brief_title>Assess the Risk of Solid Organ Transplant Rejection Following Vaccination With Pandemrix™ in UK</brief_title>
  <official_title>Risk of Solid Organ Transplant Rejection Following Vaccination With Pandemrix™ in the United Kingdom</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 assess the risk of solid organ transplant (SOT) rejection following&#xD;
      vaccination with Pandemrix™ and/ or seasonal influenza vaccination.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Data on the safety of pandemic H1N1 vaccination in transplanted patients is relatively&#xD;
      limited; to date, although some studies showed transient increases in alloreactivity, there&#xD;
      is no evidence that H1N1 vaccines caused clinical rejection or organ dysfunction. In&#xD;
      addition, studies have shown that influenza infection is a known independent risk factors for&#xD;
      rejection. Considering that transplant recipients are a target population for immunisation&#xD;
      with future pandemic vaccines, it is important to investigate the risk of rejection following&#xD;
      vaccination in this patient population.&#xD;
&#xD;
      Using the self-controlled case series design that allows to control implicitly for potential&#xD;
      confounding factors, this study aims at investigating the risk of solid organ transplant&#xD;
      rejection (liver, kidney, lung, heart, pancreas) following vaccination with Pandemrix™ in the&#xD;
      United Kingdom Clinical Practice Research Datalink GP Online Database (CPRD GOLD). Data from&#xD;
      the Hospital Episodes Statistics database will also be used. The effect of seasonal influenza&#xD;
      vaccination and of various infections including influenza H1N1 will also be explored.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 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>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Assessment of the risk of solid organ transplant rejection (liver, kidney, lung, heart, pancreas).</measure>
    <time_frame>Within one month after vaccination with Pandemrix™ (from 01 October 2009 to 31 October 2010).</time_frame>
    <description>Assessed by case data collection from CPRD GOLD and HES, and additional data obtained from complementary information provided by the GPs using a standardised questionnaire.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessment of the risk of solid organ transplant rejection (liver, kidney, lung, heart, pancreas).</measure>
    <time_frame>Within two months after vaccination with Pandemrix™ ( from 01 October 2009 to 31 October 2010).</time_frame>
    <description>Assessed by case data collection from CPRD GOLD and HES, and additional data obtained from complementary information provided by the GPs using a standardised questionnaire.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">587</enrollment>
  <condition>Influenza</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <description>Subject defined as acceptable in the CPRD GOLD with at least one solid organ transplant rejection reported during the overall study period (01 September to 31 October 2010).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Data collection</intervention_name>
    <description>Data extraction from the CPRD GOLD and HES, and additional data obtained from complementary information provided by the GPs using a standardised questionnaire.</description>
    <arm_group_label>Group 1</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Subject defined as acceptable in the CPRD GOLD with at least one solid organ transplant&#xD;
        rejection reported during the overall study periods (01 September 2006 to 31 October 2010).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject defined as acceptable in the CPRD GOLD.&#xD;
&#xD;
          -  Subject with at least one solid organ transplant rejection reported in the CPRD GOLD&#xD;
             and/or HES during the overall study periods (01 September 2006 to 31 October 2010).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        • Subject from HES matched to more than one subject in the CPRD GOLD.&#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>
  <location>
    <facility>
      <name>GSK Investigational Site</name>
      <address>
        <city>London</city>
        <zip>SW1W 9SZ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>February 2014</verification_date>
  <study_first_submitted>October 25, 2012</study_first_submitted>
  <study_first_submitted_qc>October 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 29, 2012</study_first_posted>
  <last_update_submitted>February 6, 2014</last_update_submitted>
  <last_update_submitted_qc>February 6, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 10, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Solid organ transplant rejection</keyword>
  <keyword>United Kingdom</keyword>
  <keyword>Influenza</keyword>
  <keyword>H1N1</keyword>
  <keyword>Pandemrix™</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Influenza, Human</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/NCT01715792
org study id: 116602
nct id: NCT01715792
lead sponsor: 
This study aims to assess the risk of solid organ transplant (SOT) rejection following
      vaccination with Pandemrix™ and/ or seasonal influenza vaccination.
Data on the safety of pandemic H1N1 vaccination in transplanted patients is relatively
      limited; to date, although some studies showed transient increases in alloreactivity, there
      is no evidence that H1N1 vaccines caused clinical rejection or organ dysfunction. In
      addition, studies have shown that influenza infection is a known independent risk factors for
      rejection. Considering that transplant recipients are a target population for immunisation
      with future pandemic vaccines, it is important to investigate the risk of rejection following
      vaccination in this patient population.

      Using the self-controlled case series design that allows to control implicitly for potential
      confounding factors, this study aims at investigating the risk of solid organ transplant
      rejection (liver, kidney, lung, heart, pancreas) following vaccination with Pandemrix™ in the
      United Kingdom Clinical Practice Research Datalink GP Online Database (CPRD GOLD). Data from
      the Hospital Episodes Statistics database will also be used. The effect of seasonal influenza
      vaccination and of various infections including influenza H1N1 will also be explored.
time perspective: Retrospective
measure: Assessment of the risk of solid organ transplant rejection (liver, kidney, lung, heart, pancreas).
time frame: Within one month after vaccination with Pandemrix™ (from 01 October 2009 to 31 October 2010).
description: Assessed by case data collection from CPRD GOLD and HES, and additional data obtained from complementary information provided by the GPs using a standardised questionnaire.
measure: Assessment of the risk of solid organ transplant rejection (liver, kidney, lung, heart, pancreas).
time frame: Within two months after vaccination with Pandemrix™ ( from 01 October 2009 to 31 October 2010).
description: Assessed by case data collection from CPRD GOLD and HES, and additional data obtained from complementary information provided by the GPs using a standardised questionnaire.
arm group label: Group 1
description: Subject defined as acceptable in the CPRD GOLD with at least one solid organ transplant rejection reported during the overall study period (01 September to 31 October 2010).
intervention type: Other
intervention name: Data collection
description: Data extraction from the CPRD GOLD and HES, and additional data obtained from complementary information provided by the GPs using a standardised questionnaire.
arm group label: Group 1
study pop: 
sampling method: 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
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Influenza, Human