xml: <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/NCT06035926</url>
    </required_header>
    <id_info>
      <org_study_id>EC number: 34-326 ex 21/22</org_study_id>
      <nct_id>NCT06035926</nct_id>
    </id_info>
    <brief_title>Survey of Symptoms After a COVID Vaccination in Employees</brief_title>
    <official_title>Survey of Symptoms After a COVID Vaccination in Employees: a Retrospective Study.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Medical University of Graz</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Medical University of Graz</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Background:&#xD;
  &#xD;
        SARS-CoV-2 (Severe acute respiratory syndrome coronavirus type 2) has had us firmly in its&#xD;
        grip for more than two years. In January 2021, the quality and risk management unit of the&#xD;
        LKH (Landeskrankenhaus) -Univ. Klinikum Graz commissioned to carry out vaccinations for&#xD;
        employees and subsequently for high-risk patients.&#xD;
  &#xD;
        In the vaccination line, which was open for 85 days in 2021/22, the vaccines from Astra&#xD;
        Zeneca, Biontech-Pfizer and Moderna were vaccinated. There were hardly any complications. The&#xD;
        primary immunization, booster vaccination and booster vaccination were carried out.&#xD;
  &#xD;
        Despite the small number of incidents in the sense of an immediate reaction, there were&#xD;
        numerous sick leave.&#xD;
  &#xD;
        Methods:&#xD;
  &#xD;
        For this reason, in the course of the booster vaccination, starting from October 2021 to&#xD;
        January 2022, every vaccinated person was asked to fill out a questionnaire. Participation&#xD;
        was voluntary and was supported by the works councils of the Medical University and the&#xD;
        LKH-University clinic Graz approved. The survey served to retrospectively record how many&#xD;
        employees developed symptoms in response to the respective vaccination.&#xD;
  &#xD;
        With this approach it will be possible to subject the responses to an in-depth statistical&#xD;
        analysis in order to obtain a data-based contribution to the side effects of vaccines&#xD;
        categorized with different vaccination schemes.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 1, 2021</start_date>
    <completion_date type="Actual">July 31, 2023</completion_date>
    <primary_completion_date type="Actual">July 31, 2023</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>Occurrence of symptoms after the respective vaccination</measure>
      <time_frame>10 Minutes</time_frame>
      <description>Occurence of symptoms, assessed by a questionnaire</description>
    </primary_outcome>
    <enrollment type="Actual">1093</enrollment>
    <condition>Symptoms Recoding SARS-CoV-2 After Vaccination</condition>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>questionnaire</intervention_name>
      <description>questionnaire</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Employees of the University Clinic Graz who get a booster vaccination.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Employees with appropriate indication (&gt;4 months after the second vaccination)&#xD;
               according to the recommendations of the national vaccination committee.&#xD;
  &#xD;
            -  Signed vaccination information sheet.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  no booster vaccination.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>16 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Medical University of Graz</name>
        <address>
          <city>Graz</city>
          <state>Styria</state>
          <zip>8036</zip>
          <country>Austria</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Austria</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 28, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>SARS-CoV-2</keyword>
    <keyword>Symptoms</keyword>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06035926
  org study id: EC number: 34-326 ex 21/22
  nct id: NCT06035926
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Background:
  
        SARS-CoV-2 (Severe acute respiratory syndrome coronavirus type 2) has had us firmly in its
        grip for more than two years. In January 2021, the quality and risk management unit of the
        LKH (Landeskrankenhaus) -Univ. Klinikum Graz commissioned to carry out vaccinations for
        employees and subsequently for high-risk patients.
  
        In the vaccination line, which was open for 85 days in 2021/22, the vaccines from Astra
        Zeneca, Biontech-Pfizer and Moderna were vaccinated. There were hardly any complications. The
        primary immunization, booster vaccination and booster vaccination were carried out.
  
        Despite the small number of incidents in the sense of an immediate reaction, there were
        numerous sick leave.
  
        Methods:
  
        For this reason, in the course of the booster vaccination, starting from October 2021 to
        January 2022, every vaccinated person was asked to fill out a questionnaire. Participation
        was voluntary and was supported by the works councils of the Medical University and the
        LKH-University clinic Graz approved. The survey served to retrospectively record how many
        employees developed symptoms in response to the respective vaccination.
  
        With this approach it will be possible to subject the responses to an in-depth statistical
        analysis in order to obtain a data-based contribution to the side effects of vaccines
        categorized with different vaccination schemes.
  observational model: Cohort
  time perspective: Retrospective
  measure: Occurrence of symptoms after the respective vaccination
  time frame: 10 Minutes
  description: Occurence of symptoms, assessed by a questionnaire
  intervention type: Other
  intervention name: questionnaire
  description: questionnaire
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 16 Years
  maximum age: 75 Years
  healthy volunteers: No
  facility: 
  country: Austria
  responsible party type: Sponsor
  sharing ipd: Undecided