<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/NCT03266211</url>
  </required_header>
  <id_info>
    <org_study_id>69HCL17_0375</org_study_id>
    <nct_id>NCT03266211</nct_id>
  </id_info>
  <brief_title>Antitetanus Vaccination for People Older Than 65 Years.</brief_title>
  <acronym>VAT65</acronym>
  <official_title>Antitetanus Vaccination for People Older Than 65 Years in the Auvergne-Rhône-Alpes (France) Region Depending on the Demographic and Medical Practice of Their Medical Practitioner.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospices Civils de Lyon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospices Civils de Lyon</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>
      In the last ten years, more than one hundred generalized tetanus cases were declared in&#xD;
      France. Most of them were affecting people older than 70 years with an important mortality&#xD;
      (around 28%). It is know that the only way to protect ourselves from this disease is the&#xD;
      vaccination. In France tetanus vaccination is mandatory since 1940.&#xD;
&#xD;
      Nowaday none study looked specifically for the vaccination of people older than 65 years. The&#xD;
      hypothesis is: there is a difference in the tetanus vaccination coverage for people older&#xD;
      than 65 years depending on the demographic and medical practice of their general&#xD;
      practitioner.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 9, 2017</start_date>
  <completion_date type="Actual">December 23, 2017</completion_date>
  <primary_completion_date type="Actual">December 23, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Tetanus vaccination coverage</measure>
    <time_frame>About 5 minutes</time_frame>
    <description>Patient will have to answer a quiz which is about their vaccination against tetanus.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">261</enrollment>
  <condition>Tetanus</condition>
  <arm_group>
    <arm_group_label>Patients</arm_group_label>
    <description>People older than 65 years in the Auvergne-Rhônes-Alpes region who are consulting their general practitioner.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>General practitioner</arm_group_label>
    <description>General practitioner of the Auvergne-Rhônes-Alpes region</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire Patients</intervention_name>
    <description>Patient will have to answer a quiz which is about their vaccination against tetanus.</description>
    <arm_group_label>Patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire General practitioner</intervention_name>
    <description>General practitioner will have to answer a quiz which is about their medical practice concerning vaccination against tetanus.</description>
    <arm_group_label>General practitioner</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The population will be all patients older than 65 years who are consulting their general&#xD;
        practitioner and accepting to participate to the study. And their general practitioner.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients older than 65 years consulting their attending physician in and who agreed to&#xD;
             participate in the study.&#xD;
&#xD;
          -  The doctors included are general practitioners located in a liberal office in the&#xD;
             &quot;Auvergne Rhône Alpes&quot; region for which the URPS (&quot;Union régional des Professionnels&#xD;
             de Santé&quot;) has an email address.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Service Urgence et Réanimation Pédiatrique Hôpital Femme Mère Enfant Groupement Hospitalier Est</name>
      <address>
        <city>Bron</city>
        <zip>69677</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 28, 2017</study_first_submitted>
  <study_first_submitted_qc>August 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 30, 2017</study_first_posted>
  <last_update_submitted>June 8, 2018</last_update_submitted>
  <last_update_submitted_qc>June 8, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 12, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tetanus</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03266211
org study id: 69HCL17_0375
nct id: NCT03266211
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In the last ten years, more than one hundred generalized tetanus cases were declared in
      France. Most of them were affecting people older than 70 years with an important mortality
      (around 28%). It is know that the only way to protect ourselves from this disease is the
      vaccination. In France tetanus vaccination is mandatory since 1940.

      Nowaday none study looked specifically for the vaccination of people older than 65 years. The
      hypothesis is: there is a difference in the tetanus vaccination coverage for people older
      than 65 years depending on the demographic and medical practice of their general
      practitioner.
observational model: Other
time perspective: Prospective
measure: Tetanus vaccination coverage
time frame: About 5 minutes
description: Patient will have to answer a quiz which is about their vaccination against tetanus.
arm group label: Patients
description: People older than 65 years in the Auvergne-Rhônes-Alpes region who are consulting their general practitioner.
arm group label: General practitioner
description: General practitioner of the Auvergne-Rhônes-Alpes region
intervention type: Other
intervention name: Questionnaire Patients
description: Patient will have to answer a quiz which is about their vaccination against tetanus.
arm group label: Patients
intervention type: Other
intervention name: Questionnaire General practitioner
description: General practitioner will have to answer a quiz which is about their medical practice concerning vaccination against tetanus.
arm group label: General practitioner
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: France
responsible party type: Sponsor
mesh term: Tetanus
sharing ipd: No