<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/NCT01665807</url>
  </required_header>
  <id_info>
    <org_study_id>SP1203</org_study_id>
    <nct_id>NCT01665807</nct_id>
  </id_info>
  <brief_title>A Time-motion Study Comparing Self- to Nurse-vaccination With Influenza Vaccine</brief_title>
  <official_title>A Time-Motion Study to Compare Self-vaccination With Intanza® Intradermal Influenza Vaccine to Nurse-administered Vaxigrip® Intramuscular Influenza Vaccine in Small Group Settings of Health Care Workers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brenda Coleman</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sanofi Pasteur, a Sanofi Company</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Mount Sinai Hospital, Canada</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators hypothesize that people working in an acute care hospital setting will be&#xD;
      able to successfully self-administer the intradermal vaccine (Intanza) in less time than&#xD;
      nurse-administration of the regular intramuscular influenza vaccine (Vaxigrip). The&#xD;
      investigators also hypothesize that people administering the intradermal vaccine for the&#xD;
      second time will take less time to successfully administer than people administering it for&#xD;
      the first time.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Vaccination of healthcare workers has been shown to reduce mortality and morbidity in the&#xD;
      patients they care for, as well as reducing illness and absenteeism in the healthcare workers&#xD;
      themselves, and healthcare worker vaccination programs have been shown to be cost-effective&#xD;
      for hospitals because of the reduced absenteeism. Although influenza vaccination programs&#xD;
      based on nurse-administered intramuscular vaccination are effective, easy access to&#xD;
      vaccination for hospital staff remains a challenge, in part because of large numbers of staff&#xD;
      working evening, night and weekend shifts. In addition, in the Canadian setting, increasing&#xD;
      the efficiency of all hospital programs is a priority. If regular recipients of seasonal&#xD;
      vaccine became accustomed to the practice, self-administration may significantly improve the&#xD;
      efficiency of pandemic mass vaccination campaigns.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">December 2012</completion_date>
  <primary_completion_date type="Actual">December 2012</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time to Administer Influenza Vaccine (in Seconds)</measure>
    <time_frame>Vaccination (Day 0)</time_frame>
    <description>Time required to explain vaccination, obtain consent, administer vaccine, and register vaccination</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Acceptability of Vaccine</measure>
    <time_frame>Follow up (Day 8)</time_frame>
    <description>The post-vaccination (Day 0) and follow-up (Day 8) questionnaires include questions on the participant's preference for intradermal or intramuscular injections and questions about their preference for administration by a healthcare provider or self-vaccination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Success Rate</measure>
    <time_frame>Vaccination (Day 0)</time_frame>
    <description>Successful administration, defined as being able to self-vaccinate (or for RN to provide vaccine) on the first attempt. Will be calculated using the number of participants who are successful divided by the number of participants randomized to group.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Local &amp; Systemic Reactogenicity</measure>
    <time_frame>Follow up (Day 8)</time_frame>
    <description>Maximum self-reported diameter of redness, induration, and swelling, and maximum intensity and duration of itchiness, fever, muscle ache, joint pain, headache, fatigue, feeling unwell, and injection site pain as reported on Day 8 after vaccination</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain at Injection Site</measure>
    <time_frame>Follow up (Day 8</time_frame>
    <description>Self-perceived pain of injection will be recorded on an 11-point visual analogue scale immediately following vaccination (Day 0) and at follow-up (Day 8)</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">868</enrollment>
  <condition>Influenza</condition>
  <condition>Vaccination Site Reactions (HT)</condition>
  <arm_group>
    <arm_group_label>Nurse-administered IM</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Nurse-administered intramuscular influenza vaccine (Vaxigrip, 0.5 mL)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Self-administered intradermal</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Self-administered intradermal influenza vaccine (Intanza 0.1 mL)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Repeat self-administration intradermal</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Self-administration of intradermal influenza vaccine (Intanza 0.1 mL) by participants who self-administered an intradermal vaccine in our 2010 study</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Intanza</intervention_name>
    <description>Intanza influenza vaccine, trivalent split-virion, inactivated, approved for the 2012-2013 influenza season in northern hemisphere</description>
    <arm_group_label>Repeat self-administration intradermal</arm_group_label>
    <arm_group_label>Self-administered intradermal</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Vaxigrip</intervention_name>
    <description>Influenza vaccine, trivalent, split-virion, inactivated, approved for the 2012-2013 influenza season in the northern hemisphere</description>
    <arm_group_label>Nurse-administered IM</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Medically stable men or women 18 to 69 years of age (inclusive)&#xD;
&#xD;
          -  Work in any capacity (including physicians and midwives with admitting privileges),&#xD;
             volunteer, or student at participating hospital&#xD;
&#xD;
          -  Able to read, understand, and respond to questionnaires&#xD;
&#xD;
          -  Able to read, understand, and sign an informed consent form&#xD;
&#xD;
          -  Available for follow-up for 8 days post-vaccination&#xD;
&#xD;
          -  Participants in Part B (repeat administration) of the study must also have&#xD;
             participated in the previous randomized control trial of self- versus&#xD;
             nurse-administered intradermal influenza vaccine and must have attempted to&#xD;
             self-administer the vaccine&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Already received 2012-13 influenza vaccine&#xD;
&#xD;
          -  History of a severe reaction following influenza vaccination&#xD;
&#xD;
          -  Known allergy to components of study vaccines (Intanza® or Vaxigrip®)&#xD;
&#xD;
          -  History of Guillain-Barré Syndrome (GBS) within 8 weeks following influenza&#xD;
             vaccination&#xD;
&#xD;
          -  Acute febrile illness (&gt;37.9ºC orally) within the past 48 hours (participation may be&#xD;
             deferred until recovery for these subjects)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>69 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Brenda L Coleman, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>MOUNT SINAI HOSPITAL</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Melissa Barton</last_name>
    <role>Study Director</role>
    <affiliation>MOUNT SINAI HOSPITAL</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Christine Moore</last_name>
    <role>Study Director</role>
    <affiliation>MOUNT SINAI HOSPITAL</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Shelly A McNeil, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Canadian Centre for Vaccinology</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Joanne M Langley, MD</last_name>
    <role>Study Director</role>
    <affiliation>Canadian Centre for Vaccinology</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Scott A Halperin, MD</last_name>
    <role>Study Director</role>
    <affiliation>Canadian Centre for Vaccinology</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Allison J McGeer, MD, FRCPC</last_name>
    <role>Principal Investigator</role>
    <affiliation>MOUNT SINAI HOSPITAL</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Center for Vaccinology</name>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mount Sinai Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G1X5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>August 13, 2012</study_first_submitted>
  <study_first_submitted_qc>August 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2012</study_first_posted>
  <results_first_submitted>July 31, 2013</results_first_submitted>
  <results_first_submitted_qc>July 31, 2013</results_first_submitted_qc>
  <results_first_posted type="Estimate">October 1, 2013</results_first_posted>
  <last_update_submitted>March 22, 2017</last_update_submitted>
  <last_update_submitted_qc>March 22, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 19, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Mount Sinai Hospital, Canada</investigator_affiliation>
    <investigator_full_name>Brenda Coleman</investigator_full_name>
    <investigator_title>Clinical Scientist</investigator_title>
  </responsible_party>
  <keyword>influenza</keyword>
  <keyword>vaccine</keyword>
  <keyword>administration</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Influenza, Human</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Sites: 2 acute care hospitals in Canada Dates: September 25, 2012 to November 20, 2012</recruitment_details>
      <pre_assignment_details>People who had self-administered intradermal influenza vaccine in past were only eligible for the &quot;repeat&quot; self-administration arm.&#xD;
No other pre-assignment eligibility criteria.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Nurse-administered IM</title>
          <description>Nurse-administered intramuscular influenza vaccine (Vaxigrip, 0.5 mL)&#xD;
Vaxigrip : Influenza vaccine, trivalent, split-virion, inactivated, approved for the 2012-2013 influenza season in the northern hemisphere</description>
        </group>
        <group group_id="P2">
          <title>Repeat Self-administration Intradermal</title>
          <description>Self-administration of intradermal influenza vaccine (Intanza 0.1 mL) by participants who self-administered an intradermal vaccine in our 2010 study&#xD;
Intanza : Intanza influenza vaccine, trivalent split-virion, inactivated, approved for the 2012-2013 influenza season in northern hemisphere</description>
        </group>
        <group group_id="P3">
          <title>Self-administered Intradermal</title>
          <description>Self-administered intradermal influenza vaccine (Intanza 0.1 mL)&#xD;
Intanza : Intanza influenza vaccine, trivalent split-virion, inactivated, approved for the 2012-2013 influenza season in northern hemisphere</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="411"/>
                <participants group_id="P2" count="58"/>
                <participants group_id="P3" count="402"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="409"/>
                <participants group_id="P2" count="58"/>
                <participants group_id="P3" count="401"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Nurse-administered IM</title>
          <description>Nurse-administered intramuscular influenza vaccine (Vaxigrip, 0.5 mL)&#xD;
Vaxigrip : Influenza vaccine, trivalent, split-virion, inactivated, approved for the 2012-2013 influenza season in the northern hemisphere</description>
        </group>
        <group group_id="B2">
          <title>Repeat Self-administered Intradermal</title>
          <description>Self-administration (2) of intradermal influenza vaccine (Intanza 0.1 mL) by participants who self-administered an intradermal vaccine in our 2010 study&#xD;
Intanza : Intanza influenza vaccine, trivalent split-virion, inactivated, approved for the 2012-2013 influenza season in northern hemisphere</description>
        </group>
        <group group_id="B3">
          <title>Self-administered Intradermal</title>
          <description>Self-administered intradermal influenza vaccine (Intanza 0.1 mL)&#xD;
Intanza : Intanza influenza vaccine, trivalent split-virion, inactivated, approved for the 2012-2013 influenza season in northern hemisphere</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="411"/>
            <count group_id="B2" value="58"/>
            <count group_id="B3" value="402"/>
            <count group_id="B4" value="871"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="386"/>
                    <measurement group_id="B2" value="58"/>
                    <measurement group_id="B3" value="391"/>
                    <measurement group_id="B4" value="835"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="11"/>
                    <measurement group_id="B4" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="44.0" spread="13.2"/>
                    <measurement group_id="B2" value="40.2" spread="11.3"/>
                    <measurement group_id="B3" value="41.2" spread="12.6"/>
                    <measurement group_id="B4" value="42.5" spread="12.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex/Gender, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Female</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="295"/>
                    <measurement group_id="B2" value="39"/>
                    <measurement group_id="B3" value="282"/>
                    <measurement group_id="B4" value="616"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Male</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="113"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="119"/>
                    <measurement group_id="B4" value="251"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Canada</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="411"/>
                    <measurement group_id="B2" value="58"/>
                    <measurement group_id="B3" value="402"/>
                    <measurement group_id="B4" value="871"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Time to Administer Influenza Vaccine (in Seconds)</title>
        <description>Time required to explain vaccination, obtain consent, administer vaccine, and register vaccination</description>
        <time_frame>Vaccination (Day 0)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Nurse-administered IM</title>
            <description>Nurse-administered intramuscular influenza vaccine (Vaxigrip, 0.5 mL)&#xD;
Vaxigrip : Influenza vaccine, trivalent, split-virion, inactivated, approved for the 2012-2013 influenza season in the northern hemisphere</description>
          </group>
          <group group_id="O2">
            <title>Repeat Self-administration Intradermal</title>
            <description>Self-administration of intradermal influenza vaccine (Intanza 0.1 mL) by participants who self-administered an intradermal vaccine in our 2010 study&#xD;
Intanza : Intanza influenza vaccine, trivalent split-virion, inactivated, approved for the 2012-2013 influenza season in northern hemisphere</description>
          </group>
          <group group_id="O3">
            <title>Self-administered Intradermal</title>
            <description>Self-administered intradermal influenza vaccine (Intanza 0.1 mL)&#xD;
Intanza : Intanza influenza vaccine, trivalent split-virion, inactivated, approved for the 2012-2013 influenza season in northern hemisphere</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Administer Influenza Vaccine (in Seconds)</title>
          <description>Time required to explain vaccination, obtain consent, administer vaccine, and register vaccination</description>
          <units>seconds</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="408"/>
                <count group_id="O2" value="57"/>
                <count group_id="O3" value="395"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="90.0" lower_limit="18.0" upper_limit="235.3"/>
                    <measurement group_id="O2" value="182.0" lower_limit="42.5" upper_limit="671.1"/>
                    <measurement group_id="O3" value="62.6" lower_limit="29.8" upper_limit="97.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Acceptability of Vaccine</title>
        <description>The post-vaccination (Day 0) and follow-up (Day 8) questionnaires include questions on the participant's preference for intradermal or intramuscular injections and questions about their preference for administration by a healthcare provider or self-vaccination.</description>
        <time_frame>Follow up (Day 8)</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Success Rate</title>
        <description>Successful administration, defined as being able to self-vaccinate (or for RN to provide vaccine) on the first attempt. Will be calculated using the number of participants who are successful divided by the number of participants randomized to group.</description>
        <time_frame>Vaccination (Day 0)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Nurse-administered IM</title>
            <description>Nurse-administered intramuscular influenza vaccine (Vaxigrip, 0.5 mL)&#xD;
Vaxigrip : Influenza vaccine, trivalent, split-virion, inactivated, approved for the 2012-2013 influenza season in the northern hemisphere</description>
          </group>
          <group group_id="O2">
            <title>Repeat Self-administration Intradermal</title>
            <description>Self-administration of intradermal influenza vaccine (Intanza 0.1 mL) by participants who self-administered an intradermal vaccine in our 2010 study&#xD;
Intanza : Intanza influenza vaccine, trivalent split-virion, inactivated, approved for the 2012-2013 influenza season in northern hemisphere</description>
          </group>
          <group group_id="O3">
            <title>Self-administered Intradermal</title>
            <description>Self-administered intradermal influenza vaccine (Intanza 0.1 mL)&#xD;
Intanza : Intanza influenza vaccine, trivalent split-virion, inactivated, approved for the 2012-2013 influenza season in northern hemisphere</description>
          </group>
        </group_list>
        <measure>
          <title>Success Rate</title>
          <description>Successful administration, defined as being able to self-vaccinate (or for RN to provide vaccine) on the first attempt. Will be calculated using the number of participants who are successful divided by the number of participants randomized to group.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="409"/>
                <count group_id="O2" value="58"/>
                <count group_id="O3" value="401"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="58"/>
                    <measurement group_id="O3" value="394"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Local &amp; Systemic Reactogenicity</title>
        <description>Maximum self-reported diameter of redness, induration, and swelling, and maximum intensity and duration of itchiness, fever, muscle ache, joint pain, headache, fatigue, feeling unwell, and injection site pain as reported on Day 8 after vaccination</description>
        <time_frame>Follow up (Day 8)</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pain at Injection Site</title>
        <description>Self-perceived pain of injection will be recorded on an 11-point visual analogue scale immediately following vaccination (Day 0) and at follow-up (Day 8)</description>
        <time_frame>Follow up (Day 8</time_frame>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Nurse-administered IM</title>
          <description>Nurse-administered intramuscular influenza vaccine (Vaxigrip, 0.5 mL)&#xD;
Vaxigrip : Influenza vaccine, trivalent, split-virion, inactivated, approved for the 2012-2013 influenza season in the northern hemisphere</description>
        </group>
        <group group_id="E2">
          <title>Repeat Self-administration Intradermal</title>
          <description>Self-administration of intradermal influenza vaccine (Intanza 0.1 mL) by participants who self-administered an intradermal vaccine in our 2010 study&#xD;
Intanza : Intanza influenza vaccine, trivalent split-virion, inactivated, approved for the 2012-2013 influenza season in northern hemisphere</description>
        </group>
        <group group_id="E3">
          <title>Self-administered Intradermal</title>
          <description>Self-administered intradermal influenza vaccine (Intanza 0.1 mL)&#xD;
Intanza : Intanza influenza vaccine, trivalent split-virion, inactivated, approved for the 2012-2013 influenza season in northern hemisphere</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="409"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="401"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="409"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="58"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="401"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Brenda L. Coleman, PhD,</name_or_title>
      <organization>Mount Sinai Hospital, IDERU</organization>
      <phone>416-586-4800 ext 4538</phone>
      <email>bcoleman@mtsinai.on.ca</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01665807
org study id: SP1203
nct id: NCT01665807
lead sponsor: 
collaborator: 
has dmc: No
The investigators hypothesize that people working in an acute care hospital setting will be
      able to successfully self-administer the intradermal vaccine (Intanza) in less time than
      nurse-administration of the regular intramuscular influenza vaccine (Vaxigrip). The
      investigators also hypothesize that people administering the intradermal vaccine for the
      second time will take less time to successfully administer than people administering it for
      the first time.
Vaccination of healthcare workers has been shown to reduce mortality and morbidity in the
      patients they care for, as well as reducing illness and absenteeism in the healthcare workers
      themselves, and healthcare worker vaccination programs have been shown to be cost-effective
      for hospitals because of the reduced absenteeism. Although influenza vaccination programs
      based on nurse-administered intramuscular vaccination are effective, easy access to
      vaccination for hospital staff remains a challenge, in part because of large numbers of staff
      working evening, night and weekend shifts. In addition, in the Canadian setting, increasing
      the efficiency of all hospital programs is a priority. If regular recipients of seasonal
      vaccine became accustomed to the practice, self-administration may significantly improve the
      efficiency of pandemic mass vaccination campaigns.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Time to Administer Influenza Vaccine (in Seconds)
time frame: Vaccination (Day 0)
description: Time required to explain vaccination, obtain consent, administer vaccine, and register vaccination
measure: Acceptability of Vaccine
time frame: Follow up (Day 8)
description: The post-vaccination (Day 0) and follow-up (Day 8) questionnaires include questions on the participant's preference for intradermal or intramuscular injections and questions about their preference for administration by a healthcare provider or self-vaccination.
measure: Success Rate
time frame: Vaccination (Day 0)
description: Successful administration, defined as being able to self-vaccinate (or for RN to provide vaccine) on the first attempt. Will be calculated using the number of participants who are successful divided by the number of participants randomized to group.
measure: Local & Systemic Reactogenicity
time frame: Follow up (Day 8)
description: Maximum self-reported diameter of redness, induration, and swelling, and maximum intensity and duration of itchiness, fever, muscle ache, joint pain, headache, fatigue, feeling unwell, and injection site pain as reported on Day 8 after vaccination
measure: Pain at Injection Site
time frame: Follow up (Day 8
description: Self-perceived pain of injection will be recorded on an 11-point visual analogue scale immediately following vaccination (Day 0) and at follow-up (Day 8)
arm group label: Nurse-administered IM
arm group type: Experimental
description: Nurse-administered intramuscular influenza vaccine (Vaxigrip, 0.5 mL)
arm group label: Self-administered intradermal
arm group type: Experimental
description: Self-administered intradermal influenza vaccine (Intanza 0.1 mL)
arm group label: Repeat self-administration intradermal
arm group type: Active Comparator
description: Self-administration of intradermal influenza vaccine (Intanza 0.1 mL) by participants who self-administered an intradermal vaccine in our 2010 study
intervention type: Biological
intervention name: Intanza
description: Intanza influenza vaccine, trivalent split-virion, inactivated, approved for the 2012-2013 influenza season in northern hemisphere
arm group label: Repeat self-administration intradermal
arm group label: Self-administered intradermal
intervention type: Biological
intervention name: Vaxigrip
description: Influenza vaccine, trivalent, split-virion, inactivated, approved for the 2012-2013 influenza season in the northern hemisphere
arm group label: Nurse-administered IM
criteria: 
gender: All
minimum age: 18 Years
maximum age: 69 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Brenda L Coleman, PhD
role: Principal Investigator
affiliation: MOUNT SINAI HOSPITAL
last name: Melissa Barton
role: Study Director
affiliation: MOUNT SINAI HOSPITAL
last name: Christine Moore
role: Study Director
affiliation: MOUNT SINAI HOSPITAL
last name: Shelly A McNeil, MD
role: Principal Investigator
affiliation: Canadian Centre for Vaccinology
last name: Joanne M Langley, MD
role: Study Director
affiliation: Canadian Centre for Vaccinology
last name: Scott A Halperin, MD
role: Study Director
affiliation: Canadian Centre for Vaccinology
last name: Allison J McGeer, MD, FRCPC
role: Principal Investigator
affiliation: MOUNT SINAI HOSPITAL
facility: 
facility: 
country: Canada
responsible party type: Sponsor-Investigator
investigator affiliation: Mount Sinai Hospital, Canada
investigator full name: Brenda Coleman
investigator title: Clinical Scientist
mesh term: Influenza, Human
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 