<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/NCT02263040</url>
  </required_header>
  <id_info>
    <org_study_id>14-0909</org_study_id>
    <nct_id>NCT02263040</nct_id>
  </id_info>
  <brief_title>A Pilot Study to Assess the Immunogenicity and Reactogenicity of High Versus Standard Dose TIV</brief_title>
  <official_title>A Pilot Study to Assess the Immunogenicity and Reactogenicity of High Versus Standard Dose Trivalent Inactivated Influenza Vaccine for Healthcare Workers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mount Sinai Hospital, Canada</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mount Sinai Hospital, Canada</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this pilot study is to assess the immunogenicity and reactogenicity of&#xD;
      Fluzone High Dose with Fluzone (standard adult dose) influenza vaccines in healthcare&#xD;
      workers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, randomized controlled, observer blind trial of Fluzone High Dose&#xD;
      trivalent inactivated influenza vaccine (HDTIV) versus Fluzone, standard dose TIV (SDTIV) in&#xD;
      100 healthcare workers 18-64 years of age. Participants will receive, in a 1:1 ratio, one&#xD;
      dose of either SDTIV or HDTIV containing the strains of influenza virus as recommended by the&#xD;
      World Health Organization for the season of recruitment. All adverse events will be collected&#xD;
      for 7 days following the injection, serious adverse events will be collected through day 21,&#xD;
      and serum for antibody testing will be obtained on day 0 and day 21. The primary outcome will&#xD;
      be seroconversion to each strain of vaccine included in the vaccine, as measured by change in&#xD;
      hemagglutination inhibition assay (HAI) titer between day 0 to day 21.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">December 31, 2016</completion_date>
  <primary_completion_date type="Actual">July 2016</primary_completion_date>
  <phase>Phase 1/Phase 2</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>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Seroconversion to A/California/07/2009 (H1N1)</measure>
    <time_frame>21 days (18-28)</time_frame>
    <description>Seroconversion to influenza strains contained in the vaccine, as measured by hemagglutination inhibition (HAI) assay. 4-fold or greater increase.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Seroconversion to A/Texas/50/2012 (H3N2)</measure>
    <time_frame>21 days post vaccination (18-28)</time_frame>
    <description>Four-fold or higher rise in titres to A/Texas/50/2012 (H3N2) as measured by hemagglutination inhibition assay</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Seroconversion to Influenza B/Phuket/3073/2013</measure>
    <time_frame>21 days post-vaccination (18-28)</time_frame>
    <description>Four fold or higher increase in titres to B/Phuket/3073/2013 as measured by hemagglutination inhibition assay</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Seroconversion to A/Switzerland/9715293/2013 (H3N2)</measure>
    <time_frame>21 days post vaccination (18-28)</time_frame>
    <description>Four-fold or higher rise in titres against A/Switzerland/9715293/2013 (H3N2) as measured by hemagglutination inhibition assay</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Seroconversion to B/Massachusetts/02/2012</measure>
    <time_frame>21 days post-vaccination (18-28)</time_frame>
    <description>Four fold or higher increase in titres to B/Massachusetts/02/2012 as measured by hemagglutination inhibition assay</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Geometric Mean Fold Ratio (GMFR) Against A/California/07/2009 (H1N1)</measure>
    <time_frame>21 days (18-28)</time_frame>
    <description>GMFR (mean fold increase) time2/time1, as measured by hemagglutination inhibition assay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geometric Mean Fold Ratio (GMFR): A/Switzerland/9715293/2013</measure>
    <time_frame>21 days (18-28)</time_frame>
    <description>GMFR (mean fold increase) time2/time1, as measured by HAI titres</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geometric Mean Fold Ratio (GMFR): A/Texas/50/2012</measure>
    <time_frame>21 days (18-28)</time_frame>
    <description>GMFR (mean fold increase) time2/time1, as measured by HAI titres</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geometric Mean Fold Ratio (GMFR): B/Phuket/3073/2013 Ether-treated</measure>
    <time_frame>21 days (18-28)</time_frame>
    <description>GMFR (mean fold increase) time2/time1, as measured by HAI titres</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geometric Mean Fold Ratio (GMFR): B/Massachusetts/02/2012 Ether-treated</measure>
    <time_frame>21 days (18-28)</time_frame>
    <description>GMFR (mean fold increase) time2/time1, as measured by HAI titres</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Reporting Adverse Event: Injection Site</measure>
    <time_frame>7 days</time_frame>
    <description>Any local adverse event following immunization,self reported in daily diary Includes the maximum values for any one of: redness, warmth, swelling, or bruising</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Reporting Adverse Event: Systemic</measure>
    <time_frame>7 days</time_frame>
    <description>Any systemic adverse event following immunization,self reported in daily diary Includes the maximum value reported for any one of: myalgia, arthralgia, headache, malaise, fatigue, weakness, sweating, shivering, or feverishness&#xD;
Defined as:&#xD;
None: Not at all Mild: Present, but did not interfere with activities Moderate: Interfered with activities, but didn't prevent them Extreme: Prevented activities</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">170</enrollment>
  <condition>Influenza</condition>
  <arm_group>
    <arm_group_label>High Dose Fluzone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Fluzone High-Dose® Licensed for use in the USA in persons ≥ 65 years of age as a single dose of 0.5 mL containing 60μg hemagglutinin per virus strain</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fluzone (standard dose)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Fluzone ® Licensed for the prevention of influenza as a single dose of 0.5 mL containing 15μg hemagglutinin per virus strain for adults</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Fluzone High-Dose</intervention_name>
    <description>Influenza vaccine</description>
    <arm_group_label>High Dose Fluzone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Fluzone (standard dose)</intervention_name>
    <description>Influenza vaccine</description>
    <arm_group_label>Fluzone (standard dose)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. 18-64 years old, inclusive, as of October 1st of year of enrolment;&#xD;
&#xD;
          2. Healthcare worker, broadly defined as a person either providing health care, or&#xD;
             working in an acute care hospital or long term healthcare facility;&#xD;
&#xD;
          3. Has access to email and the internet for adverse event reporting, or is willing to&#xD;
             complete forms on paper and deliver to the site study office;&#xD;
&#xD;
          4. Understand the study, agree to its requirements, and give written consent;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Receipt of influenza vaccine for the current northern hemisphere season prior to&#xD;
             randomization;&#xD;
&#xD;
          2. Serious adverse event to a previous dose of influenza vaccine;&#xD;
&#xD;
          3. Immunoglobulin E mediated allergic reaction to a previous dose of influenza vaccine or&#xD;
             to any excipients in the study vaccines&#xD;
&#xD;
          4. Previous episode of Guillain-Barré syndrome with 6 weeks of receiving an influenza&#xD;
             vaccine;&#xD;
&#xD;
          5. Receipt of immunoglobulins, blood or blood-derived products in the past 3 months;&#xD;
&#xD;
          6. Receipt of another vaccine, or initiation of new medication, or hospital admission for&#xD;
             any reason within the 30 days prior to the study dose of vaccine&#xD;
&#xD;
          7. Plans to receive any vaccine, initiate any medication, or be admitted to hospital&#xD;
             before day 21 after vaccination (visit 2);&#xD;
&#xD;
          8. Known or suspected congenital or acquired immunodeficiency (including HIV infection);&#xD;
             or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation&#xD;
             therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy&#xD;
             (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)&#xD;
&#xD;
          9. Any condition, including but not limited to drug and alcohol addiction, which, in the&#xD;
             opinion of the investigator might interfere with the ability to comply with trial&#xD;
             conduct or completion;&#xD;
&#xD;
         10. Moderate or severe acute illness or active infection or fever (temperature ≥37.8oC) on&#xD;
             the day the vaccine dose is due (participant may receive dose of vaccine 48 hours&#xD;
             after symptoms have resolved and body temperature has returned to normal without the&#xD;
             use of antipyretics.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Allison J McGeer, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>MOUNT SINAI HOSPITAL</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mount Sinai Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 1X5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>October 8, 2014</study_first_submitted>
  <study_first_submitted_qc>October 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 13, 2014</study_first_posted>
  <results_first_submitted>October 13, 2017</results_first_submitted>
  <results_first_submitted_qc>August 14, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">January 28, 2019</results_first_posted>
  <last_update_submitted>August 14, 2018</last_update_submitted>
  <last_update_submitted_qc>August 14, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 28, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>influenza vaccine</keyword>
  <keyword>adult</keyword>
  <keyword>immunogenicity</keyword>
  <keyword>reactogenicity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Influenza, Human</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Following publication of results</ipd_description>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>High Dose Fluzone</title>
          <description>Fluzone High-Dose® Licensed for use in the USA in persons ≥ 65 years of age as a single dose of 0.5 mL containing 60μg HA per virus strain&#xD;
Fluzone High-Dose: Influenza vaccine&#xD;
Either 2014/15 OR 2015/16</description>
        </group>
        <group group_id="P2">
          <title>Fluzone (Standard Dose)</title>
          <description>Fluzone ® Licensed for the prevention of influenza as a single dose of 0.5 mL containing 15μg HA per virus strain for adults&#xD;
Fluzone (standard dose): Influenza vaccine&#xD;
Either: 2014/15 OR 2015/16</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="87"/>
                <participants group_id="P2" count="83"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="87"/>
                <participants group_id="P2" count="83"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>High Dose Fluzone</title>
          <description>Fluzone High-Dose® Licensed for use in the USA in persons ≥ 65 years of age as a single dose of 0.5mL containing 60μg HA per virus strain&#xD;
Fluzone High-Dose: Influenza vaccine</description>
        </group>
        <group group_id="B2">
          <title>Fluzone (Standard Dose)</title>
          <description>Fluzone ® Licensed for the prevention of influenza as a single dose of 0.5mL containing 15μg HA per virus strain for adults&#xD;
Fluzone (standard dose): Influenza vaccine</description>
        </group>
        <group group_id="B3">
          <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="87"/>
            <count group_id="B2" value="83"/>
            <count group_id="B3" value="170"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="87"/>
                    <count group_id="B2" value="83"/>
                    <count group_id="B3" value="170"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="46" lower_limit="23" upper_limit="64"/>
                    <measurement group_id="B2" value="50" lower_limit="20" upper_limit="64"/>
                    <measurement group_id="B3" value="47.5" lower_limit="20" upper_limit="64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="87"/>
                    <count group_id="B2" value="83"/>
                    <count group_id="B3" value="170"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="64"/>
                    <measurement group_id="B2" value="59"/>
                    <measurement group_id="B3" value="123"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="87"/>
                    <count group_id="B2" value="83"/>
                    <count group_id="B3" value="170"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="87"/>
                    <measurement group_id="B2" value="83"/>
                    <measurement group_id="B3" value="170"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Underlying chronic medical condition</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="87"/>
                    <count group_id="B2" value="83"/>
                    <count group_id="B3" value="170"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Seroconversion to A/California/07/2009 (H1N1)</title>
        <description>Seroconversion to influenza strains contained in the vaccine, as measured by hemagglutination inhibition (HAI) assay. 4-fold or greater increase.</description>
        <time_frame>21 days (18-28)</time_frame>
        <population>A blood sample from one participant was hemolysed and not available for analysis</population>
        <group_list>
          <group group_id="O1">
            <title>High Dose Fluzone</title>
            <description>Fluzone High-Dose® Licensed for use in the USA in persons ≥ 65 years of age as a single dose of 0.5mL containing 60μg HA per virus strain&#xD;
Fluzone High-Dose: Influenza vaccine&#xD;
Either season: 2014/15 OR 2015/16</description>
          </group>
          <group group_id="O2">
            <title>Fluzone (Standard Dose)</title>
            <description>Fluzone ® Licensed for the prevention of influenza as a single dose of 0.5mL containing 15μg HA per virus strain for adults&#xD;
Fluzone (standard dose): Influenza vaccine&#xD;
Either season: 2014/15 OR 2015/16</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Seroconversion to A/California/07/2009 (H1N1)</title>
          <description>Seroconversion to influenza strains contained in the vaccine, as measured by hemagglutination inhibition (HAI) assay. 4-fold or greater increase.</description>
          <population>A blood sample from one participant was hemolysed and not available for analysis</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="86"/>
                <count group_id="O2" value="83"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41"/>
                    <measurement group_id="O2" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Seroconversion to A/Texas/50/2012 (H3N2)</title>
        <description>Four-fold or higher rise in titres to A/Texas/50/2012 (H3N2) as measured by hemagglutination inhibition assay</description>
        <time_frame>21 days post vaccination (18-28)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>High Dose Fluzone</title>
            <description>Fluzone High-Dose® Licensed for use in the USA in persons ≥ 65 years of age as a single dose of 0.5mL containing 60μg HA per virus strain&#xD;
Fluzone High-Dose: Influenza vaccine&#xD;
either 2014/15 OR 2015/16</description>
          </group>
          <group group_id="O2">
            <title>Fluzone (Standard Dose)</title>
            <description>Fluzone ® Licensed for the prevention of influenza as a single dose of 0.5mL containing 15μg HA per virus strain for adults&#xD;
Fluzone (standard dose): Influenza vaccine Either: 2014/15 OR 2015/16</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Seroconversion to A/Texas/50/2012 (H3N2)</title>
          <description>Four-fold or higher rise in titres to A/Texas/50/2012 (H3N2) as measured by hemagglutination inhibition assay</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Seroconversion to Influenza B/Phuket/3073/2013</title>
        <description>Four fold or higher increase in titres to B/Phuket/3073/2013 as measured by hemagglutination inhibition assay</description>
        <time_frame>21 days post-vaccination (18-28)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>High Dose Fluzone</title>
            <description>Fluzone High-Dose® Licensed for use in the USA in persons ≥ 65 years of age as a single dose of 0.5mL containing 60μg HA per virus strain&#xD;
Fluzone High-Dose: Influenza vaccine&#xD;
Either season: 2014/15 OR 2015/16</description>
          </group>
          <group group_id="O2">
            <title>Fluzone (Standard Dose)</title>
            <description>Fluzone ® Licensed for the prevention of influenza as a single dose of 0.5mL containing 15μg HA per virus strain for adults&#xD;
Fluzone (standard dose): Influenza vaccine&#xD;
Either season: 2014/15 OR 2015/16</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Seroconversion to Influenza B/Phuket/3073/2013</title>
          <description>Four fold or higher increase in titres to B/Phuket/3073/2013 as measured by hemagglutination inhibition assay</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="62"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Seroconversion to A/Switzerland/9715293/2013 (H3N2)</title>
        <description>Four-fold or higher rise in titres against A/Switzerland/9715293/2013 (H3N2) as measured by hemagglutination inhibition assay</description>
        <time_frame>21 days post vaccination (18-28)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>High Dose Fluzone</title>
            <description>Fluzone High-Dose® Licensed for use in the USA in persons ≥ 65 years of age as a single dose of 0.5mL containing 60μg HA per virus strain&#xD;
Fluzone High-Dose: Influenza vaccine&#xD;
either 2014/15 OR 2015/16</description>
          </group>
          <group group_id="O2">
            <title>Fluzone (Standard Dose)</title>
            <description>Fluzone ® Licensed for the prevention of influenza as a single dose of 0.5mL containing 15μg HA per virus strain for adults&#xD;
Fluzone (standard dose): Influenza vaccine Either: 2014/15 OR 2015/16</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Seroconversion to A/Switzerland/9715293/2013 (H3N2)</title>
          <description>Four-fold or higher rise in titres against A/Switzerland/9715293/2013 (H3N2) as measured by hemagglutination inhibition assay</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="62"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58"/>
                    <measurement group_id="O2" value="49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Seroconversion to B/Massachusetts/02/2012</title>
        <description>Four fold or higher increase in titres to B/Massachusetts/02/2012 as measured by hemagglutination inhibition assay</description>
        <time_frame>21 days post-vaccination (18-28)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>High Dose Fluzone</title>
            <description>Fluzone High-Dose® Licensed for use in the USA in persons ≥ 65 years of age as a single dose of 0.5mL containing 60μg HA per virus strain&#xD;
Fluzone High-Dose: Influenza vaccine&#xD;
Either season: 2014/15 OR 2015/16</description>
          </group>
          <group group_id="O2">
            <title>Fluzone (Standard Dose)</title>
            <description>Fluzone ® Licensed for the prevention of influenza as a single dose of 0.5mL containing 15μg HA per virus strain for adults&#xD;
Fluzone (standard dose): Influenza vaccine&#xD;
Either season: 2014/15 OR 2015/16</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Seroconversion to B/Massachusetts/02/2012</title>
          <description>Four fold or higher increase in titres to B/Massachusetts/02/2012 as measured by hemagglutination inhibition assay</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Geometric Mean Fold Ratio (GMFR) Against A/California/07/2009 (H1N1)</title>
        <description>GMFR (mean fold increase) time2/time1, as measured by hemagglutination inhibition assay</description>
        <time_frame>21 days (18-28)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>High Dose Fluzone</title>
            <description>Fluzone High-Dose® Licensed for use in the USA in persons ≥ 65 years of age as a single dose of 0.5mL containing 60μg HA per virus strain&#xD;
Fluzone High-Dose: Influenza vaccine&#xD;
Either 2014/15 OR 2015/16</description>
          </group>
          <group group_id="O2">
            <title>Fluzone (Standard Dose)</title>
            <description>Fluzone ® Licensed for the prevention of influenza as a single dose of 0.5mL containing 15μg HA per virus strain for adults&#xD;
Fluzone (standard dose): Influenza vaccine&#xD;
Either: 2014/15 OR 2015/16</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Fold Ratio (GMFR) Against A/California/07/2009 (H1N1)</title>
          <description>GMFR (mean fold increase) time2/time1, as measured by hemagglutination inhibition assay</description>
          <units>fold ratio</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="86"/>
                <count group_id="O2" value="83"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.38" lower_limit="1.28" upper_limit="1.48"/>
                    <measurement group_id="O2" value="1.20" lower_limit="1.13" upper_limit="1.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Geometric Mean Fold Ratio (GMFR): A/Switzerland/9715293/2013</title>
        <description>GMFR (mean fold increase) time2/time1, as measured by HAI titres</description>
        <time_frame>21 days (18-28)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>High Dose Fluzone</title>
            <description>Fluzone High-Dose® Licensed for use in the USA in persons ≥ 65 years of age as a single dose of 0.5mL containing 60μg HA per virus strain&#xD;
Fluzone High-Dose: Influenza vaccine&#xD;
Either 2014/15 OR 2015/16</description>
          </group>
          <group group_id="O2">
            <title>Fluzone (Standard Dose)</title>
            <description>Fluzone ® Licensed for the prevention of influenza as a single dose of 0.5mL containing 15μg HA per virus strain for adults&#xD;
Fluzone (standard dose): Influenza vaccine&#xD;
Either: 2014/15 OR 2015/16</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Fold Ratio (GMFR): A/Switzerland/9715293/2013</title>
          <description>GMFR (mean fold increase) time2/time1, as measured by HAI titres</description>
          <units>fold ratio</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="62"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.82" lower_limit="1.70" upper_limit="1.94"/>
                    <measurement group_id="O2" value="1.67" lower_limit="1.53" upper_limit="1.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Geometric Mean Fold Ratio (GMFR): A/Texas/50/2012</title>
        <description>GMFR (mean fold increase) time2/time1, as measured by HAI titres</description>
        <time_frame>21 days (18-28)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>High Dose Fluzone</title>
            <description>Fluzone High-Dose® Licensed for use in the USA in persons ≥ 65 years of age as a single dose of 0.5mL containing 60μg HA per virus strain&#xD;
Fluzone High-Dose: Influenza vaccine&#xD;
Either 2014/15 OR 2015/16</description>
          </group>
          <group group_id="O2">
            <title>Fluzone (Standard Dose)</title>
            <description>Fluzone ® Licensed for the prevention of influenza as a single dose of 0.5mL containing 15μg HA per virus strain for adults&#xD;
Fluzone (standard dose): Influenza vaccine&#xD;
Either: 2014/15 OR 2015/16</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Fold Ratio (GMFR): A/Texas/50/2012</title>
          <description>GMFR (mean fold increase) time2/time1, as measured by HAI titres</description>
          <units>fold ratio</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.76" lower_limit="1.36" upper_limit="2.16"/>
                    <measurement group_id="O2" value="1.15" lower_limit="1.08" upper_limit="1.22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Geometric Mean Fold Ratio (GMFR): B/Phuket/3073/2013 Ether-treated</title>
        <description>GMFR (mean fold increase) time2/time1, as measured by HAI titres</description>
        <time_frame>21 days (18-28)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>High Dose Fluzone</title>
            <description>Fluzone High-Dose® Licensed for use in the USA in persons ≥ 65 years of age as a single dose of 0.5mL containing 60μg HA per virus strain&#xD;
Fluzone High-Dose: Influenza vaccine&#xD;
Either 2014/15 OR 2015/16</description>
          </group>
          <group group_id="O2">
            <title>Fluzone (Standard Dose)</title>
            <description>Fluzone ® Licensed for the prevention of influenza as a single dose of 0.5mL containing 15μg HA per virus strain for adults&#xD;
Fluzone (standard dose): Influenza vaccine&#xD;
Either: 2014/15 OR 2015/16</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Fold Ratio (GMFR): B/Phuket/3073/2013 Ether-treated</title>
          <description>GMFR (mean fold increase) time2/time1, as measured by HAI titres</description>
          <units>fold ratio</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="62"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.32" lower_limit="1.23" upper_limit="1.41"/>
                    <measurement group_id="O2" value="1.19" lower_limit="1.11" upper_limit="1.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Geometric Mean Fold Ratio (GMFR): B/Massachusetts/02/2012 Ether-treated</title>
        <description>GMFR (mean fold increase) time2/time1, as measured by HAI titres</description>
        <time_frame>21 days (18-28)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>High Dose Fluzone</title>
            <description>Fluzone High-Dose® Licensed for use in the USA in persons ≥ 65 years of age as a single dose of 0.5mL containing 60μg HA per virus strain&#xD;
Fluzone High-Dose: Influenza vaccine&#xD;
Either 2014/15 OR 2015/16</description>
          </group>
          <group group_id="O2">
            <title>Fluzone (Standard Dose)</title>
            <description>Fluzone ® Licensed for the prevention of influenza as a single dose of 0.5mL containing 15μg HA per virus strain for adults&#xD;
Fluzone (standard dose): Influenza vaccine&#xD;
Either: 2014/15 OR 2015/16</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Fold Ratio (GMFR): B/Massachusetts/02/2012 Ether-treated</title>
          <description>GMFR (mean fold increase) time2/time1, as measured by HAI titres</description>
          <units>fold ratio</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.20" lower_limit="1.11" upper_limit="1.29"/>
                    <measurement group_id="O2" value="1.08" lower_limit="1.02" upper_limit="1.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Reporting Adverse Event: Injection Site</title>
        <description>Any local adverse event following immunization,self reported in daily diary Includes the maximum values for any one of: redness, warmth, swelling, or bruising</description>
        <time_frame>7 days</time_frame>
        <population>All participants were able to provide data</population>
        <group_list>
          <group group_id="O1">
            <title>High Dose Fluzone</title>
            <description>Fluzone High-Dose® Licensed for use in the USA in persons ≥ 65 years of age as a single dose of 0.5mL containing 60μg HA per virus strain&#xD;
Fluzone High-Dose: Influenza vaccine&#xD;
Either season: 2014/15 OR 2015/16</description>
          </group>
          <group group_id="O2">
            <title>Fluzone (Standard Dose)</title>
            <description>Fluzone ® Licensed for the prevention of influenza as a single dose of 0.5mL containing 15μg HA per virus strain for adults&#xD;
Fluzone (standard dose): Influenza vaccine&#xD;
Either season: 2014/15 OR 2015/16</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Reporting Adverse Event: Injection Site</title>
          <description>Any local adverse event following immunization,self reported in daily diary Includes the maximum values for any one of: redness, warmth, swelling, or bruising</description>
          <population>All participants were able to provide data</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="87"/>
                <count group_id="O2" value="83"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>none</title>
                  <measurement_list>
                    <measurement group_id="O1" value="47"/>
                    <measurement group_id="O2" value="62"/>
                  </measurement_list>
                </category>
                <category>
                  <title>mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="34"/>
                    <measurement group_id="O2" value="21"/>
                  </measurement_list>
                </category>
                <category>
                  <title>moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Reporting Adverse Event: Systemic</title>
        <description>Any systemic adverse event following immunization,self reported in daily diary Includes the maximum value reported for any one of: myalgia, arthralgia, headache, malaise, fatigue, weakness, sweating, shivering, or feverishness&#xD;
Defined as:&#xD;
None: Not at all Mild: Present, but did not interfere with activities Moderate: Interfered with activities, but didn't prevent them Extreme: Prevented activities</description>
        <time_frame>7 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>High Dose Fluzone</title>
            <description>Fluzone High-Dose® Licensed for use in the USA in persons ≥ 65 years of age as a single dose of 0.5mL containing 60μg HA per virus strain&#xD;
Fluzone High-Dose: Influenza vaccine&#xD;
Either season: 2014/15 OR 2015/16</description>
          </group>
          <group group_id="O2">
            <title>Fluzone (Standard Dose)</title>
            <description>Fluzone ® Licensed for the prevention of influenza as a single dose of 0.5mL containing 15μg HA per virus strain for adults&#xD;
Fluzone (standard dose): Influenza vaccine&#xD;
Either season: 2014/15 OR 2015/16</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Reporting Adverse Event: Systemic</title>
          <description>Any systemic adverse event following immunization,self reported in daily diary Includes the maximum value reported for any one of: myalgia, arthralgia, headache, malaise, fatigue, weakness, sweating, shivering, or feverishness&#xD;
Defined as:&#xD;
None: Not at all Mild: Present, but did not interfere with activities Moderate: Interfered with activities, but didn't prevent them Extreme: Prevented activities</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="87"/>
                <count group_id="O2" value="83"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="O1" value="41"/>
                    <measurement group_id="O2" value="42"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Extreme</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>6 months</time_frame>
      <desc>Daily diary for 7 days Nursing note at day 21 Asked to report to clinic for 6 months after vaccination</desc>
      <group_list>
        <group group_id="E1">
          <title>High Dose Fluzone</title>
          <description>Fluzone High-Dose® Licensed for use in the USA in persons ≥ 65 years of age as a single dose of 0.5mL containing 60μg HA per virus strain&#xD;
Fluzone High-Dose: Influenza vaccine&#xD;
Either season: 2014/15 OR 2015/16</description>
        </group>
        <group group_id="E2">
          <title>Fluzone (Standard Dose)</title>
          <description>Fluzone ® Licensed for the prevention of influenza as a single dose of 0.5mL containing 15μg HA per virus strain for adults&#xD;
Fluzone (standard dose): Influenza vaccine&#xD;
Either season: 2014/15 OR 2015/16</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="83"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="83"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (10.0)</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="26" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="83"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Myalgia</sub_title>
                <description>Moderate or extreme: interfered with, or prevented, daily activities</description>
                <counts group_id="E1" events="13" subjects_affected="13" subjects_at_risk="87"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="83"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <description>Moderate or extreme: interfered with, or prevented, daily activities</description>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="87"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="83"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <description>Moderate or extreme: interfered with, or prevented, daily activities</description>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="87"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="83"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <description>Moderate or extreme: interfered with, or prevented, daily activities</description>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="87"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="83"/>
              </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>Dr. Allison McGeer</name_or_title>
      <organization>Mount Sinai Hospital, Toronto</organization>
      <phone>416-586-3118</phone>
      <email>allison.mcgeer@sinaihealthsystem.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/NCT02263040
org study id: 14-0909
nct id: NCT02263040
lead sponsor: 
has dmc: No
The objective of this pilot study is to assess the immunogenicity and reactogenicity of
      Fluzone High Dose with Fluzone (standard adult dose) influenza vaccines in healthcare
      workers.
This is a prospective, randomized controlled, observer blind trial of Fluzone High Dose
      trivalent inactivated influenza vaccine (HDTIV) versus Fluzone, standard dose TIV (SDTIV) in
      100 healthcare workers 18-64 years of age. Participants will receive, in a 1:1 ratio, one
      dose of either SDTIV or HDTIV containing the strains of influenza virus as recommended by the
      World Health Organization for the season of recruitment. All adverse events will be collected
      for 7 days following the injection, serious adverse events will be collected through day 21,
      and serum for antibody testing will be obtained on day 0 and day 21. The primary outcome will
      be seroconversion to each strain of vaccine included in the vaccine, as measured by change in
      hemagglutination inhibition assay (HAI) titer between day 0 to day 21.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Number of Participants With Seroconversion to A/California/07/2009 (H1N1)
time frame: 21 days (18-28)
description: Seroconversion to influenza strains contained in the vaccine, as measured by hemagglutination inhibition (HAI) assay. 4-fold or greater increase.
measure: Number of Participants With Seroconversion to A/Texas/50/2012 (H3N2)
time frame: 21 days post vaccination (18-28)
description: Four-fold or higher rise in titres to A/Texas/50/2012 (H3N2) as measured by hemagglutination inhibition assay
measure: Number of Participants With Seroconversion to Influenza B/Phuket/3073/2013
time frame: 21 days post-vaccination (18-28)
description: Four fold or higher increase in titres to B/Phuket/3073/2013 as measured by hemagglutination inhibition assay
measure: Number of Participants With Seroconversion to A/Switzerland/9715293/2013 (H3N2)
time frame: 21 days post vaccination (18-28)
description: Four-fold or higher rise in titres against A/Switzerland/9715293/2013 (H3N2) as measured by hemagglutination inhibition assay
measure: Number of Participants With Seroconversion to B/Massachusetts/02/2012
time frame: 21 days post-vaccination (18-28)
description: Four fold or higher increase in titres to B/Massachusetts/02/2012 as measured by hemagglutination inhibition assay
measure: Geometric Mean Fold Ratio (GMFR) Against A/California/07/2009 (H1N1)
time frame: 21 days (18-28)
description: GMFR (mean fold increase) time2/time1, as measured by hemagglutination inhibition assay
measure: Geometric Mean Fold Ratio (GMFR): A/Switzerland/9715293/2013
time frame: 21 days (18-28)
description: GMFR (mean fold increase) time2/time1, as measured by HAI titres
measure: Geometric Mean Fold Ratio (GMFR): A/Texas/50/2012
time frame: 21 days (18-28)
description: GMFR (mean fold increase) time2/time1, as measured by HAI titres
measure: Geometric Mean Fold Ratio (GMFR): B/Phuket/3073/2013 Ether-treated
time frame: 21 days (18-28)
description: GMFR (mean fold increase) time2/time1, as measured by HAI titres
measure: Geometric Mean Fold Ratio (GMFR): B/Massachusetts/02/2012 Ether-treated
time frame: 21 days (18-28)
description: GMFR (mean fold increase) time2/time1, as measured by HAI titres
measure: Number of Participants Reporting Adverse Event: Injection Site
time frame: 7 days
description: Any local adverse event following immunization,self reported in daily diary Includes the maximum values for any one of: redness, warmth, swelling, or bruising
measure: Number of Participants Reporting Adverse Event: Systemic
time frame: 7 days
description: Any systemic adverse event following immunization,self reported in daily diary Includes the maximum value reported for any one of: myalgia, arthralgia, headache, malaise, fatigue, weakness, sweating, shivering, or feverishness
Defined as:
None: Not at all Mild: Present, but did not interfere with activities Moderate: Interfered with activities, but didn't prevent them Extreme: Prevented activities
arm group label: High Dose Fluzone
arm group type: Experimental
description: Fluzone High-Dose® Licensed for use in the USA in persons ≥ 65 years of age as a single dose of 0.5 mL containing 60μg hemagglutinin per virus strain
arm group label: Fluzone (standard dose)
arm group type: Active Comparator
description: Fluzone ® Licensed for the prevention of influenza as a single dose of 0.5 mL containing 15μg hemagglutinin per virus strain for adults
intervention type: Biological
intervention name: Fluzone High-Dose
description: Influenza vaccine
arm group label: High Dose Fluzone
intervention type: Biological
intervention name: Fluzone (standard dose)
description: Influenza vaccine
arm group label: Fluzone (standard dose)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 64 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Allison J McGeer, MD
role: Principal Investigator
affiliation: MOUNT SINAI HOSPITAL
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Influenza, Human
sharing ipd: Undecided
ipd description: Following publication of results
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 