<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/NCT01712984</url>
  </required_header>
  <id_info>
    <org_study_id>QID01</org_study_id>
    <secondary_id>U1111-1124-8066</secondary_id>
    <nct_id>NCT01712984</nct_id>
  </id_info>
  <brief_title>Study of Intradermal Quadrivalent Influenza Vaccine in Adults Aged 18 Through 64 Years</brief_title>
  <official_title>Immunogenicity and Safety Trial of Quadrivalent Influenza Vaccine Administered by Intradermal Route in Adult Subjects Aged 18 Through 64 Years</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sanofi Pasteur, a Sanofi Company</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sanofi</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study is to demonstrate safety and immunogenicity of the quadrivalent&#xD;
      influenza intradermal (QIV-ID) vaccine compared to the trivalent influenza vaccine (TIV)&#xD;
      containing the B strain from the primary (Yamagata) lineage (TIV-ID1) and the trivalent&#xD;
      influenza vaccine containing B strain from the alternate (Victoria) lineage (TIV-ID2)&#xD;
      vaccines in producing protection against four strains of influenza virus.&#xD;
&#xD;
      Primary Objective:&#xD;
&#xD;
        -  To demonstrate that QIV-ID induces an immune response (as assessed by hemagglutination&#xD;
           inhibition (HAI) geometric mean titers (GMTs) and seroconversion rates) that is&#xD;
           non-inferior to responses induced by TIV-ID1 and TIV-ID2 for the 4 virus strains at 28&#xD;
           days post-vaccination.&#xD;
&#xD;
      Secondary Objectives:&#xD;
&#xD;
        -  To demonstrate that each B strain in QIV-ID induces an immune response (as assessed by&#xD;
           HAI GMTs and seroconversion rates) that is superior to the response induced by the&#xD;
           TIV-ID that does not contain the corresponding B strain.&#xD;
&#xD;
        -  To describe the rate of post-vaccination seroprotection induced by QIV-ID and TIV-ID.&#xD;
&#xD;
        -  To describe post-vaccination immunogenicity stratified by age (18-49 years and 50-64&#xD;
           years), race, ethnicity, gender, previous vaccination status, and baseline&#xD;
           seropositivity status.&#xD;
&#xD;
        -  To describe the safety profile for subjects who receive QIV-ID and TIV-ID.&#xD;
&#xD;
      Observational Objectives:&#xD;
&#xD;
        -  To demonstrate non-inferiority of QIV-ID compared to TIV-ID in terms of all Grade 2 or&#xD;
           Grade 3 solicited systemic reactions combined&#xD;
&#xD;
        -  To demonstrate non-inferiority of QIV-ID compared to TIV-ID in terms of all Grade 3&#xD;
           solicited injection site reactions combined.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All participants will receive a single dose of their assigned vaccine on Day 0. A subset of&#xD;
      the participants will be assessed for immunologic response on Day 0 before vaccination and&#xD;
      Day 28 after vaccination. All subjects will be monitored for safety for up to 6 months after&#xD;
      vaccination.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">October 2013</completion_date>
  <primary_completion_date type="Actual">June 2013</primary_completion_date>
  <phase>Phase 3</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>Geometric Mean Titers Against the Influenza Virus Antigens Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route</measure>
    <time_frame>Day 28 post-vaccination</time_frame>
    <description>Antibodies against the influenza vaccine virus antigens were measured using a Hemagglutination-inhibition (HAI) assay.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Seroconversion to Influenza Virus Vaccine Antigens Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route</measure>
    <time_frame>Day 28 post-vaccination</time_frame>
    <description>Antibodies against the influenza vaccine virus antigens were measured using a Hemagglutination-inhibition (HAI) assay. Seroconversion was defined as titer&lt; 10 (1/dil) on Day 0 and post injection titer ≥ 40 (1/dil) on Day 28, or titer ≥10 (1/dil) on Day 0 and a ≥4 fold increase in titer (1/dil) on Day 28).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Geometric Mean Titers Against the Influenza Virus Antigens Before and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route</measure>
    <time_frame>Day 0 (pre-vaccination) and Day 28 post-vaccination</time_frame>
    <description>Antibodies against the influenza vaccine virus antigens were measured using a Hemagglutination-inhibition (HAI) assay.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before (Baseline) and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route</measure>
    <time_frame>Day 0 (pre-vaccination) and Day 28 post-vaccination</time_frame>
    <description>Antibodies against the influenza vaccine virus antigens were measured using a Hemagglutination-inhibition (HAI) assay. Seroprotection was defined as titer ≥ 40 [1/dil] at baseline and 28 days after vaccination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route</measure>
    <time_frame>Day 0 up to Day 7 post-vaccination</time_frame>
    <description>Solicited injection site: Pain, Erythema, Swelling, Induration, Ecchymosis, and Pruritus; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering. Grade 3 injection site: Pain and Pruritus Significant, prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis &gt;100 mm. Grade 3 systemic reactions: Fever ≥39˚C; Headache, Malaise, Myalgia, and Shivering Significant preventing daily activity.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">3360</enrollment>
  <condition>Influenza</condition>
  <arm_group>
    <arm_group_label>QIV ID Vaccine Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive the intradermal quadrivalent influenza vaccine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TIV ID1 Vaccine Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will receive the trivalent influenza vaccine containing the B strain from the primary (Yamagata) lineage</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TIV ID2 Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will receive the intradermal trivalent influenza vaccine containing B strain from the alternate (Victoria) lineage</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Influenza Virus Vaccine USP Quadrivalent, (Zonal Purified Subvirion) 2012 2013 Formulation</intervention_name>
    <description>0.1mL, Intradermal</description>
    <arm_group_label>QIV ID Vaccine Group</arm_group_label>
    <other_name>QIV ID</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Influenza Virus Vaccine USP Trivalent Types A and B (Zonal Purified Subvirion) Fluzone® Intradermal</intervention_name>
    <description>0.1mL, Intradermal</description>
    <arm_group_label>TIV ID1 Vaccine Group</arm_group_label>
    <other_name>Fluzone® Intradermal</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Influenza Virus Vaccine USP Trivalent Types A and B (Zonal Purified Subvirion) Fluzone Intradermal</intervention_name>
    <description>0.1mL, Intradermal</description>
    <arm_group_label>TIV ID2 Group</arm_group_label>
    <other_name>Fluzone® Intradermal</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 18 through 64 years on the day of inclusion&#xD;
&#xD;
          -  Informed consent form (ICF) has been signed and dated&#xD;
&#xD;
          -  Able to attend all scheduled visits and to comply with all trial procedures. Exclusion&#xD;
             Criteria:&#xD;
&#xD;
          -  Subject is pregnant, or lactating, or of childbearing potential (to be considered of&#xD;
             non-childbearing potential, a female must be post-menopausal for at least 1 year,&#xD;
             surgically sterile, or using an effective method of contraception or abstinence from&#xD;
             at least 4 weeks prior to vaccination and until at least 4 weeks after vaccination)&#xD;
&#xD;
          -  Participation at the time of trial enrollment (or in the 4 weeks preceding the trial&#xD;
             vaccination) or planned participation during the present trial period in another&#xD;
             clinical trial investigating a vaccine, drug, medical device, or medical procedure&#xD;
&#xD;
          -  Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned&#xD;
             receipt of any vaccine in the 4 weeks following trial vaccination&#xD;
&#xD;
          -  Vaccination against influenza in the past 6 months&#xD;
&#xD;
          -  Receipt of immune globulins, blood or blood-derived products in the past 3 months&#xD;
&#xD;
          -  Known or suspected congenital or acquired immunodeficiency; or receipt of&#xD;
             immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy,&#xD;
             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;
          -  Known systemic hypersensitivity to any of the vaccine components, or history of a&#xD;
             life-threatening reaction to the vaccine used in the trial or to a vaccine containing&#xD;
             any of the same substances&#xD;
&#xD;
          -  History of thrombocytopenia&#xD;
&#xD;
          -  Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion&#xD;
&#xD;
          -  Deprived of freedom by an administrative or court order, or in an emergency setting,&#xD;
             or hospitalized involuntarily&#xD;
&#xD;
          -  Current alcohol abuse or drug addiction&#xD;
&#xD;
          -  Chronic illness that, in the opinion of the investigator, is at a stage where it might&#xD;
             interfere with trial conduct or completion&#xD;
&#xD;
          -  Identified as an Investigator or employee of the Investigator or trial center with&#xD;
             direct involvement in the proposed trial, or identified as an immediate family member&#xD;
             (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with&#xD;
             direct involvement in the proposed trial&#xD;
&#xD;
          -  Personal or family history of Guillain-Barré Syndrome&#xD;
&#xD;
          -  Neoplastic disease or any hematologic malignancy (except localized skin or prostate&#xD;
             cancer that is stable at the time of vaccination in the absence of therapy, and&#xD;
             subjects who have a history of neoplastic disease and who have been disease free for ≥&#xD;
             5 years.&#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>Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Sanofi Pasteur Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Hoover</city>
        <state>Alabama</state>
        <zip>35216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Huntsville</city>
        <state>Alabama</state>
        <zip>35802</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Chandler</city>
        <state>Arizona</state>
        <zip>85224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Mesa</city>
        <state>Arizona</state>
        <zip>85213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85020</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85704</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Chula Vista</city>
        <state>California</state>
        <zip>91911</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95816</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Milford</city>
        <state>Connecticut</state>
        <zip>06460</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Coral Gables</city>
        <state>Florida</state>
        <zip>33134</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Melbourne</city>
        <state>Florida</state>
        <zip>32935</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Pinellas Park</city>
        <state>Florida</state>
        <zip>33781</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>South Miami</city>
        <state>Florida</state>
        <zip>33143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Boise</city>
        <state>Idaho</state>
        <zip>83642</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Overland Park</city>
        <state>Kansas</state>
        <zip>66212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Wichita</city>
        <state>Kansas</state>
        <zip>67207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Springfield</city>
        <state>Missouri</state>
        <zip>65802</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>St. Louis</city>
        <state>Missouri</state>
        <zip>63104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68134</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Binghamton</city>
        <state>New York</state>
        <zip>13901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14609</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14621</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Allentown</city>
        <state>Pennsylvania</state>
        <zip>18102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bensalem</city>
        <state>Pennsylvania</state>
        <zip>19020</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Warwick</city>
        <state>Rhode Island</state>
        <zip>02886</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Mt. Pleasant</city>
        <state>South Carolina</state>
        <zip>29464</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Dakota Dunes</city>
        <state>South Dakota</state>
        <zip>57049</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78745</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76135</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>San Angelo</city>
        <state>Texas</state>
        <zip>76904</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>West Jordan</city>
        <state>Utah</state>
        <zip>84088</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Marshfield</city>
        <state>Wisconsin</state>
        <zip>54449</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.sanofipasteur.com</url>
    <description>Related Info</description>
  </link>
  <reference>
    <citation>Gorse GJ, Falsey AR, Ozol-Godfrey A, Landolfi V, Tsang PH. Safety and immunogenicity of a quadrivalent intradermal influenza vaccine in adults. Vaccine. 2015 Feb 25;33(9):1151-9. doi: 10.1016/j.vaccine.2015.01.025. Epub 2015 Jan 19.</citation>
    <PMID>25613721</PMID>
  </reference>
  <verification_date>April 2015</verification_date>
  <study_first_submitted>October 22, 2012</study_first_submitted>
  <study_first_submitted_qc>October 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 24, 2012</study_first_posted>
  <results_first_submitted>December 15, 2013</results_first_submitted>
  <results_first_submitted_qc>January 30, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">February 10, 2014</results_first_posted>
  <last_update_submitted>April 20, 2015</last_update_submitted>
  <last_update_submitted_qc>April 20, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 7, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Influenza</keyword>
  <keyword>Fluzone® Intradermal vaccine</keyword>
  <keyword>Influenza Virus Vaccine USP Quadrivalent</keyword>
  <keyword>Influenza Virus Vaccine USP Trivalent Types A and B</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Influenza, Human</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fluconazole</mesh_term>
    <mesh_term>Vaccines</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The study participants were enrolled from 22 October 2012 to 28 May 2013 at 38 clinic sites in the United States.</recruitment_details>
      <pre_assignment_details>A total of 3360 participants who met all of the inclusion and none of the exclusion criteria were randomized, 3355 received one of the trial vaccines and their data are presented in this report.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>QIV ID Vaccine Group</title>
          <description>Adults 18 to &lt;65 years of age received a single injection of quadrivalent influenza intradermal (QIV ID) vaccine</description>
        </group>
        <group group_id="P2">
          <title>TIV ID1 Vaccine Group</title>
          <description>Adults 18 to &lt;65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the primary (Yamagata) lineage (TIV ID1)</description>
        </group>
        <group group_id="P3">
          <title>TIV ID2 Vaccine Group</title>
          <description>Adults 18 to &lt;65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the alternate (Victoria) lineage (TIV ID2)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1672"/>
                <participants group_id="P2" count="837"/>
                <participants group_id="P3" count="846"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1656"/>
                <participants group_id="P2" count="821"/>
                <participants group_id="P3" count="836"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="16"/>
                <participants group_id="P3" count="10"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</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>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="10"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>QIV ID Vaccine Group</title>
          <description>Adults 18 to &lt;65 years of age received a single injection of quadrivalent influenza intradermal (QIV ID) vaccine</description>
        </group>
        <group group_id="B2">
          <title>TIV ID1 Vaccine Group</title>
          <description>Adults 18 to &lt;65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the primary (Yamagata) lineage (TIV ID1)</description>
        </group>
        <group group_id="B3">
          <title>TIV ID2 Vaccine Group</title>
          <description>Adults 18 to &lt;65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the alternate (Victoria) lineage (TIV ID2)</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="1672"/>
            <count group_id="B2" value="837"/>
            <count group_id="B3" value="846"/>
            <count group_id="B4" value="3355"/>
          </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="1672"/>
                    <measurement group_id="B2" value="837"/>
                    <measurement group_id="B3" value="846"/>
                    <measurement group_id="B4" value="3355"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 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_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="41.6" spread="13.2"/>
                    <measurement group_id="B2" value="41.2" spread="13.5"/>
                    <measurement group_id="B3" value="41.9" spread="13.3"/>
                    <measurement group_id="B4" value="41.6" spread="13.3"/>
                  </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>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1022"/>
                    <measurement group_id="B2" value="505"/>
                    <measurement group_id="B3" value="528"/>
                    <measurement group_id="B4" value="2055"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="650"/>
                    <measurement group_id="B2" value="332"/>
                    <measurement group_id="B3" value="318"/>
                    <measurement group_id="B4" value="1300"/>
                  </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>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1672"/>
                    <measurement group_id="B2" value="837"/>
                    <measurement group_id="B3" value="846"/>
                    <measurement group_id="B4" value="3355"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Geometric Mean Titers Against the Influenza Virus Antigens Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route</title>
        <description>Antibodies against the influenza vaccine virus antigens were measured using a Hemagglutination-inhibition (HAI) assay.</description>
        <time_frame>Day 28 post-vaccination</time_frame>
        <population>Geometric mean titers against the influenza virus antigens were assessed in the Per-protocol Analysis Set.</population>
        <group_list>
          <group group_id="O1">
            <title>QIV ID Vaccine Group</title>
            <description>Adults 18 to &lt;65 years of age received a single injection of quadrivalent influenza intradermal (QIV ID) vaccine</description>
          </group>
          <group group_id="O2">
            <title>TIV ID1 Vaccine Group</title>
            <description>Adults 18 to &lt;65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the primary (Yamagata) lineage (TIV ID1)</description>
          </group>
          <group group_id="O3">
            <title>TIV ID2 Vaccine Group</title>
            <description>Adults 18 to &lt;65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the alternate (Victoria) lineage (TIV ID2)</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Titers Against the Influenza Virus Antigens Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route</title>
          <description>Antibodies against the influenza vaccine virus antigens were measured using a Hemagglutination-inhibition (HAI) assay.</description>
          <population>Geometric mean titers against the influenza virus antigens were assessed in the Per-protocol Analysis Set.</population>
          <units>Titers</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="1041"/>
                <count group_id="O2" value="539"/>
                <count group_id="O3" value="533"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>A/H1N1 (N=1041, 539, 533)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="589" lower_limit="546" upper_limit="636"/>
                    <measurement group_id="O2" value="728" lower_limit="653" upper_limit="811"/>
                    <measurement group_id="O3" value="635" lower_limit="568" upper_limit="709"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H3N2 (N=1041, 538, 533)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="368" lower_limit="342" upper_limit="397"/>
                    <measurement group_id="O2" value="413" lower_limit="369" upper_limit="462"/>
                    <measurement group_id="O3" value="447" lower_limit="401" upper_limit="498"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B/Texas/6/2011 (B1; N=1041, 539, 533)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="105" lower_limit="99.1" upper_limit="112"/>
                    <measurement group_id="O2" value="93.5" lower_limit="85.9" upper_limit="102"/>
                    <measurement group_id="O3" value="54.0" lower_limit="49.3" upper_limit="59.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B/Brisbane/60/2008 (B2; N=1041, 538, 533)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="136" lower_limit="128" upper_limit="145"/>
                    <measurement group_id="O2" value="66.7" lower_limit="61.0" upper_limit="72.9"/>
                    <measurement group_id="O3" value="130" lower_limit="118" upper_limit="143"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Seroconversion to Influenza Virus Vaccine Antigens Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route</title>
        <description>Antibodies against the influenza vaccine virus antigens were measured using a Hemagglutination-inhibition (HAI) assay. Seroconversion was defined as titer&lt; 10 (1/dil) on Day 0 and post injection titer ≥ 40 (1/dil) on Day 28, or titer ≥10 (1/dil) on Day 0 and a ≥4 fold increase in titer (1/dil) on Day 28).</description>
        <time_frame>Day 28 post-vaccination</time_frame>
        <population>Seroconversion to the influenza virus antigens were assessed in the Per Protocol Analysis Set.</population>
        <group_list>
          <group group_id="O1">
            <title>QIV ID Vaccine Group</title>
            <description>Adults 18 to &lt;65 years of age received a single injection of quadrivalent influenza intradermal (QIV ID) vaccine</description>
          </group>
          <group group_id="O2">
            <title>TIV ID1 Vaccine Group</title>
            <description>Adults 18 to &lt;65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the primary (Yamagata) lineage (TIV ID1)</description>
          </group>
          <group group_id="O3">
            <title>TIV ID2 Vaccine Group</title>
            <description>Adults 18 to &lt;65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the alternate (Victoria) lineage (TIV ID2)</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Seroconversion to Influenza Virus Vaccine Antigens Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route</title>
          <description>Antibodies against the influenza vaccine virus antigens were measured using a Hemagglutination-inhibition (HAI) assay. Seroconversion was defined as titer&lt; 10 (1/dil) on Day 0 and post injection titer ≥ 40 (1/dil) on Day 28, or titer ≥10 (1/dil) on Day 0 and a ≥4 fold increase in titer (1/dil) on Day 28).</description>
          <population>Seroconversion to the influenza virus antigens were assessed in the Per Protocol Analysis Set.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1041"/>
                <count group_id="O2" value="539"/>
                <count group_id="O3" value="533"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>A/H1N1 (N=1041, 539, 533)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="600"/>
                    <measurement group_id="O2" value="333" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O3" value="314" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H3N2 (N=1040, 538, 533)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="608"/>
                    <measurement group_id="O2" value="326" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O3" value="314" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B/Texas/6/2011 (B1; N=1041, 539, 533)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="580"/>
                    <measurement group_id="O2" value="253" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O3" value="131" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B/Brisbane/60/2008 (B2; N=1041, 538, 533)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="525"/>
                    <measurement group_id="O2" value="119" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O3" value="235" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Geometric Mean Titers Against the Influenza Virus Antigens Before and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route</title>
        <description>Antibodies against the influenza vaccine virus antigens were measured using a Hemagglutination-inhibition (HAI) assay.</description>
        <time_frame>Day 0 (pre-vaccination) and Day 28 post-vaccination</time_frame>
        <population>Geometric mean titers against the influenza virus antigens were assessed in the Per Protocol Analysis Set.</population>
        <group_list>
          <group group_id="O1">
            <title>QIV ID Vaccine Group</title>
            <description>Adults 18 to &lt;65 years of age received a single injection of quadrivalent influenza intradermal (QIV ID) vaccine</description>
          </group>
          <group group_id="O2">
            <title>TIV ID1 Vaccine Group</title>
            <description>Adults 18 to &lt;65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the primary (Yamagata) lineage (TIV ID1)</description>
          </group>
          <group group_id="O3">
            <title>TIV ID2 Vaccine Group</title>
            <description>Adults 18 to &lt;65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the alternate (Victoria) lineage (TIV ID2)</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Titers Against the Influenza Virus Antigens Before and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route</title>
          <description>Antibodies against the influenza vaccine virus antigens were measured using a Hemagglutination-inhibition (HAI) assay.</description>
          <population>Geometric mean titers against the influenza virus antigens were assessed in the Per Protocol Analysis Set.</population>
          <units>Titers</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="1041"/>
                <count group_id="O2" value="539"/>
                <count group_id="O3" value="533"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>A/H1N1 Day 0 (N=1041, 539, 533)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.3" lower_limit="59.5" upper_limit="73.8"/>
                    <measurement group_id="O2" value="65.2" lower_limit="56.0" upper_limit="76.0"/>
                    <measurement group_id="O3" value="66.2" lower_limit="56.9" upper_limit="77.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H1N1 Day 28 (N=1041, 539, 533)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="589" lower_limit="546" upper_limit="636"/>
                    <measurement group_id="O2" value="728" lower_limit="653" upper_limit="811"/>
                    <measurement group_id="O3" value="635" lower_limit="568" upper_limit="709"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H3N2 Day 0 (N=1040, 539, 533)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52.3" lower_limit="47.5" upper_limit="57.5"/>
                    <measurement group_id="O2" value="56.5" lower_limit="49.2" upper_limit="64.9"/>
                    <measurement group_id="O3" value="55.7" lower_limit="48.4" upper_limit="64.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H3N2 Day 28 (N=1041, 538, 533)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="368" lower_limit="342" upper_limit="397"/>
                    <measurement group_id="O2" value="413" lower_limit="369" upper_limit="462"/>
                    <measurement group_id="O3" value="447" lower_limit="401" upper_limit="498"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B1 Day 0 (N=1041, 539, 533)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.7" lower_limit="20.5" upper_limit="23.1"/>
                    <measurement group_id="O2" value="24.7" lower_limit="22.7" upper_limit="27.0"/>
                    <measurement group_id="O3" value="22.2" lower_limit="20.4" upper_limit="24.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B1 Day 28 (N=1041, 539, 533)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="105" lower_limit="99.1" upper_limit="112"/>
                    <measurement group_id="O2" value="93.5" lower_limit="85.9" upper_limit="102"/>
                    <measurement group_id="O3" value="54.0" lower_limit="49.3" upper_limit="59.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B2 Day 0 (N=1041, 539, 533)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.8" lower_limit="25.0" upper_limit="28.8"/>
                    <measurement group_id="O2" value="29.7" lower_limit="26.9" upper_limit="32.8"/>
                    <measurement group_id="O3" value="25.4" lower_limit="23.0" upper_limit="28.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B2 Day 28 (N=1041, 538, 533)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="136" lower_limit="128" upper_limit="145"/>
                    <measurement group_id="O2" value="66.7" lower_limit="61.0" upper_limit="72.9"/>
                    <measurement group_id="O3" value="130" lower_limit="118" upper_limit="143"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before (Baseline) and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route</title>
        <description>Antibodies against the influenza vaccine virus antigens were measured using a Hemagglutination-inhibition (HAI) assay. Seroprotection was defined as titer ≥ 40 [1/dil] at baseline and 28 days after vaccination.</description>
        <time_frame>Day 0 (pre-vaccination) and Day 28 post-vaccination</time_frame>
        <population>Seroprotection against influenza virus antigens was assessed in the Per Protocol Analysis Set.</population>
        <group_list>
          <group group_id="O1">
            <title>QIV ID Vaccine Group</title>
            <description>Adults 18 to &lt;65 years of age received a single injection of quadrivalent influenza intradermal (QIV ID) vaccine</description>
          </group>
          <group group_id="O2">
            <title>TIV ID1 Vaccine Group</title>
            <description>Adults 18 to &lt;65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the primary (Yamagata) lineage (TIV ID1)</description>
          </group>
          <group group_id="O3">
            <title>TIV ID2 Vaccine Group</title>
            <description>Adults 18 to &lt;65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the alternate (Victoria) lineage (TIV ID2)</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before (Baseline) and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route</title>
          <description>Antibodies against the influenza vaccine virus antigens were measured using a Hemagglutination-inhibition (HAI) assay. Seroprotection was defined as titer ≥ 40 [1/dil] at baseline and 28 days after vaccination.</description>
          <population>Seroprotection against influenza virus antigens was assessed in the Per Protocol Analysis Set.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1041"/>
                <count group_id="O2" value="539"/>
                <count group_id="O3" value="533"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>A/H1N1 Day 0 (N=1041, 539, 533)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="672"/>
                    <measurement group_id="O2" value="334" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O3" value="353" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H1N1 Day 28 (N=1041, 539, 533)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1014"/>
                    <measurement group_id="O2" value="537" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O3" value="524" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H3N2 Day 0 (N=1040, 539, 533)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="655"/>
                    <measurement group_id="O2" value="340" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O3" value="332" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H3N2 Day 28 (N=1041, 538, 533)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1008"/>
                    <measurement group_id="O2" value="526" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O3" value="519" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B1 Day 0 (N=1041, 539, 533)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="335"/>
                    <measurement group_id="O2" value="210" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O3" value="172" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B1 Day 28 (N=1041, 539, 533)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="923"/>
                    <measurement group_id="O2" value="464" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O3" value="351" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B2 Day 0 (N=1041, 539, 533)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="467"/>
                    <measurement group_id="O2" value="262" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O3" value="224" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B2 Day 28 (N=1041, 538, 533)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="976"/>
                    <measurement group_id="O2" value="403" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O3" value="477" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route</title>
        <description>Solicited injection site: Pain, Erythema, Swelling, Induration, Ecchymosis, and Pruritus; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering. Grade 3 injection site: Pain and Pruritus Significant, prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis &gt;100 mm. Grade 3 systemic reactions: Fever ≥39˚C; Headache, Malaise, Myalgia, and Shivering Significant preventing daily activity.</description>
        <time_frame>Day 0 up to Day 7 post-vaccination</time_frame>
        <population>Solicited injection site reactions and systemic reactions were assessed in the Safety Analysis Set.</population>
        <group_list>
          <group group_id="O1">
            <title>QIV ID Vaccine Group</title>
            <description>Adults 18 to &lt;65 years of age received a single injection of quadrivalent influenza intradermal (QIV ID) vaccine</description>
          </group>
          <group group_id="O2">
            <title>TIV ID1 Vaccine Group</title>
            <description>Adults 18 to &lt;65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the primary (Yamagata) lineage (TIV ID1)</description>
          </group>
          <group group_id="O3">
            <title>TIV ID2 Vaccine Group</title>
            <description>Adults 18 to &lt;65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the alternate (Victoria) lineage (TIV ID2)</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route</title>
          <description>Solicited injection site: Pain, Erythema, Swelling, Induration, Ecchymosis, and Pruritus; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering. Grade 3 injection site: Pain and Pruritus Significant, prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis &gt;100 mm. Grade 3 systemic reactions: Fever ≥39˚C; Headache, Malaise, Myalgia, and Shivering Significant preventing daily activity.</description>
          <population>Solicited injection site reactions and systemic reactions were assessed in the Safety Analysis Set.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1672"/>
                <count group_id="O2" value="837"/>
                <count group_id="O3" value="846"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Injection site Pain (N=1656,820,838)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="883"/>
                    <measurement group_id="O2" value="395" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O3" value="420" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Injection site Pain (N=1656,820,838)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                    <measurement group_id="O2" value="10" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O3" value="12" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site Erythema (N=1656,820,838)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="607"/>
                    <measurement group_id="O2" value="279" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O3" value="269" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Injection site Erythema (N=1656,820,838)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="1" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O3" value="3" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site Swelling (N=1655,820,838)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="322"/>
                    <measurement group_id="O2" value="121" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O3" value="123" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Injection site Swelling (N=1655,820,838)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O3" value="0" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site Induration (N=1656,820,837)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="282"/>
                    <measurement group_id="O2" value="111" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O3" value="94" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Injection site Induration (N=1656,820,837)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O3" value="0" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site Ecchymosis (N=1656,820,838)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43"/>
                    <measurement group_id="O2" value="15" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O3" value="15" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Injection site Ecchymosis (N=1656,820,838)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O3" value="0" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fever (N=1649,819,836)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="6" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O3" value="4" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Fever (N=1649,819,836)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O3" value="0" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Headache (N=1656,820,838)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="548"/>
                    <measurement group_id="O2" value="257" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O3" value="278" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Headache (N=1656,820,838)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53"/>
                    <measurement group_id="O2" value="20" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O3" value="15" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Malaise (N=1656,820,838)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="459"/>
                    <measurement group_id="O2" value="216" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O3" value="255" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Malaise (N=1656,820,838)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49"/>
                    <measurement group_id="O2" value="15" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O3" value="21" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Myalgia (N=1656,820,838)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="564"/>
                    <measurement group_id="O2" value="238" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O3" value="261" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Myalgia (N=1656,820,838)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43"/>
                    <measurement group_id="O2" value="12" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O3" value="21" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Shivering (N=1656,820,838)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="200"/>
                    <measurement group_id="O2" value="85" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O3" value="94" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Shivering (N=1656,820,838)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                    <measurement group_id="O2" value="5" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O3" value="13" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site Pruritus (N=1656,820,838)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="862"/>
                    <measurement group_id="O2" value="372" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O3" value="374" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Grade 3 Injection site Pruritus (N=1656,820,838)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47"/>
                    <measurement group_id="O2" value="15" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O3" value="19" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data were collected from Day 0 (post-vaccination) up to 6 months post-vaccination.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>QIV ID Vaccine Group</title>
          <description>Adults 18 to &lt;65 years of age received a single injection of quadrivalent influenza intradermal (QIV ID) vaccine</description>
        </group>
        <group group_id="E2">
          <title>TIV ID1 Vaccine Group</title>
          <description>Adults 18 to &lt;65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the primary (Yamagata) lineage (TIV ID1)</description>
        </group>
        <group group_id="E3">
          <title>TIV ID2 Vaccine Group</title>
          <description>Adults 18 to &lt;65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the alternate (Victoria) lineage (TIV ID2)</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 15.0</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="1672"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="837"/>
                <counts group_id="E3" subjects_affected="11" subjects_at_risk="846"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1672"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="837"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="846"/>
              </event>
              <event>
                <sub_title>Aortic valve disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1672"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="837"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="846"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1672"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="837"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="846"/>
              </event>
              <event>
                <sub_title>Cardiac tamponade</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1672"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="837"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="846"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Vertigo</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1672"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="837"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="846"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1672"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="837"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="846"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1672"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="837"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="846"/>
              </event>
              <event>
                <sub_title>Dysplasia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1672"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="837"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="846"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Bile duct stone</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1672"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="837"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="846"/>
              </event>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1672"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="837"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="846"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Sarcoidosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1672"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="837"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="846"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Clostridium difficile colitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1672"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="837"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="846"/>
              </event>
              <event>
                <sub_title>Osteomyelitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1672"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="837"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="846"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1672"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="837"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="846"/>
              </event>
              <event>
                <sub_title>Pneumonia primary atypical</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1672"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="837"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="846"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Alcohol poisoning</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1672"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="837"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="846"/>
              </event>
              <event>
                <sub_title>Concussion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1672"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="837"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="846"/>
              </event>
              <event>
                <sub_title>Hip fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1672"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="837"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="846"/>
              </event>
              <event>
                <sub_title>Joint injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1672"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="837"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="846"/>
              </event>
              <event>
                <sub_title>Laceration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1672"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="837"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="846"/>
              </event>
              <event>
                <sub_title>Lower limb fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1672"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="837"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="846"/>
              </event>
              <event>
                <sub_title>Neck injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1672"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="837"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="846"/>
              </event>
              <event>
                <sub_title>Seroma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1672"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="837"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="846"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1672"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="837"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="846"/>
              </event>
              <event>
                <sub_title>Hypovolaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1672"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="837"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="846"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Musculoskeletal chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1672"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="837"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="846"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1672"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="837"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="846"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Colon cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1672"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="837"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="846"/>
              </event>
              <event>
                <sub_title>Lung neoplasm malignant</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1672"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="837"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="846"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1672"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="837"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="846"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1672"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="837"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="846"/>
              </event>
              <event>
                <sub_title>Hemiplegic migraine</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1672"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="837"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="846"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1672"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="837"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="846"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>Cervical incompetence</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1672"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="837"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="846"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Conversion disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1672"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="837"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="846"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1672"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="837"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="846"/>
              </event>
              <event>
                <sub_title>Renal failure acute</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1672"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="837"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="846"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1672"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="837"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="846"/>
              </event>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1672"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="837"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="846"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1672"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="837"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="846"/>
              </event>
              <event>
                <sub_title>Respiratory distress</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1672"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="837"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="846"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1672"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="837"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="846"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetic foot</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1672"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="837"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="846"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1672"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="837"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="846"/>
              </event>
              <event>
                <sub_title>Peripheral vascular disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1672"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="837"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="846"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5.00</frequency_threshold>
        <default_vocab>MedDRA 15.0</default_vocab>
        <default_assessment>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="883" subjects_at_risk="1672"/>
                <counts group_id="E2" subjects_affected="395" subjects_at_risk="837"/>
                <counts group_id="E3" subjects_affected="420" subjects_at_risk="846"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Injection site Pain</sub_title>
                <counts group_id="E1" events="883" subjects_affected="883" subjects_at_risk="1656"/>
                <counts group_id="E2" events="395" subjects_affected="395" subjects_at_risk="820"/>
                <counts group_id="E3" events="420" subjects_affected="420" subjects_at_risk="838"/>
              </event>
              <event>
                <sub_title>Injection site Erythema</sub_title>
                <counts group_id="E1" events="607" subjects_affected="607" subjects_at_risk="1656"/>
                <counts group_id="E2" events="279" subjects_affected="279" subjects_at_risk="820"/>
                <counts group_id="E3" events="269" subjects_affected="269" subjects_at_risk="838"/>
              </event>
              <event>
                <sub_title>Injection site Swelling</sub_title>
                <counts group_id="E1" events="322" subjects_affected="322" subjects_at_risk="1655"/>
                <counts group_id="E2" events="121" subjects_affected="121" subjects_at_risk="820"/>
                <counts group_id="E3" events="123" subjects_affected="123" subjects_at_risk="838"/>
              </event>
              <event>
                <sub_title>Injection site Induration</sub_title>
                <counts group_id="E1" events="282" subjects_affected="282" subjects_at_risk="1656"/>
                <counts group_id="E2" events="111" subjects_affected="111" subjects_at_risk="820"/>
                <counts group_id="E3" events="94" subjects_affected="94" subjects_at_risk="837"/>
              </event>
              <event>
                <sub_title>Injection site Pruritus</sub_title>
                <counts group_id="E1" events="862" subjects_affected="862" subjects_at_risk="1656"/>
                <counts group_id="E2" events="372" subjects_affected="372" subjects_at_risk="820"/>
                <counts group_id="E3" events="374" subjects_affected="374" subjects_at_risk="838"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" events="459" subjects_affected="459" subjects_at_risk="1656"/>
                <counts group_id="E2" events="216" subjects_affected="216" subjects_at_risk="820"/>
                <counts group_id="E3" events="255" subjects_affected="255" subjects_at_risk="838"/>
              </event>
              <event>
                <sub_title>Shivering</sub_title>
                <counts group_id="E1" events="200" subjects_affected="200" subjects_at_risk="1656"/>
                <counts group_id="E2" events="85" subjects_affected="85" subjects_at_risk="820"/>
                <counts group_id="E3" events="94" subjects_affected="94" subjects_at_risk="838"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="564" subjects_affected="564" subjects_at_risk="1656"/>
                <counts group_id="E2" events="238" subjects_affected="238" subjects_at_risk="820"/>
                <counts group_id="E3" events="261" subjects_affected="261" subjects_at_risk="838"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="548" subjects_affected="548" subjects_at_risk="1656"/>
                <counts group_id="E2" events="257" subjects_affected="257" subjects_at_risk="820"/>
                <counts group_id="E3" events="278" subjects_affected="278" subjects_at_risk="838"/>
              </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>Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Medical Director</name_or_title>
      <organization>Sanofi Pasteur Inc.</organization>
      <email>RegistryContactUs@sanofipasteur.com</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/NCT01712984
org study id: QID01
secondary id: U1111-1124-8066
nct id: NCT01712984
lead sponsor: 
has dmc: No
The aim of the study is to demonstrate safety and immunogenicity of the quadrivalent
      influenza intradermal (QIV-ID) vaccine compared to the trivalent influenza vaccine (TIV)
      containing the B strain from the primary (Yamagata) lineage (TIV-ID1) and the trivalent
      influenza vaccine containing B strain from the alternate (Victoria) lineage (TIV-ID2)
      vaccines in producing protection against four strains of influenza virus.

      Primary Objective:

        -  To demonstrate that QIV-ID induces an immune response (as assessed by hemagglutination
           inhibition (HAI) geometric mean titers (GMTs) and seroconversion rates) that is
           non-inferior to responses induced by TIV-ID1 and TIV-ID2 for the 4 virus strains at 28
           days post-vaccination.

      Secondary Objectives:

        -  To demonstrate that each B strain in QIV-ID induces an immune response (as assessed by
           HAI GMTs and seroconversion rates) that is superior to the response induced by the
           TIV-ID that does not contain the corresponding B strain.

        -  To describe the rate of post-vaccination seroprotection induced by QIV-ID and TIV-ID.

        -  To describe post-vaccination immunogenicity stratified by age (18-49 years and 50-64
           years), race, ethnicity, gender, previous vaccination status, and baseline
           seropositivity status.

        -  To describe the safety profile for subjects who receive QIV-ID and TIV-ID.

      Observational Objectives:

        -  To demonstrate non-inferiority of QIV-ID compared to TIV-ID in terms of all Grade 2 or
           Grade 3 solicited systemic reactions combined

        -  To demonstrate non-inferiority of QIV-ID compared to TIV-ID in terms of all Grade 3
           solicited injection site reactions combined.
All participants will receive a single dose of their assigned vaccine on Day 0. A subset of
      the participants will be assessed for immunologic response on Day 0 before vaccination and
      Day 28 after vaccination. All subjects will be monitored for safety for up to 6 months after
      vaccination.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Geometric Mean Titers Against the Influenza Virus Antigens Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route
time frame: Day 28 post-vaccination
description: Antibodies against the influenza vaccine virus antigens were measured using a Hemagglutination-inhibition (HAI) assay.
measure: Number of Participants With Seroconversion to Influenza Virus Vaccine Antigens Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route
time frame: Day 28 post-vaccination
description: Antibodies against the influenza vaccine virus antigens were measured using a Hemagglutination-inhibition (HAI) assay. Seroconversion was defined as titer< 10 (1/dil) on Day 0 and post injection titer ≥ 40 (1/dil) on Day 28, or titer ≥10 (1/dil) on Day 0 and a ≥4 fold increase in titer (1/dil) on Day 28).
measure: Geometric Mean Titers Against the Influenza Virus Antigens Before and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route
time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
description: Antibodies against the influenza vaccine virus antigens were measured using a Hemagglutination-inhibition (HAI) assay.
measure: Number of Participants With Seroprotection Against Influenza Vaccine Antigens Before (Baseline) and Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route
time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
description: Antibodies against the influenza vaccine virus antigens were measured using a Hemagglutination-inhibition (HAI) assay. Seroprotection was defined as titer ≥ 40 [1/dil] at baseline and 28 days after vaccination.
measure: Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Either a Quadrivalent Influenza Vaccine or a Trivalent Influenza Vaccine Administered by Intradermal Route
time frame: Day 0 up to Day 7 post-vaccination
description: Solicited injection site: Pain, Erythema, Swelling, Induration, Ecchymosis, and Pruritus; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering. Grade 3 injection site: Pain and Pruritus Significant, prevents daily activity; Erythema, Swelling, Induration, and Ecchymosis >100 mm. Grade 3 systemic reactions: Fever ≥39˚C; Headache, Malaise, Myalgia, and Shivering Significant preventing daily activity.
arm group label: QIV ID Vaccine Group
arm group type: Experimental
description: Participants will receive the intradermal quadrivalent influenza vaccine
arm group label: TIV ID1 Vaccine Group
arm group type: Active Comparator
description: Participants will receive the trivalent influenza vaccine containing the B strain from the primary (Yamagata) lineage
arm group label: TIV ID2 Group
arm group type: Active Comparator
description: Participants will receive the intradermal trivalent influenza vaccine containing B strain from the alternate (Victoria) lineage
intervention type: Biological
intervention name: Influenza Virus Vaccine USP Quadrivalent, (Zonal Purified Subvirion) 2012 2013 Formulation
description: 0.1mL, Intradermal
arm group label: QIV ID Vaccine Group
other name: QIV ID
intervention type: Biological
intervention name: Influenza Virus Vaccine USP Trivalent Types A and B (Zonal Purified Subvirion) Fluzone® Intradermal
description: 0.1mL, Intradermal
arm group label: TIV ID1 Vaccine Group
other name: Fluzone® Intradermal
intervention type: Biological
intervention name: Influenza Virus Vaccine USP Trivalent Types A and B (Zonal Purified Subvirion) Fluzone Intradermal
description: 0.1mL, Intradermal
arm group label: TIV ID2 Group
other name: Fluzone® Intradermal
criteria: 
gender: All
minimum age: 18 Years
maximum age: 64 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Medical Director
role: Study Director
affiliation: Sanofi Pasteur Inc.
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country: United States
url: http://www.sanofipasteur.com
description: Related Info
citation: Gorse GJ, Falsey AR, Ozol-Godfrey A, Landolfi V, Tsang PH. Safety and immunogenicity of a quadrivalent intradermal influenza vaccine in adults. Vaccine. 2015 Feb 25;33(9):1151-9. doi: 10.1016/j.vaccine.2015.01.025. Epub 2015 Jan 19.
PMID: 25613721
responsible party type: Sponsor
mesh term: Influenza, Human
mesh term: Fluconazole
mesh term: Vaccines
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 