<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/NCT03282240</url>
  </required_header>
  <id_info>
    <org_study_id>QHD00013</org_study_id>
    <secondary_id>U1111-1183-5556</secondary_id>
    <nct_id>NCT03282240</nct_id>
  </id_info>
  <brief_title>Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine in Participants ≥65 Years in the US</brief_title>
  <official_title>Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine Administered by Intramuscular Route in Participants Aged 65 Years and Older</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>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This randomized, modified double-blind, active-controlled, multi-center trial assessed the&#xD;
      safety and immunogenicity of the high-dose quadrivalent influenza vaccine (QIV-HD) compared&#xD;
      to either the licensed or investigational high-dose trivalent influenza vaccine (TIV-HD) in&#xD;
      adults.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This randomized, modified double-blind, active-controlled, multi-center trial was conducted&#xD;
      in healthy adults (greater than and equal to [&gt;=] 65 years) to assess the safety and&#xD;
      immunogenicity (geometric mean titers and seroconversion for the 4 virus strains at 28 days&#xD;
      post vaccination) of the QIV-HD compared to one of the TIV-HDs containing either the B strain&#xD;
      from the primary lineage (TIV-HD1; licensed vaccine [Fluzone® High-Dose] for the 2017-2018&#xD;
      Northern Hemisphere [NH] influenza season) or the B strain from the alternate lineage&#xD;
      (TIV-HD2, investigational TIV-HD containing an alternate B strain).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 8, 2017</start_date>
  <completion_date type="Actual">April 19, 2018</completion_date>
  <primary_completion_date type="Actual">November 2, 2017</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>QHD00013 was a phase III, randomized, modified double-blind, active-controlled, multi-center trial.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>QHD00013 was a modified double-blind trial with an unblinded administrator used at each trial site. The administrator was not involved in any of the blinded study assessments (e.g., safety).</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine</measure>
    <time_frame>Day 28 post-vaccination</time_frame>
    <description>GMTs of anti-influenza antibodies were measured using an hemagglutination inhibition (HAI) assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage (B1), and B Yamagata lineage (B2). For each A strain, the comparison was made with the pooled TIV-HD groups. For each B strain, the comparison was made with the TIV-HD group containing the corresponding B strain. TIV-HD 1 did not contain B2 strain; TIV-HD2 did not contain B1 strain.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Achieving Seroconversion Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine</measure>
    <time_frame>Day 28 post-vaccination</time_frame>
    <description>Anti-influenza antibodies were measured using an HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage (B1), and B Yamagata lineage (B2). Seroconversion was defined as either a HAI titer less than (&lt;) 10 (1/dilution) at Day 0 and post-injection titer greater than or equal to (&gt;=) 40 (1/dilution) at Day 28, or HAI titer &gt;=10 (1/dilution) at Day 0 and a &gt;=4-fold increase in HAI titer (1/dilution) at Day 28. For each A strain, the comparison was made with the pooled TIV-HD groups. For each B strain, the comparison was made with the TIV-HD group containing the corresponding B strain. TIV-HD 1 did not contain B2 strain; TIV-HD2 did not contain B1 strain.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>GMTs of B Strains Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine</measure>
    <time_frame>Day 28 post-vaccination</time_frame>
    <description>Anti-influenza antibodies were measured using HAI assay for 4 strains: A/H1N1 (A1), A/H3N2 (A2), B Victoria lineage (B1), and B Yamagata lineage (B2). For each B strain, the immunogenicity of QIV-HD was compared to that of TIV-HD group which contains the corresponding B strain. TIV-HD1 did not contain B2 strain; TIV-HD2 did not contain B1 strain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>GMT Ratios of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine</measure>
    <time_frame>Day 0 (pre-vaccination) and Day 28 post-vaccination</time_frame>
    <description>GMTs of anti-influenza antibodies using an HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage (B1), and B Yamagata lineage (B2). Geometric Mean Titers Ratios (GMTRs) were calculated as the ratio of GMTs post vaccination and pre-vaccination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving Seroconversion Against Antigens of B Strains After Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine</measure>
    <time_frame>Day 28 post-vaccination</time_frame>
    <description>Seroconversion was defined as either a HAI titer &lt;10 (1/dilution) at Day 0 and post-injection titer &gt;=40 (1/dilution) at Day 28, or HAI titer &gt;=10 (1/dilution) at Day 0 and a &gt;=4-fold increase in HAI titer (1/dilution) at Day 28.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine</measure>
    <time_frame>Day 0 (pre-vaccination) and Day 28 post-vaccination</time_frame>
    <description>Anti-influenza antibodies were measured using HAI assay for 4 strains: A/H1N1 (A1), A/H3N2 (A2), B Victoria lineage (B1), and B Yamagata lineage (B2). Seroprotection was defined as a HAI titer &gt;=40 (1/dilution) at Day 0 and Day 28.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geometric Mean Titers of Influenza Antibodies (Seroneutralization [SN] Assay) Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine</measure>
    <time_frame>Day 0 (pre-vaccination) and Day 28 post-vaccination</time_frame>
    <description>GMTs of anti-influenza antibodies were measured using SN assay for 4 strains: A/H1N1 (A1), A/H3N2 (A2), B Victoria lineage (B1), and B Yamagata lineage (B2).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>GMTRs of Influenza Antibodies (SN Assay) Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine</measure>
    <time_frame>Day 0 (pre-vaccination) and Day 28 post-vaccination</time_frame>
    <description>GMTRs of anti-influenza antibodies were measured using SN assay for 4 strains: A/H1N1 (A1), A/H3N2 (A2), B Victoria lineage (B1), and B Yamagata lineage (B2). GMTRs were calculated as the ratio of GMTs post vaccination and pre-vaccination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Neutralization Antibody Titers at Day 0 and Day 28</measure>
    <time_frame>Day 0, Day 28</time_frame>
    <description>Neutralizing Antibody titer was measured for each influenza strain with the SN method for 4 strains: A/H1N1, A/H3N2, B Victoria lineage (B1), and B Yamagata lineage (B2). Neutralizing antibody was defined as titers &gt;=20 (1/dilution), &gt;=40 (1/dilution), &gt;=80 (1/dilution) at Day 0 and Day 28.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Two-Fold and Four-Fold Increase in Neutralization Antibody Titer at Day 28</measure>
    <time_frame>Day 28</time_frame>
    <description>Neutralizing Antibody titer was measured for each influenza strain with the SN method for 4 strains: A/H1N1, A/H3N2, B Victoria lineage (B1), and B Yamagata lineage (B2). 2-fold and 4-fold rise was defined as the computed value = post-vaccination computed value / baseline computed value.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Detectable Neutralization Antibody Titers at Day 0 and Day 28</measure>
    <time_frame>Day 0, Day 28</time_frame>
    <description>Neutralizing Antibody titer was measured for each influenza strain with the SN method for 4 strains: A/H1N1, A/H3N2, B Victoria lineage (B1), and B Yamagata lineage (B2). Detectable neutralization antibody titer &gt;= 1:10 (1/dilution) at Day 0 and Day 28.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine</measure>
    <time_frame>Within 7 days after vaccination</time_frame>
    <description>Solicited injection site: Pain, Erythema, Swelling, Induration, and Bruising. Grade 3 reactions: Pain - interrupts usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention; Erythema, Swelling, Induration, and Bruising: &gt;100 millimeters (mm). Systemic reactions: Fever, Headache, Malaise, Myalgia, and Shivering. Grade 3 reactions: Fever: &gt;=39°C; Headache, Malaise, Myalgia, and Shivering: interrupts usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Immediate Adverse Event (AEs)</measure>
    <time_frame>Within 30 minutes after vaccination</time_frame>
    <description>Participants were observed for 30 minutes after vaccination, and any unsolicited systemic AEs occurring during that time was recorded as immediate unsolicited systemic AEs (AEs that were related to the investigational product) in the case report book (CRB). Unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRB in terms of symptom and/ or onset post-vaccination. Unsolicited AEs included both serious and non-serious unsolicited AEs. A serious adverse event was any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participant With Unsolicited Adverse Event (AE)</measure>
    <time_frame>Within 28 days after vaccination</time_frame>
    <description>An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRB in terms of symptom and/or onset post-vaccination. Unsolicited AEs included both serious and non-serious unsolicited AEs. A serious adverse event was any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participant With Serious Adverse Event</measure>
    <time_frame>Up to 6 months after vaccination</time_frame>
    <description>An serious adverse event was any untoward medical occurrence that at any dose results in death, was life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity,is a congenital anomaly/birth defect, or was an important medical event.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">2670</enrollment>
  <condition>Influenza</condition>
  <arm_group>
    <arm_group_label>QIV-HD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants randomized to receive a single injection of 0.7 mL QIV-HD by intramuscular (IM) route at Day 0.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TIV-HD1 (Licensed TIV-HD1)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants randomized to receive a single injection of 0.5 mL licensed TIV-HD1 by IM route at Day 0.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TIV-HD2 (Investigational TIV-HD2)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants randomized to receive a single injection of 0.5 mL investigational TIV-HD2 by IM route at Day 0.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>QIV-HD</intervention_name>
    <description>0.7 mL-dose was administered intramuscularly (IM) into the upper arm area.</description>
    <arm_group_label>QIV-HD</arm_group_label>
    <other_name>High-dose quadrivalent influenza vaccine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Licensed TIV-HD1</intervention_name>
    <description>0.5 mL-dose was administered IM into the upper arm area.</description>
    <arm_group_label>TIV-HD1 (Licensed TIV-HD1)</arm_group_label>
    <other_name>High-dose trivalent influenza vaccine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Investigational TIV-HD2</intervention_name>
    <description>0.5 mL-dose was administered IM into the upper arm area.</description>
    <arm_group_label>TIV-HD2 (Investigational TIV-HD2)</arm_group_label>
    <other_name>High-dose trivalent influenza vaccine (alternate B strain)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged &gt;= 65 years on the day of inclusion.&#xD;
&#xD;
          -  Informed consent form had been signed and dated.&#xD;
&#xD;
          -  Able to attend all scheduled visits and to comply with all trial procedures.&#xD;
&#xD;
        Exclusion Criteria:&#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 (28 days) preceding the trial vaccination or&#xD;
             planned receipt of any vaccine prior to Visit 2.&#xD;
&#xD;
          -  Previous vaccination against influenza (in the preceding 6 months) with either the&#xD;
             trial vaccine or another vaccine.&#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 vaccines used in the trial or to a vaccine containing&#xD;
             any of the same substances.&#xD;
&#xD;
          -  Thrombocytopenia or bleeding disorder, contraindicating IM vaccination based on&#xD;
             investigator's judgment.&#xD;
&#xD;
          -  Deprived of freedom by an administrative or court order, or in an emergency setting,&#xD;
             or hospitalized involuntarily.&#xD;
&#xD;
          -  Alcohol or substance abuse that, in the opinion of the investigator, might interfere&#xD;
             with the trial conduct or completion.&#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;
             participants who have a history of neoplastic disease and have been disease free for&#xD;
             &gt;= 5 years).&#xD;
&#xD;
          -  Moderate or severe acute illness/infection (according to Investigator judgment) on the&#xD;
             day of vaccination or febrile illness (temperature &gt;= 38.0°C [&gt;= 100.4°F]). A&#xD;
             prospective participant should not be included in the trial until the condition has&#xD;
             resolved or the febrile event had subsided.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</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, a Sanofi Company</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sanofi Pasteur Investigational Site 037</name>
      <address>
        <city>Anaheim</city>
        <state>California</state>
        <zip>92801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanofi Pasteur Investigational Site 029</name>
      <address>
        <city>Redding</city>
        <state>California</state>
        <zip>96001</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanofi Pasteur Investigational Site 003</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92117</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanofi Pasteur Investigational Site 016</name>
      <address>
        <city>Colorado Springs</city>
        <state>Colorado</state>
        <zip>80920</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanofi Pasteur Investigational Site 035</name>
      <address>
        <city>Milford</city>
        <state>Connecticut</state>
        <zip>06460</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanofi Pasteur Investigational Site 031</name>
      <address>
        <city>Hollywood</city>
        <state>Florida</state>
        <zip>33024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanofi Pasteur Investigational Site 009</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanofi Pasteur Investigational Site 017</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanofi Pasteur Investigational Site 030</name>
      <address>
        <city>Stockbridge</city>
        <state>Georgia</state>
        <zip>30281</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanofi Pasteur Investigational Site 010</name>
      <address>
        <city>Boise</city>
        <state>Idaho</state>
        <zip>83712</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanofi Pasteur Investigational Site 034</name>
      <address>
        <city>Meridian</city>
        <state>Idaho</state>
        <zip>83642</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanofi Pasteur Investigational Site 021</name>
      <address>
        <city>Council Bluffs</city>
        <state>Iowa</state>
        <zip>51501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanofi Pasteur Investigational Site 023</name>
      <address>
        <city>Wichita</city>
        <state>Kansas</state>
        <zip>67205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanofi Pasteur Investigational Site 028</name>
      <address>
        <city>Wichita</city>
        <state>Kansas</state>
        <zip>67207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanofi Pasteur Investigational Site 012</name>
      <address>
        <city>Bardstown</city>
        <state>Kentucky</state>
        <zip>40004</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanofi Pasteur Investigational Site 018</name>
      <address>
        <city>Metairie</city>
        <state>Louisiana</state>
        <zip>70427</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanofi Pasteur Investigational Site 026</name>
      <address>
        <city>Biloxi</city>
        <state>Mississippi</state>
        <zip>39531</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanofi Pasteur Investigational Site 014</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanofi Pasteur Investigational Site 011</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68134</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanofi Pasteur Investigational Site 024</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanofi Pasteur Investigational Site 008</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14609</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanofi Pasteur Investigational Site 005</name>
      <address>
        <city>Wilmington</city>
        <state>North Carolina</state>
        <zip>28401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanofi Pasteur Investigational Site 036</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanofi Pasteur Investigational Site 004</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanofi Pasteur Investigational Site 015</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanofi Pasteur Investigational Site 013</name>
      <address>
        <city>Warwick</city>
        <state>Rhode Island</state>
        <zip>02886</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanofi Pasteur Investigational Site 033</name>
      <address>
        <city>Mount Pleasant</city>
        <state>South Carolina</state>
        <zip>29464</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanofi Pasteur Investigational Site 001</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanofi Pasteur Investigational Site 002</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75234</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanofi Pasteur Investigational Site 025</name>
      <address>
        <city>Tomball</city>
        <state>Texas</state>
        <zip>77375</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanofi Pasteur Investigational Site 027</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanofi Pasteur Investigational Site 006</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanofi Pasteur Investigational Site 019</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanofi Pasteur Investigational Site 020</name>
      <address>
        <city>South Jordan</city>
        <state>Utah</state>
        <zip>84095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanofi Pasteur Investigational Site 022</name>
      <address>
        <city>West Jordan</city>
        <state>Utah</state>
        <zip>83642</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanofi Pasteur Investigational Site 038</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <zip>23507</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>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>September 12, 2017</study_first_submitted>
  <study_first_submitted_qc>September 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 13, 2017</study_first_posted>
  <results_first_submitted>November 28, 2019</results_first_submitted>
  <results_first_submitted_qc>November 28, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">December 17, 2019</results_first_posted>
  <disposition_first_submitted>October 30, 2018</disposition_first_submitted>
  <disposition_first_submitted_qc>October 30, 2018</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">October 31, 2018</disposition_first_posted>
  <last_update_submitted>March 24, 2022</last_update_submitted>
  <last_update_submitted_qc>March 24, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 7, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Influenza</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>Vaccines</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 20, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/40/NCT03282240/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 18, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/40/NCT03282240/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Study participants were screened in 35 centers in the Unites States (US) from 08 September 2017 to 15 September 2017.</recruitment_details>
      <pre_assignment_details>A total of 2670 participants were randomized in the study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>High-Dose Quadrivalent Influenza Vaccine (QIV-HD)</title>
          <description>Participants randomized to receive a single injection of 0.7 mL high dose quadrivalent influenza vaccine (QIV-HD) by intramuscular (IM) route at Day 0.</description>
        </group>
        <group group_id="P2">
          <title>High-Dose Trivalent Influenza Vaccine (Licensed TIV-HD1)</title>
          <description>Participants randomized to receive a single injection of 0.5 mL licensed high dose trivalent influenza vaccine (TIV-HD1) by IM route at Day 0.</description>
        </group>
        <group group_id="P3">
          <title>High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2)</title>
          <description>Participants randomized to receive a single injection of 0.5 mL investigational high dose trivalent influenza vaccine with alternate B strain (TIV-HD2) by IM route at Day 0.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1777"/>
                <participants group_id="P2" count="443"/>
                <participants group_id="P3" count="450"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1767"/>
                <participants group_id="P2" count="440"/>
                <participants group_id="P3" count="447"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Deviation</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Analysis was performed on all randomized participants for whom a vaccine group was allocated.</population>
      <group_list>
        <group group_id="B1">
          <title>High-Dose Quadrivalent Influenza Vaccine (QIV-HD)</title>
          <description>Participants randomized to receive a single injection of 0.7 mL QIV-HD by IM route at Day 0.</description>
        </group>
        <group group_id="B2">
          <title>High-Dose Trivalent Influenza Vaccine (Licensed TIV-HD1)</title>
          <description>Participants randomized to receive a single injection of 0.5 mL licensed TIV-HD1 by IM route at Day 0.</description>
        </group>
        <group group_id="B3">
          <title>High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2)</title>
          <description>Participants randomized to receive a single injection of 0.5 mL investigational TIV-HD2 by IM route at Day 0.</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="1777"/>
            <count group_id="B2" value="443"/>
            <count group_id="B3" value="450"/>
            <count group_id="B4" value="2670"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <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="72.9" spread="5.63"/>
                    <measurement group_id="B2" value="72.8" spread="5.79"/>
                    <measurement group_id="B3" value="73.2" spread="5.49"/>
                    <measurement group_id="B4" value="73.0" spread="5.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1027"/>
                    <measurement group_id="B2" value="268"/>
                    <measurement group_id="B3" value="252"/>
                    <measurement group_id="B4" value="1547"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="750"/>
                    <measurement group_id="B2" value="175"/>
                    <measurement group_id="B3" value="198"/>
                    <measurement group_id="B4" value="1123"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="123"/>
                    <measurement group_id="B2" value="41"/>
                    <measurement group_id="B3" value="35"/>
                    <measurement group_id="B4" value="199"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1618"/>
                    <measurement group_id="B2" value="395"/>
                    <measurement group_id="B3" value="402"/>
                    <measurement group_id="B4" value="2415"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine</title>
        <description>GMTs of anti-influenza antibodies were measured using an hemagglutination inhibition (HAI) assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage (B1), and B Yamagata lineage (B2). For each A strain, the comparison was made with the pooled TIV-HD groups. For each B strain, the comparison was made with the TIV-HD group containing the corresponding B strain. TIV-HD 1 did not contain B2 strain; TIV-HD2 did not contain B1 strain.</description>
        <time_frame>Day 28 post-vaccination</time_frame>
        <population>Per-protocol analysis set (PPAS): all randomized participants who received at least 1 dose of trial vaccine &amp; had a post-vaccination blood sample HAI result for at least 1 strain, with no relevant protocol deviations. Here, 'number analyzed' = participants with available data for each category.</population>
        <group_list>
          <group group_id="O1">
            <title>High-Dose Quadrivalent Influenza Vaccine (QIV-HD)</title>
            <description>Participants randomized to receive a single injection of 0.7 mL QIV-HD by IM route at Day 0.</description>
          </group>
          <group group_id="O2">
            <title>High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1)</title>
            <description>Participants randomized to receive a single injection of 0.5 mL licensed TIV-HD1 by IM route at Day 0.</description>
          </group>
          <group group_id="O3">
            <title>High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2)</title>
            <description>Participants randomized to receive a single injection of 0.5 mL investigational TIV-HD2 by IM route at Day 0.</description>
          </group>
          <group group_id="O4">
            <title>High-Dose Trivalent Influenza Vaccines Pooled (TIV-HDs Pooled)</title>
            <description>Participants randomized to receive either a single injection of 0.5 mL licensed TIV-HD1 or investigational TIV-HD2 by IM route at Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine</title>
          <description>GMTs of anti-influenza antibodies were measured using an hemagglutination inhibition (HAI) assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage (B1), and B Yamagata lineage (B2). For each A strain, the comparison was made with the pooled TIV-HD groups. For each B strain, the comparison was made with the TIV-HD group containing the corresponding B strain. TIV-HD 1 did not contain B2 strain; TIV-HD2 did not contain B1 strain.</description>
          <population>Per-protocol analysis set (PPAS): all randomized participants who received at least 1 dose of trial vaccine &amp; had a post-vaccination blood sample HAI result for at least 1 strain, with no relevant protocol deviations. Here, 'number analyzed' = participants with available data for each category.</population>
          <units>titers (1/dilution)</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="1680"/>
                <count group_id="O2" value="423"/>
                <count group_id="O3" value="430"/>
                <count group_id="O4" value="853"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>A/H1N1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1680"/>
                    <count group_id="O2" value="423"/>
                    <count group_id="O3" value="430"/>
                    <count group_id="O4" value="853"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="312" lower_limit="292" upper_limit="332"/>
                    <measurement group_id="O2" value="387" lower_limit="339" upper_limit="442"/>
                    <measurement group_id="O3" value="362" lower_limit="317" upper_limit="413"/>
                    <measurement group_id="O4" value="374" lower_limit="341" upper_limit="411"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H3N2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1679"/>
                    <count group_id="O2" value="423"/>
                    <count group_id="O3" value="430"/>
                    <count group_id="O4" value="853"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="563" lower_limit="525" upper_limit="603"/>
                    <measurement group_id="O2" value="588" lower_limit="513" upper_limit="673"/>
                    <measurement group_id="O3" value="600" lower_limit="524" upper_limit="687"/>
                    <measurement group_id="O4" value="594" lower_limit="540" upper_limit="653"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B Victoria</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1680"/>
                    <count group_id="O2" value="423"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="516" lower_limit="488" upper_limit="545"/>
                    <measurement group_id="O2" value="476" lower_limit="426" upper_limit="532"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B Yamagata</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1680"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="430"/>
                    <count group_id="O4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="578" lower_limit="547" upper_limit="612"/>
                    <measurement group_id="O3" value="580" lower_limit="519" upper_limit="649"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>B Victoria: The 2-sided 95% confidence interval (CI) was based on the Student t-distribution of logarithmic transformation of the individual titers. Antilog transformations were applied to the results.</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Non-inferiority of GMTs was concluded if the lower limit of the 2-sided 95% CI of the ratio of GMTs between groups is &gt; 0.667 for each of the comparisons.</non_inferiority_desc>
            <param_type>GMT Ratio (QIV-HD/TIV-HDs)</param_type>
            <param_value>1.08</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.958</ci_lower_limit>
            <ci_upper_limit>1.224</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>B Yamagata: The 2-sided 95% CI was based on the Student t-distribution of logarithmic transformation of the individual titers. Antilog transformations were applied to the results.</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Non-inferiority of GMTs was concluded if the lower limit of the 2-sided 95% CI of the ratio of GMTs between groups is &gt; 0.667 for each of the comparisons.</non_inferiority_desc>
            <param_type>GMT Ratio (QIV-HD/TIV-HDs)</param_type>
            <param_value>1.00</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.881</ci_lower_limit>
            <ci_upper_limit>1.129</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>A/H1N1: The 2-sided 95% CI was based on the Student t-distribution of logarithmic transformation of the individual titers. Antilog transformations were applied to the results.</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Non-inferiority of GMTs was concluded if the lower limit of the 2-sided 95% CI of the ratio of GMTs between groups is &gt; 0.667 for each of the comparisons.</non_inferiority_desc>
            <param_type>GMT Ratio (QIV-HD/TIV-HDs)</param_type>
            <param_value>0.83</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.744</ci_lower_limit>
            <ci_upper_limit>0.932</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>A/H3N2: The 2-sided 95% CI was based on the Student t-distribution of logarithmic transformation of the individual titers. Antilog transformations were applied to the results.</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Non-inferiority of GMTs was concluded if the lower limit of the 2-sided 95% CI of the ratio of GMTs between groups is &gt; 0.667 for each of the comparisons.</non_inferiority_desc>
            <param_type>GMT Ratio (QIV-HD/TIV-HDs)</param_type>
            <param_value>0.95</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.842</ci_lower_limit>
            <ci_upper_limit>1.066</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Achieving Seroconversion Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine</title>
        <description>Anti-influenza antibodies were measured using an HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage (B1), and B Yamagata lineage (B2). Seroconversion was defined as either a HAI titer less than (&lt;) 10 (1/dilution) at Day 0 and post-injection titer greater than or equal to (&gt;=) 40 (1/dilution) at Day 28, or HAI titer &gt;=10 (1/dilution) at Day 0 and a &gt;=4-fold increase in HAI titer (1/dilution) at Day 28. For each A strain, the comparison was made with the pooled TIV-HD groups. For each B strain, the comparison was made with the TIV-HD group containing the corresponding B strain. TIV-HD 1 did not contain B2 strain; TIV-HD2 did not contain B1 strain.</description>
        <time_frame>Day 28 post-vaccination</time_frame>
        <population>Analysis was performed on PPAS. Here, 'number analyzed' = participants with available data for each category.</population>
        <group_list>
          <group group_id="O1">
            <title>High-Dose Quadrivalent Influenza Vaccine (QIV-HD)</title>
            <description>Participants randomized to receive a single injection of 0.7 mL QIV-HD by IM route at Day 0.</description>
          </group>
          <group group_id="O2">
            <title>High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1)</title>
            <description>Participants randomized to receive a single injection of 0.5 mL licensed TIV-HD1 by IM route at Day 0.</description>
          </group>
          <group group_id="O3">
            <title>High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2)</title>
            <description>Participants randomized to receive a single injection of 0.5 mL investigational TIV-HD2 by IM route at Day 0.</description>
          </group>
          <group group_id="O4">
            <title>High-Dose Trivalent Influenza Vaccines Pooled (TIV-HDs Pooled)</title>
            <description>Participants randomized to receive either a single injection of 0.5 mL licensed TIV-HD1 or investigational TIV-HD2 by IM route at Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving Seroconversion Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine</title>
          <description>Anti-influenza antibodies were measured using an HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage (B1), and B Yamagata lineage (B2). Seroconversion was defined as either a HAI titer less than (&lt;) 10 (1/dilution) at Day 0 and post-injection titer greater than or equal to (&gt;=) 40 (1/dilution) at Day 28, or HAI titer &gt;=10 (1/dilution) at Day 0 and a &gt;=4-fold increase in HAI titer (1/dilution) at Day 28. For each A strain, the comparison was made with the pooled TIV-HD groups. For each B strain, the comparison was made with the TIV-HD group containing the corresponding B strain. TIV-HD 1 did not contain B2 strain; TIV-HD2 did not contain B1 strain.</description>
          <population>Analysis was performed on PPAS. Here, 'number analyzed' = participants with available data for each category.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1680"/>
                <count group_id="O2" value="423"/>
                <count group_id="O3" value="430"/>
                <count group_id="O4" value="853"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>A/H1N1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1669"/>
                    <count group_id="O2" value="420"/>
                    <count group_id="O3" value="428"/>
                    <count group_id="O4" value="848"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.4" lower_limit="48.0" upper_limit="52.8"/>
                    <measurement group_id="O2" value="56.2" lower_limit="51.3" upper_limit="61.0"/>
                    <measurement group_id="O3" value="51.2" lower_limit="46.3" upper_limit="56.0"/>
                    <measurement group_id="O4" value="53.7" lower_limit="50.2" upper_limit="57.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H3N2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1668"/>
                    <count group_id="O2" value="420"/>
                    <count group_id="O3" value="428"/>
                    <count group_id="O4" value="848"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49.8" lower_limit="47.3" upper_limit="52.2"/>
                    <measurement group_id="O2" value="52.9" lower_limit="48.0" upper_limit="57.7"/>
                    <measurement group_id="O3" value="48.1" lower_limit="43.3" upper_limit="53.0"/>
                    <measurement group_id="O4" value="50.5" lower_limit="47.1" upper_limit="53.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B Victoria</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1669"/>
                    <count group_id="O2" value="421"/>
                    <count group_id="O3" value="0"/>
                    <count group_id="O4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.5" lower_limit="34.2" upper_limit="38.9"/>
                    <measurement group_id="O2" value="39.0" lower_limit="34.3" upper_limit="43.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B Yamagata</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1669"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="428"/>
                    <count group_id="O4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.6" lower_limit="44.2" upper_limit="49.0"/>
                    <measurement group_id="O3" value="48.4" lower_limit="43.5" upper_limit="53.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>B Victoria: The 2-sided 95% CI for the difference is based on the Wilson score method without continuity correction.</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Non-inferiority in seroconversion was concluded if the lower limit of the 2-sided 95% CI of the differences of seroconversion rates between groups is &gt; -10%.</non_inferiority_desc>
            <param_type>Difference in Percentage</param_type>
            <param_value>-2.41</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-7.66</ci_lower_limit>
            <ci_upper_limit>2.70</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>B Yamagata: The 2-sided 95% CI for the difference is based on the Wilson score method without continuity correction.</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Non-inferiority in seroconversion was concluded if the lower limit of the 2-sided 95% CI of the differences of seroconversion rates between groups is &gt; -10%.</non_inferiority_desc>
            <param_type>Difference in Percentage</param_type>
            <param_value>-1.75</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-7.04</ci_lower_limit>
            <ci_upper_limit>3.53</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>A/H3N2: The 2-sided 95% CI for the difference is based on the Wilson score method without continuity correction.</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Non-inferiority in seroconversion was concluded if the lower limit of the 2-sided 95% CI of the differences of seroconversion rates between groups is &gt; -10%.</non_inferiority_desc>
            <param_type>Difference in Percentage</param_type>
            <param_value>-0.71</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.83</ci_lower_limit>
            <ci_upper_limit>3.42</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>A/H1N1: The 2-sided 95% CI for the difference is based on the Wilson score method without continuity correction.</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Non-inferiority in seroconversion was concluded if the lower limit of the 2-sided 95% CI of the differences of seroconversion rates between groups is &gt; -10%.</non_inferiority_desc>
            <param_type>Difference in Percentage</param_type>
            <param_value>-3.27</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-7.37</ci_lower_limit>
            <ci_upper_limit>0.86</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>GMTs of B Strains Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine</title>
        <description>Anti-influenza antibodies were measured using HAI assay for 4 strains: A/H1N1 (A1), A/H3N2 (A2), B Victoria lineage (B1), and B Yamagata lineage (B2). For each B strain, the immunogenicity of QIV-HD was compared to that of TIV-HD group which contains the corresponding B strain. TIV-HD1 did not contain B2 strain; TIV-HD2 did not contain B1 strain.</description>
        <time_frame>Day 28 post-vaccination</time_frame>
        <population>Analysis was performed on full analysis set (FAS) that consisted who received at least 1 dose of a trial vaccine and had a post-vaccination blood sample HAI result for at least 1 strain. Participants were analyzed according to the vaccine group to which they were randomized.</population>
        <group_list>
          <group group_id="O1">
            <title>High-Dose Quadrivalent Influenza Vaccine (QIV-HD)</title>
            <description>Participants randomized to receive a single injection of 0.7 mL QIV-HD by IM route at Day 0.</description>
          </group>
          <group group_id="O2">
            <title>High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1)</title>
            <description>Participants randomized to receive a single injection of 0.5 mL licensed TIV-HD1 by IM route at Day 0.</description>
          </group>
          <group group_id="O3">
            <title>High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2)</title>
            <description>Participants randomized to receive a single injection of 0.5 mL investigational TIV-HD2 by IM route at Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>GMTs of B Strains Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine</title>
          <description>Anti-influenza antibodies were measured using HAI assay for 4 strains: A/H1N1 (A1), A/H3N2 (A2), B Victoria lineage (B1), and B Yamagata lineage (B2). For each B strain, the immunogenicity of QIV-HD was compared to that of TIV-HD group which contains the corresponding B strain. TIV-HD1 did not contain B2 strain; TIV-HD2 did not contain B1 strain.</description>
          <population>Analysis was performed on full analysis set (FAS) that consisted who received at least 1 dose of a trial vaccine and had a post-vaccination blood sample HAI result for at least 1 strain. Participants were analyzed according to the vaccine group to which they were randomized.</population>
          <units>titers (1/dilution)</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="1763"/>
                <count group_id="O2" value="439"/>
                <count group_id="O3" value="446"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>B Victoria</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1763"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="446"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="515" lower_limit="488" upper_limit="543"/>
                    <measurement group_id="O3" value="253" lower_limit="227" upper_limit="283"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B Yamagata</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1763"/>
                    <count group_id="O2" value="439"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="573" lower_limit="542" upper_limit="605"/>
                    <measurement group_id="O2" value="280" lower_limit="249" upper_limit="316"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The 2-sided 95% CI is based on the Student t-distribution of logarithmic transformation of the individual titers. Antilog transformations were applied to the results.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Superiority in GMTs was observed if the lower limit of the 2-sided 95% CI of the ratio of GMTs between groups was &gt; 1.5 for comparison group.</non_inferiority_desc>
            <param_type>GMT Ratio (QIV-HD/TIV-HDs)</param_type>
            <param_value>2.04</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.804</ci_lower_limit>
            <ci_upper_limit>2.315</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>The 2-sided 95% CI is based on the Student t-distribution of logarithmic transformation of the individual titers. Antilog transformations were applied to the results.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Superiority in GMTs was observed if the lower limit of the 2-sided 95% CI of the ratio of GMTs between groups was &gt; 1.5 for comparison group.</non_inferiority_desc>
            <param_type>GMT Ratio (QIV-HD/TIV-HDs)</param_type>
            <param_value>2.03</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.802</ci_lower_limit>
            <ci_upper_limit>2.288</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>GMT Ratios of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine</title>
        <description>GMTs of anti-influenza antibodies using an HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage (B1), and B Yamagata lineage (B2). Geometric Mean Titers Ratios (GMTRs) were calculated as the ratio of GMTs post vaccination and pre-vaccination.</description>
        <time_frame>Day 0 (pre-vaccination) and Day 28 post-vaccination</time_frame>
        <population>Analysis was performed on PPAS. Here, 'number analyzed' = participants with available data for each category.</population>
        <group_list>
          <group group_id="O1">
            <title>High-Dose Quadrivalent Influenza Vaccine (QIV-HD)</title>
            <description>Participants randomized to receive a single injection of 0.7 mL QIV-HD by IM route at Day 0.</description>
          </group>
          <group group_id="O2">
            <title>High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1)</title>
            <description>Participants randomized to receive a single injection of 0.5 mL licensed TIV-HD1 by IM route at Day 0.</description>
          </group>
          <group group_id="O3">
            <title>High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2)</title>
            <description>Participants randomized to receive a single injection of 0.5 mL investigational high dose trivalent influenza vaccine with alternate B strain (TIV-HD2) by IM route at Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>GMT Ratios of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine</title>
          <description>GMTs of anti-influenza antibodies using an HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage (B1), and B Yamagata lineage (B2). Geometric Mean Titers Ratios (GMTRs) were calculated as the ratio of GMTs post vaccination and pre-vaccination.</description>
          <population>Analysis was performed on PPAS. Here, 'number analyzed' = participants with available data for each category.</population>
          <units>ratio</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1680"/>
                <count group_id="O2" value="423"/>
                <count group_id="O3" value="430"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>A/H1N1: Day28/Day 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1669"/>
                    <count group_id="O2" value="420"/>
                    <count group_id="O3" value="428"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.38" lower_limit="4.11" upper_limit="4.66"/>
                    <measurement group_id="O2" value="5.57" lower_limit="4.85" upper_limit="6.39"/>
                    <measurement group_id="O3" value="4.76" lower_limit="4.16" upper_limit="5.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H3N2: Day28/Day 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1668"/>
                    <count group_id="O2" value="420"/>
                    <count group_id="O3" value="428"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.65" lower_limit="4.35" upper_limit="4.98"/>
                    <measurement group_id="O2" value="4.82" lower_limit="4.24" upper_limit="5.48"/>
                    <measurement group_id="O3" value="4.94" lower_limit="4.32" upper_limit="5.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B Victoria: Day28/Day 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1669"/>
                    <count group_id="O2" value="421"/>
                    <count group_id="O3" value="428"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.17" lower_limit="2.99" upper_limit="3.35"/>
                    <measurement group_id="O2" value="3.35" lower_limit="2.99" upper_limit="3.76"/>
                    <measurement group_id="O3" value="1.65" lower_limit="1.52" upper_limit="1.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B Yamagata: Day28/Day 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1669"/>
                    <count group_id="O2" value="421"/>
                    <count group_id="O3" value="428"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.82" lower_limit="3.62" upper_limit="4.03"/>
                    <measurement group_id="O2" value="1.86" lower_limit="1.73" upper_limit="2.02"/>
                    <measurement group_id="O3" value="3.82" lower_limit="3.43" upper_limit="4.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving Seroconversion Against Antigens of B Strains After Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine</title>
        <description>Seroconversion was defined as either a HAI titer &lt;10 (1/dilution) at Day 0 and post-injection titer &gt;=40 (1/dilution) at Day 28, or HAI titer &gt;=10 (1/dilution) at Day 0 and a &gt;=4-fold increase in HAI titer (1/dilution) at Day 28.</description>
        <time_frame>Day 28 post-vaccination</time_frame>
        <population>Analysis was performed on FAS. Here, 'number analyzed' = participants with available data for each category.</population>
        <group_list>
          <group group_id="O1">
            <title>High-Dose Quadrivalent Influenza Vaccine (QIV-HD)</title>
            <description>Participants randomized to receive a single injection of 0.7 mL QIV-HD by IM route at Day 0.</description>
          </group>
          <group group_id="O2">
            <title>High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1)</title>
            <description>Participants randomized to receive a single injection of 0.5 mL licensed TIV-HD1 by IM route at Day 0.</description>
          </group>
          <group group_id="O3">
            <title>High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2)</title>
            <description>Participants randomized to receive a single injection of 0.5 mL investigational TIV-HD2 by IM route at Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving Seroconversion Against Antigens of B Strains After Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine</title>
          <description>Seroconversion was defined as either a HAI titer &lt;10 (1/dilution) at Day 0 and post-injection titer &gt;=40 (1/dilution) at Day 28, or HAI titer &gt;=10 (1/dilution) at Day 0 and a &gt;=4-fold increase in HAI titer (1/dilution) at Day 28.</description>
          <population>Analysis was performed on FAS. Here, 'number analyzed' = participants with available data for each category.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1763"/>
                <count group_id="O2" value="439"/>
                <count group_id="O3" value="446"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>B Victoria</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1751"/>
                    <count group_id="O2" value="0"/>
                    <count group_id="O3" value="444"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.3" lower_limit="34.1" upper_limit="38.6"/>
                    <measurement group_id="O3" value="15.5" lower_limit="12.3" upper_limit="19.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B Yamagata</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1751"/>
                    <count group_id="O2" value="437"/>
                    <count group_id="O3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.7" lower_limit="44.3" upper_limit="49.0"/>
                    <measurement group_id="O2" value="17.4" lower_limit="14.0" upper_limit="21.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>B Yamagata: The 2-sided 95% CI for the difference was based on the Wilson score method without continuity correction.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Superiority in seroconversion was observed if the lower limit of the 2-sided 95% CI of the difference of seroconversion rates between groups is &gt; 10% for each applicable comparison.</non_inferiority_desc>
            <param_type>Difference in Percentage</param_type>
            <param_value>29.27</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>24.78</ci_lower_limit>
            <ci_upper_limit>33.29</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>B Victoria: The 2-sided 95% CI for the difference was based on the Wilson score method without continuity correction.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Superiority in seroconversion was observed if the lower limit of the 2-sided 95% CI of the difference of seroconversion rates between groups is &gt; 10% for each applicable comparison.</non_inferiority_desc>
            <param_type>Difference in Percentage</param_type>
            <param_value>20.78</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>16.5</ci_lower_limit>
            <ci_upper_limit>24.61</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine</title>
        <description>Anti-influenza antibodies were measured using HAI assay for 4 strains: A/H1N1 (A1), A/H3N2 (A2), B Victoria lineage (B1), and B Yamagata lineage (B2). Seroprotection was defined as a HAI titer &gt;=40 (1/dilution) at Day 0 and Day 28.</description>
        <time_frame>Day 0 (pre-vaccination) and Day 28 post-vaccination</time_frame>
        <population>Analysis was performed on PPAS. Here, 'number analyzed' = participants with available data for each category.</population>
        <group_list>
          <group group_id="O1">
            <title>High-Dose Quadrivalent Influenza Vaccine (QIV-HD)</title>
            <description>Participants randomized to receive a single injection of 0.7 mL QIV-HD by IM route at Day 0.</description>
          </group>
          <group group_id="O2">
            <title>High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1)</title>
            <description>Participants randomized to receive a single injection of 0.5 mL licensed TIV-HD1 by IM route at Day 0.</description>
          </group>
          <group group_id="O3">
            <title>High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2)</title>
            <description>Participants randomized to receive a single injection of 0.5 mL investigational TIV-HD2 by IM route at Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine</title>
          <description>Anti-influenza antibodies were measured using HAI assay for 4 strains: A/H1N1 (A1), A/H3N2 (A2), B Victoria lineage (B1), and B Yamagata lineage (B2). Seroprotection was defined as a HAI titer &gt;=40 (1/dilution) at Day 0 and Day 28.</description>
          <population>Analysis was performed on PPAS. Here, 'number analyzed' = participants with available data for each category.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1680"/>
                <count group_id="O2" value="423"/>
                <count group_id="O3" value="430"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>A/H1N1: Day 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1669"/>
                    <count group_id="O2" value="420"/>
                    <count group_id="O3" value="430"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69.4" lower_limit="67.2" upper_limit="71.6"/>
                    <measurement group_id="O2" value="67.9" lower_limit="63.2" upper_limit="72.3"/>
                    <measurement group_id="O3" value="70.1" lower_limit="65.5" upper_limit="74.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H3N2: Day 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1668"/>
                    <count group_id="O2" value="420"/>
                    <count group_id="O3" value="430"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77.4" lower_limit="75.3" upper_limit="79.4"/>
                    <measurement group_id="O2" value="78.1" lower_limit="73.8" upper_limit="82.0"/>
                    <measurement group_id="O3" value="77.8" lower_limit="73.6" upper_limit="81.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B Victoria: Day 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1669"/>
                    <count group_id="O2" value="421"/>
                    <count group_id="O3" value="430"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88.9" lower_limit="87.2" upper_limit="90.3"/>
                    <measurement group_id="O2" value="87.9" lower_limit="84.4" upper_limit="90.8"/>
                    <measurement group_id="O3" value="88.8" lower_limit="85.4" upper_limit="91.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B Yamagata : Day 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1669"/>
                    <count group_id="O2" value="421"/>
                    <count group_id="O3" value="430"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89.6" lower_limit="88.0" upper_limit="91.0"/>
                    <measurement group_id="O2" value="88.1" lower_limit="84.6" upper_limit="91.1"/>
                    <measurement group_id="O3" value="90.9" lower_limit="87.8" upper_limit="93.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H1N1: Day 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1680"/>
                    <count group_id="O2" value="423"/>
                    <count group_id="O3" value="430"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95.1" lower_limit="94.0" upper_limit="96.1"/>
                    <measurement group_id="O2" value="96.7" lower_limit="94.5" upper_limit="98.2"/>
                    <measurement group_id="O3" value="95.6" lower_limit="93.2" upper_limit="97.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H3N2: Day 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1679"/>
                    <count group_id="O2" value="423"/>
                    <count group_id="O3" value="430"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.9" lower_limit="96.0" upper_limit="97.7"/>
                    <measurement group_id="O2" value="96.9" lower_limit="94.8" upper_limit="98.4"/>
                    <measurement group_id="O3" value="96.7" lower_limit="94.6" upper_limit="98.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B Victoria: Day 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1680"/>
                    <count group_id="O2" value="423"/>
                    <count group_id="O3" value="430"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.0" lower_limit="98.5" upper_limit="99.5"/>
                    <measurement group_id="O2" value="99.1" lower_limit="97.6" upper_limit="99.7"/>
                    <measurement group_id="O3" value="96.5" lower_limit="94.3" upper_limit="98.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B Yamagata : Day 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1680"/>
                    <count group_id="O2" value="423"/>
                    <count group_id="O3" value="430"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.3" lower_limit="98.8" upper_limit="99.7"/>
                    <measurement group_id="O2" value="96.7" lower_limit="94.5" upper_limit="98.2"/>
                    <measurement group_id="O3" value="99.1" lower_limit="97.6" upper_limit="99.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Geometric Mean Titers of Influenza Antibodies (Seroneutralization [SN] Assay) Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine</title>
        <description>GMTs of anti-influenza antibodies were measured using SN assay for 4 strains: A/H1N1 (A1), A/H3N2 (A2), B Victoria lineage (B1), and B Yamagata lineage (B2).</description>
        <time_frame>Day 0 (pre-vaccination) and Day 28 post-vaccination</time_frame>
        <population>Expanded immunogenicity subset:participants who received at least 1 dose of trial vaccine&amp; had post-vaccination blood sample HAI result for at least 1 strain&amp; were randomized into expanded immunogenicity subset with at least 1 post-vaccination SN assay result for at least 1 strain.'Number analyzed'=participants with available data for each category</population>
        <group_list>
          <group group_id="O1">
            <title>High-Dose Quadrivalent Influenza Vaccine (QIV-HD)</title>
            <description>Participants randomized to receive a single injection of 0.7 mL QIV-HD by IM route at Day 0.</description>
          </group>
          <group group_id="O2">
            <title>High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1)</title>
            <description>Participants randomized to receive a single injection of 0.5 mL licensed TIV-HD1 by IM route at Day 0.</description>
          </group>
          <group group_id="O3">
            <title>High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2)</title>
            <description>Participants randomized to receive a single injection of 0.5 mL investigational TIV-HD2 by IM route at Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Titers of Influenza Antibodies (Seroneutralization [SN] Assay) Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine</title>
          <description>GMTs of anti-influenza antibodies were measured using SN assay for 4 strains: A/H1N1 (A1), A/H3N2 (A2), B Victoria lineage (B1), and B Yamagata lineage (B2).</description>
          <population>Expanded immunogenicity subset:participants who received at least 1 dose of trial vaccine&amp; had post-vaccination blood sample HAI result for at least 1 strain&amp; were randomized into expanded immunogenicity subset with at least 1 post-vaccination SN assay result for at least 1 strain.'Number analyzed'=participants with available data for each category</population>
          <units>titers (1/dilution)</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="102"/>
                <count group_id="O2" value="102"/>
                <count group_id="O3" value="99"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>A/H1N1: Day 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="102"/>
                    <count group_id="O2" value="100"/>
                    <count group_id="O3" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="412" lower_limit="306" upper_limit="555"/>
                    <measurement group_id="O2" value="427" lower_limit="328" upper_limit="556"/>
                    <measurement group_id="O3" value="416" lower_limit="311" upper_limit="555"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H3N2: Day 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="102"/>
                    <count group_id="O2" value="100"/>
                    <count group_id="O3" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="497" lower_limit="417" upper_limit="592"/>
                    <measurement group_id="O2" value="536" lower_limit="436" upper_limit="660"/>
                    <measurement group_id="O3" value="593" lower_limit="493" upper_limit="715"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B Victoria: Day 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="102"/>
                    <count group_id="O2" value="100"/>
                    <count group_id="O3" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="458" lower_limit="359" upper_limit="583"/>
                    <measurement group_id="O2" value="452" lower_limit="367" upper_limit="556"/>
                    <measurement group_id="O3" value="430" lower_limit="344" upper_limit="537"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B Yamagata: Day 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="102"/>
                    <count group_id="O2" value="100"/>
                    <count group_id="O3" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="156" lower_limit="124" upper_limit="196"/>
                    <measurement group_id="O2" value="155" lower_limit="126" upper_limit="190"/>
                    <measurement group_id="O3" value="192" lower_limit="152" upper_limit="242"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H1N1: Day 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="102"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2229" lower_limit="1789" upper_limit="2776"/>
                    <measurement group_id="O2" value="2050" lower_limit="1564" upper_limit="2687"/>
                    <measurement group_id="O3" value="1686" lower_limit="1331" upper_limit="2135"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H3N2: Day 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="102"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1404" lower_limit="1133" upper_limit="1741"/>
                    <measurement group_id="O2" value="1327" lower_limit="1056" upper_limit="1667"/>
                    <measurement group_id="O3" value="1301" lower_limit="1070" upper_limit="1583"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B Victoria: Day 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="102"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1288" lower_limit="1055" upper_limit="1573"/>
                    <measurement group_id="O2" value="1114" lower_limit="916" upper_limit="1354"/>
                    <measurement group_id="O3" value="590" lower_limit="476" upper_limit="730"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B Yamagata: Day 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="102"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="546" lower_limit="438" upper_limit="682"/>
                    <measurement group_id="O2" value="259" lower_limit="207" upper_limit="325"/>
                    <measurement group_id="O3" value="494" lower_limit="390" upper_limit="626"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>GMTRs of Influenza Antibodies (SN Assay) Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine</title>
        <description>GMTRs of anti-influenza antibodies were measured using SN assay for 4 strains: A/H1N1 (A1), A/H3N2 (A2), B Victoria lineage (B1), and B Yamagata lineage (B2). GMTRs were calculated as the ratio of GMTs post vaccination and pre-vaccination.</description>
        <time_frame>Day 0 (pre-vaccination) and Day 28 post-vaccination</time_frame>
        <population>Analysis was performed on expanded immunogenicity subset. Here, 'number analyzed' = participants with available data for each category.</population>
        <group_list>
          <group group_id="O1">
            <title>High-Dose Quadrivalent Influenza Vaccine (QIV-HD)</title>
            <description>Participants randomized to receive a single injection of 0.7 mL QIV-HD by IM route at Day 0.</description>
          </group>
          <group group_id="O2">
            <title>High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1)</title>
            <description>Participants randomized to receive a single injection of 0.5 mL licensed TIV-HD1 by IM route at Day 0.</description>
          </group>
          <group group_id="O3">
            <title>High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2)</title>
            <description>Participants randomized to receive a single injection of 0.5 mL investigational TIV-HD2 by IM route at Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>GMTRs of Influenza Antibodies (SN Assay) Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine</title>
          <description>GMTRs of anti-influenza antibodies were measured using SN assay for 4 strains: A/H1N1 (A1), A/H3N2 (A2), B Victoria lineage (B1), and B Yamagata lineage (B2). GMTRs were calculated as the ratio of GMTs post vaccination and pre-vaccination.</description>
          <population>Analysis was performed on expanded immunogenicity subset. Here, 'number analyzed' = participants with available data for each category.</population>
          <units>ratio</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="102"/>
                <count group_id="O2" value="102"/>
                <count group_id="O3" value="99"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>A/H1N1: Day28/Day 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="102"/>
                    <count group_id="O2" value="100"/>
                    <count group_id="O3" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.40" lower_limit="3.90" upper_limit="7.48"/>
                    <measurement group_id="O2" value="5.05" lower_limit="3.86" upper_limit="6.60"/>
                    <measurement group_id="O3" value="4.06" lower_limit="3.17" upper_limit="5.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H3N2: Day28/Day 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="102"/>
                    <count group_id="O2" value="100"/>
                    <count group_id="O3" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.83" lower_limit="2.31" upper_limit="3.46"/>
                    <measurement group_id="O2" value="2.50" lower_limit="2.04" upper_limit="3.06"/>
                    <measurement group_id="O3" value="2.19" lower_limit="1.80" upper_limit="2.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B Victoria: Day28/Day 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="102"/>
                    <count group_id="O2" value="100"/>
                    <count group_id="O3" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.81" lower_limit="2.21" upper_limit="3.58"/>
                    <measurement group_id="O2" value="2.47" lower_limit="2.04" upper_limit="2.99"/>
                    <measurement group_id="O3" value="1.37" lower_limit="1.16" upper_limit="1.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B Yamagata: Day28/Day 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="102"/>
                    <count group_id="O2" value="100"/>
                    <count group_id="O3" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.51" lower_limit="2.80" upper_limit="4.39"/>
                    <measurement group_id="O2" value="1.66" lower_limit="1.41" upper_limit="1.95"/>
                    <measurement group_id="O3" value="2.58" lower_limit="2.18" upper_limit="3.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Neutralization Antibody Titers at Day 0 and Day 28</title>
        <description>Neutralizing Antibody titer was measured for each influenza strain with the SN method for 4 strains: A/H1N1, A/H3N2, B Victoria lineage (B1), and B Yamagata lineage (B2). Neutralizing antibody was defined as titers &gt;=20 (1/dilution), &gt;=40 (1/dilution), &gt;=80 (1/dilution) at Day 0 and Day 28.</description>
        <time_frame>Day 0, Day 28</time_frame>
        <population>Analysis was performed on expanded immunogenicity subset.</population>
        <group_list>
          <group group_id="O1">
            <title>High-Dose Quadrivalent Influenza Vaccine (QIV-HD)</title>
            <description>Participants randomized to receive a single injection of the high dose QIV-HD by IM route at Day 0.</description>
          </group>
          <group group_id="O2">
            <title>High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1)</title>
            <description>Participants randomized to receive a single injection of 0.5 mL licensed TIV-HD1 by IM route at Day 0.</description>
          </group>
          <group group_id="O3">
            <title>High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2)</title>
            <description>Participants randomized to receive a single injection of 0.5 mL investigational TIV-HD2 by IM route at Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Neutralization Antibody Titers at Day 0 and Day 28</title>
          <description>Neutralizing Antibody titer was measured for each influenza strain with the SN method for 4 strains: A/H1N1, A/H3N2, B Victoria lineage (B1), and B Yamagata lineage (B2). Neutralizing antibody was defined as titers &gt;=20 (1/dilution), &gt;=40 (1/dilution), &gt;=80 (1/dilution) at Day 0 and Day 28.</description>
          <population>Analysis was performed on expanded immunogenicity subset.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="102"/>
                <count group_id="O2" value="102"/>
                <count group_id="O3" value="99"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>A/H1N1: &gt;=20 (1/dil): Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97"/>
                    <measurement group_id="O2" value="99"/>
                    <measurement group_id="O3" value="98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H1N1: &gt;=40 (1/dil): Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95"/>
                    <measurement group_id="O2" value="96"/>
                    <measurement group_id="O3" value="91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H1N1: &gt;=80 (1/dil): Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89"/>
                    <measurement group_id="O2" value="89"/>
                    <measurement group_id="O3" value="84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H3N2: &gt;=20 (1/dil): Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="102"/>
                    <measurement group_id="O2" value="100"/>
                    <measurement group_id="O3" value="99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H3N2: &gt;=40 (1/dil): Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="102"/>
                    <measurement group_id="O2" value="100"/>
                    <measurement group_id="O3" value="99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H3N2: &gt;=80 (1/dil): Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99"/>
                    <measurement group_id="O2" value="100"/>
                    <measurement group_id="O3" value="98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B Victoria: &gt;=20 (1/dil): Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="101"/>
                    <measurement group_id="O2" value="100"/>
                    <measurement group_id="O3" value="99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B Victoria: &gt;=40 (1/dil): Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97"/>
                    <measurement group_id="O2" value="99"/>
                    <measurement group_id="O3" value="99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B Victoria: &gt;=80 (1/dil): Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91"/>
                    <measurement group_id="O2" value="96"/>
                    <measurement group_id="O3" value="93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B Yamagata: &gt;=20 (1/dil): Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98"/>
                    <measurement group_id="O2" value="98"/>
                    <measurement group_id="O3" value="99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B Yamagata: &gt;=40 (1/dil): Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91"/>
                    <measurement group_id="O2" value="93"/>
                    <measurement group_id="O3" value="87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B Yamagata: &gt;=80 (1/dil): Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75"/>
                    <measurement group_id="O2" value="75"/>
                    <measurement group_id="O3" value="74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H1N1: &gt;=20 (1/dil): Day 28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="102"/>
                    <measurement group_id="O2" value="102"/>
                    <measurement group_id="O3" value="99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H1N1: &gt;=40 (1/dil): Day 28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="102"/>
                    <measurement group_id="O2" value="102"/>
                    <measurement group_id="O3" value="99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H1N1: &gt;=80 (1/dil): Day 28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="102"/>
                    <measurement group_id="O2" value="100"/>
                    <measurement group_id="O3" value="99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H3N2: &gt;=20 (1/dil): Day 28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="102"/>
                    <measurement group_id="O2" value="102"/>
                    <measurement group_id="O3" value="99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H3N2: &gt;=40 (1/dil): Day 28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="102"/>
                    <measurement group_id="O2" value="102"/>
                    <measurement group_id="O3" value="99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H3N2: &gt;=80 (1/dil): Day 28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="102"/>
                    <measurement group_id="O2" value="101"/>
                    <measurement group_id="O3" value="99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B Victoria: &gt;=20 (1/dil): Day 28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="102"/>
                    <measurement group_id="O2" value="102"/>
                    <measurement group_id="O3" value="99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B Victoria: &gt;=40 (1/dil): Day 28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="102"/>
                    <measurement group_id="O2" value="102"/>
                    <measurement group_id="O3" value="99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B Victoria: &gt;=80 (1/dil): Day 28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="102"/>
                    <measurement group_id="O2" value="102"/>
                    <measurement group_id="O3" value="97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B Yamagata: &gt;=20 (1/dil): Day 28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="102"/>
                    <measurement group_id="O2" value="101"/>
                    <measurement group_id="O3" value="99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B Yamagata: &gt;=40 (1/dil): Day 28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="102"/>
                    <measurement group_id="O2" value="99"/>
                    <measurement group_id="O3" value="97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B Yamagata: &gt;=80 (1/dil): Day 28</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99"/>
                    <measurement group_id="O2" value="83"/>
                    <measurement group_id="O3" value="91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Two-Fold and Four-Fold Increase in Neutralization Antibody Titer at Day 28</title>
        <description>Neutralizing Antibody titer was measured for each influenza strain with the SN method for 4 strains: A/H1N1, A/H3N2, B Victoria lineage (B1), and B Yamagata lineage (B2). 2-fold and 4-fold rise was defined as the computed value = post-vaccination computed value / baseline computed value.</description>
        <time_frame>Day 28</time_frame>
        <population>Analysis was performed on expanded immunogenicity subset. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>High-Dose Quadrivalent Influenza Vaccine (QIV-HD)</title>
            <description>Participants randomized to receive a single injection of the high dose QIV-HD by IM route at Day 0.</description>
          </group>
          <group group_id="O2">
            <title>High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1)</title>
            <description>Participants randomized to receive a single injection of 0.5 mL licensed TIV-HD1 by IM route at Day 0.</description>
          </group>
          <group group_id="O3">
            <title>High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2)</title>
            <description>Participants randomized to receive a single injection of 0.5 mL investigational high dose trivalent influenza vaccine with alternate B strain (TIV-HD2) by IM route at Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Two-Fold and Four-Fold Increase in Neutralization Antibody Titer at Day 28</title>
          <description>Neutralizing Antibody titer was measured for each influenza strain with the SN method for 4 strains: A/H1N1, A/H3N2, B Victoria lineage (B1), and B Yamagata lineage (B2). 2-fold and 4-fold rise was defined as the computed value = post-vaccination computed value / baseline computed value.</description>
          <population>Analysis was performed on expanded immunogenicity subset. Here, 'overall number of participants analyzed' = participants with available data for this outcome measure.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="102"/>
                <count group_id="O2" value="100"/>
                <count group_id="O3" value="99"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Participants With 2-Fold Rise: A/H1N1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74"/>
                    <measurement group_id="O2" value="71"/>
                    <measurement group_id="O3" value="64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants With 4-Fold Rise: A/H1N1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43"/>
                    <measurement group_id="O2" value="50"/>
                    <measurement group_id="O3" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants With 2-Fold Rise: A/H3N2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52"/>
                    <measurement group_id="O2" value="48"/>
                    <measurement group_id="O3" value="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants With 4-Fold Rise: A/H3N2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                    <measurement group_id="O2" value="24"/>
                    <measurement group_id="O3" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants With 2-Fold Rise: B Victoria</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52"/>
                    <measurement group_id="O2" value="51"/>
                    <measurement group_id="O3" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants With 4-Fold Rise: B Victoria</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="23"/>
                    <measurement group_id="O3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants With 2-Fold Rise: B Yamagata</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65"/>
                    <measurement group_id="O2" value="31"/>
                    <measurement group_id="O3" value="55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Participants With 4-Fold Rise: B Yamagata</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36"/>
                    <measurement group_id="O2" value="11"/>
                    <measurement group_id="O3" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Detectable Neutralization Antibody Titers at Day 0 and Day 28</title>
        <description>Neutralizing Antibody titer was measured for each influenza strain with the SN method for 4 strains: A/H1N1, A/H3N2, B Victoria lineage (B1), and B Yamagata lineage (B2). Detectable neutralization antibody titer &gt;= 1:10 (1/dilution) at Day 0 and Day 28.</description>
        <time_frame>Day 0, Day 28</time_frame>
        <population>Analysis was performed on expanded immunogenicity subset. Here, 'number analyzed' = participants with available data for each category.</population>
        <group_list>
          <group group_id="O1">
            <title>High-Dose Quadrivalent Influenza Vaccine (QIV-HD)</title>
            <description>Participants randomized to receive a single injection of the high dose QIV-HD by IM route at Day 0.</description>
          </group>
          <group group_id="O2">
            <title>High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1)</title>
            <description>Participants randomized to receive a single injection of 0.5 mL licensed TIV-HD1 by IM route at Day 0.</description>
          </group>
          <group group_id="O3">
            <title>High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2)</title>
            <description>Participants randomized to receive a single injection of 0.5 mL investigational TIV-HD2 by IM route at Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Detectable Neutralization Antibody Titers at Day 0 and Day 28</title>
          <description>Neutralizing Antibody titer was measured for each influenza strain with the SN method for 4 strains: A/H1N1, A/H3N2, B Victoria lineage (B1), and B Yamagata lineage (B2). Detectable neutralization antibody titer &gt;= 1:10 (1/dilution) at Day 0 and Day 28.</description>
          <population>Analysis was performed on expanded immunogenicity subset. Here, 'number analyzed' = participants with available data for each category.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="102"/>
                <count group_id="O2" value="102"/>
                <count group_id="O3" value="99"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>A/H1N1: Titer &gt;= 1:10: Day 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="102"/>
                    <count group_id="O2" value="100"/>
                    <count group_id="O3" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="100"/>
                    <measurement group_id="O3" value="99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H1N1: Titer &gt;= 1:10: Day 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="102"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="102"/>
                    <measurement group_id="O2" value="102"/>
                    <measurement group_id="O3" value="99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H3N2: Titer &gt;= 1:10: Day 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="102"/>
                    <count group_id="O2" value="100"/>
                    <count group_id="O3" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="102"/>
                    <measurement group_id="O2" value="100"/>
                    <measurement group_id="O3" value="99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H3N2: Titer &gt;= 1:10: Day 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="102"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="102"/>
                    <measurement group_id="O2" value="102"/>
                    <measurement group_id="O3" value="99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B Victoria: Titer &gt;= 1:10: Day 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="102"/>
                    <count group_id="O2" value="100"/>
                    <count group_id="O3" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="102"/>
                    <measurement group_id="O2" value="100"/>
                    <measurement group_id="O3" value="99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B Victoria: Titer &gt;= 1:10: Day 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="102"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="102"/>
                    <measurement group_id="O2" value="102"/>
                    <measurement group_id="O3" value="99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B Yamagata: Titer &gt;= 1:10: Day 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="102"/>
                    <count group_id="O2" value="100"/>
                    <count group_id="O3" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="100"/>
                    <measurement group_id="O3" value="99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B Yamagata: Titer &gt;= 1:10: Day 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="102"/>
                    <count group_id="O2" value="102"/>
                    <count group_id="O3" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="102"/>
                    <measurement group_id="O2" value="102"/>
                    <measurement group_id="O3" value="99"/>
                  </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 High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine</title>
        <description>Solicited injection site: Pain, Erythema, Swelling, Induration, and Bruising. Grade 3 reactions: Pain - interrupts usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention; Erythema, Swelling, Induration, and Bruising: &gt;100 millimeters (mm). Systemic reactions: Fever, Headache, Malaise, Myalgia, and Shivering. Grade 3 reactions: Fever: &gt;=39°C; Headache, Malaise, Myalgia, and Shivering: interrupts usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention.</description>
        <time_frame>Within 7 days after vaccination</time_frame>
        <population>Analysis was performed on safety analysis set that included all participants who had received study vaccine. All participants had their safety analyzed according to the vaccine they actually received. Here, 'number analyzed' = participants with available data for each specified category.</population>
        <group_list>
          <group group_id="O1">
            <title>High-Dose Quadrivalent Influenza Vaccine (QIV-HD)</title>
            <description>Participants randomized to receive a single injection of 0.7 mL QIV-HD by IM route at Day 0.</description>
          </group>
          <group group_id="O2">
            <title>High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1)</title>
            <description>Participants randomized to receive a single injection of 0.5 mL licensed TIV-HD1 by IM route at Day 0.</description>
          </group>
          <group group_id="O3">
            <title>High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2)</title>
            <description>Participants randomized to receive a single injection of 0.5 mL investigational TIV-HD2 by IM route at Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine</title>
          <description>Solicited injection site: Pain, Erythema, Swelling, Induration, and Bruising. Grade 3 reactions: Pain - interrupts usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention; Erythema, Swelling, Induration, and Bruising: &gt;100 millimeters (mm). Systemic reactions: Fever, Headache, Malaise, Myalgia, and Shivering. Grade 3 reactions: Fever: &gt;=39°C; Headache, Malaise, Myalgia, and Shivering: interrupts usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention.</description>
          <population>Analysis was performed on safety analysis set that included all participants who had received study vaccine. All participants had their safety analyzed according to the vaccine they actually received. Here, 'number analyzed' = participants with available data for each specified category.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1777"/>
                <count group_id="O2" value="443"/>
                <count group_id="O3" value="450"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Fever: Any Grade</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1761"/>
                    <count group_id="O2" value="437"/>
                    <count group_id="O3" value="448"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fever: Grade 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1761"/>
                    <count group_id="O2" value="437"/>
                    <count group_id="O3" value="448"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Headache: Any Grade</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1768"/>
                    <count group_id="O2" value="440"/>
                    <count group_id="O3" value="449"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="254"/>
                    <measurement group_id="O2" value="63"/>
                    <measurement group_id="O3" value="58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Headache: Grade 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1768"/>
                    <count group_id="O2" value="440"/>
                    <count group_id="O3" value="449"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Malaise: Any Grade</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1768"/>
                    <count group_id="O2" value="440"/>
                    <count group_id="O3" value="449"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="233"/>
                    <measurement group_id="O2" value="52"/>
                    <measurement group_id="O3" value="67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Malaise: Grade 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1768"/>
                    <count group_id="O2" value="440"/>
                    <count group_id="O3" value="449"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Myalgia: Any Grade</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1768"/>
                    <count group_id="O2" value="440"/>
                    <count group_id="O3" value="449"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="402"/>
                    <measurement group_id="O2" value="80"/>
                    <measurement group_id="O3" value="88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Myalgia: Grade 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1768"/>
                    <count group_id="O2" value="440"/>
                    <count group_id="O3" value="449"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Shivering: Any Grade</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1768"/>
                    <count group_id="O2" value="440"/>
                    <count group_id="O3" value="449"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95"/>
                    <measurement group_id="O2" value="20"/>
                    <measurement group_id="O3" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Shivering: Grade 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1768"/>
                    <count group_id="O2" value="443"/>
                    <count group_id="O3" value="449"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection Site Bruising: Any</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1765"/>
                    <count group_id="O2" value="439"/>
                    <count group_id="O3" value="448"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection Site Bruising: Grade 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1765"/>
                    <count group_id="O2" value="439"/>
                    <count group_id="O3" value="448"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection Site Erythema: Any</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1768"/>
                    <count group_id="O2" value="440"/>
                    <count group_id="O3" value="449"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="110"/>
                    <measurement group_id="O2" value="30"/>
                    <measurement group_id="O3" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection Site Erythema: Grade 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1768"/>
                    <count group_id="O2" value="440"/>
                    <count group_id="O3" value="449"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection Site Induration: Any</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1766"/>
                    <count group_id="O2" value="439"/>
                    <count group_id="O3" value="448"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66"/>
                    <measurement group_id="O2" value="17"/>
                    <measurement group_id="O3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection Site Induration: Grade 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1766"/>
                    <count group_id="O2" value="439"/>
                    <count group_id="O3" value="448"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection Site Pain: Any</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1768"/>
                    <count group_id="O2" value="440"/>
                    <count group_id="O3" value="449"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="731"/>
                    <measurement group_id="O2" value="172"/>
                    <measurement group_id="O3" value="152"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection Site Pain: Grade 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1768"/>
                    <count group_id="O2" value="440"/>
                    <count group_id="O3" value="449"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection Site Swelling: Any</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1766"/>
                    <count group_id="O2" value="439"/>
                    <count group_id="O3" value="448"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86"/>
                    <measurement group_id="O2" value="23"/>
                    <measurement group_id="O3" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection Site Swelling: Grade 3</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1766"/>
                    <count group_id="O2" value="439"/>
                    <count group_id="O3" value="448"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Immediate Adverse Event (AEs)</title>
        <description>Participants were observed for 30 minutes after vaccination, and any unsolicited systemic AEs occurring during that time was recorded as immediate unsolicited systemic AEs (AEs that were related to the investigational product) in the case report book (CRB). Unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRB in terms of symptom and/ or onset post-vaccination. Unsolicited AEs included both serious and non-serious unsolicited AEs. A serious adverse event was any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event.</description>
        <time_frame>Within 30 minutes after vaccination</time_frame>
        <population>Analysis was performed on safety analysis set.</population>
        <group_list>
          <group group_id="O1">
            <title>High-Dose Quadrivalent Influenza Vaccine (QIV-HD)</title>
            <description>Participants randomized to receive a single injection of 0.7 mL QIV-HD by IM route at Day 0.</description>
          </group>
          <group group_id="O2">
            <title>High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1)</title>
            <description>Participants randomized to receive a single injection of 0.5 mL licensed TIV-HD1 by IM route at Day 0.</description>
          </group>
          <group group_id="O3">
            <title>High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2)</title>
            <description>Participants randomized to receive a single injection of 0.5 mL investigational TIV-HD2 by IM route at Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Immediate Adverse Event (AEs)</title>
          <description>Participants were observed for 30 minutes after vaccination, and any unsolicited systemic AEs occurring during that time was recorded as immediate unsolicited systemic AEs (AEs that were related to the investigational product) in the case report book (CRB). Unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRB in terms of symptom and/ or onset post-vaccination. Unsolicited AEs included both serious and non-serious unsolicited AEs. A serious adverse event was any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event.</description>
          <population>Analysis was performed on safety analysis set.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1777"/>
                <count group_id="O2" value="443"/>
                <count group_id="O3" value="450"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participant With Unsolicited Adverse Event (AE)</title>
        <description>An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRB in terms of symptom and/or onset post-vaccination. Unsolicited AEs included both serious and non-serious unsolicited AEs. A serious adverse event was any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event.</description>
        <time_frame>Within 28 days after vaccination</time_frame>
        <population>Analysis was performed on safety analysis set.</population>
        <group_list>
          <group group_id="O1">
            <title>High-Dose Quadrivalent Influenza Vaccine (QIV-HD)</title>
            <description>Participants randomized to receive a single injection of 0.7 mL QIV-HD by IM route at Day 0.</description>
          </group>
          <group group_id="O2">
            <title>High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1)</title>
            <description>Participants randomized to receive a single injection of 0.5 mL licensed TIV-HD1 by IM route at Day 0.</description>
          </group>
          <group group_id="O3">
            <title>High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2)</title>
            <description>Participants randomized to receive a single injection of 0.5 mL investigational TIV-HD2 by IM route at Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participant With Unsolicited Adverse Event (AE)</title>
          <description>An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRB in terms of symptom and/or onset post-vaccination. Unsolicited AEs included both serious and non-serious unsolicited AEs. A serious adverse event was any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event.</description>
          <population>Analysis was performed on safety analysis set.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1777"/>
                <count group_id="O2" value="443"/>
                <count group_id="O3" value="450"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="292"/>
                    <measurement group_id="O2" value="79"/>
                    <measurement group_id="O3" value="68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participant With Serious Adverse Event</title>
        <description>An serious adverse event was any untoward medical occurrence that at any dose results in death, was life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity,is a congenital anomaly/birth defect, or was an important medical event.</description>
        <time_frame>Up to 6 months after vaccination</time_frame>
        <population>Analysis was performed on safety analysis set.</population>
        <group_list>
          <group group_id="O1">
            <title>High-Dose Quadrivalent Influenza Vaccine (QIV-HD)</title>
            <description>Participants randomized to receive a single injection of 0.7 mL QIV-HD by IM route at Day 0.</description>
          </group>
          <group group_id="O2">
            <title>High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1)</title>
            <description>Participants randomized to receive a single injection of 0.5 mL licensed TIV-HD1 by IM route at Day 0.</description>
          </group>
          <group group_id="O3">
            <title>High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2)</title>
            <description>Participants randomized to receive a single injection of 0.5 mL investigational TIV-HD2 by IM route at Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participant With Serious Adverse Event</title>
          <description>An serious adverse event was any untoward medical occurrence that at any dose results in death, was life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity,is a congenital anomaly/birth defect, or was an important medical event.</description>
          <population>Analysis was performed on safety analysis set.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1777"/>
                <count group_id="O2" value="443"/>
                <count group_id="O3" value="450"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80"/>
                    <measurement group_id="O2" value="29"/>
                    <measurement group_id="O3" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collected from Day 0 (post-vaccination) up to 28 days after last vaccination. Solicited Reaction (SR) data were collected up to Day 7 after each vaccination. Serious adverse event data were collected throughout the study (up to 180 days after last vaccination).</time_frame>
      <desc>Analysis was performed on safety analysis set. A SR was an AE that was prelisted (i.e., solicited) in the electronic case report form (eCRF) and considered to be related to vaccination (adverse drug reaction). An unsolicited AE was an observed AE that did not fulfill the conditions prelisted (i.e., solicited) in the eCRF in terms of symptom and/or onset post-vaccination.</desc>
      <group_list>
        <group group_id="E1">
          <title>High-Dose Quadrivalent Influenza Vaccine (QIV-HD)</title>
          <description>Participants randomized to receive a single injection of the high dose QIV-HD by IM route at Day 0.</description>
        </group>
        <group group_id="E2">
          <title>High-Dose Trivalent Influenza Vaccines (Licensed TIV-HD1)</title>
          <description>Participants randomized to receive a single injection of the licensed high dose TIV-HD1 by IM route at Day 0.</description>
        </group>
        <group group_id="E3">
          <title>High-Dose Trivalent Influenza Vaccine(Investigational TIV-HD2)</title>
          <description>Participants randomized to receive a single injection of the investigational TIV-HD2 by IM route at Day 0.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA-20.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="1777"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="443"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="450"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="80" subjects_at_risk="1777"/>
                <counts group_id="E2" subjects_affected="29" subjects_at_risk="443"/>
                <counts group_id="E3" subjects_affected="19" subjects_at_risk="450"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Haemorrhagic Anaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1777"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="443"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="450"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute Myocardial Infarction</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="1777"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="443"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="450"/>
              </event>
              <event>
                <sub_title>Angina Pectoris</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1777"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="443"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="450"/>
              </event>
              <event>
                <sub_title>Atrial Fibrillation</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1777"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="443"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="450"/>
              </event>
              <event>
                <sub_title>Atrioventricular Block Complete</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1777"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="443"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="450"/>
              </event>
              <event>
                <sub_title>Cardiac Failure Congestive</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1777"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="443"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="450"/>
              </event>
              <event>
                <sub_title>Coronary Artery Disease</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1777"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="443"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="450"/>
              </event>
              <event>
                <sub_title>Myocardial Infarction</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1777"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="443"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="450"/>
              </event>
              <event>
                <sub_title>Pericarditis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1777"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="443"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="450"/>
              </event>
              <event>
                <sub_title>Sinus Bradycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1777"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="443"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="450"/>
              </event>
              <event>
                <sub_title>Stress Cardiomyopathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1777"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="443"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="450"/>
              </event>
              <event>
                <sub_title>Ventricular Tachycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1777"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="443"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="450"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1777"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="443"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="450"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1777"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="443"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="450"/>
              </event>
              <event>
                <sub_title>Diverticulum Intestinal Haemorrhagic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1777"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="443"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="450"/>
              </event>
              <event>
                <sub_title>Gastritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1777"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="443"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="450"/>
              </event>
              <event>
                <sub_title>Gastrointestinal Haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1777"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="443"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="450"/>
              </event>
              <event>
                <sub_title>Gastrointestinal Ulcer Haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1777"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="443"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="450"/>
              </event>
              <event>
                <sub_title>Inguinal Hernia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1777"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="443"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="450"/>
              </event>
              <event>
                <sub_title>Pancreatitis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="1777"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="443"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="450"/>
              </event>
              <event>
                <sub_title>Small Intestinal Obstruction</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1777"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="443"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="450"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Non-Cardiac Chest Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1777"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="443"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="450"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1777"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="443"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="450"/>
              </event>
              <event>
                <sub_title>Sudden Death</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1777"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="443"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="450"/>
              </event>
              <event>
                <sub_title>Vascular Stent Thrombosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1777"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="443"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="450"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholangitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1777"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="443"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="450"/>
              </event>
              <event>
                <sub_title>Cholecystitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1777"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="443"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="450"/>
              </event>
              <event>
                <sub_title>Cholecystitis Acute</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1777"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="443"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="450"/>
              </event>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1777"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="443"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="450"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bacteraemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1777"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="443"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="450"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1777"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="443"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="450"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1777"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="443"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="450"/>
              </event>
              <event>
                <sub_title>Endocarditis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1777"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="443"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="450"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1777"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="443"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="450"/>
              </event>
              <event>
                <sub_title>Parainfluenzae Viral Laryngotracheobronchitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1777"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="443"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="450"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="1777"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="443"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="450"/>
              </event>
              <event>
                <sub_title>Respiratory Tract Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1777"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="443"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="450"/>
              </event>
              <event>
                <sub_title>Septic Shock</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1777"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="443"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="450"/>
              </event>
              <event>
                <sub_title>Staphylococcal Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1777"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="443"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="450"/>
              </event>
              <event>
                <sub_title>Streptococcal Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1777"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="443"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="450"/>
              </event>
              <event>
                <sub_title>Urinary Tract Infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1777"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="443"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="450"/>
              </event>
              <event>
                <sub_title>Viral Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1777"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="443"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="450"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Anaesthetic Complication</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1777"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="443"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="450"/>
              </event>
              <event>
                <sub_title>Ankle Fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1777"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="443"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="450"/>
              </event>
              <event>
                <sub_title>Bone Contusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1777"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="443"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="450"/>
              </event>
              <event>
                <sub_title>Femur Fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1777"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="443"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="450"/>
              </event>
              <event>
                <sub_title>Incisional Hernia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1777"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="443"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="450"/>
              </event>
              <event>
                <sub_title>Postpericardiotomy Syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1777"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="443"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="450"/>
              </event>
              <event>
                <sub_title>Rib Fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1777"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="443"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="450"/>
              </event>
              <event>
                <sub_title>Road Traffic Accident</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1777"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="443"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="450"/>
              </event>
              <event>
                <sub_title>Spinal Compression Fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1777"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="443"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="450"/>
              </event>
              <event>
                <sub_title>Tendon Rupture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1777"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="443"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="450"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Troponin Increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1777"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="443"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="450"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Type 2 Diabetes Mellitus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1777"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="443"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="450"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Back Pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1777"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="443"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="450"/>
              </event>
              <event>
                <sub_title>Groin Pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1777"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="443"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="450"/>
              </event>
              <event>
                <sub_title>Intervertebral Disc Protrusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1777"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="443"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="450"/>
              </event>
              <event>
                <sub_title>Lumbar Spinal Stenosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1777"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="443"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="450"/>
              </event>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="1777"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="443"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="450"/>
              </event>
              <event>
                <sub_title>Pain In Extremity</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1777"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="443"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="450"/>
              </event>
              <event>
                <sub_title>Rotator Cuff Syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1777"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="443"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="450"/>
              </event>
              <event>
                <sub_title>Spinal Osteoarthritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1777"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="443"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="450"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Bladder Cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1777"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="443"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="450"/>
              </event>
              <event>
                <sub_title>Brain Neoplasm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1777"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="443"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="450"/>
              </event>
              <event>
                <sub_title>Breast Cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1777"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="443"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="450"/>
              </event>
              <event>
                <sub_title>Cholangiocarcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1777"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="443"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="450"/>
              </event>
              <event>
                <sub_title>Invasive Ductal Breast Carcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1777"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="443"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="450"/>
              </event>
              <event>
                <sub_title>Malignant Melanoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1777"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="443"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="450"/>
              </event>
              <event>
                <sub_title>Neoplasm Malignant</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1777"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="443"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="450"/>
              </event>
              <event>
                <sub_title>Pancreatic Carcinoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1777"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="443"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="450"/>
              </event>
              <event>
                <sub_title>Prostate Cancer</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1777"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="443"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="450"/>
              </event>
              <event>
                <sub_title>Uterine Leiomyoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1777"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="443"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="450"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Carotid Artery Occlusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1777"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="443"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="450"/>
              </event>
              <event>
                <sub_title>Carotid Artery Stenosis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1777"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="443"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="450"/>
              </event>
              <event>
                <sub_title>Cerebrospinal Fluid Leakage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1777"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="443"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="450"/>
              </event>
              <event>
                <sub_title>Cerebrovascular Accident</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1777"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="443"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="450"/>
              </event>
              <event>
                <sub_title>Facial Paralysis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1777"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="443"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="450"/>
              </event>
              <event>
                <sub_title>Ischaemic Cerebral Infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1777"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="443"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="450"/>
              </event>
              <event>
                <sub_title>Seizure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1777"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="443"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="450"/>
              </event>
              <event>
                <sub_title>Small Fibre Neuropathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1777"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="443"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="450"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="1777"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="443"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="450"/>
              </event>
              <event>
                <sub_title>Transient Ischaemic Attack</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="1777"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="443"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="450"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Mental Status Changes</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1777"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="443"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="450"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Nephrolithiasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1777"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="443"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="450"/>
              </event>
              <event>
                <sub_title>Nephropathy</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1777"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="443"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="450"/>
              </event>
              <event>
                <sub_title>Urinary Retention</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1777"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="443"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="450"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Benign Prostatic Hyperplasia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1777"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="443"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="450"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Chronic Obstructive Pulmonary Disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1777"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="443"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="450"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1777"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="443"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="450"/>
              </event>
              <event>
                <sub_title>Pulmonary Embolism</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="1777"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="443"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="450"/>
              </event>
              <event>
                <sub_title>Respiratory Failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1777"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="443"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="450"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Skin Ulcer</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1777"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="443"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="450"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Aortic Stenosis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1777"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="443"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="450"/>
              </event>
              <event>
                <sub_title>Deep Vein Thrombosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1777"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="443"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="450"/>
              </event>
              <event>
                <sub_title>Peripheral Vascular Disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1777"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="443"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="450"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA-20.1</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="935" subjects_at_risk="1777"/>
                <counts group_id="E2" subjects_affected="234" subjects_at_risk="443"/>
                <counts group_id="E3" subjects_affected="206" subjects_at_risk="450"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" events="97" subjects_affected="96" subjects_at_risk="1777"/>
                <counts group_id="E2" events="20" subjects_affected="20" subjects_at_risk="443"/>
                <counts group_id="E3" events="22" subjects_affected="22" subjects_at_risk="450"/>
              </event>
              <event>
                <sub_title>Injection Site Erythema</sub_title>
                <counts group_id="E1" events="112" subjects_affected="110" subjects_at_risk="1777"/>
                <counts group_id="E2" events="31" subjects_affected="30" subjects_at_risk="443"/>
                <counts group_id="E3" events="21" subjects_affected="21" subjects_at_risk="450"/>
              </event>
              <event>
                <sub_title>Injection Site Pain</sub_title>
                <counts group_id="E1" events="731" subjects_affected="731" subjects_at_risk="1777"/>
                <counts group_id="E2" events="172" subjects_affected="172" subjects_at_risk="443"/>
                <counts group_id="E3" events="152" subjects_affected="152" subjects_at_risk="450"/>
              </event>
              <event>
                <sub_title>Injection Site Swelling</sub_title>
                <counts group_id="E1" events="87" subjects_affected="86" subjects_at_risk="1777"/>
                <counts group_id="E2" events="23" subjects_affected="23" subjects_at_risk="443"/>
                <counts group_id="E3" events="19" subjects_affected="19" subjects_at_risk="450"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" events="234" subjects_affected="233" subjects_at_risk="1777"/>
                <counts group_id="E2" events="53" subjects_affected="52" subjects_at_risk="443"/>
                <counts group_id="E3" events="67" subjects_affected="67" subjects_at_risk="450"/>
              </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="404" subjects_affected="404" subjects_at_risk="1777"/>
                <counts group_id="E2" events="81" subjects_affected="81" subjects_at_risk="443"/>
                <counts group_id="E3" events="88" subjects_affected="88" subjects_at_risk="450"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="262" subjects_affected="258" subjects_at_risk="1777"/>
                <counts group_id="E2" events="65" subjects_affected="65" subjects_at_risk="443"/>
                <counts group_id="E3" events="61" subjects_affected="59" subjects_at_risk="450"/>
              </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>The Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable partcipant 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>Trial Transparency Team</name_or_title>
      <organization>Sanofi Pasteur Inc.</organization>
      <phone>800-633-1610 ext 1#</phone>
      <email>Contact-US@sanofi.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/NCT03282240
org study id: QHD00013
secondary id: U1111-1183-5556
nct id: NCT03282240
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
This randomized, modified double-blind, active-controlled, multi-center trial assessed the
      safety and immunogenicity of the high-dose quadrivalent influenza vaccine (QIV-HD) compared
      to either the licensed or investigational high-dose trivalent influenza vaccine (TIV-HD) in
      adults.
This randomized, modified double-blind, active-controlled, multi-center trial was conducted
      in healthy adults (greater than and equal to [>=] 65 years) to assess the safety and
      immunogenicity (geometric mean titers and seroconversion for the 4 virus strains at 28 days
      post vaccination) of the QIV-HD compared to one of the TIV-HDs containing either the B strain
      from the primary lineage (TIV-HD1; licensed vaccine [Fluzone® High-Dose] for the 2017-2018
      Northern Hemisphere [NH] influenza season) or the B strain from the alternate lineage
      (TIV-HD2, investigational TIV-HD containing an alternate B strain).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: QHD00013 was a phase III, randomized, modified double-blind, active-controlled, multi-center trial.
primary purpose: Prevention
masking: Double (Participant, Outcomes Assessor)
masking description: QHD00013 was a modified double-blind trial with an unblinded administrator used at each trial site. The administrator was not involved in any of the blinded study assessments (e.g., safety).
measure: Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine
time frame: Day 28 post-vaccination
description: GMTs of anti-influenza antibodies were measured using an hemagglutination inhibition (HAI) assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage (B1), and B Yamagata lineage (B2). For each A strain, the comparison was made with the pooled TIV-HD groups. For each B strain, the comparison was made with the TIV-HD group containing the corresponding B strain. TIV-HD 1 did not contain B2 strain; TIV-HD2 did not contain B1 strain.
measure: Percentage of Participants Achieving Seroconversion Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine
time frame: Day 28 post-vaccination
description: Anti-influenza antibodies were measured using an HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage (B1), and B Yamagata lineage (B2). Seroconversion was defined as either a HAI titer less than (<) 10 (1/dilution) at Day 0 and post-injection titer greater than or equal to (>=) 40 (1/dilution) at Day 28, or HAI titer >=10 (1/dilution) at Day 0 and a >=4-fold increase in HAI titer (1/dilution) at Day 28. For each A strain, the comparison was made with the pooled TIV-HD groups. For each B strain, the comparison was made with the TIV-HD group containing the corresponding B strain. TIV-HD 1 did not contain B2 strain; TIV-HD2 did not contain B1 strain.
measure: GMTs of B Strains Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine
time frame: Day 28 post-vaccination
description: Anti-influenza antibodies were measured using HAI assay for 4 strains: A/H1N1 (A1), A/H3N2 (A2), B Victoria lineage (B1), and B Yamagata lineage (B2). For each B strain, the immunogenicity of QIV-HD was compared to that of TIV-HD group which contains the corresponding B strain. TIV-HD1 did not contain B2 strain; TIV-HD2 did not contain B1 strain.
measure: GMT Ratios of Influenza Antibodies Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine
time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
description: GMTs of anti-influenza antibodies using an HAI assay for 4 strains: A/H1N1, A/H3N2, B Victoria lineage (B1), and B Yamagata lineage (B2). Geometric Mean Titers Ratios (GMTRs) were calculated as the ratio of GMTs post vaccination and pre-vaccination.
measure: Percentage of Participants Achieving Seroconversion Against Antigens of B Strains After Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine
time frame: Day 28 post-vaccination
description: Seroconversion was defined as either a HAI titer <10 (1/dilution) at Day 0 and post-injection titer >=40 (1/dilution) at Day 28, or HAI titer >=10 (1/dilution) at Day 0 and a >=4-fold increase in HAI titer (1/dilution) at Day 28.
measure: Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine
time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
description: Anti-influenza antibodies were measured using HAI assay for 4 strains: A/H1N1 (A1), A/H3N2 (A2), B Victoria lineage (B1), and B Yamagata lineage (B2). Seroprotection was defined as a HAI titer >=40 (1/dilution) at Day 0 and Day 28.
measure: Geometric Mean Titers of Influenza Antibodies (Seroneutralization [SN] Assay) Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine
time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
description: GMTs of anti-influenza antibodies were measured using SN assay for 4 strains: A/H1N1 (A1), A/H3N2 (A2), B Victoria lineage (B1), and B Yamagata lineage (B2).
measure: GMTRs of Influenza Antibodies (SN Assay) Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine
time frame: Day 0 (pre-vaccination) and Day 28 post-vaccination
description: GMTRs of anti-influenza antibodies were measured using SN assay for 4 strains: A/H1N1 (A1), A/H3N2 (A2), B Victoria lineage (B1), and B Yamagata lineage (B2). GMTRs were calculated as the ratio of GMTs post vaccination and pre-vaccination.
measure: Number of Participants With Neutralization Antibody Titers at Day 0 and Day 28
time frame: Day 0, Day 28
description: Neutralizing Antibody titer was measured for each influenza strain with the SN method for 4 strains: A/H1N1, A/H3N2, B Victoria lineage (B1), and B Yamagata lineage (B2). Neutralizing antibody was defined as titers >=20 (1/dilution), >=40 (1/dilution), >=80 (1/dilution) at Day 0 and Day 28.
measure: Number of Participants With Two-Fold and Four-Fold Increase in Neutralization Antibody Titer at Day 28
time frame: Day 28
description: Neutralizing Antibody titer was measured for each influenza strain with the SN method for 4 strains: A/H1N1, A/H3N2, B Victoria lineage (B1), and B Yamagata lineage (B2). 2-fold and 4-fold rise was defined as the computed value = post-vaccination computed value / baseline computed value.
measure: Number of Participants With Detectable Neutralization Antibody Titers at Day 0 and Day 28
time frame: Day 0, Day 28
description: Neutralizing Antibody titer was measured for each influenza strain with the SN method for 4 strains: A/H1N1, A/H3N2, B Victoria lineage (B1), and B Yamagata lineage (B2). Detectable neutralization antibody titer >= 1:10 (1/dilution) at Day 0 and Day 28.
measure: Number of Participants Reporting Solicited Injection-site and Systemic Reactions Following Vaccination With Either a High-Dose Quadrivalent Influenza Vaccine or High-Dose Trivalent Influenza Vaccine
time frame: Within 7 days after vaccination
description: Solicited injection site: Pain, Erythema, Swelling, Induration, and Bruising. Grade 3 reactions: Pain - interrupts usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention; Erythema, Swelling, Induration, and Bruising: >100 millimeters (mm). Systemic reactions: Fever, Headache, Malaise, Myalgia, and Shivering. Grade 3 reactions: Fever: >=39°C; Headache, Malaise, Myalgia, and Shivering: interrupts usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention.
measure: Number of Participants With Immediate Adverse Event (AEs)
time frame: Within 30 minutes after vaccination
description: Participants were observed for 30 minutes after vaccination, and any unsolicited systemic AEs occurring during that time was recorded as immediate unsolicited systemic AEs (AEs that were related to the investigational product) in the case report book (CRB). Unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRB in terms of symptom and/ or onset post-vaccination. Unsolicited AEs included both serious and non-serious unsolicited AEs. A serious adverse event was any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event.
measure: Number of Participant With Unsolicited Adverse Event (AE)
time frame: Within 28 days after vaccination
description: An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRB in terms of symptom and/or onset post-vaccination. Unsolicited AEs included both serious and non-serious unsolicited AEs. A serious adverse event was any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event.
measure: Number of Participant With Serious Adverse Event
time frame: Up to 6 months after vaccination
description: An serious adverse event was any untoward medical occurrence that at any dose results in death, was life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity,is a congenital anomaly/birth defect, or was an important medical event.
arm group label: QIV-HD
arm group type: Experimental
description: Participants randomized to receive a single injection of 0.7 mL QIV-HD by intramuscular (IM) route at Day 0.
arm group label: TIV-HD1 (Licensed TIV-HD1)
arm group type: Active Comparator
description: Participants randomized to receive a single injection of 0.5 mL licensed TIV-HD1 by IM route at Day 0.
arm group label: TIV-HD2 (Investigational TIV-HD2)
arm group type: Active Comparator
description: Participants randomized to receive a single injection of 0.5 mL investigational TIV-HD2 by IM route at Day 0.
intervention type: Biological
intervention name: QIV-HD
description: 0.7 mL-dose was administered intramuscularly (IM) into the upper arm area.
arm group label: QIV-HD
other name: High-dose quadrivalent influenza vaccine
intervention type: Biological
intervention name: Licensed TIV-HD1
description: 0.5 mL-dose was administered IM into the upper arm area.
arm group label: TIV-HD1 (Licensed TIV-HD1)
other name: High-dose trivalent influenza vaccine
intervention type: Biological
intervention name: Investigational TIV-HD2
description: 0.5 mL-dose was administered IM into the upper arm area.
arm group label: TIV-HD2 (Investigational TIV-HD2)
other name: High-dose trivalent influenza vaccine (alternate B strain)
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Medical Director
role: Study Director
affiliation: Sanofi Pasteur, a Sanofi Company
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country: United States
url: http://www.sanofipasteur.com
description: Related info
responsible party type: Sponsor
mesh term: Influenza, Human
mesh term: Vaccines
sharing ipd: Yes
ipd description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 