<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/NCT04498832</url>
  </required_header>
  <id_info>
    <org_study_id>EFC15150</org_study_id>
    <secondary_id>U1111-1225-1085</secondary_id>
    <secondary_id>QHD00010</secondary_id>
    <nct_id>NCT04498832</nct_id>
  </id_info>
  <brief_title>Study to Assess the Immune Response and the Safety Profile of a High-Dose Quadrivalent Influenza Vaccine (QIV-HD) Compared to a Standard-Dose Quadrivalent Influenza Vaccine (QIV-SD) in Japanese Adults 60 Years of Age and Older</brief_title>
  <official_title>Immunogenicity and Safety of High-Dose Quadrivalent Influenza Vaccine (SP0178) Administered by Intramuscular Route Versus Standard-Dose Quadrivalent Influenza Vaccine by Subcutaneous Route in Subjects 60 Years of Age and Older in Japan</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>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Primary Objective:&#xD;
&#xD;
      To demonstrate that QIV-HD induced an immune response (as assessed by hemagglutination&#xD;
      inhibition [HAI] geometric mean titers [GMTs] and seroconversion rates) that was superior to&#xD;
      responses induced by QIV-SD for the 4 virus strains at 28 days post-vaccination in all&#xD;
      participants.&#xD;
&#xD;
      Secondary Objective:&#xD;
&#xD;
        -  To describe the immune response induced by QIV-HD and QIV-SD by HAI measurement method&#xD;
           in all participants.&#xD;
&#xD;
        -  To describe the safety profile of all participants in each study group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study duration per participant was approximately 28 days including: 1 day of screening and&#xD;
      vaccination, a safety follow-up telephone call and an end of study visit approximately at Day&#xD;
      8 and 28 after vaccination, respectively.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 21, 2020</start_date>
  <completion_date type="Actual">January 14, 2021</completion_date>
  <primary_completion_date type="Actual">January 14, 2021</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Participants randomized in each group were stratified by site and age (60 to 64, 65 to 74, and 75 years of age and older).</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Modified double-blind: the participant and the Investigator remain unaware of the treatment assignments throughout the study. An unblinded qualified trial staff member will administer the appropriate vaccine but will not be involved in the immunogenicity and safety evaluations.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 28</measure>
    <time_frame>Day 28 (post-vaccination)</time_frame>
    <description>GMTs of anti-influenza antibodies were measured using hemagglutination inhibition (HAI) assay for 4 influenza virus strains: A/H1N1, A/H3N2-like, B/Victoria-like, and B/Yamagata. Titers were expressed in terms of 1/dilution.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Achieving Seroconversion Against Influenza Virus Antigens: Superiority Analysis</measure>
    <time_frame>Day 28 (post-vaccination)</time_frame>
    <description>Anti-influenza antibodies were measured by HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2-like, B/Victoria-like, and B/Yamagata. Seroconversion was defined as either a pre-vaccination HAI titer less than (&lt;) 10 (1/dilution) and a post-vaccination titer &gt;=40 (1/dilution) or a pre-vaccination titer &gt;=10 (1/dilution) and a &gt;= four-fold increase in post-vaccination titer at Day 28.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>GMTs of Influenza Vaccine Antibodies at Day 0 and Day 28</measure>
    <time_frame>Day 0 (pre-vaccination) and Day 28 (post-vaccination)</time_frame>
    <description>GMTs of anti-influenza antibodies were measured using HAI assay for 6 influenza virus strains: A/H1N1, A/H3N2, A/H3N2-like, B/Victoria, B/Victoria-like, and B/Yamagata. Titers were expressed in terms of 1/dilution.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geometric Mean Titers Ratio (GMTR) of Influenza Vaccine Antibodies</measure>
    <time_frame>Day 0 (pre-vaccination), Day 28 (post-vaccination)</time_frame>
    <description>GMTs of anti-influenza antibodies were measured using HAI assay for 6 influenza virus strains: A/H1N1, A/H3N2, A/H3N2-like, B/Victoria, B/Victoria-like, and B/Yamagata. GMTRs were calculated as the ratio of GMTs post-vaccination (on Day 28) and pre-vaccination (on Day 0).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving Seroconversion Against Influenza Virus Antigens</measure>
    <time_frame>Day 28 (post-vaccination)</time_frame>
    <description>Anti-influenza antibodies were measured by HAI assay for 6 influenza virus strains: A/H1N1, A/H3N2, A/H3N2-like, B/Victoria, B/Victoria-like, and B/Yamagata. Seroconversion was defined as either a pre-vaccination HAI titer &lt;10 (1/dilution) and a post-vaccination titer &gt;=40 (1/dilution) or a pre-vaccination titer &gt;=10 (1/dilution) and a &gt;= four-fold increase in post-vaccination titer at Day 28.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With HAI Titers &gt;=40 (1/Dilution) Against Influenza Antigens</measure>
    <time_frame>Day 0 (pre-vaccination), Day 28 (post-vaccination)</time_frame>
    <description>Anti-influenza antibodies were measured using HAI assay method for 6 influenza virus strains: A/H1N1, A/H3N2, A/H3N2-like, B/Victoria, B/Victoria-like, and B/Yamagata. Percentage of participants with HAI titers &gt;=40 (1/dilution) is reported in the outcome measure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Reporting Immediate Unsolicited Adverse Events (AEs)</measure>
    <time_frame>Within 30 minutes post-vaccination</time_frame>
    <description>An AE was any untoward medical occurrence in a patient or in a clinical investigation participant administered a medicinal product and which did not necessarily have a casual relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination. All participants were observed for 30 minutes after vaccination, and any unsolicited AEs that occurred during that time were recorded as immediate unsolicited AEs in the CRB.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Reporting Solicited Injection Site and Systemic Reactions</measure>
    <time_frame>Within 7 days post-vaccination</time_frame>
    <description>A solicited reaction was an expected adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the CRB and considered as related to the product administered. Solicited injection site reactions included injection site pain, injection site erythema, injection site swelling, injection site induration, and injection site bruising. Solicited systemic reactions included fever, headache, malaise, myalgia and shivering.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Reporting Unsolicited Adverse Events (AEs)</measure>
    <time_frame>Within 28 days post-vaccination</time_frame>
    <description>An AE was any untoward medical occurrence in a patient or in a clinical investigation participant administered a medicinal product and which did not necessarily have a casual relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Reporting Serious Adverse Events (SAEs)</measure>
    <time_frame>From Day 0 up to Day 28 post-vaccination</time_frame>
    <description>A SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">2100</enrollment>
  <condition>Influenza (Healthy Volunteers)</condition>
  <arm_group>
    <arm_group_label>Group 1: QIV-HD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received a single injection of 0.7 milliliters (mL) high dose quadrivalent influenza vaccine (QIV-HD), intramuscularly (IM) at Day 0.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2: QIV-SD</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants received a single injection of 0.5 mL standard-dose quadrivalent influenza vaccine (QIV-SD), subcutaneously (SC) at Day 0.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>High-Dose Quadrivalent Influenza Vaccine, (Zonal Purified, Split Virus) 2020-2021 Strains (QIV-HD)</intervention_name>
    <description>Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: IM</description>
    <arm_group_label>Group 1: QIV-HD</arm_group_label>
    <other_name>QIV-HD</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Local Standard-Dose Inactivated Quadrivalent Influenza Vaccine, 2020-2021 Strains (QIV-SD)</intervention_name>
    <description>Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: SC</description>
    <arm_group_label>Group 2: QIV-SD</arm_group_label>
    <other_name>QIV-SD</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria :&#xD;
&#xD;
          -  Aged greater than or equal to (&gt;=) 60 years on the day of inclusion.&#xD;
&#xD;
          -  Able to attend all scheduled visits and complied with all study procedures.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Participation at the time of study enrollment (or in the 4 weeks preceding the study&#xD;
             vaccination) or planned participation during the present study period in another&#xD;
             clinical study investigating a vaccine, drug, medical device, or medical procedure.&#xD;
&#xD;
          -  Receipt of any vaccination with live vaccines within the past 27 days preceding the&#xD;
             study vaccination or any vaccination with inactivated vaccines within the past 6 days&#xD;
             preceding the study vaccination, or planned receipt of any vaccine prior to Visit 02.&#xD;
&#xD;
          -  Previous vaccination against influenza (in the preceding 6 months) with either the&#xD;
             study 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 eggs, chicken proteins, or any of the vaccine&#xD;
             components, or history of a life-threatening reaction to the vaccine used in the study&#xD;
             or to a vaccine containing any of the same substances.&#xD;
&#xD;
          -  Thrombocytopenia or bleeding disorder, contraindicating IM vaccination based on&#xD;
             Investigator's judgment.&#xD;
&#xD;
          -  Alcohol or substance abuse that, in the opinion of the Investigator might interfere&#xD;
             with the study conduct or completion.&#xD;
&#xD;
          -  Chronic illness that, in the opinion of the Investigator, was at a stage where it&#xD;
             might interfere with study conduct or completion.&#xD;
&#xD;
          -  Identified as an Investigator or employee of the Investigator or study center with&#xD;
             direct involvement in the proposed study, 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 study.&#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;=37.5 degree Celsius). A&#xD;
             prospective participant was not be included in the study until the condition had&#xD;
             resolved or the febrile event had subsided.&#xD;
&#xD;
          -  History of convulsions.&#xD;
&#xD;
          -  Any condition that in the opinion of the Investigator could interfere with the&#xD;
             evaluation of the vaccine.&#xD;
&#xD;
        The above information was not intended to contain all considerations relevant to a&#xD;
        participant's potential participation in a clinical trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Sciences &amp; Operations</last_name>
    <role>Study Director</role>
    <affiliation>Sanofi</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Investigational Site Number 3920005</name>
      <address>
        <city>Fukuoka-Shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 3920004</name>
      <address>
        <city>Koganei-Shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 3920006</name>
      <address>
        <city>Kumamoto-Shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 3920001</name>
      <address>
        <city>Osaka-Shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 3920003</name>
      <address>
        <city>Shinjuku-Ku</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 3920008</name>
      <address>
        <city>Shinjuku-Ku</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 3920009</name>
      <address>
        <city>Shinjuku-Ku</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 3920002</name>
      <address>
        <city>Suita-Shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 3920007</name>
      <address>
        <city>Toshima-Ku</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 3920010</name>
      <address>
        <city>Yokohama-Shi</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <reference>
    <citation>Sanchez L, Nakama T, Nagai H, Matsuoka O, Inoue S, Inoue T, Shrestha A, Pandey A, Chang LJ, De Bruijn I; QHD00010 Study Group. Superior immunogenicity of high-dose quadrivalent inactivated influenza vaccine versus Standard-Dose vaccine in Japanese Adults &gt;/= 60 years of age: Results from a phase III, randomized clinical trial. Vaccine. 2023 Apr 6;41(15):2553-2561. doi: 10.1016/j.vaccine.2023.02.071. Epub 2023 Mar 10.</citation>
    <PMID>36906404</PMID>
  </reference>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>July 31, 2020</study_first_submitted>
  <study_first_submitted_qc>July 31, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <results_first_submitted>January 11, 2022</results_first_submitted>
  <results_first_submitted_qc>January 11, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">February 8, 2022</results_first_posted>
  <last_update_submitted>March 22, 2023</last_update_submitted>
  <last_update_submitted_qc>March 22, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>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>April 24, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/32/NCT04498832/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>January 8, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/32/NCT04498832/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The study was conducted at 10 active centers in Japan.</recruitment_details>
      <pre_assignment_details>A total of 2100 participants were enrolled and randomized between 21 October 2020 to 14 January 2021.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>QIV-HD</title>
          <description>Participants received a single injection of 0.7 milliliters (mL) high dose quadrivalent influenza vaccine (QIV-HD), intramuscularly (IM) at Day 0.</description>
        </group>
        <group group_id="P2">
          <title>QIV-SD</title>
          <description>Participants received a single injection of 0.5 mL standard-dose quadrivalent influenza vaccine (QIV-SD), subcutaneously (SC) 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="1049"/>
                <participants group_id="P2" count="1051"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1048"/>
                <participants group_id="P2" count="1047"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Analysis was performed on all enrolled participants.</population>
      <group_list>
        <group group_id="B1">
          <title>QIV-HD</title>
          <description>Participants received a single injection of 0.7 milliliters (mL) high dose quadrivalent influenza vaccine (QIV-HD), intramuscularly (IM) at Day 0.</description>
        </group>
        <group group_id="B2">
          <title>QIV-SD</title>
          <description>Participants received a single injection of 0.5 mL standard-dose quadrivalent influenza vaccine (QIV-SD), subcutaneously (SC) at Day 0.</description>
        </group>
        <group group_id="B3">
          <title>Total Title</title>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="1049"/>
            <count group_id="B2" value="1051"/>
            <count group_id="B3" value="2100"/>
          </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="68.2" spread="4.89"/>
                    <measurement group_id="B2" value="68.4" spread="4.96"/>
                    <measurement group_id="B3" value="68.3" spread="4.93"/>
                  </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="486"/>
                    <measurement group_id="B2" value="504"/>
                    <measurement group_id="B3" value="990"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="563"/>
                    <measurement group_id="B2" value="547"/>
                    <measurement group_id="B3" value="1110"/>
                  </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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1049"/>
                    <measurement group_id="B2" value="1051"/>
                    <measurement group_id="B3" value="2100"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </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 Vaccine Antibodies at Day 28</title>
        <description>GMTs of anti-influenza antibodies were measured using hemagglutination inhibition (HAI) assay for 4 influenza virus strains: A/H1N1, A/H3N2-like, B/Victoria-like, and B/Yamagata. Titers were expressed in terms of 1/dilution.</description>
        <time_frame>Day 28 (post-vaccination)</time_frame>
        <population>Analysis was performed on full analysis set (FAS) population which included all randomized participants who received at least one dose of the study vaccine and had a post-vaccination blood sample HAI result for at least one strain. Here, 'Number analyzed' = participants with available data for each specified category.</population>
        <group_list>
          <group group_id="O1">
            <title>QIV-HD</title>
            <description>Participants received a single injection of 0.7 milliliters (mL) high dose quadrivalent influenza vaccine (QIV-HD), intramuscularly (IM) at Day 0.</description>
          </group>
          <group group_id="O2">
            <title>QIV-SD</title>
            <description>Participants received a single injection of 0.5 mL standard-dose quadrivalent influenza vaccine (QIV-SD), subcutaneously (SC) at Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 28</title>
          <description>GMTs of anti-influenza antibodies were measured using hemagglutination inhibition (HAI) assay for 4 influenza virus strains: A/H1N1, A/H3N2-like, B/Victoria-like, and B/Yamagata. Titers were expressed in terms of 1/dilution.</description>
          <population>Analysis was performed on full analysis set (FAS) population which included all randomized participants who received at least one dose of the study vaccine and had a post-vaccination blood sample HAI result for at least one strain. Here, 'Number analyzed' = participants with available data for each specified category.</population>
          <units>titers</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1048"/>
                <count group_id="O2" value="1047"/>
              </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="1048"/>
                    <count group_id="O2" value="1047"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="309.0" lower_limit="282.1" upper_limit="338.4"/>
                    <measurement group_id="O2" value="110.0" lower_limit="100.0" upper_limit="121.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H3N2-like</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1048"/>
                    <count group_id="O2" value="1046"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="540.0" lower_limit="504.4" upper_limit="578.0"/>
                    <measurement group_id="O2" value="239.9" lower_limit="222.0" upper_limit="259.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B/Victoria-like</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1048"/>
                    <count group_id="O2" value="1047"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="354.8" lower_limit="333.0" upper_limit="378.0"/>
                    <measurement group_id="O2" value="139.2" lower_limit="129.4" upper_limit="149.8"/>
                  </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="1048"/>
                    <count group_id="O2" value="1047"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="795.8" lower_limit="750.3" upper_limit="844.1"/>
                    <measurement group_id="O2" value="254.7" lower_limit="237.7" upper_limit="273.0"/>
                  </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>A/H1N1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Superiority of GMTs was concluded if the lower limit of the 2-sided 95% Confidence Interval (CI) for the ratio of GMTs was greater than (&gt;) 1 between groups for each of the comparisons.</non_inferiority_desc>
            <param_type>GMT ratio</param_type>
            <param_value>2.81</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>2.46</ci_lower_limit>
            <ci_upper_limit>3.20</ci_upper_limit>
            <estimate_desc>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.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>A/H3N2-like</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Superiority of GMTs was concluded if the lower limit of the 2-sided 95%CI for the ratio of GMTs was &gt;1 between groups for each of the comparisons.</non_inferiority_desc>
            <param_type>GMT ratio</param_type>
            <param_value>2.25</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>2.03</ci_lower_limit>
            <ci_upper_limit>2.50</ci_upper_limit>
            <estimate_desc>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.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>B/Victoria-like</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Superiority of GMTs was concluded if the lower limit of the 2-sided 95%CI for the ratio of GMTs was &gt;1 between groups for each of the comparisons.</non_inferiority_desc>
            <param_type>GMT ratio</param_type>
            <param_value>2.55</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>2.31</ci_lower_limit>
            <ci_upper_limit>2.81</ci_upper_limit>
            <estimate_desc>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.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>B/Yamagata</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Superiority of GMTs was concluded if the lower limit of the 2-sided 95%CI for the ratio of GMTs was &gt;1 between groups for each of the comparisons.</non_inferiority_desc>
            <param_type>GMT ratio</param_type>
            <param_value>3.12</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>2.85</ci_lower_limit>
            <ci_upper_limit>3.42</ci_upper_limit>
            <estimate_desc>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.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Achieving Seroconversion Against Influenza Virus Antigens: Superiority Analysis</title>
        <description>Anti-influenza antibodies were measured by HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2-like, B/Victoria-like, and B/Yamagata. Seroconversion was defined as either a pre-vaccination HAI titer less than (&lt;) 10 (1/dilution) and a post-vaccination titer &gt;=40 (1/dilution) or a pre-vaccination titer &gt;=10 (1/dilution) and a &gt;= four-fold increase in post-vaccination titer at Day 28.</description>
        <time_frame>Day 28 (post-vaccination)</time_frame>
        <population>Analysis was performed on FAS population. Here, 'number analyzed' = participants with available data for each specified category.</population>
        <group_list>
          <group group_id="O1">
            <title>QIV-HD</title>
            <description>Participants received a single injection of 0.7 milliliters (mL) high dose quadrivalent influenza vaccine (QIV-HD), intramuscularly (IM) at Day 0.</description>
          </group>
          <group group_id="O2">
            <title>QIV-SD</title>
            <description>Participants received a single injection of 0.5 mL standard-dose quadrivalent influenza vaccine (QIV-SD), subcutaneously (SC) at Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving Seroconversion Against Influenza Virus Antigens: Superiority Analysis</title>
          <description>Anti-influenza antibodies were measured by HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2-like, B/Victoria-like, and B/Yamagata. Seroconversion was defined as either a pre-vaccination HAI titer less than (&lt;) 10 (1/dilution) and a post-vaccination titer &gt;=40 (1/dilution) or a pre-vaccination titer &gt;=10 (1/dilution) and a &gt;= four-fold increase in post-vaccination titer at Day 28.</description>
          <population>Analysis was performed on FAS population. Here, 'number analyzed' = participants with available data for each specified 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="1048"/>
                <count group_id="O2" value="1047"/>
              </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="1045"/>
                    <count group_id="O2" value="1045"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77.6" lower_limit="75.0" upper_limit="80.1"/>
                    <measurement group_id="O2" value="47.9" lower_limit="44.9" upper_limit="51.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H3N2-like</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1047"/>
                    <count group_id="O2" value="1045"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.4" lower_limit="72.6" upper_limit="77.9"/>
                    <measurement group_id="O2" value="47.3" lower_limit="44.2" upper_limit="50.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B/Victoria-like</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1046"/>
                    <count group_id="O2" value="1045"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79.2" lower_limit="76.6" upper_limit="81.6"/>
                    <measurement group_id="O2" value="47.8" lower_limit="44.7" upper_limit="50.8"/>
                  </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="1045"/>
                    <count group_id="O2" value="1045"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74.4" lower_limit="71.7" upper_limit="77.1"/>
                    <measurement group_id="O2" value="39.0" lower_limit="36.1" upper_limit="42.1"/>
                  </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>A/H1N1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Superiority on seroconversions was concluded if the lower limit of the 2-sided 95% CI of the difference in percentage between groups was &gt; 0% for each of the comparisons.</non_inferiority_desc>
            <param_type>Difference in percentage</param_type>
            <param_value>29.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>25.7</ci_lower_limit>
            <ci_upper_limit>33.5</ci_upper_limit>
            <estimate_desc>The 2-sided 95% CI for the difference was based on the Wilson score method without continuity correction.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>A/H3N2-like</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Superiority on seroconversions was concluded if the lower limit of the 2-sided 95% CI of the difference in percentage between groups was &gt; 0% for each of the comparisons.</non_inferiority_desc>
            <param_type>Difference in percentage</param_type>
            <param_value>28.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>24.0</ci_lower_limit>
            <ci_upper_limit>32.0</ci_upper_limit>
            <estimate_desc>The 2-sided 95% CI for the difference was based on the Wilson score method without continuity correction.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>B/Victoria-like</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Superiority on seroconversions was concluded if the lower limit of the 2-sided 95% CI of the difference in percentage between groups was &gt; 0% for each of the comparisons.</non_inferiority_desc>
            <param_type>Difference in percentage</param_type>
            <param_value>31.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>27.4</ci_lower_limit>
            <ci_upper_limit>35.2</ci_upper_limit>
            <estimate_desc>The 2-sided 95% CI for the difference was based on the Wilson score method without continuity correction.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>B/Yamagata</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Superiority on seroconversions was concluded if the lower limit of the 2-sided 95% CI of the difference in percentage between groups was &gt; 0% for each of the comparisons.</non_inferiority_desc>
            <param_type>Difference in percentage</param_type>
            <param_value>35.4</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>31.4</ci_lower_limit>
            <ci_upper_limit>39.3</ci_upper_limit>
            <estimate_desc>The 2-sided 95% CI for the difference was based on the Wilson score method without continuity correction.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>GMTs of Influenza Vaccine Antibodies at Day 0 and Day 28</title>
        <description>GMTs of anti-influenza antibodies were measured using HAI assay for 6 influenza virus strains: A/H1N1, A/H3N2, A/H3N2-like, B/Victoria, B/Victoria-like, and B/Yamagata. Titers were expressed in terms of 1/dilution.</description>
        <time_frame>Day 0 (pre-vaccination) and Day 28 (post-vaccination)</time_frame>
        <population>Analysis was performed on FAS population. Here, 'Number analyzed' = participants with available data for each specified category.</population>
        <group_list>
          <group group_id="O1">
            <title>QIV-HD</title>
            <description>Participants received a single injection of 0.7 milliliters (mL) high dose quadrivalent influenza vaccine (QIV-HD), intramuscularly (IM) at Day 0.</description>
          </group>
          <group group_id="O2">
            <title>QIV-SD</title>
            <description>Participants received a single injection of 0.5 mL standard-dose quadrivalent influenza vaccine (QIV-SD), subcutaneously (SC) at Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>GMTs of Influenza Vaccine Antibodies at Day 0 and Day 28</title>
          <description>GMTs of anti-influenza antibodies were measured using HAI assay for 6 influenza virus strains: A/H1N1, A/H3N2, A/H3N2-like, B/Victoria, B/Victoria-like, and B/Yamagata. Titers were expressed in terms of 1/dilution.</description>
          <population>Analysis was performed on FAS population. Here, 'Number analyzed' = participants with available data for each specified category.</population>
          <units>titers</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1048"/>
                <count group_id="O2" value="1047"/>
              </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="1045"/>
                    <count group_id="O2" value="1045"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.5" lower_limit="13.5" upper_limit="15.5"/>
                    <measurement group_id="O2" value="14.9" lower_limit="13.9" upper_limit="16.1"/>
                  </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="1048"/>
                    <count group_id="O2" value="1047"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="309.0" lower_limit="282.1" upper_limit="338.4"/>
                    <measurement group_id="O2" value="110.0" lower_limit="100.0" upper_limit="121.1"/>
                  </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="1047"/>
                    <count group_id="O2" value="1045"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="54.9" lower_limit="50.3" upper_limit="59.9"/>
                    <measurement group_id="O2" value="54.6" lower_limit="50.0" upper_limit="59.7"/>
                  </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="1048"/>
                    <count group_id="O2" value="1047"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="721.4" lower_limit="676.6" upper_limit="769.2"/>
                    <measurement group_id="O2" value="319.9" lower_limit="297.1" upper_limit="344.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H3N2-like: Day 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1047"/>
                    <count group_id="O2" value="1045"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.8" lower_limit="37.5" upper_limit="44.4"/>
                    <measurement group_id="O2" value="41.0" lower_limit="37.6" upper_limit="44.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H3N2-like: Day 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1048"/>
                    <count group_id="O2" value="1046"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="540.0" lower_limit="504.4" upper_limit="578.0"/>
                    <measurement group_id="O2" value="239.9" lower_limit="222.0" upper_limit="259.1"/>
                  </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="1046"/>
                    <count group_id="O2" value="1045"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.3" lower_limit="24.4" upper_limit="28.3"/>
                    <measurement group_id="O2" value="24.7" lower_limit="23.0" upper_limit="26.5"/>
                  </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="1048"/>
                    <count group_id="O2" value="1047"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="447.3" lower_limit="420.8" upper_limit="475.5"/>
                    <measurement group_id="O2" value="152.0" lower_limit="141.4" upper_limit="163.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B/Victoria-like: Day 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1046"/>
                    <count group_id="O2" value="1045"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.7" lower_limit="22.1" upper_limit="25.5"/>
                    <measurement group_id="O2" value="22.3" lower_limit="20.9" upper_limit="23.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B/Victoria-like: Day 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1048"/>
                    <count group_id="O2" value="1047"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="354.8" lower_limit="333.0" upper_limit="378.0"/>
                    <measurement group_id="O2" value="139.2" lower_limit="129.4" upper_limit="149.8"/>
                  </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="1045"/>
                    <count group_id="O2" value="1045"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70.4" lower_limit="64.4" upper_limit="77.1"/>
                    <measurement group_id="O2" value="60.4" lower_limit="55.3" upper_limit="66.0"/>
                  </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="1048"/>
                    <count group_id="O2" value="1047"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="795.8" lower_limit="750.3" upper_limit="844.1"/>
                    <measurement group_id="O2" value="254.7" lower_limit="237.7" upper_limit="273.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Geometric Mean Titers Ratio (GMTR) of Influenza Vaccine Antibodies</title>
        <description>GMTs of anti-influenza antibodies were measured using HAI assay for 6 influenza virus strains: A/H1N1, A/H3N2, A/H3N2-like, B/Victoria, B/Victoria-like, and B/Yamagata. GMTRs were calculated as the ratio of GMTs post-vaccination (on Day 28) and pre-vaccination (on Day 0).</description>
        <time_frame>Day 0 (pre-vaccination), Day 28 (post-vaccination)</time_frame>
        <population>Analysis was performed on FAS population. Here, 'Number analyzed' = participants with available data for each specified category.</population>
        <group_list>
          <group group_id="O1">
            <title>QIV-HD</title>
            <description>Participants received a single injection of 0.7 milliliters (mL) high dose quadrivalent influenza vaccine (QIV-HD), intramuscularly (IM) at Day 0.</description>
          </group>
          <group group_id="O2">
            <title>QIV-SD</title>
            <description>Participants received a single injection of 0.5 mL standard-dose quadrivalent influenza vaccine (QIV-SD), subcutaneously (SC) at Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Titers Ratio (GMTR) of Influenza Vaccine Antibodies</title>
          <description>GMTs of anti-influenza antibodies were measured using HAI assay for 6 influenza virus strains: A/H1N1, A/H3N2, A/H3N2-like, B/Victoria, B/Victoria-like, and B/Yamagata. GMTRs were calculated as the ratio of GMTs post-vaccination (on Day 28) and pre-vaccination (on Day 0).</description>
          <population>Analysis was performed on FAS population. Here, 'Number analyzed' = participants with available data for each specified category.</population>
          <units>ratio</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1048"/>
                <count group_id="O2" value="1047"/>
              </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="1045"/>
                    <count group_id="O2" value="1045"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.33" lower_limit="19.57" upper_limit="23.25"/>
                    <measurement group_id="O2" value="7.33" lower_limit="6.71" upper_limit="8.01"/>
                  </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="1047"/>
                    <count group_id="O2" value="1045"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.14" lower_limit="12.05" upper_limit="14.32"/>
                    <measurement group_id="O2" value="5.86" lower_limit="5.34" upper_limit="6.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H3N2-like</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1047"/>
                    <count group_id="O2" value="1045"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.23" lower_limit="12.13" upper_limit="14.43"/>
                    <measurement group_id="O2" value="5.85" lower_limit="5.33" upper_limit="6.42"/>
                  </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="1046"/>
                    <count group_id="O2" value="1045"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.06" lower_limit="15.78" upper_limit="18.44"/>
                    <measurement group_id="O2" value="6.17" lower_limit="5.66" upper_limit="6.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B/Victoria-like</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1046"/>
                    <count group_id="O2" value="1045"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.97" lower_limit="13.88" upper_limit="16.14"/>
                    <measurement group_id="O2" value="6.27" lower_limit="5.76" upper_limit="6.82"/>
                  </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="1045"/>
                    <count group_id="O2" value="1045"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.29" lower_limit="10.39" upper_limit="12.27"/>
                    <measurement group_id="O2" value="4.21" lower_limit="3.88" upper_limit="4.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving Seroconversion Against Influenza Virus Antigens</title>
        <description>Anti-influenza antibodies were measured by HAI assay for 6 influenza virus strains: A/H1N1, A/H3N2, A/H3N2-like, B/Victoria, B/Victoria-like, and B/Yamagata. Seroconversion was defined as either a pre-vaccination HAI titer &lt;10 (1/dilution) and a post-vaccination titer &gt;=40 (1/dilution) or a pre-vaccination titer &gt;=10 (1/dilution) and a &gt;= four-fold increase in post-vaccination titer at Day 28.</description>
        <time_frame>Day 28 (post-vaccination)</time_frame>
        <population>Analysis was performed on FAS population. Here, 'Number analyzed' = participants with available data for each specified category.</population>
        <group_list>
          <group group_id="O1">
            <title>QIV-HD</title>
            <description>Participants received a single injection of 0.7 milliliters (mL) high dose quadrivalent influenza vaccine (QIV-HD), intramuscularly (IM) at Day 0.</description>
          </group>
          <group group_id="O2">
            <title>QIV-SD</title>
            <description>Participants received a single injection of 0.5 mL standard-dose quadrivalent influenza vaccine (QIV-SD), subcutaneously (SC) at Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving Seroconversion Against Influenza Virus Antigens</title>
          <description>Anti-influenza antibodies were measured by HAI assay for 6 influenza virus strains: A/H1N1, A/H3N2, A/H3N2-like, B/Victoria, B/Victoria-like, and B/Yamagata. Seroconversion was defined as either a pre-vaccination HAI titer &lt;10 (1/dilution) and a post-vaccination titer &gt;=40 (1/dilution) or a pre-vaccination titer &gt;=10 (1/dilution) and a &gt;= four-fold increase in post-vaccination titer at Day 28.</description>
          <population>Analysis was performed on FAS population. Here, 'Number analyzed' = participants with available data for each specified 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="1048"/>
                <count group_id="O2" value="1047"/>
              </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="1045"/>
                    <count group_id="O2" value="1045"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77.6" lower_limit="75.0" upper_limit="80.1"/>
                    <measurement group_id="O2" value="47.9" lower_limit="44.9" upper_limit="51.0"/>
                  </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="1047"/>
                    <count group_id="O2" value="1045"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76.4" lower_limit="73.7" upper_limit="79.0"/>
                    <measurement group_id="O2" value="48.2" lower_limit="45.2" upper_limit="51.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H3N2-like</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1047"/>
                    <count group_id="O2" value="1045"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.4" lower_limit="72.6" upper_limit="77.9"/>
                    <measurement group_id="O2" value="47.3" lower_limit="44.2" upper_limit="50.4"/>
                  </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="1046"/>
                    <count group_id="O2" value="1045"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82.1" lower_limit="79.7" upper_limit="84.4"/>
                    <measurement group_id="O2" value="47.4" lower_limit="44.3" upper_limit="50.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B/Victoria-like</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1046"/>
                    <count group_id="O2" value="1045"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79.2" lower_limit="76.6" upper_limit="81.6"/>
                    <measurement group_id="O2" value="47.8" lower_limit="44.7" upper_limit="50.8"/>
                  </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="1045"/>
                    <count group_id="O2" value="1045"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74.4" lower_limit="71.7" upper_limit="77.1"/>
                    <measurement group_id="O2" value="39.0" lower_limit="36.1" upper_limit="42.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With HAI Titers &gt;=40 (1/Dilution) Against Influenza Antigens</title>
        <description>Anti-influenza antibodies were measured using HAI assay method for 6 influenza virus strains: A/H1N1, A/H3N2, A/H3N2-like, B/Victoria, B/Victoria-like, and B/Yamagata. Percentage of participants with HAI titers &gt;=40 (1/dilution) is reported in the outcome measure.</description>
        <time_frame>Day 0 (pre-vaccination), Day 28 (post-vaccination)</time_frame>
        <population>Analysis was performed on FAS population. Here, 'Number analyzed' = participants with available data for each specified category.</population>
        <group_list>
          <group group_id="O1">
            <title>QIV-HD</title>
            <description>Participants received a single injection of 0.7 milliliters (mL) high dose quadrivalent influenza vaccine (QIV-HD), intramuscularly (IM) at Day 0.</description>
          </group>
          <group group_id="O2">
            <title>QIV-SD</title>
            <description>Participants received a single injection of 0.5 mL standard-dose quadrivalent influenza vaccine (QIV-SD), subcutaneously (SC) at Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With HAI Titers &gt;=40 (1/Dilution) Against Influenza Antigens</title>
          <description>Anti-influenza antibodies were measured using HAI assay method for 6 influenza virus strains: A/H1N1, A/H3N2, A/H3N2-like, B/Victoria, B/Victoria-like, and B/Yamagata. Percentage of participants with HAI titers &gt;=40 (1/dilution) is reported in the outcome measure.</description>
          <population>Analysis was performed on FAS population. Here, 'Number analyzed' = participants with available data for each specified 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="1048"/>
                <count group_id="O2" value="1047"/>
              </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="1045"/>
                    <count group_id="O2" value="1045"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.1" lower_limit="13.9" upper_limit="18.4"/>
                    <measurement group_id="O2" value="18.2" lower_limit="15.9" upper_limit="20.7"/>
                  </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="1048"/>
                    <count group_id="O2" value="1047"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="85.1" lower_limit="82.8" upper_limit="87.2"/>
                    <measurement group_id="O2" value="67.6" lower_limit="64.7" upper_limit="70.5"/>
                  </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="1047"/>
                    <count group_id="O2" value="1045"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52.3" lower_limit="49.3" upper_limit="55.4"/>
                    <measurement group_id="O2" value="51.7" lower_limit="48.6" upper_limit="54.7"/>
                  </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="1048"/>
                    <count group_id="O2" value="1047"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.9" lower_limit="98.0" upper_limit="99.4"/>
                    <measurement group_id="O2" value="93.4" lower_limit="91.7" upper_limit="94.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H3N2-like: Day 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1047"/>
                    <count group_id="O2" value="1045"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.9" lower_limit="40.9" upper_limit="47.0"/>
                    <measurement group_id="O2" value="43.7" lower_limit="40.7" upper_limit="46.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H3N2-like: Day 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1048"/>
                    <count group_id="O2" value="1046"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.8" lower_limit="95.5" upper_limit="97.7"/>
                    <measurement group_id="O2" value="88.4" lower_limit="86.3" upper_limit="90.3"/>
                  </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="1046"/>
                    <count group_id="O2" value="1045"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.7" lower_limit="27.0" upper_limit="32.6"/>
                    <measurement group_id="O2" value="27.8" lower_limit="25.1" upper_limit="30.7"/>
                  </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="1048"/>
                    <count group_id="O2" value="1047"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.9" lower_limit="96.8" upper_limit="98.7"/>
                    <measurement group_id="O2" value="81.4" lower_limit="78.9" upper_limit="83.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B/Victoria-like: Day 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1046"/>
                    <count group_id="O2" value="1045"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.1" lower_limit="22.5" upper_limit="27.9"/>
                    <measurement group_id="O2" value="24.1" lower_limit="21.5" upper_limit="26.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B/Victoria-like: Day 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1048"/>
                    <count group_id="O2" value="1047"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.8" lower_limit="95.5" upper_limit="97.7"/>
                    <measurement group_id="O2" value="79.8" lower_limit="77.2" upper_limit="82.1"/>
                  </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="1045"/>
                    <count group_id="O2" value="1045"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60.6" lower_limit="57.5" upper_limit="63.6"/>
                    <measurement group_id="O2" value="56.9" lower_limit="53.9" upper_limit="60.0"/>
                  </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="1048"/>
                    <count group_id="O2" value="1047"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.9" lower_limit="98.0" upper_limit="99.4"/>
                    <measurement group_id="O2" value="92.3" lower_limit="90.5" upper_limit="93.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Reporting Immediate Unsolicited Adverse Events (AEs)</title>
        <description>An AE was any untoward medical occurrence in a patient or in a clinical investigation participant administered a medicinal product and which did not necessarily have a casual relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination. All participants were observed for 30 minutes after vaccination, and any unsolicited AEs that occurred during that time were recorded as immediate unsolicited AEs in the CRB.</description>
        <time_frame>Within 30 minutes post-vaccination</time_frame>
        <population>Analysis was performed on safety analysis set (SafAS) population which included participants who had received the study vaccine and had any safety data available.</population>
        <group_list>
          <group group_id="O1">
            <title>QIV-HD</title>
            <description>Participants received a single injection of 0.7 milliliters (mL) high dose quadrivalent influenza vaccine (QIV-HD), intramuscularly (IM) at Day 0.</description>
          </group>
          <group group_id="O2">
            <title>QIV-SD</title>
            <description>Participants received a single injection of 0.5 mL standard-dose quadrivalent influenza vaccine (QIV-SD), subcutaneously (SC) at Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Reporting Immediate Unsolicited Adverse Events (AEs)</title>
          <description>An AE was any untoward medical occurrence in a patient or in a clinical investigation participant administered a medicinal product and which did not necessarily have a casual relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination. All participants were observed for 30 minutes after vaccination, and any unsolicited AEs that occurred during that time were recorded as immediate unsolicited AEs in the CRB.</description>
          <population>Analysis was performed on safety analysis set (SafAS) population which included participants who had received the study vaccine and had any safety data available.</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="1049"/>
                <count group_id="O2" value="1051"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </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</title>
        <description>A solicited reaction was an expected adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the CRB and considered as related to the product administered. Solicited injection site reactions included injection site pain, injection site erythema, injection site swelling, injection site induration, and injection site bruising. Solicited systemic reactions included fever, headache, malaise, myalgia and shivering.</description>
        <time_frame>Within 7 days post-vaccination</time_frame>
        <population>Analysis was performed on the SafAS population.</population>
        <group_list>
          <group group_id="O1">
            <title>QIV-HD</title>
            <description>Participants received a single injection of 0.7 milliliters (mL) high dose quadrivalent influenza vaccine (QIV-HD), intramuscularly (IM) at Day 0.</description>
          </group>
          <group group_id="O2">
            <title>QIV-SD</title>
            <description>Participants received a single injection of 0.5 mL standard-dose quadrivalent influenza vaccine (QIV-SD), subcutaneously (SC) at Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Reporting Solicited Injection Site and Systemic Reactions</title>
          <description>A solicited reaction was an expected adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the CRB and considered as related to the product administered. Solicited injection site reactions included injection site pain, injection site erythema, injection site swelling, injection site induration, and injection site bruising. Solicited systemic reactions included fever, headache, malaise, myalgia and shivering.</description>
          <population>Analysis was performed on the SafAS population.</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="1049"/>
                <count group_id="O2" value="1051"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Injection site pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="503"/>
                    <measurement group_id="O2" value="334"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site erythema</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86"/>
                    <measurement group_id="O2" value="328"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site swelling</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82"/>
                    <measurement group_id="O2" value="185"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site induration</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52"/>
                    <measurement group_id="O2" value="107"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site bruising</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fever</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Headache</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="105"/>
                    <measurement group_id="O2" value="75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Malaise</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="102"/>
                    <measurement group_id="O2" value="59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Myalgia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="197"/>
                    <measurement group_id="O2" value="130"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Shivering</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51"/>
                    <measurement group_id="O2" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Reporting Unsolicited Adverse Events (AEs)</title>
        <description>An AE was any untoward medical occurrence in a patient or in a clinical investigation participant administered a medicinal product and which did not necessarily have a casual relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination.</description>
        <time_frame>Within 28 days post-vaccination</time_frame>
        <population>Analysis was performed on SafAS population.</population>
        <group_list>
          <group group_id="O1">
            <title>QIV-HD</title>
            <description>Participants received a single injection of 0.7 milliliters (mL) high dose quadrivalent influenza vaccine (QIV-HD), intramuscularly (IM) at Day 0.</description>
          </group>
          <group group_id="O2">
            <title>QIV-SD</title>
            <description>Participants received a single injection of 0.5 mL standard-dose quadrivalent influenza vaccine (QIV-SD), subcutaneously (SC) at Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Reporting Unsolicited Adverse Events (AEs)</title>
          <description>An AE was any untoward medical occurrence in a patient or in a clinical investigation participant administered a medicinal product and which did not necessarily have a casual relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination.</description>
          <population>Analysis was performed on SafAS population.</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="1049"/>
                <count group_id="O2" value="1051"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71"/>
                    <measurement group_id="O2" value="85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Reporting Serious Adverse Events (SAEs)</title>
        <description>A SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event.</description>
        <time_frame>From Day 0 up to Day 28 post-vaccination</time_frame>
        <population>Analysis was performed on the SafAS population.</population>
        <group_list>
          <group group_id="O1">
            <title>QIV-HD</title>
            <description>Participants received a single injection of 0.7 milliliters (mL) high dose quadrivalent influenza vaccine (QIV-HD), intramuscularly (IM) at Day 0.</description>
          </group>
          <group group_id="O2">
            <title>QIV-SD</title>
            <description>Participants received a single injection of 0.5 mL standard-dose quadrivalent influenza vaccine (QIV-SD), subcutaneously (SC) at Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Reporting Serious Adverse Events (SAEs)</title>
          <description>A SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event.</description>
          <population>Analysis was performed on the SafAS population.</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="1049"/>
                <count group_id="O2" value="1051"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Unsolicited AEs were collected from Day 0 (post-vaccination) up to 28 days post-vaccination. Solicited reaction data were collected up to Day 7 post-vaccination. SAE data were collected from Day 0 up to Day 28 post-vaccination.</time_frame>
      <desc>Analysis was performed on the safety analysis set. A solicited reaction was an adverse reaction that was prelisted (i.e., solicited) in the CRB 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 CRB in terms of diagnosis and/or onset window post-vaccination.</desc>
      <group_list>
        <group group_id="E1">
          <title>QIV-HD</title>
          <description>Participants received a single injection of 0.7 milliliters (mL) high dose quadrivalent influenza vaccine (QIV-HD), intramuscularly (IM) at Day 0.</description>
        </group>
        <group group_id="E2">
          <title>QIV-SD</title>
          <description>Participants received a single injection of 0.5 mL standard-dose quadrivalent influenza vaccine (QIV-SD), subcutaneously (SC) at Day 0.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA23.1</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="0" subjects_at_risk="1049"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="1051"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="1049"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="1051"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Urinary Tract Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1049"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1051"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Femoral Neck Fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1049"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1051"/>
              </event>
              <event>
                <sub_title>Femur Fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1049"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1051"/>
              </event>
              <event>
                <sub_title>Patella Fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1049"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1051"/>
              </event>
              <event>
                <sub_title>Radius Fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1049"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1051"/>
              </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="1" subjects_affected="1" subjects_at_risk="1049"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="1051"/>
              </event>
              <event>
                <sub_title>Still's Disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1049"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="1051"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA23.1</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="614" subjects_at_risk="1049"/>
                <counts group_id="E2" subjects_affected="569" subjects_at_risk="1051"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Injection Site Erythema</sub_title>
                <counts group_id="E1" events="86" subjects_affected="86" subjects_at_risk="1049"/>
                <counts group_id="E2" events="328" subjects_affected="328" subjects_at_risk="1051"/>
              </event>
              <event>
                <sub_title>Injection Site Induration</sub_title>
                <counts group_id="E1" events="52" subjects_affected="52" subjects_at_risk="1049"/>
                <counts group_id="E2" events="107" subjects_affected="107" subjects_at_risk="1051"/>
              </event>
              <event>
                <sub_title>Injection Site Pain</sub_title>
                <counts group_id="E1" events="504" subjects_affected="503" subjects_at_risk="1049"/>
                <counts group_id="E2" events="334" subjects_affected="334" subjects_at_risk="1051"/>
              </event>
              <event>
                <sub_title>Injection Site Swelling</sub_title>
                <counts group_id="E1" events="82" subjects_affected="82" subjects_at_risk="1049"/>
                <counts group_id="E2" events="185" subjects_affected="185" subjects_at_risk="1051"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" events="103" subjects_affected="102" subjects_at_risk="1049"/>
                <counts group_id="E2" events="59" subjects_affected="59" subjects_at_risk="1051"/>
              </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="197" subjects_affected="197" subjects_at_risk="1049"/>
                <counts group_id="E2" events="130" subjects_affected="130" subjects_at_risk="1051"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <description>Headache events that occurred after 7 days post-vaccination were considered as unsolicited AE.</description>
                <counts group_id="E1" events="108" subjects_affected="107" subjects_at_risk="1049"/>
                <counts group_id="E2" events="76" subjects_affected="76" subjects_at_risk="1051"/>
              </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 participant 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</organization>
      <phone>800-633-1610 ext 6#</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/NCT04498832
org study id: EFC15150
secondary id: U1111-1225-1085
secondary id: QHD00010
nct id: NCT04498832
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
Primary Objective:

      To demonstrate that QIV-HD induced an immune response (as assessed by hemagglutination
      inhibition [HAI] geometric mean titers [GMTs] and seroconversion rates) that was superior to
      responses induced by QIV-SD for the 4 virus strains at 28 days post-vaccination in all
      participants.

      Secondary Objective:

        -  To describe the immune response induced by QIV-HD and QIV-SD by HAI measurement method
           in all participants.

        -  To describe the safety profile of all participants in each study group.
Study duration per participant was approximately 28 days including: 1 day of screening and
      vaccination, a safety follow-up telephone call and an end of study visit approximately at Day
      8 and 28 after vaccination, respectively.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants randomized in each group were stratified by site and age (60 to 64, 65 to 74, and 75 years of age and older).
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Modified double-blind: the participant and the Investigator remain unaware of the treatment assignments throughout the study. An unblinded qualified trial staff member will administer the appropriate vaccine but will not be involved in the immunogenicity and safety evaluations.
measure: Geometric Mean Titers (GMTs) of Influenza Vaccine Antibodies at Day 28
time frame: Day 28 (post-vaccination)
description: GMTs of anti-influenza antibodies were measured using hemagglutination inhibition (HAI) assay for 4 influenza virus strains: A/H1N1, A/H3N2-like, B/Victoria-like, and B/Yamagata. Titers were expressed in terms of 1/dilution.
measure: Percentage of Participants Achieving Seroconversion Against Influenza Virus Antigens: Superiority Analysis
time frame: Day 28 (post-vaccination)
description: Anti-influenza antibodies were measured by HAI assay for 4 influenza virus strains: A/H1N1, A/H3N2-like, B/Victoria-like, and B/Yamagata. Seroconversion was defined as either a pre-vaccination HAI titer less than (<) 10 (1/dilution) and a post-vaccination titer >=40 (1/dilution) or a pre-vaccination titer >=10 (1/dilution) and a >= four-fold increase in post-vaccination titer at Day 28.
measure: GMTs of Influenza Vaccine Antibodies at Day 0 and Day 28
time frame: Day 0 (pre-vaccination) and Day 28 (post-vaccination)
description: GMTs of anti-influenza antibodies were measured using HAI assay for 6 influenza virus strains: A/H1N1, A/H3N2, A/H3N2-like, B/Victoria, B/Victoria-like, and B/Yamagata. Titers were expressed in terms of 1/dilution.
measure: Geometric Mean Titers Ratio (GMTR) of Influenza Vaccine Antibodies
time frame: Day 0 (pre-vaccination), Day 28 (post-vaccination)
description: GMTs of anti-influenza antibodies were measured using HAI assay for 6 influenza virus strains: A/H1N1, A/H3N2, A/H3N2-like, B/Victoria, B/Victoria-like, and B/Yamagata. GMTRs were calculated as the ratio of GMTs post-vaccination (on Day 28) and pre-vaccination (on Day 0).
measure: Percentage of Participants Achieving Seroconversion Against Influenza Virus Antigens
time frame: Day 28 (post-vaccination)
description: Anti-influenza antibodies were measured by HAI assay for 6 influenza virus strains: A/H1N1, A/H3N2, A/H3N2-like, B/Victoria, B/Victoria-like, and B/Yamagata. Seroconversion was defined as either a pre-vaccination HAI titer <10 (1/dilution) and a post-vaccination titer >=40 (1/dilution) or a pre-vaccination titer >=10 (1/dilution) and a >= four-fold increase in post-vaccination titer at Day 28.
measure: Percentage of Participants With HAI Titers >=40 (1/Dilution) Against Influenza Antigens
time frame: Day 0 (pre-vaccination), Day 28 (post-vaccination)
description: Anti-influenza antibodies were measured using HAI assay method for 6 influenza virus strains: A/H1N1, A/H3N2, A/H3N2-like, B/Victoria, B/Victoria-like, and B/Yamagata. Percentage of participants with HAI titers >=40 (1/dilution) is reported in the outcome measure.
measure: Number of Participants Reporting Immediate Unsolicited Adverse Events (AEs)
time frame: Within 30 minutes post-vaccination
description: An AE was any untoward medical occurrence in a patient or in a clinical investigation participant administered a medicinal product and which did not necessarily have a casual relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination. All participants were observed for 30 minutes after vaccination, and any unsolicited AEs that occurred during that time were recorded as immediate unsolicited AEs in the CRB.
measure: Number of Participants Reporting Solicited Injection Site and Systemic Reactions
time frame: Within 7 days post-vaccination
description: A solicited reaction was an expected adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the CRB and considered as related to the product administered. Solicited injection site reactions included injection site pain, injection site erythema, injection site swelling, injection site induration, and injection site bruising. Solicited systemic reactions included fever, headache, malaise, myalgia and shivering.
measure: Number of Participants Reporting Unsolicited Adverse Events (AEs)
time frame: Within 28 days post-vaccination
description: An AE was any untoward medical occurrence in a patient or in a clinical investigation participant administered a medicinal product and which did not necessarily have a casual relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination.
measure: Number of Participants Reporting Serious Adverse Events (SAEs)
time frame: From Day 0 up to Day 28 post-vaccination
description: A SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event.
arm group label: Group 1: QIV-HD
arm group type: Experimental
description: Participants received a single injection of 0.7 milliliters (mL) high dose quadrivalent influenza vaccine (QIV-HD), intramuscularly (IM) at Day 0.
arm group label: Group 2: QIV-SD
arm group type: Active Comparator
description: Participants received a single injection of 0.5 mL standard-dose quadrivalent influenza vaccine (QIV-SD), subcutaneously (SC) at Day 0.
intervention type: Biological
intervention name: High-Dose Quadrivalent Influenza Vaccine, (Zonal Purified, Split Virus) 2020-2021 Strains (QIV-HD)
description: Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: IM
arm group label: Group 1: QIV-HD
other name: QIV-HD
intervention type: Biological
intervention name: Local Standard-Dose Inactivated Quadrivalent Influenza Vaccine, 2020-2021 Strains (QIV-SD)
description: Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: SC
arm group label: Group 2: QIV-SD
other name: QIV-SD
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Clinical Sciences & Operations
role: Study Director
affiliation: Sanofi
facility: 
facility: 
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country: Japan
citation: Sanchez L, Nakama T, Nagai H, Matsuoka O, Inoue S, Inoue T, Shrestha A, Pandey A, Chang LJ, De Bruijn I; QHD00010 Study Group. Superior immunogenicity of high-dose quadrivalent inactivated influenza vaccine versus Standard-Dose vaccine in Japanese Adults >/= 60 years of age: Results from a phase III, randomized clinical trial. Vaccine. 2023 Apr 6;41(15):2553-2561. doi: 10.1016/j.vaccine.2023.02.071. Epub 2023 Mar 10.
PMID: 36906404
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: 