<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/NCT03233217</url>
  </required_header>
  <id_info>
    <org_study_id>QHD00008</org_study_id>
    <secondary_id>U1111-1183-5525</secondary_id>
    <secondary_id>DFI15130</secondary_id>
    <nct_id>NCT03233217</nct_id>
  </id_info>
  <brief_title>Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine in Patients ≥65 Years</brief_title>
  <official_title>Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine Administered by Intramuscular or Subcutaneous Route in Participants Aged 65 Years and Older in Japan</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sanofi Pasteur, a Sanofi Company</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sanofi K.K.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </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>
      This phase I/II, randomized, modified double-blind, multi-center study assessed the safety&#xD;
      and immunogenicity of a high-dose Quadrivalent influenza vaccine (QIV-HD) in older adults&#xD;
      (greater than or equal to [&gt;=] 65 years).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This phase I/II, randomized, modified double-blind, multi-center study was conducted in 175&#xD;
      healthy Japanese adults aged 65 years and older to describe the safety profile and immune&#xD;
      responses (geometric mean titers and seroconversion for the 4 common strains at 28 days&#xD;
      post-vaccination) of the QIV-HD administered by intramuscular (IM) and subcutaneous (SC)&#xD;
      methods. A local standard-dose Quadrivalent Influenza Vaccine (QIV-SD) administered by SC&#xD;
      method served as a control arm.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 15, 2017</start_date>
  <completion_date type="Actual">November 28, 2017</completion_date>
  <primary_completion_date type="Actual">November 28, 2017</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <intervention_model_description>Safety and tolerability was initially assessed in the first 10 participants in a smaller cohort (Cohort 1). Participants were randomized 1:1 into 2 groups in Cohort 1: QIV-HD by IM route (n=5) and QIV-HD by SC route (n=5).&#xD;
After review of the local and systemic adverse events, the remaining 165 participants were enrolled (Cohort 2). Participants were randomized 1:1:1 into 3 groups in Cohort 2: QIV-HD by IM route (n=55), QIV-HD by SC route (n=55), and QIV-SD by SC route (n=55).</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>QHD00008 was a modified double-blind study in which only the designated administrator at each study site knew which vaccine was administered to the participants. The participants and the Investigator/Sub-investigator in charge of the safety assessment were blinded in order to decrease the potential bias in safety assessment.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Immediate Unsolicited Adverse Events (AE) After Vaccination</measure>
    <time_frame>Within 30 minutes after vaccination</time_frame>
    <description>An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of symptom and/or onset post-vaccination. Unsolicited AEs includes both serious and non-serious unsolicited AEs. A serious adverse event is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event. All participants were observed for 30 minutes after vaccination, and any unsolicited AEs occurred during that time were recorded as immediate unsolicited AEs in the CRB.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Solicited Injection Site and Systemic Reactions</measure>
    <time_frame>Within 7 days after vaccination</time_frame>
    <description>A solicited reaction was an adverse reaction observed and reported under the conditions (symptom and onset) prelisted (i.e., solicited) in the CRB and considered as related to the administered vaccination. Solicited injection site reactions: pain, erythema, swelling, induration, and bruising. Solicited systemic reactions: fever, headache, malaise, myalgia, and shivering.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Unsolicited Adverse Events After Vaccination</measure>
    <time_frame>Within 28 days after vaccination</time_frame>
    <description>An unsolicited AE was an observed AE that does not fulfill the conditions prelisted in the CRB in terms of symptom and/or onset post-vaccination. Unsolicited AEs included both serious and non-serious unsolicited AEs. A serious adverse event is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participant With Serious Adverse Events (SAEs) After Vaccination</measure>
    <time_frame>Up to 6 months after vaccination</time_frame>
    <description>An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cohort 2: Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD</measure>
    <time_frame>Day 0 (pre-vaccination) and Day 28 (post-vaccination)</time_frame>
    <description>GMT of anti-influenza antibodies strains (A1, A1-like, A2, A2-like, B1, B2, B2-like) were measured using a hemagglutination inhibition (HAI) assay.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cohort 2: Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD</measure>
    <time_frame>Day 0 (pre-vaccination) and Day 28 (post-vaccination)</time_frame>
    <description>GMT of anti-influenza antibodies strains (A1, A1-like, A2, A2-like, B1, B2, B2-like) were measured using an HAI assay. GMTRs were calculated as the ratio of GMTs post vaccination and pre-vaccination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cohort 2: Percentage of Participants Achieving Seroconversion Against Antigens Following Vaccination With QIV-HD or QIV-SD</measure>
    <time_frame>Day 28 (post-vaccination)</time_frame>
    <description>Anti-influenza antibodies were measured by using the HAI assay for the strains A1, A1-like, A2, A2-like, B1, B2, and B2-like. Seroconversion was defined as either a HAI titer lesser than (&lt;) 10 (1/dilution) at Day 0 and post-vaccination titer greater than or equal to (&gt;=) 40 (1/dilution) at Day 28, or HAI titer &gt;=10 (1/dilution) at Day 0 and a &gt;=4-fold increase in HAI titer (1/dilution) at Day 28.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cohort 2: Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With QIV-HD or QIV-SD</measure>
    <time_frame>Day 0 (pre-vaccination) and Day 28 (post-vaccination)</time_frame>
    <description>Anti-influenza antibodies were measured by using the HAI assay for the strains A1, A1-like, A2, A2-like, B1, B2, and B2-like. Seroprotection was defined as a HAI titer &gt;=40 (1/dilution) at Day 0 and Day 28.</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">175</enrollment>
  <condition>Influenza</condition>
  <arm_group>
    <arm_group_label>Cohort 1: QIV-HD by IM</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants were randomized to receive a single 0.7-milliliter (mL) injection of QIV-HD by IM route on Day 0.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 1: QIV-HD by SC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants were randomized to receive a single 0.7 mL injection of QIV-HD by SC route on Day 0.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2: QIV-HD by IM</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants were randomized to receive a single 0.7 mL injection of QIV-HD by IM route on Day 0.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2: QIV-HD by SC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants were randomized to receive a single 0.7 mL injection of QIV-HD by SC route on Day 0.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2: QIV-SD by SC</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants were randomized to receive a single 0.5 mL injection of QIV-SD by SC route on Day 0.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>QIV-HD by IM</intervention_name>
    <description>IM, injected into the upper arm (deltoid area)</description>
    <arm_group_label>Cohort 1: QIV-HD by IM</arm_group_label>
    <arm_group_label>Cohort 2: QIV-HD by IM</arm_group_label>
    <other_name>High-Dose Influenza Vaccine Quadrivalent (IM)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>QIV-SD by SC</intervention_name>
    <description>SC, injected into the upper arm (posterior region)</description>
    <arm_group_label>Cohort 2: QIV-SD by SC</arm_group_label>
    <other_name>Standard-Dose Influenza Vaccine Quadrivalent</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>QIV-HD by SC</intervention_name>
    <description>SC, injection into the upper arm (posterior region)</description>
    <arm_group_label>Cohort 1: QIV-HD by SC</arm_group_label>
    <arm_group_label>Cohort 2: QIV-HD by SC</arm_group_label>
    <other_name>High-Dose Influenza Vaccine Quadrivalent (SC)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged &gt;= 65 years on the day of inclusion.&#xD;
&#xD;
          -  Informed consent form has been signed and dated.&#xD;
&#xD;
          -  Able to attend all scheduled visits and to comply 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 3.&#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;
          -  Deprived of freedom by an administrative or court order, or in an emergency setting,&#xD;
             or hospitalized involuntarily.&#xD;
&#xD;
          -  Alcohol or substance abuse that, in the opinion of the Investigator might interfere&#xD;
             with the 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 was stable at the time of vaccination in the absence of therapy and&#xD;
             participants who had 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°Celsius). A prospective&#xD;
             participant were not be included in the study until the condition had resolved or the&#xD;
             febrile event had subsided.&#xD;
&#xD;
          -  History of convulsions.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Director</last_name>
    <role>Study Director</role>
    <affiliation>Sanofi Pasteur, a Sanofi Company</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sanofi Pasteur Investigational Site</name>
      <address>
        <city>Tokyo</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanofi Pasteur Investigational Site</name>
      <address>
        <city>Ōsaka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <link>
    <url>http://www.sanofipasteur.com</url>
    <description>Related info</description>
  </link>
  <reference>
    <citation>Sanchez L, Matsuoka O, Inoue S, Inoue T, Meng Y, Nakama T, Kato K, Pandey A, Chang LJ. Immunogenicity and safety of high-dose quadrivalent influenza vaccine in Japanese adults &gt;/=65 years of age: a randomized controlled clinical trial. Hum Vaccin Immunother. 2020 Apr 2;16(4):858-866. doi: 10.1080/21645515.2019.1677437. Epub 2019 Nov 19.</citation>
    <PMID>31634025</PMID>
  </reference>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>July 25, 2017</study_first_submitted>
  <study_first_submitted_qc>July 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2017</study_first_posted>
  <results_first_submitted>November 28, 2019</results_first_submitted>
  <results_first_submitted_qc>November 28, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">December 17, 2019</results_first_posted>
  <disposition_first_submitted>November 29, 2018</disposition_first_submitted>
  <disposition_first_submitted_qc>November 29, 2018</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">November 30, 2018</disposition_first_posted>
  <last_update_submitted>March 24, 2022</last_update_submitted>
  <last_update_submitted_qc>March 24, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 4, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Influenza</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Influenza, Human</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vaccines</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>May 12, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/17/NCT03233217/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>September 13, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/17/NCT03233217/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Study participants were enrolled from 15 September 2017 to 26 October 2017 at 2 centers in Japan.</recruitment_details>
      <pre_assignment_details>10 participants were randomized 1:1 to receive either QIV-HD by intramuscular (IM) route or QIV-HD by subcutaneous (SC) route (Cohort 1). After review of local and systemic AEs for 7 days post-vaccination in Cohort 1, remaining 165 participants were randomized 1:1:1 to receive QIV-HD by IM route, QIV-HD by SC route, or QIV-SD by SC route (Cohort 2)</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Cohort 1: QIV-HD by IM</title>
          <description>Participants were randomized to receive a single 0.7-milliliter (mL) injection of high-dose Quadrivalent influenza vaccine (QIV-HD) by IM route on Day 0.</description>
        </group>
        <group group_id="P2">
          <title>Cohort 1: QIV-HD by SC</title>
          <description>Participants were randomized to receive a single 0.7 mL injection of QIV-HD by SC route on Day 0.</description>
        </group>
        <group group_id="P3">
          <title>Cohort 2: QIV-HD by IM</title>
          <description>Participants were randomized to receive a single 0.7 mL injection of QIV-HD by IM route on Day 0.</description>
        </group>
        <group group_id="P4">
          <title>Cohort 2: QIV-HD by SC</title>
          <description>Participants were randomized to receive a single 0.7 mL injection of QIV-HD by SC route on Day 0.</description>
        </group>
        <group group_id="P5">
          <title>Cohort 2: QIV-SD by SC</title>
          <description>Participants were randomized to receive a single 0.5 mL injection of standard-dose Quadrivalent influenza vaccine (QIV-SD) by SC route on 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="5"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="55"/>
                <participants group_id="P4" count="55"/>
                <participants group_id="P5" count="55"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Safety Analysis Set (SafAS)</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="55"/>
                <participants group_id="P4" count="55"/>
                <participants group_id="P5" count="55"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Per-protocol Analysis Set (PPAS)</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="55"/>
                <participants group_id="P4" count="55"/>
                <participants group_id="P5" count="54"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="55"/>
                <participants group_id="P4" count="55"/>
                <participants group_id="P5" count="55"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The baseline characteristics was analyzed on SafAS which included participants who received study vaccine and analyzed according to the vaccine they actually received.</population>
      <group_list>
        <group group_id="B1">
          <title>Cohort 1: QIV-HD by IM</title>
          <description>Participants were randomized to receive a single 0.7 mL injection of QIV-HD by IM route on Day 0.</description>
        </group>
        <group group_id="B2">
          <title>Cohort 1: QIV-HD by SC</title>
          <description>Participants were randomized to receive a single 0.7 mL injection of QIV-HD by SC route on Day 0.</description>
        </group>
        <group group_id="B3">
          <title>Cohort 2: QIV-HD by IM</title>
          <description>Participants were randomized to receive a single 0.7 mL injection of QIV-HD by IM route on Day 0.</description>
        </group>
        <group group_id="B4">
          <title>Cohort 2: QIV-HD by SC</title>
          <description>Participants were randomized to receive a single 0.7 mL injection of QIV-HD by SC route on Day 0.</description>
        </group>
        <group group_id="B5">
          <title>Cohort 2: QIV-SD by SC</title>
          <description>Participants were randomized to receive a single 0.5 mL injection of QIV-SD by SC route on Day 0.</description>
        </group>
        <group group_id="B6">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="5"/>
            <count group_id="B2" value="5"/>
            <count group_id="B3" value="55"/>
            <count group_id="B4" value="55"/>
            <count group_id="B5" value="55"/>
            <count group_id="B6" value="175"/>
          </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="70.8" spread="2.0"/>
                    <measurement group_id="B2" value="70.8" spread="2.3"/>
                    <measurement group_id="B3" value="70.1" spread="3.7"/>
                    <measurement group_id="B4" value="70.5" spread="3.6"/>
                    <measurement group_id="B5" value="69.9" spread="3.8"/>
                    <measurement group_id="B6" value="70.2" spread="3.6"/>
                  </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="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="27"/>
                    <measurement group_id="B4" value="26"/>
                    <measurement group_id="B5" value="25"/>
                    <measurement group_id="B6" value="80"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="28"/>
                    <measurement group_id="B4" value="29"/>
                    <measurement group_id="B5" value="30"/>
                    <measurement group_id="B6" value="95"/>
                  </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 group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="55"/>
                    <measurement group_id="B4" value="55"/>
                    <measurement group_id="B5" value="55"/>
                    <measurement group_id="B6" value="175"/>
                  </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 group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" 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 group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" 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 group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" 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 group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" 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 group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Immediate Unsolicited Adverse Events (AE) After Vaccination</title>
        <description>An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of symptom and/or onset post-vaccination. Unsolicited AEs includes both serious and non-serious unsolicited AEs. A serious adverse event is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event. All participants were observed for 30 minutes after vaccination, and any unsolicited AEs occurred during that time were recorded as immediate unsolicited AEs in the CRB.</description>
        <time_frame>Within 30 minutes after vaccination</time_frame>
        <population>The safety analysis was performed on SafAS which included participants who received study vaccine and analyzed according to the vaccine they actually received. Data for this outcome measure was planned to be collected and analyzed for combined population of Cohort 1 and Cohort 2 participants who received QIV-HD (QIV-HD by IM and QIV-HD by SC).</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1 and 2: QIV-HD by IM</title>
            <description>Participants were randomized to receive a single 0.7 mL injection of QIV-HD by IM route on Day 0.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 1 and 2: QIV-HD by SC</title>
            <description>Participants were randomized to receive a single 0.7 mL injection of QIV-HD by SC route on Day 0.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 2: QIV-SD by SC</title>
            <description>Participants were randomized to receive a single 0.5 mL injection of QIV-SD by SC route on Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Immediate Unsolicited Adverse Events (AE) After Vaccination</title>
          <description>An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of symptom and/or onset post-vaccination. Unsolicited AEs includes both serious and non-serious unsolicited AEs. A serious adverse event is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event. All participants were observed for 30 minutes after vaccination, and any unsolicited AEs occurred during that time were recorded as immediate unsolicited AEs in the CRB.</description>
          <population>The safety analysis was performed on SafAS which included participants who received study vaccine and analyzed according to the vaccine they actually received. Data for this outcome measure was planned to be collected and analyzed for combined population of Cohort 1 and Cohort 2 participants who received QIV-HD (QIV-HD by IM and QIV-HD by SC).</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="60"/>
                <count group_id="O2" value="60"/>
                <count group_id="O3" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Solicited Injection Site and Systemic Reactions</title>
        <description>A solicited reaction was an adverse reaction observed and reported under the conditions (symptom and onset) prelisted (i.e., solicited) in the CRB and considered as related to the administered vaccination. Solicited injection site reactions: pain, erythema, swelling, induration, and bruising. Solicited systemic reactions: fever, headache, malaise, myalgia, and shivering.</description>
        <time_frame>Within 7 days after vaccination</time_frame>
        <population>The safety analysis was performed on SafAS which included participants who received study vaccine and analyzed according to the vaccine they actually received. Data for this outcome measure was planned to be collected and analyzed for combined population for Cohort 1 and Cohort 2 participants who received QIV-HD (QIV-HD by IM and QIV-HD by SC).</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1 and 2: QIV-HD by IM</title>
            <description>Participants were randomized to receive a single 0.7 mL injection of QIV-HD by IM route on Day 0.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 1 and 2: QIV-HD by SC</title>
            <description>Participants were randomized to receive a single 0.7 mL injection of QIV-HD by SC route on Day 0.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 2: QIV-SD by SC</title>
            <description>Participants were randomized to receive a single 0.5 mL injection of QIV-SD by SC route on Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Solicited Injection Site and Systemic Reactions</title>
          <description>A solicited reaction was an adverse reaction observed and reported under the conditions (symptom and onset) prelisted (i.e., solicited) in the CRB and considered as related to the administered vaccination. Solicited injection site reactions: pain, erythema, swelling, induration, and bruising. Solicited systemic reactions: fever, headache, malaise, myalgia, and shivering.</description>
          <population>The safety analysis was performed on SafAS which included participants who received study vaccine and analyzed according to the vaccine they actually received. Data for this outcome measure was planned to be collected and analyzed for combined population for Cohort 1 and Cohort 2 participants who received QIV-HD (QIV-HD by IM and QIV-HD by SC).</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="60"/>
                <count group_id="O2" value="60"/>
                <count group_id="O3" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Injection site pain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="27"/>
                    <measurement group_id="O3" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site erythema</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="19"/>
                    <measurement group_id="O3" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site swelling</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="17"/>
                    <measurement group_id="O3" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site induration</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection site bruising</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fever</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Headache</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Malaise</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Myalgia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="16"/>
                    <measurement group_id="O3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Shivering</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Unsolicited Adverse Events After Vaccination</title>
        <description>An unsolicited AE was an observed AE that does not fulfill the conditions prelisted in the CRB in terms of symptom and/or onset post-vaccination. Unsolicited AEs included both serious and non-serious unsolicited AEs. A serious adverse event is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.</description>
        <time_frame>Within 28 days after vaccination</time_frame>
        <population>The safety analysis was performed on SafAS which included participants who received study vaccine and analyzed according to the vaccine they actually received. Data for this outcome measure was planned to be collected and analyzed for combined population of Cohort 1 and Cohort 2 participants who received QIV-HD (QIV-HD by IM and QIV-HD by SC).</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1 and 2: QIV-HD by IM</title>
            <description>Participants were randomized to receive a single 0.7 mL injection of QIV-HD by IM route on Day 0.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 1 and 2: QIV-HD by SC</title>
            <description>Participants were randomized to receive a single 0.7 mL injection of QIV-HD by SC route on Day 0</description>
          </group>
          <group group_id="O3">
            <title>Cohort 2: QIV-SD by SC</title>
            <description>Participants were randomized to receive a single 0.5 mL injection of QIV-SD by SC route on Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Unsolicited Adverse Events After Vaccination</title>
          <description>An unsolicited AE was an observed AE that does not fulfill the conditions prelisted in the CRB in terms of symptom and/or onset post-vaccination. Unsolicited AEs included both serious and non-serious unsolicited AEs. A serious adverse event is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.</description>
          <population>The safety analysis was performed on SafAS which included participants who received study vaccine and analyzed according to the vaccine they actually received. Data for this outcome measure was planned to be collected and analyzed for combined population of Cohort 1 and Cohort 2 participants who received QIV-HD (QIV-HD by IM and QIV-HD by SC).</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="60"/>
                <count group_id="O2" value="60"/>
                <count group_id="O3" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participant With Serious Adverse Events (SAEs) After Vaccination</title>
        <description>An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.</description>
        <time_frame>Up to 6 months after vaccination</time_frame>
        <population>The safety analysis was performed on SafAS which included participants who received study vaccine and analyzed according to the vaccine they actually received. Data for this outcome measure was planned to be collected and analyzed for combined population of Cohort 1 and Cohort 2 participants who received QIV-HD (QIV-HD by IM and QIV-HD by SC).</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1 and 2: QIV-HD by IM</title>
            <description>Participants were randomized to receive a single 0.7 mL injection of QIV-HD by IM route on Day 0.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 1 and 2: QIV-HD by SC</title>
            <description>Participants were randomized to receive a single 0.7 mL injection of QIV-HD by SC route on Day 0.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 2: QIV-SD by SC</title>
            <description>Participants were randomized to receive a single 0.5 mL injection of QIV-SD by SC route on Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participant With Serious Adverse Events (SAEs) After Vaccination</title>
          <description>An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.</description>
          <population>The safety analysis was performed on SafAS which included participants who received study vaccine and analyzed according to the vaccine they actually received. Data for this outcome measure was planned to be collected and analyzed for combined population of Cohort 1 and Cohort 2 participants who received QIV-HD (QIV-HD by IM and QIV-HD by SC).</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="60"/>
                <count group_id="O2" value="60"/>
                <count group_id="O3" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cohort 2: Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD</title>
        <description>GMT of anti-influenza antibodies strains (A1, A1-like, A2, A2-like, B1, B2, B2-like) were measured using a hemagglutination inhibition (HAI) assay.</description>
        <time_frame>Day 0 (pre-vaccination) and Day 28 (post-vaccination)</time_frame>
        <population>Analyzed on PPAS which included all participants who received at least 1 dose of study vaccine, and had post-vaccination blood sample HAI result for at least 1 strain, with no protocol deviations. Here, 'number analyzed' = participants with available data for each category. Data for this outcome measure was not planned to be analyzed for Cohort 1.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 2: QIV-HD by IM</title>
            <description>Participants were randomized to receive a single 0.7 mL injection of QIV-HD by IM route on Day 0.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2: QIV-HD by SC</title>
            <description>Participants were randomized to receive a single 0.7 mL injection of QIV-HD by SC route on Day 0.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 2: QIV-SD by SC</title>
            <description>Participants were randomized to receive a single 0.5 mL injection of QIV-SD by SC route on Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Cohort 2: Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD</title>
          <description>GMT of anti-influenza antibodies strains (A1, A1-like, A2, A2-like, B1, B2, B2-like) were measured using a hemagglutination inhibition (HAI) assay.</description>
          <population>Analyzed on PPAS which included all participants who received at least 1 dose of study vaccine, and had post-vaccination blood sample HAI result for at least 1 strain, with no protocol deviations. Here, 'number analyzed' = participants with available data for each category. Data for this outcome measure was not planned to be analyzed for Cohort 1.</population>
          <units>titers (1/dilution)</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="55"/>
                <count group_id="O2" value="55"/>
                <count group_id="O3" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>A1: Day 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="55"/>
                    <count group_id="O3" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.5" lower_limit="29.4" upper_limit="67.5"/>
                    <measurement group_id="O2" value="59.5" lower_limit="39.7" upper_limit="89.2"/>
                    <measurement group_id="O3" value="41.0" lower_limit="27.7" upper_limit="60.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A1-like: Day 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="55"/>
                    <count group_id="O3" value="53"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.2" lower_limit="35.4" upper_limit="60.4"/>
                    <measurement group_id="O2" value="56.2" lower_limit="43.0" upper_limit="73.5"/>
                    <measurement group_id="O3" value="42.1" lower_limit="32.8" upper_limit="54.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A2: Day 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="55"/>
                    <count group_id="O3" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62.6" lower_limit="39.9" upper_limit="98.1"/>
                    <measurement group_id="O2" value="101.0" lower_limit="66.9" upper_limit="152.6"/>
                    <measurement group_id="O3" value="83.7" lower_limit="53.9" upper_limit="129.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A2-like: Day 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="55"/>
                    <count group_id="O3" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76.1" lower_limit="49.6" upper_limit="116.7"/>
                    <measurement group_id="O2" value="107.6" lower_limit="71.4" upper_limit="162.1"/>
                    <measurement group_id="O3" value="91.0" lower_limit="57.7" upper_limit="143.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B1: Day 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="55"/>
                    <count group_id="O3" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="116.8" lower_limit="83.2" upper_limit="163.9"/>
                    <measurement group_id="O2" value="134.1" lower_limit="92.2" upper_limit="195.0"/>
                    <measurement group_id="O3" value="108.2" lower_limit="79.5" upper_limit="147.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B2: Day 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="55"/>
                    <count group_id="O3" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76.1" lower_limit="49.9" upper_limit="115.9"/>
                    <measurement group_id="O2" value="109.6" lower_limit="73.4" upper_limit="163.8"/>
                    <measurement group_id="O3" value="97.6" lower_limit="69.6" upper_limit="137.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B2-like: Day 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="55"/>
                    <count group_id="O3" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.7" lower_limit="22.9" upper_limit="46.7"/>
                    <measurement group_id="O2" value="47.1" lower_limit="32.8" upper_limit="67.6"/>
                    <measurement group_id="O3" value="41.6" lower_limit="31.4" upper_limit="55.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A1: Day 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="55"/>
                    <count group_id="O3" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="712.4" lower_limit="509.7" upper_limit="995.7"/>
                    <measurement group_id="O2" value="550.2" lower_limit="402.2" upper_limit="752.5"/>
                    <measurement group_id="O3" value="269.1" lower_limit="181.5" upper_limit="399.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A1-like: Day 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="55"/>
                    <count group_id="O3" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="427.6" lower_limit="309.1" upper_limit="591.5"/>
                    <measurement group_id="O2" value="356.2" lower_limit="260.0" upper_limit="488.0"/>
                    <measurement group_id="O3" value="216.3" lower_limit="157.4" upper_limit="297.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A2: Day 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="55"/>
                    <count group_id="O3" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1059.5" lower_limit="759.5" upper_limit="1478.0"/>
                    <measurement group_id="O2" value="839.2" lower_limit="617.7" upper_limit="1140.0"/>
                    <measurement group_id="O3" value="405.8" lower_limit="270.5" upper_limit="608.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A2-like: Day 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="55"/>
                    <count group_id="O3" value="53"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="940.0" lower_limit="664.3" upper_limit="1330.1"/>
                    <measurement group_id="O2" value="797.9" lower_limit="586.8" upper_limit="1084.9"/>
                    <measurement group_id="O3" value="402.3" lower_limit="263.0" upper_limit="615.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B1: Day 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="55"/>
                    <count group_id="O3" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="877.0" lower_limit="632.9" upper_limit="1215.3"/>
                    <measurement group_id="O2" value="628.0" lower_limit="475.4" upper_limit="829.6"/>
                    <measurement group_id="O3" value="336.9" lower_limit="263.7" upper_limit="430.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B2: Day 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="55"/>
                    <count group_id="O3" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="813.2" lower_limit="603.0" upper_limit="1096.5"/>
                    <measurement group_id="O2" value="758.7" lower_limit="589.5" upper_limit="976.5"/>
                    <measurement group_id="O3" value="281.5" lower_limit="217.0" upper_limit="365.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B2-like: Day 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="55"/>
                    <count group_id="O3" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="269.9" lower_limit="199.4" upper_limit="365.4"/>
                    <measurement group_id="O2" value="261.6" lower_limit="201.1" upper_limit="340.2"/>
                    <measurement group_id="O3" value="111.0" lower_limit="87.6" upper_limit="140.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cohort 2: Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD</title>
        <description>GMT of anti-influenza antibodies strains (A1, A1-like, A2, A2-like, B1, B2, B2-like) were measured using an HAI assay. GMTRs were calculated as the ratio of GMTs post vaccination and pre-vaccination.</description>
        <time_frame>Day 0 (pre-vaccination) and Day 28 (post-vaccination)</time_frame>
        <population>The analysis was performed on PPAS which included all participants who received at least 1 dose of study vaccine, and had post-vaccination blood sample HAI result for at least 1 strain, with no protocol deviations. Data for this outcome measure was not planned to be analyzed for Cohort 1.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 2: QIV-HD by IM</title>
            <description>Participants were randomized to receive a single 0.7 mL injection of QIV-HD by IM route on Day 0.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2: QIV-HD by SC</title>
            <description>Participants were randomized to receive a single 0.7 mL injection of QIV-HD by SC route on Day 0.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 2: QIV-SD by SC</title>
            <description>Participants were randomized to receive a single 0.5 mL injection of QIV-SD by SC route on Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Cohort 2: Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD</title>
          <description>GMT of anti-influenza antibodies strains (A1, A1-like, A2, A2-like, B1, B2, B2-like) were measured using an HAI assay. GMTRs were calculated as the ratio of GMTs post vaccination and pre-vaccination.</description>
          <population>The analysis was performed on PPAS which included all participants who received at least 1 dose of study vaccine, and had post-vaccination blood sample HAI result for at least 1 strain, with no protocol deviations. Data for this outcome measure was not planned to be analyzed for Cohort 1.</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="55"/>
                <count group_id="O2" value="55"/>
                <count group_id="O3" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>A1: Day 28/Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.00" lower_limit="10.19" upper_limit="25.11"/>
                    <measurement group_id="O2" value="9.25" lower_limit="6.11" upper_limit="14.00"/>
                    <measurement group_id="O3" value="6.56" lower_limit="4.36" upper_limit="9.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A1-like: Day 28/Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.25" lower_limit="6.67" upper_limit="12.82"/>
                    <measurement group_id="O2" value="6.34" lower_limit="4.79" upper_limit="8.38"/>
                    <measurement group_id="O3" value="5.13" lower_limit="3.67" upper_limit="7.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A2: Day 28/Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.93" lower_limit="10.99" upper_limit="26.10"/>
                    <measurement group_id="O2" value="8.31" lower_limit="5.54" upper_limit="12.46"/>
                    <measurement group_id="O3" value="4.85" lower_limit="3.08" upper_limit="7.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A2-like: Day 28/Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.36" lower_limit="8.03" upper_limit="19.01"/>
                    <measurement group_id="O2" value="7.42" lower_limit="4.98" upper_limit="11.05"/>
                    <measurement group_id="O3" value="4.56" lower_limit="2.89" upper_limit="7.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B1: Day 28/Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.51" lower_limit="4.93" upper_limit="11.45"/>
                    <measurement group_id="O2" value="4.68" lower_limit="3.34" upper_limit="6.56"/>
                    <measurement group_id="O3" value="3.11" lower_limit="2.29" upper_limit="4.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B2: Day 28/Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.69" lower_limit="7.05" upper_limit="16.21"/>
                    <measurement group_id="O2" value="6.92" lower_limit="4.79" upper_limit="9.99"/>
                    <measurement group_id="O3" value="2.88" lower_limit="2.08" upper_limit="3.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B2-like: Day 28/Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.26" lower_limit="5.74" upper_limit="11.89"/>
                    <measurement group_id="O2" value="5.55" lower_limit="3.97" upper_limit="7.76"/>
                    <measurement group_id="O3" value="2.67" lower_limit="2.00" upper_limit="3.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cohort 2: Percentage of Participants Achieving Seroconversion Against Antigens Following Vaccination With QIV-HD or QIV-SD</title>
        <description>Anti-influenza antibodies were measured by using the HAI assay for the strains A1, A1-like, A2, A2-like, B1, B2, and B2-like. Seroconversion was defined as either a HAI titer lesser than (&lt;) 10 (1/dilution) at Day 0 and post-vaccination titer greater than or equal to (&gt;=) 40 (1/dilution) at Day 28, or HAI titer &gt;=10 (1/dilution) at Day 0 and a &gt;=4-fold increase in HAI titer (1/dilution) at Day 28.</description>
        <time_frame>Day 28 (post-vaccination)</time_frame>
        <population>Analyzed on PPAS which included all participants who received at least 1 dose of study vaccine, and had post-vaccination blood sample HAI result for at least 1 strain, with no protocol deviations. Here, 'number analyzed' = participants with available data for each category. Data for this outcome measure was not planned to be analyzed for Cohort 1.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 2: QIV-HD by IM</title>
            <description>Participants were randomized to receive a single 0.7 mL injection of QIV-HD by IM route on Day 0.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2: QIV-HD by SC</title>
            <description>Participants were randomized to receive a single 0.7 mL injection of QIV-HD by SC route on Day 0</description>
          </group>
          <group group_id="O3">
            <title>Cohort 2: QIV-SD by SC</title>
            <description>Participants were randomized to receive a single 0.5 mL injection of QIV-SD by SC route on Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Cohort 2: Percentage of Participants Achieving Seroconversion Against Antigens Following Vaccination With QIV-HD or QIV-SD</title>
          <description>Anti-influenza antibodies were measured by using the HAI assay for the strains A1, A1-like, A2, A2-like, B1, B2, and B2-like. Seroconversion was defined as either a HAI titer lesser than (&lt;) 10 (1/dilution) at Day 0 and post-vaccination titer greater than or equal to (&gt;=) 40 (1/dilution) at Day 28, or HAI titer &gt;=10 (1/dilution) at Day 0 and a &gt;=4-fold increase in HAI titer (1/dilution) at Day 28.</description>
          <population>Analyzed on PPAS which included all participants who received at least 1 dose of study vaccine, and had post-vaccination blood sample HAI result for at least 1 strain, with no protocol deviations. Here, 'number analyzed' = participants with available data for each category. Data for this outcome measure was not planned to be analyzed for Cohort 1.</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="55"/>
                <count group_id="O2" value="55"/>
                <count group_id="O3" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>A1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="55"/>
                    <count group_id="O3" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74.5" lower_limit="61.0" upper_limit="85.3"/>
                    <measurement group_id="O2" value="67.3" lower_limit="53.3" upper_limit="79.3"/>
                    <measurement group_id="O3" value="55.6" lower_limit="41.4" upper_limit="69.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A1-like</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="55"/>
                    <count group_id="O3" value="53"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74.5" lower_limit="61.0" upper_limit="85.3"/>
                    <measurement group_id="O2" value="69.1" lower_limit="55.2" upper_limit="80.9"/>
                    <measurement group_id="O3" value="56.6" lower_limit="42.3" upper_limit="70.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="55"/>
                    <count group_id="O3" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="85.5" lower_limit="73.3" upper_limit="93.5"/>
                    <measurement group_id="O2" value="63.6" lower_limit="49.6" upper_limit="76.2"/>
                    <measurement group_id="O3" value="42.6" lower_limit="29.2" upper_limit="56.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A2-like</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="55"/>
                    <count group_id="O3" value="53"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74.5" lower_limit="61.0" upper_limit="85.3"/>
                    <measurement group_id="O2" value="58.2" lower_limit="44.1" upper_limit="71.3"/>
                    <measurement group_id="O3" value="43.4" lower_limit="29.8" upper_limit="57.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="55"/>
                    <count group_id="O3" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58.2" lower_limit="44.1" upper_limit="71.3"/>
                    <measurement group_id="O2" value="47.3" lower_limit="33.7" upper_limit="61.2"/>
                    <measurement group_id="O3" value="37.0" lower_limit="24.3" upper_limit="51.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="55"/>
                    <count group_id="O3" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65.5" lower_limit="51.4" upper_limit="77.8"/>
                    <measurement group_id="O2" value="63.6" lower_limit="49.6" upper_limit="76.2"/>
                    <measurement group_id="O3" value="33.3" lower_limit="21.1" upper_limit="47.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B2-like</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="55"/>
                    <count group_id="O3" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67.3" lower_limit="53.3" upper_limit="79.3"/>
                    <measurement group_id="O2" value="60.0" lower_limit="45.9" upper_limit="73.0"/>
                    <measurement group_id="O3" value="33.3" lower_limit="21.1" upper_limit="47.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cohort 2: Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With QIV-HD or QIV-SD</title>
        <description>Anti-influenza antibodies were measured by using the HAI assay for the strains A1, A1-like, A2, A2-like, B1, B2, and B2-like. Seroprotection was defined as a HAI titer &gt;=40 (1/dilution) at Day 0 and Day 28.</description>
        <time_frame>Day 0 (pre-vaccination) and Day 28 (post-vaccination)</time_frame>
        <population>Analyzed on PPAS which included all participants who received at least 1 dose of study vaccine, and had post-vaccination blood sample HAI result for at least 1 strain, with no protocol deviations. Here, 'number analyzed' = participants with available data for each category. Data for this outcome measure was not planned to be analyzed for Cohort 1.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 2: QIV-HD by IM</title>
            <description>Participants were randomized to receive a single 0.7 mL injection of QIV-HD by IM route on Day 0.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2: QIV-HD by SC</title>
            <description>Participants were randomized to receive a single 0.7 mL injection of QIV-HD by SC route on Day 0.</description>
          </group>
          <group group_id="O3">
            <title>Cohort 2: QIV-SD by SC</title>
            <description>Participants were randomized to receive a single 0.5 mL injection of QIV-SD by SC route on Day 0.</description>
          </group>
        </group_list>
        <measure>
          <title>Cohort 2: Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With QIV-HD or QIV-SD</title>
          <description>Anti-influenza antibodies were measured by using the HAI assay for the strains A1, A1-like, A2, A2-like, B1, B2, and B2-like. Seroprotection was defined as a HAI titer &gt;=40 (1/dilution) at Day 0 and Day 28.</description>
          <population>Analyzed on PPAS which included all participants who received at least 1 dose of study vaccine, and had post-vaccination blood sample HAI result for at least 1 strain, with no protocol deviations. Here, 'number analyzed' = participants with available data for each category. Data for this outcome measure was not planned to be analyzed for Cohort 1.</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="55"/>
                <count group_id="O2" value="55"/>
                <count group_id="O3" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>A1: Day 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="55"/>
                    <count group_id="O3" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60.0" lower_limit="45.9" upper_limit="73.0"/>
                    <measurement group_id="O2" value="65.5" lower_limit="51.4" upper_limit="77.8"/>
                    <measurement group_id="O3" value="53.7" lower_limit="39.6" upper_limit="67.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A1-like: Day 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="55"/>
                    <count group_id="O3" value="53"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58.2" lower_limit="44.1" upper_limit="71.3"/>
                    <measurement group_id="O2" value="60.0" lower_limit="45.9" upper_limit="73.0"/>
                    <measurement group_id="O3" value="54.7" lower_limit="40.4" upper_limit="68.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A2: Day 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="55"/>
                    <count group_id="O3" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63.6" lower_limit="49.6" upper_limit="76.2"/>
                    <measurement group_id="O2" value="83.6" lower_limit="71.2" upper_limit="92.2"/>
                    <measurement group_id="O3" value="68.5" lower_limit="54.4" upper_limit="80.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A2-like: Day 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="55"/>
                    <count group_id="O3" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65.5" lower_limit="51.4" upper_limit="77.8"/>
                    <measurement group_id="O2" value="81.8" lower_limit="69.1" upper_limit="90.9"/>
                    <measurement group_id="O3" value="70.4" lower_limit="56.4" upper_limit="82.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B1: Day 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="55"/>
                    <count group_id="O3" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76.4" lower_limit="63.0" upper_limit="86.8"/>
                    <measurement group_id="O2" value="87.3" lower_limit="75.5" upper_limit="94.7"/>
                    <measurement group_id="O3" value="81.5" lower_limit="68.6" upper_limit="90.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B2: Day 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="55"/>
                    <count group_id="O3" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67.3" lower_limit="53.3" upper_limit="79.3"/>
                    <measurement group_id="O2" value="78.2" lower_limit="65.0" upper_limit="88.2"/>
                    <measurement group_id="O3" value="79.6" lower_limit="66.5" upper_limit="89.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B2-like: Day 0</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="55"/>
                    <count group_id="O3" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49.1" lower_limit="35.4" upper_limit="62.9"/>
                    <measurement group_id="O2" value="52.7" lower_limit="38.8" upper_limit="66.3"/>
                    <measurement group_id="O3" value="57.4" lower_limit="43.2" upper_limit="70.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A1: Day 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="55"/>
                    <count group_id="O3" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.2" lower_limit="90.3" upper_limit="100.0"/>
                    <measurement group_id="O2" value="100" lower_limit="93.5" upper_limit="100.0"/>
                    <measurement group_id="O3" value="92.6" lower_limit="82.1" upper_limit="97.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A1-like: Day 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="55"/>
                    <count group_id="O3" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.2" lower_limit="90.3" upper_limit="100.0"/>
                    <measurement group_id="O2" value="100" lower_limit="93.5" upper_limit="100.0"/>
                    <measurement group_id="O3" value="98.1" lower_limit="90.1" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A2: Day 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="55"/>
                    <count group_id="O3" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100" lower_limit="93.5" upper_limit="100.0"/>
                    <measurement group_id="O2" value="100" lower_limit="93.5" upper_limit="100.0"/>
                    <measurement group_id="O3" value="96.3" lower_limit="87.3" upper_limit="99.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A2-like: day 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="55"/>
                    <count group_id="O3" value="53"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100" lower_limit="93.5" upper_limit="100.0"/>
                    <measurement group_id="O2" value="100" lower_limit="93.5" upper_limit="100.0"/>
                    <measurement group_id="O3" value="96.2" lower_limit="87.0" upper_limit="99.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B1: Day 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="55"/>
                    <count group_id="O3" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.2" lower_limit="90.3" upper_limit="100.0"/>
                    <measurement group_id="O2" value="100" lower_limit="93.5" upper_limit="100.0"/>
                    <measurement group_id="O3" value="98.1" lower_limit="90.1" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B2: Day 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="55"/>
                    <count group_id="O3" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.2" lower_limit="90.3" upper_limit="100.0"/>
                    <measurement group_id="O2" value="100" lower_limit="93.5" upper_limit="100.0"/>
                    <measurement group_id="O3" value="98.1" lower_limit="90.1" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B2-like: Day 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="55"/>
                    <count group_id="O3" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.2" lower_limit="90.3" upper_limit="100.0"/>
                    <measurement group_id="O2" value="100" lower_limit="93.5" upper_limit="100.0"/>
                    <measurement group_id="O3" value="94.4" lower_limit="84.6" upper_limit="98.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event (AE) data was collected from Day 0 (post-vaccination) up to Day 28 after vaccination. Solicited Reaction (SR) data were collected up to Day 7 after vaccination. Serious adverse event (SAE) data were collected throughout the study (up to 28 days after vaccination).</time_frame>
      <desc>Analyzed on SafAS. SR: an AE prelisted in CRB and considered related to vaccination. SR was therefore an adverse reaction observed and reported under conditions (symptom and onset) prelisted in CRB. An unsolicited AE: an observed AE that did not fulfill conditions prelisted in CRB in terms of symptom and/or onset post-vaccination. AE data were planned to be collected and analyzed for the combined population of Cohort 1 and Cohort 2 participants who received QIV-HD (QIV-HD by IM and QIV-HD by SC)</desc>
      <group_list>
        <group group_id="E1">
          <title>Cohort 1 and 2: QIV-HD by IM</title>
          <description>Participants were randomized to receive a single 0.7 mL injection of QIV-HD by IM route on Day 0.</description>
        </group>
        <group group_id="E2">
          <title>Cohort 1 and 2: QIV-HD by SC</title>
          <description>Participants were randomized to receive a single 0.7 mL injection of QIV-HD by SC route on Day 0.</description>
        </group>
        <group group_id="E3">
          <title>Cohort 2: QIV-SD by SC</title>
          <description>Participants were randomized to receive a single 0.5 mL injection of QIV-SD by SC route on Day 0.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 20.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Sudden hearing loss</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 20.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="60"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Faeces soft</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Injection site pruritus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="60"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Cystitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Laryngitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="60"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="55"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Oropharyngeal discomfort</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="55"/>
              </event>
              <event>
                <sub_title>Sneezing</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="60"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="55"/>
              </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 subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Medical Director</name_or_title>
      <organization>Sanofi Pasteur</organization>
      <phone>800-633-1610 ext 1#</phone>
      <email>Contact-US@sanofi.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03233217
org study id: QHD00008
secondary id: U1111-1183-5525
secondary id: DFI15130
nct id: NCT03233217
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
This phase I/II, randomized, modified double-blind, multi-center study assessed the safety
      and immunogenicity of a high-dose Quadrivalent influenza vaccine (QIV-HD) in older adults
      (greater than or equal to [>=] 65 years).
This phase I/II, randomized, modified double-blind, multi-center study was conducted in 175
      healthy Japanese adults aged 65 years and older to describe the safety profile and immune
      responses (geometric mean titers and seroconversion for the 4 common strains at 28 days
      post-vaccination) of the QIV-HD administered by intramuscular (IM) and subcutaneous (SC)
      methods. A local standard-dose Quadrivalent Influenza Vaccine (QIV-SD) administered by SC
      method served as a control arm.
allocation: Randomized
intervention model: Sequential Assignment
intervention model description: Safety and tolerability was initially assessed in the first 10 participants in a smaller cohort (Cohort 1). Participants were randomized 1:1 into 2 groups in Cohort 1: QIV-HD by IM route (n=5) and QIV-HD by SC route (n=5).
After review of the local and systemic adverse events, the remaining 165 participants were enrolled (Cohort 2). Participants were randomized 1:1:1 into 3 groups in Cohort 2: QIV-HD by IM route (n=55), QIV-HD by SC route (n=55), and QIV-SD by SC route (n=55).
primary purpose: Prevention
masking: Double (Participant, Investigator)
masking description: QHD00008 was a modified double-blind study in which only the designated administrator at each study site knew which vaccine was administered to the participants. The participants and the Investigator/Sub-investigator in charge of the safety assessment were blinded in order to decrease the potential bias in safety assessment.
measure: Number of Participants With Immediate Unsolicited Adverse Events (AE) After Vaccination
time frame: Within 30 minutes after vaccination
description: An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of symptom and/or onset post-vaccination. Unsolicited AEs includes both serious and non-serious unsolicited AEs. A serious adverse event is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event. All participants were observed for 30 minutes after vaccination, and any unsolicited AEs occurred during that time were recorded as immediate unsolicited AEs in the CRB.
measure: Number of Participants With Solicited Injection Site and Systemic Reactions
time frame: Within 7 days after vaccination
description: A solicited reaction was an adverse reaction observed and reported under the conditions (symptom and onset) prelisted (i.e., solicited) in the CRB and considered as related to the administered vaccination. Solicited injection site reactions: pain, erythema, swelling, induration, and bruising. Solicited systemic reactions: fever, headache, malaise, myalgia, and shivering.
measure: Number of Participants With Unsolicited Adverse Events After Vaccination
time frame: Within 28 days after vaccination
description: An unsolicited AE was an observed AE that does not fulfill the conditions prelisted in the CRB in terms of symptom and/or onset post-vaccination. Unsolicited AEs included both serious and non-serious unsolicited AEs. A serious adverse event is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.
measure: Number of Participant With Serious Adverse Events (SAEs) After Vaccination
time frame: Up to 6 months after vaccination
description: An SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.
measure: Cohort 2: Geometric Mean Titers (GMTs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD
time frame: Day 0 (pre-vaccination) and Day 28 (post-vaccination)
description: GMT of anti-influenza antibodies strains (A1, A1-like, A2, A2-like, B1, B2, B2-like) were measured using a hemagglutination inhibition (HAI) assay.
measure: Cohort 2: Geometric Mean Titer Ratios (GMTRs) of Influenza Antibodies Following Vaccination With QIV-HD or QIV-SD
time frame: Day 0 (pre-vaccination) and Day 28 (post-vaccination)
description: GMT of anti-influenza antibodies strains (A1, A1-like, A2, A2-like, B1, B2, B2-like) were measured using an HAI assay. GMTRs were calculated as the ratio of GMTs post vaccination and pre-vaccination.
measure: Cohort 2: Percentage of Participants Achieving Seroconversion Against Antigens Following Vaccination With QIV-HD or QIV-SD
time frame: Day 28 (post-vaccination)
description: Anti-influenza antibodies were measured by using the HAI assay for the strains A1, A1-like, A2, A2-like, B1, B2, and B2-like. Seroconversion was defined as either a HAI titer lesser than (<) 10 (1/dilution) at Day 0 and post-vaccination titer greater than or equal to (>=) 40 (1/dilution) at Day 28, or HAI titer >=10 (1/dilution) at Day 0 and a >=4-fold increase in HAI titer (1/dilution) at Day 28.
measure: Cohort 2: Percentage of Participants Achieving Seroprotection Against Antigens Following Vaccination With QIV-HD or QIV-SD
time frame: Day 0 (pre-vaccination) and Day 28 (post-vaccination)
description: Anti-influenza antibodies were measured by using the HAI assay for the strains A1, A1-like, A2, A2-like, B1, B2, and B2-like. Seroprotection was defined as a HAI titer >=40 (1/dilution) at Day 0 and Day 28.
arm group label: Cohort 1: QIV-HD by IM
arm group type: Experimental
description: Participants were randomized to receive a single 0.7-milliliter (mL) injection of QIV-HD by IM route on Day 0.
arm group label: Cohort 1: QIV-HD by SC
arm group type: Experimental
description: Participants were randomized to receive a single 0.7 mL injection of QIV-HD by SC route on Day 0.
arm group label: Cohort 2: QIV-HD by IM
arm group type: Experimental
description: Participants were randomized to receive a single 0.7 mL injection of QIV-HD by IM route on Day 0.
arm group label: Cohort 2: QIV-HD by SC
arm group type: Experimental
description: Participants were randomized to receive a single 0.7 mL injection of QIV-HD by SC route on Day 0.
arm group label: Cohort 2: QIV-SD by SC
arm group type: Active Comparator
description: Participants were randomized to receive a single 0.5 mL injection of QIV-SD by SC route on Day 0.
intervention type: Biological
intervention name: QIV-HD by IM
description: IM, injected into the upper arm (deltoid area)
arm group label: Cohort 1: QIV-HD by IM
arm group label: Cohort 2: QIV-HD by IM
other name: High-Dose Influenza Vaccine Quadrivalent (IM)
intervention type: Biological
intervention name: QIV-SD by SC
description: SC, injected into the upper arm (posterior region)
arm group label: Cohort 2: QIV-SD by SC
other name: Standard-Dose Influenza Vaccine Quadrivalent
intervention type: Biological
intervention name: QIV-HD by SC
description: SC, injection into the upper arm (posterior region)
arm group label: Cohort 1: QIV-HD by SC
arm group label: Cohort 2: QIV-HD by SC
other name: High-Dose Influenza Vaccine Quadrivalent (SC)
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Medical Director
role: Study Director
affiliation: Sanofi Pasteur, a Sanofi Company
facility: 
facility: 
country: Japan
url: http://www.sanofipasteur.com
description: Related info
citation: Sanchez L, Matsuoka O, Inoue S, Inoue T, Meng Y, Nakama T, Kato K, Pandey A, Chang LJ. Immunogenicity and safety of high-dose quadrivalent influenza vaccine in Japanese adults >/=65 years of age: a randomized controlled clinical trial. Hum Vaccin Immunother. 2020 Apr 2;16(4):858-866. doi: 10.1080/21645515.2019.1677437. Epub 2019 Nov 19.
PMID: 31634025
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: 