<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/NCT02214225</url>
  </required_header>
  <id_info>
    <org_study_id>CSLCT-QIV-13-01</org_study_id>
    <nct_id>NCT02214225</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Immunogenicity and Safety of bioCSL Quadrivalent Influenza Vaccine (QIV) in Adults Aged 18 Years and Above.</brief_title>
  <official_title>A Phase 3, Randomized, Multicenter, Double-blinded Study to Evaluate the Immunogenicity and Safety of a Quadrivalent Influenza Vaccine (CSL QIV) in Comparison With a US Licensed 2014/2015 Trivalent Influenza Vaccine (CSL TIV-1), and a Trivalent Influenza Vaccine Containing the Alternate B Strain (CSL TIV-2), in Adults Aged 18 Years and Above.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seqirus</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seqirus</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a study to assess the immune (antibody) response and safety of a bioCSL split virion,&#xD;
      inactivated quadrivalent influenza vaccine, in comparison with a US licensed 2014/2015&#xD;
      trivalent influenza vaccine (bioCSL TIV-1), and a trivalent influenza vaccine containing the&#xD;
      alternate B strain (bioCSL TIV-2), in healthy adult volunteers aged 18 years and above.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This multicenter, randomized, double-blinded study was conducted during the 2014-2015&#xD;
      Northern Hemisphere influenza immunization season to evaluate the non-inferior immune&#xD;
      response of bioCSL QIV to that of bioCSL TIV-1 and bioCSL TIV-2 along with safety in healthy&#xD;
      male and female adults aged ≥ 18 years. Each vaccinated subject had a maximum 25 day on-study&#xD;
      period with a six month safety follow-up.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">April 2015</completion_date>
  <primary_completion_date type="Actual">November 2014</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Postvaccination Geometric Mean Titer (GMT) (Statistical Analysis: GMT Ratios) in Subjects Aged ≥18 Years (Per Protocol Population).</measure>
    <time_frame>21 days after vaccination.</time_frame>
    <description>Immunogenicity was assessed by measuring HI titers to the four virus strains. Postvaccination GMTs were determined. (GMT dispersion values are based on unadjusted GMT values.) The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was then determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Seroconversion Rate (SCR) (Statistical Analysis: Difference in SCR) in Subjects Aged ≥18 Years.</measure>
    <time_frame>21 days after vaccination.</time_frame>
    <description>SCR (defined as the percentage of subjects with either a prevaccination HI titer &lt; 1:10 and a postvaccination HI titer ≥ 1:40 or a prevaccination HI titer ≥ 1:10 and a 4-fold increase in postvaccination HI titer) was determined for each virus strain included in the vaccines: bioCSL TIV-1 and bioCSL TIV-2 SCRs were pooled for analysis of the A strains. The SCR difference was defined as the SCR percentage for bioCSL Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus the SCR percentage for bioCSL QIV.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postvaccination GMT (Statistical Analyses: GMT Ratios) Assessed Separately Within Each Age Group (18 Through 64 Years and ≥ 65 Years of Age) (Per-Protocol Population).</measure>
    <time_frame>21 days after vaccination.</time_frame>
    <description>Immunogenicity was assessed by measuring HI titers to the four virus strains. Postvaccination GMTs were determined. (GMT dispersion values are based on unadjusted GMT values.) The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was then determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.&#xD;
Non-inferiority of bioCSL QIV compared to bioCSL TIV-1, and to bioCSL TIV-2 was assessed separately within each age group (18 to &lt; 65 years and ≥ 65 years of age) through assessment of GMT ratios as described for the primary endpoint.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Seroconversion Rate (SCR) (Statistical Analyses: Difference in SCR) for Each Virus Strain, Assessed Separately Within Each Age Group (18 to &lt; 65 Years and ≥ 65 Years of Age) (Per Protocol Population).</measure>
    <time_frame>21 days after vaccination.</time_frame>
    <description>Non-inferiority of bioCSL QIV compared to bioCSL TIV-1, and to bioCSL TIV-2 was assessed separately within each age group (18 to &lt; 65 years and ≥ 65 years of age) through assessment of SCR differences as described for the primary endpoint.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immunologic Superiority of the Alternate B Strain in bioCSL QIV, as Determined by the GMT (Statistical Analysis: GMT Ratio) for This Strain, Overall and by Age Cohort (Per Protocol Population).</measure>
    <time_frame>21 days after vaccination.</time_frame>
    <description>Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to &lt; 65 years and ≥ 65 years of age), and overall. The GMT ratio was calculated as bioCSL QIV GMT/bioCSL TIV GMT for the superiority analyses, which is the reverse of how it was calculated for the non-inferiority analyses.&#xD;
(GMT dispersion values are based on unadjusted GMT values.)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immunologic Superiority of the Alternate B Strain in bioCSL QIV, as Determined by Seroconversion Rate (SCR) (Statistical Analysis: Difference in SCR) for This Strain, Overall and by Age Cohort (Per Protocol Population)</measure>
    <time_frame>21 days after vaccination.</time_frame>
    <description>Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to &lt; 65 years and ≥ 65 years of age), and overall. The SCR difference was calculated as bioCSL QIV SCR minus bioCSL TIV SCR, which is the reverse of how it was calculated for the non-inferiority analyses. For the SCR comparison superiority was demonstrated if the lower limit of the two-sided 95% CI of the difference of the seroconversion rates was greater than 0 for each B strain in QIV compared with the corresponding B strain not contained in each TIV.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geometric Mean of HI Titers (GMTs) Prevaccination and Postvaccination.</measure>
    <time_frame>21 days after vaccination.</time_frame>
    <description>The immunogenicity of bioCSL QIV, bioCSL TIV-1 and bioCSL TIV-2 was assessed in terms of geometric mean HI titers (GMT) prevaccination (Day 1) and postvaccination (Day 21), in age cohorts (per protocol population).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geometric Mean Fold Titer Change From Prevaccination to Postvaccination.</measure>
    <time_frame>21 days after vaccination.</time_frame>
    <description>The immunogenicity of bioCSL QIV, bioCSL TIV-1 and bioCSL TIV-2 assessed in terms of Geometric Mean Fold Increase (GMFI, defined as the geometric mean of the fold increases of postvaccination antibody titer over the prevaccination antibody titer) by Age Cohort (Per Protocol Population).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Seroprotection Rates Prevaccination and Postvaccination.</measure>
    <time_frame>21 days after vaccination.</time_frame>
    <description>The immunogenicity of bioCSL QIV, bioCSL TIV-1 and bioCSL TIV-2 was assessed in terms of percentage of subjects with a HI titer ≥40 (seroprotection rates) prevaccination (Day 1) and postvaccination (Day 21), in age cohorts (per protocol population).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Seroconversion Rates</measure>
    <time_frame>21 days after vaccination.</time_frame>
    <description>The immunogenicity of bioCSL QIV, bioCSL TIV-1 and bio CSL TIV-2 was assessed in terms of the seroconversion rate, ie, percentage of subjects with either a prevaccination HI titer &lt; 1:10 and a postvaccination HI titer ≥ 1:40, or a prevaccination titer ≥ 1:10 and a ≥ 4-fold increase in post-vaccination titer. Data presented in age cohorts (per protocol population).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Frequency and Severity of Solicited Local and Systemic Adverse Events (AEs).</measure>
    <time_frame>For 7 days following vaccination.</time_frame>
    <description>The overall number of subjects experiencing at least one event of a local and systemic solicited AE, and the overall number of subjects with at least one severe (grade 3) local and systemic solicited AE.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Frequency of Cellulitis-like Reaction and Cellulitis.</measure>
    <time_frame>For 28 days following vaccination.</time_frame>
    <description>The number of subjects experiencing at least one episode of each event.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Frequency and Severity of Unsolicited AEs.</measure>
    <time_frame>For 28 days following vaccination.</time_frame>
    <description>The overall number of subjects experiencing at least one event of an unsolicited AE, and the overall number of subjects with at least one severe (grade 3) unsolicited AE.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Frequency of Serious Adverse Events (SAEs) for 6 Months Following Vaccination.</measure>
    <time_frame>For 6 months following vaccination.</time_frame>
    <description>The number of participants reporting Serious Adverse Events for 6 months following vaccination.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">3484</enrollment>
  <condition>Influenza, Human</condition>
  <arm_group>
    <arm_group_label>Quadrivalent Influenza Vaccine (QIV)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Trivalent Influenza Vaccine (TIV-1)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Trivalent Influenza Vaccine (TIV-2)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the recommended influenza A (H1N1-, H3N2-like) strains and the alternate B strain for the Northern Hemisphere 2014/2015 influenza season).</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Quadrivalent Influenza Vaccine (QIV)</intervention_name>
    <description>One 0.5 mL intramuscular dose into the deltoid muscle</description>
    <arm_group_label>Quadrivalent Influenza Vaccine (QIV)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Trivalent Influenza Vaccine (TIV-1)</intervention_name>
    <description>One 0.5 mL intramuscular dose into the deltoid muscle.</description>
    <arm_group_label>Trivalent Influenza Vaccine (TIV-1)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Trivalent Influenza Vaccine (TIV-2)</intervention_name>
    <description>One 0.5 mL intramuscular dose into the deltoid muscle.</description>
    <arm_group_label>Trivalent Influenza Vaccine (TIV-2)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males or non-pregnant females aged ≥ 18 years at the time of vaccination.&#xD;
&#xD;
          -  Females of child-bearing potential (i.e., ovulating, pre-menopausal, not surgically&#xD;
             sterile) must be abstinent or be willing to use a medically accepted contraceptive&#xD;
             regimen for the duration of the On-study period. Females of child-bearing potential&#xD;
             must return a negative urine pregnancy test result prior to vaccination with the&#xD;
             vaccine.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known hypersensitivity to a previous dose of influenza vaccine or allergy to eggs,&#xD;
             chicken protein, neomycin, polymyxin, or any components of bioCSL influenza vaccines.&#xD;
&#xD;
          -  Vaccination against influenza in the previous 6 months.&#xD;
&#xD;
          -  Known history of Guillain-Barré Syndrome or other demyelinating disease.&#xD;
&#xD;
          -  Clinical signs of active infection and/or an oral temperature of ≥ 100.4°F (38.0°C).&#xD;
&#xD;
          -  A clinically significant medical condition.&#xD;
&#xD;
          -  Pregnant or lactating females.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>bioCSL Pty Ltd Clinical Program Director</last_name>
    <role>Study Director</role>
    <affiliation>Seqirus</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Site 296</name>
      <address>
        <city>Huntsville</city>
        <state>Alabama</state>
        <zip>35802</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 286</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90036</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 315</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 301</name>
      <address>
        <city>Milford</city>
        <state>Connecticut</state>
        <zip>06460</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 297</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 293</name>
      <address>
        <city>Melbourne</city>
        <state>Florida</state>
        <zip>32935</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 292</name>
      <address>
        <city>Savannah</city>
        <state>Georgia</state>
        <zip>31406</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 289</name>
      <address>
        <city>Meridian</city>
        <state>Idaho</state>
        <zip>83642</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 294</name>
      <address>
        <city>Peoria</city>
        <state>Illinois</state>
        <zip>61614</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 295</name>
      <address>
        <city>Mishawaka</city>
        <state>Indiana</state>
        <zip>46545</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 317</name>
      <address>
        <city>Witchita</city>
        <state>Kansas</state>
        <zip>67207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 291</name>
      <address>
        <city>Rockville</city>
        <state>Maryland</state>
        <zip>20850</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 310</name>
      <address>
        <city>Methuen</city>
        <state>Massachusetts</state>
        <zip>01844</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 287</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63141</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 316</name>
      <address>
        <city>Bellevue</city>
        <state>Nebraska</state>
        <zip>68005</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 298</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 285</name>
      <address>
        <city>Binghamton</city>
        <state>New York</state>
        <zip>13901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 313</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14642</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 302</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28209</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 306</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27609</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 309</name>
      <address>
        <city>Wilmington</city>
        <state>North Carolina</state>
        <zip>28401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 305</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 299</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 307</name>
      <address>
        <city>Mount Pleasant</city>
        <state>South Carolina</state>
        <zip>29464</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 308</name>
      <address>
        <city>Bristol</city>
        <state>Tennessee</state>
        <zip>37620</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 311</name>
      <address>
        <city>Jefferson City</city>
        <state>Tennessee</state>
        <zip>37760</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 312</name>
      <address>
        <city>Knoxville</city>
        <state>Tennessee</state>
        <zip>37912</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 304</name>
      <address>
        <city>Knoxville</city>
        <state>Tennessee</state>
        <zip>37938</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 283</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 282</name>
      <address>
        <city>Forth Worth</city>
        <state>Texas</state>
        <zip>76135</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 288</name>
      <address>
        <city>San Angelo</city>
        <state>Texas</state>
        <zip>76904</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 300</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84124</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 303</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22911</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>August 10, 2014</study_first_submitted>
  <study_first_submitted_qc>August 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 12, 2014</study_first_posted>
  <results_first_submitted>October 14, 2015</results_first_submitted>
  <results_first_submitted_qc>February 21, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">February 23, 2016</results_first_posted>
  <last_update_submitted>January 31, 2017</last_update_submitted>
  <last_update_submitted_qc>January 31, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 13, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Influenza, Human</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vaccines</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>First Patient In: 15-AUG-2014, Last Patient Last Visit: 20-APR-2015. Number of activated sites that enrolled subjects: 31 (all based in USA).</recruitment_details>
      <pre_assignment_details>Number of subjects screened: 3673. Number of subjects randomized: 3484.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Quadrivalent Influenza Vaccine (QIV)</title>
          <description>The study vaccine is a sterile, thiomersal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).&#xD;
Quadrivalent Influenza Vaccine (QIV): One 0.5 mL intramuscular dose into the deltoid muscle</description>
        </group>
        <group group_id="P2">
          <title>Trivalent Influenza Vaccine (TIV-1)</title>
          <description>The study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).&#xD;
Trivalent Influenza Vaccine (TIV-1): One 0.5 mL intramuscular dose into the deltoid muscle.</description>
        </group>
        <group group_id="P3">
          <title>Trivalent Influenza Vaccine (TIV-2)</title>
          <description>The study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the recommended influenza A (H1N1-, H3N2-like) strains and the alternative B strain for the Northern Hemisphere 2014/2015 influenza season).&#xD;
Trivalent Influenza Vaccine (TIV-2): One 0.5 mL intramuscular dose into the deltoid muscle.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1741"/>
                <participants group_id="P2" count="871"/>
                <participants group_id="P3" count="872"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1686"/>
                <participants group_id="P2" count="852"/>
                <participants group_id="P3" count="850"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="55"/>
                <participants group_id="P2" count="19"/>
                <participants group_id="P3" count="22"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="46"/>
                <participants group_id="P2" count="18"/>
                <participants group_id="P3" count="18"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>randomized in error, not vaccinated</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>The Full Analysis Set (FAS) was used for analysis of subject characteristics and comprised all subjects who gave informed consent and who were randomized to treatment. Screening failures were not included in the FAS.</population>
      <group_list>
        <group group_id="B1">
          <title>Quadrivalent Influenza Vaccine (QIV)</title>
          <description>The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).&#xD;
QIV dose: One 0.5 mL intramuscular dose into the deltoid muscle.</description>
        </group>
        <group group_id="B2">
          <title>Trivalent Influenza Vaccine (TIV-1)</title>
          <description>The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).&#xD;
TIV-1 dose: One 0.5 mL intramuscular dose into the deltoid muscle.</description>
        </group>
        <group group_id="B3">
          <title>Trivalent Influenza Vaccine (TIV-2)</title>
          <description>The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the recommended influenza A (H1N1-, H3N2-like) strains and the alternative B strain for the Northern Hemisphere 2014/2015 influenza season).&#xD;
TIV-2 dose: One 0.5 mL intramuscular dose into the deltoid muscle.</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="1741"/>
            <count group_id="B2" value="871"/>
            <count group_id="B3" value="872"/>
            <count group_id="B4" value="3484"/>
          </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="58.3" spread="18.10"/>
                    <measurement group_id="B2" value="58.2" spread="18.10"/>
                    <measurement group_id="B3" value="58.3" spread="17.89"/>
                    <measurement group_id="B4" value="58.3" spread="18.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age, Customized</title>
          <description>Number of participants allocated within each age subset category for each arm.</description>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>18 to 49 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="510"/>
                    <measurement group_id="B2" value="255"/>
                    <measurement group_id="B3" value="255"/>
                    <measurement group_id="B4" value="1020"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>50 to 64 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="361"/>
                    <measurement group_id="B2" value="179"/>
                    <measurement group_id="B3" value="181"/>
                    <measurement group_id="B4" value="721"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>65 to 74 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="541"/>
                    <measurement group_id="B2" value="271"/>
                    <measurement group_id="B3" value="270"/>
                    <measurement group_id="B4" value="1082"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>=&gt; 75 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="329"/>
                    <measurement group_id="B2" value="166"/>
                    <measurement group_id="B3" value="166"/>
                    <measurement group_id="B4" value="661"/>
                  </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="971"/>
                    <measurement group_id="B2" value="511"/>
                    <measurement group_id="B3" value="510"/>
                    <measurement group_id="B4" value="1992"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="770"/>
                    <measurement group_id="B2" value="360"/>
                    <measurement group_id="B3" value="362"/>
                    <measurement group_id="B4" value="1492"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1741"/>
                    <measurement group_id="B2" value="871"/>
                    <measurement group_id="B3" value="872"/>
                    <measurement group_id="B4" value="3484"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Postvaccination Geometric Mean Titer (GMT) (Statistical Analysis: GMT Ratios) in Subjects Aged ≥18 Years (Per Protocol Population).</title>
        <description>Immunogenicity was assessed by measuring HI titers to the four virus strains. Postvaccination GMTs were determined. (GMT dispersion values are based on unadjusted GMT values.) The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was then determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.</description>
        <time_frame>21 days after vaccination.</time_frame>
        <population>The Per Protocol Population was used for the primary and secondary analysis of immunogenicity data and included subjects in the Evaluable Population minus any subjects with deviations that were thought to potentially affect the immunogenicity results, following medical review prior to unblinding.</population>
        <group_list>
          <group group_id="O1">
            <title>GMT: bioCSL QIV</title>
            <description>Postvaccination GMT.</description>
          </group>
          <group group_id="O2">
            <title>GMT: Pooled TIV (A Strains) or TIV-1 (B/YAM) or TIV-2 (B/VIC)</title>
            <description>Postvaccination GMT.&#xD;
Pooled TIV (A strains), N=1704. TIV-1 (B/YAM), N=854. TIV-2 (B/VIC), N=850.</description>
          </group>
        </group_list>
        <measure>
          <title>Postvaccination Geometric Mean Titer (GMT) (Statistical Analysis: GMT Ratios) in Subjects Aged ≥18 Years (Per Protocol Population).</title>
          <description>Immunogenicity was assessed by measuring HI titers to the four virus strains. Postvaccination GMTs were determined. (GMT dispersion values are based on unadjusted GMT values.) The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was then determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.</description>
          <population>The Per Protocol Population was used for the primary and secondary analysis of immunogenicity data and included subjects in the Evaluable Population minus any subjects with deviations that were thought to potentially affect the immunogenicity results, following medical review prior to unblinding.</population>
          <units>Titer</units>
          <param>Geometric Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1691"/>
                <count group_id="O2" value="1704"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>A/H1N1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="303.0" lower_limit="5" upper_limit="8127"/>
                    <measurement group_id="O2" value="280.2" lower_limit="5" upper_limit="6451"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H3N2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="488.7" lower_limit="5" upper_limit="10240"/>
                    <measurement group_id="O2" value="454.2" lower_limit="5" upper_limit="12902"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B/Yamagata</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="64.3" lower_limit="5" upper_limit="2560"/>
                    <measurement group_id="O2" value="55.7" lower_limit="5" upper_limit="2560"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B/Victoria</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87.9" lower_limit="5" upper_limit="2560"/>
                    <measurement group_id="O2" value="82.2" lower_limit="5" upper_limit="5120"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>For A/H1N1 strain. The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>The non-inferiority criterion for the GMT ratio was that the upper bound of two-sided 95% CI on the ratio of Pooled TIV (for A strains) or TIV-1 (B Yamagata) or TIV-2 (B Victoria)/ bioCSL QIV should not exceed 1.5.</non_inferiority_desc>
            <param_type>GMT ratio (A/H1N1)</param_type>
            <param_value>0.92</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.87</ci_lower_limit>
            <ci_upper_limit>0.98</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>For A/H3N2 strain. The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>The non-inferiority criterion for the GMT ratio was that the upper bound of two-sided 95% CI on the ratio of Pooled TIV (for A strains) or TIV-1 (B Yamagata) or TIV-2 (B Victoria)/ bioCSL QIV should not exceed 1.5.</non_inferiority_desc>
            <param_type>GMT ratio (A/H3N2)</param_type>
            <param_value>0.93</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.88</ci_lower_limit>
            <ci_upper_limit>0.98</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>For B/Yamagata strain. The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>The non-inferiority criterion for the GMT ratio was that the upper bound of two-sided 95% CI on the ratio of Pooled TIV (for A strains) or TIV-1 (B Yamagata) or TIV-2 (B Victoria)/ bioCSL QIV should not exceed 1.5.</non_inferiority_desc>
            <param_type>GMT ratio (B/YAM)</param_type>
            <param_value>0.87</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.81</ci_lower_limit>
            <ci_upper_limit>0.93</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>For B/Victoria strain. The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>The non-inferiority criterion for the GMT ratio was that the upper bound of two-sided 95% CI on the ratio of Pooled TIV (for A strains) or TIV-1 (B Yamagata) or TIV-2 (B Victoria)/ bioCSL QIV should not exceed 1.5.</non_inferiority_desc>
            <param_type>GMT ratio (B/VIC)</param_type>
            <param_value>0.94</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.86</ci_lower_limit>
            <ci_upper_limit>1.01</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>The Seroconversion Rate (SCR) (Statistical Analysis: Difference in SCR) in Subjects Aged ≥18 Years.</title>
        <description>SCR (defined as the percentage of subjects with either a prevaccination HI titer &lt; 1:10 and a postvaccination HI titer ≥ 1:40 or a prevaccination HI titer ≥ 1:10 and a 4-fold increase in postvaccination HI titer) was determined for each virus strain included in the vaccines: bioCSL TIV-1 and bioCSL TIV-2 SCRs were pooled for analysis of the A strains. The SCR difference was defined as the SCR percentage for bioCSL Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus the SCR percentage for bioCSL QIV.</description>
        <time_frame>21 days after vaccination.</time_frame>
        <population>The Per Protocol Population was used for the primary and secondary analysis of immunogenicity data and included subjects in the Evaluable Population minus any subjects with deviations that were thought to potentially affect the immunogenicity results, following medical review prior to unblinding.</population>
        <group_list>
          <group group_id="O1">
            <title>SCR: bioCSL QIV</title>
            <description>bioCSL QIV, n=1691.</description>
          </group>
          <group group_id="O2">
            <title>SCR: Pooled TIV (A Strains) or TIV-1 (B/YAM) or TIV-2 (B/VIC)</title>
            <description>Pooled TIV (A strains), n=1704. TIV-1 (B Yamagata), n=854. TIV-2 (B Victoria), n=850.</description>
          </group>
        </group_list>
        <measure>
          <title>The Seroconversion Rate (SCR) (Statistical Analysis: Difference in SCR) in Subjects Aged ≥18 Years.</title>
          <description>SCR (defined as the percentage of subjects with either a prevaccination HI titer &lt; 1:10 and a postvaccination HI titer ≥ 1:40 or a prevaccination HI titer ≥ 1:10 and a 4-fold increase in postvaccination HI titer) was determined for each virus strain included in the vaccines: bioCSL TIV-1 and bioCSL TIV-2 SCRs were pooled for analysis of the A strains. The SCR difference was defined as the SCR percentage for bioCSL Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus the SCR percentage for bioCSL QIV.</description>
          <population>The Per Protocol Population was used for the primary and secondary analysis of immunogenicity data and included subjects in the Evaluable Population minus any subjects with deviations that were thought to potentially affect the immunogenicity results, following medical review prior to unblinding.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1691"/>
                <count group_id="O2" value="1704"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>A/H1N1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.8"/>
                    <measurement group_id="O2" value="37.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H3N2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.9"/>
                    <measurement group_id="O2" value="39.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B/Yamagata</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.0"/>
                    <measurement group_id="O2" value="27.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B/Victoria</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.3"/>
                    <measurement group_id="O2" value="38.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>For A/H1N1. The non-inferiority criterion was that the upper bound of the two sided 95% CI on the difference between SCRs (Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus bioCSL QIV) should not exceed 10%.</non_inferiority_desc>
            <param_type>Difference in SCR (A/H1N1)</param_type>
            <param_value>-1.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.4</ci_lower_limit>
            <ci_upper_limit>2.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>For A/H3N2. The non-inferiority criterion was that the upper bound of the two sided 95% CI on the difference between SCRs (Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus bioCSL QIV) should not exceed 10%.</non_inferiority_desc>
            <param_type>Difference in SCR (A/H3N2)</param_type>
            <param_value>-1.7</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.0</ci_lower_limit>
            <ci_upper_limit>1.6</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>For B/Yamagata. The non-inferiority criterion was that the upper bound of the two sided 95% CI on the difference between SCRs (Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus bioCSL QIV) should not exceed 10%.</non_inferiority_desc>
            <param_type>Difference in SCR (B/YAM)</param_type>
            <param_value>-3.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-7.0</ci_lower_limit>
            <ci_upper_limit>0.5</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>For B/Victoria. The non-inferiority criterion was that the upper bound of the two sided 95% CI on the difference between SCRs (Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus bioCSL QIV) should not exceed 10%.</non_inferiority_desc>
            <param_type>Difference in SCR (B/VIC)</param_type>
            <param_value>-1.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-5.6</ci_lower_limit>
            <ci_upper_limit>2.4</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Postvaccination GMT (Statistical Analyses: GMT Ratios) Assessed Separately Within Each Age Group (18 Through 64 Years and ≥ 65 Years of Age) (Per-Protocol Population).</title>
        <description>Immunogenicity was assessed by measuring HI titers to the four virus strains. Postvaccination GMTs were determined. (GMT dispersion values are based on unadjusted GMT values.) The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was then determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.&#xD;
Non-inferiority of bioCSL QIV compared to bioCSL TIV-1, and to bioCSL TIV-2 was assessed separately within each age group (18 to &lt; 65 years and ≥ 65 years of age) through assessment of GMT ratios as described for the primary endpoint.</description>
        <time_frame>21 days after vaccination.</time_frame>
        <population>The Per Protocol Population was used for the primary and secondary analysis of immunogenicity data and included subjects in the Evaluable Population minus any subjects with deviations that were thought to potentially affect the immunogenicity results, following medical review prior to unblinding.</population>
        <group_list>
          <group group_id="O1">
            <title>GMT: bioCSL QIV (18 to &lt;65 Years)</title>
            <description>Postvaccination GMT. bioCSL QIV, n=835.</description>
          </group>
          <group group_id="O2">
            <title>GMT: Pooled TIV (A Strains) or TIV-1 or TIV-2 (18 to &lt;65years)</title>
            <description>Postvaccination GMT. Pooled TIV (A strains), n=845. TIV-1 (B Yamagata), n=424. TIV-2 (B Victoria), n=421.</description>
          </group>
          <group group_id="O3">
            <title>GMT: bioCSL QIV (≥ 65 Years)</title>
            <description>Postvaccination GMT. bioCSL QIV, n=856.</description>
          </group>
          <group group_id="O4">
            <title>GMT: Pooled TIV (A Strains) or TIV-1 or TIV-2 (≥ 65 Years)</title>
            <description>Postvaccination GMT. Pooled TIV (A strains), n=859 TIV-1 (B/YAM), n=430. TIV-2 (B/VIC), n=429.</description>
          </group>
        </group_list>
        <measure>
          <title>Postvaccination GMT (Statistical Analyses: GMT Ratios) Assessed Separately Within Each Age Group (18 Through 64 Years and ≥ 65 Years of Age) (Per-Protocol Population).</title>
          <description>Immunogenicity was assessed by measuring HI titers to the four virus strains. Postvaccination GMTs were determined. (GMT dispersion values are based on unadjusted GMT values.) The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was then determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.&#xD;
Non-inferiority of bioCSL QIV compared to bioCSL TIV-1, and to bioCSL TIV-2 was assessed separately within each age group (18 to &lt; 65 years and ≥ 65 years of age) through assessment of GMT ratios as described for the primary endpoint.</description>
          <population>The Per Protocol Population was used for the primary and secondary analysis of immunogenicity data and included subjects in the Evaluable Population minus any subjects with deviations that were thought to potentially affect the immunogenicity results, following medical review prior to unblinding.</population>
          <units>Titer</units>
          <param>Geometric Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="835"/>
                <count group_id="O2" value="845"/>
                <count group_id="O3" value="856"/>
                <count group_id="O4" value="859"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>A/H1N1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="432.7" lower_limit="10" upper_limit="8127"/>
                    <measurement group_id="O2" value="402.8" lower_limit="20" upper_limit="6451"/>
                    <measurement group_id="O3" value="211.4" lower_limit="5" upper_limit="3225"/>
                    <measurement group_id="O4" value="199.8" lower_limit="5" upper_limit="4064"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H3N2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="569.1" lower_limit="5" upper_limit="10240"/>
                    <measurement group_id="O2" value="515.1" lower_limit="20" upper_limit="12902"/>
                    <measurement group_id="O3" value="419.5" lower_limit="5" upper_limit="10240"/>
                    <measurement group_id="O4" value="400.0" lower_limit="5" upper_limit="5120"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B/Yamagata</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="92.3" lower_limit="5" upper_limit="2560"/>
                    <measurement group_id="O2" value="79.3" lower_limit="5" upper_limit="2560"/>
                    <measurement group_id="O3" value="43.3" lower_limit="5" upper_limit="1613"/>
                    <measurement group_id="O4" value="39.1" lower_limit="5" upper_limit="1280"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B/Victoria</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="110.7" lower_limit="10" upper_limit="2560"/>
                    <measurement group_id="O2" value="95.2" lower_limit="5" upper_limit="5120"/>
                    <measurement group_id="O3" value="66.1" lower_limit="5" upper_limit="2560"/>
                    <measurement group_id="O4" value="68.4" lower_limit="5" upper_limit="2560"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>For A/H1N1 strain. The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>The non-inferiority criterion for the GMT ratio was that the upper bound of two-sided 95% CI on the ratio of Pooled TIV (for A strains) or TIV-1 (B Yamagata) or TIV-2 (B Victoria)/ bioCSL QIV should not exceed 1.5.</non_inferiority_desc>
            <param_type>GMT ratio (A/H1N1)</param_type>
            <param_value>0.93</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.85</ci_lower_limit>
            <ci_upper_limit>1.02</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>For A/H3N2 strain. The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>The non-inferiority criterion for the GMT ratio was that the upper bound of two-sided 95% CI on the ratio of Pooled TIV (for A strains) or TIV-1 (B Yamagata) or TIV-2 (B Victoria)/ bioCSL QIV should not exceed 1.5.</non_inferiority_desc>
            <param_type>GMT ratio (A/H3N2)</param_type>
            <param_value>0.91</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.83</ci_lower_limit>
            <ci_upper_limit>0.99</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>For B/YAM strain. The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>The non-inferiority criterion for the GMT ratio was that the upper bound of two-sided 95% CI on the ratio of Pooled TIV (for A strains) or TIV-1 (B Yamagata) or TIV-2 (B Victoria)/ bioCSL QIV should not exceed 1.5.</non_inferiority_desc>
            <param_type>GMT ratio (B/YAM)</param_type>
            <param_value>0.86</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.76</ci_lower_limit>
            <ci_upper_limit>0.97</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>For B/VIC strain. The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>The non-inferiority criterion for the GMT ratio was that the upper bound of two-sided 95% CI on the ratio of Pooled TIV (for A strains) or TIV-1 (B Yamagata) or TIV-2 (B Victoria)/ bioCSL QIV should not exceed 1.5.</non_inferiority_desc>
            <param_type>GMT ratio (B/VIC)</param_type>
            <param_value>0.86</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.76</ci_lower_limit>
            <ci_upper_limit>0.98</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>For A/H1N1 strain. The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>The non-inferiority criterion for the GMT ratio was that the upper bound of two-sided 95% CI on the ratio of Pooled TIV (for A strains) or TIV-1 (B Yamagata) or TIV-2 (B Victoria)/ bioCSL QIV should not exceed 1.5.</non_inferiority_desc>
            <param_type>GMT ratio (A/H1N1)</param_type>
            <param_value>0.95</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.88</ci_lower_limit>
            <ci_upper_limit>1.02</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>For A/H3N2 strain. The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>The non-inferiority criterion for the GMT ratio was that the upper bound of two-sided 95% CI on the ratio of Pooled TIV (for A strains) or TIV-1 (B Yamagata) or TIV-2 (B Victoria)/ bioCSL QIV should not exceed 1.5.</non_inferiority_desc>
            <param_type>GMT ratio (A/H3N2)</param_type>
            <param_value>0.95</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.89</ci_lower_limit>
            <ci_upper_limit>1.02</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>For B/YAM strain. The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>The non-inferiority criterion for the GMT ratio was that the upper bound of two-sided 95% CI on the ratio of Pooled TIV (for A strains) or TIV-1 (B Yamagata) or TIV-2 (B Victoria)/ bioCSL QIV should not exceed 1.5.</non_inferiority_desc>
            <param_type>GMT ratio (B/YAM)</param_type>
            <param_value>0.90</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.84</ci_lower_limit>
            <ci_upper_limit>0.97</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>For B/VIC strain. The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>The non-inferiority criterion for the GMT ratio was that the upper bound of two-sided 95% CI on the ratio of Pooled TIV (for A strains) or TIV-1 (B Yamagata) or TIV-2 (B Victoria)/ bioCSL QIV should not exceed 1.5.</non_inferiority_desc>
            <param_type>GMT ratio (B/VIC)</param_type>
            <param_value>1.03</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.94</ci_lower_limit>
            <ci_upper_limit>1.14</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Seroconversion Rate (SCR) (Statistical Analyses: Difference in SCR) for Each Virus Strain, Assessed Separately Within Each Age Group (18 to &lt; 65 Years and ≥ 65 Years of Age) (Per Protocol Population).</title>
        <description>Non-inferiority of bioCSL QIV compared to bioCSL TIV-1, and to bioCSL TIV-2 was assessed separately within each age group (18 to &lt; 65 years and ≥ 65 years of age) through assessment of SCR differences as described for the primary endpoint.</description>
        <time_frame>21 days after vaccination.</time_frame>
        <population>The Per Protocol Population was used for the primary and secondary analysis of immunogenicity data and included subjects in the Evaluable Population minus any subjects with deviations that were thought to potentially affect the immunogenicity results, following medical review prior to unblinding.</population>
        <group_list>
          <group group_id="O1">
            <title>SCR: bioCSL QIV (18 to &lt; 65 Years)</title>
            <description>bioCSL TIV-1 and bioCSL TIV-2 are pooled for analysis of the A strains. For B/Yamagata TIV=TIV-1, for B/Victoria TIV=TIV-2.&#xD;
bioCSL QIV, n=835. Pooled TIV (A strains), n=845. TIV-1 (B Yamagata), n=424. TIV-2 (B Victoria), n=421.</description>
          </group>
          <group group_id="O2">
            <title>SCR: Pooled TIV (A Strains) or TIV-1 or TIV-2 (18 to &lt;65years)</title>
            <description>bioCSL TIV-1 and bioCSL TIV-2 are pooled for analysis of the A strains. For B/Yamagata TIV=TIV-1, for B/Victoria TIV=TIV-2.&#xD;
bioCSL QIV, n=856. Pooled TIV (A strains), n=859. TIV-1 (B Yamagata), n=430. TIV-2 (B Victoria), n=429.</description>
          </group>
          <group group_id="O3">
            <title>SCR: bioCSL QIV (≥ 65 Years)</title>
            <description>bioCSL TIV-1 and bioCSL TIV-2 are pooled for analysis of the A strains. For B/Yamagata TIV=TIV-1, for B/Victoria TIV=TIV-2.&#xD;
bioCSL QIV, n=856. Pooled TIV (A strains), n=859. TIV-1 (B Yamagata), n=430. TIV-2 (B Victoria), n=429.</description>
          </group>
          <group group_id="O4">
            <title>SCR: Pooled TIV (A Strains) or TIV-1 or TIV-2 (≥ 65 Years)</title>
            <description>bioCSL TIV-1 and bioCSL TIV-2 are pooled for analysis of the A strains. For B/Yamagata TIV=TIV-1, for B/Victoria TIV=TIV-2.&#xD;
bioCSL QIV, n=856. Pooled TIV (A strains), n=859. TIV-1 (B Yamagata), n=430. TIV-2 (B Victoria), n=429.</description>
          </group>
        </group_list>
        <measure>
          <title>The Seroconversion Rate (SCR) (Statistical Analyses: Difference in SCR) for Each Virus Strain, Assessed Separately Within Each Age Group (18 to &lt; 65 Years and ≥ 65 Years of Age) (Per Protocol Population).</title>
          <description>Non-inferiority of bioCSL QIV compared to bioCSL TIV-1, and to bioCSL TIV-2 was assessed separately within each age group (18 to &lt; 65 years and ≥ 65 years of age) through assessment of SCR differences as described for the primary endpoint.</description>
          <population>The Per Protocol Population was used for the primary and secondary analysis of immunogenicity data and included subjects in the Evaluable Population minus any subjects with deviations that were thought to potentially affect the immunogenicity results, following medical review prior to unblinding.</population>
          <units>percentage of participants analyzed</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="835"/>
                <count group_id="O2" value="845"/>
                <count group_id="O3" value="856"/>
                <count group_id="O4" value="859"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>A/H1N1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51.3"/>
                    <measurement group_id="O2" value="49.1"/>
                    <measurement group_id="O3" value="26.6"/>
                    <measurement group_id="O4" value="26.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H3N2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56.3"/>
                    <measurement group_id="O2" value="51.7"/>
                    <measurement group_id="O3" value="25.9"/>
                    <measurement group_id="O4" value="27.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B/Yamagata</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.7"/>
                    <measurement group_id="O2" value="41.3"/>
                    <measurement group_id="O3" value="16.6"/>
                    <measurement group_id="O4" value="14.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B/Victoria</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.6"/>
                    <measurement group_id="O2" value="53.0"/>
                    <measurement group_id="O3" value="23.5"/>
                    <measurement group_id="O4" value="24.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The SCR difference was defined as the SCR percentage for bioCSL Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus the SCR percentage for bioCSL QIV.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>For A/H1N1. The non-inferiority criterion was that the upper bound of the two sided 95% CI on the difference between SCRs (Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus bioCSL QIV) should not exceed 10%.</non_inferiority_desc>
            <param_type>Difference in SCR (A/H1N1)</param_type>
            <param_value>-2.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.9</ci_lower_limit>
            <ci_upper_limit>2.6</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The SCR difference was defined as the SCR percentage for bioCSL Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus the SCR percentage for bioCSL QIV.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>For A/H3N2. The non-inferiority criterion was that the upper bound of the two sided 95% CI on the difference between SCRs (Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus bioCSL QIV) should not exceed 10%.</non_inferiority_desc>
            <param_type>Difference in SCR (A/H3N2)</param_type>
            <param_value>-4.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-9.3</ci_lower_limit>
            <ci_upper_limit>0.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The SCR difference was defined as the SCR percentage for bioCSL Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus the SCR percentage for bioCSL QIV.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>For B/YAM. The non-inferiority criterion was that the upper bound of the two sided 95% CI on the difference between SCRs (Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus bioCSL QIV) should not exceed 10%.</non_inferiority_desc>
            <param_type>Difference in SCR (B/YAM)</param_type>
            <param_value>-4.5</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-10.3</ci_lower_limit>
            <ci_upper_limit>1.3</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The SCR difference was defined as the SCR percentage for bioCSL Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus the SCR percentage for bioCSL QIV.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>For B/VIC. The non-inferiority criterion was that the upper bound of the two sided 95% CI on the difference between SCRs (Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus bioCSL QIV) should not exceed 10%.</non_inferiority_desc>
            <param_type>Difference in SCR (B/VIC)</param_type>
            <param_value>-4.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-10.5</ci_lower_limit>
            <ci_upper_limit>1.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The SCR difference was defined as the SCR percentage for bioCSL Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus the SCR percentage for bioCSL QIV.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>For A/H1N1. The non-inferiority criterion was that the upper bound of the two sided 95% CI on the difference between SCRs (Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus bioCSL QIV) should not exceed 10%.</non_inferiority_desc>
            <param_type>Difference in SCR (A/H1N1)</param_type>
            <param_value>-0.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.4</ci_lower_limit>
            <ci_upper_limit>4.0</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The SCR difference was defined as the SCR percentage for bioCSL Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus the SCR percentage for bioCSL QIV.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>For A/H3N2. The non-inferiority criterion was that the upper bound of the two sided 95% CI on the difference between SCRs (Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus bioCSL QIV) should not exceed 10%.</non_inferiority_desc>
            <param_type>Difference in SCR (A/H3N2)</param_type>
            <param_value>1.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.1</ci_lower_limit>
            <ci_upper_limit>5.2</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The SCR difference was defined as the SCR percentage for bioCSL Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus the SCR percentage for bioCSL QIV.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>For B/YAM. The non-inferiority criterion was that the upper bound of the two sided 95% CI on the difference between SCRs (Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus bioCSL QIV) should not exceed 10%.</non_inferiority_desc>
            <param_type>Difference in SCR (B/YAM)</param_type>
            <param_value>-2.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-6.3</ci_lower_limit>
            <ci_upper_limit>2.0</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
              <group_id>O4</group_id>
            </group_id_list>
            <groups_desc>The SCR difference was defined as the SCR percentage for bioCSL Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus the SCR percentage for bioCSL QIV.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>For B/VIC. The non-inferiority criterion was that the upper bound of the two sided 95% CI on the difference between SCRs (Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus bioCSL QIV) should not exceed 10%.</non_inferiority_desc>
            <param_type>Difference in SCR (B/VIC)</param_type>
            <param_value>1.2</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.7</ci_lower_limit>
            <ci_upper_limit>6.2</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Immunologic Superiority of the Alternate B Strain in bioCSL QIV, as Determined by the GMT (Statistical Analysis: GMT Ratio) for This Strain, Overall and by Age Cohort (Per Protocol Population).</title>
        <description>Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to &lt; 65 years and ≥ 65 years of age), and overall. The GMT ratio was calculated as bioCSL QIV GMT/bioCSL TIV GMT for the superiority analyses, which is the reverse of how it was calculated for the non-inferiority analyses.&#xD;
(GMT dispersion values are based on unadjusted GMT values.)</description>
        <time_frame>21 days after vaccination.</time_frame>
        <population>The Per Protocol Population was used for the primary and secondary analysis of immunogenicity data and included subjects in the Evaluable Population minus any subjects with deviations that were thought to potentially affect the immunogenicity results, following medical review prior to unblinding.</population>
        <group_list>
          <group group_id="O1">
            <title>Postvaccination GMT: bioCSL QIV</title>
            <description>bioCSL QIV, Adults 18 years and older, N=1691. 18 to &lt; 65 years, n=835. =&gt; 65 years, n=856.</description>
          </group>
          <group group_id="O2">
            <title>Postvaccination GMT: TIV-1 (B/YAM) or TIV-2 (B/VIC)</title>
            <description>B/Yamagata serology for TIV-2 (B Victoria), Adults 18 years and older, n=850 B/Victoria serology for TIV-1 (B Yamagata), Adults 18 years and older, n=854 B/Yamagata serology for TIV-2 (B Victoria), Adults 18 through 64 years inclusive, n=421 B/Victoria serology for TIV-1 (B Yamagata), Adults 18 through 64 years inclusive, n=424 B/Yamagata serology for TIV-2 (B Victoria), Adults 65 years and older, n=429 B/Victoria serology for TIV-1 (B Yamagata), Adults 65 years and older, n=430.</description>
          </group>
        </group_list>
        <measure>
          <title>Immunologic Superiority of the Alternate B Strain in bioCSL QIV, as Determined by the GMT (Statistical Analysis: GMT Ratio) for This Strain, Overall and by Age Cohort (Per Protocol Population).</title>
          <description>Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to &lt; 65 years and ≥ 65 years of age), and overall. The GMT ratio was calculated as bioCSL QIV GMT/bioCSL TIV GMT for the superiority analyses, which is the reverse of how it was calculated for the non-inferiority analyses.&#xD;
(GMT dispersion values are based on unadjusted GMT values.)</description>
          <population>The Per Protocol Population was used for the primary and secondary analysis of immunogenicity data and included subjects in the Evaluable Population minus any subjects with deviations that were thought to potentially affect the immunogenicity results, following medical review prior to unblinding.</population>
          <units>Titer</units>
          <param>Geometric Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1691"/>
                <count group_id="O2" value="854"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>B/Yamagata (overall, ≥18 years)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62.9" lower_limit="5" upper_limit="2560"/>
                    <measurement group_id="O2" value="42.7" lower_limit="5" upper_limit="2560"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B/Victoria (overall, ≥18 years)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86.9" lower_limit="5" upper_limit="2560"/>
                    <measurement group_id="O2" value="55.4" lower_limit="5" upper_limit="5120"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B/Yamagata (18 to &lt;65 years)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89.9" lower_limit="5" upper_limit="2560"/>
                    <measurement group_id="O2" value="53.8" lower_limit="5" upper_limit="2560"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B/Victoria (18 to &lt;65 years)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="113.5" lower_limit="10" upper_limit="2560"/>
                    <measurement group_id="O2" value="64.3" lower_limit="5" upper_limit="5120"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B/Yamagata (≥65 years)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.8" lower_limit="5" upper_limit="1613"/>
                    <measurement group_id="O2" value="33.6" lower_limit="5" upper_limit="1280"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B/Victoria (≥65 years)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="64.1" lower_limit="5" upper_limit="2560"/>
                    <measurement group_id="O2" value="46.3" lower_limit="5" upper_limit="2560"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to &lt; 65 years and ≥ 65 years of age), and overall. The GMT ratio was calculated as bioCSL QIV GMT/bioCSL TIV GMT for the superiority analyses, which is the reverse of how it was calculated for the non-inferiority analyses.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>GMT ratio (B/YAM) overall</param_type>
            <param_value>1.47</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.38</ci_lower_limit>
            <ci_upper_limit>1.57</ci_upper_limit>
            <estimate_desc>Immunologic superiority of the alternate B strain (eg, the influenza B strain included in the bioCSL QIV but not in the bioCSL TIV formulation) in bioCSL QIV was demonstrated if the lower bound of the two-sided 95% CI on GMT ratio was greater than 1.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to &lt; 65 years and ≥ 65 years of age), and overall. The GMT ratio was calculated as bioCSL QIV GMT/bioCSL TIV GMT for the superiority analyses, which is the reverse of how it was calculated for the non-inferiority analyses.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>GMT ratio (B/VIC) overall</param_type>
            <param_value>1.57</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.45</ci_lower_limit>
            <ci_upper_limit>1.70</ci_upper_limit>
            <estimate_desc>Immunologic superiority of the alternate B strain (eg, the influenza B strain included in the bioCSL QIV but not in the bioCSL TIV formulation) in bioCSL QIV was demonstrated if the lower bound of the two-sided 95% CI on GMT ratio was greater than 1.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to &lt; 65 years and ≥ 65 years of age), and overall. The GMT ratio was calculated as bioCSL QIV GMT/bioCSL TIV GMT for the superiority analyses, which is the reverse of how it was calculated for the non-inferiority analyses.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>GMT ratio (B/YAM) 18 through 64 years</param_type>
            <param_value>1.67</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.50</ci_lower_limit>
            <ci_upper_limit>1.87</ci_upper_limit>
            <estimate_desc>Immunologic superiority of the alternate B strain (eg, the influenza B strain included in the bioCSL QIV but not in the bioCSL TIV formulation) in bioCSL QIV was demonstrated if the lower bound of the two-sided 95% CI on GMT was greater than 1</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to &lt; 65 years and ≥ 65 years of age), and overall. The GMT ratio was calculated as bioCSL QIV GMT/bioCSL TIV GMT for the superiority analyses, which is the reverse of how it was calculated for the non-inferiority analyses.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>GMT ratio (B/VIC) 18 through 64 years</param_type>
            <param_value>1.76</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.55</ci_lower_limit>
            <ci_upper_limit>2.01</ci_upper_limit>
            <estimate_desc>Immunologic superiority of the alternate B strain (eg, the influenza B strain included in the bioCSL QIV but not in the bioCSL TIV formulation) in bioCSL QIV was demonstrated if the lower bound of the two-sided 95% CI on GMT was greater than 1</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to &lt; 65 years and ≥ 65 years of age), and overall. The GMT ratio was calculated as bioCSL QIV GMT/bioCSL TIV GMT for the superiority analyses, which is the reverse of how it was calculated for the non-inferiority analyses.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>GMT ratio (B/YAM) ≥ 65 years</param_type>
            <param_value>1.30</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.21</ci_lower_limit>
            <ci_upper_limit>1.40</ci_upper_limit>
            <estimate_desc>Immunologic superiority of the alternate B strain (eg, the influenza B strain included in the bioCSL QIV but not in the bioCSL TIV formulation) in bioCSL QIV was demonstrated if the lower bound of the two-sided 95% CI on GMT was greater than 1</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to &lt; 65 years and ≥ 65 years of age), and overall. The GMT ratio was calculated as bioCSL QIV GMT/bioCSL TIV GMT for the superiority analyses, which is the reverse of how it was calculated for the non-inferiority analyses.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>GMT ratio (B/VIC) ≥ 65 years</param_type>
            <param_value>1.38</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.27</ci_lower_limit>
            <ci_upper_limit>1.51</ci_upper_limit>
            <estimate_desc>Immunologic superiority of the alternate B strain (eg, the influenza B strain included in the bioCSL QIV but not in the bioCSL TIV formulation) in bioCSL QIV was demonstrated if the lower bound of the two-sided 95% CI on GMT was greater than 1</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Immunologic Superiority of the Alternate B Strain in bioCSL QIV, as Determined by Seroconversion Rate (SCR) (Statistical Analysis: Difference in SCR) for This Strain, Overall and by Age Cohort (Per Protocol Population)</title>
        <description>Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to &lt; 65 years and ≥ 65 years of age), and overall. The SCR difference was calculated as bioCSL QIV SCR minus bioCSL TIV SCR, which is the reverse of how it was calculated for the non-inferiority analyses. For the SCR comparison superiority was demonstrated if the lower limit of the two-sided 95% CI of the difference of the seroconversion rates was greater than 0 for each B strain in QIV compared with the corresponding B strain not contained in each TIV.</description>
        <time_frame>21 days after vaccination.</time_frame>
        <population>The Per Protocol Population was used for the primary and secondary analysis of immunogenicity data and included subjects in the Evaluable Population minus any subjects with deviations that were thought to potentially affect the immunogenicity results, following medical review prior to unblinding.</population>
        <group_list>
          <group group_id="O1">
            <title>SCR: bioCSL QIV</title>
            <description>For B/Yamagata TIV=TIV-1, for B/Victoria TIV=TIV-2.&#xD;
bioCSL QIV, Adults 18 years and older, n=1691. bioCSL QIV, Adults 18 years to &lt;65 years, n=835. bioCSL QIV, Adults 65 years and older, n=856.</description>
          </group>
          <group group_id="O2">
            <title>SCR: Pooled TIV-1 or TIV-2</title>
            <description>For B/Yamagata TIV=TIV-1, for B/Victoria TIV=TIV-2.&#xD;
B/Yamagata serology for TIV-2 (B Victoria), Adults 18 years and older, n=850. B/Victoria serology for TIV-1 (B Yamagata), Adults 18 years and older, n=854. B/Yamagata serology for TIV-2 (B Victoria), Adults 18 to &lt;65 years, n=421. B/Victoria serology for TIV-1 (B Yamagata), Adults 18 years to &lt;65 years, n=424.&#xD;
B/Yamagata serology for TIV-2 (B Victoria), Adults 65 years and older, n=429. B/Victoria serology for TIV-1 (B Yamagata), Adults 65 years and older, n=430.</description>
          </group>
        </group_list>
        <measure>
          <title>Immunologic Superiority of the Alternate B Strain in bioCSL QIV, as Determined by Seroconversion Rate (SCR) (Statistical Analysis: Difference in SCR) for This Strain, Overall and by Age Cohort (Per Protocol Population)</title>
          <description>Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to &lt; 65 years and ≥ 65 years of age), and overall. The SCR difference was calculated as bioCSL QIV SCR minus bioCSL TIV SCR, which is the reverse of how it was calculated for the non-inferiority analyses. For the SCR comparison superiority was demonstrated if the lower limit of the two-sided 95% CI of the difference of the seroconversion rates was greater than 0 for each B strain in QIV compared with the corresponding B strain not contained in each TIV.</description>
          <population>The Per Protocol Population was used for the primary and secondary analysis of immunogenicity data and included subjects in the Evaluable Population minus any subjects with deviations that were thought to potentially affect the immunogenicity results, following medical review prior to unblinding.</population>
          <units>percentage of participants analyzed</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1691"/>
                <count group_id="O2" value="854"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>B/Yamagata (overall, ≥18 years)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.0"/>
                    <measurement group_id="O2" value="15.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B/Victoria (overall, ≥18 years)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.3"/>
                    <measurement group_id="O2" value="20.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B/Yamagata (18 to &lt;65 years)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.7"/>
                    <measurement group_id="O2" value="22.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B/Victoria (18 to &lt;65 years)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.6"/>
                    <measurement group_id="O2" value="29.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B/Yamagata (≥65 years)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.6"/>
                    <measurement group_id="O2" value="8.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B/Victoria (≥65 years)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.5"/>
                    <measurement group_id="O2" value="11.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to &lt; 65 years and ≥ 65 years of age), and overall. Seroconversion rate difference = bioCSL QIV SCR percentage - bioCSL TIV-1 or TIV-2 SCR percentage</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference in SCR (B/YAM) overall</param_type>
            <param_value>15.3</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>12.1</ci_lower_limit>
            <ci_upper_limit>18.6</ci_upper_limit>
            <estimate_desc>Immunologic superiority of the alternate B strain (eg, the influenza B strain included in bioCSL QIV but not in the TIV formulation) in bioCSL QIV was demonstrated if the lower bound of the two-sided 95% CI for the difference in SCRs was &gt; 0.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Seroconversion rate difference = bioCSL QIV SCR percentage - bioCSL TIV-1 or TIV-2 SCR percentage</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference in SCR (B/VIC) overall</param_type>
            <param_value>20.1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>16.5</ci_lower_limit>
            <ci_upper_limit>23.6</ci_upper_limit>
            <estimate_desc>Immunologic superiority of the alternate B strain (eg, the influenza B strain included in bioCSL QIV but not in the TIV formulation) in bioCSL QIV was demonstrated if the lower bound of the two-sided 95% CI for the difference in SCRs was &gt; 0.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to &lt; 65 years and ≥ 65 years of age), and overall. Seroconversion rate difference = bioCSL QIV SCR percentage - bioCSL TIV-1 or TIV-2 SCR percentage</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference in SCR (B/YAM) 18 through 64y</param_type>
            <param_value>22.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>17.7</ci_lower_limit>
            <ci_upper_limit>28.2</ci_upper_limit>
            <estimate_desc>Immunologic superiority of the alternate B strain (eg, the influenza B strain included in bioCSL QIV but not in the TIV formulation) in bioCSL QIV was demonstrated if the lower bound of the two-sided 95% CI for the difference in SCRs was &gt; 0.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to &lt; 65 years and ≥ 65 years of age), and overall. Seroconversion rate difference = bioCSL QIV SCR percentage - bioCSL TIV-1 or TIV-2 SCR percentage</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference in SCR (B/VIC) 18 through 64y</param_type>
            <param_value>28.6</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>23.1</ci_lower_limit>
            <ci_upper_limit>34.1</ci_upper_limit>
            <estimate_desc>Immunologic superiority of the alternate B strain (eg, the influenza B strain included in bioCSL QIV but not in the TIV formulation) in bioCSL QIV was demonstrated if the lower bound of the two-sided 95% CI for the difference in SCRs was &gt; 0.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to &lt; 65 years and ≥ 65 years of age), and overall. Seroconversion rate difference = bioCSL QIV SCR percentage - bioCSL TIV-1 or TIV-2 SCR percentage</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference in SCR (B/YAM) ≥ 65 years</param_type>
            <param_value>8.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>4.3</ci_lower_limit>
            <ci_upper_limit>11.6</ci_upper_limit>
            <estimate_desc>Immunologic superiority of the alternate B strain (eg, the influenza B strain included in bioCSL QIV but not in the TIV formulation) in bioCSL QIV was demonstrated if the lower bound of the two-sided 95% CI for the difference in SCRs was &gt; 0.</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to &lt; 65 years and ≥ 65 years of age), and overall. Seroconversion rate difference = bioCSL QIV SCR percentage - bioCSL TIV-1 or TIV-2 SCR percentage.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <param_type>Difference in SCR (B/VIC) ≥ 65 years</param_type>
            <param_value>11.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>7.7</ci_lower_limit>
            <ci_upper_limit>16.0</ci_upper_limit>
            <estimate_desc>Immunologic superiority of the alternate B strain (eg, the influenza B strain included in bioCSL QIV but not in the TIV formulation) in bioCSL QIV was demonstrated if the lower bound of the two-sided 95% CI for the difference in SCRs was &gt; 0.</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Geometric Mean of HI Titers (GMTs) Prevaccination and Postvaccination.</title>
        <description>The immunogenicity of bioCSL QIV, bioCSL TIV-1 and bioCSL TIV-2 was assessed in terms of geometric mean HI titers (GMT) prevaccination (Day 1) and postvaccination (Day 21), in age cohorts (per protocol population).</description>
        <time_frame>21 days after vaccination.</time_frame>
        <population>The Per Protocol Population was used for the primary and secondary analysis of immunogenicity data and included subjects in the Evaluable Population minus any subjects with deviations that were thought to potentially affect the immunogenicity results, following medical review prior to unblinding.</population>
        <group_list>
          <group group_id="O1">
            <title>bioCSL QIV (18 to &lt;65 Years)</title>
          </group>
          <group group_id="O2">
            <title>bioCSL TIV-1 (B/YAM) (18 to &lt;65 Years)</title>
          </group>
          <group group_id="O3">
            <title>bioCSL TIV-2 (B/VIC) (18 to &lt;65 Years)</title>
          </group>
          <group group_id="O4">
            <title>bioCSL QIV (≥ 65 Years)</title>
          </group>
          <group group_id="O5">
            <title>bioCSL TIV-1 (B/YAM) (≥ 65 Years)</title>
          </group>
          <group group_id="O6">
            <title>bioCSL TIV-2 (B/VIC) (≥ 65 Years)</title>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean of HI Titers (GMTs) Prevaccination and Postvaccination.</title>
          <description>The immunogenicity of bioCSL QIV, bioCSL TIV-1 and bioCSL TIV-2 was assessed in terms of geometric mean HI titers (GMT) prevaccination (Day 1) and postvaccination (Day 21), in age cohorts (per protocol population).</description>
          <population>The Per Protocol Population was used for the primary and secondary analysis of immunogenicity data and included subjects in the Evaluable Population minus any subjects with deviations that were thought to potentially affect the immunogenicity results, following medical review prior to unblinding.</population>
          <units>Titer</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="835"/>
                <count group_id="O2" value="424"/>
                <count group_id="O3" value="421"/>
                <count group_id="O4" value="856"/>
                <count group_id="O5" value="430"/>
                <count group_id="O6" value="429"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>A/H1N1 (pre-vaccination)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78.1" lower_limit="70.51" upper_limit="86.41"/>
                    <measurement group_id="O2" value="82.3" lower_limit="71.57" upper_limit="94.74"/>
                    <measurement group_id="O3" value="82.8" lower_limit="71.98" upper_limit="95.17"/>
                    <measurement group_id="O4" value="75.7" lower_limit="69.93" upper_limit="81.84"/>
                    <measurement group_id="O5" value="72.0" lower_limit="64.58" upper_limit="80.25"/>
                    <measurement group_id="O6" value="69.2" lower_limit="61.91" upper_limit="77.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H3N2 (pre-vaccination)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.4" lower_limit="87.93" upper_limit="107.96"/>
                    <measurement group_id="O2" value="96.1" lower_limit="83.51" upper_limit="110.64"/>
                    <measurement group_id="O3" value="105.7" lower_limit="92.63" upper_limit="120.53"/>
                    <measurement group_id="O4" value="153.0" lower_limit="141.90" upper_limit="165.05"/>
                    <measurement group_id="O5" value="139.0" lower_limit="123.74" upper_limit="156.16"/>
                    <measurement group_id="O6" value="142.7" lower_limit="126.73" upper_limit="160.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B/Yamagata (pre-vaccination)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.7" lower_limit="21.89" upper_limit="25.61"/>
                    <measurement group_id="O2" value="24.7" lower_limit="22.09" upper_limit="27.60"/>
                    <measurement group_id="O3" value="23.7" lower_limit="21.32" upper_limit="26.42"/>
                    <measurement group_id="O4" value="20.3" lower_limit="19.01" upper_limit="21.70"/>
                    <measurement group_id="O5" value="18.6" lower_limit="17.02" upper_limit="20.35"/>
                    <measurement group_id="O6" value="19.6" lower_limit="17.77" upper_limit="21.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B/Victoria (pre-vaccination)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.4" lower_limit="18.95" upper_limit="21.85"/>
                    <measurement group_id="O2" value="20.4" lower_limit="18.49" upper_limit="22.56"/>
                    <measurement group_id="O3" value="21.7" lower_limit="19.54" upper_limit="24.04"/>
                    <measurement group_id="O4" value="24.4" lower_limit="22.84" upper_limit="26.17"/>
                    <measurement group_id="O5" value="23.4" lower_limit="21.31" upper_limit="25.73"/>
                    <measurement group_id="O6" value="25.1" lower_limit="22.73" upper_limit="27.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H1N1 (post-vaccination)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="429.9" lower_limit="400.38" upper_limit="461.61"/>
                    <measurement group_id="O2" value="432.8" lower_limit="392.96" upper_limit="476.66"/>
                    <measurement group_id="O3" value="433.9" lower_limit="391.46" upper_limit="481.01"/>
                    <measurement group_id="O4" value="175.9" lower_limit="163.61" upper_limit="189.11"/>
                    <measurement group_id="O5" value="169.3" lower_limit="152.67" upper_limit="187.68"/>
                    <measurement group_id="O6" value="158.7" lower_limit="143.15" upper_limit="175.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H3N2 (post-vaccination)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="533.3" lower_limit="496.04" upper_limit="573.37"/>
                    <measurement group_id="O2" value="499.4" lower_limit="449.73" upper_limit="554.62"/>
                    <measurement group_id="O3" value="532.5" lower_limit="482.62" upper_limit="587.64"/>
                    <measurement group_id="O4" value="356.4" lower_limit="333.25" upper_limit="381.14"/>
                    <measurement group_id="O5" value="336.6" lower_limit="305.26" upper_limit="371.11"/>
                    <measurement group_id="O6" value="330.3" lower_limit="297.27" upper_limit="367.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B/Yamagata (post-vaccination)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.4" lower_limit="90.04" upper_limit="105.35"/>
                    <measurement group_id="O2" value="84.6" lower_limit="75.64" upper_limit="94.65"/>
                    <measurement group_id="O3" value="53.5" lower_limit="47.85" upper_limit="59.88"/>
                    <measurement group_id="O4" value="38.1" lower_limit="35.50" upper_limit="40.86"/>
                    <measurement group_id="O5" value="33.2" lower_limit="30.18" upper_limit="36.51"/>
                    <measurement group_id="O6" value="28.6" lower_limit="25.75" upper_limit="31.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B/Victoria (post-vaccination)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="111.9" lower_limit="103.57" upper_limit="120.82"/>
                    <measurement group_id="O2" value="55.5" lower_limit="49.85" upper_limit="61.77"/>
                    <measurement group_id="O3" value="103.0" lower_limit="92.38" upper_limit="114.78"/>
                    <measurement group_id="O4" value="54.0" lower_limit="49.97" upper_limit="58.40"/>
                    <measurement group_id="O5" value="38.7" lower_limit="34.96" upper_limit="42.92"/>
                    <measurement group_id="O6" value="57.4" lower_limit="51.34" upper_limit="64.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Geometric Mean Fold Titer Change From Prevaccination to Postvaccination.</title>
        <description>The immunogenicity of bioCSL QIV, bioCSL TIV-1 and bioCSL TIV-2 assessed in terms of Geometric Mean Fold Increase (GMFI, defined as the geometric mean of the fold increases of postvaccination antibody titer over the prevaccination antibody titer) by Age Cohort (Per Protocol Population).</description>
        <time_frame>21 days after vaccination.</time_frame>
        <population>The Per Protocol Population was used for the primary and secondary analysis of immunogenicity data and included subjects in the Evaluable Population minus any subjects with deviations that were thought to potentially affect the immunogenicity results, following medical review prior to unblinding.</population>
        <group_list>
          <group group_id="O1">
            <title>bioCSL QIV (18 to &lt;65 Years)</title>
          </group>
          <group group_id="O2">
            <title>bioCSL TIV-1 (B/YAM) (18 to &lt;65 Years)</title>
          </group>
          <group group_id="O3">
            <title>bioCSL TIV-2 (B/VIC) (18 to &lt;65 Years)</title>
          </group>
          <group group_id="O4">
            <title>bioCSL QIV (≥ 65 Years)</title>
          </group>
          <group group_id="O5">
            <title>bioCSL TIV-1 (B/YAM) (≥ 65 Years)</title>
          </group>
          <group group_id="O6">
            <title>bioCSL TIV-1 (B/VIC) (≥ 65 Years)</title>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Fold Titer Change From Prevaccination to Postvaccination.</title>
          <description>The immunogenicity of bioCSL QIV, bioCSL TIV-1 and bioCSL TIV-2 assessed in terms of Geometric Mean Fold Increase (GMFI, defined as the geometric mean of the fold increases of postvaccination antibody titer over the prevaccination antibody titer) by Age Cohort (Per Protocol Population).</description>
          <population>The Per Protocol Population was used for the primary and secondary analysis of immunogenicity data and included subjects in the Evaluable Population minus any subjects with deviations that were thought to potentially affect the immunogenicity results, following medical review prior to unblinding.</population>
          <units>Fold Change Titer (GMFI)</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="835"/>
                <count group_id="O2" value="424"/>
                <count group_id="O3" value="421"/>
                <count group_id="O4" value="856"/>
                <count group_id="O5" value="430"/>
                <count group_id="O6" value="429"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>A/H1N1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.5" lower_limit="4.96" upper_limit="6.11"/>
                    <measurement group_id="O2" value="5.3" lower_limit="4.53" upper_limit="6.10"/>
                    <measurement group_id="O3" value="5.2" lower_limit="4.49" upper_limit="6.12"/>
                    <measurement group_id="O4" value="2.3" lower_limit="2.18" upper_limit="2.48"/>
                    <measurement group_id="O5" value="2.4" lower_limit="2.14" upper_limit="2.58"/>
                    <measurement group_id="O6" value="2.3" lower_limit="2.09" upper_limit="2.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H3N2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.5" lower_limit="4.98" upper_limit="6.02"/>
                    <measurement group_id="O2" value="5.2" lower_limit="4.56" upper_limit="5.91"/>
                    <measurement group_id="O3" value="5.0" lower_limit="4.43" upper_limit="5.74"/>
                    <measurement group_id="O4" value="2.3" lower_limit="2.19" upper_limit="2.47"/>
                    <measurement group_id="O5" value="2.4" lower_limit="2.21" upper_limit="2.65"/>
                    <measurement group_id="O6" value="2.3" lower_limit="2.10" upper_limit="2.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B/Yamagata</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.1" lower_limit="3.78" upper_limit="4.47"/>
                    <measurement group_id="O2" value="3.4" lower_limit="3.05" upper_limit="3.85"/>
                    <measurement group_id="O3" value="2.3" lower_limit="2.08" upper_limit="2.45"/>
                    <measurement group_id="O4" value="1.9" lower_limit="1.79" upper_limit="1.97"/>
                    <measurement group_id="O5" value="1.8" lower_limit="1.67" upper_limit="1.91"/>
                    <measurement group_id="O6" value="1.5" lower_limit="1.38" upper_limit="1.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B/Victoria</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.5" lower_limit="5.04" upper_limit="5.99"/>
                    <measurement group_id="O2" value="2.7" lower_limit="2.46" upper_limit="3.00"/>
                    <measurement group_id="O3" value="4.8" lower_limit="4.21" upper_limit="5.36"/>
                    <measurement group_id="O4" value="2.2" lower_limit="2.08" upper_limit="2.34"/>
                    <measurement group_id="O5" value="1.7" lower_limit="1.54" upper_limit="1.77"/>
                    <measurement group_id="O6" value="2.3" lower_limit="2.10" upper_limit="2.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Seroprotection Rates Prevaccination and Postvaccination.</title>
        <description>The immunogenicity of bioCSL QIV, bioCSL TIV-1 and bioCSL TIV-2 was assessed in terms of percentage of subjects with a HI titer ≥40 (seroprotection rates) prevaccination (Day 1) and postvaccination (Day 21), in age cohorts (per protocol population).</description>
        <time_frame>21 days after vaccination.</time_frame>
        <population>The Per Protocol Population was used for the primary and secondary analysis of immunogenicity data and included subjects in the Evaluable Population minus any subjects with deviations that were thought to potentially affect the immunogenicity results, following medical review prior to unblinding.</population>
        <group_list>
          <group group_id="O1">
            <title>bioCSL QIV (18 to &lt;65 Years)</title>
          </group>
          <group group_id="O2">
            <title>bioCSL TIV-1 (B/YAM) (18 to &lt;65 Years)</title>
          </group>
          <group group_id="O3">
            <title>bioCSL TIV-2 (B/VIC) (18 to &lt;65 Years)</title>
          </group>
          <group group_id="O4">
            <title>bioCSL QIV (≥ 65 Years)</title>
          </group>
          <group group_id="O5">
            <title>bioCSL TIV-1 (B/YAM) (≥ 65 Years)</title>
          </group>
          <group group_id="O6">
            <title>bioCSL TIV-1 (B/VIC) (≥ 65 Years)</title>
          </group>
        </group_list>
        <measure>
          <title>Seroprotection Rates Prevaccination and Postvaccination.</title>
          <description>The immunogenicity of bioCSL QIV, bioCSL TIV-1 and bioCSL TIV-2 was assessed in terms of percentage of subjects with a HI titer ≥40 (seroprotection rates) prevaccination (Day 1) and postvaccination (Day 21), in age cohorts (per protocol population).</description>
          <population>The Per Protocol Population was used for the primary and secondary analysis of immunogenicity data and included subjects in the Evaluable Population minus any subjects with deviations that were thought to potentially affect the immunogenicity results, following medical review prior to unblinding.</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="835"/>
                <count group_id="O2" value="424"/>
                <count group_id="O3" value="421"/>
                <count group_id="O4" value="856"/>
                <count group_id="O5" value="430"/>
                <count group_id="O6" value="429"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>A/H1N1 (pre-vaccination)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73.2" lower_limit="70.0" upper_limit="76.2"/>
                    <measurement group_id="O2" value="76.9" lower_limit="72.6" upper_limit="80.8"/>
                    <measurement group_id="O3" value="75.5" lower_limit="71.1" upper_limit="79.6"/>
                    <measurement group_id="O4" value="78.5" lower_limit="75.6" upper_limit="81.2"/>
                    <measurement group_id="O5" value="80.0" lower_limit="75.9" upper_limit="83.7"/>
                    <measurement group_id="O6" value="77.4" lower_limit="73.1" upper_limit="81.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H3N2 (pre-vaccination)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78.3" lower_limit="75.4" upper_limit="81.1"/>
                    <measurement group_id="O2" value="77.1" lower_limit="72.8" upper_limit="81.0"/>
                    <measurement group_id="O3" value="81.5" lower_limit="77.4" upper_limit="85.1"/>
                    <measurement group_id="O4" value="92.9" lower_limit="90.9" upper_limit="94.5"/>
                    <measurement group_id="O5" value="90.9" lower_limit="87.8" upper_limit="93.5"/>
                    <measurement group_id="O6" value="88.8" lower_limit="85.4" upper_limit="91.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B/Yamagata (pre-vaccination</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.9" lower_limit="36.5" upper_limit="43.3"/>
                    <measurement group_id="O2" value="39.9" lower_limit="35.2" upper_limit="44.7"/>
                    <measurement group_id="O3" value="40.9" lower_limit="36.1" upper_limit="45.7"/>
                    <measurement group_id="O4" value="33.2" lower_limit="30.0" upper_limit="36.4"/>
                    <measurement group_id="O5" value="29.1" lower_limit="24.8" upper_limit="33.6"/>
                    <measurement group_id="O6" value="31.2" lower_limit="26.9" upper_limit="35.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B/Victoria (pre-vaccination)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.5" lower_limit="30.3" upper_limit="36.8"/>
                    <measurement group_id="O2" value="32.8" lower_limit="28.3" upper_limit="37.5"/>
                    <measurement group_id="O3" value="35.9" lower_limit="31.3" upper_limit="40.7"/>
                    <measurement group_id="O4" value="38.7" lower_limit="35.4" upper_limit="42.0"/>
                    <measurement group_id="O5" value="36.3" lower_limit="31.7" upper_limit="41.0"/>
                    <measurement group_id="O6" value="40.1" lower_limit="35.4" upper_limit="44.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H1N1 (post-vaccination)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.0" lower_limit="98.1" upper_limit="99.6"/>
                    <measurement group_id="O2" value="100.0" lower_limit="99.1" upper_limit="100.0"/>
                    <measurement group_id="O3" value="99.0" lower_limit="97.6" upper_limit="99.7"/>
                    <measurement group_id="O4" value="94.6" lower_limit="92.9" upper_limit="96.0"/>
                    <measurement group_id="O5" value="95.8" lower_limit="93.5" upper_limit="97.5"/>
                    <measurement group_id="O6" value="95.3" lower_limit="92.9" upper_limit="97.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H3N2 (post-vaccination)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.0" lower_limit="98.1" upper_limit="99.6"/>
                    <measurement group_id="O2" value="98.8" lower_limit="97.3" upper_limit="99.6"/>
                    <measurement group_id="O3" value="98.8" lower_limit="97.3" upper_limit="99.6"/>
                    <measurement group_id="O4" value="99.8" lower_limit="99.2" upper_limit="100.0"/>
                    <measurement group_id="O5" value="99.1" lower_limit="97.6" upper_limit="99.7"/>
                    <measurement group_id="O6" value="98.1" lower_limit="96.4" upper_limit="99.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B/Yamagata (post-vaccination)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84.3" lower_limit="81.7" upper_limit="86.7"/>
                    <measurement group_id="O2" value="81.4" lower_limit="77.3" upper_limit="85.0"/>
                    <measurement group_id="O3" value="68.4" lower_limit="63.7" upper_limit="72.8"/>
                    <measurement group_id="O4" value="57.5" lower_limit="54.1" upper_limit="60.8"/>
                    <measurement group_id="O5" value="54.2" lower_limit="49.3" upper_limit="59.0"/>
                    <measurement group_id="O6" value="46.2" lower_limit="41.4" upper_limit="51.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B/Victoria (post-vaccination)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86.7" lower_limit="84.2" upper_limit="88.9"/>
                    <measurement group_id="O2" value="68.2" lower_limit="63.5" upper_limit="72.6"/>
                    <measurement group_id="O3" value="86.2" lower_limit="82.6" upper_limit="89.4"/>
                    <measurement group_id="O4" value="68.3" lower_limit="65.1" upper_limit="71.4"/>
                    <measurement group_id="O5" value="54.4" lower_limit="49.6" upper_limit="59.2"/>
                    <measurement group_id="O6" value="68.3" lower_limit="63.7" upper_limit="72.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Seroconversion Rates</title>
        <description>The immunogenicity of bioCSL QIV, bioCSL TIV-1 and bio CSL TIV-2 was assessed in terms of the seroconversion rate, ie, percentage of subjects with either a prevaccination HI titer &lt; 1:10 and a postvaccination HI titer ≥ 1:40, or a prevaccination titer ≥ 1:10 and a ≥ 4-fold increase in post-vaccination titer. Data presented in age cohorts (per protocol population).</description>
        <time_frame>21 days after vaccination.</time_frame>
        <population>The Per Protocol Population was used for the primary and secondary analysis of immunogenicity data and included subjects in the Evaluable Population minus any subjects with deviations that were thought to potentially affect the immunogenicity results, following medical review prior to unblinding.</population>
        <group_list>
          <group group_id="O1">
            <title>bioCSL QIV (18 to &lt;65 Years)</title>
          </group>
          <group group_id="O2">
            <title>bioCSL TIV-1 (B/YAM) (18 to &lt;65 Years)</title>
          </group>
          <group group_id="O3">
            <title>bioCSL TIV-2 (B/VIC) (18 to &lt;65 Years)</title>
          </group>
          <group group_id="O4">
            <title>bioCSL QIV (≥ 65 Years)</title>
          </group>
          <group group_id="O5">
            <title>bioCSL TIV-1 (B/YAM) (≥ 65 Years)</title>
          </group>
          <group group_id="O6">
            <title>bioCSL TIV-1 (B/VIC) (≥ 65 Years)</title>
          </group>
        </group_list>
        <measure>
          <title>Seroconversion Rates</title>
          <description>The immunogenicity of bioCSL QIV, bioCSL TIV-1 and bio CSL TIV-2 was assessed in terms of the seroconversion rate, ie, percentage of subjects with either a prevaccination HI titer &lt; 1:10 and a postvaccination HI titer ≥ 1:40, or a prevaccination titer ≥ 1:10 and a ≥ 4-fold increase in post-vaccination titer. Data presented in age cohorts (per protocol population).</description>
          <population>The Per Protocol Population was used for the primary and secondary analysis of immunogenicity data and included subjects in the Evaluable Population minus any subjects with deviations that were thought to potentially affect the immunogenicity results, following medical review prior to unblinding.</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="835"/>
                <count group_id="O2" value="424"/>
                <count group_id="O3" value="421"/>
                <count group_id="O4" value="856"/>
                <count group_id="O5" value="430"/>
                <count group_id="O6" value="429"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>A/H1N1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51.3" lower_limit="47.8" upper_limit="54.7"/>
                    <measurement group_id="O2" value="50.5" lower_limit="45.6" upper_limit="55.3"/>
                    <measurement group_id="O3" value="47.7" lower_limit="42.9" upper_limit="52.6"/>
                    <measurement group_id="O4" value="26.6" lower_limit="23.7" upper_limit="29.7"/>
                    <measurement group_id="O5" value="27.4" lower_limit="23.3" upper_limit="31.9"/>
                    <measurement group_id="O6" value="25.4" lower_limit="21.4" upper_limit="29.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/H3N2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56.3" lower_limit="52.8" upper_limit="59.7"/>
                    <measurement group_id="O2" value="52.8" lower_limit="48.0" upper_limit="57.7"/>
                    <measurement group_id="O3" value="50.6" lower_limit="45.7" upper_limit="55.5"/>
                    <measurement group_id="O4" value="25.9" lower_limit="23.0" upper_limit="29.0"/>
                    <measurement group_id="O5" value="28.6" lower_limit="24.4" upper_limit="33.1"/>
                    <measurement group_id="O6" value="25.4" lower_limit="21.4" upper_limit="29.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B/Yamagata</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45.7" lower_limit="42.3" upper_limit="49.2"/>
                    <measurement group_id="O2" value="41.3" lower_limit="36.5" upper_limit="46.1"/>
                    <measurement group_id="O3" value="22.8" lower_limit="18.9" upper_limit="27.1"/>
                    <measurement group_id="O4" value="16.6" lower_limit="14.2" upper_limit="19.3"/>
                    <measurement group_id="O5" value="14.4" lower_limit="11.2" upper_limit="18.1"/>
                    <measurement group_id="O6" value="8.6" lower_limit="6.1" upper_limit="11.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B/Victoria</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.6" lower_limit="54.2" upper_limit="61.0"/>
                    <measurement group_id="O2" value="29.0" lower_limit="24.7" upper_limit="33.6"/>
                    <measurement group_id="O3" value="53.0" lower_limit="48.1" upper_limit="57.8"/>
                    <measurement group_id="O4" value="23.5" lower_limit="20.7" upper_limit="26.5"/>
                    <measurement group_id="O5" value="11.6" lower_limit="8.8" upper_limit="15.0"/>
                    <measurement group_id="O6" value="24.7" lower_limit="20.7" upper_limit="29.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Frequency and Severity of Solicited Local and Systemic Adverse Events (AEs).</title>
        <description>The overall number of subjects experiencing at least one event of a local and systemic solicited AE, and the overall number of subjects with at least one severe (grade 3) local and systemic solicited AE.</description>
        <time_frame>For 7 days following vaccination.</time_frame>
        <population>The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.</population>
        <group_list>
          <group group_id="O1">
            <title>Quadrivalent Influenza Vaccine (QIV)</title>
            <description>The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).&#xD;
Quadrivalent Influenza Vaccine (QIV): One 0.5 mL intramuscular dose into the deltoid muscle</description>
          </group>
          <group group_id="O2">
            <title>Trivalent Influenza Vaccine (TIV-1)</title>
            <description>The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).&#xD;
Trivalent Influenza Vaccine (TIV-1): One 0.5 mL intramuscular dose into the deltoid muscle.</description>
          </group>
          <group group_id="O3">
            <title>Trivalent Influenza Vaccine (TIV-2)</title>
            <description>The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the recommended influenza A (H1N1-, H3N2-like) strains and the alternative B strain for the Northern Hemisphere 2014/2015 influenza season).&#xD;
Trivalent Influenza Vaccine (TIV-2): One 0.5 mL intramuscular dose into the deltoid muscle.</description>
          </group>
        </group_list>
        <measure>
          <title>The Frequency and Severity of Solicited Local and Systemic Adverse Events (AEs).</title>
          <description>The overall number of subjects experiencing at least one event of a local and systemic solicited AE, and the overall number of subjects with at least one severe (grade 3) local and systemic solicited AE.</description>
          <population>The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1721"/>
                <count group_id="O2" value="864"/>
                <count group_id="O3" value="864"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Frequency of solicited AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="803"/>
                    <measurement group_id="O2" value="391"/>
                    <measurement group_id="O3" value="397"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe (grade 3) solicited AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42"/>
                    <measurement group_id="O2" value="15"/>
                    <measurement group_id="O3" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Frequency of Cellulitis-like Reaction and Cellulitis.</title>
        <description>The number of subjects experiencing at least one episode of each event.</description>
        <time_frame>For 28 days following vaccination.</time_frame>
        <population>The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.</population>
        <group_list>
          <group group_id="O1">
            <title>Quadrivalent Influenza Vaccine (QIV)</title>
            <description>The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).&#xD;
Quadrivalent Influenza Vaccine (QIV): One 0.5 mL intramuscular dose into the deltoid muscle</description>
          </group>
          <group group_id="O2">
            <title>Trivalent Influenza Vaccine (TIV-1)</title>
            <description>The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).&#xD;
Trivalent Influenza Vaccine (TIV-1): One 0.5 mL intramuscular dose into the deltoid muscle.</description>
          </group>
          <group group_id="O3">
            <title>Trivalent Influenza Vaccine (TIV-2)</title>
            <description>The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the recommended influenza A (H1N1-, H3N2-like) strains and the alternative B strain for the Northern Hemisphere 2014/2015 influenza season).&#xD;
Trivalent Influenza Vaccine (TIV-2): One 0.5 mL intramuscular dose into the deltoid muscle.</description>
          </group>
        </group_list>
        <measure>
          <title>The Frequency of Cellulitis-like Reaction and Cellulitis.</title>
          <description>The number of subjects experiencing at least one episode of each event.</description>
          <population>The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1721"/>
                <count group_id="O2" value="864"/>
                <count group_id="O3" value="864"/>
              </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>Secondary</type>
        <title>The Frequency and Severity of Unsolicited AEs.</title>
        <description>The overall number of subjects experiencing at least one event of an unsolicited AE, and the overall number of subjects with at least one severe (grade 3) unsolicited AE.</description>
        <time_frame>For 28 days following vaccination.</time_frame>
        <population>The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.</population>
        <group_list>
          <group group_id="O1">
            <title>Quadrivalent Influenza Vaccine (QIV)</title>
            <description>The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).&#xD;
Quadrivalent Influenza Vaccine (QIV): One 0.5 mL intramuscular dose into the deltoid muscle</description>
          </group>
          <group group_id="O2">
            <title>Trivalent Influenza Vaccine (TIV-1)</title>
            <description>The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).&#xD;
Trivalent Influenza Vaccine (TIV-1): One 0.5 mL intramuscular dose into the deltoid muscle.</description>
          </group>
          <group group_id="O3">
            <title>Trivalent Influenza Vaccine (TIV-2)</title>
            <description>The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the recommended influenza A (H1N1-, H3N2-like) strains and the alternative B strain for the Northern Hemisphere 2014/2015 influenza season).&#xD;
Trivalent Influenza Vaccine (TIV-2): One 0.5 mL intramuscular dose into the deltoid muscle.</description>
          </group>
        </group_list>
        <measure>
          <title>The Frequency and Severity of Unsolicited AEs.</title>
          <description>The overall number of subjects experiencing at least one event of an unsolicited AE, and the overall number of subjects with at least one severe (grade 3) unsolicited AE.</description>
          <population>The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1721"/>
                <count group_id="O2" value="864"/>
                <count group_id="O3" value="864"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>At least one unsolicited AE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="351"/>
                    <measurement group_id="O2" value="191"/>
                    <measurement group_id="O3" value="176"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe (grade 3) unsolicited AE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73"/>
                    <measurement group_id="O2" value="29"/>
                    <measurement group_id="O3" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Frequency of Serious Adverse Events (SAEs) for 6 Months Following Vaccination.</title>
        <description>The number of participants reporting Serious Adverse Events for 6 months following vaccination.</description>
        <time_frame>For 6 months following vaccination.</time_frame>
        <population>The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.</population>
        <group_list>
          <group group_id="O1">
            <title>Quadrivalent Influenza Vaccine (QIV)</title>
            <description>The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).&#xD;
Quadrivalent Influenza Vaccine (QIV): One 0.5 mL intramuscular dose into the deltoid muscle</description>
          </group>
          <group group_id="O2">
            <title>Trivalent Influenza Vaccine (TIV-1)</title>
            <description>The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).&#xD;
Trivalent Influenza Vaccine (TIV-1): One 0.5 mL intramuscular dose into the deltoid muscle.</description>
          </group>
          <group group_id="O3">
            <title>Trivalent Influenza Vaccine (TIV-2)</title>
            <description>The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the recommended influenza A (H1N1-, H3N2-like) strains and the alternative B strain for the Northern Hemisphere 2014/2015 influenza season).&#xD;
Trivalent Influenza Vaccine (TIV-2): One 0.5 mL intramuscular dose into the deltoid muscle.</description>
          </group>
        </group_list>
        <measure>
          <title>The Frequency of Serious Adverse Events (SAEs) for 6 Months Following Vaccination.</title>
          <description>The number of participants reporting Serious Adverse Events for 6 months following vaccination.</description>
          <population>The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1721"/>
                <count group_id="O2" value="864"/>
                <count group_id="O3" value="864"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39"/>
                    <measurement group_id="O2" value="14"/>
                    <measurement group_id="O3" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Local and systemic solicited AEs collected from Day 1 to Day 7. Unsolicited AEs collected for 28 days after vaccination. SAEs collected for 6 months after vaccination.</time_frame>
      <desc>The Safety Population was used for the analysis of safety and comprised all subjects in the Full Analysis Set (FAS) who received the study vaccine and provided follow-up safety data. A statement that they were no AEs constituted follow-up safety data. A total of 31 subjects were assessed as having no follow-up safety data post-vaccination.</desc>
      <group_list>
        <group group_id="E1">
          <title>Quadrivalent Influenza Vaccine (QIV)</title>
          <description>The study vaccine is a sterile, thiomersal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).&#xD;
Quadrivalent Influenza Vaccine (QIV): One 0.5 mL intramuscular dose into the deltoid muscle</description>
        </group>
        <group group_id="E2">
          <title>Trivalent Influenza Vaccine (TIV-1)</title>
          <description>The study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).&#xD;
Trivalent Influenza Vaccine (TIV-1): One 0.5 mL intramuscular dose into the deltoid muscle.</description>
        </group>
        <group group_id="E3">
          <title>Trivalent Influenza Vaccine (TIV-2)</title>
          <description>The study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the recommended influenza A (H1N1-, H3N2-like) strains and the alternative B strain for the Northern Hemisphere 2014/2015 influenza season).&#xD;
Trivalent Influenza Vaccine (TIV-2): One 0.5 mL intramuscular dose into the deltoid muscle.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="39" subjects_at_risk="1721"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="864"/>
                <counts group_id="E3" subjects_affected="13" subjects_at_risk="864"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="1721"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="864"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="864"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1721"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="864"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="864"/>
              </event>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1721"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="864"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="864"/>
              </event>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1721"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="864"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="864"/>
              </event>
              <event>
                <sub_title>Atrioventricular block second degree</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1721"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="864"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="864"/>
              </event>
              <event>
                <sub_title>Bundle branch block left</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1721"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="864"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="864"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1721"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="864"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="864"/>
              </event>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1721"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="864"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="864"/>
              </event>
              <event>
                <sub_title>Sick sinus syndrome</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1721"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="864"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="864"/>
              </event>
              <event>
                <sub_title>Ventricular arrhythmia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1721"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="864"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="864"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abominable pain upper</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1721"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="864"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="864"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1721"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="864"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="864"/>
              </event>
              <event>
                <sub_title>Diverticulum intestinal</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1721"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="864"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="864"/>
              </event>
              <event>
                <sub_title>Pancreatitis acute</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1721"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="864"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="864"/>
              </event>
              <event>
                <sub_title>Small intestinal obstruction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1721"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="864"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="864"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1721"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="864"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="864"/>
              </event>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1721"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="864"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="864"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1721"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="864"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="864"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1721"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="864"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="864"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1721"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="864"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="864"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1721"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="864"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="864"/>
              </event>
              <event>
                <sub_title>Atypical pneumonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1721"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="864"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="864"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1721"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="864"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="864"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1721"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="864"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="864"/>
              </event>
              <event>
                <sub_title>Pelvic inflammatory disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1721"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="864"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="864"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1721"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="864"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="864"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Esophageal injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1721"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="864"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="864"/>
              </event>
              <event>
                <sub_title>Postprocedural hematuria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1721"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="864"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="864"/>
              </event>
              <event>
                <sub_title>Road traffic accident</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1721"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="864"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="864"/>
              </event>
              <event>
                <sub_title>Upper limb fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1721"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="864"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="864"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Oxygen saturation decreased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1721"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="864"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="864"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1721"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="864"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="864"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Osteoarthritis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1721"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="864"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="864"/>
              </event>
              <event>
                <sub_title>Joint swelling</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1721"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="864"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="864"/>
              </event>
              <event>
                <sub_title>Musculoskeletal chest pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1721"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="864"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="864"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Lung neoplasm malignant</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1721"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="864"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="864"/>
              </event>
              <event>
                <sub_title>Adenocarcinoma of colon</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1721"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="864"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="864"/>
              </event>
              <event>
                <sub_title>Parathyroid tumor benign</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1721"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="864"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="864"/>
              </event>
              <event>
                <sub_title>Prostate cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1721"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="864"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="864"/>
              </event>
              <event>
                <sub_title>Renal cell carcinoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1721"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="864"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="864"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1721"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="864"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="864"/>
              </event>
              <event>
                <sub_title>Transient ischemic attack</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1721"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="864"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="864"/>
              </event>
              <event>
                <sub_title>Carotid artery disease</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1721"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="864"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="864"/>
              </event>
              <event>
                <sub_title>Carotid artery stenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1721"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="864"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="864"/>
              </event>
              <event>
                <sub_title>Hemorrhage intracranial</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1721"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="864"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="864"/>
              </event>
              <event>
                <sub_title>Ischemic stroke</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1721"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="864"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="864"/>
              </event>
              <event>
                <sub_title>Posterior reversible encephalopathy syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1721"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="864"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="864"/>
              </event>
              <event>
                <sub_title>Spasmodic dysphonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1721"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="864"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="864"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1721"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="864"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="864"/>
              </event>
              <event>
                <sub_title>Thalamic infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1721"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="864"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="864"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Bipolar I disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1721"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="864"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="864"/>
              </event>
              <event>
                <sub_title>Bipolar disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1721"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="864"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="864"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Hydronephrosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1721"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="864"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="864"/>
              </event>
              <event>
                <sub_title>Renal failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1721"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="864"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="864"/>
              </event>
              <event>
                <sub_title>Renal failure acute</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1721"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="864"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="864"/>
              </event>
              <event>
                <sub_title>Renal impairment</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1721"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="864"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="864"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1721"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="864"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="864"/>
              </event>
              <event>
                <sub_title>Acute respiratory failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1721"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="864"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="864"/>
              </event>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1721"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="864"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="864"/>
              </event>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1721"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="864"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="864"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1721"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="864"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="864"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1721"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="864"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="864"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetic foot</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1721"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="864"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="864"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Accelerated hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1721"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="864"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="864"/>
              </event>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1721"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="864"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="864"/>
              </event>
              <event>
                <sub_title>Granulomatosis with polyangiitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1721"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="864"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="864"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1721"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="864"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="864"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <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="872" subjects_at_risk="1721"/>
                <counts group_id="E2" subjects_affected="445" subjects_at_risk="864"/>
                <counts group_id="E3" subjects_affected="397" subjects_at_risk="864"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="629" subjects_affected="622" subjects_at_risk="1721"/>
                <counts group_id="E2" events="292" subjects_affected="286" subjects_at_risk="864"/>
                <counts group_id="E3" events="316" subjects_affected="309" subjects_at_risk="864"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="352" subjects_affected="328" subjects_at_risk="1721"/>
                <counts group_id="E2" events="171" subjects_affected="161" subjects_at_risk="864"/>
                <counts group_id="E3" events="173" subjects_affected="157" subjects_at_risk="864"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="300" subjects_affected="258" subjects_at_risk="1721"/>
                <counts group_id="E2" events="113" subjects_affected="96" subjects_at_risk="864"/>
                <counts group_id="E3" events="133" subjects_affected="116" subjects_at_risk="864"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" events="125" subjects_affected="114" subjects_at_risk="1721"/>
                <counts group_id="E2" events="67" subjects_affected="61" subjects_at_risk="864"/>
                <counts group_id="E3" events="72" subjects_affected="62" subjects_at_risk="864"/>
              </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>bioCSL agreements and restrictions on publishing may vary with individual investigators; however, bioCSL will not prohibit any investigator from publishing. bioCSL supports the publication of results from all centers of a multi-center trial and generally requires that reports based on single-site data not precede the primary publication of the entire clinical trial.&#xD;
(Note: bioCSL was previously known as CSL Biotherapies; bioCSL QIV &amp; TIV were called CSL QIV &amp; TIV in the original protocol)</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Seqirus Clinical Trial Disclosure Lead</name_or_title>
      <organization>Seqirus</organization>
      <email>Seqirus.ClinicalTrials@Seqirus.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/NCT02214225
org study id: CSLCT-QIV-13-01
nct id: NCT02214225
lead sponsor: 
has dmc: Yes
This is a study to assess the immune (antibody) response and safety of a bioCSL split virion,
      inactivated quadrivalent influenza vaccine, in comparison with a US licensed 2014/2015
      trivalent influenza vaccine (bioCSL TIV-1), and a trivalent influenza vaccine containing the
      alternate B strain (bioCSL TIV-2), in healthy adult volunteers aged 18 years and above.
This multicenter, randomized, double-blinded study was conducted during the 2014-2015
      Northern Hemisphere influenza immunization season to evaluate the non-inferior immune
      response of bioCSL QIV to that of bioCSL TIV-1 and bioCSL TIV-2 along with safety in healthy
      male and female adults aged ≥ 18 years. Each vaccinated subject had a maximum 25 day on-study
      period with a six month safety follow-up.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Postvaccination Geometric Mean Titer (GMT) (Statistical Analysis: GMT Ratios) in Subjects Aged ≥18 Years (Per Protocol Population).
time frame: 21 days after vaccination.
description: Immunogenicity was assessed by measuring HI titers to the four virus strains. Postvaccination GMTs were determined. (GMT dispersion values are based on unadjusted GMT values.) The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was then determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.
measure: The Seroconversion Rate (SCR) (Statistical Analysis: Difference in SCR) in Subjects Aged ≥18 Years.
time frame: 21 days after vaccination.
description: SCR (defined as the percentage of subjects with either a prevaccination HI titer < 1:10 and a postvaccination HI titer ≥ 1:40 or a prevaccination HI titer ≥ 1:10 and a 4-fold increase in postvaccination HI titer) was determined for each virus strain included in the vaccines: bioCSL TIV-1 and bioCSL TIV-2 SCRs were pooled for analysis of the A strains. The SCR difference was defined as the SCR percentage for bioCSL Pooled TIV or TIV-1 (B Yamagata) or TIV-2 (B Victoria) minus the SCR percentage for bioCSL QIV.
measure: Postvaccination GMT (Statistical Analyses: GMT Ratios) Assessed Separately Within Each Age Group (18 Through 64 Years and ≥ 65 Years of Age) (Per-Protocol Population).
time frame: 21 days after vaccination.
description: Immunogenicity was assessed by measuring HI titers to the four virus strains. Postvaccination GMTs were determined. (GMT dispersion values are based on unadjusted GMT values.) The GMT ratio (defined as the geometric mean of postvaccination (day 21) HI titer for TIV divided by the geometric mean of the postvaccination HI titer for QIV) for each virus strain included in the vaccines was then determined: bioCSL TIV-1 and bioCSL TIV-2 GMTs were pooled for analysis of the A strains.
Non-inferiority of bioCSL QIV compared to bioCSL TIV-1, and to bioCSL TIV-2 was assessed separately within each age group (18 to < 65 years and ≥ 65 years of age) through assessment of GMT ratios as described for the primary endpoint.
measure: The Seroconversion Rate (SCR) (Statistical Analyses: Difference in SCR) for Each Virus Strain, Assessed Separately Within Each Age Group (18 to < 65 Years and ≥ 65 Years of Age) (Per Protocol Population).
time frame: 21 days after vaccination.
description: Non-inferiority of bioCSL QIV compared to bioCSL TIV-1, and to bioCSL TIV-2 was assessed separately within each age group (18 to < 65 years and ≥ 65 years of age) through assessment of SCR differences as described for the primary endpoint.
measure: Immunologic Superiority of the Alternate B Strain in bioCSL QIV, as Determined by the GMT (Statistical Analysis: GMT Ratio) for This Strain, Overall and by Age Cohort (Per Protocol Population).
time frame: 21 days after vaccination.
description: Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to < 65 years and ≥ 65 years of age), and overall. The GMT ratio was calculated as bioCSL QIV GMT/bioCSL TIV GMT for the superiority analyses, which is the reverse of how it was calculated for the non-inferiority analyses.
(GMT dispersion values are based on unadjusted GMT values.)
measure: Immunologic Superiority of the Alternate B Strain in bioCSL QIV, as Determined by Seroconversion Rate (SCR) (Statistical Analysis: Difference in SCR) for This Strain, Overall and by Age Cohort (Per Protocol Population)
time frame: 21 days after vaccination.
description: Immunologic superiority of the alternate B strain (ie, the influenza B strain included in the QIV but not in the TIV formulation) in bioCSL QIV was assessed separately within each age group (18 to < 65 years and ≥ 65 years of age), and overall. The SCR difference was calculated as bioCSL QIV SCR minus bioCSL TIV SCR, which is the reverse of how it was calculated for the non-inferiority analyses. For the SCR comparison superiority was demonstrated if the lower limit of the two-sided 95% CI of the difference of the seroconversion rates was greater than 0 for each B strain in QIV compared with the corresponding B strain not contained in each TIV.
measure: Geometric Mean of HI Titers (GMTs) Prevaccination and Postvaccination.
time frame: 21 days after vaccination.
description: The immunogenicity of bioCSL QIV, bioCSL TIV-1 and bioCSL TIV-2 was assessed in terms of geometric mean HI titers (GMT) prevaccination (Day 1) and postvaccination (Day 21), in age cohorts (per protocol population).
measure: Geometric Mean Fold Titer Change From Prevaccination to Postvaccination.
time frame: 21 days after vaccination.
description: The immunogenicity of bioCSL QIV, bioCSL TIV-1 and bioCSL TIV-2 assessed in terms of Geometric Mean Fold Increase (GMFI, defined as the geometric mean of the fold increases of postvaccination antibody titer over the prevaccination antibody titer) by Age Cohort (Per Protocol Population).
measure: Seroprotection Rates Prevaccination and Postvaccination.
time frame: 21 days after vaccination.
description: The immunogenicity of bioCSL QIV, bioCSL TIV-1 and bioCSL TIV-2 was assessed in terms of percentage of subjects with a HI titer ≥40 (seroprotection rates) prevaccination (Day 1) and postvaccination (Day 21), in age cohorts (per protocol population).
measure: Seroconversion Rates
time frame: 21 days after vaccination.
description: The immunogenicity of bioCSL QIV, bioCSL TIV-1 and bio CSL TIV-2 was assessed in terms of the seroconversion rate, ie, percentage of subjects with either a prevaccination HI titer < 1:10 and a postvaccination HI titer ≥ 1:40, or a prevaccination titer ≥ 1:10 and a ≥ 4-fold increase in post-vaccination titer. Data presented in age cohorts (per protocol population).
measure: The Frequency and Severity of Solicited Local and Systemic Adverse Events (AEs).
time frame: For 7 days following vaccination.
description: The overall number of subjects experiencing at least one event of a local and systemic solicited AE, and the overall number of subjects with at least one severe (grade 3) local and systemic solicited AE.
measure: The Frequency of Cellulitis-like Reaction and Cellulitis.
time frame: For 28 days following vaccination.
description: The number of subjects experiencing at least one episode of each event.
measure: The Frequency and Severity of Unsolicited AEs.
time frame: For 28 days following vaccination.
description: The overall number of subjects experiencing at least one event of an unsolicited AE, and the overall number of subjects with at least one severe (grade 3) unsolicited AE.
measure: The Frequency of Serious Adverse Events (SAEs) for 6 Months Following Vaccination.
time frame: For 6 months following vaccination.
description: The number of participants reporting Serious Adverse Events for 6 months following vaccination.
arm group label: Quadrivalent Influenza Vaccine (QIV)
arm group type: Experimental
description: The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).
arm group label: Trivalent Influenza Vaccine (TIV-1)
arm group type: Active Comparator
description: The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).
arm group label: Trivalent Influenza Vaccine (TIV-2)
arm group type: Active Comparator
description: The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the recommended influenza A (H1N1-, H3N2-like) strains and the alternate B strain for the Northern Hemisphere 2014/2015 influenza season).
intervention type: Biological
intervention name: Quadrivalent Influenza Vaccine (QIV)
description: One 0.5 mL intramuscular dose into the deltoid muscle
arm group label: Quadrivalent Influenza Vaccine (QIV)
intervention type: Biological
intervention name: Trivalent Influenza Vaccine (TIV-1)
description: One 0.5 mL intramuscular dose into the deltoid muscle.
arm group label: Trivalent Influenza Vaccine (TIV-1)
intervention type: Biological
intervention name: Trivalent Influenza Vaccine (TIV-2)
description: One 0.5 mL intramuscular dose into the deltoid muscle.
arm group label: Trivalent Influenza Vaccine (TIV-2)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: bioCSL Pty Ltd Clinical Program Director
role: Study Director
affiliation: Seqirus
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country: United States
responsible party type: Sponsor
mesh term: Influenza, Human
mesh term: Vaccines
participant flow: 
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outcome list: 
reported events: 
certain agreements: 
point of contact: 