<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/NCT02212106</url>
  </required_header>
  <id_info>
    <org_study_id>CSLCT-USF-10-69</org_study_id>
    <secondary_id>2015-000175-27</secondary_id>
    <nct_id>NCT02212106</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Safety and Tolerability of Trivalent Influenza Virus Vaccine in Children Aged 5 Years to &lt; 9 Years</brief_title>
  <official_title>A Phase IV, Multicenter, Randomized, Observer-blind, Parallel-arm Study to Evaluate the Safety and Tolerability of CSL's Trivalent Influenza Virus Vaccine (CSL TIV) in Children 5 to Less Than 9 Years of Age.</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 safety of a bioCSL split virion, inactivated Trivalent&#xD;
      Influenza Virus vaccine containing the 2014/2015 Northern Hemisphere strains of vaccine in&#xD;
      children aged 5 years to less than 9 years. Comparison will be made to a licensed&#xD;
      Quadrivalent Influenza Virus vaccine that complies with the FDA recommendations for the&#xD;
      2014/2015 influenza season in the US.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2014</primary_completion_date>
  <phase>Phase 4</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The Frequency and Intensity of Fever Events Occurring During the 7 Days After Each Administration of CSL TIV Vaccine.</measure>
    <time_frame>7 days after each administration of vaccine.</time_frame>
    <description>The overall percentage of subjects reporting at least one fever event after administration of bioCSL TIV. A fever event was defined as an oral temperature ≥ 38°C (≥ 100.4°F). The intensity was calculated as follows: • Mild: ≥ 100.4 to &lt; 101.3°F (≥ 38.0 to &lt; 38.5°C) • Moderate: ≥ 101.3 to &lt; 102.2°F (≥ 38.5 to &lt; 39.0°C) • Severe: ≥ 102.2°F (≥ 39.0°C)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The Frequency and Intensity of Fever Events Occurring During the 7 Days After Each Administration of the Comparator Influenza Virus Vaccine.</measure>
    <time_frame>7 days after each administration of vaccine.</time_frame>
    <description>The overall percentage of subjects reporting at least one fever event after administration of the comparator influenza virus vaccine. A fever event was defined as an oral temperature ≥ 38°C (≥ 100.4°F). The intensity was calculated as follows: • Mild: ≥ 100.4 to &lt; 101.3°F (≥ 38.0 to &lt; 38.5°C) • Moderate: ≥ 101.3 to &lt; 102.2°F (≥ 38.5 to &lt; 39.0°C) • Severe: ≥ 102.2°F (≥ 39.0°C).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Frequency and Intensity of Vaccine-related Fever Events Occurring During the 7 Days After Each Administration of CSL TIV Vaccine or Comparator Influenza Virus Vaccine.</measure>
    <time_frame>7 days after each administration of vaccine.</time_frame>
    <description>Percentage of subjects with a related fever event (overall) by study vaccine group based on the number of subjects contributing any follow up safety information for at least one data value of an individual sign/symptom. Excludes subjects with missing intensity information for the whole 7 days. Mild fever: ≥ 100.4 to &lt; 101.3º F (≥ 38.0 to &lt; 38.5º C). Moderate fever: ≥ 101.3 to &lt; 102.2º F (≥ 38.5 to &lt; 39.0º C). Severe fever: ≥ 102.2º F (≥ 39.0º C).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Frequency and Intensity of Solicited Local Adverse Events (AEs) Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.</measure>
    <time_frame>7 days after each administration of vaccine.</time_frame>
    <description>The overall frequency and intensity of solicited local Adverse Events (AEs) occurring during the 7 days after each administration of bioCSL TIV or the comparator influenza virus vaccine. Percentage of subjects who experienced each event are based on the number of subjects in the Safety Population group. Excludes subjects with missing intensity information for the whole 7 days. Percentages for intensity are based on the number of subjects with non-missing intensity data. Only the maximum intensity experienced between Day 1 and Day 7 are presented for each subject.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Frequency and Intensity of Solicited Systemic AEs Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.</measure>
    <time_frame>7 days after each administration of vaccine.</time_frame>
    <description>The overall frequency and intensity of solicited systemic Adverse Events (AEs) occurring during the 7 days after each administration of CSL TIV or the comparator influenza virus vaccine. Percentage of subjects who experienced each event are based on the number of subjects in the Safety Population group. Excludes subjects with missing intensity information for the whole 7 days. Percentages for intensity are based on the number of subjects with non-missing intensity data. Only the maximum intensity experienced between Day 1 and Day 7 are presented for each subject.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Frequency and Intensity of Unsolicited AEs Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.</measure>
    <time_frame>7 days after each administration of vaccine.</time_frame>
    <description>The overall frequency and intensity of unsolicited Adverse Events (AEs) occurring during the 7 days after each administration of CSL TIV or the comparator influenza virus vaccine. Percentage of subjects who experienced each event are based on the number of subjects in the Safety Population group. Excludes subjects with missing intensity information for the whole 7 days. If a subject has multiple events of the same intensity or causality, then they are counted only once in that intensity or causality. However, subjects can be counted more than once overall.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Incidence of Serious Adverse Events (SAEs) Occurring up to 7 Days After the Last Administration of CSL TIV or the Comparator Influenza Virus Vaccine.</measure>
    <time_frame>7 days after each administration of vaccine.</time_frame>
    <description>The number of subjects experiencing at least one SAE.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">402</enrollment>
  <condition>Influenza, Human</condition>
  <arm_group>
    <arm_group_label>bioCSL Trivalent Influenza Virus Vaccine (CSL TIV)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total haemagglutinin 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>Comparator Quadrivalent Influenza Virus Vaccine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The comparator vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>bioCSL Trivalent Influenza Virus Vaccine (CSL TIV)</intervention_name>
    <description>Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection.</description>
    <arm_group_label>bioCSL Trivalent Influenza Virus Vaccine (CSL TIV)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Comparator Quadrivalent Influenza Virus Vaccine</intervention_name>
    <description>Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection.</description>
    <arm_group_label>Comparator Quadrivalent Influenza Virus Vaccine</arm_group_label>
    <other_name>Fluzone Quadrivalent</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males or females aged 5 to less than 9 years at the time of first study vaccination.&#xD;
&#xD;
          -  The subject's parent or guardian to provide written informed consent and be willing&#xD;
             and able to adhere to all protocol requirements.&#xD;
&#xD;
          -  In good health, as determined by medical history and a targeted physical examination&#xD;
             (if warranted).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known hypersensitivity to a previous dose of Influenza Virus Vaccine or allergy to&#xD;
             eggs or any components of the study vaccines.&#xD;
&#xD;
          -  Clinical signs of significant active infection or an elevated oral temperature at&#xD;
             study entry.&#xD;
&#xD;
          -  A clinically significant medical or psychiatric condition.&#xD;
&#xD;
          -  A history of seizures or febrile convulsions or Guillain-Barré syndrome.&#xD;
&#xD;
          -  Vaccination with a seasonal or experimental influenza virus vaccine in the 6 months&#xD;
             preceding study entry.&#xD;
&#xD;
          -  Vaccination with a licensed vaccine within 14 days preceding study entry, or planning&#xD;
             to be vaccinated with another licensed vaccine before the study exit evaluation.&#xD;
&#xD;
          -  Currently receiving systemic glucocorticoid therapy (excluding intra-articular,&#xD;
             topical or inhaled preparations) or have received such therapy within the 3 months&#xD;
             preceding study entry.&#xD;
&#xD;
          -  Currently receiving immunoglobulins and/or any blood products or have received such&#xD;
             treatment within the 3 months preceding the administration of the study vaccine.&#xD;
&#xD;
          -  Currently receiving treatment with warfarin or other anticoagulants.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>8 Years</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 286</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90036</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 289</name>
      <address>
        <city>Boise</city>
        <state>Idaho</state>
        <zip>83642</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 285</name>
      <address>
        <city>Binghamton</city>
        <state>New York</state>
        <zip>13901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 290</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27704</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 281</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27609</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 280</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 284</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29403</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>Fort 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_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2015</verification_date>
  <study_first_submitted>August 6, 2014</study_first_submitted>
  <study_first_submitted_qc>August 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 8, 2014</study_first_posted>
  <results_first_submitted>August 20, 2015</results_first_submitted>
  <results_first_submitted_qc>September 20, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">October 16, 2015</results_first_posted>
  <last_update_submitted>September 20, 2015</last_update_submitted>
  <last_update_submitted_qc>September 20, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 16, 2015</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: 22-SEP-2014, Last Patient In: 15-OCT-2014, Last Patient Last Visit: 05-DEC-2014. Number of activated sites that enrolled subjects: 11 (all based in USA).</recruitment_details>
      <pre_assignment_details>Number of subjects screened: 407 Number of screen failures: 5 (Reason: all due to not meeting inclusion/exclusion criteria).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>bioCSL Trivalent Influenza Virus Vaccine (CSL TIV)</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;
bioCSL Trivalent Influenza Virus Vaccine (CSL TIV): Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection.</description>
        </group>
        <group group_id="P2">
          <title>Comparator Quadrivalent Influenza Virus Vaccine</title>
          <description>The comparator vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season.&#xD;
Comparator Quadrivalent Influenza Virus Vaccine: Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="302"/>
                <participants group_id="P2" count="100"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="292"/>
                <participants group_id="P2" count="96"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>bioCSL Trivalent Influenza Virus Vaccine (CSL TIV)</title>
          <description>The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total haemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).&#xD;
bioCSL Trivalent Influenza Virus Vaccine (CSL TIV): Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection.</description>
        </group>
        <group group_id="B2">
          <title>Comparator Quadrivalent Influenza Virus Vaccine</title>
          <description>The comparator vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season.&#xD;
Comparator Quadrivalent Influenza Virus Vaccine: Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection.</description>
        </group>
        <group group_id="B3">
          <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="302"/>
            <count group_id="B2" value="100"/>
            <count group_id="B3" value="402"/>
          </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="6.7" spread="1.05"/>
                    <measurement group_id="B2" value="6.6" spread="1.02"/>
                    <measurement group_id="B3" value="6.6" spread="1.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Age 5 to &lt; 9 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="302"/>
                    <measurement group_id="B2" value="100"/>
                    <measurement group_id="B3" value="402"/>
                  </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="147"/>
                    <measurement group_id="B2" value="46"/>
                    <measurement group_id="B3" value="193"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="155"/>
                    <measurement group_id="B2" value="54"/>
                    <measurement group_id="B3" value="209"/>
                  </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="302"/>
                    <measurement group_id="B2" value="100"/>
                    <measurement group_id="B3" value="402"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>The Frequency and Intensity of Fever Events Occurring During the 7 Days After Each Administration of CSL TIV Vaccine.</title>
        <description>The overall percentage of subjects reporting at least one fever event after administration of bioCSL TIV. A fever event was defined as an oral temperature ≥ 38°C (≥ 100.4°F). The intensity was calculated as follows: • Mild: ≥ 100.4 to &lt; 101.3°F (≥ 38.0 to &lt; 38.5°C) • Moderate: ≥ 101.3 to &lt; 102.2°F (≥ 38.5 to &lt; 39.0°C) • Severe: ≥ 102.2°F (≥ 39.0°C)</description>
        <time_frame>7 days after each administration of vaccine.</time_frame>
        <population>All randomized subjects who received at least one scheduled vaccination and had post-vaccination follow-up safety data available.</population>
        <group_list>
          <group group_id="O1">
            <title>bioCSL Trivalent Influenza Virus Vaccine (CSL TIV)</title>
            <description>The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total haemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).&#xD;
bioCSL Trivalent Influenza Virus Vaccine (CSL TIV): Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection.</description>
          </group>
        </group_list>
        <measure>
          <title>The Frequency and Intensity of Fever Events Occurring During the 7 Days After Each Administration of CSL TIV Vaccine.</title>
          <description>The overall percentage of subjects reporting at least one fever event after administration of bioCSL TIV. A fever event was defined as an oral temperature ≥ 38°C (≥ 100.4°F). The intensity was calculated as follows: • Mild: ≥ 100.4 to &lt; 101.3°F (≥ 38.0 to &lt; 38.5°C) • Moderate: ≥ 101.3 to &lt; 102.2°F (≥ 38.5 to &lt; 39.0°C) • Severe: ≥ 102.2°F (≥ 39.0°C)</description>
          <population>All randomized subjects who received at least one scheduled vaccination and had post-vaccination follow-up safety data available.</population>
          <units>Percentage of subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="292"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Total</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Frequency and Intensity of Fever Events Occurring During the 7 Days After Each Administration of the Comparator Influenza Virus Vaccine.</title>
        <description>The overall percentage of subjects reporting at least one fever event after administration of the comparator influenza virus vaccine. A fever event was defined as an oral temperature ≥ 38°C (≥ 100.4°F). The intensity was calculated as follows: • Mild: ≥ 100.4 to &lt; 101.3°F (≥ 38.0 to &lt; 38.5°C) • Moderate: ≥ 101.3 to &lt; 102.2°F (≥ 38.5 to &lt; 39.0°C) • Severe: ≥ 102.2°F (≥ 39.0°C).</description>
        <time_frame>7 days after each administration of vaccine.</time_frame>
        <population>All randomized subjects who received at least one scheduled vaccination and had post-vaccination follow-up safety data available.</population>
        <group_list>
          <group group_id="O1">
            <title>Comparator Quadrivalent Influenza Virus Vaccine</title>
            <description>The comparator vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season.&#xD;
Comparator Quadrivalent Influenza Virus Vaccine: Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection.</description>
          </group>
        </group_list>
        <measure>
          <title>The Frequency and Intensity of Fever Events Occurring During the 7 Days After Each Administration of the Comparator Influenza Virus Vaccine.</title>
          <description>The overall percentage of subjects reporting at least one fever event after administration of the comparator influenza virus vaccine. A fever event was defined as an oral temperature ≥ 38°C (≥ 100.4°F). The intensity was calculated as follows: • Mild: ≥ 100.4 to &lt; 101.3°F (≥ 38.0 to &lt; 38.5°C) • Moderate: ≥ 101.3 to &lt; 102.2°F (≥ 38.5 to &lt; 39.0°C) • Severe: ≥ 102.2°F (≥ 39.0°C).</description>
          <population>All randomized subjects who received at least one scheduled vaccination and had post-vaccination follow-up safety data available.</population>
          <units>Percentage of subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="98"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Total</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Frequency and Intensity of Vaccine-related Fever Events Occurring During the 7 Days After Each Administration of CSL TIV Vaccine or Comparator Influenza Virus Vaccine.</title>
        <description>Percentage of subjects with a related fever event (overall) by study vaccine group based on the number of subjects contributing any follow up safety information for at least one data value of an individual sign/symptom. Excludes subjects with missing intensity information for the whole 7 days. Mild fever: ≥ 100.4 to &lt; 101.3º F (≥ 38.0 to &lt; 38.5º C). Moderate fever: ≥ 101.3 to &lt; 102.2º F (≥ 38.5 to &lt; 39.0º C). Severe fever: ≥ 102.2º F (≥ 39.0º C).</description>
        <time_frame>7 days after each administration of vaccine.</time_frame>
        <population>All randomized subjects who received at least one scheduled vaccination and had post-vaccination followup safety data available.</population>
        <group_list>
          <group group_id="O1">
            <title>bioCSL Trivalent Influenza Virus Vaccine (CSL TIV)</title>
            <description>The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total haemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).&#xD;
bioCSL Trivalent Influenza Virus Vaccine (CSL TIV): Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection.</description>
          </group>
          <group group_id="O2">
            <title>Comparator Quadrivalent Influenza Virus Vaccine</title>
            <description>The comparator vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season.&#xD;
Comparator Quadrivalent Influenza Virus Vaccine: Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection.</description>
          </group>
        </group_list>
        <measure>
          <title>The Frequency and Intensity of Vaccine-related Fever Events Occurring During the 7 Days After Each Administration of CSL TIV Vaccine or Comparator Influenza Virus Vaccine.</title>
          <description>Percentage of subjects with a related fever event (overall) by study vaccine group based on the number of subjects contributing any follow up safety information for at least one data value of an individual sign/symptom. Excludes subjects with missing intensity information for the whole 7 days. Mild fever: ≥ 100.4 to &lt; 101.3º F (≥ 38.0 to &lt; 38.5º C). Moderate fever: ≥ 101.3 to &lt; 102.2º F (≥ 38.5 to &lt; 39.0º C). Severe fever: ≥ 102.2º F (≥ 39.0º C).</description>
          <population>All randomized subjects who received at least one scheduled vaccination and had post-vaccination followup safety data available.</population>
          <units>Percentage of subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="292"/>
                <count group_id="O2" value="98"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Total</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.5"/>
                    <measurement group_id="O2" value="5.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.1"/>
                    <measurement group_id="O2" value="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.7"/>
                    <measurement group_id="O2" value="4.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.7"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Frequency and Intensity of Solicited Local Adverse Events (AEs) Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.</title>
        <description>The overall frequency and intensity of solicited local Adverse Events (AEs) occurring during the 7 days after each administration of bioCSL TIV or the comparator influenza virus vaccine. Percentage of subjects who experienced each event are based on the number of subjects in the Safety Population group. Excludes subjects with missing intensity information for the whole 7 days. Percentages for intensity are based on the number of subjects with non-missing intensity data. Only the maximum intensity experienced between Day 1 and Day 7 are presented for each subject.</description>
        <time_frame>7 days after each administration of vaccine.</time_frame>
        <population>All randomized subjects who received at least one scheduled vaccination and had post-vaccination followup safety data available.</population>
        <group_list>
          <group group_id="O1">
            <title>bioCSL Trivalent Influenza Virus Vaccine (CSL TIV)</title>
            <description>The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total haemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).&#xD;
bioCSL Trivalent Influenza Virus Vaccine (CSL TIV): Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection.</description>
          </group>
          <group group_id="O2">
            <title>Comparator Quadrivalent Influenza Virus Vaccine</title>
            <description>The comparator vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season.&#xD;
Comparator Quadrivalent Influenza Virus Vaccine: Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection.</description>
          </group>
        </group_list>
        <measure>
          <title>The Frequency and Intensity of Solicited Local Adverse Events (AEs) Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.</title>
          <description>The overall frequency and intensity of solicited local Adverse Events (AEs) occurring during the 7 days after each administration of bioCSL TIV or the comparator influenza virus vaccine. Percentage of subjects who experienced each event are based on the number of subjects in the Safety Population group. Excludes subjects with missing intensity information for the whole 7 days. Percentages for intensity are based on the number of subjects with non-missing intensity data. Only the maximum intensity experienced between Day 1 and Day 7 are presented for each subject.</description>
          <population>All randomized subjects who received at least one scheduled vaccination and had post-vaccination followup safety data available.</population>
          <units>Percentage of subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="292"/>
                <count group_id="O2" value="98"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Total</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70.2"/>
                    <measurement group_id="O2" value="68.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total - mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49.8"/>
                    <measurement group_id="O2" value="46.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total - moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.2"/>
                    <measurement group_id="O2" value="15.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total - severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.4"/>
                    <measurement group_id="O2" value="6.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain - total</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="64.4"/>
                    <measurement group_id="O2" value="57.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain - mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53.3"/>
                    <measurement group_id="O2" value="42.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain - moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.6"/>
                    <measurement group_id="O2" value="13.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain - severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.7"/>
                    <measurement group_id="O2" value="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Redness - total</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.9"/>
                    <measurement group_id="O2" value="37.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Redness - mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.8"/>
                    <measurement group_id="O2" value="30.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Redness - moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.2"/>
                    <measurement group_id="O2" value="3.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Redness - severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0"/>
                    <measurement group_id="O2" value="4.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Swelling/Lump - total</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.8"/>
                    <measurement group_id="O2" value="40.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Swelling/Lump - mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.0"/>
                    <measurement group_id="O2" value="28.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Swelling/Lump - moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.9"/>
                    <measurement group_id="O2" value="8.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Swelling/Lump - severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0"/>
                    <measurement group_id="O2" value="4.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Frequency and Intensity of Solicited Systemic AEs Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.</title>
        <description>The overall frequency and intensity of solicited systemic Adverse Events (AEs) occurring during the 7 days after each administration of CSL TIV or the comparator influenza virus vaccine. Percentage of subjects who experienced each event are based on the number of subjects in the Safety Population group. Excludes subjects with missing intensity information for the whole 7 days. Percentages for intensity are based on the number of subjects with non-missing intensity data. Only the maximum intensity experienced between Day 1 and Day 7 are presented for each subject.</description>
        <time_frame>7 days after each administration of vaccine.</time_frame>
        <population>All randomized subjects who received at least one scheduled vaccination and had post-vaccination followup safety data available.</population>
        <group_list>
          <group group_id="O1">
            <title>bioCSL Trivalent Influenza Virus Vaccine (CSL TIV)</title>
            <description>The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total haemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).&#xD;
bioCSL Trivalent Influenza Virus Vaccine (CSL TIV): Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection.</description>
          </group>
          <group group_id="O2">
            <title>Comparator Quadrivalent Influenza Virus Vaccine</title>
            <description>The comparator vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season.&#xD;
Comparator Quadrivalent Influenza Virus Vaccine: Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection.</description>
          </group>
        </group_list>
        <measure>
          <title>The Frequency and Intensity of Solicited Systemic AEs Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.</title>
          <description>The overall frequency and intensity of solicited systemic Adverse Events (AEs) occurring during the 7 days after each administration of CSL TIV or the comparator influenza virus vaccine. Percentage of subjects who experienced each event are based on the number of subjects in the Safety Population group. Excludes subjects with missing intensity information for the whole 7 days. Percentages for intensity are based on the number of subjects with non-missing intensity data. Only the maximum intensity experienced between Day 1 and Day 7 are presented for each subject.</description>
          <population>All randomized subjects who received at least one scheduled vaccination and had post-vaccination followup safety data available.</population>
          <units>Percentage of subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="292"/>
                <count group_id="O2" value="98"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Total</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.8"/>
                    <measurement group_id="O2" value="44.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total - mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.4"/>
                    <measurement group_id="O2" value="21.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total - moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.6"/>
                    <measurement group_id="O2" value="19.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total - severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.8"/>
                    <measurement group_id="O2" value="4.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Headache - total</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.7"/>
                    <measurement group_id="O2" value="23.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Headache - mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.4"/>
                    <measurement group_id="O2" value="12.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Headache - moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.1"/>
                    <measurement group_id="O2" value="10.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Headache - severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3"/>
                    <measurement group_id="O2" value="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Malaise - total</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.9"/>
                    <measurement group_id="O2" value="14.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Malaise - mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.2"/>
                    <measurement group_id="O2" value="9.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Malaise - moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0"/>
                    <measurement group_id="O2" value="5.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Malaise - severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Muscle ache (myalgia) - total</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.3"/>
                    <measurement group_id="O2" value="23.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Muscle ache (myalgia) - mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.0"/>
                    <measurement group_id="O2" value="15.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Muscle ache (myalgia) - moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.4"/>
                    <measurement group_id="O2" value="7.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Muscle ache (myalgia) - severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0"/>
                    <measurement group_id="O2" value="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diarrhea - total</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.1"/>
                    <measurement group_id="O2" value="11.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diarrhea - mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.8"/>
                    <measurement group_id="O2" value="6.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diarrhea - moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0"/>
                    <measurement group_id="O2" value="4.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diarrhea - severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3"/>
                    <measurement group_id="O2" value="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Nausea - total</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.8"/>
                    <measurement group_id="O2" value="9.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Nausea - mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.5"/>
                    <measurement group_id="O2" value="6.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Nausea - moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7"/>
                    <measurement group_id="O2" value="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Nausea - severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7"/>
                    <measurement group_id="O2" value="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vomiting - total</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.7"/>
                    <measurement group_id="O2" value="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vomiting - mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vomiting - moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3"/>
                    <measurement group_id="O2" value="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vomiting - severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3"/>
                    <measurement group_id="O2" value="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fever - total</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.2"/>
                    <measurement group_id="O2" value="9.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fever - mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.1"/>
                    <measurement group_id="O2" value="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fever - moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.1"/>
                    <measurement group_id="O2" value="4.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fever - severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.1"/>
                    <measurement group_id="O2" value="4.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Frequency and Intensity of Unsolicited AEs Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.</title>
        <description>The overall frequency and intensity of unsolicited Adverse Events (AEs) occurring during the 7 days after each administration of CSL TIV or the comparator influenza virus vaccine. Percentage of subjects who experienced each event are based on the number of subjects in the Safety Population group. Excludes subjects with missing intensity information for the whole 7 days. If a subject has multiple events of the same intensity or causality, then they are counted only once in that intensity or causality. However, subjects can be counted more than once overall.</description>
        <time_frame>7 days after each administration of vaccine.</time_frame>
        <population>All randomized subjects who received at least one scheduled vaccination and had post-vaccination followup safety data available.</population>
        <group_list>
          <group group_id="O1">
            <title>bioCSL Trivalent Influenza Virus Vaccine (CSL TIV)</title>
            <description>The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total haemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).&#xD;
bioCSL Trivalent Influenza Virus Vaccine (CSL TIV): Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection.</description>
          </group>
          <group group_id="O2">
            <title>Comparator Quadrivalent Influenza Virus Vaccine</title>
            <description>The comparator vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season.&#xD;
Comparator Quadrivalent Influenza Virus Vaccine: Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection.</description>
          </group>
        </group_list>
        <measure>
          <title>The Frequency and Intensity of Unsolicited AEs Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.</title>
          <description>The overall frequency and intensity of unsolicited Adverse Events (AEs) occurring during the 7 days after each administration of CSL TIV or the comparator influenza virus vaccine. Percentage of subjects who experienced each event are based on the number of subjects in the Safety Population group. Excludes subjects with missing intensity information for the whole 7 days. If a subject has multiple events of the same intensity or causality, then they are counted only once in that intensity or causality. However, subjects can be counted more than once overall.</description>
          <population>All randomized subjects who received at least one scheduled vaccination and had post-vaccination followup safety data available.</population>
          <units>Percentage of subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="292"/>
                <count group_id="O2" value="98"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Total</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.0"/>
                    <measurement group_id="O2" value="22.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total - mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.2"/>
                    <measurement group_id="O2" value="12.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total - moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.8"/>
                    <measurement group_id="O2" value="10.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total - severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7"/>
                    <measurement group_id="O2" value="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Incidence of Serious Adverse Events (SAEs) Occurring up to 7 Days After the Last Administration of CSL TIV or the Comparator Influenza Virus Vaccine.</title>
        <description>The number of subjects experiencing at least one SAE.</description>
        <time_frame>7 days after each administration of vaccine.</time_frame>
        <population>All randomized subjects who received at least one scheduled vaccination and had post-vaccination followup safety data available.</population>
        <group_list>
          <group group_id="O1">
            <title>bioCSL Trivalent Influenza Virus Vaccine (CSL TIV)</title>
            <description>The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total haemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).&#xD;
bioCSL Trivalent Influenza Virus Vaccine (CSL TIV): Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection.</description>
          </group>
          <group group_id="O2">
            <title>Comparator Quadrivalent Influenza Virus Vaccine</title>
            <description>The comparator vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season.&#xD;
Comparator Quadrivalent Influenza Virus Vaccine: Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection.</description>
          </group>
        </group_list>
        <measure>
          <title>The Incidence of Serious Adverse Events (SAEs) Occurring up to 7 Days After the Last Administration of CSL TIV or the Comparator Influenza Virus Vaccine.</title>
          <description>The number of subjects experiencing at least one SAE.</description>
          <population>All randomized subjects who received at least one scheduled vaccination and had post-vaccination followup safety data available.</population>
          <units>Number of subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="292"/>
                <count group_id="O2" value="98"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>7 days after each vaccination.</time_frame>
      <desc>Overall data (following first &amp; second vaccination) for Safety Population is shown. If a subject has multiple events of the same intensity or causality, then they are counted only once in that intensity or causality. However, subjects can be counted more than once overall</desc>
      <group_list>
        <group group_id="E1">
          <title>bioCSL Trivalent Influenza Virus Vaccine (CSL TIV)</title>
          <description>The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total haemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).&#xD;
bioCSL Trivalent Influenza Virus Vaccine (CSL TIV): Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection.</description>
        </group>
        <group group_id="E2">
          <title>Comparator Quadrivalent Influenza Virus Vaccine</title>
          <description>The comparator vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season.&#xD;
Comparator Quadrivalent Influenza Virus Vaccine: Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (17)</default_vocab>
        <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="1" subjects_at_risk="292"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="98"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Delirium febrile</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="292"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="98"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (17)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="222" subjects_at_risk="292"/>
                <counts group_id="E2" subjects_affected="75" subjects_at_risk="98"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" events="19" subjects_affected="15" subjects_at_risk="292"/>
                <counts group_id="E2" events="16" subjects_affected="11" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="22" subjects_affected="20" subjects_at_risk="292"/>
                <counts group_id="E2" events="9" subjects_affected="9" subjects_at_risk="98"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="230" subjects_affected="188" subjects_at_risk="292"/>
                <counts group_id="E2" events="71" subjects_affected="56" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Redness</sub_title>
                <counts group_id="E1" events="117" subjects_affected="102" subjects_at_risk="292"/>
                <counts group_id="E2" events="44" subjects_affected="37" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Swelling / lump</sub_title>
                <counts group_id="E1" events="101" subjects_affected="87" subjects_at_risk="292"/>
                <counts group_id="E2" events="50" subjects_affected="40" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" events="32" subjects_affected="26" subjects_at_risk="292"/>
                <counts group_id="E2" events="18" subjects_affected="14" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Fever</sub_title>
                <counts group_id="E1" events="25" subjects_affected="24" subjects_at_risk="292"/>
                <counts group_id="E2" events="11" subjects_affected="9" subjects_at_risk="98"/>
              </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="80" subjects_affected="71" subjects_at_risk="292"/>
                <counts group_id="E2" events="26" subjects_affected="23" subjects_at_risk="98"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="55" subjects_affected="43" subjects_at_risk="292"/>
                <counts group_id="E2" events="32" subjects_affected="23" subjects_at_risk="98"/>
              </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>CSL agreements and restrictions on publishing may vary with individual investigators; however, CSL will not prohibit any investigator from publishing. CSL 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.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Clinical Program Director</name_or_title>
      <organization>bioCSL PTY LTD</organization>
      <email>bioCSL.ClinicalTrials@biocsl.com.au</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/NCT02212106
org study id: CSLCT-USF-10-69
secondary id: 2015-000175-27
nct id: NCT02212106
lead sponsor: 
has dmc: Yes
This is a study to assess the safety of a bioCSL split virion, inactivated Trivalent
      Influenza Virus vaccine containing the 2014/2015 Northern Hemisphere strains of vaccine in
      children aged 5 years to less than 9 years. Comparison will be made to a licensed
      Quadrivalent Influenza Virus vaccine that complies with the FDA recommendations for the
      2014/2015 influenza season in the US.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: The Frequency and Intensity of Fever Events Occurring During the 7 Days After Each Administration of CSL TIV Vaccine.
time frame: 7 days after each administration of vaccine.
description: The overall percentage of subjects reporting at least one fever event after administration of bioCSL TIV. A fever event was defined as an oral temperature ≥ 38°C (≥ 100.4°F). The intensity was calculated as follows: • Mild: ≥ 100.4 to < 101.3°F (≥ 38.0 to < 38.5°C) • Moderate: ≥ 101.3 to < 102.2°F (≥ 38.5 to < 39.0°C) • Severe: ≥ 102.2°F (≥ 39.0°C)
measure: The Frequency and Intensity of Fever Events Occurring During the 7 Days After Each Administration of the Comparator Influenza Virus Vaccine.
time frame: 7 days after each administration of vaccine.
description: The overall percentage of subjects reporting at least one fever event after administration of the comparator influenza virus vaccine. A fever event was defined as an oral temperature ≥ 38°C (≥ 100.4°F). The intensity was calculated as follows: • Mild: ≥ 100.4 to < 101.3°F (≥ 38.0 to < 38.5°C) • Moderate: ≥ 101.3 to < 102.2°F (≥ 38.5 to < 39.0°C) • Severe: ≥ 102.2°F (≥ 39.0°C).
measure: The Frequency and Intensity of Vaccine-related Fever Events Occurring During the 7 Days After Each Administration of CSL TIV Vaccine or Comparator Influenza Virus Vaccine.
time frame: 7 days after each administration of vaccine.
description: Percentage of subjects with a related fever event (overall) by study vaccine group based on the number of subjects contributing any follow up safety information for at least one data value of an individual sign/symptom. Excludes subjects with missing intensity information for the whole 7 days. Mild fever: ≥ 100.4 to < 101.3º F (≥ 38.0 to < 38.5º C). Moderate fever: ≥ 101.3 to < 102.2º F (≥ 38.5 to < 39.0º C). Severe fever: ≥ 102.2º F (≥ 39.0º C).
measure: The Frequency and Intensity of Solicited Local Adverse Events (AEs) Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.
time frame: 7 days after each administration of vaccine.
description: The overall frequency and intensity of solicited local Adverse Events (AEs) occurring during the 7 days after each administration of bioCSL TIV or the comparator influenza virus vaccine. Percentage of subjects who experienced each event are based on the number of subjects in the Safety Population group. Excludes subjects with missing intensity information for the whole 7 days. Percentages for intensity are based on the number of subjects with non-missing intensity data. Only the maximum intensity experienced between Day 1 and Day 7 are presented for each subject.
measure: The Frequency and Intensity of Solicited Systemic AEs Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.
time frame: 7 days after each administration of vaccine.
description: The overall frequency and intensity of solicited systemic Adverse Events (AEs) occurring during the 7 days after each administration of CSL TIV or the comparator influenza virus vaccine. Percentage of subjects who experienced each event are based on the number of subjects in the Safety Population group. Excludes subjects with missing intensity information for the whole 7 days. Percentages for intensity are based on the number of subjects with non-missing intensity data. Only the maximum intensity experienced between Day 1 and Day 7 are presented for each subject.
measure: The Frequency and Intensity of Unsolicited AEs Occurring During the 7 Days After Each Administration of CSL TIV or the Comparator Influenza Virus Vaccine.
time frame: 7 days after each administration of vaccine.
description: The overall frequency and intensity of unsolicited Adverse Events (AEs) occurring during the 7 days after each administration of CSL TIV or the comparator influenza virus vaccine. Percentage of subjects who experienced each event are based on the number of subjects in the Safety Population group. Excludes subjects with missing intensity information for the whole 7 days. If a subject has multiple events of the same intensity or causality, then they are counted only once in that intensity or causality. However, subjects can be counted more than once overall.
measure: The Incidence of Serious Adverse Events (SAEs) Occurring up to 7 Days After the Last Administration of CSL TIV or the Comparator Influenza Virus Vaccine.
time frame: 7 days after each administration of vaccine.
description: The number of subjects experiencing at least one SAE.
arm group label: bioCSL Trivalent Influenza Virus Vaccine (CSL TIV)
arm group type: Experimental
description: The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total haemagglutinin 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: Comparator Quadrivalent Influenza Virus Vaccine
arm group type: Active Comparator
description: The comparator vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season.
intervention type: Biological
intervention name: bioCSL Trivalent Influenza Virus Vaccine (CSL TIV)
description: Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection.
arm group label: bioCSL Trivalent Influenza Virus Vaccine (CSL TIV)
intervention type: Biological
intervention name: Comparator Quadrivalent Influenza Virus Vaccine
description: Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection.
arm group label: Comparator Quadrivalent Influenza Virus Vaccine
other name: Fluzone Quadrivalent
criteria: 
gender: All
minimum age: 5 Years
maximum age: 8 Years
healthy volunteers: Accepts Healthy Volunteers
last name: bioCSL Pty Ltd Clinical Program Director
role: Study Director
affiliation: Seqirus
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Influenza, Human
mesh term: Vaccines
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 