<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/NCT02256488</url>
  </required_header>
  <id_info>
    <org_study_id>V58_23</org_study_id>
    <nct_id>NCT02256488</nct_id>
  </id_info>
  <brief_title>Safety and Immunogenicity of Two Trivalent Subunit Influenza Vaccines in Healthy Adult Subjects</brief_title>
  <official_title>A Phase III, Multicenter, Randomized, Double-Blind, Controlled Study to Evaluate the Safety and Immunogenicity of Two Trivalent Subunit Influenza Vaccines in Healthy Adult Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Novartis Vaccines</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Novartis</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the immunologic equivalence of three consecutive&#xD;
      lots of a cell based trivalent subunit influenza vaccine (TIVc), and to assess&#xD;
      immunogenicity, safety and tolerability of the vaccine and an egg based trivalent subunit&#xD;
      influenza vaccine (TIVf).&#xD;
&#xD;
      The study comprised 1 vaccination, 2 clinic visits, 3 reminder calls and 2 blood draws.&#xD;
      Female subjects of childbearing potential were tested for pregnancy before the administration&#xD;
      of the vaccine and included only if using and agreeing to continue to use contraception&#xD;
      during the course of the study.&#xD;
&#xD;
      The total study participation time per subject is about 3 weeks.&#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 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>Other</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Immunologic Equivalence of 3 Consecutive Influenza Vaccine (TIVc) Production Lots.</measure>
    <time_frame>Day 22</time_frame>
    <description>Hemagglutination inhibition (HI) geometric mean titers (GMTs) achieved by subjects, for each three vaccine strains, three weeks after one vaccination of one lot of TIVc vaccine (Day 22), evaluated using HI antigen assay.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentages of Subjects Who Achieved HI Seroconversion and HI Titer ≥1:40 Against Each of Three Strains After One Vaccination of TIVc and TIVf Vaccine.</measure>
    <time_frame>Day 22</time_frame>
    <description>Percentages of subjects achieving HI seroconversion after each of three vaccine strains were measured three weeks after vaccination of TIVc or TIVf vaccine (day 22).&#xD;
Percentages of subjects who achieved HI titer ≥1:40 against each of three vaccine strains were measured three weeks after one vaccination of TIVc or TIVf vaccine.&#xD;
HI assay analysis for TIVc vaccine was based on cell-based antigen and for TIVf vaccine was based on egg based antigen.&#xD;
According to Center for Biologics Evaluation and Research recommendations (CBER 2007), CBER criteria are met when the lower limit of the 2-sided 95% CI for seroconversion/significant increase is ≥ 40%, and the lower limit of the 2-sided 95% CI for HI titers ≥ 1:40 is ≥ 70%.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIVc and TIVf</measure>
    <time_frame>Day 1 through day 7 (without 30 min)</time_frame>
    <description>Safety was assessed as the number of subjects who reported solicited local and systemic adverse events from day 1 up to and including day 7 after vaccination of TIVc and control vaccines.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With Unsolicited Adverse Events</measure>
    <time_frame>Day 1 through day 22</time_frame>
    <description>Safety was assessed as the number of subjects who reported Unsolicited Adverse Events after vaccination of TIVc and control vaccine.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">1561</enrollment>
  <condition>Prophylaxis: Influenza</condition>
  <arm_group>
    <arm_group_label>TIVc-Lot A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot A</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TIVc-Lot B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot B</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TIVc-Lot C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot C</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TIVf</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects 18 to ≤ 49 years of age who received one vaccination of Control vaccine TIVf</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>TIVc_LOT A</intervention_name>
    <description>Single IM (Intramuscular) administration dose of 0.5 mL of TIVc</description>
    <arm_group_label>TIVc-Lot A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>TIVc_LOT B</intervention_name>
    <description>Single IM administration dose of 0.5 mL of TIVc</description>
    <arm_group_label>TIVc-Lot B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>TIVc_LOT C</intervention_name>
    <description>Single IM administration dose of 0.5 mL of TIVc</description>
    <arm_group_label>TIVc-Lot C</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>TIVf</intervention_name>
    <description>Single IM administration dose of 0.5 mL of TIVf</description>
    <arm_group_label>TIVf</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males or females 18 through 49 years of age.&#xD;
&#xD;
          -  Subjects having provided informed consent.&#xD;
&#xD;
          -  Individuals in good health&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Chronic or acute illness that would interfere with the subject's safety and/or could&#xD;
             interfere with the evaluation of study vaccine, including known history of&#xD;
             anaphylaxis, serious vaccine reactions or hypersensitivity, known immunodeficiency or&#xD;
             receiving immunosuppressive therapy.&#xD;
&#xD;
          -  Female of childbearing potential not using acceptable contraceptive methods, pregnant&#xD;
             or breastfeeding.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>49 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Anaheim Clincial Trials</name>
      <address>
        <city>Anaheim</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northern California Clinical Research Center</name>
      <address>
        <city>Redding</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southern California CRC</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Broward Research Group</name>
      <address>
        <city>Hollywood</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Comprehensive Clinical Trials, LLC</name>
      <address>
        <city>West Palm Beach</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Palm Bech Research</name>
      <address>
        <city>West Palm Beach</city>
        <state>Florida</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meridian Clinical Research</name>
      <address>
        <city>Savannah</city>
        <state>Georgia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Johnson County Clin-Trials, LLC</name>
      <address>
        <city>Lenexa</city>
        <state>Kansas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Heartland Research Associates, LLC</name>
      <address>
        <city>Wichita</city>
        <state>Kansas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Milford Emergency Associate,Inc</name>
      <address>
        <city>Milford</city>
        <state>Massachusetts</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Meridian Clinical Research</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rochester Clinical Research, Inc</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PMG Research of Charlotte</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PMG Research of Hickory</name>
      <address>
        <city>Hickory</city>
        <state>North Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PMG Research of Raleigh</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New Horizons Clinical Research</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbia Research Group, Inc</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Omega Medical Research</name>
      <address>
        <city>Warwick</city>
        <state>Rhode Island</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Solutions, LLC</name>
      <address>
        <city>Franklin</city>
        <state>Tennessee</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Associates, Inc</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foothill Family Clinc South, J. Lewis Research Inc.</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foothill Family Clinic, J. Lewis Research Inc.</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jordan River Family Medicine, J. Lewis Research, Inc.</name>
      <address>
        <city>South Jordan</city>
        <state>Utah</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Associates</name>
      <address>
        <city>Norfolk</city>
        <state>Virginia</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>September 26, 2014</study_first_submitted>
  <study_first_submitted_qc>September 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2014</study_first_posted>
  <results_first_submitted>July 10, 2015</results_first_submitted>
  <results_first_submitted_qc>July 10, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">August 7, 2015</results_first_posted>
  <last_update_submitted>May 28, 2019</last_update_submitted>
  <last_update_submitted_qc>May 28, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2019</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>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Subjects were enrolled at Twenty five study centers in the United States of America.</recruitment_details>
      <pre_assignment_details>All enrolled subjects were included in the trial.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>TIVc_LOT A</title>
          <description>Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot A</description>
        </group>
        <group group_id="P2">
          <title>TIVc_LOT B</title>
          <description>Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot B</description>
        </group>
        <group group_id="P3">
          <title>TIVc_LOT C</title>
          <description>Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot C</description>
        </group>
        <group group_id="P4">
          <title>TIVf</title>
          <description>Subjects 18 to ≤ 49 years of age who received one vaccination of Control vaccine TIVf</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="387"/>
                <participants group_id="P2" count="392"/>
                <participants group_id="P3" count="392"/>
                <participants group_id="P4" count="390"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="379"/>
                <participants group_id="P2" count="386"/>
                <participants group_id="P3" count="382"/>
                <participants group_id="P4" count="384"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="10"/>
                <participants group_id="P4" count="6"/>
              </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="6"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="9"/>
                <participants group_id="P4" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>OTHER</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>TIVc_LOT A</title>
          <description>Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot A</description>
        </group>
        <group group_id="B2">
          <title>TIVc_LOT B</title>
          <description>Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot B</description>
        </group>
        <group group_id="B3">
          <title>TIVc_LOT C</title>
          <description>Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot C</description>
        </group>
        <group group_id="B4">
          <title>TIVf</title>
          <description>Subjects 18 to ≤ 49 years of age who received one vaccination of Control vaccine TIVf</description>
        </group>
        <group group_id="B5">
          <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="387"/>
            <count group_id="B2" value="392"/>
            <count group_id="B3" value="392"/>
            <count group_id="B4" value="390"/>
            <count group_id="B5" value="1561"/>
          </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="32.4" spread="9.1"/>
                    <measurement group_id="B2" value="33.1" spread="8.8"/>
                    <measurement group_id="B3" value="33.8" spread="8.8"/>
                    <measurement group_id="B4" value="33.2" spread="9.0"/>
                    <measurement group_id="B5" value="33.1" spread="8.9"/>
                  </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="221"/>
                    <measurement group_id="B2" value="227"/>
                    <measurement group_id="B3" value="243"/>
                    <measurement group_id="B4" value="250"/>
                    <measurement group_id="B5" value="941"/>
                  </measurement_list>
                </category>
                <category>
                  <title>MALE</title>
                  <measurement_list>
                    <measurement group_id="B1" value="166"/>
                    <measurement group_id="B2" value="165"/>
                    <measurement group_id="B3" value="149"/>
                    <measurement group_id="B4" value="140"/>
                    <measurement group_id="B5" value="620"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Immunologic Equivalence of 3 Consecutive Influenza Vaccine (TIVc) Production Lots.</title>
        <description>Hemagglutination inhibition (HI) geometric mean titers (GMTs) achieved by subjects, for each three vaccine strains, three weeks after one vaccination of one lot of TIVc vaccine (Day 22), evaluated using HI antigen assay.</description>
        <time_frame>Day 22</time_frame>
        <population>Per Protocol Set(PPS) All subjects in the FAS (Full Analysis Set) Immunogenicity Population who were not excluded due to reasons defined prior to unblinding or analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>TIVc_LOT A</title>
            <description>Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot A</description>
          </group>
          <group group_id="O2">
            <title>TIVc_LOT B</title>
            <description>Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot B</description>
          </group>
          <group group_id="O3">
            <title>TIVc_LOT C</title>
            <description>Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot C</description>
          </group>
        </group_list>
        <measure>
          <title>Immunologic Equivalence of 3 Consecutive Influenza Vaccine (TIVc) Production Lots.</title>
          <description>Hemagglutination inhibition (HI) geometric mean titers (GMTs) achieved by subjects, for each three vaccine strains, three weeks after one vaccination of one lot of TIVc vaccine (Day 22), evaluated using HI antigen assay.</description>
          <population>Per Protocol Set(PPS) All subjects in the FAS (Full Analysis Set) Immunogenicity Population who were not excluded due to reasons defined prior to unblinding or analysis.</population>
          <units>Titers</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="363"/>
                <count group_id="O2" value="375"/>
                <count group_id="O3" value="374"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>A/Brisbane/10/2010 (H1N1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="667" lower_limit="595" upper_limit="747"/>
                    <measurement group_id="O2" value="738" lower_limit="660" upper_limit="824"/>
                    <measurement group_id="O3" value="655" lower_limit="586" upper_limit="733"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/Texas/50/2012 (H3N2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="466" lower_limit="417" upper_limit="519"/>
                    <measurement group_id="O2" value="472" lower_limit="424" upper_limit="525"/>
                    <measurement group_id="O3" value="437" lower_limit="392" upper_limit="486"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B Massachusetts/2/2012 (B)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="178" lower_limit="161" upper_limit="196"/>
                    <measurement group_id="O2" value="175" lower_limit="159" upper_limit="192"/>
                    <measurement group_id="O3" value="172" lower_limit="156" upper_limit="189"/>
                  </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>To demonstrate immunologic equivalence of three consecutive TIVc production lots as evaluated by HI antibody responses after vaccination for all 3 influenza strains at day 22.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>The lot-to-lot consistency was claimed if the 2-sided 95% CIs of all the three pairwise comparisons was within the equivalence ranges, that is:&#xD;
(μlot A - μlot B) &gt; -0.176 and (μlot A - μlot B) &lt; 0.176 and (μlot A - μlot C) &gt; -0.176 and (μlot A - μlot C) &lt; 0.176 and (μlot B - μlot C) &gt; -0.176 and (μlot B - μlot C) &lt; 0.176</non_inferiority_desc>
            <param_type>Ratio of GMTs</param_type>
            <param_value>0.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.667</ci_lower_limit>
            <ci_upper_limit>1.5</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>To demonstrate immunologic equivalence of three consecutive TIVc production lots as evaluated by HI antibody responses after vaccination for for all 3 influenza strains at day 22</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>The lot-to-lot consistency was claimed if the 2-sided 95% CIs of all the three pairwise comparisons was within the equivalence ranges, that is:&#xD;
(μlot A - μlot B) &gt; -0.176 and (μlot A - μlot B) &lt; 0.176 and (μlot A - μlot C) &gt; -0.176 and (μlot A - μlot C) &lt; 0.176 and (μlot B - μlot C) &gt; -0.176 and (μlot B - μlot C) &lt; 0.176</non_inferiority_desc>
            <param_type>Ratio of GMTs</param_type>
            <param_value>1.02</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.667</ci_lower_limit>
            <ci_upper_limit>1.5</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>To demonstrate immunologic equivalence of three consecutive TIVc production lots as evaluated by HI antibody responses after vaccination for all 3 influenza strains at day 22</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>The lot-to-lot consistency was claimed if the 2-sided 95% CIs of all the three pairwise comparisons was within the equivalence ranges, that is:&#xD;
(μlot A - μlot B) &gt; -0.176 and (μlot A - μlot B) &lt; 0.176 and (μlot A - μlot C) &gt; -0.176 and (μlot A - μlot C) &lt; 0.176 and (μlot B - μlot C) &gt; -0.176 and (μlot B - μlot C) &lt; 0.176</non_inferiority_desc>
            <param_type>Ratio of GMTs</param_type>
            <param_value>1.12</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.667</ci_lower_limit>
            <ci_upper_limit>1.5</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentages of Subjects Who Achieved HI Seroconversion and HI Titer ≥1:40 Against Each of Three Strains After One Vaccination of TIVc and TIVf Vaccine.</title>
        <description>Percentages of subjects achieving HI seroconversion after each of three vaccine strains were measured three weeks after vaccination of TIVc or TIVf vaccine (day 22).&#xD;
Percentages of subjects who achieved HI titer ≥1:40 against each of three vaccine strains were measured three weeks after one vaccination of TIVc or TIVf vaccine.&#xD;
HI assay analysis for TIVc vaccine was based on cell-based antigen and for TIVf vaccine was based on egg based antigen.&#xD;
According to Center for Biologics Evaluation and Research recommendations (CBER 2007), CBER criteria are met when the lower limit of the 2-sided 95% CI for seroconversion/significant increase is ≥ 40%, and the lower limit of the 2-sided 95% CI for HI titers ≥ 1:40 is ≥ 70%.</description>
        <time_frame>Day 22</time_frame>
        <population>FAS(Full Analysis Set) All subjects in the Enrolled Population who: ▫ receive a study vaccination and provide immunogenicity data at Day 1 and at Day 22 FAS populations was analyzed &quot;as randomized&quot; (i.e., according to the vaccine a subject was designated to receive, which may be different from the vaccine the subject actually received).</population>
        <group_list>
          <group group_id="O1">
            <title>TIVc (3 TIVc Lots Pooled)</title>
            <description>Subjects 18 to ≤ 49 years of age who received one vaccination of an investigational vaccine TIVc</description>
          </group>
          <group group_id="O2">
            <title>TIVf</title>
            <description>Subjects 18 to ≤ 49 years of age who received one vaccination of Control vaccine TIVf</description>
          </group>
        </group_list>
        <measure>
          <title>Percentages of Subjects Who Achieved HI Seroconversion and HI Titer ≥1:40 Against Each of Three Strains After One Vaccination of TIVc and TIVf Vaccine.</title>
          <description>Percentages of subjects achieving HI seroconversion after each of three vaccine strains were measured three weeks after vaccination of TIVc or TIVf vaccine (day 22).&#xD;
Percentages of subjects who achieved HI titer ≥1:40 against each of three vaccine strains were measured three weeks after one vaccination of TIVc or TIVf vaccine.&#xD;
HI assay analysis for TIVc vaccine was based on cell-based antigen and for TIVf vaccine was based on egg based antigen.&#xD;
According to Center for Biologics Evaluation and Research recommendations (CBER 2007), CBER criteria are met when the lower limit of the 2-sided 95% CI for seroconversion/significant increase is ≥ 40%, and the lower limit of the 2-sided 95% CI for HI titers ≥ 1:40 is ≥ 70%.</description>
          <population>FAS(Full Analysis Set) All subjects in the Enrolled Population who: ▫ receive a study vaccination and provide immunogenicity data at Day 1 and at Day 22 FAS populations was analyzed &quot;as randomized&quot; (i.e., according to the vaccine a subject was designated to receive, which may be different from the vaccine the subject actually received).</population>
          <units>percentages of subjects</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="1144"/>
                <count group_id="O2" value="379"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Influenza A H1N1 Brisbane/2010 CC Ab-SC(1143,379 )</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60" lower_limit="57" upper_limit="62"/>
                    <measurement group_id="O2" value="69" lower_limit="64" upper_limit="74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/Texas/50/2012 (H3N2)- Seroconversion</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49" lower_limit="46" upper_limit="52"/>
                    <measurement group_id="O2" value="63" lower_limit="58" upper_limit="68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B Massachusetts/2/2012 (B) - Seroconversion</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39" lower_limit="36" upper_limit="42"/>
                    <measurement group_id="O2" value="45" lower_limit="40" upper_limit="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Influenza A H1N1 Brisbane/2010 CC Ab-HI ≥1:40Day22</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99" lower_limit="99" upper_limit="100"/>
                    <measurement group_id="O2" value="99" lower_limit="98" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/Texas/50/2012 (H3N2)- HI ≥1:40(Day 22)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100" lower_limit="99" upper_limit="100"/>
                    <measurement group_id="O2" value="100" lower_limit="99" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>B Massachusetts/2/2012 (B) - HI ≥1:40 (Day 22)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98" lower_limit="97" upper_limit="99"/>
                    <measurement group_id="O2" value="92" lower_limit="89" upper_limit="95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIVc and TIVf</title>
        <description>Safety was assessed as the number of subjects who reported solicited local and systemic adverse events from day 1 up to and including day 7 after vaccination of TIVc and control vaccines.</description>
        <time_frame>Day 1 through day 7 (without 30 min)</time_frame>
        <population>Solicited Safety Set-All subjects in the exposed set with any solicited AE data postvaccination or indicators of solicited AEs postvaccination</population>
        <group_list>
          <group group_id="O1">
            <title>TIVc (3 TIVc Lots Pooled)</title>
            <description>Subjects 18 to ≤ 49 years of age who received one vaccination of an investigational vaccine TIVc</description>
          </group>
          <group group_id="O2">
            <title>TIVf</title>
            <description>Subjects 18 to ≤ 49 years of age who received one vaccination of Control vaccine TIVf;</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIVc and TIVf</title>
          <description>Safety was assessed as the number of subjects who reported solicited local and systemic adverse events from day 1 up to and including day 7 after vaccination of TIVc and control vaccines.</description>
          <population>Solicited Safety Set-All subjects in the exposed set with any solicited AE data postvaccination or indicators of solicited AEs postvaccination</population>
          <units>Subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1169"/>
                <count group_id="O2" value="391"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Induration</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1166"/>
                    <count group_id="O2" value="390"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="168"/>
                    <measurement group_id="O2" value="62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Erythema</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1166"/>
                    <count group_id="O2" value="390"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="208"/>
                    <measurement group_id="O2" value="77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ecchymosis</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1166"/>
                    <count group_id="O2" value="390"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76"/>
                    <measurement group_id="O2" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1169"/>
                    <count group_id="O2" value="391"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="481"/>
                    <measurement group_id="O2" value="135"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Nausea</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1169"/>
                    <count group_id="O2" value="391"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91"/>
                    <measurement group_id="O2" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Myalgia</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1169"/>
                    <count group_id="O2" value="391"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="109"/>
                    <measurement group_id="O2" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Arthralgia</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1169"/>
                    <count group_id="O2" value="391"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84"/>
                    <measurement group_id="O2" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Headache</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1169"/>
                    <count group_id="O2" value="391"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="259"/>
                    <measurement group_id="O2" value="80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fatigue</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1169"/>
                    <count group_id="O2" value="391"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="221"/>
                    <measurement group_id="O2" value="77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diarrhea</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1169"/>
                    <count group_id="O2" value="391"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="85"/>
                    <measurement group_id="O2" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chills</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1169"/>
                    <count group_id="O2" value="391"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Loss of appetite</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1169"/>
                    <count group_id="O2" value="391"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66"/>
                    <measurement group_id="O2" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vomiting</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1169"/>
                    <count group_id="O2" value="391"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fever (≥38°C)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="1169"/>
                    <count group_id="O2" value="391"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects With Unsolicited Adverse Events</title>
        <description>Safety was assessed as the number of subjects who reported Unsolicited Adverse Events after vaccination of TIVc and control vaccine.</description>
        <time_frame>Day 1 through day 22</time_frame>
        <population>Unsolicited Safety Set-All subjects in the exposed set with unsolicited AE data postvaccination.</population>
        <group_list>
          <group group_id="O1">
            <title>TIVc (3 TIVc Lots Pooled)</title>
            <description>Subjects 18 to ≤ 49 years of age who received one vaccination of an investigational vaccine TIVc</description>
          </group>
          <group group_id="O2">
            <title>TIVf</title>
            <description>Subjects 18 to ≤ 49 years of age who received one vaccination of Control vaccine TIVf;</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Unsolicited Adverse Events</title>
          <description>Safety was assessed as the number of subjects who reported Unsolicited Adverse Events after vaccination of TIVc and control vaccine.</description>
          <population>Unsolicited Safety Set-All subjects in the exposed set with unsolicited AE data postvaccination.</population>
          <units>Subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1169"/>
                <count group_id="O2" value="391"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any AE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="139"/>
                    <measurement group_id="O2" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Possibly or probably related AE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50"/>
                    <measurement group_id="O2" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Possibly or probably related SAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AE leading to withdrawal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Medically attended AE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>New Onset of Chronic Disease</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Death</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Throughout the study period, (Day 1 through Day 22)</time_frame>
      <desc>SAEs were collected from day 1 through day 22. Unsolicited non-SAEs were also collected through day 22.&#xD;
1560 of 1561 subjects received study vaccination and were included in the safety analysis. 1 subject was a screen failure and did not receive study vaccination. 1 subject was randomized to TIVc Lot C, received TIVf, and 1 subject was randomized to TIVc Lot B, received TIVc Lot C vaccine. In the safety analysis 1169 subjects were included in TIVc pooled and 391 subjects in TIVf.</desc>
      <group_list>
        <group group_id="E1">
          <title>TIVc Pooled</title>
          <description>Subjects 18 to ≤ 49 years of age who received one vaccination of an investigational vaccine TIVc</description>
        </group>
        <group group_id="E2">
          <title>TIVf</title>
          <description>Subjects 18 to ≤ 49 years of age who received one vaccination of Control vaccine TIVf;</description>
        </group>
        <group group_id="E3">
          <title>Total</title>
          <description>Total number of subjects</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (17.1)</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="0" subjects_at_risk="1169"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="391"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="1560"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>APPENDICITIS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1169"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="391"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="1560"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Pregnancy, puerperium and perinatal conditions</title>
            <event_list>
              <event>
                <sub_title>ABORTION SPONTANEOUS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1169"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="391"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="1560"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (17.1)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="709" subjects_at_risk="1169"/>
                <counts group_id="E2" subjects_affected="237" subjects_at_risk="391"/>
                <counts group_id="E3" subjects_affected="946" subjects_at_risk="1560"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>DIARRHOEA</sub_title>
                <counts group_id="E1" subjects_affected="86" subjects_at_risk="1169"/>
                <counts group_id="E2" subjects_affected="47" subjects_at_risk="391"/>
                <counts group_id="E3" subjects_affected="133" subjects_at_risk="1560"/>
              </event>
              <event>
                <sub_title>NAUSEA</sub_title>
                <counts group_id="E1" subjects_affected="91" subjects_at_risk="1169"/>
                <counts group_id="E2" subjects_affected="30" subjects_at_risk="391"/>
                <counts group_id="E3" subjects_affected="121" subjects_at_risk="1560"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>FATIGUE</sub_title>
                <counts group_id="E1" subjects_affected="222" subjects_at_risk="1169"/>
                <counts group_id="E2" subjects_affected="77" subjects_at_risk="391"/>
                <counts group_id="E3" subjects_affected="299" subjects_at_risk="1560"/>
              </event>
              <event>
                <sub_title>INJECTION SITE ERYTHEMA</sub_title>
                <counts group_id="E1" subjects_affected="208" subjects_at_risk="1169"/>
                <counts group_id="E2" subjects_affected="77" subjects_at_risk="391"/>
                <counts group_id="E3" subjects_affected="285" subjects_at_risk="1560"/>
              </event>
              <event>
                <sub_title>INJECTION SITE HAEMORRHAGE</sub_title>
                <counts group_id="E1" subjects_affected="76" subjects_at_risk="1169"/>
                <counts group_id="E2" subjects_affected="30" subjects_at_risk="391"/>
                <counts group_id="E3" subjects_affected="106" subjects_at_risk="1560"/>
              </event>
              <event>
                <sub_title>INJECTION SITE INDURATION</sub_title>
                <counts group_id="E1" subjects_affected="168" subjects_at_risk="1169"/>
                <counts group_id="E2" subjects_affected="62" subjects_at_risk="391"/>
                <counts group_id="E3" subjects_affected="230" subjects_at_risk="1560"/>
              </event>
              <event>
                <sub_title>INJECTION SITE PAIN</sub_title>
                <counts group_id="E1" subjects_affected="481" subjects_at_risk="1169"/>
                <counts group_id="E2" subjects_affected="135" subjects_at_risk="391"/>
                <counts group_id="E3" subjects_affected="616" subjects_at_risk="1560"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>DECREASED APPETITE</sub_title>
                <counts group_id="E1" subjects_affected="66" subjects_at_risk="1169"/>
                <counts group_id="E2" subjects_affected="39" subjects_at_risk="391"/>
                <counts group_id="E3" subjects_affected="105" subjects_at_risk="1560"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>ARTHRALGIA</sub_title>
                <counts group_id="E1" subjects_affected="84" subjects_at_risk="1169"/>
                <counts group_id="E2" subjects_affected="29" subjects_at_risk="391"/>
                <counts group_id="E3" subjects_affected="113" subjects_at_risk="1560"/>
              </event>
              <event>
                <sub_title>MYALGIA</sub_title>
                <counts group_id="E1" subjects_affected="110" subjects_at_risk="1169"/>
                <counts group_id="E2" subjects_affected="28" subjects_at_risk="391"/>
                <counts group_id="E3" subjects_affected="138" subjects_at_risk="1560"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>HEADACHE</sub_title>
                <counts group_id="E1" subjects_affected="262" subjects_at_risk="1169"/>
                <counts group_id="E2" subjects_affected="82" subjects_at_risk="391"/>
                <counts group_id="E3" subjects_affected="344" subjects_at_risk="1560"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The terms and conditions of Novartis' agreement with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site was postponed until the publications of the pooled data (i.e., data from all sites) in the clinical trial.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Posting Director</name_or_title>
      <organization>Novartis Vaccines</organization>
      <email>RegistryContactVaccinesUS@novartis.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/NCT02256488
org study id: V58_23
nct id: NCT02256488
lead sponsor: 
The purpose of this study is to evaluate the immunologic equivalence of three consecutive
      lots of a cell based trivalent subunit influenza vaccine (TIVc), and to assess
      immunogenicity, safety and tolerability of the vaccine and an egg based trivalent subunit
      influenza vaccine (TIVf).

      The study comprised 1 vaccination, 2 clinic visits, 3 reminder calls and 2 blood draws.
      Female subjects of childbearing potential were tested for pregnancy before the administration
      of the vaccine and included only if using and agreeing to continue to use contraception
      during the course of the study.

      The total study participation time per subject is about 3 weeks.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Double (Participant, Investigator)
measure: Immunologic Equivalence of 3 Consecutive Influenza Vaccine (TIVc) Production Lots.
time frame: Day 22
description: Hemagglutination inhibition (HI) geometric mean titers (GMTs) achieved by subjects, for each three vaccine strains, three weeks after one vaccination of one lot of TIVc vaccine (Day 22), evaluated using HI antigen assay.
measure: Percentages of Subjects Who Achieved HI Seroconversion and HI Titer ≥1:40 Against Each of Three Strains After One Vaccination of TIVc and TIVf Vaccine.
time frame: Day 22
description: Percentages of subjects achieving HI seroconversion after each of three vaccine strains were measured three weeks after vaccination of TIVc or TIVf vaccine (day 22).
Percentages of subjects who achieved HI titer ≥1:40 against each of three vaccine strains were measured three weeks after one vaccination of TIVc or TIVf vaccine.
HI assay analysis for TIVc vaccine was based on cell-based antigen and for TIVf vaccine was based on egg based antigen.
According to Center for Biologics Evaluation and Research recommendations (CBER 2007), CBER criteria are met when the lower limit of the 2-sided 95% CI for seroconversion/significant increase is ≥ 40%, and the lower limit of the 2-sided 95% CI for HI titers ≥ 1:40 is ≥ 70%.
measure: Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIVc and TIVf
time frame: Day 1 through day 7 (without 30 min)
description: Safety was assessed as the number of subjects who reported solicited local and systemic adverse events from day 1 up to and including day 7 after vaccination of TIVc and control vaccines.
measure: Number of Subjects With Unsolicited Adverse Events
time frame: Day 1 through day 22
description: Safety was assessed as the number of subjects who reported Unsolicited Adverse Events after vaccination of TIVc and control vaccine.
arm group label: TIVc-Lot A
arm group type: Experimental
description: Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot A
arm group label: TIVc-Lot B
arm group type: Experimental
description: Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot B
arm group label: TIVc-Lot C
arm group type: Experimental
description: Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot C
arm group label: TIVf
arm group type: Active Comparator
description: Subjects 18 to ≤ 49 years of age who received one vaccination of Control vaccine TIVf
intervention type: Biological
intervention name: TIVc_LOT A
description: Single IM (Intramuscular) administration dose of 0.5 mL of TIVc
arm group label: TIVc-Lot A
intervention type: Biological
intervention name: TIVc_LOT B
description: Single IM administration dose of 0.5 mL of TIVc
arm group label: TIVc-Lot B
intervention type: Biological
intervention name: TIVc_LOT C
description: Single IM administration dose of 0.5 mL of TIVc
arm group label: TIVc-Lot C
intervention type: Biological
intervention name: TIVf
description: Single IM administration dose of 0.5 mL of TIVf
arm group label: TIVf
criteria: 
gender: All
minimum age: 18 Years
maximum age: 49 Years
healthy volunteers: Accepts Healthy Volunteers
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country: United States
responsible party type: Sponsor
mesh term: Influenza, Human
participant flow: 
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outcome list: 
reported events: 
certain agreements: 
point of contact: 