<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/NCT03293498</url>
  </required_header>
  <id_info>
    <org_study_id>tNIV-E-101</org_study_id>
    <nct_id>NCT03293498</nct_id>
  </id_info>
  <brief_title>Evaluation of the Safety and Immunogenicity of a Recombinant Trivalent Nanoparticle Influenza Vaccine With Matrix M-1 Adjuvant (NanoFlu)</brief_title>
  <official_title>A Phase 1/2, Randomized, Observer-Blinded, Active-Controlled Trials to Evaluate the Safety and Immunogenicity of a Recombinant Trivalent Nanoparticle Influenza Vaccine With Matrix-M1 Adjuvant (NanoFlu) in Healthy Older Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Novavax</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Novavax</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This was a Phase 1/2, randomized, observer-blinded, active-controlled trial to assess the&#xD;
      Safety and Tolerability of a Recombinant Trivalent Nanoparticle Influenza Vaccine (Tri-NIV)&#xD;
      with Matrix M1™ Adjuvant in Healthy Older Adults ≥ 60 Years of Age&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study tNIV-E-101 a randomized, observer-blinded, active-controlled trial designed to evaluate&#xD;
      the safety and immunogenicity of Novavax's insect cell-derived, egg-free, influenza vaccine&#xD;
      (Tri-NIV) based on recombinant HA nanoparticle antigens, representing the 3 major influenza&#xD;
      types/subtypes recommended for inclusion in the 2017 - 2018 seasonal influenza vaccine by the&#xD;
      World Health Organization (WHO) and the Center for Biologics Evaluation and Research (CBER)&#xD;
      Approximately 330 eligible subjects were enrolled and randomized into 1 of 3 treatment groups&#xD;
      Each group consisted of approximately 110 subjects total, stratified by age, gender, and&#xD;
      history of receipt of the 2016 - 17 influenza vaccine. On Day 0, subjects in Groups A and B&#xD;
      were administered an IM injection of NanoFlu at one of two dose levels; subjects in Group C&#xD;
      received the preconfigured comparator (Fluzone HD) at the manufacturer's recommended dose and&#xD;
      volume. On Day 21, all Group A and B subjects were administered a rescue injection with a&#xD;
      licensed seasonal influenza vaccine. In contrast, all Group C subjects were administered an&#xD;
      injection with a sterile saline placebo to maintain the trial blind. Trial follow-up for each&#xD;
      subject spanned approximately 1 year from Day 0.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 18, 2017</start_date>
  <completion_date type="Actual">October 29, 2018</completion_date>
  <primary_completion_date type="Actual">March 14, 2018</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With All Adverse Events (AEs), Medically Attended Adverse Events (MAAEs), Serious Adverse Events (SAEs), and Significant New Medical Conditions (SNMCs).</measure>
    <time_frame>Day 0 - Day 21 post dosing</time_frame>
    <description>Number of participants that reported all adverse event (AE) profile (including adverse changes in clinical laboratory parameters) ; medically-attended adverse event (MAE), serious adverse event (SAE), and significant new medical condition (SNMC) post dosing.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Solicited Local and Systemic AEs</measure>
    <time_frame>Day 0 - Day 6 post-dosing</time_frame>
    <description>Number of participants with solicited local and systemic adverse events over the 7 days post-injection</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Geometric Mean Titers (GMT) Specific for the Hemagglutinin (HA) Receptor Binding Domains of Each of the Virus Strains Included in the NanoFlu as Measured by the Hemagglutination Inhibition (HAI) Assay.</measure>
    <time_frame>Day 0 - Day 21 post dosing</time_frame>
    <description>The immunogenicity of Tri-NIV at 2 different doses, and the licensed comparator Fluzone HD (Sanofi Pasteur), in healthy older adults ≥ 60 years of age, based on hemagglutination inhibition (HAI) responses to vaccine-homologous influenza A and B strains, as recommended for the 2017 - 18 Northern hemisphere vaccine, at Day 21 post-dosing expressed as GMTs.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Geometric Mean Ratio (GMR) Specific for the HA Receptor Binding Domains of Each of the Virus Strains Included in the NanoFlu as Measured by the HAI Assay.</measure>
    <time_frame>Day 0 - Day 21 post dosing</time_frame>
    <description>The immunogenicity of Tri-NIV at 2 different doses, and the licensed comparator Fluzone HD (Sanofi Pasteur), in healthy older adults ≥ 60 years of age, based on hemagglutination inhibition (HAI) responses to vaccine-homologous influenza A and B strains, as recommended for the 2017 - 18 Northern hemisphere vaccine, at Day 21 post-dosing expressed as GMR.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Seroconversion Rate (SCR) Specific for the HA Receptor Binding Domains of Each of the Virus Strains Included in the NanoFlu as Measured by the HAI Assay.</measure>
    <time_frame>Day 0 - Day 21 post dosing</time_frame>
    <description>The immunogenicity of Tri-NIV at 2 different doses, and the licensed comparator Fluzone HD (Sanofi Pasteur), in healthy older adults ≥ 60 years of age, based on hemagglutination inhibition (HAI) responses to vaccine-homologous influenza A and B strains, as recommended for the 2017 - 18 Northern hemisphere vaccine, at Day 21 post-dosing expressed as SCRs.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Seroprotection Specific for the HA Receptor Binding Domains of Each of the Virus Strains Included in the NanoFlu as Measured by the HAI Assay.</measure>
    <time_frame>Day 0 - Day 21 post dosing</time_frame>
    <description>The immunogenicity of Tri-NIV at 2 different doses, and the licensed comparator Fluzone HD (Sanofi Pasteur), in healthy older adults ≥ 60 years of age, based on hemagglutination inhibition (HAI) responses to vaccine-homologous influenza A and B strains, as recommended for the 2017 - 18 Northern hemisphere vaccine, at Day 21 post-dosing expressed as SPRs.&#xD;
Seroprotection rate (SPR) - defined as the number of subjects with an HAI titer ≥ 1:40.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Geometric Mean Titers (GMT) Specific for the HA Receptor Binding Domains of at Least 2 Historic A Virus Strains (One H1N1 and One H3N2) as Measured by the HAI Assay</measure>
    <time_frame>Day 0 - Day 21</time_frame>
    <description>The immunogenicity of Tri-NIV at 2 different doses and the licensed comparator Fluzone HD (Sanofi Pasteur) based on hemagglutination inhibition (HAI) responses to at least 2 historic and/or drifted A virus strains (one H1N1 and one H3N2) expressed as GMTs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geometric Mean Ratio (GMR) Specific for the HA Receptor Binding Domains of at Least 2 Historic A Virus Strains (One H1N1 and One H3N2) as Measured by the HAI Assay</measure>
    <time_frame>Day 0 - Day 21</time_frame>
    <description>The immunogenicity of Tri-NIV at 2 different doses and the licensed comparator Fluzone HD (Sanofi Pasteur) based on hemagglutination inhibition (HAI) responses to at least 2 historic and/or drifted A virus strains (one H1N1 and one H3N2) expressed as GMRs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Seroconversion Rate (SCR) Specific for the HA Receptor Binding Domains of at Least 2 Historic A Virus Strains (One H1N1 and One H3N2) as Measured by the HAI Assay</measure>
    <time_frame>Day 0 - Day 21</time_frame>
    <description>The immunogenicity of Tri-NIV at 2 different doses and the licensed comparator Fluzone HD (Sanofi Pasteur) based on hemagglutination inhibition (HAI) responses to at least 2 historic and/or drifted A virus strains (one H1N1 and one H3N2) expressed as SCRs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Seroprotection Specific for the HA Receptor Binding Domains of at Least 2 Historic A Virus Strains (One H1N1 and One H3N2) as Measured by the HAI Assay</measure>
    <time_frame>Day 0 - Day 21</time_frame>
    <description>The immunogenicity of Tri-NIV at 2 different doses and the licensed comparator Fluzone HD (Sanofi Pasteur) based on hemagglutination inhibition (HAI) responses to at least 2 historic and/or drifted A virus strains (one H1N1 and one H3N2) expressed as SPRs.&#xD;
Seroprotection rate (SPR) - defined as the percentage of subjects with an HAI titer ≥ 1:40.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geometric Mean Titers (GMT) for Neutralizing Antibody Titers Specific for the Virus Strains Included in NanoFlu and the Fluzone HD Comparator, as Well as Selected Historical A Strains, as Measured by a Microneutralization Assay.</measure>
    <time_frame>Day 0 - Day 21 post dosing</time_frame>
    <description>The immunogenicity of Tri-NIV at 2 different doses, and the licensed comparator Fluzone HD (Sanofi Pasteur), based on microneutralization (MN) responses to vaccine-homologous and historic and/or drifted influenza A strains, and the vaccine-homologous B/Victoria lineage strain, at Day 21 post-dosing expressed as GMTs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geometric Mean Ratio (GMR) for Neutralizing Antibody Titers Specific for the Virus Strains Included in NanoFlu and the Fluzone HD Comparator, as Well as Selected Historical A Strains, as Measured by a Microneutralization Assay.</measure>
    <time_frame>Day 0 - Day 21</time_frame>
    <description>The immunogenicity of Tri-NIV at 2 different doses, and the licensed comparator Fluzone HD (Sanofi Pasteur), based on microneutralization (MN) responses to vaccine-homologous and historic and/or drifted influenza A strains, and the vaccine-homologous B/Victoria lineage strain, at Day 21 post-dosing expressed as GMRs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Seroconversion Rate (SCR) for Neutralizing Antibody Titers Specific for the Virus Strains Included in NanoFlu and the Fluzone HD Comparator, as Well as Selected Historical A Strains, as Measured by a Microneutralization Assay.</measure>
    <time_frame>Day 0 - Day 21</time_frame>
    <description>The immunogenicity of Tri-NIV at 2 different doses, and the licensed comparator Fluzone HD (Sanofi Pasteur), based on microneutralization (MN) responses to vaccine-homologous and historic and/or drifted influenza A strains, and the vaccine-homologous B/Victoria lineage strain, at Day 21 post-dosing expressed as SPRs.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">330</enrollment>
  <condition>Influenza</condition>
  <arm_group>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Low dose NanoFlu - Day 0; Fluzone HD - Day 21</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>High dose NanoFlu - Day 0; Fluzone HD - Day 21</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group C</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Fluzone HD - Day 0; Saline - Day 21</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>NanoFlu</intervention_name>
    <description>Vaccine</description>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_label>Group B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Fluzone HD - Day 0</intervention_name>
    <description>Vaccine</description>
    <arm_group_label>Group C</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Fluzone HD - Day 21</intervention_name>
    <description>Vaccine</description>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_label>Group B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Saline - Day 21</intervention_name>
    <description>Placebo</description>
    <arm_group_label>Group C</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy older adults, male or female,&#xD;
&#xD;
          2. Willing and able to give informed consent prior to trial enrollment, and&#xD;
&#xD;
          3. Able to attend trial visits, comply with trial requirements, and provide reliable and&#xD;
             complete reports of adverse events.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Any ongoing, symptomatic acute or chronic illness requiring medical or surgical care.&#xD;
&#xD;
               -  Asymptomatic chronic conditions or findings (eg, mild hypertension, dyslipidemia)&#xD;
                  that are not associated with evidence of end-organ damage are not exclusionary&#xD;
                  provided that they are being appropriately managed and are clinically stable (ie,&#xD;
                  unlikely to result in symptomatic illness within the time-course of this trial)&#xD;
                  in the opinion of the investigator.&#xD;
&#xD;
               -  Acute or chronic illnesses or conditions which may be reasonably predicted to&#xD;
                  become symptomatic if treatment were withdrawn or interrupted are exclusionary,&#xD;
                  even if stable.&#xD;
&#xD;
               -  Acute or chronic illnesses reasonably expected to be associated with increased&#xD;
                  risks in the event of influenza infection (eg, cardio-pulmonary diseases,&#xD;
                  diabetes mellitus, renal or hepatic dysfunction, hemoglobinopathies) are&#xD;
                  exclusionary, even if stable.&#xD;
&#xD;
               -  Note that illnesses or conditions may be exclusionary, even if otherwise stable,&#xD;
                  due to therapies used to treat them (see exclusion criteria 2, 5, 8, 9).&#xD;
&#xD;
          2. Participation in research involving investigational product (drug / biologic / device)&#xD;
             within 45 days before planned date of first injection.&#xD;
&#xD;
          3. History of a serious reaction to prior influenza vaccination, or known allergy to&#xD;
             constituents of influenza vaccines - including egg proteins - or polysorbate 80.&#xD;
&#xD;
          4. History of Guillain-Barré Syndrome (GBS) within 6 weeks following a previous influenza&#xD;
             vaccine.&#xD;
&#xD;
          5. Receipt of any vaccine in the 4 weeks preceding the trial vaccination and any&#xD;
             influenza vaccine within 6 months preceding the trial vaccination.&#xD;
&#xD;
          6. Any known or suspected immunosuppressive illness, congenital or acquired, based on&#xD;
             medical history and/or physical examination.&#xD;
&#xD;
          7. Chronic administration (defined as more than 14 continuous days) of immunosuppressants&#xD;
             or other immune-modifying drugs within 6 months prior to the administration of the&#xD;
             trial vaccine. An immunosuppressant dose of glucocorticoid will be defined as a&#xD;
             systemic dose ≥ 10 mg of prednisone per day or equivalent. The use of topical,&#xD;
             inhaled, and nasal glucocorticoids will be permitted.&#xD;
&#xD;
          8. Administration of immunoglobulins and/or any blood products within the 3 months&#xD;
             preceding the administration of the trial vaccine or during the trial.&#xD;
&#xD;
          9. Acute disease at the time of enrollment (defined as the presence of a moderate or&#xD;
             severe illness with or without fever, or an oral temperature &gt; 38.0°C, on the planned&#xD;
             day of vaccine administration).&#xD;
&#xD;
         10. Any condition that in the opinion of the investigator would pose a health risk to the&#xD;
             subject if enrolled or could interfere with evaluation of the vaccine or&#xD;
             interpretation of trial results (including neurologic or psychiatric conditions deemed&#xD;
             likely to impair the quality of safety reporting).&#xD;
&#xD;
         11. Known disturbance of coagulation.&#xD;
&#xD;
         12. Suspicion or recent history (within one year of planned vaccination) of alcohol or&#xD;
             other substance abuse.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Development</last_name>
    <role>Study Director</role>
    <affiliation>Novavax</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Research Site US108</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27609</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site US106</name>
      <address>
        <city>Rocky Mount</city>
        <state>North Carolina</state>
        <zip>27804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site US132</name>
      <address>
        <city>Statesville</city>
        <state>North Carolina</state>
        <zip>28625</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>September 19, 2017</study_first_submitted>
  <study_first_submitted_qc>September 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 26, 2017</study_first_posted>
  <results_first_submitted>October 12, 2022</results_first_submitted>
  <results_first_submitted_qc>November 29, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">December 21, 2022</results_first_posted>
  <disposition_first_submitted>August 20, 2019</disposition_first_submitted>
  <disposition_first_submitted_qc>November 29, 2022</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">December 21, 2022</disposition_first_posted>
  <last_update_submitted>November 29, 2022</last_update_submitted>
  <last_update_submitted_qc>November 29, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 21, 2022</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>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 13, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/98/NCT03293498/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 24, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/98/NCT03293498/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants took part in a study conducted at 3 different clinical sites from September 18, 2017 to October 29, 2018.</recruitment_details>
      <pre_assignment_details>Healthy older adults (≥ 60 years of age) were enrolled in the study and divided into 3 treatment groups based on gender, age, and history of 2016-17 influenza vaccine. Participants were treated with different doses of Tri-NIV Vaccine (0.3 mL,0.8mL), Fluzone HD (0.8 mL), and Placebo (0.5 mL) as Intramuscular (IM) injection into the deltoid muscle.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21</title>
          <description>Participants received 15 µg in a 0.3 mL dose of Tri-NIV vaccine, intramuscularly, at Day 0 and received 60 µg in a 0.8 mL dose of Fluzone HD, intramuscularly, at Day 21.</description>
        </group>
        <group group_id="P2">
          <title>Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21</title>
          <description>Participants received 60 µg in a 0.8 mL dose of Tri-NIV vaccine, intramuscularly, at Day 0 and received 60 µg in a 0.8 mL dose of Fluzone HD, intramuscularly, at Day 21.</description>
        </group>
        <group group_id="P3">
          <title>Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21.</title>
          <description>Participants received 60 µg in a 0.8 mL dose of Fluzone HD, intramuscularly, at Day 0 and received 60 µg in a 0.5 mL dose of Placebo, intramuscularly, at Day 21.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="109"/>
                <participants group_id="P2" count="111"/>
                <participants group_id="P3" count="110"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="109"/>
                <participants group_id="P2" count="111"/>
                <participants group_id="P3" count="110"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>330 participants were randomized to 1 of 3 treatment groups based on age, gender, and history of receipt of the 2016 - 17 influenza vaccine.</population>
      <group_list>
        <group group_id="B1">
          <title>Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21</title>
          <description>Participants received 15 µg in a 0.3 mL dose of Tri-NIV vaccine, intramuscularly, at Day 0 and received 60 µg in a 0.8 mL dose of Fluzone HD, intramuscularly, at Day 21.</description>
        </group>
        <group group_id="B2">
          <title>Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21</title>
          <description>Participants received 60 µg in a 0.8 mL dose of Tri-NIV vaccine, intramuscularly, at Day 0 and received 60 µg in a 0.8 mL dose of Fluzone HD, intramuscularly, at Day 21.</description>
        </group>
        <group group_id="B3">
          <title>Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21.</title>
          <description>Participants received 60 µg in a 0.8 mL dose of Fluzone HD, intramuscularly, at Day 0 and received 60 µg in a 0.5 mL dose of Placebo, intramuscularly, at Day 21.</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="109"/>
            <count group_id="B2" value="111"/>
            <count group_id="B3" value="110"/>
            <count group_id="B4" value="330"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>60 to &lt; 75 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="90"/>
                    <measurement group_id="B2" value="91"/>
                    <measurement group_id="B3" value="90"/>
                    <measurement group_id="B4" value="271"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>≥ 75 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="20"/>
                    <measurement group_id="B4" value="59"/>
                  </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="58"/>
                    <measurement group_id="B2" value="60"/>
                    <measurement group_id="B3" value="57"/>
                    <measurement group_id="B4" value="175"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="51"/>
                    <measurement group_id="B2" value="51"/>
                    <measurement group_id="B3" value="53"/>
                    <measurement group_id="B4" value="155"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="108"/>
                    <measurement group_id="B2" value="110"/>
                    <measurement group_id="B3" value="109"/>
                    <measurement group_id="B4" value="327"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="39"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="91"/>
                    <measurement group_id="B2" value="98"/>
                    <measurement group_id="B3" value="99"/>
                    <measurement group_id="B4" value="288"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>History of Prior Flu Vaccinations</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Receipt of 2016 - 17 Flu Vaccine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="95"/>
                    <measurement group_id="B2" value="94"/>
                    <measurement group_id="B3" value="93"/>
                    <measurement group_id="B4" value="282"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Receipt of Flu Vaccine in Past 3 Years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="102"/>
                    <measurement group_id="B2" value="101"/>
                    <measurement group_id="B3" value="102"/>
                    <measurement group_id="B4" value="305"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With All Adverse Events (AEs), Medically Attended Adverse Events (MAAEs), Serious Adverse Events (SAEs), and Significant New Medical Conditions (SNMCs).</title>
        <description>Number of participants that reported all adverse event (AE) profile (including adverse changes in clinical laboratory parameters) ; medically-attended adverse event (MAE), serious adverse event (SAE), and significant new medical condition (SNMC) post dosing.</description>
        <time_frame>Day 0 - Day 21 post dosing</time_frame>
        <population>Group A and B participants received different doses of the Tri-NIV vaccine on Day 0 and Fluzone HD on Day 21. Group C participants received Fluzone HD on Day 0 and Placebo on Day 21.</population>
        <group_list>
          <group group_id="O1">
            <title>Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21</title>
            <description>Participants received 15 µg in a 0.3 mL dose of Tri-NIV vaccine, intramuscularly, at Day 0 and received 60 µg in a 0.8 mL dose of Fluzone HD, intramuscularly, at Day 21.</description>
          </group>
          <group group_id="O2">
            <title>Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21</title>
            <description>Participants received 60 µg in a 0.8 mL dose of Tri-NIV vaccine, intramuscularly, at Day 0 and received 60 µg in a 0.8 mL dose of Fluzone HD, intramuscularly, at Day 21.</description>
          </group>
          <group group_id="O3">
            <title>Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21.</title>
            <description>Participants received 60 µg in a 0.8 mL dose of Fluzone HD, intramuscularly, at Day 0 and received 60 µg in a 0.5 mL dose of Placebo, intramuscularly, at Day 21.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With All Adverse Events (AEs), Medically Attended Adverse Events (MAAEs), Serious Adverse Events (SAEs), and Significant New Medical Conditions (SNMCs).</title>
          <description>Number of participants that reported all adverse event (AE) profile (including adverse changes in clinical laboratory parameters) ; medically-attended adverse event (MAE), serious adverse event (SAE), and significant new medical condition (SNMC) post dosing.</description>
          <population>Group A and B participants received different doses of the Tri-NIV vaccine on Day 0 and Fluzone HD on Day 21. Group C participants received Fluzone HD on Day 0 and Placebo on Day 21.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="109"/>
                <count group_id="O2" value="111"/>
                <count group_id="O3" value="110"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>MAE's</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SAE's</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SNMC's</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>All AEs (21 days post-injection)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40"/>
                    <measurement group_id="O2" value="52"/>
                    <measurement group_id="O3" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Solicited Local and Systemic AEs</title>
        <description>Number of participants with solicited local and systemic adverse events over the 7 days post-injection</description>
        <time_frame>Day 0 - Day 6 post-dosing</time_frame>
        <population>Group A and B participants received different doses of the Tri-NIV vaccine on Day 0 and Fluzone HD on Day 21. Group C participants received Fluzone HD on Day 0 and Placebo on Day 21.</population>
        <group_list>
          <group group_id="O1">
            <title>Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21</title>
            <description>Participants received 15 µg in a 0.3 mL dose of Tri-NIV vaccine, intramuscularly, at Day 0 and received 60 µg in a 0.8 mL dose of Fluzone HD, intramuscularly, at Day 21.</description>
          </group>
          <group group_id="O2">
            <title>Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21</title>
            <description>Participants received 60 µg in a 0.8 mL dose of Tri-NIV vaccine, intramuscularly, at Day 0 and received 60 µg in a 0.8 mL dose of Fluzone HD, intramuscularly, at Day 21.</description>
          </group>
          <group group_id="O3">
            <title>Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21.</title>
            <description>Participants received 60 µg in a 0.8 mL dose of Fluzone HD, intramuscularly, at Day 0 and received 60 µg in a 0.5 mL dose of Placebo, intramuscularly, at Day 21.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Solicited Local and Systemic AEs</title>
          <description>Number of participants with solicited local and systemic adverse events over the 7 days post-injection</description>
          <population>Group A and B participants received different doses of the Tri-NIV vaccine on Day 0 and Fluzone HD on Day 21. Group C participants received Fluzone HD on Day 0 and Placebo on Day 21.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="109"/>
                <count group_id="O2" value="111"/>
                <count group_id="O3" value="110"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Solicited Local AE's (Day 0 to Day 6)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="26"/>
                    <measurement group_id="O3" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Solicited Systemic AE's (Day 0 to Day 6)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="24"/>
                    <measurement group_id="O3" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Geometric Mean Titers (GMT) Specific for the Hemagglutinin (HA) Receptor Binding Domains of Each of the Virus Strains Included in the NanoFlu as Measured by the Hemagglutination Inhibition (HAI) Assay.</title>
        <description>The immunogenicity of Tri-NIV at 2 different doses, and the licensed comparator Fluzone HD (Sanofi Pasteur), in healthy older adults ≥ 60 years of age, based on hemagglutination inhibition (HAI) responses to vaccine-homologous influenza A and B strains, as recommended for the 2017 - 18 Northern hemisphere vaccine, at Day 21 post-dosing expressed as GMTs.</description>
        <time_frame>Day 0 - Day 21 post dosing</time_frame>
        <population>Group A and B participants received different doses of the Tri-NIV vaccine on Day 0 and Fluzone HD on Day 21. Group C participants received Fluzone HD on Day 0 and Placebo on Day 21.</population>
        <group_list>
          <group group_id="O1">
            <title>Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21</title>
            <description>Participants received 15 µg in a 0.3 mL dose of Tri-NIV vaccine, intramuscularly, at Day 0 and received 60 µg in a 0.8 mL dose of Fluzone HD, intramuscularly, at Day 21.</description>
          </group>
          <group group_id="O2">
            <title>Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21</title>
            <description>Participants received 60 µg in a 0.8 mL dose of Tri-NIV vaccine, intramuscularly, at Day 0 and received 60 µg in a 0.8 mL dose of Fluzone HD, intramuscularly, at Day 21.</description>
          </group>
          <group group_id="O3">
            <title>Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21.</title>
            <description>Participants received 60 µg in a 0.8 mL dose of Fluzone HD, intramuscularly, at Day 0 and received 60 µg in a 0.5 mL dose of Placebo, intramuscularly, at Day 21.</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Titers (GMT) Specific for the Hemagglutinin (HA) Receptor Binding Domains of Each of the Virus Strains Included in the NanoFlu as Measured by the Hemagglutination Inhibition (HAI) Assay.</title>
          <description>The immunogenicity of Tri-NIV at 2 different doses, and the licensed comparator Fluzone HD (Sanofi Pasteur), in healthy older adults ≥ 60 years of age, based on hemagglutination inhibition (HAI) responses to vaccine-homologous influenza A and B strains, as recommended for the 2017 - 18 Northern hemisphere vaccine, at Day 21 post-dosing expressed as GMTs.</description>
          <population>Group A and B participants received different doses of the Tri-NIV vaccine on Day 0 and Fluzone HD on Day 21. Group C participants received Fluzone HD on Day 0 and Placebo on Day 21.</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="109"/>
                <count group_id="O2" value="111"/>
                <count group_id="O3" value="110"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 0 (A/Michigan/45/2015 (H1N1))</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39" lower_limit="31" upper_limit="48"/>
                    <measurement group_id="O2" value="34" lower_limit="27" upper_limit="42"/>
                    <measurement group_id="O3" value="31" lower_limit="25" upper_limit="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 21 (A/Michigan/45/2015 (H1N1))</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95" lower_limit="75" upper_limit="121"/>
                    <measurement group_id="O2" value="130" lower_limit="102" upper_limit="166"/>
                    <measurement group_id="O3" value="139.1" lower_limit="112" upper_limit="174"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 0 (A/HongKong/4801/2014 (H3N2) )</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26" lower_limit="21" upper_limit="33"/>
                    <measurement group_id="O2" value="21" lower_limit="17" upper_limit="27"/>
                    <measurement group_id="O3" value="26" lower_limit="21" upper_limit="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 21 (A/HongKong/4801/2014 (H3N2) )</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62" lower_limit="48" upper_limit="79"/>
                    <measurement group_id="O2" value="75" lower_limit="59" upper_limit="94"/>
                    <measurement group_id="O3" value="94" lower_limit="74" upper_limit="119"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 0 (B/Brisbane/60/2008 (Victoria Lineage))</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19" lower_limit="15" upper_limit="23"/>
                    <measurement group_id="O2" value="18" lower_limit="15" upper_limit="22"/>
                    <measurement group_id="O3" value="15" lower_limit="12" upper_limit="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 21 (B/Brisbane/60/2008 (Victoria Lineage))</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24" lower_limit="20" upper_limit="30"/>
                    <measurement group_id="O2" value="29" lower_limit="24" upper_limit="35"/>
                    <measurement group_id="O3" value="37" lower_limit="31" upper_limit="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 0 (A/California/07/2009 (H1N1))</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65" lower_limit="53" upper_limit="80"/>
                    <measurement group_id="O2" value="59" lower_limit="48" upper_limit="73"/>
                    <measurement group_id="O3" value="52" lower_limit="42" upper_limit="64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 21 (A/California/07/2009 (H1N1) )</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="143" lower_limit="116" upper_limit="176"/>
                    <measurement group_id="O2" value="194" lower_limit="156" upper_limit="242"/>
                    <measurement group_id="O3" value="206" lower_limit="169" upper_limit="222"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 0 (A/Texas/50/2012 (H3N2) )</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="197" lower_limit="155" upper_limit="251"/>
                    <measurement group_id="O2" value="160" lower_limit="123" upper_limit="207"/>
                    <measurement group_id="O3" value="196" lower_limit="151" upper_limit="253"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 21 (A/Texas/50/2012 (H3N2) )</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="429" lower_limit="352" upper_limit="523"/>
                    <measurement group_id="O2" value="485" lower_limit="397" upper_limit="592"/>
                    <measurement group_id="O3" value="470" lower_limit="382" upper_limit="577"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 0 (A/Switzerland/9715293/2013 (H3N2))</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65" lower_limit="50" upper_limit="83"/>
                    <measurement group_id="O2" value="55" lower_limit="43" upper_limit="71"/>
                    <measurement group_id="O3" value="60" lower_limit="47" upper_limit="78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 21 (A/Switzerland/9715293/2013 (H3N2))</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="159" lower_limit="128" upper_limit="198"/>
                    <measurement group_id="O2" value="187" lower_limit="150" upper_limit="234"/>
                    <measurement group_id="O3" value="151" lower_limit="122" upper_limit="188"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Geometric Mean Ratio (GMR) Specific for the HA Receptor Binding Domains of Each of the Virus Strains Included in the NanoFlu as Measured by the HAI Assay.</title>
        <description>The immunogenicity of Tri-NIV at 2 different doses, and the licensed comparator Fluzone HD (Sanofi Pasteur), in healthy older adults ≥ 60 years of age, based on hemagglutination inhibition (HAI) responses to vaccine-homologous influenza A and B strains, as recommended for the 2017 - 18 Northern hemisphere vaccine, at Day 21 post-dosing expressed as GMR.</description>
        <time_frame>Day 0 - Day 21 post dosing</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21</title>
            <description>Participants received 15 µg in a 0.3 mL dose of Tri-NIV vaccine, intramuscularly, at Day 0 and received 60 µg in a 0.8 mL dose of Fluzone HD, intramuscularly, at Day 21.</description>
          </group>
          <group group_id="O2">
            <title>Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21</title>
            <description>Participants received 60 µg in a 0.8 mL dose of Tri-NIV vaccine, intramuscularly, at Day 0 and received 60 µg in a 0.8 mL dose of Fluzone HD, intramuscularly, at Day 21.</description>
          </group>
          <group group_id="O3">
            <title>Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21.</title>
            <description>Participants received 60 µg in a 0.8 mL dose of Fluzone HD, intramuscularly, at Day 0 and received 60 µg in a 0.5 mL dose of Placebo, intramuscularly, at Day 21.</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Ratio (GMR) Specific for the HA Receptor Binding Domains of Each of the Virus Strains Included in the NanoFlu as Measured by the HAI Assay.</title>
          <description>The immunogenicity of Tri-NIV at 2 different doses, and the licensed comparator Fluzone HD (Sanofi Pasteur), in healthy older adults ≥ 60 years of age, based on hemagglutination inhibition (HAI) responses to vaccine-homologous influenza A and B strains, as recommended for the 2017 - 18 Northern hemisphere vaccine, at Day 21 post-dosing expressed as GMR.</description>
          <units>Ratio</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="109"/>
                <count group_id="O2" value="111"/>
                <count group_id="O3" value="110"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 21 (A/Michigan/45/2015 (H1N1))</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.47" lower_limit="2.05" upper_limit="2.98"/>
                    <measurement group_id="O2" value="3.86" lower_limit="3.07" upper_limit="4.85"/>
                    <measurement group_id="O3" value="4.55" lower_limit="3.60" upper_limit="5.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 21 (A/HongKong/4801/2014 (H3N2) )</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.35" lower_limit="1.94" upper_limit="2.84"/>
                    <measurement group_id="O2" value="3.49" lower_limit="2.78" upper_limit="4.37"/>
                    <measurement group_id="O3" value="3.57" lower_limit="2.87" upper_limit="4.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 21 (B/Brisbane/60/2008 (Victoria Lineage))</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.30" lower_limit="1.16" upper_limit="1.44"/>
                    <measurement group_id="O2" value="1.57" lower_limit="1.39" upper_limit="1.78"/>
                    <measurement group_id="O3" value="2.56" lower_limit="2.10" upper_limit="3.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 21 (A/California/07/2009 (H1N1) )</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.20" lower_limit="1.87" upper_limit="2.59"/>
                    <measurement group_id="O2" value="3.29" lower_limit="2.67" upper_limit="4.05"/>
                    <measurement group_id="O3" value="3.94" lower_limit="3.16" upper_limit="4.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 21 (A/Texas/50/2012 (H3N2) )</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.17" lower_limit="1.83" upper_limit="2.58"/>
                    <measurement group_id="O2" value="3.04" lower_limit="2.48" upper_limit="3.72"/>
                    <measurement group_id="O3" value="2.40" lower_limit="2.01" upper_limit="2.87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 21 (A/Switzerland/9715293/2013 (H3N2))</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.46" lower_limit="2.04" upper_limit="2.95"/>
                    <measurement group_id="O2" value="3.38" lower_limit="2.72" upper_limit="4.21"/>
                    <measurement group_id="O3" value="2.51" lower_limit="2.08" upper_limit="3.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Seroconversion Rate (SCR) Specific for the HA Receptor Binding Domains of Each of the Virus Strains Included in the NanoFlu as Measured by the HAI Assay.</title>
        <description>The immunogenicity of Tri-NIV at 2 different doses, and the licensed comparator Fluzone HD (Sanofi Pasteur), in healthy older adults ≥ 60 years of age, based on hemagglutination inhibition (HAI) responses to vaccine-homologous influenza A and B strains, as recommended for the 2017 - 18 Northern hemisphere vaccine, at Day 21 post-dosing expressed as SCRs.</description>
        <time_frame>Day 0 - Day 21 post dosing</time_frame>
        <population>Group A and B participants received different doses of the Tri-NIV vaccine on Day 0 and Fluzone HD on Day 21. Group C participants received Fluzone HD on Day 0 and Placebo on Day 21.</population>
        <group_list>
          <group group_id="O1">
            <title>Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21</title>
            <description>Participants received 15 µg in a 0.3 mL dose of Tri-NIV vaccine, intramuscularly, at Day 0 and received 60 µg in a 0.8 mL dose of Fluzone HD, intramuscularly, at Day 21.</description>
          </group>
          <group group_id="O2">
            <title>Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21</title>
            <description>Participants received 60 µg in a 0.8 mL dose of Tri-NIV vaccine, intramuscularly, at Day 0 and received 60 µg in a 0.8 mL dose of Fluzone HD, intramuscularly, at Day 21.</description>
          </group>
          <group group_id="O3">
            <title>Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21.</title>
            <description>Participants received 60 µg in a 0.8 mL dose of Fluzone HD, intramuscularly, at Day 0 and received 60 µg in a 0.5 mL dose of Placebo, intramuscularly, at Day 21.</description>
          </group>
        </group_list>
        <measure>
          <title>Seroconversion Rate (SCR) Specific for the HA Receptor Binding Domains of Each of the Virus Strains Included in the NanoFlu as Measured by the HAI Assay.</title>
          <description>The immunogenicity of Tri-NIV at 2 different doses, and the licensed comparator Fluzone HD (Sanofi Pasteur), in healthy older adults ≥ 60 years of age, based on hemagglutination inhibition (HAI) responses to vaccine-homologous influenza A and B strains, as recommended for the 2017 - 18 Northern hemisphere vaccine, at Day 21 post-dosing expressed as SCRs.</description>
          <population>Group A and B participants received different doses of the Tri-NIV vaccine on Day 0 and Fluzone HD on Day 21. Group C participants received Fluzone HD on Day 0 and Placebo on Day 21.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="109"/>
                <count group_id="O2" value="111"/>
                <count group_id="O3" value="110"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 21 (A/Michigan/45/2015 (H1N1))</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34"/>
                    <measurement group_id="O2" value="49"/>
                    <measurement group_id="O3" value="54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 21 (A/HongKong/4801/2014 (H3N2) )</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                    <measurement group_id="O2" value="34"/>
                    <measurement group_id="O3" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 21 (B/Brisbane/60/2008 (Victoria Lineage))</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="13"/>
                    <measurement group_id="O3" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 21 (A/California/07/2009 (H1N1) )</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                    <measurement group_id="O2" value="45"/>
                    <measurement group_id="O3" value="53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 21 (A/Texas/50/2012 (H3N2) )</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="38"/>
                    <measurement group_id="O3" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 21 (A/Switzerland/9715293/2013 (H3N2))</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="43"/>
                    <measurement group_id="O3" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Seroprotection Specific for the HA Receptor Binding Domains of Each of the Virus Strains Included in the NanoFlu as Measured by the HAI Assay.</title>
        <description>The immunogenicity of Tri-NIV at 2 different doses, and the licensed comparator Fluzone HD (Sanofi Pasteur), in healthy older adults ≥ 60 years of age, based on hemagglutination inhibition (HAI) responses to vaccine-homologous influenza A and B strains, as recommended for the 2017 - 18 Northern hemisphere vaccine, at Day 21 post-dosing expressed as SPRs.&#xD;
Seroprotection rate (SPR) - defined as the number of subjects with an HAI titer ≥ 1:40.</description>
        <time_frame>Day 0 - Day 21 post dosing</time_frame>
        <population>Group A and B participants received different doses of the Tri-NIV vaccine on Day 0 and Fluzone HD on Day 21. Group C participants received Fluzone HD on Day 0 and Placebo on Day 21.</population>
        <group_list>
          <group group_id="O1">
            <title>Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21</title>
            <description>Participants received 15 µg in a 0.3 mL dose of Tri-NIV vaccine, intramuscularly, at Day 0 and received 60 µg in a 0.8 mL dose of Fluzone HD, intramuscularly, at Day 21.</description>
          </group>
          <group group_id="O2">
            <title>Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21</title>
            <description>Participants received 60 µg in a 0.8 mL dose of Tri-NIV vaccine, intramuscularly, at Day 0 and received 60 µg in a 0.8 mL dose of Fluzone HD, intramuscularly, at Day 21.</description>
          </group>
          <group group_id="O3">
            <title>Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21.</title>
            <description>Participants received 60 µg in a 0.8 mL dose of Fluzone HD, intramuscularly, at Day 0 and received 60 µg in a 0.5 mL dose of Placebo, intramuscularly, at Day 21.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Seroprotection Specific for the HA Receptor Binding Domains of Each of the Virus Strains Included in the NanoFlu as Measured by the HAI Assay.</title>
          <description>The immunogenicity of Tri-NIV at 2 different doses, and the licensed comparator Fluzone HD (Sanofi Pasteur), in healthy older adults ≥ 60 years of age, based on hemagglutination inhibition (HAI) responses to vaccine-homologous influenza A and B strains, as recommended for the 2017 - 18 Northern hemisphere vaccine, at Day 21 post-dosing expressed as SPRs.&#xD;
Seroprotection rate (SPR) - defined as the number of subjects with an HAI titer ≥ 1:40.</description>
          <population>Group A and B participants received different doses of the Tri-NIV vaccine on Day 0 and Fluzone HD on Day 21. Group C participants received Fluzone HD on Day 0 and Placebo on Day 21.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="109"/>
                <count group_id="O2" value="111"/>
                <count group_id="O3" value="110"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 0 (A/Michigan/45/2015 (H1N1))</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65"/>
                    <measurement group_id="O2" value="63"/>
                    <measurement group_id="O3" value="57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 21 (A/Michigan/45/2015 (H1N1))</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93"/>
                    <measurement group_id="O2" value="96"/>
                    <measurement group_id="O3" value="98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 0 (A/HongKong/4801/2014 (H3N2) )</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="51"/>
                    <measurement group_id="O2" value="45"/>
                    <measurement group_id="O3" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 21 (A/HongKong/4801/2014 (H3N2) )</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76"/>
                    <measurement group_id="O2" value="79"/>
                    <measurement group_id="O3" value="89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 0 (B/Brisbane/60/2008 (Victoria Lineage))</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                    <measurement group_id="O2" value="30"/>
                    <measurement group_id="O3" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 21 (B/Brisbane/60/2008 (Victoria Lineage))</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42"/>
                    <measurement group_id="O2" value="53"/>
                    <measurement group_id="O3" value="57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 0 (A/California/07/2009 (H1N1) )</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80"/>
                    <measurement group_id="O2" value="77"/>
                    <measurement group_id="O3" value="74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 21 (A/California/07/2009 (H1N1) )</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98"/>
                    <measurement group_id="O2" value="102"/>
                    <measurement group_id="O3" value="104"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 0 (A/Texas/50/2012 (H3N2) )</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98"/>
                    <measurement group_id="O2" value="96"/>
                    <measurement group_id="O3" value="98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 21 (A/Texas/50/2012 (H3N2) )</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="109"/>
                    <measurement group_id="O2" value="110"/>
                    <measurement group_id="O3" value="108"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 0 (A/Switzerland/9715293/2013 (H3N2))</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="79"/>
                    <measurement group_id="O2" value="71"/>
                    <measurement group_id="O3" value="73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 21 (A/Switzerland/9715293/2013 (H3N2))</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="101"/>
                    <measurement group_id="O2" value="103"/>
                    <measurement group_id="O3" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Geometric Mean Titers (GMT) Specific for the HA Receptor Binding Domains of at Least 2 Historic A Virus Strains (One H1N1 and One H3N2) as Measured by the HAI Assay</title>
        <description>The immunogenicity of Tri-NIV at 2 different doses and the licensed comparator Fluzone HD (Sanofi Pasteur) based on hemagglutination inhibition (HAI) responses to at least 2 historic and/or drifted A virus strains (one H1N1 and one H3N2) expressed as GMTs.</description>
        <time_frame>Day 0 - Day 21</time_frame>
        <population>Group A and B participants received different doses of the Tri-NIV vaccine on Day 0 and Fluzone HD on Day 21. Group C participants received Fluzone HD on Day 0 and Placebo on Day 21.</population>
        <group_list>
          <group group_id="O1">
            <title>Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21</title>
            <description>Participants received 15 µg in a 0.3 mL dose of Tri-NIV vaccine, intramuscularly, at Day 0 and received 60 µg in a 0.8 mL dose of Fluzone HD, intramuscularly, at Day 21.</description>
          </group>
          <group group_id="O2">
            <title>Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21</title>
            <description>Participants received 60 µg in a 0.8 mL dose of Tri-NIV vaccine, intramuscularly, at Day 0 and received 60 µg in a 0.8 mL dose of Fluzone HD, intramuscularly, at Day 21.</description>
          </group>
          <group group_id="O3">
            <title>Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21.</title>
            <description>Participants received 60 µg in a 0.8 mL dose of Fluzone HD, intramuscularly, at Day 0 and received 60 µg in a 0.5 mL dose of Placebo, intramuscularly, at Day 21.</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Titers (GMT) Specific for the HA Receptor Binding Domains of at Least 2 Historic A Virus Strains (One H1N1 and One H3N2) as Measured by the HAI Assay</title>
          <description>The immunogenicity of Tri-NIV at 2 different doses and the licensed comparator Fluzone HD (Sanofi Pasteur) based on hemagglutination inhibition (HAI) responses to at least 2 historic and/or drifted A virus strains (one H1N1 and one H3N2) expressed as GMTs.</description>
          <population>Group A and B participants received different doses of the Tri-NIV vaccine on Day 0 and Fluzone HD on Day 21. Group C participants received Fluzone HD on Day 0 and Placebo on Day 21.</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="109"/>
                <count group_id="O2" value="111"/>
                <count group_id="O3" value="110"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>A/Michigan/45/2015 (H1N1) : Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69" lower_limit="61" upper_limit="78"/>
                    <measurement group_id="O2" value="66" lower_limit="59" upper_limit="74"/>
                    <measurement group_id="O3" value="65" lower_limit="58" upper_limit="74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/Michigan/45/2015 (H1N1): Day 21</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="146" lower_limit="120" upper_limit="178"/>
                    <measurement group_id="O2" value="210" lower_limit="171" upper_limit="258"/>
                    <measurement group_id="O3" value="171" lower_limit="141" upper_limit="206"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/HongKong/4801/2014 (H3N2) : Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60" lower_limit="53" upper_limit="69"/>
                    <measurement group_id="O2" value="58" lower_limit="51" upper_limit="66"/>
                    <measurement group_id="O3" value="62" lower_limit="53" upper_limit="74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/HongKong/4801/2014 (H3N2) : Day 21</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="127" lower_limit="103" upper_limit="157"/>
                    <measurement group_id="O2" value="159" lower_limit="126" upper_limit="201"/>
                    <measurement group_id="O3" value="116" lower_limit="91" upper_limit="147"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Geometric Mean Ratio (GMR) Specific for the HA Receptor Binding Domains of at Least 2 Historic A Virus Strains (One H1N1 and One H3N2) as Measured by the HAI Assay</title>
        <description>The immunogenicity of Tri-NIV at 2 different doses and the licensed comparator Fluzone HD (Sanofi Pasteur) based on hemagglutination inhibition (HAI) responses to at least 2 historic and/or drifted A virus strains (one H1N1 and one H3N2) expressed as GMRs.</description>
        <time_frame>Day 0 - Day 21</time_frame>
        <population>Group A and B participants received different doses of the Tri-NIV vaccine on Day 0 and Fluzone HD on Day 21. Group C participants received Fluzone HD on Day 0 and Placebo on Day 21.</population>
        <group_list>
          <group group_id="O1">
            <title>Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21</title>
            <description>Participants received 15 µg in a 0.3 mL dose of Tri-NIV vaccine, intramuscularly, at Day 0 and received 60 µg in a 0.8 mL dose of Fluzone HD, intramuscularly, at Day 21.</description>
          </group>
          <group group_id="O2">
            <title>Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21</title>
            <description>Participants received 60 µg in a 0.8 mL dose of Tri-NIV vaccine, intramuscularly, at Day 0 and received 60 µg in a 0.8 mL dose of Fluzone HD, intramuscularly, at Day 21.</description>
          </group>
          <group group_id="O3">
            <title>Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21.</title>
            <description>Participants received 60 µg in a 0.8 mL dose of Fluzone HD, intramuscularly, at Day 0 and received 60 µg in a 0.5 mL dose of Placebo, intramuscularly, at Day 21.</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Ratio (GMR) Specific for the HA Receptor Binding Domains of at Least 2 Historic A Virus Strains (One H1N1 and One H3N2) as Measured by the HAI Assay</title>
          <description>The immunogenicity of Tri-NIV at 2 different doses and the licensed comparator Fluzone HD (Sanofi Pasteur) based on hemagglutination inhibition (HAI) responses to at least 2 historic and/or drifted A virus strains (one H1N1 and one H3N2) expressed as GMRs.</description>
          <population>Group A and B participants received different doses of the Tri-NIV vaccine on Day 0 and Fluzone HD on Day 21. Group C participants received Fluzone HD on Day 0 and Placebo on Day 21.</population>
          <units>Ratio</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="109"/>
                <count group_id="O2" value="111"/>
                <count group_id="O3" value="110"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>A/Michigan/45/2015 (H1N1) : Day 21</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.13" lower_limit="1.83" upper_limit="2.48"/>
                    <measurement group_id="O2" value="3.17" lower_limit="2.61" upper_limit="3.85"/>
                    <measurement group_id="O3" value="2.61" lower_limit="2.21" upper_limit="3.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/HongKong/4801/2014 (H3N2) : Day 21</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.10" lower_limit="1.75" upper_limit="2.53"/>
                    <measurement group_id="O2" value="2.74" lower_limit="2.22" upper_limit="3.38"/>
                    <measurement group_id="O3" value="1.85" lower_limit="1.56" upper_limit="2.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Seroconversion Rate (SCR) Specific for the HA Receptor Binding Domains of at Least 2 Historic A Virus Strains (One H1N1 and One H3N2) as Measured by the HAI Assay</title>
        <description>The immunogenicity of Tri-NIV at 2 different doses and the licensed comparator Fluzone HD (Sanofi Pasteur) based on hemagglutination inhibition (HAI) responses to at least 2 historic and/or drifted A virus strains (one H1N1 and one H3N2) expressed as SCRs.</description>
        <time_frame>Day 0 - Day 21</time_frame>
        <population>Group A and B participants received different doses of the Tri-NIV vaccine on Day 0 and Fluzone HD on Day 21. Group C participants received Fluzone HD on Day 0 and Placebo on Day 21.</population>
        <group_list>
          <group group_id="O1">
            <title>Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21</title>
            <description>Participants received 15 µg in a 0.3 mL dose of Tri-NIV vaccine, intramuscularly, at Day 0 and received 60 µg in a 0.8 mL dose of Fluzone HD, intramuscularly, at Day 21.</description>
          </group>
          <group group_id="O2">
            <title>Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21</title>
            <description>Participants received 60 µg in a 0.8 mL dose of Tri-NIV vaccine, intramuscularly, at Day 0 and received 60 µg in a 0.8 mL dose of Fluzone HD, intramuscularly, at Day 21.</description>
          </group>
          <group group_id="O3">
            <title>Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21.</title>
            <description>Participants received 60 µg in a 0.8 mL dose of Fluzone HD, intramuscularly, at Day 0 and received 60 µg in a 0.5 mL dose of Placebo, intramuscularly, at Day 21.</description>
          </group>
        </group_list>
        <measure>
          <title>Seroconversion Rate (SCR) Specific for the HA Receptor Binding Domains of at Least 2 Historic A Virus Strains (One H1N1 and One H3N2) as Measured by the HAI Assay</title>
          <description>The immunogenicity of Tri-NIV at 2 different doses and the licensed comparator Fluzone HD (Sanofi Pasteur) based on hemagglutination inhibition (HAI) responses to at least 2 historic and/or drifted A virus strains (one H1N1 and one H3N2) expressed as SCRs.</description>
          <population>Group A and B participants received different doses of the Tri-NIV vaccine on Day 0 and Fluzone HD on Day 21. Group C participants received Fluzone HD on Day 0 and Placebo on Day 21.</population>
          <units>participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="109"/>
                <count group_id="O2" value="111"/>
                <count group_id="O3" value="110"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>A/Michigan/45/2015 (H1N1): Day 21</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27" lower_limit="17.0" upper_limit="34.0"/>
                    <measurement group_id="O2" value="45" lower_limit="31.6" upper_limit="50.7"/>
                    <measurement group_id="O3" value="40" lower_limit="27.7" upper_limit="46.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/Michigan/45/2015 (H1N1) : Day 21</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29" lower_limit="18.6" upper_limit="35.9"/>
                    <measurement group_id="O2" value="38" lower_limit="25.7" upper_limit="44.2"/>
                    <measurement group_id="O3" value="25" lower_limit="15.4" upper_limit="32.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Seroprotection Specific for the HA Receptor Binding Domains of at Least 2 Historic A Virus Strains (One H1N1 and One H3N2) as Measured by the HAI Assay</title>
        <description>The immunogenicity of Tri-NIV at 2 different doses and the licensed comparator Fluzone HD (Sanofi Pasteur) based on hemagglutination inhibition (HAI) responses to at least 2 historic and/or drifted A virus strains (one H1N1 and one H3N2) expressed as SPRs.&#xD;
Seroprotection rate (SPR) - defined as the percentage of subjects with an HAI titer ≥ 1:40.</description>
        <time_frame>Day 0 - Day 21</time_frame>
        <population>Group A and B participants received different doses of the Tri-NIV vaccine on Day 0 and Fluzone HD on Day 21. Group C participants received Fluzone HD on Day 0 and Placebo on Day 21.</population>
        <group_list>
          <group group_id="O1">
            <title>Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21</title>
            <description>Participants received 15 µg in a 0.3 mL dose of Tri-NIV vaccine, intramuscularly, at Day 0 and received 60 µg in a 0.8 mL dose of Fluzone HD, intramuscularly, at Day 21.</description>
          </group>
          <group group_id="O2">
            <title>Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21</title>
            <description>Participants received 60 µg in a 0.8 mL dose of Tri-NIV vaccine, intramuscularly, at Day 0 and received 60 µg in a 0.8 mL dose of Fluzone HD, intramuscularly, at Day 21.</description>
          </group>
          <group group_id="O3">
            <title>Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21.</title>
            <description>Participants received 60 µg in a 0.8 mL dose of Fluzone HD, intramuscularly, at Day 0 and received 60 µg in a 0.5 mL dose of Placebo, intramuscularly, at Day 21.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Seroprotection Specific for the HA Receptor Binding Domains of at Least 2 Historic A Virus Strains (One H1N1 and One H3N2) as Measured by the HAI Assay</title>
          <description>The immunogenicity of Tri-NIV at 2 different doses and the licensed comparator Fluzone HD (Sanofi Pasteur) based on hemagglutination inhibition (HAI) responses to at least 2 historic and/or drifted A virus strains (one H1N1 and one H3N2) expressed as SPRs.&#xD;
Seroprotection rate (SPR) - defined as the percentage of subjects with an HAI titer ≥ 1:40.</description>
          <population>Group A and B participants received different doses of the Tri-NIV vaccine on Day 0 and Fluzone HD on Day 21. Group C participants received Fluzone HD on Day 0 and Placebo on Day 21.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="109"/>
                <count group_id="O2" value="111"/>
                <count group_id="O3" value="110"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>A/Michigan/45/2015 (H1N1) : Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.1" lower_limit="95.0" upper_limit="100.0"/>
                    <measurement group_id="O2" value="98.2" lower_limit="93.6" upper_limit="99.8"/>
                    <measurement group_id="O3" value="97.2" lower_limit="92.2" upper_limit="99.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/Michigan/45/2015 (H1N1) : Day 21</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0" lower_limit="96.7" upper_limit="100.0"/>
                    <measurement group_id="O2" value="100" lower_limit="96.7" upper_limit="100.0"/>
                    <measurement group_id="O3" value="99.1" lower_limit="95.0" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/HongKong/4801/2014 (H3N2) : Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.2" lower_limit="92.2" upper_limit="99.4"/>
                    <measurement group_id="O2" value="96.4" lower_limit="91.0" upper_limit="99.0"/>
                    <measurement group_id="O3" value="90.8" lower_limit="83.8" upper_limit="95.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>A/HongKong/4801/2014 (H3N2) : Day 21</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0" lower_limit="96.7" upper_limit="100.0"/>
                    <measurement group_id="O2" value="98.2" lower_limit="93.6" upper_limit="99.8"/>
                    <measurement group_id="O3" value="94.5" lower_limit="88.4" upper_limit="98.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Geometric Mean Titers (GMT) for Neutralizing Antibody Titers Specific for the Virus Strains Included in NanoFlu and the Fluzone HD Comparator, as Well as Selected Historical A Strains, as Measured by a Microneutralization Assay.</title>
        <description>The immunogenicity of Tri-NIV at 2 different doses, and the licensed comparator Fluzone HD (Sanofi Pasteur), based on microneutralization (MN) responses to vaccine-homologous and historic and/or drifted influenza A strains, and the vaccine-homologous B/Victoria lineage strain, at Day 21 post-dosing expressed as GMTs.</description>
        <time_frame>Day 0 - Day 21 post dosing</time_frame>
        <population>Group A and B participants received different doses of the Tri-NIV vaccine on Day 0 and Fluzone HD on Day 21. Group C participants received Fluzone HD on Day 0 and Placebo on Day 21.</population>
        <group_list>
          <group group_id="O1">
            <title>Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21</title>
            <description>Participants received 15 µg in a 0.3 mL dose of Tri-NIV vaccine, intramuscularly, at Day 0 and received 60 µg in a 0.8 mL dose of Fluzone HD, intramuscularly, at Day 21.</description>
          </group>
          <group group_id="O2">
            <title>Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21</title>
            <description>Participants received 60 µg in a 0.8 mL dose of Tri-NIV vaccine, intramuscularly, at Day 0 and received 60 µg in a 0.8 mL dose of Fluzone HD, intramuscularly, at Day 21.</description>
          </group>
          <group group_id="O3">
            <title>Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21.</title>
            <description>Participants received 60 µg in a 0.8 mL dose of Fluzone HD, intramuscularly, at Day 0 and received 60 µg in a 0.5 mL dose of Placebo, intramuscularly, at Day 21.</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Titers (GMT) for Neutralizing Antibody Titers Specific for the Virus Strains Included in NanoFlu and the Fluzone HD Comparator, as Well as Selected Historical A Strains, as Measured by a Microneutralization Assay.</title>
          <description>The immunogenicity of Tri-NIV at 2 different doses, and the licensed comparator Fluzone HD (Sanofi Pasteur), based on microneutralization (MN) responses to vaccine-homologous and historic and/or drifted influenza A strains, and the vaccine-homologous B/Victoria lineage strain, at Day 21 post-dosing expressed as GMTs.</description>
          <population>Group A and B participants received different doses of the Tri-NIV vaccine on Day 0 and Fluzone HD on Day 21. Group C participants received Fluzone HD on Day 0 and Placebo on Day 21.</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="109"/>
                <count group_id="O2" value="111"/>
                <count group_id="O3" value="110"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 0 (A/Switzerland/9715293/2013 (H3N2))</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1696" lower_limit="1292" upper_limit="2227"/>
                    <measurement group_id="O2" value="1258" lower_limit="954" upper_limit="1658"/>
                    <measurement group_id="O3" value="1400" lower_limit="1046" upper_limit="1873"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 21 (A/Switzerland/9715293/2013 (H3N2))</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4419" lower_limit="3391" upper_limit="5758"/>
                    <measurement group_id="O2" value="5223" lower_limit="3997" upper_limit="6824"/>
                    <measurement group_id="O3" value="3011" lower_limit="2268" upper_limit="3997"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 0 (A/Texas/50/2012 (H3N2))</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3660" lower_limit="2803" upper_limit="4778"/>
                    <measurement group_id="O2" value="2768" lower_limit="2142" upper_limit="3577"/>
                    <measurement group_id="O3" value="3307" lower_limit="2484" upper_limit="4402"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 21 (A/Texas/50/2012 (H3N2))</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9204" lower_limit="7165" upper_limit="11822"/>
                    <measurement group_id="O2" value="10495" lower_limit="8213" upper_limit="13410"/>
                    <measurement group_id="O3" value="8383" lower_limit="6409" upper_limit="10964"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 0 (A/Singapore/INFIMH-16-0019/2016 (H3N2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="587" lower_limit="461" upper_limit="748"/>
                    <measurement group_id="O2" value="437" lower_limit="349" upper_limit="547"/>
                    <measurement group_id="O3" value="489" lower_limit="367" upper_limit="651"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 21 (A/Singapore/INFIMH-16-0019/2016 (H3N2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1469" lower_limit="1113" upper_limit="1940"/>
                    <measurement group_id="O2" value="1640" lower_limit="1254" upper_limit="2146"/>
                    <measurement group_id="O3" value="1905" lower_limit="1434" upper_limit="2531"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 0 (A/Michigan/45/2015 (H1N1))</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="411" lower_limit="327" upper_limit="516"/>
                    <measurement group_id="O2" value="342" lower_limit="269" upper_limit="436"/>
                    <measurement group_id="O3" value="334" lower_limit="259" upper_limit="432"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 21 (A/Michigan/45/2015 (H1N1))</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1414" lower_limit="1070" upper_limit="1868"/>
                    <measurement group_id="O2" value="2005" lower_limit="1485" upper_limit="2708"/>
                    <measurement group_id="O3" value="1741" lower_limit="1313" upper_limit="2309"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 0 (A/HongKong/4801/2014 (H3N2) )</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1239" lower_limit="957" upper_limit="1605"/>
                    <measurement group_id="O2" value="891" lower_limit="698" upper_limit="1137"/>
                    <measurement group_id="O3" value="1081" lower_limit="816" upper_limit="1433"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 21 (A/HongKong/4801/2014 (H3N2) )</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3359" lower_limit="2577" upper_limit="4378"/>
                    <measurement group_id="O2" value="3791" lower_limit="2906" upper_limit="4944"/>
                    <measurement group_id="O3" value="4455" lower_limit="3426" upper_limit="5793"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 0 (B/Brisbane/60/2008 (Victoria Lineage))</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="167" lower_limit="129" upper_limit="216"/>
                    <measurement group_id="O2" value="174" lower_limit="137" upper_limit="220"/>
                    <measurement group_id="O3" value="154" lower_limit="124" upper_limit="193"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 21 (B/Brisbane/60/2008 (Victoria Lineage))</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="287" lower_limit="228" upper_limit="361"/>
                    <measurement group_id="O2" value="354" lower_limit="285" upper_limit="439"/>
                    <measurement group_id="O3" value="425" lower_limit="341" upper_limit="529"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Geometric Mean Ratio (GMR) for Neutralizing Antibody Titers Specific for the Virus Strains Included in NanoFlu and the Fluzone HD Comparator, as Well as Selected Historical A Strains, as Measured by a Microneutralization Assay.</title>
        <description>The immunogenicity of Tri-NIV at 2 different doses, and the licensed comparator Fluzone HD (Sanofi Pasteur), based on microneutralization (MN) responses to vaccine-homologous and historic and/or drifted influenza A strains, and the vaccine-homologous B/Victoria lineage strain, at Day 21 post-dosing expressed as GMRs.</description>
        <time_frame>Day 0 - Day 21</time_frame>
        <population>Group A and B participants received different doses of the Tri-NIV vaccine on Day 0 and Fluzone HD on Day 21. Group C participants received Fluzone HD on Day 0 and Placebo on Day 21.</population>
        <group_list>
          <group group_id="O1">
            <title>Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21</title>
            <description>Participants received 15 µg in a 0.3 mL dose of Tri-NIV vaccine, intramuscularly, at Day 0 and received 60 µg in a 0.8 mL dose of Fluzone HD, intramuscularly, at Day 21.</description>
          </group>
          <group group_id="O2">
            <title>Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21</title>
            <description>Participants received 60 µg in a 0.8 mL dose of Tri-NIV vaccine, intramuscularly, at Day 0 and received 60 µg in a 0.8 mL dose of Fluzone HD, intramuscularly, at Day 21.</description>
          </group>
          <group group_id="O3">
            <title>Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21.</title>
            <description>Participants received 60 µg in a 0.8 mL dose of Fluzone HD, intramuscularly, at Day 0 and received 60 µg in a 0.5 mL dose of Placebo, intramuscularly, at Day 21.</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Ratio (GMR) for Neutralizing Antibody Titers Specific for the Virus Strains Included in NanoFlu and the Fluzone HD Comparator, as Well as Selected Historical A Strains, as Measured by a Microneutralization Assay.</title>
          <description>The immunogenicity of Tri-NIV at 2 different doses, and the licensed comparator Fluzone HD (Sanofi Pasteur), based on microneutralization (MN) responses to vaccine-homologous and historic and/or drifted influenza A strains, and the vaccine-homologous B/Victoria lineage strain, at Day 21 post-dosing expressed as GMRs.</description>
          <population>Group A and B participants received different doses of the Tri-NIV vaccine on Day 0 and Fluzone HD on Day 21. Group C participants received Fluzone HD on Day 0 and Placebo on Day 21.</population>
          <units>Ratio</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="109"/>
                <count group_id="O2" value="111"/>
                <count group_id="O3" value="110"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 21 (A/Switzerland/9715293/2013 (H3N2))</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.61" lower_limit="2.13" upper_limit="3.19"/>
                    <measurement group_id="O2" value="4.15" lower_limit="3.25" upper_limit="5.31"/>
                    <measurement group_id="O3" value="2.15" lower_limit="1.82" upper_limit="2.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 21 (A/Texas/50/2012 (H3N2))</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.51" lower_limit="2.04" upper_limit="3.10"/>
                    <measurement group_id="O2" value="3.79" lower_limit="3.05" upper_limit="4.72"/>
                    <measurement group_id="O3" value="2.53" lower_limit="2.09" upper_limit="3.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 21 (A/Singapore/INFIMH-16-0019/2016 (H3N2))</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.50" lower_limit="1.99" upper_limit="3.15"/>
                    <measurement group_id="O2" value="3.76" lower_limit="2.98" upper_limit="4.74"/>
                    <measurement group_id="O3" value="3.90" lower_limit="3.09" upper_limit="4.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 21: A/Michigan/45/2015 (H1N1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.44" lower_limit="2.74" upper_limit="4.33"/>
                    <measurement group_id="O2" value="5.86" lower_limit="4.45" upper_limit="7.72"/>
                    <measurement group_id="O3" value="5.21" lower_limit="3.94" upper_limit="6.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 21: A/HongKong/4801/2014 (H3N2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.71" lower_limit="2.20" upper_limit="3.33"/>
                    <measurement group_id="O2" value="4.25" lower_limit="3.34" upper_limit="5.42"/>
                    <measurement group_id="O3" value="4.12" lower_limit="3.26" upper_limit="5.20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 21: B/Brisbane/60/2008 (Victoria Lineage)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.72" lower_limit="1.48" upper_limit="2.00"/>
                    <measurement group_id="O2" value="2.03" lower_limit="1.70" upper_limit="2.43"/>
                    <measurement group_id="O3" value="2.75" lower_limit="2.19" upper_limit="3.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Seroconversion Rate (SCR) for Neutralizing Antibody Titers Specific for the Virus Strains Included in NanoFlu and the Fluzone HD Comparator, as Well as Selected Historical A Strains, as Measured by a Microneutralization Assay.</title>
        <description>The immunogenicity of Tri-NIV at 2 different doses, and the licensed comparator Fluzone HD (Sanofi Pasteur), based on microneutralization (MN) responses to vaccine-homologous and historic and/or drifted influenza A strains, and the vaccine-homologous B/Victoria lineage strain, at Day 21 post-dosing expressed as SPRs.</description>
        <time_frame>Day 0 - Day 21</time_frame>
        <population>Group A and B participants received different doses of the Tri-NIV vaccine on Day 0 and Fluzone HD on Day 21. Group C participants received Fluzone HD on Day 0 and Placebo on Day 21.</population>
        <group_list>
          <group group_id="O1">
            <title>Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21</title>
            <description>Participants received 15 µg in a 0.3 mL dose of Tri-NIV vaccine, intramuscularly, at Day 0 and received 60 µg in a 0.8 mL dose of Fluzone HD, intramuscularly, at Day 21.</description>
          </group>
          <group group_id="O2">
            <title>Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21</title>
            <description>Participants received 60 µg in a 0.8 mL dose of Tri-NIV vaccine, intramuscularly, at Day 0 and received 60 µg in a 0.8 mL dose of Fluzone HD, intramuscularly, at Day 21.</description>
          </group>
          <group group_id="O3">
            <title>Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21.</title>
            <description>Participants received 60 µg in a 0.8 mL dose of Fluzone HD, intramuscularly, at Day 0 and received 60 µg in a 0.5 mL dose of Placebo, intramuscularly, at Day 21.</description>
          </group>
        </group_list>
        <measure>
          <title>Seroconversion Rate (SCR) for Neutralizing Antibody Titers Specific for the Virus Strains Included in NanoFlu and the Fluzone HD Comparator, as Well as Selected Historical A Strains, as Measured by a Microneutralization Assay.</title>
          <description>The immunogenicity of Tri-NIV at 2 different doses, and the licensed comparator Fluzone HD (Sanofi Pasteur), based on microneutralization (MN) responses to vaccine-homologous and historic and/or drifted influenza A strains, and the vaccine-homologous B/Victoria lineage strain, at Day 21 post-dosing expressed as SPRs.</description>
          <population>Group A and B participants received different doses of the Tri-NIV vaccine on Day 0 and Fluzone HD on Day 21. Group C participants received Fluzone HD on Day 0 and Placebo on Day 21.</population>
          <units>participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="109"/>
                <count group_id="O2" value="111"/>
                <count group_id="O3" value="110"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 21 (A/Switzerland/9715293/2013 (H3N2))</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22" lower_limit="13.1" upper_limit="29.0"/>
                    <measurement group_id="O2" value="45" lower_limit="31.6" upper_limit="50.7"/>
                    <measurement group_id="O3" value="20" lower_limit="11.6" upper_limit="26.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 21 (A/Texas/50/2012 (H3N2))</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26" lower_limit="16.2" upper_limit="33.0"/>
                    <measurement group_id="O2" value="47" lower_limit="33.3" upper_limit="52.5"/>
                    <measurement group_id="O3" value="28" lower_limit="17.8" upper_limit="34.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 21 (A/Singapore/INFIMH-16-0019/2016 (H3N2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27" lower_limit="17.0" upper_limit="34.0"/>
                    <measurement group_id="O2" value="38" lower_limit="25.7" upper_limit="44.2"/>
                    <measurement group_id="O3" value="43" lower_limit="30.2" upper_limit="49.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 21: A/Michigan/45/2015 (H1N1)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33" lower_limit="21.8" upper_limit="39.8"/>
                    <measurement group_id="O2" value="53" lower_limit="38.6" upper_limit="57.9"/>
                    <measurement group_id="O3" value="50" lower_limit="36.3" upper_limit="55.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 21: A/HongKong/4801/2014 (H3N2)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28" lower_limit="17.8" upper_limit="34.9"/>
                    <measurement group_id="O2" value="43" lower_limit="29.9" upper_limit="48.9"/>
                    <measurement group_id="O3" value="48" lower_limit="34.5" upper_limit="53.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 21: B/Brisbane/60/2008 (Victoria Lineage)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13" lower_limit="6.5" upper_limit="19.5"/>
                    <measurement group_id="O2" value="18" lower_limit="10.0" upper_limit="24.6"/>
                    <measurement group_id="O3" value="23" lower_limit="13.9" upper_limit="30.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 year</time_frame>
      <desc>Serious Adverse Events Other (Not Including Serious) Adverse Events</desc>
      <group_list>
        <group group_id="E1">
          <title>Group A- Participants Received Low Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21</title>
          <description>Participants received 15 µg in a 0.3 mL dose of Tri-NIV vaccine, intramuscularly, at Day 0 and received 60 µg in a 0.8 mL dose of Fluzone HD, intramuscularly, at Day 21.</description>
        </group>
        <group group_id="E2">
          <title>Group B- Participants Received High Dose Tri-NIV Vaccine at Day 0 and Received Fluzone HD at Day 21</title>
          <description>Participants received 60 µg in a 0.8 mL dose of Tri-NIV vaccine, intramuscularly, at Day 0 and received 60 µg in a 0.8 mL dose of Fluzone HD, intramuscularly, at Day 21.</description>
        </group>
        <group group_id="E3">
          <title>Group C - Participants Received Fluzone HD at Day 0 and Received Dose of Placebo at Day 21.</title>
          <description>Participants received 60 µg in a 0.8 mL dose of Fluzone HD, intramuscularly, at Day 0 and received 60 µg in a 0.5 mL dose of Placebo, intramuscularly, at Day 21.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="110"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="111"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="110"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>ATRIAL FIBRILLATION</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="110"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>COLITIS MICROSCOPIC</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="110"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>CHEST DISCOMFORT</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="110"/>
              </event>
              <event>
                <sub_title>CHEST PAIN</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="110"/>
              </event>
              <event>
                <sub_title>PYREXIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="110"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>BETA HAEMOLYTIC STREPTOCOCCAL INFECTION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="110"/>
              </event>
              <event>
                <sub_title>PELVIC ABSCESS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="110"/>
              </event>
              <event>
                <sub_title>PNEUMONIA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="110"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>OVERDOSE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="110"/>
              </event>
              <event>
                <sub_title>SEROMA</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="110"/>
              </event>
              <event>
                <sub_title>UPPER LIMB FRACTURE</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="110"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>ADENOCARCINOMA GASTRIC</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="110"/>
              </event>
              <event>
                <sub_title>ADENOCARCINOMA OF COLON</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="110"/>
              </event>
              <event>
                <sub_title>ADENOCARCINOMA PANCREAS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="110"/>
              </event>
              <event>
                <sub_title>BLADDER TRANSITIONAL CELL CARCINOMA</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="110"/>
              </event>
              <event>
                <sub_title>METASTASES TO MENINGES</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="110"/>
              </event>
              <event>
                <sub_title>PROSTATE CANCER</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="110"/>
              </event>
              <event>
                <sub_title>PROSTATE CANCER METASTATIC</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="110"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>CEREBROVASCULAR ACCIDENT</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="111"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="110"/>
              </event>
              <event>
                <sub_title>CERVICAL RADICULOPATHY</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="110"/>
              </event>
              <event>
                <sub_title>SYNCOPE</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="110"/>
              </event>
              <event>
                <sub_title>TRANSIENT ISCHAEMIC ATTACK</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="110"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>DEVICE DISLOCATION</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="109"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="110"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>NEPHROLITHIASIS</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="109"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="110"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="32" subjects_at_risk="109"/>
                <counts group_id="E2" subjects_affected="27" subjects_at_risk="111"/>
                <counts group_id="E3" subjects_affected="28" subjects_at_risk="110"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>BRONCHITIS</sub_title>
                <counts group_id="E1" events="11" subjects_affected="11" subjects_at_risk="109"/>
                <counts group_id="E2" events="10" subjects_affected="9" subjects_at_risk="111"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="110"/>
              </event>
              <event>
                <sub_title>SINUSITIS</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="109"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="111"/>
                <counts group_id="E3" events="7" subjects_affected="7" subjects_at_risk="110"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>BLOOD PRESSURE SYSTOLIC INCREASED</sub_title>
                <counts group_id="E1" events="11" subjects_affected="11" subjects_at_risk="109"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="111"/>
                <counts group_id="E3" events="8" subjects_affected="8" subjects_at_risk="110"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>HEADACHE</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="109"/>
                <counts group_id="E2" events="8" subjects_affected="7" subjects_at_risk="111"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="110"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>HYPERTENSION</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="109"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="111"/>
                <counts group_id="E3" events="6" subjects_affected="6" subjects_at_risk="110"/>
              </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>There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Novavax Customer Service Center</name_or_title>
      <organization>Novavax Inc.</organization>
      <phone>1-844-Novavax (668-2829)</phone>
      <email>Clinicaltrials@novavax.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/NCT03293498
org study id: tNIV-E-101
nct id: NCT03293498
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This was a Phase 1/2, randomized, observer-blinded, active-controlled trial to assess the
      Safety and Tolerability of a Recombinant Trivalent Nanoparticle Influenza Vaccine (Tri-NIV)
      with Matrix M1™ Adjuvant in Healthy Older Adults ≥ 60 Years of Age
Study tNIV-E-101 a randomized, observer-blinded, active-controlled trial designed to evaluate
      the safety and immunogenicity of Novavax's insect cell-derived, egg-free, influenza vaccine
      (Tri-NIV) based on recombinant HA nanoparticle antigens, representing the 3 major influenza
      types/subtypes recommended for inclusion in the 2017 - 2018 seasonal influenza vaccine by the
      World Health Organization (WHO) and the Center for Biologics Evaluation and Research (CBER)
      Approximately 330 eligible subjects were enrolled and randomized into 1 of 3 treatment groups
      Each group consisted of approximately 110 subjects total, stratified by age, gender, and
      history of receipt of the 2016 - 17 influenza vaccine. On Day 0, subjects in Groups A and B
      were administered an IM injection of NanoFlu at one of two dose levels; subjects in Group C
      received the preconfigured comparator (Fluzone HD) at the manufacturer's recommended dose and
      volume. On Day 21, all Group A and B subjects were administered a rescue injection with a
      licensed seasonal influenza vaccine. In contrast, all Group C subjects were administered an
      injection with a sterile saline placebo to maintain the trial blind. Trial follow-up for each
      subject spanned approximately 1 year from Day 0.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Number of Participants With All Adverse Events (AEs), Medically Attended Adverse Events (MAAEs), Serious Adverse Events (SAEs), and Significant New Medical Conditions (SNMCs).
time frame: Day 0 - Day 21 post dosing
description: Number of participants that reported all adverse event (AE) profile (including adverse changes in clinical laboratory parameters) ; medically-attended adverse event (MAE), serious adverse event (SAE), and significant new medical condition (SNMC) post dosing.
measure: Number of Participants With Solicited Local and Systemic AEs
time frame: Day 0 - Day 6 post-dosing
description: Number of participants with solicited local and systemic adverse events over the 7 days post-injection
measure: Geometric Mean Titers (GMT) Specific for the Hemagglutinin (HA) Receptor Binding Domains of Each of the Virus Strains Included in the NanoFlu as Measured by the Hemagglutination Inhibition (HAI) Assay.
time frame: Day 0 - Day 21 post dosing
description: The immunogenicity of Tri-NIV at 2 different doses, and the licensed comparator Fluzone HD (Sanofi Pasteur), in healthy older adults ≥ 60 years of age, based on hemagglutination inhibition (HAI) responses to vaccine-homologous influenza A and B strains, as recommended for the 2017 - 18 Northern hemisphere vaccine, at Day 21 post-dosing expressed as GMTs.
measure: Geometric Mean Ratio (GMR) Specific for the HA Receptor Binding Domains of Each of the Virus Strains Included in the NanoFlu as Measured by the HAI Assay.
time frame: Day 0 - Day 21 post dosing
description: The immunogenicity of Tri-NIV at 2 different doses, and the licensed comparator Fluzone HD (Sanofi Pasteur), in healthy older adults ≥ 60 years of age, based on hemagglutination inhibition (HAI) responses to vaccine-homologous influenza A and B strains, as recommended for the 2017 - 18 Northern hemisphere vaccine, at Day 21 post-dosing expressed as GMR.
measure: Seroconversion Rate (SCR) Specific for the HA Receptor Binding Domains of Each of the Virus Strains Included in the NanoFlu as Measured by the HAI Assay.
time frame: Day 0 - Day 21 post dosing
description: The immunogenicity of Tri-NIV at 2 different doses, and the licensed comparator Fluzone HD (Sanofi Pasteur), in healthy older adults ≥ 60 years of age, based on hemagglutination inhibition (HAI) responses to vaccine-homologous influenza A and B strains, as recommended for the 2017 - 18 Northern hemisphere vaccine, at Day 21 post-dosing expressed as SCRs.
measure: Number of Participants With Seroprotection Specific for the HA Receptor Binding Domains of Each of the Virus Strains Included in the NanoFlu as Measured by the HAI Assay.
time frame: Day 0 - Day 21 post dosing
description: The immunogenicity of Tri-NIV at 2 different doses, and the licensed comparator Fluzone HD (Sanofi Pasteur), in healthy older adults ≥ 60 years of age, based on hemagglutination inhibition (HAI) responses to vaccine-homologous influenza A and B strains, as recommended for the 2017 - 18 Northern hemisphere vaccine, at Day 21 post-dosing expressed as SPRs.
Seroprotection rate (SPR) - defined as the number of subjects with an HAI titer ≥ 1:40.
measure: Geometric Mean Titers (GMT) Specific for the HA Receptor Binding Domains of at Least 2 Historic A Virus Strains (One H1N1 and One H3N2) as Measured by the HAI Assay
time frame: Day 0 - Day 21
description: The immunogenicity of Tri-NIV at 2 different doses and the licensed comparator Fluzone HD (Sanofi Pasteur) based on hemagglutination inhibition (HAI) responses to at least 2 historic and/or drifted A virus strains (one H1N1 and one H3N2) expressed as GMTs.
measure: Geometric Mean Ratio (GMR) Specific for the HA Receptor Binding Domains of at Least 2 Historic A Virus Strains (One H1N1 and One H3N2) as Measured by the HAI Assay
time frame: Day 0 - Day 21
description: The immunogenicity of Tri-NIV at 2 different doses and the licensed comparator Fluzone HD (Sanofi Pasteur) based on hemagglutination inhibition (HAI) responses to at least 2 historic and/or drifted A virus strains (one H1N1 and one H3N2) expressed as GMRs.
measure: Seroconversion Rate (SCR) Specific for the HA Receptor Binding Domains of at Least 2 Historic A Virus Strains (One H1N1 and One H3N2) as Measured by the HAI Assay
time frame: Day 0 - Day 21
description: The immunogenicity of Tri-NIV at 2 different doses and the licensed comparator Fluzone HD (Sanofi Pasteur) based on hemagglutination inhibition (HAI) responses to at least 2 historic and/or drifted A virus strains (one H1N1 and one H3N2) expressed as SCRs.
measure: Number of Participants With Seroprotection Specific for the HA Receptor Binding Domains of at Least 2 Historic A Virus Strains (One H1N1 and One H3N2) as Measured by the HAI Assay
time frame: Day 0 - Day 21
description: The immunogenicity of Tri-NIV at 2 different doses and the licensed comparator Fluzone HD (Sanofi Pasteur) based on hemagglutination inhibition (HAI) responses to at least 2 historic and/or drifted A virus strains (one H1N1 and one H3N2) expressed as SPRs.
Seroprotection rate (SPR) - defined as the percentage of subjects with an HAI titer ≥ 1:40.
measure: Geometric Mean Titers (GMT) for Neutralizing Antibody Titers Specific for the Virus Strains Included in NanoFlu and the Fluzone HD Comparator, as Well as Selected Historical A Strains, as Measured by a Microneutralization Assay.
time frame: Day 0 - Day 21 post dosing
description: The immunogenicity of Tri-NIV at 2 different doses, and the licensed comparator Fluzone HD (Sanofi Pasteur), based on microneutralization (MN) responses to vaccine-homologous and historic and/or drifted influenza A strains, and the vaccine-homologous B/Victoria lineage strain, at Day 21 post-dosing expressed as GMTs.
measure: Geometric Mean Ratio (GMR) for Neutralizing Antibody Titers Specific for the Virus Strains Included in NanoFlu and the Fluzone HD Comparator, as Well as Selected Historical A Strains, as Measured by a Microneutralization Assay.
time frame: Day 0 - Day 21
description: The immunogenicity of Tri-NIV at 2 different doses, and the licensed comparator Fluzone HD (Sanofi Pasteur), based on microneutralization (MN) responses to vaccine-homologous and historic and/or drifted influenza A strains, and the vaccine-homologous B/Victoria lineage strain, at Day 21 post-dosing expressed as GMRs.
measure: Seroconversion Rate (SCR) for Neutralizing Antibody Titers Specific for the Virus Strains Included in NanoFlu and the Fluzone HD Comparator, as Well as Selected Historical A Strains, as Measured by a Microneutralization Assay.
time frame: Day 0 - Day 21
description: The immunogenicity of Tri-NIV at 2 different doses, and the licensed comparator Fluzone HD (Sanofi Pasteur), based on microneutralization (MN) responses to vaccine-homologous and historic and/or drifted influenza A strains, and the vaccine-homologous B/Victoria lineage strain, at Day 21 post-dosing expressed as SPRs.
arm group label: Group A
arm group type: Experimental
description: Low dose NanoFlu - Day 0; Fluzone HD - Day 21
arm group label: Group B
arm group type: Experimental
description: High dose NanoFlu - Day 0; Fluzone HD - Day 21
arm group label: Group C
arm group type: Active Comparator
description: Fluzone HD - Day 0; Saline - Day 21
intervention type: Biological
intervention name: NanoFlu
description: Vaccine
arm group label: Group A
arm group label: Group B
intervention type: Biological
intervention name: Fluzone HD - Day 0
description: Vaccine
arm group label: Group C
intervention type: Biological
intervention name: Fluzone HD - Day 21
description: Vaccine
arm group label: Group A
arm group label: Group B
intervention type: Other
intervention name: Saline - Day 21
description: Placebo
arm group label: Group C
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Clinical Development
role: Study Director
affiliation: Novavax
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Influenza, Human
sharing ipd: Undecided
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 