<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/NCT02998996</url>
  </required_header>
  <id_info>
    <org_study_id>EURO 15-11</org_study_id>
    <nct_id>NCT02998996</nct_id>
  </id_info>
  <brief_title>Study to Assess the Safety, Tolerability and Immune Response Following Vaccination With Immunose™ FLU</brief_title>
  <official_title>A Phase I/II, Randomised, Placebo-controlled, Partially-blinded, Parallel-group Study to Assess the Safety, Tolerability and Immune Response Following Vaccination With Immunose™ FLU</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eurocine Vaccines AB</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Eurocine Vaccines AB</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main purpose of the this study is to evaluate the safety and tolerability of Immunose™&#xD;
      FLU based on Endocine™ and quadrivalent influenza antigen.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2016</start_date>
  <completion_date type="Actual">June 1, 2017</completion_date>
  <primary_completion_date type="Actual">June 1, 2017</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Local Tolerability - First Dose</measure>
    <time_frame>Pre-dose, and 15 and 120 min after study drug administration (Visit 2).</time_frame>
    <description>Local tolerability, as measured by at least one of the administration site reactions swelling, redness, pain and pruritus, regardless of severity.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Local Tolerability - Second Dose (Group 1-4 Only)</measure>
    <time_frame>Pre-dose, and 15 and 120 min after second study drug administration (Visit 3).</time_frame>
    <description>Local tolerability, as measured by at least one of the administration site reactions swelling, redness, pain and pruritus, regardless of severity.</description>
  </primary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">162</enrollment>
  <condition>Influenza, Human</condition>
  <arm_group>
    <arm_group_label>Immunose™ FLU 1%,</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>15 µg haemagglutinin(HA)/strain and 1% Endocine™</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Immunose™ FLU 2%,</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>15 µg HA/strain and 2% Endocine™</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Influenza antigen,</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>15 µg HA/strain</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Saline (NaCl),</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>i.m. comparator,</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>15 µg HA/strain</description>
  </arm_group>
  <arm_group>
    <arm_group_label>i.n. comparator</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>15 µg HA/strain and 1% Endocine™</intervention_name>
    <description>intranasal administration</description>
    <arm_group_label>Immunose™ FLU 1%,</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>15 µg HA/strain and 2% Endocine™</intervention_name>
    <description>intranasal administration</description>
    <arm_group_label>Immunose™ FLU 2%,</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>15 µg HA/strain</intervention_name>
    <description>intranasal administration</description>
    <arm_group_label>Influenza antigen,</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>intramuscular comparator</intervention_name>
    <description>intramuscular administration</description>
    <arm_group_label>i.m. comparator,</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>intranasal comparator</intervention_name>
    <description>intranasal administration</description>
    <arm_group_label>i.n. comparator</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Placebo, Saline</intervention_name>
    <description>intranasal administration</description>
    <arm_group_label>Saline (NaCl),</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Signed informed consent prior to any study related procedures.&#xD;
&#xD;
          -  Male or female 18-39 years of age (both inclusive) at screening&#xD;
&#xD;
          -  Subjects who the Investigator believes will comply with the requirements of the&#xD;
             protocol.&#xD;
&#xD;
          -  BMI: 18.0 and 30.0 kg/m2 (inclusive).&#xD;
&#xD;
          -  Judged by the Investigator to have no serious illness based on medical history,&#xD;
             physical examination, ECG, vital signs and blood and urine assessments at screening.&#xD;
&#xD;
          -  From the signing of the informed consent until 2 months after the last vaccination&#xD;
             (Visit 3 for group 1 to 4 and Visit 2 for group 5 and 6) female subjects have to use&#xD;
             contraceptive methods with a failure rate of &lt; 1% to prevent pregnancy (combined&#xD;
             [oestrogen and progestogen containing] hormonal contraception associated with&#xD;
             inhibition of ovulation [oral, intravaginal, transdermal], progestogen- only hormonal&#xD;
             contraception associated with inhibition of ovulation [oral, injectable, implantable],&#xD;
             intrauterine device [IUD], intrauterine hormone-releasing system [IUS], bilateral&#xD;
             tubal occlusion, sexual abstinence). Any male partner should be willing to use condom&#xD;
             or should be vasectomized.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of laboratory-confirmed influenza in the 2015/2016 season.&#xD;
&#xD;
          -  Use of any investigational drug product within 3 months before screening or planned&#xD;
             use during the study period, including the safety follow-up.&#xD;
&#xD;
          -  Administration of an influenza vaccine during the 6 months before screening.&#xD;
&#xD;
          -  Previously received another vaccine within 28 days before administration of the study&#xD;
             vaccine, or is scheduled to receive another vaccine during the study period, excluding&#xD;
             the safety follow-up.&#xD;
&#xD;
          -  Any contra-indication to intramuscular administration of the influenza vaccine&#xD;
             AdimFlu-S according to its prescribing information.&#xD;
&#xD;
          -  Any contra-indication to administration of the influenza vaccine Fluenz Tetra&#xD;
             according to its summary of product characteristics (SmPC).&#xD;
&#xD;
          -  History of any anaphylactic reaction and/or serious allergic reaction following a&#xD;
             vaccination, a proven hypersensitivity to any component of the study vaccine (e.g., to&#xD;
             eggs or egg product as well as ovalbumin, chicken protein, chicken feathers, influenza&#xD;
             viral protein, kanamycin, gentamycin and neomycin sulphate).&#xD;
&#xD;
          -  Diagnosis of asthma with poor disease control as assessed by the Investigator.&#xD;
&#xD;
          -  Potent immunosuppressive therapy including cytostatics, antibodies, drugs acting on&#xD;
             immunophilins, interferons and other drugs used to prevent rejection of organ&#xD;
             transplants, within 6 months before screening.&#xD;
&#xD;
          -  Use of any parenteral or oral corticosteroids within 30 days prior to screening.&#xD;
             Inhaled steroids are allowed.&#xD;
&#xD;
          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on&#xD;
             medical history and physical examination.&#xD;
&#xD;
          -  Any progressive or severe neurologic disorder, seizure disorder or Guillain-Barré&#xD;
             syndrome.&#xD;
&#xD;
          -  History of Guillain-Barré syndrome within 6 weeks of receipt of prior inactivated&#xD;
             influenza virus vaccine.&#xD;
&#xD;
          -  Received blood, blood products and/or plasma derivatives or any administration of&#xD;
             immunoglobulin preparation within the three months prior to Visit 2, or planned during&#xD;
             the study.&#xD;
&#xD;
          -  Participation in blood donation within 3 months or plasma donation within 1 month&#xD;
             prior to Visit 2.&#xD;
&#xD;
          -  History of substance or alcohol abuse within the past 2 years.&#xD;
&#xD;
          -  History or any illness/condition that, in the opinion of the Investigator, might&#xD;
             interfere with the results of the study or pose additional risk to the subjects due to&#xD;
             participation in the study.&#xD;
&#xD;
          -  Any positive result on screening for serum hepatitis B surface antigen, hepatitis C&#xD;
             antibody and HIV.&#xD;
&#xD;
          -  Pregnant or lactating female or intent to become pregnant during the clinic phase (up&#xD;
             until and including Visit 4 for group 1 to 4 and Visit 3 for group 5 and 6) and for 2&#xD;
             months after the last vaccination.&#xD;
&#xD;
          -  History of Bell's palsy.&#xD;
&#xD;
          -  Ongoing regular use of intranasal sprays including corticosteroids and decongestants.&#xD;
&#xD;
          -  Ongoing cough, sinusitis, allergic rhinitis, nasal polyps or obstruction, including&#xD;
             septum deviation significant enough to prevent bilateral administration of study&#xD;
             vaccine.&#xD;
&#xD;
          -  Known bleeding diathesis, or any condition that may be associated with a prolonged&#xD;
             bleeding time.&#xD;
&#xD;
          -  Subjects that are prone to nosebleed.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>39 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cornelia Lif-Tiberg, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CTC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Site 2</name>
      <address>
        <city>Linkoping</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Site 1</name>
      <address>
        <city>Uppsala</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>November 10, 2016</study_first_submitted>
  <study_first_submitted_qc>December 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 21, 2016</study_first_posted>
  <results_first_submitted>October 8, 2018</results_first_submitted>
  <results_first_submitted_qc>October 8, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">February 21, 2019</results_first_posted>
  <last_update_submitted>October 8, 2018</last_update_submitted>
  <last_update_submitted_qc>October 8, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 21, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Influenza, Human</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Endocine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 30, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/96/NCT02998996/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Immunose™ FLU 1%,</title>
          <description>15 µg haemagglutinin(HA)/strain and 1% Endocine™&#xD;
15 µg HA/strain and 1% Endocine™: intranasal administration</description>
        </group>
        <group group_id="P2">
          <title>Immunose™ FLU 2%,</title>
          <description>15 µg HA/strain and 2% Endocine™&#xD;
15 µg HA/strain and 2% Endocine™: intranasal administration</description>
        </group>
        <group group_id="P3">
          <title>Influenza Antigen,</title>
          <description>15 µg HA/strain&#xD;
15 µg HA/strain: intranasal administration</description>
        </group>
        <group group_id="P4">
          <title>Saline (NaCl),</title>
          <description>Placebo&#xD;
Placebo, Saline: intranasal administration</description>
        </group>
        <group group_id="P5">
          <title>i.m. Comparator,</title>
          <description>15 µg HA/strain&#xD;
intramuscular comparator: intramuscular administration</description>
        </group>
        <group group_id="P6">
          <title>i.n. Comparator</title>
          <description>intranasal comparator: intranasal administration</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="36"/>
                <participants group_id="P2" count="35"/>
                <participants group_id="P3" count="36"/>
                <participants group_id="P4" count="18"/>
                <participants group_id="P5" count="18"/>
                <participants group_id="P6" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="36"/>
                <participants group_id="P2" count="34"/>
                <participants group_id="P3" count="35"/>
                <participants group_id="P4" count="18"/>
                <participants group_id="P5" count="17"/>
                <participants group_id="P6" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Pregnancy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="0"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Family reasons</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
                <participants group_id="P5" count="1"/>
                <participants group_id="P6" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Immunose™ FLU 1%,</title>
          <description>15 µg haemagglutinin(HA)/strain and 1% Endocine™&#xD;
15 µg HA/strain and 1% Endocine™: intranasal administration</description>
        </group>
        <group group_id="B2">
          <title>Immunose™ FLU 2%,</title>
          <description>15 µg HA/strain and 2% Endocine™&#xD;
15 µg HA/strain and 2% Endocine™: intranasal administration</description>
        </group>
        <group group_id="B3">
          <title>Influenza Antigen,</title>
          <description>15 µg HA/strain&#xD;
15 µg HA/strain: intranasal administration</description>
        </group>
        <group group_id="B4">
          <title>Saline (NaCl),</title>
          <description>Placebo&#xD;
Placebo, Saline: intranasal administration</description>
        </group>
        <group group_id="B5">
          <title>i.m. Comparator,</title>
          <description>15 µg HA/strain&#xD;
intramuscular comparator: intramuscular administration</description>
        </group>
        <group group_id="B6">
          <title>i.n. Comparator</title>
          <description>intranasal comparator: intranasal administration</description>
        </group>
        <group group_id="B7">
          <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="36"/>
            <count group_id="B2" value="35"/>
            <count group_id="B3" value="36"/>
            <count group_id="B4" value="18"/>
            <count group_id="B5" value="18"/>
            <count group_id="B6" value="19"/>
            <count group_id="B7" value="162"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                    <measurement group_id="B2" value="35"/>
                    <measurement group_id="B3" value="36"/>
                    <measurement group_id="B4" value="18"/>
                    <measurement group_id="B5" value="18"/>
                    <measurement group_id="B6" value="19"/>
                    <measurement group_id="B7" value="162"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26.36" spread="5.69"/>
                    <measurement group_id="B2" value="26.34" spread="5.46"/>
                    <measurement group_id="B3" value="25.11" spread="4.8"/>
                    <measurement group_id="B4" value="27.72" spread="5.6"/>
                    <measurement group_id="B5" value="27.22" spread="4.75"/>
                    <measurement group_id="B6" value="24.68" spread="4.32"/>
                    <measurement group_id="B7" value="26.13" spread="5.20"/>
                  </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="20"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="20"/>
                    <measurement group_id="B4" value="15"/>
                    <measurement group_id="B5" value="9"/>
                    <measurement group_id="B6" value="8"/>
                    <measurement group_id="B7" value="91"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="16"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="9"/>
                    <measurement group_id="B6" value="11"/>
                    <measurement group_id="B7" value="71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Ethnicity</title>
              <category_list>
                <category>
                  <title>African descent</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian or Pacific Islander</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="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Caucasian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="34"/>
                    <measurement group_id="B4" value="17"/>
                    <measurement group_id="B5" value="17"/>
                    <measurement group_id="B6" value="19"/>
                    <measurement group_id="B7" value="154"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mixed/multi-racial</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="0"/>
                    <measurement group_id="B7" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Sweden</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                    <measurement group_id="B2" value="35"/>
                    <measurement group_id="B3" value="36"/>
                    <measurement group_id="B4" value="18"/>
                    <measurement group_id="B5" value="18"/>
                    <measurement group_id="B6" value="19"/>
                    <measurement group_id="B7" value="162"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Local Tolerability - First Dose</title>
        <description>Local tolerability, as measured by at least one of the administration site reactions swelling, redness, pain and pruritus, regardless of severity.</description>
        <time_frame>Pre-dose, and 15 and 120 min after study drug administration (Visit 2).</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Immunose™ FLU 1%,</title>
            <description>15 µg haemagglutinin(HA)/strain and 1% Endocine™&#xD;
15 µg HA/strain and 1% Endocine™: intranasal administration</description>
          </group>
          <group group_id="O2">
            <title>Immunose™ FLU 2%,</title>
            <description>15 µg HA/strain and 2% Endocine™&#xD;
15 µg HA/strain and 2% Endocine™: intranasal administration</description>
          </group>
          <group group_id="O3">
            <title>Influenza Antigen,</title>
            <description>15 µg HA/strain&#xD;
15 µg HA/strain: intranasal administration</description>
          </group>
          <group group_id="O4">
            <title>Saline (NaCl),</title>
            <description>Placebo&#xD;
Placebo, Saline: intranasal administration</description>
          </group>
          <group group_id="O5">
            <title>i.m. Comparator,</title>
            <description>15 µg HA/strain&#xD;
intramuscular comparator: intramuscular administration</description>
          </group>
          <group group_id="O6">
            <title>i.n. Comparator</title>
            <description>intranasal comparator: intranasal administration</description>
          </group>
        </group_list>
        <measure>
          <title>Local Tolerability - First Dose</title>
          <description>Local tolerability, as measured by at least one of the administration site reactions swelling, redness, pain and pruritus, regardless of severity.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="36"/>
                <count group_id="O2" value="35"/>
                <count group_id="O3" value="36"/>
                <count group_id="O4" value="18"/>
                <count group_id="O5" value="18"/>
                <count group_id="O6" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="9"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>15 min post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="7"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="9"/>
                    <measurement group_id="O6" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>120 min post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="7"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="6"/>
                    <measurement group_id="O6" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Local Tolerability - Second Dose (Group 1-4 Only)</title>
        <description>Local tolerability, as measured by at least one of the administration site reactions swelling, redness, pain and pruritus, regardless of severity.</description>
        <time_frame>Pre-dose, and 15 and 120 min after second study drug administration (Visit 3).</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Immunose™ FLU 1%,</title>
            <description>15 µg haemagglutinin(HA)/strain and 1% Endocine™&#xD;
15 µg HA/strain and 1% Endocine™: intranasal administration</description>
          </group>
          <group group_id="O2">
            <title>Immunose™ FLU 2%,</title>
            <description>15 µg HA/strain and 2% Endocine™&#xD;
15 µg HA/strain and 2% Endocine™: intranasal administration</description>
          </group>
          <group group_id="O3">
            <title>Influenza Antigen,</title>
            <description>15 µg HA/strain&#xD;
15 µg HA/strain: intranasal administration</description>
          </group>
          <group group_id="O4">
            <title>Saline (NaCl),</title>
            <description>Placebo&#xD;
Placebo, Saline: intranasal administration</description>
          </group>
        </group_list>
        <measure>
          <title>Local Tolerability - Second Dose (Group 1-4 Only)</title>
          <description>Local tolerability, as measured by at least one of the administration site reactions swelling, redness, pain and pruritus, regardless of severity.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="36"/>
                <count group_id="O2" value="35"/>
                <count group_id="O3" value="36"/>
                <count group_id="O4" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="7"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>15 min post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="12"/>
                    <measurement group_id="O3" value="10"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>120 min post-dose</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From first dose of IMP until the subject's last visit to the clinic (Visit 4 for Group 1 to 4 and Visit 3 for Group 5 and 6). In addition to collection of AEs at the clinic visits, solicited and unsolicited AEs were collected using a diary for 10 days after each dose administration. SAEs and AEs of special interest were also collected during 6 months after the last vaccination.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Immunose™ FLU 1%,</title>
          <description>15 µg haemagglutinin(HA)/strain and 1% Endocine™&#xD;
15 µg HA/strain and 1% Endocine™: intranasal administration</description>
        </group>
        <group group_id="E2">
          <title>Immunose™ FLU 2%,</title>
          <description>15 µg HA/strain and 2% Endocine™&#xD;
15 µg HA/strain and 2% Endocine™: intranasal administration</description>
        </group>
        <group group_id="E3">
          <title>Influenza Antigen,</title>
          <description>15 µg HA/strain&#xD;
15 µg HA/strain: intranasal administration</description>
        </group>
        <group group_id="E4">
          <title>Saline (NaCl),</title>
          <description>Placebo&#xD;
Placebo, Saline: intranasal administration</description>
        </group>
        <group group_id="E5">
          <title>i.m. Comparator,</title>
          <description>15 µg HA/strain&#xD;
intramuscular comparator: intramuscular administration</description>
        </group>
        <group group_id="E6">
          <title>i.n. Comparator</title>
          <description>intranasal comparator: intranasal administration</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (19.1)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E6" subjects_affected="0" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Eryipelas</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Gastroenteritis bacterial</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (19.1)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="32" subjects_at_risk="36"/>
                <counts group_id="E2" subjects_affected="30" subjects_at_risk="35"/>
                <counts group_id="E3" subjects_affected="26" subjects_at_risk="36"/>
                <counts group_id="E4" subjects_affected="10" subjects_at_risk="18"/>
                <counts group_id="E5" subjects_affected="13" subjects_at_risk="18"/>
                <counts group_id="E6" subjects_affected="10" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Ear pain</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="36"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="9" subjects_affected="6" subjects_at_risk="36"/>
                <counts group_id="E2" events="6" subjects_affected="2" subjects_at_risk="35"/>
                <counts group_id="E3" events="5" subjects_affected="4" subjects_at_risk="36"/>
                <counts group_id="E4" events="4" subjects_affected="3" subjects_at_risk="18"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Oral discomfort</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="36"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Oral pruritus</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="36"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Application site erythema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Application site swelling</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="36"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="35"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="36"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E6" events="3" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="22" subjects_affected="13" subjects_at_risk="36"/>
                <counts group_id="E2" events="22" subjects_affected="13" subjects_at_risk="35"/>
                <counts group_id="E3" events="22" subjects_affected="14" subjects_at_risk="36"/>
                <counts group_id="E4" events="8" subjects_affected="5" subjects_at_risk="18"/>
                <counts group_id="E5" events="8" subjects_affected="8" subjects_at_risk="18"/>
                <counts group_id="E6" events="6" subjects_affected="4" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Injection site erythema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="4" subjects_affected="4" subjects_at_risk="18"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Injection site hypoaesthesia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Injection site pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="8" subjects_affected="7" subjects_at_risk="18"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Injection site paraesthesia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Injection site pruritus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Injection site reaction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Injection site swelling</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="18"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="36"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="36"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="11" subjects_affected="9" subjects_at_risk="36"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="35"/>
                <counts group_id="E3" events="6" subjects_affected="4" subjects_at_risk="36"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Swelling</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="36"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="36"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="35"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="36"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="36"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="8" subjects_affected="5" subjects_at_risk="36"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="36"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="4" subjects_affected="3" subjects_at_risk="18"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Musculoskeletal stiffness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="36"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="35"/>
                <counts group_id="E3" events="7" subjects_affected="6" subjects_at_risk="36"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E5" events="4" subjects_affected="4" subjects_at_risk="18"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Trismus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="36"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="3" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="18" subjects_affected="10" subjects_at_risk="36"/>
                <counts group_id="E2" events="17" subjects_affected="10" subjects_at_risk="35"/>
                <counts group_id="E3" events="17" subjects_affected="14" subjects_at_risk="36"/>
                <counts group_id="E4" events="4" subjects_affected="3" subjects_at_risk="18"/>
                <counts group_id="E5" events="5" subjects_affected="5" subjects_at_risk="18"/>
                <counts group_id="E6" events="8" subjects_affected="6" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Dysmenorrhoea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="9" subjects_affected="8" subjects_at_risk="36"/>
                <counts group_id="E2" events="7" subjects_affected="6" subjects_at_risk="35"/>
                <counts group_id="E3" events="9" subjects_affected="8" subjects_at_risk="36"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Dry throat</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E4" events="2" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Dysphonia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="36"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="36"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E6" events="2" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" events="25" subjects_affected="15" subjects_at_risk="36"/>
                <counts group_id="E2" events="31" subjects_affected="20" subjects_at_risk="35"/>
                <counts group_id="E3" events="19" subjects_affected="13" subjects_at_risk="36"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E6" events="9" subjects_affected="7" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Nasal discomfort</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E2" events="3" subjects_affected="1" subjects_at_risk="35"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="36"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Nasal dryness</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Nasal muscosal disorder</sub_title>
                <counts group_id="E1" events="11" subjects_affected="10" subjects_at_risk="36"/>
                <counts group_id="E2" events="8" subjects_affected="7" subjects_at_risk="35"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="36"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Nasal pruritus</sub_title>
                <counts group_id="E1" events="8" subjects_affected="7" subjects_at_risk="36"/>
                <counts group_id="E2" events="8" subjects_affected="5" subjects_at_risk="35"/>
                <counts group_id="E3" events="14" subjects_affected="8" subjects_at_risk="36"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" events="28" subjects_affected="15" subjects_at_risk="36"/>
                <counts group_id="E2" events="23" subjects_affected="13" subjects_at_risk="35"/>
                <counts group_id="E3" events="16" subjects_affected="10" subjects_at_risk="36"/>
                <counts group_id="E4" events="7" subjects_affected="5" subjects_at_risk="18"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="18"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Pharyngeal oedema</sub_title>
                <counts group_id="E1" events="5" subjects_affected="4" subjects_at_risk="36"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="35"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Rhinalgia</sub_title>
                <counts group_id="E1" events="11" subjects_affected="7" subjects_at_risk="36"/>
                <counts group_id="E2" events="12" subjects_affected="10" subjects_at_risk="35"/>
                <counts group_id="E3" events="9" subjects_affected="6" subjects_at_risk="36"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" events="20" subjects_affected="15" subjects_at_risk="36"/>
                <counts group_id="E2" events="20" subjects_affected="12" subjects_at_risk="35"/>
                <counts group_id="E3" events="9" subjects_affected="7" subjects_at_risk="36"/>
                <counts group_id="E4" events="3" subjects_affected="3" subjects_at_risk="18"/>
                <counts group_id="E5" events="3" subjects_affected="3" subjects_at_risk="18"/>
                <counts group_id="E6" events="5" subjects_affected="4" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Sinus pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E6" events="1" subjects_affected="1" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Sneezing</sub_title>
                <counts group_id="E1" events="10" subjects_affected="9" subjects_at_risk="36"/>
                <counts group_id="E2" events="15" subjects_affected="8" subjects_at_risk="35"/>
                <counts group_id="E3" events="17" subjects_affected="12" subjects_at_risk="36"/>
                <counts group_id="E4" events="4" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E6" events="5" subjects_affected="4" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Throat irritation</sub_title>
                <counts group_id="E1" events="38" subjects_affected="22" subjects_at_risk="36"/>
                <counts group_id="E2" events="38" subjects_affected="21" subjects_at_risk="35"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="36"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E5" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E6" events="2" subjects_affected="1" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Erythema</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="35"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="36"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Hyperhidrosis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="36"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="35"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="36"/>
                <counts group_id="E4" events="3" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E5" events="2" subjects_affected="2" subjects_at_risk="18"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="35"/>
                <counts group_id="E3" events="2" subjects_affected="1" subjects_at_risk="36"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Pruritus generalised</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="35"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="36"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="18"/>
                <counts group_id="E5" events="1" subjects_affected="1" subjects_at_risk="18"/>
                <counts group_id="E6" events="0" subjects_affected="0" subjects_at_risk="19"/>
              </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>Anna-Karin Maltais</name_or_title>
      <organization>Eurocine Vaccines AB</organization>
      <phone>+46 76 233 81 62</phone>
      <email>annakarin.maltais@eurocine-vaccines.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/NCT02998996
org study id: EURO 15-11
nct id: NCT02998996
lead sponsor: 
has dmc: No
The main purpose of the this study is to evaluate the safety and tolerability of Immunose™
      FLU based on Endocine™ and quadrivalent influenza antigen.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Local Tolerability - First Dose
time frame: Pre-dose, and 15 and 120 min after study drug administration (Visit 2).
description: Local tolerability, as measured by at least one of the administration site reactions swelling, redness, pain and pruritus, regardless of severity.
measure: Local Tolerability - Second Dose (Group 1-4 Only)
time frame: Pre-dose, and 15 and 120 min after second study drug administration (Visit 3).
description: Local tolerability, as measured by at least one of the administration site reactions swelling, redness, pain and pruritus, regardless of severity.
arm group label: Immunose™ FLU 1%,
arm group type: Experimental
description: 15 µg haemagglutinin(HA)/strain and 1% Endocine™
arm group label: Immunose™ FLU 2%,
arm group type: Experimental
description: 15 µg HA/strain and 2% Endocine™
arm group label: Influenza antigen,
arm group type: Experimental
description: 15 µg HA/strain
arm group label: Saline (NaCl),
arm group type: Placebo Comparator
description: Placebo
arm group label: i.m. comparator,
arm group type: Active Comparator
description: 15 µg HA/strain
arm group label: i.n. comparator
arm group type: Active Comparator
intervention type: Biological
intervention name: 15 µg HA/strain and 1% Endocine™
description: intranasal administration
arm group label: Immunose™ FLU 1%,
intervention type: Biological
intervention name: 15 µg HA/strain and 2% Endocine™
description: intranasal administration
arm group label: Immunose™ FLU 2%,
intervention type: Biological
intervention name: 15 µg HA/strain
description: intranasal administration
arm group label: Influenza antigen,
intervention type: Biological
intervention name: intramuscular comparator
description: intramuscular administration
arm group label: i.m. comparator,
intervention type: Biological
intervention name: intranasal comparator
description: intranasal administration
arm group label: i.n. comparator
intervention type: Biological
intervention name: Placebo, Saline
description: intranasal administration
arm group label: Saline (NaCl),
criteria: 
gender: All
minimum age: 18 Years
maximum age: 39 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Cornelia Lif-Tiberg, MD
role: Principal Investigator
affiliation: CTC
facility: 
facility: 
country: Sweden
responsible party type: Sponsor
mesh term: Influenza, Human
mesh term: Endocine
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 