<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/NCT01719783</url>
  </required_header>
  <id_info>
    <org_study_id>LAIV-H5N2-01</org_study_id>
    <nct_id>NCT01719783</nct_id>
  </id_info>
  <brief_title>Reactogenicity, Safety, and Immunogenicity of a Live Monovalent H5N2 Influenza Vaccine</brief_title>
  <official_title>Reactogenicity, Safety and Immunogenicity of a Live Monovalent A/17/Turkey/Turkey/05/133 (H5N2) Influenza Vaccine</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>PATH</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Microgen</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Institute of Experimental Medicine, Russia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>PATH</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the safety profile of two intranasal doses of LAIV A/17/turkey/Turkey/05/133&#xD;
      (H5N2) in healthy adults.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">January 2013</completion_date>
  <primary_completion_date type="Actual">January 2013</primary_completion_date>
  <phase>Phase 1</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>Adverse Events by Severity</measure>
    <time_frame>6 days</time_frame>
    <description>Occurrence of participants with adverse events associated with intranasal administration, by worst grade of severity</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number/Percentage of Subjects With Seroconversion for Serum Hemagglutination Inhibition (HAI)</measure>
    <time_frame>28 days (Dose 1) and 56 days (Dose 2)</time_frame>
    <description>Defined as a four-fold or greater antibody rise in titer from pre-vaccination level.&#xD;
HAI = hemagglutination-inhibition, conducted using World Health Organization (WHO)-recommended protocols.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number/Percentage of Subjects With Serum Neutralizing Antibodies</measure>
    <time_frame>28 days (Dose 1) and 56 days (Dose 2)</time_frame>
    <description>Defined as a four-fold or greater antibody rise in titer from pre-vaccination level.&#xD;
Measured by microneutralization assay in Madin-Darby canine kidney cells (MDCK).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number/Percentage of Subjects With Seroconversion for Serum Immunoglobulin A (IgA)</measure>
    <time_frame>28 days (Dose 1) and 56 days (Dose 2)</time_frame>
    <description>IgA = immunoglobulin class A antibodies Determined using ELISA using whole purified H5N2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number/Percentage of Subjects With Seroconversion for Serum Immunoglobulin G (IgG)</measure>
    <time_frame>28 days (Dose 1) and 56 days (Dose 2)</time_frame>
    <description>Determined using ELISA using whole purified H5N2.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number/Percentage of Subjects With Seroconversion for Secretory IgA</measure>
    <time_frame>28 days (Dose 1) and 56 days (Dose 2)</time_frame>
    <description>IgA antibodies from the nasal mucosa detected in nasal wick specimens. Determined using ELISA using whole purified H5N2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number/Percentage of Subjects With Seroconversion for IgA in Saliva</measure>
    <time_frame>28 days (Dose 1) and 56 days (Dose 2)</time_frame>
    <description>IgA = Immunoglobulin Class A antibodies. Determined using ELISA using whole purified H5N2.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number/Percentage of Vaccinated Participants Shedding Influenza Virus After First Dose</measure>
    <time_frame>6 days post-vaccination</time_frame>
    <description>Nasal swabs were collected and used for Reverse transcription polymerase chain reaction (rRTPCR) assays to detect shedding of influenza virus for days 1-6 of the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number/Percentage of Vaccinated Participants Shedding Influenza Virus After Second Dose</measure>
    <time_frame>6 days post-vaccination</time_frame>
    <description>Nasal swabs were collected and used for Reverse transcription polymerase chain reaction (rRTPCR) assays to detect shedding of influenza virus for days 29-34 of the study (6 days after the second vaccination).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geometric Mean Titers for Serum HAI Antibodies</measure>
    <time_frame>0 days, 28 days (Dose 1) and 56 days (Dose 2)</time_frame>
    <description>Geometric mean titers for serum hemagglutination inhibition antibodies</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geometric Mean Titers (GMT) for Serum Neutralizing Antibodies</measure>
    <time_frame>0 days, 28 days (Dose 1) and 56 days (Dose 2)</time_frame>
    <description>Geometric mean titers for serum neutralizing antibodies measured by microneutralization assay</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Number/Percentage of Subjects Exhibiting CD8+ IFNγ+ Responses</measure>
    <time_frame>28 days (Dose 1) and 56 days (Dose 2)</time_frame>
    <description>Nasal swabs from days 1, 2, 3, 5, and 7 after the first vaccination and on days 1 and 3, corresponding to days 29 and 31,respectively, after the second dose were tested for viral shedding by inoculation in 10- to 11-day-old embryonated chicken eggs (ECE) followed by incubation at 32◦C for 72 h. Influenza virus was detected by standard hemagglutination test with 1% chicken red blood cells.&#xD;
An increase in the number of antigenic-specific T cells greater than 3 standard deviations over the mean placebo values was regarded as a positive T cell response.</description>
  </other_outcome>
  <other_outcome>
    <measure>Number/Percentage of Subjects Exhibiting CD4+ IFNγ+ Responses</measure>
    <time_frame>28 days (Dose 1) and 56 days (Dose 2)</time_frame>
    <description>Nasal swabs from days 1, 2, 3, 5, and 7 after the first vaccination and on days 1 and 3, corresponding to days 29 and 31,respectively, after the second dose were tested for viral shedding by inoculation in 10- to 11-day-old ECE followed by incubation at 32◦C for 72 h. Influenza virus was detected by standard hemagglutination test with 1% chicken red blood cells.&#xD;
An increase in the number of antigenic-specific T cells greater than 3 standard deviations over the mean placebo values was regarded as a positive T cell response.</description>
  </other_outcome>
  <other_outcome>
    <measure>Number/Percentage of Subjects Exhibiting CD8+ IFNγ+ Effector Memory T Cell Responses</measure>
    <time_frame>28 days (Dose 1) and 56 days (Dose 2)</time_frame>
    <description>Nasal swabs from days 1, 2, 3, 5, and 7 after the first vaccination and on days 1 and 3, corresponding to days 29 and 31,respectively, after the second dose were tested for viral shedding by inoculation in 10- to 11-day-old ECE followed by incubation at 32◦C for 72 h. Influenza virus was detected by standard hemagglutination test with 1% chicken red blood cells.&#xD;
An increase in the number of antigenic-specific T cells greater than 3SD over the mean placebo values was regarded as a positive T cell response.</description>
  </other_outcome>
  <other_outcome>
    <measure>Number/Percentage of Subjects Exhibiting CD4+ IFNγ+ Central Memory T Cell Responses</measure>
    <time_frame>28 days (Dose 1) and 56 days (Dose 2)</time_frame>
    <description>Nasal swabs from days 1, 2, 3, 5, and 7 after the first vaccination and on days 1 and 3, corresponding to days 29 and 31,respectively, after the second dose were tested for viral shedding by inoculation in 10- to 11-day-old ECE followed by incubation at 32◦C for 72 h. Influenza virus was detected by standard hemagglutination test with 1% chicken red blood cells.&#xD;
An increase in the number of antigenic-specific T cells greater than 3SD over the mean placebo values was regarded as a positive T cell response.</description>
  </other_outcome>
  <other_outcome>
    <measure>Number/Percentage of Subjects Exhibiting CD4+ IFNγ+ Effector Memory T Cell Responses</measure>
    <time_frame>28 days (Dose 1) and 56 days (Dose 2)</time_frame>
    <description>Nasal swabs from days 1, 2, 3, 5, and 7 after the first vaccination and on days 1 and 3, corresponding to days 29 and 31,respectively, after the second dose were tested for viral shedding by inoculation in 10- to 11-day-old ECE followed by incubation at 32◦C for 72 h. Influenza virus was detected by standard hemagglutination test with 1% chicken red blood cells.&#xD;
An increase in the number of antigenic-specific T cells greater than 3SD over the mean placebo values was regarded as a positive T cell response.</description>
  </other_outcome>
  <other_outcome>
    <measure>Number/Percentage of Subjects Exhibiting CD8+ IFNγ+ Central Memory T Cell Responses</measure>
    <time_frame>28 days (Dose 1) and 56 days (Dose 2)</time_frame>
    <description>Nasal swabs from days 1, 2, 3, 5, and 7 after the first vaccination and on days 1 and 3, corresponding to days 29 and 31,respectively, after the second dose were tested for viral shedding by inoculation in 10- to 11-day-old ECE followed by incubation at 32◦C for 72 h. Influenza virus was detected by standard hemagglutination test with 1% chicken red blood cells.&#xD;
An increase in the number of antigenic-specific T cells greater than 3SD over the mean placebo values was regarded as a positive T cell response.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Influenza</condition>
  <arm_group>
    <arm_group_label>LAIV H5N2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Two doses of live monovalent influenza vaccine A/17/turkey/Turkey/05/133 ( live monovalent (LAIV H5N2) given intranasally</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>two doses of placebo solution intranasal</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>LAIV H5N2</intervention_name>
    <description>2 doses provided intranasally</description>
    <arm_group_label>LAIV H5N2</arm_group_label>
    <other_name>A/17/turkey/Turkey/05/133(H5N2)live influenza vaccine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>2 doses of placebo provided intranasally</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Legal male or female adult 18 through 49 years of age at the enrollment visit.&#xD;
&#xD;
          -  Literate and willing to provide written informed consent.&#xD;
&#xD;
          -  Free of obvious health problems, as established by the medical history and screening&#xD;
             evaluations, including physical examination.&#xD;
&#xD;
          -  Capable and willing to complete diary cards and willing to return for all follow-up&#xD;
             visits&#xD;
&#xD;
          -  Willing to comply with the rules of the isolation unit (including willing and able to&#xD;
             take oseltamivir influenza antiviral medication, should that be recommended by a study&#xD;
             physician).&#xD;
&#xD;
          -  For females, willing to take reliable birth control measures throughout the entire&#xD;
             period of participation in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participation in another clinical trial involving any therapy within the previous&#xD;
             three months or planned enrollment in such a trial during the period of this study.&#xD;
&#xD;
          -  Receipt of any non-study vaccine within four weeks prior to enrollment or refusal to&#xD;
             postpone receipt of such vaccines until four weeks after study completion.&#xD;
&#xD;
          -  Practice of nasal irrigation on a regular basis within the past six months or has&#xD;
             engaged in nasal irrigation within two weeks prior to enrollment.&#xD;
&#xD;
          -  Recent history of frequent nose bleeds (&gt;5 within the past year).&#xD;
&#xD;
          -  Clinically relevant abnormal paranasal anatomy.&#xD;
&#xD;
          -  Recent history (within the past month) of rhino or sinus surgery, or surgery for any&#xD;
             traumatic injury of the nose.&#xD;
&#xD;
          -  Current or recent (within two weeks of enrollment) acute respiratory illness with or&#xD;
             without fever.&#xD;
&#xD;
          -  Other acute illness at the time of study enrollment.&#xD;
&#xD;
          -  Receipt of immune globulin or other blood products within three months prior to study&#xD;
             enrollment or planned receipt of such products during the period of subject&#xD;
             participation in the study.&#xD;
&#xD;
          -  Chronic administration (defined as more than 14 consecutively-prescribed days) of&#xD;
             immunosuppressants or other immune-modulating therapy within six months prior to study&#xD;
             enrollment. (For corticosteroids, this means prednisone or equivalent, 0.5 mg per kg&#xD;
             per day; topical steroids are allowed, exclusive of nasal.)&#xD;
&#xD;
          -  Participation in any previous trial of any H5 or H7 containing influenza vaccine.&#xD;
&#xD;
          -  History of asthma.&#xD;
&#xD;
          -  Hypersensitivity after previous administration of any influenza vaccine.&#xD;
&#xD;
          -  History of wheezing after past receipt of any live influenza vaccine.&#xD;
&#xD;
          -  Other adverse event (AE) following immunization, at least possibly related to previous&#xD;
             receipt of any influenza vaccine.&#xD;
&#xD;
          -  Suspected or known hypersensitivity to any of the study vaccine components, including&#xD;
             chicken or egg protein.&#xD;
&#xD;
          -  Seasonal (autumnal) hypersensitivity to the natural environment.&#xD;
&#xD;
          -  Acute or chronic clinically significant pulmonary, cardiovascular, hepatic, metabolic,&#xD;
             neurologic, psychiatric or renal functional abnormality, as determined by medical&#xD;
             history, physical examination or clinical laboratory screening tests, which in the&#xD;
             opinion of the investigator, might interfere with the study objectives. Subjects with&#xD;
             physical examination findings or clinical laboratory screening results which would be&#xD;
             graded 2 or higher on the AE severity grading scale (see Attachments) will be excluded&#xD;
             from entry into the study and will be excluded from receipt of dose two of study&#xD;
             vaccine or placebo.&#xD;
&#xD;
          -  History of leukemia or any other blood or solid organ cancer.&#xD;
&#xD;
          -  History of thrombocytopenic purpura or known bleeding disorder.&#xD;
&#xD;
          -  History of seizures.&#xD;
&#xD;
          -  Known or suspected immunosuppressive or immunodeficient condition of any kind,&#xD;
             including HIV infection.&#xD;
&#xD;
          -  Known chronic hepatitis B (HBV) or hepatitis C (HCV) infection.&#xD;
&#xD;
          -  Known tuberculosis infection or evidence of previous tuberculosis exposure.&#xD;
&#xD;
          -  History of chronic alcohol abuse and/or illegal drug use.&#xD;
&#xD;
          -  Claustrophobia or sociophobia.&#xD;
&#xD;
          -  Pregnancy or lactation. (A negative pregnancy test will be required before&#xD;
             administration of study vaccine or placebo for all women of childbearing potential.)&#xD;
&#xD;
          -  Any condition that, in the opinion of the investigator, would increase the health risk&#xD;
             to the subject if he/she participates in the study or would interfere with the&#xD;
             evaluation of the study objectives&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>49 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Research Institute of Influenza</name>
      <address>
        <city>St. Petersburg</city>
        <zip>197376</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>October 26, 2012</study_first_submitted>
  <study_first_submitted_qc>October 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 1, 2012</study_first_posted>
  <results_first_submitted>April 9, 2018</results_first_submitted>
  <results_first_submitted_qc>November 26, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">November 28, 2018</results_first_posted>
  <last_update_submitted>November 26, 2018</last_update_submitted>
  <last_update_submitted_qc>November 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 28, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>influenza</keyword>
  <keyword>vaccine</keyword>
  <keyword>pandemic</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Influenza, Human</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vaccines</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>LAIV H5N2</title>
          <description>Two doses of live monovalent influenza vaccine A/17/turkey/Turkey/05/133 ( live monovalent (LAIV H5N2) given intranasally</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>two doses of placebo solution provided intranasally</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Dose 1</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Dose 2</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="29"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>LAIV H5N2</title>
          <description>Two doses of live monovalent influenza vaccine A/17/turkey/Turkey/05/133 ( live monovalent (LAIV H5N2) given intranasally</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>two doses of placebo solution intranasal</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="30"/>
            <count group_id="B2" value="10"/>
            <count group_id="B3" value="40"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27.7" spread="10.4"/>
                    <measurement group_id="B2" value="29.2" spread="10.8"/>
                    <measurement group_id="B3" value="28.1" spread="10.4"/>
                  </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="9"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="27"/>
                  </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>Russia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Adverse Events by Severity</title>
        <description>Occurrence of participants with adverse events associated with intranasal administration, by worst grade of severity</description>
        <time_frame>6 days</time_frame>
        <population>All participants that received either a vaccine or placebo, by dose</population>
        <group_list>
          <group group_id="O1">
            <title>Dose 1: Vaccine</title>
            <description>Received dose 1 of vaccine</description>
          </group>
          <group group_id="O2">
            <title>Dose 1: Placebo</title>
            <description>Received Dose 1 of Placebo</description>
          </group>
          <group group_id="O3">
            <title>Dose 2: Vaccine</title>
            <description>Received Dose 2 of vaccine</description>
          </group>
          <group group_id="O4">
            <title>Dose 2: Placebo</title>
            <description>Received Dose 2 of placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Adverse Events by Severity</title>
          <description>Occurrence of participants with adverse events associated with intranasal administration, by worst grade of severity</description>
          <population>All participants that received either a vaccine or placebo, by dose</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="29"/>
                <count group_id="O4" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Worst grade: mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="25"/>
                    <measurement group_id="O4" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Worst grade: moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Worst grade: severe</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number/Percentage of Subjects With Seroconversion for Serum Hemagglutination Inhibition (HAI)</title>
        <description>Defined as a four-fold or greater antibody rise in titer from pre-vaccination level.&#xD;
HAI = hemagglutination-inhibition, conducted using World Health Organization (WHO)-recommended protocols.</description>
        <time_frame>28 days (Dose 1) and 56 days (Dose 2)</time_frame>
        <population>Participants receiving study vaccine or placebo and with pre- and post-vaccination immunologic parameters measured</population>
        <group_list>
          <group group_id="O1">
            <title>Dose 1: Vaccine</title>
            <description>Received dose 1 of vaccine</description>
          </group>
          <group group_id="O2">
            <title>Dose 1: Placebo</title>
            <description>Received Dose 1 of Placebo</description>
          </group>
          <group group_id="O3">
            <title>Dose 2: Vaccine</title>
            <description>Received Dose 2 of vaccine</description>
          </group>
          <group group_id="O4">
            <title>Dose 2: Placebo</title>
            <description>Received Dose 2 of placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Number/Percentage of Subjects With Seroconversion for Serum Hemagglutination Inhibition (HAI)</title>
          <description>Defined as a four-fold or greater antibody rise in titer from pre-vaccination level.&#xD;
HAI = hemagglutination-inhibition, conducted using World Health Organization (WHO)-recommended protocols.</description>
          <population>Participants receiving study vaccine or placebo and with pre- and post-vaccination immunologic parameters measured</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="29"/>
                <count group_id="O4" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Seroconversion</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="11"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No seroconversion</title>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="18"/>
                    <measurement group_id="O4" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number/Percentage of Subjects With Serum Neutralizing Antibodies</title>
        <description>Defined as a four-fold or greater antibody rise in titer from pre-vaccination level.&#xD;
Measured by microneutralization assay in Madin-Darby canine kidney cells (MDCK).</description>
        <time_frame>28 days (Dose 1) and 56 days (Dose 2)</time_frame>
        <population>Participants receiving study vaccine or placebo and with pre- and post-vaccination immunologic parameters measured</population>
        <group_list>
          <group group_id="O1">
            <title>Dose 1: Vaccine</title>
            <description>Received dose 1 of vaccine</description>
          </group>
          <group group_id="O2">
            <title>Dose 1: Placebo</title>
            <description>Received Dose 1 of Placebo</description>
          </group>
          <group group_id="O3">
            <title>Dose 2: Vaccine</title>
            <description>Received Dose 2 of vaccine</description>
          </group>
          <group group_id="O4">
            <title>Dose 2: Placebo</title>
            <description>Received Dose 2 of placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Number/Percentage of Subjects With Serum Neutralizing Antibodies</title>
          <description>Defined as a four-fold or greater antibody rise in titer from pre-vaccination level.&#xD;
Measured by microneutralization assay in Madin-Darby canine kidney cells (MDCK).</description>
          <population>Participants receiving study vaccine or placebo and with pre- and post-vaccination immunologic parameters measured</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="29"/>
                <count group_id="O4" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Seroconversion</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="14"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No seroconversion</title>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="15"/>
                    <measurement group_id="O4" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number/Percentage of Subjects With Seroconversion for Serum Immunoglobulin A (IgA)</title>
        <description>IgA = immunoglobulin class A antibodies Determined using ELISA using whole purified H5N2</description>
        <time_frame>28 days (Dose 1) and 56 days (Dose 2)</time_frame>
        <population>Participants receiving study vaccine or placebo and with pre- and post-vaccination immunologic parameters measured</population>
        <group_list>
          <group group_id="O1">
            <title>Dose 1: Vaccine</title>
            <description>Received dose 1 of vaccine</description>
          </group>
          <group group_id="O2">
            <title>Dose 1: Placebo</title>
            <description>Received Dose 1 of Placebo</description>
          </group>
          <group group_id="O3">
            <title>Dose 2: Vaccine</title>
            <description>Received Dose 2 of vaccine</description>
          </group>
          <group group_id="O4">
            <title>Dose 2: Placebo</title>
            <description>Received Dose 2 of placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Number/Percentage of Subjects With Seroconversion for Serum Immunoglobulin A (IgA)</title>
          <description>IgA = immunoglobulin class A antibodies Determined using ELISA using whole purified H5N2</description>
          <population>Participants receiving study vaccine or placebo and with pre- and post-vaccination immunologic parameters measured</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="29"/>
                <count group_id="O4" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Seroconversion</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No seroconversion</title>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="27"/>
                    <measurement group_id="O4" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number/Percentage of Subjects With Seroconversion for Serum Immunoglobulin G (IgG)</title>
        <description>Determined using ELISA using whole purified H5N2.</description>
        <time_frame>28 days (Dose 1) and 56 days (Dose 2)</time_frame>
        <population>Participants receiving study vaccine or placebo and with pre- and post-vaccination immunologic parameters measured</population>
        <group_list>
          <group group_id="O1">
            <title>Dose 1: Vaccine</title>
            <description>Received dose 1 of vaccine</description>
          </group>
          <group group_id="O2">
            <title>Dose 1: Placebo</title>
            <description>Received Dose 1 of Placebo</description>
          </group>
          <group group_id="O3">
            <title>Dose 2: Vaccine</title>
            <description>Received Dose 2 of vaccine</description>
          </group>
          <group group_id="O4">
            <title>Dose 2: Placebo</title>
            <description>Received Dose 2 of placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Number/Percentage of Subjects With Seroconversion for Serum Immunoglobulin G (IgG)</title>
          <description>Determined using ELISA using whole purified H5N2.</description>
          <population>Participants receiving study vaccine or placebo and with pre- and post-vaccination immunologic parameters measured</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="29"/>
                <count group_id="O4" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Seroconversion</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No seroconversion</title>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="28"/>
                    <measurement group_id="O4" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number/Percentage of Subjects With Seroconversion for Secretory IgA</title>
        <description>IgA antibodies from the nasal mucosa detected in nasal wick specimens. Determined using ELISA using whole purified H5N2</description>
        <time_frame>28 days (Dose 1) and 56 days (Dose 2)</time_frame>
        <population>Participants receiving study vaccine or placebo and with pre- and post-vaccination immunologic parameters measured</population>
        <group_list>
          <group group_id="O1">
            <title>Dose 1: Vaccine</title>
            <description>Received dose 1 of vaccine</description>
          </group>
          <group group_id="O2">
            <title>Dose 1: Placebo</title>
            <description>Received Dose 1 of Placebo</description>
          </group>
          <group group_id="O3">
            <title>Dose 2: Vaccine</title>
            <description>Received Dose 2 of vaccine</description>
          </group>
          <group group_id="O4">
            <title>Dose 2: Placebo</title>
            <description>Received Dose 2 of placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Number/Percentage of Subjects With Seroconversion for Secretory IgA</title>
          <description>IgA antibodies from the nasal mucosa detected in nasal wick specimens. Determined using ELISA using whole purified H5N2</description>
          <population>Participants receiving study vaccine or placebo and with pre- and post-vaccination immunologic parameters measured</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="29"/>
                <count group_id="O4" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Seroconversion</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No seroconversion</title>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="23"/>
                    <measurement group_id="O4" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number/Percentage of Subjects With Seroconversion for IgA in Saliva</title>
        <description>IgA = Immunoglobulin Class A antibodies. Determined using ELISA using whole purified H5N2.</description>
        <time_frame>28 days (Dose 1) and 56 days (Dose 2)</time_frame>
        <population>Participants receiving study vaccine or placebo and with pre- and post-vaccination immunologic parameters measured</population>
        <group_list>
          <group group_id="O1">
            <title>Dose 1: Vaccine</title>
            <description>Received dose 1 of vaccine</description>
          </group>
          <group group_id="O2">
            <title>Dose 1: Placebo</title>
            <description>Received Dose 1 of Placebo</description>
          </group>
          <group group_id="O3">
            <title>Dose 2: Vaccine</title>
            <description>Received Dose 2 of vaccine</description>
          </group>
          <group group_id="O4">
            <title>Dose 2: Placebo</title>
            <description>Received Dose 2 of placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Number/Percentage of Subjects With Seroconversion for IgA in Saliva</title>
          <description>IgA = Immunoglobulin Class A antibodies. Determined using ELISA using whole purified H5N2.</description>
          <population>Participants receiving study vaccine or placebo and with pre- and post-vaccination immunologic parameters measured</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="29"/>
                <count group_id="O4" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Seroconversion</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="10"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No seroconversion</title>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="19"/>
                    <measurement group_id="O4" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number/Percentage of Vaccinated Participants Shedding Influenza Virus After First Dose</title>
        <description>Nasal swabs were collected and used for Reverse transcription polymerase chain reaction (rRTPCR) assays to detect shedding of influenza virus for days 1-6 of the study.</description>
        <time_frame>6 days post-vaccination</time_frame>
        <population>Participants receiving first dose of study vaccine and with post-vaccination immunologic parameters measured</population>
        <group_list>
          <group group_id="O1">
            <title>Day 1</title>
            <description>Shedding 1 day after first dose was administered</description>
          </group>
          <group group_id="O2">
            <title>Day 2</title>
            <description>Shedding 2 days after first dose was administered</description>
          </group>
          <group group_id="O3">
            <title>Day 3</title>
            <description>Shedding 3 days after dose was administered</description>
          </group>
          <group group_id="O4">
            <title>Day 4</title>
            <description>Shedding 4 days after dose was administered</description>
          </group>
          <group group_id="O5">
            <title>Day 5</title>
            <description>Shedding 5 days after dose was administered</description>
          </group>
          <group group_id="O6">
            <title>Day 6</title>
            <description>Shedding 6 days after dose was administered</description>
          </group>
        </group_list>
        <measure>
          <title>Number/Percentage of Vaccinated Participants Shedding Influenza Virus After First Dose</title>
          <description>Nasal swabs were collected and used for Reverse transcription polymerase chain reaction (rRTPCR) assays to detect shedding of influenza virus for days 1-6 of the study.</description>
          <population>Participants receiving first dose of study vaccine and with post-vaccination immunologic parameters measured</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
                <count group_id="O3" value="30"/>
                <count group_id="O4" value="30"/>
                <count group_id="O5" value="30"/>
                <count group_id="O6" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Shedding</title>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No shedding</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="25"/>
                    <measurement group_id="O3" value="30"/>
                    <measurement group_id="O4" value="30"/>
                    <measurement group_id="O5" value="30"/>
                    <measurement group_id="O6" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number/Percentage of Vaccinated Participants Shedding Influenza Virus After Second Dose</title>
        <description>Nasal swabs were collected and used for Reverse transcription polymerase chain reaction (rRTPCR) assays to detect shedding of influenza virus for days 29-34 of the study (6 days after the second vaccination).</description>
        <time_frame>6 days post-vaccination</time_frame>
        <population>Participants receiving second dose of study vaccine and with post-vaccination immunologic parameters measured</population>
        <group_list>
          <group group_id="O1">
            <title>Day 1</title>
            <description>Shedding 1 day after first dose was administered</description>
          </group>
          <group group_id="O2">
            <title>Day 2</title>
            <description>Shedding 2 days after first dose was administered</description>
          </group>
          <group group_id="O3">
            <title>Day 3</title>
            <description>Shedding 3 days after dose was administered</description>
          </group>
          <group group_id="O4">
            <title>Day 4</title>
            <description>Shedding 4 days after dose was administered</description>
          </group>
          <group group_id="O5">
            <title>Day 5</title>
            <description>Shedding 5 days after dose was administered</description>
          </group>
          <group group_id="O6">
            <title>Day 6</title>
            <description>Shedding 6 days after dose was administered</description>
          </group>
        </group_list>
        <measure>
          <title>Number/Percentage of Vaccinated Participants Shedding Influenza Virus After Second Dose</title>
          <description>Nasal swabs were collected and used for Reverse transcription polymerase chain reaction (rRTPCR) assays to detect shedding of influenza virus for days 29-34 of the study (6 days after the second vaccination).</description>
          <population>Participants receiving second dose of study vaccine and with post-vaccination immunologic parameters measured</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="29"/>
                <count group_id="O3" value="29"/>
                <count group_id="O4" value="29"/>
                <count group_id="O5" value="29"/>
                <count group_id="O6" value="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Shedding</title>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No shedding</title>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="25"/>
                    <measurement group_id="O3" value="29"/>
                    <measurement group_id="O4" value="29"/>
                    <measurement group_id="O5" value="29"/>
                    <measurement group_id="O6" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Geometric Mean Titers for Serum HAI Antibodies</title>
        <description>Geometric mean titers for serum hemagglutination inhibition antibodies</description>
        <time_frame>0 days, 28 days (Dose 1) and 56 days (Dose 2)</time_frame>
        <population>Participants receiving both doses of study vaccine or placebo and with pre- and post-vaccination immunologic parameters measured</population>
        <group_list>
          <group group_id="O1">
            <title>LAIV H5N2</title>
            <description>Two doses of live monovalent influenza vaccine A/17/turkey/Turkey/05/133 ( live monovalent (LAIV H5N2) given intranasally</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>two doses of placebo solution provided intranasally</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Titers for Serum HAI Antibodies</title>
          <description>Geometric mean titers for serum hemagglutination inhibition antibodies</description>
          <population>Participants receiving both doses of study vaccine or placebo and with pre- and post-vaccination immunologic parameters measured</population>
          <units>titer</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5" lower_limit="2.5" upper_limit="2.5"/>
                    <measurement group_id="O2" value="2.7" lower_limit="2.3" upper_limit="3.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>After dose 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.5" lower_limit="2.9" upper_limit="4.2"/>
                    <measurement group_id="O2" value="2.7" lower_limit="2.3" upper_limit="3.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>After dose 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.7" lower_limit="3.6" upper_limit="6.1"/>
                    <measurement group_id="O2" value="2.9" lower_limit="2.1" upper_limit="3.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Geometric Mean Titers (GMT) for Serum Neutralizing Antibodies</title>
        <description>Geometric mean titers for serum neutralizing antibodies measured by microneutralization assay</description>
        <time_frame>0 days, 28 days (Dose 1) and 56 days (Dose 2)</time_frame>
        <population>Participants receiving both doses of study vaccine or placebo and with pre- and post-vaccination immunologic parameters measured</population>
        <group_list>
          <group group_id="O1">
            <title>LAIV H5N2</title>
            <description>Two doses of live monovalent influenza vaccine A/17/turkey/Turkey/05/133 ( live monovalent (LAIV H5N2) given intranasally</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>two doses of placebo solution provided intranasally</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Titers (GMT) for Serum Neutralizing Antibodies</title>
          <description>Geometric mean titers for serum neutralizing antibodies measured by microneutralization assay</description>
          <population>Participants receiving both doses of study vaccine or placebo and with pre- and post-vaccination immunologic parameters measured</population>
          <units>titer</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.2" lower_limit="4.9" upper_limit="5.6"/>
                    <measurement group_id="O2" value="5.4" lower_limit="4.6" upper_limit="6.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>After dose 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.7" lower_limit="5.6" upper_limit="8.0"/>
                    <measurement group_id="O2" value="5.4" lower_limit="4.6" upper_limit="6.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>After dose 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.8" lower_limit="8.7" upper_limit="16"/>
                    <measurement group_id="O2" value="5.7" lower_limit="4.7" upper_limit="7.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number/Percentage of Subjects Exhibiting CD8+ IFNγ+ Responses</title>
        <description>Nasal swabs from days 1, 2, 3, 5, and 7 after the first vaccination and on days 1 and 3, corresponding to days 29 and 31,respectively, after the second dose were tested for viral shedding by inoculation in 10- to 11-day-old embryonated chicken eggs (ECE) followed by incubation at 32◦C for 72 h. Influenza virus was detected by standard hemagglutination test with 1% chicken red blood cells.&#xD;
An increase in the number of antigenic-specific T cells greater than 3 standard deviations over the mean placebo values was regarded as a positive T cell response.</description>
        <time_frame>28 days (Dose 1) and 56 days (Dose 2)</time_frame>
        <population>Participants receiving study vaccine or placebo and with pre- and post-vaccination immunologic parameters measured</population>
        <group_list>
          <group group_id="O1">
            <title>Dose 1: Vaccine</title>
            <description>Received dose 1 of vaccine</description>
          </group>
          <group group_id="O2">
            <title>Dose 1: Placebo</title>
            <description>Received Dose 1 of Placebo</description>
          </group>
          <group group_id="O3">
            <title>Dose 2: Vaccine</title>
            <description>Received Dose 2 of vaccine</description>
          </group>
          <group group_id="O4">
            <title>Dose 2: Placebo</title>
            <description>Received Dose 2 of placebo</description>
          </group>
          <group group_id="O5">
            <title>Dose 1 or 2: Vaccine</title>
            <description>Received dose 1 or 2 of vaccine</description>
          </group>
          <group group_id="O6">
            <title>Dose 1 or 2: Placebo</title>
            <description>Received dose 1 or 2 of placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Number/Percentage of Subjects Exhibiting CD8+ IFNγ+ Responses</title>
          <description>Nasal swabs from days 1, 2, 3, 5, and 7 after the first vaccination and on days 1 and 3, corresponding to days 29 and 31,respectively, after the second dose were tested for viral shedding by inoculation in 10- to 11-day-old embryonated chicken eggs (ECE) followed by incubation at 32◦C for 72 h. Influenza virus was detected by standard hemagglutination test with 1% chicken red blood cells.&#xD;
An increase in the number of antigenic-specific T cells greater than 3 standard deviations over the mean placebo values was regarded as a positive T cell response.</description>
          <population>Participants receiving study vaccine or placebo and with pre- and post-vaccination immunologic parameters measured</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="29"/>
                <count group_id="O4" value="10"/>
                <count group_id="O5" value="29"/>
                <count group_id="O6" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Positive response</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="3"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No response</title>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="27"/>
                    <measurement group_id="O4" value="10"/>
                    <measurement group_id="O5" value="26"/>
                    <measurement group_id="O6" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number/Percentage of Subjects Exhibiting CD4+ IFNγ+ Responses</title>
        <description>Nasal swabs from days 1, 2, 3, 5, and 7 after the first vaccination and on days 1 and 3, corresponding to days 29 and 31,respectively, after the second dose were tested for viral shedding by inoculation in 10- to 11-day-old ECE followed by incubation at 32◦C for 72 h. Influenza virus was detected by standard hemagglutination test with 1% chicken red blood cells.&#xD;
An increase in the number of antigenic-specific T cells greater than 3 standard deviations over the mean placebo values was regarded as a positive T cell response.</description>
        <time_frame>28 days (Dose 1) and 56 days (Dose 2)</time_frame>
        <population>Participants receiving study vaccine or placebo and with pre- and post-vaccination immunologic parameters measured</population>
        <group_list>
          <group group_id="O1">
            <title>Dose 1: Vaccine</title>
            <description>After receiving dose 1 of vaccine</description>
          </group>
          <group group_id="O2">
            <title>Dose 1: Placebo</title>
            <description>After receiving Dose 1 of Placebo</description>
          </group>
          <group group_id="O3">
            <title>Dose 2: Vaccine</title>
            <description>After receiving Dose 2 of vaccine</description>
          </group>
          <group group_id="O4">
            <title>Dose 2: Placebo</title>
            <description>After receiving Dose 2 of placebo</description>
          </group>
          <group group_id="O5">
            <title>Dose 1 or 2: Vaccine</title>
            <description>Received dose 1 or 2 of vaccine</description>
          </group>
          <group group_id="O6">
            <title>Dose 1 or 2: Placebo</title>
            <description>Received dose 1 or 2 of placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Number/Percentage of Subjects Exhibiting CD4+ IFNγ+ Responses</title>
          <description>Nasal swabs from days 1, 2, 3, 5, and 7 after the first vaccination and on days 1 and 3, corresponding to days 29 and 31,respectively, after the second dose were tested for viral shedding by inoculation in 10- to 11-day-old ECE followed by incubation at 32◦C for 72 h. Influenza virus was detected by standard hemagglutination test with 1% chicken red blood cells.&#xD;
An increase in the number of antigenic-specific T cells greater than 3 standard deviations over the mean placebo values was regarded as a positive T cell response.</description>
          <population>Participants receiving study vaccine or placebo and with pre- and post-vaccination immunologic parameters measured</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="30"/>
                <count group_id="O4" value="10"/>
                <count group_id="O5" value="29"/>
                <count group_id="O6" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Positive response</title>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="6"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No response</title>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="25"/>
                    <measurement group_id="O4" value="10"/>
                    <measurement group_id="O5" value="23"/>
                    <measurement group_id="O6" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number/Percentage of Subjects Exhibiting CD8+ IFNγ+ Effector Memory T Cell Responses</title>
        <description>Nasal swabs from days 1, 2, 3, 5, and 7 after the first vaccination and on days 1 and 3, corresponding to days 29 and 31,respectively, after the second dose were tested for viral shedding by inoculation in 10- to 11-day-old ECE followed by incubation at 32◦C for 72 h. Influenza virus was detected by standard hemagglutination test with 1% chicken red blood cells.&#xD;
An increase in the number of antigenic-specific T cells greater than 3SD over the mean placebo values was regarded as a positive T cell response.</description>
        <time_frame>28 days (Dose 1) and 56 days (Dose 2)</time_frame>
        <population>Participants receiving both doses of study vaccine or placebo and with pre- and post-vaccination immunologic parameters measured</population>
        <group_list>
          <group group_id="O1">
            <title>Dose 1: Vaccine</title>
            <description>After receiving dose 1 of vaccine</description>
          </group>
          <group group_id="O2">
            <title>Dose 1: Placebo</title>
            <description>After receiving Dose 1 of Placebo</description>
          </group>
          <group group_id="O3">
            <title>Dose 2: Vaccine</title>
            <description>After receiving Dose 2 of vaccine</description>
          </group>
          <group group_id="O4">
            <title>Dose 2: Placebo</title>
            <description>After receiving Dose 2 of placebo</description>
          </group>
          <group group_id="O5">
            <title>Dose 1 or 2: Vaccine</title>
            <description>Received dose 1 or 2 of vaccine</description>
          </group>
          <group group_id="O6">
            <title>Dose 1 or 2: Placebo</title>
            <description>Received dose 1 or 2 of placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Number/Percentage of Subjects Exhibiting CD8+ IFNγ+ Effector Memory T Cell Responses</title>
          <description>Nasal swabs from days 1, 2, 3, 5, and 7 after the first vaccination and on days 1 and 3, corresponding to days 29 and 31,respectively, after the second dose were tested for viral shedding by inoculation in 10- to 11-day-old ECE followed by incubation at 32◦C for 72 h. Influenza virus was detected by standard hemagglutination test with 1% chicken red blood cells.&#xD;
An increase in the number of antigenic-specific T cells greater than 3SD over the mean placebo values was regarded as a positive T cell response.</description>
          <population>Participants receiving both doses of study vaccine or placebo and with pre- and post-vaccination immunologic parameters measured</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="29"/>
                <count group_id="O4" value="10"/>
                <count group_id="O5" value="29"/>
                <count group_id="O6" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Positive response</title>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="8"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No response</title>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="26"/>
                    <measurement group_id="O4" value="10"/>
                    <measurement group_id="O5" value="21"/>
                    <measurement group_id="O6" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number/Percentage of Subjects Exhibiting CD4+ IFNγ+ Central Memory T Cell Responses</title>
        <description>Nasal swabs from days 1, 2, 3, 5, and 7 after the first vaccination and on days 1 and 3, corresponding to days 29 and 31,respectively, after the second dose were tested for viral shedding by inoculation in 10- to 11-day-old ECE followed by incubation at 32◦C for 72 h. Influenza virus was detected by standard hemagglutination test with 1% chicken red blood cells.&#xD;
An increase in the number of antigenic-specific T cells greater than 3SD over the mean placebo values was regarded as a positive T cell response.</description>
        <time_frame>28 days (Dose 1) and 56 days (Dose 2)</time_frame>
        <population>Participants receiving both doses of study vaccine or placebo and with pre- and post-vaccination immunologic parameters measured</population>
        <group_list>
          <group group_id="O1">
            <title>Dose 1: Vaccine</title>
            <description>After receiving dose 1 of vaccine</description>
          </group>
          <group group_id="O2">
            <title>Dose 1: Placebo</title>
            <description>After receiving Dose 1 of Placebo</description>
          </group>
          <group group_id="O3">
            <title>Dose 2: Vaccine</title>
            <description>After receiving Dose 2 of vaccine</description>
          </group>
          <group group_id="O4">
            <title>Dose 2: Placebo</title>
            <description>After receiving Dose 2 of placebo</description>
          </group>
          <group group_id="O5">
            <title>Dose 1 or 2: Vaccine</title>
            <description>Received dose 1 or 2 of vaccine</description>
          </group>
          <group group_id="O6">
            <title>Dose 1 or 2: Placebo</title>
            <description>Received dose 1 or 2 of placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Number/Percentage of Subjects Exhibiting CD4+ IFNγ+ Central Memory T Cell Responses</title>
          <description>Nasal swabs from days 1, 2, 3, 5, and 7 after the first vaccination and on days 1 and 3, corresponding to days 29 and 31,respectively, after the second dose were tested for viral shedding by inoculation in 10- to 11-day-old ECE followed by incubation at 32◦C for 72 h. Influenza virus was detected by standard hemagglutination test with 1% chicken red blood cells.&#xD;
An increase in the number of antigenic-specific T cells greater than 3SD over the mean placebo values was regarded as a positive T cell response.</description>
          <population>Participants receiving both doses of study vaccine or placebo and with pre- and post-vaccination immunologic parameters measured</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="29"/>
                <count group_id="O4" value="10"/>
                <count group_id="O5" value="29"/>
                <count group_id="O6" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Positive response</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="8"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No response</title>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="23"/>
                    <measurement group_id="O4" value="10"/>
                    <measurement group_id="O5" value="21"/>
                    <measurement group_id="O6" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number/Percentage of Subjects Exhibiting CD4+ IFNγ+ Effector Memory T Cell Responses</title>
        <description>Nasal swabs from days 1, 2, 3, 5, and 7 after the first vaccination and on days 1 and 3, corresponding to days 29 and 31,respectively, after the second dose were tested for viral shedding by inoculation in 10- to 11-day-old ECE followed by incubation at 32◦C for 72 h. Influenza virus was detected by standard hemagglutination test with 1% chicken red blood cells.&#xD;
An increase in the number of antigenic-specific T cells greater than 3SD over the mean placebo values was regarded as a positive T cell response.</description>
        <time_frame>28 days (Dose 1) and 56 days (Dose 2)</time_frame>
        <population>Participants receiving both doses of study vaccine or placebo and with pre- and post-vaccination immunologic parameters measured</population>
        <group_list>
          <group group_id="O1">
            <title>Dose 1: Vaccine</title>
            <description>After receiving dose 1 of vaccine</description>
          </group>
          <group group_id="O2">
            <title>Dose 1: Placebo</title>
            <description>After receiving Dose 1 of Placebo</description>
          </group>
          <group group_id="O3">
            <title>Dose 2: Vaccine</title>
            <description>After receiving Dose 2 of vaccine</description>
          </group>
          <group group_id="O4">
            <title>Dose 2: Placebo</title>
            <description>After receiving Dose 2 of placebo</description>
          </group>
          <group group_id="O5">
            <title>Dose 1 or 2: Vaccine</title>
            <description>After receiving dose 1 or 2 of vaccine</description>
          </group>
          <group group_id="O6">
            <title>Dose 1 or 2: Placebo</title>
            <description>After receiving dose 1 or 2 of placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Number/Percentage of Subjects Exhibiting CD4+ IFNγ+ Effector Memory T Cell Responses</title>
          <description>Nasal swabs from days 1, 2, 3, 5, and 7 after the first vaccination and on days 1 and 3, corresponding to days 29 and 31,respectively, after the second dose were tested for viral shedding by inoculation in 10- to 11-day-old ECE followed by incubation at 32◦C for 72 h. Influenza virus was detected by standard hemagglutination test with 1% chicken red blood cells.&#xD;
An increase in the number of antigenic-specific T cells greater than 3SD over the mean placebo values was regarded as a positive T cell response.</description>
          <population>Participants receiving both doses of study vaccine or placebo and with pre- and post-vaccination immunologic parameters measured</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="29"/>
                <count group_id="O4" value="10"/>
                <count group_id="O5" value="29"/>
                <count group_id="O6" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Positive response</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="11"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No response</title>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="23"/>
                    <measurement group_id="O4" value="10"/>
                    <measurement group_id="O5" value="18"/>
                    <measurement group_id="O6" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number/Percentage of Subjects Exhibiting CD8+ IFNγ+ Central Memory T Cell Responses</title>
        <description>Nasal swabs from days 1, 2, 3, 5, and 7 after the first vaccination and on days 1 and 3, corresponding to days 29 and 31,respectively, after the second dose were tested for viral shedding by inoculation in 10- to 11-day-old ECE followed by incubation at 32◦C for 72 h. Influenza virus was detected by standard hemagglutination test with 1% chicken red blood cells.&#xD;
An increase in the number of antigenic-specific T cells greater than 3SD over the mean placebo values was regarded as a positive T cell response.</description>
        <time_frame>28 days (Dose 1) and 56 days (Dose 2)</time_frame>
        <population>Participants receiving both doses of study vaccine or placebo and with pre- and post-vaccination immunologic parameters measured</population>
        <group_list>
          <group group_id="O1">
            <title>Dose 1: Vaccine</title>
            <description>After receiving dose 1 of vaccine</description>
          </group>
          <group group_id="O2">
            <title>Dose 1: Placebo</title>
            <description>After receiving Dose 1 of Placebo</description>
          </group>
          <group group_id="O3">
            <title>Dose 2: Vaccine</title>
            <description>After receiving Dose 2 of vaccine</description>
          </group>
          <group group_id="O4">
            <title>Dose 2: Placebo</title>
            <description>After receiving Dose 2 of placebo</description>
          </group>
          <group group_id="O5">
            <title>Dose 1 or 2: Vaccine</title>
            <description>Received dose 1 or 2 of vaccine</description>
          </group>
          <group group_id="O6">
            <title>Dose 1 or 2: Placebo</title>
            <description>Received dose 1 or 2 of placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Number/Percentage of Subjects Exhibiting CD8+ IFNγ+ Central Memory T Cell Responses</title>
          <description>Nasal swabs from days 1, 2, 3, 5, and 7 after the first vaccination and on days 1 and 3, corresponding to days 29 and 31,respectively, after the second dose were tested for viral shedding by inoculation in 10- to 11-day-old ECE followed by incubation at 32◦C for 72 h. Influenza virus was detected by standard hemagglutination test with 1% chicken red blood cells.&#xD;
An increase in the number of antigenic-specific T cells greater than 3SD over the mean placebo values was regarded as a positive T cell response.</description>
          <population>Participants receiving both doses of study vaccine or placebo and with pre- and post-vaccination immunologic parameters measured</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="10"/>
                <count group_id="O3" value="29"/>
                <count group_id="O4" value="10"/>
                <count group_id="O5" value="29"/>
                <count group_id="O6" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Positive response</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="3"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No response</title>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="23"/>
                    <measurement group_id="O4" value="7"/>
                    <measurement group_id="O5" value="26"/>
                    <measurement group_id="O6" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Within 7 days of administration of dose</time_frame>
      <desc>Definition of adverse event does not differ from clinicaltrials.gov.&#xD;
Adverse events occurring during the 6 days following any dose, measured as observed by study staff or reported by the subject to study staff. This includes abnormal laboratory findings from blood and urine specimens collected on Days 6 and 34.</desc>
      <group_list>
        <group group_id="E1">
          <title>Dose 1: Vaccine</title>
          <description>Received dose 1 of vaccine</description>
        </group>
        <group group_id="E2">
          <title>Dose 1: Placebo</title>
          <description>Received Dose 1 of Placebo</description>
        </group>
        <group group_id="E3">
          <title>Dose 2: Vaccine</title>
          <description>Received Dose 2 of vaccine</description>
        </group>
        <group group_id="E4">
          <title>Dose 2: Placebo</title>
          <description>Received Dose 2 of placebo</description>
        </group>
      </group_list>
      <serious_events>
        <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="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="29"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA (Unspecified)</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="21" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="25" subjects_at_risk="30"/>
                <counts group_id="E4" subjects_affected="8" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine Aminotransferase Increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Aspartate Aminotransferase Increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Blood Alkaline Phopsphatase Decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Blood Bicarbonate Increased</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="15" subjects_at_risk="30"/>
                <counts group_id="E4" subjects_affected="4" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Blood Bilirubin Increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Blood Calcium Increased</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="30"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Blood Potassium Increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Haemoglobin Increased</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="30"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Lymphocyte Count Increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="10" subjects_at_risk="30"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Monocyte Count Increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Red Blood Cell Count Decreased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>White Blood Cell Count Increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Blood Glucose Increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="30"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Haematocrit Decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Haemoglobin Decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="30"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Mean Cell Haemoglobin Concentraion Increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Mean Cell Volume Decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Mean Platelet Volume Decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Protein Total Increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Red Blood Cell Sedimentation Decreased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Proteinuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="30"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="10"/>
              </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 NOT 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>
    <limitations_and_caveats>Study was completed as expected.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Jorge Flores</name_or_title>
      <organization>PATH</organization>
      <phone>(202) 822-0033</phone>
      <email>jeflores@path.org</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/NCT01719783
org study id: LAIV-H5N2-01
nct id: NCT01719783
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
To evaluate the safety profile of two intranasal doses of LAIV A/17/turkey/Turkey/05/133
      (H5N2) in healthy adults.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Adverse Events by Severity
time frame: 6 days
description: Occurrence of participants with adverse events associated with intranasal administration, by worst grade of severity
measure: Number/Percentage of Subjects With Seroconversion for Serum Hemagglutination Inhibition (HAI)
time frame: 28 days (Dose 1) and 56 days (Dose 2)
description: Defined as a four-fold or greater antibody rise in titer from pre-vaccination level.
HAI = hemagglutination-inhibition, conducted using World Health Organization (WHO)-recommended protocols.
measure: Number/Percentage of Subjects With Serum Neutralizing Antibodies
time frame: 28 days (Dose 1) and 56 days (Dose 2)
description: Defined as a four-fold or greater antibody rise in titer from pre-vaccination level.
Measured by microneutralization assay in Madin-Darby canine kidney cells (MDCK).
measure: Number/Percentage of Subjects With Seroconversion for Serum Immunoglobulin A (IgA)
time frame: 28 days (Dose 1) and 56 days (Dose 2)
description: IgA = immunoglobulin class A antibodies Determined using ELISA using whole purified H5N2
measure: Number/Percentage of Subjects With Seroconversion for Serum Immunoglobulin G (IgG)
time frame: 28 days (Dose 1) and 56 days (Dose 2)
description: Determined using ELISA using whole purified H5N2.
measure: Number/Percentage of Subjects With Seroconversion for Secretory IgA
time frame: 28 days (Dose 1) and 56 days (Dose 2)
description: IgA antibodies from the nasal mucosa detected in nasal wick specimens. Determined using ELISA using whole purified H5N2
measure: Number/Percentage of Subjects With Seroconversion for IgA in Saliva
time frame: 28 days (Dose 1) and 56 days (Dose 2)
description: IgA = Immunoglobulin Class A antibodies. Determined using ELISA using whole purified H5N2.
measure: Number/Percentage of Vaccinated Participants Shedding Influenza Virus After First Dose
time frame: 6 days post-vaccination
description: Nasal swabs were collected and used for Reverse transcription polymerase chain reaction (rRTPCR) assays to detect shedding of influenza virus for days 1-6 of the study.
measure: Number/Percentage of Vaccinated Participants Shedding Influenza Virus After Second Dose
time frame: 6 days post-vaccination
description: Nasal swabs were collected and used for Reverse transcription polymerase chain reaction (rRTPCR) assays to detect shedding of influenza virus for days 29-34 of the study (6 days after the second vaccination).
measure: Geometric Mean Titers for Serum HAI Antibodies
time frame: 0 days, 28 days (Dose 1) and 56 days (Dose 2)
description: Geometric mean titers for serum hemagglutination inhibition antibodies
measure: Geometric Mean Titers (GMT) for Serum Neutralizing Antibodies
time frame: 0 days, 28 days (Dose 1) and 56 days (Dose 2)
description: Geometric mean titers for serum neutralizing antibodies measured by microneutralization assay
measure: Number/Percentage of Subjects Exhibiting CD8+ IFNγ+ Responses
time frame: 28 days (Dose 1) and 56 days (Dose 2)
description: Nasal swabs from days 1, 2, 3, 5, and 7 after the first vaccination and on days 1 and 3, corresponding to days 29 and 31,respectively, after the second dose were tested for viral shedding by inoculation in 10- to 11-day-old embryonated chicken eggs (ECE) followed by incubation at 32◦C for 72 h. Influenza virus was detected by standard hemagglutination test with 1% chicken red blood cells.
An increase in the number of antigenic-specific T cells greater than 3 standard deviations over the mean placebo values was regarded as a positive T cell response.
measure: Number/Percentage of Subjects Exhibiting CD4+ IFNγ+ Responses
time frame: 28 days (Dose 1) and 56 days (Dose 2)
description: Nasal swabs from days 1, 2, 3, 5, and 7 after the first vaccination and on days 1 and 3, corresponding to days 29 and 31,respectively, after the second dose were tested for viral shedding by inoculation in 10- to 11-day-old ECE followed by incubation at 32◦C for 72 h. Influenza virus was detected by standard hemagglutination test with 1% chicken red blood cells.
An increase in the number of antigenic-specific T cells greater than 3 standard deviations over the mean placebo values was regarded as a positive T cell response.
measure: Number/Percentage of Subjects Exhibiting CD8+ IFNγ+ Effector Memory T Cell Responses
time frame: 28 days (Dose 1) and 56 days (Dose 2)
description: Nasal swabs from days 1, 2, 3, 5, and 7 after the first vaccination and on days 1 and 3, corresponding to days 29 and 31,respectively, after the second dose were tested for viral shedding by inoculation in 10- to 11-day-old ECE followed by incubation at 32◦C for 72 h. Influenza virus was detected by standard hemagglutination test with 1% chicken red blood cells.
An increase in the number of antigenic-specific T cells greater than 3SD over the mean placebo values was regarded as a positive T cell response.
measure: Number/Percentage of Subjects Exhibiting CD4+ IFNγ+ Central Memory T Cell Responses
time frame: 28 days (Dose 1) and 56 days (Dose 2)
description: Nasal swabs from days 1, 2, 3, 5, and 7 after the first vaccination and on days 1 and 3, corresponding to days 29 and 31,respectively, after the second dose were tested for viral shedding by inoculation in 10- to 11-day-old ECE followed by incubation at 32◦C for 72 h. Influenza virus was detected by standard hemagglutination test with 1% chicken red blood cells.
An increase in the number of antigenic-specific T cells greater than 3SD over the mean placebo values was regarded as a positive T cell response.
measure: Number/Percentage of Subjects Exhibiting CD4+ IFNγ+ Effector Memory T Cell Responses
time frame: 28 days (Dose 1) and 56 days (Dose 2)
description: Nasal swabs from days 1, 2, 3, 5, and 7 after the first vaccination and on days 1 and 3, corresponding to days 29 and 31,respectively, after the second dose were tested for viral shedding by inoculation in 10- to 11-day-old ECE followed by incubation at 32◦C for 72 h. Influenza virus was detected by standard hemagglutination test with 1% chicken red blood cells.
An increase in the number of antigenic-specific T cells greater than 3SD over the mean placebo values was regarded as a positive T cell response.
measure: Number/Percentage of Subjects Exhibiting CD8+ IFNγ+ Central Memory T Cell Responses
time frame: 28 days (Dose 1) and 56 days (Dose 2)
description: Nasal swabs from days 1, 2, 3, 5, and 7 after the first vaccination and on days 1 and 3, corresponding to days 29 and 31,respectively, after the second dose were tested for viral shedding by inoculation in 10- to 11-day-old ECE followed by incubation at 32◦C for 72 h. Influenza virus was detected by standard hemagglutination test with 1% chicken red blood cells.
An increase in the number of antigenic-specific T cells greater than 3SD over the mean placebo values was regarded as a positive T cell response.
arm group label: LAIV H5N2
arm group type: Experimental
description: Two doses of live monovalent influenza vaccine A/17/turkey/Turkey/05/133 ( live monovalent (LAIV H5N2) given intranasally
arm group label: Placebo
arm group type: Placebo Comparator
description: two doses of placebo solution intranasal
intervention type: Biological
intervention name: LAIV H5N2
description: 2 doses provided intranasally
arm group label: LAIV H5N2
other name: A/17/turkey/Turkey/05/133(H5N2)live influenza vaccine
intervention type: Other
intervention name: Placebo
description: 2 doses of placebo provided intranasally
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 49 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Russian Federation
responsible party type: Sponsor
mesh term: Influenza, Human
mesh term: Vaccines
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Study was completed as expected.
point of contact: 