<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/NCT02250274</url>
  </required_header>
  <id_info>
    <org_study_id>5U01IP000471-04</org_study_id>
    <nct_id>NCT02250274</nct_id>
  </id_info>
  <brief_title>Randomized Study of Immune Response to Licensed Influenza Vaccines in Children and Adolescents</brief_title>
  <official_title>Prospective Randomized Study of Immune Response to Licensed Influenza Vaccines in Children and Adolescents</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Marshfield Clinic Research Foundation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Centers for Disease Control and Prevention</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Wisconsin, Madison</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Marshfield Clinic Research Foundation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the serologic and cell-mediated immune response to&#xD;
      licensed live attenuated influenza vaccine (LAIV) and inactivated influenza vaccine (IIV) in&#xD;
      children 5-17 years old. The effects of prior infection and or prior season vaccination will&#xD;
      be examined. Children will be followed during the influenza season to identify&#xD;
      laboratory-confirmed influenza (i.e. vaccine failure).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All children will have baseline blood samples drawn and will then be vaccinated with licensed&#xD;
      and approved influenza vaccines. Following the recommendation from the Advisory Committee on&#xD;
      Immunization Practices, children 5-8 years old will preferentially receive live attenuated&#xD;
      influenza vaccine (LAIV). Children aged 9-17 will be randomized to receive either LAIV or&#xD;
      inactivated influenza vaccine (IIV). Children with a medical contraindication to any licensed&#xD;
      influenza vaccine will be excluded from the study.&#xD;
&#xD;
      The children will have their blood drawn between 2 and 4 times total over the course of two&#xD;
      months in order to test their immune response to the vaccine. Between approximately December&#xD;
      and April, study participants will be contacted weekly to monitor for any new respiratory&#xD;
      illnesses with cough, and if present, nasal and throat swabs will be collected to test for&#xD;
      influenza.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">April 2015</completion_date>
  <primary_completion_date type="Actual">December 2014</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Hemagglutination Inhibition (HI) Titer Response to Vaccine and Circulating Strains of Influenza</measure>
    <time_frame>Change from Baseline to 28 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Polymerase Chain Reaction (PCR) Confirmed Influenza Illness</measure>
    <time_frame>Onset &gt;13 days after vaccination and before April 1, 2015</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Antibody Dependent Cellular Cytotoxicity (ADCC) Titers</measure>
    <time_frame>Change from Baseline to 28 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ratio Between Immunoglobulin A (IgA):Immunoglobulin G (IgG)</measure>
    <time_frame>Day 7</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">131</enrollment>
  <condition>Immune Response to Influenza Vaccine</condition>
  <condition>Influenza A Virus Infection</condition>
  <condition>Influenza B Virus Infection</condition>
  <arm_group>
    <arm_group_label>LAIV 2014-15</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Will receive LAIV this year. Includes 5-8 year olds and approximately half of the 9-17 year olds. Prior history includes vaccine failures, vaccinated/uninfected and unvaccinated/uninfected last year. PBMC available for those who were infected last year, all ages.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IIV 2014-15</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Will receive IIV this year. Includes only 9-17 year olds (unless shortages of LAIV encountered). Prior history includes vaccine failures, vaccinated/uninfected and unvaccinated/uninfected last year. PBMC available for those who were infected last year, only 9-17 year olds.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>LAIV</intervention_name>
    <description>Licensed and approved Live Attenuated Influenza Vaccination (LAIV) will be preferentially given to all children aged 5-8 years old as recommended by Advisory Committee on Immunization Practices. A modified randomization scheme in which every other child aged 9-17 years enrolled in the study will be given LAIV will be used. The rest of the children aged 9-17 years old will receive IIV.</description>
    <arm_group_label>LAIV 2014-15</arm_group_label>
    <other_name>FluMist</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>IIV</intervention_name>
    <description>A modified randomization scheme in which every other child aged 9-17 years enrolled in the study will be given IIV will be used. The rest of the children 9-17 years old will receive LAIV.&#xD;
[Note: Although we do not anticipate exhausting the supply of LAIV, should this occur, children aged 5-8 will be offered IIV as it is also approved in this age group and should be used if LAIV is unavailable.]</description>
    <arm_group_label>IIV 2014-15</arm_group_label>
    <other_name>FluZone</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 5-17 years for the duration of the study period (Sept 1, 2014-Apr 1, 2015)&#xD;
&#xD;
          -  Enrolled in either the immune response study or the vaccine effectiveness study&#xD;
             conducted at the site in the 2013-14 influenza season&#xD;
&#xD;
          -  If enrolled in the vaccine effectiveness study the previous season must have either&#xD;
             been vaccinated and infected with influenza or unvaccinated and uninfected with&#xD;
             influenza&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children with contraindications to either the quadrivalent live attenuated influenza&#xD;
             vaccine or to the trivalent inactivated influenza vaccine will be excluded.&#xD;
&#xD;
          -  Anyone unwilling or unable to complete all required study activities including&#xD;
             informed consent&#xD;
&#xD;
          -  Subjects who already received the influenza vaccine for the 2014-15 season&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Edward A Belongia, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Marshfield Clinic Research Foundation - Center for Clinical Epidemiology &amp; Population Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Marshfield Clinic - Marshfield Center</name>
      <address>
        <city>Marshfield</city>
        <state>Wisconsin</state>
        <zip>54449</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>September 17, 2014</study_first_submitted>
  <study_first_submitted_qc>September 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2014</study_first_posted>
  <results_first_submitted>September 22, 2015</results_first_submitted>
  <results_first_submitted_qc>January 29, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">February 26, 2016</results_first_posted>
  <last_update_submitted>March 26, 2018</last_update_submitted>
  <last_update_submitted_qc>March 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 26, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Marshfield Clinic Research Foundation</investigator_affiliation>
    <investigator_full_name>Edward Belongia</investigator_full_name>
    <investigator_title>Director of Center for Clinical Epidemiology and Population Health</investigator_title>
  </responsible_party>
  <keyword>Immune response to influenza vaccine</keyword>
  <keyword>PCR confirmed Influenza A virus</keyword>
  <keyword>PCR confirmed Influenza B virus</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Virus Diseases</mesh_term>
    <mesh_term>Influenza, Human</mesh_term>
    <mesh_term>Herpesviridae Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>There is a plan to publish the results of the study in a manuscript but no plans to release individual level data as the results are not clinically actionable.</ipd_description>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>LAIV 2014-15</title>
          <description>Will receive LAIV this year. Includes 5-8 year olds and approximately half of the 9-17 year olds. Prior history includes vaccine failures, vaccinated/uninfected and unvaccinated/uninfected last year. PBMC available for those who were infected last year, all ages.&#xD;
LAIV: Licensed and approved Live Attenuated Influenza Vaccination (LAIV) will be preferentially given to all children aged 5-8 years old as recommended by Advisory Committee on Immunization Practices. A modified randomization scheme in which every other child aged 9-17 years enrolled in the study will be given LAIV will be used. The rest of the children aged 9-17 years old will receive IIV.</description>
        </group>
        <group group_id="P2">
          <title>IIV 2014-15</title>
          <description>Will receive IIV this year. Includes only 9-17 year olds (unless shortages of LAIV encountered). Prior history includes vaccine failures, vaccinated/uninfected and unvaccinated/uninfected last year. PBMC available for those who were infected last year, only 9-17 year olds.&#xD;
IIV: A modified randomization scheme in which every other child aged 9-17 years enrolled in the study will be given IIV will be used. The rest of the children 9-17 years old will receive LAIV.&#xD;
[Note: Although we do not anticipate exhausting the supply of LAIV, should this occur, children aged 5-8 will be offered IIV as it is also approved in this age group and should be used if LAIV is unavailable.]</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="85"/>
                <participants group_id="P2" count="46"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="78"/>
                <participants group_id="P2" count="40"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Insufficient blood draw amount</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>LAIV 2014-15</title>
          <description>Will receive LAIV this year. Includes 5-8 year olds and approximately half of the 9-17 year olds. Prior history includes vaccine failures, vaccinated/uninfected and unvaccinated/uninfected last year. PBMC available for those who were infected last year, all ages.&#xD;
LAIV: Licensed and approved Live Attenuated Influenza Vaccination (LAIV) will be preferentially given to all children aged 5-8 years old as recommended by Advisory Committee on Immunization Practices. A modified randomization scheme in which every other child aged 9-17 years enrolled in the study will be given LAIV will be used. The rest of the children aged 9-17 years old will receive IIV.</description>
        </group>
        <group group_id="B2">
          <title>IIV 2014-15</title>
          <description>Will receive IIV this year. Includes only 9-17 year olds (unless shortages of LAIV encountered). Prior history includes vaccine failures, vaccinated/uninfected and unvaccinated/uninfected last year. PBMC available for those who were infected last year, only 9-17 year olds.&#xD;
IIV: A modified randomization scheme in which every other child aged 9-17 years enrolled in the study will be given IIV will be used. The rest of the children 9-17 years old will receive LAIV.&#xD;
[Note: Although we do not anticipate exhausting the supply of LAIV, should this occur, children aged 5-8 will be offered IIV as it is also approved in this age group and should be used if LAIV is unavailable.]</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="85"/>
            <count group_id="B2" value="46"/>
            <count group_id="B3" value="131"/>
          </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="10" spread="3.2"/>
                    <measurement group_id="B2" value="12" spread="2.5"/>
                    <measurement group_id="B3" value="11" spread="3.2"/>
                  </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="35"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="56"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Hemagglutination Inhibition (HI) Titer Response to Vaccine and Circulating Strains of Influenza</title>
        <time_frame>Change from Baseline to 28 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>LAIV 2014-15</title>
            <description>Will receive LAIV this year. Includes 5-8 year olds and approximately half of the 9-17 year olds. Prior history includes vaccine failures, vaccinated/uninfected and unvaccinated/uninfected last year. PBMC available for those who were infected last year, all ages.&#xD;
LAIV: Licensed and approved Live Attenuated Influenza Vaccination (LAIV) will be preferentially given to all children aged 5-8 years old as recommended by Advisory Committee on Immunization Practices. A modified randomization scheme in which every other child aged 9-17 years enrolled in the study will be given LAIV will be used. The rest of the children aged 9-17 years old will receive IIV.</description>
          </group>
          <group group_id="O2">
            <title>IIV 2014-15</title>
            <description>Will receive IIV this year. Includes only 9-17 year olds (unless shortages of LAIV encountered). Prior history includes vaccine failures, vaccinated/uninfected and unvaccinated/uninfected last year. PBMC available for those who were infected last year, only 9-17 year olds.&#xD;
IIV: A modified randomization scheme in which every other child aged 9-17 years enrolled in the study will be given IIV will be used. The rest of the children 9-17 years old will receive LAIV.&#xD;
[Note: Although we do not anticipate exhausting the supply of LAIV, should this occur, children aged 5-8 will be offered IIV as it is also approved in this age group and should be used if LAIV is unavailable.]</description>
          </group>
        </group_list>
        <measure>
          <title>Hemagglutination Inhibition (HI) Titer Response to Vaccine and Circulating Strains of Influenza</title>
          <units>Titers</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="78"/>
                <count group_id="O2" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>H3N2 Day 28 HI Titer</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99" lower_limit="79" upper_limit="124"/>
                    <measurement group_id="O2" value="295" lower_limit="227" upper_limit="383"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>H3N2 Baseline HI Titer</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96" lower_limit="76" upper_limit="122"/>
                    <measurement group_id="O2" value="100" lower_limit="67" upper_limit="149"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Polymerase Chain Reaction (PCR) Confirmed Influenza Illness</title>
        <time_frame>Onset &gt;13 days after vaccination and before April 1, 2015</time_frame>
        <group_list>
          <group group_id="O1">
            <title>LAIV 2014-15</title>
            <description>Will receive LAIV this year. Includes 5-8 year olds and approximately half of the 9-17 year olds. Prior history includes vaccine failures, vaccinated/uninfected and unvaccinated/uninfected last year. PBMC available for those who were infected last year, all ages.&#xD;
LAIV: Licensed and approved Live Attenuated Influenza Vaccination (LAIV) will be preferentially given to all children aged 5-8 years old as recommended by Advisory Committee on Immunization Practices. A modified randomization scheme in which every other child aged 9-17 years enrolled in the study will be given LAIV will be used. The rest of the children aged 9-17 years old will receive IIV.</description>
          </group>
          <group group_id="O2">
            <title>IIV 2014-15</title>
            <description>Will receive IIV this year. Includes only 9-17 year olds (unless shortages of LAIV encountered). Prior history includes vaccine failures, vaccinated/uninfected and unvaccinated/uninfected last year. PBMC available for those who were infected last year, only 9-17 year olds.&#xD;
IIV: A modified randomization scheme in which every other child aged 9-17 years enrolled in the study will be given IIV will be used. The rest of the children 9-17 years old will receive LAIV.&#xD;
[Note: Although we do not anticipate exhausting the supply of LAIV, should this occur, children aged 5-8 will be offered IIV as it is also approved in this age group and should be used if LAIV is unavailable.]</description>
          </group>
        </group_list>
        <measure>
          <title>Polymerase Chain Reaction (PCR) Confirmed Influenza Illness</title>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="85"/>
                <count group_id="O2" value="46"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Antibody Dependent Cellular Cytotoxicity (ADCC) Titers</title>
        <time_frame>Change from Baseline to 28 days</time_frame>
        <population>Fold change in NK cell degranulation</population>
        <group_list>
          <group group_id="O1">
            <title>IIV-IIV</title>
            <description>Participants receiving IIV in 2013-14 and IIV again in 2014-15.</description>
          </group>
          <group group_id="O2">
            <title>IIV-LAIV</title>
            <description>Participants receiving IIV in 2013-14 and LAIV in 2014-15.</description>
          </group>
          <group group_id="O3">
            <title>LAIV-IIV</title>
            <description>Participants receiving LAIV in 2013-14 and IIV in 2014-15.</description>
          </group>
          <group group_id="O4">
            <title>LAIV-LAIV</title>
            <description>Participants receiving LAIV in 2013-14 and LAIV in 2014-15.</description>
          </group>
          <group group_id="O5">
            <title>Unvax-IIV</title>
            <description>Participants unvaccinated in 2013-14 and receiving IIV in 2014-15.</description>
          </group>
          <group group_id="O6">
            <title>Unvax-LAIV</title>
            <description>Participants unvaccinated in 2013-14 and receiving LAIV in 2014-15.</description>
          </group>
        </group_list>
        <measure>
          <title>Antibody Dependent Cellular Cytotoxicity (ADCC) Titers</title>
          <population>Fold change in NK cell degranulation</population>
          <units>Fold change</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="19"/>
                <count group_id="O2" value="31"/>
                <count group_id="O3" value="13"/>
                <count group_id="O4" value="28"/>
                <count group_id="O5" value="7"/>
                <count group_id="O6" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Fold change in NK cell degranulation to SW antigen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.02" lower_limit="0.76" upper_limit="1.36"/>
                    <measurement group_id="O2" value="0.99" lower_limit="0.93" upper_limit="1.05"/>
                    <measurement group_id="O3" value="1.47" lower_limit="1.03" upper_limit="2.09"/>
                    <measurement group_id="O4" value="0.86" lower_limit="0.76" upper_limit="0.98"/>
                    <measurement group_id="O5" value="1.31" lower_limit="0.96" upper_limit="1.8"/>
                    <measurement group_id="O6" value="1.08" lower_limit="0.90" upper_limit="1.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fold change in NK cell degranulation to TX antigen</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.10" lower_limit="0.96" upper_limit="1.25"/>
                    <measurement group_id="O2" value="0.95" lower_limit="0.86" upper_limit="1.06"/>
                    <measurement group_id="O3" value="1.39" lower_limit="1.18" upper_limit="1.64"/>
                    <measurement group_id="O4" value="1.01" lower_limit="0.92" upper_limit="1.11"/>
                    <measurement group_id="O5" value="1.13" lower_limit="0.75" upper_limit="1.70"/>
                    <measurement group_id="O6" value="1.33" lower_limit="1.18" upper_limit="1.49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Ratio Between Immunoglobulin A (IgA):Immunoglobulin G (IgG)</title>
        <time_frame>Day 7</time_frame>
        <population>There were too few samples collected within each group to conduct a reasonable analysis of this outcome. The samples collected are being stored for potential future use.</population>
        <group_list>
          <group group_id="O1">
            <title>LAIV 2014-15</title>
            <description>Will receive LAIV this year. Includes 5-8 year olds and approximately half of the 9-17 year olds. Prior history includes vaccine failures, vaccinated/uninfected and unvaccinated/uninfected last year. PBMC available for those who were infected last year, all ages.&#xD;
LAIV: Licensed and approved Live Attenuated Influenza Vaccination (LAIV) will be preferentially given to all children aged 5-8 years old as recommended by Advisory Committee on Immunization Practices. A modified randomization scheme in which every other child aged 9-17 years enrolled in the study will be given LAIV will be used. The rest of the children aged 9-17 years old will receive IIV.</description>
          </group>
          <group group_id="O2">
            <title>IIV 2014-15</title>
            <description>Will receive IIV this year. Includes only 9-17 year olds (unless shortages of LAIV encountered). Prior history includes vaccine failures, vaccinated/uninfected and unvaccinated/uninfected last year. PBMC available for those who were infected last year, only 9-17 year olds.&#xD;
IIV: A modified randomization scheme in which every other child aged 9-17 years enrolled in the study will be given IIV will be used. The rest of the children 9-17 years old will receive LAIV.&#xD;
[Note: Although we do not anticipate exhausting the supply of LAIV, should this occur, children aged 5-8 will be offered IIV as it is also approved in this age group and should be used if LAIV is unavailable.]</description>
          </group>
        </group_list>
        <measure>
          <title>Ratio Between Immunoglobulin A (IgA):Immunoglobulin G (IgG)</title>
          <population>There were too few samples collected within each group to conduct a reasonable analysis of this outcome. The samples collected are being stored for potential future use.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>LAIV 2014-15</title>
          <description>Will receive LAIV this year. Includes 5-8 year olds and approximately half of the 9-17 year olds. Prior history includes vaccine failures, vaccinated/uninfected and unvaccinated/uninfected last year. PBMC available for those who were infected last year, all ages.&#xD;
LAIV: Licensed and approved Live Attenuated Influenza Vaccination (LAIV) will be preferentially given to all children aged 5-8 years old as recommended by Advisory Committee on Immunization Practices. A modified randomization scheme in which every other child aged 9-17 years enrolled in the study will be given LAIV will be used. The rest of the children aged 9-17 years old will receive IIV.</description>
        </group>
        <group group_id="E2">
          <title>IIV 2014-15</title>
          <description>Will receive IIV this year. Includes only 9-17 year olds (unless shortages of LAIV encountered). Prior history includes vaccine failures, vaccinated/uninfected and unvaccinated/uninfected last year. PBMC available for those who were infected last year, only 9-17 year olds.&#xD;
IIV: A modified randomization scheme in which every other child aged 9-17 years enrolled in the study will be given IIV will be used. The rest of the children 9-17 years old will receive LAIV.&#xD;
[Note: Although we do not anticipate exhausting the supply of LAIV, should this occur, children aged 5-8 will be offered IIV as it is also approved in this age group and should be used if LAIV is unavailable.]</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="46"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="85"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="46"/>
              </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>
    <point_of_contact>
      <name_or_title>Director of the Center for Clinical Epidemiology &amp; Population Health</name_or_title>
      <organization>Marshfield Clinic Research Foundation</organization>
      <phone>715-389-3444</phone>
      <email>belongia.edward@mcrf.mfldclin.edu</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/NCT02250274
org study id: 5U01IP000471-04
nct id: NCT02250274
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The purpose of this study is to assess the serologic and cell-mediated immune response to
      licensed live attenuated influenza vaccine (LAIV) and inactivated influenza vaccine (IIV) in
      children 5-17 years old. The effects of prior infection and or prior season vaccination will
      be examined. Children will be followed during the influenza season to identify
      laboratory-confirmed influenza (i.e. vaccine failure).
All children will have baseline blood samples drawn and will then be vaccinated with licensed
      and approved influenza vaccines. Following the recommendation from the Advisory Committee on
      Immunization Practices, children 5-8 years old will preferentially receive live attenuated
      influenza vaccine (LAIV). Children aged 9-17 will be randomized to receive either LAIV or
      inactivated influenza vaccine (IIV). Children with a medical contraindication to any licensed
      influenza vaccine will be excluded from the study.

      The children will have their blood drawn between 2 and 4 times total over the course of two
      months in order to test their immune response to the vaccine. Between approximately December
      and April, study participants will be contacted weekly to monitor for any new respiratory
      illnesses with cough, and if present, nasal and throat swabs will be collected to test for
      influenza.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Hemagglutination Inhibition (HI) Titer Response to Vaccine and Circulating Strains of Influenza
time frame: Change from Baseline to 28 days
measure: Polymerase Chain Reaction (PCR) Confirmed Influenza Illness
time frame: Onset >13 days after vaccination and before April 1, 2015
measure: Antibody Dependent Cellular Cytotoxicity (ADCC) Titers
time frame: Change from Baseline to 28 days
measure: Ratio Between Immunoglobulin A (IgA):Immunoglobulin G (IgG)
time frame: Day 7
arm group label: LAIV 2014-15
arm group type: Other
description: Will receive LAIV this year. Includes 5-8 year olds and approximately half of the 9-17 year olds. Prior history includes vaccine failures, vaccinated/uninfected and unvaccinated/uninfected last year. PBMC available for those who were infected last year, all ages.
arm group label: IIV 2014-15
arm group type: Other
description: Will receive IIV this year. Includes only 9-17 year olds (unless shortages of LAIV encountered). Prior history includes vaccine failures, vaccinated/uninfected and unvaccinated/uninfected last year. PBMC available for those who were infected last year, only 9-17 year olds.
intervention type: Biological
intervention name: LAIV
description: Licensed and approved Live Attenuated Influenza Vaccination (LAIV) will be preferentially given to all children aged 5-8 years old as recommended by Advisory Committee on Immunization Practices. A modified randomization scheme in which every other child aged 9-17 years enrolled in the study will be given LAIV will be used. The rest of the children aged 9-17 years old will receive IIV.
arm group label: LAIV 2014-15
other name: FluMist
intervention type: Biological
intervention name: IIV
description: A modified randomization scheme in which every other child aged 9-17 years enrolled in the study will be given IIV will be used. The rest of the children 9-17 years old will receive LAIV.
[Note: Although we do not anticipate exhausting the supply of LAIV, should this occur, children aged 5-8 will be offered IIV as it is also approved in this age group and should be used if LAIV is unavailable.]
arm group label: IIV 2014-15
other name: FluZone
criteria: 
gender: All
minimum age: 5 Years
maximum age: 17 Years
healthy volunteers: No
last name: Edward A Belongia, MD
role: Principal Investigator
affiliation: Marshfield Clinic Research Foundation - Center for Clinical Epidemiology & Population Health
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Marshfield Clinic Research Foundation
investigator full name: Edward Belongia
investigator title: Director of Center for Clinical Epidemiology and Population Health
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Virus Diseases
mesh term: Influenza, Human
mesh term: Herpesviridae Infections
sharing ipd: No
ipd description: There is a plan to publish the results of the study in a manuscript but no plans to release individual level data as the results are not clinically actionable.
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 