<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/NCT03023683</url>
  </required_header>
  <id_info>
    <org_study_id>SU-24965</org_study_id>
    <secondary_id>U19AI057229-07</secondary_id>
    <nct_id>NCT03023683</nct_id>
  </id_info>
  <brief_title>Protective Mechanisms Against a Pandemic Respiratory Virus (SLVP024)</brief_title>
  <official_title>U19 Influenza Immunity: Protective Mechanisms Against a Pandemic Respiratory Virus. Project 1: B-cell Immunity to Influenza</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Allergy and Infectious Diseases (NIAID)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Stanford University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to investigate and compare the human immune response in&#xD;
      epithelial cells of the nasopharyngeal mucosa and in blood to live, attenuated influenza&#xD;
      vaccine (LAIV) in adults and in children.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of the protocol is to investigate the human innate and adaptive immune&#xD;
      responses in blood (only for adults) and nasopharyngeal mucosa resident cells to the live,&#xD;
      attenuated influenza vaccine (LAIV) in both adults and children. The investigators hope to&#xD;
      learn how the upper respiratory tract (URT) epithelial cells, the primary target of&#xD;
      respiratory viruses, and the B cells and T cells, two major components of the immune system,&#xD;
      respond to the influenza vaccine.&#xD;
&#xD;
      The volunteers will be enrolled in two age groups:&#xD;
&#xD;
      Group A: Up to 12 healthy non-twin volunteers, 2-8 years old, will be given seasonal LAIV.&#xD;
      Each volunteer will complete a total of 3 visits. Volunteers will be divided in 2 sub-groups&#xD;
      A-1 (n=6) and A-2 (n= 6) in order to collect nasopharyngeal swabs on different schedules (Day&#xD;
      1 or Day 2). Volunteers will be assigned to these sub-groups based on convenience sampling.&#xD;
      Both sub-groups will complete the Day 0 and Day 28 visits and one visit at either Day 1 or&#xD;
      Day 2 post-immunization. Specimens will include nasopharyngeal swabs collected at Day 1 for&#xD;
      Sub-group A1 and Day 2 for Sub-group A-2, and Day 28 for both sub-groups. No blood samples&#xD;
      will be collected in this age group.&#xD;
&#xD;
      Children with no prior influenza vaccine history will receive a second dose of vaccine (LAIV)&#xD;
      at least 28 days after the first study dose, according to the ACIP guidelines.&#xD;
&#xD;
      Group B: Up to 18 healthy non-twin volunteers, 18-49 yrs old, will be given seasonal LAIV&#xD;
      vaccine. Each volunteer will complete a total of 5 visits. Volunteers will be divided into 3&#xD;
      sub-groups B-1, B-2 and B-3 in order to collect nasopharyngeal swabs and blood specimens on&#xD;
      different schedules (Day 0-6 hrs, Day 1 or Day 2). Volunteers will be assigned to these&#xD;
      sub-groups based on convenience sampling. All sub-groups will complete visits at Day -7, Day&#xD;
      0 pre-immunization, Day 7 and Day 28 and 1 additional time point: Sub-group B-1 at Day 0, 6&#xD;
      hours post-immunization, Sub-group B-2 at Day 1 and Sub-group B-3 at Day 2. A nasopharyngeal&#xD;
      swab will be collected at each visit except for Day 0 (baseline) and Day 7. A blood sample&#xD;
      will be collected at each visit except Day -7&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">November 2012</completion_date>
  <primary_completion_date type="Actual">November 2012</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-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>Number of Participants From Each Arm Who Received Influenza Vaccine</measure>
    <time_frame>Day 0 to 28</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Related Adverse Events</measure>
    <time_frame>Day 0 to 28 post-immunization</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Influenza</condition>
  <arm_group>
    <arm_group_label>Group A: 2-8 yo healthy non-twins</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Participants will be given seasonal live, attenuated influenza vaccine (LAIV), FluMist® . Children with no prior influenza vaccine history will receive a second dose of LAIV at least 28 days after the first study dose.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B: 18-49 yo healthy non-twins</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Participants will be given seasonal LAIV, FluMist® .</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>FluMist®</intervention_name>
    <description>Influenza Virus Vaccine Live, Intranasal Spray</description>
    <arm_group_label>Group A: 2-8 yo healthy non-twins</arm_group_label>
    <arm_group_label>Group B: 18-49 yo healthy non-twins</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Otherwise healthy, ambulatory 2-8 years old (Group A) or 18-49 years old (Group B).&#xD;
&#xD;
          2. Willing to complete the informed consent process (including assent for minors 7 years&#xD;
             old and above).&#xD;
&#xD;
          3. Availability for follow-up for the planned duration of the study at least 28 days&#xD;
             after immunization.&#xD;
&#xD;
          4. Acceptable medical history by review of inclusion and exclusion criteria and vital&#xD;
             signs.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Prior off-study vaccination with the current 2012-2013 seasonal TIV or LAIV.&#xD;
&#xD;
          2. Allergy to egg or egg products, or to vaccine components, including gentamicin,&#xD;
             gelatin, arginine or MSG (LAIV)&#xD;
&#xD;
          3. Life-threatening reactions to previous influenza vaccinations&#xD;
&#xD;
          4. Asthma or history of wheezing&#xD;
&#xD;
          5. Active systemic or serious concurrent illness, including febrile illness on the day of&#xD;
             vaccination&#xD;
&#xD;
          6. History of immunodeficiency (including HIV infection)&#xD;
&#xD;
          7. Known or suspected impairment of immunologic function, including, but not limited to,&#xD;
             clinically significant liver disease, diabetes mellitus treated with insulin, moderate&#xD;
             to severe renal disease, or any other chronic disorder which, in the opinion of the&#xD;
             investigator, might jeopardize volunteer safety or compliance with the protocol.&#xD;
&#xD;
          8. Blood pressure &gt;150 systolic or &gt;95 diastolic at the first study visit and on the day&#xD;
             of vaccination.&#xD;
&#xD;
          9. Hospitalization in the past year for congestive heart failure or emphysema.&#xD;
&#xD;
         10. Chronic Hepatitis B or C.&#xD;
&#xD;
         11. Recent or current use of immunosuppressive medication, including systemic&#xD;
             glucocorticoids (corticosteroid nasal sprays and topical steroids are permissible in&#xD;
             all groups; inhaled steroid use is not permissible)&#xD;
&#xD;
         12. Participants in close contact with anyone who has a severely weakened immune system&#xD;
             should not receive LAIV&#xD;
&#xD;
         13. Malignancy, other than squamous cell or basal cell skin cancer (includes solid tumors&#xD;
             such as breast cancer or prostate cancer with recurrence in the past year, and any&#xD;
             hematologic cancer such as leukemia).&#xD;
&#xD;
         14. Autoimmune disease (including rheumatoid arthritis treated with immunosuppressive&#xD;
             medication such as Plaquenil, methotrexate, prednisone, Enbrel) which, in the opinion&#xD;
             of the investigator, might jeopardize volunteer safety or compliance with the&#xD;
             protocol.&#xD;
&#xD;
         15. History of blood dyscrasias, renal disease, or hemoglobinopathies requiring regular&#xD;
             medical follow up or hospitalization during the preceding year&#xD;
&#xD;
         16. Use of any anti-coagulation medication such as Coumadin or Lovenox, or anti-platelet&#xD;
             agents such as aspirin (except up to 325 mg. per day), Plavix, or Aggrenox must be&#xD;
             reviewed by investigator to determine if this would affect the volunteer's safety.&#xD;
&#xD;
         17. Receipt of blood or blood products within the past 6 months or planned used during the&#xD;
             study.&#xD;
&#xD;
         18. Medical or psychiatric condition or occupational responsibilities that preclude&#xD;
             participant compliance with the protocol&#xD;
&#xD;
         19. Receipt of Inactivated vaccine 14 days prior to study enrollment, or planned&#xD;
             vaccinations prior to completion of last visit ( Day ~28 after study vaccination)&#xD;
&#xD;
         20. Receipt of live, attenuated vaccine within 60 days prior to enrollment of planned&#xD;
             vaccination prior to completion of last visit (Day ~28 after study vaccination)&#xD;
&#xD;
         21. Need for allergy immunization (that cannot be postponed) during the study period.&#xD;
&#xD;
         22. History of Guillain-Barré syndrome&#xD;
&#xD;
         23. Pregnant or lactating woman (NA for children in Group A)&#xD;
&#xD;
         24. Use of investigational agents within 30 days prior to enrollment or planned use during&#xD;
             the study.&#xD;
&#xD;
         25. Donation of the equivalent of a unit of blood within 6 weeks prior to enrollment or&#xD;
             planned donation prior to completion of the last visit.&#xD;
&#xD;
         26. A current member of the clinical study team.&#xD;
&#xD;
         27. Any condition which, in the opinion of the investigator, might interfere with&#xD;
             volunteer safety, study objectives or the ability of the participant to understand or&#xD;
             comply with the study protocol.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>49 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cornelia Dekker, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Harry Greenberg, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Xiaosong He, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford University</affiliation>
  </overall_official>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 13, 2017</study_first_submitted>
  <study_first_submitted_qc>January 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 18, 2017</study_first_posted>
  <results_first_submitted>January 18, 2017</results_first_submitted>
  <results_first_submitted_qc>January 18, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">March 9, 2017</results_first_posted>
  <last_update_submitted>September 21, 2021</last_update_submitted>
  <last_update_submitted_qc>September 21, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 18, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stanford University</investigator_affiliation>
    <investigator_full_name>Philip Grant</investigator_full_name>
    <investigator_title>Assistant Professor of Medicine (Infectious Diseases)</investigator_title>
  </responsible_party>
  <keyword>Live, attenuated influenza vaccine</keyword>
  <keyword>Children and young adults</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Influenza, Human</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Group A: 2-8 yo Healthy Non-twins</title>
          <description>Participants will be given seasonal live, attenuated influenza vaccine (LAIV), FluMist® . Children with no prior influenza vaccine history will receive a second dose of LAIV at least 28 days after the first study dose.&#xD;
FluMist®: Influenza Virus Vaccine Live, Intranasal Spray</description>
        </group>
        <group group_id="P2">
          <title>Group B: 18-49 yo Healthy Non-twins</title>
          <description>Participants will be given seasonal LAIV, FluMist® .&#xD;
FluMist®: Influenza Virus Vaccine Live, Intranasal Spray</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="18"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="17"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Group A: 2-8 yo Healthy Non-twins</title>
          <description>Participants will be given seasonal live, attenuated influenza vaccine (LAIV), FluMist® . Children with no prior influenza vaccine history will receive a second dose of LAIV at least 28 days after the first study dose.&#xD;
FluMist®: Influenza Virus Vaccine Live, Intranasal Spray</description>
        </group>
        <group group_id="B2">
          <title>Group B: 18-49 yo Healthy Non-twins</title>
          <description>Participants will be given seasonal LAIV, FluMist® .&#xD;
FluMist®: Influenza Virus Vaccine Live, Intranasal Spray</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="0"/>
            <count group_id="B2" value="18"/>
            <count group_id="B3" value="18"/>
          </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="B2" value="28.07" spread="8.09"/>
                    <measurement group_id="B3" value="28.07" spread="8.09"/>
                  </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="B2" value="7"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </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>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants From Each Arm Who Received Influenza Vaccine</title>
        <time_frame>Day 0 to 28</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group A: 2-8 yo Healthy Non-twins</title>
            <description>Participants will be given seasonal live, attenuated influenza vaccine (LAIV), FluMist® . Children with no prior influenza vaccine history will receive a second dose of LAIV at least 28 days after the first study dose.&#xD;
FluMist®: Influenza Virus Vaccine Live, Intranasal Spray</description>
          </group>
          <group group_id="O2">
            <title>Group B: 18-49 yo Healthy Non-twins</title>
            <description>Participants will be given seasonal LAIV, FluMist® .&#xD;
FluMist®: Influenza Virus Vaccine Live, Intranasal Spray</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants From Each Arm Who Received Influenza Vaccine</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Related Adverse Events</title>
        <time_frame>Day 0 to 28 post-immunization</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group A: 2-8 yo Healthy Non-twins</title>
            <description>Participants will be given seasonal live, attenuated influenza vaccine (LAIV), FluMist® . Children with no prior influenza vaccine history will receive a second dose of LAIV at least 28 days after the first study dose.&#xD;
FluMist®: Influenza Virus Vaccine Live, Intranasal Spray</description>
          </group>
          <group group_id="O2">
            <title>Group B: 18-49 yo Healthy Non-twins</title>
            <description>Participants will be given seasonal LAIV, FluMist® .&#xD;
FluMist®: Influenza Virus Vaccine Live, Intranasal Spray</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Related Adverse Events</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Day 0 to 28</time_frame>
      <desc>Clinical Assessment performed at each visit</desc>
      <group_list>
        <group group_id="E1">
          <title>Group A: 2-8 yo Healthy Non-twins</title>
          <description>Participants will be given seasonal live, attenuated influenza vaccine (LAIV), FluMist® . Children with no prior influenza vaccine history will receive a second dose of LAIV at least 28 days after the first study dose.&#xD;
FluMist®: Influenza Virus Vaccine Live, Intranasal Spray</description>
        </group>
        <group group_id="E2">
          <title>Group B: 18-49 yo Healthy Non-twins</title>
          <description>Participants will be given seasonal LAIV, FluMist® .&#xD;
FluMist®: Influenza Virus Vaccine Live, Intranasal Spray</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="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
              </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="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
              </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>Dr. Cornelia Dekker</name_or_title>
      <organization>Stanford University School of Medicine, Dept. of Pediatrics</organization>
      <phone>650-724-4437</phone>
      <email>cdekker@stanford.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/NCT03023683
org study id: SU-24965
secondary id: U19AI057229-07
nct id: NCT03023683
lead sponsor: 
collaborator: 
has dmc: No
The purpose of the study is to investigate and compare the human immune response in
      epithelial cells of the nasopharyngeal mucosa and in blood to live, attenuated influenza
      vaccine (LAIV) in adults and in children.
The objective of the protocol is to investigate the human innate and adaptive immune
      responses in blood (only for adults) and nasopharyngeal mucosa resident cells to the live,
      attenuated influenza vaccine (LAIV) in both adults and children. The investigators hope to
      learn how the upper respiratory tract (URT) epithelial cells, the primary target of
      respiratory viruses, and the B cells and T cells, two major components of the immune system,
      respond to the influenza vaccine.

      The volunteers will be enrolled in two age groups:

      Group A: Up to 12 healthy non-twin volunteers, 2-8 years old, will be given seasonal LAIV.
      Each volunteer will complete a total of 3 visits. Volunteers will be divided in 2 sub-groups
      A-1 (n=6) and A-2 (n= 6) in order to collect nasopharyngeal swabs on different schedules (Day
      1 or Day 2). Volunteers will be assigned to these sub-groups based on convenience sampling.
      Both sub-groups will complete the Day 0 and Day 28 visits and one visit at either Day 1 or
      Day 2 post-immunization. Specimens will include nasopharyngeal swabs collected at Day 1 for
      Sub-group A1 and Day 2 for Sub-group A-2, and Day 28 for both sub-groups. No blood samples
      will be collected in this age group.

      Children with no prior influenza vaccine history will receive a second dose of vaccine (LAIV)
      at least 28 days after the first study dose, according to the ACIP guidelines.

      Group B: Up to 18 healthy non-twin volunteers, 18-49 yrs old, will be given seasonal LAIV
      vaccine. Each volunteer will complete a total of 5 visits. Volunteers will be divided into 3
      sub-groups B-1, B-2 and B-3 in order to collect nasopharyngeal swabs and blood specimens on
      different schedules (Day 0-6 hrs, Day 1 or Day 2). Volunteers will be assigned to these
      sub-groups based on convenience sampling. All sub-groups will complete visits at Day -7, Day
      0 pre-immunization, Day 7 and Day 28 and 1 additional time point: Sub-group B-1 at Day 0, 6
      hours post-immunization, Sub-group B-2 at Day 1 and Sub-group B-3 at Day 2. A nasopharyngeal
      swab will be collected at each visit except for Day 0 (baseline) and Day 7. A blood sample
      will be collected at each visit except Day -7
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Number of Participants From Each Arm Who Received Influenza Vaccine
time frame: Day 0 to 28
measure: Number of Participants With Related Adverse Events
time frame: Day 0 to 28 post-immunization
arm group label: Group A: 2-8 yo healthy non-twins
arm group type: Other
description: Participants will be given seasonal live, attenuated influenza vaccine (LAIV), FluMist® . Children with no prior influenza vaccine history will receive a second dose of LAIV at least 28 days after the first study dose.
arm group label: Group B: 18-49 yo healthy non-twins
arm group type: Other
description: Participants will be given seasonal LAIV, FluMist® .
intervention type: Biological
intervention name: FluMist®
description: Influenza Virus Vaccine Live, Intranasal Spray
arm group label: Group A: 2-8 yo healthy non-twins
arm group label: Group B: 18-49 yo healthy non-twins
criteria: 
gender: All
minimum age: 2 Years
maximum age: 49 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Cornelia Dekker, MD
role: Principal Investigator
affiliation: Stanford University
last name: Harry Greenberg, MD
role: Principal Investigator
affiliation: Stanford University
last name: Xiaosong He, PhD
role: Principal Investigator
affiliation: Stanford University
responsible party type: Principal Investigator
investigator affiliation: Stanford University
investigator full name: Philip Grant
investigator title: Assistant Professor of Medicine (Infectious Diseases)
mesh term: Influenza, Human
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 