<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/NCT03023709</url>
  </required_header>
  <id_info>
    <org_study_id>SU-33722</org_study_id>
    <secondary_id>2U19AI057229-11</secondary_id>
    <nct_id>NCT03023709</nct_id>
  </id_info>
  <brief_title>Tissue-specific Responses to Influenza Immunization and Their Relation to Blood Biomarkers (SLVP032)</brief_title>
  <official_title>Tissue-specific Responses to Influenza Immunization and Their Relation to Blood Biomarkers. U19-HIPC Vaccination and Infection: Indicators of Immunological Health and Responsiveness</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 investigators collected blood and lymphoid tissues routinely discarded during surgery&#xD;
      from adults after a routine seasonal influenza vaccination to determine how immune memory&#xD;
      develops at the actual site of infection, and how immunization may alter this process.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a Phase IV study of licensed influenza vaccines with up to 30 male and female adults,&#xD;
      18-49 years of age that was halted due to the recommendation that live, attenuated influenza&#xD;
      vaccine (LAIV) not be used as a seasonal flu vaccine. Volunteers were patients undergoing&#xD;
      tonsillectomy for treatment of obstructive sleep apnea (OSA).&#xD;
&#xD;
      In the initial pilot phase of the study, up to 3 volunteers will be enrolled and will receive&#xD;
      the current seasonal quadrivalent, inactivated influenza vaccine (IIV4) given intramuscularly&#xD;
      to confirm the safety of administering the seasonal influenza vaccine 3-14 days prior to&#xD;
      tonsillectomy. Enrollment of the remaining study volunteers into the main portion of the&#xD;
      study will begin once the initial pilot phase is completed. All of the remaining study&#xD;
      volunteers will be given the current year's quadrivalent, live, attenuated seasonal influenza&#xD;
      vaccine (LAIV4) intranasally.&#xD;
&#xD;
      The second study visit for all volunteers will occur at the time of the volunteer's&#xD;
      tonsillectomy surgery, 3-14 days after Visit 01. A member of the surgical team will collect a&#xD;
      20 mL blood sample and a sample of the resected tonsil tissue that would otherwise be&#xD;
      discarded to be distributed to the lab.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Due to the ACIP guidelines halting the use of LAIV&#xD;
  </why_stopped>
  <start_date>September 2015</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2015</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>Sequential Assignment</intervention_model>
    <intervention_model_description>3-5 participants will receive quadrivalent inactivated flu (IIV4) vaccine as a pilot study to establish protocols for immune cell isolation. Once the pilot study ends, all new participants will receive live, attenuated influenza vaccine and IIV4 will no longer be utilitzed.</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants Who Received Influenza Vaccine</measure>
    <time_frame>Day 0</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Related Adverse Events</measure>
    <time_frame>Day 0 to 14 post-immunization</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">3</enrollment>
  <condition>Influenza</condition>
  <arm_group>
    <arm_group_label>Pilot phase</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Participants will receive the current seasonal quadrivalent, inactivated influenza vaccine (IIV4)/Fluzone® given intramuscularly to confirm the safety of administering the seasonal influenza vaccine 3-14 days prior to tonsillectomy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Study phase</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Participants will be given the current year's quadrivalent, live, attenuated seasonal influenza vaccine (LAIV4)/FluMist® intranasally 3-14 days prior to tonsillectomy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Fluzone®</intervention_name>
    <description>quadrivalent, inactivated influenza virus vaccine, intramuscular</description>
    <arm_group_label>Pilot phase</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>FluMist®</intervention_name>
    <description>quadrivalent, live, attenuated influenza vaccine, intranasal spray</description>
    <arm_group_label>Study phase</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Generally healthy 18-49 year old male and female patients undergoing tonsillectomy for&#xD;
             obstructive sleep apnea.&#xD;
&#xD;
          2. Willing to complete the informed consent process&#xD;
&#xD;
          3. Availability for follow-up for the planned duration of the study&#xD;
&#xD;
          4. Acceptable medical history by review of inclusion/exclusion criteria&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Prior off-study vaccination with seasonal influenza vaccine within three months of&#xD;
             study vaccination&#xD;
&#xD;
          2. Life-threatening reactions to previous influenza vaccinations&#xD;
&#xD;
          3. Asthma (contraindication for receipt of LAIV4) for study volunteers; not a&#xD;
             contraindication for enrolling as a pilot phase volunteer receiving IIV4.&#xD;
&#xD;
          4. Allergy to egg or egg products or to vaccine components (including gentamicin,&#xD;
             gelatin, arginine or MSG for participants receiving LAIV4).&#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; may include significant liver&#xD;
             disease, diabetes mellitus treated with insulin or moderate to severe renal disease&#xD;
&#xD;
          8. Hospitalization in the past year for congestive heart failure or emphysema.&#xD;
&#xD;
          9. Chronic Hepatitis B or C.&#xD;
&#xD;
         10. Recent or current use of immunosuppressive medication, including systemic&#xD;
             glucocorticoids (corticosteroid nasal sprays and topical steroids are permissible).&#xD;
             Use of oral steroids (&lt;20mg prednisone-equivalent/day) may be acceptable after review&#xD;
             by the investigator.&#xD;
&#xD;
         11. Participants who care for severely immunosuppressed persons that require a protective&#xD;
             environment should not receive LAIV, or should avoid contact with such persons for 7&#xD;
             days after receipt, given the theoretical risk for transmission of the live attenuated&#xD;
             vaccine virus to close contacts. [If yes, may be ineligible]&#xD;
&#xD;
         12. 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;
         13. 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 protocol.&#xD;
&#xD;
         14. History of blood dyscrasias, renal disease, or hemoglobinopathies requiring regular&#xD;
             medical follow up or hospitalization during the preceding year&#xD;
&#xD;
         15. 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 will be&#xD;
             reviewed by investigators to determine if study participation would affect the&#xD;
             volunteer's safety or compliance with the protocol.&#xD;
&#xD;
         16. Has taken an influenza antiviral medication within 48 hours prior to study vaccination&#xD;
             [For volunteers receiving LAIV; If yes, may not eligible if unable to schedule at an&#xD;
             appropriate interval].&#xD;
&#xD;
         17. Receipt of blood or blood products within the past 6 months or planned use 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 an inactivated vaccine 14 days prior to study enrollment, or planned&#xD;
             vaccinations prior to completion of last study visit (~ 14 days after study&#xD;
             vaccination)&#xD;
&#xD;
         20. Receipt of a live, attenuated vaccine within 60 days prior to enrollment of planned&#xD;
             vaccination prior to completion of last study visit (~ 14 days after study enrollment)&#xD;
&#xD;
         21. Need for allergy immunization (that cannot be postponed) until after the last study&#xD;
             visit.&#xD;
&#xD;
         22. History of Guillain-Barré syndrome&#xD;
&#xD;
         23. Pregnant woman;&#xD;
&#xD;
         24. Breastfeeding woman [if volunteer will receive LAIV4]&#xD;
&#xD;
         25. Use of investigational agents within 30 days prior to enrollment or planned use during&#xD;
             the study.&#xD;
&#xD;
         26. Donation of the equivalent of a unit of blood within 6 weeks prior to enrollment or&#xD;
             donation of platelets within 2 weeks of enrollment or planned donation prior to&#xD;
             completion of the last visit.&#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>18 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>Mark Davis, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford University</affiliation>
  </overall_official>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>January 13, 2017</study_first_submitted>
  <study_first_submitted_qc>January 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 18, 2017</study_first_posted>
  <results_first_submitted>January 19, 2017</results_first_submitted>
  <results_first_submitted_qc>March 30, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">May 10, 2017</results_first_posted>
  <last_update_submitted>March 30, 2017</last_update_submitted>
  <last_update_submitted_qc>March 30, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 10, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stanford University</investigator_affiliation>
    <investigator_full_name>Cornelia L. Dekker</investigator_full_name>
    <investigator_title>Professor, Pediatrics</investigator_title>
  </responsible_party>
  <keyword>Quadrivalent inactivated influenza vaccine</keyword>
  <keyword>Quadrivalent live, attenuated influenza vaccine</keyword>
  <keyword>Adults with obstructive sleep apnea</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>
      <recruitment_details>The study was halted after the IIV pilot phase because the LAIV vaccine for the study phase was not recommended for use by ACIP so no participants enrolled in the LAIV study phase.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Pilot Phase (IIV4)</title>
          <description>Participants will receive the seasonal quadrivalent, inactivated influenza vaccine (IIV4), Fluzone®, given intramuscularly to confirm the safety of administering licensed seasonal influenza vaccine 3-14 days prior to tonsillectomy.&#xD;
Fluzone®: quadrivalent, inactivated influenza virus vaccine, intramuscular</description>
        </group>
        <group group_id="P2">
          <title>Study Phase (LAIV4)</title>
          <description>Participants will be given the quadrivalent, live, attenuated seasonal influenza vaccine (LAIV4), FluMist®, intranasally 3-14 days prior to tonsillectomy.&#xD;
FluMist®: quadrivalent, live, attenuated influenza vaccine, 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="3"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="0"/>
              </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_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Pilot Phase (IIV4)</title>
          <description>Participants will receive the seasonal quadrivalent, inactivated influenza vaccine (IIV4), Fluzone®, given intramuscularly to confirm the safety of administering the seasonal influenza vaccine 3-14 days prior to tonsillectomy.&#xD;
Fluzone®: quadrivalent, inactivated influenza virus vaccine, intramuscular</description>
        </group>
        <group group_id="B2">
          <title>Study Phase (LAIV4)</title>
          <description>Participants will be given quadrivalent, live, attenuated seasonal influenza vaccine (LAIV4), FluMist®, intranasally 3-14 days prior to tonsillectomy.&#xD;
FluMist®: quadrivalent, live, attenuated influenza vaccine, 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="3"/>
            <count group_id="B2" value="0"/>
            <count group_id="B3" value="3"/>
          </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="32" spread="7.93"/>
                    <measurement group_id="B3" value="32" spread="7.93"/>
                  </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="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" 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="B1" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" 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="B1" value="3"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Who Received Influenza Vaccine</title>
        <time_frame>Day 0</time_frame>
        <population>Study halted after Pilot Phase</population>
        <group_list>
          <group group_id="O1">
            <title>Pilot Phase</title>
            <description>Participants will receive the current seasonal quadrivalent, inactivated influenza vaccine (IIV4)/Fluzone® given intramuscularly to confirm the safety of administering the seasonal influenza vaccine 3-14 days prior to tonsillectomy.&#xD;
Fluzone®: quadrivalent, inactivated influenza virus vaccine, intramuscular</description>
          </group>
          <group group_id="O2">
            <title>Study Phase</title>
            <description>Participants will be given the current year's quadrivalent, live, attenuated seasonal influenza vaccine (LAIV4)/FluMist® intranasally 3-14 days prior to tonsillectomy.&#xD;
FluMist®: quadrivalent, live, attenuated influenza vaccine, intranasal spray</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Who Received Influenza Vaccine</title>
          <population>Study halted after Pilot Phase</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="3"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Related Adverse Events</title>
        <time_frame>Day 0 to 14 post-immunization</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Pilot Phase (IIV4)</title>
            <description>Participants will receive the current seasonal quadrivalent, inactivated influenza vaccine (IIV4)/Fluzone® given intramuscularly to confirm the safety of administering the seasonal influenza vaccine 3-14 days prior to tonsillectomy.&#xD;
Fluzone®: quadrivalent, inactivated influenza virus vaccine, intramuscular</description>
          </group>
          <group group_id="O2">
            <title>Study Phase (LAIV4)</title>
            <description>Participants will be given the current year's quadrivalent, live, attenuated seasonal influenza vaccine (LAIV4)/FluMist® intranasally 3-14 days prior to tonsillectomy.&#xD;
FluMist®: quadrivalent, live, attenuated influenza vaccine, 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="3"/>
                <count group_id="O2" value="0"/>
              </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>14 days</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Pilot Phase (IIV4)</title>
          <description>Participants will receive the current seasonal quadrivalent, inactivated influenza vaccine (IIV4)/Fluzone® given intramuscularly to confirm the safety of administering the seasonal influenza vaccine 3-14 days prior to tonsillectomy.&#xD;
Fluzone®: quadrivalent, inactivated influenza virus vaccine, intramuscular</description>
        </group>
        <group group_id="E2">
          <title>Study Phase (LAIV4)</title>
          <description>Participants will be given the current year's quadrivalent, live, attenuated seasonal influenza vaccine (LAIV4)/FluMist® intranasally 3-14 days prior to tonsillectomy.&#xD;
FluMist®: quadrivalent, live, attenuated influenza vaccine, intranasal spray</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="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </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="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </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/NCT03023709
org study id: SU-33722
secondary id: 2U19AI057229-11
nct id: NCT03023709
lead sponsor: 
collaborator: 
has dmc: No
The investigators collected blood and lymphoid tissues routinely discarded during surgery
      from adults after a routine seasonal influenza vaccination to determine how immune memory
      develops at the actual site of infection, and how immunization may alter this process.
This is a Phase IV study of licensed influenza vaccines with up to 30 male and female adults,
      18-49 years of age that was halted due to the recommendation that live, attenuated influenza
      vaccine (LAIV) not be used as a seasonal flu vaccine. Volunteers were patients undergoing
      tonsillectomy for treatment of obstructive sleep apnea (OSA).

      In the initial pilot phase of the study, up to 3 volunteers will be enrolled and will receive
      the current seasonal quadrivalent, inactivated influenza vaccine (IIV4) given intramuscularly
      to confirm the safety of administering the seasonal influenza vaccine 3-14 days prior to
      tonsillectomy. Enrollment of the remaining study volunteers into the main portion of the
      study will begin once the initial pilot phase is completed. All of the remaining study
      volunteers will be given the current year's quadrivalent, live, attenuated seasonal influenza
      vaccine (LAIV4) intranasally.

      The second study visit for all volunteers will occur at the time of the volunteer's
      tonsillectomy surgery, 3-14 days after Visit 01. A member of the surgical team will collect a
      20 mL blood sample and a sample of the resected tonsil tissue that would otherwise be
      discarded to be distributed to the lab.
allocation: Non-Randomized
intervention model: Sequential Assignment
intervention model description: 3-5 participants will receive quadrivalent inactivated flu (IIV4) vaccine as a pilot study to establish protocols for immune cell isolation. Once the pilot study ends, all new participants will receive live, attenuated influenza vaccine and IIV4 will no longer be utilitzed.
primary purpose: Basic Science
masking: None (Open Label)
measure: Number of Participants Who Received Influenza Vaccine
time frame: Day 0
measure: Number of Participants With Related Adverse Events
time frame: Day 0 to 14 post-immunization
arm group label: Pilot phase
arm group type: Other
description: Participants will receive the current seasonal quadrivalent, inactivated influenza vaccine (IIV4)/Fluzone® given intramuscularly to confirm the safety of administering the seasonal influenza vaccine 3-14 days prior to tonsillectomy.
arm group label: Study phase
arm group type: Other
description: Participants will be given the current year's quadrivalent, live, attenuated seasonal influenza vaccine (LAIV4)/FluMist® intranasally 3-14 days prior to tonsillectomy.
intervention type: Biological
intervention name: Fluzone®
description: quadrivalent, inactivated influenza virus vaccine, intramuscular
arm group label: Pilot phase
intervention type: Biological
intervention name: FluMist®
description: quadrivalent, live, attenuated influenza vaccine, intranasal spray
arm group label: Study phase
criteria: 
gender: All
minimum age: 18 Years
maximum age: 49 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Cornelia Dekker, MD
role: Principal Investigator
affiliation: Stanford University
last name: Mark Davis, PhD
role: Principal Investigator
affiliation: Stanford University
responsible party type: Principal Investigator
investigator affiliation: Stanford University
investigator full name: Cornelia L. Dekker
investigator title: Professor, Pediatrics
mesh term: Influenza, Human
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 