<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/NCT03023553</url>
  </required_header>
  <id_info>
    <org_study_id>SU-25537</org_study_id>
    <secondary_id>U19AI090019</secondary_id>
    <nct_id>NCT03023553</nct_id>
  </id_info>
  <brief_title>The Human Mucosal Immune Responses to Influenza Virus (SLVP026)</brief_title>
  <official_title>The Human Mucosal Immune Responses to Influenza Virus: A Systems Biology Approach. Innate Immune Responses to Influenza Virus in Single Human Nasal Epithelial Cells</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>
      This study will examine the immune responses to the seasonal influenza vaccine in single&#xD;
      cells of the nasal passages when compared with cells in circulating blood.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Using state-of-the-art technology, the investigators hope the information learned from this&#xD;
      study will help identify and describe important factors in the early-stage development of&#xD;
      influenza immunity and possibly lead to the development of more effective vaccines. This&#xD;
      study will be conducted in healthy male and female volunteers 18-30 years of age who received&#xD;
      one of two seasonal influenza vaccine types, intramuscular standard trivalent inactivated&#xD;
      influenza vaccine (TIV) or live, attenuated influenza vaccine (LAIV) given by intranasal&#xD;
      spray.&#xD;
&#xD;
      Participants are divided into two groups. The control group will receive the 2012-2013&#xD;
      formulation of the standard intramuscular trivalent inactivated influenza vaccine (TIV). A&#xD;
      blood sample and nasopharyngeal swab samples (one from each nostril) will be collected at a&#xD;
      single visit, Day 0. For those in the live, attenuated influenza vaccine (LAIV) group, at the&#xD;
      first visit, they will receive a single administration of the 2012-2013 formulation of LAIV.&#xD;
      At the second study visit two days later, they will provide a blood sample and two&#xD;
      nasopharyngeal swab samples (one from each nostril).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">February 2013</completion_date>
  <primary_completion_date type="Actual">February 2013</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">13</enrollment>
  <condition>Influenza</condition>
  <arm_group>
    <arm_group_label>TIV Group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Healthy adult males and females, 18-30 years of age. Immunization with standard trivalent, inactivated influenza vaccine (TIV), Fluzone®.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>LAIV Group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Healthy adult males and females, 18-30 years of age. Immunize with intranasal live, attenuated influenza vaccine (LAIV), FluMist®.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Fluzone®</intervention_name>
    <description>Influenza Virus Vaccine Suspension for Intramuscular Injection</description>
    <arm_group_label>TIV Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>FluMist®</intervention_name>
    <description>Influenza Virus Vaccine Live, Intranasal Spray</description>
    <arm_group_label>LAIV Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Otherwise healthy, ambulatory adult between the ages of 18-30 years&#xD;
&#xD;
          2. Willing to complete the informed consent process.&#xD;
&#xD;
          3. Availability for follow-up at Day 2 (LAIV Group only)&#xD;
&#xD;
          4. Acceptable medical history by review of inclusion/exclusion criteria and vital 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 thimerosal (TIV&#xD;
             multidose vials only), or gentamicin, gelatin, arginine or MSG (for LAIV only).&#xD;
&#xD;
          3. Life-threatening reactions to previous influenza vaccinations&#xD;
&#xD;
          4. Asthma or history of wheezing (except for controls in the study who will be assigned&#xD;
             to receive TIV).&#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 first study visit&#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 for allergies and topical steroids are&#xD;
             permissible. Inhaled steroids for conditions such as asthma are not permissible for&#xD;
             volunteers in the LAIV group.&#xD;
&#xD;
         12. Participants in close contact with anyone who has a severely weakened immune system&#xD;
             should not receive LAIV (LAIV Group only).&#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. aspirin per day), Plavix, or Aggrenox&#xD;
             must be reviewed by investigator to determine if this would affect the volunteer's&#xD;
             safety..&#xD;
&#xD;
         17. Receipt of blood or blood products within the past 6 months of 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. Inactivated vaccine 14 days prior to vaccination or planned non-study vaccination&#xD;
             prior to completion of the last study visit.&#xD;
&#xD;
         20. Live, attenuated vaccine within 60 days of vaccination or planned non-study&#xD;
             vaccination prior to completion of the last study visit.&#xD;
&#xD;
         21. History of Guillain-Barré Syndrome&#xD;
&#xD;
         22. Pregnant or lactating woman&#xD;
&#xD;
         23. Use of investigational agents within 30 days prior to enrollment or planned use of&#xD;
             investigational agents prior to completion of study visits.&#xD;
&#xD;
         24. 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;
         25. 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>30 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 Universityh</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 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>March 27, 2017</last_update_submitted>
  <last_update_submitted_qc>March 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 21, 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>Trivalent, inactivated influenza vaccine</keyword>
  <keyword>Live, attenuated influenza vaccine</keyword>
  <keyword>Nasopharyngeal swabs</keyword>
  <keyword>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>Yes</sharing_ipd>
    <ipd_description>The NIH Human Immunology Project Consortium (HIPC) data repositories (ImmPORT) may store the results of the research assays results. Genetic data that is developed in this study may be made available to other researchers through the National Center for Biotechnology Information (NCBI) databases. Results from research assays will be labeled with a unique identification code and the volunteer identity (except for age) will not be disclosed.</ipd_description>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>TIV/ Control Group</title>
          <description>Healthy adult males and females, 18-30 years of age. Immunization with standard trivalent, inactivated influenza vaccine (TIV), Fluzone®.&#xD;
Fluzone®: Influenza Virus Vaccine Suspension for Intramuscular Injection</description>
        </group>
        <group group_id="P2">
          <title>LAIV Group</title>
          <description>Healthy adult males and females, 18-30 years of age. Immunize with intranasal live, attenuated influenza vaccine (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="4"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="8"/>
              </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>
      <population>In LAIV Group, 13 subjects initially consented. One subject was determined ineligible due to age. Twelve subjects completed the LAIV Group.</population>
      <group_list>
        <group group_id="B1">
          <title>TIV/ Control Group</title>
          <description>Healthy adult males and females, 18-30 years of age. Immunization with standard trivalent, inactivated influenza vaccine (TIV), Fluzone®.&#xD;
Fluzone®: Influenza Virus Vaccine Suspension for Intramuscular Injection</description>
        </group>
        <group group_id="B2">
          <title>LAIV Group</title>
          <description>Healthy adult males and females, 18-30 years of age. Immunize with intranasal live, attenuated influenza vaccine (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="4"/>
            <count group_id="B2" value="8"/>
            <count group_id="B3" value="12"/>
          </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="23.99" spread="2.955"/>
                    <measurement group_id="B2" value="24.60" spread="5.22"/>
                    <measurement group_id="B3" value="24.40" spread="4.45"/>
                  </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="1"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                  </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="B2" 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="4"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <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="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <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="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <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="B1" value="4"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="12"/>
                  </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>TIV/ Control Group</title>
            <description>Healthy adult males and females, 18-30 years of age. Immunization with standard trivalent, inactivated influenza vaccine (TIV), Fluzone®.&#xD;
Fluzone®: Influenza Virus Vaccine Suspension for Intramuscular Injection</description>
          </group>
          <group group_id="O2">
            <title>LAIV Group</title>
            <description>Healthy adult males and females, 18-30 years of age. Immunize with intranasal live, attenuated influenza vaccine (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="4"/>
                <count group_id="O2" value="9"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="8"/>
                  </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>TIV/ Control Group</title>
            <description>Healthy adult males and females, 18-30 years of age. Immunization with standard trivalent, inactivated influenza vaccine (TIV), Fluzone®.&#xD;
Fluzone®: Influenza Virus Vaccine Suspension for Intramuscular Injection</description>
          </group>
          <group group_id="O2">
            <title>LAIV Group</title>
            <description>Healthy adult males and females, 18-30 years of age. Immunize with intranasal live, attenuated influenza vaccine (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="3"/>
                <count group_id="O2" value="8"/>
              </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>TIV/ Control Group</title>
          <description>Healthy adult males and females, 18-30 years of age. Immunization with standard trivalent, inactivated influenza vaccine (TIV), Fluzone®.&#xD;
Fluzone®: Influenza Virus Vaccine Suspension for Intramuscular Injection</description>
        </group>
        <group group_id="E2">
          <title>LAIV Group</title>
          <description>Healthy adult males and females, 18-30 years of age. Immunize with intranasal live, attenuated influenza vaccine (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="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
              </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="8"/>
              </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/NCT03023553
org study id: SU-25537
secondary id: U19AI090019
nct id: NCT03023553
lead sponsor: 
collaborator: 
has dmc: No
This study will examine the immune responses to the seasonal influenza vaccine in single
      cells of the nasal passages when compared with cells in circulating blood.
Using state-of-the-art technology, the investigators hope the information learned from this
      study will help identify and describe important factors in the early-stage development of
      influenza immunity and possibly lead to the development of more effective vaccines. This
      study will be conducted in healthy male and female volunteers 18-30 years of age who received
      one of two seasonal influenza vaccine types, intramuscular standard trivalent inactivated
      influenza vaccine (TIV) or live, attenuated influenza vaccine (LAIV) given by intranasal
      spray.

      Participants are divided into two groups. The control group will receive the 2012-2013
      formulation of the standard intramuscular trivalent inactivated influenza vaccine (TIV). A
      blood sample and nasopharyngeal swab samples (one from each nostril) will be collected at a
      single visit, Day 0. For those in the live, attenuated influenza vaccine (LAIV) group, at the
      first visit, they will receive a single administration of the 2012-2013 formulation of LAIV.
      At the second study visit two days later, they will provide a blood sample and two
      nasopharyngeal swab samples (one from each nostril).
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: TIV Group
arm group type: Other
description: Healthy adult males and females, 18-30 years of age. Immunization with standard trivalent, inactivated influenza vaccine (TIV), Fluzone®.
arm group label: LAIV Group
arm group type: Other
description: Healthy adult males and females, 18-30 years of age. Immunize with intranasal live, attenuated influenza vaccine (LAIV), FluMist®.
intervention type: Biological
intervention name: Fluzone®
description: Influenza Virus Vaccine Suspension for Intramuscular Injection
arm group label: TIV Group
intervention type: Biological
intervention name: FluMist®
description: Influenza Virus Vaccine Live, Intranasal Spray
arm group label: LAIV Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 30 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 Universityh
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: Yes
ipd description: The NIH Human Immunology Project Consortium (HIPC) data repositories (ImmPORT) may store the results of the research assays results. Genetic data that is developed in this study may be made available to other researchers through the National Center for Biotechnology Information (NCBI) databases. Results from research assays will be labeled with a unique identification code and the volunteer identity (except for age) will not be disclosed.
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 