<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/NCT03020498</url>
  </required_header>
  <id_info>
    <org_study_id>SU-17218-2010-2011</org_study_id>
    <secondary_id>2U19AI057229-06</secondary_id>
    <nct_id>NCT03020498</nct_id>
  </id_info>
  <brief_title>B-cell Immunity to Influenza (SLVP017) - Years 2 (2010) &amp; 3 (2011)</brief_title>
  <official_title>Protective Mechanisms Against a Pandemic Respiratory Virus. Project 1: B-cell Immunity to Influenza. Technical Development Project 1: Measuring the Immunome: Genomic Approaches to B-cell Repertoire - Years 2 (2010) &amp; 3 (2011)</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>
      In this exploratory study, investigators will be looking at immune response differences&#xD;
      between age groups and between the two different influenza vaccines given to identical twins,&#xD;
      vaccine-naive young adults and elderly participants.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an exploratory study of healthy children and adults who are given either standard&#xD;
      trivalent, inactivated influenza vaccine (TIV) or live, attenuated influenza vaccine (LAIV).&#xD;
      There are no exclusions for gender, ethnicity or race. Following confirmation of written&#xD;
      informed consent, baseline blood samples will be drawn from all study participants prior to&#xD;
      immunization. The volunteers enrolled in any the three groups (A,B,C) cannot have been&#xD;
      immunized with previous year's seasonal influenza vaccine. The identical twins in Groups A&#xD;
      will be randomized to each receive a different vaccine (TIV or LAIV) than their twin. The&#xD;
      non-twin children in Group B will also be randomly assigned to receive either TIV or LAIV.&#xD;
      Non-twin elderly adults in Group C will be given standard TIV. All participants will receive&#xD;
      a single dose of their assigned influenza vaccine, either by intramuscular (IM) injection&#xD;
      (TIV) or intranasal application (LAIV).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2010</start_date>
  <completion_date type="Actual">December 2011</completion_date>
  <primary_completion_date type="Actual">December 2011</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants 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>
  <other_outcome>
    <measure>Investigate the Effects of Different Influenza Vaccines, Including Live Attenuated Vaccine (LAIV) and Inactivated Vaccine Delivered by Different Routes (Intranasal and IM), on B-cell Responses.</measure>
    <time_frame>Day 0 to 28</time_frame>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">91</enrollment>
  <condition>Influenza</condition>
  <arm_group>
    <arm_group_label>Group A: 8-17 yo identical twins</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Group A: 8-17 year-old identical twin pairs randomly assigned to Fluzone (trivalent, inactivated influenza vaccine (TIV)) or FluMist (live, attenuated influenza vaccine (LAIV)) within the pair</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B: 8-30 yo non-twin</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Group B: 8-30 years old non-twin individuals randomly assigned to Fluzone (trivalent, inactivated influenza vaccine (TIV)) or FluMist (live, attenuated influenza vaccine (LAIV))</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group C: 70-100 yo non-twin</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Group C: 70-100 years old non-twin elderly adults given Fluzone (trivalent, inactivated influenza vaccine (TIV))</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>Group A: 8-17 yo identical twins</arm_group_label>
    <arm_group_label>Group B: 8-30 yo non-twin</arm_group_label>
    <arm_group_label>Group C: 70-100 yo non-twin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>FluMist</intervention_name>
    <description>Influenza Virus Vaccine Live, Intranasal Intranasal Spray</description>
    <arm_group_label>Group A: 8-17 yo identical twins</arm_group_label>
    <arm_group_label>Group B: 8-30 yo non-twin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy, ambulatory 8-17 year old identical twins, 8-30 year old non-twins, or 70-100&#xD;
             year old elderly non-twin adults.&#xD;
&#xD;
          2. Willing to complete the informed consent process.&#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 medical history and vital signs.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Prior vaccination with seasonal TIV or LAIV or H1N1.&#xD;
&#xD;
          2. Prior off-study vaccination with the current seasonal TIV or LAIV&#xD;
&#xD;
          3. Allergy to egg or egg products, or to vaccine components&#xD;
&#xD;
          4. Life-threatening reactions to previous influenza vaccinations&#xD;
&#xD;
          5. Asthma or history of wheezing&#xD;
&#xD;
          6. Active systemic or serious concurrent illness, including febrile illness on the day of&#xD;
             vaccination&#xD;
&#xD;
          7. History of immunodeficiency (including HIV infection)&#xD;
&#xD;
          8. 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;
          9. Blood pressure &gt;150 systolic or &gt;95 diastolic at first study visit&#xD;
&#xD;
         10. Hospitalization in the past year for congestive heart failure or emphysema.&#xD;
&#xD;
         11. Chronic Hepatitis B or C.&#xD;
&#xD;
         12. 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 except for non-LAIV Group C only).&#xD;
             Use of oral steroids (&lt;20mg prednisone-equivalent/day) may be acceptable for&#xD;
             volunteers 70-100 yrs of age after review by the investigator.&#xD;
&#xD;
         13. Participants in close contact with anyone who has a severely weakened immune system&#xD;
             should not receive LAIV (Groups A and B only)&#xD;
&#xD;
         14. 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;
         15. 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;
         16. History of blood dyscrasias, renal disease, or hemoglobinopathies requiring regular&#xD;
             medical follow up or hospitalization during the preceding year&#xD;
&#xD;
         17. 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;
         18. Receipt of blood or blood products within the past 6 months&#xD;
&#xD;
         19. Medical or psychiatric condition or occupational responsibilities that preclude&#xD;
             participant compliance with the protocol&#xD;
&#xD;
         20. Inactivated vaccine 14 days prior to vaccination&#xD;
&#xD;
         21. Live, attenuated vaccine within 60 days of vaccination&#xD;
&#xD;
         22. History of Guillain-Barré Syndrome&#xD;
&#xD;
         23. Pregnant or lactating woman&#xD;
&#xD;
         24. Use of investigational agents within 30 days prior to enrollment&#xD;
&#xD;
         25. Donation of the equivalent of a unit of blood within 6 weeks prior to enrollment&#xD;
&#xD;
         26. 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>8 Years</minimum_age>
    <maximum_age>100 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>Stephen Quake, PhD</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>
  <reference>
    <citation>Sasaki S, Holmes TH, Albrecht RA, Garcia-Sastre A, Dekker CL, He XS, Greenberg HB. Distinct cross-reactive B-cell responses to live attenuated and inactivated influenza vaccines. J Infect Dis. 2014 Sep 15;210(6):865-74. doi: 10.1093/infdis/jiu190. Epub 2014 Mar 27.</citation>
    <PMID>24676204</PMID>
  </reference>
  <reference>
    <citation>He XS, Holmes TH, Sanyal M, Albrecht RA, Garcia-Sastre A, Dekker CL, Davis MM, Greenberg HB. Distinct patterns of B-cell activation and priming by natural influenza virus infection versus inactivated influenza vaccination. J Infect Dis. 2015 Apr 1;211(7):1051-9. doi: 10.1093/infdis/jiu580. Epub 2014 Oct 21.</citation>
    <PMID>25336731</PMID>
  </reference>
  <reference>
    <citation>Brodin P, Jojic V, Gao T, Bhattacharya S, Angel CJ, Furman D, Shen-Orr S, Dekker CL, Swan GE, Butte AJ, Maecker HT, Davis MM. Variation in the human immune system is largely driven by non-heritable influences. Cell. 2015 Jan 15;160(1-2):37-47. doi: 10.1016/j.cell.2014.12.020.</citation>
    <PMID>25594173</PMID>
  </reference>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>January 11, 2017</study_first_submitted>
  <study_first_submitted_qc>January 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 13, 2017</study_first_posted>
  <results_first_submitted>January 13, 2017</results_first_submitted>
  <results_first_submitted_qc>January 13, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">March 9, 2017</results_first_posted>
  <last_update_submitted>May 7, 2018</last_update_submitted>
  <last_update_submitted_qc>May 7, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 6, 2018</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>Study Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Inactivated influenza vaccine</keyword>
  <keyword>Live, attenuated influenza vaccine</keyword>
  <keyword>Child identical twins and non-twins</keyword>
  <keyword>Young and elderly non-twin 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: 8-17 yo Identical Twins</title>
          <description>Group A: 8-17 year-old identical twin pairs randomly assigned to Fluzone (trivalent, inactivated influenza vaccine (TIV)) or FluMist (live, attenuated influenza vaccine (LAIV)) within the pair&#xD;
Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection&#xD;
FluMist: Influenza Virus Vaccine Live, Intranasal Intranasal Spray</description>
        </group>
        <group group_id="P2">
          <title>Group B: 8-30 yo Non-twin</title>
          <description>Group B: 8-30 years old non-twin individuals given Fluzone (trivalent, inactivated influenza vaccine (TIV)) or FluMist (live, attenuated influenza vaccine (LAIV))&#xD;
Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection&#xD;
FluMist: Influenza Virus Vaccine Live, Intranasal Intranasal Spray</description>
        </group>
        <group group_id="P3">
          <title>Group C: 70-100 yo Non-twin</title>
          <description>Group C: 70-100 years old non-twin elderly adults given Fluzone (trivalent, inactivated influenza vaccine (TIV))&#xD;
Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="41"/>
                <participants group_id="P3" count="36"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="38"/>
                <participants group_id="P3" count="36"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Group A: 8-17 yo Identical Twins</title>
          <description>Group A: 8-17 year-old identical twin pairs randomly assigned to Fluzone (trivalent, inactivated influenza vaccine (TIV)) or FluMist (live, attenuated influenza vaccine (LAIV)) within the pair&#xD;
Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection&#xD;
FluMist: Influenza Virus Vaccine Live, Intranasal Intranasal Spray</description>
        </group>
        <group group_id="B2">
          <title>Group B: 8-30 yo Non-twin</title>
          <description>Group B: 8-30 years old non-twin individuals given Fluzone (trivalent, inactivated influenza vaccine (TIV)) or FluMist (live, attenuated influenza vaccine (LAIV))&#xD;
Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection&#xD;
FluMist: Influenza Virus Vaccine Live, Intranasal Intranasal Spray</description>
        </group>
        <group group_id="B3">
          <title>Group C: 70-100 yo Non-twin</title>
          <description>Group C: 70-100 years old non-twin elderly adults given Fluzone (trivalent, inactivated influenza vaccine (TIV))&#xD;
Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection</description>
        </group>
        <group group_id="B4">
          <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="14"/>
            <count group_id="B2" value="41"/>
            <count group_id="B3" value="36"/>
            <count group_id="B4" value="91"/>
          </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="12.84" spread="3.53"/>
                    <measurement group_id="B2" value="21.82" spread="5.32"/>
                    <measurement group_id="B3" value="77.00" spread="5.313"/>
                    <measurement group_id="B4" value="42.27" spread="28.86"/>
                  </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="10"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="21"/>
                    <measurement group_id="B4" value="54"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="15"/>
                    <measurement group_id="B4" value="37"/>
                  </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="2"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="36"/>
                    <measurement group_id="B3" value="36"/>
                    <measurement group_id="B4" value="84"/>
                  </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 group_id="B4" 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 group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="13"/>
                  </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 group_id="B4" 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="2"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="36"/>
                    <measurement group_id="B4" value="70"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" 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="2"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="2"/>
                  </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="14"/>
                    <measurement group_id="B2" value="41"/>
                    <measurement group_id="B3" value="36"/>
                    <measurement group_id="B4" value="91"/>
                  </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 to 28</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Group A: 8-17 yo Identical Twins</title>
            <description>Group A: 8-17 year-old identical twin pairs randomly assigned to Fluzone (trivalent, inactivated influenza vaccine (TIV)) or FluMist (live, attenuated influenza vaccine (LAIV)) within the pair&#xD;
Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection&#xD;
FluMist: Influenza Virus Vaccine Live, Intranasal Intranasal Spray</description>
          </group>
          <group group_id="O2">
            <title>Group B: 8-30 yo Non-twin</title>
            <description>Group B: 8-30 years old non-twin individuals given Fluzone (trivalent, inactivated influenza vaccine (TIV)) or FluMist (live, attenuated influenza vaccine (LAIV))&#xD;
Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection&#xD;
FluMist: Influenza Virus Vaccine Live, Intranasal Intranasal Spray</description>
          </group>
          <group group_id="O3">
            <title>Group C: 70-100 yo Non-twin</title>
            <description>Group C: 70-100 years old non-twin elderly adults given Fluzone (trivalent, inactivated influenza vaccine (TIV))&#xD;
Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants 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="14"/>
                <count group_id="O2" value="41"/>
                <count group_id="O3" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="38"/>
                    <measurement group_id="O3" value="36"/>
                  </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: 8-17 yo Identical Twins</title>
            <description>Group A: 8-17 year-old identical twin pairs randomly assigned to Fluzone (trivalent, inactivated influenza vaccine (TIV)) or FluMist (live, attenuated influenza vaccine (LAIV)) within the pair&#xD;
Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection&#xD;
FluMist: Influenza Virus Vaccine Live, Intranasal Intranasal Spray</description>
          </group>
          <group group_id="O2">
            <title>Group B: 8-30 yo Non-twin</title>
            <description>Group B: 8-30 years old non-twin individuals given Fluzone (trivalent, inactivated influenza vaccine (TIV)) or FluMist (live, attenuated influenza vaccine (LAIV))&#xD;
Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection&#xD;
FluMist: Influenza Virus Vaccine Live, Intranasal Intranasal Spray</description>
          </group>
          <group group_id="O3">
            <title>Group C: 70-100 yo Non-twin</title>
            <description>Group C: 70-100 years old non-twin elderly adults given Fluzone (trivalent, inactivated influenza vaccine (TIV))&#xD;
Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection</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="14"/>
                <count group_id="O2" value="38"/>
                <count group_id="O3" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Investigate the Effects of Different Influenza Vaccines, Including Live Attenuated Vaccine (LAIV) and Inactivated Vaccine Delivered by Different Routes (Intranasal and IM), on B-cell Responses.</title>
        <time_frame>Day 0 to 28</time_frame>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Day 0 to Day 28 of study participation</time_frame>
      <desc>Clinical Assessment performed at each visit</desc>
      <group_list>
        <group group_id="E1">
          <title>Group A: 8-17 yo Identical Twins</title>
          <description>Group A: 8-17 year-old identical twin pairs randomly assigned to Fluzone (trivalent, inactivated influenza vaccine (TIV)) or FluMist (live, attenuated influenza vaccine (LAIV)) within the pair&#xD;
Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection&#xD;
FluMist: Influenza Virus Vaccine Live, Intranasal Intranasal Spray</description>
        </group>
        <group group_id="E2">
          <title>Group B: 8-30 yo Non-twin</title>
          <description>Group B: 8-30 years old non-twin individuals given Fluzone (trivalent, inactivated influenza vaccine (TIV)) or FluMist (live, attenuated influenza vaccine (LAIV))&#xD;
Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection&#xD;
FluMist: Influenza Virus Vaccine Live, Intranasal Intranasal Spray</description>
        </group>
        <group group_id="E3">
          <title>Group C: 70-100 yo Non-twin</title>
          <description>Group C: 70-100 years old non-twin elderly adults given Fluzone (trivalent, inactivated influenza vaccine (TIV))&#xD;
Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection</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="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="36"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Light headedness</sub_title>
                <description>Reported after the blood draw.</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="38"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <description>Reported during blood draw</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="36"/>
              </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/NCT03020498
org study id: SU-17218-2010-2011
secondary id: 2U19AI057229-06
nct id: NCT03020498
lead sponsor: 
collaborator: 
has dmc: No
In this exploratory study, investigators will be looking at immune response differences
      between age groups and between the two different influenza vaccines given to identical twins,
      vaccine-naive young adults and elderly participants.
This is an exploratory study of healthy children and adults who are given either standard
      trivalent, inactivated influenza vaccine (TIV) or live, attenuated influenza vaccine (LAIV).
      There are no exclusions for gender, ethnicity or race. Following confirmation of written
      informed consent, baseline blood samples will be drawn from all study participants prior to
      immunization. The volunteers enrolled in any the three groups (A,B,C) cannot have been
      immunized with previous year's seasonal influenza vaccine. The identical twins in Groups A
      will be randomized to each receive a different vaccine (TIV or LAIV) than their twin. The
      non-twin children in Group B will also be randomly assigned to receive either TIV or LAIV.
      Non-twin elderly adults in Group C will be given standard TIV. All participants will receive
      a single dose of their assigned influenza vaccine, either by intramuscular (IM) injection
      (TIV) or intranasal application (LAIV).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Number of Participants 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
measure: Investigate the Effects of Different Influenza Vaccines, Including Live Attenuated Vaccine (LAIV) and Inactivated Vaccine Delivered by Different Routes (Intranasal and IM), on B-cell Responses.
time frame: Day 0 to 28
arm group label: Group A: 8-17 yo identical twins
arm group type: Other
description: Group A: 8-17 year-old identical twin pairs randomly assigned to Fluzone (trivalent, inactivated influenza vaccine (TIV)) or FluMist (live, attenuated influenza vaccine (LAIV)) within the pair
arm group label: Group B: 8-30 yo non-twin
arm group type: Other
description: Group B: 8-30 years old non-twin individuals randomly assigned to Fluzone (trivalent, inactivated influenza vaccine (TIV)) or FluMist (live, attenuated influenza vaccine (LAIV))
arm group label: Group C: 70-100 yo non-twin
arm group type: Other
description: Group C: 70-100 years old non-twin elderly adults given Fluzone (trivalent, inactivated influenza vaccine (TIV))
intervention type: Biological
intervention name: Fluzone
description: Influenza Virus Vaccine Suspension for Intramuscular Injection
arm group label: Group A: 8-17 yo identical twins
arm group label: Group B: 8-30 yo non-twin
arm group label: Group C: 70-100 yo non-twin
intervention type: Biological
intervention name: FluMist
description: Influenza Virus Vaccine Live, Intranasal Intranasal Spray
arm group label: Group A: 8-17 yo identical twins
arm group label: Group B: 8-30 yo non-twin
criteria: 
gender: All
minimum age: 8 Years
maximum age: 100 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: Stephen Quake, PhD
role: Principal Investigator
affiliation: Stanford University
last name: Xiaosong He, PhD
role: Principal Investigator
affiliation: Stanford University
citation: Sasaki S, Holmes TH, Albrecht RA, Garcia-Sastre A, Dekker CL, He XS, Greenberg HB. Distinct cross-reactive B-cell responses to live attenuated and inactivated influenza vaccines. J Infect Dis. 2014 Sep 15;210(6):865-74. doi: 10.1093/infdis/jiu190. Epub 2014 Mar 27.
PMID: 24676204
citation: He XS, Holmes TH, Sanyal M, Albrecht RA, Garcia-Sastre A, Dekker CL, Davis MM, Greenberg HB. Distinct patterns of B-cell activation and priming by natural influenza virus infection versus inactivated influenza vaccination. J Infect Dis. 2015 Apr 1;211(7):1051-9. doi: 10.1093/infdis/jiu580. Epub 2014 Oct 21.
PMID: 25336731
citation: Brodin P, Jojic V, Gao T, Bhattacharya S, Angel CJ, Furman D, Shen-Orr S, Dekker CL, Swan GE, Butte AJ, Maecker HT, Davis MM. Variation in the human immune system is largely driven by non-heritable influences. Cell. 2015 Jan 15;160(1-2):37-47. doi: 10.1016/j.cell.2014.12.020.
PMID: 25594173
responsible party type: Principal Investigator
investigator affiliation: Stanford University
investigator full name: Cornelia L. Dekker
investigator title: Study Principal Investigator
mesh term: Influenza, Human
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 