<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/NCT03020537</url>
  </required_header>
  <id_info>
    <org_study_id>SU-17218-2013</org_study_id>
    <secondary_id>2U19AI057229-06</secondary_id>
    <nct_id>NCT03020537</nct_id>
  </id_info>
  <brief_title>B-cell Immunity to Influenza (SLVP017)- Year 5, 2013</brief_title>
  <official_title>U19 Influenza Immunity: 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- Year 5, 2013</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 vaccines given to identical twins and&#xD;
      vaccine-naive young adults.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a study of healthy children and adults who will be given standard seasonal influenza&#xD;
      vaccination (IIV3). There are no exclusions for gender, ethnicity or race. Following review&#xD;
      and confirmation of written informed consent, volunteers will be enrolled into the study.&#xD;
&#xD;
      The 1-2 year-old child volunteers enrolled in Group A cannot have been previously immunized&#xD;
      with an influenza vaccine. They will receive two single doses of the 2013-2014 pediatric&#xD;
      formulation of seasonal trivalent inactivated influenza vaccine (IIV3), at least 28 days&#xD;
      apart, given by intramuscular (IM) injection. The child volunteers will complete 4 clinic&#xD;
      visits with 3 blood sample collections. Study visits will be on Day 0 (first immunization),&#xD;
      Day 28-32 (second immunization), Day 6-8 post-Dose 2, and Day 28+4 post-Dose 2. The baseline&#xD;
      blood sample will be drawn prior to immunization at Day 0, followed by two additional blood&#xD;
      samples at Day 6-8 post-Dose 2, and Day 28+4 post-Dose 2. There will not be a blood sample&#xD;
      collected at Day 28-32.&#xD;
&#xD;
      The 18-30 year-old young adults in Group B cannot have been immunized with the 2012-2013&#xD;
      seasonal influenza vaccine. Participants in Group B will receive a single dose of the&#xD;
      2013-2014 IIV3 by IM injection. Young adult volunteers will complete 3 clinic visits with 3&#xD;
      blood sample collections on Day 0, Day 6-8, and Day 28+4. The baseline blood sample will be&#xD;
      drawn prior to immunization at Day 0.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2013</start_date>
  <completion_date type="Actual">December 2013</completion_date>
  <primary_completion_date type="Actual">December 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 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">8</enrollment>
  <condition>Influenza</condition>
  <arm_group>
    <arm_group_label>Group A: 1-2 years old</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Group A: 1-2 years old, seasonal influenza vaccine-naive. Given intramuscular,inactivated influenza vaccine-trivalent (IM IIV3) - Fluzone (pediatric formulation).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B: 18-30 years old</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Group B: 18-30 years old, who did not receive the 20l2-2013 seasonal influenza vaccine. Given intramuscular,inactivated influenza vaccine-trivalent (IM IIV3) - Fluzone.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Fluzone</intervention_name>
    <description>Fluzone (Influenza Virus Vaccine) Suspension for Intramuscular Injection 2013-2014 Formula.</description>
    <arm_group_label>Group A: 1-2 years old</arm_group_label>
    <arm_group_label>Group B: 18-30 years old</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy, ambulatory children 1-2 years of age or 18-30 year-old young 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 (after last study&#xD;
             immunization, approximately 8 weeks for Group A and 4 weeks for Group B).&#xD;
&#xD;
          4. Acceptable medical history by medical history and vital signs.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Group A: Prior vaccination with a seasonal flu vaccine (IIV). Group B: Prior&#xD;
             vaccination with the 2012-2013 seasonal flu vaccine (IIV or LAIV).&#xD;
&#xD;
          2. Prior off-study vaccination with the current 2013-2014 seasonal IIV 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. 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. Chronic Hepatitis B or C.&#xD;
&#xD;
          9. Recent or current use of immunosuppressive medication, including systemic&#xD;
             glucocorticoids (corticosteroid nasal sprays and topical steroids are permissible; use&#xD;
             of inhaled steroids, or oral steroids (&lt;20mg prednisone-equivalent/day), may be&#xD;
             acceptable after review by the investigator.&#xD;
&#xD;
         10. 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;
         11. 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;
         12. History of blood dyscrasias, renal disease, or hemoglobinopathies requiring regular&#xD;
             medical follow up or hospitalization during the preceding year&#xD;
&#xD;
         13. 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;
         14. Receipt of blood or blood products within the past 6 months&#xD;
&#xD;
         15. Medical or psychiatric condition or occupational responsibilities that preclude&#xD;
             participant compliance with the protocol&#xD;
&#xD;
         16. Inactivated vaccine within 14 days prior to study vaccination (inform study staff of&#xD;
             any non-study vaccinations received during study period)&#xD;
&#xD;
         17. Live, attenuated vaccine within 30 days prior to first study vaccination, or planned&#xD;
             immunization with a live, attenuated vaccine before completion of study visits (inform&#xD;
             study staff of any non-study vaccinations received during study period).&#xD;
&#xD;
         18. Need for allergy immunizations (that cannot be rescheduled if necessary) during the&#xD;
             study period&#xD;
&#xD;
         19. History of Guillain-Barre Syndrome&#xD;
&#xD;
         20. Pregnant or lactating woman&#xD;
&#xD;
         21. 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;
         22. Donation of the equivalent of a unit of blood within 6 weeks prior to enrollment&#xD;
&#xD;
         23. 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>1 Year</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>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>Le Gars M, Kay AW, Bayless NL, Aziz N, Dekker CL, Swan GE, Davis MM, Blish CA. Increased Proinflammatory Responses of Monocytes and Plasmacytoid Dendritic Cells to Influenza A Virus Infection During Pregnancy. J Infect Dis. 2016 Dec 1;214(11):1666-1671. doi: 10.1093/infdis/jiw448. Epub 2016 Sep 21.</citation>
    <PMID>27655870</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>Trivalent inactivated influenza vaccine</keyword>
  <keyword>Young children</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>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Group A: 1 - 2 Years Old</title>
          <description>Group A: 1-2 years old, seasonal influenza vaccine-naive. Given intramuscular,inactivated influenza vaccine-trivalent (IM IIV3) - Fluzone (pediatric formulation).&#xD;
Fluzone: Fluzone (Influenza Virus Vaccine) Suspension for Intramuscular Injection 2013-2014 Formula.</description>
        </group>
        <group group_id="P2">
          <title>Group B: 18-30 Years Old</title>
          <description>Group B: 18-30 years old, who did not receive the 20l2-2013 seasonal influenza vaccine. Given intramuscular,inactivated influenza vaccine-trivalent (IM IIV3) - Fluzone.&#xD;
Fluzone: Fluzone (Influenza Virus Vaccine) Suspension for Intramuscular Injection 2013-2014 Formula.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="7"/>
              </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>Group A: 1 - 2 Years Old</title>
          <description>Group A: 1-2 years old, seasonal influenza vaccine-naive. Given intramuscular,inactivated influenza vaccine-trivalent (IM IIV3) - Fluzone (pediatric formulation).&#xD;
Fluzone: Fluzone (Influenza Virus Vaccine) Suspension for Intramuscular Injection 2013-2014 Formula.</description>
        </group>
        <group group_id="B2">
          <title>Group B: 18-30 Years Old</title>
          <description>Group B: 18-30 years old, who did not receive the 20l2-2013 seasonal influenza vaccine. Given intramuscular,inactivated influenza vaccine-trivalent (IM IIV3) - Fluzone.&#xD;
Fluzone: Fluzone (Influenza Virus Vaccine) Suspension for Intramuscular Injection 2013-2014 Formula.</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="1"/>
            <count group_id="B2" value="7"/>
            <count group_id="B3" value="8"/>
          </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="1.128" spread="0"/>
                    <measurement group_id="B2" value="27.29" spread="4.066"/>
                    <measurement group_id="B3" value="24.025" spread="9.98"/>
                  </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="6"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" 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="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</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>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="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="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="0"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </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="1"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="8"/>
                  </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: 1 - 2 Years Old</title>
            <description>Group A: 1-2 years old, seasonal influenza vaccine-naive. Given intramuscular,inactivated influenza vaccine-trivalent (IM IIV3) - Fluzone (pediatric formulation).&#xD;
Fluzone: Fluzone (Influenza Virus Vaccine) Suspension for Intramuscular Injection 2013-2014 Formula.</description>
          </group>
          <group group_id="O2">
            <title>Group B: 18-30 Years Old</title>
            <description>Group B: 18-30 years old, who did not receive the 20l2-2013 seasonal influenza vaccine. Given intramuscular,inactivated influenza vaccine-trivalent (IM IIV3) - Fluzone.&#xD;
Fluzone: Fluzone (Influenza Virus Vaccine) Suspension for Intramuscular Injection 2013-2014 Formula.</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="1"/>
                <count group_id="O2" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="7"/>
                  </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: 1 - 2 Years Old</title>
            <description>Group A: 1-2 years old, seasonal influenza vaccine-naive. Given intramuscular,inactivated influenza vaccine-trivalent (IM IIV3) - Fluzone (pediatric formulation).&#xD;
Fluzone: Fluzone (Influenza Virus Vaccine) Suspension for Intramuscular Injection 2013-2014 Formula.</description>
          </group>
          <group group_id="O2">
            <title>Group B: 18-30 Years Old</title>
            <description>Group B: 18-30 years old, who did not receive the 20l2-2013 seasonal influenza vaccine. Given intramuscular,inactivated influenza vaccine-trivalent (IM IIV3) - Fluzone.&#xD;
Fluzone: Fluzone (Influenza Virus Vaccine) Suspension for Intramuscular Injection 2013-2014 Formula.</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="1"/>
                <count group_id="O2" value="7"/>
              </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_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Day 0 to 28 of study participation</time_frame>
      <desc>Clinical Assessment performed at each visit</desc>
      <group_list>
        <group group_id="E1">
          <title>Group A: 1 - 2 Years Old</title>
          <description>Group A: 1-2 years old, seasonal influenza vaccine-naive. Given intramuscular,inactivated influenza vaccine-trivalent (IM IIV3) - Fluzone (pediatric formulation).&#xD;
Fluzone: Fluzone (Influenza Virus Vaccine) Suspension for Intramuscular Injection 2013-2014 Formula.</description>
        </group>
        <group group_id="E2">
          <title>Group B: 18-30 Years Old</title>
          <description>Group B: 18-30 years old, who did not receive the 20l2-2013 seasonal influenza vaccine. Given intramuscular,inactivated influenza vaccine-trivalent (IM IIV3) - Fluzone.&#xD;
Fluzone: Fluzone (Influenza Virus Vaccine) Suspension for Intramuscular Injection 2013-2014 Formula.</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="1"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="7"/>
              </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="1"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="7"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Erythema at vaccination site 0.5 cm</sub_title>
                <description>Erythema at vaccination site after dose 2</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </event>
              <event>
                <sub_title>Mild Pruritus at Vaccination site Right Deltoid</sub_title>
                <description>Mild Pruritus at Vaccination site Right Deltoid</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="1"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="7"/>
              </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/NCT03020537
org study id: SU-17218-2013
secondary id: 2U19AI057229-06
nct id: NCT03020537
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 vaccines given to identical twins and
      vaccine-naive young adults.
This is a study of healthy children and adults who will be given standard seasonal influenza
      vaccination (IIV3). There are no exclusions for gender, ethnicity or race. Following review
      and confirmation of written informed consent, volunteers will be enrolled into the study.

      The 1-2 year-old child volunteers enrolled in Group A cannot have been previously immunized
      with an influenza vaccine. They will receive two single doses of the 2013-2014 pediatric
      formulation of seasonal trivalent inactivated influenza vaccine (IIV3), at least 28 days
      apart, given by intramuscular (IM) injection. The child volunteers will complete 4 clinic
      visits with 3 blood sample collections. Study visits will be on Day 0 (first immunization),
      Day 28-32 (second immunization), Day 6-8 post-Dose 2, and Day 28+4 post-Dose 2. The baseline
      blood sample will be drawn prior to immunization at Day 0, followed by two additional blood
      samples at Day 6-8 post-Dose 2, and Day 28+4 post-Dose 2. There will not be a blood sample
      collected at Day 28-32.

      The 18-30 year-old young adults in Group B cannot have been immunized with the 2012-2013
      seasonal influenza vaccine. Participants in Group B will receive a single dose of the
      2013-2014 IIV3 by IM injection. Young adult volunteers will complete 3 clinic visits with 3
      blood sample collections on Day 0, Day 6-8, and Day 28+4. The baseline blood sample will be
      drawn prior to immunization at Day 0.
allocation: Non-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
arm group label: Group A: 1-2 years old
arm group type: Other
description: Group A: 1-2 years old, seasonal influenza vaccine-naive. Given intramuscular,inactivated influenza vaccine-trivalent (IM IIV3) - Fluzone (pediatric formulation).
arm group label: Group B: 18-30 years old
arm group type: Other
description: Group B: 18-30 years old, who did not receive the 20l2-2013 seasonal influenza vaccine. Given intramuscular,inactivated influenza vaccine-trivalent (IM IIV3) - Fluzone.
intervention type: Biological
intervention name: Fluzone
description: Fluzone (Influenza Virus Vaccine) Suspension for Intramuscular Injection 2013-2014 Formula.
arm group label: Group A: 1-2 years old
arm group label: Group B: 18-30 years old
criteria: 
gender: All
minimum age: 1 Year
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: Stephen Quake, PhD
role: Principal Investigator
affiliation: Stanford University
last name: Xiaosong He, PhD
role: Principal Investigator
affiliation: Stanford University
citation: Le Gars M, Kay AW, Bayless NL, Aziz N, Dekker CL, Swan GE, Davis MM, Blish CA. Increased Proinflammatory Responses of Monocytes and Plasmacytoid Dendritic Cells to Influenza A Virus Infection During Pregnancy. J Infect Dis. 2016 Dec 1;214(11):1666-1671. doi: 10.1093/infdis/jiw448. Epub 2016 Sep 21.
PMID: 27655870
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: 