<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/NCT03023176</url>
  </required_header>
  <id_info>
    <org_study_id>SU-17219-2013</org_study_id>
    <secondary_id>2U19AI057229-06</secondary_id>
    <nct_id>NCT03023176</nct_id>
  </id_info>
  <brief_title>T-cell And General Immune Response to Seasonal Influenza Vaccine (SLVP018) Year 5, 2013</brief_title>
  <official_title>Protective Mechanisms Against a Pandemic Respiratory Virus: B-cell, T-cell, and General Immune Response to Seasonal Influenza Vaccine. 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>
      This study will investigate markers, mechanisms and define general predictors for&#xD;
      immunological health by comparing influenza vaccine responses in monozygotic and dizygotic&#xD;
      twins.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators plan to study the immune response to different influenza vaccines much more&#xD;
      broadly and deeply across different age groups and with different vaccine modalities and to&#xD;
      probe the influence of genetics on these responses using monozygotic and dizygotic twins. The&#xD;
      investigators plan to compare various immunological responses, identify age-specific&#xD;
      biomarkers or clusters of markers, quantify the frequency of influenza-specific T-cells pre-&#xD;
      and post-vaccination, and determine the effective breadth of T-cell repertoire to an&#xD;
      influenza vaccine within an individual as a function of age and to what degree this is&#xD;
      genetically determined.&#xD;
&#xD;
      The study will be conducted in healthy young identical and fraternal 1-8 year-old twins. All&#xD;
      participants will be immunized with seasonal trivalent inactivated influenza vaccine (IIV3).&#xD;
      Blood samples to conduct the assays described will be taken at pre-immunization, Days 6-8 and&#xD;
      28 post-immunization for children requiring 1 dose of vaccine. For children requiring 2 doses&#xD;
      of vaccine, a second immunization will be given at least 28 days after Dose 1 with responses&#xD;
      measured on Day 6-8 and Day 28-32 post-second immunization.&#xD;
&#xD;
      Children 35 months and under will receive Fluzone® standard IIV3 Pediatric Dose, while&#xD;
      children 36 months and older will receive Fluzone® standard IIV3.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2013</start_date>
  <completion_date type="Actual">November 2013</completion_date>
  <primary_completion_date type="Actual">November 2013</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group 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 32</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Related Adverse Events</measure>
    <time_frame>Day 0 to 32 post-immunization</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Influenza</condition>
  <arm_group>
    <arm_group_label>Healthy 1-8 year-old twins</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Healthy 1-8 yr old identical and fraternal twin pairs given trivalent, inactivated influenza (Fluzone® standard IIV3 0.5ml or Fluzone® standard IIV3 Pediatric Dose) per participant age and standard of care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Fluzone® standard IIV3</intervention_name>
    <description>Influenza Virus Vaccine Suspension (0.5ml) for Intramuscular Injection</description>
    <arm_group_label>Healthy 1-8 year-old twins</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Fluzone® standard IIV3 Pediatric Dose</intervention_name>
    <description>Influenza Virus Vaccine Suspension (0.25ml) for Intramuscular Injection</description>
    <arm_group_label>Healthy 1-8 year-old twins</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Otherwise healthy, twin children age 1-8 years (identical or fraternal twin pairs)&#xD;
&#xD;
          2. Parent willing to sign the informed consent form and child willing to sign assent if&#xD;
             indicated.&#xD;
&#xD;
          3. Availability for follow-up for the planned duration of the study at least 28 days&#xD;
             after last immunization.&#xD;
&#xD;
          4. Acceptable relevant medical history and vital signs.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Prior off-study vaccination with trivalent inactivated influenza vaccine (IIV3) or&#xD;
             live attenuated influenza vaccine (LAIV) in Fall 2013&#xD;
&#xD;
          2. Allergy to egg or egg products, or to vaccine components or thimerosal (if IIV3&#xD;
             multidose vials used)&#xD;
&#xD;
          3. Life-threatening reactions to previous influenza vaccinations&#xD;
&#xD;
          4. Active systemic or serious concurrent illness, including febrile illness on the day of&#xD;
             vaccination&#xD;
&#xD;
          5. History of immunodeficiency (including HIV infection)&#xD;
&#xD;
          6. 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;
          7. Chronic Hepatitis B or C&#xD;
&#xD;
          8. Recent or current use of immunosuppressive medication, including glucocorticoids&#xD;
             (corticosteroid nasal sprays, topical steroids are permissible). History of any&#xD;
             cancer.&#xD;
&#xD;
          9. 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;
         10. History of blood dyscrasias, or hemoglobinopathies requiring regular medical follow up&#xD;
             or hospitalization during the preceding year&#xD;
&#xD;
         11. Use of any anti-coagulation medication such as Coumadin or Lovenox, or anti-platelet&#xD;
             agents such as aspirin.&#xD;
&#xD;
         12. Receipt of blood or blood products within the past 6 months or planned receipt of&#xD;
             blood products prior to completion of study visits.&#xD;
&#xD;
         13. Medical or psychiatric condition or occupational responsibilities that preclude&#xD;
             participant compliance with the protocol&#xD;
&#xD;
         14. Receipt of inactivated vaccine 14 days prior to enrollment, or planned non-study&#xD;
             vaccination prior to completion of Visit 03 or 04 (~Day 28 after the last study&#xD;
             vaccination)&#xD;
&#xD;
         15. Receipt of a live, attenuated vaccine within 30 days prior to first vaccination, or&#xD;
             planned immunization with a live, attenuated vaccine before completion of study visits&#xD;
             (inform study staff of any non-study vaccinations received during the study period).&#xD;
&#xD;
         16. Need for allergy immunization (that cannot be postponed) during the study period.&#xD;
&#xD;
         17. History of Guillain-Barre Syndrome&#xD;
&#xD;
         18. 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;
         19. 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>8 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cornelia Dekker, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mark Davis, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Garry Nolan, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ann Arvin, 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>
  <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>April 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>April 3, 2017</last_update_submitted>
  <last_update_submitted_qc>April 3, 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>Child identical twins</keyword>
  <keyword>Child fraternal twins</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>Healthy 1-8 Year-old Twins</title>
          <description>Healthy 1-8 yr old identical and fraternal twin pairs given trivalent, inactivated influenza (Fluzone® standard IIV3 0.5ml or Fluzone® standard IIV3 Pediatric Dose) per participant age and standard of care.&#xD;
Fluzone® standard IIV3: Influenza Virus Vaccine Suspension (0.5ml) for Intramuscular Injection&#xD;
Fluzone® standard IIV3 Pediatric Dose: Influenza Virus Vaccine Suspension (0.25ml) 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="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Healthy 1-8 Year-old Twins</title>
          <description>Healthy 1-8 yr old identical and fraternal twin pairs given trivalent, inactivated influenza (Fluzone® standard IIV3 0.5ml or Fluzone® standard IIV3 Pediatric Dose) per participant age and standard of care.&#xD;
Fluzone® standard IIV3: Influenza Virus Vaccine Suspension (0.5ml) for Intramuscular Injection&#xD;
Fluzone® standard IIV3 Pediatric Dose: Influenza Virus Vaccine Suspension (0.25ml) for Intramuscular Injection</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="20"/>
          </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="4.06" spread="1.46"/>
                  </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="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </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_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" 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_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" 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="20"/>
                  </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 32</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Healthy 1-8 Year-old Twins</title>
            <description>Healthy 1-8 yr old identical and fraternal twin pairs given trivalent, inactivated influenza (Fluzone® standard IIV3 0.5ml or Fluzone® standard IIV3 Pediatric Dose) per participant age and standard of care.&#xD;
Fluzone® standard IIV3: Influenza Virus Vaccine Suspension (0.5ml) for Intramuscular Injection&#xD;
Fluzone® standard IIV3 Pediatric Dose: Influenza Virus Vaccine Suspension (0.25ml) 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="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                  </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 32 post-immunization</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Healthy 1-8 Year-old Twins</title>
            <description>Healthy 1-8 yr old identical and fraternal twin pairs given trivalent, inactivated influenza (Fluzone® standard IIV3 0.5ml or Fluzone® standard IIV3 Pediatric Dose) per participant age and standard of care.&#xD;
Fluzone® standard IIV3: Influenza Virus Vaccine Suspension (0.5ml) for Intramuscular Injection&#xD;
Fluzone® standard IIV3 Pediatric Dose: Influenza Virus Vaccine Suspension (0.25ml) 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="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Day 0 to 32</time_frame>
      <desc>Clinical Assessment performed at each visit</desc>
      <group_list>
        <group group_id="E1">
          <title>Healthy 1-8 Year-old Twins</title>
          <description>Healthy 1-8 yr old identical and fraternal twin pairs given trivalent, inactivated influenza (Fluzone® standard IIV3 0.5ml or Fluzone® standard IIV3 Pediatric Dose) per participant age and standard of care.&#xD;
Fluzone® standard IIV3: Influenza Virus Vaccine Suspension (0.5ml) for Intramuscular Injection&#xD;
Fluzone® standard IIV3 Pediatric Dose: Influenza Virus Vaccine Suspension (0.25ml) 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="20"/>
              </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="20"/>
              </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/NCT03023176
org study id: SU-17219-2013
secondary id: 2U19AI057229-06
nct id: NCT03023176
lead sponsor: 
collaborator: 
has dmc: No
This study will investigate markers, mechanisms and define general predictors for
      immunological health by comparing influenza vaccine responses in monozygotic and dizygotic
      twins.
The investigators plan to study the immune response to different influenza vaccines much more
      broadly and deeply across different age groups and with different vaccine modalities and to
      probe the influence of genetics on these responses using monozygotic and dizygotic twins. The
      investigators plan to compare various immunological responses, identify age-specific
      biomarkers or clusters of markers, quantify the frequency of influenza-specific T-cells pre-
      and post-vaccination, and determine the effective breadth of T-cell repertoire to an
      influenza vaccine within an individual as a function of age and to what degree this is
      genetically determined.

      The study will be conducted in healthy young identical and fraternal 1-8 year-old twins. All
      participants will be immunized with seasonal trivalent inactivated influenza vaccine (IIV3).
      Blood samples to conduct the assays described will be taken at pre-immunization, Days 6-8 and
      28 post-immunization for children requiring 1 dose of vaccine. For children requiring 2 doses
      of vaccine, a second immunization will be given at least 28 days after Dose 1 with responses
      measured on Day 6-8 and Day 28-32 post-second immunization.

      Children 35 months and under will receive Fluzone® standard IIV3 Pediatric Dose, while
      children 36 months and older will receive Fluzone® standard IIV3.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Number of Participants Who Received Influenza Vaccine
time frame: Day 0 to 32
measure: Number of Participants With Related Adverse Events
time frame: Day 0 to 32 post-immunization
arm group label: Healthy 1-8 year-old twins
arm group type: Other
description: Healthy 1-8 yr old identical and fraternal twin pairs given trivalent, inactivated influenza (Fluzone® standard IIV3 0.5ml or Fluzone® standard IIV3 Pediatric Dose) per participant age and standard of care.
intervention type: Biological
intervention name: Fluzone® standard IIV3
description: Influenza Virus Vaccine Suspension (0.5ml) for Intramuscular Injection
arm group label: Healthy 1-8 year-old twins
intervention type: Biological
intervention name: Fluzone® standard IIV3 Pediatric Dose
description: Influenza Virus Vaccine Suspension (0.25ml) for Intramuscular Injection
arm group label: Healthy 1-8 year-old twins
criteria: 
gender: All
minimum age: 1 Year
maximum age: 8 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Cornelia Dekker, MD
role: Principal Investigator
affiliation: Stanford University
last name: Mark Davis, PhD
role: Principal Investigator
affiliation: Stanford University
last name: Garry Nolan, PhD
role: Principal Investigator
affiliation: Stanford University
last name: Ann Arvin, MD
role: Principal Investigator
affiliation: Stanford University
last name: Stephen Quake, 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: Professor, Pediatrics
mesh term: Influenza, Human
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 