<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/NCT03020472</url>
  </required_header>
  <id_info>
    <org_study_id>SU-15086</org_study_id>
    <secondary_id>U19AI057229</secondary_id>
    <nct_id>NCT03020472</nct_id>
  </id_info>
  <brief_title>Kinetics of B-Cell Responses to Live, Attenuated Influenza Vaccine (LAIV) in Young Children Two Years of Age</brief_title>
  <acronym>SLVP016</acronym>
  <official_title>U19 Year 6: Kinetics of B-Cell Responses to Live, Attenuated Influenza Vaccine (LAIV) in Young Children Two Years of Age, SLVP016</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 pilot study will investigate B-cell responses following vaccination with live,&#xD;
      attenuated influenza vaccine (LAIV) in healthy children 2 years of age from blood samples&#xD;
      taken at designated time points before and after vaccination.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an exploratory study to determine the peripheral antibody secreting cell response&#xD;
      during Days 5-13 after immunization with live, attenuated influenza vaccine (LAIV).&#xD;
&#xD;
      Investigators hoped to enroll 27 healthy children, 2 years of age who had not had any prior&#xD;
      LAIV or trivalent inactivated vaccine (TIV) within the past 2 years. Due to low enrollment,&#xD;
      the study was halted. Due to the limited number of samples, no analysis was performed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Due to low enrollment&#xD;
  </why_stopped>
  <start_date>November 2008</start_date>
  <completion_date type="Actual">January 2009</completion_date>
  <primary_completion_date type="Actual">January 2009</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 Day 28</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Related Adverse Events</measure>
    <time_frame>Day 0 to Day 28</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Post- Immunization B- Cell Response</measure>
    <time_frame>5-13 days post immunization</time_frame>
    <description>Identify peak of the post-immunization B-cell responses following vaccination with live, attenuated influenza vaccine (LAIV)</description>
  </other_outcome>
  <other_outcome>
    <measure>PBMC Samples Will be Tested by Flow Cytometry to Determine the Percentage of Influenza-specific Antibody Cells That Are CD27+CD38+CD19+ Plasmablasts and by ELISPOT.</measure>
    <time_frame>Day 0 to Day 28</time_frame>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>Influenza</condition>
  <arm_group>
    <arm_group_label>2008-2009 FluMist LAIV (Intranasal)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2008-2009 FluMist LAIV (Intranasal) Seasonal live, attenuated influenza vaccine</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>2008-2009 FluMist LAIV (Intranasal)</intervention_name>
    <description>2008-2009 FluMist vaccine delivered intranasally</description>
    <arm_group_label>2008-2009 FluMist LAIV (Intranasal)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          1. Otherwise healthy children, aged 24-35 months of age, inclusive.&#xD;
&#xD;
          2. Parent(s) or guardian(s) willing to sign informed consent.&#xD;
&#xD;
          3. Availability for follow-up for the planned duration of the study.&#xD;
&#xD;
          4. Acceptable medical history by screening evaluation and brief clinical assessment.&#xD;
&#xD;
          5. Able to understand and comply with planned study procedures&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          1. Prior vaccination with LAIV.&#xD;
&#xD;
          2. TIV vaccination during two prior influenza vaccine seasons&#xD;
&#xD;
          3. Known prior MD diagnosis of, or hospitalization for influenza&#xD;
&#xD;
          4. History of asthma, active/recurrent wheezing or reactive airways disease&#xD;
&#xD;
          5. History of immunodeficiency&#xD;
&#xD;
          6. Known or suspected impairment of immunologic function including, but not limited to,&#xD;
             clinically significant liver disease; diabetes mellitus; moderate to severe kidney&#xD;
             impairment.&#xD;
&#xD;
          7. Known underlying medical conditions (e.g. hemoglobinopathy, congestive heart failure)&#xD;
             predisposing to influenza complications.&#xD;
&#xD;
          8. Household contact with immunodeficiency due to disease, medication or radiation&#xD;
&#xD;
          9. Child receiving aspirin therapy or aspirin-containing therapy&#xD;
&#xD;
         10. History of Guillain-Barré syndrome&#xD;
&#xD;
         11. Malignancy, other than squamous cell or basal cell skin cancer&#xD;
&#xD;
         12. Autoimmune disease&#xD;
&#xD;
         13. Use of immunosuppressive medication. Corticosteroid nasal sprays are permissible.&#xD;
&#xD;
         14. Use of antiviral agents against Influenza A and/or B (such as Tamiflu, Relenza,&#xD;
             Flumodine, Symmetrel) less than 48 hours before and/or less than two weeks after&#xD;
             administration of FluMist.&#xD;
&#xD;
         15. History of blood dyscrasias, renal disease, or hemoglobinopathies requiring regular&#xD;
             medical follow-up or hospitalization during the preceding year.&#xD;
&#xD;
         16. Use of investigational agents within 30 days prior to study&#xD;
&#xD;
         17. Receipt of blood products or immunoglobulin in the past 6 months&#xD;
&#xD;
         18. Donation of the equivalent of a unit of blood within 6 weeks prior to enrollment&#xD;
&#xD;
         19. Acute febrile illness on the day of vaccination&#xD;
&#xD;
         20. Known allergies to any component of the vaccine, including eggs or egg products,&#xD;
             gentamicin, gelatin,or arginine, or known life-threatening reactions to previous&#xD;
             influenza vaccinations.&#xD;
&#xD;
         21. Concurrent participation in other investigational protocols or receipt of an&#xD;
             investigational product within the previous 30 days or planned receipt of an&#xD;
             investigational product within 28 days following the last immunization dose.&#xD;
&#xD;
         22. Any condition that, in the opinion of the investigator, might interfere with study&#xD;
             objectives&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>24 Months</minimum_age>
    <maximum_age>35 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Harry B Greenberg, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Xiaosong He, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stanford University School of Medicine</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2021</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 12, 2017</results_first_submitted>
  <results_first_submitted_qc>January 12, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">March 3, 2017</results_first_posted>
  <last_update_submitted>September 21, 2021</last_update_submitted>
  <last_update_submitted_qc>September 21, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 18, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stanford University</investigator_affiliation>
    <investigator_full_name>Philip Grant</investigator_full_name>
    <investigator_title>Assistant Professor of Medicine (Infectious Diseases)</investigator_title>
  </responsible_party>
  <keyword>Live, attenuated influenza vaccine</keyword>
  <keyword>Children</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>2008-2009 FluMist LAIV (Intranasal)</title>
          <description>Seasonal live, attenuated influenza vaccine (LAIV)&#xD;
2008-2009 FluMist LAIV (Intranasal): 2008-2009 FluMist vaccine delivered intranasally</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </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>2008-2009 FluMist LAIV (Intranasal)</title>
          <description>2008-2009 FluMist LAIV (Intranasal) Seasonal live, attenuated influenza vaccine&#xD;
2008-2009 FluMist LAIV (Intranasal): 2008-2009 FluMist vaccine delivered intranasally</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="6"/>
          </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="2.4" spread="0.1"/>
                  </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="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </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="4"/>
                  </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="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </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 Day 28</time_frame>
        <group_list>
          <group group_id="O1">
            <title>2008-2009 FluMist LAIV (Intranasal)</title>
            <description>2008-2009 FluMist LAIV (Intranasal) Seasonal live, attenuated influenza vaccine&#xD;
2008-2009 FluMist LAIV (Intranasal): 2008-2009 FluMist vaccine delivered intranasally</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="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </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 Day 28</time_frame>
        <group_list>
          <group group_id="O1">
            <title>2008-2009 FluMist LAIV (Intranasal)</title>
            <description>2008-2009 FluMist LAIV (Intranasal) Seasonal live, attenuated influenza vaccine&#xD;
2008-2009 FluMist LAIV (Intranasal): 2008-2009 FluMist vaccine delivered intranasally</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="6"/>
              </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>
        <type>Other Pre-specified</type>
        <title>Post- Immunization B- Cell Response</title>
        <description>Identify peak of the post-immunization B-cell responses following vaccination with live, attenuated influenza vaccine (LAIV)</description>
        <time_frame>5-13 days post immunization</time_frame>
        <population>Due to the low enrollment, the study was terminated and analysis was not performed.</population>
        <group_list>
          <group group_id="O1">
            <title>2008-2009 FluMist LAIV (Intranasal)</title>
            <description>2008-2009 FluMist LAIV (Intranasal) Seasonal live, attenuated influenza vaccine&#xD;
2008-2009 FluMist LAIV (Intranasal): 2008-2009 FluMist vaccine delivered intranasally</description>
          </group>
        </group_list>
        <measure>
          <title>Post- Immunization B- Cell Response</title>
          <description>Identify peak of the post-immunization B-cell responses following vaccination with live, attenuated influenza vaccine (LAIV)</description>
          <population>Due to the low enrollment, the study was terminated and analysis was not performed.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>PBMC Samples Will be Tested by Flow Cytometry to Determine the Percentage of Influenza-specific Antibody Cells That Are CD27+CD38+CD19+ Plasmablasts and by ELISPOT.</title>
        <time_frame>Day 0 to Day 28</time_frame>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>2008-2009 FluMist LAIV (Intranasal)</title>
          <description>2008-2009 FluMist LAIV (Intranasal) Seasonal live, attenuated influenza vaccine&#xD;
2008-2009 FluMist LAIV (Intranasal): 2008-2009 FluMist vaccine delivered intranasally</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
              </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="6"/>
              </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/NCT03020472
org study id: SU-15086
secondary id: U19AI057229
nct id: NCT03020472
lead sponsor: 
collaborator: 
has dmc: No
This pilot study will investigate B-cell responses following vaccination with live,
      attenuated influenza vaccine (LAIV) in healthy children 2 years of age from blood samples
      taken at designated time points before and after vaccination.
This is an exploratory study to determine the peripheral antibody secreting cell response
      during Days 5-13 after immunization with live, attenuated influenza vaccine (LAIV).

      Investigators hoped to enroll 27 healthy children, 2 years of age who had not had any prior
      LAIV or trivalent inactivated vaccine (TIV) within the past 2 years. Due to low enrollment,
      the study was halted. Due to the limited number of samples, no analysis was performed.
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 Day 28
measure: Number of Participants With Related Adverse Events
time frame: Day 0 to Day 28
measure: Post- Immunization B- Cell Response
time frame: 5-13 days post immunization
description: Identify peak of the post-immunization B-cell responses following vaccination with live, attenuated influenza vaccine (LAIV)
measure: PBMC Samples Will be Tested by Flow Cytometry to Determine the Percentage of Influenza-specific Antibody Cells That Are CD27+CD38+CD19+ Plasmablasts and by ELISPOT.
time frame: Day 0 to Day 28
arm group label: 2008-2009 FluMist LAIV (Intranasal)
arm group type: Experimental
description: 2008-2009 FluMist LAIV (Intranasal) Seasonal live, attenuated influenza vaccine
intervention type: Biological
intervention name: 2008-2009 FluMist LAIV (Intranasal)
description: 2008-2009 FluMist vaccine delivered intranasally
arm group label: 2008-2009 FluMist LAIV (Intranasal)
criteria: 
gender: All
minimum age: 24 Months
maximum age: 35 Months
healthy volunteers: Accepts Healthy Volunteers
last name: Harry B Greenberg, MD
role: Principal Investigator
affiliation: Stanford University
last name: Xiaosong He, PhD
role: Principal Investigator
affiliation: Stanford University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Stanford University
investigator full name: Philip Grant
investigator title: Assistant Professor of Medicine (Infectious Diseases)
mesh term: Influenza, Human
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 