xml: <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/NCT06020118</url>
    </required_header>
    <id_info>
      <org_study_id>Pro00113674</org_study_id>
      <nct_id>NCT06020118</nct_id>
    </id_info>
    <brief_title>Comparative Immunogenicity of Concomitant vs Sequential mRNA COVID-19 and Influenza Vaccinations</brief_title>
    <official_title>Randomized Study of the Immunogenicity and Duration of Antibody Response Against Circulating SARS-CoV-2 Variant and Influenza Viruses Following Concomitant Versus Sequential Administration of mRNA COVID-19 Vaccine and Quadrivalent Cell Culture-based Influenza Vaccine Among Children and Adults</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Duke University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Centers for Disease Control and Prevention</agency>
        <agency_class>U.S. Fed</agency_class>
      </collaborator>
      <collaborator>
        <agency>Arizona State University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University Hospitals Cleveland Medical Center</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>University of Pittsburgh</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Washington University School of Medicine</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Valleywise Health</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>VA Northeast Ohio Health Care</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Senders Pediatrics</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Duke University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a prospective, randomized randomized immunologic study of response to influenza and&#xD;
        SARS-CoV-2 vaccination across four of the US Influenza Vaccine Effectiveness (Flu VE) Network&#xD;
        study sites.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study is a prospective, randomized comparative immunogenicity study in an enrolled&#xD;
        cohort. During this study, eligible participants will be randomly assigned to receive an&#xD;
        approved quadrivalent cell culture-based influenza vaccine (ccIIV4, Seqirus) and an approved&#xD;
        mRNA COVID-19 vaccine (Moderna) either concomitantly or sequentially, 28 days apart.&#xD;
        Participants (aged 6-11 years and 18-64 years) will be enrolled in the 2023-2024 influenza&#xD;
        season.&#xD;
  &#xD;
        Demographic and health data (including influenza and COVID-19 vaccination and infection&#xD;
        history) will be collected upon enrollment. Enrolled participants will be randomized to one&#xD;
        of the following interventions (2:1:1) (i) concomitant administration of the mRNA COVID-19&#xD;
        vaccine (Moderna) and quadrivalent influenza vaccine (ccIIV4, Seqirus); (ii)sequential&#xD;
        administration of the quadrivalent influenza vaccine (ccIIV4, Seqirus) at Visit 1 (day 0) and&#xD;
        the mRNA COVID-19 vaccine(Moderna) at Visit 2 (day 28); (iii) sequential administration of&#xD;
        the mRNA COVID-19 vaccine (Moderna) at Visit 1 (day 0) followed by the quadrivalent influenza&#xD;
        vaccine (ccIIV4, Seqirus) at Visit 2 (day 28). Participants will not be blinded to vaccine&#xD;
        group.&#xD;
  &#xD;
        Whole blood samples to isolate sera for immune assays will be collected prior to vaccination&#xD;
        administration at Visit 1 (day 0), Visit 2 (day 28) Visit 3 (day 56; post-vaccination 2) and&#xD;
        Visit 4 (day180; end of local flu circulation). Blood samples to isolate PBMC and plasma will&#xD;
        be collected from a subset of 250 participants (200 adults and 50 children). If participants&#xD;
        exhibit ARI during the study period, the participants may be asked to present for collection&#xD;
        of a nasal swab for viral testing for acute influenza or SAR-CoV-2 infection (within 10 days&#xD;
        after symptom onset), and blood specimen to isolate sera for immune assays. For participants&#xD;
        with confirmed acute infection, the participants may be asked to present for collection of a&#xD;
        convalescent-phase blood specimen approximately 28 days after acute visit for isolation of&#xD;
        sera, PBMC and plasma.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 15, 2023</start_date>
    <completion_date type="Anticipated">April 28, 2024</completion_date>
    <primary_completion_date type="Anticipated">February 28, 2024</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>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in influenza antibody titer as measured by hemagglutination inhibition (HAI)</measure>
      <time_frame>Visit 1 (baseline), Visit 2 (day 28), and Visit 3 (day 56)</time_frame>
      <description>Baseline and post-vaccination influenza antibody titer for each ccIIV4 vaccine antigen by hemagglutination inhibition (HAI).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in influenza antibody titer as measured by microneutralization (MN)</measure>
      <time_frame>Visit 1 (baseline), Visit 2 (day 28), and Visit 3 (day 56)</time_frame>
      <description>Baseline and post-vaccination influenza antibody titer for each ccIIV4 vaccine antigen by microneutralization (MN).</description>
    </primary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">800</enrollment>
    <condition>Influenza</condition>
    <condition>COVID-19</condition>
    <arm_group>
      <arm_group_label>Group i</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Simultaneous Vaccination (Influenza vaccine and mRNA COVID booster) at Visit 1</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group ii</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Sequential vaccination with Influenza vaccination at Visit 1 and mRNA COVID booster at Visit 2</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group iii</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Sequential vaccination with mRNA COVID booster at Visit 1 and Influenza vaccination at Visit 2</description>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>Simultaneous Vaccination (Influenza Vaccine and mRNA COVID booster)</intervention_name>
      <description>Influenza vaccination and mRNA COVID-19 booster will be given at Visit 1.</description>
      <arm_group_label>Group i</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>Sequential Vaccination (Influenza vaccine then mRNA COVID booster)</intervention_name>
      <description>Influenza vaccine will be given at Visit 1 and mRNA COVID booster will be given at Visit 2.</description>
      <arm_group_label>Group ii</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>Sequential Vaccination (mRNA COVID booster then Influenza vaccine)</intervention_name>
      <description>mRNA COVID booster will be given at Visit 1 and Influenza vaccine will be given at Visit 2.</description>
      <arm_group_label>Group iii</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Healthy children aged 6-11 years and healthy adults aged 18-64 years that have not&#xD;
               received the current season's influenza vaccination or a mRNA COVID-19 vaccination in&#xD;
               the past 6 months and have already completed at least a two-dose primary series of an&#xD;
               mRNA COVID-19 vaccination&#xD;
  &#xD;
            -  English or Spanish literate&#xD;
  &#xD;
            -  Email or text message capability for weekly follow-up&#xD;
  &#xD;
            -  Intention of receiving influenza vaccine and mRNA COVID-19 vaccine based on ACIP-CDC&#xD;
               guidelines&#xD;
  &#xD;
            -  Willing to provide written/electronic informed consent&#xD;
  &#xD;
            -  Intention of being available for entire study period and able to complete all relevant&#xD;
               study procedures, including follow-up phone calls and clinic visits&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Self-reported COVID-19 infection within 3 months prior to enrollment&#xD;
  &#xD;
            -  Received COVID-19 vaccine within 6 months prior to enrollment&#xD;
  &#xD;
            -  Received influenza vaccine during the respective influenza season in which the&#xD;
               participants are being enrolled&#xD;
  &#xD;
            -  &lt; 9 years of age and recommended to receive two doses of IIV4 during the respective&#xD;
               influenza season in which they are being enrolled&#xD;
  &#xD;
            -  History of severe allergic reaction after a previous dose of any influenza or COVID-19&#xD;
               mRNA vaccine; or to an influenza or COVID-19 mRNA vaccine component&#xD;
  &#xD;
            -  Receipt of any licensed vaccine within 6 weeks prior to enrollment in this study or&#xD;
               planning receipt of any vaccines within 4 weeks after the receipt of the second&#xD;
               vaccine dose administered during study procedures&#xD;
  &#xD;
            -  Has an immunocompromising condition or taking immunosuppressive medication*&#xD;
  &#xD;
               * Received oral, intramuscular or intravenous systemic immunosuppressants, or immune&#xD;
               modifying drugs for &gt;14 days in total within 6 months prior to any study vaccine dose&#xD;
               (for corticosteroids ≥ 20 mg/day of prednisone equivalent).&#xD;
  &#xD;
               ** Note: Topical medications are allowed&#xD;
  &#xD;
            -  Received immunoglobulin, SARS-CoV-2 immunoglobulin, SARS-CoV-2 monoclonal antibody, or&#xD;
               blood-derived products, within 3 months prior any study vaccine dose.&#xD;
  &#xD;
            -  History of Guillain-Barré syndrome&#xD;
  &#xD;
            -  History of myocarditis or pericarditis&#xD;
  &#xD;
            -  History of multisystem inflammatory syndrome in children (MIS-C) or adults (MIS-A)&#xD;
  &#xD;
            -  Currently pregnant, planning to become pregnant within the first three months of the&#xD;
               study per participant self-report or likely to be pregnant per screening criteria&#xD;
  &#xD;
            -  Bleeding disorder diagnosed by a healthcare provider or bleeding difficulties with&#xD;
               intramuscular injections or blood draws.&#xD;
  &#xD;
            -  Has injury or other reason why deltoid site on both arms cannot be used for&#xD;
               vaccinations&#xD;
  &#xD;
            -  Any condition which, in the opinion of the investigators, may pose a health risk to&#xD;
               the participant or interfere with the evaluation of the study objectives&#xD;
  &#xD;
            -  Temporary Delay Criteria: History of febrile illness (&gt; 100.0°F or 37.8°C) within the&#xD;
               past 72 hours prior to vaccine administration&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>6 Years</minimum_age>
      <maximum_age>64 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Emmanuel B Walter, MD, MPH</last_name>
      <phone>(919) 970-5720</phone>
      <email>chip.walter@duke.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Grace N Davis, MS</last_name>
      <phone>(919) 385-5786</phone>
      <email>grace.davis@duke.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Valleywise Health Comprehensive Health Center</name>
        <address>
          <city>Phoenix</city>
          <state>Arizona</state>
          <zip>85008</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Lora Nordstrom, BSN, PhD</last_name>
        <phone>602-344-2759</phone>
        <email>Lora.Nordstrom@ValleywiseHealth.org</email>
      </contact>
      <contact_backup>
        <last_name>Mary Mulrow, RN, MSN</last_name>
        <phone>602-344-5058</phone>
        <email>Mary.Mulrow@ValleywiseHealth.org</email>
      </contact_backup>
      <investigator>
        <last_name>Michael White, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Jeffrey Curtis, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>ASU Biodesign Institute</name>
        <address>
          <city>Tempe</city>
          <state>Arizona</state>
          <zip>85281</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Vel Murugan, PhD, MBA</last_name>
        <phone>480-727-0402</phone>
        <email>Vel.murugan@asu.edu</email>
      </contact>
      <contact_backup>
        <last_name>Mario Islas, MD</last_name>
        <phone>480-965-7005</phone>
        <email>mario.islas@asu.edu</email>
      </contact_backup>
      <investigator>
        <last_name>Vel Murugan, PhD, MBA</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Centers for Disease Control and Prevention</name>
        <address>
          <city>Atlanta</city>
          <state>Georgia</state>
          <zip>30333</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Brendan Flannery, PhD</last_name>
        <phone>404-718-4276</phone>
        <email>bflannery@cdc.gov</email>
      </contact>
      <contact_backup>
        <last_name>Kelsey Sumner, PhD, MSPH</last_name>
        <phone>404-639-0546</phone>
        <email>rhq3@cdc.gov</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>Washington University IDCRU</name>
        <address>
          <city>Saint Louis</city>
          <state>Missouri</state>
          <zip>63110</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Rachel Presti, MD, PhD</last_name>
        <phone>314-454-0058</phone>
        <email>prestir@wustl.edu</email>
      </contact>
      <contact_backup>
        <last_name>Michael Klebert, PhD, RNP</last_name>
        <phone>314-454-0058</phone>
        <email>mklebert@wustl.edu</email>
      </contact_backup>
      <investigator>
        <last_name>Michael Klebert, PhD, RNP</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Luis Parra-Rodriguez</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Adriana Rauseo</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Shashwatee Bagchi</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>University Hospitals Cleveland Medical Center</name>
        <address>
          <city>Cleveland</city>
          <state>Ohio</state>
          <zip>44106</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Sheree White, BSN</last_name>
        <phone>216-286-7589</phone>
        <email>sheree.white@uhhospitals.org</email>
      </contact>
      <contact_backup>
        <last_name>Kieran McKibben, BSN</last_name>
        <phone>216-286-7589</phone>
        <email>kieran.mckibben@uhhospitals.org</email>
      </contact_backup>
      <investigator>
        <last_name>Elie Saade, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Claudia Hoyen, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Robert Salata, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>VA Northeast Ohio Healthcare System (VANEOHS)</name>
        <address>
          <city>Cleveland</city>
          <state>Ohio</state>
          <zip>44106</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Joy Lawrence</last_name>
        <phone>216-791-3800</phone>
        <phone_ext>65103</phone_ext>
        <email>Joy.Lawrence@va.gov</email>
      </contact>
      <contact_backup>
        <last_name>Martin Varghese</last_name>
        <phone>216-791-3800</phone>
        <phone_ext>64788</phone_ext>
        <email>Martin.Vaghese@va.gov</email>
      </contact_backup>
      <investigator>
        <last_name>Curtis Donskey</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Senders Pediatrics</name>
        <address>
          <city>South Euclid</city>
          <state>Ohio</state>
          <zip>44121</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Shelly Senders, MD</last_name>
        <phone>216-291-9210</phone>
        <email>ssenders@senderspediatrics.com</email>
      </contact>
      <contact_backup>
        <last_name>Timonthy Hudec, BA</last_name>
        <phone>216-658-2408</phone>
        <email>thudec@sendersresearch.com</email>
      </contact_backup>
      <investigator>
        <last_name>Shelly Senders, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Department of Family Medicine, University of Pittsburgh School of Medicine</name>
        <address>
          <city>Pittsburgh</city>
          <state>Pennsylvania</state>
          <zip>15260</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Katherine Williams, MD, MPH</last_name>
        <phone>412-383-1979</phone>
        <email>kvw3@pitt.edu</email>
      </contact>
      <contact_backup>
        <last_name>Tricia Nowalk, PhD, RDN</last_name>
        <phone>412-383-2355</phone>
        <email>tnowalk@pitt.edu</email>
      </contact_backup>
      <investigator>
        <last_name>Richard Zimmerman, MD,MPH</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Tricia Nowalk, PhD, RDN</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 30, 2023</study_first_submitted>
    <study_first_submitted_qc>August 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Influenza</keyword>
    <keyword>COVID-19</keyword>
    <keyword>Immunogencity</keyword>
    <keyword>Health</keyword>
    <keyword>Reactogenicity</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>COVID-19</mesh_term>
      <mesh_term>Influenza, Human</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Vaccines</mesh_term>
    </intervention_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06020118
  org study id: Pro00113674
  nct id: NCT06020118
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: Yes
  This is a prospective, randomized randomized immunologic study of response to influenza and
        SARS-CoV-2 vaccination across four of the US Influenza Vaccine Effectiveness (Flu VE) Network
        study sites.
  This study is a prospective, randomized comparative immunogenicity study in an enrolled
        cohort. During this study, eligible participants will be randomly assigned to receive an
        approved quadrivalent cell culture-based influenza vaccine (ccIIV4, Seqirus) and an approved
        mRNA COVID-19 vaccine (Moderna) either concomitantly or sequentially, 28 days apart.
        Participants (aged 6-11 years and 18-64 years) will be enrolled in the 2023-2024 influenza
        season.
  
        Demographic and health data (including influenza and COVID-19 vaccination and infection
        history) will be collected upon enrollment. Enrolled participants will be randomized to one
        of the following interventions (2:1:1) (i) concomitant administration of the mRNA COVID-19
        vaccine (Moderna) and quadrivalent influenza vaccine (ccIIV4, Seqirus); (ii)sequential
        administration of the quadrivalent influenza vaccine (ccIIV4, Seqirus) at Visit 1 (day 0) and
        the mRNA COVID-19 vaccine(Moderna) at Visit 2 (day 28); (iii) sequential administration of
        the mRNA COVID-19 vaccine (Moderna) at Visit 1 (day 0) followed by the quadrivalent influenza
        vaccine (ccIIV4, Seqirus) at Visit 2 (day 28). Participants will not be blinded to vaccine
        group.
  
        Whole blood samples to isolate sera for immune assays will be collected prior to vaccination
        administration at Visit 1 (day 0), Visit 2 (day 28) Visit 3 (day 56; post-vaccination 2) and
        Visit 4 (day180; end of local flu circulation). Blood samples to isolate PBMC and plasma will
        be collected from a subset of 250 participants (200 adults and 50 children). If participants
        exhibit ARI during the study period, the participants may be asked to present for collection
        of a nasal swab for viral testing for acute influenza or SAR-CoV-2 infection (within 10 days
        after symptom onset), and blood specimen to isolate sera for immune assays. For participants
        with confirmed acute infection, the participants may be asked to present for collection of a
        convalescent-phase blood specimen approximately 28 days after acute visit for isolation of
        sera, PBMC and plasma.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Change in influenza antibody titer as measured by hemagglutination inhibition (HAI)
  time frame: Visit 1 (baseline), Visit 2 (day 28), and Visit 3 (day 56)
  description: Baseline and post-vaccination influenza antibody titer for each ccIIV4 vaccine antigen by hemagglutination inhibition (HAI).
  measure: Change in influenza antibody titer as measured by microneutralization (MN)
  time frame: Visit 1 (baseline), Visit 2 (day 28), and Visit 3 (day 56)
  description: Baseline and post-vaccination influenza antibody titer for each ccIIV4 vaccine antigen by microneutralization (MN).
  arm group label: Group i
  arm group type: Experimental
  description: Simultaneous Vaccination (Influenza vaccine and mRNA COVID booster) at Visit 1
  arm group label: Group ii
  arm group type: Experimental
  description: Sequential vaccination with Influenza vaccination at Visit 1 and mRNA COVID booster at Visit 2
  arm group label: Group iii
  arm group type: Experimental
  description: Sequential vaccination with mRNA COVID booster at Visit 1 and Influenza vaccination at Visit 2
  intervention type: Biological
  intervention name: Simultaneous Vaccination (Influenza Vaccine and mRNA COVID booster)
  description: Influenza vaccination and mRNA COVID-19 booster will be given at Visit 1.
  arm group label: Group i
  intervention type: Biological
  intervention name: Sequential Vaccination (Influenza vaccine then mRNA COVID booster)
  description: Influenza vaccine will be given at Visit 1 and mRNA COVID booster will be given at Visit 2.
  arm group label: Group ii
  intervention type: Biological
  intervention name: Sequential Vaccination (mRNA COVID booster then Influenza vaccine)
  description: mRNA COVID booster will be given at Visit 1 and Influenza vaccine will be given at Visit 2.
  arm group label: Group iii
  criteria: 
  gender: All
  minimum age: 6 Years
  maximum age: 64 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Emmanuel B Walter, MD, MPH
  phone: (919) 970-5720
  email: chip.walter@duke.edu
  last name: Grace N Davis, MS
  phone: (919) 385-5786
  email: grace.davis@duke.edu
  facility: 
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  facility: 
  contact: 
  contact backup: 
  investigator: 
  facility: 
  contact: 
  contact backup: 
  facility: 
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  facility: 
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  investigator: 
  facility: 
  contact: 
  contact backup: 
  investigator: 
  facility: 
  contact: 
  contact backup: 
  investigator: 
  facility: 
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: COVID-19
  mesh term: Influenza, Human
  mesh term: Vaccines