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/NCT05970887</url>
    </required_header>
    <id_info>
      <org_study_id>IS22OISE0060</org_study_id>
      <nct_id>NCT05970887</nct_id>
    </id_info>
    <brief_title>Immunogenicity and Safety of Concomitant Administration of Bivalent COVID-19 Vaccines With Influenza Vaccines</brief_title>
    <official_title>Immunogenicity and Safety of Concomitant Administration of Omicron-containing Bivalent COVID-19 Vaccines With Seasonal Influenza Vaccines Among Healthcare Workers : a Single Center Prospective Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Catholic Kwandong University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Korea University Guro Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Catholic Kwandong University</source>
    <oversight_info>
      <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>
        The goal is to evaluate the immunogenicity and safety of coadministration of a bivalent&#xD;
        BA.4/BA.5-adapted COVID-19 booster vaccine, and influenza vaccine among healthcare workers&#xD;
        (HCWs) during 2022-23 season.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a single-center, prospective, non-randomized clinical cohort study. This study&#xD;
        included two study groups: Concomitant administration of bivalent BA.4/BA.5 mRNA COVID-19&#xD;
        booster and quadrivalent influenza vaccination (QIV) and separate administration of influenza&#xD;
        vaccination followed by bivalent BA.4/BA.5 mRNA booster ≥4 weeks later&#xD;
  &#xD;
          -  immunogenicity analysis : Blood was drawn at baseline and follow-up visit 4 weeks (day&#xD;
             28±7) after immunization.&#xD;
  &#xD;
          -  safety analysis : At 7 days after each vaccine dose, the participants were requested to&#xD;
             record the occurrence, severity of solicited adverse events (AEs) through a standardized&#xD;
             electronic questionnaire. Participants were also asked to record any unsolicited AEs&#xD;
             during the 28 days after vaccination.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">October 12, 2022</start_date>
    <completion_date type="Anticipated">October 12, 2023</completion_date>
    <primary_completion_date type="Actual">December 30, 2022</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>
      <intervention_model_description>prospective, non-randomized clinical cohort study</intervention_model_description>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>seroconversion rate of anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike (S) immunoglobulin (IgG) between the C and S groups</measure>
      <time_frame>at 28 days after booster dose</time_frame>
      <description>seroconversion rate of anti-SARS-CoV-2 S IgG</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>seroconversion rate of neutralizing antibody against SARS-CoV-2</measure>
      <time_frame>at 28 days after booster dose</time_frame>
      <description>seroconversion rate of neutralizing antibody against wild type, Omicron BA.5</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>geometric mean titer against SARS-CoV-2</measure>
      <time_frame>at 28 days after booster dose</time_frame>
      <description>geometric mean titer against SARS-CoV-2 (Anti-S IgG, neutralizing antibody)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>seroconversion rate of four influenza strains</measure>
      <time_frame>at 28 days after immunization</time_frame>
      <description>seroconversion rate of four influenza strains</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>seropositive rate of four influenza strains</measure>
      <time_frame>at 28 days after immunization</time_frame>
      <description>seropositive rate of four influenza strains</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>geometric mean titer against four influenza strain</measure>
      <time_frame>at 28 days after immunization</time_frame>
      <description>geometric mean titer against four influenza strain</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The incidence rate of adverse events (AEs)</measure>
      <time_frame>within 28 days</time_frame>
      <description>The incidence rate of AEs within 7 days, AEs within 28 days, and serious AEs</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Actual">154</enrollment>
    <condition>Immune Response</condition>
    <condition>Safety</condition>
    <arm_group>
      <arm_group_label>C group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Concomitant administration of bivalent mRNA COVID-19 booster and quadrivalent influenza vaccination</description>
    </arm_group>
    <arm_group>
      <arm_group_label>S group (COVID-19 vaccine only)</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>sequential administration of influenza vaccination followed by bivalent BA.4/BA.5 mRNA booster ≥4 weeks later</description>
    </arm_group>
    <arm_group>
      <arm_group_label>S group (influenza vaccine only)</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>sequential administration of influenza vaccination followed by bivalent BA.4/BA.5 mRNA booster ≥4 weeks later</description>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>bivalent BNT162b2 mRNA original/omicron BA.4-5 vaccine</intervention_name>
      <description>The bivalent BNT162b2 mRNA original/omicron BA.4-5 vaccine is a combination of 15-µg of mRNA encoding the wild-type (WT) spike protein and 15-µg of mRNA encoding the spike protein of the Omicron BA.4/BA.5 subvariant.</description>
      <arm_group_label>C group</arm_group_label>
      <arm_group_label>S group (COVID-19 vaccine only)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>quadrivalent influenza vaccine</intervention_name>
      <description>The quadrivalent influenza vaccine is an inactivated vaccine containing 15μg HA/strain in each 0.5-mL dose, containing four influenza vaccine strains from the 2022-2023 northern hemisphere season</description>
      <arm_group_label>C group</arm_group_label>
      <arm_group_label>S group (influenza vaccine only)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  who agreed to receive both bivalent booster COVID-19 vaccine and influenza vaccine&#xD;
  &#xD;
            -  Only individuals who had passed at least 3 months after the last confirmation of&#xD;
               SARS-CoV-2 infection and/or the third dose of COVID-19 vaccination&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Individuals with a contraindication to any of the vaccine compounds were excluded from&#xD;
               the study&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Min Joo Choi, Doctor</last_name>
      <role>Principal Investigator</role>
      <affiliation>International St. Mary's Hospital</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>International St. Mary's hospital</name>
        <address>
          <city>Incheon</city>
          <state>Seo-gu</state>
          <zip>22711</zip>
          <country>Korea, Republic of</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Korea, Republic of</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 28, 2023</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 28, 2023</last_update_submitted>
    <last_update_submitted_qc>July 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Catholic Kwandong University</investigator_affiliation>
      <investigator_full_name>Min Joo Choi</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <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>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05970887
  org study id: IS22OISE0060
  nct id: NCT05970887
  lead sponsor: 
  collaborator: 
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: Yes
  The goal is to evaluate the immunogenicity and safety of coadministration of a bivalent
        BA.4/BA.5-adapted COVID-19 booster vaccine, and influenza vaccine among healthcare workers
        (HCWs) during 2022-23 season.
  This is a single-center, prospective, non-randomized clinical cohort study. This study
        included two study groups: Concomitant administration of bivalent BA.4/BA.5 mRNA COVID-19
        booster and quadrivalent influenza vaccination (QIV) and separate administration of influenza
        vaccination followed by bivalent BA.4/BA.5 mRNA booster ≥4 weeks later
  
          -  immunogenicity analysis : Blood was drawn at baseline and follow-up visit 4 weeks (day
             28±7) after immunization.
  
          -  safety analysis : At 7 days after each vaccine dose, the participants were requested to
             record the occurrence, severity of solicited adverse events (AEs) through a standardized
             electronic questionnaire. Participants were also asked to record any unsolicited AEs
             during the 28 days after vaccination.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  intervention model description: prospective, non-randomized clinical cohort study
  primary purpose: Basic Science
  masking: None (Open Label)
  measure: seroconversion rate of anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike (S) immunoglobulin (IgG) between the C and S groups
  time frame: at 28 days after booster dose
  description: seroconversion rate of anti-SARS-CoV-2 S IgG
  measure: seroconversion rate of neutralizing antibody against SARS-CoV-2
  time frame: at 28 days after booster dose
  description: seroconversion rate of neutralizing antibody against wild type, Omicron BA.5
  measure: geometric mean titer against SARS-CoV-2
  time frame: at 28 days after booster dose
  description: geometric mean titer against SARS-CoV-2 (Anti-S IgG, neutralizing antibody)
  measure: seroconversion rate of four influenza strains
  time frame: at 28 days after immunization
  description: seroconversion rate of four influenza strains
  measure: seropositive rate of four influenza strains
  time frame: at 28 days after immunization
  description: seropositive rate of four influenza strains
  measure: geometric mean titer against four influenza strain
  time frame: at 28 days after immunization
  description: geometric mean titer against four influenza strain
  measure: The incidence rate of adverse events (AEs)
  time frame: within 28 days
  description: The incidence rate of AEs within 7 days, AEs within 28 days, and serious AEs
  arm group label: C group
  arm group type: Experimental
  description: Concomitant administration of bivalent mRNA COVID-19 booster and quadrivalent influenza vaccination
  arm group label: S group (COVID-19 vaccine only)
  arm group type: Placebo Comparator
  description: sequential administration of influenza vaccination followed by bivalent BA.4/BA.5 mRNA booster ≥4 weeks later
  arm group label: S group (influenza vaccine only)
  arm group type: Placebo Comparator
  description: sequential administration of influenza vaccination followed by bivalent BA.4/BA.5 mRNA booster ≥4 weeks later
  intervention type: Biological
  intervention name: bivalent BNT162b2 mRNA original/omicron BA.4-5 vaccine
  description: The bivalent BNT162b2 mRNA original/omicron BA.4-5 vaccine is a combination of 15-µg of mRNA encoding the wild-type (WT) spike protein and 15-µg of mRNA encoding the spike protein of the Omicron BA.4/BA.5 subvariant.
  arm group label: C group
  arm group label: S group (COVID-19 vaccine only)
  intervention type: Biological
  intervention name: quadrivalent influenza vaccine
  description: The quadrivalent influenza vaccine is an inactivated vaccine containing 15μg HA/strain in each 0.5-mL dose, containing four influenza vaccine strains from the 2022-2023 northern hemisphere season
  arm group label: C group
  arm group label: S group (influenza vaccine only)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Min Joo Choi, Doctor
  role: Principal Investigator
  affiliation: International St. Mary's Hospital
  facility: 
  country: Korea, Republic of
  responsible party type: Principal Investigator
  investigator affiliation: Catholic Kwandong University
  investigator full name: Min Joo Choi
  investigator title: Assistant Professor
  mesh term: Influenza, Human
  mesh term: Vaccines
  sharing ipd: No