<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/NCT03826719</url>
  </required_header>
  <id_info>
    <org_study_id>NBP607QIV_Flu_I_2013</org_study_id>
    <nct_id>NCT03826719</nct_id>
  </id_info>
  <brief_title>Safety, Tolerability and Immunogenicity of NBP607QIV in Healthy Adult Volunteers</brief_title>
  <official_title>A Randomized, Double-blinded, Controlled, Phase I/II Clinical Trial to Assess the Safety, Tolerability and Immunogenicity of NBP607QIV Compared to Trivalent Egg-based Influenza Vaccine in Healty Adult Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>SK Chemicals Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>SK Chemicals Co., Ltd.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study assesses safety, tolerability and immunogenicity of NBP607QIV to Agrippal which&#xD;
      are indicated for active immunization for the prevention of influenza disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects are randomly assigned in a 1:1 ratio to NBP607QIV versus Agrippal S1. To assess the&#xD;
      safety, solicited adverse events for 7 days post-vaccination and unsolicited adverse events&#xD;
      for 28 days post-vaccination are assessed and reported. To assess the immunogenicity,&#xD;
      antibody levels are evaluated by hemagglutination inhibition(HI) assay from sera obtained at&#xD;
      pre-vaccination and 21 days post-vaccination.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 17, 2014</start_date>
  <completion_date type="Actual">March 28, 2014</completion_date>
  <primary_completion_date type="Actual">March 28, 2014</primary_completion_date>
  <phase>Phase 1/Phase 2</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence rate of solicited local adverse events(AEs)</measure>
    <time_frame>7 days after vaccination</time_frame>
    <description>All AEs were classified and analyzed according to its severity and causality. The number and percentage of subjects with AEs were analyzed. Incidence rate, 95% confidence interval as well as number of occurrences were calculated.&#xD;
Comparisons within each group between pre-/post- vaccination were summarized and presented.&#xD;
The number and percentage of subjects with AEs were analyzed. Incidence rate, 95% confidence interval as well as number of occurrences were calculated.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence rate of solicited systemic AEs</measure>
    <time_frame>7 days after vaccination</time_frame>
    <description>The number and percentage of subjects with AEs were analyzed. Incidence rate, 95% confidence interval as well as number of occurrences were calculated.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence rate of unsolicited AEs</measure>
    <time_frame>21 days after vaccination</time_frame>
    <description>The number and percentage of subjects with AEs were analyzed. Incidence rate, 95% confidence interval as well as number of occurrences were calculated.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Seroprotection rate measured by post-vaccination Haemagglutination Inhibition(HI) titer[Immunogenicity]</measure>
    <time_frame>21-28 days after vaccination</time_frame>
    <description>The proportion of subjects with post-vaccination HI titers of ≥1:40</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Seroconversion rate measured by pre-/post-vaccination HI titerImmunogenicity]</measure>
    <time_frame>21-28 days after vaccination</time_frame>
    <description>The proportion of subjects achieving one of the following conditions; i)If the pre-vaccination HI titer were &lt;1:10, subjects achieving an HI titer ≥1:40 after vaccination ii)If the pre-vaccination HI titers were ≥1:10, subjects with a minimum 4-fold rise in HI titer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>9. Geometric Mean Ratio (GMR) measured by pre-/post-vaccination HI titer[Immunogenicity]</measure>
    <time_frame>21-28 days after vaccination</time_frame>
    <description>The mean increase in geometric mean HI titer</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Influenza</condition>
  <arm_group>
    <arm_group_label>NBP607QIV</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1 dose of 0.5mL by Intramuscular injection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Agrippal</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>1 dose of 0.5mL by Intramuscular injection</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>NBP607QIV</intervention_name>
    <description>Purified inactivated influenza virus surface antigens of four strains(quadrivalent)</description>
    <arm_group_label>NBP607QIV</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Agrippal</intervention_name>
    <description>Influenza virus surface antigens of three strains(trivalent)</description>
    <arm_group_label>Agrippal</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy adults aged 19 to 59 years&#xD;
&#xD;
          2. Those who are able and willing to give written informed consent to study participation&#xD;
             and compliance with study instructions after being informed of and understand details&#xD;
             of the study&#xD;
&#xD;
          3. If female, at least 2 years after post- menopausal and negative result of urine-human&#xD;
             chorionic gonadotropin (HCG) test at screening&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Those with hypersensitivity to any component of the study medication or chemically&#xD;
             related substances, such as allergy to eggs or egg products&#xD;
&#xD;
          2. Those with Immunodeficiency disease&#xD;
&#xD;
          3. Those with history of hypersensitivity when vaccination, such as Guillain-Barre&#xD;
             syndrome&#xD;
&#xD;
          4. Those who are contraindicated for intramuscular injection due to thrombocytopenia or&#xD;
             coagulopathy&#xD;
&#xD;
          5. Those who experienced fever (&gt;38°C) within the past 24 hours or any acute respiratory&#xD;
             infection&#xD;
&#xD;
          6. Those with history of treatment with any of Immunosuppressants or Immunomodulators&#xD;
             within the past 3 months&#xD;
&#xD;
          7. Those with history of receiving blood products or immunoglobulin within the past 3&#xD;
             months&#xD;
&#xD;
          8. Those with history of influenza vaccination within the past 6 months&#xD;
&#xD;
          9. Those who received another vaccine within the past 1 month or have plan to receive&#xD;
             another vaccine within 1 months following the study vaccination&#xD;
&#xD;
         10. Those with history of participation on another clinical trial within 1 month prior to&#xD;
             the study vaccination&#xD;
&#xD;
         11. Those with history of blood donation within 1 week prior to the study vaccination or&#xD;
             plan of blood donation within 7 days following the study vaccination&#xD;
&#xD;
         12. Those with any chronic diseases that interfere with the clinical trial or malignant&#xD;
             tumors&#xD;
&#xD;
         13. Pregnant or breastfeeding&#xD;
&#xD;
         14. Those with any condition which, in the opinion of the investigator, might interfere&#xD;
             with the evaluation of the study objectives or might interfere with the safety of the&#xD;
             study subject.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>59 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Woo Joo Kim, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Korea University Guro Hospital</affiliation>
  </overall_official>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 31, 2019</study_first_submitted>
  <study_first_submitted_qc>January 31, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <last_update_submitted>January 31, 2019</last_update_submitted>
  <last_update_submitted_qc>January 31, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 1, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03826719
org study id: NBP607QIV_Flu_I_2013
nct id: NCT03826719
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study assesses safety, tolerability and immunogenicity of NBP607QIV to Agrippal which
      are indicated for active immunization for the prevention of influenza disease.
Subjects are randomly assigned in a 1:1 ratio to NBP607QIV versus Agrippal S1. To assess the
      safety, solicited adverse events for 7 days post-vaccination and unsolicited adverse events
      for 28 days post-vaccination are assessed and reported. To assess the immunogenicity,
      antibody levels are evaluated by hemagglutination inhibition(HI) assay from sera obtained at
      pre-vaccination and 21 days post-vaccination.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Incidence rate of solicited local adverse events(AEs)
time frame: 7 days after vaccination
description: All AEs were classified and analyzed according to its severity and causality. The number and percentage of subjects with AEs were analyzed. Incidence rate, 95% confidence interval as well as number of occurrences were calculated.
Comparisons within each group between pre-/post- vaccination were summarized and presented.
The number and percentage of subjects with AEs were analyzed. Incidence rate, 95% confidence interval as well as number of occurrences were calculated.
measure: Incidence rate of solicited systemic AEs
time frame: 7 days after vaccination
description: The number and percentage of subjects with AEs were analyzed. Incidence rate, 95% confidence interval as well as number of occurrences were calculated.
measure: Incidence rate of unsolicited AEs
time frame: 21 days after vaccination
description: The number and percentage of subjects with AEs were analyzed. Incidence rate, 95% confidence interval as well as number of occurrences were calculated.
measure: Seroprotection rate measured by post-vaccination Haemagglutination Inhibition(HI) titer[Immunogenicity]
time frame: 21-28 days after vaccination
description: The proportion of subjects with post-vaccination HI titers of ≥1:40
measure: Seroconversion rate measured by pre-/post-vaccination HI titerImmunogenicity]
time frame: 21-28 days after vaccination
description: The proportion of subjects achieving one of the following conditions; i)If the pre-vaccination HI titer were <1:10, subjects achieving an HI titer ≥1:40 after vaccination ii)If the pre-vaccination HI titers were ≥1:10, subjects with a minimum 4-fold rise in HI titer
measure: 9. Geometric Mean Ratio (GMR) measured by pre-/post-vaccination HI titer[Immunogenicity]
time frame: 21-28 days after vaccination
description: The mean increase in geometric mean HI titer
arm group label: NBP607QIV
arm group type: Experimental
description: 1 dose of 0.5mL by Intramuscular injection
arm group label: Agrippal
arm group type: Active Comparator
description: 1 dose of 0.5mL by Intramuscular injection
intervention type: Biological
intervention name: NBP607QIV
description: Purified inactivated influenza virus surface antigens of four strains(quadrivalent)
arm group label: NBP607QIV
intervention type: Biological
intervention name: Agrippal
description: Influenza virus surface antigens of three strains(trivalent)
arm group label: Agrippal
criteria: 
gender: All
minimum age: 19 Years
maximum age: 59 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Woo Joo Kim, MD, PhD
role: Study Chair
affiliation: Korea University Guro Hospital
responsible party type: Sponsor
mesh term: Influenza, Human
sharing ipd: No