<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/NCT03020628</url>
  </required_header>
  <id_info>
    <org_study_id>NBP607-QIV_FluC_III_2016</org_study_id>
    <nct_id>NCT03020628</nct_id>
  </id_info>
  <brief_title>Immunogenicity and Safety of Quadrivalent Influenza Vaccine in Children Aged 6~35 Months</brief_title>
  <official_title>A Multi-center, Randomized, Double-blind Phase III Clinical Trial to Assess the Immunogenicity and Safety of 'NBP607-QIV(Quadrivalent Inactivated Cell Culture-derived Influenza Vaccine)' in Children Aged 6~35 Months</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a multi-center, randomized, double-blind Phase III Clinical trial. The purpose&#xD;
      of this study is to assess the immunogenicity and safety of the quadrivalent cell&#xD;
      culture-derived influenza vaccine compare to the trivalent cell culture-derived influenza&#xD;
      vaccine in children aged 6~35 months.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects are randomly assigned in a 2:1 ratio to NBP607-QIV 0.5mL versus NBP607-TIV 0.25mL.&#xD;
      To assess the immunogenicity, antibody levels are evaluated by hemagglutination&#xD;
      inhibition(HI) assay from sera obtained at pre-vaccination and 28 days post-vaccination. To&#xD;
      assess the safety, solicited adverse events for 7 days post-vaccination and unsolicited&#xD;
      adverse events for 28 days post-vaccination are assessed and reported. The serious adverse&#xD;
      events are collected during 6 months post-vaccination.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2016</start_date>
  <completion_date type="Actual">June 2017</completion_date>
  <primary_completion_date type="Actual">March 2017</primary_completion_date>
  <phase>Phase 3</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>HI[hemagglutination Inhibition] derived parameters: Seroprotection rate(a lower bound of 95% CI) &gt; 70%</measure>
    <time_frame>At Day 28 post-vaccination</time_frame>
    <description>Seroprotection rate is the proportion of subjects achieving a post-vaccination HI titer ≥ 1:40</description>
  </primary_outcome>
  <primary_outcome>
    <measure>HI[hemagglutination Inhibition] derived parameters: Seroconversion rate(a lower bound of 95% CI) &gt; 40%</measure>
    <time_frame>At Day 28 post-vaccination</time_frame>
    <description>Seroconversion is defined as a pre-vaccination HI titer of &lt;1:10 with a post-vaccination titer ≥ 1:40, and a significant increase was defined as at least a four fold increase in HI titer</description>
  </primary_outcome>
  <primary_outcome>
    <measure>HI[hemagglutination Inhibition] derived parameters: GMR (a lower bound of 95% CI) &gt; 2.5</measure>
    <time_frame>At Day 28 post-vaccination</time_frame>
    <description>GMR [geometric mean ratio, mean fold increase]</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">171</enrollment>
  <condition>Influenza, Human</condition>
  <arm_group>
    <arm_group_label>NBP607-QIV 0.5mL</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Quadrivalent Inactivated Cell Culture-derived Influenza Vaccine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NBP607-TIV 0.25mL</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Trivalent Inactivated Cell Culture-derived Influenza Vaccine</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>NBP607-QIV</intervention_name>
    <description>For subjects 6 months to 35 months of age, Single dose administration, Intra-muscular [* 2 doses for subjects without influenza vaccination history, administered at least 4 weeks apart]</description>
    <arm_group_label>NBP607-QIV 0.5mL</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>NBP607-TIV</intervention_name>
    <description>For subjects 6 months to 35 months of age, Single dose administration, Intra-muscular [* 2 doses for subjects without influenza vaccination history, administered at least 4 weeks apart]</description>
    <arm_group_label>NBP607-TIV 0.25mL</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children aged 6 months to 35 months&#xD;
&#xD;
          -  Those who was born after normal pregnancy period(37 weeks) for aged 6 months to &lt; 1&#xD;
             year&#xD;
&#xD;
          -  Those whose legally acceptable representative have given written consent to&#xD;
             participate in the study and comply with all study requirements.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with immune deficiency disorder or malignant cancer.&#xD;
&#xD;
          -  History of any hypersensitivity following administration of vaccine or Guillain-Barre&#xD;
             syndrome.&#xD;
&#xD;
          -  Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination.&#xD;
&#xD;
          -  Subjects who experienced fever within 72 hours before vaccination or with the febrile&#xD;
             disease(exceeding 38.0℃) on screening day.&#xD;
&#xD;
          -  Subjects who had received immunosuppressant or immune-modifying drug within 3 months&#xD;
             before screening.&#xD;
&#xD;
          -  Subjects who had received blood products or immunoglobulin within 3 months before&#xD;
             screening.&#xD;
&#xD;
          -  Subjects who had received influenza vaccination within 6 months prior to the&#xD;
             screening.&#xD;
&#xD;
          -  Subjects who had received other vaccination within a month before screening, or those&#xD;
             who had another vaccination scheduled within a month after study vaccination.&#xD;
&#xD;
          -  Subjects who had received any other investigational products within 4 weeks prior to&#xD;
             study vaccination.&#xD;
&#xD;
          -  Subjects with clinically significant chronic disease.&#xD;
&#xD;
          -  Any other condition which, in the opinion of the Investigator, prevents the subject&#xD;
             from participating in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>35 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yun Kyung Kim</last_name>
    <role>Study Chair</role>
    <affiliation>Korea University Ansan Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hye Kyung Cho</last_name>
    <role>Principal Investigator</role>
    <affiliation>Gachon University Gil Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ki Hwan Kim</last_name>
    <role>Principal Investigator</role>
    <affiliation>Incheon St.Mary's Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Byung Wook Eun</last_name>
    <role>Principal Investigator</role>
    <affiliation>Eulji General Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Yae Jean Kim</last_name>
    <role>Principal Investigator</role>
    <affiliation>Samsung Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jina Lee</last_name>
    <role>Principal Investigator</role>
    <affiliation>Asan Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dong Ho Kim</last_name>
    <role>Principal Investigator</role>
    <affiliation>Korea Institute of Radiological and Medical Science</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hwang Min Kim</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wonju Severance Christian Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Nam Hee Kim</last_name>
    <role>Principal Investigator</role>
    <affiliation>Inje University Ilsan Paik Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dae Sun Jo</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chonbuk National University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Eun Young Cho</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chungnam National University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Seon Hee Shin</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hallym University Dongtan Sacred Heart Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Korea University ANSAN hospital</name>
      <address>
        <city>Ansan</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chungnam National University Hospital</name>
      <address>
        <city>Daejeon</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inje University Ilsan Paik Hospital</name>
      <address>
        <city>Goyang</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gachon University Gil Medical center</name>
      <address>
        <city>Incheon</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Catholic University of Korea, Incheon ST. Mary's Hospital</name>
      <address>
        <city>Incheon</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chonbuk National University Hospital</name>
      <address>
        <city>Jeonju</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eulji General Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hallym University Dongtan Sacred Heart Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Korea Institute of Radiological and Medical Science</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wonju Severance Christian Hospital</name>
      <address>
        <city>Wonju</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>October 2017</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>
  <last_update_submitted>October 31, 2017</last_update_submitted>
  <last_update_submitted_qc>October 31, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 1, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Influenza Vaccines</keyword>
  <keyword>Vaccines, Inactivated</keyword>
  <keyword>Cell Culture-Derived</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>
  <!-- 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/NCT03020628
org study id: NBP607-QIV_FluC_III_2016
nct id: NCT03020628
lead sponsor: 
has dmc: Yes
This study is a multi-center, randomized, double-blind Phase III Clinical trial. The purpose
      of this study is to assess the immunogenicity and safety of the quadrivalent cell
      culture-derived influenza vaccine compare to the trivalent cell culture-derived influenza
      vaccine in children aged 6~35 months.
Subjects are randomly assigned in a 2:1 ratio to NBP607-QIV 0.5mL versus NBP607-TIV 0.25mL.
      To assess the immunogenicity, antibody levels are evaluated by hemagglutination
      inhibition(HI) assay from sera obtained at pre-vaccination and 28 days post-vaccination. 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. The serious adverse
      events are collected during 6 months post-vaccination.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: HI[hemagglutination Inhibition] derived parameters: Seroprotection rate(a lower bound of 95% CI) > 70%
time frame: At Day 28 post-vaccination
description: Seroprotection rate is the proportion of subjects achieving a post-vaccination HI titer ≥ 1:40
measure: HI[hemagglutination Inhibition] derived parameters: Seroconversion rate(a lower bound of 95% CI) > 40%
time frame: At Day 28 post-vaccination
description: Seroconversion is defined as a pre-vaccination HI titer of <1:10 with a post-vaccination titer ≥ 1:40, and a significant increase was defined as at least a four fold increase in HI titer
measure: HI[hemagglutination Inhibition] derived parameters: GMR (a lower bound of 95% CI) > 2.5
time frame: At Day 28 post-vaccination
description: GMR [geometric mean ratio, mean fold increase]
arm group label: NBP607-QIV 0.5mL
arm group type: Experimental
description: Quadrivalent Inactivated Cell Culture-derived Influenza Vaccine
arm group label: NBP607-TIV 0.25mL
arm group type: Active Comparator
description: Trivalent Inactivated Cell Culture-derived Influenza Vaccine
intervention type: Biological
intervention name: NBP607-QIV
description: For subjects 6 months to 35 months of age, Single dose administration, Intra-muscular [* 2 doses for subjects without influenza vaccination history, administered at least 4 weeks apart]
arm group label: NBP607-QIV 0.5mL
intervention type: Biological
intervention name: NBP607-TIV
description: For subjects 6 months to 35 months of age, Single dose administration, Intra-muscular [* 2 doses for subjects without influenza vaccination history, administered at least 4 weeks apart]
arm group label: NBP607-TIV 0.25mL
criteria: 
gender: All
minimum age: 6 Months
maximum age: 35 Months
healthy volunteers: Accepts Healthy Volunteers
last name: Yun Kyung Kim
role: Study Chair
affiliation: Korea University Ansan Hospital
last name: Hye Kyung Cho
role: Principal Investigator
affiliation: Gachon University Gil Medical Center
last name: Ki Hwan Kim
role: Principal Investigator
affiliation: Incheon St.Mary's Hospital
last name: Byung Wook Eun
role: Principal Investigator
affiliation: Eulji General Hospital
last name: Yae Jean Kim
role: Principal Investigator
affiliation: Samsung Medical Center
last name: Jina Lee
role: Principal Investigator
affiliation: Asan Medical Center
last name: Dong Ho Kim
role: Principal Investigator
affiliation: Korea Institute of Radiological and Medical Science
last name: Hwang Min Kim
role: Principal Investigator
affiliation: Wonju Severance Christian Hospital
last name: Nam Hee Kim
role: Principal Investigator
affiliation: Inje University Ilsan Paik Hospital
last name: Dae Sun Jo
role: Principal Investigator
affiliation: Chonbuk National University Hospital
last name: Eun Young Cho
role: Principal Investigator
affiliation: Chungnam National University Hospital
last name: Seon Hee Shin
role: Principal Investigator
affiliation: Hallym University Dongtan Sacred Heart Hospital
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Influenza, Human
sharing ipd: No