<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/NCT02992925</url>
  </required_header>
  <id_info>
    <org_study_id>BK1310-J01</org_study_id>
    <nct_id>NCT02992925</nct_id>
  </id_info>
  <brief_title>Phase 3 Study of BK1310 in Healthy Infants</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mitsubishi Tanabe Pharma Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Research Foundation for Microbial Diseases of Osaka University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Mitsubishi Tanabe Pharma Corporation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to:&#xD;
&#xD;
        -  (cohort 1) evaluate safety and immunogenicity (Haemophilus influenzae type b, Hib) of&#xD;
           BK1310.&#xD;
&#xD;
        -  (cohort 2) evaluate efficacy and safety of BK1310 using ActHIB® and Tetrabik as a&#xD;
           control in healthy infants.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      &lt;Cohort 1&gt;&#xD;
&#xD;
        -  Arm: BK1310-High. Intervention: DPT-IPV-Hib-High(Combined Vaccine) 0.5mL, subcutaneous&#xD;
           injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13&#xD;
           months.&#xD;
&#xD;
        -  Arm: BK1310-Low. Intervention: DPT-IPV-Hib-Low(Combined Vaccine) 0.5mL, subcutaneous&#xD;
           injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13&#xD;
           months.&#xD;
&#xD;
      &lt;Cohort 2&gt;&#xD;
&#xD;
        -  Arm: BK1310-High or Low. Intervention: DPT-IPV-Hib-High(Combined Vaccine) or&#xD;
           DPT-IPV-Hib-Low(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the&#xD;
           3-8weeks intervals.&#xD;
&#xD;
        -  Arm: ActHIB® and Tetrabik. Intervention: Hib vaccine and DPT-IPV 0.5mL, subcutaneous&#xD;
           injection, 3 times with the 3-8weeks intervals.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2016</start_date>
  <completion_date type="Actual">November 2018</completion_date>
  <primary_completion_date type="Actual">December 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>Antibody prevalence rate against anti-PRP with 1 μg/mL or higher, diphtheria toxin, pertussis, tetanus toxin, and polio virus</measure>
    <time_frame>4 weeks after the primary immunization (Visit 4)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Anti-PRP antibody prevalence rate with 0.15 μg/mL or higher</measure>
    <time_frame>4 weeks after the primary immunization (Visit 4)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geometric mean antibody titer of anti-PRP antibody</measure>
    <time_frame>4 weeks after the primary immunization (Visit 4)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anti-PRP antibody prevalence rate with 1 μg/mL or higher</measure>
    <time_frame>4 weeks after the booster dose (Visit 6)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anti-PRP antibody prevalence rate with 0.15 μg/mL or higher</measure>
    <time_frame>4 weeks after the booster dose (Visit 6)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geometric mean antibody titer of anti-PRP antibody</measure>
    <time_frame>4 weeks after the booster dose (Visit 6)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geometric mean antibody titer against diphtheria toxin, pertussis, tetanus toxin, and polio virus</measure>
    <time_frame>4 weeks after the primary immunization (Visit 4)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Antibody prevalence rate against diphtheria toxin, pertussis, tetanus toxin, and polio virus</measure>
    <time_frame>4 weeks after the booster dose (Visit 6)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geometric mean antibody titer against diphtheria toxin, pertussis, tetanus toxin, and polio virus</measure>
    <time_frame>4 weeks after the booster dose (Visit 6)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with adverse events and adverse reactions</measure>
    <time_frame>Through the first dose (Visit 1) to 4 weeks after the booster dose (Visit 6)</time_frame>
    <description>Cohort 1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with adverse events and adverse reactions</measure>
    <time_frame>Through the first dose (Visit 1) to 4 weeks after the primary immunization (Visit 4)</time_frame>
    <description>Cohort 2</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">370</enrollment>
  <condition>Immunization; Infection</condition>
  <arm_group>
    <arm_group_label>Cohort 1: BK1310-High</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 1: BK1310-Low</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2: BK1310-High or -Low</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Either BK1310-High or -Low will be chosen based on the result of cohort 1</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2: ActHIB® and Tetrabik</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>DPT-IPV-Hib-High（Combined Vaccine）</intervention_name>
    <arm_group_label>Cohort 1: BK1310-High</arm_group_label>
    <arm_group_label>Cohort 2: BK1310-High or -Low</arm_group_label>
    <other_name>BK1310-High</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>DPT-IPV-Hib-Low（Combined Vaccine）</intervention_name>
    <arm_group_label>Cohort 1: BK1310-Low</arm_group_label>
    <arm_group_label>Cohort 2: BK1310-High or -Low</arm_group_label>
    <other_name>BK1310-Low</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Hib vaccine</intervention_name>
    <arm_group_label>Cohort 2: ActHIB® and Tetrabik</arm_group_label>
    <other_name>ActHIB®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>DPT-IPV</intervention_name>
    <arm_group_label>Cohort 2: ActHIB® and Tetrabik</arm_group_label>
    <other_name>Tetrabik</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy infants aged ≥2 and &lt;43 months at the first vaccination of the study drug&#xD;
             (recommended: ≥2 and &lt;7 months). Those who are applicable of the following conditions&#xD;
             must be carefully observed before the enrollment: infants with known underlying&#xD;
             disease such as cardiovascular disease, renal disease, hepatic disease, blood&#xD;
             dyscrasia, respiratory disease or developmental disorder. Infants who developed fever&#xD;
             within 2 days after any previous vaccination. Infants with history of convulsions.&#xD;
&#xD;
          -  Written informed consent is obtained from a legal guardian (parent)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  With past diagnosis of immunodeficiency or currently under immunosuppressive treatment&#xD;
&#xD;
          -  Have close relatives (the third degree of kinship) diagnosed with congenital&#xD;
             immunodeficiency&#xD;
&#xD;
          -  Possibility of anaphylaxis due to food or pharmaceuticals&#xD;
&#xD;
          -  With experience of Hib infection, diphtheria, pertussis, tetanus or acute&#xD;
             poliomyelitis&#xD;
&#xD;
          -  With experience of Hib, diphteria, pertussis, tetanus or polio vaccination.&#xD;
&#xD;
          -  Administered a live vaccine within 27 days before the first vaccination of the study&#xD;
             drug, or inactivated vaccine or toxoid within 6 days before vaccination&#xD;
&#xD;
          -  Administered transfusion, immunosuppressant (excluding drugs for external use), or&#xD;
             immunoglobulin formulation&#xD;
&#xD;
          -  Administered corticosteroid 2 mg/kg per day or more as prednisolone (excluding drugs&#xD;
             for external use)&#xD;
&#xD;
          -  Participated in other studies within 12 weeks before obtaining consent&#xD;
&#xD;
          -  With the gestational age &lt;37 weeks or weighed less than 2500 grams at birth.&#xD;
&#xD;
          -  Considered to be not eligible by the principal investigators (sub-investigators) of&#xD;
             the enrollment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Months</minimum_age>
    <maximum_age>43 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>General Manager</last_name>
    <role>Study Director</role>
    <affiliation>Mitsubishi Tanabe Pharma Corporation</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Fukuoka-shi</city>
        <state>Fukuoka</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kasuga-shi</city>
        <state>Fukuoka</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Sendai-shi</city>
        <state>Miyagi</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>December 1, 2016</study_first_submitted>
  <study_first_submitted_qc>December 12, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 14, 2016</study_first_posted>
  <last_update_submitted>February 4, 2019</last_update_submitted>
  <last_update_submitted_qc>February 4, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 6, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Haemophilus influenza type b</keyword>
  <keyword>Adsorbed Diphteria-purified Pertussis-Tetanus-Inactivate poliovirus combined vaccine</keyword>
  <keyword>Hib</keyword>
  <keyword>DPT-IPV</keyword>
  <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>


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/NCT02992925
org study id: BK1310-J01
nct id: NCT02992925
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to:

        -  (cohort 1) evaluate safety and immunogenicity (Haemophilus influenzae type b, Hib) of
           BK1310.

        -  (cohort 2) evaluate efficacy and safety of BK1310 using ActHIB® and Tetrabik as a
           control in healthy infants.
<Cohort 1>

        -  Arm: BK1310-High. Intervention: DPT-IPV-Hib-High(Combined Vaccine) 0.5mL, subcutaneous
           injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13
           months.

        -  Arm: BK1310-Low. Intervention: DPT-IPV-Hib-Low(Combined Vaccine) 0.5mL, subcutaneous
           injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13
           months.

      <Cohort 2>

        -  Arm: BK1310-High or Low. Intervention: DPT-IPV-Hib-High(Combined Vaccine) or
           DPT-IPV-Hib-Low(Combined Vaccine) 0.5mL, subcutaneous injection, 3 times with the
           3-8weeks intervals.

        -  Arm: ActHIB® and Tetrabik. Intervention: Hib vaccine and DPT-IPV 0.5mL, subcutaneous
           injection, 3 times with the 3-8weeks intervals.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Antibody prevalence rate against anti-PRP with 1 μg/mL or higher, diphtheria toxin, pertussis, tetanus toxin, and polio virus
time frame: 4 weeks after the primary immunization (Visit 4)
measure: Anti-PRP antibody prevalence rate with 0.15 μg/mL or higher
time frame: 4 weeks after the primary immunization (Visit 4)
measure: Geometric mean antibody titer of anti-PRP antibody
time frame: 4 weeks after the primary immunization (Visit 4)
measure: Anti-PRP antibody prevalence rate with 1 μg/mL or higher
time frame: 4 weeks after the booster dose (Visit 6)
measure: Anti-PRP antibody prevalence rate with 0.15 μg/mL or higher
time frame: 4 weeks after the booster dose (Visit 6)
measure: Geometric mean antibody titer of anti-PRP antibody
time frame: 4 weeks after the booster dose (Visit 6)
measure: Geometric mean antibody titer against diphtheria toxin, pertussis, tetanus toxin, and polio virus
time frame: 4 weeks after the primary immunization (Visit 4)
measure: Antibody prevalence rate against diphtheria toxin, pertussis, tetanus toxin, and polio virus
time frame: 4 weeks after the booster dose (Visit 6)
measure: Geometric mean antibody titer against diphtheria toxin, pertussis, tetanus toxin, and polio virus
time frame: 4 weeks after the booster dose (Visit 6)
measure: Number of participants with adverse events and adverse reactions
time frame: Through the first dose (Visit 1) to 4 weeks after the booster dose (Visit 6)
description: Cohort 1
measure: Number of participants with adverse events and adverse reactions
time frame: Through the first dose (Visit 1) to 4 weeks after the primary immunization (Visit 4)
description: Cohort 2
arm group label: Cohort 1: BK1310-High
arm group type: Experimental
arm group label: Cohort 1: BK1310-Low
arm group type: Experimental
arm group label: Cohort 2: BK1310-High or -Low
arm group type: Experimental
description: Either BK1310-High or -Low will be chosen based on the result of cohort 1
arm group label: Cohort 2: ActHIB® and Tetrabik
arm group type: Active Comparator
intervention type: Biological
intervention name: DPT-IPV-Hib-High（Combined Vaccine）
arm group label: Cohort 1: BK1310-High
arm group label: Cohort 2: BK1310-High or -Low
other name: BK1310-High
intervention type: Biological
intervention name: DPT-IPV-Hib-Low（Combined Vaccine）
arm group label: Cohort 1: BK1310-Low
arm group label: Cohort 2: BK1310-High or -Low
other name: BK1310-Low
intervention type: Biological
intervention name: Hib vaccine
arm group label: Cohort 2: ActHIB® and Tetrabik
other name: ActHIB®
intervention type: Biological
intervention name: DPT-IPV
arm group label: Cohort 2: ActHIB® and Tetrabik
other name: Tetrabik
criteria: 
gender: All
minimum age: 2 Months
maximum age: 43 Months
healthy volunteers: Accepts Healthy Volunteers
last name: General Manager
role: Study Director
affiliation: Mitsubishi Tanabe Pharma Corporation
facility: 
facility: 
facility: 
country: Japan
responsible party type: Sponsor
mesh term: Vaccines