<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/NCT03282370</url>
  </required_header>
  <id_info>
    <org_study_id>2017-JECEVAX-3</org_study_id>
    <nct_id>NCT03282370</nct_id>
  </id_info>
  <brief_title>Evaluate Safety and Immunogenicity of a Vero Cell-Derived JE Vaccine in 9-24 Months of Age Children in Vietnam</brief_title>
  <acronym>JECEVAX-3</acronym>
  <official_title>Evaluate the Safety and Immunogenicity of a Vero Cell - Derived Inactivated Japanese Encephalitis Vaccine (JECEVAX) Produced by VABIOTECH (Vietnam) in Vietnamese Children Aged 9-24 Months</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Institute of Hygiene and Epidemiology, Vietnam</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministry of Science and Technology, Vietnam</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ministry of Health, Vietnam</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>National Institute of Hygiene and Epidemiology, Vietnam</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>
      A study of the study vaccine (JECEVAX- VABIOTECH-Vietnam) and a licensed vaccine&#xD;
      (JEVAX-VABIOTECH-Vietnam) is conducted in Vietnamese children, aged 9 to 24 months to assess&#xD;
      the safety of the study vaccine compares to licenced vaccine. Two hundred and twenty children&#xD;
      are enrolled and randomly assigned into 2 groups (110 children/group), each of which receive&#xD;
      2 doses of study / control vaccine subcutaneously, at 28-34 days interval. Safety data&#xD;
      included immediate reaction at the injection site and systemic reaction within 30 min of&#xD;
      administration, solicited and unsolicited adverse events occurs from the 1st dose to 28-34&#xD;
      days after first dose and from the second dose to 28-34 days after 2nd dose. SAE (from start&#xD;
      of first dose to 28-34 days after second dose).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Mouse brain-derived Japanese Encephalitis (JE) vaccine was developed in Vietnam since 1989&#xD;
      with the support from WHO and BIKEN institute, Japan. It helped Viet Nam prevents Japanese&#xD;
      Encephalitis outbreaks successfully during those years.&#xD;
&#xD;
      However, mouse brain-derived JE vaccine production requires companies to compliance various&#xD;
      requirements from WHO. Especially, WHO has a plan to replace the mouse brain-derived JE&#xD;
      vaccines with Cell culture-derived JE vaccines.&#xD;
&#xD;
      Vero cell-derived vaccine technology shows many advantages compares to Mouse brain-derived&#xD;
      vaccine technology. VABIOTECH has been approved and sponsored by the Ministry of Science and&#xD;
      Technology to produce Vero cell - derived JE vaccine. The vaccine demonstrated a good safety&#xD;
      and immunogenicity profile in animal models. The vaccine has been proven safety in volunteer&#xD;
      adults and in phase 2 which evaluated the safety and immunogenicity of 3 difference antigen&#xD;
      concentrations.&#xD;
&#xD;
      In this study, a selected dose of the studied vaccine (JECEVAX) derived from phase 2 will be&#xD;
      compared the safety with a licensed vaccine (JEVAX-VABIOTECH Vietnam) in Vietnamese children,&#xD;
      aged 9-24 months to assess the safety and immunogenicity. Two hundred and twenty children are&#xD;
      enrolled and randomly assigned into 2 groups (110 children/group), each of which receive 2&#xD;
      doses of investigate vaccines or control vaccine subcutaneously, at 28-34 days interval.&#xD;
      Safety data included immediate reaction at the injection site and systemic reaction within 30&#xD;
      min of administration, solicited and unsolicited adverse events occurs from the 1st dose to&#xD;
      28-34 days after first dose (up to date of 2nd dose) and from the second dose to 28-34 days&#xD;
      after 2nd dose (up to date of 3rd visit). SAE (from start of first dose to 28-34 days after&#xD;
      second dose - date of 3rd visit).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 30, 2017</start_date>
  <completion_date type="Actual">April 8, 2018</completion_date>
  <primary_completion_date type="Actual">February 6, 2018</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>Percent of participants with treatment-related adverse events during study period.</measure>
    <time_frame>Up to 28-34 days after 2nd dose</time_frame>
    <description>Percent of participants with solicited and unsolicited adverse events after each dose of vaccine: immediately injection site and systemic AEs after vaccination (within 30 min), solicited AEs within 7 days after each dose, unsolicited AEs from date 1st dose 1 to date of dose 2 and from date of 2nd dose to 28-34 day post 2nd dose (3rd visit), as assessed by CTCAE v.4.0.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percent of participants who has antibody sero-conversion in study group and control group at 28-34 days post dose 2.</measure>
    <time_frame>Up to 28-34 days after 2nd dose</time_frame>
    <description>Serum samples will be taken before 1 dose and 28-34 days post 2nd dose to be tested for JE antibody by PRNT.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Frequencies of participants with treatment-related SAE during study period</measure>
    <time_frame>Up to 28-34 days after the 2nd dose (3rd visit)</time_frame>
    <description>Frequencies of participants with treatment-related SAE during study period of JECEVAX compared to that of JEVAX, as assessed by CTCAE ver 4.0</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">655</enrollment>
  <condition>Japanese Encephalitis</condition>
  <arm_group>
    <arm_group_label>JECEVAX</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>JECEVAX - VABIOTECH Vietnam Liquid form Composition: 0.5 BR209 Subcutaneous injection 0.5ml/dose, 2 doses, interval 28-34 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>JEVAX</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>JEVAX - VABIOTECH Vietnam Liquid form Composition: 1,0 BR209 Subcutaneous injection 0.5ml/dose, 2 doses, interval 28-34 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>JEVAX</intervention_name>
    <description>JEVAX - VABIOTECH Vietnam Liquid form Subcutaneous injection 0.5ml/dose, 2 doses, 28-34 days interval</description>
    <arm_group_label>JEVAX</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>JECEVAX</intervention_name>
    <description>JECEVAX - VABIOTECH Vietnam Liquid form Composition: 0.5 BR209 Subcutaneous injection 0.5ml/dose, 2 doses, interval 28-34 days</description>
    <arm_group_label>JECEVAX</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy children of both sexes, 9-24 months of age;&#xD;
&#xD;
          -  Have not been vaccinated with JE vaccine;&#xD;
&#xD;
          -  Parents/legally guardians agree their children to participate in the study and sign&#xD;
             the paper informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Currently has chronic diseases (cardiovascular, liver and spleen related etc);&#xD;
&#xD;
          -  Currently has acute diseases;&#xD;
&#xD;
          -  Use of immunocompromised treatment within 4 weeks of enrollment;&#xD;
&#xD;
          -  Being immunocompromised and autoimmune diseases (HIV, lupus);&#xD;
&#xD;
          -  The family history of immunocompromised;&#xD;
&#xD;
          -  History of febrile seizure;&#xD;
&#xD;
          -  Allergic to any vaccine component;&#xD;
&#xD;
          -  Fever (&gt;38 Celsius degree) within 3 days before vaccination or at enrollment;&#xD;
&#xD;
          -  Malnourished (2nd grade or above);&#xD;
&#xD;
          -  Blood disorder;&#xD;
&#xD;
          -  Use of vaccines which have not been licenced 7 days before enrolment in this study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>9 Months</minimum_age>
    <maximum_age>24 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thiem D Vu, MD., PhD.</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Institute of Hygiene and Epidemiology, Vietnam</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hoa Binh Provincial Preventive Medicine Center</name>
      <address>
        <city>Hòa Bình</city>
        <state>Hoa Binh</state>
        <zip>350000</zip>
        <country>Vietnam</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hoa Binh City Health Center</name>
      <address>
        <city>Hòa Bình</city>
        <state>Hoa Binh</state>
        <zip>35000</zip>
        <country>Vietnam</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>District Health Center</name>
      <address>
        <city>Thanh Son</city>
        <state>Phu Tho</state>
        <country>Vietnam</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Phu Tho Preventive Medicine Center</name>
      <address>
        <city>Viet tri</city>
        <state>Phu Tho</state>
        <country>Vietnam</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Vietnam</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>July 1, 2017</study_first_submitted>
  <study_first_submitted_qc>September 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 13, 2017</study_first_posted>
  <last_update_submitted>September 14, 2018</last_update_submitted>
  <last_update_submitted_qc>September 14, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 17, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Institute of Hygiene and Epidemiology, Vietnam</investigator_affiliation>
    <investigator_full_name>Vu Dinh Thiem</investigator_full_name>
    <investigator_title>Head, Department of Epidemiology</investigator_title>
  </responsible_party>
  <keyword>Japanese Encephalitis</keyword>
  <keyword>JECEVAX</keyword>
  <keyword>Vietnam</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Encephalitis, Japanese</mesh_term>
    <mesh_term>Encephalitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Individual data with identification removed are to be available for Ethical committee, Ministry of Health and National Foundation of Science and Technology Development to avoid misuse of data.&#xD;
Public shared data will be in the form of summarised tables and figures.</ipd_description>
  </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/NCT03282370
org study id: 2017-JECEVAX-3
nct id: NCT03282370
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
A study of the study vaccine (JECEVAX- VABIOTECH-Vietnam) and a licensed vaccine
      (JEVAX-VABIOTECH-Vietnam) is conducted in Vietnamese children, aged 9 to 24 months to assess
      the safety of the study vaccine compares to licenced vaccine. Two hundred and twenty children
      are enrolled and randomly assigned into 2 groups (110 children/group), each of which receive
      2 doses of study / control vaccine subcutaneously, at 28-34 days interval. Safety data
      included immediate reaction at the injection site and systemic reaction within 30 min of
      administration, solicited and unsolicited adverse events occurs from the 1st dose to 28-34
      days after first dose and from the second dose to 28-34 days after 2nd dose. SAE (from start
      of first dose to 28-34 days after second dose).
Mouse brain-derived Japanese Encephalitis (JE) vaccine was developed in Vietnam since 1989
      with the support from WHO and BIKEN institute, Japan. It helped Viet Nam prevents Japanese
      Encephalitis outbreaks successfully during those years.

      However, mouse brain-derived JE vaccine production requires companies to compliance various
      requirements from WHO. Especially, WHO has a plan to replace the mouse brain-derived JE
      vaccines with Cell culture-derived JE vaccines.

      Vero cell-derived vaccine technology shows many advantages compares to Mouse brain-derived
      vaccine technology. VABIOTECH has been approved and sponsored by the Ministry of Science and
      Technology to produce Vero cell - derived JE vaccine. The vaccine demonstrated a good safety
      and immunogenicity profile in animal models. The vaccine has been proven safety in volunteer
      adults and in phase 2 which evaluated the safety and immunogenicity of 3 difference antigen
      concentrations.

      In this study, a selected dose of the studied vaccine (JECEVAX) derived from phase 2 will be
      compared the safety with a licensed vaccine (JEVAX-VABIOTECH Vietnam) in Vietnamese children,
      aged 9-24 months to assess the safety and immunogenicity. Two hundred and twenty children are
      enrolled and randomly assigned into 2 groups (110 children/group), each of which receive 2
      doses of investigate vaccines or control vaccine subcutaneously, at 28-34 days interval.
      Safety data included immediate reaction at the injection site and systemic reaction within 30
      min of administration, solicited and unsolicited adverse events occurs from the 1st dose to
      28-34 days after first dose (up to date of 2nd dose) and from the second dose to 28-34 days
      after 2nd dose (up to date of 3rd visit). SAE (from start of first dose to 28-34 days after
      second dose - date of 3rd visit).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Percent of participants with treatment-related adverse events during study period.
time frame: Up to 28-34 days after 2nd dose
description: Percent of participants with solicited and unsolicited adverse events after each dose of vaccine: immediately injection site and systemic AEs after vaccination (within 30 min), solicited AEs within 7 days after each dose, unsolicited AEs from date 1st dose 1 to date of dose 2 and from date of 2nd dose to 28-34 day post 2nd dose (3rd visit), as assessed by CTCAE v.4.0.
measure: Percent of participants who has antibody sero-conversion in study group and control group at 28-34 days post dose 2.
time frame: Up to 28-34 days after 2nd dose
description: Serum samples will be taken before 1 dose and 28-34 days post 2nd dose to be tested for JE antibody by PRNT.
measure: Frequencies of participants with treatment-related SAE during study period
time frame: Up to 28-34 days after the 2nd dose (3rd visit)
description: Frequencies of participants with treatment-related SAE during study period of JECEVAX compared to that of JEVAX, as assessed by CTCAE ver 4.0
arm group label: JECEVAX
arm group type: Experimental
description: JECEVAX - VABIOTECH Vietnam Liquid form Composition: 0.5 BR209 Subcutaneous injection 0.5ml/dose, 2 doses, interval 28-34 days
arm group label: JEVAX
arm group type: Active Comparator
description: JEVAX - VABIOTECH Vietnam Liquid form Composition: 1,0 BR209 Subcutaneous injection 0.5ml/dose, 2 doses, interval 28-34 days
intervention type: Biological
intervention name: JEVAX
description: JEVAX - VABIOTECH Vietnam Liquid form Subcutaneous injection 0.5ml/dose, 2 doses, 28-34 days interval
arm group label: JEVAX
intervention type: Biological
intervention name: JECEVAX
description: JECEVAX - VABIOTECH Vietnam Liquid form Composition: 0.5 BR209 Subcutaneous injection 0.5ml/dose, 2 doses, interval 28-34 days
arm group label: JECEVAX
criteria: 
gender: All
minimum age: 9 Months
maximum age: 24 Months
healthy volunteers: Accepts Healthy Volunteers
last name: Thiem D Vu, MD., PhD.
role: Principal Investigator
affiliation: National Institute of Hygiene and Epidemiology, Vietnam
facility: 
facility: 
facility: 
facility: 
country: Vietnam
responsible party type: Principal Investigator
investigator affiliation: National Institute of Hygiene and Epidemiology, Vietnam
investigator full name: Vu Dinh Thiem
investigator title: Head, Department of Epidemiology
mesh term: Encephalitis, Japanese
mesh term: Encephalitis
sharing ipd: No
ipd description: Individual data with identification removed are to be available for Ethical committee, Ministry of Health and National Foundation of Science and Technology Development to avoid misuse of data.
Public shared data will be in the form of summarised tables and figures.