<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/NCT02200237</url>
  </required_header>
  <id_info>
    <org_study_id>CT-EV-21</org_study_id>
    <nct_id>NCT02200237</nct_id>
  </id_info>
  <brief_title>A Clinical Study for Inactivated Vaccine Against EV71</brief_title>
  <acronym>EV71</acronym>
  <sponsors>
    <lead_sponsor>
      <agency>Medigen Vaccine Biologics Corp.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medigen Vaccine Biologics Corp.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to evaluate the safety, reactogenicity and immunogenicity of EV71 vaccine in&#xD;
      health children and infants aged from 2 months to &lt;12yrs.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">August 2017</completion_date>
  <primary_completion_date type="Actual">May 2017</primary_completion_date>
  <phase>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>To evaluate overall safety of EV71 vaccine in children, throughout the study period</measure>
    <time_frame>2 years after study initiation</time_frame>
    <description>Occurrence of overall adverse events and serious adverse events during the entire period of study.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To evaluate immunogenicity, serum neutralizing antibody titers humoral immune response, induced by candidate vaccine</measure>
    <time_frame>2 years from study initiation</time_frame>
    <description>To evaluate the immunogencity in terms of&#xD;
Geometric mean titer (GMT) of EV71 neutralizing antibody titers&#xD;
Post-vaccination-to-pre-vaccination GMT ratio of EV 71 neutralizing antibody titers&#xD;
Seropositivity rate</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">366</enrollment>
  <condition>Enterovirus 71 Human</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Phosphate Buffer Saline with adjuvant aluminium phosphate</description>
  </arm_group>
  <arm_group>
    <arm_group_label>EV71 with adjuvant aluminium phosphate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Inactive whole monovalent EV71 virion vaccine formulated with phosphate-buffered saline based adjuvanted aluminium phosphate 150 μg/0.5ml</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>EV71 with adjuvant aluminium phosphate</intervention_name>
    <description>Two arms, EV71 with aluminium phosphate</description>
    <arm_group_label>EV71 with adjuvant aluminium phosphate</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Phosphate Buffer Saline with adjuvant aluminium phosphate</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Main Inclusion Criteria:&#xD;
&#xD;
          1. Healthy children and infants aged from 2 months to less than 12 years as established&#xD;
             by medical history and clinical examination&#xD;
&#xD;
          2. The subjects' guardians are able to understand and sign the informed consent&#xD;
&#xD;
        Main Exclusion Criteria:&#xD;
&#xD;
          1. Subject with previous known exposure to EV71.&#xD;
&#xD;
          2. Subject with a history of herpangina or hand, foot and mouth disease associated with&#xD;
             enterovirus infection in the past 3 months.&#xD;
&#xD;
          3. Subject who was diagnosed with a significant neurological, pulmonary, cardiovascular,&#xD;
             hematological, hepatic or renal disorder.&#xD;
&#xD;
          4. Use of any investigational/non-registered product (including drug, vaccine and&#xD;
             invasive medical device) within 30 days prior to vaccination or planned use during&#xD;
             study period.&#xD;
&#xD;
          5. Subject with any confirmed or suspected autoimmune disorder, or immunodeficiency&#xD;
&#xD;
          6. Use of immunoglobulins or any blood products within 3 months prior to vaccination or&#xD;
             planned use during the whole study period.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Months</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Li-Min Huang, M.D., PhD.</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Taiwan University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chang-Guang Memorial Hospital Lin-Kou</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Far Eastern Memorial Hospital</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MacKay Memorial Hospital</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Taiwan University Hosptial</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>July 18, 2014</study_first_submitted>
  <study_first_submitted_qc>July 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 25, 2014</study_first_posted>
  <last_update_submitted>August 15, 2017</last_update_submitted>
  <last_update_submitted_qc>August 15, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 18, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>EV71 Vaccine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Enterovirus Infections</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aluminum phosphate</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/NCT02200237
org study id: CT-EV-21
nct id: NCT02200237
lead sponsor: 
has dmc: Yes
This study aims to evaluate the safety, reactogenicity and immunogenicity of EV71 vaccine in
      health children and infants aged from 2 months to <12yrs.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: To evaluate overall safety of EV71 vaccine in children, throughout the study period
time frame: 2 years after study initiation
description: Occurrence of overall adverse events and serious adverse events during the entire period of study.
measure: To evaluate immunogenicity, serum neutralizing antibody titers humoral immune response, induced by candidate vaccine
time frame: 2 years from study initiation
description: To evaluate the immunogencity in terms of
Geometric mean titer (GMT) of EV71 neutralizing antibody titers
Post-vaccination-to-pre-vaccination GMT ratio of EV 71 neutralizing antibody titers
Seropositivity rate
arm group label: Placebo
arm group type: Placebo Comparator
description: Phosphate Buffer Saline with adjuvant aluminium phosphate
arm group label: EV71 with adjuvant aluminium phosphate
arm group type: Experimental
description: Inactive whole monovalent EV71 virion vaccine formulated with phosphate-buffered saline based adjuvanted aluminium phosphate 150 μg/0.5ml
intervention type: Biological
intervention name: EV71 with adjuvant aluminium phosphate
description: Two arms, EV71 with aluminium phosphate
arm group label: EV71 with adjuvant aluminium phosphate
intervention type: Biological
intervention name: Placebo
description: Phosphate Buffer Saline with adjuvant aluminium phosphate
arm group label: Placebo
criteria: 
gender: All
minimum age: 2 Months
maximum age: 12 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Li-Min Huang, M.D., PhD.
role: Principal Investigator
affiliation: National Taiwan University Hospital
facility: 
facility: 
facility: 
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Enterovirus Infections
mesh term: Aluminum phosphate