<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/NCT03281174</url>
  </required_header>
  <id_info>
    <org_study_id>PRO-EV71-4007</org_study_id>
    <nct_id>NCT03281174</nct_id>
  </id_info>
  <brief_title>Five-year Immune Persistence Study of Inactivated Enterovirus Type 71 (EV71) Vaccine</brief_title>
  <official_title>Phase IV, Open-labelled, Five-year Immune Persistence Study of Inactivated Enterovirus Type 71 (EV71) Vaccine</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sinovac Biotech Co., Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sinovac Biotech Co., Ltd</source>
  <oversight_info>
    <has_dmc>No</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>
      The purpose of this study is to evaluate the 5-year Immune Persistence of Inactivated&#xD;
      Enterovirus Type 71 (EV71) Vaccine manufactured by Sinovac (Beijing) Biotech Co., Ltd.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The phase III, efficacy trial of inactivated vaccine (vero cell) against EV71 has completed&#xD;
      on March 2013 in China,and a follow up study for phase III clinical trial has completed on&#xD;
      March 2014.&#xD;
&#xD;
      On the basis of phase III, this study is the Phase IV, open-labelled research, in order to&#xD;
      evaluate the 5-year immune persistence of EV71 vaccine.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 20, 2017</start_date>
  <completion_date type="Actual">May 21, 2017</completion_date>
  <primary_completion_date type="Actual">May 21, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The seropositive rate of EV71 neutralizing antibody-1</measure>
    <time_frame>5 years (64 months)</time_frame>
    <description>Calculated based on the cutoff value of 1:8</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The seropositive rate of EV71 neutralizing antibody-2</measure>
    <time_frame>5 years (64 months)</time_frame>
    <description>Calculated based on the cutoff value of 1:16</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The seropositive rate of EV71 neutralizing antibody-3</measure>
    <time_frame>5 years (64 months)</time_frame>
    <description>Calculated based on the cutoff value of 1:32</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The GMT of EV71 neutralizing antibody</measure>
    <time_frame>5 years (64 months)</time_frame>
    <description>The GMT of EV71 neutralizing antibody 64 months after the first dose injection</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">343</enrollment>
  <condition>Hand, Foot and Mouth Disease</condition>
  <arm_group>
    <arm_group_label>EV71 vaccine group</arm_group_label>
    <description>The group which received two doses EV71 vaccine (400U/0.5ml) on day 0,28 in phase III clinical trial.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo group</arm_group_label>
    <description>The group which received two doses placebo (0U/0.5ml) on day 0,28 in phase III clinical trial.</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      The venous blood was collected for EV71 neutralizing antibody detection&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The studied subjects are infants aged 6-35 months old infants when enrolled into the phase&#xD;
        III clinical trial, and they are children aged 6-8 years old five years after the EV71&#xD;
        vaccine /placebo injection.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        In the prior phase III clinical trial, 10077 subjects in three counties (Ganyu, Sheyang and&#xD;
        Taixing ) were enrolled ( Experimental group: 5044; Control group: 5043 ), with 1293 of&#xD;
        them in immunogenicity subgroup (Experimental group: 648; Control group: 645). In Sheyang&#xD;
        county, 3351 subjects were enrolled (Experimental group: 1676 ; Control group :1675) , with&#xD;
        435 of them in immunogenicity subgroup (Experimental group: 418 ; Control group :418).&#xD;
&#xD;
        The subjects in Sheyang immunogenicity subgroup with the following conditions were included&#xD;
        in this study:&#xD;
&#xD;
          -  Guardian(s) of the volunteer should be capable of understanding the written consent&#xD;
             form, and such form should be signed before the infant being included into this study&#xD;
&#xD;
          -  Received at least one injection of EV71 vaccine or the placebo in the phase III&#xD;
             clinical trial&#xD;
&#xD;
          -  Finished the blood sampling 64 months after the vaccination&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Received extra EV71 vaccination after the phase III clinical trial&#xD;
&#xD;
          -  Refused to join 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>Yuemei Hu</last_name>
    <role>Principal Investigator</role>
    <affiliation>Jiangsu Provicial Center for Disease Control and Prevention</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sheyang Center for Disease Control and Prevention</name>
      <address>
        <city>Yancheng</city>
        <state>Jiangsu</state>
        <zip>210009</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 8, 2017</study_first_submitted>
  <study_first_submitted_qc>September 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 13, 2017</study_first_posted>
  <last_update_submitted>September 8, 2017</last_update_submitted>
  <last_update_submitted_qc>September 8, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Inactivated Enterovirus Type 71 (EV71) Vaccine</keyword>
  <keyword>5-year Immune Persistence</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Enterovirus Infections</mesh_term>
    <mesh_term>Foot-and-Mouth Disease</mesh_term>
    <mesh_term>Hand, Foot and Mouth Disease</mesh_term>
    <mesh_term>Mouth Diseases</mesh_term>
  </condition_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/NCT03281174
org study id: PRO-EV71-4007
nct id: NCT03281174
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the 5-year Immune Persistence of Inactivated
      Enterovirus Type 71 (EV71) Vaccine manufactured by Sinovac (Beijing) Biotech Co., Ltd.
The phase III, efficacy trial of inactivated vaccine (vero cell) against EV71 has completed
      on March 2013 in China,and a follow up study for phase III clinical trial has completed on
      March 2014.

      On the basis of phase III, this study is the Phase IV, open-labelled research, in order to
      evaluate the 5-year immune persistence of EV71 vaccine.
observational model: Other
time perspective: Prospective
measure: The seropositive rate of EV71 neutralizing antibody-1
time frame: 5 years (64 months)
description: Calculated based on the cutoff value of 1:8
measure: The seropositive rate of EV71 neutralizing antibody-2
time frame: 5 years (64 months)
description: Calculated based on the cutoff value of 1:16
measure: The seropositive rate of EV71 neutralizing antibody-3
time frame: 5 years (64 months)
description: Calculated based on the cutoff value of 1:32
measure: The GMT of EV71 neutralizing antibody
time frame: 5 years (64 months)
description: The GMT of EV71 neutralizing antibody 64 months after the first dose injection
arm group label: EV71 vaccine group
description: The group which received two doses EV71 vaccine (400U/0.5ml) on day 0,28 in phase III clinical trial.
arm group label: Placebo group
description: The group which received two doses placebo (0U/0.5ml) on day 0,28 in phase III clinical trial.
The venous blood was collected for EV71 neutralizing antibody detection
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 6 Months
maximum age: 35 Months
healthy volunteers: Accepts Healthy Volunteers
last name: Yuemei Hu
role: Principal Investigator
affiliation: Jiangsu Provicial Center for Disease Control and Prevention
facility: 
country: China
responsible party type: Sponsor
mesh term: Enterovirus Infections
mesh term: Foot-and-Mouth Disease
mesh term: Hand, Foot and Mouth Disease
mesh term: Mouth Diseases