<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/NCT02983656</url>
  </required_header>
  <id_info>
    <org_study_id>ZJCDC20161121</org_study_id>
    <nct_id>NCT02983656</nct_id>
  </id_info>
  <brief_title>Analysis on AEFI Surveillance Data for Live Attenuated Varicella Vaccine</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zhejiang Provincial Center for Disease Control and Prevention</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Changchun Keygen Biological Products Co., Ltd.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Zhejiang Provincial Center for Disease Control and Prevention</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to observe the occurrence of adverse events of live attenuated&#xD;
      varicella vaccine.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2016</start_date>
  <completion_date type="Actual">August 31, 2017</completion_date>
  <primary_completion_date type="Actual">August 31, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>incidence of adverse reactions</measure>
    <time_frame>1 year after the first and second doses</time_frame>
  </primary_outcome>
  <enrollment type="Actual">394</enrollment>
  <condition>Varicocele</condition>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>live attenuated varicella vaccine</intervention_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Participant preventive inoculation of varicella vaccine in 2014-2015&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The registered permanent residence or resident place are local (reside more than 3&#xD;
             months);&#xD;
&#xD;
          -  Participant preventive inoculation of varicella vaccine in 2014-2015;&#xD;
&#xD;
          -  Adverse reactions occurred and should be reported in the AEFI monitoring system.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with a known allergy to any ingredient of the vaccine, and with any allergy&#xD;
             history to any vaccine;&#xD;
&#xD;
          -  Subjects with any acute diseases, severe chronic diseases, acute bout of chronic&#xD;
             diseases, and catching cold and fever;&#xD;
&#xD;
          -  Subjects with uncontrolled seizures and other progressive neurological diseases, with&#xD;
             a history of Guillain-Barré syndrome.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>15 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Qian Li, Bachelor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Zhejiang Provincial Center for Disease Control and Prevention</affiliation>
  </overall_official>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>December 1, 2016</study_first_submitted>
  <study_first_submitted_qc>December 1, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 6, 2016</study_first_posted>
  <last_update_submitted>January 10, 2018</last_update_submitted>
  <last_update_submitted_qc>January 10, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 11, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Zhejiang Provincial Center for Disease Control and Prevention</investigator_affiliation>
    <investigator_full_name>Qian Li</investigator_full_name>
    <investigator_title>Deputy chief physician</investigator_title>
  </responsible_party>
  <keyword>Vaccine Safety</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Varicocele</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/NCT02983656
org study id: ZJCDC20161121
nct id: NCT02983656
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to observe the occurrence of adverse events of live attenuated
      varicella vaccine.
observational model: Case-Only
time perspective: Retrospective
measure: incidence of adverse reactions
time frame: 1 year after the first and second doses
intervention type: Biological
intervention name: live attenuated varicella vaccine
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 1 Year
maximum age: 15 Years
healthy volunteers: No
last name: Qian Li, Bachelor
role: Principal Investigator
affiliation: Zhejiang Provincial Center for Disease Control and Prevention
responsible party type: Principal Investigator
investigator affiliation: Zhejiang Provincial Center for Disease Control and Prevention
investigator full name: Qian Li
investigator title: Deputy chief physician
mesh term: Varicocele
sharing ipd: No