<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/NCT02981836</url>
  </required_header>
  <id_info>
    <org_study_id>PRO-VZV-3001</org_study_id>
    <nct_id>NCT02981836</nct_id>
  </id_info>
  <brief_title>A Blind, Randomized and Controlled Study of Live Attenuated Varicella Vaccines</brief_title>
  <official_title>A Blind, Randomized and Controlled Clinical Trial to Evaluate the Protective Effect, Safety and Immunogenicity of Live Attenuated Varicella Vaccines for Healthy Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sinovac (Dalian) Vaccine Technology Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sinovac (Dalian) Vaccine Technology Co., Ltd.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the protective effect, safety and immunogenicity of&#xD;
      a live attenuated varicella vaccine in healthy children.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a randomized, blind, controlled phase III clinical trial. The purpose of this&#xD;
      study is to evaluate the protective effect, safety and immunogenicity of a live attenuated&#xD;
      varicella vaccine manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. The control&#xD;
      is diluent of lyophilized vaccine manufactured by Sinovac (Dalian) Vaccine Technology Co.,&#xD;
      Ltd. All participants are healthy, and will be randomly assigned into experimental group or&#xD;
      control group in the ratio 1:1.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2016</start_date>
  <completion_date type="Actual">September 2017</completion_date>
  <primary_completion_date type="Actual">June 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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The incidences of varicella of each group</measure>
    <time_frame>≥30 cases reported 30 days after injection</time_frame>
    <description>The first 30 cases of varicella occurred 30 days after injection will be collected.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The protection rate of the vaccine</measure>
    <time_frame>≥30 cases reported after 30 days of the injection</time_frame>
    <description>The protection rate will be calculated based on the reported cases occurred 30 days after injection.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The incidences of adverse events (AEs) of each group</measure>
    <time_frame>30 days</time_frame>
    <description>AEs occurred within 30 days after injection will be collected.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The incidences of serious adverse events (SAEs) of each group</measure>
    <time_frame>6 months</time_frame>
    <description>SAEs occurred within 6 months after injection will be collected.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The seroconversion rate of the immunogenicity group</measure>
    <time_frame>30 days after injection</time_frame>
    <description>Seroconversion rate of the immonogenicity group 30 days after injection will be collected.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The geometric mean titer (GMT) of the immunogenicity group</measure>
    <time_frame>30 days</time_frame>
    <description>Geometric mean titer (GMT) of the immonogenicity group will be collected before and 30 days after injection.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The geometric mean fold increase (GMI) of the immunogenicity group</measure>
    <time_frame>30 days after injection</time_frame>
    <description>Geometric mean fold increse (GMI) of the immonogenicity group will be calculated based on the geometric mean titer.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">5997</enrollment>
  <condition>Varicella</condition>
  <arm_group>
    <arm_group_label>Experimental Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single intramuscular injection of the investigational vaccine (0.5 ml) on Day 0;&#xD;
Intervention: investigational live attenuated varicella vaccine;</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Single intramuscular injection of the diluent of lyophilized vaccine (0.5 ml) on Day 0;&#xD;
Intervention: diluent of lyophilized vaccine;</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Investigational live attenuated varicella vaccine</intervention_name>
    <description>The investigational vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.</description>
    <arm_group_label>Experimental Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>diluent of lyophilized vaccine</intervention_name>
    <description>The diluent of lyophilized vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.</description>
    <arm_group_label>Control Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy volunteer between 1 - 12 years old;&#xD;
&#xD;
          -  Proven legal identity;&#xD;
&#xD;
          -  Guardian(s) of the volunteer and/or volunteers themselves should be capable of&#xD;
             understanding the written consent form, and such form should be signed before the&#xD;
             volunteer being included into this study;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior vaccination with varicella vaccine or with history of varicella zoster virus&#xD;
             (VZV) infection;&#xD;
&#xD;
          -  Axillaty temperature &gt; 37.0 °C;&#xD;
&#xD;
          -  History of allergy to any vaccine or vaccine ingredient, or serious adverse&#xD;
             reaction(s) to vaccination, such as urticaria, difficulty in breathing, angioneurotic&#xD;
             edema, abdominal pain, etc;&#xD;
&#xD;
          -  History of epilepsy, seizures or convulsions, or a family history of mental illness,&#xD;
             autoimmune disease or immunodeficiency;&#xD;
&#xD;
          -  Severe malnutrition, congenital malformation, developmental disorders, or serious&#xD;
             chronic diseases;&#xD;
&#xD;
          -  Acute disease or acute stage of chronic disease within 7 days prior to study entry;&#xD;
&#xD;
          -  Receipt of any of the following products:&#xD;
&#xD;
               1. Any subunit vaccine or inactivated vaccine within 7 days prior to study entry;&#xD;
&#xD;
               2. Any live attenuated vaccine within 1 month prior to study entry;&#xD;
&#xD;
               3. Any blood product, immunosuppressant, hormone, or other investigational&#xD;
                  medicine(s) within 30 days prior to study entry;&#xD;
&#xD;
          -  Any significant abnormity of heart, lung, skin, or pharynx;&#xD;
&#xD;
          -  Any other factor that suggesting the volunteer is unsuitable for this study based on&#xD;
             the opinions of investigators;&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shengli Xia</last_name>
    <role>Principal Investigator</role>
    <affiliation>Henan Provincial Center for Disease Control and Prevention</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Xiangcheng County Center for Disease Control and Prevention</name>
      <address>
        <city>Xuchang</city>
        <state>Henan</state>
        <zip>461700</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Biyang County Center for Disease Control and Prevention</name>
      <address>
        <city>Zhumadian</city>
        <state>Henan</state>
        <zip>463700</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 28, 2016</study_first_submitted>
  <study_first_submitted_qc>November 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 5, 2016</study_first_posted>
  <last_update_submitted>October 24, 2017</last_update_submitted>
  <last_update_submitted_qc>October 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 26, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>live attenuated varicella vaccine</keyword>
  <keyword>protective effect</keyword>
  <keyword>safety</keyword>
  <keyword>immunogenicity</keyword>
  <keyword>child</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chickenpox</mesh_term>
    <mesh_term>Herpes Zoster</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vaccines</mesh_term>
  </intervention_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/NCT02981836
org study id: PRO-VZV-3001
nct id: NCT02981836
lead sponsor: 
has dmc: Yes
The purpose of this study is to evaluate the protective effect, safety and immunogenicity of
      a live attenuated varicella vaccine in healthy children.
This study is a randomized, blind, controlled phase III clinical trial. The purpose of this
      study is to evaluate the protective effect, safety and immunogenicity of a live attenuated
      varicella vaccine manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. The control
      is diluent of lyophilized vaccine manufactured by Sinovac (Dalian) Vaccine Technology Co.,
      Ltd. All participants are healthy, and will be randomly assigned into experimental group or
      control group in the ratio 1:1.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: The incidences of varicella of each group
time frame: ≥30 cases reported 30 days after injection
description: The first 30 cases of varicella occurred 30 days after injection will be collected.
measure: The protection rate of the vaccine
time frame: ≥30 cases reported after 30 days of the injection
description: The protection rate will be calculated based on the reported cases occurred 30 days after injection.
measure: The incidences of adverse events (AEs) of each group
time frame: 30 days
description: AEs occurred within 30 days after injection will be collected.
measure: The incidences of serious adverse events (SAEs) of each group
time frame: 6 months
description: SAEs occurred within 6 months after injection will be collected.
measure: The seroconversion rate of the immunogenicity group
time frame: 30 days after injection
description: Seroconversion rate of the immonogenicity group 30 days after injection will be collected.
measure: The geometric mean titer (GMT) of the immunogenicity group
time frame: 30 days
description: Geometric mean titer (GMT) of the immonogenicity group will be collected before and 30 days after injection.
measure: The geometric mean fold increase (GMI) of the immunogenicity group
time frame: 30 days after injection
description: Geometric mean fold increse (GMI) of the immonogenicity group will be calculated based on the geometric mean titer.
arm group label: Experimental Group
arm group type: Experimental
description: Single intramuscular injection of the investigational vaccine (0.5 ml) on Day 0;
Intervention: investigational live attenuated varicella vaccine;
arm group label: Control Group
arm group type: Sham Comparator
description: Single intramuscular injection of the diluent of lyophilized vaccine (0.5 ml) on Day 0;
Intervention: diluent of lyophilized vaccine;
intervention type: Biological
intervention name: Investigational live attenuated varicella vaccine
description: The investigational vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.
arm group label: Experimental Group
intervention type: Biological
intervention name: diluent of lyophilized vaccine
description: The diluent of lyophilized vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.
arm group label: Control Group
criteria: 
gender: All
minimum age: 1 Year
maximum age: 12 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Shengli Xia
role: Principal Investigator
affiliation: Henan Provincial Center for Disease Control and Prevention
facility: 
facility: 
country: China
responsible party type: Sponsor
mesh term: Chickenpox
mesh term: Herpes Zoster
mesh term: Vaccines
sharing ipd: No