<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/NCT01684072</url>
  </required_header>
  <id_info>
    <org_study_id>BJCDPC-2</org_study_id>
    <nct_id>NCT01684072</nct_id>
  </id_info>
  <brief_title>Safety and Immunogenicity Study of Live Attenuated Vaccine Against Varicella Without Gelatin</brief_title>
  <official_title>Evaluation of Safety and Immunogenicity Receiving Live Attenuated Vaccine Against Varicella Without Gelatin</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beijing Center for Disease Control and Prevention</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Beijing 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 reaction and antibody&#xD;
      positive rate, the elevated level of antibody，Geometric mean titer (GMT) between groups of&#xD;
      live attenuated varicella vaccine without gelatin.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Observational Objectives:&#xD;
&#xD;
      To describe the safety of evaluated vaccine, in children aged ≥ 1th birthday and ≤ 12th&#xD;
      birthday.&#xD;
&#xD;
      To describe the immunogenicity of evaluated vaccine, in children aged ≥ 1th birthday and ≤&#xD;
      12th birthday.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2011</start_date>
  <completion_date type="Actual">January 2012</completion_date>
  <primary_completion_date type="Actual">September 2011</primary_completion_date>
  <phase>Phase 4</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To evaluate the immunogenicity of evaluated vaccine</measure>
    <time_frame>8 months</time_frame>
    <description>The immunologic equivalence of 4weeks after vaccination of influenza virus vaccine was measured in terms of the level of antibody.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To evaluate the safety of live attenuated varicella vaccine</measure>
    <time_frame>4 months</time_frame>
    <description>The incidence of adverse events was analyzed statistically.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1200</enrollment>
  <condition>Chickenpox</condition>
  <condition>Zoster</condition>
  <arm_group>
    <arm_group_label>vaccine without gelatin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>use the upper arm flank deltoid muscle adheres to stick cohere place the skin after 75% ethyl alcohol disinfection the hypodermic injection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>vaccine with gelatin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>use the upper arm flank deltoid muscle adheres to stick cohere place the skin after 75% ethyl alcohol disinfection the hypodermic injection</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>vaccine without gelatin</intervention_name>
    <description>use the upper arm flank deltoid muscle adheres to stick cohere place the skin after 75% ethyl alcohol disinfection the hypodermic injection</description>
    <arm_group_label>vaccine with gelatin</arm_group_label>
    <arm_group_label>vaccine without gelatin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>vaccine with gelatin</intervention_name>
    <description>use the upper arm flank deltoid muscle adheres to stick cohere place the skin after 75% ethyl alcohol disinfection the hypodermic injection</description>
    <arm_group_label>vaccine with gelatin</arm_group_label>
    <arm_group_label>vaccine without gelatin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Parent/legal acceptable representative is willing and able to understand the protocol&#xD;
             requirements and provide informed consent&#xD;
&#xD;
          -  Participant is considered to be in good health including the body and mental status on&#xD;
             the basis of reported medical history and limited physical examination and live in&#xD;
             local ≥ 12 months&#xD;
&#xD;
          -  Participant is aged ≥ 1 year to ≤ 12 years&#xD;
&#xD;
          -  Body temperature ≤ 37.0℃&#xD;
&#xD;
          -  Participant without preventive inoculation of varicella vaccine and previous history&#xD;
             of chickenpox and zoster&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known allergy to any constituent of the vaccine&#xD;
&#xD;
          -  Reported the history of allergies, convulsions, epilepsy, mental illness and brain&#xD;
             disease and clear serious systemic reaction&#xD;
&#xD;
          -  Known bleeding disorder&#xD;
&#xD;
          -  Known or suspected impairment of immunologic function, or receipt of immunosuppressive&#xD;
             therapy or immunoglobulin since birth&#xD;
&#xD;
          -  Participation in any other interventional clinical trial&#xD;
&#xD;
          -  An acute illness with or without fever (temperature &gt; 37.0℃) in the latest week&#xD;
             preceding enrollment in the trial&#xD;
&#xD;
          -  Inoculated other vaccines, immunoglobulin or investigational drugs within 4 weeks&#xD;
             prior to participation in the study&#xD;
&#xD;
          -  Reported clearly the infection of the upper respiratory tract with 6 months&#xD;
&#xD;
          -  Clinical Manifestation of Metabolic, blood system, lungs, heart, the gastrointestinal&#xD;
             tract, nervous system, kidneys, urinary system, endocrine, liver disease or malignant&#xD;
             tumor&#xD;
&#xD;
          -  Any condition which, in the opinion of the investigator, would pose a health risk to&#xD;
             the subject or interfere with the vaccine&#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>Nianmin Shi</last_name>
    <role>Study Chair</role>
    <affiliation>Beijing Chaoyang District Center for Disease Control and Prevention</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chaoyang District Center for Disease Control and Prevention</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanhe Center for Disease Control and Prevention</name>
      <address>
        <city>Langfang</city>
        <state>Hebei</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jiuyuan Center for Disease Control and Prevention</name>
      <address>
        <city>Baotou</city>
        <state>Inner Mongolia</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 9, 2012</study_first_submitted>
  <study_first_submitted_qc>September 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2012</study_first_posted>
  <last_update_submitted>September 9, 2012</last_update_submitted>
  <last_update_submitted_qc>September 9, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 12, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>varicella vaccine</keyword>
  <keyword>gelatin</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>
  <!-- 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/NCT01684072
org study id: BJCDPC-2
nct id: NCT01684072
lead sponsor: 
has dmc: No
The purpose of this study is to observe the occurrence of adverse reaction and antibody
      positive rate, the elevated level of antibody，Geometric mean titer (GMT) between groups of
      live attenuated varicella vaccine without gelatin.
Observational Objectives:

      To describe the safety of evaluated vaccine, in children aged ≥ 1th birthday and ≤ 12th
      birthday.

      To describe the immunogenicity of evaluated vaccine, in children aged ≥ 1th birthday and ≤
      12th birthday.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: To evaluate the immunogenicity of evaluated vaccine
time frame: 8 months
description: The immunologic equivalence of 4weeks after vaccination of influenza virus vaccine was measured in terms of the level of antibody.
measure: To evaluate the safety of live attenuated varicella vaccine
time frame: 4 months
description: The incidence of adverse events was analyzed statistically.
arm group label: vaccine without gelatin
arm group type: Experimental
description: use the upper arm flank deltoid muscle adheres to stick cohere place the skin after 75% ethyl alcohol disinfection the hypodermic injection
arm group label: vaccine with gelatin
arm group type: Active Comparator
description: use the upper arm flank deltoid muscle adheres to stick cohere place the skin after 75% ethyl alcohol disinfection the hypodermic injection
intervention type: Biological
intervention name: vaccine without gelatin
description: use the upper arm flank deltoid muscle adheres to stick cohere place the skin after 75% ethyl alcohol disinfection the hypodermic injection
arm group label: vaccine with gelatin
arm group label: vaccine without gelatin
intervention type: Biological
intervention name: vaccine with gelatin
description: use the upper arm flank deltoid muscle adheres to stick cohere place the skin after 75% ethyl alcohol disinfection the hypodermic injection
arm group label: vaccine with gelatin
arm group label: vaccine without gelatin
criteria: 
gender: All
minimum age: 1 Year
maximum age: 12 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Nianmin Shi
role: Study Chair
affiliation: Beijing Chaoyang District Center for Disease Control and Prevention
facility: 
facility: 
facility: 
country: China
responsible party type: Sponsor
mesh term: Chickenpox
mesh term: Herpes Zoster
mesh term: Vaccines