<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/NCT03231605</url>
  </required_header>
  <id_info>
    <org_study_id>91110000100010062X</org_study_id>
    <nct_id>NCT03231605</nct_id>
  </id_info>
  <brief_title>Comparative Immunogenicity Study of Two Hepatitis A Vaccines</brief_title>
  <official_title>Comparative Immunogenicity Study of Two Live Attenuated Hepatitis A Vaccines</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>China National Biotec Group Company Limited</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Shaanxi Provincial Center for Disease Control and Prevention</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>China National Biotec Group Company Limited</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hepatitis A is the most prevalent hepatitis which account for approximately 45% . The&#xD;
      susceptible population is Children and adolescence, also the morbidity in adult presented&#xD;
      rising trend in recent years. Therefore, vaccination of Hepatitis A Vaccine play an important&#xD;
      role in National Immunisation Program(China). The aim of this experiment is to verify the&#xD;
      effects of experimental group non-inferior than control group. The experiment methods is&#xD;
      compared the difference of seroconversion rate and Antibody geometric mean titer (GMT)between&#xD;
      experimental and control Hepatitis A Vaccines. In addition, evaluating the safety of two&#xD;
      Hepatitis A Vaccines in 18-24 months Chinese Children.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">July 26, 2017</start_date>
  <completion_date type="Anticipated">December 29, 2017</completion_date>
  <primary_completion_date type="Anticipated">August 31, 2017</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, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To verify the protection rate and antibody quantity of experimental vaccine non-inferior than control vaccine.</measure>
    <time_frame>35-42 days</time_frame>
    <description>Collecting serum of subjects before, after vaccination immediately and after 35-42 days, and testing the quantity of antibody. Compared the difference of antibody quantity between two types Hepatitis A Vaccine and the Multiple of antibody based on the time.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with treatment-related adverse events as assessed by CTCAE v4.0</measure>
    <time_frame>1 month</time_frame>
    <description>Observation 30 minutes after vaccination and give guardians feedback forms to record untoward effects, collecting the forms after 1 month when the subjects conduct the third time blood collection.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Hepatitis A</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group 1 is experimental group which used the Hepatitis A Vaccine product by Changchun Institute of Biological Co.,Ltd</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Group 2 is control group which used the Hepatitis A Vaccine product by Changchun Changsheng Life Sciences Limited</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Hepatitis A Vaccine</intervention_name>
    <description>Vaccinating two Hepatitis A Vaccines separately in 18-24 months Children based on the grouping result .</description>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_label>Group 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The healthy children in mental and physical aged between 18-24 months, and the&#xD;
             guardians agree and fully understand the protocol.&#xD;
&#xD;
          -  No Hepatitis A disease and contraindication of vaccination&#xD;
&#xD;
          -  No history of Hepatitis A Vaccine&#xD;
&#xD;
          -  The subjects can follow the requirements of experiment project.&#xD;
&#xD;
          -  Do not vaccinate other vaccine in one months.&#xD;
&#xD;
          -  Axillary's temperature≤37℃&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Having severe diseases.&#xD;
&#xD;
          -  Allergy to the components in Vaccine&#xD;
&#xD;
          -  Immune abnormalities&#xD;
&#xD;
          -  The people who do not agree with the Inclusion Criteria&#xD;
&#xD;
          -  Have a serious chronic disease&#xD;
&#xD;
          -  Any conditions which researcher think will influence the results or the subjects.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Months</minimum_age>
    <maximum_age>24 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Shanxi Provincial Center for Disease Control and Prevention</name>
      <address>
        <city>Yuncheng</city>
        <state>Shanxi</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <link>
    <url>http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003939.pdf</url>
    <description>The reference 5</description>
  </link>
  <link>
    <url>https://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Vaccines/UCM164319.pdf</url>
    <description>The reference 6</description>
  </link>
  <link>
    <url>http://med.wanfangdata.com.cn/Paper/Detail?id=PeriodicalPaper_zgswzpxzz200909021</url>
    <description>The reference 8</description>
  </link>
  <link>
    <url>http://www.wenkuxiazai.com/doc/c36ab52c58fb770bf78a5529.html</url>
    <description>The reference 9</description>
  </link>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 20, 2017</study_first_submitted>
  <study_first_submitted_qc>July 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2017</study_first_posted>
  <last_update_submitted>July 30, 2017</last_update_submitted>
  <last_update_submitted_qc>July 30, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 1, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatitis A</mesh_term>
    <mesh_term>Hepatitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Based on the literature public progress.</ipd_description>
  </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/NCT03231605
org study id: 91110000100010062X
nct id: NCT03231605
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
Hepatitis A is the most prevalent hepatitis which account for approximately 45% . The
      susceptible population is Children and adolescence, also the morbidity in adult presented
      rising trend in recent years. Therefore, vaccination of Hepatitis A Vaccine play an important
      role in National Immunisation Program(China). The aim of this experiment is to verify the
      effects of experimental group non-inferior than control group. The experiment methods is
      compared the difference of seroconversion rate and Antibody geometric mean titer (GMT)between
      experimental and control Hepatitis A Vaccines. In addition, evaluating the safety of two
      Hepatitis A Vaccines in 18-24 months Chinese Children.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Outcomes Assessor)
measure: To verify the protection rate and antibody quantity of experimental vaccine non-inferior than control vaccine.
time frame: 35-42 days
description: Collecting serum of subjects before, after vaccination immediately and after 35-42 days, and testing the quantity of antibody. Compared the difference of antibody quantity between two types Hepatitis A Vaccine and the Multiple of antibody based on the time.
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
time frame: 1 month
description: Observation 30 minutes after vaccination and give guardians feedback forms to record untoward effects, collecting the forms after 1 month when the subjects conduct the third time blood collection.
arm group label: Group 1
arm group type: Experimental
description: Group 1 is experimental group which used the Hepatitis A Vaccine product by Changchun Institute of Biological Co.,Ltd
arm group label: Group 2
arm group type: Active Comparator
description: Group 2 is control group which used the Hepatitis A Vaccine product by Changchun Changsheng Life Sciences Limited
intervention type: Biological
intervention name: Hepatitis A Vaccine
description: Vaccinating two Hepatitis A Vaccines separately in 18-24 months Children based on the grouping result .
arm group label: Group 1
arm group label: Group 2
criteria: 
gender: All
minimum age: 18 Months
maximum age: 24 Months
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: China
url: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003939.pdf
description: The reference 5
url: https://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Vaccines/UCM164319.pdf
description: The reference 6
url: http://med.wanfangdata.com.cn/Paper/Detail?id=PeriodicalPaper_zgswzpxzz200909021
description: The reference 8
url: http://www.wenkuxiazai.com/doc/c36ab52c58fb770bf78a5529.html
description: The reference 9
responsible party type: Sponsor
mesh term: Hepatitis A
mesh term: Hepatitis
sharing ipd: Undecided
ipd description: Based on the literature public progress.