<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/NCT02231632</url>
  </required_header>
  <id_info>
    <org_study_id>Yangjingsi2014</org_study_id>
    <nct_id>NCT02231632</nct_id>
  </id_info>
  <brief_title>The Immunogenicity and Safety of Live Attenuated Poliomyelitis Vaccine (Human Diploid Cell)</brief_title>
  <official_title>Phase 2/3 Clinical Trial to Assess the Safety and Immunogenicity of Live Attenuated Poliomyelitis Vaccine (Human Diploid Cell)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Guangxi Center for Disease Control and Prevention</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this Phase 2/3 trial is to assess the safety and immunogenicity of Live&#xD;
      attenuated Poliomyelitis vaccine (human diploid cell)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Live attenuated Poliomyelitis vaccine (human diploid cell) is used for poliovirus prevention&#xD;
      in children above 2 years old , Which was developed by Institute of Medical Biology , Chinese&#xD;
      Academy of Medical Sciences , based on the other two products : Poliomyelitis Vaccine in&#xD;
      Dragee Candy (Monkey Kidney Cell), Live ; and Poliomyelitis（Live）Vaccine (Monkey Kidney&#xD;
      Cell),Oral . After its safety been proved in phase 1 clinical trail evaluation , the phase&#xD;
      2/3 trail was started in Guangxi Province, China during 2011-2012. The purpose of this trial&#xD;
      is to assess the safety and immunogenicity in healthy children of 2,3 and 4 months old .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2011</start_date>
  <completion_date type="Actual">August 2012</completion_date>
  <primary_completion_date type="Actual">March 2012</primary_completion_date>
  <phase>Phase 2/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, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Comparison of virogene VP1 genovariation between vaccinal I-III Sabin strains and poliovirus separated from faeces of study objects after vaccinated</measure>
    <time_frame>up to 90 days</time_frame>
    <description>20 children aged 4 years old and 20 infants aged 2 months were vaccinated with 3 dose of Live attenuated Poliomyelitis vaccine (human diploid cell). Their faeces on day 0,7,30,60 and 90 were collected and incubated in L20B and RD cells for 2 generations, in order to separate and amplify poliovirus I-III Sabin strains in faeces of study objects . Extract total viral RNA from the culture supernatants and detect virogene VP1 through RT-PCR and sequencing ,in order to test the genovariation of vaccinal I-III Sabin strains in faeces after vaccinated .</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The frequency of all the adverse events in vaccine group and placebo group</measure>
    <time_frame>up to 30 days</time_frame>
    <description>compare frequency of all the solicited events, unsolicited adverse events and serious adverse events between vaccine groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of seroconversion from baseline to 3 months</measure>
    <time_frame>up to 3 months</time_frame>
    <description>Randomly chose 600 infants respectively from two study arms, get 2.5ml of the blood on the first day and 3 months during vaccination .Reciprocal antibody titers of at least 1:8, the lowest detectable titer, is considered to indicate seropositivity with regards to the presence of poliovirus neutralizing antibodies. Seroconversion is defined as either seronegative participants (&lt;1:8 titers) who become seropositive (≥1:8) or participants who demonstrate a 4-fold change in titers between two specimens, e.g. a change from 1:8 to 1:32. Chi-square tests will be used to test the statistical significance among seroconversion rates across study arms.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1200</enrollment>
  <condition>Poliomyelitis</condition>
  <arm_group>
    <arm_group_label>Live attenuated Poliomyelitis vaccine (human diploid cell)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>6.15 lgCCID50(containing typeⅠattenuated poliomyelitis not lower than 6.0 lgCCID50，typeⅡnot lower than 5.0 lgCCID50，type Ⅲ not lower than 5.5 lgCCID50).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Poliomyelitis（Live）Vaccine(Monkey Kidney Cell),Oral</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>6.15 lgCCID50(containing typeⅠattenuated poliomyelitis not lower than 6.0 lgCCID50，typeⅡnot lower than 5.0 lgCCID50，type Ⅲ not lower than 5.5 lgCCID50).</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Live attenuated Poliomyelitis vaccine (Human Diploid Cell)</intervention_name>
    <description>6.15 lgCCID50 /Vial, 0.1ml/dose(10 dose /Vial) in babies aged 2-3 months, three dose(4 weeks'interval for each Intervention).</description>
    <arm_group_label>Live attenuated Poliomyelitis vaccine (human diploid cell)</arm_group_label>
    <other_name>Poliomyelitis（Live）Vaccine(Human Diploid Cell),Oral</other_name>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Live attenuated Poliomyelitis vaccine (Monkey Kidney Cell)</intervention_name>
    <description>6.15 lgCCID50 /Vial, 0.1ml/dose(10 dose /Vial) in babies aged 2-3 months, three dose(4 weeks'interval for each Intervention).</description>
    <arm_group_label>Poliomyelitis（Live）Vaccine(Monkey Kidney Cell),Oral</arm_group_label>
    <other_name>Poliomyelitis（Live）Vaccine(Monkey Kidney Cell),Oral</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:Only subjects fulfilling all of the following criteria will be eligible&#xD;
        for the study:&#xD;
&#xD;
          -  People aged from 2 months to 4 months old.&#xD;
&#xD;
          -  The subjects or subjects' guardians are able to understand and sign the informed&#xD;
             consent&#xD;
&#xD;
          -  The subjects or subjects' guardians allow to comply with the requirements of the&#xD;
             protocol&#xD;
&#xD;
          -  Subjects with temperature &lt;=37.0°C on axillary setting&#xD;
&#xD;
          -  The subjects have signed informed consent already&#xD;
&#xD;
        Exclusion Criteria:The subjects have never been vaccinated with any Poliomyelitis Vaccine.&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Months</minimum_age>
    <maximum_age>4 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Qihan Li, Ph.D</last_name>
    <role>Study Chair</role>
    <affiliation>Institude of Medical Biology, Chinese Academy of Medical Sciences</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jingsi Yang</last_name>
    <role>Study Director</role>
    <affiliation>Institude of Medical Biology, Chinese Academy of Medical Sciences</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Rongcheng Li</last_name>
    <role>Principal Investigator</role>
    <affiliation>Guangxi Provincial Center for Disease Control and Prevention</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institute of Medical Biology -Chinese Academy of Medical Sciences Kunming, Yunnan, China 650118</name>
      <address>
        <city>Kunming</city>
        <state>Yunnan</state>
        <zip>650118</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>August 1, 2014</study_first_submitted>
  <study_first_submitted_qc>September 1, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 4, 2014</study_first_posted>
  <last_update_submitted>September 1, 2014</last_update_submitted>
  <last_update_submitted_qc>September 1, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 4, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</investigator_affiliation>
    <investigator_full_name>Qiangming Sun</investigator_full_name>
    <investigator_title>Molecular Epidemiology Joint Laboratory</investigator_title>
  </responsible_party>
  <keyword>Poliomyelitis</keyword>
  <keyword>Vaccine</keyword>
  <keyword>Safety</keyword>
  <keyword>efficacy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Poliomyelitis</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/NCT02231632
org study id: Yangjingsi2014
nct id: NCT02231632
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this Phase 2/3 trial is to assess the safety and immunogenicity of Live
      attenuated Poliomyelitis vaccine (human diploid cell)
Live attenuated Poliomyelitis vaccine (human diploid cell) is used for poliovirus prevention
      in children above 2 years old , Which was developed by Institute of Medical Biology , Chinese
      Academy of Medical Sciences , based on the other two products : Poliomyelitis Vaccine in
      Dragee Candy (Monkey Kidney Cell), Live ; and Poliomyelitis（Live）Vaccine (Monkey Kidney
      Cell),Oral . After its safety been proved in phase 1 clinical trail evaluation , the phase
      2/3 trail was started in Guangxi Province, China during 2011-2012. The purpose of this trial
      is to assess the safety and immunogenicity in healthy children of 2,3 and 4 months old .
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Care Provider, Investigator)
measure: Comparison of virogene VP1 genovariation between vaccinal I-III Sabin strains and poliovirus separated from faeces of study objects after vaccinated
time frame: up to 90 days
description: 20 children aged 4 years old and 20 infants aged 2 months were vaccinated with 3 dose of Live attenuated Poliomyelitis vaccine (human diploid cell). Their faeces on day 0,7,30,60 and 90 were collected and incubated in L20B and RD cells for 2 generations, in order to separate and amplify poliovirus I-III Sabin strains in faeces of study objects . Extract total viral RNA from the culture supernatants and detect virogene VP1 through RT-PCR and sequencing ,in order to test the genovariation of vaccinal I-III Sabin strains in faeces after vaccinated .
measure: The frequency of all the adverse events in vaccine group and placebo group
time frame: up to 30 days
description: compare frequency of all the solicited events, unsolicited adverse events and serious adverse events between vaccine groups.
measure: Change of seroconversion from baseline to 3 months
time frame: up to 3 months
description: Randomly chose 600 infants respectively from two study arms, get 2.5ml of the blood on the first day and 3 months during vaccination .Reciprocal antibody titers of at least 1:8, the lowest detectable titer, is considered to indicate seropositivity with regards to the presence of poliovirus neutralizing antibodies. Seroconversion is defined as either seronegative participants (<1:8 titers) who become seropositive (≥1:8) or participants who demonstrate a 4-fold change in titers between two specimens, e.g. a change from 1:8 to 1:32. Chi-square tests will be used to test the statistical significance among seroconversion rates across study arms.
arm group label: Live attenuated Poliomyelitis vaccine (human diploid cell)
arm group type: Experimental
description: 6.15 lgCCID50(containing typeⅠattenuated poliomyelitis not lower than 6.0 lgCCID50，typeⅡnot lower than 5.0 lgCCID50，type Ⅲ not lower than 5.5 lgCCID50).
arm group label: Poliomyelitis（Live）Vaccine(Monkey Kidney Cell),Oral
arm group type: Experimental
description: 6.15 lgCCID50(containing typeⅠattenuated poliomyelitis not lower than 6.0 lgCCID50，typeⅡnot lower than 5.0 lgCCID50，type Ⅲ not lower than 5.5 lgCCID50).
intervention type: Biological
intervention name: Live attenuated Poliomyelitis vaccine (Human Diploid Cell)
description: 6.15 lgCCID50 /Vial, 0.1ml/dose(10 dose /Vial) in babies aged 2-3 months, three dose(4 weeks'interval for each Intervention).
arm group label: Live attenuated Poliomyelitis vaccine (human diploid cell)
other name: Poliomyelitis（Live）Vaccine(Human Diploid Cell),Oral
intervention type: Biological
intervention name: Live attenuated Poliomyelitis vaccine (Monkey Kidney Cell)
description: 6.15 lgCCID50 /Vial, 0.1ml/dose(10 dose /Vial) in babies aged 2-3 months, three dose(4 weeks'interval for each Intervention).
arm group label: Poliomyelitis（Live）Vaccine(Monkey Kidney Cell),Oral
other name: Poliomyelitis（Live）Vaccine(Monkey Kidney Cell),Oral
criteria: 
gender: All
minimum age: 2 Months
maximum age: 4 Months
healthy volunteers: Accepts Healthy Volunteers
last name: Qihan Li, Ph.D
role: Study Chair
affiliation: Institude of Medical Biology, Chinese Academy of Medical Sciences
last name: Jingsi Yang
role: Study Director
affiliation: Institude of Medical Biology, Chinese Academy of Medical Sciences
last name: Rongcheng Li
role: Principal Investigator
affiliation: Guangxi Provincial Center for Disease Control and Prevention
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
investigator full name: Qiangming Sun
investigator title: Molecular Epidemiology Joint Laboratory
mesh term: Poliomyelitis
mesh term: Vaccines