<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/NCT03822767</url>
  </required_header>
  <id_info>
    <org_study_id>PRO-sIPV-3001-2</org_study_id>
    <nct_id>NCT03822767</nct_id>
  </id_info>
  <brief_title>A Clinical Trial to Evaluate the Immunogenicity and Safety of sIPV in a &quot;2+1&quot;Sequential Schedule With bOPV in Infants</brief_title>
  <official_title>A Randomized, Double-blind, Controlled Clinical Trial to Evaluate the Immunogenicity and Safety of Sabin Inactivated Poliovirus Vaccine (Vero Cell) in a '2+1'Sequential Schedule With Bivalent Oral Poliovirus Vaccine in 2-month-old Infants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sinovac Biotech Co., Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sinovac Biotech Co., Ltd</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this phrase III clinical trial is to evaluate the immunogenicity and safety of&#xD;
      Sabin Inactivated Poliovirus Vaccine (Vero cell) in a '2+1'sequential schedule with bivalent&#xD;
      oral poliovirus vaccine in 2-month-old infants&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      his study is a randomized, double-blind, active-controlled phrase III clinical trial. The&#xD;
      purpose of this study is to evaluate the immunogenicity and safety of sIPV manufactured by&#xD;
      Sinovac Biotech Co., Ltd in a '2+1' sequential schedule with bOPV in 2-month-old infants. 240&#xD;
      infants aged between 60-90 days will be randomly assigned into experimental group or control&#xD;
      group in the ratio 1:1. The experimental group received sIPV-sIPV-bOPV vaccination schedule&#xD;
      at one month doses interval (i.e., month 0, 1, 2), and the control group received&#xD;
      wIPV-wIPV-bOPV vaccination schedule at one month doses interval (i.e., month 0, 1, 2). The&#xD;
      control wIPV was manufactured by SANOFI PASTEUR S.A.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 12, 2018</start_date>
  <completion_date type="Actual">December 11, 2018</completion_date>
  <primary_completion_date type="Actual">September 20, 2018</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The difference between experimental group and control group of type I,III neutralizing antibody seroconversion rate after primary immunization. And the lower limit of 95% confidence intervals of the difference value.</measure>
    <time_frame>30 days</time_frame>
    <description>Subjects whose pre-immune antibody level &lt; 1:8 and post-immune antibody level ≥ 1:8, or those whose pre-immune antibody level ≥ 1:8 and the increase of post-immune antibody level ≥ 4 folds are considered seroconverted. Primary vaccination schedule: 3 doses with one month interval between doses (i.e., month 0, 1, 2).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The incidences of solicited adverse events (AEs) within 7 or 14 days after each dose of each group.</measure>
    <time_frame>7 days or 14 days</time_frame>
    <description>Solicited AEs occurred within 7 days (for sIPV) or 14 days (for bOPV) after each injection will be collected.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The incidence of unsolicited AE within 30 days after each dose of each group.</measure>
    <time_frame>30 days</time_frame>
    <description>Unsolicited AEs occurred within 30 days after each injection will be collected.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of serious adverse events (SAEs) during the period of safety monitoring.</measure>
    <time_frame>30 days</time_frame>
    <description>SAEs during the period of safety monitoring will be collected.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Type I,II and III neutralizing antibody positive rate of each group after primary immunization</measure>
    <time_frame>30 days</time_frame>
    <description>Subjects whose post-immune antibody level ≥ 1:8 are considered antibody positive. Primary vaccination schedule: 3 doses with one month interval between doses (i.e., month 0, 1, 2).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Type I,II and III post-immune geometric mean titer (GMT) of each group after primary immunization.</measure>
    <time_frame>30 days</time_frame>
    <description>GMT of each group after primary immunization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Type I,II and III post-immune geometric mean fold increase (GMI) of each group after primary immunization.</measure>
    <time_frame>30 days</time_frame>
    <description>The GMI is the increase of post-immune GMT from pre-immune GMT.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Type I,II and III percentage of subjects with post-immune antibody level ≥1:64 of each group after primary immunization.</measure>
    <time_frame>30 days</time_frame>
    <description>Subjects whose post-immune antibody level ≥ 1:64 will be collected.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">240</enrollment>
  <condition>Poliomyelitis</condition>
  <arm_group>
    <arm_group_label>Experimental Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>sIPV-sIPV-bOPV vaccination schedule</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>wIPV-wIPV-bOPV vaccination schedule</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>sIPV-sIPV-bOPV vaccination schedule</intervention_name>
    <description>Two intramuscular injections of the investigational vaccine (0.5 ml) on Day 0 and Day 30 respectively; Single dose of bOPV (0.1 ml) on Day 60. The investigational Sabin strain inactivated poliovirus vaccine (Vero cell)(sIPV) was manufactured by Sinovac Biotech Co., Ltd . The poliovirus (Live) vaccine type I &amp; type III (Human Diploid cell) ( bOPV) was manufactured by Beijing Bio-institute Biological Products Co., Ltd.</description>
    <arm_group_label>Experimental Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>wIPV-wIPV-bOPV vaccination schedule</intervention_name>
    <description>Two intramuscular injections of the control vaccine(0.5 ml) on Day 0 and Day 30 respectively; Single dose of bOPV (0.1 ml) on Day 60. The investigational Sabin strain inactivated poliovirus vaccine (Vero cell)(sIPV) was manufactured by SANOFI PASTEUR S.A. The poliovirus (Live) vaccine type I &amp; type III (Human Diploid cell) ( bOPV) was manufactured by Beijing Bio-institute Biological Products Co., Ltd.</description>
    <arm_group_label>Control Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy volunteer between 60-90 days old;&#xD;
&#xD;
          -  Healthy volunteers who fulfill all the required conditions for receiving the&#xD;
             investigational vaccine as established by medical history and clinical examination and&#xD;
             determined by investigators;&#xD;
&#xD;
          -  Proven legal identity;&#xD;
&#xD;
          -  Participants or guardians of the participants should be capable of understanding the&#xD;
             written consent form, and such form should be signed prior to enrolment;&#xD;
&#xD;
          -  Complying with the requirement of the study protocol;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior vaccination with Poliovirus Vaccine;&#xD;
&#xD;
          -  History of allergy to any vaccine, or any ingredient, excipients and Gentamycin&#xD;
             Sulfate of the vaccine, or serious adverse reaction(s) to vaccination, such as&#xD;
             urticaria, dyspnea, angioneurotic edema, abdominal pain, etc;&#xD;
&#xD;
          -  Congenital malformation, developmental disorders, genetic defects, or severe&#xD;
             malnutrition;&#xD;
&#xD;
          -  Autoimmune disease or immunodeficiency/immunosuppressive;&#xD;
&#xD;
          -  Severe/uncontrollable nervous system disease (epilepsy, seizures or convulsions) or&#xD;
             mental illness;&#xD;
&#xD;
          -  Diagnosed coagulation function abnormal (e.g., coagulation factor deficiency,&#xD;
             coagulation disorder, or platelet abnormalities) , or obvious bruising or coagulation&#xD;
             disorders;&#xD;
&#xD;
          -  Any immunosuppressant, cytotoxic medicine, or inhaled corticosteroids (except&#xD;
             corticosteroid spray for treatment of allergic rhinitis or corticosteroid treatment on&#xD;
             surface for acute non-complicated dermatitis) prior to study entry;&#xD;
&#xD;
          -  Blood product prior to study entry;&#xD;
&#xD;
          -  Any other investigational medicine(s) within 30 days prior to study entry;&#xD;
&#xD;
          -  Any live attenuated vaccine within 14 days prior to study entry;&#xD;
&#xD;
          -  Any subunit vaccine or inactivated vaccine within 7 days prior to study entry;&#xD;
&#xD;
          -  Acute disease or acute stage of chronic disease within 7 days prior to study entry;&#xD;
&#xD;
          -  Axillary temperature &gt; 37.0 °C;&#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>60 Days</minimum_age>
    <maximum_age>90 Days</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yuemei Hu</last_name>
    <role>Principal Investigator</role>
    <affiliation>Jiangsu Provincial Center for Disease Control and Prevention</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pizhou Center for Disease Control and Prevention</name>
      <address>
        <city>Xuzhou</city>
        <state>Jiangsu</state>
        <zip>221300</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 29, 2019</study_first_submitted>
  <study_first_submitted_qc>January 29, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>January 29, 2019</last_update_submitted>
  <last_update_submitted_qc>January 29, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 31, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Sabin strain</keyword>
  <keyword>Inactivated poliovirus vaccine</keyword>
  <keyword>poliomyelitis</keyword>
  <keyword>safety</keyword>
  <keyword>immunogenicity</keyword>
  <keyword>infant</keyword>
  <keyword>sequential schedule</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Poliomyelitis</mesh_term>
  </condition_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/NCT03822767
org study id: PRO-sIPV-3001-2
nct id: NCT03822767
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this phrase III clinical trial is to evaluate the immunogenicity and safety of
      Sabin Inactivated Poliovirus Vaccine (Vero cell) in a '2+1'sequential schedule with bivalent
      oral poliovirus vaccine in 2-month-old infants
his study is a randomized, double-blind, active-controlled phrase III clinical trial. The
      purpose of this study is to evaluate the immunogenicity and safety of sIPV manufactured by
      Sinovac Biotech Co., Ltd in a '2+1' sequential schedule with bOPV in 2-month-old infants. 240
      infants aged between 60-90 days will be randomly assigned into experimental group or control
      group in the ratio 1:1. The experimental group received sIPV-sIPV-bOPV vaccination schedule
      at one month doses interval (i.e., month 0, 1, 2), and the control group received
      wIPV-wIPV-bOPV vaccination schedule at one month doses interval (i.e., month 0, 1, 2). The
      control wIPV was manufactured by SANOFI PASTEUR S.A.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: The difference between experimental group and control group of type I,III neutralizing antibody seroconversion rate after primary immunization. And the lower limit of 95% confidence intervals of the difference value.
time frame: 30 days
description: Subjects whose pre-immune antibody level < 1:8 and post-immune antibody level ≥ 1:8, or those whose pre-immune antibody level ≥ 1:8 and the increase of post-immune antibody level ≥ 4 folds are considered seroconverted. Primary vaccination schedule: 3 doses with one month interval between doses (i.e., month 0, 1, 2).
measure: The incidences of solicited adverse events (AEs) within 7 or 14 days after each dose of each group.
time frame: 7 days or 14 days
description: Solicited AEs occurred within 7 days (for sIPV) or 14 days (for bOPV) after each injection will be collected.
measure: The incidence of unsolicited AE within 30 days after each dose of each group.
time frame: 30 days
description: Unsolicited AEs occurred within 30 days after each injection will be collected.
measure: Incidence of serious adverse events (SAEs) during the period of safety monitoring.
time frame: 30 days
description: SAEs during the period of safety monitoring will be collected.
measure: Type I,II and III neutralizing antibody positive rate of each group after primary immunization
time frame: 30 days
description: Subjects whose post-immune antibody level ≥ 1:8 are considered antibody positive. Primary vaccination schedule: 3 doses with one month interval between doses (i.e., month 0, 1, 2).
measure: Type I,II and III post-immune geometric mean titer (GMT) of each group after primary immunization.
time frame: 30 days
description: GMT of each group after primary immunization
measure: Type I,II and III post-immune geometric mean fold increase (GMI) of each group after primary immunization.
time frame: 30 days
description: The GMI is the increase of post-immune GMT from pre-immune GMT.
measure: Type I,II and III percentage of subjects with post-immune antibody level ≥1:64 of each group after primary immunization.
time frame: 30 days
description: Subjects whose post-immune antibody level ≥ 1:64 will be collected.
arm group label: Experimental Group
arm group type: Experimental
description: sIPV-sIPV-bOPV vaccination schedule
arm group label: Control Group
arm group type: Active Comparator
description: wIPV-wIPV-bOPV vaccination schedule
intervention type: Biological
intervention name: sIPV-sIPV-bOPV vaccination schedule
description: Two intramuscular injections of the investigational vaccine (0.5 ml) on Day 0 and Day 30 respectively; Single dose of bOPV (0.1 ml) on Day 60. The investigational Sabin strain inactivated poliovirus vaccine (Vero cell)(sIPV) was manufactured by Sinovac Biotech Co., Ltd . The poliovirus (Live) vaccine type I & type III (Human Diploid cell) ( bOPV) was manufactured by Beijing Bio-institute Biological Products Co., Ltd.
arm group label: Experimental Group
intervention type: Biological
intervention name: wIPV-wIPV-bOPV vaccination schedule
description: Two intramuscular injections of the control vaccine(0.5 ml) on Day 0 and Day 30 respectively; Single dose of bOPV (0.1 ml) on Day 60. The investigational Sabin strain inactivated poliovirus vaccine (Vero cell)(sIPV) was manufactured by SANOFI PASTEUR S.A. The poliovirus (Live) vaccine type I & type III (Human Diploid cell) ( bOPV) was manufactured by Beijing Bio-institute Biological Products Co., Ltd.
arm group label: Control Group
criteria: 
gender: All
minimum age: 60 Days
maximum age: 90 Days
healthy volunteers: Accepts Healthy Volunteers
last name: Yuemei Hu
role: Principal Investigator
affiliation: Jiangsu Provincial Center for Disease Control and Prevention
facility: 
country: China
responsible party type: Sponsor
mesh term: Poliomyelitis