<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/NCT03822754</url>
  </required_header>
  <id_info>
    <org_study_id>PRO-sIPV-3001-1</org_study_id>
    <nct_id>NCT03822754</nct_id>
  </id_info>
  <brief_title>A Clinical Trial to Evaluate the Immunogenicity and Safety of sIPV in a '1+2' 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 '1+2' 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 '1+2' sequential schedule with bivalent&#xD;
      oral poliovirus vaccine in 2-month-old infants&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This 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 Vaccine Technology Co., Ltd in a '1+2' sequential schedule with bOPV in 2-month-old&#xD;
      infants. 240 infants aged between 60-90 days will be randomly assigned into experimental&#xD;
      group or control group in the ratio 1:1. The experimental group received sIPV-bOPV-bOPV&#xD;
      vaccination schedule at one month doses interval (i.e., month 0, 1, 2), and the control group&#xD;
      received wIPV-bOPV-bOPV vaccination schedule at one month doses interval (i.e., month 0, 1,&#xD;
      2). The control wIPV was manufactured by SANOFI PASTEUR S.A.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 6, 2018</start_date>
  <completion_date type="Actual">December 11, 2018</completion_date>
  <primary_completion_date type="Actual">September 26, 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/wIPV) 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>
  <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-bOPV-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-bOPV-bOPV vaccination schedule</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>sIPV-bOPV-bOPV vaccination schedule</intervention_name>
    <description>Single intramuscular injection of the experimental sIPV (0.5 ml) on Day 0, following two doses of bOPV (0.1 ml) on Day 30 and Day 60 respectively. The investigational Sabin strain inactivated poliovirus vaccine (Vero cell)(sIPV) was manufactured by Sinovac Vaccine Technology Co., Ltd. The poliovirus (Live) vaccine type I &amp; type III (Human Dipoid 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-bOPV-bOPV vaccination schedule</intervention_name>
    <description>Single intramuscular injection of the control wIPV (0.5 ml) on Day 0, following two doses of bOPV (0.1 ml) on Day 30 and Day 60 respectively.The control wild strain inactivated poliovirus vaccine (wIPV) was manufactured by SANOFI PASTEUR S.A. The poliovirus (Live) vaccine type I &amp; type III (Human Dipoid 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>Guanyun Center for Disease Control and Prevention</name>
      <address>
        <city>Lianyungang</city>
        <state>Jiangsu</state>
        <zip>222200</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 30, 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/NCT03822754
org study id: PRO-sIPV-3001-1
nct id: NCT03822754
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 '1+2' sequential schedule with bivalent
      oral poliovirus vaccine in 2-month-old infants
This 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 Vaccine Technology Co., Ltd in a '1+2' 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-bOPV-bOPV
      vaccination schedule at one month doses interval (i.e., month 0, 1, 2), and the control group
      received wIPV-bOPV-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/wIPV) 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.
arm group label: Experimental Group
arm group type: Experimental
description: sIPV-bOPV-bOPV vaccination schedule
arm group label: Control Group
arm group type: Active Comparator
description: wIPV-bOPV-bOPV vaccination schedule
intervention type: Biological
intervention name: sIPV-bOPV-bOPV vaccination schedule
description: Single intramuscular injection of the experimental sIPV (0.5 ml) on Day 0, following two doses of bOPV (0.1 ml) on Day 30 and Day 60 respectively. The investigational Sabin strain inactivated poliovirus vaccine (Vero cell)(sIPV) was manufactured by Sinovac Vaccine Technology Co., Ltd. The poliovirus (Live) vaccine type I & type III (Human Dipoid cell) ( bOPV) was manufactured by Beijing Bio-institute Biological Products Co., Ltd.
arm group label: Experimental Group
intervention type: Biological
intervention name: wIPV-bOPV-bOPV vaccination schedule
description: Single intramuscular injection of the control wIPV (0.5 ml) on Day 0, following two doses of bOPV (0.1 ml) on Day 30 and Day 60 respectively.The control wild strain inactivated poliovirus vaccine (wIPV) was manufactured by SANOFI PASTEUR S.A. The poliovirus (Live) vaccine type I & type III (Human Dipoid 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