<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/NCT02985320</url>
  </required_header>
  <id_info>
    <org_study_id>PRO-sIPV-1001</org_study_id>
    <nct_id>NCT02985320</nct_id>
  </id_info>
  <brief_title>Studies of the Safety and Immunogenicity of a Sabin Inactivated Poliovirus Vaccine</brief_title>
  <official_title>A Open-label Phase I Study to Evaluate Safety of a Sabin Inactivated Poliovirus Vaccine (sIPV) in Adults, Children, and Infants, and a Blinded, Randomized and Controlled Phase II to Evaluate Safety and Immunogenicity of it in 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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the safety of sIPVs of different dosages in adults,&#xD;
      children and infants in a phase I open-label study, and then assess its immunogenicity and&#xD;
      safety in healthy infants between 60 and 90 days old in a phase II blind, randomized, and&#xD;
      controlled study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a combination of phases I and II. Phase I study is open-label, and only collect&#xD;
      safety information of the investigational sIPVs in adults, children and infants. Phase II&#xD;
      study is double-blind, randomized, controlled study of the immunogenicity and safety of the&#xD;
      investigational vaccines and two other commercialized inactivated poliovirus vaccines in&#xD;
      healthy infants.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2016</start_date>
  <completion_date type="Actual">June 2017</completion_date>
  <primary_completion_date type="Actual">June 2017</primary_completion_date>
  <phase>Phase 1/Phase 2</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The seroconversion rates (SCRs) of each group of the phase II trial after three-dose regimen</measure>
    <time_frame>90 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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The post-immune geometric mean titer (GMT) of each group of the phase II trial after three-dose regimen</measure>
    <time_frame>90 days</time_frame>
    <description>GMT of each group of the phase II trial 30 days after three-dose regimen which lasts 60 days.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The geometric mean fold increase (GMI) of each group after three-dose regimen</measure>
    <time_frame>90 days</time_frame>
    <description>The GMI is the increase of post-immune GMT from pre-immune GMT.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The incidences of solicited adverse events (AEs) of each group in both phase I and II trials</measure>
    <time_frame>7 days</time_frame>
    <description>Solicited AEs occurred within 7 days after each injection will be collected.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The incidences of unsolicited adverse events (AEs) of each group in both phase I and II trials</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>The incidences of serious adverse events (SAEs) of each group in both phase I and II trials</measure>
    <time_frame>30 days</time_frame>
    <description>SAEs occurred within 30 days after each injection will be collected.</description>
  </secondary_outcome>
  <number_of_arms>12</number_of_arms>
  <enrollment type="Actual">708</enrollment>
  <condition>Poliomyelitis</condition>
  <arm_group>
    <arm_group_label>Phase I Adult Group - High dosage</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single intramuscular injection of the investigational vaccine(0.5 ml) on Day 0;&#xD;
Intervention: Single-dose regimen of high dosage investigational sIPV</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase I Adult Group - Medium dosage</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single intramuscular injection of the investigational vaccine(0.5 ml) on Day 0;&#xD;
Intervention: Single-dose regimen of medium dosage investigational sIPV</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase I Child Group - High dosage</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single intramuscular injection of the investigational vaccine(0.5 ml) on Day 0;&#xD;
Intervention: Single-dose regimen of high dosage investigational sIPV</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase I Child Group - Medium dosage</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single intramuscular injection of the investigational vaccine(0.5 ml) on Day 0;&#xD;
Intervention: Single-dose regimen of medium dosage investigational sIPV</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase I Infant Group - High dosage</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively;&#xD;
Intervention: Three-dose regimen of high dosage investigational sIPV</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase I Infant Group - Medium dosage</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively;&#xD;
Intervention: Three-dose regimen of medium dosage investigational sIPV</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase I Infant Group - Low dosage</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively;&#xD;
Intervention: Three-dose regimen of low dosage investigational sIPV</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PhaseⅡExperimental Group - High dosage</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively;&#xD;
Intervention: Three-dose regimen of high dosage investigational sIPV</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PhaseⅡExperimental Group - Medium dosage</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively;&#xD;
Intervention: Three-dose regimen of medium dosage investigational sIPV</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PhaseⅡExperimental Group - Low dosage</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively;&#xD;
Intervention: Three-dose regimen of low dosage investigational sIPV</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PhaseⅡControl Group -commercialized sIPV</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively;&#xD;
Intervention:Three-dose regimen of commercialized sIPV</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PhaseⅡ Control Group -commercialized IPV</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively;&#xD;
Intervention: Three-dose regimen of commercialized IPV</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Single-dose regimen of high dosage investigational sIPV</intervention_name>
    <description>The investigational vaccines were manufactured by Sinovac Biotech Co., Ltd..</description>
    <arm_group_label>Phase I Adult Group - High dosage</arm_group_label>
    <arm_group_label>Phase I Child Group - High dosage</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Single-dose regimen of medium dosage investigational sIPV</intervention_name>
    <description>The investigational vaccines were manufactured by Sinovac Biotech Co., Ltd..</description>
    <arm_group_label>Phase I Adult Group - Medium dosage</arm_group_label>
    <arm_group_label>Phase I Child Group - Medium dosage</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Three-dose regimen of high dosage investigational sIPV</intervention_name>
    <description>The investigational vaccines were manufactured by Sinovac Biotech Co., Ltd..</description>
    <arm_group_label>Phase I Infant Group - High dosage</arm_group_label>
    <arm_group_label>PhaseⅡExperimental Group - High dosage</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Three-dose regimen of medium dosage investigational sIPV</intervention_name>
    <description>The investigational vaccines were manufactured by Sinovac Biotech Co., Ltd..</description>
    <arm_group_label>Phase I Infant Group - Medium dosage</arm_group_label>
    <arm_group_label>PhaseⅡExperimental Group - Medium dosage</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Three-dose regimen of low dosage investigational sIPV</intervention_name>
    <description>The investigational vaccines were manufactured by Sinovac Biotech Co., Ltd..</description>
    <arm_group_label>Phase I Infant Group - Low dosage</arm_group_label>
    <arm_group_label>PhaseⅡExperimental Group - Low dosage</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Three-dose regimen of commercialized sIPV</intervention_name>
    <description>The control vaccine was manufactured by Chinese Academy of Medical Sciences.</description>
    <arm_group_label>PhaseⅡControl Group -commercialized sIPV</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Three-dose regimen of commercialized IPV</intervention_name>
    <description>The control vaccine was manufactured by Sanofi Pasteur S.A (IMOVAX POLIO).</description>
    <arm_group_label>PhaseⅡ Control Group -commercialized IPV</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy volunteer between 60-90 days old, 6-12 years old, or 18-49 years 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 (≥ 18 years old), or guardians of the participants (&lt; 18 years old)&#xD;
             should be capable of understanding the written consent form, and such form should be&#xD;
             signed prior to enrolment;&#xD;
&#xD;
          -  Complying with the requirement of the study protocol;&#xD;
&#xD;
          -  Axillary temperature ≤ 37.0 °C;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Breast feeding, pregnant, or expected to conceive in the next 60 days;&#xD;
&#xD;
          -  History of allergy to any vaccine, or any ingredient of the vaccine, or serious&#xD;
             adverse reaction(s) to vaccination, such as urticaria, dyspnea, angioneurotic edema,&#xD;
             abdominal pain, etc;&#xD;
&#xD;
          -  Congenital malformation, developmental disorders, genetic defects, or severe&#xD;
             malnutrition;&#xD;
&#xD;
          -  Autoimmune disease or immunodeficiency/immunosuppressive;&#xD;
&#xD;
          -  serious chronic diseases, serious cardiovascular disease, hypertension or diabetes&#xD;
             that cannot be stabilized by medication, liver or kidney disease, malignancy, etc;&#xD;
&#xD;
          -  severe nervous system disease (epilepsy, seizures or convulsions) or mental illness;&#xD;
&#xD;
          -  History of thyroidectomy, asplenia, functional asplenia, or any condition resulting in&#xD;
             the absence or removal the spleen;&#xD;
&#xD;
          -  Bleeding disorder diagnosed by a doctor (e.g., coagulation factor deficiency,&#xD;
             coagulation disorder, or platelet disorder) , or significant bruising or coagulopathy;&#xD;
&#xD;
          -  Long term history of alcoholism or drug abuse;&#xD;
&#xD;
          -  Receipt of any of the following products:&#xD;
&#xD;
               1. Any subunit or inactivated vaccine within the past 7 day;&#xD;
&#xD;
               2. Any live attenuated vaccine within the past 14 days;&#xD;
&#xD;
               3. Any other investigational medicine(s) within the past 30 days;&#xD;
&#xD;
               4. Any blood product within the past 3 months;&#xD;
&#xD;
               5. Any immunosuppressant, cytotoxic medications, or inhaled corticosteroids (except&#xD;
                  corticosteroid spray for treatment of allergic rhinitis or corticosteroid&#xD;
                  treatment on surface for acute non-complicated dermatitis) within the past 6&#xD;
                  month prior to study entry;&#xD;
&#xD;
          -  Acute illness or acute exacerbation of chronic disease within the past 7 days;&#xD;
&#xD;
          -  Axillary temperature &gt; 37.0 °C;&#xD;
&#xD;
          -  Infant participants with prior vaccination of poliovirus;&#xD;
&#xD;
          -  Any other factor that, in the judgment of the investigator, suggesting the volunteer&#xD;
             is unsuitable for this study;&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Months</minimum_age>
    <maximum_age>49 Years</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 City 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>July 2017</verification_date>
  <study_first_submitted>December 5, 2016</study_first_submitted>
  <study_first_submitted_qc>December 5, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 7, 2016</study_first_posted>
  <last_update_submitted>July 25, 2017</last_update_submitted>
  <last_update_submitted_qc>July 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 26, 2017</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>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Poliomyelitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT02985320
org study id: PRO-sIPV-1001
nct id: NCT02985320
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the safety of sIPVs of different dosages in adults,
      children and infants in a phase I open-label study, and then assess its immunogenicity and
      safety in healthy infants between 60 and 90 days old in a phase II blind, randomized, and
      controlled study.
This study is a combination of phases I and II. Phase I study is open-label, and only collect
      safety information of the investigational sIPVs in adults, children and infants. Phase II
      study is double-blind, randomized, controlled study of the immunogenicity and safety of the
      investigational vaccines and two other commercialized inactivated poliovirus vaccines in
      healthy infants.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: The seroconversion rates (SCRs) of each group of the phase II trial after three-dose regimen
time frame: 90 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.
measure: The post-immune geometric mean titer (GMT) of each group of the phase II trial after three-dose regimen
time frame: 90 days
description: GMT of each group of the phase II trial 30 days after three-dose regimen which lasts 60 days.
measure: The geometric mean fold increase (GMI) of each group after three-dose regimen
time frame: 90 days
description: The GMI is the increase of post-immune GMT from pre-immune GMT.
measure: The incidences of solicited adverse events (AEs) of each group in both phase I and II trials
time frame: 7 days
description: Solicited AEs occurred within 7 days after each injection will be collected.
measure: The incidences of unsolicited adverse events (AEs) of each group in both phase I and II trials
time frame: 30 days
description: Unsolicited AEs occurred within 30 days after each injection will be collected.
measure: The incidences of serious adverse events (SAEs) of each group in both phase I and II trials
time frame: 30 days
description: SAEs occurred within 30 days after each injection will be collected.
arm group label: Phase I Adult Group - High dosage
arm group type: Experimental
description: Single intramuscular injection of the investigational vaccine(0.5 ml) on Day 0;
Intervention: Single-dose regimen of high dosage investigational sIPV
arm group label: Phase I Adult Group - Medium dosage
arm group type: Experimental
description: Single intramuscular injection of the investigational vaccine(0.5 ml) on Day 0;
Intervention: Single-dose regimen of medium dosage investigational sIPV
arm group label: Phase I Child Group - High dosage
arm group type: Experimental
description: Single intramuscular injection of the investigational vaccine(0.5 ml) on Day 0;
Intervention: Single-dose regimen of high dosage investigational sIPV
arm group label: Phase I Child Group - Medium dosage
arm group type: Experimental
description: Single intramuscular injection of the investigational vaccine(0.5 ml) on Day 0;
Intervention: Single-dose regimen of medium dosage investigational sIPV
arm group label: Phase I Infant Group - High dosage
arm group type: Experimental
description: Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively;
Intervention: Three-dose regimen of high dosage investigational sIPV
arm group label: Phase I Infant Group - Medium dosage
arm group type: Experimental
description: Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively;
Intervention: Three-dose regimen of medium dosage investigational sIPV
arm group label: Phase I Infant Group - Low dosage
arm group type: Experimental
description: Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively;
Intervention: Three-dose regimen of low dosage investigational sIPV
arm group label: PhaseⅡExperimental Group - High dosage
arm group type: Experimental
description: Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively;
Intervention: Three-dose regimen of high dosage investigational sIPV
arm group label: PhaseⅡExperimental Group - Medium dosage
arm group type: Experimental
description: Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively;
Intervention: Three-dose regimen of medium dosage investigational sIPV
arm group label: PhaseⅡExperimental Group - Low dosage
arm group type: Experimental
description: Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively;
Intervention: Three-dose regimen of low dosage investigational sIPV
arm group label: PhaseⅡControl Group -commercialized sIPV
arm group type: Active Comparator
description: Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively;
Intervention:Three-dose regimen of commercialized sIPV
arm group label: PhaseⅡ Control Group -commercialized IPV
arm group type: Active Comparator
description: Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively;
Intervention: Three-dose regimen of commercialized IPV
intervention type: Biological
intervention name: Single-dose regimen of high dosage investigational sIPV
description: The investigational vaccines were manufactured by Sinovac Biotech Co., Ltd..
arm group label: Phase I Adult Group - High dosage
arm group label: Phase I Child Group - High dosage
intervention type: Biological
intervention name: Single-dose regimen of medium dosage investigational sIPV
description: The investigational vaccines were manufactured by Sinovac Biotech Co., Ltd..
arm group label: Phase I Adult Group - Medium dosage
arm group label: Phase I Child Group - Medium dosage
intervention type: Biological
intervention name: Three-dose regimen of high dosage investigational sIPV
description: The investigational vaccines were manufactured by Sinovac Biotech Co., Ltd..
arm group label: Phase I Infant Group - High dosage
arm group label: PhaseⅡExperimental Group - High dosage
intervention type: Biological
intervention name: Three-dose regimen of medium dosage investigational sIPV
description: The investigational vaccines were manufactured by Sinovac Biotech Co., Ltd..
arm group label: Phase I Infant Group - Medium dosage
arm group label: PhaseⅡExperimental Group - Medium dosage
intervention type: Biological
intervention name: Three-dose regimen of low dosage investigational sIPV
description: The investigational vaccines were manufactured by Sinovac Biotech Co., Ltd..
arm group label: Phase I Infant Group - Low dosage
arm group label: PhaseⅡExperimental Group - Low dosage
intervention type: Biological
intervention name: Three-dose regimen of commercialized sIPV
description: The control vaccine was manufactured by Chinese Academy of Medical Sciences.
arm group label: PhaseⅡControl Group -commercialized sIPV
intervention type: Biological
intervention name: Three-dose regimen of commercialized IPV
description: The control vaccine was manufactured by Sanofi Pasteur S.A (IMOVAX POLIO).
arm group label: PhaseⅡ Control Group -commercialized IPV
criteria: 
gender: All
minimum age: 2 Months
maximum age: 49 Years
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
sharing ipd: No