<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/NCT03239496</url>
  </required_header>
  <id_info>
    <org_study_id>IPV004</org_study_id>
    <nct_id>NCT03239496</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate Immunogenicity of Intramuscular Full-Dose and Intradermal Fractional Dose of IPV</brief_title>
  <official_title>A Phase 3, Open-label, Multicenter Randomized Trial to Evaluate Humoral Immunogenicity of Various Schedules of Intramuscular Full-Dose and Intradermal Fractional Dose of Inactivated Polio Vaccine in Latin American Infants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fidec Corporation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Bill and Melinda Gates Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Fidec Corporation</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 study will assess and compare the immune response to full-dose inactivated polio vaccines&#xD;
      (IPV) via intramuscular (IM) administration and of the fractional dose of inactivated&#xD;
      poliovirus vaccine (f-IPV) via intradermal (ID) administration, in different schedule&#xD;
      combinations in the Expanded Program on Immunization (EPI) primary series.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study prioritizes comparisons involving two-dose regimens recently recommended by the&#xD;
      World Health Organization (WHO) Strategic Advisory Group of Experts on immunization (SAGE)&#xD;
      and Pan American Health Organization (PAHO) in response to global IPV supply shortages 21.&#xD;
      Furthermore, the study will provide data on the comparative humoral immunogenicity of various&#xD;
      schedules to inform polio immunization policy for the post-eradication era.&#xD;
&#xD;
      The study population will include infants in Dominican Republic and Panama. Absence of wild&#xD;
      and circulating vaccine derived polioviruses along with the lack of regular Supplementary&#xD;
      Immunization Activities (SIAs) in the Latin America region provide an ideal epidemiologic&#xD;
      setting to study polio vaccine immunogenicity.&#xD;
&#xD;
      Infants will receive two or three doses of full-dose IPV IM or f-IPV ID, in two schedules&#xD;
      (10, 14 and 36 weeks and 14 and 36 weeks). Immunological and safety assessments will be made&#xD;
      after one dose, two doses and three doses.&#xD;
&#xD;
      A total of 773 infants will be enrolled and distributed into 4 groups, according to a&#xD;
      randomization scheme. During the study period, infants will be administered other concomitant&#xD;
      vaccines according to the national schedules of the participating countries, but the effect,&#xD;
      if any, of the concomitant administration on IPV immunogenicity will not be assessed.&#xD;
&#xD;
      Optimum immunogenicity expected from the dose(s) of IPV in the post-eradication era will have&#xD;
      to be balanced with the cost and supply constraints of IPV. This study will be critical to&#xD;
      determine how many doses of IPV and which schedule are optimal for the post-eradication era&#xD;
      after the global cessation of Oral Polio Vaccine (OPV) use.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 23, 2017</start_date>
  <completion_date type="Actual">November 13, 2018</completion_date>
  <primary_completion_date type="Actual">November 13, 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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Seroconversion Non-inferiority of 2 Doses f-IPV ID vs 2 Doses IPV IM</measure>
    <time_frame>To be assessed 4 weeks after the last dose</time_frame>
    <description>To determine if the seroconversion rate of a 2-dose intradermally administered fractional-dose inactivated poliovirus vaccine (f-IPV) regimen administered at 14 and 36 weeks of age is non-inferior to that of a 2-dose intramuscularly administered inactivated poliovirus vaccine (IPV) regimen administered at 14 and 36 weeks of age for poliovirus serotypes 1 and 2.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Seroconversion Non-inferiority of 2 Doses IPV IM vs 3 Doses IPV IM</measure>
    <time_frame>To be assessed 4 weeks after the last dose</time_frame>
    <description>To determine if the seroconversion rate of a 2-dose IPV regimen administered at 14 and 36 weeks of age is non-inferior to that of a 3-dose IPV regimen administered at 10, 14, and 36 weeks of age for poliovirus serotypes 1 and 2.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Seroconversion Non-inferiority of 2 Doses f-IPV ID vs 3 Doses f-IPV ID</measure>
    <time_frame>To be assessed 4 weeks after the last dose</time_frame>
    <description>To determine if the seroconversion rate of a 2-dose f-IPV regimen administered at 14 and 36 weeks of age is non-inferior to that of a 3-dose f-IPV regimen administered at 10, 14, and 36 weeks of age for poliovirus serotypes 1 and 2.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Seroconversion Superiority of 2 Doses IPV IM at Different Schedules</measure>
    <time_frame>To be assessed 4 weeks after the second dose</time_frame>
    <description>To determine if the seroconversion rate of a 2-dose IPV regimen administered at 14 and 36 weeks of age is superior to that of a 2-dose IPV regimen administered at 10 and 14 weeks of age for poliovirus serotypes 1 and 2.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Seroconversion Superiority of 2 Dose f-IPV ID at Different Schedules</measure>
    <time_frame>To be assessed 4 weeks after the second dose</time_frame>
    <description>To determine if the seroconversion rate of a 2-dose f-IPV regimen administered at 14 and 36 weeks of age is superior to that of a 2-dose f-IPV regimen administered at 10 and 14 weeks of age for poliovirus serotypes 1 and 2.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Seroconversion Non-inferiority of 2 Dose f-IPV ID vs 3 Dose IPV IM</measure>
    <time_frame>To be assessed 4 weeks after the last dose</time_frame>
    <description>To determine if the seroconversion rate of a 2-dose f-IPV regimen administered at 14 and 36 weeks of age is non-inferior to that of a 3-dose IPV regimen administered at 10, 14, and 36 weeks of age for poliovirus serotypes 1 and 2.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Seroconversion Non Inferiority of 3 Doses f-IPV ID vs 3 Doses IPV IM</measure>
    <time_frame>To be assessed 4 weeks after the last dose</time_frame>
    <description>To determine if the seroconversion rate of a 3-dose f-IPV regimen administered at 10, 14, and 36 weeks of age is non-inferior to that of a 3-dose IPV regimen also administered at 10, 14, and 36 weeks of age for poliovirus serotypes 1 and 2.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Seroconversion Non Inferiority of 3 Doses f-IPV ID vs 2 Doses IPV IM</measure>
    <time_frame>To be assessed 4 weeks after the last dose</time_frame>
    <description>To determine if the seroconversion rate to a 3-dose regimen of f-IPV administered at 10, 14, and 36 weeks of age is non-inferior to that of a 2-dose IPV regimen administered at 14 and 36 weeks of age for poliovirus serotypes 1 and 2.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Experiencing SAEs, IMEs and/or Severe Local Reactions</measure>
    <time_frame>9 months</time_frame>
    <description>To assess the safety of each vaccine (IPV and f-IPV) as measured by the number of subjects experiencing serious adverse events (SAEs), important medical events (IMEs) and/or severe local reactions. This assessments is done in the Total Vaccinated Population (744 subjects).</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">773</enrollment>
  <condition>Poliomyelitis</condition>
  <arm_group>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>3 doses IPV IM at 10, 14 &amp; 36 weeks of age incl. blood sampling at 10, 14, 18 &amp; 40 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2 doses IPV IM at 14 &amp; 36 weeks of age incl. blood sampling at 14, 18, 36 &amp; 40 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group C</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>3 doses f-IPV ID at 10, 14 &amp; 36 weeks of age incl. blood sampling at 10, 14, 18 &amp; 40 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group D</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2 doses f-IPV ID at 14 &amp; 36 weeks of age incl. blood sampling at 14, 18, 36 &amp; 40 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>IPV</intervention_name>
    <description>Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)</description>
    <arm_group_label>Group A</arm_group_label>
    <arm_group_label>Group B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>f-IPV</intervention_name>
    <description>Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)</description>
    <arm_group_label>Group C</arm_group_label>
    <arm_group_label>Group D</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Infants of 6 weeks of age (-7 to + 7 days) on date of enrollment.&#xD;
&#xD;
          2. Healthy, as assessed from medical history and physical examination by a study&#xD;
             physician,&#xD;
&#xD;
          3. Written informed consent obtained from parents or legal representatives who have been&#xD;
             properly informed about the study and are able to comply with planned study&#xD;
             procedures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Vaccinated with any poliovirus vaccine prior to inclusion,&#xD;
&#xD;
          2. A household contact with OPV vaccination history in the past 4 weeks,&#xD;
&#xD;
          3. HIV infection or pharmacologic immunosuppression,&#xD;
&#xD;
          4. Known allergy to any component of the study vaccines (phenoxyethanol, formaldehyde),&#xD;
&#xD;
          5. Uncontrolled coagulopathy or blood disorder contraindicating intramuscular and&#xD;
             intradermal injections,&#xD;
&#xD;
          6. Acute severe febrile illness on day of vaccination deemed by the Investigator(s) to be&#xD;
             a contraindication for vaccination,&#xD;
&#xD;
          7. Not suitable for inclusion or is unlikely to comply with the protocol in the opinion&#xD;
             of the investigator(s).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Weeks</minimum_age>
    <maximum_age>7 Weeks</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hospital Universitario Nuestra Señora de la Alta Gracia</name>
      <address>
        <city>Santo Domingo</city>
        <country>Dominican Republic</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cevaxin Vaccination Center</name>
      <address>
        <city>David</city>
        <country>Panama</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cevaxin Vaccination Center</name>
      <address>
        <city>La Chorrera</city>
        <country>Panama</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cevaxin Vaccination Center</name>
      <address>
        <city>Panama city</city>
        <country>Panama</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Dominican Republic</country>
    <country>Panama</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>July 28, 2017</study_first_submitted>
  <study_first_submitted_qc>August 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2017</study_first_posted>
  <results_first_submitted>August 1, 2020</results_first_submitted>
  <results_first_submitted_qc>August 1, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">August 18, 2020</results_first_posted>
  <last_update_submitted>July 10, 2023</last_update_submitted>
  <last_update_submitted_qc>July 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2023</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>Poliomyelitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 12, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/96/NCT03239496/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Group A - 3 Doses IPV IM</title>
          <description>3 doses IPV IM at 10, 14 &amp; 36 weeks of age incl. blood sampling at 10, 14, 18 &amp; 40 weeks.&#xD;
IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)</description>
        </group>
        <group group_id="P2">
          <title>Group B - 2 Doses IPV IM</title>
          <description>2 doses IPV IM at 14 &amp; 36 weeks of age incl. blood sampling at 14, 18, 36 &amp; 40 weeks.&#xD;
IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)</description>
        </group>
        <group group_id="P3">
          <title>Group C - 3 Doses f-IPV</title>
          <description>3 doses f-IPV ID at 10, 14 &amp; 36 weeks of age incl. blood sampling at 10, 14, 18 &amp; 40 weeks.&#xD;
f-IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)</description>
        </group>
        <group group_id="P4">
          <title>Group D - 2 Doses f-IPV ID</title>
          <description>2 doses f-IPV ID at 14 &amp; 36 weeks of age incl. blood sampling at 14, 18, 36 &amp; 40 weeks.&#xD;
f-IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="200"/>
                <participants group_id="P2" count="178"/>
                <participants group_id="P3" count="178"/>
                <participants group_id="P4" count="217"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="186"/>
                <participants group_id="P2" count="168"/>
                <participants group_id="P3" count="166"/>
                <participants group_id="P4" count="203"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="10"/>
                <participants group_id="P3" count="12"/>
                <participants group_id="P4" count="14"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Group A</title>
          <description>3 doses IPV IM at 10, 14 &amp; 36 weeks of age incl. blood sampling at 10, 14, 18 &amp; 40 weeks.&#xD;
IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)</description>
        </group>
        <group group_id="B2">
          <title>Group B</title>
          <description>2 doses IPV IM at 14 &amp; 36 weeks of age incl. blood sampling at 14, 18, 36 &amp; 40 weeks.&#xD;
IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)</description>
        </group>
        <group group_id="B3">
          <title>Group C</title>
          <description>3 doses f-IPV ID at 10, 14 &amp; 36 weeks of age incl. blood sampling at 10, 14, 18 &amp; 40 weeks.&#xD;
f-IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)</description>
        </group>
        <group group_id="B4">
          <title>Group D</title>
          <description>2 doses f-IPV ID at 14 &amp; 36 weeks of age incl. blood sampling at 14, 18, 36 &amp; 40 weeks.&#xD;
f-IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)</description>
        </group>
        <group group_id="B5">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="200"/>
            <count group_id="B2" value="178"/>
            <count group_id="B3" value="178"/>
            <count group_id="B4" value="217"/>
            <count group_id="B5" value="773"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="200"/>
                    <measurement group_id="B2" value="178"/>
                    <measurement group_id="B3" value="178"/>
                    <measurement group_id="B4" value="217"/>
                    <measurement group_id="B5" value="773"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="93"/>
                    <measurement group_id="B2" value="92"/>
                    <measurement group_id="B3" value="82"/>
                    <measurement group_id="B4" value="105"/>
                    <measurement group_id="B5" value="372"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="107"/>
                    <measurement group_id="B2" value="86"/>
                    <measurement group_id="B3" value="96"/>
                    <measurement group_id="B4" value="112"/>
                    <measurement group_id="B5" value="401"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Black or African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hispanic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="105"/>
                    <measurement group_id="B2" value="108"/>
                    <measurement group_id="B3" value="101"/>
                    <measurement group_id="B4" value="132"/>
                    <measurement group_id="B5" value="446"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Latin American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="88"/>
                    <measurement group_id="B2" value="69"/>
                    <measurement group_id="B3" value="68"/>
                    <measurement group_id="B4" value="78"/>
                    <measurement group_id="B5" value="303"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White / Caucasian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Panama</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="112"/>
                    <measurement group_id="B2" value="82"/>
                    <measurement group_id="B3" value="93"/>
                    <measurement group_id="B4" value="100"/>
                    <measurement group_id="B5" value="387"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dominican Republic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="88"/>
                    <measurement group_id="B2" value="96"/>
                    <measurement group_id="B3" value="85"/>
                    <measurement group_id="B4" value="117"/>
                    <measurement group_id="B5" value="386"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Seroconversion Non-inferiority of 2 Doses f-IPV ID vs 2 Doses IPV IM</title>
        <description>To determine if the seroconversion rate of a 2-dose intradermally administered fractional-dose inactivated poliovirus vaccine (f-IPV) regimen administered at 14 and 36 weeks of age is non-inferior to that of a 2-dose intramuscularly administered inactivated poliovirus vaccine (IPV) regimen administered at 14 and 36 weeks of age for poliovirus serotypes 1 and 2.</description>
        <time_frame>To be assessed 4 weeks after the last dose</time_frame>
        <population>Per Protocol Population (692 subjects) is used for this assessment. The participants flow includes the Intended to Treat population (773 subjects).</population>
        <group_list>
          <group group_id="O1">
            <title>Group B</title>
            <description>2 doses IPV IM at 14 &amp; 36 weeks of age incl. blood sampling at 14, 18, 36 &amp; 40 weeks.&#xD;
IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)</description>
          </group>
          <group group_id="O2">
            <title>Group D</title>
            <description>2 doses f-IPV ID at 14 &amp; 36 weeks of age incl. blood sampling at 14, 18, 36 &amp; 40 weeks.&#xD;
f-IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)</description>
          </group>
        </group_list>
        <measure>
          <title>Seroconversion Non-inferiority of 2 Doses f-IPV ID vs 2 Doses IPV IM</title>
          <description>To determine if the seroconversion rate of a 2-dose intradermally administered fractional-dose inactivated poliovirus vaccine (f-IPV) regimen administered at 14 and 36 weeks of age is non-inferior to that of a 2-dose intramuscularly administered inactivated poliovirus vaccine (IPV) regimen administered at 14 and 36 weeks of age for poliovirus serotypes 1 and 2.</description>
          <population>Per Protocol Population (692 subjects) is used for this assessment. The participants flow includes the Intended to Treat population (773 subjects).</population>
          <units>percentage of seroconversion</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="159"/>
                <count group_id="O2" value="195"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Serotype 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.1" lower_limit="94.6" upper_limit="99.6"/>
                    <measurement group_id="O2" value="95.9" lower_limit="92.1" upper_limit="98.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.7" lower_limit="95.5" upper_limit="99.8"/>
                    <measurement group_id="O2" value="97.9" lower_limit="94.8" upper_limit="99.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The group sizes are chosen to provide ≥ 80% power for each of the primary objectives, for the individual statistical tests of each serotype, as well as across both serotypes simultaneously. Power of ≥80% is also available for all secondary objectives, except for the comparison of the f-IPV regimen administered at weeks 14 and 36 to the 3-dose IPV regimen, which has power of 62% for individual serotypes, and 39% for the combined serotypes.</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>All non-inferiority comparisons of seroconversion rates will be made utilizing the lower bound of two-sided score-based confidence intervals (α = 0.05) with non-inferiority margin 10%.</non_inferiority_desc>
            <p_value>0.05</p_value>
            <method>t-test, 1 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Seroconversion Non-inferiority of 2 Doses IPV IM vs 3 Doses IPV IM</title>
        <description>To determine if the seroconversion rate of a 2-dose IPV regimen administered at 14 and 36 weeks of age is non-inferior to that of a 3-dose IPV regimen administered at 10, 14, and 36 weeks of age for poliovirus serotypes 1 and 2.</description>
        <time_frame>To be assessed 4 weeks after the last dose</time_frame>
        <population>Per Protocol Population</population>
        <group_list>
          <group group_id="O1">
            <title>Group A</title>
            <description>3 doses IPV IM at 10, 14 &amp; 36 weeks of age incl. blood sampling at 10, 14, 18 &amp; 40 weeks.&#xD;
IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)</description>
          </group>
          <group group_id="O2">
            <title>Group B</title>
            <description>2 doses IPV IM at 14 &amp; 36 weeks of age incl. blood sampling at 14, 18, 36 &amp; 40 weeks.&#xD;
IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)</description>
          </group>
        </group_list>
        <measure>
          <title>Seroconversion Non-inferiority of 2 Doses IPV IM vs 3 Doses IPV IM</title>
          <description>To determine if the seroconversion rate of a 2-dose IPV regimen administered at 14 and 36 weeks of age is non-inferior to that of a 3-dose IPV regimen administered at 10, 14, and 36 weeks of age for poliovirus serotypes 1 and 2.</description>
          <population>Per Protocol Population</population>
          <units>percentage of seroconversion</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="159"/>
                <count group_id="O2" value="178"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Serotype 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100" lower_limit="97.9" upper_limit="100"/>
                    <measurement group_id="O2" value="98.1" lower_limit="94.6" upper_limit="99.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100" lower_limit="97.9" upper_limit="100"/>
                    <measurement group_id="O2" value="98.7" lower_limit="95.5" upper_limit="99.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The group sizes are chosen to provide ≥ 80% power for each of the primary objectives, for the individual statistical tests of each serotype, as well as across both serotypes simultaneously. Power of ≥80% is also available for all secondary objectives, except for the comparison of the f-IPV regimen administered at weeks 14 and 36 to the 3-dose IPV regimen, which has power of 62% for individual serotypes, and 39% for the combined serotypes.</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>All non-inferiority comparisons of seroconversion rates will be made utilizing the lower bound of two-sided score-based confidence intervals (α = 0.05) with non-inferiority margin 10%.</non_inferiority_desc>
            <p_value>0.05</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Seroconversion Non-inferiority of 2 Doses f-IPV ID vs 3 Doses f-IPV ID</title>
        <description>To determine if the seroconversion rate of a 2-dose f-IPV regimen administered at 14 and 36 weeks of age is non-inferior to that of a 3-dose f-IPV regimen administered at 10, 14, and 36 weeks of age for poliovirus serotypes 1 and 2.</description>
        <time_frame>To be assessed 4 weeks after the last dose</time_frame>
        <population>Per Protocol Population</population>
        <group_list>
          <group group_id="O1">
            <title>Group C</title>
            <description>3 doses f-IPV ID at 10, 14 &amp; 36 weeks of age incl. blood sampling at 10, 14, 18 &amp; 40 weeks.&#xD;
f-IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)</description>
          </group>
          <group group_id="O2">
            <title>Group D</title>
            <description>2 doses f-IPV ID at 14 &amp; 36 weeks of age incl. blood sampling at 14, 18, 36 &amp; 40 weeks.&#xD;
f-IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)</description>
          </group>
        </group_list>
        <measure>
          <title>Seroconversion Non-inferiority of 2 Doses f-IPV ID vs 3 Doses f-IPV ID</title>
          <description>To determine if the seroconversion rate of a 2-dose f-IPV regimen administered at 14 and 36 weeks of age is non-inferior to that of a 3-dose f-IPV regimen administered at 10, 14, and 36 weeks of age for poliovirus serotypes 1 and 2.</description>
          <population>Per Protocol Population</population>
          <units>percentage of seroconversion</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="160"/>
                <count group_id="O2" value="195"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Serotype 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.8" lower_limit="95.6" upper_limit="98.8"/>
                    <measurement group_id="O2" value="95.9" lower_limit="92.1" upper_limit="98.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100" lower_limit="97.7" upper_limit="100"/>
                    <measurement group_id="O2" value="97.9" lower_limit="94.8" upper_limit="99.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The group sizes are chosen to provide ≥ 80% power for each of the primary objectives, for the individual statistical tests of each serotype, as well as across both serotypes simultaneously. Power of ≥80% is also available for all secondary objectives, except for the comparison of the f-IPV regimen administered at weeks 14 and 36 to the 3-dose IPV regimen, which has power of 62% for individual serotypes, and 39% for the combined serotypes.</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>All non-inferiority comparisons of seroconversion rates will be made utilizing the lower bound of two-sided score-based confidence intervals (α = 0.05) with non-inferiority margin 10%.</non_inferiority_desc>
            <p_value>0.05</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Seroconversion Superiority of 2 Doses IPV IM at Different Schedules</title>
        <description>To determine if the seroconversion rate of a 2-dose IPV regimen administered at 14 and 36 weeks of age is superior to that of a 2-dose IPV regimen administered at 10 and 14 weeks of age for poliovirus serotypes 1 and 2.</description>
        <time_frame>To be assessed 4 weeks after the second dose</time_frame>
        <population>Per Protocol Population</population>
        <group_list>
          <group group_id="O1">
            <title>Group A</title>
            <description>3 doses IPV IM at 10, 14 &amp; 36 weeks of age incl. blood sampling at 10, 14, 18 &amp; 40 weeks.&#xD;
IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)</description>
          </group>
          <group group_id="O2">
            <title>Group B</title>
            <description>2 doses IPV IM at 14 &amp; 36 weeks of age incl. blood sampling at 14, 18, 36 &amp; 40 weeks.&#xD;
IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)</description>
          </group>
        </group_list>
        <measure>
          <title>Seroconversion Superiority of 2 Doses IPV IM at Different Schedules</title>
          <description>To determine if the seroconversion rate of a 2-dose IPV regimen administered at 14 and 36 weeks of age is superior to that of a 2-dose IPV regimen administered at 10 and 14 weeks of age for poliovirus serotypes 1 and 2.</description>
          <population>Per Protocol Population</population>
          <units>percentage of seroconversion</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="180"/>
                <count group_id="O2" value="159"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Serotype 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95.6" lower_limit="94.6" upper_limit="99.6"/>
                    <measurement group_id="O2" value="98.1" lower_limit="94.6" upper_limit="99.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88.9" lower_limit="83.4" upper_limit="93.1"/>
                    <measurement group_id="O2" value="98.7" lower_limit="95.5" upper_limit="99.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The group sizes are chosen to provide ≥ 80% power for each of the primary objectives, for the individual statistical tests of each serotype, as well as across both serotypes simultaneously. Power of ≥80% is also available for all secondary objectives, except for the comparison of the f-IPV regimen administered at weeks 14 and 36 to the 3-dose IPV regimen, which has power of 62% for individual serotypes, and 39% for the combined serotypes.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0001</p_value>
            <method>Fisher Exact</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Seroconversion Superiority of 2 Dose f-IPV ID at Different Schedules</title>
        <description>To determine if the seroconversion rate of a 2-dose f-IPV regimen administered at 14 and 36 weeks of age is superior to that of a 2-dose f-IPV regimen administered at 10 and 14 weeks of age for poliovirus serotypes 1 and 2.</description>
        <time_frame>To be assessed 4 weeks after the second dose</time_frame>
        <population>Per Protocol Population</population>
        <group_list>
          <group group_id="O1">
            <title>Group C</title>
            <description>3 doses f-IPV ID at 10, 14 &amp; 36 weeks of age incl. blood sampling at 10, 14, 18 &amp; 40 weeks.&#xD;
f-IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)</description>
          </group>
          <group group_id="O2">
            <title>Group D</title>
            <description>2 doses f-IPV ID at 14 &amp; 36 weeks of age incl. blood sampling at 14, 18, 36 &amp; 40 weeks.&#xD;
f-IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)</description>
          </group>
        </group_list>
        <measure>
          <title>Seroconversion Superiority of 2 Dose f-IPV ID at Different Schedules</title>
          <description>To determine if the seroconversion rate of a 2-dose f-IPV regimen administered at 14 and 36 weeks of age is superior to that of a 2-dose f-IPV regimen administered at 10 and 14 weeks of age for poliovirus serotypes 1 and 2.</description>
          <population>Per Protocol Population</population>
          <units>percentage of seroconversion</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="161"/>
                <count group_id="O2" value="195"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Serotype 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83.2" lower_limit="76.5" upper_limit="88.6"/>
                    <measurement group_id="O2" value="95.9" lower_limit="92.1" upper_limit="98.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83.9" lower_limit="77.2" upper_limit="89.2"/>
                    <measurement group_id="O2" value="97.9" lower_limit="94.8" upper_limit="99.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The group sizes are chosen to provide ≥ 80% power for each of the primary objectives, for the individual statistical tests of each serotype, as well as across both serotypes simultaneously. Power of ≥80% is also available for all secondary objectives, except for the comparison of the f-IPV regimen administered at weeks 14 and 36 to the 3-dose IPV regimen, which has power of 62% for individual serotypes, and 39% for the combined serotypes.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0001</p_value>
            <method>Fisher Exact</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Seroconversion Non-inferiority of 2 Dose f-IPV ID vs 3 Dose IPV IM</title>
        <description>To determine if the seroconversion rate of a 2-dose f-IPV regimen administered at 14 and 36 weeks of age is non-inferior to that of a 3-dose IPV regimen administered at 10, 14, and 36 weeks of age for poliovirus serotypes 1 and 2.</description>
        <time_frame>To be assessed 4 weeks after the last dose</time_frame>
        <population>Per Protocol Population</population>
        <group_list>
          <group group_id="O1">
            <title>Group A</title>
            <description>3 doses IPV IM at 10, 14 &amp; 36 weeks of age incl. blood sampling at 10, 14, 18 &amp; 40 weeks.&#xD;
IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)</description>
          </group>
          <group group_id="O2">
            <title>Group D</title>
            <description>2 doses f-IPV ID at 14 &amp; 36 weeks of age incl. blood sampling at 14, 18, 36 &amp; 40 weeks.&#xD;
f-IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)</description>
          </group>
        </group_list>
        <measure>
          <title>Seroconversion Non-inferiority of 2 Dose f-IPV ID vs 3 Dose IPV IM</title>
          <description>To determine if the seroconversion rate of a 2-dose f-IPV regimen administered at 14 and 36 weeks of age is non-inferior to that of a 3-dose IPV regimen administered at 10, 14, and 36 weeks of age for poliovirus serotypes 1 and 2.</description>
          <population>Per Protocol Population</population>
          <units>percentage of seroconversion</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="178"/>
                <count group_id="O2" value="195"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Serotype 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100" lower_limit="97.9" upper_limit="100"/>
                    <measurement group_id="O2" value="95.9" lower_limit="92.1" upper_limit="98.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100" lower_limit="97.9" upper_limit="100"/>
                    <measurement group_id="O2" value="97.9" lower_limit="94.8" upper_limit="99.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The group sizes are chosen to provide ≥ 80% power for each of the primary objectives, for the individual statistical tests of each serotype, as well as across both serotypes simultaneously. Power of ≥80% is also available for all secondary objectives, except for the comparison of the f-IPV regimen administered at weeks 14 and 36 to the 3-dose IPV regimen, which has power of 62% for individual serotypes, and 39% for the combined serotypes.</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>All non-inferiority comparisons of seroconversion rates will be made utilizing the lower bound of two-sided score-based confidence intervals (α = 0.05) with non-inferiority margin 10%.</non_inferiority_desc>
            <p_value>0.05</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Seroconversion Non Inferiority of 3 Doses f-IPV ID vs 3 Doses IPV IM</title>
        <description>To determine if the seroconversion rate of a 3-dose f-IPV regimen administered at 10, 14, and 36 weeks of age is non-inferior to that of a 3-dose IPV regimen also administered at 10, 14, and 36 weeks of age for poliovirus serotypes 1 and 2.</description>
        <time_frame>To be assessed 4 weeks after the last dose</time_frame>
        <population>Per Protocol Population</population>
        <group_list>
          <group group_id="O1">
            <title>Group A</title>
            <description>3 doses IPV IM at 10, 14 &amp; 36 weeks of age incl. blood sampling at 10, 14, 18 &amp; 40 weeks.&#xD;
IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)</description>
          </group>
          <group group_id="O2">
            <title>Group C</title>
            <description>3 doses f-IPV ID at 10, 14 &amp; 36 weeks of age incl. blood sampling at 10, 14, 18 &amp; 40 weeks.&#xD;
f-IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)</description>
          </group>
        </group_list>
        <measure>
          <title>Seroconversion Non Inferiority of 3 Doses f-IPV ID vs 3 Doses IPV IM</title>
          <description>To determine if the seroconversion rate of a 3-dose f-IPV regimen administered at 10, 14, and 36 weeks of age is non-inferior to that of a 3-dose IPV regimen also administered at 10, 14, and 36 weeks of age for poliovirus serotypes 1 and 2.</description>
          <population>Per Protocol Population</population>
          <units>percentage of seroconversion</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="178"/>
                <count group_id="O2" value="160"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Serotype 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100" lower_limit="97.9" upper_limit="100"/>
                    <measurement group_id="O2" value="98.8" lower_limit="95.6" upper_limit="99.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100" lower_limit="97.9" upper_limit="100"/>
                    <measurement group_id="O2" value="100" lower_limit="97.7" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The group sizes are chosen to provide ≥ 80% power for each of the primary objectives, for the individual statistical tests of each serotype, as well as across both serotypes simultaneously. Power of ≥80% is also available for all secondary objectives, except for the comparison of the f-IPV regimen administered at weeks 14 and 36 to the 3-dose IPV regimen, which has power of 62% for individual serotypes, and 39% for the combined serotypes.</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>All non-inferiority comparisons of seroconversion rates will be made utilizing the lower bound of two-sided score-based confidence intervals (α = 0.05) with non-inferiority margin 10%.</non_inferiority_desc>
            <p_value>0.05</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Seroconversion Non Inferiority of 3 Doses f-IPV ID vs 2 Doses IPV IM</title>
        <description>To determine if the seroconversion rate to a 3-dose regimen of f-IPV administered at 10, 14, and 36 weeks of age is non-inferior to that of a 2-dose IPV regimen administered at 14 and 36 weeks of age for poliovirus serotypes 1 and 2.</description>
        <time_frame>To be assessed 4 weeks after the last dose</time_frame>
        <population>Per Protocol Population</population>
        <group_list>
          <group group_id="O1">
            <title>Group B</title>
            <description>2 doses IPV IM at 14 &amp; 36 weeks of age incl. blood sampling at 14, 18, 36 &amp; 40 weeks.&#xD;
IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)</description>
          </group>
          <group group_id="O2">
            <title>Group C</title>
            <description>3 doses f-IPV ID at 10, 14 &amp; 36 weeks of age incl. blood sampling at 10, 14, 18 &amp; 40 weeks.&#xD;
f-IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)</description>
          </group>
        </group_list>
        <measure>
          <title>Seroconversion Non Inferiority of 3 Doses f-IPV ID vs 2 Doses IPV IM</title>
          <description>To determine if the seroconversion rate to a 3-dose regimen of f-IPV administered at 10, 14, and 36 weeks of age is non-inferior to that of a 2-dose IPV regimen administered at 14 and 36 weeks of age for poliovirus serotypes 1 and 2.</description>
          <population>Per Protocol Population</population>
          <units>percentage of seroconversion</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="159"/>
                <count group_id="O2" value="160"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Serotype 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.1" lower_limit="94.6" upper_limit="99.6"/>
                    <measurement group_id="O2" value="98.8" lower_limit="95.6" upper_limit="99.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serotype 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.7" lower_limit="95.5" upper_limit="99.8"/>
                    <measurement group_id="O2" value="100" lower_limit="97.7" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The group sizes are chosen to provide ≥ 80% power for each of the primary objectives, for the individual statistical tests of each serotype, as well as across both serotypes simultaneously. Power of ≥80% is also available for all secondary objectives, except for the comparison of the f-IPV regimen administered at weeks 14 and 36 to the 3-dose IPV regimen, which has power of 62% for individual serotypes, and 39% for the combined serotypes.</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>All non-inferiority comparisons of seroconversion rates will be made utilizing the lower bound of two-sided score-based confidence intervals (α = 0.05) with non-inferiority margin 10%.</non_inferiority_desc>
            <p_value>0.05</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Experiencing SAEs, IMEs and/or Severe Local Reactions</title>
        <description>To assess the safety of each vaccine (IPV and f-IPV) as measured by the number of subjects experiencing serious adverse events (SAEs), important medical events (IMEs) and/or severe local reactions. This assessments is done in the Total Vaccinated Population (744 subjects).</description>
        <time_frame>9 months</time_frame>
        <population>Total Vaccinated Population (744 subjects) is used for safety analysis. The participants flow indicate the Intended To Treat population (773 subjects).</population>
        <group_list>
          <group group_id="O1">
            <title>Group A</title>
            <description>3 doses IPV IM at 10, 14 &amp; 36 weeks of age incl. blood sampling at 10, 14, 18 &amp; 40 weeks.&#xD;
IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)</description>
          </group>
          <group group_id="O2">
            <title>Group B</title>
            <description>2 doses IPV IM at 14 &amp; 36 weeks of age incl. blood sampling at 14, 18, 36 &amp; 40 weeks.&#xD;
IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)</description>
          </group>
          <group group_id="O3">
            <title>Group C</title>
            <description>3 doses f-IPV ID at 10, 14 &amp; 36 weeks of age incl. blood sampling at 10, 14, 18 &amp; 40 weeks.&#xD;
f-IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)</description>
          </group>
          <group group_id="O4">
            <title>Group D</title>
            <description>2 doses f-IPV ID at 14 &amp; 36 weeks of age incl. blood sampling at 14, 18, 36 &amp; 40 weeks.&#xD;
f-IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Experiencing SAEs, IMEs and/or Severe Local Reactions</title>
          <description>To assess the safety of each vaccine (IPV and f-IPV) as measured by the number of subjects experiencing serious adverse events (SAEs), important medical events (IMEs) and/or severe local reactions. This assessments is done in the Total Vaccinated Population (744 subjects).</description>
          <population>Total Vaccinated Population (744 subjects) is used for safety analysis. The participants flow indicate the Intended To Treat population (773 subjects).</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="195"/>
                <count group_id="O2" value="172"/>
                <count group_id="O3" value="170"/>
                <count group_id="O4" value="207"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>SAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="7"/>
                    <measurement group_id="O4" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>IME</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SLR</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>9 months</time_frame>
      <desc>The Total Vaccinated Population (744 subjects) was used for safety analysis.</desc>
      <group_list>
        <group group_id="E1">
          <title>Group A</title>
          <description>3 doses IPV IM at 10, 14 &amp; 36 weeks of age incl. blood sampling at 10, 14, 18 &amp; 40 weeks.&#xD;
IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)</description>
        </group>
        <group group_id="E2">
          <title>Group B</title>
          <description>2 doses IPV IM at 14 &amp; 36 weeks of age incl. blood sampling at 14, 18, 36 &amp; 40 weeks.&#xD;
IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)</description>
        </group>
        <group group_id="E3">
          <title>Group C</title>
          <description>3 doses f-IPV ID at 10, 14 &amp; 36 weeks of age incl. blood sampling at 10, 14, 18 &amp; 40 weeks.&#xD;
f-IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)</description>
        </group>
        <group group_id="E4">
          <title>Group D</title>
          <description>2 doses f-IPV ID at 14 &amp; 36 weeks of age incl. blood sampling at 14, 18, 36 &amp; 40 weeks.&#xD;
f-IPV: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="195"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="172"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="207"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="195"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="172"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="170"/>
                <counts group_id="E4" subjects_affected="9" subjects_at_risk="207"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Congenital, familial and genetic disorders</title>
            <event_list>
              <event>
                <sub_title>Adrenogenital syndrome</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="195"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="172"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="207"/>
              </event>
              <event>
                <sub_title>Glucose-6-Phosphate Dehydrogenase Deficiency</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="195"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="172"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="207"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Intussusception</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="195"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="172"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="207"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="195"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="172"/>
                <counts group_id="E3" events="5" subjects_affected="4" subjects_at_risk="170"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="207"/>
              </event>
              <event>
                <sub_title>Bronchiolitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="195"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="172"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="207"/>
              </event>
              <event>
                <sub_title>Amoebic dysentery</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="195"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="172"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="170"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="207"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="195"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="172"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="207"/>
              </event>
              <event>
                <sub_title>Urinary Tract Infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="195"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="172"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="207"/>
              </event>
              <event>
                <sub_title>Abscess limb</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="195"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="172"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="207"/>
              </event>
              <event>
                <sub_title>Otitis media</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="195"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="172"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="207"/>
              </event>
              <event>
                <sub_title>Pertussis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="195"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="172"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="207"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="195"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="172"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="207"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Thermal burn</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="195"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="172"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="207"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hypoglycemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="195"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="172"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="207"/>
              </event>
              <event>
                <sub_title>Cow milk intolerance</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="195"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="172"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="207"/>
              </event>
              <event>
                <sub_title>Malnutrition</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="195"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="172"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="207"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Epilepsy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="195"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="172"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E4" events="1" subjects_affected="1" subjects_at_risk="207"/>
              </event>
              <event>
                <sub_title>Hydrocephalus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="195"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="172"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="207"/>
              </event>
              <event>
                <sub_title>Intracranial pressure increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="195"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="172"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="207"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="195"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="172"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="207"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="195"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="172"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="207"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="195"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="172"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="170"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="207"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Congenital, familial and genetic disorders</title>
            <event_list>
              <event>
                <sub_title>Cryptorchism</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="195"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="172"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="207"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="195"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="172"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="207"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchiolitis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="195"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="172"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="170"/>
                <counts group_id="E4" events="2" subjects_affected="2" subjects_at_risk="207"/>
              </event>
              <event>
                <sub_title>Pharyngotonsillitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="195"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="172"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="207"/>
              </event>
              <event>
                <sub_title>Febrile convulsion</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="195"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="172"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="207"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Cow milk intolerance</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="195"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="172"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="170"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="207"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Ricardo Rüttimann</name_or_title>
      <organization>FIDEC Corporation</organization>
      <phone>+17863546335</phone>
      <email>rruttimann@fidec-online.org</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03239496
org study id: IPV004
nct id: NCT03239496
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study will assess and compare the immune response to full-dose inactivated polio vaccines
      (IPV) via intramuscular (IM) administration and of the fractional dose of inactivated
      poliovirus vaccine (f-IPV) via intradermal (ID) administration, in different schedule
      combinations in the Expanded Program on Immunization (EPI) primary series.
This study prioritizes comparisons involving two-dose regimens recently recommended by the
      World Health Organization (WHO) Strategic Advisory Group of Experts on immunization (SAGE)
      and Pan American Health Organization (PAHO) in response to global IPV supply shortages 21.
      Furthermore, the study will provide data on the comparative humoral immunogenicity of various
      schedules to inform polio immunization policy for the post-eradication era.

      The study population will include infants in Dominican Republic and Panama. Absence of wild
      and circulating vaccine derived polioviruses along with the lack of regular Supplementary
      Immunization Activities (SIAs) in the Latin America region provide an ideal epidemiologic
      setting to study polio vaccine immunogenicity.

      Infants will receive two or three doses of full-dose IPV IM or f-IPV ID, in two schedules
      (10, 14 and 36 weeks and 14 and 36 weeks). Immunological and safety assessments will be made
      after one dose, two doses and three doses.

      A total of 773 infants will be enrolled and distributed into 4 groups, according to a
      randomization scheme. During the study period, infants will be administered other concomitant
      vaccines according to the national schedules of the participating countries, but the effect,
      if any, of the concomitant administration on IPV immunogenicity will not be assessed.

      Optimum immunogenicity expected from the dose(s) of IPV in the post-eradication era will have
      to be balanced with the cost and supply constraints of IPV. This study will be critical to
      determine how many doses of IPV and which schedule are optimal for the post-eradication era
      after the global cessation of Oral Polio Vaccine (OPV) use.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Seroconversion Non-inferiority of 2 Doses f-IPV ID vs 2 Doses IPV IM
time frame: To be assessed 4 weeks after the last dose
description: To determine if the seroconversion rate of a 2-dose intradermally administered fractional-dose inactivated poliovirus vaccine (f-IPV) regimen administered at 14 and 36 weeks of age is non-inferior to that of a 2-dose intramuscularly administered inactivated poliovirus vaccine (IPV) regimen administered at 14 and 36 weeks of age for poliovirus serotypes 1 and 2.
measure: Seroconversion Non-inferiority of 2 Doses IPV IM vs 3 Doses IPV IM
time frame: To be assessed 4 weeks after the last dose
description: To determine if the seroconversion rate of a 2-dose IPV regimen administered at 14 and 36 weeks of age is non-inferior to that of a 3-dose IPV regimen administered at 10, 14, and 36 weeks of age for poliovirus serotypes 1 and 2.
measure: Seroconversion Non-inferiority of 2 Doses f-IPV ID vs 3 Doses f-IPV ID
time frame: To be assessed 4 weeks after the last dose
description: To determine if the seroconversion rate of a 2-dose f-IPV regimen administered at 14 and 36 weeks of age is non-inferior to that of a 3-dose f-IPV regimen administered at 10, 14, and 36 weeks of age for poliovirus serotypes 1 and 2.
measure: Seroconversion Superiority of 2 Doses IPV IM at Different Schedules
time frame: To be assessed 4 weeks after the second dose
description: To determine if the seroconversion rate of a 2-dose IPV regimen administered at 14 and 36 weeks of age is superior to that of a 2-dose IPV regimen administered at 10 and 14 weeks of age for poliovirus serotypes 1 and 2.
measure: Seroconversion Superiority of 2 Dose f-IPV ID at Different Schedules
time frame: To be assessed 4 weeks after the second dose
description: To determine if the seroconversion rate of a 2-dose f-IPV regimen administered at 14 and 36 weeks of age is superior to that of a 2-dose f-IPV regimen administered at 10 and 14 weeks of age for poliovirus serotypes 1 and 2.
measure: Seroconversion Non-inferiority of 2 Dose f-IPV ID vs 3 Dose IPV IM
time frame: To be assessed 4 weeks after the last dose
description: To determine if the seroconversion rate of a 2-dose f-IPV regimen administered at 14 and 36 weeks of age is non-inferior to that of a 3-dose IPV regimen administered at 10, 14, and 36 weeks of age for poliovirus serotypes 1 and 2.
measure: Seroconversion Non Inferiority of 3 Doses f-IPV ID vs 3 Doses IPV IM
time frame: To be assessed 4 weeks after the last dose
description: To determine if the seroconversion rate of a 3-dose f-IPV regimen administered at 10, 14, and 36 weeks of age is non-inferior to that of a 3-dose IPV regimen also administered at 10, 14, and 36 weeks of age for poliovirus serotypes 1 and 2.
measure: Seroconversion Non Inferiority of 3 Doses f-IPV ID vs 2 Doses IPV IM
time frame: To be assessed 4 weeks after the last dose
description: To determine if the seroconversion rate to a 3-dose regimen of f-IPV administered at 10, 14, and 36 weeks of age is non-inferior to that of a 2-dose IPV regimen administered at 14 and 36 weeks of age for poliovirus serotypes 1 and 2.
measure: Number of Participants Experiencing SAEs, IMEs and/or Severe Local Reactions
time frame: 9 months
description: To assess the safety of each vaccine (IPV and f-IPV) as measured by the number of subjects experiencing serious adverse events (SAEs), important medical events (IMEs) and/or severe local reactions. This assessments is done in the Total Vaccinated Population (744 subjects).
arm group label: Group A
arm group type: Experimental
description: 3 doses IPV IM at 10, 14 & 36 weeks of age incl. blood sampling at 10, 14, 18 & 40 weeks.
arm group label: Group B
arm group type: Experimental
description: 2 doses IPV IM at 14 & 36 weeks of age incl. blood sampling at 14, 18, 36 & 40 weeks.
arm group label: Group C
arm group type: Experimental
description: 3 doses f-IPV ID at 10, 14 & 36 weeks of age incl. blood sampling at 10, 14, 18 & 40 weeks.
arm group label: Group D
arm group type: Experimental
description: 2 doses f-IPV ID at 14 & 36 weeks of age incl. blood sampling at 14, 18, 36 & 40 weeks.
intervention type: Biological
intervention name: IPV
description: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)
arm group label: Group A
arm group label: Group B
intervention type: Biological
intervention name: f-IPV
description: Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)
arm group label: Group C
arm group label: Group D
criteria: 
gender: All
minimum age: 5 Weeks
maximum age: 7 Weeks
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
facility: 
facility: 
country: Dominican Republic
country: Panama
responsible party type: Sponsor
mesh term: Poliomyelitis
sharing ipd: Undecided
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 