<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/NCT01680016</url>
  </required_header>
  <id_info>
    <org_study_id>V49_24</org_study_id>
    <nct_id>NCT01680016</nct_id>
  </id_info>
  <brief_title>A Randomized, Open-label Study Comparing Two Different Rabies Vaccine Schedules in Chinese Children and Older Adults</brief_title>
  <official_title>A Phase IIIb, Randomized, Open-label Study Comparing Two Different Rabies Vaccine Post-exposure Schedules (Zagreb 2-1-1 and Rabipur® Essen 1-1-1-1-1) in Chinese Children and Older Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Novartis Vaccines</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Novartis</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study was designed to evaluate the safety and immunogenicity of two simulated&#xD;
      postexposure rabies vaccination schedules (Zagreb 2-1-1 and Essen 1-1-1-1-1) in Chinese&#xD;
      children and older adults.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study was designed to evaluate the safety and immunogenicity of Rabipur Zagreb (2-1-1)&#xD;
      and Rabipur Essen (1-1-1-1-1) simulated post exposure vaccination schedules in Chinese&#xD;
      children and older adults. Subjects randomized to Group 1 (Zagreb) will receive 4 doses of&#xD;
      rabies vaccine Day 1 (2 doses), and on Day 8 and Day 22. Subjects randomized to Group 2&#xD;
      (Essen) will receive 5 doses of rabies vaccine on Days 1, 4, 8, 15, and 29. First vaccine&#xD;
      will be administered on study Day 1.&#xD;
&#xD;
      240 children and 400 older adults, a total of 640, is planned to be enrolled into the study.&#xD;
      Subjects will be divided further into age subsets of equal numbers within each age cohort&#xD;
      (children: 6 to 11 years of age and 12 to 17 years of age; older adults: 51 to 60 years of&#xD;
      age and 61 years of age and older. Within each age subset, subjects will be assigned randomly&#xD;
      in a 1:1 ratio.&#xD;
&#xD;
      The primary objective is to establish the non-inferiority of the Rabipur Zagreb (2-1-1)&#xD;
      schedule relative to the conventional Rabipur Essen (1-1-1-1-1) schedule based on geometric&#xD;
      mean titers (GMC), and the secondary objective is to assess the percent of subjects with&#xD;
      rabies virus neutralizing titer ≥ 0.5 IU/mL 14 days after the first vaccinations (study Day&#xD;
      15) for each schedule and age cohort&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">January 2013</completion_date>
  <primary_completion_date type="Actual">January 2013</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>Non-inferiority in Immune Response of the Zagreb Postexposure Schedule of Rabipur to That of the Conventional Essen Postexposure Schedule of Rabipur as Measured by GMC of RVNA Titer 14 Days After First Vaccination in Children Aged ≥6 to ≤17 Years.</measure>
    <time_frame>Before vaccination (day 1) and 14 days after first vaccination (day 15)</time_frame>
    <description>Immunogenicity was measured as the geometric mean concentrations (GMCs) of rabies virus neutralizing antibody (RVNA) titer , evaluated using the rapid fluorescent focus inhibition test, before vaccination and 14 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Non-inferiority in Immune Response of the Zagreb Postexposure Schedule of Rabipur to That of the Conventional Essen Postexposure Schedule of Rabipur as Measured by GMC of RVNA Titer 14 Days After the First Vaccination in Older Adults Aged ≥51 Years</measure>
    <time_frame>Before vaccination (day 1) and 14 days after first vaccination (day 15).</time_frame>
    <description>Immunogenicity was measured as the GMCs of Rabies Virus Neutralizing Antibody (RVNA) titer , evaluated using the rapid fluorescent focus inhibition test, before vaccination and 14 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Children Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination of Rabipur</measure>
    <time_frame>Days 1 to 7 postvaccination</time_frame>
    <description>Safety was assessed as the number of children who reported solicited local and systemic adverse events from day 1 up to and including day 7 after any vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Older Adults Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination of Rabipur</measure>
    <time_frame>Days 1 to 7 postvaccination</time_frame>
    <description>Safety was assessed as the number of subjects who reported solicited local and systemic adverse events from day 1 up to and including day 7 after any vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Children Who Reported Unsolicited Adverse Events (AEs)</measure>
    <time_frame>From V1/day 1 (postvaccination) through V7/study termination day 43</time_frame>
    <description>The safety of Rabipur was assessed in terms of subjects(Children) exposed to study vaccine who reported all Unsolicited AEs (including serious adverse events [SAE]s and AEs leading to subject withdrawal) from V1/day 1 (postvaccination) through V7/study termination day 43.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Older Adults Who Reported Unsolicited Adverse Events (AEs)</measure>
    <time_frame>from V1/day 1 (postvaccination) through V7/study termination day 43</time_frame>
    <description>The safety of Rabipur was assessed in terms of subjects(Older Adults) exposed to study vaccine who reported all Unsolicited AEs (including serious adverse events [SAE]s and AEs leading to subject withdrawal) from V1/day 1 (postvaccination) through V7/study termination day 43.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentages of Children With RVNA Titers ≥0.5 IU/mL 14 Days After First Vaccination of Rabipur</measure>
    <time_frame>Before vaccination (day 1) and 14 days after first vaccination (day 15).</time_frame>
    <description>Immunogenicity was measured as the percentages of subjects who achieved RVNA titers ≥0.5 IU/mL, 14 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentages of Older Adults With RVNA Titers ≥0.5 IU/mL 14 Days After First Vaccination of Rabipur</measure>
    <time_frame>Before vaccination (day 1) and 14 days after first vaccination (day 15).</time_frame>
    <description>Immunogenicity was measured as the percentages of subjects who achieved RVNA titers ≥0.5 IU/mL, 14 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentages of Children With RVNA Titers ≥0.5 IU/mL 42 Days After First Vaccination of Rabipur</measure>
    <time_frame>Before vaccination (day 1) and 42 days after first vaccination (day 43).</time_frame>
    <description>Immunogenicity was measured as the percentages of subjects who achieved RVNA titers ≥0.5 IU/mL, 42 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentages of Older Adults With RVNA Titers ≥0.5 IU/mL 42 Days After First Vaccination of Rabipur</measure>
    <time_frame>Before vaccination (day 1) and 42 days after first vaccination (day 43).</time_frame>
    <description>Immunogenicity was measured as the percentages of subjects who achieved RVNA titers ≥0.5 IU/mL, 42 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>GMCs of RVNA Titer 42 Days After First Vaccination in Children.</measure>
    <time_frame>Before vaccination (day 1) and 42 days after first vaccination (day 43)</time_frame>
    <description>Immunogenicity was measured as the GMCs of RVNA titers, evaluated using the rapid fluorescent focus inhibition test, before vaccination and 42 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>GMCs of RVNA Titer 42 Days After the First Vaccination in Older Adults.</measure>
    <time_frame>Before vaccination (day 1) and 42 days after first vaccination (day 43)</time_frame>
    <description>Immunogenicity was measured as the GMCs of RVNA titers, evaluated using the rapid fluorescent focus inhibition test, before vaccination and 42 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">644</enrollment>
  <condition>Rabies</condition>
  <arm_group>
    <arm_group_label>Zagreb(≥6 to ≤17 Years)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Zagreb(≥51 Years)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Essen(≥6 to ≤17 Years)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Essen(≥51 Years)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Zagreb</intervention_name>
    <description>Subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22</description>
    <arm_group_label>Zagreb(≥51 Years)</arm_group_label>
    <arm_group_label>Zagreb(≥6 to ≤17 Years)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Essen</intervention_name>
    <description>Subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29</description>
    <arm_group_label>Essen(≥51 Years)</arm_group_label>
    <arm_group_label>Essen(≥6 to ≤17 Years)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Individuals between 6-17 years of age and 51 years of age or older&#xD;
&#xD;
          -  Individuals who were in good health&#xD;
&#xD;
          -  Provided consent, complied with study procedures and duration of follow-up&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindications to vaccination with rabies vaccine&#xD;
&#xD;
          -  Body temperature ≥37.5◦C (axillary) within 3 days of intended study vaccination&#xD;
&#xD;
          -  Known hypersensitivity to the components of the vaccine&#xD;
&#xD;
          -  Previously received any rabies vaccine or immune globulin&#xD;
&#xD;
          -  Previous or planned treatment with antimalarial medications&#xD;
&#xD;
          -  History of psychiatric disease, immune disorder, bleeding disorder, drug/alcohol abuse&#xD;
             within the past 2 years, malignancy&#xD;
&#xD;
          -  Female subjects who were pregnant or unwilling to practice acceptable birth control&#xD;
             methods&#xD;
&#xD;
          -  Individuals enrolled or plans to enroll in another investigational trial&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Novartis Vaccines</last_name>
    <role>Study Chair</role>
    <affiliation>Novartis Vaccines</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mengshan Center for Disease Prevention and Control (CDC)</name>
      <address>
        <city>Mengshan</city>
        <state>Guangxi</state>
        <zip>530028</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>April 2014</verification_date>
  <study_first_submitted>September 3, 2012</study_first_submitted>
  <study_first_submitted_qc>September 3, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 6, 2012</study_first_posted>
  <results_first_submitted>January 7, 2014</results_first_submitted>
  <results_first_submitted_qc>April 22, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">May 20, 2014</results_first_posted>
  <last_update_submitted>April 22, 2014</last_update_submitted>
  <last_update_submitted_qc>April 22, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 20, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Rabies virus, postexposure, vaccine schedule, children, older adults</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rabies</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Subjects were enrolled at Mengshan CDC</recruitment_details>
      <pre_assignment_details>All enrolled subjects were included in the trial</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Zagreb(≥6 to ≤17 Years)</title>
          <description>≥6 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1, 8 and 22</description>
        </group>
        <group group_id="P2">
          <title>Essen(≥6 to ≤17 Years)</title>
          <description>≥6 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29</description>
        </group>
        <group group_id="P3">
          <title>Zagreb(≥51 Years)</title>
          <description>≥51 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22</description>
        </group>
        <group group_id="P4">
          <title>Essen(≥51 Years)</title>
          <description>≥51 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="121"/>
                <participants group_id="P2" count="122"/>
                <participants group_id="P3" count="201"/>
                <participants group_id="P4" count="200"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="115"/>
                <participants group_id="P2" count="114"/>
                <participants group_id="P3" count="196"/>
                <participants group_id="P4" count="195"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="8"/>
                <participants group_id="P3" count="5"/>
                <participants group_id="P4" count="5"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="4"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>The Subject went out of The Trial</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Enrolled set:All subjects who had signed an informed consent, undergone screening procedure(s) and were randomized</population>
      <group_list>
        <group group_id="B1">
          <title>Zagreb</title>
          <description>Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22</description>
        </group>
        <group group_id="B2">
          <title>Essen</title>
          <description>Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29</description>
        </group>
        <group group_id="B3">
          <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="322"/>
            <count group_id="B2" value="322"/>
            <count group_id="B3" value="644"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>Children (≥6 to ≤17 Years)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11" spread="3.0"/>
                    <measurement group_id="B2" value="10.8" spread="2.9"/>
                    <measurement group_id="B3" value="10.9" spread="3.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Older Adults (≥51 Years)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="62.1" spread="6.5"/>
                    <measurement group_id="B2" value="61.9" spread="6.8"/>
                    <measurement group_id="B3" value="62.0" spread="6.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex/Gender, Customized</title>
          <units>Subjects</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Female (≥6 to ≤17 Years)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="49"/>
                    <measurement group_id="B2" value="76"/>
                    <measurement group_id="B3" value="125"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Male (≥6 to ≤17 Years)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="72"/>
                    <measurement group_id="B2" value="46"/>
                    <measurement group_id="B3" value="118"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Female (≥51 Years)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="118"/>
                    <measurement group_id="B2" value="123"/>
                    <measurement group_id="B3" value="241"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Male (≥51 Years)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="83"/>
                    <measurement group_id="B2" value="77"/>
                    <measurement group_id="B3" value="160"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Non-inferiority in Immune Response of the Zagreb Postexposure Schedule of Rabipur to That of the Conventional Essen Postexposure Schedule of Rabipur as Measured by GMC of RVNA Titer 14 Days After First Vaccination in Children Aged ≥6 to ≤17 Years.</title>
        <description>Immunogenicity was measured as the geometric mean concentrations (GMCs) of rabies virus neutralizing antibody (RVNA) titer , evaluated using the rapid fluorescent focus inhibition test, before vaccination and 14 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.</description>
        <time_frame>Before vaccination (day 1) and 14 days after first vaccination (day 15)</time_frame>
        <population>Analysis was done on the per-protocol (PP) set, i.e. the subjects who received the vaccine correctly; provided evaluable serum samples at the relevant time points; and had no major protocol violations as defined prior to analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Zagreb(≥6 to ≤17 Years)</title>
            <description>≥6 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1, 8 and 22</description>
          </group>
          <group group_id="O2">
            <title>Essen(≥6 to ≤17 Years)</title>
            <description>≥6 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29</description>
          </group>
        </group_list>
        <measure>
          <title>Non-inferiority in Immune Response of the Zagreb Postexposure Schedule of Rabipur to That of the Conventional Essen Postexposure Schedule of Rabipur as Measured by GMC of RVNA Titer 14 Days After First Vaccination in Children Aged ≥6 to ≤17 Years.</title>
          <description>Immunogenicity was measured as the geometric mean concentrations (GMCs) of rabies virus neutralizing antibody (RVNA) titer , evaluated using the rapid fluorescent focus inhibition test, before vaccination and 14 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.</description>
          <population>Analysis was done on the per-protocol (PP) set, i.e. the subjects who received the vaccine correctly; provided evaluable serum samples at the relevant time points; and had no major protocol violations as defined prior to analysis.</population>
          <units>IU/mL</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="114"/>
                <count group_id="O2" value="110"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.052" lower_limit="0.048" upper_limit="0.056"/>
                    <measurement group_id="O2" value="0.054" lower_limit="0.05" upper_limit="0.058"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12" lower_limit="10" upper_limit="14"/>
                    <measurement group_id="O2" value="14" lower_limit="12" upper_limit="16"/>
                  </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>To demonstrate noninferiority in immune response of the Zagreb post-exposure schedule of Rabipur to that of the conventional Essen post-exposure schedule at day 15 in children aged ≥6 to ≤17 years</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Noninferiority was achieved if the lower limit of the two-sided 95% CI around the observed ratio of GMCs between the groups (GMCGroup Zagreb / GMCGroup Essen) was greater than 0.5</non_inferiority_desc>
            <param_type>Ratio of GMCs between two groups(Day 15)</param_type>
            <param_value>0.84</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.69</ci_lower_limit>
            <ci_upper_limit>1.02</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Non-inferiority in Immune Response of the Zagreb Postexposure Schedule of Rabipur to That of the Conventional Essen Postexposure Schedule of Rabipur as Measured by GMC of RVNA Titer 14 Days After the First Vaccination in Older Adults Aged ≥51 Years</title>
        <description>Immunogenicity was measured as the GMCs of Rabies Virus Neutralizing Antibody (RVNA) titer , evaluated using the rapid fluorescent focus inhibition test, before vaccination and 14 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.</description>
        <time_frame>Before vaccination (day 1) and 14 days after first vaccination (day 15).</time_frame>
        <population>Analysis was done on the PP set.</population>
        <group_list>
          <group group_id="O1">
            <title>Zagreb(≥51 Years)</title>
            <description>≥51 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22</description>
          </group>
          <group group_id="O2">
            <title>Essen(≥51 Years)</title>
            <description>≥51 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29</description>
          </group>
        </group_list>
        <measure>
          <title>Non-inferiority in Immune Response of the Zagreb Postexposure Schedule of Rabipur to That of the Conventional Essen Postexposure Schedule of Rabipur as Measured by GMC of RVNA Titer 14 Days After the First Vaccination in Older Adults Aged ≥51 Years</title>
          <description>Immunogenicity was measured as the GMCs of Rabies Virus Neutralizing Antibody (RVNA) titer , evaluated using the rapid fluorescent focus inhibition test, before vaccination and 14 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.</description>
          <population>Analysis was done on the PP set.</population>
          <units>IU/mL</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="190"/>
                <count group_id="O2" value="188"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.057" lower_limit="0.052" upper_limit="0.063"/>
                    <measurement group_id="O2" value="0.06" lower_limit="0.055" upper_limit="0.066"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 15</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.57" lower_limit="7.34" upper_limit="10"/>
                    <measurement group_id="O2" value="7.89" lower_limit="6.75" upper_limit="9.21"/>
                  </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>To demonstrate noninferiority in immune response of the Zagreb post-exposure schedule of Rabipur to that of the conventional Essen post-exposure schedule at day 15 in older adults aged ≥51 years</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Noninferiority was achieved if the lower limit of the two-sided 95% CI around the observed ratio of GMCs between the groups (GMCGroup Zagreb / GMCGroup Essen) was greater than 0.5</non_inferiority_desc>
            <param_type>Ratio of GMCs between two groups(Day 15)</param_type>
            <param_value>1.09</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.87</ci_lower_limit>
            <ci_upper_limit>1.35</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentages of Children With RVNA Titers ≥0.5 IU/mL 14 Days After First Vaccination of Rabipur</title>
        <description>Immunogenicity was measured as the percentages of subjects who achieved RVNA titers ≥0.5 IU/mL, 14 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.</description>
        <time_frame>Before vaccination (day 1) and 14 days after first vaccination (day 15).</time_frame>
        <population>For the analysis of this outcome measure children aged ≥6 to ≤17 years were divided into two subgroups, i.e. ≥6 to ≤11 years and ≥12 to ≤17 years. Analysis was done on the PP set.</population>
        <group_list>
          <group group_id="O1">
            <title>Zagreb(≥6 to ≤11 Years)</title>
            <description>≥6 to ≤11 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22</description>
          </group>
          <group group_id="O2">
            <title>Essen(≥6 to ≤11 Years)</title>
            <description>≥6 to ≤11 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29</description>
          </group>
          <group group_id="O3">
            <title>Zagreb(≥12 to ≤17 Years)</title>
            <description>≥12 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22</description>
          </group>
          <group group_id="O4">
            <title>Essen(≥12 to ≤17 Years)</title>
            <description>≥12 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29</description>
          </group>
          <group group_id="O5">
            <title>Zagreb( ≥6 to ≤17 Years)</title>
            <description>≥6 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22</description>
          </group>
          <group group_id="O6">
            <title>Essen(≥6 to ≤17 Years)</title>
            <description>≥6 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29</description>
          </group>
        </group_list>
        <measure>
          <title>Percentages of Children With RVNA Titers ≥0.5 IU/mL 14 Days After First Vaccination of Rabipur</title>
          <description>Immunogenicity was measured as the percentages of subjects who achieved RVNA titers ≥0.5 IU/mL, 14 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.</description>
          <population>For the analysis of this outcome measure children aged ≥6 to ≤17 years were divided into two subgroups, i.e. ≥6 to ≤11 years and ≥12 to ≤17 years. Analysis was done on the PP set.</population>
          <units>Percentages of subjects</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="58"/>
                <count group_id="O2" value="56"/>
                <count group_id="O3" value="56"/>
                <count group_id="O4" value="54"/>
                <count group_id="O5" value="114"/>
                <count group_id="O6" value="110"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1(58,56,56,54,114,110)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="6"/>
                    <measurement group_id="O2" value="2" lower_limit="0.045" upper_limit="10"/>
                    <measurement group_id="O3" value="0" lower_limit="0" upper_limit="6"/>
                    <measurement group_id="O4" value="4" lower_limit="0" upper_limit="13"/>
                    <measurement group_id="O5" value="0" lower_limit="0" upper_limit="3"/>
                    <measurement group_id="O6" value="3" lower_limit="1" upper_limit="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 15(58,56,56,54,114, 110)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100" lower_limit="94" upper_limit="100"/>
                    <measurement group_id="O2" value="100" lower_limit="94" upper_limit="100"/>
                    <measurement group_id="O3" value="100" lower_limit="94" upper_limit="100"/>
                    <measurement group_id="O4" value="100" lower_limit="93" upper_limit="100"/>
                    <measurement group_id="O5" value="100" lower_limit="97" upper_limit="100"/>
                    <measurement group_id="O6" value="100" lower_limit="97" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentages of Older Adults With RVNA Titers ≥0.5 IU/mL 14 Days After First Vaccination of Rabipur</title>
        <description>Immunogenicity was measured as the percentages of subjects who achieved RVNA titers ≥0.5 IU/mL, 14 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.</description>
        <time_frame>Before vaccination (day 1) and 14 days after first vaccination (day 15).</time_frame>
        <population>For the analysis of this outcome measure older adults aged ≥51 years were divided into two subgroups, i.e. ≥51 to ≤60 years and ≥61 years. Analysis was done on the PP set.</population>
        <group_list>
          <group group_id="O1">
            <title>Zagreb(≥51 to ≤60 Years)</title>
            <description>≥51 to ≤60 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22</description>
          </group>
          <group group_id="O2">
            <title>Essen(≥51 to ≤60 Years)</title>
            <description>≥51 to ≤60 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29</description>
          </group>
          <group group_id="O3">
            <title>Zagreb(≥61 Years)</title>
            <description>≥61 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22</description>
          </group>
          <group group_id="O4">
            <title>Essen(≥61 Years)</title>
            <description>≥61 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29</description>
          </group>
          <group group_id="O5">
            <title>Zagreb(≥51 Years)</title>
            <description>≥51 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22</description>
          </group>
          <group group_id="O6">
            <title>Essen(≥51 Years)</title>
            <description>≥51 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29</description>
          </group>
        </group_list>
        <measure>
          <title>Percentages of Older Adults With RVNA Titers ≥0.5 IU/mL 14 Days After First Vaccination of Rabipur</title>
          <description>Immunogenicity was measured as the percentages of subjects who achieved RVNA titers ≥0.5 IU/mL, 14 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.</description>
          <population>For the analysis of this outcome measure older adults aged ≥51 years were divided into two subgroups, i.e. ≥51 to ≤60 years and ≥61 years. Analysis was done on the PP set.</population>
          <units>Percentages of subjects</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="93"/>
                <count group_id="O2" value="93"/>
                <count group_id="O3" value="97"/>
                <count group_id="O4" value="95"/>
                <count group_id="O5" value="190"/>
                <count group_id="O6" value="188"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1(93,93,97,95,190,188)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5" lower_limit="2" upper_limit="12"/>
                    <measurement group_id="O2" value="4" lower_limit="1" upper_limit="11"/>
                    <measurement group_id="O3" value="1" lower_limit="0.026" upper_limit="6"/>
                    <measurement group_id="O4" value="4" lower_limit="1" upper_limit="10"/>
                    <measurement group_id="O5" value="3" lower_limit="1" upper_limit="7"/>
                    <measurement group_id="O6" value="4" lower_limit="2" upper_limit="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 15 (93,93,97,95,190, 188)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100" lower_limit="96" upper_limit="100"/>
                    <measurement group_id="O2" value="100" lower_limit="96" upper_limit="100"/>
                    <measurement group_id="O3" value="99" lower_limit="94" upper_limit="100"/>
                    <measurement group_id="O4" value="99" lower_limit="94" upper_limit="100"/>
                    <measurement group_id="O5" value="99" lower_limit="97" upper_limit="100"/>
                    <measurement group_id="O6" value="99" lower_limit="97" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentages of Children With RVNA Titers ≥0.5 IU/mL 42 Days After First Vaccination of Rabipur</title>
        <description>Immunogenicity was measured as the percentages of subjects who achieved RVNA titers ≥0.5 IU/mL, 42 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.</description>
        <time_frame>Before vaccination (day 1) and 42 days after first vaccination (day 43).</time_frame>
        <population>For the analysis of this outcome measure children aged ≥6 to ≤17 years were divided into two subgroups, i.e. ≥6 to ≤11 years and ≥12 to ≤17 years. Analysis was done on the PP set.</population>
        <group_list>
          <group group_id="O1">
            <title>Zagreb(≥6 to ≤11 Years)</title>
            <description>≥6 to ≤11 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22</description>
          </group>
          <group group_id="O2">
            <title>Essen(≥6 to ≤11 Years)</title>
            <description>≥6 to ≤11 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29</description>
          </group>
          <group group_id="O3">
            <title>Zagreb(≥12 to ≤17 Years)</title>
            <description>≥12 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22</description>
          </group>
          <group group_id="O4">
            <title>Essen(≥12 to ≤17 Years)</title>
            <description>≥12 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29</description>
          </group>
          <group group_id="O5">
            <title>Zagreb( ≥6 to ≤17 Years)</title>
            <description>≥6 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22</description>
          </group>
          <group group_id="O6">
            <title>Essen(≥6 to ≤17 Years)</title>
            <description>≥6 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29</description>
          </group>
        </group_list>
        <measure>
          <title>Percentages of Children With RVNA Titers ≥0.5 IU/mL 42 Days After First Vaccination of Rabipur</title>
          <description>Immunogenicity was measured as the percentages of subjects who achieved RVNA titers ≥0.5 IU/mL, 42 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.</description>
          <population>For the analysis of this outcome measure children aged ≥6 to ≤17 years were divided into two subgroups, i.e. ≥6 to ≤11 years and ≥12 to ≤17 years. Analysis was done on the PP set.</population>
          <units>Percentages of subjects</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="57"/>
                <count group_id="O2" value="56"/>
                <count group_id="O3" value="56"/>
                <count group_id="O4" value="55"/>
                <count group_id="O5" value="113"/>
                <count group_id="O6" value="111"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1(57,56,56,55,113,111)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="6"/>
                    <measurement group_id="O2" value="2" lower_limit="0.045" upper_limit="10"/>
                    <measurement group_id="O3" value="0" lower_limit="0" upper_limit="6"/>
                    <measurement group_id="O4" value="4" lower_limit="0" upper_limit="13"/>
                    <measurement group_id="O5" value="0" lower_limit="0" upper_limit="3"/>
                    <measurement group_id="O6" value="3" lower_limit="1" upper_limit="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 43 (57,56,56,55,113,111)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100" lower_limit="94" upper_limit="100"/>
                    <measurement group_id="O2" value="100" lower_limit="94" upper_limit="100"/>
                    <measurement group_id="O3" value="100" lower_limit="94" upper_limit="100"/>
                    <measurement group_id="O4" value="100" lower_limit="94" upper_limit="100"/>
                    <measurement group_id="O5" value="100" lower_limit="97" upper_limit="100"/>
                    <measurement group_id="O6" value="100" lower_limit="97" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentages of Older Adults With RVNA Titers ≥0.5 IU/mL 42 Days After First Vaccination of Rabipur</title>
        <description>Immunogenicity was measured as the percentages of subjects who achieved RVNA titers ≥0.5 IU/mL, 42 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.</description>
        <time_frame>Before vaccination (day 1) and 42 days after first vaccination (day 43).</time_frame>
        <population>For the analysis of this outcome measure older adults aged ≥51 years were divided into two subgroups, i.e. ≥51 to ≤60 years and ≥61 years. Analysis was done on the PP set.</population>
        <group_list>
          <group group_id="O1">
            <title>Zagreb(≥51 to ≤60 Years)</title>
            <description>≥51 to ≤60 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22</description>
          </group>
          <group group_id="O2">
            <title>Essen(≥51 to ≤60 Years)</title>
            <description>≥51 to ≤60 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29</description>
          </group>
          <group group_id="O3">
            <title>Zagreb(≥61 Years)</title>
            <description>≥61 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22</description>
          </group>
          <group group_id="O4">
            <title>Essen(≥61 Years)</title>
            <description>≥61 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29</description>
          </group>
          <group group_id="O5">
            <title>Zagreb(≥51 Years)</title>
            <description>≥51 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22</description>
          </group>
          <group group_id="O6">
            <title>Essen(≥51 Years)</title>
            <description>≥51 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29</description>
          </group>
        </group_list>
        <measure>
          <title>Percentages of Older Adults With RVNA Titers ≥0.5 IU/mL 42 Days After First Vaccination of Rabipur</title>
          <description>Immunogenicity was measured as the percentages of subjects who achieved RVNA titers ≥0.5 IU/mL, 42 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.</description>
          <population>For the analysis of this outcome measure older adults aged ≥51 years were divided into two subgroups, i.e. ≥51 to ≤60 years and ≥61 years. Analysis was done on the PP set.</population>
          <units>Percentages of subjects</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="92"/>
                <count group_id="O2" value="90"/>
                <count group_id="O3" value="96"/>
                <count group_id="O4" value="93"/>
                <count group_id="O5" value="188"/>
                <count group_id="O6" value="183"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1(92,90,96,93,188,183)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5" lower_limit="2" upper_limit="12"/>
                    <measurement group_id="O2" value="4" lower_limit="1" upper_limit="11"/>
                    <measurement group_id="O3" value="1" lower_limit="0.026" upper_limit="6"/>
                    <measurement group_id="O4" value="4" lower_limit="1" upper_limit="11"/>
                    <measurement group_id="O5" value="3" lower_limit="1" upper_limit="7"/>
                    <measurement group_id="O6" value="4" lower_limit="2" upper_limit="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 43 (92,90,96,93,188,183)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100" lower_limit="96" upper_limit="100"/>
                    <measurement group_id="O2" value="100" lower_limit="96" upper_limit="100"/>
                    <measurement group_id="O3" value="100" lower_limit="96" upper_limit="100"/>
                    <measurement group_id="O4" value="100" lower_limit="96" upper_limit="100"/>
                    <measurement group_id="O5" value="100" lower_limit="98" upper_limit="100"/>
                    <measurement group_id="O6" value="100" lower_limit="98" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Children Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination of Rabipur</title>
        <description>Safety was assessed as the number of children who reported solicited local and systemic adverse events from day 1 up to and including day 7 after any vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.</description>
        <time_frame>Days 1 to 7 postvaccination</time_frame>
        <population>Analysis was done on the safety set, i.e. the subjects in the exposed population who provided postvaccination safety data.</population>
        <group_list>
          <group group_id="O1">
            <title>Zagreb(≥6 to ≤11 Years)</title>
            <description>≥6 to ≤11 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22</description>
          </group>
          <group group_id="O2">
            <title>Essen(≥6 to ≤11 Years)</title>
            <description>≥6 to ≤11 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29</description>
          </group>
          <group group_id="O3">
            <title>Zagreb(≥12 to ≤17 Years)</title>
            <description>≥12 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22</description>
          </group>
          <group group_id="O4">
            <title>Essen(≥12 to ≤17 Years)</title>
            <description>≥12 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29</description>
          </group>
          <group group_id="O5">
            <title>Zagreb( ≥6 to ≤17 Years)</title>
            <description>≥6 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22</description>
          </group>
          <group group_id="O6">
            <title>Essen(≥6 to ≤17 Years)</title>
            <description>≥6 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Children Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination of Rabipur</title>
          <description>Safety was assessed as the number of children who reported solicited local and systemic adverse events from day 1 up to and including day 7 after any vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.</description>
          <population>Analysis was done on the safety set, i.e. the subjects in the exposed population who provided postvaccination safety data.</population>
          <units>Subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="60"/>
                <count group_id="O2" value="59"/>
                <count group_id="O3" value="61"/>
                <count group_id="O4" value="60"/>
                <count group_id="O5" value="121"/>
                <count group_id="O6" value="119"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Injection Site Erythema(N=59,58,60,60,119,118)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection Site Induration(N=59,58,60,60,119,118)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection Site Pain(N=59,58,60,60,119,118)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="18"/>
                    <measurement group_id="O3" value="24"/>
                    <measurement group_id="O4" value="29"/>
                    <measurement group_id="O5" value="45"/>
                    <measurement group_id="O6" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Nausea(N=59,58,60,60,119,118)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="6"/>
                    <measurement group_id="O5" value="7"/>
                    <measurement group_id="O6" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Myalgia(N=59,58,60,60,119,118)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="7"/>
                    <measurement group_id="O4" value="9"/>
                    <measurement group_id="O5" value="11"/>
                    <measurement group_id="O6" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Arthralgia(N=59,58,60,60,119,118)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="3"/>
                    <measurement group_id="O6" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Headache(N=59,58,60,60,119,118)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="7"/>
                    <measurement group_id="O4" value="6"/>
                    <measurement group_id="O5" value="11"/>
                    <measurement group_id="O6" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fatigue(N=59,58,60,60,119,118)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="10"/>
                    <measurement group_id="O4" value="11"/>
                    <measurement group_id="O5" value="18"/>
                    <measurement group_id="O6" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Loss of Appetite(N=59,58,60,60,119,118)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="7"/>
                    <measurement group_id="O4" value="7"/>
                    <measurement group_id="O5" value="14"/>
                    <measurement group_id="O6" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Body Temp. (≥38°C)(N=59,58,60,60,119,118)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="8"/>
                    <measurement group_id="O6" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Low Grade Fever(N=59,58,60,60,119,118)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="11"/>
                    <measurement group_id="O4" value="11"/>
                    <measurement group_id="O5" value="17"/>
                    <measurement group_id="O6" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Medium Grade Fever(N=59,58,60,60,119,118)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="13"/>
                    <measurement group_id="O6" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>High Grade Fever(N=59,58,60,60,119,118)</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 group_id="O5" value="0"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Analge,Antipyr Used(N=59,58,60,60,119,118)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="4"/>
                    <measurement group_id="O5" value="11"/>
                    <measurement group_id="O6" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Older Adults Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination of Rabipur</title>
        <description>Safety was assessed as the number of subjects who reported solicited local and systemic adverse events from day 1 up to and including day 7 after any vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.</description>
        <time_frame>Days 1 to 7 postvaccination</time_frame>
        <population>Analysis was done on the safety set</population>
        <group_list>
          <group group_id="O1">
            <title>Zagreb(≥51 to ≤60 Years)</title>
            <description>≥51 to ≤60 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22</description>
          </group>
          <group group_id="O2">
            <title>Essen(≥51 to ≤60 Years)</title>
            <description>≥51 to ≤60 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29</description>
          </group>
          <group group_id="O3">
            <title>Zagreb(≥61 Years)</title>
            <description>≥61 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22</description>
          </group>
          <group group_id="O4">
            <title>Essen(≥61 Years)</title>
            <description>≥61 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29</description>
          </group>
          <group group_id="O5">
            <title>Zagreb(≥51 Years)</title>
            <description>≥51 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22</description>
          </group>
          <group group_id="O6">
            <title>Essen(≥51 Years)</title>
            <description>≥51 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Older Adults Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination of Rabipur</title>
          <description>Safety was assessed as the number of subjects who reported solicited local and systemic adverse events from day 1 up to and including day 7 after any vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.</description>
          <population>Analysis was done on the safety set</population>
          <units>Subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
                <count group_id="O2" value="100"/>
                <count group_id="O3" value="100"/>
                <count group_id="O4" value="100"/>
                <count group_id="O5" value="200"/>
                <count group_id="O6" value="200"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Injection Site Erythema(N=98,100,99,100,197,200)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection Site Induration(N=98,100,99,100,197,200)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Injection Site Pain(N=98,100,99,100,197,200)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="12"/>
                    <measurement group_id="O3" value="9"/>
                    <measurement group_id="O4" value="10"/>
                    <measurement group_id="O5" value="18"/>
                    <measurement group_id="O6" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Nausea(N=98,100,99,100,197,200)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="2"/>
                    <measurement group_id="O6" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Myalgia(N=98,100,99,100,197,200)</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="2"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Arthralgia(N=98,100,99,100,197,200)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="3"/>
                    <measurement group_id="O6" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Headache(N=98,100,99,100,197,200)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="6"/>
                    <measurement group_id="O5" value="7"/>
                    <measurement group_id="O6" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fatigue(N=98,100,99,100,197,200)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="9"/>
                    <measurement group_id="O6" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Loss of Appetite(N=98,100,99,100,197,200)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                    <measurement group_id="O6" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Body Temp.(≥38°C)(N=98,100,99,100,197,200)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="4"/>
                    <measurement group_id="O5" value="5"/>
                    <measurement group_id="O6" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Low Grade Fever(N=98,100,99,100,197,200)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="6"/>
                    <measurement group_id="O5" value="6"/>
                    <measurement group_id="O6" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Medium Grade Fever(N=98,100,99,100,197,200)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="6"/>
                    <measurement group_id="O5" value="6"/>
                    <measurement group_id="O6" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>High Grade Fever(N=98,100,99,100,197,200)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                    <measurement group_id="O6" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Analgesic,Antipyretic use(N=98,100,99,100,197,200)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="7"/>
                    <measurement group_id="O4" value="9"/>
                    <measurement group_id="O5" value="13"/>
                    <measurement group_id="O6" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>GMCs of RVNA Titer 42 Days After First Vaccination in Children.</title>
        <description>Immunogenicity was measured as the GMCs of RVNA titers, evaluated using the rapid fluorescent focus inhibition test, before vaccination and 42 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.</description>
        <time_frame>Before vaccination (day 1) and 42 days after first vaccination (day 43)</time_frame>
        <population>For the analysis of this outcome measure children aged ≥6 to ≤17 years were divided into two subgroups, i.e. ≥6 to ≤11 years and ≥12 to ≤17 years. Analysis was done on the PP set.</population>
        <group_list>
          <group group_id="O1">
            <title>Zagreb(≥6 to ≤11 Years)</title>
            <description>≥6 to ≤11 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22</description>
          </group>
          <group group_id="O2">
            <title>Essen(≥6 to ≤11 Years)</title>
            <description>≥6 to ≤11 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29</description>
          </group>
          <group group_id="O3">
            <title>Zagreb(≥12 to ≤17 Years)</title>
            <description>≥12 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22</description>
          </group>
          <group group_id="O4">
            <title>Essen(≥12 to ≤17 Years)</title>
            <description>≥12 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29</description>
          </group>
          <group group_id="O5">
            <title>Zagreb( ≥6 to ≤17 Years)</title>
            <description>≥6 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22</description>
          </group>
          <group group_id="O6">
            <title>Essen(≥6 to ≤17 Years)</title>
            <description>≥6 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29</description>
          </group>
        </group_list>
        <measure>
          <title>GMCs of RVNA Titer 42 Days After First Vaccination in Children.</title>
          <description>Immunogenicity was measured as the GMCs of RVNA titers, evaluated using the rapid fluorescent focus inhibition test, before vaccination and 42 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.</description>
          <population>For the analysis of this outcome measure children aged ≥6 to ≤17 years were divided into two subgroups, i.e. ≥6 to ≤11 years and ≥12 to ≤17 years. Analysis was done on the PP set.</population>
          <units>Concentration (IU/mL)</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="57"/>
                <count group_id="O2" value="56"/>
                <count group_id="O3" value="56"/>
                <count group_id="O4" value="55"/>
                <count group_id="O5" value="113"/>
                <count group_id="O6" value="111"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1(N=57,56,56,55,113,111)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.054" lower_limit="0.048" upper_limit="0.06"/>
                    <measurement group_id="O2" value="0.053" lower_limit="0.048" upper_limit="0.059"/>
                    <measurement group_id="O3" value="0.05" lower_limit="0.046" upper_limit="0.055"/>
                    <measurement group_id="O4" value="0.055" lower_limit="0.05" upper_limit="0.06"/>
                    <measurement group_id="O5" value="0.052" lower_limit="0.048" upper_limit="0.056"/>
                    <measurement group_id="O6" value="0.054" lower_limit="0.05" upper_limit="0.058"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 43(N=57,56,56,55,113,111)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13" lower_limit="11" upper_limit="15"/>
                    <measurement group_id="O2" value="24" lower_limit="20" upper_limit="29"/>
                    <measurement group_id="O3" value="13" lower_limit="11" upper_limit="16"/>
                    <measurement group_id="O4" value="23" lower_limit="19" upper_limit="28"/>
                    <measurement group_id="O5" value="13" lower_limit="11" upper_limit="15"/>
                    <measurement group_id="O6" value="24" lower_limit="21" upper_limit="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>GMCs of RVNA Titer 42 Days After the First Vaccination in Older Adults.</title>
        <description>Immunogenicity was measured as the GMCs of RVNA titers, evaluated using the rapid fluorescent focus inhibition test, before vaccination and 42 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.</description>
        <time_frame>Before vaccination (day 1) and 42 days after first vaccination (day 43)</time_frame>
        <population>For the analysis of this outcome measure older adults aged ≥51 years were divided into two subgroups, i.e. ≥51 to ≤60 years and ≥61 years. Analysis was done on the PP set.</population>
        <group_list>
          <group group_id="O1">
            <title>Zagreb(≥51 to ≤60 Years)</title>
            <description>≥51 to ≤60 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22</description>
          </group>
          <group group_id="O2">
            <title>Essen(≥51 to ≤60 Years)</title>
            <description>≥51 to ≤60 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29</description>
          </group>
          <group group_id="O3">
            <title>Zagreb(≥61 Years)</title>
            <description>≥61 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22</description>
          </group>
          <group group_id="O4">
            <title>Essen(≥61 Years)</title>
            <description>≥61 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29</description>
          </group>
          <group group_id="O5">
            <title>Zagreb(≥51 Years)</title>
            <description>≥51 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22</description>
          </group>
          <group group_id="O6">
            <title>Essen(≥51 Years)</title>
            <description>≥51 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29</description>
          </group>
        </group_list>
        <measure>
          <title>GMCs of RVNA Titer 42 Days After the First Vaccination in Older Adults.</title>
          <description>Immunogenicity was measured as the GMCs of RVNA titers, evaluated using the rapid fluorescent focus inhibition test, before vaccination and 42 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.</description>
          <population>For the analysis of this outcome measure older adults aged ≥51 years were divided into two subgroups, i.e. ≥51 to ≤60 years and ≥61 years. Analysis was done on the PP set.</population>
          <units>Concentration (IU/ml)</units>
          <param>Geometric Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="92"/>
                <count group_id="O2" value="90"/>
                <count group_id="O3" value="96"/>
                <count group_id="O4" value="93"/>
                <count group_id="O5" value="188"/>
                <count group_id="O6" value="183"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1(92,90,96,93,188,183)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.063" lower_limit="0.054" upper_limit="0.074"/>
                    <measurement group_id="O2" value="0.06" lower_limit="0.052" upper_limit="0.07"/>
                    <measurement group_id="O3" value="0.052" lower_limit="0.047" upper_limit="0.058"/>
                    <measurement group_id="O4" value="0.06" lower_limit="0.054" upper_limit="0.068"/>
                    <measurement group_id="O5" value="0.057" lower_limit="0.052" upper_limit="0.063"/>
                    <measurement group_id="O6" value="0.06" lower_limit="0.055" upper_limit="0.066"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 43(92,90,96,93,188,183)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12" lower_limit="9.36" upper_limit="15"/>
                    <measurement group_id="O2" value="16" lower_limit="13" upper_limit="20"/>
                    <measurement group_id="O3" value="12" lower_limit="9.39" upper_limit="15"/>
                    <measurement group_id="O4" value="11" lower_limit="8.67" upper_limit="14"/>
                    <measurement group_id="O5" value="12" lower_limit="10" upper_limit="14"/>
                    <measurement group_id="O6" value="13" lower_limit="11" upper_limit="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Children Who Reported Unsolicited Adverse Events (AEs)</title>
        <description>The safety of Rabipur was assessed in terms of subjects(Children) exposed to study vaccine who reported all Unsolicited AEs (including serious adverse events [SAE]s and AEs leading to subject withdrawal) from V1/day 1 (postvaccination) through V7/study termination day 43.</description>
        <time_frame>From V1/day 1 (postvaccination) through V7/study termination day 43</time_frame>
        <population>Analysis was done on the safety set, i.e. the subjects in the exposed population who provided postvaccination safety data.</population>
        <group_list>
          <group group_id="O1">
            <title>Zagreb(≥6 to ≤17 Years)</title>
            <description>≥6 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1, 8 and 22</description>
          </group>
          <group group_id="O2">
            <title>Essen(≥6 to ≤17 Years)</title>
            <description>≥6 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Children Who Reported Unsolicited Adverse Events (AEs)</title>
          <description>The safety of Rabipur was assessed in terms of subjects(Children) exposed to study vaccine who reported all Unsolicited AEs (including serious adverse events [SAE]s and AEs leading to subject withdrawal) from V1/day 1 (postvaccination) through V7/study termination day 43.</description>
          <population>Analysis was done on the safety set, i.e. the subjects in the exposed population who provided postvaccination safety data.</population>
          <units>Subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="121"/>
                <count group_id="O2" value="119"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any unsolicited AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                    <measurement group_id="O2" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At least possibly related unsolicited AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serious AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At least possibly related Serious AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Death</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Premature withdrawals due to AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Older Adults Who Reported Unsolicited Adverse Events (AEs)</title>
        <description>The safety of Rabipur was assessed in terms of subjects(Older Adults) exposed to study vaccine who reported all Unsolicited AEs (including serious adverse events [SAE]s and AEs leading to subject withdrawal) from V1/day 1 (postvaccination) through V7/study termination day 43.</description>
        <time_frame>from V1/day 1 (postvaccination) through V7/study termination day 43</time_frame>
        <population>Analysis was done on the safety set, i.e. the subjects in the exposed population who provided postvaccination safety data.</population>
        <group_list>
          <group group_id="O1">
            <title>Zagreb(≥51 Years)</title>
            <description>≥51 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22</description>
          </group>
          <group group_id="O2">
            <title>Essen(≥51 Years)</title>
            <description>≥51 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Older Adults Who Reported Unsolicited Adverse Events (AEs)</title>
          <description>The safety of Rabipur was assessed in terms of subjects(Older Adults) exposed to study vaccine who reported all Unsolicited AEs (including serious adverse events [SAE]s and AEs leading to subject withdrawal) from V1/day 1 (postvaccination) through V7/study termination day 43.</description>
          <population>Analysis was done on the safety set, i.e. the subjects in the exposed population who provided postvaccination safety data.</population>
          <units>Subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="200"/>
                <count group_id="O2" value="200"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any unsolicited AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36"/>
                    <measurement group_id="O2" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At least possibly related unsolicited AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serious AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>At least possibly related Serious AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Death</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Premature withdrawals due to AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Whole study period (From day 1 to day 43)</time_frame>
      <desc>Serious adverse events (SAEs) were collected from day 1 to study termination (day 43).The safety analysis was performed in all exposed set -All subjects in the Enrolled Set who received a study vaccination</desc>
      <group_list>
        <group group_id="E1">
          <title>Zagreb(≥6 to ≤17 Years)</title>
          <description>≥6 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22</description>
        </group>
        <group group_id="E2">
          <title>Essen(≥6 to ≤17 Years)</title>
          <description>≥6 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 doses of Rabipur at days 1, 4, 8, 15 and 29</description>
        </group>
        <group group_id="E3">
          <title>Zagreb(≥51 Years)</title>
          <description>≥51 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22</description>
        </group>
        <group group_id="E4">
          <title>Essen(≥51 Years)</title>
          <description>≥51 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 doses of Rabipur at days 1, 4, 8, 15 and 29</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 15.0v</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="121"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="119"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="200"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pancreatitis Acute</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="121"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="119"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E4" events="0" subjects_affected="0" subjects_at_risk="200"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 15.0v</default_vocab>
        <default_assessment>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="64" subjects_at_risk="121"/>
                <counts group_id="E2" subjects_affected="63" subjects_at_risk="119"/>
                <counts group_id="E3" subjects_affected="19" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="24" subjects_at_risk="200"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="121"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="119"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="200"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="121"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="119"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>Injection Site Pain</sub_title>
                <counts group_id="E1" subjects_affected="48" subjects_at_risk="121"/>
                <counts group_id="E2" subjects_affected="50" subjects_at_risk="119"/>
                <counts group_id="E3" subjects_affected="19" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="24" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>Injection Site Erythema</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="121"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="119"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="200"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="121"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="119"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="200"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Upper Respiratory Tract Infection</sub_title>
                <assessment>Non-systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="121"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="119"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="200"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased Appetite</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="121"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="119"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="200"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="121"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="119"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="200"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="121"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="119"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="200"/>
                <counts group_id="E4" subjects_affected="9" subjects_at_risk="200"/>
              </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>The terms and conditions of Novartis' agreement with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publications of the pooled data (i.e., data from all sites) in the clinical trial</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Posting Director</name_or_title>
      <organization>Novartis Vaccines and Diagnostics</organization>
      <email>RegistryContactVaccinesUS@novartis.com</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/NCT01680016
org study id: V49_24
nct id: NCT01680016
lead sponsor: 
has dmc: No
This study was designed to evaluate the safety and immunogenicity of two simulated
      postexposure rabies vaccination schedules (Zagreb 2-1-1 and Essen 1-1-1-1-1) in Chinese
      children and older adults.
This study was designed to evaluate the safety and immunogenicity of Rabipur Zagreb (2-1-1)
      and Rabipur Essen (1-1-1-1-1) simulated post exposure vaccination schedules in Chinese
      children and older adults. Subjects randomized to Group 1 (Zagreb) will receive 4 doses of
      rabies vaccine Day 1 (2 doses), and on Day 8 and Day 22. Subjects randomized to Group 2
      (Essen) will receive 5 doses of rabies vaccine on Days 1, 4, 8, 15, and 29. First vaccine
      will be administered on study Day 1.

      240 children and 400 older adults, a total of 640, is planned to be enrolled into the study.
      Subjects will be divided further into age subsets of equal numbers within each age cohort
      (children: 6 to 11 years of age and 12 to 17 years of age; older adults: 51 to 60 years of
      age and 61 years of age and older. Within each age subset, subjects will be assigned randomly
      in a 1:1 ratio.

      The primary objective is to establish the non-inferiority of the Rabipur Zagreb (2-1-1)
      schedule relative to the conventional Rabipur Essen (1-1-1-1-1) schedule based on geometric
      mean titers (GMC), and the secondary objective is to assess the percent of subjects with
      rabies virus neutralizing titer ≥ 0.5 IU/mL 14 days after the first vaccinations (study Day
      15) for each schedule and age cohort
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Non-inferiority in Immune Response of the Zagreb Postexposure Schedule of Rabipur to That of the Conventional Essen Postexposure Schedule of Rabipur as Measured by GMC of RVNA Titer 14 Days After First Vaccination in Children Aged ≥6 to ≤17 Years.
time frame: Before vaccination (day 1) and 14 days after first vaccination (day 15)
description: Immunogenicity was measured as the geometric mean concentrations (GMCs) of rabies virus neutralizing antibody (RVNA) titer , evaluated using the rapid fluorescent focus inhibition test, before vaccination and 14 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.
measure: Non-inferiority in Immune Response of the Zagreb Postexposure Schedule of Rabipur to That of the Conventional Essen Postexposure Schedule of Rabipur as Measured by GMC of RVNA Titer 14 Days After the First Vaccination in Older Adults Aged ≥51 Years
time frame: Before vaccination (day 1) and 14 days after first vaccination (day 15).
description: Immunogenicity was measured as the GMCs of Rabies Virus Neutralizing Antibody (RVNA) titer , evaluated using the rapid fluorescent focus inhibition test, before vaccination and 14 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.
measure: Number of Children Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination of Rabipur
time frame: Days 1 to 7 postvaccination
description: Safety was assessed as the number of children who reported solicited local and systemic adverse events from day 1 up to and including day 7 after any vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.
measure: Number of Older Adults Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination of Rabipur
time frame: Days 1 to 7 postvaccination
description: Safety was assessed as the number of subjects who reported solicited local and systemic adverse events from day 1 up to and including day 7 after any vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.
measure: Number of Children Who Reported Unsolicited Adverse Events (AEs)
time frame: From V1/day 1 (postvaccination) through V7/study termination day 43
description: The safety of Rabipur was assessed in terms of subjects(Children) exposed to study vaccine who reported all Unsolicited AEs (including serious adverse events [SAE]s and AEs leading to subject withdrawal) from V1/day 1 (postvaccination) through V7/study termination day 43.
measure: Number of Older Adults Who Reported Unsolicited Adverse Events (AEs)
time frame: from V1/day 1 (postvaccination) through V7/study termination day 43
description: The safety of Rabipur was assessed in terms of subjects(Older Adults) exposed to study vaccine who reported all Unsolicited AEs (including serious adverse events [SAE]s and AEs leading to subject withdrawal) from V1/day 1 (postvaccination) through V7/study termination day 43.
measure: Percentages of Children With RVNA Titers ≥0.5 IU/mL 14 Days After First Vaccination of Rabipur
time frame: Before vaccination (day 1) and 14 days after first vaccination (day 15).
description: Immunogenicity was measured as the percentages of subjects who achieved RVNA titers ≥0.5 IU/mL, 14 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.
measure: Percentages of Older Adults With RVNA Titers ≥0.5 IU/mL 14 Days After First Vaccination of Rabipur
time frame: Before vaccination (day 1) and 14 days after first vaccination (day 15).
description: Immunogenicity was measured as the percentages of subjects who achieved RVNA titers ≥0.5 IU/mL, 14 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.
measure: Percentages of Children With RVNA Titers ≥0.5 IU/mL 42 Days After First Vaccination of Rabipur
time frame: Before vaccination (day 1) and 42 days after first vaccination (day 43).
description: Immunogenicity was measured as the percentages of subjects who achieved RVNA titers ≥0.5 IU/mL, 42 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.
measure: Percentages of Older Adults With RVNA Titers ≥0.5 IU/mL 42 Days After First Vaccination of Rabipur
time frame: Before vaccination (day 1) and 42 days after first vaccination (day 43).
description: Immunogenicity was measured as the percentages of subjects who achieved RVNA titers ≥0.5 IU/mL, 42 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.
measure: GMCs of RVNA Titer 42 Days After First Vaccination in Children.
time frame: Before vaccination (day 1) and 42 days after first vaccination (day 43)
description: Immunogenicity was measured as the GMCs of RVNA titers, evaluated using the rapid fluorescent focus inhibition test, before vaccination and 42 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.
measure: GMCs of RVNA Titer 42 Days After the First Vaccination in Older Adults.
time frame: Before vaccination (day 1) and 42 days after first vaccination (day 43)
description: Immunogenicity was measured as the GMCs of RVNA titers, evaluated using the rapid fluorescent focus inhibition test, before vaccination and 42 days after first vaccination of Rabipur as per Zagreb (2-1-1) and Essen (1-1-1-1-1) postexposure schedule.
arm group label: Zagreb(≥6 to ≤17 Years)
arm group type: Experimental
arm group label: Zagreb(≥51 Years)
arm group type: Experimental
arm group label: Essen(≥6 to ≤17 Years)
arm group type: Active Comparator
arm group label: Essen(≥51 Years)
arm group type: Active Comparator
intervention type: Biological
intervention name: Zagreb
description: Subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
arm group label: Zagreb(≥51 Years)
arm group label: Zagreb(≥6 to ≤17 Years)
intervention type: Biological
intervention name: Essen
description: Subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
arm group label: Essen(≥51 Years)
arm group label: Essen(≥6 to ≤17 Years)
criteria: 
gender: All
minimum age: 6 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Novartis Vaccines
role: Study Chair
affiliation: Novartis Vaccines
facility: 
country: China
responsible party type: Sponsor
mesh term: Rabies
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 