<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/NCT01662440</url>
  </required_header>
  <id_info>
    <org_study_id>V49_23</org_study_id>
    <secondary_id>2011-005173-23</secondary_id>
    <nct_id>NCT01662440</nct_id>
  </id_info>
  <brief_title>Safety and Immunogenicity of 2 Different Vaccination Schedules of Rabies and Japanese Encephalitis Vaccines in Healthy Adult Subjects</brief_title>
  <official_title>A Phase III, Multicenter, Observer-blind, Safety and Immunogenicity Study of Rabies Vaccine and Japanese Encephalitis Vaccine Administered Concomitantly and/or Separately According to 1 of 2 Different Preexposure Prophylaxis Schedules to Healthy Adult Subjects.</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>
      Establish non-inferiority of the immune response and evaluate the safety and tolerability of&#xD;
      Rabies and Japanese Encephalitis (JE) vaccines given concomitantly or alone and according to&#xD;
      either of 2 schedules for preexposure prophylaxis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">October 2013</completion_date>
  <primary_completion_date type="Actual">December 2012</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentages of Subjects With RVNA Concentrations ≥0.5 IU/mL At 7 Days After Last Active Vaccination</measure>
    <time_frame>Day 7 after last active vaccination (day 15 - group that received accelerated schedule, day 36 - group that received conventional schedule)</time_frame>
    <description>Immune response was measured as the percentage of subjects with rabies virus neutralizing antibody (RVNA) concentrations ≥0.5 IU/mL, evaluated using the rapid fluorescent focus inhibition test at day 7 after last active vaccination, i.e. the third out of four vaccinations given in the accelerated Rabies vaccine schedule and the fourth out of four vaccinations given in the conventional Rabies vaccine schedule.&#xD;
As per study design, this primary immunogenicity outcome measure aimed to demonstrate non-inferiority of R/JE - Acc Vs R - Conv.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentages of Subjects With PRNT50 Titer ≥1:10 At 28 Days After Last Active Vaccination</measure>
    <time_frame>Day 28 after last active vaccination (day 36 - group that received accelerated schedule, day 57 - group that received conventional schedule)</time_frame>
    <description>Immune response was measured as the percentages of subjects with a titer of ≥1:10 in a 50% plaque reduction neutralization test (PRNT50) 28 days after last active vaccination, ie, the second out of three vaccinations given in the accelerated JE vaccine schedule and the third out of three vaccinations given in the conventional JE vaccine schedule.&#xD;
As per study design, this primary immunogenicity outcome measure aimed to demonstrate non-inferiority of R/JE - Acc Vs JE - Conv.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>RVNA Geometric Mean Concentrations (GMCs) At 28 Days After Last Active Vaccination</measure>
    <time_frame>Day 57 (28 days after last active vaccination)</time_frame>
    <description>Immune response was measured as the RVNA GMCs 28 days after last active vaccination, ie, day 57 for all groups that received the conventional schedule.&#xD;
Data were adjusted using ANOVA model, as per protocol specification.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PRNT50 Geometric Mean Titers (GMTs) At 28 Days After Last Active Vaccination</measure>
    <time_frame>Day 57 (28 days after last active vaccination)</time_frame>
    <description>Immune response was measured as the PRNT50 GMTs 28 days after last active vaccination, ie, day 57 for all groups that received the conventional schedule.&#xD;
Data were adjusted using ANOVA model, as per protocol specifications.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentages of Subjects With RVNA Concentrations ≥0.5 IU/mL At 28 Days After Last Active Vaccination</measure>
    <time_frame>Day 36 and day 57 (28 days after last active vaccination)</time_frame>
    <description>Immune response was measured as the percentages of subjects with RVNA concentration ≥0.5 IU/mL 28 days after last active vaccination, ie, day 36 for the group that received the accelerated schedule and day 57 for the group that received the conventional schedule.&#xD;
As per study design, this secondary immunogenicity outcome measure aimed to demonstrate non-inferiority of R/JE - Acc Vs R - Conv.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Subjects With PRNT50 Titer ≥1:10 At 7 Days After Last Active Vaccination</measure>
    <time_frame>Day 15 and day 36 (28 after last active vaccination)</time_frame>
    <description>Immune response was measured as the percentage of subjects with PRNT50 titer of ≥1:10 7 days after last active vaccination, ie, day 15 for the group that received the accelerated schedule and day 36 for the group that received the conventional schedule.&#xD;
As per study design, this secondary immunogenicity outcome measure aimed to demonstrate non-inferiority of R/JE - Acc Vs JE - Conv.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Kinetics of Rabies Immune Response Measured as Percentage of Subjects With RVNA Concentration ≥0.5 IU/mL</measure>
    <time_frame>Day 1, 8, 15, 36, 57, 91, 181 and Day 366</time_frame>
    <description>To evaluate the kinetics of antibody response to Rabies vaccine, the immunogenicity was measured as the percentage of subjects with RVNA concentrations ≥0.5 IU/mL on days 1, 8, 15, 36, 57, 91, 181, and 366.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Kinetics of Rabies Immune Response Measured as the RVNA GMCs</measure>
    <time_frame>Day 1, 8, 15, 36, 57, 91, 181, and 366</time_frame>
    <description>To evaluate the kinetics of antibody response to Rabies vaccine, the immunogenicity was measured as the RVNA GMCs on days 1, 8, 15, 36, 57, 91, 181, and 366.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Kinetics of JE Immune Response Measured as Percentage of Subjects With PRNT50 Titers ≥1:10</measure>
    <time_frame>Days 1, 15, 22, 36, 57, 91, 181 and 366</time_frame>
    <description>To evaluate the kinetics of antibody response to JE vaccine, the immunogenicity was measured as the percentage of subjects with PRNT50 titer ≥1:10 on days 1, 15, 22, 36, 57, 91, 181, and 366 (group that received JE vaccine as an accelerated schedule) and days 1, 36, 57, 181, and 366 (group that received JE vaccine as a conventional schedule).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Kinetics of JE Immune Response Measured as PRNT50 GMTs</measure>
    <time_frame>Day 1, 15, 22, 36, 57, 91, 181, and 366 (accelerated schedule) and day 1, 36, 57, 181, and 366 (conventional schedule)</time_frame>
    <description>To evaluate the kinetics of antibody response to JE vaccine, the immunogenicity was measured as the PRNT50 GMTs on days 1, 15, 22, 36, 57, 91, 181, and 366 (group that received JE vaccine as an accelerated schedule) and days 1, 36, 57, 181, and 366 (group that received JE vaccine as a conventional schedule).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Who Reported Solicited Local Adverse Events After Each Rabies Vaccination</measure>
    <time_frame>Day 1 through day 7 after each vaccination (on day 1, 4, 8 and 29)</time_frame>
    <description>Safety was assessed as the number of subjects who reported solicited local adverse events (AEs) after each rabies vaccination given according to accelerated or conventional schedule as follows: from day 1 through day 7 (vaccination on day 1; all Rabies groups), day 4 through day 10 (vaccination on day 4; in R/JE - Acc group only), day 8 through day 14 (vaccination on day 8; all Rabies groups), or day 29 through day 35 (vaccination on day 29; R/JE - Conv and R - Conv groups).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Who Reported Solicited Local AEs After Each JE Vaccination</measure>
    <time_frame>Day 1 through day 7 after each vaccination (on day 1, 8 and 29)</time_frame>
    <description>Safety was assessed as the number of subjects who reported solicited local AEs after each JE vaccination given according to accelerated or conventional schedule as follow: from day 1 through day 7 (vaccination on day 1; all JE groups), day 8 through day 14 (vaccination on day 8; R/JE - Acc group only), or day 29 through day 35 (vaccination on day 29; R/JE - Con and JE - Conv groups).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection</measure>
    <time_frame>Day 1 through day 7 after each injection (day 1, 4, 8 and 29)</time_frame>
    <description>Safety was assessed as the number of subjects who reported solicited local AEs after each placebo injection given according to accelerated and conventional schedule as follow: from day 1 through day 7 (injection on day 1; R - Conv and JE - Conv groups), day 4 through day 10 (injection on day 4; in R/JE - Conv, R - Conv and JE - Conv groups), day 8 through day 14 (injection on day 8; in R/JE - Conv, R - Conv and JE - Conv groups), and day 29 through day 35 (injection on day 29; R/JE - Acc, R - Con and JE - Conv groups).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination</measure>
    <time_frame>Day 1 through day 7 after each vaccination (day 1, 4, 8 and 29)</time_frame>
    <description>Safety was assessed as the number of subjects who reported solicited systemic AEs and other indicators of reactogenicity after each vaccination given according to accelerated and conventional schedule.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Numbers of Subjects Reporting Unsolicited AEs After Any Vaccination From Day 1 Through Day 57</measure>
    <time_frame>Day 1 through Day 57</time_frame>
    <description>Safety was assessed as the number of subjects who reported unsolicited AEs after any vaccination given according to accelerated and conventional schedule.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">661</enrollment>
  <condition>Rabies</condition>
  <condition>Japanese Encephalitis</condition>
  <arm_group>
    <arm_group_label>R/JE - Conv</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects received Rabies and Japanese Encephalitis (JE) vaccines following the conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg; and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>R/JE - Acc</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects received Rabies and JE vaccines following the accelerated schedule, ie, Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg; and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>R - Conv</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects received Rabies vaccine following the conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg; and placebo on days 1, 8 and 29 in the left arm.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>JE - Conv</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects received JE vaccine following the conventional schedule, ie, placebo on days 1, 4, 8 and 29 in the right arm or leg; and JE vaccination on days 1 and 29 and placebo injection on day 8 in the left arm.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Rabies</intervention_name>
    <description>Subjects received three doses of Rabies, whole virus vaccine (inactivated, Germany).</description>
    <arm_group_label>R - Conv</arm_group_label>
    <arm_group_label>R/JE - Acc</arm_group_label>
    <arm_group_label>R/JE - Conv</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Japanese Encephalitis</intervention_name>
    <description>Subjects received two doses of Japanese Encephalitis vaccine.</description>
    <arm_group_label>JE - Conv</arm_group_label>
    <arm_group_label>R/JE - Acc</arm_group_label>
    <arm_group_label>R/JE - Conv</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Subjects received either two, three, four or five doses of normal saline, 0.9% w/v sodium chloride depending on the vaccine group.</description>
    <arm_group_label>JE - Conv</arm_group_label>
    <arm_group_label>R - Conv</arm_group_label>
    <arm_group_label>R/JE - Acc</arm_group_label>
    <arm_group_label>R/JE - Conv</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Males and females between 18 and 65 years of age (inclusive).&#xD;
&#xD;
          2. Subjects who have given written consent.&#xD;
&#xD;
          3. Individuals in good health as per investigator judgement.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. If female, pregnancy or unwillingness to practice acceptable contraception.&#xD;
&#xD;
          2. If female, pregnant or breast-feeding or any positive/indeterminate pregnancy test.&#xD;
&#xD;
          3. Contraindication or precaution against Rabies and Japanese Encephalitis vaccination.&#xD;
&#xD;
          4. Unable to comprehend and to follow all required study procedures for the whole period&#xD;
             of the study.&#xD;
&#xD;
          5. Participating in any other clinical trial 30 days prior to first study visit.&#xD;
&#xD;
          6. History of previous rabies/rabies immunoglobulin and/or Japanese Encephalitis&#xD;
             immunization.&#xD;
&#xD;
          7. Receiving or planning to receive anti-malarial medications (e.g. Mefloquine) 14 days&#xD;
             prior to Day 1 vaccination through Day 43.&#xD;
&#xD;
          8. Received any other vaccines within 2 weeks prior to enrollment in this study or plan&#xD;
             to receive any vaccine within 4 weeks from the study vaccines.&#xD;
&#xD;
          9. Ever received blood, blood products and/or plasma derivatives or any parenteral&#xD;
             immunoglobulin preparation in the past 12 weeks.&#xD;
&#xD;
         10. Individuals who are part of study personnel or close family members conducting this&#xD;
             study.&#xD;
&#xD;
         11. Body temperature ≥38 degrees Celsius (≥ 100.4° F) within 3 days of intended study&#xD;
             vaccination.&#xD;
&#xD;
         12. Plans to travel within the next year to areas where Rabies and/or Japanese&#xD;
             Encephalitis vaccine may be considered or offered. This includes but is not limited to&#xD;
             India, Asia, Pacific-Rim, African countries.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Novartis Vaccines and Diagnostics</last_name>
    <role>Study Chair</role>
    <affiliation>Novartis Vaccines</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institute of Specific Prophylaxis and Tropical Medicine Center for Pathophysiology, Infectious Diseases and Immunology Medical University of Vienna</name>
      <address>
        <city>Kinderspitalgasse 15</city>
        <state>Vienna</state>
        <zip>A-1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bernhard Nocht Institute for Tropical Medicine</name>
      <address>
        <city>Bernhard-Nocht-Strasse 74</city>
        <state>Hamburg</state>
        <zip>D-20359</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of Zurich</name>
      <address>
        <city>Rämistrasse 71</city>
        <state>Zürich</state>
        <zip>CH-8006</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>Germany</country>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>December 2014</verification_date>
  <study_first_submitted>August 2, 2012</study_first_submitted>
  <study_first_submitted_qc>August 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 10, 2012</study_first_posted>
  <results_first_submitted>October 6, 2014</results_first_submitted>
  <results_first_submitted_qc>December 2, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">December 8, 2014</results_first_posted>
  <disposition_first_submitted>April 23, 2013</disposition_first_submitted>
  <disposition_first_submitted_qc>April 23, 2013</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">May 1, 2013</disposition_first_posted>
  <last_update_submitted>December 2, 2014</last_update_submitted>
  <last_update_submitted_qc>December 2, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 8, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Rabies</keyword>
  <keyword>JE</keyword>
  <keyword>accelerated schedule</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rabies</mesh_term>
    <mesh_term>Encephalitis, Japanese</mesh_term>
    <mesh_term>Encephalitis</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Subjects were enrolled from five sites in Germany, one site in Austria, and one site in Switzerland.</recruitment_details>
      <pre_assignment_details>All subjects were included in the trial.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>R/JE - Conv</title>
          <description>Subjects received Rabies and Japanese Encephalitis (JE) vaccines, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg; and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.</description>
        </group>
        <group group_id="P2">
          <title>R/JE - Acc</title>
          <description>Subjects received Rabies and JE vaccines, accelerated schedule, ie, Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg; and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm.</description>
        </group>
        <group group_id="P3">
          <title>R - Conv</title>
          <description>Subjects received Rabies vaccine, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg; and placebo on days 1, 8 and 29 in the left arm.</description>
        </group>
        <group group_id="P4">
          <title>JE - Conv</title>
          <description>Subjects received JE vaccine, conventional schedule, ie, placebo on days 1, 4, 8 and 29 in the right arm or leg; and JE vaccination on days 1 and 29 and placebo injection on day 8 in the left arm.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="167"/>
                <participants group_id="P2" count="217"/>
                <participants group_id="P3" count="221"/>
                <participants group_id="P4" count="56"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="158"/>
                <participants group_id="P2" count="211"/>
                <participants group_id="P3" count="215"/>
                <participants group_id="P4" count="52"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="6"/>
                <participants group_id="P4" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</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>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Subject moved to another country.</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>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <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="2"/>
                <participants group_id="P3" count="2"/>
                <participants group_id="P4" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>R/JE - Conv</title>
          <description>Subjects received Rabies and JE vaccines, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg; and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.</description>
        </group>
        <group group_id="B2">
          <title>R/JE - Acc</title>
          <description>Subjects received Rabies and JE vaccines, accelerated schedule, ie, Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg; and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm.</description>
        </group>
        <group group_id="B3">
          <title>R - Conv</title>
          <description>Subjects received Rabies vaccine, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg; and placebo on days 1, 8 and 29 in the left arm.</description>
        </group>
        <group group_id="B4">
          <title>JE - Conv</title>
          <description>Subjects received JE vaccine, conventional schedule, ie, placebo on days 1, 4, 8 and 29 in the right arm or leg; and JE vaccination on days 1 and 29 and placebo injection on day 8 in the left arm.</description>
        </group>
        <group group_id="B5">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="167"/>
            <count group_id="B2" value="217"/>
            <count group_id="B3" value="221"/>
            <count group_id="B4" value="56"/>
            <count group_id="B5" value="661"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>year</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="37.3" spread="13.4"/>
                    <measurement group_id="B2" value="36.8" spread="12.7"/>
                    <measurement group_id="B3" value="35.7" spread="12.6"/>
                    <measurement group_id="B4" value="38.8" spread="13.3"/>
                    <measurement group_id="B5" value="36.7" spread="12.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="76"/>
                    <measurement group_id="B2" value="128"/>
                    <measurement group_id="B3" value="125"/>
                    <measurement group_id="B4" value="30"/>
                    <measurement group_id="B5" value="359"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="91"/>
                    <measurement group_id="B2" value="89"/>
                    <measurement group_id="B3" value="96"/>
                    <measurement group_id="B4" value="26"/>
                    <measurement group_id="B5" value="302"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentages of Subjects With RVNA Concentrations ≥0.5 IU/mL At 7 Days After Last Active Vaccination</title>
        <description>Immune response was measured as the percentage of subjects with rabies virus neutralizing antibody (RVNA) concentrations ≥0.5 IU/mL, evaluated using the rapid fluorescent focus inhibition test at day 7 after last active vaccination, i.e. the third out of four vaccinations given in the accelerated Rabies vaccine schedule and the fourth out of four vaccinations given in the conventional Rabies vaccine schedule.&#xD;
As per study design, this primary immunogenicity outcome measure aimed to demonstrate non-inferiority of R/JE - Acc Vs R - Conv.</description>
        <time_frame>Day 7 after last active vaccination (day 15 - group that received accelerated schedule, day 36 - group that received conventional schedule)</time_frame>
        <population>Analysis was done on the per-protocol (PP) dataset, ie, 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 unblinding.</population>
        <group_list>
          <group group_id="O1">
            <title>R/JE - Acc</title>
            <description>Subjects received Rabies and JE vaccines, accelerated schedule, ie, Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg, and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm.</description>
          </group>
          <group group_id="O2">
            <title>R - Conv</title>
            <description>Subjects received Rabies vaccine, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and placebo on days 1, 8 and 29 in the left arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentages of Subjects With RVNA Concentrations ≥0.5 IU/mL At 7 Days After Last Active Vaccination</title>
          <description>Immune response was measured as the percentage of subjects with rabies virus neutralizing antibody (RVNA) concentrations ≥0.5 IU/mL, evaluated using the rapid fluorescent focus inhibition test at day 7 after last active vaccination, i.e. the third out of four vaccinations given in the accelerated Rabies vaccine schedule and the fourth out of four vaccinations given in the conventional Rabies vaccine schedule.&#xD;
As per study design, this primary immunogenicity outcome measure aimed to demonstrate non-inferiority of R/JE - Acc Vs R - Conv.</description>
          <population>Analysis was done on the per-protocol (PP) dataset, ie, 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 unblinding.</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="209"/>
                <count group_id="O2" value="207"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100" lower_limit="97" upper_limit="100"/>
                    <measurement group_id="O2" value="100" lower_limit="97" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>To establish non-inferiority of the immune response of Rabies vaccine (administered concomitantly with JE vaccine) accelerated schedule as compared to conventional schedule at 7 days after last active vaccination.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>The immune response of accelerated schedule of the Rabies vaccine considered non-inferior to the conventional schedule if the lower bound of the two-sided 97.5% Confidence Intervals (CI) of the difference in the percentages of subjects with RVNA titer ≥0.5 IU/mL measured 7 days after last active vaccination is greater than -5.</non_inferiority_desc>
            <param_type>Difference in percentages of subjects</param_type>
            <param_value>0</param_value>
            <ci_percent>97.5</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-2.8</ci_lower_limit>
            <ci_upper_limit>2.8</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Percentages of Subjects With PRNT50 Titer ≥1:10 At 28 Days After Last Active Vaccination</title>
        <description>Immune response was measured as the percentages of subjects with a titer of ≥1:10 in a 50% plaque reduction neutralization test (PRNT50) 28 days after last active vaccination, ie, the second out of three vaccinations given in the accelerated JE vaccine schedule and the third out of three vaccinations given in the conventional JE vaccine schedule.&#xD;
As per study design, this primary immunogenicity outcome measure aimed to demonstrate non-inferiority of R/JE - Acc Vs JE - Conv.</description>
        <time_frame>Day 28 after last active vaccination (day 36 - group that received accelerated schedule, day 57 - group that received conventional schedule)</time_frame>
        <population>Analysis was done on the PP dataset.</population>
        <group_list>
          <group group_id="O1">
            <title>R/JE - Acc</title>
            <description>Subjects received Rabies and JE vaccines, accelerated schedule, ie, Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg, and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm.</description>
          </group>
          <group group_id="O2">
            <title>JE - Conv</title>
            <description>Subjects received JE vaccine, conventional schedule, ie, placebo on days 1, 4, 8 and 29 in the right arm or leg, and JE vaccination on days 1 and 29 and placebo injection on day 8 in the left arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentages of Subjects With PRNT50 Titer ≥1:10 At 28 Days After Last Active Vaccination</title>
          <description>Immune response was measured as the percentages of subjects with a titer of ≥1:10 in a 50% plaque reduction neutralization test (PRNT50) 28 days after last active vaccination, ie, the second out of three vaccinations given in the accelerated JE vaccine schedule and the third out of three vaccinations given in the conventional JE vaccine schedule.&#xD;
As per study design, this primary immunogenicity outcome measure aimed to demonstrate non-inferiority of R/JE - Acc Vs JE - Conv.</description>
          <population>Analysis was done on the PP dataset.</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="209"/>
                <count group_id="O2" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99" lower_limit="96" upper_limit="100"/>
                    <measurement group_id="O2" value="100" lower_limit="93" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Non-inferiority of the immune response of JE vaccine (administered concomitantly with Rabies vaccine) accelerated schedule as compared to conventional schedule at 28 day after last active vaccination</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>The immune response of accelerated schedule of the JE vaccine is considered non-inferior to the conventional schedule if the lower bound of the two-sided 97.5% CI of the difference in the percentages of subjects with PRNT50 titer ≥1:10 measured 28 days after last active vaccination is greater than -10.</non_inferiority_desc>
            <param_type>Difference in percentages of subjects</param_type>
            <param_value>-1</param_value>
            <ci_percent>97.5</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.8</ci_lower_limit>
            <ci_upper_limit>7.9</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>RVNA Geometric Mean Concentrations (GMCs) At 28 Days After Last Active Vaccination</title>
        <description>Immune response was measured as the RVNA GMCs 28 days after last active vaccination, ie, day 57 for all groups that received the conventional schedule.&#xD;
Data were adjusted using ANOVA model, as per protocol specification.</description>
        <time_frame>Day 57 (28 days after last active vaccination)</time_frame>
        <population>Analysis was done on the PP dataset.</population>
        <group_list>
          <group group_id="O1">
            <title>R/JE - Conv</title>
            <description>Subjects received Rabies and JE vaccines, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.</description>
          </group>
          <group group_id="O2">
            <title>R - Conv</title>
            <description>Subjects received Rabies vaccine, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and placebo on days 1, 8 and 29 in the left arm.</description>
          </group>
        </group_list>
        <measure>
          <title>RVNA Geometric Mean Concentrations (GMCs) At 28 Days After Last Active Vaccination</title>
          <description>Immune response was measured as the RVNA GMCs 28 days after last active vaccination, ie, day 57 for all groups that received the conventional schedule.&#xD;
Data were adjusted using ANOVA model, as per protocol specification.</description>
          <population>Analysis was done on the PP dataset.</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="157"/>
                <count group_id="O2" value="204"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11" lower_limit="9" upper_limit="12"/>
                    <measurement group_id="O2" value="9.9" lower_limit="8.57" upper_limit="11"/>
                  </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>Non-inferiority of the immune response of Rabies vaccine (administered concomitantly with JE vaccine) as compared to Rabies vaccines (administered alone) as given according to conventional schedule at 28day after last active vaccination</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>The conventional schedule of Rabies vaccine co-administered with JE vaccine considered non inferior to the conventional schedule of Rabies vaccine administered alone if the lower bound of the two-sided 95% CI of the ratio of GMCs measured 28 days after last active vaccination is greater than 0.667.</non_inferiority_desc>
            <param_type>Between groups ratio of GMCs</param_type>
            <param_value>1.07</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.86</ci_lower_limit>
            <ci_upper_limit>1.32</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PRNT50 Geometric Mean Titers (GMTs) At 28 Days After Last Active Vaccination</title>
        <description>Immune response was measured as the PRNT50 GMTs 28 days after last active vaccination, ie, day 57 for all groups that received the conventional schedule.&#xD;
Data were adjusted using ANOVA model, as per protocol specifications.</description>
        <time_frame>Day 57 (28 days after last active vaccination)</time_frame>
        <population>Analysis was done on the PP dataset.</population>
        <group_list>
          <group group_id="O1">
            <title>R/JE - Conv</title>
            <description>Subjects received Rabies and JE vaccines, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.</description>
          </group>
          <group group_id="O2">
            <title>JE - Conv</title>
            <description>Subjects received JE vaccine, conventional schedule, i.e. placebo on days 1, 4, 8 and 29 in the right arm or leg; and JE vaccination on days 1 and 29 and placebo injection on day 8 in the left arm.</description>
          </group>
        </group_list>
        <measure>
          <title>PRNT50 Geometric Mean Titers (GMTs) At 28 Days After Last Active Vaccination</title>
          <description>Immune response was measured as the PRNT50 GMTs 28 days after last active vaccination, ie, day 57 for all groups that received the conventional schedule.&#xD;
Data were adjusted using ANOVA model, as per protocol specifications.</description>
          <population>Analysis was done on the PP dataset.</population>
          <units>Titers</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="157"/>
                <count group_id="O2" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="291" lower_limit="256" upper_limit="331"/>
                    <measurement group_id="O2" value="331" lower_limit="265" upper_limit="415"/>
                  </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>Non-inferiority of the immune response of JE vaccine (administered concomitantly with Rabies vaccine) as compared to JE vaccine (administered alone) as given according to conventional schedule at day 28 after last active vaccination.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>The conventional schedule of JE vaccine co-administered with Rabies vaccine considered non inferior to the conventional schedule of JE vaccine administered alone if the lower bound of the two-sided 95% CI of the ratio of GMTs measured 28 days after last active vaccination is greater than 0.5.</non_inferiority_desc>
            <param_type>Ratio of GMTs</param_type>
            <param_value>0.88</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.68</ci_lower_limit>
            <ci_upper_limit>1.13</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentages of Subjects With RVNA Concentrations ≥0.5 IU/mL At 28 Days After Last Active Vaccination</title>
        <description>Immune response was measured as the percentages of subjects with RVNA concentration ≥0.5 IU/mL 28 days after last active vaccination, ie, day 36 for the group that received the accelerated schedule and day 57 for the group that received the conventional schedule.&#xD;
As per study design, this secondary immunogenicity outcome measure aimed to demonstrate non-inferiority of R/JE - Acc Vs R - Conv.</description>
        <time_frame>Day 36 and day 57 (28 days after last active vaccination)</time_frame>
        <population>Analysis was done on the PP set.</population>
        <group_list>
          <group group_id="O1">
            <title>R/JE - Acc</title>
            <description>Subjects received Rabies and JE vaccines, accelerated schedule, ie, Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg, and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm.</description>
          </group>
          <group group_id="O2">
            <title>R - Conv</title>
            <description>Subjects received Rabies vaccine, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and placebo on days 1, 8 and 29 in the left arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentages of Subjects With RVNA Concentrations ≥0.5 IU/mL At 28 Days After Last Active Vaccination</title>
          <description>Immune response was measured as the percentages of subjects with RVNA concentration ≥0.5 IU/mL 28 days after last active vaccination, ie, day 36 for the group that received the accelerated schedule and day 57 for the group that received the conventional schedule.&#xD;
As per study design, this secondary immunogenicity outcome measure aimed to demonstrate non-inferiority of R/JE - Acc Vs R - Conv.</description>
          <population>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="206"/>
                <count group_id="O2" value="204"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99" lower_limit="96" upper_limit="100"/>
                    <measurement group_id="O2" value="100" lower_limit="97" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Non-inferiority of the Rabies immune response (administered concomitantly with JE vaccine) as given according to an accelerated schedule as compared Rabies vaccine (administered alone) as given to a conventional schedule at day 28 after last active vaccination</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>The immune response of accelerated schedule of the Rabies vaccine is considered non-inferior to the Rabies vaccine conventional schedule if the lower bound of the two-sided 95% CI of the difference in the percentages of subjects with RVNA titer ≥0.5 IU/mL measured 28 days after last active vaccine administration is greater than -5.</non_inferiority_desc>
            <param_type>Difference in percentages of subjects</param_type>
            <param_value>-1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.8</ci_lower_limit>
            <ci_upper_limit>1.4</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Subjects With PRNT50 Titer ≥1:10 At 7 Days After Last Active Vaccination</title>
        <description>Immune response was measured as the percentage of subjects with PRNT50 titer of ≥1:10 7 days after last active vaccination, ie, day 15 for the group that received the accelerated schedule and day 36 for the group that received the conventional schedule.&#xD;
As per study design, this secondary immunogenicity outcome measure aimed to demonstrate non-inferiority of R/JE - Acc Vs JE - Conv.</description>
        <time_frame>Day 15 and day 36 (28 after last active vaccination)</time_frame>
        <population>Analysis was done on the PP dataset.</population>
        <group_list>
          <group group_id="O1">
            <title>R/JE - Acc</title>
            <description>Subjects received Rabies and JE vaccines, accelerated schedule, ie, Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg, and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm.</description>
          </group>
          <group group_id="O2">
            <title>JE - Conv</title>
            <description>Group Description Subjects received Rabies and JE vaccines, conventional schedule, i.e. Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg; and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Subjects With PRNT50 Titer ≥1:10 At 7 Days After Last Active Vaccination</title>
          <description>Immune response was measured as the percentage of subjects with PRNT50 titer of ≥1:10 7 days after last active vaccination, ie, day 15 for the group that received the accelerated schedule and day 36 for the group that received the conventional schedule.&#xD;
As per study design, this secondary immunogenicity outcome measure aimed to demonstrate non-inferiority of R/JE - Acc Vs JE - Conv.</description>
          <population>Analysis was done on the PP dataset.</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="209"/>
                <count group_id="O2" value="47"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99" lower_limit="96" upper_limit="100"/>
                    <measurement group_id="O2" value="100" lower_limit="92" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Non-inferiority of the immune response of JE vaccine (administered concomitantly with Rabies vaccine) as given according to an accelerated schedule as compared to JE vaccine (administered alone) as given according to a conventional schedule at 7day after last active vaccine administration.</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>The immune response of accelerated schedule of the JE vaccine considered non-inferior to the conventional schedule if the lower bound of the two-sided 95% CI of the difference in the percentages of subjects with PRNT50 titer ≥1:10 measured 7 days after last active vaccine administration is greater than -10.</non_inferiority_desc>
            <param_type>Difference in percentages of subjects</param_type>
            <param_value>-1</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-4.1</ci_lower_limit>
            <ci_upper_limit>6.2</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Kinetics of Rabies Immune Response Measured as Percentage of Subjects With RVNA Concentration ≥0.5 IU/mL</title>
        <description>To evaluate the kinetics of antibody response to Rabies vaccine, the immunogenicity was measured as the percentage of subjects with RVNA concentrations ≥0.5 IU/mL on days 1, 8, 15, 36, 57, 91, 181, and 366.</description>
        <time_frame>Day 1, 8, 15, 36, 57, 91, 181 and Day 366</time_frame>
        <population>Analysis was done on the PP dataset.</population>
        <group_list>
          <group group_id="O1">
            <title>R/JE - Conv</title>
            <description>Subjects received Rabies and JE vaccines, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.</description>
          </group>
          <group group_id="O2">
            <title>R/JE - Acc</title>
            <description>Subjects received Rabies and JE vaccines, accelerated schedule, ie, Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg, and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm.</description>
          </group>
          <group group_id="O3">
            <title>R - Conv</title>
            <description>Subjects received Rabies vaccine, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and placebo on days 1, 8 and 29 in the left arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Kinetics of Rabies Immune Response Measured as Percentage of Subjects With RVNA Concentration ≥0.5 IU/mL</title>
          <description>To evaluate the kinetics of antibody response to Rabies vaccine, the immunogenicity was measured as the percentage of subjects with RVNA concentrations ≥0.5 IU/mL on days 1, 8, 15, 36, 57, 91, 181, and 366.</description>
          <population>Analysis was done on the PP dataset.</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="166"/>
                <count group_id="O2" value="215"/>
                <count group_id="O3" value="218"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1" lower_limit="0.015" upper_limit="3"/>
                    <measurement group_id="O2" value="1" lower_limit="0" upper_limit="3"/>
                    <measurement group_id="O3" value="1" lower_limit="0" upper_limit="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 8 (N=161, 210, 213)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4" lower_limit="2" upper_limit="9"/>
                    <measurement group_id="O2" value="16" lower_limit="11" upper_limit="21"/>
                    <measurement group_id="O3" value="4" lower_limit="2" upper_limit="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 15 (N=161, 209, 210)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99" lower_limit="96" upper_limit="100"/>
                    <measurement group_id="O2" value="100" lower_limit="97" upper_limit="100"/>
                    <measurement group_id="O3" value="99" lower_limit="97" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 36 (N=157, 206, 207)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100" lower_limit="98" upper_limit="100"/>
                    <measurement group_id="O2" value="99" lower_limit="96" upper_limit="100"/>
                    <measurement group_id="O3" value="100" lower_limit="97" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 57 (157, 204, 204)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100" lower_limit="98" upper_limit="100"/>
                    <measurement group_id="O2" value="97" lower_limit="93" upper_limit="99"/>
                    <measurement group_id="O3" value="100" lower_limit="97" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 91 (N=152, 206, 204)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99" lower_limit="95" upper_limit="100"/>
                    <measurement group_id="O2" value="85" lower_limit="79" upper_limit="90"/>
                    <measurement group_id="O3" value="98" lower_limit="95" upper_limit="99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 181 (N= 155, 200, 202)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88" lower_limit="82" upper_limit="92"/>
                    <measurement group_id="O2" value="75" lower_limit="68" upper_limit="81"/>
                    <measurement group_id="O3" value="89" lower_limit="84" upper_limit="93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 366 (154, 199, 204)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76" lower_limit="68" upper_limit="82"/>
                    <measurement group_id="O2" value="68" lower_limit="61" upper_limit="74"/>
                    <measurement group_id="O3" value="80" lower_limit="74" upper_limit="85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Kinetics of Rabies Immune Response Measured as the RVNA GMCs</title>
        <description>To evaluate the kinetics of antibody response to Rabies vaccine, the immunogenicity was measured as the RVNA GMCs on days 1, 8, 15, 36, 57, 91, 181, and 366.</description>
        <time_frame>Day 1, 8, 15, 36, 57, 91, 181, and 366</time_frame>
        <population>Analysis was done on the PP dataset.</population>
        <group_list>
          <group group_id="O1">
            <title>R/JE - Conv</title>
            <description>Subjects received Rabies and JE vaccines, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.</description>
          </group>
          <group group_id="O2">
            <title>R/JE - Acc</title>
            <description>Subjects received Rabies and JE vaccines, accelerated schedule, ie, Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg, and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm.</description>
          </group>
          <group group_id="O3">
            <title>R - Conv</title>
            <description>Subjects received Rabies vaccine, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and placebo on days 1, 8 and 29 in the left arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Kinetics of Rabies Immune Response Measured as the RVNA GMCs</title>
          <description>To evaluate the kinetics of antibody response to Rabies vaccine, the immunogenicity was measured as the RVNA GMCs on days 1, 8, 15, 36, 57, 91, 181, and 366.</description>
          <population>Analysis was done on the PP dataset.</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="166"/>
                <count group_id="O2" value="215"/>
                <count group_id="O3" value="218"/>
              </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="0.053" lower_limit="0.049" upper_limit="0.056"/>
                    <measurement group_id="O3" value="0.054" lower_limit="0.05" upper_limit="0.057"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 8 (N=161, 210, 213)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.071" lower_limit="0.061" upper_limit="0.084"/>
                    <measurement group_id="O2" value="0.13" lower_limit="0.12" upper_limit="0.16"/>
                    <measurement group_id="O3" value="0.076" lower_limit="0.066" upper_limit="0.088"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 15 (N=161, 209, 210),</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21" lower_limit="17" upper_limit="25"/>
                    <measurement group_id="O2" value="26" lower_limit="22" upper_limit="30"/>
                    <measurement group_id="O3" value="24" lower_limit="20" upper_limit="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 36 (N=157, 206, 207)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14" lower_limit="12" upper_limit="17"/>
                    <measurement group_id="O2" value="5.75" lower_limit="4.95" upper_limit="6.67"/>
                    <measurement group_id="O3" value="13" lower_limit="11" upper_limit="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 57 (N=157, 204, 204)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10" lower_limit="8.72" upper_limit="12"/>
                    <measurement group_id="O2" value="3.01" lower_limit="2.59" upper_limit="3.51"/>
                    <measurement group_id="O3" value="9.66" lower_limit="8.31" upper_limit="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 91 (N=152, 206, 204)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.79" lower_limit="3.98" upper_limit="5.76"/>
                    <measurement group_id="O2" value="1.63" lower_limit="1.39" upper_limit="1.91"/>
                    <measurement group_id="O3" value="5.04" lower_limit="4.29" upper_limit="5.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 181 (N= 155, 200, 202)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.86" lower_limit="1.15" upper_limit="2.3"/>
                    <measurement group_id="O2" value="1" lower_limit="0.83" upper_limit="1.21"/>
                    <measurement group_id="O3" value="2.04" lower_limit="1.69" upper_limit="2.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 366 (N=154, 199, 204)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.93" lower_limit="0.75" upper_limit="1.16"/>
                    <measurement group_id="O2" value="0.82" lower_limit="0.67" upper_limit="1"/>
                    <measurement group_id="O3" value="1.14" lower_limit="0.94" upper_limit="1.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Kinetics of JE Immune Response Measured as Percentage of Subjects With PRNT50 Titers ≥1:10</title>
        <description>To evaluate the kinetics of antibody response to JE vaccine, the immunogenicity was measured as the percentage of subjects with PRNT50 titer ≥1:10 on days 1, 15, 22, 36, 57, 91, 181, and 366 (group that received JE vaccine as an accelerated schedule) and days 1, 36, 57, 181, and 366 (group that received JE vaccine as a conventional schedule).</description>
        <time_frame>Days 1, 15, 22, 36, 57, 91, 181 and 366</time_frame>
        <population>Analysis was done on the PP dataset.</population>
        <group_list>
          <group group_id="O1">
            <title>R/JE - Conv</title>
            <description>Subjects received Rabies and JE vaccines, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.</description>
          </group>
          <group group_id="O2">
            <title>R/JE - Acc</title>
            <description>Subjects received Rabies and JE vaccines, accelerated schedule, ie, Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg, and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm.</description>
          </group>
          <group group_id="O3">
            <title>JE - Conv</title>
            <description>Subjects received JE vaccine, conventional schedule, ie, placebo on days 1, 4, 8 and 29 in the right arm or leg, and JE vaccination on days 1 and 29 and placebo injection on day 8 in the left arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Kinetics of JE Immune Response Measured as Percentage of Subjects With PRNT50 Titers ≥1:10</title>
          <description>To evaluate the kinetics of antibody response to JE vaccine, the immunogenicity was measured as the percentage of subjects with PRNT50 titer ≥1:10 on days 1, 15, 22, 36, 57, 91, 181, and 366 (group that received JE vaccine as an accelerated schedule) and days 1, 36, 57, 181, and 366 (group that received JE vaccine as a conventional schedule).</description>
          <population>Analysis was done on the PP dataset.</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="165"/>
                <count group_id="O2" value="215"/>
                <count group_id="O3" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1" lower_limit="0" upper_limit="4"/>
                    <measurement group_id="O2" value="6" lower_limit="3" upper_limit="10"/>
                    <measurement group_id="O3" value="9" lower_limit="3" upper_limit="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 15 (N=0, 209, 0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">Analysis was not performed in this group at this timepoint.</measurement>
                    <measurement group_id="O2" value="99" lower_limit="96" upper_limit="100"/>
                    <measurement group_id="O3" value="NA" lower_limit="NA" upper_limit="NA">Analysis was not performed in this group at this timepoint.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 22 (N=0, 208, 0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">Analysis was not performed in this group at this timepoint.</measurement>
                    <measurement group_id="O2" value="100" lower_limit="97" upper_limit="100"/>
                    <measurement group_id="O3" value="NA" lower_limit="NA" upper_limit="NA">Analysis was not performed in this group at this timepoint.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 36 (157, 206, 47)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99" lower_limit="97" upper_limit="100"/>
                    <measurement group_id="O2" value="99" lower_limit="96" upper_limit="100"/>
                    <measurement group_id="O3" value="100" lower_limit="92" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 57 (N=157, 204, 49)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100" lower_limit="98" upper_limit="100"/>
                    <measurement group_id="O2" value="98" lower_limit="95" upper_limit="99"/>
                    <measurement group_id="O3" value="100" lower_limit="93" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 91 (N=0, 206, 0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">Analysis was not performed in this group at this timepoint.</measurement>
                    <measurement group_id="O2" value="98" lower_limit="95" upper_limit="99"/>
                    <measurement group_id="O3" value="NA" lower_limit="NA" upper_limit="NA">Analysis was not performed in this group at this timepoint.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 181 (N=155, 200, 49)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94" lower_limit="88" upper_limit="97"/>
                    <measurement group_id="O2" value="98" lower_limit="94" upper_limit="99"/>
                    <measurement group_id="O3" value="92" lower_limit="80" upper_limit="98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 366 (N=154, 199, 48)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86" lower_limit="79" upper_limit="91"/>
                    <measurement group_id="O2" value="94" lower_limit="90" upper_limit="97"/>
                    <measurement group_id="O3" value="88" lower_limit="75" upper_limit="95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Kinetics of JE Immune Response Measured as PRNT50 GMTs</title>
        <description>To evaluate the kinetics of antibody response to JE vaccine, the immunogenicity was measured as the PRNT50 GMTs on days 1, 15, 22, 36, 57, 91, 181, and 366 (group that received JE vaccine as an accelerated schedule) and days 1, 36, 57, 181, and 366 (group that received JE vaccine as a conventional schedule).</description>
        <time_frame>Day 1, 15, 22, 36, 57, 91, 181, and 366 (accelerated schedule) and day 1, 36, 57, 181, and 366 (conventional schedule)</time_frame>
        <population>Analysis was done on the PP dataset.</population>
        <group_list>
          <group group_id="O1">
            <title>R/JE - Conv</title>
            <description>Subjects received Rabies and JE vaccines, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.</description>
          </group>
          <group group_id="O2">
            <title>R/JE - Acc</title>
            <description>Subjects received Rabies and JE vaccines, accelerated schedule, ie, Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg, and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm.</description>
          </group>
          <group group_id="O3">
            <title>JE - Conv</title>
            <description>Subjects received JE vaccine, conventional schedule, ie, placebo on days 1, 4, 8 and 29 in the right arm or leg, and JE vaccination on days 1 and 29 and placebo injection on day 8 in the left arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Kinetics of JE Immune Response Measured as PRNT50 GMTs</title>
          <description>To evaluate the kinetics of antibody response to JE vaccine, the immunogenicity was measured as the PRNT50 GMTs on days 1, 15, 22, 36, 57, 91, 181, and 366 (group that received JE vaccine as an accelerated schedule) and days 1, 36, 57, 181, and 366 (group that received JE vaccine as a conventional schedule).</description>
          <population>Analysis was done on the PP dataset.</population>
          <units>Titers</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="165"/>
                <count group_id="O2" value="215"/>
                <count group_id="O3" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.13" lower_limit="4.84" upper_limit="5.43"/>
                    <measurement group_id="O2" value="5.63" lower_limit="5.35" upper_limit="5.92"/>
                    <measurement group_id="O3" value="5.73" lower_limit="5.2" upper_limit="6.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 15 (N=0, 209, 0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">Analysis was not performed in this group at this timepoint.</measurement>
                    <measurement group_id="O2" value="715" lower_limit="608" upper_limit="842"/>
                    <measurement group_id="O3" value="NA" lower_limit="NA" upper_limit="NA">Analysis was not performed in this group at this timepoint.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 22 (0, 208, 0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">Analysis was not performed in this group at this timepoint.</measurement>
                    <measurement group_id="O2" value="1255" lower_limit="1068" upper_limit="1475"/>
                    <measurement group_id="O3" value="NA" lower_limit="NA" upper_limit="NA">Analysis was not performed in this group at this timepoint.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 36 (N=157, 206, 47)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="292" lower_limit="247" upper_limit="346"/>
                    <measurement group_id="O2" value="690" lower_limit="595" upper_limit="801"/>
                    <measurement group_id="O3" value="376" lower_limit="277" upper_limit="510"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 57 (N= 157, 204, 49)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="299" lower_limit="254" upper_limit="352"/>
                    <measurement group_id="O2" value="372" lower_limit="322" upper_limit="430"/>
                    <measurement group_id="O3" value="337" lower_limit="252" upper_limit="451"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 91 (N=0, 206, 0)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA" lower_limit="NA" upper_limit="NA">Analysis was not performed in this group at this timepoint.</measurement>
                    <measurement group_id="O2" value="228" lower_limit="192" upper_limit="272"/>
                    <measurement group_id="O3" value="NA" lower_limit="NA" upper_limit="NA">Analysis was not performed in this group at this timepoint.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 181 (N=155, 200, 49)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63" lower_limit="53" upper_limit="75"/>
                    <measurement group_id="O2" value="151" lower_limit="130" upper_limit="176"/>
                    <measurement group_id="O3" value="64" lower_limit="47" upper_limit="87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 366 (N=154, 199, 48)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39" lower_limit="33" upper_limit="47"/>
                    <measurement group_id="O2" value="117" lower_limit="100" upper_limit="137"/>
                    <measurement group_id="O3" value="39" lower_limit="28" upper_limit="54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects Who Reported Solicited Local Adverse Events After Each Rabies Vaccination</title>
        <description>Safety was assessed as the number of subjects who reported solicited local adverse events (AEs) after each rabies vaccination given according to accelerated or conventional schedule as follows: from day 1 through day 7 (vaccination on day 1; all Rabies groups), day 4 through day 10 (vaccination on day 4; in R/JE - Acc group only), day 8 through day 14 (vaccination on day 8; all Rabies groups), or day 29 through day 35 (vaccination on day 29; R/JE - Conv and R - Conv groups).</description>
        <time_frame>Day 1 through day 7 after each vaccination (on day 1, 4, 8 and 29)</time_frame>
        <population>Analysis was done on the solicited safety set, i.e. the subjects in the exposed population who provided postvaccination solicited safety data.</population>
        <group_list>
          <group group_id="O1">
            <title>R/JE - Conv</title>
            <description>Subjects received Rabies and JE vaccines, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.</description>
          </group>
          <group group_id="O2">
            <title>R/JE - Acc</title>
            <description>Subjects received Rabies and JE vaccines, accelerated schedule, ie, Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg, and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm.</description>
          </group>
          <group group_id="O3">
            <title>R - Conv</title>
            <description>Subjects received Rabies vaccine, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and placebo on days 1, 8 and 29 in the left arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Who Reported Solicited Local Adverse Events After Each Rabies Vaccination</title>
          <description>Safety was assessed as the number of subjects who reported solicited local adverse events (AEs) after each rabies vaccination given according to accelerated or conventional schedule as follows: from day 1 through day 7 (vaccination on day 1; all Rabies groups), day 4 through day 10 (vaccination on day 4; in R/JE - Acc group only), day 8 through day 14 (vaccination on day 8; all Rabies groups), or day 29 through day 35 (vaccination on day 29; R/JE - Conv and R - Conv groups).</description>
          <population>Analysis was done on the solicited safety set, i.e. the subjects in the exposed population who provided postvaccination solicited safety data.</population>
          <units>Number of subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="166"/>
                <count group_id="O2" value="217"/>
                <count group_id="O3" value="220"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Erythema (day 1 to 7)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="31"/>
                    <measurement group_id="O3" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Induration (day 1 to 7)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="16"/>
                    <measurement group_id="O3" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain (day 1 to 7)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43"/>
                    <measurement group_id="O2" value="69"/>
                    <measurement group_id="O3" value="72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Erythema (day 4 to 10)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Subjects in this group received placebo at day 4</measurement>
                    <measurement group_id="O2" value="17"/>
                    <measurement group_id="O3" value="NA">Subjects in this group received placebo at day 4</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Induration (day 4 to 10)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Subjects in this group received placebo at day 4</measurement>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="NA">Subjects in this group received placebo at day 4</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain (day 4 to 10)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Subjects in this group received placebo at day 4</measurement>
                    <measurement group_id="O2" value="55"/>
                    <measurement group_id="O3" value="NA">Subjects in this group received placebo at day 4</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Erythema (day 8 to 14)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="31"/>
                    <measurement group_id="O3" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Induration (day 8 to 14)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="15"/>
                    <measurement group_id="O3" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain (day 8 to 14)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57"/>
                    <measurement group_id="O2" value="87"/>
                    <measurement group_id="O3" value="90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Erythema (day 29 to 35)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="NA">Subjects in this group received placebo at day 29</measurement>
                    <measurement group_id="O3" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Induration (day 29 to 35)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="NA">Subjects in this group received placebo at day 29</measurement>
                    <measurement group_id="O3" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain (day 29 to 35)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52"/>
                    <measurement group_id="O2" value="NA">Subjects in this group received placebo at day 29</measurement>
                    <measurement group_id="O3" value="87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects Who Reported Solicited Local AEs After Each JE Vaccination</title>
        <description>Safety was assessed as the number of subjects who reported solicited local AEs after each JE vaccination given according to accelerated or conventional schedule as follow: from day 1 through day 7 (vaccination on day 1; all JE groups), day 8 through day 14 (vaccination on day 8; R/JE - Acc group only), or day 29 through day 35 (vaccination on day 29; R/JE - Con and JE - Conv groups).</description>
        <time_frame>Day 1 through day 7 after each vaccination (on day 1, 8 and 29)</time_frame>
        <population>Analysis was done on the solicited safety set.</population>
        <group_list>
          <group group_id="O1">
            <title>R/JE - Conv</title>
            <description>Subjects received Rabies and JE vaccines, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.</description>
          </group>
          <group group_id="O2">
            <title>R/JE - Acc</title>
            <description>Subjects received Rabies and JE vaccines, accelerated schedule, ie, Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg, and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm.</description>
          </group>
          <group group_id="O3">
            <title>JE - Conv</title>
            <description>Subjects received JE vaccine, conventional schedule, ie, placebo on days 1, 4, 8 and 29 in the right arm or leg, and JE vaccination on days 1 and 29 and placebo injection on day 8 in the left arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Who Reported Solicited Local AEs After Each JE Vaccination</title>
          <description>Safety was assessed as the number of subjects who reported solicited local AEs after each JE vaccination given according to accelerated or conventional schedule as follow: from day 1 through day 7 (vaccination on day 1; all JE groups), day 8 through day 14 (vaccination on day 8; R/JE - Acc group only), or day 29 through day 35 (vaccination on day 29; R/JE - Con and JE - Conv groups).</description>
          <population>Analysis was done on the solicited safety set.</population>
          <units>Number of subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="166"/>
                <count group_id="O2" value="217"/>
                <count group_id="O3" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Erythema (day 1 to 7)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20"/>
                    <measurement group_id="O2" value="30"/>
                    <measurement group_id="O3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Induration (day 1 to 7)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="19"/>
                    <measurement group_id="O3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain (day 1 to 7)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82"/>
                    <measurement group_id="O2" value="102"/>
                    <measurement group_id="O3" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Erythema (day 8 to 14)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Subjects in this group didn't receive JE vaccination on day 8.</measurement>
                    <measurement group_id="O2" value="18"/>
                    <measurement group_id="O3" value="NA">Subjects in this group didn't receive JE vaccination on day 8.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Induration (day 8 to 14)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Subjects in this group didn't receive JE vaccination on day 8.</measurement>
                    <measurement group_id="O2" value="12"/>
                    <measurement group_id="O3" value="NA">Subjects in this group didn't receive JE vaccination on day 8.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain (day 8 to 14)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Subjects in this group didn't receive JE vaccination on day 8.</measurement>
                    <measurement group_id="O2" value="60"/>
                    <measurement group_id="O3" value="NA">Subjects in this group didn't receive JE vaccination on day 8.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Erythema (day 29 to 35)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="NA">Subjects in this group didn't receive JE vaccination on day 29.</measurement>
                    <measurement group_id="O3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Induration (day 29 to 35)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="NA">Subjects in this group didn't receive JE vaccination on day 29.</measurement>
                    <measurement group_id="O3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain (day 29 to 35)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46"/>
                    <measurement group_id="O2" value="NA">Subjects in this group didn't receive JE vaccination on day 29.</measurement>
                    <measurement group_id="O3" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection</title>
        <description>Safety was assessed as the number of subjects who reported solicited local AEs after each placebo injection given according to accelerated and conventional schedule as follow: from day 1 through day 7 (injection on day 1; R - Conv and JE - Conv groups), day 4 through day 10 (injection on day 4; in R/JE - Conv, R - Conv and JE - Conv groups), day 8 through day 14 (injection on day 8; in R/JE - Conv, R - Conv and JE - Conv groups), and day 29 through day 35 (injection on day 29; R/JE - Acc, R - Con and JE - Conv groups).</description>
        <time_frame>Day 1 through day 7 after each injection (day 1, 4, 8 and 29)</time_frame>
        <population>Analysis was done on the solicited safety set.</population>
        <group_list>
          <group group_id="O1">
            <title>R/JE - Conv</title>
            <description>Subjects received Rabies and JE vaccines, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.</description>
          </group>
          <group group_id="O2">
            <title>R/JE - Acc</title>
            <description>Subjects received Rabies and JE vaccines, accelerated schedule, ie, Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg, and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm.</description>
          </group>
          <group group_id="O3">
            <title>R - Conv</title>
            <description>Subjects received Rabies vaccine, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and placebo on days 1, 8 and 29 in the left arm.</description>
          </group>
          <group group_id="O4">
            <title>JE - Conv</title>
            <description>Subjects received JE vaccine, conventional schedule, ie, placebo on days 1, 4, 8 and 29 in the right arm or leg, and JE vaccination on days 1 and 29 and placebo injection on day 8 in the left arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection</title>
          <description>Safety was assessed as the number of subjects who reported solicited local AEs after each placebo injection given according to accelerated and conventional schedule as follow: from day 1 through day 7 (injection on day 1; R - Conv and JE - Conv groups), day 4 through day 10 (injection on day 4; in R/JE - Conv, R - Conv and JE - Conv groups), day 8 through day 14 (injection on day 8; in R/JE - Conv, R - Conv and JE - Conv groups), and day 29 through day 35 (injection on day 29; R/JE - Acc, R - Con and JE - Conv groups).</description>
          <population>Analysis was done on the solicited safety set.</population>
          <units>Number of Subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="163"/>
                <count group_id="O2" value="213"/>
                <count group_id="O3" value="220"/>
                <count group_id="O4" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Erythema (day 1 to 7)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Subjects in this group didn't receive placebo at day 1.</measurement>
                    <measurement group_id="O2" value="NA">Subjects in this group didn't receive placebo at day 1.</measurement>
                    <measurement group_id="O3" value="20"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Induration (day 1 to 7)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Subjects in this group didn't receive placebo at day 1.</measurement>
                    <measurement group_id="O2" value="NA">Subjects in this group didn't receive placebo at day 1.</measurement>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain (day 1 to 7)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Subjects in this group didn't receive placebo at day 1.</measurement>
                    <measurement group_id="O2" value="NA">Subjects in this group didn't receive placebo at day 1.</measurement>
                    <measurement group_id="O3" value="26"/>
                    <measurement group_id="O4" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Erythema (day 4 to 10)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="NA">Subjects in this group didn't receive placebo at day 4.</measurement>
                    <measurement group_id="O3" value="13"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Induration (day 4 to 10)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="NA">Subjects in this group didn't receive placebo at day 4.</measurement>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain (day 4 to 10)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="NA">Subjects in this group didn't receive placebo at day 4.</measurement>
                    <measurement group_id="O3" value="15"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Erythema (day 8 to 14)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="NA">Subjects in this group didn't receive placebo at day 8.</measurement>
                    <measurement group_id="O3" value="11"/>
                    <measurement group_id="O4" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Erythema (day 8 to 14 after 2nd Placebo dose)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Subjects in this group received only 1 dose of placebo at day 8.</measurement>
                    <measurement group_id="O2" value="NA">Subjects in this group didn't receive placebo at day 8.</measurement>
                    <measurement group_id="O3" value="NA">Subjects in this group received only 1 dose of placebo at day 8.</measurement>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Induration (day 8 to 14)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="NA">Subjects in this group didn't receive placebo at day 8.</measurement>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Induration (day 8 to 14 after 2nd Placebo dose)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Subjects in this group received only 1 dose of placebo at day 8.</measurement>
                    <measurement group_id="O2" value="NA">Subjects in this group didn't receive placebo at day 8.</measurement>
                    <measurement group_id="O3" value="NA">Subjects in this group received only 1 dose of placebo at day 8.</measurement>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain (day 8 to 14)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="NA">Subjects in this group didn't receive placebo at day 8.</measurement>
                    <measurement group_id="O3" value="20"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain (day 8 to 14 after 2nd Placebo dose)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Subjects in this group received only 1 dose of placebo at day 8.</measurement>
                    <measurement group_id="O2" value="NA">Subjects in this group didn't receive placebo at day 8.</measurement>
                    <measurement group_id="O3" value="NA">Subjects in this group received only 1 dose of placebo at day 8.</measurement>
                    <measurement group_id="O4" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Erythema (day 29 to 35)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Subjects in this group didn't receive placebo at day 29.</measurement>
                    <measurement group_id="O2" value="15"/>
                    <measurement group_id="O3" value="15"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Erythema (day 29 to 35 after 2nd Placebo dose)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Subjects in this group didn't receive placebo at day 29.</measurement>
                    <measurement group_id="O2" value="14"/>
                    <measurement group_id="O3" value="NA">Subjects in this group received only 1 dose of placebo at day 29.</measurement>
                    <measurement group_id="O4" value="NA">Subjects in this group received only 1 dose of placebo at day 29.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Induration (day 29 to 35)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Subjects in this group didn't receive placebo at day 29.</measurement>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Induration (day 29 to 35 after 2nd Placebo dose)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Subjects in this group didn't receive placebo at day 29.</measurement>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="NA">Subjects in this group received only 1 dose of placebo at day 29.</measurement>
                    <measurement group_id="O4" value="NA">Subjects in this group received only 1 dose of placebo at day 29.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain (day 29 to 35)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Subjects in this group didn't receive placebo at day 29.</measurement>
                    <measurement group_id="O2" value="15"/>
                    <measurement group_id="O3" value="28"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain (day 29 to 35 after 2nd Placebo dose)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="NA">Subjects in this group didn't receive placebo at day 29.</measurement>
                    <measurement group_id="O2" value="19"/>
                    <measurement group_id="O3" value="NA">Subjects in this group received only 1 dose of placebo at day 29.</measurement>
                    <measurement group_id="O4" value="NA">Subjects in this group received only 1 dose of placebo at day 29.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination</title>
        <description>Safety was assessed as the number of subjects who reported solicited systemic AEs and other indicators of reactogenicity after each vaccination given according to accelerated and conventional schedule.</description>
        <time_frame>Day 1 through day 7 after each vaccination (day 1, 4, 8 and 29)</time_frame>
        <population>Analysis was done on the solicited safety set.</population>
        <group_list>
          <group group_id="O1">
            <title>R/JE - Conv</title>
            <description>Subjects received Rabies and JE vaccines, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.</description>
          </group>
          <group group_id="O2">
            <title>R/JE - Acc</title>
            <description>Subjects received Rabies and JE vaccines, accelerated schedule, ie, Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg, and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm.</description>
          </group>
          <group group_id="O3">
            <title>R - Conv</title>
            <description>Subjects received Rabies vaccine, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and placebo on days 1, 8 and 29 in the left arm.</description>
          </group>
          <group group_id="O4">
            <title>JE - Conv</title>
            <description>Subjects received JE vaccine, conventional schedule, ie, placebo on days 1, 4, 8 and 29 in the right arm or leg, and JE vaccination on days 1 and 29 and placebo injection on day 8 in the left arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination</title>
          <description>Safety was assessed as the number of subjects who reported solicited systemic AEs and other indicators of reactogenicity after each vaccination given according to accelerated and conventional schedule.</description>
          <population>Analysis was done on the solicited safety set.</population>
          <units>Number of Subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="166"/>
                <count group_id="O2" value="217"/>
                <count group_id="O3" value="220"/>
                <count group_id="O4" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Fatigue (day 1 to 7)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39"/>
                    <measurement group_id="O2" value="56"/>
                    <measurement group_id="O3" value="46"/>
                    <measurement group_id="O4" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Headache (day 1 to 7)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35"/>
                    <measurement group_id="O2" value="46"/>
                    <measurement group_id="O3" value="38"/>
                    <measurement group_id="O4" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Myalgia (day 1 to 7)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                    <measurement group_id="O2" value="55"/>
                    <measurement group_id="O3" value="31"/>
                    <measurement group_id="O4" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Arthralgia (day 1 to 7)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="13"/>
                    <measurement group_id="O3" value="7"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Loss of Appetite (day1 to day 7)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="12"/>
                    <measurement group_id="O4" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Nausea (day1 to day 7)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="13"/>
                    <measurement group_id="O4" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Body temperature (≥38 °C, day 1 to day 7)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Analgesic/Antipyretic used (day 1 to day 7)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="11"/>
                    <measurement group_id="O3" value="8"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fatigue (day 4 to 10)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="30"/>
                    <measurement group_id="O3" value="33"/>
                    <measurement group_id="O4" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Headache (day 4 to 10)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="28"/>
                    <measurement group_id="O3" value="29"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Myalgia (day 4 to 10)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="19"/>
                    <measurement group_id="O3" value="14"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Arthralgia (day 4 to 10)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="9"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Loss of Appetite (day4 to day 10)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="9"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Nausea (day4 to day 10)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="8"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Body temperature (≥38 °C, day 4 to day 10)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Analgesic/Antipyretic used (day 4 to 10)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="15"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fatigue (day 8 to 14)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24"/>
                    <measurement group_id="O2" value="47"/>
                    <measurement group_id="O3" value="47"/>
                    <measurement group_id="O4" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Headache (day 8 to 14)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33"/>
                    <measurement group_id="O2" value="43"/>
                    <measurement group_id="O3" value="41"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Myalgia (day 8 to 14)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="41"/>
                    <measurement group_id="O3" value="38"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Arthralgia (day 8 to 14)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="13"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Loss of Appetite (day8 to day 14)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="14"/>
                    <measurement group_id="O3" value="13"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Nausea (day8 to day 14)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="14"/>
                    <measurement group_id="O3" value="16"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Body temperature (≥38 °C, day 8 to 14)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Analgesic/Antipyretic used (day 8 to 14)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="17"/>
                    <measurement group_id="O3" value="20"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fatigue (day 29 to 35)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="29"/>
                    <measurement group_id="O3" value="36"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Headache (day 29 to 35)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27"/>
                    <measurement group_id="O2" value="22"/>
                    <measurement group_id="O3" value="40"/>
                    <measurement group_id="O4" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Myalgia (day 29 to 35)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="15"/>
                    <measurement group_id="O3" value="28"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Arthralgia (day 29 to 35)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="14"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Body temperature (≥38 °C, day 29 to day 35)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Analgesic/Antipyretic used (day 29 to day 35)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="10"/>
                    <measurement group_id="O3" value="11"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Loss if appetite (day 29 to day 25)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="8"/>
                    <measurement group_id="O3" value="9"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>nausea (day29 to day 25)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="12"/>
                    <measurement group_id="O3" value="9"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Numbers of Subjects Reporting Unsolicited AEs After Any Vaccination From Day 1 Through Day 57</title>
        <description>Safety was assessed as the number of subjects who reported unsolicited AEs after any vaccination given according to accelerated and conventional schedule.</description>
        <time_frame>Day 1 through Day 57</time_frame>
        <population>Analysis was done on the unsolicited safety set, ie, the subjects in the exposed population who provided postvaccination unsolicited safety data.</population>
        <group_list>
          <group group_id="O1">
            <title>R/JE - Conv</title>
            <description>Subjects received Rabies and JE vaccines, conventional schedule, i.e. Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg; and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.</description>
          </group>
          <group group_id="O2">
            <title>R/JE - Acc</title>
            <description>Subjects received Rabies and JE vaccines, accelerated schedule, i.e. Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg; and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm.</description>
          </group>
          <group group_id="O3">
            <title>R - Conv</title>
            <description>Subjects received Rabies vaccine, conventional schedule, i.e. Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg; and placebo on days 1, 8 and 29 in the left arm.</description>
          </group>
          <group group_id="O4">
            <title>JE - Conv</title>
            <description>Subjects received JE vaccine, conventional schedule, i.e. placebo on days 1, 4, 8 and 29 in the right arm or leg; and JE vaccination on days 1 and 29 and placebo injection on day 8 in the left arm.</description>
          </group>
        </group_list>
        <measure>
          <title>Numbers of Subjects Reporting Unsolicited AEs After Any Vaccination From Day 1 Through Day 57</title>
          <description>Safety was assessed as the number of subjects who reported unsolicited AEs after any vaccination given according to accelerated and conventional schedule.</description>
          <population>Analysis was done on the unsolicited safety set, ie, the subjects in the exposed population who provided postvaccination unsolicited safety data.</population>
          <units>Number of subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="166"/>
                <count group_id="O2" value="217"/>
                <count group_id="O3" value="220"/>
                <count group_id="O4" value="56"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any AE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="69"/>
                    <measurement group_id="O2" value="108"/>
                    <measurement group_id="O3" value="110"/>
                    <measurement group_id="O4" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AEs leading to premature withdrawal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Solicited AEs were collected for 7 days after each vaccination. All unsolicited AEs, serious adverse events (SAEs), AEs leading to study and/or treatment withdrawal were collected through day 57. From day 57 to day 366 vaccine-related SAEs were collected.</time_frame>
      <desc>Solicited adverse events were collected by systematic assessment, unsolicited AEs by non-systematic assessment. SAEs analysis was done one the unsolicited safety set, other AEs analysis was done on the overall safety set.</desc>
      <group_list>
        <group group_id="E1">
          <title>R/JE - Conv</title>
          <description>Subjects received Rabies and JE vaccines, conventional schedule, i.e. Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg; and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.</description>
        </group>
        <group group_id="E2">
          <title>R/JE - Acc</title>
          <description>Subjects received Rabies and JE vaccines, accelerated schedule, i.e. Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg; and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm.</description>
        </group>
        <group group_id="E3">
          <title>R - Conv</title>
          <description>Subjects received Rabies vaccine, conventional schedule, i.e. Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg; and placebo on days 1, 8 and 29 in the left arm.</description>
        </group>
        <group group_id="E4">
          <title>JE - Conv</title>
          <description>Subjects received JE vaccine, conventional schedule, i.e. placebo on days 1, 4, 8 and 29 in the right arm or leg; and JE vaccination on days 1 and 29 and placebo injection on day 8 in the left arm.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (17.0)</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="2" subjects_at_risk="166"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="217"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="220"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>ATRIAL FIBRILLATION</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="166"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="220"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>TACHYCARDIA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="166"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="220"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>EYELID OEDEMA</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="166"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>PANCREATITIS ACUTE</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="166"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>CHOLECYSTITIS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="166"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>CHOLELITHIASIS</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="166"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>HUMERUS FRACTURE</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="166"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>MENISCUS INJURY</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="166"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>OVARIAN GERM CELL TERATOMA BENIGN</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="166"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="217"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>SYNCOPE</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="166"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="220"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>ALCOHOL WITHDRAWAL SYNDROME</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="166"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>DEPRESSION</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="166"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>PRURITUS GENERALISED</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="166"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="217"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="220"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (17.0)</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="138" subjects_at_risk="166"/>
                <counts group_id="E2" subjects_affected="186" subjects_at_risk="217"/>
                <counts group_id="E3" subjects_affected="185" subjects_at_risk="220"/>
                <counts group_id="E4" subjects_affected="45" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>NAUSEA</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="166"/>
                <counts group_id="E2" subjects_affected="31" subjects_at_risk="217"/>
                <counts group_id="E3" subjects_affected="35" subjects_at_risk="220"/>
                <counts group_id="E4" subjects_affected="9" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>FATIGUE</sub_title>
                <counts group_id="E1" subjects_affected="54" subjects_at_risk="166"/>
                <counts group_id="E2" subjects_affected="93" subjects_at_risk="217"/>
                <counts group_id="E3" subjects_affected="84" subjects_at_risk="220"/>
                <counts group_id="E4" subjects_affected="19" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>INJECTION SITE ERYTHEMA</sub_title>
                <counts group_id="E1" subjects_affected="48" subjects_at_risk="166"/>
                <counts group_id="E2" subjects_affected="73" subjects_at_risk="217"/>
                <counts group_id="E3" subjects_affected="85" subjects_at_risk="220"/>
                <counts group_id="E4" subjects_affected="13" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>INJECTION SITE INDURATION</sub_title>
                <counts group_id="E1" subjects_affected="29" subjects_at_risk="166"/>
                <counts group_id="E2" subjects_affected="43" subjects_at_risk="217"/>
                <counts group_id="E3" subjects_affected="48" subjects_at_risk="220"/>
                <counts group_id="E4" subjects_affected="10" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>INJECTION SITE PAIN</sub_title>
                <counts group_id="E1" subjects_affected="115" subjects_at_risk="166"/>
                <counts group_id="E2" subjects_affected="146" subjects_at_risk="217"/>
                <counts group_id="E3" subjects_affected="131" subjects_at_risk="220"/>
                <counts group_id="E4" subjects_affected="31" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>NASOPHARYNGITIS</sub_title>
                <assessment>Non-systematic Assessment</assessment>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="166"/>
                <counts group_id="E2" subjects_affected="33" subjects_at_risk="217"/>
                <counts group_id="E3" subjects_affected="32" subjects_at_risk="220"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="56"/>
              </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="19" subjects_at_risk="166"/>
                <counts group_id="E2" subjects_affected="24" subjects_at_risk="217"/>
                <counts group_id="E3" subjects_affected="27" subjects_at_risk="220"/>
                <counts group_id="E4" subjects_affected="9" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>ARTHRALGIA</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="166"/>
                <counts group_id="E2" subjects_affected="29" subjects_at_risk="217"/>
                <counts group_id="E3" subjects_affected="31" subjects_at_risk="220"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="56"/>
              </event>
              <event>
                <sub_title>MYALGIA</sub_title>
                <counts group_id="E1" subjects_affected="50" subjects_at_risk="166"/>
                <counts group_id="E2" subjects_affected="75" subjects_at_risk="217"/>
                <counts group_id="E3" subjects_affected="60" subjects_at_risk="220"/>
                <counts group_id="E4" subjects_affected="10" subjects_at_risk="56"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>HEADACHE</sub_title>
                <counts group_id="E1" subjects_affected="63" subjects_at_risk="166"/>
                <counts group_id="E2" subjects_affected="94" subjects_at_risk="217"/>
                <counts group_id="E3" subjects_affected="95" subjects_at_risk="220"/>
                <counts group_id="E4" subjects_affected="19" subjects_at_risk="56"/>
              </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 only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Posting Director</name_or_title>
      <organization>Novartis Vaccines</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/NCT01662440
org study id: V49_23
secondary id: 2011-005173-23
nct id: NCT01662440
lead sponsor: 
has dmc: No
Establish non-inferiority of the immune response and evaluate the safety and tolerability of
      Rabies and Japanese Encephalitis (JE) vaccines given concomitantly or alone and according to
      either of 2 schedules for preexposure prophylaxis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Percentages of Subjects With RVNA Concentrations ≥0.5 IU/mL At 7 Days After Last Active Vaccination
time frame: Day 7 after last active vaccination (day 15 - group that received accelerated schedule, day 36 - group that received conventional schedule)
description: Immune response was measured as the percentage of subjects with rabies virus neutralizing antibody (RVNA) concentrations ≥0.5 IU/mL, evaluated using the rapid fluorescent focus inhibition test at day 7 after last active vaccination, i.e. the third out of four vaccinations given in the accelerated Rabies vaccine schedule and the fourth out of four vaccinations given in the conventional Rabies vaccine schedule.
As per study design, this primary immunogenicity outcome measure aimed to demonstrate non-inferiority of R/JE - Acc Vs R - Conv.
measure: Percentages of Subjects With PRNT50 Titer ≥1:10 At 28 Days After Last Active Vaccination
time frame: Day 28 after last active vaccination (day 36 - group that received accelerated schedule, day 57 - group that received conventional schedule)
description: Immune response was measured as the percentages of subjects with a titer of ≥1:10 in a 50% plaque reduction neutralization test (PRNT50) 28 days after last active vaccination, ie, the second out of three vaccinations given in the accelerated JE vaccine schedule and the third out of three vaccinations given in the conventional JE vaccine schedule.
As per study design, this primary immunogenicity outcome measure aimed to demonstrate non-inferiority of R/JE - Acc Vs JE - Conv.
measure: RVNA Geometric Mean Concentrations (GMCs) At 28 Days After Last Active Vaccination
time frame: Day 57 (28 days after last active vaccination)
description: Immune response was measured as the RVNA GMCs 28 days after last active vaccination, ie, day 57 for all groups that received the conventional schedule.
Data were adjusted using ANOVA model, as per protocol specification.
measure: PRNT50 Geometric Mean Titers (GMTs) At 28 Days After Last Active Vaccination
time frame: Day 57 (28 days after last active vaccination)
description: Immune response was measured as the PRNT50 GMTs 28 days after last active vaccination, ie, day 57 for all groups that received the conventional schedule.
Data were adjusted using ANOVA model, as per protocol specifications.
measure: Percentages of Subjects With RVNA Concentrations ≥0.5 IU/mL At 28 Days After Last Active Vaccination
time frame: Day 36 and day 57 (28 days after last active vaccination)
description: Immune response was measured as the percentages of subjects with RVNA concentration ≥0.5 IU/mL 28 days after last active vaccination, ie, day 36 for the group that received the accelerated schedule and day 57 for the group that received the conventional schedule.
As per study design, this secondary immunogenicity outcome measure aimed to demonstrate non-inferiority of R/JE - Acc Vs R - Conv.
measure: Percentage of Subjects With PRNT50 Titer ≥1:10 At 7 Days After Last Active Vaccination
time frame: Day 15 and day 36 (28 after last active vaccination)
description: Immune response was measured as the percentage of subjects with PRNT50 titer of ≥1:10 7 days after last active vaccination, ie, day 15 for the group that received the accelerated schedule and day 36 for the group that received the conventional schedule.
As per study design, this secondary immunogenicity outcome measure aimed to demonstrate non-inferiority of R/JE - Acc Vs JE - Conv.
measure: Kinetics of Rabies Immune Response Measured as Percentage of Subjects With RVNA Concentration ≥0.5 IU/mL
time frame: Day 1, 8, 15, 36, 57, 91, 181 and Day 366
description: To evaluate the kinetics of antibody response to Rabies vaccine, the immunogenicity was measured as the percentage of subjects with RVNA concentrations ≥0.5 IU/mL on days 1, 8, 15, 36, 57, 91, 181, and 366.
measure: Kinetics of Rabies Immune Response Measured as the RVNA GMCs
time frame: Day 1, 8, 15, 36, 57, 91, 181, and 366
description: To evaluate the kinetics of antibody response to Rabies vaccine, the immunogenicity was measured as the RVNA GMCs on days 1, 8, 15, 36, 57, 91, 181, and 366.
measure: Kinetics of JE Immune Response Measured as Percentage of Subjects With PRNT50 Titers ≥1:10
time frame: Days 1, 15, 22, 36, 57, 91, 181 and 366
description: To evaluate the kinetics of antibody response to JE vaccine, the immunogenicity was measured as the percentage of subjects with PRNT50 titer ≥1:10 on days 1, 15, 22, 36, 57, 91, 181, and 366 (group that received JE vaccine as an accelerated schedule) and days 1, 36, 57, 181, and 366 (group that received JE vaccine as a conventional schedule).
measure: Kinetics of JE Immune Response Measured as PRNT50 GMTs
time frame: Day 1, 15, 22, 36, 57, 91, 181, and 366 (accelerated schedule) and day 1, 36, 57, 181, and 366 (conventional schedule)
description: To evaluate the kinetics of antibody response to JE vaccine, the immunogenicity was measured as the PRNT50 GMTs on days 1, 15, 22, 36, 57, 91, 181, and 366 (group that received JE vaccine as an accelerated schedule) and days 1, 36, 57, 181, and 366 (group that received JE vaccine as a conventional schedule).
measure: Number of Subjects Who Reported Solicited Local Adverse Events After Each Rabies Vaccination
time frame: Day 1 through day 7 after each vaccination (on day 1, 4, 8 and 29)
description: Safety was assessed as the number of subjects who reported solicited local adverse events (AEs) after each rabies vaccination given according to accelerated or conventional schedule as follows: from day 1 through day 7 (vaccination on day 1; all Rabies groups), day 4 through day 10 (vaccination on day 4; in R/JE - Acc group only), day 8 through day 14 (vaccination on day 8; all Rabies groups), or day 29 through day 35 (vaccination on day 29; R/JE - Conv and R - Conv groups).
measure: Number of Subjects Who Reported Solicited Local AEs After Each JE Vaccination
time frame: Day 1 through day 7 after each vaccination (on day 1, 8 and 29)
description: Safety was assessed as the number of subjects who reported solicited local AEs after each JE vaccination given according to accelerated or conventional schedule as follow: from day 1 through day 7 (vaccination on day 1; all JE groups), day 8 through day 14 (vaccination on day 8; R/JE - Acc group only), or day 29 through day 35 (vaccination on day 29; R/JE - Con and JE - Conv groups).
measure: Number of Subjects Who Reported Solicited Local AEs After Each Placebo Injection
time frame: Day 1 through day 7 after each injection (day 1, 4, 8 and 29)
description: Safety was assessed as the number of subjects who reported solicited local AEs after each placebo injection given according to accelerated and conventional schedule as follow: from day 1 through day 7 (injection on day 1; R - Conv and JE - Conv groups), day 4 through day 10 (injection on day 4; in R/JE - Conv, R - Conv and JE - Conv groups), day 8 through day 14 (injection on day 8; in R/JE - Conv, R - Conv and JE - Conv groups), and day 29 through day 35 (injection on day 29; R/JE - Acc, R - Con and JE - Conv groups).
measure: Number of Subjects Who Reported Solicited Systemic AEs and Other Indicators of Reactogenicity After Each Vaccination
time frame: Day 1 through day 7 after each vaccination (day 1, 4, 8 and 29)
description: Safety was assessed as the number of subjects who reported solicited systemic AEs and other indicators of reactogenicity after each vaccination given according to accelerated and conventional schedule.
measure: Numbers of Subjects Reporting Unsolicited AEs After Any Vaccination From Day 1 Through Day 57
time frame: Day 1 through Day 57
description: Safety was assessed as the number of subjects who reported unsolicited AEs after any vaccination given according to accelerated and conventional schedule.
arm group label: R/JE - Conv
arm group type: Active Comparator
description: Subjects received Rabies and Japanese Encephalitis (JE) vaccines following the conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg; and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.
arm group label: R/JE - Acc
arm group type: Experimental
description: Subjects received Rabies and JE vaccines following the accelerated schedule, ie, Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg; and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm.
arm group label: R - Conv
arm group type: Active Comparator
description: Subjects received Rabies vaccine following the conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg; and placebo on days 1, 8 and 29 in the left arm.
arm group label: JE - Conv
arm group type: Active Comparator
description: Subjects received JE vaccine following the conventional schedule, ie, placebo on days 1, 4, 8 and 29 in the right arm or leg; and JE vaccination on days 1 and 29 and placebo injection on day 8 in the left arm.
intervention type: Biological
intervention name: Rabies
description: Subjects received three doses of Rabies, whole virus vaccine (inactivated, Germany).
arm group label: R - Conv
arm group label: R/JE - Acc
arm group label: R/JE - Conv
intervention type: Biological
intervention name: Japanese Encephalitis
description: Subjects received two doses of Japanese Encephalitis vaccine.
arm group label: JE - Conv
arm group label: R/JE - Acc
arm group label: R/JE - Conv
intervention type: Other
intervention name: Placebo
description: Subjects received either two, three, four or five doses of normal saline, 0.9% w/v sodium chloride depending on the vaccine group.
arm group label: JE - Conv
arm group label: R - Conv
arm group label: R/JE - Acc
arm group label: R/JE - Conv
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Novartis Vaccines and Diagnostics
role: Study Chair
affiliation: Novartis Vaccines
facility: 
facility: 
facility: 
country: Austria
country: Germany
country: Switzerland
responsible party type: Sponsor
mesh term: Rabies
mesh term: Encephalitis, Japanese
mesh term: Encephalitis
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 