<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/NCT02193087</url>
  </required_header>
  <id_info>
    <org_study_id>DEN-106</org_study_id>
    <secondary_id>U1111-1154-9746</secondary_id>
    <nct_id>NCT02193087</nct_id>
  </id_info>
  <brief_title>Safety and Immunogenicity of Three Formulations of Takeda's Tetravalent Dengue Vaccine Candidate (TDV)</brief_title>
  <official_title>A Randomized, Double Blind, Phase 2 Study to Assess the Safety and Immunogenicity of Three Formulations of Takeda's Tetravalent Dengue Vaccine Candidate (TDV) in Healthy Adults</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Takeda</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Takeda</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the equivalence of the lyophilized formulation of&#xD;
      Takeda's Tetravalent Dengue Vaccine Candidate (TDV) compared with the liquid formulation of&#xD;
      TDV.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The vaccine being tested in this study is Takeda's Tetravalent Dengue Vaccine Candidate&#xD;
      (TDV). This study is designed to determine whether the lyophilized formulation provides&#xD;
      equivalent safety and immunogenicity as the original liquid formulation. An exploratory&#xD;
      analysis has been added for the purpose of understanding whether there is a manufacturing or&#xD;
      formulation effect on the vaccine.&#xD;
&#xD;
      The study will enroll approximately 1000 participants. Participants will be randomly assigned&#xD;
      (by chance, like flipping a coin) to one of the four study groups-which will remain&#xD;
      undisclosed to the participant and study doctor during the study (unless there is an urgent&#xD;
      medical need):&#xD;
&#xD;
        -  Group A: TDV Liquid Formulation 1, subcutaneous (SC) injection on Day 1 and placebo&#xD;
           (dummy) SC at Month 3 - this is a liquid that looks like the study drug but has no&#xD;
           active ingredient&#xD;
&#xD;
        -  Group B: TDV Liquid Formulation 1, SC injection Day 1 and Month 3&#xD;
&#xD;
        -  Group C: TDV Liquid Formulation 2, SC injection Day 1 and Month 3&#xD;
&#xD;
        -  Group D: TDV Lyophilized formulation SC injection Day 1 and Month 3&#xD;
&#xD;
      In order to keep the treatment arms undisclosed to the participant and the doctor,&#xD;
      participants will receive a placebo injection at any study visit where TDV is not being&#xD;
      administered (Month 3). Participants will be asked to record any adverse events that may be&#xD;
      related to the vaccine or the injection in a diary card for 28 days after each vaccination.&#xD;
&#xD;
      This multi-center trial will be conducted in the United States. The overall time to&#xD;
      participate in this study is up to 10 months. Participants will make 9 visits to the clinic&#xD;
      including a final visit 1 month after last dose of study drug for a follow-up assessment. A&#xD;
      follow up phone call will be done 6 months after the last dose to assess serious adverse&#xD;
      events.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 6, 2014</start_date>
  <completion_date type="Actual">May 19, 2015</completion_date>
  <primary_completion_date type="Actual">May 19, 2015</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Geometric Mean Titer (GMT) of Neutralizing Antibodies for Each of the Four Dengue Serotypes Comparing Group D To Groups A and B Combined</measure>
    <time_frame>Month 1</time_frame>
    <description>Geometric mean titer (GMT) of neutralizing antibodies for each of the four dengue serotypes as measured by Plaque Reduction Neutralization Test resulting in 50% reduction in Plaques (PRNT50). The four dengue serotypes are DEN-1, DEN-2, DEN-3 and DEN-4.&#xD;
A 90% Confidence Interval (CI) for the ratio of GMT (or equivalently the difference of the log transformed GMT) was provided, for each serotype, for the comparison of the lyophilized formulation (Group D) versus the liquid formulation 1 (Groups A+B combined). An Analysis of Variance (ANOVA) model for the natural log-transformed GMT at month 1 with study group as a factor was used for analysis.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Geometric Mean Titers (GMT) of Neutralizing Antibodies for Each of the Four Dengue Serotypes Comparing Group D With Group B</measure>
    <time_frame>Months 1 and 4</time_frame>
    <description>Geometric mean titer (GMT) of neutralizing antibodies for each of the four dengue serotypes as measured by Plaque Reduction Neutralization Test resulting in 50% reduction in Plaques (PRNT50). The four dengue serotypes are DEN-1, DEN-2, DEN-3 and DEN-4. ANOVA model for the natural log-transformed GMT at month 1 with study group as a factor was used for analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With a Seropositive Response for Each of the Four Dengue Serotypes Comparing Group D With Groups A and B Combined</measure>
    <time_frame>Month 1</time_frame>
    <description>A seropositive response is defined as a reciprocal neutralizing titer ≥ 10. The four dengue serotypes are DEN-1, DEN-2, DEN-3 and DEN-4.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With a Seropositive Response for Each of the Four Dengue Serotypes Comparing Group D With Group B</measure>
    <time_frame>Months 1 and 4</time_frame>
    <description>A seropositive response is defined as a reciprocal neutralizing titer ≥ 10. The four dengue serotypes are DEN-1, DEN-2, DEN-3 and DEN-4.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs)</measure>
    <time_frame>Days 1 through 7 after each vaccination</time_frame>
    <description>Solicited local AEs at injection site are defined as pain, erythema and swelling that occurred at least once within 7 days after either vaccination, as recorded by the participants in a diary. Percentages are based on the number of participants with diary data available.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Solicited Systemic Adverse Events (AEs)</measure>
    <time_frame>Days 1 through 14 after each vaccination</time_frame>
    <description>Solicited systemic AEs are defined as asthenia, fever, headache, malaise, and myalgia that occurred at least once within 14 days after either vaccination, as recorded by the participants in a diary. Percentages are based on the number of participants with diary data available.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity</measure>
    <time_frame>Days 1 through 7 after each vaccination</time_frame>
    <description>The percentage of participants with solicited local AEs at injection site of varying severity are reported. Solicited local AEs are defined as pain, erythema and swelling that occurred at least once within 7 days after either vaccination, as recorded by the participants in a diary. Participants with multiple episodes are categorized using the highest severity level. Percentages are based on the number of participants with diary data available.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity</measure>
    <time_frame>Days 1 through 14 after each vaccination</time_frame>
    <description>The percentage of participants with solicited systemic AEs of varying severity are reported. Solicited systemic AEs are defined as asthenia, fever, headache, malaise, and myalgia that occurred at least once within 14 days after either vaccination, as recorded by the participants in a diary. Participants with multiple episodes are categorized using the highest severity level. Percentages are based on the number of participants with diary data available.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Any Unsolicited Adverse Events (AEs)</measure>
    <time_frame>Up to Day 28 after each vaccination</time_frame>
    <description>Unsolicited AEs are any AEs that are not solicited local or systemic AEs, as defined by this study, that occurred at least once within 28 days after either vaccination. An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. The investigator assessed whether the AE was related to the study vaccination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Serious Adverse Events (SAEs)</measure>
    <time_frame>Up to 6 Months after the last dose (9 months)</time_frame>
    <description>A serious adverse event (SAE) is defined as any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Markedly Abnormal Laboratory Values in the Safety Sub-Set</measure>
    <time_frame>Days 8, 15, 91, 97 and 104</time_frame>
    <description>Percentage of participants with markedly abnormal standard safety laboratory values collected at any time after the first vaccination.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">1002</enrollment>
  <condition>Dengue Fever</condition>
  <arm_group>
    <arm_group_label>Group A: TDV Liquid + Placebo</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B: TDV Liquid</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group C: TDV Liquid</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TDV Liquid Formulation 2, subcutaneous injection on Day 1 and Day 90 (Month 3).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group D: TDV Lyophilized</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TDV Liquid Formulation 1</intervention_name>
    <description>TDV Liquid Formulation 1 for subcutaneous injection</description>
    <arm_group_label>Group A: TDV Liquid + Placebo</arm_group_label>
    <arm_group_label>Group B: TDV Liquid</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TDV Liquid Formulation 2</intervention_name>
    <description>TDV Liquid Formulation 2 for subcutaneous injection</description>
    <arm_group_label>Group C: TDV Liquid</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TDV IDT Lyophilized</intervention_name>
    <description>TDV Lyophilized Formulation for subcutaneous injection</description>
    <arm_group_label>Group D: TDV Lyophilized</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>TDV liquid formulation placebo-matching solution for subcutaneous injection</description>
    <arm_group_label>Group A: TDV Liquid + Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Is aged 18 to 49 years, at the time of enrollment inclusive.&#xD;
&#xD;
          2. Individuals who are in good health at the time of entry into the trial as determined&#xD;
             by medical history, physical examination (including vital signs) and clinical judgment&#xD;
             of the investigator.&#xD;
&#xD;
          3. Signs and dates a written, informed consent form and any required privacy&#xD;
             authorization prior to the initiation of any trial procedures, after the nature of the&#xD;
             trial has been explained according to local regulatory requirements.&#xD;
&#xD;
          4. Individuals who can comply with trial procedures and are available for the duration of&#xD;
             follow-up.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Febrile illness (temperature ≥ 38°C or 100.4°F) or moderate or severe acute illness or&#xD;
             infection at the time of enrollment. Trial entry should be delayed until the illness&#xD;
             has improved.&#xD;
&#xD;
          2. History or any illness that, in the opinion of the investigator, might interfere with&#xD;
             the results of the trial or pose additional risk to the participants due to&#xD;
             participation in the trial, including but not limited to: a. Known hypersensitivity or&#xD;
             allergy to any of the vaccine components; b. Individuals with history of substance or&#xD;
             alcohol abuse within the past 6 months; c. Female participants who are pregnant or&#xD;
             breastfeeding; d. Individuals with any serious chronic or progressive disease&#xD;
             according to judgment of the investigator (e.g., neoplasm, insulin dependent diabetes,&#xD;
             cardiac, renal or hepatic disease, neurologic or seizure disorder or Guillain-Barré&#xD;
             syndrome); e. Known or suspected impairment/alteration of immune function, including:&#xD;
             i. Chronic use of oral steroids (equivalent to 20 mg/day prednisone ≥ 12 weeks / ≥ 2&#xD;
             mg/kg body weight / day prednisone ≥ 2 weeks) within 60 days prior to Day 1 (use of&#xD;
             inhaled, intranasal, or topical corticosteroids is allowed); Receipt of parenteral&#xD;
             steroids (equivalent to 20 mg/day prednisone ≥ 12 weeks / ≥ 2 mg/kg body weight / day&#xD;
             prednisone ≥ 2 weeks) within 60 days prior to Day 1; iii. Administration of&#xD;
             immunoglobulins and/or any blood products within the three months preceding the first&#xD;
             administration of the investigational vaccine or planned administration during the&#xD;
             trial; iv. Receipt of immunostimulants within 60 days prior to Day 1; v.&#xD;
             Immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within&#xD;
             6 months preceding (first) vaccination; vi. human immunodeficiency virus (HIV)&#xD;
             infection or HIV-related disease; vii. Genetic immunodeficiency.&#xD;
&#xD;
          3. Individuals who received any other vaccines within 14 days (for inactivated vaccines)&#xD;
             or 28 days (for live vaccines) prior to enrollment in this trial or who are planning&#xD;
             to receive any vaccine within 28 days of investigational vaccine administration.&#xD;
&#xD;
          4. Individuals participating in any clinical trial with another investigational product&#xD;
             30 days prior to first trial visit or intent to participate in another clinical trial&#xD;
             at any time during the conduct of this trial.&#xD;
&#xD;
          5. Individuals who are first degree relatives of individuals involved in trial conduct.&#xD;
&#xD;
          6. If female of childbearing potential, sexually active, and has not used any of the&#xD;
             acceptable contraceptive methods for at least 2 months prior to trial entry: a. Of&#xD;
             childbearing potential is defined as status post onset of menarche and not meeting any&#xD;
             of the following conditions: menopausal (for at least 2 years), bilateral tubal&#xD;
             ligation (at least 1 year previously), bilateral oophorectomy (at least 1 year&#xD;
             previously) or hysterectomy; b. Acceptable birth control methods are defined as one or&#xD;
             more of the following: i. Hormonal contraceptive (such as oral, injection, transdermal&#xD;
             patch, implant, cervical ring); ii. Barrier (condom with spermicide or diaphragm with&#xD;
             spermicide) each and every time during intercourse; iii. Intrauterine device (IUD);&#xD;
             iv. Monogamous relationship with vasectomized partner. Partner must have been&#xD;
             vasectomized for at least six months prior to the participants' trial entry.&#xD;
&#xD;
          7. If female of childbearing potential, sexually active and refuses to use an acceptable&#xD;
             contraceptive method through to 6 weeks after the last dose of investigational&#xD;
             vaccine.&#xD;
&#xD;
          8. Individuals with body mass index (BMI) greater than or equal to 35.&#xD;
&#xD;
          9. Participants who received previous vaccination (in a clinical trial or with an&#xD;
             approved product) against flaviviruses including dengue, yellow fever (YF), West Nile&#xD;
             (WN), Japanese Encephalitis (JE), and St. Louis encephalitis.&#xD;
&#xD;
         10. Documented or suspected disease caused by dengue, JE, WN, YF virus, and/or St. Louis&#xD;
             encephalitis.&#xD;
&#xD;
         11. History of travel to dengue endemic areas including the Caribbean, Mexico, Central&#xD;
             America, South America or Southeast Asia during the 6 months prior to screening or&#xD;
             planned travel to a dengue endemic area during the study period.&#xD;
&#xD;
         12. Clinically significant abnormality in the screening laboratory tests as judged by the&#xD;
             Investigator.&#xD;
&#xD;
         13. History of recurring headaches or migraines (more frequent than once per week) or on&#xD;
             prescription medication for treatment of recurring headaches or migraines.&#xD;
&#xD;
         14. Blood tests positive for antibodies to HIV-1/2, Hepatitis C and Hepatitis B surface&#xD;
             antigen.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>49 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Medical Director Clinical Science</last_name>
    <role>Study Director</role>
    <affiliation>Takeda</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hope Research Institute</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85018</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Anaheim Clinical Trials, LLC</name>
      <address>
        <city>Anaheim</city>
        <state>California</state>
        <zip>92805</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Atlanta</name>
      <address>
        <city>Stockbridge</city>
        <state>Georgia</state>
        <zip>30281</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Clinical Research</name>
      <address>
        <city>Meridian</city>
        <state>Idaho</state>
        <zip>83462</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Johnson County Clin-Trials</name>
      <address>
        <city>Lenexa</city>
        <state>Kansas</state>
        <zip>66219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Research Center of Nevada</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tekton Research</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78745</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>July 15, 2014</study_first_submitted>
  <study_first_submitted_qc>July 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 17, 2014</study_first_posted>
  <results_first_submitted>May 19, 2016</results_first_submitted>
  <results_first_submitted_qc>May 19, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">June 29, 2016</results_first_posted>
  <last_update_submitted>July 16, 2019</last_update_submitted>
  <last_update_submitted_qc>July 16, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Drug therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dengue</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants took part in the study at 7 investigative sites in the United States from 22 July 2014 to 19 May 2015.</recruitment_details>
      <pre_assignment_details>Healthy volunteers were enrolled in a 2:1:1:6 ratio into 1 of 4 study groups: 1 study group received 1 dose and 3 study groups received 2 doses.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Group A: TDV Liquid + Placebo</title>
          <description>Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).</description>
        </group>
        <group group_id="P2">
          <title>Group B: TDV Liquid</title>
          <description>TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).</description>
        </group>
        <group group_id="P3">
          <title>Group C: TDV Liquid</title>
          <description>TDV Liquid Formulation 2, subcutaneous injection on Day 1 and Day 90 (Month 3).</description>
        </group>
        <group group_id="P4">
          <title>Group D: TDV Lyophilized</title>
          <description>TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="199"/>
                <participants group_id="P2" count="100"/>
                <participants group_id="P3" count="100"/>
                <participants group_id="P4" count="603"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received Vaccination</title>
              <participants_list>
                <participants group_id="P1" count="197"/>
                <participants group_id="P2" count="97"/>
                <participants group_id="P3" count="100"/>
                <participants group_id="P4" count="602"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="162"/>
                <participants group_id="P2" count="86"/>
                <participants group_id="P3" count="93"/>
                <participants group_id="P4" count="524"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="37"/>
                <participants group_id="P2" count="14"/>
                <participants group_id="P3" count="7"/>
                <participants group_id="P4" count="79"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="11"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="37"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="19"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other Reason Not Specified</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="9"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Did Not Receive Any Vaccination</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All randomized participants.</population>
      <group_list>
        <group group_id="B1">
          <title>Group A: TDV Liquid + Placebo</title>
          <description>Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).</description>
        </group>
        <group group_id="B2">
          <title>Group B: TDV Liquid</title>
          <description>TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).</description>
        </group>
        <group group_id="B3">
          <title>Group C: TDV Liquid</title>
          <description>TDV Liquid Formulation 2, subcutaneous injection on Day 1 and Day 90 (Month 3).</description>
        </group>
        <group group_id="B4">
          <title>Group D: TDV Lyophilized</title>
          <description>TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).</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="199"/>
            <count group_id="B2" value="100"/>
            <count group_id="B3" value="100"/>
            <count group_id="B4" value="603"/>
            <count group_id="B5" value="1002"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32.1" spread="8.66"/>
                    <measurement group_id="B2" value="30.9" spread="8.72"/>
                    <measurement group_id="B3" value="34.1" spread="9.20"/>
                    <measurement group_id="B4" value="31.9" spread="8.89"/>
                    <measurement group_id="B5" value="32.1" spread="8.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Adults (18-64 Years)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="199"/>
                    <measurement group_id="B2" value="100"/>
                    <measurement group_id="B3" value="100"/>
                    <measurement group_id="B4" value="603"/>
                    <measurement group_id="B5" value="1002"/>
                  </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="109"/>
                    <measurement group_id="B2" value="51"/>
                    <measurement group_id="B3" value="47"/>
                    <measurement group_id="B4" value="298"/>
                    <measurement group_id="B5" value="505"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="90"/>
                    <measurement group_id="B2" value="49"/>
                    <measurement group_id="B3" value="53"/>
                    <measurement group_id="B4" value="305"/>
                    <measurement group_id="B5" value="497"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Hispanic or Latino</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="40"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="21"/>
                    <measurement group_id="B4" value="120"/>
                    <measurement group_id="B5" value="203"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Non-Hispanic or Latino</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="152"/>
                    <measurement group_id="B2" value="75"/>
                    <measurement group_id="B3" value="76"/>
                    <measurement group_id="B4" value="464"/>
                    <measurement group_id="B5" value="767"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not Reported</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="15"/>
                    <measurement group_id="B5" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Missing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>American Indian or Alaska Native</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="16"/>
                    <measurement group_id="B5" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black or African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="51"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="26"/>
                    <measurement group_id="B4" value="146"/>
                    <measurement group_id="B5" value="250"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Native Hawaiian or Other Pacific Islander</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="2"/>
                    <measurement group_id="B5" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="125"/>
                    <measurement group_id="B2" value="66"/>
                    <measurement group_id="B3" value="69"/>
                    <measurement group_id="B4" value="408"/>
                    <measurement group_id="B5" value="668"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Multiracial</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="15"/>
                    <measurement group_id="B5" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Missing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="199"/>
                    <measurement group_id="B2" value="100"/>
                    <measurement group_id="B3" value="100"/>
                    <measurement group_id="B4" value="603"/>
                    <measurement group_id="B5" value="1002"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Height</title>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="169.55" spread="9.284"/>
                    <measurement group_id="B2" value="171.13" spread="10.466"/>
                    <measurement group_id="B3" value="169.84" spread="9.727"/>
                    <measurement group_id="B4" value="170.69" spread="9.680"/>
                    <measurement group_id="B5" value="170.42" spread="9.689"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="76.95" spread="14.362"/>
                    <measurement group_id="B2" value="78.96" spread="16.878"/>
                    <measurement group_id="B3" value="75.96" spread="16.099"/>
                    <measurement group_id="B4" value="77.49" spread="15.649"/>
                    <measurement group_id="B5" value="77.37" spread="15.569"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index (BMI)</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26.71" spread="4.180"/>
                    <measurement group_id="B2" value="26.81" spread="4.496"/>
                    <measurement group_id="B3" value="26.30" spread="5.006"/>
                    <measurement group_id="B4" value="26.53" spread="4.513"/>
                    <measurement group_id="B5" value="26.57" spread="4.494"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Geometric Mean Titer (GMT) of Neutralizing Antibodies for Each of the Four Dengue Serotypes Comparing Group D To Groups A and B Combined</title>
        <description>Geometric mean titer (GMT) of neutralizing antibodies for each of the four dengue serotypes as measured by Plaque Reduction Neutralization Test resulting in 50% reduction in Plaques (PRNT50). The four dengue serotypes are DEN-1, DEN-2, DEN-3 and DEN-4.&#xD;
A 90% Confidence Interval (CI) for the ratio of GMT (or equivalently the difference of the log transformed GMT) was provided, for each serotype, for the comparison of the lyophilized formulation (Group D) versus the liquid formulation 1 (Groups A+B combined). An Analysis of Variance (ANOVA) model for the natural log-transformed GMT at month 1 with study group as a factor was used for analysis.</description>
        <time_frame>Month 1</time_frame>
        <population>Per-Protocol Set (PPS) included all randomized participants who received the planned number of investigational vaccine doses, had serology data at Baseline and Month 1 and had no major protocol violations. Participants seropositive at Baseline are not included.</population>
        <group_list>
          <group group_id="O1">
            <title>Group A + Group B Combined</title>
            <description>Group A: Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).&#xD;
Group B: TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).</description>
          </group>
          <group group_id="O2">
            <title>Group D: TDV Lyophilized</title>
            <description>TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Titer (GMT) of Neutralizing Antibodies for Each of the Four Dengue Serotypes Comparing Group D To Groups A and B Combined</title>
          <description>Geometric mean titer (GMT) of neutralizing antibodies for each of the four dengue serotypes as measured by Plaque Reduction Neutralization Test resulting in 50% reduction in Plaques (PRNT50). The four dengue serotypes are DEN-1, DEN-2, DEN-3 and DEN-4.&#xD;
A 90% Confidence Interval (CI) for the ratio of GMT (or equivalently the difference of the log transformed GMT) was provided, for each serotype, for the comparison of the lyophilized formulation (Group D) versus the liquid formulation 1 (Groups A+B combined). An Analysis of Variance (ANOVA) model for the natural log-transformed GMT at month 1 with study group as a factor was used for analysis.</description>
          <population>Per-Protocol Set (PPS) included all randomized participants who received the planned number of investigational vaccine doses, had serology data at Baseline and Month 1 and had no major protocol violations. Participants seropositive at Baseline are not included.</population>
          <units>titer</units>
          <param>Least Squares Mean</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="220"/>
                <count group_id="O2" value="454"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>DEN-1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="635.04" lower_limit="530.62" upper_limit="760.00"/>
                    <measurement group_id="O2" value="181.23" lower_limit="159.92" upper_limit="205.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DEN-2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15104.68" lower_limit="13135.48" upper_limit="17369.09"/>
                    <measurement group_id="O2" value="16072.59" lower_limit="14583.29" upper_limit="17713.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DEN-3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="186.32" lower_limit="151.11" upper_limit="229.74"/>
                    <measurement group_id="O2" value="272.75" lower_limit="235.75" upper_limit="315.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DEN-4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88.87" lower_limit="72.29" upper_limit="109.25"/>
                    <measurement group_id="O2" value="65.67" lower_limit="56.88" upper_limit="75.82"/>
                  </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>DEN-1</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Based on the Two One-Sided Tests (TOST) with α=0.05, if the 90% CI for the ratio of GMT for a given dengue serotype for the comparison was within the range of 0.67 and 1, then the 2 formulations were deemed equivalent.</non_inferiority_desc>
            <param_type>LS Mean Ratio</param_type>
            <param_value>0.29</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.23</ci_lower_limit>
            <ci_upper_limit>0.36</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>DEN-2</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Based on the Two One-Sided Tests (TOST) with α=0.05, if the 90% CI for the ratio of GMT for a given dengue serotype for the comparison was within the range of 0.67 and 1, then the 2 formulations were deemed equivalent.</non_inferiority_desc>
            <param_type>LS Mean Ratio</param_type>
            <param_value>1.06</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.90</ci_lower_limit>
            <ci_upper_limit>1.26</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>DEN-3</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Based on the Two One-Sided Tests (TOST) with α=0.05, if the 90% CI for the ratio of GMT for a given dengue serotype for the comparison was within the range of 0.67 and 1, then the 2 formulations were deemed equivalent.</non_inferiority_desc>
            <param_type>LS Mean Ratio</param_type>
            <param_value>1.46</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>1.13</ci_lower_limit>
            <ci_upper_limit>1.89</ci_upper_limit>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>DEN-4</groups_desc>
            <non_inferiority_type>Non-Inferiority or Equivalence</non_inferiority_type>
            <non_inferiority_desc>Based on the Two One-Sided Tests (TOST) with α=0.05, if the 90% CI for the ratio of GMT for a given dengue serotype for the comparison was within the range of 0.67 and 1, then the 2 formulations were deemed equivalent.</non_inferiority_desc>
            <param_type>LS Mean Ratio</param_type>
            <param_value>0.74</param_value>
            <ci_percent>90</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.57</ci_lower_limit>
            <ci_upper_limit>0.95</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Geometric Mean Titers (GMT) of Neutralizing Antibodies for Each of the Four Dengue Serotypes Comparing Group D With Group B</title>
        <description>Geometric mean titer (GMT) of neutralizing antibodies for each of the four dengue serotypes as measured by Plaque Reduction Neutralization Test resulting in 50% reduction in Plaques (PRNT50). The four dengue serotypes are DEN-1, DEN-2, DEN-3 and DEN-4. ANOVA model for the natural log-transformed GMT at month 1 with study group as a factor was used for analysis.</description>
        <time_frame>Months 1 and 4</time_frame>
        <population>PPS included all randomized participants who received the planned number of investigational vaccine doses, had serology data at Baseline and Month 1 and had no major protocol violations. Participants seropositive at Baseline are not included. &quot;n&quot; in each of the categories is the number of participants with data available at the given time-point.</population>
        <group_list>
          <group group_id="O1">
            <title>Group B: TDV Liquid</title>
            <description>TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).</description>
          </group>
          <group group_id="O2">
            <title>Group D: TDV Lyophilized</title>
            <description>TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Titers (GMT) of Neutralizing Antibodies for Each of the Four Dengue Serotypes Comparing Group D With Group B</title>
          <description>Geometric mean titer (GMT) of neutralizing antibodies for each of the four dengue serotypes as measured by Plaque Reduction Neutralization Test resulting in 50% reduction in Plaques (PRNT50). The four dengue serotypes are DEN-1, DEN-2, DEN-3 and DEN-4. ANOVA model for the natural log-transformed GMT at month 1 with study group as a factor was used for analysis.</description>
          <population>PPS included all randomized participants who received the planned number of investigational vaccine doses, had serology data at Baseline and Month 1 and had no major protocol violations. Participants seropositive at Baseline are not included. &quot;n&quot; in each of the categories is the number of participants with data available at the given time-point.</population>
          <units>titer</units>
          <param>Least Squares Mean</param>
          <dispersion>90% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="74"/>
                <count group_id="O2" value="454"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 1 DEN-1 (n=74, 454)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="627.56" lower_limit="458.91" upper_limit="858.18"/>
                    <measurement group_id="O2" value="181.23" lower_limit="159.71" upper_limit="205.63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 1 DEN-2 (n=74, 454)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17876.66" lower_limit="14186.79" upper_limit="22526.23"/>
                    <measurement group_id="O2" value="16072.59" lower_limit="14640.33" upper_limit="17644.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 1 DEN-3 (n=74, 454)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="220.29" lower_limit="154.23" upper_limit="314.64"/>
                    <measurement group_id="O2" value="272.75" lower_limit="236.19" upper_limit="314.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 1 DEN-4 (n=74, 454)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88.25" lower_limit="62.10" upper_limit="125.43"/>
                    <measurement group_id="O2" value="65.67" lower_limit="56.98" upper_limit="75.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 4 DEN-1 (n=73, 435)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="267.80" lower_limit="205.46" upper_limit="349.06"/>
                    <measurement group_id="O2" value="113.43" lower_limit="101.76" upper_limit="126.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 4 DEN-2 (n=73, 435)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4160.29" lower_limit="3508.92" upper_limit="4932.58"/>
                    <measurement group_id="O2" value="3772.95" lower_limit="3518.74" upper_limit="4045.53"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 4 DEN-3 (n=73, 435)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="106.98" lower_limit="85.08" upper_limit="134.52"/>
                    <measurement group_id="O2" value="132.73" lower_limit="120.84" upper_limit="145.79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 4 DEN-4 (n=73, 435)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.56" lower_limit="24.82" upper_limit="40.14"/>
                    <measurement group_id="O2" value="28.84" lower_limit="26.13" upper_limit="31.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With a Seropositive Response for Each of the Four Dengue Serotypes Comparing Group D With Groups A and B Combined</title>
        <description>A seropositive response is defined as a reciprocal neutralizing titer ≥ 10. The four dengue serotypes are DEN-1, DEN-2, DEN-3 and DEN-4.</description>
        <time_frame>Month 1</time_frame>
        <population>Per-Protocol Set (PPS) included all randomized participants who received the planned number of investigational vaccine doses, had serology data at Baseline and Month 1, and have no major protocol violations. Participants seropositive at Baseline are not included.</population>
        <group_list>
          <group group_id="O1">
            <title>Group A + Group B Combined</title>
            <description>Group A: TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).&#xD;
Group B: TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).</description>
          </group>
          <group group_id="O2">
            <title>Group D: TDV Lyophilized</title>
            <description>TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With a Seropositive Response for Each of the Four Dengue Serotypes Comparing Group D With Groups A and B Combined</title>
          <description>A seropositive response is defined as a reciprocal neutralizing titer ≥ 10. The four dengue serotypes are DEN-1, DEN-2, DEN-3 and DEN-4.</description>
          <population>Per-Protocol Set (PPS) included all randomized participants who received the planned number of investigational vaccine doses, had serology data at Baseline and Month 1, and have no major protocol violations. Participants seropositive at Baseline are not included.</population>
          <units>percentage of participants</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="220"/>
                <count group_id="O2" value="454"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>DEN-1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.7" lower_limit="94.8" upper_limit="99.3"/>
                    <measurement group_id="O2" value="93.6" lower_limit="91.0" upper_limit="95.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DEN-2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0" lower_limit="98.3" upper_limit="100.0"/>
                    <measurement group_id="O2" value="99.6" lower_limit="98.4" upper_limit="99.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DEN-3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91.8" lower_limit="87.4" upper_limit="95.1"/>
                    <measurement group_id="O2" value="93.4" lower_limit="90.7" upper_limit="95.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DEN-4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80.9" lower_limit="75.1" upper_limit="85.9"/>
                    <measurement group_id="O2" value="80.0" lower_limit="76.0" upper_limit="83.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With a Seropositive Response for Each of the Four Dengue Serotypes Comparing Group D With Group B</title>
        <description>A seropositive response is defined as a reciprocal neutralizing titer ≥ 10. The four dengue serotypes are DEN-1, DEN-2, DEN-3 and DEN-4.</description>
        <time_frame>Months 1 and 4</time_frame>
        <population>PPS included all randomized participants who received the planned number of investigational vaccine doses, had serology data at Baseline and Month 1 and had no major protocol violations. Participants seropositive at Baseline are not included. &quot;n&quot; in each of the categories is the number of participants with data available at the given time-point.</population>
        <group_list>
          <group group_id="O1">
            <title>Group B: TDV Liquid</title>
            <description>TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).</description>
          </group>
          <group group_id="O2">
            <title>Group D: TDV Lyophilized</title>
            <description>TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With a Seropositive Response for Each of the Four Dengue Serotypes Comparing Group D With Group B</title>
          <description>A seropositive response is defined as a reciprocal neutralizing titer ≥ 10. The four dengue serotypes are DEN-1, DEN-2, DEN-3 and DEN-4.</description>
          <population>PPS included all randomized participants who received the planned number of investigational vaccine doses, had serology data at Baseline and Month 1 and had no major protocol violations. Participants seropositive at Baseline are not included. &quot;n&quot; in each of the categories is the number of participants with data available at the given time-point.</population>
          <units>percentage of participants</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="74"/>
                <count group_id="O2" value="454"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Month 1 DEN-1 (n=74, 454)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.3" lower_limit="90.6" upper_limit="99.7"/>
                    <measurement group_id="O2" value="93.6" lower_limit="91.0" upper_limit="95.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 1 DEN-2 (n=74, 454)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0" lower_limit="95.1" upper_limit="100.0"/>
                    <measurement group_id="O2" value="99.6" lower_limit="98.4" upper_limit="99.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 1 DEN-3 (n=74, 454)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="95.9" lower_limit="88.6" upper_limit="99.2"/>
                    <measurement group_id="O2" value="93.4" lower_limit="90.7" upper_limit="95.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 1 DEN-4 (n=74, 454)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78.4" lower_limit="67.3" upper_limit="87.1"/>
                    <measurement group_id="O2" value="80.0" lower_limit="76.0" upper_limit="83.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 4 DEN-1 (n=73, 435)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.3" lower_limit="90.5" upper_limit="99.7"/>
                    <measurement group_id="O2" value="98.2" lower_limit="96.4" upper_limit="99.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 4 DEN-2 (n=73, 435)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100.0" lower_limit="95.0" upper_limit="100.0"/>
                    <measurement group_id="O2" value="100.0" lower_limit="99.1" upper_limit="100.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 4 DEN-3 (n=73, 435)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="98.6" lower_limit="92.6" upper_limit="100.0"/>
                    <measurement group_id="O2" value="98.9" lower_limit="97.3" upper_limit="99.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Month 4 DEN-4 (n=73, 435)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83.6" lower_limit="73.0" upper_limit="91.2"/>
                    <measurement group_id="O2" value="79.3" lower_limit="75.2" upper_limit="83.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs)</title>
        <description>Solicited local AEs at injection site are defined as pain, erythema and swelling that occurred at least once within 7 days after either vaccination, as recorded by the participants in a diary. Percentages are based on the number of participants with diary data available.</description>
        <time_frame>Days 1 through 7 after each vaccination</time_frame>
        <population>Participants from the Safety Set (SS) with evaluable data and who received at least 1 dose of study vaccine (or placebo), including a partial dose. &quot;n&quot; in each of the categories is the number of participants with data available for analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Group A: TDV Liquid + Placebo</title>
            <description>Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).</description>
          </group>
          <group group_id="O2">
            <title>Group B: TDV Liquid</title>
            <description>TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).</description>
          </group>
          <group group_id="O3">
            <title>Group A and Group B Combined</title>
            <description>Group A: Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).&#xD;
Group B: TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).</description>
          </group>
          <group group_id="O4">
            <title>Group C: TDV Liquid</title>
            <description>TDV Liquid Formulation 2, subcutaneous injection on Day 1 and Day 90 (Month 3).</description>
          </group>
          <group group_id="O5">
            <title>Group D: TDV Lyophilized</title>
            <description>TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs)</title>
          <description>Solicited local AEs at injection site are defined as pain, erythema and swelling that occurred at least once within 7 days after either vaccination, as recorded by the participants in a diary. Percentages are based on the number of participants with diary data available.</description>
          <population>Participants from the Safety Set (SS) with evaluable data and who received at least 1 dose of study vaccine (or placebo), including a partial dose. &quot;n&quot; in each of the categories is the number of participants with data available for analysis.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="191"/>
                <count group_id="O2" value="95"/>
                <count group_id="O3" value="294"/>
                <count group_id="O4" value="99"/>
                <count group_id="O5" value="583"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pain (n=191, 95, 99, 583)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.5"/>
                    <measurement group_id="O2" value="48.4"/>
                    <measurement group_id="O3" value="45.1"/>
                    <measurement group_id="O4" value="51.5"/>
                    <measurement group_id="O5" value="45.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Erythema (n=191, 95, 99, 582)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.6"/>
                    <measurement group_id="O2" value="41.1"/>
                    <measurement group_id="O3" value="37.4"/>
                    <measurement group_id="O4" value="51.5"/>
                    <measurement group_id="O5" value="43.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Swelling (n=191, 95, 99, 582)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.5"/>
                    <measurement group_id="O2" value="20.0"/>
                    <measurement group_id="O3" value="14.3"/>
                    <measurement group_id="O4" value="24.2"/>
                    <measurement group_id="O5" value="21.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Solicited Systemic Adverse Events (AEs)</title>
        <description>Solicited systemic AEs are defined as asthenia, fever, headache, malaise, and myalgia that occurred at least once within 14 days after either vaccination, as recorded by the participants in a diary. Percentages are based on the number of participants with diary data available.</description>
        <time_frame>Days 1 through 14 after each vaccination</time_frame>
        <population>Participants from the SS with evaluable data and who received at least 1 dose of study vaccine (or placebo), including a partial dose.</population>
        <group_list>
          <group group_id="O1">
            <title>Group A: TDV Liquid + Placebo</title>
            <description>Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).</description>
          </group>
          <group group_id="O2">
            <title>Group B: TDV Liquid</title>
            <description>TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).</description>
          </group>
          <group group_id="O3">
            <title>Group C: TDV Liquid</title>
            <description>TDV Liquid Formulation 2, subcutaneous injection on Day 1 and Day 90 (Month 3).</description>
          </group>
          <group group_id="O4">
            <title>Group D: TDV Lyophilized</title>
            <description>TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Solicited Systemic Adverse Events (AEs)</title>
          <description>Solicited systemic AEs are defined as asthenia, fever, headache, malaise, and myalgia that occurred at least once within 14 days after either vaccination, as recorded by the participants in a diary. Percentages are based on the number of participants with diary data available.</description>
          <population>Participants from the SS with evaluable data and who received at least 1 dose of study vaccine (or placebo), including a partial dose.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="191"/>
                <count group_id="O2" value="95"/>
                <count group_id="O3" value="99"/>
                <count group_id="O4" value="584"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Headache</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.8"/>
                    <measurement group_id="O2" value="43.2"/>
                    <measurement group_id="O3" value="38.4"/>
                    <measurement group_id="O4" value="41.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asthenia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.7"/>
                    <measurement group_id="O2" value="23.2"/>
                    <measurement group_id="O3" value="25.3"/>
                    <measurement group_id="O4" value="26.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Malaise</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.3"/>
                    <measurement group_id="O2" value="27.4"/>
                    <measurement group_id="O3" value="25.3"/>
                    <measurement group_id="O4" value="25.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Myalgia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.4"/>
                    <measurement group_id="O2" value="38.9"/>
                    <measurement group_id="O3" value="30.3"/>
                    <measurement group_id="O4" value="33.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fever (≥38 °C)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.6"/>
                    <measurement group_id="O2" value="3.2"/>
                    <measurement group_id="O3" value="1.0"/>
                    <measurement group_id="O4" value="1.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity</title>
        <description>The percentage of participants with solicited local AEs at injection site of varying severity are reported. Solicited local AEs are defined as pain, erythema and swelling that occurred at least once within 7 days after either vaccination, as recorded by the participants in a diary. Participants with multiple episodes are categorized using the highest severity level. Percentages are based on the number of participants with diary data available.</description>
        <time_frame>Days 1 through 7 after each vaccination</time_frame>
        <population>Participants from the SS with evaluable data and who received at least 1 dose of study vaccine (or placebo), including a partial dose. &quot;n&quot; in each of the categories is the number of participants with data available for analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Group A: TDV Liquid + Placebo</title>
            <description>Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).</description>
          </group>
          <group group_id="O2">
            <title>Group B: TDV Liquid</title>
            <description>TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).</description>
          </group>
          <group group_id="O3">
            <title>Group C: TDV Liquid</title>
            <description>TDV Liquid Formulation 2, subcutaneous injection on Day 1 and Day 90 (Month 3).</description>
          </group>
          <group group_id="O4">
            <title>Group D: TDV Lyophilized</title>
            <description>TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity</title>
          <description>The percentage of participants with solicited local AEs at injection site of varying severity are reported. Solicited local AEs are defined as pain, erythema and swelling that occurred at least once within 7 days after either vaccination, as recorded by the participants in a diary. Participants with multiple episodes are categorized using the highest severity level. Percentages are based on the number of participants with diary data available.</description>
          <population>Participants from the SS with evaluable data and who received at least 1 dose of study vaccine (or placebo), including a partial dose. &quot;n&quot; in each of the categories is the number of participants with data available for analysis.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="191"/>
                <count group_id="O2" value="95"/>
                <count group_id="O3" value="99"/>
                <count group_id="O4" value="583"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pain_Mild (n=191, 95, 99, 583)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.6"/>
                    <measurement group_id="O2" value="36.8"/>
                    <measurement group_id="O3" value="41.4"/>
                    <measurement group_id="O4" value="34.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain_Moderate (n=191, 95, 99, 583)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.8"/>
                    <measurement group_id="O2" value="8.4"/>
                    <measurement group_id="O3" value="8.1"/>
                    <measurement group_id="O4" value="9.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain_Severe (n=191, 95, 99, 583)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.1"/>
                    <measurement group_id="O2" value="3.2"/>
                    <measurement group_id="O3" value="2.0"/>
                    <measurement group_id="O4" value="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Erythema_Mild (n=191, 95, 99, 582)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.3"/>
                    <measurement group_id="O2" value="22.1"/>
                    <measurement group_id="O3" value="18.2"/>
                    <measurement group_id="O4" value="16.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Erythema_Moderate (n=191, 95, 99, 582)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.1"/>
                    <measurement group_id="O2" value="9.5"/>
                    <measurement group_id="O3" value="11.1"/>
                    <measurement group_id="O4" value="6.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Erythema_Severe (n=191, 95, 99, 582)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Swelling_Mild (n=191, 95, 99, 582)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.6"/>
                    <measurement group_id="O2" value="5.3"/>
                    <measurement group_id="O3" value="9.1"/>
                    <measurement group_id="O4" value="5.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Swelling_Moderate (n=191, 95, 99, 582)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="3.2"/>
                    <measurement group_id="O3" value="5.1"/>
                    <measurement group_id="O4" value="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Swelling_Severe (n=191, 95, 99, 582)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity</title>
        <description>The percentage of participants with solicited systemic AEs of varying severity are reported. Solicited systemic AEs are defined as asthenia, fever, headache, malaise, and myalgia that occurred at least once within 14 days after either vaccination, as recorded by the participants in a diary. Participants with multiple episodes are categorized using the highest severity level. Percentages are based on the number of participants with diary data available.</description>
        <time_frame>Days 1 through 14 after each vaccination</time_frame>
        <population>Participants from the SS with evaluable data and who received at least 1 dose of study vaccine (or placebo), including a partial dose.</population>
        <group_list>
          <group group_id="O1">
            <title>Group A: TDV Liquid + Placebo</title>
            <description>Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).</description>
          </group>
          <group group_id="O2">
            <title>Group B: TDV Liquid</title>
            <description>TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).</description>
          </group>
          <group group_id="O3">
            <title>Group C: TDV Liquid</title>
            <description>TDV Liquid Formulation 2, subcutaneous injection on Day 1 and Day 90 (Month 3).</description>
          </group>
          <group group_id="O4">
            <title>Group D: TDV Lyophilized</title>
            <description>TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity</title>
          <description>The percentage of participants with solicited systemic AEs of varying severity are reported. Solicited systemic AEs are defined as asthenia, fever, headache, malaise, and myalgia that occurred at least once within 14 days after either vaccination, as recorded by the participants in a diary. Participants with multiple episodes are categorized using the highest severity level. Percentages are based on the number of participants with diary data available.</description>
          <population>Participants from the SS with evaluable data and who received at least 1 dose of study vaccine (or placebo), including a partial dose.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="191"/>
                <count group_id="O2" value="95"/>
                <count group_id="O3" value="99"/>
                <count group_id="O4" value="584"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Headache_Mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.2"/>
                    <measurement group_id="O2" value="26.3"/>
                    <measurement group_id="O3" value="21.2"/>
                    <measurement group_id="O4" value="23.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Headache_Moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.4"/>
                    <measurement group_id="O2" value="9.5"/>
                    <measurement group_id="O3" value="13.1"/>
                    <measurement group_id="O4" value="13.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Headache_Severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.2"/>
                    <measurement group_id="O2" value="7.4"/>
                    <measurement group_id="O3" value="4.0"/>
                    <measurement group_id="O4" value="4.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asthenia_Mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.8"/>
                    <measurement group_id="O2" value="11.6"/>
                    <measurement group_id="O3" value="13.1"/>
                    <measurement group_id="O4" value="16.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asthenia_Moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.8"/>
                    <measurement group_id="O2" value="10.5"/>
                    <measurement group_id="O3" value="10.1"/>
                    <measurement group_id="O4" value="7.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asthenia_Severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.1"/>
                    <measurement group_id="O2" value="1.1"/>
                    <measurement group_id="O3" value="2.0"/>
                    <measurement group_id="O4" value="2.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Malaise_Mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.8"/>
                    <measurement group_id="O2" value="15.8"/>
                    <measurement group_id="O3" value="15.2"/>
                    <measurement group_id="O4" value="14.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Malaise_Moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.3"/>
                    <measurement group_id="O2" value="9.5"/>
                    <measurement group_id="O3" value="7.1"/>
                    <measurement group_id="O4" value="8.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Malaise_Severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.2"/>
                    <measurement group_id="O2" value="2.1"/>
                    <measurement group_id="O3" value="3.0"/>
                    <measurement group_id="O4" value="2.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Myalgia_Mild</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.9"/>
                    <measurement group_id="O2" value="23.2"/>
                    <measurement group_id="O3" value="22.2"/>
                    <measurement group_id="O4" value="23.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Myalgia_Moderate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.3"/>
                    <measurement group_id="O2" value="11.6"/>
                    <measurement group_id="O3" value="6.1"/>
                    <measurement group_id="O4" value="8.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Myalgia_Severe</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.1"/>
                    <measurement group_id="O2" value="4.2"/>
                    <measurement group_id="O3" value="2.0"/>
                    <measurement group_id="O4" value="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fever_38.0 - 38.4 °C</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0"/>
                    <measurement group_id="O2" value="2.1"/>
                    <measurement group_id="O3" value="1.0"/>
                    <measurement group_id="O4" value="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fever_38.5 - 38.9 °C</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.5"/>
                    <measurement group_id="O2" value="1.1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fever_39.0 - 40.0 °C</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fever_&gt;40 °C</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Any Unsolicited Adverse Events (AEs)</title>
        <description>Unsolicited AEs are any AEs that are not solicited local or systemic AEs, as defined by this study, that occurred at least once within 28 days after either vaccination. An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. The investigator assessed whether the AE was related to the study vaccination.</description>
        <time_frame>Up to Day 28 after each vaccination</time_frame>
        <population>SS included all randomized participants who received at least 1 dose of study vaccine (or placebo), including a partial dose.</population>
        <group_list>
          <group group_id="O1">
            <title>Group A: TDV Liquid + Placebo</title>
            <description>Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).</description>
          </group>
          <group group_id="O2">
            <title>Group B: TDV Liquid</title>
            <description>TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).</description>
          </group>
          <group group_id="O3">
            <title>Group C: TDV Liquid</title>
            <description>TDV Liquid Formulation 2, subcutaneous injection on Day 1 and Day 90 (Month 3).</description>
          </group>
          <group group_id="O4">
            <title>Group D: TDV Lyophilized</title>
            <description>TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Any Unsolicited Adverse Events (AEs)</title>
          <description>Unsolicited AEs are any AEs that are not solicited local or systemic AEs, as defined by this study, that occurred at least once within 28 days after either vaccination. An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. The investigator assessed whether the AE was related to the study vaccination.</description>
          <population>SS included all randomized participants who received at least 1 dose of study vaccine (or placebo), including a partial dose.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="197"/>
                <count group_id="O2" value="97"/>
                <count group_id="O3" value="100"/>
                <count group_id="O4" value="602"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.1"/>
                    <measurement group_id="O2" value="47.4"/>
                    <measurement group_id="O3" value="45.0"/>
                    <measurement group_id="O4" value="43.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Serious Adverse Events (SAEs)</title>
        <description>A serious adverse event (SAE) is defined as any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria.</description>
        <time_frame>Up to 6 Months after the last dose (9 months)</time_frame>
        <population>SS included all randomized participants who received at least 1 dose of study vaccine (or placebo), including a partial dose.</population>
        <group_list>
          <group group_id="O1">
            <title>Group A: TDV Liquid + Placebo</title>
            <description>Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).</description>
          </group>
          <group group_id="O2">
            <title>Group B: TDV Liquid</title>
            <description>TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).</description>
          </group>
          <group group_id="O3">
            <title>Group C: TDV Liquid</title>
            <description>TDV Liquid Formulation 2, subcutaneous injection on Day 1 and Day 90 (Month 3).</description>
          </group>
          <group group_id="O4">
            <title>Group D: TDV Lyophilized</title>
            <description>TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Serious Adverse Events (SAEs)</title>
          <description>A serious adverse event (SAE) is defined as any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria.</description>
          <population>SS included all randomized participants who received at least 1 dose of study vaccine (or placebo), including a partial dose.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="197"/>
                <count group_id="O2" value="97"/>
                <count group_id="O3" value="100"/>
                <count group_id="O4" value="602"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0"/>
                    <measurement group_id="O2" value="1.0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Markedly Abnormal Laboratory Values in the Safety Sub-Set</title>
        <description>Percentage of participants with markedly abnormal standard safety laboratory values collected at any time after the first vaccination.</description>
        <time_frame>Days 8, 15, 91, 97 and 104</time_frame>
        <population>The Safety Laboratory Sub-Set included randomly chosen participants from each treatment group for whom samples for clinical safety lab tests were collected and who received at least one vaccination dose. &quot;n&quot; in each of the categories is the number of participants with data available at the given time-point.</population>
        <group_list>
          <group group_id="O1">
            <title>Group A: TDV Liquid + Placebo</title>
            <description>Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).</description>
          </group>
          <group group_id="O2">
            <title>Group B: TDV Liquid</title>
            <description>TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).</description>
          </group>
          <group group_id="O3">
            <title>Group C: TDV Liquid</title>
            <description>TDV Liquid Formulation 2, subcutaneous injection on Day 1 and Day 90 (Month 3).</description>
          </group>
          <group group_id="O4">
            <title>Group D: TDV Lyophilized</title>
            <description>TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Markedly Abnormal Laboratory Values in the Safety Sub-Set</title>
          <description>Percentage of participants with markedly abnormal standard safety laboratory values collected at any time after the first vaccination.</description>
          <population>The Safety Laboratory Sub-Set included randomly chosen participants from each treatment group for whom samples for clinical safety lab tests were collected and who received at least one vaccination dose. &quot;n&quot; in each of the categories is the number of participants with data available at the given time-point.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="121"/>
                <count group_id="O2" value="61"/>
                <count group_id="O3" value="64"/>
                <count group_id="O4" value="405"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Hemoglobin</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutrophils (Abs.)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymphocytes (Abs.)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Eosinophils (Abs.)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8"/>
                    <measurement group_id="O2" value="1.6"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutrophils (%)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymphocytes (%)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Eosinophils (%)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5"/>
                    <measurement group_id="O2" value="1.6"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelet Count</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Prothrombin Time</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>aPTT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALT(SGPT) (n=121,61,64,404)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.3"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="3.1"/>
                    <measurement group_id="O4" value="1.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AST(SGOT) (n=121,61,64,404)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1.6"/>
                    <measurement group_id="O4" value="1.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Alkaline Phosphatase (n=121,61,64,404)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>BUN (n=121,61,64,404)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Serious Adverse Events: 9 months. Non-Serious Adverse Events: 28 Days after each vaccination.</time_frame>
      <desc>At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study vaccine.</desc>
      <group_list>
        <group group_id="E1">
          <title>Group A: TDV Liquid + Placebo</title>
          <description>Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).</description>
        </group>
        <group group_id="E2">
          <title>Group B: TDV Liquid</title>
          <description>TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).</description>
        </group>
        <group group_id="E3">
          <title>Group C: TDV Liquid</title>
          <description>TDV Liquid Formulation 2, subcutaneous injection on Day 1 and Day 90 (Month 3).</description>
        </group>
        <group group_id="E4">
          <title>Group D: TDV Lyophilized</title>
          <description>TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).</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="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="97"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" subjects_affected="8" subjects_at_risk="602"/>
              </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="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="97"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="602"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="97"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="602"/>
              </event>
              <event>
                <sub_title>Hepatitis C</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="97"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="602"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Heat exhaustion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="97"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="602"/>
              </event>
              <event>
                <sub_title>Injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="97"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="602"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Altered state of consciousness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="97"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="602"/>
              </event>
              <event>
                <sub_title>Cerebral artery occlusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="97"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="602"/>
              </event>
              <event>
                <sub_title>Complex partial seizures</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="97"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="602"/>
              </event>
              <event>
                <sub_title>Guillain-Barre syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="97"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="602"/>
              </event>
              <event>
                <sub_title>Lacunar infarction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="97"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="602"/>
              </event>
              <event>
                <sub_title>Temporal lobe epilepsy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="97"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="602"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Major depression</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="97"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="602"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Cervical cyst</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="97"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="602"/>
              </event>
              <event>
                <sub_title>Ovarian cyst</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="97"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="602"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="97"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="602"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>2</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="50" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="34" subjects_at_risk="97"/>
                <counts group_id="E3" subjects_affected="29" subjects_at_risk="100"/>
                <counts group_id="E4" subjects_affected="178" subjects_at_risk="602"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Lymphadenopathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="97"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="602"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="97"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" subjects_affected="21" subjects_at_risk="602"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="97"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="100"/>
                <counts group_id="E4" subjects_affected="10" subjects_at_risk="602"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="97"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" subjects_affected="11" subjects_at_risk="602"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Injection site erythema</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="97"/>
                <counts group_id="E3" subjects_affected="10" subjects_at_risk="100"/>
                <counts group_id="E4" subjects_affected="41" subjects_at_risk="602"/>
              </event>
              <event>
                <sub_title>Injection site pain</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="97"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="100"/>
                <counts group_id="E4" subjects_affected="25" subjects_at_risk="602"/>
              </event>
              <event>
                <sub_title>Injection site pruritus</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="97"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="100"/>
                <counts group_id="E4" subjects_affected="19" subjects_at_risk="602"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="97"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" subjects_affected="8" subjects_at_risk="602"/>
              </event>
              <event>
                <sub_title>Injection site discolouration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="97"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="100"/>
                <counts group_id="E4" subjects_affected="11" subjects_at_risk="602"/>
              </event>
              <event>
                <sub_title>Injection site swelling</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="97"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="100"/>
                <counts group_id="E4" subjects_affected="8" subjects_at_risk="602"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="97"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="602"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="97"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="100"/>
                <counts group_id="E4" subjects_affected="23" subjects_at_risk="602"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="97"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="100"/>
                <counts group_id="E4" subjects_affected="9" subjects_at_risk="602"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Laceration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="97"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="602"/>
              </event>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="97"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="602"/>
              </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="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="97"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="100"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="602"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="97"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="100"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="602"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="97"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="602"/>
              </event>
              <event>
                <sub_title>Neck pain</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="97"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="100"/>
                <counts group_id="E4" subjects_affected="3" subjects_at_risk="602"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="97"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" subjects_affected="22" subjects_at_risk="602"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="97"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" subjects_affected="6" subjects_at_risk="602"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="97"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="602"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="97"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="100"/>
                <counts group_id="E4" subjects_affected="8" subjects_at_risk="602"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="197"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="97"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="100"/>
                <counts group_id="E4" subjects_affected="5" subjects_at_risk="602"/>
              </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 first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Medical Director Clinical Science, Study Official</name_or_title>
      <organization>Takeda</organization>
      <phone>+1-877-825-3327</phone>
      <email>trialdisclosures@takeda.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/NCT02193087
org study id: DEN-106
secondary id: U1111-1154-9746
nct id: NCT02193087
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the equivalence of the lyophilized formulation of
      Takeda's Tetravalent Dengue Vaccine Candidate (TDV) compared with the liquid formulation of
      TDV.
The vaccine being tested in this study is Takeda's Tetravalent Dengue Vaccine Candidate
      (TDV). This study is designed to determine whether the lyophilized formulation provides
      equivalent safety and immunogenicity as the original liquid formulation. An exploratory
      analysis has been added for the purpose of understanding whether there is a manufacturing or
      formulation effect on the vaccine.

      The study will enroll approximately 1000 participants. Participants will be randomly assigned
      (by chance, like flipping a coin) to one of the four study groups-which will remain
      undisclosed to the participant and study doctor during the study (unless there is an urgent
      medical need):

        -  Group A: TDV Liquid Formulation 1, subcutaneous (SC) injection on Day 1 and placebo
           (dummy) SC at Month 3 - this is a liquid that looks like the study drug but has no
           active ingredient

        -  Group B: TDV Liquid Formulation 1, SC injection Day 1 and Month 3

        -  Group C: TDV Liquid Formulation 2, SC injection Day 1 and Month 3

        -  Group D: TDV Lyophilized formulation SC injection Day 1 and Month 3

      In order to keep the treatment arms undisclosed to the participant and the doctor,
      participants will receive a placebo injection at any study visit where TDV is not being
      administered (Month 3). Participants will be asked to record any adverse events that may be
      related to the vaccine or the injection in a diary card for 28 days after each vaccination.

      This multi-center trial will be conducted in the United States. The overall time to
      participate in this study is up to 10 months. Participants will make 9 visits to the clinic
      including a final visit 1 month after last dose of study drug for a follow-up assessment. A
      follow up phone call will be done 6 months after the last dose to assess serious adverse
      events.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Geometric Mean Titer (GMT) of Neutralizing Antibodies for Each of the Four Dengue Serotypes Comparing Group D To Groups A and B Combined
time frame: Month 1
description: Geometric mean titer (GMT) of neutralizing antibodies for each of the four dengue serotypes as measured by Plaque Reduction Neutralization Test resulting in 50% reduction in Plaques (PRNT50). The four dengue serotypes are DEN-1, DEN-2, DEN-3 and DEN-4.
A 90% Confidence Interval (CI) for the ratio of GMT (or equivalently the difference of the log transformed GMT) was provided, for each serotype, for the comparison of the lyophilized formulation (Group D) versus the liquid formulation 1 (Groups A+B combined). An Analysis of Variance (ANOVA) model for the natural log-transformed GMT at month 1 with study group as a factor was used for analysis.
measure: Geometric Mean Titers (GMT) of Neutralizing Antibodies for Each of the Four Dengue Serotypes Comparing Group D With Group B
time frame: Months 1 and 4
description: Geometric mean titer (GMT) of neutralizing antibodies for each of the four dengue serotypes as measured by Plaque Reduction Neutralization Test resulting in 50% reduction in Plaques (PRNT50). The four dengue serotypes are DEN-1, DEN-2, DEN-3 and DEN-4. ANOVA model for the natural log-transformed GMT at month 1 with study group as a factor was used for analysis.
measure: Percentage of Participants With a Seropositive Response for Each of the Four Dengue Serotypes Comparing Group D With Groups A and B Combined
time frame: Month 1
description: A seropositive response is defined as a reciprocal neutralizing titer ≥ 10. The four dengue serotypes are DEN-1, DEN-2, DEN-3 and DEN-4.
measure: Percentage of Participants With a Seropositive Response for Each of the Four Dengue Serotypes Comparing Group D With Group B
time frame: Months 1 and 4
description: A seropositive response is defined as a reciprocal neutralizing titer ≥ 10. The four dengue serotypes are DEN-1, DEN-2, DEN-3 and DEN-4.
measure: Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs)
time frame: Days 1 through 7 after each vaccination
description: Solicited local AEs at injection site are defined as pain, erythema and swelling that occurred at least once within 7 days after either vaccination, as recorded by the participants in a diary. Percentages are based on the number of participants with diary data available.
measure: Percentage of Participants With Solicited Systemic Adverse Events (AEs)
time frame: Days 1 through 14 after each vaccination
description: Solicited systemic AEs are defined as asthenia, fever, headache, malaise, and myalgia that occurred at least once within 14 days after either vaccination, as recorded by the participants in a diary. Percentages are based on the number of participants with diary data available.
measure: Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity
time frame: Days 1 through 7 after each vaccination
description: The percentage of participants with solicited local AEs at injection site of varying severity are reported. Solicited local AEs are defined as pain, erythema and swelling that occurred at least once within 7 days after either vaccination, as recorded by the participants in a diary. Participants with multiple episodes are categorized using the highest severity level. Percentages are based on the number of participants with diary data available.
measure: Percentage of Participants With Solicited Systemic Adverse Events (AEs) by Severity
time frame: Days 1 through 14 after each vaccination
description: The percentage of participants with solicited systemic AEs of varying severity are reported. Solicited systemic AEs are defined as asthenia, fever, headache, malaise, and myalgia that occurred at least once within 14 days after either vaccination, as recorded by the participants in a diary. Participants with multiple episodes are categorized using the highest severity level. Percentages are based on the number of participants with diary data available.
measure: Percentage of Participants With Any Unsolicited Adverse Events (AEs)
time frame: Up to Day 28 after each vaccination
description: Unsolicited AEs are any AEs that are not solicited local or systemic AEs, as defined by this study, that occurred at least once within 28 days after either vaccination. An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. The investigator assessed whether the AE was related to the study vaccination.
measure: Percentage of Participants With Serious Adverse Events (SAEs)
time frame: Up to 6 Months after the last dose (9 months)
description: A serious adverse event (SAE) is defined as any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria.
measure: Percentage of Participants With Markedly Abnormal Laboratory Values in the Safety Sub-Set
time frame: Days 8, 15, 91, 97 and 104
description: Percentage of participants with markedly abnormal standard safety laboratory values collected at any time after the first vaccination.
arm group label: Group A: TDV Liquid + Placebo
arm group type: Active Comparator
description: Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).
arm group label: Group B: TDV Liquid
arm group type: Active Comparator
description: TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).
arm group label: Group C: TDV Liquid
arm group type: Experimental
description: TDV Liquid Formulation 2, subcutaneous injection on Day 1 and Day 90 (Month 3).
arm group label: Group D: TDV Lyophilized
arm group type: Experimental
description: TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).
intervention type: Drug
intervention name: TDV Liquid Formulation 1
description: TDV Liquid Formulation 1 for subcutaneous injection
arm group label: Group A: TDV Liquid + Placebo
arm group label: Group B: TDV Liquid
intervention type: Drug
intervention name: TDV Liquid Formulation 2
description: TDV Liquid Formulation 2 for subcutaneous injection
arm group label: Group C: TDV Liquid
intervention type: Drug
intervention name: TDV IDT Lyophilized
description: TDV Lyophilized Formulation for subcutaneous injection
arm group label: Group D: TDV Lyophilized
intervention type: Drug
intervention name: Placebo
description: TDV liquid formulation placebo-matching solution for subcutaneous injection
arm group label: Group A: TDV Liquid + Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 49 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Medical Director Clinical Science
role: Study Director
affiliation: Takeda
facility: 
facility: 
facility: 
facility: 
facility: 
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facility: 
country: United States
responsible party type: Sponsor
mesh term: Dengue
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 