<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/NCT01728792</url>
  </required_header>
  <id_info>
    <org_study_id>INV-DEN-105</org_study_id>
    <secondary_id>U1111-1181-0251</secondary_id>
    <nct_id>NCT01728792</nct_id>
  </id_info>
  <brief_title>Impact of SC vs IM Administration of DENVax (TDV) on Safety and Immunogenicity</brief_title>
  <official_title>Impact of Subcutaneous Versus Intramuscular Administration of Inviragen's Live Attenuated Dengue Vaccine on Safety and Immunogenicity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Takeda</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Walter Reed Army Institute of Research (WRAIR)</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>Takeda</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study assessed the safety and immunogenicity of Takeda's Tetravalent Dengue Vaccine&#xD;
      Candidate (TDV) previously referred to as DENVax of various dosing schedules via subcutaneous&#xD;
      (SC) or intramuscular (IM) administration with needle/syringe or needle-free injector&#xD;
      (PharmaJet Stratis™).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The vaccine tested in this study was TDV. TDV was tested to assess safety and immunogenicity&#xD;
      of various dosing schedules, routes of administration, and delivery methods in healthy&#xD;
      flavivirus-seronegative adults living in a dengue non-endemic country.&#xD;
&#xD;
      The study enrolled 80 participants. Participants were randomly assigned to one of the five&#xD;
      treatment groups:&#xD;
&#xD;
        -  Group 1: TDV SC injection on Day 0 in each arm using needle/syringe&#xD;
&#xD;
        -  Group 2: TDV IM injection on Day 0 in each arm using needle/syringe&#xD;
&#xD;
        -  Group3: TDV IM injection on Days 0 and 90 using needle/syringe&#xD;
&#xD;
        -  Group 4: TDV SC on Day 0 in each arm using the PharmaJet Stratis™ device&#xD;
&#xD;
        -  Group 5: TDV IM on Day 0 in each arm using the PharmaJet Stratis™ device&#xD;
&#xD;
      This single-center trial was conducted in the United States. The overall time to participate&#xD;
      in this study was up to 5 months. Participants made multiple visits to the clinic including a&#xD;
      final visit at Day 120 for a safety follow-up assessment.&#xD;
&#xD;
      This work was supported by the US Army Medical Research and Materiel Command under Contract&#xD;
      No. W81XWH-12-C-0278.&#xD;
&#xD;
      The views, opinions and/or findings contained in this report are those of the author(s) and&#xD;
      should not be construed as an official Department of the Army position, policy or decision&#xD;
      unless so designated by other documentation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 22, 2013</start_date>
  <completion_date type="Actual">November 21, 2013</completion_date>
  <primary_completion_date type="Actual">November 1, 2013</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Solicited Local (Injection Site) Reactions Following Either Vaccine Administration (Day 0 or Day 90) by Maximum Severity as Assessed by the Investigator</measure>
    <time_frame>For 14 days after each vaccination (Up to Day 14 and/or Day 104)</time_frame>
    <description>Injection site reactions were evaluated by the investigator within 14 days following each injection. Erythema (redness), edema (swelling/induration) and pain were graded per The FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Pain was graded from 0=None to 4=Life-threatening. Erythema and Edema longest diameter were graded using the scale: 0=&lt;2.5 centimeters (cm) to 3=Severe: &gt;10 cm. Itching was graded using Common Terminology Criteria for Adverse Events (CTCAE) 4.03 where: Grade 0=no itching to Grade 3=severe. Injection site reactions are presented as the number of participants experiencing a reaction, by reaction type, overall and by severity, using the participant's worst reported severity grade. Only categories for which there was at least 1 participant are reported. Group 3 participants received 2 doses 90 days apart; injection site reactions following either vaccination are combined.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Solicited Participant-Reported Local (Injection Site) Reactions Following Either Vaccine by Maximum Severity</measure>
    <time_frame>For 14 days after each vaccination (Up to Day 14 and/or Day 104)</time_frame>
    <description>Injection site reactions were recorded by the participant in a memory aid for 14 days following each injection. Participants measured and recorded the longest diameter of redness (erythema) or swelling (edema) using the scale: 0=&lt; 2.5 cm to 3= Severe: &gt; 10 cm. For pain and itching they recorded intensity grade: 0=not present, 1=mild, 2=moderate or 3=severe. Participant-recorded local reactions are presented as number of participants reporting a reaction, by reaction type, overall and by severity, using the participant's worst reported severity grade. Only those score categories for which there was at least 1 participant are reported. Group 3 participants received 2 doses 90 days apart; injection site reactions following either vaccination are combined.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Solicited Participant-Reported Systemic Adverse Events (AEs) Following Either Vaccine by Maximum Severity</measure>
    <time_frame>For 14 days after each vaccination (Up to Day 14 and/or Day 104)</time_frame>
    <description>Solicited systemic AEs were recorded by the participant into a memory aid for 14 days following each vaccination. Solicited systemic AEs included: headache, muscle pain (myalgia), joint pain (arthralgia), eye pain, sensitivity to light (photophobia), tiredness (fatigue), body rash, nausea and vomiting. Systemic AEs were graded per The FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trial where: Grade 0=none to Grade 4=severe. A systemic AE of fever (defined as ≥ 100.4°F) was derived from a daily temperature reading recorded in the memory aid. Solicited systemic AEs are presented as the number of participants reporting the event, by, AE, overall and by severity, using the participant's worst reported severity grade. Group 3 participants received 2 doses 90 days apart; systemic AEs following either vaccination are combined.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With at Least 1 Unsolicited Related Adverse Event Following Either Vaccine Dose</measure>
    <time_frame>For 30 days after each vaccination for non-serious AEs and through the end of the study for SAEs (Up to 120 Days)</time_frame>
    <description>An Adverse Event (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>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With at Least 1 Serious Adverse Event During the Study</measure>
    <time_frame>First Vaccination to End of Study (Up to Day 120)</time_frame>
    <description>An Adverse Event (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.&#xD;
A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Seroconversion Rate to Each of Four Dengue Serotypes</measure>
    <time_frame>Approximately 28 to 30 days after each vaccination (Up to Day 30 and/or Day 104)</time_frame>
    <description>Seroconversion rate was defined as the percentage of participants with Plaque Reduction Neutralization Test titer resulting in 50 % reduction in Plaques (PRNT50) titer ≥ 10 for participants seronegative at Baseline or a greater than four-fold increase in PRNT50 for participants seropositive at Baseline.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Detected Viral RNA for Each TDV Component After First and Second Vaccinations</measure>
    <time_frame>Days 0, 7, 9, 11, 14, 17, 21, 90, 97 and 104</time_frame>
    <description>Viral RNA was assessed for the four dengue components: Dengue-1 (TDV-1), Dengue-2 (TDV-2), Dengue-3 (TDV-3) and Dengue-4 (TDV-4). Only those time-points where at least 1 participant had Viral RNA detected are reported. Baseline (Day 0) and Day 7 are added for reference. &quot;n&quot; in each of the categories is the number of participants with data available.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes</measure>
    <time_frame>Days 28, 90 and 120 after 1st vaccination</time_frame>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Dengue Fever</condition>
  <arm_group>
    <arm_group_label>Group 1: TDV SC_2 Doses Day 0</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous (SC) injection, one dose in each arm, Day 0 using a needle/syringe.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2: TDV IM_2 Doses Day 0</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TDV, 0.5 mL, intramuscular (IM) injection, one dose in each arm, Day 0 using a needle/syringe.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3: TDV IM_2 Doses Days 0 and 90</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TDV, 0.5 mL, IM injection, one dose on Day 0 and one dose on Day 90 using a needle/syringe.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 4: TDV SC_2 Doses Day 0</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TDV, 0.5 mL, SC injection, one dose in each arm, Day 0 using the PharmaJet Stratis™ device.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 5: TDV IM_2 Doses Day 0</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TDV, 0.5 mL, IM injection, one dose in each arm, Day 0 using the PharmaJet Stratis™ device.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>TDV</intervention_name>
    <description>TDV IM or SC injection</description>
    <arm_group_label>Group 1: TDV SC_2 Doses Day 0</arm_group_label>
    <arm_group_label>Group 2: TDV IM_2 Doses Day 0</arm_group_label>
    <arm_group_label>Group 3: TDV IM_2 Doses Days 0 and 90</arm_group_label>
    <arm_group_label>Group 4: TDV SC_2 Doses Day 0</arm_group_label>
    <arm_group_label>Group 5: TDV IM_2 Doses Day 0</arm_group_label>
    <other_name>DENVax</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Men and women at least 18 years and ≤ 45 years of age at time of screening.&#xD;
&#xD;
          2. In good health as determined by medical history and physical examination (including&#xD;
             blood pressure and heart rate).&#xD;
&#xD;
          3. Weight: Body Mass Index (BMI) ≤ 35.&#xD;
&#xD;
          4. Blood tests negative for antibodies to human immunodeficiency virus-1 (HIV-1),&#xD;
             Hepatitis C, and Hepatitis B surface antigen.&#xD;
&#xD;
          5. Females who are not surgically sterile or post-menopausal must have a negative urine&#xD;
             pregnancy test immediately prior to vaccination and be willing to use oral,&#xD;
             implantable, transdermal or injectable contraceptives or another reliable means of&#xD;
             contraception approved by the Investigator (intrauterine device, female condom,&#xD;
             diaphragm with spermicidal foam, cervical cap, use of condom by the sexual partner or&#xD;
             a sterile sexual partner, or abstinence) from screening until the blood sample on Day&#xD;
             120.&#xD;
&#xD;
          6. Willing and able to give written informed consent to participate.&#xD;
&#xD;
          7. Willing and able to communicate with the Investigator and understand the requirements&#xD;
             of the study.&#xD;
&#xD;
          8. Access to a fixed or mobile telephone.&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          1. Any condition which would limit the participant's ability to complete the study in the&#xD;
             opinion of the Investigator.&#xD;
&#xD;
          2. Any Grade 2 or above abnormality in the screening laboratory tests.&#xD;
&#xD;
          3. Febrile illness (temperature ≥ 38°C or 100.4°F) or moderate or severe acute illness or&#xD;
             infection within three days before vaccination.&#xD;
&#xD;
          4. History of any significant dermatologic disease in the last 6 months, particularly&#xD;
             with a maculopapular or petechial rash. However, if a participant had a self-limited&#xD;
             Candida infection that was cured, then the participant can be enrolled if there is no&#xD;
             evidence of an infection for at least 3 weeks prior to the date of dosing. If the&#xD;
             participant has acne limited to the face, topical medications are allowed except for 2&#xD;
             weeks prior and 4 weeks after each dose. Oral medications for acne are excluded for 1&#xD;
             month prior to the start of dosing.&#xD;
&#xD;
          5. History of dengue fever, Japanese encephalitis, West Nile, or Yellow Fever disease.&#xD;
&#xD;
          6. Seropositivity to dengue or West Nile (WN) virus.&#xD;
&#xD;
          7. History of travel to dengue endemic areas including the Caribbean, Mexico, Central&#xD;
             America, South America or Southeast Asia during the month prior to screening, or&#xD;
             planned travel to a dengue endemic area during the study period.&#xD;
&#xD;
          8. Extensive scarring or tattoo (&gt; 50%) on arms, shoulders, neck, face and head that&#xD;
             could identify a participant in photos or hinder the evaluation of injection site&#xD;
             reactions. In addition, no tattoo on the arms is permitted during the study and for&#xD;
             one month after the final injection.&#xD;
&#xD;
          9. 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;
         10. Hypersensitivity to any vaccine.&#xD;
&#xD;
         11. Receipt or planned receipt of any vaccine in the 4 weeks preceding or following the&#xD;
             Day 0 or 90 injections.&#xD;
&#xD;
         12. Previous vaccination (in a clinical trial or with an approved product) against yellow&#xD;
             fever (YF) or Japanese Encephalitis (JE).&#xD;
&#xD;
         13. Known or suspected congenital or acquired immunodeficiency or immunosuppressive&#xD;
             therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6&#xD;
             months.&#xD;
&#xD;
         14. Use of systemic corticosteroids therapy within the previous 6 months (at a dose of at&#xD;
             least 0.5 mg/kg/day prednisone equivalent). Topical prednisone is not permitted if&#xD;
             currently in use or used within the last month. Inhaled prednisone is permitted.&#xD;
&#xD;
         15. Use of any non-steroidal anti-inflammatory drugs (NSAIDs), acetaminophen or&#xD;
             antihistamines for the 3 days immediately prior to each vaccination.&#xD;
&#xD;
         16. History of diabetes mellitus.&#xD;
&#xD;
         17. History of thymic pathology, thymectomy, myasthenia or any immunodeficiency.&#xD;
&#xD;
         18. Positive urine screen for cocaine, amphetamines, opiates, or cannabinoids&#xD;
&#xD;
         19. Known history of alcohol abuse.&#xD;
&#xD;
         20. Receipt of any other investigational product or participation in any other clinical&#xD;
             trial of a product or device within 30 days before the first vaccination (Day 0) or&#xD;
             planned participation in any other clinical trial while enrolled in this trial (though&#xD;
             Day 120).&#xD;
&#xD;
         21. Receipt of blood products or immunoglobulins 8 weeks before the first vaccination (Day&#xD;
             0) or planned use during the period of this study (through Day 120).&#xD;
&#xD;
         22. Planned donation of blood during the period of this study (through Day 120).&#xD;
&#xD;
         23. Females who are pregnant or lactating.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 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>SUNY Upstate Medical University</name>
      <address>
        <city>Syracuse</city>
        <state>New York</state>
        <zip>13210</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>October 16, 2012</study_first_submitted>
  <study_first_submitted_qc>November 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 20, 2012</study_first_posted>
  <results_first_submitted>August 30, 2016</results_first_submitted>
  <results_first_submitted_qc>November 4, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">January 4, 2017</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>Prophylactic vaccination</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 1 investigative site in the United States from 22 January 2013 to 21 November 2013.</recruitment_details>
      <pre_assignment_details>Healthy participants were randomized equally to 1 of 5 TDV treatment groups: 2 doses subcutaneous (SC) on Day 0 using needle/syringe, 2 doses intramuscular (IM) on Day 0 using needle/syringe, 1 dose IM on Days 0 and 90 using needle/syringe, 2 doses SC on Day 0 using the PharmaJet Stratis™ device and 2 doses IM on Day 0 using the PharmaJet Stratis™.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Group 1: TDV SC_ 2 Doses Day 0</title>
          <description>Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous (SC) injection, one dose in each arm, Day 0 using needle/syringe.</description>
        </group>
        <group group_id="P2">
          <title>Group 2: TDV IM_2 Doses Day 0</title>
          <description>TDV, 0.5 mL, intramuscular (IM) injection, one dose in each arm, Day 0 using needle/syringe.</description>
        </group>
        <group group_id="P3">
          <title>Group 3: TDV IM_2 Doses Days 0 and 90</title>
          <description>TDV, 0.5 mL, IM injection, one dose on Day 0 and one dose on Day 90 using needle/syringe.</description>
        </group>
        <group group_id="P4">
          <title>Group 4: TDV SC_2 Doses Day 0</title>
          <description>TDV, 0.5 mL, SC injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.</description>
        </group>
        <group group_id="P5">
          <title>Group 5: TDV IM_2 Doses Day 0</title>
          <description>TDV, 0.5 mL, IM injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="16"/>
                <participants group_id="P3" count="17"/>
                <participants group_id="P4" count="17"/>
                <participants group_id="P5" count="16"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="14"/>
                <participants group_id="P3" count="13"/>
                <participants group_id="P4" count="14"/>
                <participants group_id="P5" count="16"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="3"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal of Consent</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="4"/>
                <participants group_id="P4" count="2"/>
                <participants group_id="P5" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Safety Analysis Set included all enrolled participants who received at least 1 dose of study vaccine and for whom any post-vaccination safety data has been obtained.</population>
      <group_list>
        <group group_id="B1">
          <title>Group 1: TDV SC_ 2 Doses Day 0</title>
          <description>Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous (SC) injection, one dose in each arm, Day 0 using needle/syringe.</description>
        </group>
        <group group_id="B2">
          <title>Group 2: TDV IM_2 Doses Day 0</title>
          <description>TDV, 0.5 mL, intramuscular (IM) injection, one dose in each arm, Day 0 using needle/syringe.</description>
        </group>
        <group group_id="B3">
          <title>Group 3: TDV IM_2 Doses Days 0 and 90</title>
          <description>TDV, 0.5 mL, IM injection, one dose on Day 0 and one dose on Day 90 using needle/syringe.</description>
        </group>
        <group group_id="B4">
          <title>Group 4: TDV SC_2 Doses Day 0</title>
          <description>TDV, 0.5 mL, SC injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.</description>
        </group>
        <group group_id="B5">
          <title>Group 5: TDV IM_2 Doses Day 0</title>
          <description>TDV, 0.5 mL, IM injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.</description>
        </group>
        <group group_id="B6">
          <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="14"/>
            <count group_id="B2" value="16"/>
            <count group_id="B3" value="17"/>
            <count group_id="B4" value="17"/>
            <count group_id="B5" value="16"/>
            <count group_id="B6" value="80"/>
          </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="28.2" spread="5.81"/>
                    <measurement group_id="B2" value="30.2" spread="7.49"/>
                    <measurement group_id="B3" value="27.5" spread="7.92"/>
                    <measurement group_id="B4" value="30.4" spread="7.48"/>
                    <measurement group_id="B5" value="30.8" spread="7.79"/>
                    <measurement group_id="B6" value="29.4" spread="7.31"/>
                  </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="5"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="6"/>
                    <measurement group_id="B6" value="30"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="11"/>
                    <measurement group_id="B5" value="10"/>
                    <measurement group_id="B6" value="50"/>
                  </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</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Non-Hispanic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="15"/>
                    <measurement group_id="B4" value="16"/>
                    <measurement group_id="B5" value="16"/>
                    <measurement group_id="B6" value="76"/>
                  </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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="2"/>
                    <measurement group_id="B6" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black or African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="4"/>
                    <measurement group_id="B5" value="1"/>
                    <measurement group_id="B6" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Native Hawaiian or Pacific Islander</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="13"/>
                    <measurement group_id="B5" value="13"/>
                    <measurement group_id="B6" value="63"/>
                  </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="1"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                    <measurement group_id="B6" value="1"/>
                  </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="14"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="17"/>
                    <measurement group_id="B4" value="17"/>
                    <measurement group_id="B5" value="16"/>
                    <measurement group_id="B6" value="80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Solicited Local (Injection Site) Reactions Following Either Vaccine Administration (Day 0 or Day 90) by Maximum Severity as Assessed by the Investigator</title>
        <description>Injection site reactions were evaluated by the investigator within 14 days following each injection. Erythema (redness), edema (swelling/induration) and pain were graded per The FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Pain was graded from 0=None to 4=Life-threatening. Erythema and Edema longest diameter were graded using the scale: 0=&lt;2.5 centimeters (cm) to 3=Severe: &gt;10 cm. Itching was graded using Common Terminology Criteria for Adverse Events (CTCAE) 4.03 where: Grade 0=no itching to Grade 3=severe. Injection site reactions are presented as the number of participants experiencing a reaction, by reaction type, overall and by severity, using the participant's worst reported severity grade. Only categories for which there was at least 1 participant are reported. Group 3 participants received 2 doses 90 days apart; injection site reactions following either vaccination are combined.</description>
        <time_frame>For 14 days after each vaccination (Up to Day 14 and/or Day 104)</time_frame>
        <population>Safety Analysis Set included all enrolled participants who received at least 1 dose of study vaccine and for whom post-dosing data was obtained.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: TDV SC_ 2 Doses Day 0</title>
            <description>Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous (SC) injection, one dose in each arm, Day 0 using needle/syringe.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: TDV IM_2 Doses Day 0</title>
            <description>TDV, 0.5 mL, intramuscular (IM) injection, one dose in each arm, Day 0 using needle/syringe.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: TDV IM_2 Doses Days 0 and 90</title>
            <description>TDV, 0.5 mL, IM injection, one dose on Day 0 and one dose on Day 90 using needle/syringe.</description>
          </group>
          <group group_id="O4">
            <title>Group 4: TDV SC_2 Doses Day 0</title>
            <description>TDV, 0.5 mL, SC injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.</description>
          </group>
          <group group_id="O5">
            <title>Group 5: TDV IM_2 Doses Day 0</title>
            <description>TDV, 0.5 mL, IM injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Solicited Local (Injection Site) Reactions Following Either Vaccine Administration (Day 0 or Day 90) by Maximum Severity as Assessed by the Investigator</title>
          <description>Injection site reactions were evaluated by the investigator within 14 days following each injection. Erythema (redness), edema (swelling/induration) and pain were graded per The FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Pain was graded from 0=None to 4=Life-threatening. Erythema and Edema longest diameter were graded using the scale: 0=&lt;2.5 centimeters (cm) to 3=Severe: &gt;10 cm. Itching was graded using Common Terminology Criteria for Adverse Events (CTCAE) 4.03 where: Grade 0=no itching to Grade 3=severe. Injection site reactions are presented as the number of participants experiencing a reaction, by reaction type, overall and by severity, using the participant's worst reported severity grade. Only categories for which there was at least 1 participant are reported. Group 3 participants received 2 doses 90 days apart; injection site reactions following either vaccination are combined.</description>
          <population>Safety Analysis Set included all enrolled participants who received at least 1 dose of study vaccine and for whom post-dosing data was obtained.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="16"/>
                <count group_id="O3" value="17"/>
                <count group_id="O4" value="17"/>
                <count group_id="O5" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Erythema_Any Grade</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="4"/>
                    <measurement group_id="O5" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Erythema_Grade 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Erythema_Grade 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Edema_Any Grade</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain_Any Grade</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="7"/>
                    <measurement group_id="O4" value="6"/>
                    <measurement group_id="O5" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain_Grade 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="5"/>
                    <measurement group_id="O5" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain_Grade 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Itching_Any Grade</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Itching_Grade 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Itching_Grade 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Solicited Participant-Reported Local (Injection Site) Reactions Following Either Vaccine by Maximum Severity</title>
        <description>Injection site reactions were recorded by the participant in a memory aid for 14 days following each injection. Participants measured and recorded the longest diameter of redness (erythema) or swelling (edema) using the scale: 0=&lt; 2.5 cm to 3= Severe: &gt; 10 cm. For pain and itching they recorded intensity grade: 0=not present, 1=mild, 2=moderate or 3=severe. Participant-recorded local reactions are presented as number of participants reporting a reaction, by reaction type, overall and by severity, using the participant's worst reported severity grade. Only those score categories for which there was at least 1 participant are reported. Group 3 participants received 2 doses 90 days apart; injection site reactions following either vaccination are combined.</description>
        <time_frame>For 14 days after each vaccination (Up to Day 14 and/or Day 104)</time_frame>
        <population>Participants from the Safety Analysis Set, all enrolled participants who received at least 1 dose of study vaccine and for whom post-dosing data was obtained.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: TDV SC_ 2 Doses Day 0</title>
            <description>Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous (SC) injection, one dose in each arm, Day 0 using needle/syringe.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: TDV IM_2 Doses Day 0</title>
            <description>TDV, 0.5 mL, intramuscular (IM) injection, one dose in each arm, Day 0 using needle/syringe.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: TDV IM_2 Doses Days 0 and 90</title>
            <description>TDV, 0.5 mL, IM injection, one dose on Day 0 and one dose on Day 90 using needle/syringe.</description>
          </group>
          <group group_id="O4">
            <title>Group 4: TDV SC_2 Doses Day 0</title>
            <description>TDV, 0.5 mL, SC injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.</description>
          </group>
          <group group_id="O5">
            <title>Group 5: TDV IM_2 Doses Day 0</title>
            <description>TDV, 0.5 mL, IM injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Solicited Participant-Reported Local (Injection Site) Reactions Following Either Vaccine by Maximum Severity</title>
          <description>Injection site reactions were recorded by the participant in a memory aid for 14 days following each injection. Participants measured and recorded the longest diameter of redness (erythema) or swelling (edema) using the scale: 0=&lt; 2.5 cm to 3= Severe: &gt; 10 cm. For pain and itching they recorded intensity grade: 0=not present, 1=mild, 2=moderate or 3=severe. Participant-recorded local reactions are presented as number of participants reporting a reaction, by reaction type, overall and by severity, using the participant's worst reported severity grade. Only those score categories for which there was at least 1 participant are reported. Group 3 participants received 2 doses 90 days apart; injection site reactions following either vaccination are combined.</description>
          <population>Participants from the Safety Analysis Set, all enrolled participants who received at least 1 dose of study vaccine and for whom post-dosing data was obtained.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="16"/>
                <count group_id="O3" value="17"/>
                <count group_id="O4" value="17"/>
                <count group_id="O5" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Erythema_Any Grade (n=9,10,14,14,13)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="4"/>
                    <measurement group_id="O5" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Erythema_Grade 1 (n=9,10,14,14,13)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Erythema_Grade 2 (n=9,10,14,14,13)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Erythema_Grade 3 (n=9,10,14,14,13)</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="1"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Edema_Any Grade (n=8,10,14,12,12)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Edema_Grade 1 (n=8,10,14,12,12)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Edema_Grade 2 (n=8,10,14,12,12)</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="1"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain_Any Grade (n=13,16,17,17,16)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="8"/>
                    <measurement group_id="O4" value="11"/>
                    <measurement group_id="O5" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain_Grade 1 (n=13,16,17,17,16)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="8"/>
                    <measurement group_id="O4" value="9"/>
                    <measurement group_id="O5" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain_Grade 2 (n=13,16,17,17,16)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Itching_Any Grade (n=13,15,17,17,16)</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="3"/>
                    <measurement group_id="O5" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Itching_Grade 1 (n=13,15,17,17,16)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Itching_Grade 2 (n=13,15,17,17,16)</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="1"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Solicited Participant-Reported Systemic Adverse Events (AEs) Following Either Vaccine by Maximum Severity</title>
        <description>Solicited systemic AEs were recorded by the participant into a memory aid for 14 days following each vaccination. Solicited systemic AEs included: headache, muscle pain (myalgia), joint pain (arthralgia), eye pain, sensitivity to light (photophobia), tiredness (fatigue), body rash, nausea and vomiting. Systemic AEs were graded per The FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trial where: Grade 0=none to Grade 4=severe. A systemic AE of fever (defined as ≥ 100.4°F) was derived from a daily temperature reading recorded in the memory aid. Solicited systemic AEs are presented as the number of participants reporting the event, by, AE, overall and by severity, using the participant's worst reported severity grade. Group 3 participants received 2 doses 90 days apart; systemic AEs following either vaccination are combined.</description>
        <time_frame>For 14 days after each vaccination (Up to Day 14 and/or Day 104)</time_frame>
        <population>Participants from the Safety Analysis Set included all enrolled participants who received at least 1 dose of study vaccine and for whom post-dosing data was obtained.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: TDV SC_ 2 Doses Day 0</title>
            <description>Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous (SC) injection, one dose in each arm, Day 0 using needle/syringe.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: TDV IM_2 Doses Day 0</title>
            <description>TDV, 0.5 mL, intramuscular (IM) injection, one dose in each arm, Day 0 using needle/syringe.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: TDV IM_2 Doses Days 0 and 90</title>
            <description>TDV, 0.5 mL, IM injection, one dose on Day 0 and one dose on Day 90 using needle/syringe.</description>
          </group>
          <group group_id="O4">
            <title>Group 4: TDV SC_2 Doses Day 0</title>
            <description>TDV, 0.5 mL, SC injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.</description>
          </group>
          <group group_id="O5">
            <title>Group 5: TDV IM_2 Doses Day 0</title>
            <description>TDV, 0.5 mL, IM injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Solicited Participant-Reported Systemic Adverse Events (AEs) Following Either Vaccine by Maximum Severity</title>
          <description>Solicited systemic AEs were recorded by the participant into a memory aid for 14 days following each vaccination. Solicited systemic AEs included: headache, muscle pain (myalgia), joint pain (arthralgia), eye pain, sensitivity to light (photophobia), tiredness (fatigue), body rash, nausea and vomiting. Systemic AEs were graded per The FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trial where: Grade 0=none to Grade 4=severe. A systemic AE of fever (defined as ≥ 100.4°F) was derived from a daily temperature reading recorded in the memory aid. Solicited systemic AEs are presented as the number of participants reporting the event, by, AE, overall and by severity, using the participant's worst reported severity grade. Group 3 participants received 2 doses 90 days apart; systemic AEs following either vaccination are combined.</description>
          <population>Participants from the Safety Analysis Set included all enrolled participants who received at least 1 dose of study vaccine and for whom post-dosing data was obtained.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="16"/>
                <count group_id="O3" value="17"/>
                <count group_id="O4" value="17"/>
                <count group_id="O5" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Fever_Any Grade (n=13,16,17,17,16)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Headache_Any Grade</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="9"/>
                    <measurement group_id="O4" value="6"/>
                    <measurement group_id="O5" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Headache_Grade 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="5"/>
                    <measurement group_id="O5" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Headache_Grade 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Headache_Grade 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Myalgia_Any Grade</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Myalgia_Grade 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Myalgia_Grade 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Arthralgia_Any Grade</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Arthralgia_Grade 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Arthralgia_Grade 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Eye Pain_Any Grade</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Photophobia_Any Grade</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Photophobia_Grade 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Photophobia_Grade 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fatigue_Any Grade</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="6"/>
                    <measurement group_id="O4" value="6"/>
                    <measurement group_id="O5" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fatigue_Grade 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="6"/>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fatigue_Grade 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="5"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fatigue_Grade 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Rash_Any Grade</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Rash_Grade 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Rash_Grade 2</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="1"/>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Nausea_Any Grade</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="2"/>
                    <measurement group_id="O5" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Nausea_Grade1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="1"/>
                    <measurement group_id="O5" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Nausea_Grade 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Nausea_Grade 3</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="1"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Vomiting_Any Grade</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With at Least 1 Unsolicited Related Adverse Event Following Either Vaccine Dose</title>
        <description>An Adverse Event (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>For 30 days after each vaccination for non-serious AEs and through the end of the study for SAEs (Up to 120 Days)</time_frame>
        <population>Safety Analysis Set included all enrolled participants who received at least 1 dose of study vaccine and for whom post-dosing data was obtained.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: TDV SC_ 2 Doses Day 0</title>
            <description>Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous (SC) injection, one dose in each arm, Day 0 using needle/syringe.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: TDV IM_2 Doses Day 0</title>
            <description>TDV, 0.5 mL, intramuscular (IM) injection, one dose in each arm, Day 0 using needle/syringe.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: TDV IM_2 Doses Days 0 and 90</title>
            <description>TDV, 0.5 mL, IM injection, one dose on Day 0 and one dose on Day 90 using needle/syringe.</description>
          </group>
          <group group_id="O4">
            <title>Group 4: TDV SC_2 Doses Day 0</title>
            <description>TDV, 0.5 mL, SC injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.</description>
          </group>
          <group group_id="O5">
            <title>Group 5: TDV IM_2 Doses Day 0</title>
            <description>TDV, 0.5 mL, IM injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With at Least 1 Unsolicited Related Adverse Event Following Either Vaccine Dose</title>
          <description>An Adverse Event (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>Safety Analysis Set included all enrolled participants who received at least 1 dose of study vaccine and for whom post-dosing data was obtained.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="16"/>
                <count group_id="O3" value="17"/>
                <count group_id="O4" value="17"/>
                <count group_id="O5" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With at Least 1 Serious Adverse Event During the Study</title>
        <description>An Adverse Event (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.&#xD;
A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.</description>
        <time_frame>First Vaccination to End of Study (Up to Day 120)</time_frame>
        <population>Safety Analysis Set includes all enrolled participants who received at least 1 dose of study vaccine and for whom post-dosing data was obtained.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: TDV SC_ 2 Doses Day 0</title>
            <description>Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous (SC) injection, one dose in each arm, Day 0 using needle/syringe.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: TDV IM_2 Doses Day 0</title>
            <description>TDV, 0.5 mL, intramuscular (IM) injection, one dose in each arm, Day 0 using needle/syringe.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: TDV IM_2 Doses Days 0 and 90</title>
            <description>TDV, 0.5 mL, IM injection, one dose on Day 0 and one dose on Day 90 using needle/syringe.</description>
          </group>
          <group group_id="O4">
            <title>Group 4: TDV SC_2 Doses Day 0</title>
            <description>TDV, 0.5 mL, SC injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.</description>
          </group>
          <group group_id="O5">
            <title>Group 5: TDV IM_2 Doses Day 0</title>
            <description>TDV, 0.5 mL, IM injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With at Least 1 Serious Adverse Event During the Study</title>
          <description>An Adverse Event (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.&#xD;
A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.</description>
          <population>Safety Analysis Set includes all enrolled participants who received at least 1 dose of study vaccine and for whom post-dosing data was obtained.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="16"/>
                <count group_id="O3" value="17"/>
                <count group_id="O4" value="17"/>
                <count group_id="O5" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Seroconversion Rate to Each of Four Dengue Serotypes</title>
        <description>Seroconversion rate was defined as the percentage of participants with Plaque Reduction Neutralization Test titer resulting in 50 % reduction in Plaques (PRNT50) titer ≥ 10 for participants seronegative at Baseline or a greater than four-fold increase in PRNT50 for participants seropositive at Baseline.</description>
        <time_frame>Approximately 28 to 30 days after each vaccination (Up to Day 30 and/or Day 104)</time_frame>
        <population>Protocol deviations results in testing not performed for outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: TDV SC_ 2 Doses Day 0</title>
            <description>Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous (SC) injection, one dose in each arm, Day 0 using needle/syringe.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: TDV IM_2 Doses Day 0</title>
            <description>TDV, 0.5 mL, intramuscular (IM) injection, one dose in each arm, Day 0 using needle/syringe.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: TDV IM_2 Doses Days 0 and 90</title>
            <description>TDV, 0.5 mL, IM injection, one dose on Day 0 and one dose on Day 90 using needle/syringe.</description>
          </group>
          <group group_id="O4">
            <title>Group 4: TDV SC_2 Doses Day 0</title>
            <description>TDV, 0.5 mL, SC injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.</description>
          </group>
          <group group_id="O5">
            <title>Group 5: TDV IM_2 Doses Day 0</title>
            <description>TDV, 0.5 mL, IM injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.</description>
          </group>
        </group_list>
        <measure>
          <title>Seroconversion Rate to Each of Four Dengue Serotypes</title>
          <description>Seroconversion rate was defined as the percentage of participants with Plaque Reduction Neutralization Test titer resulting in 50 % reduction in Plaques (PRNT50) titer ≥ 10 for participants seronegative at Baseline or a greater than four-fold increase in PRNT50 for participants seropositive at Baseline.</description>
          <population>Protocol deviations results in testing not performed for outcome measure.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
                <count group_id="O5" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Detected Viral RNA for Each TDV Component After First and Second Vaccinations</title>
        <description>Viral RNA was assessed for the four dengue components: Dengue-1 (TDV-1), Dengue-2 (TDV-2), Dengue-3 (TDV-3) and Dengue-4 (TDV-4). Only those time-points where at least 1 participant had Viral RNA detected are reported. Baseline (Day 0) and Day 7 are added for reference. &quot;n&quot; in each of the categories is the number of participants with data available.</description>
        <time_frame>Days 0, 7, 9, 11, 14, 17, 21, 90, 97 and 104</time_frame>
        <population>Participants from the Safety Analysis Set, all enrolled participants who received at least 1 dose of study vaccine, with data available at the given time-point.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: TDV SC_ 2 Doses Day 0</title>
            <description>Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous (SC) injection, one dose in each arm, Day 0 using needle/syringe.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: TDV IM_2 Doses Day 0</title>
            <description>TDV, 0.5 mL, intramuscular (IM) injection, one dose in each arm, Day 0 using needle/syringe.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: TDV IM_2 Doses Days 0 and 90</title>
            <description>TDV, 0.5 mL, IM injection, one dose on Day 0 and one dose on Day 90 using needle/syringe.</description>
          </group>
          <group group_id="O4">
            <title>Group 4: TDV SC_2 Doses Day 0</title>
            <description>TDV, 0.5 mL, SC injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.</description>
          </group>
          <group group_id="O5">
            <title>Group 5: TDV IM_2 Doses Day 0</title>
            <description>TDV, 0.5 mL, IM injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Detected Viral RNA for Each TDV Component After First and Second Vaccinations</title>
          <description>Viral RNA was assessed for the four dengue components: Dengue-1 (TDV-1), Dengue-2 (TDV-2), Dengue-3 (TDV-3) and Dengue-4 (TDV-4). Only those time-points where at least 1 participant had Viral RNA detected are reported. Baseline (Day 0) and Day 7 are added for reference. &quot;n&quot; in each of the categories is the number of participants with data available.</description>
          <population>Participants from the Safety Analysis Set, all enrolled participants who received at least 1 dose of study vaccine, with data available at the given time-point.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="14"/>
                <count group_id="O2" value="16"/>
                <count group_id="O3" value="17"/>
                <count group_id="O4" value="17"/>
                <count group_id="O5" value="16"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 0_TDV-1, TDV-2, TDV-3, TDV-4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 7_TDV-1, TDV-2, TDV-3, TDV-4 (n=7,8,9,8,7)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 9_TDV-1, TDV-3, TDV-4 (n=6,8,7,9,9)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 9 _TDV-2 (n=6,8,7,9,9)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="5"/>
                    <measurement group_id="O5" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 11_TDV-1, TDV-3 (n=7,8,9,7,7)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 11_TDV-2 (n=7,8,9,7,7)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 11_TDV-4 (n=7,8,9,7,7)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14_TDV-1, TDV-3, TDV-4 (n=6,8,7,10,9)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 14_TDV-2 (n=6,8,7,10,9)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="9"/>
                    <measurement group_id="O5" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 17_TDV-1, TDV-3, TDV-4 (n=7,8,9,8,7)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 17_TDV-2 (n=7,8,9,8,7)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="3"/>
                    <measurement group_id="O5" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 21_TDV-1, TDV-3, TDV-4 (n=6,8,8,9,9)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 21_TDV-2 (n=6,8,8,9,9)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                    <measurement group_id="O5" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes</title>
        <time_frame>Days 28, 90 and 120 after 1st vaccination</time_frame>
        <population>Protocol deviations results in testing not performed for outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Group 1: TDV SC_ 2 Doses Day 0</title>
            <description>Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous (SC) injection, one dose in each arm, Day 0 using needle/syringe.</description>
          </group>
          <group group_id="O2">
            <title>Group 2: TDV IM_2 Doses Day 0</title>
            <description>TDV, 0.5 mL, intramuscular (IM) injection, one dose in each arm, Day 0 using needle/syringe.</description>
          </group>
          <group group_id="O3">
            <title>Group 3: TDV IM_2 Doses Days 0 and 90</title>
            <description>TDV, 0.5 mL, IM injection, one dose on Day 0 and one dose on Day 90 using needle/syringe.</description>
          </group>
          <group group_id="O4">
            <title>Group 4: TDV SC_2 Doses Day 0</title>
            <description>TDV, 0.5 mL, SC injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.</description>
          </group>
          <group group_id="O5">
            <title>Group 5: TDV IM_2 Doses Day 0</title>
            <description>TDV, 0.5 mL, IM injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.</description>
          </group>
        </group_list>
        <measure>
          <title>Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes</title>
          <population>Protocol deviations results in testing not performed for outcome measure.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
                <count group_id="O4" value="0"/>
                <count group_id="O5" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Unsolicited AEs: up to 30 days after each vaccination; SAEs: throughout the study (Up to Day 120)</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 1: TDV SC_ 2 Doses Day 0</title>
          <description>Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous (SC) injection, one dose in each arm, Day 0 using needle/syringe.</description>
        </group>
        <group group_id="E2">
          <title>Group 2: TDV IM_2 Doses Day 0</title>
          <description>TDV, 0.5 mL, intramuscular (IM) injection, one dose in each arm, Day 0 using needle/syringe.</description>
        </group>
        <group group_id="E3">
          <title>Group 3: TDV IM_2 Doses Days 0 and 90</title>
          <description>TDV, 0.5 mL, IM injection, one dose on Day 0 and one dose on Day 90 using needle/syringe.</description>
        </group>
        <group group_id="E4">
          <title>Group 4: TDV SC_2 Doses Day 0</title>
          <description>TDV, 0.5 mL, SC injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.</description>
        </group>
        <group group_id="E5">
          <title>Group 5: TDV IM_2 Doses Day 0</title>
          <description>TDV, 0.5 mL, IM injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 16.1</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cyanosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Hypoaesthesia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Neuralgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>2</frequency_threshold>
        <default_vocab>MedDRA 16.1</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="9" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="10" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="7" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="11" subjects_at_risk="16"/>
              </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="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Endocrine disorder</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Eye pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Dyspepsia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Gastrooesophageal reflux disease</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Chest pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Chills</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Injection site scar</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Multiple allergies</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Eye infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Gastroenteritis viral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Pharyngitis streptococcal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Sinusitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Tooth infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Vaginitis bacterial</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Viral infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Corneal abrasion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Epicondylitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Laceration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Muscle strain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Wrist fracture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="16"/>
              </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="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Joint swelling</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="2" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Migraine</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Paraesthesia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Glycosuria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Benign prostatic hyperplasia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Dysmenorrhoea</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Erectile dysfunction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Asthma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Respiratory tract congestion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Sinus congestion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Sneezing</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Tonsillar hypertrophy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dermatitis contact</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Ecchymosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="2" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Hyperkeratosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Ingrown hair</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Hot flush</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="1" subjects_at_risk="16"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="17"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E5" subjects_affected="0" subjects_at_risk="16"/>
              </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>No publication related to study results will be made without Sponsor's prior written approval. Any proposed publication or presentation will be submitted to Sponsor for review 60 days in advance of publication. Institution will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for an additional 60 days to preserve intellectual property.</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Due to protocol non-compliance issues, sponsor decided to only report safety data.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Takeda Study Registration Call Center, Central Contact</name_or_title>
      <organization>Takeda</organization>
      <phone>+1-877-825-3327</phone>
      <email>medicalinformation@tpna.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/NCT01728792
org study id: INV-DEN-105
secondary id: U1111-1181-0251
nct id: NCT01728792
lead sponsor: 
collaborator: 
has dmc: No
This study assessed the safety and immunogenicity of Takeda's Tetravalent Dengue Vaccine
      Candidate (TDV) previously referred to as DENVax of various dosing schedules via subcutaneous
      (SC) or intramuscular (IM) administration with needle/syringe or needle-free injector
      (PharmaJet Stratis™).
The vaccine tested in this study was TDV. TDV was tested to assess safety and immunogenicity
      of various dosing schedules, routes of administration, and delivery methods in healthy
      flavivirus-seronegative adults living in a dengue non-endemic country.

      The study enrolled 80 participants. Participants were randomly assigned to one of the five
      treatment groups:

        -  Group 1: TDV SC injection on Day 0 in each arm using needle/syringe

        -  Group 2: TDV IM injection on Day 0 in each arm using needle/syringe

        -  Group3: TDV IM injection on Days 0 and 90 using needle/syringe

        -  Group 4: TDV SC on Day 0 in each arm using the PharmaJet Stratis™ device

        -  Group 5: TDV IM on Day 0 in each arm using the PharmaJet Stratis™ device

      This single-center trial was conducted in the United States. The overall time to participate
      in this study was up to 5 months. Participants made multiple visits to the clinic including a
      final visit at Day 120 for a safety follow-up assessment.

      This work was supported by the US Army Medical Research and Materiel Command under Contract
      No. W81XWH-12-C-0278.

      The views, opinions and/or findings contained in this report are those of the author(s) and
      should not be construed as an official Department of the Army position, policy or decision
      unless so designated by other documentation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Number of Participants With Solicited Local (Injection Site) Reactions Following Either Vaccine Administration (Day 0 or Day 90) by Maximum Severity as Assessed by the Investigator
time frame: For 14 days after each vaccination (Up to Day 14 and/or Day 104)
description: Injection site reactions were evaluated by the investigator within 14 days following each injection. Erythema (redness), edema (swelling/induration) and pain were graded per The FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Pain was graded from 0=None to 4=Life-threatening. Erythema and Edema longest diameter were graded using the scale: 0=<2.5 centimeters (cm) to 3=Severe: >10 cm. Itching was graded using Common Terminology Criteria for Adverse Events (CTCAE) 4.03 where: Grade 0=no itching to Grade 3=severe. Injection site reactions are presented as the number of participants experiencing a reaction, by reaction type, overall and by severity, using the participant's worst reported severity grade. Only categories for which there was at least 1 participant are reported. Group 3 participants received 2 doses 90 days apart; injection site reactions following either vaccination are combined.
measure: Number of Participants With Solicited Participant-Reported Local (Injection Site) Reactions Following Either Vaccine by Maximum Severity
time frame: For 14 days after each vaccination (Up to Day 14 and/or Day 104)
description: Injection site reactions were recorded by the participant in a memory aid for 14 days following each injection. Participants measured and recorded the longest diameter of redness (erythema) or swelling (edema) using the scale: 0=< 2.5 cm to 3= Severe: > 10 cm. For pain and itching they recorded intensity grade: 0=not present, 1=mild, 2=moderate or 3=severe. Participant-recorded local reactions are presented as number of participants reporting a reaction, by reaction type, overall and by severity, using the participant's worst reported severity grade. Only those score categories for which there was at least 1 participant are reported. Group 3 participants received 2 doses 90 days apart; injection site reactions following either vaccination are combined.
measure: Number of Participants With Solicited Participant-Reported Systemic Adverse Events (AEs) Following Either Vaccine by Maximum Severity
time frame: For 14 days after each vaccination (Up to Day 14 and/or Day 104)
description: Solicited systemic AEs were recorded by the participant into a memory aid for 14 days following each vaccination. Solicited systemic AEs included: headache, muscle pain (myalgia), joint pain (arthralgia), eye pain, sensitivity to light (photophobia), tiredness (fatigue), body rash, nausea and vomiting. Systemic AEs were graded per The FDA Guidance for Industry: Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trial where: Grade 0=none to Grade 4=severe. A systemic AE of fever (defined as ≥ 100.4°F) was derived from a daily temperature reading recorded in the memory aid. Solicited systemic AEs are presented as the number of participants reporting the event, by, AE, overall and by severity, using the participant's worst reported severity grade. Group 3 participants received 2 doses 90 days apart; systemic AEs following either vaccination are combined.
measure: Number of Participants With at Least 1 Unsolicited Related Adverse Event Following Either Vaccine Dose
time frame: For 30 days after each vaccination for non-serious AEs and through the end of the study for SAEs (Up to 120 Days)
description: An Adverse Event (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: Number of Participants With at Least 1 Serious Adverse Event During the Study
time frame: First Vaccination to End of Study (Up to Day 120)
description: An Adverse Event (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.
A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.
measure: Seroconversion Rate to Each of Four Dengue Serotypes
time frame: Approximately 28 to 30 days after each vaccination (Up to Day 30 and/or Day 104)
description: Seroconversion rate was defined as the percentage of participants with Plaque Reduction Neutralization Test titer resulting in 50 % reduction in Plaques (PRNT50) titer ≥ 10 for participants seronegative at Baseline or a greater than four-fold increase in PRNT50 for participants seropositive at Baseline.
measure: Number of Participants With Detected Viral RNA for Each TDV Component After First and Second Vaccinations
time frame: Days 0, 7, 9, 11, 14, 17, 21, 90, 97 and 104
description: Viral RNA was assessed for the four dengue components: Dengue-1 (TDV-1), Dengue-2 (TDV-2), Dengue-3 (TDV-3) and Dengue-4 (TDV-4). Only those time-points where at least 1 participant had Viral RNA detected are reported. Baseline (Day 0) and Day 7 are added for reference. "n" in each of the categories is the number of participants with data available.
measure: Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes
time frame: Days 28, 90 and 120 after 1st vaccination
arm group label: Group 1: TDV SC_2 Doses Day 0
arm group type: Experimental
description: Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous (SC) injection, one dose in each arm, Day 0 using a needle/syringe.
arm group label: Group 2: TDV IM_2 Doses Day 0
arm group type: Experimental
description: TDV, 0.5 mL, intramuscular (IM) injection, one dose in each arm, Day 0 using a needle/syringe.
arm group label: Group 3: TDV IM_2 Doses Days 0 and 90
arm group type: Experimental
description: TDV, 0.5 mL, IM injection, one dose on Day 0 and one dose on Day 90 using a needle/syringe.
arm group label: Group 4: TDV SC_2 Doses Day 0
arm group type: Experimental
description: TDV, 0.5 mL, SC injection, one dose in each arm, Day 0 using the PharmaJet Stratis™ device.
arm group label: Group 5: TDV IM_2 Doses Day 0
arm group type: Experimental
description: TDV, 0.5 mL, IM injection, one dose in each arm, Day 0 using the PharmaJet Stratis™ device.
intervention type: Biological
intervention name: TDV
description: TDV IM or SC injection
arm group label: Group 1: TDV SC_2 Doses Day 0
arm group label: Group 2: TDV IM_2 Doses Day 0
arm group label: Group 3: TDV IM_2 Doses Days 0 and 90
arm group label: Group 4: TDV SC_2 Doses Day 0
arm group label: Group 5: TDV IM_2 Doses Day 0
other name: DENVax
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Medical Director Clinical Science
role: Study Director
affiliation: Takeda
facility: 
country: United States
responsible party type: Sponsor
mesh term: Dengue
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Due to protocol non-compliance issues, sponsor decided to only report safety data.
point of contact: 