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    Clinical Trial Results:
    A Phase II, Double-Blind, Controlled Trial to Assess the Safety and Immunogenicity of Different Schedules of Takeda's Tetravalent Dengue Vaccine Candidate (TDV) in Healthy Subjects Aged Between 2 and <18 Years and Living in Dengue Endemic Countries in Asia and Latin America

    Summary
    EudraCT number
    		 2018-003978-28
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    18 Feb 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    26 Feb 2020
    First version publication date
    26 Feb 2020
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    DEN-204
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02302066
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Takeda
    Sponsor organisation address
    Takeda Vaccines, Inc., 40 Landsdowne Street Cambridge, MA, United States, United States, 02139
    Public contact
    Medical Director, Takeda, +1 877-825-3327, clinicaltrialregistry@tpna.com
    Scientific contact
    Medical Director, Takeda, +1 8778253327, trialdisclosures@takeda.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-001888-PIP01-15
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    18 Feb 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Feb 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this study is to assess the humoral immune responses to Takeda's Tetravalent Dengue Vaccine Candidate (TDV) administered subcutaneously in a subset of healthy participants between 2 and <18 years of age living in dengue endemic countries.
    Protection of trial subjects
    All study subjects or their guardians were required to read and sign an Informed Consent Form
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 Dec 2014
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 3 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Dominican Republic: 535
    Country: Number of subjects enrolled
    Panama: 935
    Country: Number of subjects enrolled
    Philippines: 330
    Worldwide total number of subjects
    1800
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    1463
    Adolescents (12-17 years)
    337
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Participants took part in the study at 3 investigative sites in Dominican Republic, Panama and Philippines from 05 Dec 2014 to 18 Feb 2019.

    Pre-assignment
    Screening details
    		 Healthy volunteers were enrolled in a 1:2:5:1 ratio into 4 study groups: Group 1 received two doses of Tetravalent Dengue Vaccine (TDV), Group 2 received one dose of TDV, Group 3 received one dose of TDV along with booster vaccination and Group 4 received placebo.

    Pre-assignment period milestones
    Number of subjects started
    		 1800
    Number of subjects completed
    		 1794

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Randomized but not Treated: 6
    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1 (TDV 2-Dose)
    Arm description
    		 Takeda's tetravalent dengue vaccine candidate (TDV), 0.5 mL, subcutaneous injection on Days 1 and 91. Placebo-matching, 0.5 mL, subcutaneous injection on Day 365.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Takeda's tetravalent dengue vaccine candidate (TDV)
    Investigational medicinal product code
    Other name
    DenVax
    Pharmaceutical forms
    Concentrate and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Takeda's tetravalent dengue vaccine candidate (TDV), 0.5 mL, subcutaneous injection on Days 1 and 91.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo-matching, 0.5 mL, subcutaneous injection on Day 365.

    Arm title
    		 Group 2 (TDV 1-Dose)
    Arm description
    		 Takeda's TDV, 0.5 mL, subcutaneous injection on Day 1. Placebo-matching, 0.5 mL, subcutaneous injection on Days 91 and 365.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Takeda\'s tetravalent dengue vaccine candidate (TDV)
    Investigational medicinal product code
    Other name
    DenVax
    Pharmaceutical forms
    Concentrate and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Takeda's tetravalent dengue vaccine candidate (TDV), 0.5 mL, subcutaneous injection on Days 1.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo-matching, 0.5 mL, subcutaneous injection on Days 91 and 365.

    Arm title
    		 Group 3 (TDV 1-Dose + Booster)
    Arm description
    		 Takeda's TDV, 0.5 mL, subcutaneous injection on Days 1 and 365. Placebo-matching, 0.5 mL, subcutaneous injection on Day 91.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Takeda\'s tetravalent dengue vaccine candidate (TDV)
    Investigational medicinal product code
    Other name
    DenVax
    Pharmaceutical forms
    Concentrate and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Takeda's tetravalent dengue vaccine candidate (TDV), 0.5 mL, subcutaneous injection on Days 1 and 365.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo-matching, 0.5 mL, subcutaneous injection on Day 91.

    Arm title
    		 Group 4 (Placebo Control)
    Arm description
    		 Placebo-matching, 0.5 mL, subcutaneous injection on Days 1, 91 and 365.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo-matching, 0.5 mL, subcutaneous injection on Day 1, 91 and 365

    Number of subjects in period 1 [1]
    		Group 1 (TDV 2-Dose) Group 2 (TDV 1-Dose) Group 3 (TDV 1-Dose + Booster) Group 4 (Placebo Control)
    Started
    200
    398
    998
    198
    Immunogenicity Subset
    92 [2]
    187 [3]
    192 [4]
    94 [5]
    Per-Protocol Set (PPS)
    83 [6]
    171 [7]
    174 [8]
    81 [9]
    Completed
    192
    376
    954
    187
    Not completed
    8
    22
    44
    11
         Adverse Event
    2
    1
    4
    -
         Reason Not Specified
    -
    1
    5
    2
         Pregnancy
    -
    4
    -
    -
         Withdrawal by Subject
    5
    15
    27
    5
         Lost to follow-up
    1
    1
    8
    4
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: This is based on Safety Set.
    [2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: This is Per-protocol Set.
    [3] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: This is Per-protocol Set.
    [4] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: This is Per-protocol Set.
    [5] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: This is Per-protocol Set.
    [6] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: This is Per-protocol Set.
    [7] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: This is Per-protocol Set.
    [8] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: This is Per-protocol Set.
    [9] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: This is Per-protocol Set.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group 1 (TDV 2-Dose)
    Reporting group description
    		 Takeda's tetravalent dengue vaccine candidate (TDV), 0.5 mL, subcutaneous injection on Days 1 and 91. Placebo-matching, 0.5 mL, subcutaneous injection on Day 365.

    Reporting group title
    Group 2 (TDV 1-Dose)
    Reporting group description
    		 Takeda's TDV, 0.5 mL, subcutaneous injection on Day 1. Placebo-matching, 0.5 mL, subcutaneous injection on Days 91 and 365.

    Reporting group title
    Group 3 (TDV 1-Dose + Booster)
    Reporting group description
    		 Takeda's TDV, 0.5 mL, subcutaneous injection on Days 1 and 365. Placebo-matching, 0.5 mL, subcutaneous injection on Day 91.

    Reporting group title
    Group 4 (Placebo Control)
    Reporting group description
    		 Placebo-matching, 0.5 mL, subcutaneous injection on Days 1, 91 and 365.

    Reporting group values
    		 Group 1 (TDV 2-Dose) Group 2 (TDV 1-Dose) Group 3 (TDV 1-Dose + Booster) Group 4 (Placebo Control) Total
    Number of subjects
    		 200 398 998 198 1794
    Age categorical
    Units: Subjects
        Children (2-11 years)
    		 162 323 811 162 1458
        Adolescents (12-17 years)
    		 38 75 187 36 336
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 7.3 ( 4.01 ) 7.3 ( 4.14 ) 7.3 ( 4.06 ) 7.0 ( 3.96 ) -
    Sex: Female, Male
    Units: Subjects
        Female
    		 100 207 486 95 888
        Male
    		 100 191 512 103 906
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 165 317 825 158 1465
        Not Hispanic or Latino
    		 35 81 173 40 329
        Unknown or Not Reported
    		 0 0 0 0 0
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 102 204 505 101 912
        Asian
    		 35 82 174 40 331
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0 0
        Black or African American
    		 63 110 311 56 540
        White
    		 0 2 8 1 11
        More than one race
    		 0 0 0 0 0
        Unknown or Not Reported
    		 0 0 0 0 0
    Height
    Units: cm
        arithmetic mean (standard deviation)
    		 122.1 ( 22.59 ) 120.9 ( 23.15 ) 121.4 ( 22.60 ) 119.3 ( 21.88 ) -
    Weight
    Units: kg
        arithmetic mean (standard deviation)
    		 27.86 ( 15.069 ) 27.25 ( 14.368 ) 27.12 ( 13.612 ) 25.66 ( 13.371 ) -
    Body Mass Index (BMI)
    Body Mass Index=weight/[height^2]
    Units: kg/m^2
        arithmetic mean (standard deviation)
    		 17.42 ( 3.558 ) 17.43 ( 3.306 ) 17.29 ( 3.123 ) 16.93 ( 2.975 ) -

    End points

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    End points reporting groups
    Reporting group title
    Group 1 (TDV 2-Dose)
    Reporting group description
    		 Takeda's tetravalent dengue vaccine candidate (TDV), 0.5 mL, subcutaneous injection on Days 1 and 91. Placebo-matching, 0.5 mL, subcutaneous injection on Day 365.

    Reporting group title
    Group 2 (TDV 1-Dose)
    Reporting group description
    		 Takeda's TDV, 0.5 mL, subcutaneous injection on Day 1. Placebo-matching, 0.5 mL, subcutaneous injection on Days 91 and 365.

    Reporting group title
    Group 3 (TDV 1-Dose + Booster)
    Reporting group description
    		 Takeda's TDV, 0.5 mL, subcutaneous injection on Days 1 and 365. Placebo-matching, 0.5 mL, subcutaneous injection on Day 91.

    Reporting group title
    Group 4 (Placebo Control)
    Reporting group description
    		 Placebo-matching, 0.5 mL, subcutaneous injection on Days 1, 91 and 365.

    Subject analysis set title
    Group 1 (TDV 2-Dose) Infant/Toddler
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants aged <6 years received Takeda's tetravalent dengue vaccine candidate (TDV), 0.5 mL, subcutaneous injection on Days 1 and 91. Placebo matching, 0.5 mL, subcutaneous injection on Day 365.

    Subject analysis set title
    Group 2 (TDV 1-Dose) Infant/Toddler
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants aged <6 years received Takeda's TDV, 0.5 mL, subcutaneous injection on Day 1. Placebo matching, 0.5 mL, subcutaneous injection on Days 91 and 365.

    Subject analysis set title
    Group 3 (TDV 2-Dose) Infant/Toddler
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants aged <6 years received Takeda's TDV, 0.5 mL, subcutaneous injection on Days 1 and 365. Placebo matching, 0.5 mL, subcutaneous injection on Day 91.

    Subject analysis set title
    Group 4 (Placebo Control) Infant/Toddler
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants aged <6 years received placebo matching, 0.5 mL, subcutaneous injection on Days 1, 91 and 365.

    Subject analysis set title
    Group 1 (TDV 2-Dose) Adult/Children
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants aged ≥6 years received Takeda's tetravalent dengue vaccine candidate (TDV), 0.5 mL, subcutaneous injection on Days 1 and 91. Placebo matching, 0.5 mL, subcutaneous injection on Day 365.

    Subject analysis set title
    Group 2 (TDV 1-Dose) Adult/Children
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants aged ≥6 years received Takeda's TDV, 0.5 mL, subcutaneous injection on Day 1. Placebo matching, 0.5 mL, subcutaneous injection on Days 91 and 365.

    Subject analysis set title
    Group 3 (TDV 1-Dose + Booster) Adult/Children
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants aged ≥6 years received Takeda's TDV, 0.5 mL, subcutaneous injection on Days 1 and 365. Placebo matching, 0.5 mL, subcutaneous injection on Day 91.

    Subject analysis set title
    Group 4 (Placebo Control) Adult/Children
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participant aged ≥6 years received placebo matching, 0.5 mL, subcutaneous injection on Days 1, 91 and 365.

    Primary: Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset.

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    End point title
    		 Geometric Mean Titers (GMTs) of Neutralizing Antibodies (Microneutralization Test [MNT50]) for Each of the Four DENV Serotypes for Participants in the Immunogenicity Subset. [1]
    End point description
    GMTs of neutralizing antibodies were measured by microneutralization test 50% [MNT50] for each of the 4 Dengue Serotypes. The 4 dengue virus serotypes were DENV-1, DENV-2, DENV-3 and DENV-4. PPS: All participants who received at least 1 dose of trial vaccine, who had a valid pre-dose and at least 1 valid post-dose measurement for immunogenicity and no major protocol violations. PPS included only participants from Immunogenicity Subset. 'n' indicates number analyzed are participants with data available at the given timepoint. Data reported for up to Month 48 was collected at Months 1, 3, 6, 12, 13, 18, 24, 36 and 48.
    End point type
    Primary
    End point timeframe
    Up to Month 48
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical Analyses is not available for this endpoint.
    End point values
    		 Group 1 (TDV 2-Dose) Group 2 (TDV 1-Dose) Group 3 (TDV 1-Dose + Booster) Group 4 (Placebo Control)
    Number of subjects analysed
    83
    171
    174
    81
    Units: titer
    geometric mean (confidence interval 95%)
        DENV-1, Day 28 (Month 1),n=83,171,174,81
    768.2 (498.7 to 1183.4)
    999.7 (723.6 to 1381.2)
    920.9 (689.4 to 1230.1)
    60.7 (31.8 to 116.0)
        DENV-2, Day 28 (Month 1),n=83,171,174,81
    4329.7 (2847.6 to 6583.2)
    4219.3 (3118.9 to 5708.1)
    3572.2 (2674.6 to 4771.2)
    75.0 (39.6 to 141.8)
        DENV-3, Day 28 (Month 1),n=83,171,174,81
    216.1 (124.7 to 374.6)
    352.8 (237.5 to 524.2)
    363.6 (249.8 to 529.1)
    45.8 (25.9 to 81.1)
        DENV-4, Day 28 (Month 1),n=83,171,174,81
    199.2 (130.0 to 305.2)
    317.3 (232.2 to 433.5)
    260.4 (195.0 to 347.7)
    24.8 (16.2 to 38.0)
        DENV-1, Day 91 (Month 3),n=83,171,174,81
    422.3 (256.7 to 695.0)
    684.2 (491.4 to 952.8)
    708.9 (522.6 to 961.6)
    64.6 (33.8 to 123.4)
        DENV-2, Day 91 (Month 3),n=83,171,174,81
    1810.1 (1311.1 to 2499.2)
    2216.9 (1750.8 to 2807.2)
    1709.6 (1370.4 to 2132.7)
    76.0 (40.1 to 144.3)
        DENV-3, Day 91 (Month 3),n=83,171,174,81
    140.8 (83.8 to 236.6)
    250.8 (174.5 to 360.6)
    251.9 (175.7 to 361.2)
    39.3 (22.6 to 68.2)
        DENV-4, Day 91 (Month 3),n=83,171,174,81
    122.9 (77.6 to 194.6)
    170.8 (122.6 to 237.8)
    147.0 (108.4 to 199.2)
    23.4 (14.9 to 36.9)
        DENV-1, Day 180 (Month 6),n=83,170,174,81
    448.8 (293.0 to 687.5)
    463.7 (329.5 to 652.6)
    538.9 (391.2 to 742.3)
    55.7 (29.2 to 106.6)
        DENV-2, Day 180 (Month 6),n=83,170,174,81
    1461.5 (1071.7 to 1992.9)
    1682.9 (1333.5 to 2124.0)
    1335.1 (1067.7 to 1669.5)
    77.2 (39.8 to 149.6)
        DENV-3, Day 180 (Month 6),n=83,170,174,81
    150.1 (96.9 to 232.6)
    166.3 (117.6 to 235.3)
    173.9 (125.8 to 240.5)
    37.4 (21.7 to 64.6)
        DENV-4, Day 180 (Month 6),n=83,170,174,81
    109.1 (72.9 to 163.2)
    110.0 (81.0 to 149.2)
    92.3 (68.7 to 123.9)
    22.3 (14.1 to 35.1)
        DENV-1, Day 365 (Month 12),n=79,161,164,76
    370.7 (232.3 to 591.8)
    409.6 (287.9 to 582.5)
    487.3 (346.2 to 686.0)
    72.7 (38.0 to 139.1)
        DENV-2, Day 365 (Month 12),n=79,161,164,76
    1070.0 (746.7 to 1533.2)
    1529.8 (1179.0 to 1985.0)
    1041.0 (802.8 to 1349.9)
    133.9 (67.7 to 264.9)
        DENV-3, Day 365 (Month 12),n=79,161,164,76
    166.8 (101.4 to 274.2)
    201.0 (139.0 to 290.4)
    199.2 (138.7 to 286.1)
    62.0 (34.6 to 111.0)
        DENV-4, Day 365 (Month 12),n=79,161,164,76
    87.9 (57.7 to 133.8)
    85.6 (63.0 to 116.3)
    89.3 (64.5 to 123.6)
    29.3 (18.5 to 46.6)
        DENV-1, Day 393 (Month 13),n=80,163,167,75
    454.4 (273.4 to 755.2)
    385.8 (271.6 to 548.2)
    1598.8 (1258.2 to 2031.6)
    80.6 (41.4 to 156.9)
        DENV-2, Day 393 (Month 13),n=80,163,167,75
    1152.4 (796.3 to 1667.6)
    1384.1 (1066.3 to 1796.7)
    1866.1 (1551.4 to 2244.6)
    129.5 (64.9 to 258.6)
        DENV-3, Day 393 (Month 13),n=80,163,167,75
    192.1 (115.3 to 320.3)
    225.1 (157.1 to 322.7)
    767.6 (615.4 to 957.4)
    68.5 (36.5 to 128.8)
        DENV-4, Day 393 (Month 13),n=80,163,167,75
    90.5 (58.1 to 141.2)
    86.3 (64.2 to 116.1)
    278.0 (226.6 to 340.9)
    28.8 (18.0 to 46.0)
        DENV-1, Day 540 (Month 18),n=81,168,172,80
    475.9 (286.3 to 791.0)
    461.3 (329.1 to 646.6)
    1056.3 (804.0 to 1387.9)
    92.2 (49.1 to 172.9)
        DENV-2, Day 540 (Month 18),n=81,168,172,80
    1211.5 (841.6 to 1744.1)
    1241.8 (947.1 to 1628.1)
    1456.6 (1181.7 to 1795.5)
    176.7 (92.8 to 336.7)
        DENV-3, Day 540 (Month 18),n=81,168,172,80
    285.5 (170.7 to 477.5)
    298.0 (205.0 to 433.3)
    548.0 (411.2 to 730.3)
    77.6 (44.0 to 136.9)
        DENV-4, Day 540 (Month 18),n=81,168,172,80
    98.3 (64.5 to 149.9)
    102.0 (75.1 to 138.6)
    171.6 (132.9 to 221.6)
    33.1 (21.1 to 51.9)
        DENV-1, Day 730 (Month 24),n=71,145,148,70
    471.1 (289.9 to 765.4)
    441.5 (302.4 to 644.3)
    920.9 (699.9 to 1211.8)
    114.5 (58.8 to 223.0)
        DENV-2, Day 730 (Month 24),n=71,145,148,70
    1395.5 (962.1 to 2024.3)
    1748.2 (1328.8 to 2300.0)
    1685.8 (1346.1 to 2111.3)
    244.6 (118.2 to 506.3)
        DENV-3, Day 730 (Month 24),n=71,145,148,70
    243.0 (144.2 to 409.3)
    276.0 (188.3 to 404.7)
    470.1 (347.7 to 635.7)
    90.8 (46.6 to 176.8)
        DENV-4, Day 730 (Month 24),n=71,145,148,70
    180.0 (113.5 to 285.6)
    170.4 (121.3 to 239.4)
    285.9 (219.6 to 372.1)
    56.3 (32.1 to 98.9)
        DENV-1, Day 1095 (Month 36)n=66,137,139,66
    495.2 (278.9 to 879.3)
    364.7 (246.3 to 540.1)
    742.8 (553.6 to 996.8)
    90.7 (47.3 to 173.7)
        DENV-2, Day 1095 (Month 36),n=66,137,139,66
    1394.2 (946.4 to 2053.9)
    1408.4 (1057.3 to 1876.0)
    1476.2 (1153.3 to 1889.7)
    203.5 (100.0 to 414.0)
        DENV-3, Day 1095 (Month 36),n=66,137,139,66
    262.8 (158.2 to 436.5)
    214.9 (144.5 to 319.7)
    364.8 (266.4 to 499.4)
    66.4 (35.1 to 125.5)
        DENV-4, Day 1095 (Month 36),n=66,137,139,66
    201.8 (125.2 to 325.3)
    148.1 (104.8 to 209.3)
    236.1 (179.4 to 310.6)
    45.7 (27.0 to 77.2)
        DENV-1, Day 1460 (Month 48),n=65,133,136,63
    377.8 (226.1 to 631.5)
    421.0 (285.1 to 621.9)
    718.5 (537.7 to 959.9)
    100.0 (49.8 to 200.7)
        DENV-2, Day 1460 (Month 48),n=65,133,136,63
    1051.9 (732.2 to 1511.1)
    1319.0 (970.1 to 1793.5)
    1200.0 (927.1 to 1553.1)
    208.1 (99.2 to 436.5)
        DENV-3, Day 1460 (Month 48),n=65,133,136,63
    183.4 (112.9 to 298.0)
    200.5 (135.1 to 297.6)
    287.5 (210.7 to 392.4)
    71.3 (36.6 to 138.9)
        DENV-4, Day 1460 (Month 48),n=65,133,136,63
    152.0 (96.6 to 239.2)
    164.1 (114.1 to 236.0)
    218.6 (164.7 to 290.2)
    46.2 (26.1 to 81.8)
    No statistical analyses for this end point

    Secondary: Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset

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    End point title
    		 Seropositivity Rates For Each of the 4 Dengue Serotypes for Participants in the Immunogenicity Subset
    End point description
    Seropositivity rate, defined as the percentage of participants seropositive, was derived from the titers of dengue-neutralizing antibodies. Seropositivity defined as a reciprocal neutralizing titer ≥10 (for each serotype). The 4 dengue virus serotypes were DENV-1, DENV-2, DENV-3 and DENV-4.PPS included all participants who received at least 1 dose of trial vaccine, who had a valid pre-dose and at least 1 valid post-dose measurement for immunogenicity and no major protocol violations. PPS included only participants from Immunogenicity Subset. 'n' indicates number analyzed are participants with data available at the given timepoint
    End point type
    Secondary
    End point timeframe
    Months 1, 3, 6, 12, 13, 18, 24, 36, and 48
    End point values
    		 Group 1 (TDV 2-Dose) Group 2 (TDV 1-Dose) Group 3 (TDV 1-Dose + Booster) Group 4 (Placebo Control)
    Number of subjects analysed
    83
    171
    174
    81
    Units: percentage of participants
    number (confidence interval 95%)
        DENV-1, Day 28 (Month 1),n=83,171,174,81
    97.6 (91.6 to 99.7)
    97.7 (94.1 to 99.4)
    100.0 (97.9 to 100.0)
    49.4 (38.1 to 60.7)
        DENV-2, Day 28 (Month 1),n=83,171,174,81
    96.4 (89.8 to 99.2)
    95.3 (91.0 to 98.0)
    96.6 (92.6 to 98.7)
    51.9 (40.5 to 63.1)
        DENV-3, Day 28 (Month 1),n=83,171,174,81
    88.0 (79.0 to 94.1)
    90.1 (84.6 to 94.1)
    90.8 (85.5 to 94.7)
    50.6 (39.3 to 61.9)
        DENV-4, Day 28 (Month 1),n=83,171,174,81
    94.0 (86.5 to 98.0)
    93.6 (88.8 to 96.7)
    95.4 (91.1 to 98.0)
    49.4 (38.1 to 60.7)
        DENV-1, Day 91 (Month 3),n=83,171,174,81
    95.2 (88.1 to 98.7)
    97.7 (94.1 to 99.4)
    99.4 (96.8 to 100.0)
    51.9 (40.5 to 63.1)
        DENV-2, Day 91 (Month 3),n=83,171,174,81
    98.8 (93.5 to 100.0)
    98.8 (95.8 to 99.9)
    99.4 (96.8 to 100.0)
    53.1 (41.7 to 64.3)
        DENV-3, Day 91 (Month 3),n=83,171,174,81
    89.2 (80.4 to 94.9)
    95.3 (91.0 to 98.0)
    91.4 (86.2 to 95.1)
    48.1 (36.9 to 59.5)
        DENV-4, Day 91 (Month 3),n=83,171,174,81
    88.0 (79.0 to 94.1)
    90.6 (85.3 to 94.6)
    90.8 (85.5 to 94.7)
    45.7 (34.6 to 57.1)
        DENV-1, Day 180 (Month 6),n=83,170,174,81
    100.0 (95.7 to 100.0)
    97.1 (93.3 to 99.0)
    99.4 (96.8 to 100.0)
    49.4 (38.1 to 60.7)
        DENV-2, Day 180 (Month 6),n=83,170,174,81
    98.8 (93.5 to 100.0)
    99.4 (96.8 to 100.0)
    99.4 (96.8 to 100.0)
    49.4 (38.1 to 60.7)
        DENV-3, Day 180 (Month 6),n=83,170,174,81
    98.8 (93.5 to 100.0)
    92.9 (88.0 to 96.3)
    93.1 (88.3 to 96.4)
    48.1 (36.9 to 59.5)
        DENV-4, Day 180 (Month 6),n=83,170,174,81
    92.8 (84.9 to 97.3)
    90.6 (85.2 to 94.5)
    85.1 (78.9 to 90.0)
    44.4 (33.4 to 55.9)
        DENV-1, Day 365 (Month 12),n=79,161,164,76
    98.7 (93.1 to 100.0)
    97.5 (93.8 to 99.3)
    97.6 (93.9 to 99.3)
    57.9 (46.0 to 69.1)
        DENV-2, Day 365 (Month 12),n=79,161,164,76
    98.7 (93.1 to 100.0)
    99.4 (96.6 to 100.0)
    100.0 (97.8 to 100.0)
    60.5 (48.6 to 71.6)
        DENV-3, Day 365 (Month 12),n=79,161,164,76
    94.9 (87.5 to 98.6)
    94.4 (89.7 to 97.4)
    90.2 (84.6 to 94.3)
    57.9 (46.0 to 69.1)
        DENV-4, Day 365 (Month 12),n=79,161,164,76
    92.4 (84.2 to 97.2)
    85.1 (78.6 to 90.2)
    82.9 (76.3 to 88.3)
    55.3 (43.4 to 66.7)
        DENV-1, Day 393 (Month 13),n=80,163,167,75
    97.5 (91.3 to 99.7)
    95.7 (91.4 to 98.3)
    100.0 (97.8 to 100.0)
    60.0 (48.0 to 71.1)
        DENV-2, Day 393 (Month 13),n=80,163,167,75
    98.8 (93.2 to 100.0)
    98.8 (95.6 to 99.9)
    100.0 (97.8 to 100.0)
    61.3 (49.4 to 72.4)
        DENV-3, Day 393 (Month 13),n=80,163,167,75
    95.0 (87.7 to 98.6)
    95.1 (90.6 to 97.9)
    100.0 (97.8 to 100.0)
    57.3 (45.4 to 68.7)
        DENV-4, Day 393 (Month 13),n=80,163,167,75
    90.0 (81.2 to 95.6)
    86.5 (80.3 to 91.3)
    100.0 (97.8 to 100.0)
    53.3 (41.4 to 64.9)
        DENV-1, Day 540 (Month 18),n=81,168,172,80
    95.1 (87.8 to 98.6)
    97.0 (93.2 to 99.0)
    98.8 (95.9 to 99.9)
    62.5 (51.0 to 73.1)
        DENV-2, Day 540 (Month 18),n=81,168,172,80
    98.8 (93.3 to 100.0)
    97.6 (94.0 to 99.3)
    100.0 (97.9 to 100.0)
    68.8 (57.4 to 78.7)
        DENV-3, Day 540 (Month 18),n=81,168,172,80
    95.1 (87.8 to 98.6)
    92.3 (87.1 to 95.8)
    98.3 (95.0 to 99.6)
    63.8 (52.2 to 74.2)
        DENV-4, Day 540 (Month 18),n=81,168,172,80
    87.7 (78.5 to 93.9)
    86.9 (80.8 to 91.6)
    97.1 (93.3 to 99.0)
    57.5 (45.9 to 68.5)
        DENV-1, Day 730 (Month 24),n=71,145,148,70
    100.0 (94.9 to 100.0)
    95.9 (91.2 to 98.5)
    100.0 (97.5 to 100.0)
    68.6 (56.4 to 79.1)
        DENV-2, Day 730 (Month 24),n=71,145,148,70
    100.0 (94.9 to 100.0)
    99.3 (96.2 to 100.0)
    100.0 (97.5 to 100.0)
    71.4 (59.4 to 81.6)
        DENV-3, Day 730 (Month 24),n=71,145,148,70
    94.4 (86.2 to 98.4)
    93.1 (87.7 to 96.6)
    98.6 (95.2 to 99.8)
    65.7 (53.4 to 76.7)
        DENV-4, Day 730 (Month 24),n=71,145,148,70
    94.4 (86.2 to 98.4)
    91.7 (86.0 to 95.7)
    98.6 (95.2 to 99.8)
    61.4 (49.0 to 72.8)
        DENV-1, Day 1095 (Month 36),n=66,137,139,66
    100.0 (94.6 to 100.0)
    92.7 (87.0 to 96.4)
    100.0 (97.4 to 100.0)
    68.2 (55.6 to 79.1)
        DENV-2, Day 1095 (Month 36),n=66,137,139,66
    100.0 (94.6 to 100.0)
    99.3 (96.0 to 100.0)
    100.0 (97.4 to 100.0)
    71.2 (58.7 to 81.7)
        DENV-3, Day 1095 (Month 36),n=66,137,139,66
    97.0 (89.5 to 99.6)
    88.3 (81.7 to 93.2)
    98.6 (94.9 to 99.8)
    63.6 (50.9 to 75.1)
        DENV-4, Day 1095 (Month 36),n=66,137,139,66
    95.5 (87.3 to 99.1)
    88.3 (81.7 to 93.2)
    98.6 (94.9 to 99.8)
    63.6 (50.9 to 75.1)
        DENV-1, Day 1460 (Month 48),n=65,133,136,63
    96.9 (89.3 to 99.6)
    94.7 (89.5 to 97.9)
    100.0 (97.3 to 100.0)
    68.3 (55.3 to 79.4)
        DENV-2, Day 1460 (Month 48),n=65,133,136,63
    100.0 (94.5 to 100.0)
    98.5 (94.7 to 99.8)
    100.0 (97.3 to 100.0)
    68.3 (55.3 to 79.4)
        DENV-3, Day 1460 (Month 48),n=65,133,136,63
    95.4 (87.1 to 99.0)
    90.2 (83.9 to 94.7)
    97.8 (93.7 to 99.5)
    63.5 (50.4 to 75.3)
        DENV-4, Day 1460 (Month 48),n=65,133,136,63
    90.8 (81.0 to 96.5)
    91.0 (84.8 to 95.3)
    99.3 (96.0 to 100.0)
    60.3 (47.2 to 72.4)
    No statistical analyses for this end point

    Secondary: Percentage of Participants with Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following each Vaccination

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    End point title
    		 Percentage of Participants with Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following each Vaccination
    End point description
    Solicited local injection included pain, erythema at injection site, and swelling at injection site. They were collected using a diary and graded as [Grade 0 (no pain), 1 (mild: minor reaction to touch), 2 (moderate: cries/protests on touch) and 3 (severe: cries when limb is moved/spontaneously painful)]. Erythema and Swelling at injection site were graded as Grade 0 (<10 mm), 1 (mild: ≥10 – ≤ 20 mm), 2 (moderate: > 20 – ≤ 40 mm) and 3 (severe: > 40 mm).Safety Analysis Set included all participants who received at least 1 dose of trial vaccine. Only participants in immunogenicity subset were included. Data were summarized separately for each age group. 'n' indicates number analyzed are participants with data available for the category. Only categories for which there was at least 1 participant are reported.
    End point type
    Secondary
    End point timeframe
    Within 7 days after each vaccination
    End point values
    		 Group 1 (TDV 2-Dose) Infant/Toddler Group 2 (TDV 1-Dose) Infant/Toddler Group 3 (TDV 2-Dose) Infant/Toddler Group 4 (Placebo Control) Infant/Toddler
    Number of subjects analysed
    29
    60
    62
    32
    Units: percentage of participants
    number (not applicable)
        After Vaccination 1, Pain: Any, n=27,54,55,28
    11.1
    5.6
    12.7
    7.1
        After Vaccination 1, Pain: Mild,n=27,54,55,28
    11.1
    1.9
    10.9
    3.6
        After Vaccination 1, Pain: Moderate, n=27,54,55,28
    0
    3.7
    1.8
    3.6
        After Vaccination 1, Erythema: Any, n=27,53,55,27
    0
    3.8
    3.6
    0
        After Vaccination1,Erythema (1-2 cm),n=27,53,55,27
    0
    3.8
    3.6
    0
        After Vaccination 1, Swelling: Any, n=27,53,55,27
    0
    3.8
    0
    0
        After Vaccination 1,Swelling(1-2 cm),n=27,53,55,27
    0
    3.8
    0
    0
        After Vaccination 2,Pain: Any,n=26,53,54,29
    3.8
    3.8
    13.0
    6.9
        After Vaccination 2, Pain: Mild, n=26,53,54,29
    3.8
    3.8
    9.3
    6.9
        After Vaccination 2, Pain: Moderate, n=26,53,54,29
    0
    0
    3.7
    0
        After Vaccination 3, Pain: Any, n=27,56,60,29
    7.4
    8.9
    15.0
    3.4
        After Vaccination 3, Pain: Mild, n=27,56,60,29
    7.4
    7.1
    11.7
    3.4
        After Vaccination 3, Pain: Moderate, n=27,56,60,29
    0
    1.8
    1.7
    0
        After Vaccination 3, Pain: Severe, n=27,56,60,29
    0
    0
    1.7
    0
        After Vaccination 3, Swelling: Any, n=27,56,59,29
    0
    0
    1.7
    0
        After Vaccination3,Swelling(1-2 cm),n=27,56,59,29
    0
    0
    1.7
    0
    No statistical analyses for this end point

    Secondary: Percentage of Participants with Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following each Vaccination

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    End point title
    		 Percentage of Participants with Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following each Vaccination
    End point description
    Solicited local injection site reactions were collected by participant diary and graded as [Grade 0 (no pain), 1 (mild: no interference with daily activity), 2 (moderate: interference with daily activity with or without treatment) and 3 (severe: prevents daily activity with or without treatment)]. Erythema and Swelling at injection site were graded as Grade 0 (<25 mm), 1 (mild: ≥25 – ≤ 50 mm), 2 (moderate: > 50 – ≤ 100 mm).Safety Analysis Set included all participants who received at least 1 dose of trial vaccine. Only participants in immunogenicity subset were included. Data were summarized separately for each age group. 'n' indicates number analyzed are participants with data available for the category. Only categories for which there was at least 1 participant are reported
    End point type
    Secondary
    End point timeframe
    Within 7 days after each vaccination
    End point values
    		 Group 1 (TDV 2-Dose) Adult/Children Group 2 (TDV 1-Dose) Adult/Children Group 3 (TDV 1-Dose + Booster) Adult/Children Group 4 (Placebo Control) Adult/Children
    Number of subjects analysed
    62
    127
    129
    61
    Units: percentage of participants
    number (not applicable)
        After Vaccination 1, Pain:Any, n=60,126,123,57
    25.0
    31.7
    26.8
    8.8
        After Vaccination 1, Pain:Mild, n=60,126,123,57
    23.3
    28.6
    22.0
    7.0
        After Vaccination 1, Pain:Moderate,n=60,126,123,57
    1.7
    2.4
    4.1
    1.8
        After Vaccination 1, Pain:Severe,n=62,126,123,57
    0
    0.8
    0.8
    0
        After Vaccination 1, Erythema:Any,n=60,126,122,57
    0
    0.8
    0
    0
        AfterVaccination1Erythema(2.5-5 cm)n=60,126,122,57
    0
    0.8
    0
    0
        After Vaccination 1, Swelling:Any,n=60,126,122,57
    0
    0
    0
    1.8
        AfterVaccination1Swelling(2.5-5 cm)n=60,126,122,57
    0
    0
    0
    1.8
        After Vaccination 2, Pain:Any, n=60,116,119,55
    31.7
    18.1
    10.9
    14.5
        After Vaccination 2, Pain:Mild, n=60,116,119,55
    20.0
    16.4
    6.7
    10.9
        After Vaccination 2,Pain: Moderate,n=60,116,119,55
    5.0
    0
    4.2
    1.8
        After Vaccination 2, Pain:Severe, n=60,116,119,55
    6.7
    1.7
    0
    1.8
        After Vaccination 3, Pain:Any, n=59,115,120,55
    16.9
    20.0
    19.2
    16.4
        After Vaccination 3, Pain: Mild,n=59,115,120,55
    13.6
    18.3
    15.8
    12.7
        After Vaccination 3, Pain:Moderate,n=59,115,120,55
    3.4
    0
    3.3
    3.6
        After Vaccination 3, Pain:Severe, n=59,115,120,55
    0
    1.7
    0
    0
        AfterVaccination3, Erythema:Any,n=58,115,120,55
    0
    0
    0.8
    0
        AfterVaccination3,Erythema,2.5-5cm,n=58,115,120,55
    0
    0
    0.8
    0
    No statistical analyses for this end point

    Secondary: Percentage of Participants with Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following each Vaccination

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    End point title
    		 Percentage of Participants with Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Infant/Toddler Following each Vaccination
    End point description
    Solicited systemic AEs included drowsiness, graded as 0-behavior as usual, 1-mild: drowsiness easily tolerated, 2-moderate: drowsiness that interferes with normal activity and 3-severe: prevents normal activity with/without treatment; irritability/fussiness, graded as 0-behavior as usual, mild: crying more than usual/no effect on normal activity, moderate: crying more than usual/interferes with normal activity and severe: crying that cannot be comforted/prevents normal; loss of appetite, graded as 0-apetite as usual, mild: eating less than usual/no effect on normal activity, moderate: eating less than usual/interferes with normal activity, severe: not eating at all. A systemic AE of fever (≥38°C or ≥100.4°F) was recorded but excluded from overall count as no severity grading was applied for it. Safety Analysis Set from immunogenicity subset. Data were summarized for each age group. ‘n’=participants with data available for the category. Only categories with data are reported.
    End point type
    Secondary
    End point timeframe
    Within 14 days after each vaccination
    End point values
    		 Group 1 (TDV 2-Dose) Group 2 (TDV 1-Dose) Group 3 (TDV 1-Dose + Booster) Group 4 (Placebo Control)
    Number of subjects analysed
    29
    60
    62
    32
    Units: percentage of participants
    number (not applicable)
        After Vaccination 1,Irritability:Any,n=27,54,55,28
    3.7
    1.9
    9.1
    0
        After Vac.1,Irritability:Mild,n=27,54,55,28
    3.7
    0
    3.6
    0
        After Vac.1,Irritability:Moderate ,n=27,54,55,27
    0
    1.9
    3.6
    0
        After Vac. 1, Irritability: Severe, n=27,54,55,27
    0
    0
    1.8
    0
        After Vac. 1,Drowsiness: Any, n=27,54,55,28
    0
    7.4
    7.3
    7.1
        After Vac.1, Drowsiness: Mild, n=27,54,55,28
    0
    7.4
    5.5
    7.1
        After Vac.1, Drowsiness: Moderate, n=27,54,55,28
    0
    0
    1.8
    0
        After Vac.1,Loss of Appetite:Any, n=27,54,55,28
    7.4
    9.3
    10.9
    7.1
        After Vac.1,Loss of Appetite:Mild, n=27,54,55,28
    7.4
    7.4
    5.5
    0
        After Vac.1Loss of Appetite:Moderate,n=27,54,55,28
    0
    1.9
    3.6
    7.1
        After Vac.1,Loss of Appetite:Severe, n=27,54,55,28
    0
    0
    1.8
    0
        After Vac.1Fever Any, n=25,50,52,27
    0
    6.0
    5.8
    3.7
        After Vac.1,Fever (38.0 - < 38.5 °C),n=25,50,52,27
    0
    2.0
    3.8
    0
        After Vac.1,Fever (38.5 - < 39.0 °C),n=25,50,52,27
    0
    4.0
    1.9
    3.7
        After Vac.2,Irritability: Any, n=26,53,53,28
    15.4
    1.9
    1.9
    10.7
        After Vac.2, Irritability: Mild, n=26,53,53,28
    15.4
    1.9
    1.9
    10.7
        After Vac.2, Drowsiness: Any, n=26,53,53,28
    3.8
    3.8
    3.8
    0
        After Vac.2, Drowsiness: Mild,n=26,53,53,28
    3.8
    3.8
    3.8
    0
        After Vac.2, Loss of Appetite: Any, n=26,53,53,28
    7.7
    13.2
    5.7
    0
        After Vac.2, Loss of Appetite: Mild,n=26,53,53,28
    3.8
    9.4
    5.7
    0
        After Vac.2Loss of Appetite:Moderate,n=26,53,53,28
    3.8
    1.9
    0
    0
        After Vac.2,Loss of Appetite:Severe, n=26,53,53,28
    0
    1.9
    0
    0
        After Vac.2,Fever,Any, n=25,52,52,28
    16.0
    9.6
    11.5
    3.6
        After Vac.2,Fever (38.0 - < 38.5 °C),n=25,52,52,28
    0
    3.8
    5.8
    0
        After Vac.2,Fever (38.5 - < 39.0 °C),n=25,52,52,28
    8.0
    5.8
    3.8
    3.6
        After Vac.2,Fever (39.0 - < 39.5 °C),n=25,52,52,28
    4.0
    0
    1.9
    0
        After Vac.2,Fever (39.5 - < 40.0 °C),n=25,52,52,28
    4.0
    0
    0
    0
        After Vac.3,Irritability: Any, n=27,56,59,29
    3.7
    0
    1.7
    10.3
        After Vac.3, Irritability: Mild, n=27,56,59,29
    3.7
    0
    0
    6.9
        After Vac.3, Irritability: Moderate,n=27,56,59,29
    0
    0
    1.7
    3.4
        After Vac.3,Drowsiness: Any, n=27,56,59,29
    3.7
    3.6
    3.4
    3.4
        After Vac.1,Drowsiness: Mild,n=27,56,59,29
    3.7
    3.6
    1.7
    0
        After Vac.1,Drowsiness: Moderate,n=27,56,59,29
    0
    0
    1.7
    0
        After Vac.3,Drowsiness: Severe,n=27,56,59,29
    0
    0
    0
    3.4
        After Vac.3,Loss of Appetite: Any,n=27,56,59,29
    7.4
    12.5
    3.4
    10.3
        After Vac.3, Loss of Appetite: Mild,n=27,56,59,29
    3.7
    7.1
    3.4
    6.9
        After Vac.3,Lossof Appetite:Moderate,n=27,56,59,29
    3.7
    5.4
    0
    3.4
        After Vac.3 Fever:Any, n=26,55,60,29
    0
    3.6
    3.3
    6.9
        After Vac.3,Fever(38.0 - < 38.5 °C), n=26,55,60,29
    0
    0
    1.7
    3.4
        After Vac.3,Fever (38.5 - < 39.0 °C) n=26,55,60,29
    0
    1.8
    1.7
    0
        After Vac.3,Fever (39.0 - < 39.5 °C) n=26,55,60,29
    0
    1.8
    0
    3.4
    No statistical analyses for this end point

    Secondary: Percentage of Participants with Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following each Vaccination

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    End point title
    		 Percentage of Participants with Solicited Systemic Adverse Events (AEs) (Diary Recorded) by Severity in the Immunogenicity Subset of Adult/Children Following each Vaccination
    End point description
    Solicited systemic AEs were collected after vaccination and included headache, asthenia, malaise, myalgia and fever. Severity scales for headache were none, mild: no interference with daily activity, moderate: interference with daily activity with or without treatment and severe: prevents normal activity with or without treatment. Severity scales for others were none, mild: no interference with daily activity, moderate: interference with daily activity and severe: prevents daily activity. A systemic AE of fever (defined as ≥38°C or ≥100.4°F) was recorded but excluded from the overall count as no severity grading was applied for it. Safety Analysis Set from immunogenicity subset. Data were summarized for each age group. ‘n’=participants with data available for the category. Only categories with data are reported.
    End point type
    Secondary
    End point timeframe
    Within 14 days after each vaccination
    End point values
    		 Group 1 (TDV 2-Dose) Group 2 (TDV 1-Dose) Group 3 (TDV 1-Dose + Booster) Group 4 (Placebo Control)
    Number of subjects analysed
    62
    127
    129
    61
    Units: percentage of participants
    number (not applicable)
        After Vac.1, Headache: Any, n=60,126,123,57
    20.0
    23.8
    16.3
    21.1
        After Vac.1, Headache: Mild, n=60,126,123,57
    16.7
    20.6
    13.0
    14.0
        After Vac.1, Headache:Moderate, n=60,126,123,57
    3.3
    2.4
    1.6
    5.3
        After Vac.1, Headache: Severe, n=60,126,123,57
    0
    0.8
    1.6
    1.8
        After Vac.1, Asthenia: Any, n=60,126,123,57
    5.0
    11.1
    7.3
    7.0
        After Vac.1, Asthenia: Mild, n=60,126,123,57
    3.3
    10.3
    4.9
    3.5
        After Vac.1, Asthenia: Moderate,n=60,126,123,57
    1.7
    0.8
    1.6
    3.5
        After Vac.1, Asthenia: Severe,n=60,126,123,57
    0
    0
    0.8
    0
        After Vac.1, Malaise: Any, n=60,126,123,57
    8.3
    14.3
    8.9
    10.5
        After Vac.1, Malaise: Mild, n=60,126,123,57
    6.7
    13.5
    7.3
    8.8
        After Vac.1, Malaise: Moderate,n=60,126,123,57
    1.7
    0.8
    0.8
    0
        After Vac.1, Malaise: Severe, n=60,126,123,57
    0
    0
    0.8
    1.8
        After Vac.1, Myalgia: Any, n=60,126,123,57
    10.0
    20.6
    11.4
    7.0
        After Vac.1, Myalgia: Mild, n=60,126,123,57
    8.3
    18.3
    10.6
    7.0
        After Vac.1, Myalgia: Moderate,n=60,126,123,57
    1.7
    2.4
    0
    0
        After Vac.1, Myalgia: Severe, n=60,126,123,57
    0
    0
    0.8
    0
        After Vac.1, Fever: Any, n=51,119,110,51
    5.9
    2.5
    4.5
    5.9
        After Vac.1,Fever:38.0 - < 38.5 °C,n=51,119,110,51
    2.0
    1.7
    0
    2.0
        After Vac.1,Fever:38.5 - < 39.0 °C,n=51,119,110,51
    2.0
    0
    1.8
    3.9
        After Vac.1,Fever:39.0-< 39.5°C,n=51,119,110,51
    2.0
    0.8
    0.9
    0
        After Vac.1,Fever: 39.5-< 40.0 °C,n=51,119,110,51
    0
    0
    1.8
    0
        After Vac.2,Headache:Any,n=59,115,118,55
    18.6
    9.6
    6.8
    16.4
        After Vac.2,Headache:Mild,n=59,115,118,55
    11.9
    7.8
    4.2
    12.7
        After Vac.2,Headache:Moderate,n=59,115,118,55
    5.1
    0.9
    2.5
    1.8
        After Vac.2,Headache:Severe,n=59,115,118,55
    1.7
    0.9
    0
    1.8
        After Vac.2,Asthenia:Any,n=59,115,118,55
    8.5
    7.8
    4.2
    3.6
        After Vac.2,Asthenia:Mild,n=59,115,118,55
    5.1
    7.0
    2.5
    3.6
        After Vac.2,Asthenia:Moderate,n=59,115,118,55
    1.7
    0
    1.7
    0
        After Vac.2,Asthenia:Severe,n=59,115,118,55
    1.7
    0.9
    0
    0
        After Vac.2,Malaise:Any,n=59,115,118,55
    15.3
    8.7
    6.8
    9.1
        After Vac.2, Malaise: Mild, n=59,115,118,55
    10.2
    6.1
    4.2
    7.3
        After Vac.2, Malaise: Moderate,n=59,115,118,55
    3.4
    1.7
    1.7
    0
        After Vac.2, Malaise: Severe,n=59,115,118,55
    1.7
    0.9
    0.8
    1.8
        After Vac.2, Myalgia: Any, n=59,115,118,55
    16.9
    5.2
    5.9
    5.5
        After Vac.2, Myalgia: Mild, n=59,115,118,55
    10.2
    5.2
    2.5
    5.5
        After Vac.2, Myalgia: Moderate,n=59,115,118,55
    3.4
    0
    2.5
    0
        After Vac.2, Myalgia: Severe,n=59,115,118,55
    3.4
    0
    0.8
    0
        After Vac.2, Fever: Any, n=51,104,110,49
    2.0
    2.9
    2.7
    4.1
        After Vac.2,Fever:38.0-< 38.5 °C,n=51,104,110,49
    2.0
    1.0
    0.9
    0
        After Vac.2,Fever:38.5-< 39.0°C,n=51,104,110,49
    0
    1.0
    0.9
    2.0
        AfterVac.2,Fever: 39.5-<40.0 °C,n=51,104,110,49
    0
    1.0
    0.9
    2.0
        After Vac.3, Headache: Any, n=59,115,120,55
    10.2
    11.3
    7.5
    7.3
        After Vac.3, Headache: Mild, n=59,115,120,55
    10.2
    7.8
    5.8
    5.5
        After Vac.3, Headache: Moderate,n=59,115,120,55
    0
    1.7
    1.7
    0
        After Vac.3, Headache: Severe,n=59,115,120,55
    0
    1.7
    0
    1.8
        After Vac.3, Asthenia: Any, n=59,115,120,55
    6.8
    7.0
    2.5
    7.3
        After Vac.3, Asthenia: Mild, n=59,115,120,55
    6.8
    5.2
    2.5
    7.3
        After Vac.3, Asthenia: Moderate,n=59,115,120,55
    0
    0.9
    0
    0
        After Vac.3, Asthenia: Severe,n=59,115,120,55
    0
    0.9
    0
    0
        After Vac.3,Malaise: Any, n=59,115,120,55
    5.1
    7.8
    8.3
    3.6
        After Vac.3,Malaise: Mild, n=59,115,120,55
    3.4
    5.2
    5.8
    1.8
        After Vac.3,Malaise: Moderate,n=59,115,120,55
    0
    0.9
    1.7
    1.8
        After Vac.3,Malaise: Severe,n=59,115,120,55
    1.7
    1.7
    0.8
    0
        After Vac.3,Myalgia: Any, n=59,115,120,55
    6.8
    11.3
    8.3
    5.5
        After Vac.3,Myalgia: Mild, n=59,115,120,55
    5.1
    9.6
    5.8
    5.5
        After Vac.3,Myalgia: Moderate,n=59,115,120,55
    0
    0.9
    1.7
    0
        After Vac.3,Myalgia:Severe,n=59,115,120,55
    1.7
    0.9
    0.8
    0
        After Vac.3,Fever:Any,n=56,106,115,51
    1.8
    1.9
    1.7
    2.0
        After Vac.3,Fever:38.0 - < 38.5 °C,n=56,106,115,51
    0
    1.9
    0.9
    2.0
        After Vac.3,Fever:38.5 - < 39.0 °C,n=56,106,115,51
    0
    0
    0.9
    0
        After Vac.3,Fever:39.0 - < 39.5 °C,n=56,106,115,51
    1.8
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Percentage of Participants with Any Unsolicited Adverse Events (AEs) in the Immunogenicity Subset Following each Vaccination

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    End point title
    		 Percentage of Participants with Any Unsolicited Adverse Events (AEs) in the Immunogenicity Subset Following each Vaccination
    End point description
    An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment.Safety Analysis Set included all participants who received at least 1 dose of trial vaccine. Only participants in the immunogenicity subset were included. 'n' indicates number analyzed is number of participants with data available at the given timepoint.
    End point type
    Secondary
    End point timeframe
    Within 28 days after each vaccination
    End point values
    		 Group 1 (TDV 2-Dose) Group 2 (TDV 1-Dose) Group 3 (TDV 1-Dose + Booster) Group 4 (Placebo Control)
    Number of subjects analysed
    91
    187
    191
    93
    Units: percentage of participants
    number (not applicable)
        After Vaccination 1,n=91,187,191,93
    19.8
    20.3
    19.4
    21.5
        After Vaccination 2,n=90,176,181,87
    12.2
    10.2
    11.0
    16.1
        After Vaccination 3,n=88,172,179,84
    6.8
    12.8
    10.1
    9.5
    No statistical analyses for this end point

    Secondary: Percentage of Participants with Serious Adverse Events (SAEs)

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    End point title
    		 Percentage of Participants with Serious Adverse Events (SAEs)
    End point description
    An SAE was defined as any untoward medical occurrence or effect that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically important due to other reasons than the above mentioned criteria.Safety Analysis Set included all participants who received at least 1 dose of trial vaccine.
    End point type
    Secondary
    End point timeframe
    From first vaccination through end of study (Day 1460)
    End point values
    		 Group 1 (TDV 2-Dose) Group 2 (TDV 1-Dose) Group 3 (TDV 1-Dose + Booster) Group 4 (Placebo Control)
    Number of subjects analysed
    200
    398
    998
    198
    Units: percentage of participants
        number (not applicable)
    5.0
    4.5
    6.5
    5.1
    No statistical analyses for this end point

    Secondary: Percentage of Participants with Febrile Episodes of Virologically Confirmed Dengue with Onset 30 days Post-first Vaccination

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    End point title
    		 Percentage of Participants with Febrile Episodes of Virologically Confirmed Dengue with Onset 30 days Post-first Vaccination
    End point description
    Participants with febrile illness (defined as temperature ≥ 38°C on 2 consecutive days) were evaluated for dengue. A dengue infection was considered virologically confirmed by either positive polymerase chain reaction (PCR) or NS1 enzyme-linked immunosorbent assay (ELISA). virologically confirmed dengue with onset 30 days after first vaccination within each group.Safety Analysis Set included all participants who received at least 1 dose of trial vaccine.
    End point type
    Secondary
    End point timeframe
    From 30 days post-first vaccination through end of study (Day 1460)
    End point values
    		 Group 1 (TDV 2-Dose) Group 2 (TDV 1-Dose) Group 3 (TDV 1-Dose + Booster) Group 4 (Placebo Control)
    Number of subjects analysed
    200
    398
    998
    198
    Units: percentage of participants
        number (not applicable)
    3.5
    2.0
    2.2
    6.6
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All-Cause Mortality and Serious adverse events: From first vaccination (Day 1) through end of study (Day 540); Other adverse events: From any vaccination (Day 1, Day 91, and Day 365) up to 28 days post vaccination.
    Adverse event reporting additional description
    Safety Analysis Set included all participants who received at least 1 dose of trial vaccine. Data for other (non-serious) adverse events is reported for participants from Immunogenicity Subset with available data for analyses.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    Group 1 (TDV 2-Dose)
    Reporting group description
    		 Takeda's tetravalent dengue vaccine candidate (TDV), 0.5 mL, subcutaneous injection on Days 1 and 91. Placebo-matching, 0.5 mL, subcutaneous injection on Day 365.

    Reporting group title
    Group 2 (TDV 1-Dose)
    Reporting group description
    		 Takeda's TDV, 0.5 mL, subcutaneous injection on Day 1. Placebo-matching, 0.5 mL, subcutaneous injection on Days 91 and 365.

    Reporting group title
    Group 4 (Placebo Control)
    Reporting group description
    		 Placebo matching, 0.5 mL, subcutaneous injection on Days 1, 91 and 365.

    Reporting group title
    Group 3 (TDV 1-Dose + Booster)
    Reporting group description
    		 Takeda's TDV, 0.5 mL, subcutaneous injection on Days 1 and 365. Placebo-matching, 0.5 mL, subcutaneous injection on Day 91.

    Serious adverse events
    		 Group 1 (TDV 2-Dose) Group 2 (TDV 1-Dose) Group 4 (Placebo Control) Group 3 (TDV 1-Dose + Booster)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    10 / 200 (5.00%)
    18 / 398 (4.52%)
    10 / 198 (5.05%)
    65 / 998 (6.51%)
         number of deaths (all causes)
    0
    1
    0
    1
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Teratoma Benign
         subjects affected / exposed
    1 / 200 (0.50%)
    0 / 398 (0.00%)
    0 / 198 (0.00%)
    0 / 998 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Surgical and medical procedures
    Finger Amputation
         subjects affected / exposed
    0 / 200 (0.00%)
    0 / 398 (0.00%)
    0 / 198 (0.00%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion Spontaneous
         subjects affected / exposed
    0 / 200 (0.00%)
    1 / 398 (0.25%)
    0 / 198 (0.00%)
    0 / 998 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Premature Baby
         subjects affected / exposed
    0 / 200 (0.00%)
    0 / 398 (0.00%)
    0 / 198 (0.00%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Dehiscence
         subjects affected / exposed
    0 / 200 (0.00%)
    0 / 398 (0.00%)
    0 / 198 (0.00%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Food Allergy
         subjects affected / exposed
    0 / 200 (0.00%)
    0 / 398 (0.00%)
    0 / 198 (0.00%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypersensitivity
         subjects affected / exposed
    0 / 200 (0.00%)
    0 / 398 (0.00%)
    0 / 198 (0.00%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Social circumstances
    Homicide
         subjects affected / exposed
    0 / 200 (0.00%)
    0 / 398 (0.00%)
    0 / 198 (0.00%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    Reproductive system and breast disorders
    Ovarian Cyst
         subjects affected / exposed
    0 / 200 (0.00%)
    0 / 398 (0.00%)
    0 / 198 (0.00%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ovarian Cyst Torsion
         subjects affected / exposed
    0 / 200 (0.00%)
    0 / 398 (0.00%)
    0 / 198 (0.00%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthmatic Crisis
         subjects affected / exposed
    0 / 200 (0.00%)
    1 / 398 (0.25%)
    0 / 198 (0.00%)
    4 / 998 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Asthma
         subjects affected / exposed
    0 / 200 (0.00%)
    0 / 398 (0.00%)
    1 / 198 (0.51%)
    2 / 998 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchospasm
         subjects affected / exposed
    0 / 200 (0.00%)
    1 / 398 (0.25%)
    0 / 198 (0.00%)
    0 / 998 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    0 / 200 (0.00%)
    1 / 398 (0.25%)
    0 / 198 (0.00%)
    2 / 998 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Head Injury
         subjects affected / exposed
    1 / 200 (0.50%)
    0 / 398 (0.00%)
    0 / 198 (0.00%)
    2 / 998 (0.20%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Multiple Injuries
         subjects affected / exposed
    0 / 200 (0.00%)
    0 / 398 (0.00%)
    0 / 198 (0.00%)
    3 / 998 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abdominal Injury
         subjects affected / exposed
    0 / 200 (0.00%)
    0 / 398 (0.00%)
    0 / 198 (0.00%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ankle Fracture
         subjects affected / exposed
    1 / 200 (0.50%)
    0 / 398 (0.00%)
    0 / 198 (0.00%)
    0 / 998 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arthropod Bite
         subjects affected / exposed
    0 / 200 (0.00%)
    0 / 398 (0.00%)
    0 / 198 (0.00%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Arthropod Sting
         subjects affected / exposed
    0 / 200 (0.00%)
    0 / 398 (0.00%)
    1 / 198 (0.51%)
    0 / 998 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Burns Second Degree
         subjects affected / exposed
    0 / 200 (0.00%)
    1 / 398 (0.25%)
    0 / 198 (0.00%)
    0 / 998 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Facial Bones Fracture
         subjects affected / exposed
    1 / 200 (0.50%)
    0 / 398 (0.00%)
    0 / 198 (0.00%)
    0 / 998 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Seizure
         subjects affected / exposed
    0 / 200 (0.00%)
    0 / 398 (0.00%)
    0 / 198 (0.00%)
    2 / 998 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    0 / 200 (0.00%)
    1 / 398 (0.25%)
    0 / 198 (0.00%)
    0 / 998 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Generalised Tonic-Clonic
         subjects affected / exposed
    0 / 200 (0.00%)
    0 / 398 (0.00%)
    0 / 198 (0.00%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    0 / 200 (0.00%)
    1 / 398 (0.25%)
    0 / 198 (0.00%)
    0 / 998 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Migraine
         subjects affected / exposed
    0 / 200 (0.00%)
    1 / 398 (0.25%)
    0 / 198 (0.00%)
    0 / 998 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Relapsing-Remitting Multiple Sclerosis
         subjects affected / exposed
    0 / 200 (0.00%)
    1 / 398 (0.25%)
    0 / 198 (0.00%)
    0 / 998 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Immune Thrombocytopenic Purpura
         subjects affected / exposed
    1 / 200 (0.50%)
    0 / 398 (0.00%)
    0 / 198 (0.00%)
    0 / 998 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Eye disorders
    Ocular Myasthenia
         subjects affected / exposed
    0 / 200 (0.00%)
    0 / 398 (0.00%)
    0 / 198 (0.00%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    0 / 200 (0.00%)
    1 / 398 (0.25%)
    0 / 198 (0.00%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 200 (0.00%)
    0 / 398 (0.00%)
    0 / 198 (0.00%)
    2 / 998 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    0 / 200 (0.00%)
    0 / 398 (0.00%)
    0 / 198 (0.00%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    0 / 200 (0.00%)
    1 / 398 (0.25%)
    0 / 198 (0.00%)
    0 / 998 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ileus Paralytic
         subjects affected / exposed
    0 / 200 (0.00%)
    0 / 398 (0.00%)
    0 / 198 (0.00%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Inguinal Hernia
         subjects affected / exposed
    0 / 200 (0.00%)
    0 / 398 (0.00%)
    0 / 198 (0.00%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Intestinal Obstruction
         subjects affected / exposed
    0 / 200 (0.00%)
    0 / 398 (0.00%)
    0 / 198 (0.00%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Volvulus
         subjects affected / exposed
    0 / 200 (0.00%)
    0 / 398 (0.00%)
    0 / 198 (0.00%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Glomerulonephritis Acute
         subjects affected / exposed
    0 / 200 (0.00%)
    0 / 398 (0.00%)
    0 / 198 (0.00%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nephritic Syndrome
         subjects affected / exposed
    0 / 200 (0.00%)
    0 / 398 (0.00%)
    1 / 198 (0.51%)
    0 / 998 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Aneurysmal Bone Cyst
         subjects affected / exposed
    0 / 200 (0.00%)
    0 / 398 (0.00%)
    0 / 198 (0.00%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Amoebic Dysentery
         subjects affected / exposed
    1 / 200 (0.50%)
    1 / 398 (0.25%)
    1 / 198 (0.51%)
    5 / 998 (0.50%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    0 / 200 (0.00%)
    2 / 398 (0.50%)
    1 / 198 (0.51%)
    5 / 998 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    2 / 200 (1.00%)
    0 / 398 (0.00%)
    0 / 198 (0.00%)
    4 / 998 (0.40%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 200 (0.00%)
    1 / 398 (0.25%)
    0 / 198 (0.00%)
    5 / 998 (0.50%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary Tract Infection
         subjects affected / exposed
    0 / 200 (0.00%)
    1 / 398 (0.25%)
    0 / 198 (0.00%)
    4 / 998 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abscess Limb
         subjects affected / exposed
    0 / 200 (0.00%)
    0 / 398 (0.00%)
    1 / 198 (0.51%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ascariasis
         subjects affected / exposed
    0 / 200 (0.00%)
    1 / 398 (0.25%)
    0 / 198 (0.00%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Dengue Fever
         subjects affected / exposed
    0 / 200 (0.00%)
    1 / 398 (0.25%)
    0 / 198 (0.00%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Scarlet Fever
         subjects affected / exposed
    0 / 200 (0.00%)
    0 / 398 (0.00%)
    0 / 198 (0.00%)
    2 / 998 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Amoebiasis
         subjects affected / exposed
    0 / 200 (0.00%)
    0 / 398 (0.00%)
    0 / 198 (0.00%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Appendicitis Perforated
         subjects affected / exposed
    0 / 200 (0.00%)
    0 / 398 (0.00%)
    1 / 198 (0.51%)
    0 / 998 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    0 / 200 (0.00%)
    0 / 398 (0.00%)
    0 / 198 (0.00%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Burkholderia Cepacia Complex Sepsis
         subjects affected / exposed
    0 / 200 (0.00%)
    0 / 398 (0.00%)
    1 / 198 (0.51%)
    0 / 998 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Encephalomyelitis
         subjects affected / exposed
    0 / 200 (0.00%)
    1 / 398 (0.25%)
    0 / 198 (0.00%)
    0 / 998 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Endometritis
         subjects affected / exposed
    1 / 200 (0.50%)
    0 / 398 (0.00%)
    0 / 198 (0.00%)
    0 / 998 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis Rotavirus
         subjects affected / exposed
    0 / 200 (0.00%)
    0 / 398 (0.00%)
    0 / 198 (0.00%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatitis A
         subjects affected / exposed
    0 / 200 (0.00%)
    0 / 398 (0.00%)
    0 / 198 (0.00%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infectious Colitis
         subjects affected / exposed
    0 / 200 (0.00%)
    0 / 398 (0.00%)
    0 / 198 (0.00%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nasal Abscess
         subjects affected / exposed
    0 / 200 (0.00%)
    0 / 398 (0.00%)
    0 / 198 (0.00%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    0 / 200 (0.00%)
    0 / 398 (0.00%)
    1 / 198 (0.51%)
    0 / 998 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peritonitis
         subjects affected / exposed
    0 / 200 (0.00%)
    0 / 398 (0.00%)
    0 / 198 (0.00%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Peritonsillar Abscess
         subjects affected / exposed
    0 / 200 (0.00%)
    0 / 398 (0.00%)
    0 / 198 (0.00%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pharyngotonsillitis
         subjects affected / exposed
    0 / 200 (0.00%)
    1 / 398 (0.25%)
    0 / 198 (0.00%)
    0 / 998 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary Tuberculosis
         subjects affected / exposed
    0 / 200 (0.00%)
    1 / 398 (0.25%)
    0 / 198 (0.00%)
    0 / 998 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    0 / 200 (0.00%)
    0 / 398 (0.00%)
    1 / 198 (0.51%)
    0 / 998 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory Tract Infection
         subjects affected / exposed
    0 / 200 (0.00%)
    1 / 398 (0.25%)
    0 / 198 (0.00%)
    0 / 998 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 200 (0.00%)
    1 / 398 (0.25%)
    0 / 198 (0.00%)
    0 / 998 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Septic Shock
         subjects affected / exposed
    0 / 200 (0.00%)
    1 / 398 (0.25%)
    0 / 198 (0.00%)
    0 / 998 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    Sinusitis
         subjects affected / exposed
    0 / 200 (0.00%)
    0 / 398 (0.00%)
    0 / 198 (0.00%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tonsillitis
         subjects affected / exposed
    1 / 200 (0.50%)
    0 / 398 (0.00%)
    0 / 198 (0.00%)
    0 / 998 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tooth Abscess
         subjects affected / exposed
    0 / 200 (0.00%)
    0 / 398 (0.00%)
    0 / 198 (0.00%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Viral Infection
         subjects affected / exposed
    0 / 200 (0.00%)
    0 / 398 (0.00%)
    1 / 198 (0.51%)
    0 / 998 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 200 (0.50%)
    0 / 398 (0.00%)
    0 / 198 (0.00%)
    1 / 998 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Group 1 (TDV 2-Dose) Group 2 (TDV 1-Dose) Group 4 (Placebo Control) Group 3 (TDV 1-Dose + Booster)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    17 / 200 (8.50%)
    43 / 398 (10.80%)
    22 / 198 (11.11%)
    41 / 998 (4.11%)
    Nervous system disorders
    Headache
         subjects affected / exposed [1]
    1 / 91 (1.10%)
    2 / 187 (1.07%)
    1 / 93 (1.08%)
    5 / 191 (2.62%)
         occurrences all number
    1
    2
    2
    5
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed [2]
    2 / 91 (2.20%)
    1 / 187 (0.53%)
    1 / 93 (1.08%)
    2 / 191 (1.05%)
         occurrences all number
    2
    1
    1
    2
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed [3]
    0 / 91 (0.00%)
    0 / 187 (0.00%)
    2 / 93 (2.15%)
    2 / 191 (1.05%)
         occurrences all number
    0
    0
    2
    2
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed [4]
    1 / 91 (1.10%)
    4 / 187 (2.14%)
    2 / 93 (2.15%)
    2 / 191 (1.05%)
         occurrences all number
    1
    4
    2
    2
    Vomiting
         subjects affected / exposed [5]
    1 / 91 (1.10%)
    3 / 187 (1.60%)
    3 / 93 (3.23%)
    0 / 191 (0.00%)
         occurrences all number
    1
    3
    3
    0
    Respiratory, thoracic and mediastinal disorders
    Nasal Congestion
         subjects affected / exposed [6]
    0 / 91 (0.00%)
    1 / 187 (0.53%)
    2 / 93 (2.15%)
    0 / 191 (0.00%)
         occurrences all number
    0
    2
    2
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed [7]
    10 / 91 (10.99%)
    25 / 187 (13.37%)
    10 / 93 (10.75%)
    21 / 191 (10.99%)
         occurrences all number
    11
    31
    10
    22
    Viral Infection
         subjects affected / exposed [8]
    1 / 91 (1.10%)
    4 / 187 (2.14%)
    2 / 93 (2.15%)
    4 / 191 (2.09%)
         occurrences all number
    1
    4
    2
    4
    Bronchitis
         subjects affected / exposed [9]
    0 / 91 (0.00%)
    4 / 187 (2.14%)
    0 / 93 (0.00%)
    3 / 191 (1.57%)
         occurrences all number
    0
    5
    0
    3
    Tonsillitis
         subjects affected / exposed [10]
    2 / 91 (2.20%)
    3 / 187 (1.60%)
    0 / 93 (0.00%)
    2 / 191 (1.05%)
         occurrences all number
    2
    3
    0
    2
    Parasitic Gastroenteritis
         subjects affected / exposed [11]
    2 / 91 (2.20%)
    0 / 187 (0.00%)
    2 / 93 (2.15%)
    1 / 191 (0.52%)
         occurrences all number
    2
    0
    2
    1
    Gastroenteritis
         subjects affected / exposed [12]
    1 / 91 (1.10%)
    7 / 187 (3.74%)
    5 / 93 (5.38%)
    5 / 191 (2.62%)
         occurrences all number
    1
    7
    6
    6
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Non-serious adverse events were based on Immunogenicity Set.
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Non-serious adverse events were based on Immunogenicity Set.
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Non-serious adverse events were based on Immunogenicity Set.
    [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Non-serious adverse events were based on Immunogenicity Set.
    [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Non-serious adverse events were based on Immunogenicity Set.
    [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Non-serious adverse events were based on Immunogenicity Set.
    [7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Non-serious adverse events were based on Immunogenicity Set.
    [8] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Non-serious adverse events were based on Immunogenicity Set.
    [9] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Non-serious adverse events were based on Immunogenicity Set.
    [10] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Non-serious adverse events were based on Immunogenicity Set.
    [11] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Non-serious adverse events were based on Immunogenicity Set.
    [12] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Non-serious adverse events were based on Immunogenicity Set.

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    23 Jul 2015
    Study duration was extended from 18 months to 48 months.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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