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    Clinical Trial Results:
    A Phase 3, Follow-Up Trial to Evaluate Long-Term Safety and Antibody Persistence, and the Impact of a Booster Dose of a Tetravalent Dengue Vaccine Candidate in Healthy Adolescents and Adults in Areas Non-Endemic for Dengue

    Summary
    EudraCT number
    		 2023-000027-36
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    25 May 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 Jun 2025
    First version publication date
    08 Jun 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    DEN-303
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03999996
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Takeda
    Sponsor organisation address
    95 Hayden Ave, Lexington, MA, United States, 02421
    Public contact
    Study Director, Takeda, TrialDisclosures@takeda.com
    Scientific contact
    Study Director, Takeda, TrialDisclosures@takeda.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    25 May 2024
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    25 May 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main purpose of this study was to evaluate the long-term safety and antibody persistence, and the impact of a booster dose of TDV.
    Protection of trial subjects
    Each participant or their parents/guardians/legally authorized representatives signed an informed consent form (ICF) before participating in the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    12 Nov 2019
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 246
    Country: Number of subjects enrolled
    Mexico: 119
    Worldwide total number of subjects
    365
    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)
    0
    Adolescents (12-17 years)
    79
    Adults (18-64 years)
    286
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants took part in the study at multiple investigative sites in United States (US) and Mexico from 12 November 2019 to 25 May 2024.

    Pre-assignment
    Screening details
    		 Healthy participants who received Takeda's Dengue Tetravalent Vaccine (TDV) in two parent trials, DEN-304 [NCT03423173] and DEN-315 [NCT03341637] were enrolled to receive either placebo or TDV.

    Period 1
    Period 1 title
    Prior to Booster
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Prior to Booster: DEN-304
    Arm description
    		 Participants who received TDV in parent trial DEN-304 (US) were assessed before they received booster dose (Placebo/TDV) at Visit 3 (Month 15).
    Arm type
    		 Experimental

    Investigational medicinal product name
    TDV
    Investigational medicinal product code
    Other name
    Takeda’s Dengue Tetravalent Vaccine (TDV)
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Month 15

    Arm title
    		 Prior to Booster: DEN-315
    Arm description
    		 Participants who received TDV in parent trial DEN-315 (Mexico) were assessed before they received booster dose (Placebo/TDV) at Visit 3 (Month 42).
    Arm type
    		 Experimental

    Investigational medicinal product name
    TDV
    Investigational medicinal product code
    Other name
    Takeda’s Dengue Tetravalent Vaccine (TDV)
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Month 42

    Number of subjects in period 1
    		Prior to Booster: DEN-304 Prior to Booster: DEN-315
    Started
    246
    119
    Completed
    149
    84
    Not completed
    97
    35
         Withdrawal of Consent
    51
    8
         Adverse event, serious fatal
    -
    1
         Adverse event, non-fatal
    2
    -
         Reason Not Specified
    27
    4
         Lost to follow-up
    17
    22
    Period 2
    Period 2 title
    Booster Phase
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Investigator, Data analyst, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Booster Phase: Placebo
    Arm description
    		 Participants received TDV placebo-matching 0.5 ml injection, SC, once at Visit 3 (Month 15) for participants from parent trial DEN-304 (US) or once at Visit 3 (Month 42) for participants from parent trial DEN-315 (Mexico).
    Arm type
    		 Placebo

    Investigational medicinal product name
    TDV matching Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0.5 ml injection, SC, once at Month 15 for participants from parent trial DEN-304 (US) or once at Month 42 for participants from parent trial DEN-315 (Mexico).

    Arm title
    		 Booster Phase: TDV
    Arm description
    		 Participants received TDV 0.5 ml, injection, SC, once at Visit 3 (Month 15) for participants from parent trial DEN-304 (US) or once at Visit 3 (Month 42) for participants from parent trial DEN-315 (Mexico).
    Arm type
    		 Experimental

    Investigational medicinal product name
    TDV
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    0.5 ml injection, SC, once at Month 15 for participants from parent trial DEN-304 (US) or once at Month 42 for participants from parent trial DEN-315 (Mexico).

    Number of subjects in period 2
    		Booster Phase: Placebo Booster Phase: TDV
    Started
    118
    115
    Completed
    115
    110
    Not completed
    3
    5
         Withdrawal of Consent
    -
    1
         Reason Not Specified
    -
    1
         Lost to follow-up
    3
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Prior to Booster: DEN-304
    Reporting group description
    		 Participants who received TDV in parent trial DEN-304 (US) were assessed before they received booster dose (Placebo/TDV) at Visit 3 (Month 15).

    Reporting group title
    Prior to Booster: DEN-315
    Reporting group description
    		 Participants who received TDV in parent trial DEN-315 (Mexico) were assessed before they received booster dose (Placebo/TDV) at Visit 3 (Month 42).

    Reporting group values
    		 Prior to Booster: DEN-304 Prior to Booster: DEN-315 Total
    Number of subjects
    		 246 119
    Age Categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 44.4 ( 11.03 ) 16.3 ( 1.77 ) -
    Gender categorical
    Units: Subjects
        Female
    		 145 70 215
        Male
    		 101 49 150
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 1 2 3
        Asian
    		 4 0 4
        Native Hawaiian or Other Pacific Islander
    		 1 0 1
        Black or African American
    		 35 0 35
        White
    		 201 0 201
        More than one race
    		 4 117 121
        Unknown or Not Reported
    		 0 0 0
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    		 8 119 127
        Not Hispanic or Latino
    		 238 0 238
        Unknown or Not Reported
    		 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Prior to Booster: DEN-304
    Reporting group description
    		 Participants who received TDV in parent trial DEN-304 (US) were assessed before they received booster dose (Placebo/TDV) at Visit 3 (Month 15).

    Reporting group title
    Prior to Booster: DEN-315
    Reporting group description
    		 Participants who received TDV in parent trial DEN-315 (Mexico) were assessed before they received booster dose (Placebo/TDV) at Visit 3 (Month 42).
    Reporting group title
    Booster Phase: Placebo
    Reporting group description
    		 Participants received TDV placebo-matching 0.5 ml injection, SC, once at Visit 3 (Month 15) for participants from parent trial DEN-304 (US) or once at Visit 3 (Month 42) for participants from parent trial DEN-315 (Mexico).

    Reporting group title
    Booster Phase: TDV
    Reporting group description
    		 Participants received TDV 0.5 ml, injection, SC, once at Visit 3 (Month 15) for participants from parent trial DEN-304 (US) or once at Visit 3 (Month 42) for participants from parent trial DEN-315 (Mexico).

    Primary: Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes in the Period Prior to Booster at Visit 1 (Month 0 [Day 1])

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    End point title
    		 Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes in the Period Prior to Booster at Visit 1 (Month 0 [Day 1]) [1]
    End point description
    GMTs of neutralizing antibodies were measured by microneutralization test 50% (MNT50) for each of the 4 Dengue Serotypes (DENV-1, DENV-2, DENV-3 and DENV-4). Reported here is the data from Visit 1 at Month 0 for participants from both parent trials (DEN-304 and DEN-315). Per Protocol Set (PPS) included all participants from the Full Analysis Set (FAS) who received two doses of Takeda’s TDV in the parent trials with no new major protocol violations in this trial prior to administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial.
    End point type
    Primary
    End point timeframe
    Month 0 (Day 1)
    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: Only descriptive analyses were planned for this endpoint.
    End point values
    		 Prior to Booster: DEN-304 Prior to Booster: DEN-315
    Number of subjects analysed
    239
    119
    Units: titer
    geometric mean (confidence interval 95%)
        DENV-1
    76.8 (62.0 to 95.2)
    88.6 (70.4 to 111.5)
        DENV-2
    539.6 (460.9 to 631.7)
    425.6 (352.7 to 513.5)
        DENV-3
    33.7 (28.0 to 40.5)
    29.5 (24.1 to 36.1)
        DENV-4
    40.0 (33.1 to 48.4)
    27.1 (21.9 to 33.6)
    No statistical analyses for this end point

    Primary: Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes in the Period Prior to Booster at Visit 2 (Month 12)

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    End point title
    		 Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes in the Period Prior to Booster at Visit 2 (Month 12) [2]
    End point description
    GMTs of neutralizing antibodies were measured by MNT50 for each of the 4 Dengue Serotypes (DENV-1, DENV-2, DENV-3 and DENV-4). Reported here is the data from Visit 2 at Month 12 for participants from both parent trials (DEN-304 and DEN-315). PPS included all participants from the FAS who received two doses of Takeda’s TDV in the parent trials with no new major protocol violations in this trial prior to administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Subjects analysed: number of subjects with data available for analyses.
    End point type
    Primary
    End point timeframe
    Month 12
    Notes
    [2] - 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: Only descriptive analyses were planned for this endpoint.
    End point values
    		 Prior to Booster: DEN-304 Prior to Booster: DEN-315
    Number of subjects analysed
    182
    48
    Units: titer
    geometric mean (confidence interval 95%)
        DENV-1
    58.4 (45.0 to 75.7)
    96.4 (69.9 to 132.7)
        DENV-2
    427.3 (360.2 to 507.0)
    276.1 (208.3 to 365.9)
        DENV-3
    32.8 (26.5 to 40.4)
    25.3 (18.5 to 34.7)
        DENV-4
    30.0 (24.4 to 37.0)
    22.9 (17.6 to 29.8)
    No statistical analyses for this end point

    Primary: Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes in the Period Prior to Booster at Visit 3 (Month 15) (DEN-304)

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    End point title
    		 Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes in the Period Prior to Booster at Visit 3 (Month 15) (DEN-304) [3] [4]
    End point description
    GMTs of neutralizing antibodies were measured by MNT50 for each of the 4 Dengue Serotypes (DENV-1, DENV-2, DENV-3 and DENV-4). Reported here is the data from Visit 3 at Month 15 for participants from parent trial DEN-304. PPS included all participants from the FAS who received two doses of Takeda’s TDV in the parent trials with no new major protocol violations in this trial prior to administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Subjects analysed: number of subjects with data available for analyses.
    End point type
    Primary
    End point timeframe
    Month 15 (DEN-304)
    Notes
    [3] - 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: Only descriptive analyses were planned for this endpoint.
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only data for participants from parent trial DEN-304 was included for this endpoint.
    End point values
    		 Prior to Booster: DEN-304
    Number of subjects analysed
    171
    Units: titer
    geometric mean (confidence interval 95%)
        DENV-1
    121.7 (93.3 to 158.7)
        DENV-2
    560.2 (473.9 to 662.2)
        DENV-3
    40.3 (32.6 to 49.8)
        DENV-4
    34.1 (27.3 to 42.6)
    No statistical analyses for this end point

    Primary: Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes in the Period Prior to Booster at Visit 3 (Month 42) (DEN-315)

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    End point title
    		 Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes in the Period Prior to Booster at Visit 3 (Month 42) (DEN-315) [5] [6]
    End point description
    GMTs of neutralizing antibodies were measured by MNT50 for each of the 4 Dengue Serotypes (DENV-1, DENV-2, DENV-3 and DENV-4). Reported here is the data from Visit 3 at Month 42 for participants from parent trial DEN-315. PPS included all participants from the FAS who received two doses of Takeda’s TDV in the parent trials with no new major protocol violations in this trial prior to administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Subjects analysed: number of subjects with data available for analyses.
    End point type
    Primary
    End point timeframe
    Month 42 (DEN-315)
    Notes
    [5] - 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: Only descriptive analyses were planned for this endpoint.
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only data for participants from parent trial DEN-315 was included for this endpoint.
    End point values
    		 Prior to Booster: DEN-315
    Number of subjects analysed
    80
    Units: titer
    geometric mean (confidence interval 95%)
        DENV-1
    106.5 (80.8 to 140.4)
        DENV-2
    202.9 (159.5 to 258.2)
        DENV-3
    21.9 (16.8 to 28.5)
        DENV-4
    11.2 (9.1 to 13.6)
    No statistical analyses for this end point

    Primary: Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes in the Period Prior to Booster by Serostatus at Baseline in the Parent Trials at Visit 1 (Month 0 [Day 1])

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    End point title
    		 Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes in the Period Prior to Booster by Serostatus at Baseline in the Parent Trials at Visit 1 (Month 0 [Day 1]) [7]
    End point description
    GMTs of neutralizing antibodies were measured by MNT50 for each of the 4 Dengue Serotypes (DENV-1, DENV-2, DENV-3 and DENV-4). Baseline seropositivity is defined as reciprocal neutralizing titer ≥10 for one or more dengue serotypes at baseline in the parent trial. Reported here is the data from Visit 1 at Month 0 for participants from both parent trials (DEN-304 and DEN-315). PPS included all participants from the FAS who received two doses of Takeda’s TDV in the parent trials with no new major protocol violations in this trial prior to administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Number of subjects analysed was variable for each category.
    End point type
    Primary
    End point timeframe
    Month 0 [Day 1)
    Notes
    [7] - 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: Only descriptive analyses were planned for this endpoint.
    End point values
    		 Prior to Booster: DEN-304 Prior to Booster: DEN-315
    Number of subjects analysed
    239
    119
    Units: titer
    geometric mean (confidence interval 95%)
        Parent Trial BL Serostatus:Positive: DENV-1
    122.8 (59.5 to 253.2)
    259.3 (135.7 to 495.5)
        Parent Trial BL Serostatus:Positive: DENV-2
    560.1 (314.3 to 998.1)
    714.1 (355.2 to 1435.7)
        Parent Trial BL Serostatus:Positive: DENV-3
    48.2 (26.1 to 88.9)
    118.7 (28.3 to 497.3)
        Parent Trial BL Serostatus:Positive: DENV-4
    61.5 (32.1 to 118.2)
    112.4 (29.6 to 427.5)
        Parent Trial BL Serostatus:Negative; DENV-1
    71.3 (57.2 to 88.9)
    82.0 (64.7 to 103.9)
        Parent Trial BL Serostatus:Negative; DENV-2
    536.4 (456.9 to 629.6)
    410.0 (337.1 to 498.6)
        Parent Trial BL Serostatus:Negative; DENV-3
    31.8 (26.3 to 38.5)
    26.7 (22.1 to 32.2)
        Parent Trial BL Serostatus:Negative; DENV-4
    37.3 (30.7 to 45.4)
    24.5 (19.9 to 30.0)
    No statistical analyses for this end point

    Primary: Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes in the Period Prior to Booster by Serostatus at Baseline in the Parent Trials at Visit 2 (Month 12)

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    End point title
    		 Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes in the Period Prior to Booster by Serostatus at Baseline in the Parent Trials at Visit 2 (Month 12) [8]
    End point description
    GMTs of neutralizing antibodies were measured by MNT50 for each of the 4 Dengue Serotypes (DENV-1, DENV-2, DENV-3 and DENV-4). Baseline seropositivity is defined as reciprocal neutralizing titer ≥10 for one or more dengue serotypes at baseline in the parent trial. Reported here is the data from Visit 2 at Month 12 for participants from both parent trials (DEN-304 and DEN-315). PPS included all participants from the FAS who received two doses of Takeda’s TDV in the parent trials with no new major protocol violations in this trial prior to administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Subjects analysed: number of subjects with data available for analyses. Number of subjects analysed was variable for each category. '9.99' and '99.9' indicates that the confidence interval was not estimable due to an observed standard deviation of 0.
    End point type
    Primary
    End point timeframe
    Month 12
    Notes
    [8] - 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: Only descriptive analyses were planned for this endpoint.
    End point values
    		 Prior to Booster: DEN-304 Prior to Booster: DEN-315
    Number of subjects analysed
    182
    48
    Units: titer
    geometric mean (confidence interval 95%)
        Parent Trial BL Serostatus:Positive; DENV-1
    87.2 (37.2 to 204.4)
    93.5 (0.0 to 6220000)
        Parent Trial BL Serostatus:Positive; DENV-2
    544.5 (279.1 to 1062.4)
    272.6 (0.0 to 12600000)
        Parent Trial BL Serostatus:Positive; DENV-3
    48.6 (23.2 to 101.6)
    34.0 (9.99 to 99.9)
        Parent Trial BL Serostatus:Positive; DENV-4
    48.0 (22.2 to 104.0)
    21.5 (16.0 to 28.9)
        Parent Trial BL Serostatus:Negative; DENV-1
    54.8 (41.7 to 71.9)
    96.5 (69.3 to 134.2)
        Parent Trial BL Serostatus:Negative; DENV-2
    411.1 (346.6 to 487.6)
    276.2 (206.7 to 369.0)
        Parent Trial BL Serostatus:Negative; DENV-3
    30.8 (24.8 to 38.2)
    25.0 (18.0 to 34.7)
        Parent Trial BL Serostatus:Negative; DENV-4
    27.8 (22.6 to 34.4)
    23.0 (17.5 to 30.2)
    No statistical analyses for this end point

    Primary: Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes in the Period Prior to Booster by Serostatus at Baseline in the Parent Trials at Visit 3 (Month 42) (DEN-315)

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    End point title
    		 Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes in the Period Prior to Booster by Serostatus at Baseline in the Parent Trials at Visit 3 (Month 42) (DEN-315) [9] [10]
    End point description
    GMTs of neutralizing antibodies were measured by MNT50 for each of the 4 Dengue Serotypes (DENV-1, DENV-2, DENV-3 and DENV-4). Baseline seropositivity is defined as reciprocal neutralizing titer ≥10 for one or more dengue serotypes at baseline in the parent trial. Reported here is the data from Visit 3 at Month 42 for participants from parent trial DEN-315. PPS included all participants from the FAS who received two doses of Takeda’s TDV in the parent trials with no new major protocol violations in this trial prior to administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Subjects analysed: number of subjects with data available for analyses. Number of subjects analysed was variable for each category.
    End point type
    Primary
    End point timeframe
    Month 42 (DEN-315)
    Notes
    [9] - 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: Only descriptive analyses were planned for this endpoint.
    [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only data for participants from parent trial DEN-315 was included for this endpoint.
    End point values
    		 Prior to Booster: DEN-315
    Number of subjects analysed
    80
    Units: titer
    geometric mean (confidence interval 95%)
        Parent Trial Baseline Serostatus:Positive; DENV-1
    320.0 (119.6 to 856.4)
        Parent Trial Baseline Serostatus:Positive; DENV-2
    436.6 (156.3 to 1219.1)
        Parent Trial Baseline Serostatus:Positive; DENV-3
    80.4 (17.5 to 369.3)
        Parent Trial Baseline Serostatus:Positive; DENV-4
    23.3 (4.3 to 125.1)
        Parent Trial Baseline Serostatus:Negative; DENV-1
    95.8 (72.2 to 127.2)
        Parent Trial Baseline Serostatus:Negative; DENV-2
    188.6 (147.3 to 241.4)
        Parent Trial Baseline Serostatus:Negative; DENV-3
    19.3 (15.1 to 24.8)
        Parent Trial Baseline Serostatus:Negative; DENV-4
    10.4 (8.8 to 12.4)
    No statistical analyses for this end point

    Primary: Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes in the Period Prior to Booster by Serostatus at Baseline in the Parent Trials at Visit 3 (Month 15) (DEN-304)

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    End point title
    		 Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes in the Period Prior to Booster by Serostatus at Baseline in the Parent Trials at Visit 3 (Month 15) (DEN-304) [11] [12]
    End point description
    GMTs of neutralizing antibodies were measured by MNT50 for each of the 4 Dengue Serotypes (DENV-1, DENV-2, DENV-3 and DENV-4). Baseline seropositivity is defined as reciprocal neutralizing titer ≥10 for one or more dengue serotypes at baseline in the parent trial. Reported here is the data from Visit 3 at Month 15 for participants from parent trial DEN-304. PPS included all participants from the FAS who received two doses of Takeda’s TDV in the parent trials with no new major protocol violations in this trial prior to administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Subjects analysed: number of subjects with data available for analyses. Number of subjects analysed was variable for each category.
    End point type
    Primary
    End point timeframe
    Month 15 (DEN-304)
    Notes
    [11] - 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: Only descriptive analyses were planned for this endpoint.
    [12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only data for participants from parent trial DEN-304 was included for this endpoint.
    End point values
    		 Prior to Booster: DEN-304
    Number of subjects analysed
    171
    Units: titer
    geometric mean (confidence interval 95%)
        Parent Trial BL Serostatus:Positive; DENV-1
    214.3 (80.6 to 569.9)
        Parent Trial BL Serostatus:Positive; DENV-2
    484.5 (263.4 to 891.3)
        Parent Trial BL Serostatus:Positive; DENV-3
    60.4 (29.9 to 122.1)
        Parent Trial BL Serostatus:Positive; DENV-4
    47.0 (21.7 to 102.1)
        Parent Trial BL Serostatus:Negative; DENV-1
    110.9 (84.9 to 145.0)
        Parent Trial BL Serostatus:Negative; DENV-2
    573.6 (483.5 to 680.4)
        Parent Trial BL Serostatus:Negative; DENV-3
    37.7 (30.3 to 46.9)
        Parent Trial BL Serostatus:Negative; DENV-4
    32.4 (25.7 to 40.7)
    No statistical analyses for this end point

    Primary: Seropositivity Rate for Each of the 4 Dengue Serotypes in the Period Prior to Booster at Visit 1 (Month 0 [Day 1])

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    End point title
    		 Seropositivity Rate for Each of the 4 Dengue Serotypes in the Period Prior to Booster at Visit 1 (Month 0 [Day 1]) [13]
    End point description
    Seropositivity rate, defined as the percentage of participants seropositive, is derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a reciprocal neutralizing titer ≥10. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Reported here is the data from Visit 1 at Month 0 for participants from both parent trials (DEN-304 and DEN-315). PPS included all participants from the FAS who received two doses of Takeda’s TDV in the parent trials with no new major protocol violations in this trial prior to administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial.
    End point type
    Primary
    End point timeframe
    Month 0 (Day 1)
    Notes
    [13] - 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: Only descriptive analyses were planned for this endpoint.
    End point values
    		 Prior to Booster: DEN-304 Prior to Booster: DEN-315
    Number of subjects analysed
    239
    119
    Units: percentage of participants
    number (confidence interval 95%)
        DENV-1
    85.8 (80.7 to 89.9)
    92.4 (86.1 to 96.5)
        DENV-2
    98.7 (96.4 to 99.7)
    99.2 (95.4 to 100)
        DENV-3
    72.4 (66.3 to 78.0)
    79.8 (71.5 to 86.6)
        DENV-4
    80.8 (75.2 to 85.6)
    76.5 (67.8 to 83.8)
    No statistical analyses for this end point

    Primary: Seropositivity Rate for Each of the 4 Dengue Serotypes in the Period Prior to Booster at Visit 3 (Month 15) (DEN-304)

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    End point title
    		 Seropositivity Rate for Each of the 4 Dengue Serotypes in the Period Prior to Booster at Visit 3 (Month 15) (DEN-304) [14] [15]
    End point description
    Seropositivity Rate, defined as the percentage of participants seropositive, is derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a reciprocal neutralizing titer ≥10. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Reported here is the data from Visit 3 at Month 15 for participants from parent trial DEN-304. PPS included all participants from the FAS who received two doses of Takeda’s TDV in the parent trials with no new major protocol violations in this trial prior to administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Subjects analysed: number of subjects with data available for analyses.
    End point type
    Primary
    End point timeframe
    Month 15 (DEN-304)
    Notes
    [14] - 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: Only descriptive analyses were planned for this endpoint.
    [15] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only data for participants from parent trial DEN-304 was included for this endpoint.
    End point values
    		 Prior to Booster: DEN-304
    Number of subjects analysed
    171
    Units: percentage of participants
    number (confidence interval 95%)
        DENV-1
    94.2 (89.5 to 97.2)
        DENV-2
    99.4 (96.8 to 100)
        DENV-3
    81.9 (75.3 to 87.3)
        DENV-4
    76.0 (68.9 to 82.2)
    No statistical analyses for this end point

    Primary: Seropositivity Rate for Each of the 4 Dengue Serotypes in the Period Prior to Booster at Visit 2 (Month 12)

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    End point title
    		 Seropositivity Rate for Each of the 4 Dengue Serotypes in the Period Prior to Booster at Visit 2 (Month 12) [16]
    End point description
    Seropositivity rate, defined as the percentage of participants seropositive, is derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a reciprocal neutralizing titer ≥10. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Reported here is the data from Visit 2 at Month 12 for participants from both parent trials (DEN-304 and DEN-315). PPS included all participants from the FAS who received two doses of Takeda’s TDV in the parent trials with no new major protocol violations in this trial prior to administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Subjects analysed: number of subjects with data available for analyses.
    End point type
    Primary
    End point timeframe
    Month 12
    Notes
    [16] - 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: Only descriptive analyses were planned for this endpoint.
    End point values
    		 Prior to Booster: DEN-304 Prior to Booster: DEN-315
    Number of subjects analysed
    182
    48
    Units: percentage of participants
    number (confidence interval 95%)
        DENV-1
    78.6 (71.9 to 84.3)
    97.9 (88.9 to 100)
        DENV-2
    100 (98.0 to 100)
    100 (92.6 to 100)
        DENV-3
    72.0 (64.9 to 78.4)
    75.0 (60.4 to 86.4)
        DENV-4
    76.4 (69.5 to 82.3)
    83.3 (69.8 to 92.5)
    No statistical analyses for this end point

    Primary: Seropositivity Rate for Each of the 4 Dengue Serotypes in the Period Prior to Booster at Visit 3 (Month 42) (DEN-315)

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    End point title
    		 Seropositivity Rate for Each of the 4 Dengue Serotypes in the Period Prior to Booster at Visit 3 (Month 42) (DEN-315) [17] [18]
    End point description
    Seropositivity rate, defined as the percentage of participants seropositive, is derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a reciprocal neutralizing titer ≥10. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Reported here is the data from Visit 3 at Month 42 for parent trial DEN-315. PPS included all participants from the FAS who received two doses of Takeda’s TDV in the parent trials with no new major protocol violations in this trial prior to administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Subjects analysed: number of subjects with data available for analyses.
    End point type
    Primary
    End point timeframe
    Month 42 (DEN-315)
    Notes
    [17] - 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: Only descriptive analyses were planned for this endpoint.
    [18] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only data for participants from parent trial DEN-315 was included for this endpoint.
    End point values
    		 Prior to Booster: DEN-315
    Number of subjects analysed
    80
    Units: percentage of participants
    number (confidence interval 95%)
        DENV-1
    96.3 (89.4 to 99.2)
        DENV-2
    98.8 (93.2 to 100)
        DENV-3
    71.3 (60.0 to 80.8)
        DENV-4
    55.0 (43.5 to 66.2)
    No statistical analyses for this end point

    Primary: Seropositivity Rate for Each of the 4 Dengue Serotypes in the Period Prior to Booster by Serostatus at Baseline in the Parent Trials at Visit 1 [Month 0 (Day 1])

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    End point title
    		 Seropositivity Rate for Each of the 4 Dengue Serotypes in the Period Prior to Booster by Serostatus at Baseline in the Parent Trials at Visit 1 [Month 0 (Day 1]) [19]
    End point description
    Seropositivity rate, defined as the percentage of participants seropositive, is derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a reciprocal neutralizing titer ≥10. Baseline seropositivity is defined as reciprocal neutralizing titer ≥10 for one or more dengue serotypes at baseline in the parent trial. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Reported here is the data from Visit 1 at Month 0 for participants from both parent trials (DEN-304 and DEN-315). PPS included all participants from the FAS who received two doses of Takeda’s TDV in the parent trials with no new major protocol violations in this trial prior to administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Subjects analysed: number of subjects with data available for analyses.
    End point type
    Primary
    End point timeframe
    Month 0 (Day 1)
    Notes
    [19] - 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: Only descriptive analyses were planned for this endpoint.
    End point values
    		 Prior to Booster: DEN-304 Prior to Booster: DEN-315
    Number of subjects analysed
    239
    119
    Units: percentage of participants
    number (confidence interval 95%)
        Parent Trial Baseline Serostatus:Positive; DENV-1
    81.8 (64.5 to 93.0)
    100 (63.1 to 100)
        Parent Trial Baseline Serostatus:Positive; DENV-2
    97.0 (84.2 to 100)
    100 (63.1 to 100)
        Parent Trial Baseline Serostatus:Positive; DENV-3
    75.8 (57.7 to 88.9)
    100 (63.1 to 100)
        Parent Trial Baseline Serostatus:Positive; DENV-4
    87.9 (71.8 to 96.6)
    100 (63.1 to 100)
        Parent Trial Baseline Serostatus:Negative; DENV-1
    86.4 (81.0 to 90.8)
    91.9 (85.2 to 96.2)
        Parent Trial Baseline Serostatus:Negative; DENV-2
    99.0 (96.5 to 99.9)
    99.1 (95.1 to 100)
        Parent Trial Baseline Serostatus:Negative; DENV-3
    71.8 (65.2 to 77.9)
    78.4 (69.6 to 85.6)
        Parent Trial Baseline Serostatus:Negative; DENV-4
    79.6 (73.5 to 84.9)
    74.8 (65.6 to 82.5)
    No statistical analyses for this end point

    Primary: Seropositivity Rate for Each of the 4 Dengue Serotypes in the Period Prior to Booster by Serostatus at Baseline in the Parent Trials at Visit 2 (Month 12)

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    End point title
    		 Seropositivity Rate for Each of the 4 Dengue Serotypes in the Period Prior to Booster by Serostatus at Baseline in the Parent Trials at Visit 2 (Month 12) [20]
    End point description
    Seropositivity rate, defined as the percentage of participants seropositive, is derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a reciprocal neutralizing titer ≥10. Baseline seropositivity is defined as reciprocal neutralizing titer ≥10 for one or more dengue serotypes at baseline in the parent trial. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Reported here is the data from Visit 2 at Month 12 for participants from both parent trials (DEN-304 and DEN-315). PPS included all participants from the FAS who received two doses of Takeda’s TDV in the parent trials with no new major protocol violations in this trial prior to administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Subjects analysed: number of subjects with data available for analyses. Number of subjects analysed was variable for each category.
    End point type
    Primary
    End point timeframe
    Month 12
    Notes
    [20] - 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: Only descriptive analyses were planned for this endpoint.
    End point values
    		 Prior to Booster: DEN-304 Prior to Booster: DEN-315
    Number of subjects analysed
    182
    48
    Units: percentage of participants
    number (confidence interval 95%)
        Parent Trial Baseline Serostatus:Positive; DENV-1
    80.0 (59.3 to 93.2)
    100 (15.8 to 100)
        Parent Trial Baseline Serostatus:Positive; DENV-2
    100 (86.3 to 100)
    100 (15.8 to 100)
        Parent Trial Baseline Serostatus:Positive; DENV-3
    76.0 (54.9 to 90.6)
    100 (15.8 to 100)
        Parent Trial Baseline Serostatus:Positive; DENV-4
    80.0 (59.3 to 93.2)
    100 (15.8 to 100)
        Parent Trial Baseline Serostatus:Negative; DENV-1
    78.3 (71.1 to 84.5)
    97.8 (88.5 to 100)
        Parent Trial Baseline Serostatus:Negative; DENV-2
    100 (97.7 to 100)
    100 (92.3 to 100)
        Parent Trial Baseline Serostatus:Negative; DENV-3
    71.3 (63.6 to 78.3)
    73.9 (58.9 to 85.7)
        Parent Trial Baseline Serostatus:Negative; DENV-4
    75.8 (68.3 to 82.3)
    82.6 (68.6 to 92.2)
    No statistical analyses for this end point

    Primary: Seropositivity Rate for Each of the 4 Dengue Serotypes in the Period Prior to Booster by Serostatus at Baseline in the Parent Trials at Visit 3 (Month 15) (DEN-304)

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    End point title
    		 Seropositivity Rate for Each of the 4 Dengue Serotypes in the Period Prior to Booster by Serostatus at Baseline in the Parent Trials at Visit 3 (Month 15) (DEN-304) [21] [22]
    End point description
    Seropositivity rate, defined as the percentage of participants seropositive, is derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a reciprocal neutralizing titer ≥10. Baseline seropositivity is defined as reciprocal neutralizing titer ≥10 for one or more dengue serotypes at baseline in the parent trial. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Reported here is the data from Visit 3 at Month 15 for participants from parent trial DEN-304. PPS included all participants from the FAS who received two doses of Takeda’s TDV in the parent trials with no new major protocol violations in this trial prior to administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Subjects analysed: number of subjects with data available for analyses. Number of subjects analysed was variable for each category.
    End point type
    Primary
    End point timeframe
    Month 15 (DEN-304)
    Notes
    [21] - 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: Only descriptive analyses were planned for this endpoint.
    [22] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only data for participants from parent trial DEN-304 was included for this endpoint.
    End point values
    		 Prior to Booster: DEN-304
    Number of subjects analysed
    171
    Units: percentage of participants
    number (confidence interval 95%)
        Parent Trial Baseline Serostatus:Positive; DENV-1
    87.5 (67.6 to 97.3)
        Parent Trial Baseline Serostatus:Positive; DENV-2
    100 (85.8 to 100)
        Parent Trial Baseline Serostatus:Positive; DENV-3
    83.3 (62.6 to 95.3)
        Parent Trial Baseline Serostatus:Positive: DENV-4
    79.2 (57.8 to 92.9)
        Parent Trial Baseline Serostatus:Negative: DENV-1
    95.2 (90.4 to 98.1)
        Parent Trial Baseline Serostatus:Negative: DENV-2
    99.3 (96.3 to 100)
        Parent Trial Baseline Serostatus:Negative: DENV-3
    81.6 (74.4 to 87.5)
        Parent Trial Baseline Serostatus:Negative: DENV-4
    75.5 (67.7 to 82.2)
    No statistical analyses for this end point

    Primary: Seropositivity Rate for Each of the 4 Dengue Serotypes in the Period Prior to Booster by Serostatus at Baseline in the Parent Trials at Visit 3 (Month 42) (DEN-315)

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    End point title
    		 Seropositivity Rate for Each of the 4 Dengue Serotypes in the Period Prior to Booster by Serostatus at Baseline in the Parent Trials at Visit 3 (Month 42) (DEN-315) [23] [24]
    End point description
    Seropositivity rate, defined as the percentage of participants seropositive, is derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a reciprocal neutralizing titer ≥10. Baseline seropositivity is defined as reciprocal neutralizing titer ≥10 for one or more dengue serotypes at baseline in the parent trial. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Reported here is the data from Visit 3 at Month 42 for parent trial DEN-315. PPS included all participants from the FAS who received two doses of Takeda’s TDV in the parent trials with no new major protocol violations in this trial prior to administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Subjects analysed: number of subjects with data available for analyses. Number of subjects analysed was variable for each category.
    End point type
    Primary
    End point timeframe
    Month 42 (DEN-315)
    Notes
    [23] - 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: Only descriptive analyses were planned for this endpoint.
    [24] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only data for participants from parent trial DEN-315 was included for this endpoint.
    End point values
    		 Prior to Booster: DEN-315
    Number of subjects analysed
    80
    Units: percentage of participants
    number (confidence interval 95%)
        Parent Trial Baseline Serostatus:Positive: DENV-1
    100 (59.0 to 100)
        Parent Trial Baseline Serostatus:Positive: DENV-2
    100 (59.0 to 100)
        Parent Trial Baseline Serostatus:Positive: DENV-3
    100 (59.0 to 100)
        Parent Trial Baseline Serostatus:Positive: DENV-4
    57.1 (18.4 to 90.1)
        Parent Trial Baseline Serostatus:Negative: DENV-1
    95.9 (88.5 to 99.1)
        Parent Trial Baseline Serostatus;Negative: DENV-2
    98.6 (92.6 to 100)
        Parent Trial Baseline Serostatus; Negative:DENV-3
    68.5 (56.6 to 78.9)
        Parent Trial Baseline Serostatus; Negative:DENV-4
    54.8 (42.7 to 66.5)
    No statistical analyses for this end point

    Primary: Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes in the Period Prior to Booster at Visit 1 (Month 0 [Day 1])

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    End point title
    		 Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes in the Period Prior to Booster at Visit 1 (Month 0 [Day 1]) [25]
    End point description
    Seropositivity rate for multiple Dengue serotypes, defined as the percentage of participants seropositive for more than one Dengue serotype, is derived from the titers of dengue-neutralizing antibodies. All 4 dengue serotypes (tetravalent), any 2 of the 4 dengue serotypes (bivalent), any 3 of the 4 dengue serotypes (trivalent). Seropositivity is defined as a reciprocal neutralizing titer ≥10. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Reported here is the data from Visit 1 at Month 0 for both parent trials (DEN-304 and DEN-315). PPS included all participants from the FAS who received two doses of Takeda’s TDV in the parent trials with no new major protocol violations in this trial prior to administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial.
    End point type
    Primary
    End point timeframe
    Month 0 (Day 1)
    Notes
    [25] - 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: Only descriptive analyses were planned for this endpoint.
    End point values
    		 Prior to Booster: DEN-304 Prior to Booster: DEN-315
    Number of subjects analysed
    239
    119
    Units: percentage of participants
    number (confidence interval 95%)
        Bivalent
    10.9 (7.2 to 15.5)
    9.2 (4.7 to 15.9)
        Trivalent
    20.5 (15.6 to 26.2)
    18.5 (12.0 to 26.6)
        Tetravalent
    61.9 (55.4 to 68.1)
    67.2 (58.0 to 75.6)
    No statistical analyses for this end point

    Primary: Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes in the Period Prior to Booster at Visit 3 (Month 15) (DEN-304)

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    End point title
    		 Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes in the Period Prior to Booster at Visit 3 (Month 15) (DEN-304) [26] [27]
    End point description
    Seropositivity rate for multiple Dengue serotypes, defined as the percentage of participants seropositive for more than one Dengue serotype, is derived from the titers of dengue-neutralizing antibodies. All 4 dengue serotypes (tetravalent), any 2 of the 4 dengue serotypes (bivalent), any 3 of the 4 dengue serotypes (trivalent). Seropositivity is defined as a reciprocal neutralizing titer ≥10. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Reported here is the data from Visit 3 at Month 15 for parent trial DEN-304. PPS included all participants from the FAS who received two doses of Takeda’s TDV in the parent trials with no new major protocol violations in this trial prior to administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Subjects analysed: number of subjects with data available for analyses.
    End point type
    Primary
    End point timeframe
    Month 15 (DEN-304)
    Notes
    [26] - 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: Only descriptive analyses were planned for this endpoint.
    [27] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only data for participants from parent trial DEN-304 was included for this endpoint.
    End point values
    		 Prior to Booster: DEN-304
    Number of subjects analysed
    171
    Units: percentage of participants
    number (confidence interval 95%)
        Bivalent
    10.5 (6.4 to 16.1)
        Trivalent
    17.0 (11.7 to 23.4)
        Tetravalent
    69.0 (61.5 to 75.8)
    No statistical analyses for this end point

    Primary: Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes in the Period Prior to Booster at Visit 2 (Month 12)

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    End point title
    		 Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes in the Period Prior to Booster at Visit 2 (Month 12) [28]
    End point description
    Seropositivity rate for multiple Dengue serotypes, defined as the percentage of participants seropositive for more than one Dengue serotype, is derived from the titers of dengue-neutralizing antibodies. All 4 dengue serotypes (tetravalent), any 2 of the 4 dengue serotypes (bivalent), any 3 of the 4 dengue serotypes (trivalent). Seropositivity is defined as a reciprocal neutralizing titer ≥10. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Reported here is the data from Visit 2 at Month 12 for both parent trials (DEN-304 and DEN-315). PPS included all participants from the FAS who received two doses of Takeda’s TDV in the parent trials with no new major protocol violations in this trial prior to administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Subjects analysed: number of subjects with data available for analyses.
    End point type
    Primary
    End point timeframe
    Month 12
    Notes
    [28] - 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: Only descriptive analyses were planned for this endpoint.
    End point values
    		 Prior to Booster: DEN-304 Prior to Booster: DEN-315
    Number of subjects analysed
    182
    48
    Units: percentage of participants
    number (confidence interval 95%)
        Bivalent
    12.6 (8.2 to 18.4)
    10.4 (3.5 to 22.7)
        Trivalent
    21.4 (15.7 to 28.1)
    22.9 (12.0 to 37.3)
        Tetravalent
    57.1 (49.6 to 64.4)
    66.7 (51.6 to 79.6)
    No statistical analyses for this end point

    Primary: Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes in the Period Prior to Booster by Serostatus at Baseline in the Parent Trials at Visit 1 (Month 0 [Day 1])

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    End point title
    		 Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes in the Period Prior to Booster by Serostatus at Baseline in the Parent Trials at Visit 1 (Month 0 [Day 1]) [29]
    End point description
    Seropositivity rate for multiple Dengue serotypes, defined as the percentage of participants seropositive for more than one Dengue serotype, is derived from the titers of dengue-neutralizing antibodies. All 4 dengue serotypes (tetravalent), any 2 of the 4 dengue serotypes (bivalent), any 3 of the 4 dengue serotypes (trivalent). Seropositivity is defined as a reciprocal neutralizing titer ≥10. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Reported here is the data from Visit 1 at Month 0 for both parent trials (DEN-304 and DEN-315).PPS included all participants from the FAS who received two doses of Takeda’s TDV in the parent trials with no new major protocol violations in this trial prior to administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Number of subjects analysed was variable for each category. 'BL' indicates Baseline.
    End point type
    Primary
    End point timeframe
    Month 0 (Day 1)
    Notes
    [29] - 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: Only descriptive analyses were planned for this endpoint.
    End point values
    		 Prior to Booster: DEN-304 Prior to Booster: DEN-315
    Number of subjects analysed
    239
    119
    Units: percentage of participants
    number (confidence interval 95%)
        Parent Trial BL Serostatus;Positive: Bivalent
    9.1 (1.9 to 24.3)
    0 (0.0 to 36.9)
        Parent Trial BL Serostatus;Positive: Trivalent
    12.1 (3.4 to 28.2)
    0 (0.0 to 36.9)
        Parent Trial BL Serostatus;Positive: Tetravalent
    69.7 (51.3 to 84.4)
    100 (63.1 to 100)
        Parent Trial BL Serostatus;Negative: Bivalent
    11.2 (7.2 to 16.3)
    9.9 (5.1 to 17.0)
        Parent Trial BL Serostatus;Negative: Trivalent
    21.8 (16.4 to 28.1)
    19.8 (12.9 to 28.5)
        Parent Trial BL Serostatus;Negative: Tetravalent
    60.7 (53.7 to 67.4)
    64.9 (55.2 to 73.7)
    No statistical analyses for this end point

    Primary: Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes in the Period Prior to Booster at Visit 3 (Month 42) (DEN-315)

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    End point title
    		 Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes in the Period Prior to Booster at Visit 3 (Month 42) (DEN-315) [30] [31]
    End point description
    Seropositivity rate for multiple Dengue serotypes, defined as the percentage of participants seropositive for more than one Dengue serotype, is derived from the titers of dengue-neutralizing antibodies. All 4 dengue serotypes (tetravalent), any 2 of the 4 dengue serotypes (bivalent), any 3 of the 4 dengue serotypes (trivalent). Seropositivity is defined as a reciprocal neutralizing titer ≥10. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Reported here is the data from Visit 3 at Month 42 for parent trial DEN-315. PPS included all participants from the FAS who received two doses of Takeda’s TDV in the parent trials with no new major protocol violations in this trial prior to administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Subjects analysed: number of subjects with data available for analyses.
    End point type
    Primary
    End point timeframe
    Month 42 (DEN-315)
    Notes
    [30] - 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: Only descriptive analyses were planned for this endpoint.
    [31] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only data for participants from parent trial DEN-315 was included for this endpoint.
    End point values
    		 Prior to Booster: DEN-315
    Number of subjects analysed
    80
    Units: percentage of participants
    number (confidence interval 95%)
        Bivalent
    20.0 (11.9 to 30.4)
        Trivalent
    27.5 (18.1 to 38.6)
        Tetravalent
    48.8 (37.4 to 60.2)
    No statistical analyses for this end point

    Primary: Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes in the Period Prior to Booster by Serostatus at Baseline in the Parent Trials at Visit 2 (Month 12)

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    End point title
    		 Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes in the Period Prior to Booster by Serostatus at Baseline in the Parent Trials at Visit 2 (Month 12) [32]
    End point description
    Seropositivity rate for multiple Dengue serotypes:percentage of participants seropositive for more than 1 Dengue serotype,is derived from titers of dengue-neutralizing antibodies.All 4 dengue serotypes(tetravalent),any 2 of 4 dengue serotypes(bivalent),any 3 of 4 dengue serotypes(trivalent).Seropositivity:reciprocal neutralizing titer≥10.Baseline seropositivity:reciprocal neutralizing titer≥10 for one or more dengue serotypes at baseline in parent trial.4 dengue virus serotypes are DENV-1,DENV-2,DENV-3&DENV-4.Reported here is data from Visit 2 at Month12 for both parent trials(DEN-304&DEN-315).PPS:all participants from FAS who received two doses of Takeda’s TDV in parent trials with no new major protocol violations in this trial prior to administration of trial vaccination at Visit 3 that could potentially confound primary endpoints in current trial.Subjects analyzed:number of subjects with data available for analyses.Number of subjects analysed:variable for each category.BL:Baseline.
    End point type
    Primary
    End point timeframe
    Month 12
    Notes
    [32] - 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: Only descriptive analyses were planned for this endpoint.
    End point values
    		 Prior to Booster: DEN-304 Prior to Booster: DEN-315
    Number of subjects analysed
    182
    48
    Units: percentage of participants
    number (confidence interval 95%)
        Parent Trial BL Serostatus;Positive:Bivalent
    4.0 (0.1 to 20.4)
    0 (0.0 to 84.2)
        Parent Trial BL Serostatus;Positive:Trivalent
    20.0 (6.8 to 40.7)
    0 (0.0 to 84.2)
        Parent Trial BL Serostatus;Positive:Tetravalent
    64.0 (42.5 to 82.0)
    100 (15.8 to 100)
        Parent Trial BL Serostatus;Negative:Bivalent
    14.0 (9.0 to 20.4)
    10.9 (3.6 to 23.6)
        Parent Trial BL Serostatus;Negative: Trivalent
    21.7 (15.5 to 28.9)
    23.9 (12.6 to 38.8)
        Parent Trial BL Serostatus;Negative: Tetravalent
    56.1 (47.9 to 64.0)
    65.2 (49.8 to 78.6)
    No statistical analyses for this end point

    Primary: Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes in the Period Prior to Booster by Serostatus at Baseline in the Parent Trials at Visit 3 (Month 15) (DEN-304)

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    End point title
    		 Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes in the Period Prior to Booster by Serostatus at Baseline in the Parent Trials at Visit 3 (Month 15) (DEN-304) [33] [34]
    End point description
    Seropositivity rate for multiple Dengue serotypes,defined as percentage of participants seropositive for more than 1 Dengue serotype,is derived from titers of dengue-neutralizing antibodies.All 4 dengue serotypes(tetravalent),any 2 of 4 dengue serotypes(bivalent),any 3 of 4 dengue serotypes(trivalent).Seropositivity:as reciprocal neutralizing titer≥10.Baseline seropositivity: as reciprocal neutralizing titer≥10 for one/more dengue serotypes at baseline in parent trial.4 dengue virus serotypes are DENV-1,DENV-2,DENV-3&DENV-4.Reported here is data from Visit3 at Month15 for parent trial DEN-304. PPS:all participants from FAS who received two doses of Takeda’s TDV in parent trials with no new major protocol violations in this trial prior to administration of trial vaccination at Visit3 that could potentially confound primary endpoints in current trial.Subjects analysed:number of subjects with data available for analyses.Number of subjects analysed:variable for each category.BL:Baseline.
    End point type
    Primary
    End point timeframe
    Month 15 (DEN-304)
    Notes
    [33] - 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: Only descriptive analyses were planned for this endpoint.
    [34] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only data for participants from parent trial DEN-304 was included for this endpoint.
    End point values
    		 Prior to Booster: DEN-304
    Number of subjects analysed
    171
    Units: percentage of participants
    number (confidence interval 95%)
        Parent Trial BL Serostatus; Positive: Bivalent
    8.3 (1.0 to 27.0)
        Parent Trial BL Serostatus; Positive: Trivalent
    8.3 (1.0 to 27.0)
        Parent Trial BL Serostatus; Positive: Tetravalent
    75.0 (53.3 to 90.2)
        Parent Trial BL Serostatus; Negative: Bivalent
    10.9 (6.4 to 17.1)
        Parent Trial BL Serostatus; Negative: Trivalent
    18.4 (12.5 to 25.6)
        Parent Trial BL Serostatus; Negative: Tetravalent
    68.0 (59.8 to 75.5)
    No statistical analyses for this end point

    Primary: Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes in the Period Prior to Booster by Serostatus at Baseline in the Parent Trials at Visit 3 (Month 42) (DEN-315)

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    End point title
    		 Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes in the Period Prior to Booster by Serostatus at Baseline in the Parent Trials at Visit 3 (Month 42) (DEN-315) [35] [36]
    End point description
    Seropositivity rate for multiple Dengue serotypes,defined as percentage of participants seropositive for more than 1 Dengue serotype,is derived from titers of dengue-neutralizing antibodies.All 4 dengue serotypes(tetravalent),any 2 of 4 dengue serotypes(bivalent),any 3 of 4 dengue serotypes(trivalent).Seropositivity:reciprocal neutralizing titer ≥10.Baseline seropositivity:reciprocal neutralizing titer≥10 for one or more dengue serotypes at baseline in parent trial.4 dengue virus serotypes are DENV-1,DENV-2,DENV-3&DENV-4.Reported here is data from Visit3 at Month42 for parent trial DEN-315.PPS:all participants from FAS who received two doses of Takeda’s TDV in parent trials with no new major protocol violations in this trial prior to administration of trial vaccination at Visit 3 that could potentially confound primary endpoints in current trial.Subjects analysed:number of subjects with data available for analyses.Number of subjects analysed was variable for each category.BL:Baseline.
    End point type
    Primary
    End point timeframe
    Month 42 (DEN-315)
    Notes
    [35] - 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: Only descriptive analyses were planned for this endpoint.
    [36] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Only data for participants from parent trial DEN-315 was included for this endpoint.
    End point values
    		 Prior to Booster: DEN-315
    Number of subjects analysed
    80
    Units: percentage of participants
    number (confidence interval 95%)
        Parent Trial BL Serostatus; Positive: Bivalent
    0 (0.0 to 41.0)
        Parent Trial BL Serostatus; Positive: Trivalent
    42.9 (9.9 to 81.6)
        Parent Trial BL Serostatus; Positive: Tetravalent
    57.1 (18.4 to 90.1)
        Parent Trial BL Serostatus; Negative: Bivalent
    21.9 (13.1 to 33.1)
        Parent Trial BL Serostatus; Negative: Trivalent
    26.0 (16.5 to 37.6)
        Parent Trial BL Serostatus; Negative: Tetravalent
    47.9 (36.1 to 60.0)
    No statistical analyses for this end point

    Primary: GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Pre-Booster Dose at Visit 3 for Both Parent Trials

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    End point title
    		 GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Pre-Booster Dose at Visit 3 for Both Parent Trials [37]
    End point description
    GMTs of neutralizing antibodies were measured by MNT50 for each of the 4 Dengue Serotypes (DENV-1, DENV-2, DENV-3 and DENV-4). Reported here is the data from Visit 3, pre-booster dose for all participants (Month 15 for parent trial DEN-304 and Month 42 for parent trial DEN-315). Pre-booster dose is defined as the last non-missing value before booster administration. Per Protocol Set-Booster (PPS-B) included all participants from the FAS-B who received two doses of Takeda’s TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Subjects analysed: number of participants with data available for analyses.
    End point type
    Primary
    End point timeframe
    Pre-booster dose at Month 15 (DEN-304) and Month 42 (DEN-315)
    Notes
    [37] - 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: Only descriptive analyses were planned for this endpoint.
    End point values
    		 Booster Phase: Placebo Booster Phase: TDV
    Number of subjects analysed
    102
    100
    Units: titer
    geometric mean (confidence interval 95%)
        DENV-1
    116.2 (86.6 to 156.0)
    120.7 (86.9 to 167.8)
        DENV-2
    404.0 (327.2 to 498.8)
    361.7 (279.7 to 467.9)
        DENV-3
    32.3 (24.8 to 41.9)
    30.1 (22.5 to 40.3)
        DENV-4
    20.8 (16.0 to 27.1)
    21.4 (16.1 to 28.3)
    No statistical analyses for this end point

    Primary: GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 for Both Parent Trials

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    End point title
    		 GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 for Both Parent Trials [38]
    End point description
    GMTs of neutralizing antibodies were measured by MNT50 for each of the 4 Dengue Serotypes (DENV-1, DENV-2, DENV-3 and DENV-4). Reported here is the data from Visit 4, 1 month post-booster dose for all participants (Month 16 for parent trial DEN-304 and Month 43 for parent trial DEN-315). PPS-B included all participants from the FAS-B who received two doses of Takeda’s TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Subjects analyzed: number of participants with data available for analyses.
    End point type
    Primary
    End point timeframe
    1 month post-booster dose at Month 16 (DEN-304) and Month 43 (DEN-315)
    Notes
    [38] - 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: Only descriptive analyses were planned for this endpoint.
    End point values
    		 Booster Phase: Placebo Booster Phase: TDV
    Number of subjects analysed
    99
    97
    Units: titer
    geometric mean (confidence interval 95%)
        DENV-1
    110.8 (82.2 to 149.5)
    1438.3 (1104.0 to 1873.8)
        DENV-2
    363.4 (291.8 to 452.7)
    1038.8 (833.7 to 1294.4)
        DENV-3
    27.7 (21.0 to 36.5)
    446.5 (356.8 to 558.8)
        DENV-4
    20.0 (15.4 to 26.0)
    273.5 (213.2 to 350.8)
    No statistical analyses for this end point

    Primary: GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Pre-Booster Dose at Visit 3 (Month 15) (DEN-304)

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    End point title
    		 GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Pre-Booster Dose at Visit 3 (Month 15) (DEN-304) [39]
    End point description
    GMTs of neutralizing antibodies were measured by MNT50 for each of the 4 Dengue Serotypes (DENV-1, DENV-2, DENV-3 and DENV-4). Reported here is the pre-booster data from Visit 3 at Month 15 for participants from parent trial DEN-304. Pre-booster dose is defined as the last non-missing value before booster administration. PPS-B included all participants from the FAS-B who received two doses of Takeda’s TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Subjects analyzed: number of participants with data available for analyses.
    End point type
    Primary
    End point timeframe
    Pre-booster dose at Month 15 (DEN-304)
    Notes
    [39] - 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: Only descriptive analyses were planned for this endpoint.
    End point values
    		 Booster Phase: Placebo Booster Phase: TDV
    Number of subjects analysed
    61
    61
    Units: titer
    geometric mean (confidence interval 95%)
        DENV-1
    126.4 (82.2 to 194.4)
    130.6 (81.9 to 208.4)
        DENV-2
    583.9 (448.5 to 760.2)
    596.6 (453.4 to 785.1)
        DENV-3
    36.9 (26.6 to 51.3)
    39.5 (26.3 to 59.6)
        DENV-4
    31.3 (21.9 to 44.9)
    29.9 (19.9 to 44.8)
    No statistical analyses for this end point

    Primary: GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 (Month 16) (DEN-304)

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    End point title
    		 GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 (Month 16) (DEN-304) [40]
    End point description
    GMTs of neutralizing antibodies were measured by MNT50 for each of the 4 Dengue Serotypes (DENV-1, DENV-2, DENV-3 and DENV-4). Reported here is the data from Visit 4 at Month 16 for participants from parent trial DEN-304. PPS-B included all participants from the FAS-B who received two doses of Takeda’s TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Subjects analyzed: number of participants with data available for analyses.
    End point type
    Primary
    End point timeframe
    1 month post-booster dose at Month 16 (DEN-304)
    Notes
    [40] - 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: Only descriptive analyses were planned for this endpoint.
    End point values
    		 Booster Phase: Placebo Booster Phase: TDV
    Number of subjects analysed
    59
    60
    Units: titer
    geometric mean (confidence interval 95%)
        DENV-1
    120.1 (78.5 to 184.0)
    1254.3 (862.2 to 1824.5)
        DENV-2
    499.2 (379.7 to 656.4)
    1121.4 (867.5 to 1449.5)
        DENV-3
    30.6 (21.4 to 43.5)
    389.7 (280.8 to 540.8)
        DENV-4
    29.4 (20.5 to 42.2)
    260.9 (189.0 to 360.1)
    No statistical analyses for this end point

    Primary: GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 (Month 43) (DEN-315)

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    End point title
    		 GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 (Month 43) (DEN-315) [41]
    End point description
    GMTs of neutralizing antibodies were measured by MNT50 for each of the 4 Dengue Serotypes (DENV-1, DENV-2, DENV-3 and DENV-4). Reported here is the data from Visit 4 at Month 43 for participants from parent trial DEN-315. PPS-B included all participants from the FAS-B who received two doses of Takeda’s TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Subjects analyzed: number of participants with data available for analyses.
    End point type
    Primary
    End point timeframe
    1 month post-booster dose at Month 43 (DEN-315)
    Notes
    [41] - 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: Only descriptive analyses were planned for this endpoint.
    End point values
    		 Booster Phase: Placebo Booster Phase: TDV
    Number of subjects analysed
    40
    37
    Units: titer
    geometric mean (confidence interval 95%)
        DENV-1
    98.4 (65.1 to 148.7)
    1795.8 (1273.5 to 2532.5)
        DENV-2
    227.5 (164.5 to 314.6)
    917.6 (607.2 to 1386.7)
        DENV-3
    24.0 (15.2 to 37.8)
    556.8 (431.6 to 718.3)
        DENV-4
    11.3 (8.3 to 15.4)
    295.3 (196.0 to 444.8)
    No statistical analyses for this end point

    Primary: GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Pre-Booster Dose at Visit 3 (Month 42) (DEN-315)

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    End point title
    		 GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Pre-Booster Dose at Visit 3 (Month 42) (DEN-315) [42]
    End point description
    GMTs of neutralizing antibodies were measured by MNT50 for each of the 4 Dengue Serotypes (DENV-1, DENV-2, DENV-3 and DENV-4). Reported here is the pre-booster data from Visit 3 at Month 42 for participants from parent trial DEN-315. Pre-booster dose is defined as the last non-missing value before booster administration. PPS-B included all participants from the FAS-B who received two doses of Takeda’s TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Subjects analyzed: number of participants with data available for analyses.
    End point type
    Primary
    End point timeframe
    Pre-booster dose at Month 42 (DEN-315)
    Notes
    [42] - 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: Only descriptive analyses were planned for this endpoint.
    End point values
    		 Booster Phase: Placebo Booster Phase: TDV
    Number of subjects analysed
    41
    39
    Units: titer
    geometric mean (confidence interval 95%)
        DENV-1
    102.6 (70.6 to 149.0)
    106.7 (68.3 to 166.7)
        DENV-2
    233.5 (176.1 to 309.8)
    165.4 (110.7 to 247.1)
        DENV-3
    26.4 (17.0 to 41.1)
    19.6 (13.6 to 28.2)
        DENV-4
    11.3 (8.3 to 15.5)
    12.7 (9.4 to 17.1)
    No statistical analyses for this end point

    Primary: GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Pre-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 3 for Both Parent Trials

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    End point title
    		 GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Pre-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 3 for Both Parent Trials [43]
    End point description
    GMTs of neutralizing antibodies were measured by MNT50 for each of the 4 Dengue Serotypes (DENV-1, DENV-2, DENV-3 and DENV-4). Baseline seropositivity is defined as reciprocal neutralizing titer ≥10 for one or more dengue serotypes at baseline in the parent trial. Reported here is the data from Visit 3, pre-booster dose for all participants (Month 15 for parent trial DEN-304 and Month 42 for parent trial DEN-315). Pre-booster dose is defined as the last non-missing value before booster administration. PPS-B included all participants from the FAS-B who received two doses of Takeda’s TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Subjects analyzed: number of participants with data available for analyses.Number of subjects analysed was variable for each category.
    End point type
    Primary
    End point timeframe
    Pre-booster dose at Month 15 (DEN-304) and Month 42 (DEN-315)
    Notes
    [43] - 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: Only descriptive analyses were planned for this endpoint.
    End point values
    		 Booster Phase: Placebo Booster Phase: TDV
    Number of subjects analysed
    102
    100
    Units: titer
    geometric mean (confidence interval 95%)
        Parent Trial Baseline Serostatus;Positive: DENV-1
    165.0 (62.2 to 437.8)
    310.4 (67.2 to 1434.4)
        Parent Trial Baseline Serostatus;Positive: DENV-2
    353.6 (192.1 to 650.8)
    771.3 (334.8 to 1776.9)
        Parent Trial Baseline Serostatus;Positive: DENV-3
    53.8 (23.4 to 123.6)
    88.8 (25.1 to 313.4)
        Parent Trial Baseline Serostatus;Positive: DENV-4
    27.7 (14.0 to 55.0)
    43.5 (10.6 to 177.6)
        Parent Trial Baseline Serostatus;Negative: DENV-1
    110.4 (80.8 to 150.9)
    106.1 (77.2 to 145.9)
        Parent Trial Baseline Serostatus;Negative: DENV-2
    411.9 (327.7 to 517.8)
    326.2 (249.4 to 426.7)
        Parent Trial Baseline Serostatus;Negative: DENV-3
    30.0 (22.7 to 39.6)
    26.0 (19.6 to 34.4)
        Parent Trial Baseline Serostatus;Negative: DENV-4
    20.0 (15.0 to 26.7)
    19.4 (14.8 to 25.4)
    No statistical analyses for this end point

    Primary: GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 4 for Both Parent Trials

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    End point title
    		 GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 4 for Both Parent Trials [44]
    End point description
    GMTs of neutralizing antibodies were measured by MNT50 for each of the 4 Dengue Serotypes (DENV-1, DENV-2, DENV-3 and DENV-4). Baseline seropositivity is defined as reciprocal neutralizing titer ≥10 for one or more dengue serotypes at baseline in the parent trial. Reported here is the data from Visit 4, 1 month post-booster dose for all participants (Month 16 for parent trial DEN-304 and Month 43 for parent trial DEN-315). PPS-B included all participants from the FAS-B who received two doses of Takeda’s TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Subjects analyzed: number of participants with data available for analyses.Number of subjects analysed was variable for each category.
    End point type
    Primary
    End point timeframe
    1 month post-booster dose at Month 16 (DEN-304) and Month 43 (DEN-315)
    Notes
    [44] - 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: Only descriptive analyses were planned for this endpoint.
    End point values
    		 Booster Phase: Placebo Booster Phase: TDV
    Number of subjects analysed
    99
    97
    Units: titer
    geometric mean (confidence interval 95%)
        Parent Trial Baseline Serostatus;Positive: DENV-1
    170.5 (59.7 to 487.0)
    1192.5 (343.2 to 4143.7)
        Parent Trial Baseline Serostatus;Positive: DENV-2
    264.2 (124.8 to 559.2)
    1533.3 (720.1 to 3264.5)
        Parent Trial Baseline Serostatus;Positive: DENV-3
    46.2 (16.9 to 126.4)
    286.5 (124.6 to 658.9)
        Parent Trial Baseline Serostatus;Positive: DENV-4
    34.4 (19.6 to 60.5)
    204.2 (83.4 to 500.1)
        Parent Trial Baseline Serostatus;Negative: DENV-1
    104.4 (76.2 to 143.2)
    1473.2 (1129.4 to 1921.6)
        Parent Trial Baseline Serostatus;Negative: DENV-2
    379.8 (301.1 to 479.0)
    988.3 (783.4 to 1246.9)
        Parent Trial Baseline Serostatus;Negative: DENV-3
    25.8 (19.4 to 34.4)
    472.6 (374.1 to 597.1)
        Parent Trial Baseline Serostatus;Negative: DENV-4
    18.6 (13.9 to 24.8)
    283.9 (218.3 to 369.2)
    No statistical analyses for this end point

    Primary: GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Pre-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 3 (Month 15) (DEN-304)

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    End point title
    		 GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Pre-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 3 (Month 15) (DEN-304) [45]
    End point description
    GMTs of neutralizing antibodies were measured by MNT50 for each of the 4 Dengue Serotypes (DENV-1, DENV-2, DENV-3 and DENV-4). Baseline seropositivity is defined as reciprocal neutralizing titer ≥10 for one or more dengue serotypes at baseline in the parent trial. Reported here is the pre-booster data from Visit 3 at Month 15 for participants from parent trial DEN-304. Pre-booster dose is defined as the last non-missing value before booster administration. PPS-B included all participants from the FAS-B who received two doses of Takeda’s TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Subjects analyzed: number of participants with data available for analyses.Number of subjects analysed was variable for each category.
    End point type
    Primary
    End point timeframe
    Pre-booster dose at Month 15 (DEN-304)
    Notes
    [45] - 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: Only descriptive analyses were planned for this endpoint.
    End point values
    		 Booster Phase: Placebo Booster Phase: TDV
    Number of subjects analysed
    61
    61
    Units: titer
    geometric mean (confidence interval 95%)
        Parent Trial Baseline Serostatus;Positive: DENV-1
    120.5 (37.2 to 390.0)
    368.4 (44.6 to 3040.1)
        Parent Trial Baseline Serostatus;Positive: DENV-2
    368.8 (175.4 to 775.7)
    839.4 (298.9 to 2357.3)
        Parent Trial Baseline Serostatus;Positive: DENV-3
    39.4 (19.3 to 80.6)
    102.1 (19.0 to 549.3)
        Parent Trial Baseline Serostatus;Positive: DENV-4
    22.9 (11.8 to 44.6)
    59.1 (10.3 to 339.8)
        Parent Trial Baseline Serostatus;Negative: DENV-1
    127.6 (79.0 to 206.0)
    109.2 (70.2 to 169.7)
        Parent Trial Baseline Serostatus;Negative: DENV-2
    639.0 (480.4 to 849.9)
    562.4 (423.1 to 747.5)
        Parent Trial Baseline Serostatus;Negative: DENV-3
    36.4 (25.0 to 53.2)
    33.6 (22.5 to 50.1)
        Parent Trial Baseline Serostatus;Negative: DENV-4
    33.3 (22.0 to 50.5)
    26.5 (17.8 to 39.5)
    No statistical analyses for this end point

    Primary: GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 4 (Month 16) (DEN-304)

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    End point title
    		 GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 4 (Month 16) (DEN-304) [46]
    End point description
    GMTs of neutralizing antibodies were measured by MNT50 for each of the 4 Dengue Serotypes (DENV-1, DENV-2, DENV-3 and DENV-4). Baseline seropositivity is defined as reciprocal neutralizing titer ≥10 for one or more dengue serotypes at baseline in the parent trial. Reported here is the data from Visit 4 at Month 16 for participants from parent trial DEN-304. PPS-B included all participants from the FAS-B who received two doses of Takeda’s TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Subjects analyzed: number of participants with data available for analyses.Number of subjects analysed was variable for each category.
    End point type
    Primary
    End point timeframe
    1 month post-booster dose at Month 16 (DEN-304)
    Notes
    [46] - 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: Only descriptive analyses were planned for this endpoint.
    End point values
    		 Booster Phase: Placebo Booster Phase: TDV
    Number of subjects analysed
    59
    60
    Units: titer
    geometric mean (confidence interval 95%)
        Parent Trial Baseline Serostatus;Positive: DENV-1
    125.6 (32.3 to 488.7)
    1124.7 (182.3 to 6939.8)
        Parent Trial Baseline Serostatus;Positive: DENV-2
    264.3 (105.0 to 665.2)
    1545.0 (528.1 to 4519.9)
        Parent Trial Baseline Serostatus;Positive: DENV-3
    29.3 (11.6 to 74.3)
    239.1 (72.7 to 786.1)
        Parent Trial Baseline Serostatus;Positive: DENV-4
    29.8 (19.5 to 45.6)
    202.8 (57.6 to 714.0)
        Parent Trial Baseline Serostatus;Negative: DENV-1
    119.2 (75.0 to 189.3)
    1275.5 (879.5 to 1849.6)
        Parent Trial Baseline Serostatus;Negative: DENV-2
    559.8 (422.3 to 742.0)
    1067.4 (820.0 to 1389.6)
        Parent Trial Baseline Serostatus;Negative: DENV-3
    30.8 (20.7 to 45.8)
    420.1 (297.4 to 593.5)
        Parent Trial Baseline Serostatus;Negative: DENV-4
    29.4 (19.2 to 44.8)
    271.1 (193.3 to 380.4)
    No statistical analyses for this end point

    Primary: GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Pre-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 3 (Month 42) (DEN-315)

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    End point title
    		 GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Pre-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 3 (Month 42) (DEN-315) [47]
    End point description
    GMTs of neutralizing antibodies were measured by MNT50 for each of the 4 Dengue Serotypes (DENV-1, DENV-2, DENV-3 and DENV-4). Baseline seropositivity is defined as reciprocal neutralizing titer ≥10 for one or more dengue serotypes at baseline in the parent trial. Reported here is the pre-booster data from Visit 3 at Month 42 for participants from parent trial DEN-315. Pre-booster dose is defined as the last non-missing value before booster administration. PPS-B included all participants from the FAS-B who received two doses of Takeda’s TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Subjects analyzed: number of participants with data available for analyses. Number of subjects analysed was variable for each category.
    End point type
    Primary
    End point timeframe
    Pre-booster dose at Month 42 (DEN-315)
    Notes
    [47] - 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: Only descriptive analyses were planned for this endpoint.
    End point values
    		 Booster Phase: Placebo Booster Phase: TDV
    Number of subjects analysed
    41
    39
    Units: titer
    geometric mean (confidence interval 95%)
        Parent Trial Baseline Serostatus;Positive:DENV-1
    470.4 (25.4 to 8709.7)
    185.7 (11.7 to 2940.9)
        Parent Trial Baseline Serostatus;Positive:DENV-2
    307.1 (19.8 to 4754.2)
    598.4 (15.8 to 22694.8)
        Parent Trial Baseline Serostatus;Positive:DENV-3
    151.1 (0.7 to 34960.6)
    58.2 (1.5 to 2257.4)
        Parent Trial Baseline Serostatus;Positive:DENV-4
    52.5 (0.7 to 3894.5)
    17.2 (0.1 to 3545.3)
        Parent Trial Baseline Serostatus;Negative:DENV-1
    91.0 (63.1 to 131.1)
    101.9 (63.5 to 163.5)
        Parent Trial Baseline Serostatus;Negative:DENV-2
    228.5 (170.5 to 306.3)
    148.6 (99.7 to 221.4)
        Parent Trial Baseline Serostatus;Negative:DENV-3
    23.0 (15.2 to 34.8)
    17.9 (12.5 to 25.7)
        Parent Trial Baseline Serostatus;Negative:DENV-4
    10.0 (7.6 to 13.2)
    12.3 (9.4 to 16.2)
    No statistical analyses for this end point

    Primary: GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 4 (Month 43) (DEN-315)

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    End point title
    		 GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 4 (Month 43) (DEN-315) [48]
    End point description
    GMTs of neutralizing antibodies were measured by MNT50 for each of the 4 Dengue Serotypes (DENV-1, DENV-2, DENV-3 and DENV-4). Baseline seropositivity is defined as reciprocal neutralizing titer ≥10 for one or more dengue serotypes at baseline in the parent trial. Reported here is the data from Visit 4 at Month 43 for participants from parent trial DEN-315. PPS-B included all participants from the FAS-B who received two doses of Takeda’s TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Subjects analyzed: number of participants with data available for analyses. Number of subjects analysed was variable for each category.
    End point type
    Primary
    End point timeframe
    1 month post-booster dose at Month 43 (DEN-315)
    Notes
    [48] - 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: Only descriptive analyses were planned for this endpoint.
    End point values
    		 Booster Phase: Placebo Booster Phase: TDV
    Number of subjects analysed
    40
    37
    Units: titer
    geometric mean (confidence interval 95%)
        Parent Trial Baseline Serostatus;Positive:DENV-1
    427.0 (45.4 to 4020.4)
    1393.8 (219.3 to 8859.8)
        Parent Trial Baseline Serostatus;Positive:DENV-2
    264.1 (8.7 to 8032.8)
    1502.5 (236.0 to 9565.9)
        Parent Trial Baseline Serostatus;Positive:DENV-3
    180.8 (1.1 to 29718.0)
    464.2 (204.7 to 1052.5)
        Parent Trial Baseline Serostatus;Positive:DENV-4
    53.0 (0.9 to 3256.9)
    208.0 (18.4 to 2353.2)
        Parent Trial Baseline Serostatus;Negative:DENV-1
    87.3 (57.6 to 132.5)
    1836.5 (1269.6 to 2656.5)
        Parent Trial Baseline Serostatus;Negative:DENV-2
    224.8 (160.9 to 314.1)
    878.5 (563.9 to 1368.8)
        Parent Trial Baseline Serostatus;Negative:DENV-3
    20.4 (13.4 to 31.0)
    565.8 (429.2 to 745.8)
        Parent Trial Baseline Serostatus;Negative:DENV-4
    10.0 (7.7 to 13.1)
    304.5 (196.5 to 472.0)
    No statistical analyses for this end point

    Primary: GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose at Visit 5 for Both Parent Trials

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    End point title
    		 GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose at Visit 5 for Both Parent Trials [49]
    End point description
    GMTs of neutralizing antibodies were measured by MNT50 for each of the 4 Dengue Serotypes (DENV-1, DENV-2, DENV-3 and DENV-4). Reported here is the data from Visit 5, 6 months post-booster dose for all participants (Month 21 for parent trial DEN-304 and Month 48 for parent trial DEN-315). PPS-B included all participants from the FAS-B who received two doses of Takeda’s TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Subjects analyzed: number of participants with data available for analyses.
    End point type
    Primary
    End point timeframe
    6 months post-booster dose at Month 21 (DEN-304) and Month 48 (DEN-315)
    Notes
    [49] - 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: Only descriptive analyses were planned for this endpoint.
    End point values
    		 Booster Phase: Placebo Booster Phase: TDV
    Number of subjects analysed
    96
    92
    Units: titer
    geometric mean (confidence interval 95%)
        DENV-1
    94.2 (66.9 to 132.7)
    464.9 (336.1 to 642.9)
        DENV-2
    305.2 (244.7 to 380.7)
    552.5 (442.1 to 690.5)
        DENV-3
    27.4 (21.4 to 35.3)
    159.5 (122.6 to 207.4)
        DENV-4
    16.7 (13.0 to 21.5)
    87.5 (65.8 to 116.2)
    No statistical analyses for this end point

    Primary: GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose at Visit 5 (Month 21) (DEN-304)

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    End point title
    		 GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose at Visit 5 (Month 21) (DEN-304) [50]
    End point description
    GMTs of neutralizing antibodies were measured by MNT50 for each of the 4 Dengue Serotypes (DENV-1, DENV-2, DENV-3 and DENV-4). Reported here is the data from Visit 5 at Month 21 for participants from parent trial DEN-304. PPS-B included all participants from the FAS-B who received two doses of Takeda’s TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Subjects analyzed: number of participants with data available for analyses.
    End point type
    Primary
    End point timeframe
    6 months post-booster dose at Month 21 (DEN-304)
    Notes
    [50] - 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: Only descriptive analyses were planned for this endpoint.
    End point values
    		 Booster Phase: Placebo Booster Phase: TDV
    Number of subjects analysed
    56
    54
    Units: titer
    geometric mean (confidence interval 95%)
        DENV-1
    107.8 (65.0 to 179.0)
    410.9 (259.7 to 650.1)
        DENV-2
    433.0 (321.4 to 583.5)
    689.4 (530.6 to 895.8)
        DENV-3
    30.7 (21.9 to 42.9)
    133.5 (90.5 to 197.0)
        DENV-4
    24.3 (16.7 to 35.3)
    89.2 (60.5 to 131.7)
    No statistical analyses for this end point

    Primary: GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose at Visit 5 (Month 48) (DEN-315)

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    End point title
    		 GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose at Visit 5 (Month 48) (DEN-315) [51]
    End point description
    GMTs of neutralizing antibodies were measured by MNT50 for each of the 4 Dengue Serotypes (DENV-1, DENV-2, DENV-3 and DENV-4). Reported here is the data from Visit 5 at Month 48 for participants from parent trial DEN-315. PPS-B included all participants from the FAS-B who received two doses of Takeda’s TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Subjects analyzed: number of participants with data available for analyses.
    End point type
    Primary
    End point timeframe
    6 months post-booster dose at Month 48 (DEN-315)
    Notes
    [51] - 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: Only descriptive analyses were planned for this endpoint.
    End point values
    		 Booster Phase: Placebo Booster Phase: TDV
    Number of subjects analysed
    40
    38
    Units: titer
    geometric mean (confidence interval 95%)
        DENV-1
    78.0 (50.6 to 120.2)
    553.9 (350.8 to 874.6)
        DENV-2
    187.0 (142.3 to 245.6)
    403.4 (275.1 to 591.6)
        DENV-3
    23.5 (15.9 to 34.6)
    205.2 (149.1 to 282.5)
        DENV-4
    9.9 (7.8 to 12.5)
    85.0 (55.3 to 130.6)
    No statistical analyses for this end point

    Primary: GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 5 for Both Parent Trials

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    End point title
    		 GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 5 for Both Parent Trials [52]
    End point description
    GMTs of neutralizing antibodies were measured by MNT50 for each of the 4 Dengue Serotypes (DENV-1, DENV-2, DENV-3 and DENV-4). Baseline seropositivity is defined as reciprocal neutralizing titer ≥10 for one or more dengue serotypes at baseline in the parent trial. Reported here is the data from Visit 5, 6 month post-booster dose for all participants (Month 21 for parent trial DEN-304 and Month 48 for parent trial DEN-315). PPS-B included all participants from the FAS-B who received two doses of Takeda’s TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Subjects analyzed: number of participants with data available for analyses. Number of subjects analysed was variable for each category.
    End point type
    Primary
    End point timeframe
    6 months post-booster dose at Month 21 (DEN-304) and Month 48 (DEN-315)
    Notes
    [52] - 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: Only descriptive analyses were planned for this endpoint.
    End point values
    		 Booster Phase: Placebo Booster Phase: TDV
    Number of subjects analysed
    96
    92
    Units: titer
    geometric mean (confidence interval 95%)
        Parent Trial Baseline Serostatus;Positive: DENV-1
    166.2 (48.3 to 571.7)
    435.8 (106.8 to 1777.8)
        Parent Trial Baseline Serostatus;Positive: DENV-2
    278.9 (108.9 to 714.1)
    699.2 (305.0 to 1603.0)
        Parent Trial Baseline Serostatus;Positive: DENV-3
    39.0 (18.8 to 80.8)
    137.1 (44.9 to 418.7)
        Parent Trial Baseline Serostatus;Positive: DENV-4
    22.0 (12.1 to 40.1)
    83.6 (25.0 to 279.0)
        Parent Trial Baseline Serostatus;Negative: DENV-1
    88.2 (61.5 to 126.5)
    469.4 (338.9 to 650.1)
        Parent Trial Baseline Serostatus;Negative: DENV-2
    308.4 (245.1 to 387.9)
    533.4 (422.9 to 672.6)
        Parent Trial Baseline Serostatus;Negative: DENV-3
    26.3 (20.1 to 34.5)
    163.1 (125.1 to 212.7)
        Parent Trial Baseline Serostatus;Negative: DENV-4
    16.2 (12.3 to 21.3)
    88.1 (66.1 to 117.3)
    No statistical analyses for this end point

    Primary: GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 5 (Month 21) (DEN-304)

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    End point title
    		 GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 5 (Month 21) (DEN-304) [53]
    End point description
    GMTs of neutralizing antibodies were measured by MNT50 for each of the 4 Dengue Serotypes (DENV-1, DENV-2, DENV-3 and DENV-4). Baseline seropositivity is defined as reciprocal neutralizing titer ≥10 for one or more dengue serotypes at baseline in the parent trial. Reported here is the data from Visit 5 at Month 21 for participants from parent trial DEN-304. PPS-B included all participants from the FAS-B who received two doses of Takeda’s TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Subjects analyzed: number of participants with data available for analyses. Number of subjects analysed was variable for each category.
    End point type
    Primary
    End point timeframe
    6 months post-booster dose at Month 21 (DEN-304)
    Notes
    [53] - 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: Only descriptive analyses were planned for this endpoint.
    End point values
    		 Booster Phase: Placebo Booster Phase: TDV
    Number of subjects analysed
    56
    54
    Units: titer
    geometric mean (confidence interval 95%)
        Parent Trial Baseline Serostatus;Positive: DENV-1
    154.2 (30.2 to 786.6)
    461.7 (68.8 to 3098.9)
        Parent Trial Baseline Serostatus;Positive: DENV-2
    337.6 (104.5 to 1090.2)
    825.4 (309.0 to 2205.1)
        Parent Trial Baseline Serostatus;Positive: DENV-3
    37.5 (14.4 to 98.0)
    145.5 (32.0 to 661.2)
        Parent Trial Baseline Serostatus;Positive: DENV-4
    21.7 (10.2 to 46.3)
    95.7 (21.6 to 423.2)
        Parent Trial Baseline Serostatus;Negative: DENV-1
    101.6 (58.6 to 176.2)
    401.4 (254.9 to 632.2)
        Parent Trial Baseline Serostatus;Negative: DENV-2
    451.4 (330.8 to 615.9)
    665.0 (508.0 to 870.6)
        Parent Trial Baseline Serostatus;Negative: DENV-3
    29.7 (20.5 to 43.0)
    131.3 (88.3 to 195.1)
        Parent Trial Baseline Serostatus;Negative: DENV-4
    24.8 (16.2 to 37.9)
    88.0 (59.0 to 131.2)
    No statistical analyses for this end point

    Primary: GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 5 (Month 48) (DEN-315)

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    End point title
    		 GMTs of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 5 (Month 48) (DEN-315) [54]
    End point description
    GMTs of neutralizing antibodies were measured by MNT50 for each of the 4 Dengue Serotypes (DENV-1, DENV-2, DENV-3 and DENV-4). Baseline seropositivity is defined as reciprocal neutralizing titer ≥10 for one or more dengue serotypes at baseline in the parent trial. Reported here is the data from Visit 5 at Month 48 for participants from parent trial DEN-315. PPS-B included all participants from the FAS-B who received two doses of Takeda’s TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Subjects analyzed: number of participants with data available for analyses. Number of subjects analysed was variable for each category.
    End point type
    Primary
    End point timeframe
    6 months post-booster dose at Month 48 (DEN-315)
    Notes
    [54] - 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: Only descriptive analyses were planned for this endpoint.
    End point values
    		 Booster Phase: Placebo Booster Phase: TDV
    Number of subjects analysed
    40
    38
    Units: titer
    geometric mean (confidence interval 95%)
        Parent Trial Baseline Serostatus;Positive:DENV-1
    223.9 (31.8 to 1574.3)
    366.4 (8.2 to 16297.5)
        Parent Trial Baseline Serostatus;Positive:DEN-2
    129.9 (0.8 to 21199.9)
    425.0 (9.5 to 19098.8)
        Parent Trial Baseline Serostatus;Positive:DENV-3
    45.5 (6.5 to 319.1)
    114.5 (6.0 to 2196.9)
        Parent Trial Baseline Serostatus;Positive:DENV-4
    23.2 (0.0 to 23073.9)
    55.8 (0.3 to 10826.4)
        Parent Trial Baseline Serostatus;Negative:DENV-1
    73.8 (47.1 to 115.6)
    573.9 (355.3 to 927.0)
        Parent Trial Baseline Serostatus;Negative:DENV-2
    190.6 (143.4 to 253.4)
    401.6 (269.9 to 597.6)
        Parent Trial Baseline Serostatus;Negative:DENV-3
    22.7 (15.1 to 34.0)
    215.7 (155.4 to 299.5)
        Parent Trial Baseline Serostatus;Negative: DENV-4
    9.4 (7.5 to 11.9)
    88.2 (57.3 to 135.7)
    No statistical analyses for this end point

    Primary: Seropositivity Rate for Each of the 4 Dengue Serotypes at Pre-Booster Dose at Visit 3 for Both Parent Trials

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    End point title
    		 Seropositivity Rate for Each of the 4 Dengue Serotypes at Pre-Booster Dose at Visit 3 for Both Parent Trials [55]
    End point description
    Seropositivity rate, defined as the percentage of participants seropositive, is derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a reciprocal neutralizing titer ≥10. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Reported here is the data from Visit 3, pre-booster dose for all participants (Month 15 for parent trial DEN-304 and Month 42 for parent trial DEN-315). Pre-booster dose is defined as the last non-missing value before booster administration. PPS-B included all participants from the FAS-B who received two doses of Takeda’s TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Subjects analyzed: number of participants with data available for analyses.
    End point type
    Primary
    End point timeframe
    Pre-booster dose at Month 15 (DEN-304) and Month 42 (DEN-315)
    Notes
    [55] - 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: Only descriptive analyses were planned for this endpoint.
    End point values
    		 Booster Phase: Placebo Booster Phase: TDV
    Number of subjects analysed
    102
    100
    Units: percentage of participants
    number (confidence interval 95%)
        DENV-1
    98.0 (93.1 to 99.8)
    94.0 (87.4 to 97.8)
        DENV-2
    100 (96.4 to 100.0)
    99.0 (94.6 to 100.0)
        DENV-3
    80.4 (71.4 to 87.6)
    73.0 (63.2 to 81.4)
        DENV-4
    66.7 (56.6 to 75.7)
    67.0 (56.9 to 76.1)
    No statistical analyses for this end point

    Primary: Seropositivity Rate for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 for Both Parent Trials

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    End point title
    		 Seropositivity Rate for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 for Both Parent Trials [56]
    End point description
    Seropositivity rate, defined as the percentage of participants seropositive, is derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a reciprocal neutralizing titer ≥10. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Reported here is the data from Visit 4, 1 month post-booster dose for all participants (Month 16 for parent trial DEN-304 and Month 43 for parent trial DEN-315).PPS-B included all participants from the FAS-B who received two doses of Takeda’s TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Subjects analyzed: number of participants with data available for analyses.
    End point type
    Primary
    End point timeframe
    1 month post-booster dose at Month 16 (DEN-304) and Month 43 (DEN-315)
    Notes
    [56] - 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: Only descriptive analyses were planned for this endpoint.
    End point values
    		 Booster Phase: Placebo Booster Phase: TDV
    Number of subjects analysed
    99
    97
    Units: percentage of participants
    number (confidence interval 95%)
        DENV-1
    98.0 (92.9 to 99.8)
    100 (96.3 to 100.0)
        DENV-2
    100 (96.3 to 100.0)
    100 (96.3 to 100.0)
        DENV-3
    71.7 (61.8 to 80.3)
    100 (96.3 to 100.0)
        DENV-4
    66.7 (56.5 to 75.8)
    100 (96.3 to 100.0)
    No statistical analyses for this end point

    Primary: Seropositivity Rate for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 (Month 16) (DEN-304)

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    End point title
    		 Seropositivity Rate for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 (Month 16) (DEN-304) [57]
    End point description
    Seropositivity rate, defined as the percentage of participants seropositive, is derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a reciprocal neutralizing titer ≥10. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Reported here is the data from Visit 4 at Month 16 for participants from parent trial DEN-304. PPS-B included all participants from the FAS-B who received two doses of Takeda’s TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Subjects analyzed: number of participants with data available for analyses.
    End point type
    Primary
    End point timeframe
    1 month post-booster dose at Month 16 (DEN-304)
    Notes
    [57] - 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: Only descriptive analyses were planned for this endpoint.
    End point values
    		 Booster Phase: Placebo Booster Phase: TDV
    Number of subjects analysed
    59
    60
    Units: percentage of participants
    number (confidence interval 95%)
        DENV-1
    98.3 (90.9 to 100.0)
    100 (94.0 to 100.0)
        DENV-2
    100 (93.9 to 100.0)
    100 (94.0 to 100.0)
        DENV-3
    74.6 (61.6 to 85.0)
    100 (94.0 to 100.0)
        DENV-4
    76.3 (63.4 to 86.4)
    100 (94.0 to 100.0)
    No statistical analyses for this end point

    Primary: Seropositivity Rate for Each of the 4 Dengue Serotypes at Pre-Booster Dose at Visit 3 (Month 15) (DEN-304)

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    End point title
    		 Seropositivity Rate for Each of the 4 Dengue Serotypes at Pre-Booster Dose at Visit 3 (Month 15) (DEN-304) [58]
    End point description
    Seropositivity rate, defined as the percentage of participants seropositive, is derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a reciprocal neutralizing titer ≥10. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Reported here is the pre-booster data from Visit 3 at Month 15 for participants from parent trial DEN-304. Pre-booster dose is defined as the last non-missing value before booster administration. PPS-B included all participants from the FAS-B who received two doses of Takeda’s TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Subjects analyzed: number of participants with data available for analyses.
    End point type
    Primary
    End point timeframe
    Pre-booster dose at Month 15 (DEN-304)
    Notes
    [58] - 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: Only descriptive analyses were planned for this endpoint.
    End point values
    		 Booster Phase: Placebo Booster Phase: TDV
    Number of subjects analysed
    61
    61
    Units: percentage of participants
    number (confidence interval 95%)
        DENV-1
    96.7 (88.7 to 99.6)
    95.1 (86.3 to 99.0)
        DENV-2
    100 (94.1 to 100.0)
    100 (94.1 to 100.0)
        DENV-3
    83.6 (71.9 to 91.8)
    77.0 (64.5 to 86.8)
        DENV-4
    75.4 (62.7 to 85.5)
    72.1 (59.2 to 82.9)
    No statistical analyses for this end point

    Primary: Seropositivity Rate for Each of the 4 Dengue Serotypes at Pre-Booster Dose at Visit 3 (Month 42) (DEN-315)

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    End point title
    		 Seropositivity Rate for Each of the 4 Dengue Serotypes at Pre-Booster Dose at Visit 3 (Month 42) (DEN-315) [59]
    End point description
    Seropositivity rate, defined as the percentage of participants seropositive, is derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a reciprocal neutralizing titer ≥10. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Reported here is the pre-booster data from Visit 3 at Month 42 for participants from parent trial DEN-315. Pre-booster dose is defined as the last non-missing value before booster administration. PPS-B included all participants from the FAS-B who received two doses of Takeda’s TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Subjects analyzed: number of participants with data available for analyses.
    End point type
    Primary
    End point timeframe
    Pre-booster dose at Month 42 (DEN-315)
    Notes
    [59] - 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: Only descriptive analyses were planned for this endpoint.
    End point values
    		 Booster Phase: Placebo Booster Phase: TDV
    Number of subjects analysed
    41
    39
    Units: percentage of participants
    number (confidence interval 95%)
        DENV-1
    100 (91.4 to 100.0)
    92.3 (79.1 to 98.4)
        DENV-2
    100 (91.4 to 100.0)
    97.4 (86.5 to 99.9)
        DENV-3
    75.6 (59.7 to 87.6)
    66.7 (49.8 to 80.9)
        DENV-4
    53.7 (37.4 to 69.3)
    59.0 (42.1 to 74.4)
    No statistical analyses for this end point

    Primary: Seropositivity Rate for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 (Month 43) (DEN-315)

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    End point title
    		 Seropositivity Rate for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 (Month 43) (DEN-315) [60]
    End point description
    Seropositivity rate, defined as the percentage of participants seropositive, is derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a reciprocal neutralizing titer ≥10. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Reported here is the data from Visit 4 at Month 43 for participants from parent trial DEN-315.PPS-B included all participants from the FAS-B who received two doses of Takeda’s TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Subjects analyzed: number of participants with data available for analyses.
    End point type
    Primary
    End point timeframe
    1 month post-booster dose at Month 43 (DEN-315)
    Notes
    [60] - 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: Only descriptive analyses were planned for this endpoint.
    End point values
    		 Booster Phase: Placebo Booster Phase: TDV
    Number of subjects analysed
    40
    37
    Units: percentage of participants
    number (confidence interval 95%)
        DENV-1
    97.5 (86.8 to 99.9)
    100 (90.5 to 100.0)
        DENV-2
    100 (91.2 to 100.0)
    100 (90.5 to 100.0)
        DENV-3
    67.5 (50.9 to 81.4)
    100 (90.5 to 100.0)
        DENV-4
    52.5 (36.1 to 68.5)
    100 (90.5 to 100.0)
    No statistical analyses for this end point

    Primary: Seropositivity Rate for Each of the 4 Dengue Serotypes at Pre-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 3 for Both Parent Trials

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    End point title
    		 Seropositivity Rate for Each of the 4 Dengue Serotypes at Pre-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 3 for Both Parent Trials [61]
    End point description
    Seropositivity rate,defined as percentage of participants seropositive,is derived from titers of dengue-neutralizing antibodies.Seropositivity:reciprocal neutralizing titer ≥10.Baseline seropositivity:reciprocal neutralizing titer ≥10 for one or more dengue serotypes at baseline in parent trial. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3&DENV-4. Reported here is data from Visit 3,pre-booster dose for all participants (Month 15 for parent trial DEN-304&Month 42 for parent trial DEN-315).Pre-booster dose is defined as last non-missing value before booster administration. PPS-B included all participants from the FAS-B who received two doses of Takeda’s TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound primary endpoints in the current trial. Subjects analyzed: number of participants with data available for analyses.Number of subjects analysed was variable for each category.
    End point type
    Primary
    End point timeframe
    Pre-booster dose at Month 15 (DEN-304) and Month 42 (DEN-315)
    Notes
    [61] - 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: Only descriptive analyses were planned for this endpoint.
    End point values
    		 Booster Phase: Placebo Booster Phase: TDV
    Number of subjects analysed
    102
    100
    Units: percentage of participants
    number (confidence interval 95%)
        Parent Trial Baseline Serostatus;Positive: DENV-1
    92.3 (64.0 to 99.8)
    91.7 (61.5 to 99.8)
        Parent Trial Baseline Serostatus;Positive: DENV-2
    100 (75.3 to 100.0)
    100 (73.5 to 100.0)
        Parent Trial Baseline Serostatus;Positive: DENV-3
    92.3 (64.0 to 99.8)
    83.3 (51.6 to 97.9)
        Parent Trial Baseline Serostatus;Positive: DENV-4
    84.6 (54.6 to 98.1)
    66.7 (34.9 to 90.1)
        Parent Trial Baseline Serostatus;Negative: DENV-1
    98.9 (93.9 to 100.0)
    94.3 (87.2 to 98.1)
        Parent Trial Baseline Serostatus;Negative: DENV-2
    100 (95.9 to 100.0)
    98.9 (93.8 to 100.0)
        Parent Trial Baseline Serostatus;Negative: DENV-3
    78.7 (68.7 to 86.6)
    71.6 (61.0 to 80.7)
        Parent Trial Baseline Serostatus;Negative: DENV-4
    64.0 (53.2 to 73.9)
    67.0 (56.2 to 76.7)
    No statistical analyses for this end point

    Primary: Seropositivity Rate for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 4 for Both Parent Trials

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    End point title
    		 Seropositivity Rate for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 4 for Both Parent Trials [62]
    End point description
    Seropositivity rate, defined as the percentage of participants seropositive, is derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a reciprocal neutralizing titer ≥10. Baseline seropositivity is defined as reciprocal neutralizing titer ≥10 for one or more dengue serotypes at baseline in the parent trial. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Reported here is the data from Visit 4, 1 month post-booster dose for all participants (Month 16 for parent trial DEN-304 and Month 43 for parent trial DEN-315).PPS-B included all participants from the FAS-B who received two doses of Takeda’s TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Subjects analyzed: number of participants with data available for analyses. Number of subjects analysed was variable for each category.
    End point type
    Primary
    End point timeframe
    1 month post-booster dose at Month 16 (DEN-304) and Month 43 (DEN-315)
    Notes
    [62] - 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: Only descriptive analyses were planned for this endpoint.
    End point values
    		 Booster Phase: Placebo Booster Phase: TDV
    Number of subjects analysed
    99
    97
    Units: percentage of participants
    number (confidence interval 95%)
        Parent Trial Baseline Serostatus;Positive: DENV-1
    91.7 (61.5 to 99.8)
    100 (71.5 to 100.0)
        Parent Trial Baseline Serostatus;Positive: DENV-2
    100 (73.5 to 100.0)
    100 (71.5 to 100.0)
        Parent Trial Baseline Serostatus;Positive: DENV-3
    83.3 (51.6 to 97.9)
    100 (71.5 to 100.0)
        Parent Trial Baseline Serostatus;Positive: DENV-4
    100 (73.5 to 100.0)
    100 (71.5 to 100.0)
        Parent Trial Baseline Serostatus;Negative: DENV-1
    98.9 (93.8 to 100.0)
    100 (95.8 to 100.0)
        Parent Trial Baseline Serostatus;Negative: DENV-2
    100 (95.8 to 100.0)
    100 (95.8 to 100.0)
        Parent Trial Baseline Serostatus;Negative: DENV-3
    70.1 (59.4 to 79.5)
    100 (95.8 to 100.0)
        Parent Trial Baseline Serostatus;Negative: DENV-4
    62.1 (51.0 to 72.3)
    100 (95.8 to 100.0)
    No statistical analyses for this end point

    Primary: Seropositivity Rate for Each of the 4 Dengue Serotypes at Pre-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 3 (Month 15) (DEN-304)

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    End point title
    		 Seropositivity Rate for Each of the 4 Dengue Serotypes at Pre-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 3 (Month 15) (DEN-304) [63]
    End point description
    Seropositivity rate, defined as percentage of participants seropositive, is derived from titers of dengue-neutralizing antibodies. Seropositivity is defined as a reciprocal neutralizing titer ≥10.Baseline seropositivity is defined as reciprocal neutralizing titer ≥10 for one or more dengue serotypes at baseline in parent trial. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 & DENV-4. Reported here is pre-booster data from Visit 3 at Month 15 for participants from parent trial DEN-304. Pre-booster dose is defined as last non-missing value before booster administration.PPS-B included all participants from the FAS-B who received two doses of Takeda’s TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Subjects analyzed: number of participants with data available for analyses. Number of subjects analysed was variable for each category.
    End point type
    Primary
    End point timeframe
    Pre-booster dose at Month 15 (DEN-304)
    Notes
    [63] - 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: Only descriptive analyses were planned for this endpoint.
    End point values
    		 Booster Phase: Placebo Booster Phase: TDV
    Number of subjects analysed
    61
    61
    Units: percentage of participants
    number (confidence interval 95%)
        Parent Trial Baseline Serostatus;Positive:DENV-1
    90.0 (55.5 to 99.7)
    88.9 (51.8 to 99.7)
        Parent Trial Baseline Serostatus;Positive:DENV-2
    100 (69.2 to 100.0)
    100 (66.4 to 100.0)
        Parent Trial Baseline Serostatus;Positive:DENV-3
    90.0 (55.5 to 99.7)
    77.8 (40.0 to 97.2)
        Parent Trial Baseline Serostatus;Positive:DENV-4
    80.0 (44.4 to 97.5)
    77.8 (40.0 to 97.2)
        Parent Trial Baseline Serostatus;Negative:DENV-1
    98.0 (89.6 to 100.0)
    96.2 (86.8 to 99.5)
        Parent Trial Baseline Serostatus;Negative:DENV-2
    100 (93.0 to 100.0)
    100 (93.2 to 100.0)
        Parent Trial Baseline Serostatus;Negative:DENV-3
    82.4 (69.1 to 91.6)
    76.9 (63.2 to 87.5)
        Parent Trial Baseline Serostatus;Negative:DENV-4
    74.5 (60.4 to 85.7)
    71.2 (56.9 to 82.9)
    No statistical analyses for this end point

    Primary: Seropositivity Rate for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 4 (Month 16) (DEN-304)

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    End point title
    		 Seropositivity Rate for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 4 (Month 16) (DEN-304) [64]
    End point description
    Seropositivity rate, defined as the percentage of participants seropositive, is derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a reciprocal neutralizing titer ≥10. Baseline seropositivity is defined as reciprocal neutralizing titer ≥10 for one or more dengue serotypes at baseline in the parent trial. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Reported here is the data from Visit 4 at Month 16 for participants from parent trial DEN-304. PPS-B included all participants from the FAS-B who received two doses of Takeda’s TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Subjects analyzed: number of participants with data available for analyses. Number of subjects analysed was variable for each category.
    End point type
    Primary
    End point timeframe
    1 month post-booster dose at Month 16 (DEN-304)
    Notes
    [64] - 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: Only descriptive analyses were planned for this endpoint.
    End point values
    		 Booster Phase: Placebo Booster Phase: TDV
    Number of subjects analysed
    59
    60
    Units: percentage of participants
    number (confidence interval 95%)
        Parent Trial Baseline Serostatus;Positive:DENV-1
    88.9 (51.8 to 99.7)
    100 (63.1 to 100.0)
        Parent Trial Baseline Serostatus;Positive:DENV-2
    100 (66.4 to 100.0)
    100 (63.1 to 100.0)
        Parent Trial Baseline Serostatus;Positive:DENV-3
    77.8 (40.0 to 97.2)
    100 (63.1 to 100.0)
        Parent Trial Baseline Serostatus;Positive:DENV-4
    100 (66.4 to 100.0)
    100 (63.1 to 100.0)
        Parent Trial Baseline Serostatus;Negative:DENV-1
    100 (92.9 to 100.0)
    100 (93.2 to 100.0)
        Parent Trial Baseline Serostatus;Negative:DENV-2
    100 (92.9 to 100.0)
    100 (93.2 to 100.0)
        Parent Trial Baseline Serostatus;Negative:DENV-3
    74.0 (59.7 to 85.4)
    100 (93.2 to 100.0)
        Parent Trial Baseline Serostatus;Negative:DENV-4
    72.0 (57.5 to 83.8)
    100 (93.2 to 100.0)
    No statistical analyses for this end point

    Primary: Seropositivity Rate for Each of the 4 Dengue Serotypes at Pre-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 3 (Month 42) (DEN-315)

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    End point title
    		 Seropositivity Rate for Each of the 4 Dengue Serotypes at Pre-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 3 (Month 42) (DEN-315) [65]
    End point description
    Seropositivity rate, defined as percentage of participants seropositive, is derived from titers of dengue-neutralizing antibodies.Seropositivity is defined as a reciprocal neutralizing titer ≥10. Baseline seropositivity is defined as reciprocal neutralizing titer ≥10 for one or more dengue serotypes at baseline in parent trial. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 & DENV-4. Reported here is pre-booster data from Visit 3 at Month 42 for participants from parent trial DEN-315. Pre-booster dose is defined as last non-missing value before booster administration. PPS-B included all participants from the FAS-B who received two doses of Takeda’s TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Subjects analyzed: number of participants with data available for analyses. Number of subjects analysed was variable for each category.
    End point type
    Primary
    End point timeframe
    Pre-booster dose at Month 42 (DEN-315)
    Notes
    [65] - 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: Only descriptive analyses were planned for this endpoint.
    End point values
    		 Booster Phase: Placebo Booster Phase: TDV
    Number of subjects analysed
    41
    39
    Units: percentage of participants
    number (confidence interval 95%)
        Parent Trial Baseline Serostatus;Positive: DENV-1
    100 (29.2 to 100.0)
    100 (29.2 to 100.0)
        Parent Trial Baseline Serostatus;Positive: DENV-2
    100 (29.2 to 100.0)
    100 (29.2 to 100.0)
        Parent Trial Baseline Serostatus;Positive: DENV-3
    100 (29.2 to 100.0)
    100 (29.2 to 100.0)
        Parent Trial Baseline Serostatus;Positive: DENV-4
    100 (29.2 to 100.0)
    33.3 (0.8 to 90.6)
        Parent Trial Baseline Serostatus;Negative: DENV-1
    100 (90.7 to 100.0)
    91.7 (77.5 to 98.2)
        Parent Trial Baseline Serostatus;Negative: DENV-2
    100 (90.7 to 100.0)
    97.2 (85.5 to 99.9)
        Parent Trial Baseline Serostatus;Negative: DENV-3
    73.7 (56.9 to 86.6)
    63.9 (46.2 to 79.2)
        Parent Trial Baseline Serostatus;Negative: DENV-4
    50.0 (33.4 to 66.6)
    61.1 (43.5 to 76.9)
    No statistical analyses for this end point

    Primary: Seropositivity Rate for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 4 (Month 43) (DEN-315)

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    End point title
    		 Seropositivity Rate for Each of the 4 Dengue Serotypes at 1 Month Post-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 4 (Month 43) (DEN-315) [66]
    End point description
    Seropositivity rate, defined as the percentage of participants seropositive, is derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a reciprocal neutralizing titer ≥10. Baseline seropositivity is defined as reciprocal neutralizing titer ≥10 for one or more dengue serotypes at baseline in the parent trial. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Reported here is the data from Visit 4 at Month 43 for participants from parent trial DEN-315. PPS-B included all participants from the FAS-B who received two doses of Takeda’s TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Subjects analyzed: number of participants with data available for analyses. Number of subjects analysed was variable for each category.
    End point type
    Primary
    End point timeframe
    1 month post-booster dose at Month 43 (DEN-315)
    Notes
    [66] - 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: Only descriptive analyses were planned for this endpoint.
    End point values
    		 Booster Phase: Placebo Booster Phase: TDV
    Number of subjects analysed
    40
    37
    Units: percentage of participants
    number (confidence interval 95%)
        Parent Trial Baseline Serostatus;Positive: DENV-1
    100 (29.2 to 100.0)
    100 (29.2 to 100.0)
        Parent Trial Baseline Serostatus;Positive: DENV-2
    100 (29.2 to 100.0)
    100 (29.2 to 100.0)
        Parent Trial Baseline Serostatus;Positive: DENV-3
    100 (29.2 to 100.0)
    100 (29.2 to 100.0)
        Parent Trial Baseline Serostatus;Positive: DENV-4
    100 (29.2 to 100.0)
    100 (29.2 to 100.0)
        Parent Trial Baseline Serostatus;Negative: DENV-1
    97.3 (85.8 to 99.9)
    100 (89.7 to 100.0)
        Parent Trial Baseline Serostatus;Negative: DENV-2
    100 (90.5 to 100.0)
    100 (89.7 to 100.0)
        Parent Trial Baseline Serostatus;Negative: DENV-3
    64.9 (47.5 to 79.8)
    100 (89.7 to 100.0)
        Parent Trial Baseline Serostatus;Negative: DENV-4
    48.6 (31.9 to 65.6)
    100 (89.7 to 100.0)
    No statistical analyses for this end point

    Primary: Seropositivity Rate for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose at Visit 5 for Both Parent Trials

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    End point title
    		 Seropositivity Rate for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose at Visit 5 for Both Parent Trials [67]
    End point description
    Seropositivity rate, defined as the percentage of participants seropositive, is derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a reciprocal neutralizing titer ≥10. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Reported here is the data from Visit 5, 6 month post-booster dose for all participants (Month 21 for parent trial DEN-304 and Month 48 for parent trial DEN-315). PPS-B included all participants from the FAS-B who received two doses of Takeda’s TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Subjects analyzed: number of participants with data available for analyses.
    End point type
    Primary
    End point timeframe
    6 months post-booster dose at Month 21 (DEN-304) and Month 48 (DEN-315)
    Notes
    [67] - 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: Only descriptive analyses were planned for this endpoint.
    End point values
    		 Booster Phase: Placebo Booster Phase: TDV
    Number of subjects analysed
    96
    92
    Units: percentage of participants
    number (confidence interval 95%)
        DENV-1
    90.6 (82.9 to 95.6)
    96.7 (90.8 to 99.3)
        DENV-2
    100 (96.2 to 100.0)
    100 (96.1 to 100.0)
        DENV-3
    76.0 (66.3 to 84.2)
    98.9 (94.1 to 100.0)
        DENV-4
    63.5 (53.1 to 73.1)
    94.6 (87.8 to 98.2)
    No statistical analyses for this end point

    Primary: Seropositivity Rate for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose at Visit 5 (Month 21) (DEN-304)

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    End point title
    		 Seropositivity Rate for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose at Visit 5 (Month 21) (DEN-304) [68]
    End point description
    Seropositivity rate, defined as the percentage of participants seropositive, is derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a reciprocal neutralizing titer ≥10. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Reported here is the data from Visit 5 at Month 21 for participants from parent trial DEN-304. PPS-B included all participants from the FAS-B who received two doses of Takeda’s TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Subjects analyzed: number of participants with data available for analyses.
    End point type
    Primary
    End point timeframe
    6 months post-booster dose at Month 21 (DEN-304)
    Notes
    [68] - 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: Only descriptive analyses were planned for this endpoint.
    End point values
    		 Booster Phase: Placebo Booster Phase: TDV
    Number of subjects analysed
    56
    54
    Units: percentage of participants
    number (confidence interval 95%)
        DENV-1
    89.3 (78.1 to 96.0)
    96.3 (87.3 to 99.5)
        DENV-2
    100 (93.6 to 100.0)
    100 (93.4 to 100.0)
        DENV-3
    78.6 (65.6 to 88.4)
    98.1 (90.1 to 100.0)
        DENV-4
    71.4 (57.8 to 82.7)
    96.3 (87.3 to 99.5)
    No statistical analyses for this end point

    Primary: Seropositivity Rate for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose at Visit 5 (Month 48) (DEN-315)

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    End point title
    		 Seropositivity Rate for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose at Visit 5 (Month 48) (DEN-315) [69]
    End point description
    Seropositivity rate, defined as the percentage of participants seropositive, is derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a reciprocal neutralizing titer ≥10. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Reported here is the data from Visit 5 at Month 48 for participants from parent trial DEN-315. PPS-B included all participants from the FAS-B who received two doses of Takeda’s TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Subjects analyzed: number of participants with data available for analyses.
    End point type
    Primary
    End point timeframe
    6 months post-booster dose at Month 48 (DEN-315)
    Notes
    [69] - 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: Only descriptive analyses were planned for this endpoint.
    End point values
    		 Booster Phase: Placebo Booster Phase: TDV
    Number of subjects analysed
    40
    38
    Units: percentage of participants
    number (confidence interval 95%)
        DENV-1
    92.5 (79.6 to 98.4)
    97.4 (86.2 to 99.9)
        DENV-2
    100 (91.2 to 100.0)
    100 (90.7 to 100.0)
        DENV-3
    72.5 (56.1 to 85.4)
    100 (90.7 to 100.0)
        DENV-4
    52.5 (36.1 to 68.5)
    92.1 (78.6 to 98.3)
    No statistical analyses for this end point

    Primary: Seropositivity Rate for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 5 for Both Parent Trials

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    End point title
    		 Seropositivity Rate for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 5 for Both Parent Trials [70]
    End point description
    Seropositivity rate, defined as the percentage of participants seropositive, is derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a reciprocal neutralizing titer ≥10. Baseline seropositivity is defined as reciprocal neutralizing titer ≥10 for one or more dengue serotypes at baseline in the parent trial. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Reported here is the data from Visit 5, 6 month post-booster dose for all participants (Month 21 for parent trial DEN-304 and Month 48 for parent trial DEN-315). PPS-B included all participants from the FAS-B who received two doses of Takeda’s TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Subjects analyzed: number of participants with data available for analyses. Number of subjects analysed was variable for each category.
    End point type
    Primary
    End point timeframe
    6 months post-booster dose at Month 21 (DEN-304) and Month 48 (DEN-315)
    Notes
    [70] - 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: Only descriptive analyses were planned for this endpoint.
    End point values
    		 Booster Phase: Placebo Booster Phase: TDV
    Number of subjects analysed
    96
    92
    Units: percentage of participants
    number (confidence interval 95%)
        Parent Trial Baseline Serostatus;Positive: DENV-1
    90.0 (55.5 to 99.7)
    91.7 (61.5 to 99.8)
        Parent Trial Baseline Serostatus;Positive: DENV-2
    100 (69.2 to 100.0)
    100 (73.5 to 100.0)
        Parent Trial Baseline Serostatus;Positive: DENV-3
    90.0 (55.5 to 99.7)
    91.7 (61.5 to 99.8)
        Parent Trial Baseline Serostatus;Positive: DENV-4
    90.0 (55.5 to 99.7)
    83.3 (51.6 to 97.9)
        Parent Trial Baseline Serostatus;Negative: DENV-1
    90.7 (82.5 to 95.9)
    97.5 (91.3 to 99.7)
        Parent Trial Baseline Serostatus;Negative: DENV-2
    100 (95.8 to 100.0)
    100 (95.5 to 100.0)
        Parent Trial Baseline Serostatus;Negative: DENV-3
    74.4 (63.9 to 83.2)
    100 (95.5 to 100.0)
        Parent Trial Baseline Serostatus;Negative: DENV-4
    60.5 (49.3 to 70.8)
    96.3 (89.4 to 99.2)
    No statistical analyses for this end point

    Primary: Seropositivity Rate for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 5 (Month 21) (DEN-304)

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    End point title
    		 Seropositivity Rate for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 5 (Month 21) (DEN-304) [71]
    End point description
    Seropositivity rate, defined as the percentage of participants seropositive, is derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a reciprocal neutralizing titer ≥10. Baseline seropositivity is defined as reciprocal neutralizing titer ≥10 for one or more dengue serotypes at baseline in the parent trial. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Reported here is the data from Visit 5 at Month 21 for participants from parent trial DEN-304. PPS-B included all participants from the FAS-B who received two doses of Takeda’s TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Subjects analyzed: number of participants with data available for analyses. Number of subjects analysed was variable for each category.
    End point type
    Primary
    End point timeframe
    6 months post-booster dose at Month 21 (DEN-304)
    Notes
    [71] - 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: Only descriptive analyses were planned for this endpoint.
    End point values
    		 Booster Phase: Placebo Booster Phase: TDV
    Number of subjects analysed
    56
    54
    Units: percentage of participants
    number (confidence interval 95%)
        Parent Trial Baseline Serostatus;Positive: DENV-1
    87.5 (47.3 to 99.7)
    88.9 (51.8 to 99.7)
        Parent Trial Baseline Serostatus;Positive: DENV-2
    100 (63.1 to 100.0)
    100 (66.4 to 100.0)
        Parent Trial Baseline Serostatus;Positive: DENV-3
    87.5 (47.3 to 99.7)
    88.9 (51.8 to 99.7)
        Parent Trial Baseline Serostatus;Positive: DENV-4
    87.5 (47.3 to 99.7)
    88.9 (51.8 to 99.7)
        Parent Trial Baseline Serostatus;Negative: DENV-1
    89.6 (77.3 to 96.5)
    97.8 (88.2 to 99.9)
        Parent Trial Baseline Serostatus;Negative: DENV-2
    100 (92.6 to 100.0)
    100 (92.1 to 100.0)
        Parent Trial Baseline Serostatus;Negative: DENV-3
    77.1 (62.7 to 88.0)
    100 (92.1 to 100.0)
        Parent Trial Baseline Serostatus;Negative: DENV-4
    68.8 (53.7 to 81.3)
    97.8 (88.2 to 99.9)
    No statistical analyses for this end point

    Primary: Seropositivity Rate for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 5 (Month 48) (DEN-315)

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    End point title
    		 Seropositivity Rate for Each of the 4 Dengue Serotypes at 6 Months Post-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 5 (Month 48) (DEN-315) [72]
    End point description
    Seropositivity rate, defined as the percentage of participants seropositive, is derived from the titers of dengue-neutralizing antibodies. Seropositivity is defined as a reciprocal neutralizing titer ≥10. Baseline seropositivity is defined as reciprocal neutralizing titer ≥10 for one or more dengue serotypes at baseline in the parent trial. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Reported here is the data from Visit 5 at Month 48 for participants from parent trial DEN-315. PPS-B included all participants from the FAS-B who received two doses of Takeda’s TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Subjects analyzed: number of participants with data available for analyses. Number of subjects analysed was variable for each category.
    End point type
    Primary
    End point timeframe
    6 months post-booster dose at Month 48 (DEN-315)
    Notes
    [72] - 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: Only descriptive analyses were planned for this endpoint.
    End point values
    		 Booster Phase: Placebo Booster Phase: TDV
    Number of subjects analysed
    40
    38
    Units: percentage of participants
    number (confidence interval 95%)
        Parent Trial Baseline Serostatus;Positive: DENV-1
    100 (15.8 to 100.0)
    100 (29.2 to 100.0)
        Parent Trial Baseline Serostatus;Positive: DENV-2
    100 (15.8 to 100.0)
    100 (29.2 to 100.0)
        Parent Trial Baseline Serostatus;Positive: DENV-3
    100 (15.8 to 100.0)
    100 (29.2 to 100.0)
        Parent Trial Baseline Serostatus;Positive: DENV-4
    100 (15.8 to 100.0)
    66.7 (9.4 to 99.2)
        Parent Trial Baseline Serostatus;Negative: DENV-1
    92.1 (78.6 to 98.3)
    97.1 (85.1 to 99.9)
        Parent Trial Baseline Serostatus;Negative: DENV-2
    100 (90.7 to 100.0)
    100 (90.0 to 100.0)
        Parent Trial Baseline Serostatus;Negative: DENV-3
    71.1 (54.1 to 84.6)
    100 (90.0 to 100.0)
        Parent Trial Baseline Serostatus;Negative: DENV-4
    50.0 (33.4 to 66.6)
    94.3 (80.8 to 99.3)
    No statistical analyses for this end point

    Primary: Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes at Pre-Booster Dose at Visit 3 for Both Parent Trials

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    End point title
    		 Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes at Pre-Booster Dose at Visit 3 for Both Parent Trials [73]
    End point description
    Seropositivity rate for multiple Dengue serotypes, defined as percentage of participants seropositive for more than one Dengue serotype,is derived from titers of dengue-neutralizing antibodies.All 4 dengue serotypes (tetravalent), any 2 of the 4 dengue serotypes (bivalent), any 3 of the 4 dengue serotypes (trivalent). Seropositivity is defined as a reciprocal neutralizing titer ≥10. The 4 dengue virus serotypes are DENV-1,DENV-2,DENV-3&DENV-4. Reported here is data from Visit 3, pre-booster dose for all participants (Month 15 for parent trial DEN-304 and Month 42 for parent trial DEN-315).Pre-booster dose: last non-missing value before booster administration. PPS-B included all participants from FAS-B who received two doses of Takeda’s TDV in parent trials with no new major protocol violations after administration of trial vaccination at Visit 3 that could potentially confound primary endpoints in current trial. Subjects analyzed: number of subjects with data available for analyses.
    End point type
    Primary
    End point timeframe
    Pre-booster dose at Month 15 (DEN-304) and Month 42 (DEN-315)
    Notes
    [73] - 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: Only descriptive analyses were planned for this endpoint.
    End point values
    		 Booster Phase: Placebo Booster Phase: TDV
    Number of subjects analysed
    102
    100
    Units: percentage of participants
    number (confidence interval 95%)
        Bivalent
    15.7 (9.2 to 24.2)
    16.0 (9.4 to 24.7)
        Trivalent
    20.6 (13.2 to 29.7)
    20.0 (12.7 to 29.2)
        Tetravalent
    62.7 (52.6 to 72.1)
    59.0 (48.7 to 68.7)
    No statistical analyses for this end point

    Primary: Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 for Both Parent Trials

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    End point title
    		 Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 for Both Parent Trials [74]
    End point description
    Seropositivity rate for multiple Dengue serotypes, defined as the percentage of participants seropositive for more than one Dengue serotype, is derived from the titers of dengue-neutralizing antibodies. All 4 dengue serotypes (tetravalent), any 2 of the 4 dengue serotypes (bivalent), any 3 of the 4 dengue serotypes (trivalent). Seropositivity is defined as a reciprocal neutralizing titer ≥10. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Reported here is the data from Visit 4, 1 month post-booster dose for all participants (Month 16 for parent trial DEN-304 and Month 43 for parent trial DEN-315). PPS-B included all participants from the FAS-B who received two doses of Takeda’s TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Subjects analyzed: number of participants with data available for analyses.
    End point type
    Primary
    End point timeframe
    1 month post-booster dose at Month 16 (DEN-304) and Month 43 (DEN-315)
    Notes
    [74] - 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: Only descriptive analyses were planned for this endpoint.
    End point values
    		 Booster Phase: Placebo Booster Phase: TDV
    Number of subjects analysed
    99
    97
    Units: percentage of participants
    number (confidence interval 95%)
        Bivalent
    18.2 (11.1 to 27.2)
    0 (0.0 to 3.7)
        Trivalent
    24.2 (16.2 to 33.9)
    0 (0.0 to 3.7)
        Tetravalent
    56.6 (46.2 to 66.5)
    100 (96.3 to 100.0)
    No statistical analyses for this end point

    Primary: Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes at Pre-Booster Dose at Visit 3 (Month 15) (DEN-304)

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    End point title
    		 Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes at Pre-Booster Dose at Visit 3 (Month 15) (DEN-304) [75]
    End point description
    Seropositivity rate for multiple Dengue serotypes, defined as percentage of participants seropositive for more than one Dengue serotype, is derived from titers of dengue-neutralizing antibodies. All 4 dengue serotypes (tetravalent), any 2 of 4 dengue serotypes (bivalent), any 3 of 4 dengue serotypes (trivalent). Seropositivity is defined as a reciprocal neutralizing titer ≥10. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 & DENV-4. Reported here is pre-booster data from Visit 3 at Month 15 for participants from parent trial DEN-304. Pre-booster dose is defined as last non-missing value before booster administration.PPS-B included all participants from the FAS-B who received two doses of Takeda’s TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Subjects analyzed: number of participants with data available for analyses.
    End point type
    Primary
    End point timeframe
    Pre-booster dose at Month 15 (DEN-304)
    Notes
    [75] - 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: Only descriptive analyses were planned for this endpoint.
    End point values
    		 Booster Phase: Placebo Booster Phase: TDV
    Number of subjects analysed
    61
    61
    Units: percentage of participants
    number (confidence interval 95%)
        Bivalent
    11.5 (4.7 to 22.2)
    14.8 (7.0 to 26.2)
        Trivalent
    16.4 (8.2 to 28.1)
    16.4 (8.2 to 28.1)
        Tetravalent
    70.5 (57.4 to 81.5)
    65.6 (52.3 to 77.3)
    No statistical analyses for this end point

    Primary: Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 (Month 16) (DEN-304)

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    End point title
    		 Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes at 1 Month Post-Booster Dose at Visit 4 (Month 16) (DEN-304) [76]
    End point description
    Seropositivity rate for multiple Dengue serotypes, defined as the percentage of participants seropositive for more than one Dengue serotype, is derived from the titers of dengue-neutralizing antibodies. All 4 dengue serotypes (tetravalent), any 2 of the 4 dengue serotypes (bivalent), any 3 of the 4 dengue serotypes (trivalent). Seropositivity is defined as a reciprocal neutralizing titer ≥10. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Reported here is the data from Visit 4 at Month 16 for participants from parent trial DEN-304. PPS-B included all participants from the FAS-B who received two doses of Takeda’s TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Subjects analyzed: number of participants with data available for analyses.
    End point type
    Primary
    End point timeframe
    1 month post-booster dose at Month 16 (DEN-304.)
    Notes
    [76] - 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: Only descriptive analyses were planned for this endpoint.
    End point values
    		 Booster Phase: Placebo Booster Phase: TDV
    Number of subjects analysed
    59
    60
    Units: percentage of participants
    number (confidence interval 95%)
        Bivalent
    15.3 (7.2 to 27.0)
    0 (0.0 to 6.0)
        Trivalent
    20.3 (11.0 to 32.8)
    0 (0.0 to 6.0)
        Tetravalent
    64.4 (50.9 to 76.4)
    100 (94.0 to 100.0)
    No statistical analyses for this end point

    Primary: Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes at Pre-Booster Dose at Visit 3 (Month 42) (DEN-315)

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    End point title
    		 Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes at Pre-Booster Dose at Visit 3 (Month 42) (DEN-315) [77]
    End point description
    Seropositivity rate for multiple Dengue serotypes, defined as percentage of participants seropositive for more than one Dengue serotype, is derived from titers of dengue-neutralizing antibodies. All 4 dengue serotypes (tetravalent), any 2 of 4 dengue serotypes (bivalent), any 3 of 4 dengue serotypes (trivalent). Seropositivity is defined as a reciprocal neutralizing titer ≥10. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3&DENV-4. Reported here is pre-booster data from Visit 3 at Month 42 for participants from parent trial DEN-315. Pre-booster dose is defined as last non-missing value before booster administration. PPS-B included all participants from the FAS-B who received two doses of Takeda’s TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Subjects analyzed: number of participants with data available for analyses.
    End point type
    Primary
    End point timeframe
    Pre-booster dose at Month 42 (DEN-315)
    Notes
    [77] - 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: Only descriptive analyses were planned for this endpoint.
    End point values
    		 Booster Phase: Placebo Booster Phase: TDV
    Number of subjects analysed
    41
    39
    Units: percentage of participants
    number (confidence interval 95%)
        Bivalent
    22.0 (10.6 to 37.6)
    17.9 (7.5 to 33.5)
        Trivalent
    26.8 (14.2 to 42.9)
    25.6 (13.0 to 42.1)
        Tetravalent
    51.2 (35.1 to 67.1)
    48.7 (32.4 to 65.2)
    No statistical analyses for this end point

    Primary: Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes Post-Booster Dose at 1 Month Post-Booster Dose at Visit 4 (Month 43) (DEN-315)

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    End point title
    		 Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes Post-Booster Dose at 1 Month Post-Booster Dose at Visit 4 (Month 43) (DEN-315) [78]
    End point description
    Seropositivity rate for multiple Dengue serotypes, defined as the percentage of participants seropositive for more than one Dengue serotype, is derived from the titers of dengue-neutralizing antibodies. All 4 dengue serotypes (tetravalent), any 2 of the 4 dengue serotypes (bivalent), any 3 of the 4 dengue serotypes (trivalent). Seropositivity is defined as a reciprocal neutralizing titer ≥10. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Reported here is the data from Visit 4 at Month 43 for participants from parent trial DEN-315. PPS-B included all participants from the FAS-B who received two doses of Takeda’s TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Subjects analyzed: number of participants with data available for analyses.
    End point type
    Primary
    End point timeframe
    1 month post-booster dose at Month 43 (DEN-315)
    Notes
    [78] - 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: Only descriptive analyses were planned for this endpoint.
    End point values
    		 Booster Phase: Placebo Booster Phase: TDV
    Number of subjects analysed
    40
    37
    Units: percentage of participants
    number (confidence interval 95%)
        Bivalent
    22.5 (10.8 to 38.5)
    0 (0.0 to 9.5)
        Trivalent
    30.0 (16.6 to 46.5)
    0 (0.0 to 9.5)
        Tetravalent
    45.0 (29.3 to 61.5)
    100 (90.5 to 100.0)
    No statistical analyses for this end point

    Primary: Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes at Pre-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 3 for Both Parent Trials

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    End point title
    		 Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes at Pre-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 3 for Both Parent Trials [79]
    End point description
    Seropositivity rate for multiple Dengue serotypes,defined as percentage of participants seropositive for more than 1 Dengue serotype,is derived from titers of dengue-neutralizing antibodies.All 4 dengue serotypes(tetravalent),any 2 of 4 dengue serotypes (bivalent),any 3 of 4 dengue serotypes(trivalent).Seropositivity:reciprocal neutralizing titer≥10.Baseline seropositivity:reciprocal neutralizing titer≥10 for one/more dengue serotypes at baseline in parent trial.4 dengue virus serotypes are DENV-1,DENV-2,DENV-3&DENV-4.Reported here is data from Visit 3,pre-booster dose for all participants(Month15 for parent trial DEN-304&Month42 for parent trial DEN-315). Pre-booster dose is defined as last non-missing value before booster administration. Analysis Population: PPS-B. Subjects analyzed: number of participants with data available for analyses. Number of subjects analysed was variable for each category. 'BL' indicates Baseline.
    End point type
    Primary
    End point timeframe
    Pre-booster dose at Month 15 (DEN-304) and Month 42 (DEN-315)
    Notes
    [79] - 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: Only descriptive analyses were planned for this endpoint.
    End point values
    		 Booster Phase: Placebo Booster Phase: TDV
    Number of subjects analysed
    102
    100
    Units: percentage of participants
    number (confidence interval 95%)
        Parent Trial BL Serostatus: Positive; Bivalent
    7.7 (0.2 to 36.0)
    8.3 (0.2 to 38.5)
        Parent Trial BL Serostatus: Positive; Trivalent
    15.4 (1.9 to 45.4)
    16.7 (2.1 to 48.4)
        Parent Trial BL Serostatus:Positive;Tetravalent
    76.9 (46.2 to 95.0)
    66.7 (34.9 to 90.1)
        Parent Trial BL Serostatus: Negative; Bivalent
    16.9 (9.8 to 26.3)
    17.0 (9.9 to 26.6)
        Parent Trial BL Serostatus: Negative; Trivalent
    21.3 (13.4 to 31.3)
    20.5 (12.6 to 30.4)
        Parent Trial BL Serostatus:Negative;Tetravalent
    60.7 (49.7 to 70.9)
    58.0 (47.0 to 68.4)
    No statistical analyses for this end point

    Primary: Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes at 1 Month Post-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 4 for Both Parent Trials

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    End point title
    		 Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes at 1 Month Post-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 4 for Both Parent Trials [80]
    End point description
    Seropositivity rate for multiple Dengue serotypes, defined as the percentage of participants seropositive for more than one Dengue serotype, is derived from the titers of dengue-neutralizing antibodies. All 4 dengue serotypes (tetravalent), any 2 of the 4 dengue serotypes (bivalent), any 3 of the 4 dengue serotypes (trivalent). Seropositivity is defined as a reciprocal neutralizing titer ≥10. Baseline seropositivity is defined as reciprocal neutralizing titer ≥10 for one or more dengue serotypes at baseline in the parent trial. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Reported here is the data from Visit 4, 1 month post-booster dose for all participants (Month 16 for parent trial DEN-304 and Month 43 for parent trial DEN-315). Analysis Population: PPS-B. Subjects analyzed: number of participants with data available for analyses. Number of subjects analysed was variable for each category. 'BL' indicates Baseline.
    End point type
    Primary
    End point timeframe
    1 month post-booster dose at Month 16 (DEN-304) and Month 43 (DEN-315)
    Notes
    [80] - 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: Only descriptive analyses were planned for this endpoint.
    End point values
    		 Booster Phase: Placebo Booster Phase: TDV
    Number of subjects analysed
    99
    97
    Units: percentage of participants
    number (confidence interval 95%)
        Parent Trial BL Serostatus: Positive; Bivalent
    8.3 (0.2 to 38.5)
    0 (0.0 to 28.5)
        Parent Trial BL Serostatus: Positive; Trivalent
    8.3 (0.2 to 38.5)
    0 (0.0 to 28.5)
        Parent Trial BL Serostatus: Positive; Tetravalent
    83.3 (51.6 to 97.9)
    100 (71.5 to 100.0)
        Parent Trial BL Serostatus: Negative; Bivalent
    19.5 (11.8 to 29.4)
    0 (0.0 to 4.2)
        Parent Trial BL Serostatus: Negative; Trivalent
    26.4 (17.6 to 37.0)
    0 (0.0 to 4.2)
        Parent Trial BL Serostatus: Negative; Tetravalent
    52.9 (41.9 to 63.7)
    100 (95.8 to 100.0)
    No statistical analyses for this end point

    Primary: Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes at Pre-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 3 (Month 15) (DEN-304)

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    End point title
    		 Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes at Pre-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 3 (Month 15) (DEN-304) [81]
    End point description
    Seropositivity rate for multiple Dengue serotypes, defined as the percentage of participants seropositive for more than one Dengue serotype, is derived from the titers of dengue-neutralizing antibodies. All 4 dengue serotypes (tetravalent), any 2 of the 4 dengue serotypes (bivalent), any 3 of the 4 dengue serotypes (trivalent). Seropositivity is defined as a reciprocal neutralizing titer ≥10. Baseline seropositivity is defined as reciprocal neutralizing titer ≥10 for one or more dengue serotypes at baseline in the parent trial. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Reported here is the pre-booster data from Visit 3 at Month 15 for participants from parent trial DEN-304. Pre-booster dose is defined as the last non-missing value before booster administration. Analysis Population: PPS-B. Subjects analyzed: number of participants with data available for analyses. Number of subjects analysed was variable for each category. 'BL' indicates Baseline.
    End point type
    Primary
    End point timeframe
    Pre-booster dose at Month 15 (DEN-304)
    Notes
    [81] - 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: Only descriptive analyses were planned for this endpoint.
    End point values
    		 Booster Phase: Placebo Booster Phase: TDV
    Number of subjects analysed
    61
    61
    Units: percentage of participants
    number (confidence interval 95%)
        Parent Trial BL Serostatus: Positive; Bivalent
    10.0 (0.3 to 44.5)
    11.1 (0.3 to 48.2)
        Parent Trial BL Serostatus: Positive; Trivalent
    20.0 (2.5 to 55.6)
    0 (0.0 to 33.6)
        Parent Trial BL Serostatus:Positive;Tetravalent
    70.0 (34.8 to 93.3)
    77.8 (40.0 to 97.2)
        Parent Trial BL Serostatus: Negative; Bivalent
    11.8 (4.4 to 23.9)
    15.4 (6.9 to 28.1)
        Parent Trial BL Serostatus: Negative; Trivalent
    15.7 (7.0 to 28.6)
    19.2 (9.6 to 32.5)
        Parent Trial BL Serostatus:Negative;Tetravalent
    70.6 (56.2 to 82.5)
    63.5 (49.0 to 76.4)
    No statistical analyses for this end point

    Primary: Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes at 1 Month Post-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 4 (Month 16) (DEN-304)

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    End point title
    		 Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes at 1 Month Post-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 4 (Month 16) (DEN-304) [82]
    End point description
    Seropositivity rate for multiple Dengue serotypes, defined as the percentage of participants seropositive for more than one Dengue serotype, is derived from the titers of dengue-neutralizing antibodies. All 4 dengue serotypes (tetravalent), \any 2 of the 4 dengue serotypes (bivalent), any 3 of the 4 dengue serotypes (trivalent). Seropositivity is defined as a reciprocal neutralizing titer ≥10. Baseline seropositivity is defined as reciprocal neutralizing titer ≥10 for one or more dengue serotypes at baseline in the parent trial. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Reported here is the data from Visit 4 at Month 16 for participants from parent trial DEN-304. Analysis Population: PPS-B. Subjects analyzed: number of participants with data available for analyses. Number of subjects analysed was variable for each category. 'BL' indicates Baseline.
    End point type
    Primary
    End point timeframe
    1 month post-booster dose at Month 16 (DEN-304)
    Notes
    [82] - 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: Only descriptive analyses were planned for this endpoint.
    End point values
    		 Booster Phase: Placebo Booster Phase: TDV
    Number of subjects analysed
    59
    60
    Units: percentage of participants
    number (confidence interval 95%)
        Parent Trial BL Serostatus: Positive; Bivalent
    11.1 (0.3 to 48.2)
    0 (0.0 to 36.9)
        Parent Trial BL Serostatus: Positive; Trivalent
    11.1 (0.3 to 48.2)
    0 (0.0 to 36.9)
        Parent Trial BL Serostatus: Positive; Tetravalent
    77.8 (40.0 to 97.2)
    100 (63.1 to 100.0)
        Parent Trial BL Serostatus: Negative; Bivalent
    16.0 (7.2 to 29.1)
    0 (0.0 to 6.8)
        Parent Trial BL Serostatus: Negative; Trivalent
    22.0 (11.5 to 36.0)
    0 (0.0 to 6.8)
        Parent Trial BL Serostatus: Negative; Tetravalent
    62.0 (47.2 to 75.3)
    100 (93.2 to 100.0)
    No statistical analyses for this end point

    Primary: Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes at Pre-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 3 (Month 42) (DEN-315)

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    End point title
    		 Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes at Pre-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 3 (Month 42) (DEN-315) [83]
    End point description
    Seropositivity rate for multiple Dengue serotypes, defined as the percentage of participants seropositive for more than one Dengue serotype, is derived from the titers of dengue-neutralizing antibodies. All 4 dengue serotypes (tetravalent), any 2 of the 4 dengue serotypes (bivalent), any 3 of the 4 dengue serotypes (trivalent). Seropositivity is defined as a reciprocal neutralizing titer ≥10. Baseline seropositivity is defined as reciprocal neutralizing titer ≥10 for one or more dengue serotypes at baseline in the parent trial. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Reported here is the pre-booster data from Visit 3 at Month 42 for participants from parent trial DEN-315. Pre-booster dose is defined as the last non-missing value before booster administration. Analysis Population: PPS-B. Subjects analyzed: number of participants with data available for analyses. Number of subjects analysed was variable for each category. 'BL' indicates Baseline.
    End point type
    Primary
    End point timeframe
    Pre-booster dose at Month 42 (DEN-315)
    Notes
    [83] - 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: Only descriptive analyses were planned for this endpoint.
    End point values
    		 Booster Phase: Placebo Booster Phase: TDV
    Number of subjects analysed
    41
    39
    Units: percentage of participants
    number (confidence interval 95%)
        Parent Trial BL Serostatus: Positive; Bivalent
    0 (0.0 to 70.8)
    0 (0.0 to 70.8)
        Parent Trial BL Serostatus: Positive; Trivalent
    0 (0.0 to 70.8)
    66.7 (9.4 to 99.2)
        Parent Trial BL Serostatus: Positive; Tetravalent
    100 (29.2 to 100.0)
    33.3 (0.8 to 90.6)
        Parent Trial BL Serostatus: Negative; Bivalent
    23.7 (11.4 to 40.2)
    19.4 (8.2 to 36.0)
        Parent Trial BL Serostatus: Negative; Trivalent
    28.9 (15.4 to 45.9)
    22.2 (10.1 to 39.2)
        Parent Trial BL Serostatus: Negative; Tetravalent
    47.4 (31.0 to 64.2)
    50.0 (32.9 to 67.1)
    No statistical analyses for this end point

    Primary: Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes at 1 Month Post-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 4 (Month 43) (DEN-315)

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    End point title
    		 Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes at 1 Month Post-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 4 (Month 43) (DEN-315) [84]
    End point description
    Seropositivity rate for multiple Dengue serotypes, defined as the percentage of participants seropositive for more than one Dengue serotype, is derived from the titers of dengue-neutralizing antibodies. All 4 dengue serotypes (tetravalent), any 2 of the 4 dengue serotypes (bivalent), any 3 of the 4 dengue serotypes (trivalent). Seropositivity is defined as a reciprocal neutralizing titer ≥10. Baseline seropositivity is defined as reciprocal neutralizing titer ≥10 for one or more dengue serotypes at baseline in the parent trial. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Reported here is the data from Visit 4 at Month 43 for participants from parent trial DEN-315. Analysis Population: PPS-B. Subjects analyzed: number of participants with data available for analyses. Number of subjects analysed was variable for each category. 'BL' indicates Baseline.
    End point type
    Primary
    End point timeframe
    1 month post-booster dose at Month 43 (DEN-315)
    Notes
    [84] - 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: Only descriptive analyses were planned for this endpoint.
    End point values
    		 Booster Phase: Placebo Booster Phase: TDV
    Number of subjects analysed
    40
    37
    Units: percentage of participants
    number (confidence interval 95%)
        Parent Trial BL Serostatus: Positive; Bivalent
    0 (0.0 to 70.8)
    0 (0.0 to 70.8)
        Parent Trial BL Serostatus: Positive; Trivalent
    0 (0.0 to 70.8)
    0 (0.0 to 70.8)
        Parent Trial BL Serostatus: Positive; Tetravalent
    100 (29.2 to 100.0)
    100 (29.2 to 100.0)
        Parent Trial BL Serostatus: Negative; Bivalent
    24.3 (11.8 to 41.2)
    0 (0.0 to 10.3)
        Parent Trial BL Serostatus: Negative; Trivalent
    32.4 (18.0 to 49.8)
    0 (0.0 to 10.3)
        Parent Trial BL Serostatus: Negative; Tetravalent
    40.5 (24.8 to 57.9)
    100 (89.7 to 100.0)
    No statistical analyses for this end point

    Primary: Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes Post-Booster Dose at 6 Months Post-Booster Dose at Visit 5 for Both Parent Trials

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    End point title
    		 Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes Post-Booster Dose at 6 Months Post-Booster Dose at Visit 5 for Both Parent Trials [85]
    End point description
    Seropositivity rate for multiple Dengue serotypes,defined as percentage of participants seropositive for more than one Dengue serotype,is derived from titers of dengue-neutralizing antibodies.All 4 dengue serotypes(tetravalent),any 2 of 4 dengue serotypes (bivalent),any 3 of 4 dengue serotypes (trivalent). Seropositivity is defined as a reciprocal neutralizing titer ≥10.4 dengue virus serotypes are DENV-1,DENV-2,DENV-3&DENV-4.Reported here is data from Visit 5, 6 month post-booster dose for all participants(Month 21 for parent trial DEN-304&Month 48 for parent trial DEN-315).PPS-B included all participants from the FAS-B who received two doses of Takeda’s TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Subjects analyzed: number of participants with data available for analyses.
    End point type
    Primary
    End point timeframe
    6 months post-booster dose at Month 21 (DEN-304) and Month 48 (DEN-315)
    Notes
    [85] - 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: Only descriptive analyses were planned for this endpoint.
    End point values
    		 Booster Phase: Placebo Booster Phase: TDV
    Number of subjects analysed
    96
    92
    Units: percentage of participants
    number (confidence interval 95%)
        Bivalent
    14.6 (8.2 to 23.3)
    2.2 (0.3 to 7.6)
        Trivalent
    21.9 (14.1 to 31.5)
    5.4 (1.8 to 12.2)
        Tetravalent
    57.3 (46.8 to 67.3)
    92.4 (84.9 to 96.9)
    No statistical analyses for this end point

    Primary: Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes Post-Booster Dose at 6 Months Post-Booster Dose at Visit 5 (Month 21) (DEN-304)

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    End point title
    		 Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes Post-Booster Dose at 6 Months Post-Booster Dose at Visit 5 (Month 21) (DEN-304) [86]
    End point description
    Seropositivity rate for multiple Dengue serotypes, defined as the percentage of participants seropositive for more than one Dengue serotype, is derived from the titers of dengue-neutralizing antibodies. All 4 dengue serotypes (tetravalent), any 2 of the 4 dengue serotypes (bivalent), any 3 of the 4 dengue serotypes (trivalent). Seropositivity is defined as a reciprocal neutralizing titer ≥10. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Reported here is the data from Visit 5 at Month 21 for participants from parent trial DEN-304. PPS-B included all participants from the FAS-B who received two doses of Takeda’s TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Subjects analyzed: number of participants with data available for analyses.
    End point type
    Primary
    End point timeframe
    6 months post-booster dose at Month 21 (DEN-304)
    Notes
    [86] - 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: Only descriptive analyses were planned for this endpoint.
    End point values
    		 Booster Phase: Placebo Booster Phase: TDV
    Number of subjects analysed
    56
    54
    Units: percentage of participants
    number (confidence interval 95%)
        Bivalent
    14.3 (6.4 to 26.2)
    1.9 (0.0 to 9.9)
        Trivalent
    16.1 (7.6 to 28.3)
    5.6 (1.2 to 15.4)
        Tetravalent
    64.3 (50.4 to 76.6)
    92.6 (82.1 to 97.9)
    No statistical analyses for this end point

    Primary: Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes Post-booster Dose at 6 Months Post-Booster Dose at Visit 5 (Month 48) (DEN-315)

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    End point title
    		 Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes Post-booster Dose at 6 Months Post-Booster Dose at Visit 5 (Month 48) (DEN-315) [87]
    End point description
    Seropositivity rate for multiple Dengue serotypes, defined as the percentage of participants seropositive for more than one Dengue serotype, is derived from the titers of dengue-neutralizing antibodies. All 4 dengue serotypes (tetravalent), any 2 of the 4 dengue serotypes (bivalent), any 3 of the 4 dengue serotypes (trivalent). Seropositivity is defined as a reciprocal neutralizing titer ≥10. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Reported here is the data from Visit 5 at Month 48 for participants from parent trial DEN-315. PPS-B included all participants from the FAS-B who received two doses of Takeda’s TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Subjects analyzed: number of participants with data available for analyses.
    End point type
    Primary
    End point timeframe
    6 months post-Booster dose at Month 48 (DEN-315)
    Notes
    [87] - 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: Only descriptive analyses were planned for this endpoint.
    End point values
    		 Booster Phase: Placebo Booster Phase: TDV
    Number of subjects analysed
    40
    38
    Units: percentage of participants
    number (confidence interval 95%)
        Bivalent
    15.0 (5.7 to 29.8)
    2.6 (0.1 to 13.8)
        Trivalent
    30.0 (16.6 to 46.5)
    5.3 (0.6 to 17.7)
        Tetravalent
    47.5 (31.5 to 63.9)
    92.1 (78.6 to 98.3)
    No statistical analyses for this end point

    Primary: Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes Post-Booster Dose at 6 Months Post-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 5 for Both Parent Trials

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    End point title
    		 Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes Post-Booster Dose at 6 Months Post-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 5 for Both Parent Trials [88]
    End point description
    Seropositivity rate for multiple Dengue serotypes,defined as percentage of participants seropositive for more than 1 Dengue serotype, is derived from titers of dengue-neutralizing antibodies.All 4 dengue serotypes (tetravalent),any 2 of 4 dengue serotypes bivalent),any 3 of 4 dengue serotypes(trivalent).Seropositivity:reciprocal neutralizing titer ≥10.Baseline seropositivity: reciprocal neutralizing titer ≥10 for one/more dengue serotypes at baseline in the parent trial. 4 dengue virus serotypes are DENV-1,DENV-2,DENV-3&DENV-4.Reported here is data from Visit 5, 6 month post-booster dose for all participants (Month 21 for parent trial DEN-304 and Month 48 for parent trial DEN-315). Analysis Population: PPS-B. Subjects analyzed: number of participants with data available for analyses. Number of subjects analysed was variable for each category. 'BL' indicates Baseline.
    End point type
    Primary
    End point timeframe
    6 months post-booster dose at Month 21 (DEN-304) and Month 48 (DEN-315)
    Notes
    [88] - 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: Only descriptive analyses were planned for this endpoint.
    End point values
    		 Booster Phase: Placebo Booster Phase: TDV
    Number of subjects analysed
    96
    92
    Units: percentage of participants
    number (confidence interval 95%)
        Parent Trial BL Serostatus: Positive; Bivalent
    0 (0.0 to 30.8)
    8.3 (0.2 to 38.5)
        Parent Trial BL Serostatus: Positive; Trivalent
    0 (0.0 to 30.8)
    16.7 (2.1 to 48.4)
        Parent Trial BL Serostatus: Positive; Tetravalent
    90.0 (55.5 to 99.7)
    75.0 (42.8 to 94.5)
        Parent Trial BL Serostatus: Negative; Bivalent
    16.3 (9.2 to 25.8)
    1.3 (0.0 to 6.8)
        Parent Trial BL Serostatus: Negative; Trivalent
    24.4 (15.8 to 34.9)
    3.8 (0.8 to 10.6)
        Parent Trial BL Serostatus: Negative; Tetravalent
    53.5 (42.4 to 64.3)
    95.0 (87.7 to 98.6)
    No statistical analyses for this end point

    Primary: Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes Post-Booster Dose at 6 Months Post-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 5 (Month 21) (DEN-304)

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    End point title
    		 Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes Post-Booster Dose at 6 Months Post-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 5 (Month 21) (DEN-304) [89]
    End point description
    Seropositivity rate for multiple Dengue serotypes, defined as the percentage of participants seropositive for more than one Dengue serotype, is derived from the titers of dengue-neutralizing antibodies. All 4 dengue serotypes (tetravalent), any 2 of the 4 dengue serotypes (bivalent), any 3 of the 4 dengue serotypes (trivalent). Seropositivity is defined as a reciprocal neutralizing titer ≥10. Baseline seropositivity is defined as reciprocal neutralizing titer ≥10 for one or more dengue serotypes at baseline in the parent trial. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Reported here is the data from Visit 5 at Month 21 for participants from parent trial DEN-304. Analysis Population: PPS-B. Subjects analyzed: number of participants with data available for analyses. Number of subjects analysed was variable for each category. 'BL' indicates Baseline.
    End point type
    Primary
    End point timeframe
    6 months post-booster dose at Month 21 (DEN-304)
    Notes
    [89] - 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: Only descriptive analyses were planned for this endpoint.
    End point values
    		 Booster Phase: Placebo Booster Phase: TDV
    Number of subjects analysed
    56
    54
    Units: percentage of participants
    number (confidence interval 95%)
        Parent Trial BL Serostatus: Positive; Bivalent
    0 (0.0 to 36.9)
    11.1 (0.3 to 48.2)
        Parent Trial BL Serostatus: Positive; Trivalent
    0 (0.0 to 36.9)
    11.1 (0.3 to 48.2)
        Parent Trial BL Serostatus: Positive; Tetravalent
    87.5 (47.3 to 99.7)
    77.8 (40.0 to 97.2)
        Parent Trial BL Serostatus: Negative; Bivalent
    16.7 (7.5 to 30.2)
    0 (0.0 to 7.9)
        Parent Trial BL Serostatus: Negative; Tetravalent
    60.4 (45.3 to 74.2)
    95.6 (84.9 to 99.5)
        Parent Trial BL Serostatus: Negative; Trivalent
    18.8 (8.9 to 32.6)
    4.4 (0.5 to 15.1)
    No statistical analyses for this end point

    Primary: Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes Post-booster Dose at 6 Months Post-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 5 (Month 48) (DEN-315)

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    End point title
    		 Seropositivity Rate for Multiple (2, 3 or 4) Dengue Serotypes Post-booster Dose at 6 Months Post-Booster Dose by Serostatus at Baseline in the Parent Trials at Visit 5 (Month 48) (DEN-315) [90]
    End point description
    Seropositivity rate for multiple Dengue serotypes, defined as the percentage of participants seropositive for more than one Dengue serotype, is derived from the titers of dengue-neutralizing antibodies. All 4 dengue serotypes (tetravalent), any 2 of the 4 dengue serotypes (bivalent), any 3 of the 4 dengue serotypes (trivalent). Seropositivity is defined as a reciprocal neutralizing titer ≥10. Baseline seropositivity is defined as reciprocal neutralizing titer ≥10 for one or more dengue serotypes at baseline in the parent trial. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4. Reported here is the data from Visit 5 at Month 48 for participants from parent trial DEN-315. Analysis Population: PPS-B. Subjects analyzed: number of participants with data available for analyses. Number of subjects analysed was variable for each category. 'BL' indicates Baseline.
    End point type
    Primary
    End point timeframe
    6 months post-Booster dose at Month 48 (DEN-315)
    Notes
    [90] - 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: Only descriptive analyses were planned for this endpoint.
    End point values
    		 Booster Phase: Placebo Booster Phase: TDV
    Number of subjects analysed
    40
    38
    Units: percentage of participants
    number (confidence interval 95%)
        Parent Trial BL Serostatus: Positive; Bivalent
    0 (0.0 to 84.2)
    0 (0.0 to 70.8)
        Parent Trial BL Serostatus: Positive; Trivalent
    0 (0.0 to 84.2)
    33.3 (0.8 to 90.6)
        Parent Trial BL Serostatus:Positive;Tetravalent
    100 (15.8 to 100.0)
    66.7 (9.4 to 99.2)
        Parent Trial BL Serostatus: Negative; Bivalent
    15.8 (6.0 to 31.3)
    2.9 (0.1 to 14.9)
        Parent Trial BL Serostatus: Negative; Trivalent
    31.6 (17.5 to 48.7)
    2.9 (0.1 to 14.9)
        Parent Trial BL Serostatus:Negative;Tetravalent
    44.7 (28.6 to 61.7)
    94.3 (80.8 to 99.3)
    No statistical analyses for this end point

    Secondary: Geometric Mean Ratio (GMR) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes for all Participants Prior to the Booster Dose

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    End point title
    		 Geometric Mean Ratio (GMR) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes for all Participants Prior to the Booster Dose
    End point description
    The geometric mean ratio is the geometric mean of the ratio of the two visits being compared. PPS included all participants from the FAS who received two doses of Takeda’s TDV in the parent trials with no new major protocol violations in this trial prior to administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Number of subjects analysed was variable for each category. 'PT' stands for Parent Trials.'999 'indicates that zero participants were analysed for the specified category.
    End point type
    Secondary
    End point timeframe
    Month 12 vs Month 0, Month 15 (DEN-304) vs parent trial Month 4, Mont 42 (DEN315) vs parent trial Month 4, Month 0 vs parent trial Month 9, Month 12 vs parent trial Month 9
    End point values
    		 Prior to Booster: DEN-304 Prior to Booster: DEN-315
    Number of subjects analysed
    239
    119
    Units: unitless ratio
    geometric mean (confidence interval 95%)
        Month 12 vs Month 0: DENV-1
    0.753 (0.675 to 0.840)
    0.891 (0.741 to 1.071)
        Month 12 vs Month 0: DENV-2
    0.698 (0.650 to 0.749)
    0.622 (0.548 to 0.705)
        Month 12 vs Month 0: DENV-3
    0.864 (0.791 to 0.945)
    0.852 (0.668 to 1.088)
        Month 12 vs Month 0: DENV-4
    0.689 (0.632 to 0.751)
    0.861 (0.708 to 1.046)
        Month 15 (DEN-304) vs PT Month 4: DENV-1
    0.438 (0.382 to 0.502)
    999 (999 to 999)
        Month 15 (DEN-304) vs PT Month 4: DENV-2
    0.159 (0.137 to 0.185)
    999 (999 to 999)
        Month 15 (DEN-304) vs PT Month 4: DENV-3
    0.275 (0.241 to 0.315)
    999 (999 to 999)
        Month 15 (DEN-304) vs PT Month 4: DENV-4
    0.216 (0.183 to 0.255)
    999 (999 to 999)
        Month 42 (DEN-315) vs PT Month 4: DENV-1
    999 (999 to 999)
    0.296 (0.240 to 0.366)
        Month 42 (DEN-315) vs PT Month 4: DENV-2
    999 (999 to 999)
    0.108 (0.089 to 0.130)
        Month 42 (DEN-315) vs PT Month 4: DENV-3
    999 (999 to 999)
    0.202 (0.162 to 0.252)
        Month 42 (DEN-315) vs PT Month 4: DENV-4
    999 (999 to 999)
    0.066 (0.055 to 0.079)
        Month 0 vs Parent Trial Month 9: DENV-1
    0.529 (0.482 to 0.582)
    0.517 (0.455 to 0.587)
        Month 0 vs Parent Trial Month 9: DENV-2
    0.396 (0.369 to 0.426)
    0.466 (0.415 to 0.522)
        Month 0 vs Parent Trial Month 9: DENV-3
    0.440 (0.394 to 0.492)
    0.547 (0.477 to 0.629)
        Month 0 vs Parent Trial Month 9: DENV-4
    0.577 (0.518 to 0.641)
    0.568 (0.504 to 0.641)
        Month 12 vs Parent Trial Month 9: DENV-1
    0.415 (0.367 to 0.470)
    0.486 (0.377 to 0.627)
        Month 12 vs Parent Trial Month 9: DENV-2
    0.265 (0.239 to 0.295)
    0.289 (0.238 to 0.351)
        Month 12 vs Parent Trial Month 9: DENV-3
    0.407 (0.353 to 0.470)
    0.435 (0.336 to 0.562)
        Month 12 vs Parent Trial Month 9: DENV-4
    0.384 (0.335 to 0.440)
    0.567 (0.431 to 0.745)
    No statistical analyses for this end point

    Secondary: Geometric Mean Ratio (GMR) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes by Serostatus at Baseline in the Parent Trials Prior to the Booster Dose

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    End point title
    		 Geometric Mean Ratio (GMR) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes by Serostatus at Baseline in the Parent Trials Prior to the Booster Dose
    End point description
    The geometric mean ratio is the geometric mean of the ratio of the two visits being compared. Baseline seropositivity is defined as reciprocal neutralizing titer ≥10 for one or more dengue serotypes at baseline in the parent trial. PPS included all participants from the FAS who received two doses of Takeda’s TDV in the parent trials with no new major protocol violations in this trial prior to administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Number of subjects analysed was variable for each category. 'PT' stands for Parent Trials. 'BL' indicates Baseline. '+ve' indicates positive. 'M' stands for Month. '999 'indicates that zero participants were analysed for the specified category. '-99999' and '99999' indicates that the confidence interval was not estimable due to an observed standard deviation of 0.
    End point type
    Secondary
    End point timeframe
    Month 12 vs Month 0, Month 15 (DEN-304) vs parent trial Month 4, Month 42 (DEN315) vs parent trial Month 4, Month 0 vs parent trial Month 9, Month 12 vs parent trial Month 9
    End point values
    		 Prior to Booster: DEN-304 Prior to Booster: DEN-315
    Number of subjects analysed
    239
    119
    Units: unitless ratio
    geometric mean (confidence interval 95%)
        PT BL Serostatus: +ve;M12 vs M0:DENV-1
    0.736 (0.556 to 0.974)
    0.705 (0.002 to 222.445)
        PT BL Serostatus: +ve;M 12 vs M0:DENV-2
    0.756 (0.599 to 0.955)
    0.456 (0.056 to 3.733)
        PT BL Serostatus: +ve;M 12 vs M0:DENV-3
    0.980 (0.834 to 1.152)
    1.000 (-99999 to 99999)
        PT BL Serostatus: +ve;M 12 vs M0:DENV-4
    0.736 (0.598 to 0.906)
    0.727 (0.064 to 8.280)
        PT BL Serostatus:+ve;M15 (DEN-304)vsPT M4:DENV1
    0.506 (0.349 to 0.733)
    999 (999 to 999)
        PT BL Serostatus:+ve;M15 (DEN-304)vsPT M4:DENV2
    0.164 (0.108 to 0.249)
    999 (999 to 999)
        PT BL Serostatus:+ve;M15 (DEN-304)vsPT M4:DENV3
    0.350 (0.238 to 0.514)
    999 (999 to 999)
        PT BL Serostatus:+ve;M15 (DEN-304)vsPT M4:DENV4
    0.178 (0.125 to 0.253)
    999 (999 to 999)
        PT BL Serostatus: +ve;M42 (DEN-315) vsPT M4:DENV1
    999 (999 to 999)
    0.393 (0.155 to 0.998)
        PT BL Serostatus: +ve;M42(DEN-315) vsPT M4:DENV2
    999 (999 to 999)
    0.164 (0.066 to 0.408)
        PT BL Serostatus: +ve;M42(DEN-315) vsPT M4:DENV-3
    999 (999 to 999)
    0.319 (0.204 to 0.499)
        PT BL Serostatus: +ve;M42(DEN-315) vsPT M4:DENV-4
    999 (999 to 999)
    0.070 (0.036 to 0.138)
        PT BL Serostatus: +ve;M0vsPT M9:DENV1
    0.635 (0.467 to 0.864)
    0.528 (0.453 to 0.616)
        PT BL Serostatus: +ve;M0vs PT M9:DENV2
    0.469 (0.356 to 0.619)
    0.454 (0.312 to 0.661)
        PT BL Serostatus: +ve;M0 vs PT M9:DENV3
    0.538 (0.361 to 0.801)
    0.556 (0.356 to 0.868)
        PT BL Serostatus: +ve;M0 vs PT M9: DENV-4
    0.710 (0.475 to 1.062)
    0.684 (0.401 to 1.165)
        PT BL Serostatus: +ve;M12 vs PT M 9:DENV-1
    0.497 (0.330 to 0.748)
    0.375 (0.000 to 400.159)
        PT BL Serostatus: +ve;M12 vs PT M 9:DENV-2
    0.311 (0.203 to 0.477)
    0.172 (0.161 to 0.184)
        PT BL Serostatus: +ve;M12 vs PT M 9:DENV-3
    0.561 (0.329 to 0.957)
    0.664 (0.004 to 119.652)
        PT BL Serostatus: +ve;M12 vs PT M 9:DENV-4
    0.577 (0.335 to 0.994)
    0.966 (0.005 to 194.455)
        PT BL Serostatus:-ve;M12 vs M0; DENV-1
    0.756 (0.671 to 0.851)
    0.900 (0.745 to 1.088)
        PT BL Serostatus:-ve;M12 vs M0; DENV-2
    0.689 (0.639 to 0.742)
    0.630 (0.553 to 0.718)
        PT BL Serostatus:-ve;M12 vs M0; DENV-3
    0.847 (0.767 to 0.936)
    0.846 (0.656 to 1.092)
        PT BL Serostatus: -ve;M12 vs M0; DENV-4
    0.681 (0.619 to 0.750)
    0.867 (0.708 to 1.063)
        PT BL Serostatus:-ve;M15(DEN-304)vsPT M4;DENV1
    0.427 (0.368 to 0.496)
    999 (999 to 999)
        PT BL Serostatus:-ve;M15(DEN-304)vsPT M4;DENV2
    0.158 (0.135 to 0.186)
    999 (999 to 999)
        PT BL Serostatus:-ve;M15(DEN-304)vsPT M4;DENV3
    0.265 (0.229 to 0.305)
    999 (999 to 999)
        PT BL Serostatus:-ve;M15(DEN-304)vsPT M4;DENV4
    0.223 (0.186 to 0.268)
    999 (999 to 999)
        PT BL Serostatus:-ve;M42(DEN-315)vsPT M4;DENV1
    999 (999 to 999)
    0.288 (0.231 to 0.359)
        PT BL Serostatus:-ve;M42(DEN-315)vsPT M4;DENV2
    999 (999 to 999)
    0.103 (0.085 to 0.125)
        PT BL Serostatus:-ve;M42(DEN-315)vsPT M4;DENV3
    999 (999 to 999)
    0.192 (0.152 to 0.244)
        PT BL Serostatus:-ve;M42(DEN-315)vsPT M4;DENV4
    999 (999 to 999)
    0.065 (0.053 to 0.080)
        PT BL Serostatus: Negative;M0 vs PT M 9;DENV-1
    0.514 (0.466 to 0.567)
    0.516 (0.450 to 0.592)
        PT BL Serostatus: Negative;M0 vs PT M9;DENV-2
    0.385 (0.359 to 0.414)
    0.467 (0.413 to 0.527)
        PT BL Serostatus: Negative;M0 vs PT M9;DENV-3
    0.426 (0.381 to 0.477)
    0.547 (0.472 to 0.633)
        PT BL Serostatus: Negative;M0 vs PT M9;DENV-4
    0.557 (0.501 to 0.619)
    0.560 (0.494 to 0.634)
        PT BL Serostatus: Negative;M12 vs PT M9;DENV-1
    0.403 (0.354 to 0.459)
    0.492 (0.378 to 0.641)
        PT BL Serostatus: Negative;M12 vs PT M9;DENV-2
    0.259 (0.233 to 0.287)
    0.296 (0.242 to 0.362)
        PT BL Serostatus: Negative;M12 vs PT M9;DENV-3
    0.387 (0.335 to 0.446)
    0.426 (0.327 to 0.556)
        PT BL Serostatus: Negative;M12 vs PT M9;DENV-4
    0.359 (0.315 to 0.410)
    0.553 (0.416 to 0.734)
    No statistical analyses for this end point

    Secondary: GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes in the Booster Phase

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    End point title
    		 GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes in the Booster Phase
    End point description
    The geometric mean ratio is the geometric mean of the ratio of the two visits being compared. PPS-B included all participants from the FAS-B who received two doses of Takeda’s TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Number of subjects analysed was variable for each category.
    End point type
    Secondary
    End point timeframe
    Months (M) 1&6 post-booster dose in current trial vs M 4 in parent trials; post-booster M 6 vs post-booster M 1; post-booster M 1 vs pre-booster (M 15 for DEN-304/M 42 for DEN-315); post-booster M 6 vs pre-booster (M 15 for DEN-304/M 42 for DEN-315)
    End point values
    		 Booster Phase: Placebo Booster Phase: TDV
    Number of subjects analysed
    102
    100
    Units: unitless ratio
    geometric mean (confidence interval 95%)
        Booster Month 1 vs Parent Trial Month 4: DENV-1
    0.352 (0.296 to 0.417)
    4.298 (3.204 to 5.767)
        Booster Month 1 vs Parent Trial Month 4: DENV-2
    0.124 (0.107 to 0.144)
    0.378 (0.285 to 0.502)
        Booster Month 1 vs Parent Trial Month 4: DENV-3
    0.231 (0.188 to 0.284)
    3.042 (2.217 to 4.175)
        Booster Month 1 vs Parent Trial Month 4: DENV-4
    0.136 (0.107 to 0.174)
    1.505 (1.093 to 2.072)
        Booster Month 6 vs Parent Trial Month 4: DENV-1
    0.285 (0.235 to 0.345)
    1.409 (1.036 to 1.917)
        Booster Month 6 vs Parent Trial Month 4: DENV-2
    0.100 (0.086 to 0.117)
    0.206 (0.158 to 0.269)
        Booster Month 6 vs Parent Trial Month 4:DENV-3
    0.225 (0.187 to 0.272)
    1.133 (0.816 to 1.573)
        Booster Month 6 vs Parent Trial Month 4: DENV-4
    0.110 (0.088 to 0.137)
    0.468 (0.345 to 0.635)
        Booster Month 6 vs Booster Month 1: DENV-1
    0.817 (0.730 to 0.914)
    0.334 (0.283 to 0.395)
        Booster Month 6 vs Booster Month 1: DENV-2
    0.825 (0.753 to 0.903)
    0.535 (0.452 to 0.634)
        Booster Month 6 vs Booster Month 1: DENV-3
    0.990 (0.894 to 1.096)
    0.370 (0.295 to 0.463)
        Booster Month 6 vs Booster Month 1: DENV-4
    0.842 (0.744 to 0.954)
    0.323 (0.263 to 0.396)
        Booster Month 1 vs Pre-booster dose: DENV-1
    0.962 (0.879 to 1.053)
    11.762 (8.660 to 15.975)
        Booster Month 1 vs Pre-booster dose: DENV-2
    0.936 (0.862 to 1.016)
    2.822 (2.208 to 3.607)
        Booster Month 1 vs Pre-booster dose: DENV-3
    0.856 (0.773 to 0.948)
    14.889 (10.992 to 20.170)
        Booster Month 1 vs Pre-booster dose: DENV-4
    0.977 (0.855 to 1.117)
    13.162 (9.443 to 18.345)
        Booster Month 6 vs Pre-booster dose: DENV-1
    0.784 (0.699 to 0.879)
    3.810 (2.847 to 5.097)
        Booster Month 6 vs Pre-booster dose: DENV-2
    0.763 (0.697 to 0.835)
    1.550 (1.250 to 1.923)
        Booster Month 6 vs Pre-booster dose: DENV-3
    0.858 (0.767 to 0.960)
    5.622 (4.151 to 7.614)
        Booster Month 6 vs Pre-booster dose: DENV-4
    0.808 (0.703 to 0.929)
    4.289 (3.205 to 5.741)
    No statistical analyses for this end point

    Secondary: GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes by Serostatus at Baseline in the Parent Trials in the Booster Phase

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    End point title
    		 GMR of Neutralizing Antibodies for Each of the 4 Dengue Serotypes by Serostatus at Baseline in the Parent Trials in the Booster Phase
    End point description
    The geometric mean ratio is the geometric mean of the ratio of the two visits being compared. Baseline seropositivity is defined as reciprocal neutralizing titer ≥10 for one or more dengue serotypes at baseline in the parent trial. PPS-B included all participants from the FAS-B who received two doses of Takeda’s TDV in the parent trials with no new major protocol violations after administration of the trial vaccination at Visit 3 that could potentially confound the primary endpoints in the current trial. Number of subjects analysed was variable for each category. 'PT' stands for Parent Trials. 'BL' indicates Baseline. '+ve' indicates positive. '-ve' indicates negative. 'M' stands for Month.
    End point type
    Secondary
    End point timeframe
    Months (M) 1&6 post-booster dose in current trial vs M 4 in parent trials; post-booster M 1 vs pre-booster (M 15 for DEN-304/M 42 for DEN-315); post-booster M 6 vs pre-booster (M 15 for DEN-304/M 42 for DEN-315); post-booster M 6 vs post-booster M 1
    End point values
    		 Booster Phase: Placebo Booster Phase: TDV
    Number of subjects analysed
    102
    100
    Units: unitless ratio
    geometric mean (confidence interval 95%)
        PT BL Serostatus:+ve;Booster M1 vs PT M4:DENV-1
    0.413 (0.236 to 0.721)
    2.219 (1.181 to 4.169)
        PT BL Serostatus:+ve;Booster M1 vs PT M4:DENV-2
    0.118 (0.077 to 0.180)
    0.355 (0.203 to 0.620)
        PT BL Serostatus:+ve;Booster M1 vs PT M4:DENV-3
    0.311 (0.186 to 0.520)
    1.566 (0.684 to 3.583)
        PT BL Serostatus:+ve;Booster M1 vs PT M4:DENV-4
    0.187 (0.111 to 0.315)
    1.018 (0.539 to 1.922)
        PT BL Serostatus:+ve;Booster M1vsPrebooster:DENV1
    1.033 (0.833 to 1.280)
    3.683 (1.612 to 8.412)
        PT BL Serostatus:+ve;Booster M1vsPrebooster:DENV2
    0.803 (0.615 to 1.049)
    1.805 (1.311 to 2.485)
        PT BL Serostatus:+ve;Booster M1vsPrebooster:DENV3
    0.825 (0.580 to 1.174)
    3.699 (1.738 to 7.873)
        PT BL Serostatus:+ve;Booster M1vsPrebooster:DENV4
    1.310 (0.754 to 2.279)
    5.895 (2.657 to 13.078)
        PT BL Serostatus:+ve;Booster M6vsPrebooster:DENV1
    1.065 (0.673 to 1.686)
    1.404 (0.787 to 2.506)
        PT BL Serostatus:+ve;Booster M6vsPrebooster:DENV2
    0.739 (0.480 to 1.137)
    0.906 (0.673 to 1.221)
        PT BL Serostatus:+ve;Booster M6vsPrebooster:DENV3
    0.965 (0.733 to 1.271)
    1.544 (0.868 to 2.748)
        PT BL Serostatus:+ve;Booster M6vsPrebooster:DENV4
    0.871 (0.492 to 1.543)
    1.923 (0.941 to 3.931)
        PT BL Serostatus:+ve;Booster M6vsBooster M1:DENV1
    0.998 (0.742 to 1.343)
    0.379 (0.221 to 0.650)
        PT BL Serostatus:+ve;Booster M6vsBooster M1:DENV2
    1.026 (0.713 to 1.475)
    0.506 (0.330 to 0.775)
        PT BL Serostatus:+ve;Booster M6vsBooster M1:DENV3
    1.024 (0.821 to 1.278)
    0.437 (0.255 to 0.750)
        PT BL Serostatus:+ve;Booster M6vsBooster M1:DENV4
    0.772 (0.462 to 1.292)
    0.349 (0.204 to 0.597)
        PT BL Serostatus:+ve;Booster M6vsPT M4:DENV1
    0.400 (0.175 to 0.915)
    0.779 (0.379 to 1.599)
        PT BL Serostatus:+ve;Booster M6vsPT M4:DENV2
    0.103 (0.066 to 0.162)
    0.161 (0.086 to 0.304)
        PT BL Serostatus:+ve;Booster M6vsPT M4:DENV3
    0.333 (0.215 to 0.515)
    0.593 (0.267 to 1.321)
        PT BL Serostatus:+ve;Booster M6vsPT M4:DENV4
    0.113 (0.063 to 0.201)
    0.314 (0.134 to 0.735)
        PT BL Serostatus:-ve;Booster M1vsPT M4;DENV1
    0.343 (0.286 to 0.413)
    4.692 (3.404 to 6.467)
        PT BL Serostatus:-ve;Booster M1vsPT M4;DENV2
    0.125 (0.106 to 0.147)
    0.382 (0.278 to 0.523)
        PT BL Serostatus:-ve;Booster M1vsPT M4;DENV3
    0.221 (0.177 to 0.277)
    3.322 (2.359 to 4.678)
        PT BL Serostatus:-ve;Booster M1vsPT M4;DENV4
    0.130 (0.099 to 0.171)
    1.585 (1.112 to 2.259)
        PT BL Serostatus:-ve;Booster M1vsPrebooster;DENV1
    0.953 (0.862 to 1.053)
    13.646 (9.906 to 18.796)
        PT BL Serostatus:-ve;Booster M1vsPrebooster;DENV2
    0.956 (0.876 to 1.043)
    2.988 (2.275 to 3.925)
        PT BL Serostatus:-ve;Booster M1vsPrebooster;DENV3
    0.860 (0.771 to 0.959)
    17.792 (13.012 to 24.329)
        PT BL Serostatus:-ve;Booster M1vsPrebooster;DENV4
    0.939 (0.820 to 1.074)
    14.586 (10.186 to 20.888)
        PT BL Serostatus:-ve;Booster M6vsPrebooster;DENV1
    0.756 (0.672 to 0.851)
    4.425 (3.233 to 6.056)
        PT BL Serostatus:-ve;Booster M6vsPrebooster;DENV2
    0.766 (0.698 to 0.840)
    1.680 (1.321 to 2.137)
        PT BL Serostatus:-ve;Booster M6vsPrebooster;DENV3
    0.846 (0.749 to 0.957)
    6.824 (4.957 to 9.395)
        PT BL Serostatus:-ve;Booster M6vsPrebooster;DENV4
    0.801 (0.692 to 0.926)
    4.837 (3.533 to 6.623)
        PT BL Serostatus:-ve;Booster M6vsBooster M1;DENV1
    0.799 (0.709 to 0.902)
    0.328 (0.274 to 0.393)
        PT BL Serostatus:-ve;Booster M6vsBooster M1;DENV2
    0.805 (0.733 to 0.885)
    0.539 (0.447 to 0.650)
        PT BL Serostatus:-ve;Booster M6vsBooster M1;DENV3
    0.986 (0.882 to 1.103)
    0.361 (0.282 to 0.463)
        PT BL Serostatus:-ve;Booster M6vsBooster M1;DENV4
    0.850 (0.746 to 0.969)
    0.319 (0.255 to 0.399)
        PT BL Serostatus:-ve;Booster M6vs PT M4;DENV1
    0.273 (0.224 to 0.333)
    1.546 (1.102 to 2.168)
        PT BL Serostatus:-ve;Booster M6vs PT M4;DENV2
    0.100 (0.085 to 0.118)
    0.214 (0.160 to 0.288)
        PT BL Serostatus:-ve;Booster M6vs PT M4;DENV3
    0.215 (0.175 to 0.263)
    1.253 (0.875 to 1.795)
        PT BL Serostatus:-ve;Booster M6vs PT M4;DENV4
    0.109 (0.086 to 0.139)
    0.498 (0.357 to 0.694)
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) within 7 Days Post-Booster Vaccination

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    End point title
    		 Percentage of Participants With Solicited Local (Injection Site) Adverse Events (AEs) within 7 Days Post-Booster Vaccination
    End point description
    Solicited local AEs at injection site are defined as pain, erythema and swelling that occurred within 7 days post-booster dose at Month 15 (DEN-304) and Month 42 (DEN-315). AEs were graded by the investigator in the following manner: Mild: Grade 1: Awareness of symptoms that are easily tolerated, causing minimal discomfort and not interfering with everyday activities. Relieved with or without symptomatic treatment; Moderate: Grade 2: Sufficient discomfort is present to cause interference with normal activity.Only partially relieved with symptomatic treatment; Severe: Grade 3: Extreme distress, causing significant impairment of functioning or incapacitation. Prevents normal everyday activities. Not relieved with symptomatic treatment.Safety Set-Booster (SAF-B) included all participants who received at least one dose of Takeda’s TDV in the parent trials and who received the trial vaccination in the current trial.Subjects analyzed: number of participants with data available for analyses.
    End point type
    Secondary
    End point timeframe
    Days 1 through 7 post-booster dose at Visit 3 (Month 15 [DEN-304]) and (Month 42 [DEN-315])
    End point values
    		 Booster Phase: Placebo Booster Phase: TDV
    Number of subjects analysed
    115
    112
    Units: percentage of participants
    number (not applicable)
        Mild
    17.4
    50.0
        Moderate
    5.2
    14.3
        Severe
    0
    1.8
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Solicited Systemic Adverse Events within 14 Days Post-Booster Vaccination by Severity

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    End point title
    		 Percentage of Participants With Solicited Systemic Adverse Events within 14 Days Post-Booster Vaccination by Severity
    End point description
    Solicited systemic AEs are defined as fever, headache, asthenia, malaise and myalgia that occurred within 14 days post-booster dose at Month 15 (DEN-304) and Month 42 (DEN-315). AEs were graded by the investigator in the following manner: Mild: Grade 1: Awareness of symptoms that are easily tolerated, causing minimal discomfort and not interfering with everyday activities. Relieved with or without symptomatic treatment; Moderate: Grade 2: Sufficient discomfort is present to cause interference with normal activity. Only partially relieved with symptomatic treatment; Severe: Grade 3: Extreme distress, causing significant impairment of functioning or incapacitation. Prevents normal everyday activities. Not relieved with symptomatic treatment. SAF-B included all participants who received at least one dose of Takeda’s TDV in the parent trials and who received the trial vaccination in the current trial. Subjects analyzed: number of participants with data available for analyses.
    End point type
    Secondary
    End point timeframe
    Days 1 through 14 post-booster dose at Visit 3 (Month 15 [DEN-304]) and (Month 42 [DEN-315])
    End point values
    		 Booster Phase: Placebo Booster Phase: TDV
    Number of subjects analysed
    115
    112
    Units: percentage of participants
    number (not applicable)
        Mild
    30.4
    32.1
        Moderate
    12.2
    17.0
        Severe
    1.7
    3.6
    No statistical analyses for this end point

    Secondary: Percentage of Participants with any SAEs in the Booster Phase

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    End point title
    		 Percentage of Participants with any SAEs in the Booster Phase
    End point description
    An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a trial vaccine or placebo; it does not necessarily have to have a causal relationship with this treatment. An SAE is defined as any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically important event. SAF-B included all participants who received at least one dose of Takeda’s TDV in the parent trials and who received the trial vaccination in the current trial.
    End point type
    Secondary
    End point timeframe
    Month 15 post-booster dose after vaccination through Month 21 (DEN-304); Month 42 post-booster dose after vaccination through Month 48 (DEN-315)
    End point values
    		 Booster Phase: Placebo Booster Phase: TDV
    Number of subjects analysed
    118
    115
    Units: percentage of participants
        number (not applicable)
    2.5
    0
    No statistical analyses for this end point

    Secondary: Percentage of Participants with any Serious Adverse Events (SAEs) Prior to the Booster Dose

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    End point title
    		 Percentage of Participants with any Serious Adverse Events (SAEs) Prior to the Booster Dose
    End point description
    An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a trial vaccine or placebo; it does not necessarily have to have a causal relationship with this treatment. An SAE is defined as any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically important event. SAF included all participants who agreed to participate in the current trial, did not screen fail, and who received at least one dose of Takeda’s TDV in the parent trials.
    End point type
    Secondary
    End point timeframe
    Month 0 through Month 15 (DEN-304) and Month 42 (DEN-315)
    End point values
    		 Prior to Booster: DEN-304 Prior to Booster: DEN-315
    Number of subjects analysed
    246
    119
    Units: percentage of participants
        number (not applicable)
    2.4
    6.7
    No statistical analyses for this end point

    Secondary: Percentage of Participants with any Unsolicited AEs in the Booster Phase

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    End point title
    		 Percentage of Participants with any Unsolicited AEs in the Booster Phase
    End point description
    An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a trial vaccine or placebo; it does not necessarily have to have a causal relationship with this treatment.SAF-B included all participants who received at least one dose of Takeda’s TDV in the parent trials and who received the trial vaccination in the current trial.
    End point type
    Secondary
    End point timeframe
    Days 1 through 28 post-booster dose at Visit 3 (Month 15 [DEN-304]) and (Month 42 [DEN-315])
    End point values
    		 Booster Phase: Placebo Booster Phase: TDV
    Number of subjects analysed
    118
    115
    Units: percentage of participants
        number (not applicable)
    6.8
    6.1
    No statistical analyses for this end point

    Secondary: Percentage of Participants with any Medically Attended AEs (MAAEs) in the Booster Phase

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    End point title
    		 Percentage of Participants with any Medically Attended AEs (MAAEs) in the Booster Phase
    End point description
    MAAEs are defined as AEs leading to an unscheduled visit to or by a healthcare professional including visits to an emergency department, but not fulfilling seriousness criteria. SAF-B included all participants who received at least one dose of Takeda’s TDV in the parent trials and who received the trial vaccination in the current trial.
    End point type
    Secondary
    End point timeframe
    Month 15 post-booster dose through Month 21 (DEN-304); Month 42 post-booster dose through Month 48 (DEN-315)
    End point values
    		 Booster Phase: Placebo Booster Phase: TDV
    Number of subjects analysed
    118
    115
    Units: percentage of participants
        number (not applicable)
    16.9
    11.3
    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 SAEs:From Day 1 [Month 0] up to Month 21 (DEN-304), Month 48 (DEN-315); Non-serious adverse events: Up to 28 days (day of vaccination + 27 days) after administration of each vaccine dose on Months 15 (DEN-304), 42 (DEN-315).
    Adverse event reporting additional description
    Prior to Booster Arms: SAF included all participants who agreed to participate in current trial,did not screen fail, who received at least 1 dose of Takeda’s TDV in parent trials. Booster Phase Arms: SAF-B included all participants who received at least 1 dose of Takeda’s TDV in parent trials, who received the trial vaccination in current trial.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27.0
    Reporting groups
    Reporting group title
    Prior to Booster: DEN-304
    Reporting group description
    		 Participants who received TDV in parent trial DEN-304 (US) were assessed before they received booster dose (Placebo/TDV) at Visit 3 (Month 15).

    Reporting group title
    Booster Phase: Placebo
    Reporting group description
    		 Participants received TDV placebo-matching 0.5 mL injection, subcutaneously, once at Month 15 for participants from parent trial DEN-304 (US) or once at Month 42 for participants from parent trial DEN-315 (Mexico).

    Reporting group title
    Booster Phase: TDV
    Reporting group description
    		 Participants received TDV 0.5 mL, injection, subcutaneously, once at Month 15 for participants from parent trials DEN-304 (US) or once at Month 42 for participants from parent trial DEN-315 (Mexico).

    Reporting group title
    Prior to Booster: DEN-315
    Reporting group description
    		 Participants who received TDV in parent trial DEN-315 (Mexico) were assessed before they received booster dose (Placebo/TDV) at Visit 3 (Month 42).

    Serious adverse events
    		 Prior to Booster: DEN-304 Booster Phase: Placebo Booster Phase: TDV Prior to Booster: DEN-315
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 246 (2.44%)
    3 / 118 (2.54%)
    0 / 115 (0.00%)
    8 / 119 (6.72%)
         number of deaths (all causes)
    0
    0
    0
    1
         number of deaths resulting from adverse events
    0
    0
    0
    1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Leukaemia
         subjects affected / exposed
    0 / 246 (0.00%)
    0 / 118 (0.00%)
    0 / 115 (0.00%)
    1 / 119 (0.84%)
         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
    Breast cancer
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 118 (0.00%)
    0 / 115 (0.00%)
    0 / 119 (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
    Injury, poisoning and procedural complications
    Femoral neck fracture
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 118 (0.85%)
    0 / 115 (0.00%)
    0 / 119 (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
    Fall
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 118 (0.00%)
    0 / 115 (0.00%)
    0 / 119 (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
    Rib fracture
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 118 (0.00%)
    0 / 115 (0.00%)
    0 / 119 (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
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 118 (0.85%)
    0 / 115 (0.00%)
    0 / 119 (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
    Acute coronary syndrome
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 118 (0.00%)
    0 / 115 (0.00%)
    0 / 119 (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
    Pregnancy, puerperium and perinatal conditions
    Uterine atony
         subjects affected / exposed
    0 / 246 (0.00%)
    0 / 118 (0.00%)
    0 / 115 (0.00%)
    2 / 119 (1.68%)
         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
    Abortion spontaneous
         subjects affected / exposed
    0 / 246 (0.00%)
    1 / 118 (0.85%)
    0 / 115 (0.00%)
    1 / 119 (0.84%)
         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
    Respiratory, thoracic and mediastinal disorders
    Pneumothorax
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 118 (0.00%)
    0 / 115 (0.00%)
    0 / 119 (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
    Psychiatric disorders
    Psychotic disorder
         subjects affected / exposed
    0 / 246 (0.00%)
    0 / 118 (0.00%)
    0 / 115 (0.00%)
    1 / 119 (0.84%)
         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
    Musculoskeletal and connective tissue disorders
    Intervertebral disc degeneration
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 118 (0.00%)
    0 / 115 (0.00%)
    0 / 119 (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
    Osteonecrosis
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 118 (0.00%)
    0 / 115 (0.00%)
    0 / 119 (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
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    1 / 246 (0.41%)
    0 / 118 (0.00%)
    0 / 115 (0.00%)
    1 / 119 (0.84%)
         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
    Mastitis
         subjects affected / exposed
    0 / 246 (0.00%)
    0 / 118 (0.00%)
    0 / 115 (0.00%)
    1 / 119 (0.84%)
         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
    Pilonidal disease
         subjects affected / exposed
    0 / 246 (0.00%)
    0 / 118 (0.00%)
    0 / 115 (0.00%)
    1 / 119 (0.84%)
         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
    Pneumonia bacterial
         subjects affected / exposed
    0 / 246 (0.00%)
    0 / 118 (0.00%)
    0 / 115 (0.00%)
    1 / 119 (0.84%)
         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
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 246 (0.00%)
    0 / 118 (0.00%)
    0 / 115 (0.00%)
    1 / 119 (0.84%)
         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
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Prior to Booster: DEN-304 Booster Phase: Placebo Booster Phase: TDV Prior to Booster: DEN-315
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 246 (0.00%)
    57 / 118 (48.31%)
    83 / 115 (72.17%)
    0 / 119 (0.00%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 246 (0.00%)
    38 / 118 (32.20%)
    42 / 115 (36.52%)
    0 / 119 (0.00%)
         occurrences all number
    0
    111
    153
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 246 (0.00%)
    22 / 118 (18.64%)
    28 / 115 (24.35%)
    0 / 119 (0.00%)
         occurrences all number
    0
    49
    84
    0
    Injection site erythema
         subjects affected / exposed
    0 / 246 (0.00%)
    2 / 118 (1.69%)
    8 / 115 (6.96%)
    0 / 119 (0.00%)
         occurrences all number
    0
    2
    8
    0
    Malaise
         subjects affected / exposed
    0 / 246 (0.00%)
    23 / 118 (19.49%)
    28 / 115 (24.35%)
    0 / 119 (0.00%)
         occurrences all number
    0
    48
    81
    0
    Pain
         subjects affected / exposed
    0 / 246 (0.00%)
    26 / 118 (22.03%)
    70 / 115 (60.87%)
    0 / 119 (0.00%)
         occurrences all number
    0
    56
    247
    0
    Swelling
         subjects affected / exposed
    0 / 246 (0.00%)
    0 / 118 (0.00%)
    16 / 115 (13.91%)
    0 / 119 (0.00%)
         occurrences all number
    0
    0
    47
    0
    Skin and subcutaneous tissue disorders
    Erythema
         subjects affected / exposed
    0 / 246 (0.00%)
    0 / 118 (0.00%)
    29 / 115 (25.22%)
    0 / 119 (0.00%)
         occurrences all number
    0
    0
    97
    0
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    0 / 246 (0.00%)
    22 / 118 (18.64%)
    40 / 115 (34.78%)
    0 / 119 (0.00%)
         occurrences all number
    0
    59
    154
    0
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 246 (0.00%)
    6 / 118 (5.08%)
    5 / 115 (4.35%)
    0 / 119 (0.00%)
         occurrences all number
    0
    6
    6
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    09 Mar 2020
    The following change was made as per amendment 01: 1. The booster dose administration schedule was changed from 57 months to 36 months after the first vaccination in the primary vaccination series.
    22 Feb 2021
    The following change was made as per amendment 02: 1. The booster dose administration schedule was changed from 36 months to 45 months after the first vaccination in the primary for subjects from parent trial DEN-315 (Mexico).
    22 Aug 2022
    The following change was made as per amendment 03: 1. The booster dose administration schedule was changed from 45 months to 63 months after the first vaccination in the primary vaccination series for subjects from parent trial DEN-315 (Mexico).

    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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