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    Clinical Trial Results:
    A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial to Investigate the Immunogenicity and Safety of Subcutaneous Administration of a Tetravalent Dengue Vaccine Candidate in Healthy Adolescent Subjects in Non-Endemic Area(s) for Dengue

    Summary
    EudraCT number
    		 2018-003980-77
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    26 Jan 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 Apr 2020
    First version publication date
    02 Apr 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    DEN-315
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03341637
    WHO universal trial number (UTN)
    		 U1111-1192-7827
    Sponsors
    Sponsor organisation name
    Takeda Vaccines, Inc.
    Sponsor organisation address
    40 Landsdowne Street, Cambridge, United States, MA 02139
    Public contact
    Medical Director, Takeda Vaccines, Inc., +1 8778253327, trialdisclosures@takeda.com
    Scientific contact
    Medical Director, Takeda Vaccines, Inc., +1 8778253327, trialdisclosures@takeda.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-001888-PIP01-15
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    26 Jan 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Jan 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of this study was to describe the neutralizing antibody response against each dengue serotype at 1 month post second dose of TDV or placebo in dengue-naive adolescent participants.
    Protection of trial subjects
    All study participants were required to read and sign an Informed Consent Form.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    14 Dec 2017
    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
    Mexico: 400
    Worldwide total number of subjects
    400
    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)
    400
    Adults (18-64 years)
    0
    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 5 investigative sites in Mexico from 14-Dec-2017 to 26-Jan-2019.

    Pre-assignment
    Screening details
    		 Healthy volunteers were enrolled in a 3:1 ratio into 2 parallel study groups: 1 study group received 2 doses of Tetravalent Dengue vaccine (TDV) and another group received 2 doses of TDV matching placebo subcutaneously (SC).

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo- matching TDV injection
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Normal Saline (0.9% NaCl) subcutaneous injection

    Arm title
    		 Tetravalent Dengue Vaccine (TDV)
    Arm description
    		 TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
    Arm type
    		 Experimental

    Investigational medicinal product name
    TDV injection
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    TDV subcutaneous injection

    Number of subjects in period 1
    		Placebo Tetravalent Dengue Vaccine (TDV)
    Started
    100
    300
    Completed
    95
    296
    Not completed
    5
    4
         Consent withdrawn by subject
    3
    3
         Lost to follow-up
    1
    -
         Reason not Specified
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).

    Reporting group title
    Tetravalent Dengue Vaccine (TDV)
    Reporting group description
    		 TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).

    Reporting group values
    		 Placebo Tetravalent Dengue Vaccine (TDV) Total
    Number of subjects
    		 100 300 400
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 100 300 400
        Adults (18-64 years)
    		 0 0 0
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 14.3 ( 1.57 ) 14.3 ( 1.69 ) -
    Sex: Female, Male
    Units: Subjects
        Female
    		 51 176 227
        Male
    		 49 124 173
    Race/Ethnicity, Customized
    Units: Subjects
        Hispanic or Latino
    		 100 300 400
    Race/Ethnicity, Customized
    Units: Subjects
        American Indian or Alaska Native
    		 55 148 203
        Multiracial
    		 45 152 197
    Region of Enrollment
    Units: Subjects
    Height
    Units: cm
        arithmetic mean (standard deviation)
    		 159.6 ( 8.94 ) 159.0 ( 8.68 ) -
    Weight
    Units: kg
        arithmetic mean (standard deviation)
    		 57.60 ( 14.045 ) 56.84 ( 12.708 ) -
    Body Mass Index (BMI)
    BMI=Weight/Height.
    Units: kg/m^2
        arithmetic mean (standard deviation)
    		 22.42 ( 4.237 ) 22.39 ( 4.266 ) -

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).

    Reporting group title
    Tetravalent Dengue Vaccine (TDV)
    Reporting group description
    		 TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).

    Primary: Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 120

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    End point title
    		 Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 120 [1]
    End point description
    GMTs of neutralizing antibodies were measured by microneutralization test 50% [MNT50] for each of the 4 Dengue Serotypes. The 4 dengue virus serotypes were DENV-1, DENV-2, DENV-3 and DENV-4. Seropositivity is defined as reciprocal neutralizing titer ≥10. Per Protocol Set (PPS): all participants seronegative to all serotypes of dengue virus at baseline who received at least 1 dose of trial vaccine, who had a valid pre-dose (baseline) and at least 1 valid post-dose measurement for immunogenicity and no major protocol violations. n=participants with data available at given time-point.
    End point type
    Primary
    End point timeframe
    One month post second dose (Day 120)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses was not available.
    End point values
    		 Placebo Tetravalent Dengue Vaccine (TDV)
    Number of subjects analysed
    82
    271
    Units: titer
    geometric mean (confidence interval 95%)
        DENV-1 (n=72, 243)
    5.3 (4.7 to 5.8)
    327.9 (281.7 to 381.8)
        DENV-2 (n=72, 243)
    6.0 (5.2 to 7.0)
    1742.5 (1522.6 to 1994.3)
        DENV-3 (n=72, 243)
    5.2 (4.8 to 5.6)
    119.5 (106.4 to 134.2)
        DENV-4 (n=72, 243)
    5.1 (4.9 to 5.2)
    142.7 (126.4 to 161.0)
    No statistical analyses for this end point

    Secondary: Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 270

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    End point title
    		 Geometric Mean Titers (GMTs) of Neutralizing Antibodies for Each of the 4 Dengue Serotypes at Day 270
    End point description
    GMTs of neutralizing antibodies were measured by microneutralization test 50% [MNT50] for each of the 4 Dengue Serotypes. The 4 dengue virus serotypes were DENV-1, DENV-2, DENV-3 and DENV-4. Seropositivity is defined as reciprocal neutralizing titer ≥10. PPS: all participants seronegative to all serotypes of dengue virus at baseline who received at least 1 dose of trial vaccine, who had a valid pre-dose (baseline) and at least 1 valid post-dose measurement for immunogenicity and no major protocol violations. n=participants with data available at given time-point. 99999 indicates data for 95% CI was not evaluable at this time point.
    End point type
    Secondary
    End point timeframe
    Six months post second dose (Day 270)
    End point values
    		 Placebo Tetravalent Dengue Vaccine (TDV)
    Number of subjects analysed
    82
    271
    Units: titer
    geometric mean (standard deviation)
        DENV-1 (n=73, 254)
    5.4 ( 1.58 )
    134.7 ( 3.73 )
        DENV-2 (n= 73, 254)
    5.2 ( 1.30 )
    740.9 ( 3.06 )
        DENV-3 (n=73, 254)
    5.3 ( 1.49 )
    45.8 ( 2.59 )
        DENV-4 (n=73, 254)
    5.0 ( 1.00 )
    37.5 ( 2.88 )
    No statistical analyses for this end point

    Secondary: Seropositivity Rates for Each of the 4 Dengue Serotypes

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    End point title
    		 Seropositivity Rates for Each of the 4 Dengue Serotypes
    End point description
    Seropositivity rate, defined as the percentage of participants seropositive, was derived from the titers of dengue-neutralizing antibodies. Seropositivity defined as a reciprocal neutralizing titer ≥10. The 4 dengue virus serotypes were DENV-1, DENV-2, DENV-3 and DENV-4. PPS: all participants seronegative to all serotypes of dengue virus at baseline who received at least 1 dose of trial vaccine, who had a valid pre-dose (baseline) and at least 1 valid post-dose measurement for immunogenicity and no major protocol violations. n= participants with data available at given time-point.
    End point type
    Secondary
    End point timeframe
    One month and six months post second dose (Day 120 and Day 270)
    End point values
    		 Placebo Tetravalent Dengue Vaccine (TDV)
    Number of subjects analysed
    82
    271
    Units: percentage of participants
    number (confidence interval 95%)
        Day 120 (Month 4): DENV-1 (n=72,243)
    1.4 (0.0 to 7.5)
    100.0 (98.5 to 100.0)
        Day 120 (Month 4): DENV-2 (n=72,243)
    8.3 (3.1 to 17.3)
    100.0 (98.5 to 100.0)
        Day 120 (Month 4): DENV-3 (n=72,243)
    1.4 (0.0 to 7.5)
    100.0 (98.5 to 100.0)
        Day 120 (Month 4): DENV-4 (n=72,243)
    1.4 (0.0 to 7.5)
    99.6 (97.7 to 100.0)
        Day 270 (Month 9): DENV-1 (n=73,254)
    2.7 (0.3 to 9.5)
    98.4 (96.0 to 99.6)
        Day 270 (Month 9): DENV-2 (n=73,254)
    1.4 (0.0 to 7.4)
    99.6 (97.8 to 100.0)
        Day 270 (Month 9): DENV-3 (n=73,254)
    2.7 (0.3 to 9.5)
    92.1 (88.1 to 95.1)
        Day 270 (Month 9): DENV-4 (n=73,254)
    0 (0.0 to 4.9)
    89.4 (84.9 to 92.9)
    No statistical analyses for this end point

    Secondary: Seropositivity Rates for Multiple (2, 3 or 4) Dengue Serotypes

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    End point title
    		 Seropositivity Rates for Multiple (2, 3 or 4) Dengue Serotypes
    End point description
    Seropositivity rate, defined as the percentage of participants seropositive, was derived from the titers of dengue-neutralizing antibodies. Seropositivity was defined as a reciprocal neutralizing titer ≥10. PPS: all participants seronegative to all serotypes of dengue virus at baseline who received at least 1 dose of trial vaccine, who had a valid pre-dose (baseline) and at least 1 valid post-dose measurement for immunogenicity and no major protocol violations. n= participants with data available at given time-point.
    End point type
    Secondary
    End point timeframe
    One month and six months post second dose (Day 120 and Day 270)
    End point values
    		 Placebo Tetravalent Dengue Vaccine (TDV)
    Number of subjects analysed
    82
    271
    Units: percentage of participants
    number (confidence interval 95%)
        Day 120 (Month 4): At Least Bivalent (n=72, 243)
    1.4 (0.0 to 7.5)
    100.0 (98.5 to 100.0)
        Day 120 (Month 4): At Least Trivalent (n=72, 243)
    1.4 (0.0 to 7.5)
    100.0 (98.5 to 100.0)
        Day 120 (Month 4): Tetravalent (n=72, 243)
    1.4 (0.0 to 7.5)
    99.6 (97.7 to 100.0)
        Day 270 (Month 9): At Least Bivalent (n=73, 254)
    0 (0.0 to 4.9)
    99.2 (97.2 to 99.9)
        Day 270 (Month 9): At Least Trivalent (n=73, 254)
    0 (0.0 to 4.9)
    94.5 (90.9 to 97.0)
        Day 270 (Month 9): Tetravalent (n=73, 254)
    0 (0.0 to 4.9)
    85.8 (80.9 to 89.9)
    No statistical analyses for this end point

    Secondary: Percentage of Participants with Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) Following Each Vaccination by Severity

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    End point title
    		 Percentage of Participants with Solicited Local (Injection Site) Adverse Events (AEs) (Diary Recorded) Following Each Vaccination by Severity
    End point description
    Solicited local AEs (at injection site) were collected by participants using diary cards within 7 days after vaccination (Vac.) and included pain (none, mild: no interference with daily activity, moderate: interference with daily activity with or without treatment and severe: prevents daily activity with or without treatment), redness (erythema) (<2.5 cm, mild: 2.5-5 cm, moderate: >5 to <=10 cm, severe: >10 cm) and swelling (edema/induration) (<2.5 cm, mild: 2.5-5 cm, moderate: >5 to <=10 cm, severe: >10 cm). Safety Set included of all participants who received at least 1 dose of trial vaccine. Number analyzed is the number of participants with data available at the given timepoint. Only categories for which there was at least 1 participant are reported. n=participants with data available for given category. First vaccination= 1st vac.; Second vaccination=2nd vac.
    End point type
    Secondary
    End point timeframe
    Within 7 days after each vaccination
    End point values
    		 Placebo Tetravalent Dengue Vaccine (TDV)
    Number of subjects analysed
    100
    300
    Units: percentage of participants
    number (not applicable)
        After First Vaccination (Vac.),Any AEs(n=99,299)
    34.3
    56.2
        After First Vac., Pain:Mild (n=99, 299)
    26.3
    44.8
        After First Vac., Pain:Moderate (n=99, 299)
    7.1
    9.7
        After First Vac., Pain:Severe (n=99, 299)
    1.0
    0.7
        After First Vac., Erythema:Mild (n=99, 299)
    0
    5.7
        After First Vac., Swelling:Mild (n=99, 299)
    0
    4.3
        After Second Vac.,Any AEs(n=94,295)
    30.9
    52.2
        After Second Vac., Pain:Mild (n=94, 295)
    24.5
    35.6
        After Second Vac., Pain:Moderate(n=94,295)
    5.3
    13.2
        After Second Vac., Pain:Severe (n=94, 295)
    1.1
    3.1
        After Second Vac., Erythema:Mild(n=94,295)
    0
    4.1
        After Second Vac., Swelling:Mild(n=100,300)
    0
    1.7
        After Second Vac., Swelling:Moderate(n=100,300)
    0
    0.3
    No statistical analyses for this end point

    Secondary: Percentage of Participants with Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Each Vaccination by Severity

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    End point title
    		 Percentage of Participants with Solicited Systemic Adverse Events (AEs) (Diary Recorded) Following Each Vaccination by Severity
    End point description
    Solicited systemic AEs were collected by participants using diary cards within 14 days after vaccination and included fever, headache, tiredness or weakness (asthenia), feeling of discomfort (malaise) and muscle pain (myalgia). Severity scales for headache:none, mild:no interference with daily activity, moderate:interference with daily activity with or without treatment and severe:prevents normal activity with/without treatment. Severity scales for others:none, mild:no interference with daily activity, moderate:interference with daily activity and severe: prevents daily activity. systemic AE of fever (i.e. ≥38°C or ≥100.4°F) was derived from daily temperature reading recorded within 14 days after vaccination. Fever was excluded from overall count as no severity grading was applied for it. Safety Set:participants who received at least 1 dose of trial vaccine.Only categories for which there was at least 1 participant are reported. n= participants with data available for given category.
    End point type
    Secondary
    End point timeframe
    Within 14 days after each vaccination
    End point values
    		 Placebo Tetravalent Dengue Vaccine (TDV)
    Number of subjects analysed
    100
    300
    Units: percentage of participants
    number (not applicable)
        After First Vaccination(Vac.): Any (n=99, 299)
    58.6
    66.6
        After First Vac.: Headache-Mild (n=99, 299)
    25.3
    31.4
        After First Vac.:Headache-Moderate(n=99,299)
    18.2
    10.4
        After First Vac.:Headache-Severe(n=99,299)
    1.0
    2.7
        After First Vac.:Asthenia-Mild (n=99,299)
    20.2
    24.7
        After First Vac.:Asthenia-Moderate(n=99,299)
    13.1
    7.7
        After First Vac.: Asthenia-Severe(n=99,299)
    2.0
    2.3
        After First Vac.: Malaise-Mild (n=99,299)
    20.2
    18.7
        After First Vac.:Malaise-Moderate(n=99,299)
    11.1
    7.7
        After First Vac.:Malaise-Severe(n=99,299)
    2.0
    1.3
        After First Vac.:Myalgia-Mild (n=99,299)
    26.3
    36.1
        After First Vac.:Myalgia-Moderate(n=99,299)
    13.1
    10.7
        After First Vac.:Myalgia-Severe(n=99,299)
    1.0
    1.0
        After 1st Vaccination:Fever-Any (n=100,300)
    5.1
    6.7
        After First Vac.:Fever(38-<38.5°C)(n=99,299)
    3.0
    3.0
        After First Vac.:Fever (38.5-<39°C)(n=99,299)
    2.0
    2.3
        After First Vac.:Fever(39-<39.5°C)(n=99,299)
    0.0
    1.0
        After First Vac.:Fever (39.5-<40°C)(n=99,299)
    0.0
    0.3
        After Second Vac: Any (n=94,296)
    45.7
    49.3
        After Second Vac: Headache-Mild (n=94,296)
    20.2
    24.3
        After Second Vac.:Headache-Moderate(n=94,296)
    6.4
    8.4
        After Second Vac.:Headache-Severe(n=94,296)
    3.2
    2.7
        After Second Vac.:Asthenia-Mild(n=94,296)
    22.3
    19.9
        After Second Vac.:Asthenia-Moderate(n=94,296)
    4.3
    6.8
        After Second Vac.:Asthenia-Severe(n=94,296)
    1.1
    1.4
        After Second Vac.:Malaise-Mild(n=94,296)
    12.8
    16.2
        After Second Vac.:Malaise-Moderate(n=94,296)
    6.4
    5.1
        After Second Vac.:Malaise-Severe(n=94,296)
    4.3
    2.4
        After Second Vac.:Myalgia-Mild(n=94,296)
    21.3
    25.7
        After Second Vac.:Myalgia-Moderate(n=94,296)
    8.5
    6.8
        After Second Vac.:Myalgia-Severe(n=94,296)
    1.1
    2.4
        After Second Vac.:Fever-Any(n=100,300)
    3.2
    6.8
        After Second Vac.:Fever(38-<38.5°C)(n=94,296)
    1.1
    3.7
        After Second Vac.:Fever(38.5-<39°C)(n=94,296)
    1.1
    2.0
        After Second Vac.:Fever(39-<39.5°C)(n=100,300)
    1.1
    0.7
        After Second Vac.:Fever(39.5-<40°C)(n=100,300)
    0.0
    0.3
    No statistical analyses for this end point

    Secondary: Percentage of Participants with any Unsolicited Adverse Events (AEs) Following Each Vaccination

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    End point title
    		 Percentage of Participants with any Unsolicited Adverse Events (AEs) Following Each Vaccination
    End point description
    An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. Safety Set included of all participants who received at least 1 dose of trial vaccine. Number analyzed is the number of participants with data available at the given timepoint. Only categories for which there was at least 1 participant are reported. n= participants with data available for given category.
    End point type
    Secondary
    End point timeframe
    Within 28 days after each vaccination
    End point values
    		 Placebo Tetravalent Dengue Vaccine (TDV)
    Number of subjects analysed
    100
    300
    Units: percentage of participants
    number (not applicable)
        After First Vaccination (n=100, 300)
    25.0
    30.0
        After Second Vaccination (n=95, 297)
    17.9
    23.2
    No statistical analyses for this end point

    Secondary: Percentage of Participants with Medically Attended AEs (MAAEs) Throughout the Study

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    End point title
    		 Percentage of Participants with Medically Attended AEs (MAAEs) Throughout the Study
    End point description
    MAAEs were defined as AEs leading to a medical visit to or by a healthcare professional including visits to an emergency department, but not fulfilling seriousness criteria. Safety Set included of all participants who received at least 1 dose of trial vaccine.
    End point type
    Secondary
    End point timeframe
    From first vaccination (Day 1) through end of study (Day 270)
    End point values
    		 Placebo Tetravalent Dengue Vaccine (TDV)
    Number of subjects analysed
    100
    300
    Units: percentage of participants
        number (not applicable)
    38.0
    47.3
    No statistical analyses for this end point

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

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    End point title
    		 Percentage of Participants with Serious Adverse Events (SAEs) Throughout the Study
    End point description
    An SAE was defined as any untoward medical occurrence or effect that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically important due to other reasons than the above mentioned criteria. Safety Set included of all participants who received at least 1 dose of trial vaccine.
    End point type
    Secondary
    End point timeframe
    From first vaccination (Day 1) through end of study (Day 270)
    End point values
    		 Placebo Tetravalent Dengue Vaccine (TDV)
    Number of subjects analysed
    100
    300
    Units: percentage of participants
        number (not applicable)
    2.0
    0.3
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Non-serious adverse events: Within 28 days of Vaccination; Serious adverse events (SAEs): From first vaccination (Day 1) through end of study (Day 270)
    Adverse event reporting additional description
    At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).

    Reporting group title
    Tetravalent Dengue Vaccine (TDV)
    Reporting group description
    		 TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).

    Serious adverse events
    		 Placebo Tetravalent Dengue Vaccine (TDV)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 100 (2.00%)
    1 / 300 (0.33%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Ankle fracture
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 300 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 300 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    1 / 100 (1.00%)
    0 / 300 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 100 (0.00%)
    1 / 300 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Placebo Tetravalent Dengue Vaccine (TDV)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    38 / 100 (38.00%)
    112 / 300 (37.33%)
    Nervous system disorders
    Syncope
         subjects affected / exposed
    2 / 100 (2.00%)
    9 / 300 (3.00%)
         occurrences all number
    2
    10
    Gastrointestinal disorders
    Gastritis
         subjects affected / exposed
    3 / 100 (3.00%)
    7 / 300 (2.33%)
         occurrences all number
    3
    7
    Infections and infestations
    Viral upper respiratory tract infection
         subjects affected / exposed
    14 / 100 (14.00%)
    43 / 300 (14.33%)
         occurrences all number
    17
    47
    Nasopharyngitis
         subjects affected / exposed
    6 / 100 (6.00%)
    24 / 300 (8.00%)
         occurrences all number
    6
    25
    Viral pharyngitis
         subjects affected / exposed
    7 / 100 (7.00%)
    15 / 300 (5.00%)
         occurrences all number
    7
    15
    Pharyngitis
         subjects affected / exposed
    4 / 100 (4.00%)
    10 / 300 (3.33%)
         occurrences all number
    4
    10
    Pharyngitis bacterial
         subjects affected / exposed
    2 / 100 (2.00%)
    9 / 300 (3.00%)
         occurrences all number
    2
    9
    Gastroenteritis
         subjects affected / exposed
    2 / 100 (2.00%)
    8 / 300 (2.67%)
         occurrences all number
    2
    8
    Upper respiratory tract infection bacterial
         subjects affected / exposed
    1 / 100 (1.00%)
    9 / 300 (3.00%)
         occurrences all number
    1
    9

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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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