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    Clinical Trial Results:
    A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial to Investigate the Safety and Immunogenicity of a Dengue Tetravalent Vaccine (Live, Attenuated) (TDV) Administered Subcutaneously to Healthy Subjects Aged 4 to 60 Years in India

    Summary
    EudraCT number
    		 2023-000134-15
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    05 May 2025

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 Nov 2025
    First version publication date
    21 Nov 2025
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    DEN-302
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT06060067
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Takeda Vaccines, Inc.
    Sponsor organisation address
    40 Landsdowne Street, Cambridge, MA, United States, 02139
    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
    05 May 2025
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    05 May 2025
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objective of the trial was to evaluate the immunogenicity and safety of TDV in the Indian population
    Protection of trial subjects
    Each participant or their legally authorized representative signed an informed consent form (ICF)
    Background therapy
    		 NA
    Evidence for comparator
    		 NA
    Actual start date of recruitment
    29 Mar 2024
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    India: 480
    Worldwide total number of subjects
    480
    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)
    141
    Adolescents (12-17 years)
    99
    Adults (18-64 years)
    240
    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 10 investigative sites in India from 29 March 2024 to 05 May 2025.

    Pre-assignment
    Screening details
    		 Healthy children and adult participants were enrolled in Cohort 1 (≥18 to ≤60 Age Group) and Cohort 2 (≥4 to <18 Age Group) to receive either tetravalent dengue vaccine (TDV) or placebo in a 3:1 ratio for this study.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Cohort 1: ≥18 to ≤60 Age Group: TDV
    Arm description
    		 Participants randomized to receive TDV subcutaneous (SC) injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dengue Tetravalent Vaccine (Live, Attenuated)
    Investigational medicinal product code
    Other name
    TAK-003
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    TDV SC injection on Day 1 and Day 90 of the study.

    Arm title
    		 Cohort 1: ≥18 to ≤60 Age Group: Placebo
    Arm description
    		 Participants received TDV-matching placebo SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Normal Saline (0.9% NaCl) SC injection on Day 1 and Day 90 of the study.

    Arm title
    		 Cohort 2: ≥4 to <18 Age Group: TDV
    Arm description
    		 Participants received TDV SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dengue Tetravalent Vaccine (Live, Attenuated)
    Investigational medicinal product code
    Other name
    TAK-003
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    TDV SC injection on Day 1 and Day 90 of the study.

    Arm title
    		 Cohort 2: ≥4 to <18 Age Group: Placebo
    Arm description
    		 Participants received TDV-matching placebo SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Normal Saline (0.9% NaCl) SC injection on Day 1 and Day 90 of the study.

    Number of subjects in period 1
    		Cohort 1: ≥18 to ≤60 Age Group: TDV Cohort 1: ≥18 to ≤60 Age Group: Placebo Cohort 2: ≥4 to <18 Age Group: TDV Cohort 2: ≥4 to <18 Age Group: Placebo
    Started
    180
    60
    180
    60
    Completed
    175
    59
    178
    58
    Not completed
    5
    1
    2
    2
         Consent withdrawn by subject
    2
    -
    -
    1
         Adverse event, non-fatal
    1
    -
    -
    -
         Reason Not Specified
    1
    -
    1
    -
         Lost to follow-up
    1
    1
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Cohort 1: ≥18 to ≤60 Age Group: TDV
    Reporting group description
    		 Participants randomized to receive TDV subcutaneous (SC) injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.

    Reporting group title
    Cohort 1: ≥18 to ≤60 Age Group: Placebo
    Reporting group description
    		 Participants received TDV-matching placebo SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.

    Reporting group title
    Cohort 2: ≥4 to <18 Age Group: TDV
    Reporting group description
    		 Participants received TDV SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.

    Reporting group title
    Cohort 2: ≥4 to <18 Age Group: Placebo
    Reporting group description
    		 Participants received TDV-matching placebo SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.

    Reporting group values
    		 Cohort 1: ≥18 to ≤60 Age Group: TDV Cohort 1: ≥18 to ≤60 Age Group: Placebo Cohort 2: ≥4 to <18 Age Group: TDV Cohort 2: ≥4 to <18 Age Group: Placebo Total
    Number of subjects
    		 180 60 180 60
    Age Categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 37.2 ( 11.66 ) 36.5 ( 11.12 ) 9.7 ( 4.05 ) 10.3 ( 4.35 ) -
    Gender categorical
    Units: Subjects
        Female
    		 54 14 79 29 176
        Male
    		 126 46 101 31 304

    End points

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    End points reporting groups
    Reporting group title
    Cohort 1: ≥18 to ≤60 Age Group: TDV
    Reporting group description
    		 Participants randomized to receive TDV subcutaneous (SC) injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.

    Reporting group title
    Cohort 1: ≥18 to ≤60 Age Group: Placebo
    Reporting group description
    		 Participants received TDV-matching placebo SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.

    Reporting group title
    Cohort 2: ≥4 to <18 Age Group: TDV
    Reporting group description
    		 Participants received TDV SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.

    Reporting group title
    Cohort 2: ≥4 to <18 Age Group: Placebo
    Reporting group description
    		 Participants received TDV-matching placebo SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.

    Subject analysis set title
    Cohort 2: ≥ 4 to <6 Age group: TDV
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants received TDV SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.

    Subject analysis set title
    Cohort 2: ≥ 4 to <6 Age group: Placebo
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants received TDV-matching placebo SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.

    Subject analysis set title
    Cohort 2: ≥ 6 to <18 Age group: TDV
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants received TDV SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.

    Subject analysis set title
    Cohort 2: ≥ 6 to < 18 Age group: Placebo
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants received TDV-matching placebo SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.

    Subject analysis set title
    Cohort 1 and 2 Combined: TDV
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants received TDV SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.

    Subject analysis set title
    Cohort 1 and 2 Combined: Placebo
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Participants received TDV-matching placebo SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.

    Primary: Number of Participants with Solicited Local (Injection Site) Adverse Events (AEs) by Severity Within 7 Days Post Vaccination at Day 1

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    End point title
    		 Number of Participants with Solicited Local (Injection Site) Adverse Events (AEs) by Severity Within 7 Days Post Vaccination at Day 1 [1] [2]
    End point description
    Solicited local AEs at injection site were defined as injection site pain, injection site erythema, and injection site swelling. The AEs were graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe. Safety Analysis Set included all randomized participants who received at least 1 dose of investigational product (IP). Data are presented separately for the subgroups of age <6 years old and age ≥ 6 years old to < 18 years old, because the solicited local AEs grades were determined in a different manner. Subjects analysed are the number of participants with data available for analysis.
    End point type
    Primary
    End point timeframe
    Within 7 days postvaccination at 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.
    [2] - 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 descriptive analyses were planned for this endpoint.
    End point values
    		 Cohort 1: ≥18 to ≤60 Age Group: TDV Cohort 1: ≥18 to ≤60 Age Group: Placebo Cohort 2: ≥ 4 to <6 Age group: TDV Cohort 2: ≥ 4 to <6 Age group: Placebo Cohort 2: ≥ 6 to <18 Age group: TDV Cohort 2: ≥ 6 to < 18 Age group: Placebo
    Number of subjects analysed
    179
    59
    46
    14
    133
    46
    Units: participants
    number (not applicable)
        Pain: None
    152
    53
    42
    10
    119
    42
        Pain: Mild
    25
    7
    4
    4
    13
    4
        Pain: Moderate
    2
    0
    0
    0
    1
    0
        Pain: Severe
    0
    0
    0
    0
    0
    0
        Erythema: None
    177
    60
    46
    14
    133
    46
        Erythema: Mild
    2
    0
    0
    0
    0
    0
        Erythema: Moderate
    0
    0
    0
    0
    0
    0
        Erythema: Severe
    0
    0
    0
    0
    0
    0
        Swelling: None
    179
    60
    45
    14
    132
    46
        Swelling: Mild
    0
    0
    1
    0
    1
    0
        Swelling: Moderate
    0
    0
    0
    0
    0
    0
        Swelling: Severe
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Number of Participants with Solicited Local Injection Site AEs, by Severity Within 7 Days Post Vaccination at Day 90

    		Close Top of page
    End point title
    		 Number of Participants with Solicited Local Injection Site AEs, by Severity Within 7 Days Post Vaccination at Day 90 [3] [4]
    End point description
    Solicited local AEs at injection site were defined as injection site pain, injection site erythema, and injection site swelling. The AEs were graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe. Safety Analysis Set included all randomized participants who received at least 1 dose of IP. Data are presented separately for the subgroups of age <6 years old and age ≥ 6 years old to < 18 years old, because the solicited local AEs grades were determined in a different manner. Subjects analysed are the number of participants with data available for analysis.
    End point type
    Primary
    End point timeframe
    Within 7 days postvaccination at Day 90
    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 descriptive analyses were planned for this endpoint.
    End point values
    		 Cohort 1: ≥18 to ≤60 Age Group: TDV Cohort 1: ≥18 to ≤60 Age Group: Placebo Cohort 2: ≥ 4 to <6 Age group: TDV Cohort 2: ≥ 4 to <6 Age group: Placebo Cohort 2: ≥ 6 to <18 Age group: TDV Cohort 2: ≥ 6 to < 18 Age group: Placebo
    Number of subjects analysed
    176
    59
    46
    14
    132
    45
    Units: participants
    number (not applicable)
        Pain: None
    163
    55
    44
    14
    117
    41
        Pain: Mild
    12
    3
    2
    0
    14
    4
        Pain: Moderate
    1
    1
    0
    0
    1
    0
        Pain: Severe
    0
    0
    0
    0
    0
    0
        Erythema: None
    176
    59
    46
    14
    132
    45
        Erythema: Mild
    0
    0
    0
    0
    0
    0
        Erythema: Moderate
    0
    0
    0
    0
    0
    0
        Erythema: Severe
    0
    0
    0
    0
    0
    0
        Swelling: None
    176
    59
    46
    14
    132
    45
        Swelling: Mild
    0
    0
    0
    0
    0
    0
        Swelling: Moderate
    0
    0
    0
    0
    0
    0
        Swelling: Severe
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Number of Participants with Solicited Systemic AEs by Severity Within 14 Days Post Vaccination at Day 1 for Age Group Less Than 6 Years

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    End point title
    		 Number of Participants with Solicited Systemic AEs by Severity Within 14 Days Post Vaccination at Day 1 for Age Group Less Than 6 Years [5]
    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. Solicited systemic AEs assessments for children <6 years old comprised: drowsiness, irritability/fussiness, loss of appetite and fever. The AEs were graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe. Safety Analysis Set included all randomized participants who received at least 1 dose of IP. Data are presented separately for the subgroups of age <6 years old and age ≥ 6 years old to < 18 years old, because the solicited systemic AEs grades are based on different assessments. Subjects analysed are the number of participants with data available for analysis.
    End point type
    Primary
    End point timeframe
    Within 14 days postvaccination at Day 1
    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.
    End point values
    		 Cohort 2: ≥ 4 to <6 Age group: TDV Cohort 2: ≥ 4 to <6 Age group: Placebo
    Number of subjects analysed
    46
    14
    Units: participants
    number (not applicable)
        Irritability Or Fussiness: None
    45
    13
        Irritability Or Fussiness: Mild
    1
    1
        Irritability Or Fussiness: Moderate
    0
    0
        Irritability Or Fussiness: Severe
    0
    0
        Drowsiness: None
    45
    13
        Drowsiness: Mild
    1
    1
        Drowsiness: Moderate
    0
    0
        Drowsiness: Severe
    0
    0
        Loss Of Appetite: None
    46
    14
        Loss Of Appetite: Mild
    0
    0
        Loss Of Appetite: Moderate
    0
    0
        Loss Of Appetite: Severe
    0
    0
        Fever: None
    46
    16
        Fever: 38.0-< 38.5
    0
    0
        Fever: 38.5- <39.0
    0
    0
        Fever: 39.0 -< 39.5
    0
    0
        Fever: 39.5-< 40.0
    0
    0
        Fever: 40.0 -< 40.5
    0
    0
        Fever: 40.5 -<41.0
    0
    0
        Fever: ≥ 41.0
    0
    0
    No statistical analyses for this end point

    Primary: Number of Participants with Solicited Systemic AEs by Severity Within 14 Days Post Vaccination at Day 1 for Age Group More Than 6 Years

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    End point title
    		 Number of Participants with Solicited Systemic AEs by Severity Within 14 Days Post Vaccination at Day 1 for Age Group More Than 6 Years [6] [7]
    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. Solicited systemic AEs assessments for children ≥ 6 years old/adolescents/adults comprised: headache, asthenia, malaise, myalgia and fever. The AEs were graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe. Safety Analysis Set included all randomized participants who received at least 1 dose of IP. Data are presented separately for the subgroups of age <6 years old and age ≥ 6 years old to < 18 years old, because the solicited systemic AEs grades are based on different manner. Subjects analysed are the number of participants with data available for analysis.
    End point type
    Primary
    End point timeframe
    Within 14 days postvaccination at Day 1
    Notes
    [6] - 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.
    [7] - 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 descriptive analyses were planned for this endpoint.
    End point values
    		 Cohort 1: ≥18 to ≤60 Age Group: TDV Cohort 1: ≥18 to ≤60 Age Group: Placebo Cohort 2: ≥ 6 to <18 Age group: TDV Cohort 2: ≥ 6 to < 18 Age group: Placebo
    Number of subjects analysed
    179
    60
    133
    46
    Units: participants
    number (not applicable)
        Headache: None
    165
    54
    127
    46
        Headache: Mild
    11
    6
    6
    1
        Headache: Moderate
    1
    0
    0
    0
        Headache: Severe
    2
    0
    0
    0
        Asthenia: None
    168
    56
    126
    44
        Asthenia: Mild
    11
    4
    6
    2
        Asthenia: Moderate
    0
    0
    1
    0
        Asthenia: Severe
    0
    0
    0
    0
        Malaise: None
    174
    57
    130
    46
        Malaise: Mild
    5
    3
    2
    0
        Malaise: Moderate
    0
    0
    1
    0
        Malaise: Severe
    0
    0
    0
    0
        Myalgia: None
    168
    56
    128
    45
        Myalgia: Mild
    10
    3
    4
    1
        Myalgia: Moderate
    1
    1
    1
    0
        Myalgia: Severe
    0
    0
    0
    0
        Fever: None
    178
    58
    131
    45
        Fever: 38.0-< 38.5
    0
    2
    1
    0
        Fever: 38.5- <39.0
    0
    0
    0
    0
        Fever: 39.0 -< 39.5
    0
    0
    0
    1
        Fever: 39.5-< 40.0
    0
    0
    0
    0
        Fever: 40.0 -< 40.5
    1
    0
    1
    0
        Fever: 40.5 -<41.0
    0
    0
    0
    0
        Fever: ≥ 41.0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Number of Participants with Solicited Systemic AEs, by Severity Within 14 Days Post Vaccination at Day 90 for Age Group Less Than 6 Years

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    End point title
    		 Number of Participants with Solicited Systemic AEs, by Severity Within 14 Days Post Vaccination at Day 90 for Age Group Less Than 6 Years [8]
    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. Solicited systemic AEs assessments for children <6 years old comprised: drowsiness, irritability/fussiness, loss of appetite and fever. The AEs were graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe. Safety Analysis Set included all randomized participants who received at least 1 dose of IP. Data are presented separately for the subgroups of age <6 years old and age ≥ 6 years old to < 18 years old, because the solicited systemic AEs grades are based on different assessments. Subjects analysed are the number of participants with data available for analysis.
    End point type
    Primary
    End point timeframe
    Within 14 days postvaccination at Day 1
    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
    		 Cohort 2: ≥ 4 to <6 Age group: TDV Cohort 2: ≥ 4 to <6 Age group: Placebo
    Number of subjects analysed
    46
    14
    Units: participants
    number (not applicable)
        Irritability Or Fussiness: None
    38
    14
        Irritability Or Fussiness: Mild
    0
    0
        Irritability Or Fussiness: Moderate
    0
    0
        Irritability Or Fussiness: Severe
    0
    0
        Drowsiness: None
    37
    13
        Drowsiness: Mild
    1
    1
        Drowsiness: Moderate
    0
    0
        Drowsiness: Severe
    0
    0
        Loss Of Appetite: None
    38
    13
        Loss Of Appetite: Mild
    0
    1
        Loss Of Appetite: Moderate
    0
    0
        Loss Of Appetite: Severe
    0
    0
        Fever: None
    46
    14
        Fever: 38.0-< 38.5
    0
    0
        Fever: 38.5- <39.0
    0
    0
        Fever: 39.0 -< 39.5
    0
    0
        Fever: 39.5-< 40.0
    0
    0
        Fever: 40.0 -< 40.5
    0
    0
        Fever: 40.5 -<41.0
    0
    0
        Fever: ≥ 41.0
    0
    0
    No statistical analyses for this end point

    Primary: Number of Participants with Solicited Systemic AEs, by Severity Within 14 Days Post Vaccination at Day 90 for Age Group More Than 6 Years

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    End point title
    		 Number of Participants with Solicited Systemic AEs, by Severity Within 14 Days Post Vaccination at Day 90 for Age Group More Than 6 Years [9] [10]
    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. Solicited systemic AEs assessments for children ≥ 6 years old/adolescents/adults comprised: headache, asthenia, malaise, myalgia and fever. The AEs were graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe. Safety Analysis Set included all randomized participants who received at least 1 dose of IP. Data are presented separately for the subgroups of age <6 years old and age ≥ 6 years old to < 18 years old, because the solicited systemic AEs grades are based on different assessments. Subjects analysed are the number of participants with data available for analysis.
    End point type
    Primary
    End point timeframe
    Within 14 days postvaccination at Day 90
    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 descriptive analyses were planned for this endpoint.
    End point values
    		 Cohort 1: ≥18 to ≤60 Age Group: TDV Cohort 1: ≥18 to ≤60 Age Group: Placebo Cohort 2: ≥ 6 to <18 Age group: TDV Cohort 2: ≥ 6 to < 18 Age group: Placebo
    Number of subjects analysed
    176
    59
    132
    45
    Units: participants
    number (not applicable)
        Headache: None
    169
    59
    129
    45
        Headache: Mild
    6
    0
    3
    0
        Headache: Moderate
    1
    0
    0
    0
        Headache: Severe
    0
    0
    0
    0
        Asthenia: None
    172
    58
    129
    44
        Asthenia: Mild
    3
    1
    3
    1
        Asthenia: Moderate
    1
    0
    0
    0
        Asthenia: Severe
    0
    0
    0
    0
        Malaise: None
    173
    59
    132
    45
        Malaise: Mild
    3
    0
    0
    0
        Malaise: Moderate
    0
    0
    0
    0
        Malaise: Severe
    0
    0
    0
    0
        Myalgia: None
    173
    59
    129
    44
        Myalgia: Mild
    1
    0
    3
    1
        Myalgia: Moderate
    2
    0
    0
    0
        Myalgia: Severe
    0
    0
    0
    0
        Fever: None
    172
    57
    129
    44
        Fever: 38.0 -<38.5
    3
    1
    2
    0
        Fever: 38.5 -<39.0
    1
    1
    0
    1
        Fever: 39.0 -<39.5
    0
    0
    0
    0
        Fever: 39.5 -<40.0
    0
    0
    0
    0
        Fever: 40.0 -<40.5
    0
    0
    1
    0
        Fever: 40.5- <41.0
    0
    0
    0
    0
        Fever: ≥ 41.0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Percentage of Participants with Any Unsolicited AEs Within 28 Days Post Vaccination at Day 1

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    End point title
    		 Percentage of Participants with Any Unsolicited AEs Within 28 Days Post Vaccination at Day 1 [11]
    End point description
    An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. Safety Analysis Set included all randomized participants who received at least 1 dose of IP.
    End point type
    Primary
    End point timeframe
    Within 28 days postvaccination at Day 1
    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.
    End point values
    		 Cohort 1: ≥18 to ≤60 Age Group: TDV Cohort 1: ≥18 to ≤60 Age Group: Placebo Cohort 2: ≥4 to <18 Age Group: TDV Cohort 2: ≥4 to <18 Age Group: Placebo
    Number of subjects analysed
    180
    60
    180
    60
    Units: percentage of participants
        number (not applicable)
    2.2
    1.7
    2.2
    1.7
    No statistical analyses for this end point

    Primary: Percentage of Participants with Any Unsolicited AEs Within 28 Days Post Vaccination at Day 90

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    End point title
    		 Percentage of Participants with Any Unsolicited AEs Within 28 Days Post Vaccination at Day 90 [12]
    End point description
    An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. Safety Analysis Set included all randomized participants who received at least 1 dose of IP.
    End point type
    Primary
    End point timeframe
    Within 28 days postvaccination at Day 90
    Notes
    [12] - 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
    		 Cohort 1: ≥18 to ≤60 Age Group: TDV Cohort 1: ≥18 to ≤60 Age Group: Placebo Cohort 2: ≥4 to <18 Age Group: TDV Cohort 2: ≥4 to <18 Age Group: Placebo
    Number of subjects analysed
    180
    60
    180
    60
    Units: percentage of participants
        number (not applicable)
    1.7
    3.4
    4.5
    3.4
    No statistical analyses for this end point

    Primary: Percentage of Participants with an AE Leading to Participant Withdrawal from Trial

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    End point title
    		 Percentage of Participants with an AE Leading to Participant Withdrawal from Trial [13]
    End point description
    An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. Safety Analysis Set included all randomized participants who received at least 1 dose of IP.
    End point type
    Primary
    End point timeframe
    From first vaccination on Day 1 through the end of trial (up to Day 270)
    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
    		 Cohort 1: ≥18 to ≤60 Age Group: TDV Cohort 1: ≥18 to ≤60 Age Group: Placebo Cohort 2: ≥4 to <18 Age Group: TDV Cohort 2: ≥4 to <18 Age Group: Placebo
    Number of subjects analysed
    180
    60
    180
    60
    Units: percentage of participants
        number (not applicable)
    0.6
    0
    0
    0
    No statistical analyses for this end point

    Primary: Percentage of Participants with an AE Leading to TDV or Placebo Discontinuation

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    End point title
    		 Percentage of Participants with an AE Leading to TDV or Placebo Discontinuation [14]
    End point description
    An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. Safety Analysis Set included all randomized participants who received at least 1 dose of IP.
    End point type
    Primary
    End point timeframe
    From first vaccination on Day 1 through the end of trial (up to Day 270)
    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.
    End point values
    		 Cohort 1: ≥18 to ≤60 Age Group: TDV Cohort 1: ≥18 to ≤60 Age Group: Placebo Cohort 2: ≥4 to <18 Age Group: TDV Cohort 2: ≥4 to <18 Age Group: Placebo
    Number of subjects analysed
    180
    60
    180
    60
    Units: percentage of participants
        number (not applicable)
    0.6
    0
    0
    0
    No statistical analyses for this end point

    Primary: Percentage of Participants with a Medically-attended AE (MAAE)

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    End point title
    		 Percentage of Participants with a Medically-attended AE (MAAE) [15]
    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. Safety Analysis Set included all randomized participants who received at least 1 dose of IP.
    End point type
    Primary
    End point timeframe
    From first vaccination on Day 1 through the end of trial (up to Day 270)
    Notes
    [15] - 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
    		 Cohort 1: ≥18 to ≤60 Age Group: TDV Cohort 1: ≥18 to ≤60 Age Group: Placebo Cohort 2: ≥4 to <18 Age Group: TDV Cohort 2: ≥4 to <18 Age Group: Placebo
    Number of subjects analysed
    180
    60
    180
    60
    Units: percentage of participants
        number (not applicable)
    11.1
    6.7
    14.4
    16.7
    No statistical analyses for this end point

    Primary: Percentage of Participants with a Serious Adverse Event (SAE)

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    End point title
    		 Percentage of Participants with a Serious Adverse Event (SAE) [16]
    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. An SAE is defined as any untoward medical occurrence that: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/ incapacity, leads to a congenital anomaly/birth defect in the offspring of a participant, is an important medical event. Safety Analysis Set included all randomized participants who received at least 1 dose of IP.
    End point type
    Primary
    End point timeframe
    From first vaccination on Day 1 through the end of trial (up to Day 270)
    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
    		 Cohort 1 and 2 Combined: TDV Cohort 1 and 2 Combined: Placebo
    Number of subjects analysed
    360
    120
    Units: percentage of participants
        number (not applicable)
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From Day 1 through end of trial on Day 270; Non-serious adverse events: Up to 28 days (day of vaccination + 27 days) following administration of TDV or placebo
    Adverse event reporting additional description
    The Safety Analysis Set included all randomized participants who received at least 1 dose of IP.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    28.0
    Reporting groups
    Reporting group title
    Cohort 1: >=18 to <=60 Age Group: TDV
    Reporting group description
    		 Participants randomized to receive TDV subcutaneous (SC) injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.

    Reporting group title
    Cohort 2: >=4 to <18 Age Group: Placebo
    Reporting group description
    		 Participants received TDV-matching placebo SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.

    Reporting group title
    Cohort 2: >=4 to <18 Age Group: TDV
    Reporting group description
    		 Participants received TDV SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.

    Reporting group title
    Cohort 1: >=18 to <=60 Age Group: Placebo
    Reporting group description
    		 Participants received TDV-matching placebo SC injection on Day 1 (Month 0) and Day 90 (Month 3) of the study.

    Serious adverse events
    		 Cohort 1: >=18 to <=60 Age Group: TDV Cohort 2: >=4 to <18 Age Group: Placebo Cohort 2: >=4 to <18 Age Group: TDV Cohort 1: >=18 to <=60 Age Group: Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 180 (0.00%)
    0 / 60 (0.00%)
    0 / 180 (0.00%)
    0 / 60 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Cohort 1: >=18 to <=60 Age Group: TDV Cohort 2: >=4 to <18 Age Group: Placebo Cohort 2: >=4 to <18 Age Group: TDV Cohort 1: >=18 to <=60 Age Group: Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    53 / 180 (29.44%)
    15 / 60 (25.00%)
    52 / 180 (28.89%)
    19 / 60 (31.67%)
    Investigations
    Body temperature
         subjects affected / exposed
    5 / 180 (2.78%)
    1 / 60 (1.67%)
    5 / 180 (2.78%)
    4 / 60 (6.67%)
         occurrences all number
    10
    6
    6
    7
    Nervous system disorders
    Headache
         subjects affected / exposed
    20 / 180 (11.11%)
    1 / 60 (1.67%)
    8 / 180 (4.44%)
    7 / 60 (11.67%)
         occurrences all number
    42
    3
    18
    18
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    15 / 180 (8.33%)
    3 / 60 (5.00%)
    10 / 180 (5.56%)
    5 / 60 (8.33%)
         occurrences all number
    37
    11
    26
    13
    Pain
         subjects affected / exposed
    38 / 180 (21.11%)
    15 / 60 (25.00%)
    41 / 180 (22.78%)
    8 / 60 (13.33%)
         occurrences all number
    89
    23
    74
    17
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    14 / 180 (7.78%)
    2 / 60 (3.33%)
    7 / 180 (3.89%)
    4 / 60 (6.67%)
         occurrences all number
    35
    6
    17
    8

    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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