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    Clinical Trial Results:
    A Randomized, Observer-blinded, Dose Response Phase 2 Trial to Assess the Safety and Immunogenicity of Two Different Dose Levels of a Live-attenuated Chikungunya Virus Vaccine (VLA1553) in Healthy Children Aged 1 to 11 Years PIP #: P/0457/2021 and P/0501/2023

    Summary
    EudraCT number
    		 2026-000022-41
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    02 Jul 2025

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Sep 2026
    First version publication date
    03 Sep 2026
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    VLA1553-221
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT06106581
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Valneva Austria GmbH
    Sponsor organisation address
    Campus Vienna Biocenter3, Vienna, Austria, 1030
    Public contact
    Study Director, Valneva Austria GmbH, 0043 1206200, office@valneva.com
    Scientific contact
    Study Director, Valneva Austria GmbH, 0043 1206200, office@valneva.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMA/PE/0000265459
    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
    20 Jan 2026
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Jul 2025
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the tolerability of the full dose and half dose formulation of the live-attenuated CHIKV vaccine (VLA1553) following vaccination in healthy children aged 1 to 11 years after a single immunization.
    Protection of trial subjects
    Number of trial visits and interventions was limited to the minimum required to generate the required safety and immunogenicity data. Participants were closely monitored for safety during the entire trial period. Participant diaries were distributed for the collection of safety information from the day of vaccination until the first 14 post-vaccination days. Memory Aids were distributed fort the collection of safety information outside the first 14 post-vaccination days until trial end. An independent Data Safety Monitoring Board was established that continuously reviewed accruing safety information or ad-hoc safety data, as needed, to ensure participants' wellbeing.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Dec 2023
    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
    Dominican Republic: 194
    Country: Number of subjects enrolled
    Honduras: 110
    Worldwide total number of subjects
    304
    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)
    44
    Children (2-11 years)
    260
    Adolescents (12-17 years)
    0
    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 were recruited between 18-Dec-2023 and 17-Jul-2024 at two sites in the Dominican Republic and one site in Honduras.

    Pre-assignment
    Screening details
    		 In total, 391 participants were screened, 56 were screening failures. The reasons for screening failures were: - failure to meet eligibility criteria 55 (98.2) - physician decision 31 (55.4) - withdrawal by participant 1 (1.8) - Other 10 (17.9)

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor
    Blinding implementation details
    In order to minimize/avoid bias, assignment into one of the trial arms was blinded for the participants and the site staff performing the safety assessments as well as the biostatistician (i.e. double-blind). Randomization was performed via the RTSM. At Day 1 (Visit 1, Day of vaccination) eligible participants were assigned to VLA1553 or control. Participants were allocated to trial arms according to the randomization code.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 CHIKV vaccine Half Dose
    Arm description
    		 CHIKV vaccine Half Dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)
    Arm type
    		 Experimental

    Investigational medicinal product name
    CHIKV vaccine Half Dose
    Investigational medicinal product code
    VLA1553
    Other name
    Pharmaceutical forms
    Solution for injection in vial
    Routes of administration
    Intramuscular use
    Dosage and administration details
    CHIKV vaccine Half Dose formulation (target 3.7 log 10 TCID50 per 0.5 mL) - Lyophilisate for solution for injection

    Arm title
    		 CHIKV vaccine Full Dose
    Arm description
    		 CHIKV vaccine Full Dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)
    Arm type
    		 Experimental

    Investigational medicinal product name
    CHIKV vaccine Full Dose
    Investigational medicinal product code
    VLA1553
    Other name
    Pharmaceutical forms
    Solution for injection in vial
    Routes of administration
    Intramuscular use
    Dosage and administration details
    CHIKV vaccine Half Dose formulation (target 4.0 log 10 TCID50 per 0.5 mL) - Lyophilisate for solution for injection

    Arm title
    		 Nimenrix
    Arm description
    		 Nimenrix is a conjugate vaccine indicated for the active immunization of individuals from the age of 6 weeks against invasive meningococcal disease caused by Neisseria meningitidis groups A, C, W-135, and Y. Nimenrix is present as powder and solvent for solution for injection in pre-filled syringe. The reconstituted vaccine is a clear colourless solution. Nimenrix should be used in accordance with available official recommendations. Primary immunization in infants from 6 months of age, children, adolescents and adults: a single 0.5 mL dose should be administered.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Nimenrix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Nimenrix is a conjugate vaccine indicated for the active immunization of individuals from the age of 6 weeks against invasive meningococcal disease caused by Neisseria meningitidis groups A, C, W-135, and Y. Nimenrix is present as powder and solvent for solution for injection in pre-filled syringe. The reconstituted vaccine is a clear colourless solution. Nimenrix should be used in accordance with available official recommendations. Primary immunization in infants from 6 months of age, children, adolescents and adults: a single 0.5 mL dose should be administered.

    Number of subjects in period 1
    		CHIKV vaccine Half Dose CHIKV vaccine Full Dose Nimenrix
    Started
    119
    124
    61
    Completed
    115
    122
    60
    Not completed
    4
    2
    1
         Consent withdrawn by subject
    1
    -
    1
         Physician decision
    1
    -
    -
         n/a
    -
    1
    -
         Lost to follow-up
    2
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    CHIKV vaccine Half Dose
    Reporting group description
    		 CHIKV vaccine Half Dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)

    Reporting group title
    CHIKV vaccine Full Dose
    Reporting group description
    		 CHIKV vaccine Full Dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)

    Reporting group title
    Nimenrix
    Reporting group description
    		 Nimenrix is a conjugate vaccine indicated for the active immunization of individuals from the age of 6 weeks against invasive meningococcal disease caused by Neisseria meningitidis groups A, C, W-135, and Y. Nimenrix is present as powder and solvent for solution for injection in pre-filled syringe. The reconstituted vaccine is a clear colourless solution. Nimenrix should be used in accordance with available official recommendations. Primary immunization in infants from 6 months of age, children, adolescents and adults: a single 0.5 mL dose should be administered.

    Reporting group values
    		 CHIKV vaccine Half Dose CHIKV vaccine Full Dose Nimenrix Total
    Number of subjects
    		 119 124 61 304
    Age categorical
    Units: Subjects
        1 - 2 Years
    		 39 41 20 100
        3 - 6 Years
    		 40 40 20 100
        7 - 11 Years
    		 40 43 21 104
    Age continuous
    Units: years
        geometric mean (standard deviation)
    		 5.0 ( 3.05 ) 5.0 ( 3.05 ) 5.1 ( 3.37 ) -
    Gender categorical
    Units: Subjects
        Female
    		 52 65 29 146
        Male
    		 67 59 32 158
    Subject analysis sets

    Subject analysis set title
    Safety
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The safety analysis population contains all participants who entered into the trial and received one vaccination.

    Subject analysis set title
    Per-Protocol
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The per protocol analysis population (PP) contains all seronegative participants of the Immunogenicity Analysis Population (The IMM includes all vaccinated participants who have evaluable μPRNT antibody titer results at baseline (Visit 1/ Day 1) who have no major protocol violations that could impact immune response.

    Subject analysis sets values
    		 Safety Per-Protocol
    Number of subjects
    304
    275
    Age categorical
    Units: Subjects
        1 - 2 Years
    100
    98
        3 - 6 Years
    100
    99
        7 - 11 Years
    104
    78
    Age continuous
    Units: years
        geometric mean (standard deviation)
    5.0 ( 3.11 )
    4.6 ( 2.83 )
    Gender categorical
    Units: Subjects
        Female
    146
    134
        Male
    158
    141

    End points

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    End points reporting groups
    Reporting group title
    CHIKV vaccine Half Dose
    Reporting group description
    		 CHIKV vaccine Half Dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)

    Reporting group title
    CHIKV vaccine Full Dose
    Reporting group description
    		 CHIKV vaccine Full Dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)

    Reporting group title
    Nimenrix
    Reporting group description
    		 Nimenrix is a conjugate vaccine indicated for the active immunization of individuals from the age of 6 weeks against invasive meningococcal disease caused by Neisseria meningitidis groups A, C, W-135, and Y. Nimenrix is present as powder and solvent for solution for injection in pre-filled syringe. The reconstituted vaccine is a clear colourless solution. Nimenrix should be used in accordance with available official recommendations. Primary immunization in infants from 6 months of age, children, adolescents and adults: a single 0.5 mL dose should be administered.

    Subject analysis set title
    Safety
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The safety analysis population contains all participants who entered into the trial and received one vaccination.

    Subject analysis set title
    Per-Protocol
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The per protocol analysis population (PP) contains all seronegative participants of the Immunogenicity Analysis Population (The IMM includes all vaccinated participants who have evaluable μPRNT antibody titer results at baseline (Visit 1/ Day 1) who have no major protocol violations that could impact immune response.

    Primary: 1. Number of Participants with solicited injection site reactions

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    End point title
    		 1. Number of Participants with solicited injection site reactions [1]
    End point description
    End point type
    Primary
    End point timeframe
    within 14 days post-vaccination
    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: safety analysis was choosen
    End point values
    		 CHIKV vaccine Half Dose CHIKV vaccine Full Dose Nimenrix Safety
    Number of subjects analysed
    119
    124
    61
    304
    Units: participants
    number (not applicable)
        7 - 11 Years
    12
    8
    7
    27
        3 - 6 Years
    6
    7
    0
    13
        1 - 2 Years
    3
    1
    1
    5
    No statistical analyses for this end point

    Primary: 2. Severity of solicited injection site reactions

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    End point title
    		 2. Severity of solicited injection site reactions [2]
    End point description
    Safety Population
    End point type
    Primary
    End point timeframe
    within 14 days post-vaccination
    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: safety analysis was choosen
    End point values
    		 CHIKV vaccine Half Dose CHIKV vaccine Full Dose Nimenrix Safety
    Number of subjects analysed
    119
    124
    61
    304
    Units: participants
    number (not applicable)
        Grade 4: 7 - 11 Years
    0
    0
    0
    0
        Grade 3: 7 - 11 Years
    0
    0
    0
    0
        Grade 2: 7 - 11 Years
    5
    1
    2
    8
        Grade 1: 7 - 11 Years
    9
    7
    6
    24
        Grade 4: 3 - 6 Years
    0
    0
    0
    0
        Grade 3: 3 - 6 Years
    0
    0
    0
    0
        Grade 2: 3 - 6 Years
    0
    0
    0
    0
        Grade 1: 3 - 6 Years
    6
    7
    0
    13
        Grade 4: 1 - 2 Years
    0
    0
    0
    0
        Grade 3: 1 - 2 Years
    0
    0
    0
    0
        Grade 2: 1 - 2 Years
    0
    0
    0
    0
        Grade 1: 1 - 2 Years
    3
    1
    1
    5
    No statistical analyses for this end point

    Primary: 3. Number of Participants with solicited systemic reactions

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    End point title
    		 3. Number of Participants with solicited systemic reactions [3]
    End point description
    End point type
    Primary
    End point timeframe
    within 14 days post-vaccination
    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: safety analysis was choosen
    End point values
    		 CHIKV vaccine Half Dose CHIKV vaccine Full Dose Nimenrix Safety
    Number of subjects analysed
    119
    124
    61
    304
    Units: participants
    number (not applicable)
        7 - 11 years
    11
    17
    3
    31
        3 - 6 years
    10
    10
    4
    24
        1 - 2 years
    9
    15
    3
    27
    No statistical analyses for this end point

    Primary: 4. Severity of solicited systemic reactions

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    End point title
    		 4. Severity of solicited systemic reactions [4]
    End point description
    End point type
    Primary
    End point timeframe
    within 14 days post-vaccination
    Notes
    [4] - 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: safety analysis was choosen
    End point values
    		 CHIKV vaccine Half Dose CHIKV vaccine Full Dose Nimenrix Safety
    Number of subjects analysed
    119
    124
    61
    304
    Units: participants
    number (not applicable)
        Grade 4: 7 - 11 Years
    0
    0
    0
    0
        Grade 3: 7 - 11 Years
    0
    0
    0
    0
        Grade 2: 7 - 11 Years
    8
    3
    0
    3
        Grade 1: 7 - 11 Years
    6
    15
    3
    24
        Grade 4: 3 - 6 Years
    0
    0
    0
    0
        Grade 3: 3 - 6 Years
    0
    3
    0
    3
        Grade 2: 3 - 6 Years
    0
    2
    3
    5
        Grade 1: 3 - 6 Years
    10
    9
    1
    20
        Grade 4: 1 - 2 Years
    1
    0
    0
    1
        Grade 3: 1 - 2 Years
    1
    1
    0
    2
        Grade 2: 1 - 2 Years
    1
    3
    1
    5
        Grade 1: 1 - 2 Years
    7
    13
    2
    22
    No statistical analyses for this end point

    Secondary: 5. Number of Participants with any adverse event (AE)

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    End point title
    		 5. Number of Participants with any adverse event (AE)
    End point description
    Safety Population
    End point type
    Secondary
    End point timeframe
    within 28 days post-vaccination
    End point values
    		 CHIKV vaccine Half Dose CHIKV vaccine Full Dose Nimenrix Safety
    Number of subjects analysed
    119
    124
    61
    304
    Units: participants
    number (not applicable)
        7 - 11 Years
    22
    23
    11
    56
        3 - 6 Years
    20
    16
    6
    42
        1 - 2 Years
    16
    20
    8
    44
    No statistical analyses for this end point

    Secondary: 6. Severity of any adverse event (AE)

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    End point title
    		 6. Severity of any adverse event (AE)
    End point description
    In the Outcome measure “Severity of any AE”, subjects may be represented in more than one AE category. Therefore, the total number of subjects with any AE may be lower than the sum of the numbers of subjects in the individual AE categories (solicited / unsolicited AE).
    End point type
    Secondary
    End point timeframe
    within 28 days post-vaccination
    End point values
    		 CHIKV vaccine Half Dose CHIKV vaccine Full Dose Nimenrix Safety
    Number of subjects analysed
    119
    124
    61
    304
    Units: participants
    number (not applicable)
        any solicited AE: 7 - 11 Years
    17
    20
    9
    46
        Solicited AE Grade 4: 7 - 11 Years
    0
    0
    0
    0
        solicited AE Grade 3: 7 - 11 Years
    0
    0
    0
    0
        solicited AE Grade 2: 7 - 11 Years
    11
    4
    2
    17
        solicited AE Grade 1: 7 - 11 Years
    6
    16
    7
    29
        any unsolicited AE: 7 - 11 Years
    10
    13
    6
    29
        unsolicited AE Grade 4: 7 - 11 Years
    0
    0
    0
    0
        unsolicited AE Grade 3: 7 - 11 Years
    1
    0
    0
    1
        unsolicited AE Grade 2: 7 - 11 Years
    2
    0
    1
    3
        unsolicited AE Grade 1: 7 - 11 Years
    7
    13
    5
    25
        any solicited AE: 3 - 6 Years
    14
    12
    4
    30
        Solicited AE Grade 4: 3 - 6 Years
    0
    0
    0
    0
        Solicited AE Grade 3: 3 - 6 Years
    0
    3
    0
    3
        Solicited AE Grade 2: 3 - 6 Years
    0
    2
    3
    5
        Solicited AE Grade 1: 3 - 6 Years
    14
    7
    1
    22
        any unsolicited AE: 3 - 6 Years
    12
    11
    5
    27
        unsolicited AE Grade 4: 3 - 6 Years
    0
    0
    0
    0
        unsolicited AE Grade 3: 3 - 6 Years
    0
    0
    0
    0
        unsolicited AE Grade 2: 3 - 6 Years
    1
    2
    0
    3
        unsolicited AE Grade 1: 3 - 6 Years
    11
    9
    5
    25
        any solicited AE: 1 - 2 Years
    10
    15
    3
    28
        Solicited AE Grade 4: 1 - 2 Years
    1
    0
    0
    1
        Solicited AE Grade 3: 1 - 2 Years
    1
    1
    0
    2
        Solicited AE Grade 2: 1 - 2 Years
    1
    3
    1
    5
        Solicited AE Grade 1: 1 - 2 Years
    7
    11
    2
    20
        any unsolicited AE: 1 - 2 Years
    12
    13
    6
    31
        unsolicited AE Grade 4: 1 - 2 Years
    0
    0
    0
    0
        unsolicited AE Grade 3: 1 - 2 Years
    1
    0
    0
    1
        unsolicited AE Grade 2: 1 - 2 Years
    0
    0
    0
    0
        unsolicited AE Grade 1: 1 - 2 Years
    11
    13
    6
    30
    No statistical analyses for this end point

    Secondary: 7. Number of Participants with of unsolicited AE

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    End point title
    		 7. Number of Participants with of unsolicited AE
    End point description
    Safety Population
    End point type
    Secondary
    End point timeframe
    until Month 6 (Day 180) and Month 12 (Day 365) post-vaccination
    End point values
    		 CHIKV vaccine Half Dose CHIKV vaccine Full Dose Nimenrix Safety
    Number of subjects analysed
    119
    124
    61
    304
    Units: participants
    number (not applicable)
        Month 6/Day 180: 7 - 11 Years
    25
    25
    11
    61
        Month 12/Day 365: 7 - 11 Years
    25
    31
    12
    68
        Month 6/Day 180: 3 - 6 Years
    27
    20
    13
    60
        Month 12/Day 365: 3 - 6 Years
    30
    24
    16
    70
        Month 6/Day 180: 1 - 2 Years
    27
    28
    14
    69
        Month 12/Day 365: 1 - 2 Year
    29
    33
    17
    79
    No statistical analyses for this end point

    Secondary: 8. Severity of unsolicited AE

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    End point title
    		 8. Severity of unsolicited AE
    End point description
    Safety Population
    End point type
    Secondary
    End point timeframe
    until Month 6 (Day 180) and Month 12 (Day 365) post-vaccination
    End point values
    		 CHIKV vaccine Half Dose CHIKV vaccine Full Dose Nimenrix Safety
    Number of subjects analysed
    119
    124
    61
    304
    Units: participants
    number (not applicable)
        Month 6 Grade 4: 7 - 11 Years
    0
    0
    0
    0
        Month 6 Grade 3: 7 - 11 Years
    1
    2
    0
    3
        Month 6 Grade 2: 7 - 11 Years
    8
    4
    3
    15
        Month 6 Grade 1: 7 - 11 Years
    16
    19
    8
    43
        Month 12 Grade 4: 7 - 11 Years
    0
    0
    0
    0
        Month 12 Grade 3: 7 - 11 Years
    1
    4
    1
    6
        Month 12 Grade 2: 7 - 11 Years
    10
    5
    4
    19
        Month 12 Grade 1: 7 - 11 Years
    14
    22
    7
    43
        Month 6 Grade 4: 3 - 6 Years
    0
    0
    0
    0
        Month 6 Grade 3: 3 - 6 Years
    1
    0
    0
    1
        Month 6 Grade 2: 3 - 6 Years
    8
    4
    2
    14
        Month 6 Grade 1: 3 - 6 Years
    18
    16
    11
    45
        Month 12 Grade 4: 3 - 6 Years
    0
    0
    0
    0
        Month 12 Grade 3: 3 - 6 Years
    2
    0
    0
    2
        Month 12 Grade 2: 3 - 6 Years
    9
    8
    5
    22
        Month 12 Grade 1: 3 - 6 Years
    19
    16
    11
    46
        Month 6 Grade 4: 1 - 2 Years
    0
    0
    0
    0
        Month 6 Grade 3: 1 - 2 Years
    3
    2
    0
    5
        Month 6 Grade 2: 1 - 2 Years
    8
    7
    4
    19
        Month 6 Grade 1: 1 - 2 Years
    16
    19
    10
    45
        Month 12 Grade 4: 1 - 2 Years
    0
    0
    1
    1
        Month 12 Grade 3: 1 - 2 Years
    3
    2
    0
    5
        Month 12 Grade 2: 1 - 2 Years
    11
    16
    6
    33
        Month 12 Grade 1: 1 - 2 Years
    15
    15
    10
    40
    No statistical analyses for this end point

    Secondary: 9. Number of Participants with any serious adverse event (SAE)

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    End point title
    		 9. Number of Participants with any serious adverse event (SAE)
    End point description
    Safety Population
    End point type
    Secondary
    End point timeframe
    until Month 6 (Day 180) and Month 12 (Day 365) post-vaccination
    End point values
    		 CHIKV vaccine Half Dose CHIKV vaccine Full Dose Nimenrix Safety
    Number of subjects analysed
    119
    124
    61
    304
    Units: participants
    number (not applicable)
        Month 6/Day 180: 7 - 11 Years
    1
    0
    0
    1
        Month 12/Day 365: 7 - 11 Years
    1
    2
    0
    3
        Month 6/Day 180: 3 - 6 Years
    0
    0
    0
    0
        Month 12/Day 365: 3 - 6 Years
    1
    0
    0
    1
        Month 6/Day 180: 1 - 2 Years
    0
    1
    0
    1
        Month 12/Day 365: 1 - 2 Years
    0
    2
    1
    3
    No statistical analyses for this end point

    Secondary: 10. Number of Participants with any early onset adverse event of special interest (AESI)

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    End point title
    		 10. Number of Participants with any early onset adverse event of special interest (AESI)
    End point description
    Early onset AESI were defined as: 1. Fever (≥ 38.0 °c / 100.4 °f,) AND 2. symptoms suggesting acute (poly)arthralgia/arthritis, myalgia, neurological symptoms (e.g., for meningoencephalitis, acute encephalitis, headache, seizures), back pain, lymphadenopathy, cardiac or ocular symptoms (e.g., for uveitis and retinitis); OR one or more of the following signs and symptoms: macular to maculopapular rash (sometimes with cutaneous pruritus [foot plant]), pigmentary changes, bullous rash/ skin blistering, purpura, ecchymosis and 3. Onset of symptoms 2 to 21 days after vaccination AND 4. Duration of event ≥ 3 days.
    End point type
    Secondary
    End point timeframe
    2 to 21 days post-vaccination
    End point values
    		 CHIKV vaccine Half Dose CHIKV vaccine Full Dose Nimenrix Safety
    Number of subjects analysed
    119
    124
    61
    304
    Units: participants
        number (not applicable)
    3
    0
    0
    3
    No statistical analyses for this end point

    Secondary: 11. Severity of any early onset adverse event of special interest (AESI)

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    End point title
    		 11. Severity of any early onset adverse event of special interest (AESI)
    End point description
    Safety Population
    End point type
    Secondary
    End point timeframe
    2 to 21 days post-vaccination
    End point values
    		 CHIKV vaccine Half Dose CHIKV vaccine Full Dose Nimenrix Safety
    Number of subjects analysed
    119
    124
    61
    304
    Units: participants
    number (not applicable)
        Grade 4
    0
    0
    0
    0
        Grade 3
    0
    0
    0
    0
        Grade 2
    2
    0
    0
    2
        Grade 1
    1
    0
    0
    1
    No statistical analyses for this end point

    Secondary: 12. Number of Participants with any late onset adverse event of special interest (AESI)

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    End point title
    		 12. Number of Participants with any late onset adverse event of special interest (AESI)
    End point description
    End point type
    Secondary
    End point timeframe
    Starting 22 days post-vaccination until end of trial, 12 months post-vaccination
    End point values
    		 CHIKV vaccine Half Dose CHIKV vaccine Full Dose Nimenrix Safety
    Number of subjects analysed
    119
    124
    61
    304
    Units: participants
        number (not applicable)
    2
    0
    0
    2
    No statistical analyses for this end point

    Secondary: 13. Severity of any late onset adverse event of special interest (AESI)

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    End point title
    		 13. Severity of any late onset adverse event of special interest (AESI)
    End point description
    End point type
    Secondary
    End point timeframe
    Starting 22 days post-vaccination until end of trial, 12 months post-vaccination
    End point values
    		 CHIKV vaccine Half Dose CHIKV vaccine Full Dose Nimenrix Safety
    Number of subjects analysed
    119
    124
    61
    304
    Units: participants
    number (not applicable)
        Grade 4
    0
    0
    0
    0
        Grade 3
    0
    0
    0
    0
        Grade 2
    1
    0
    0
    1
        Grade 1
    1
    0
    0
    1
    No statistical analyses for this end point

    Secondary: 14. Assessment of viremia

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    End point title
    		 14. Assessment of viremia
    End point description
    Viremia subset of the Safety Analysis Population including 124 participants.
    End point type
    Secondary
    End point timeframe
    on Days 1, 4, 8 and 15 and beyond as applicable
    End point values
    		 CHIKV vaccine Half Dose CHIKV vaccine Full Dose Nimenrix
    Number of subjects analysed
    50
    53
    21
    Units: participants
    number (not applicable)
        Visit 1/Day 1: Quantifiable
    0
    0
    0
        Visit 1/Day 1: Below LLOQ
    0
    0
    0
        Visit 2/Day 4: Quantifiable
    12
    23
    0
        Visit 2/Day 4: Below LLOQ
    6
    10
    0
        Visit 3/Day 8: Quantifiable
    10
    8
    0
        Visit 3/Day 8: Below LLOQ
    6
    5
    0
        Visit 4/Day 15: Quantifiable
    1
    0
    0
        Visit 4/Day 15: Below LLOQ
    0
    0
    0
        Visit 5/Day 29: Quantifiable
    0
    0
    0
        Visit 5/Day 29: Below LLOQ
    0
    0
    0
    No statistical analyses for this end point

    Secondary: 15. Immune response in baseline seronegative participants as measured by CHIKV-specific neutralizing antibody titers

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    End point title
    		 15. Immune response in baseline seronegative participants as measured by CHIKV-specific neutralizing antibody titers
    End point description
    Immune Response provided by Geometric Mean Titers (GMTs) in Baseline Seronegative Participants pooled by Trial Arm up to 12 months post vaccination. Immunogenicity Population - seronegative at baseline (μPRNT50 ≤ 40)
    End point type
    Secondary
    End point timeframe
    on Day 1, Day 15, Day 29, Day 85, Day 180 and Month 12 post-vaccination
    End point values
    		 CHIKV vaccine Half Dose CHIKV vaccine Full Dose Nimenrix
    Number of subjects analysed
    109
    116
    53
    Units: titer
    geometric mean (confidence interval 95%)
        Visit 1/Day 1
    10.1 (9.9 to 10.3)
    10.0 (10.0 to 10.0)
    10.3 (9.9 to 10.7)
        Visit 4/Day 15
    1046.1 (726.6 to 1506.0)
    1949.9 (1513.7 to 2511.8)
    10.2 (9.8 to 10.7)
        Visit 5/Day 29
    1845.4 (1300.3 to 2618.8)
    2860.6 (2267.8 to 3608.3)
    10.3 (9.9 to 10.8)
        Visit 6/Day 85
    630.8 (465.8 to 854.4)
    1031.5 (830.6 to 1281.0)
    10.0 (10.0 to 10.0)
        Visit 7/Day 180
    514.2 (383.2 to 690.0)
    813.7 (658.5 to 1005.4)
    10.0 (10.0 to 10.0)
        Visit 8/Day 365
    798.7 (573.4 to 1112.5)
    1355.7 (1071.5 to 1715.2)
    10.5 (9.9 to 11.0)
    No statistical analyses for this end point

    Secondary: 16. Immune Response as measured by CHIKV-specific neutralizing antibody titers by age group and trial arm.

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    End point title
    		 16. Immune Response as measured by CHIKV-specific neutralizing antibody titers by age group and trial arm.
    End point description
    Immune Response provided by Geometric Mean Titers (GMTs) by Visit, by Age Group and Trial Arm up to 12 months post vaccination. (Per-Protocol Analysis)
    End point type
    Secondary
    End point timeframe
    on Day 1, Day 15, Day 29, Day 85, Day 180 and Month 12 post-vaccination
    End point values
    		 CHIKV vaccine Half Dose CHIKV vaccine Full Dose Nimenrix
    Number of subjects analysed
    107
    115
    53
    Units: titer
    geometric mean (confidence interval 95%)
        Visit 1/Day 1: 7 - 11 Years
    10.0 (10.0 to 10.0)
    10.0 (10.0 to 10.0)
    10.7 (9.3 to 12.3)
        Visit 4/Day 15: 7 - 11 Years
    836.0 (443.2 to 1576.7)
    2214.5 (1716.3 to 2857.2)
    10.0 (10.0 to 10.0)
        Visit 5/Day 29: 7 - 11 Years
    1979.1 (941.9 to 4158.4)
    3443.6 (2957.0 to 4010.3)
    10.0 (10.0 to 10.0)
        Visit 6/Day 85: 7 - 11 Years
    634.5 (347.7 to 1157.7)
    1240.8 (1003.9 to 1533.6)
    10.0 (10.0 to 10.0)
        Visit 7/Day 180: 7 - 11 Years
    573.8 (315.9 to 1042.1)
    835.4 (648.3 to 1076.7)
    10.0 (10.0 to 10.0)
        Visit 8/Day 365: 7 - 11 Years
    693.3 (376.4 to 1277.2)
    1451.0 (1102.4 to 1909.9)
    10.7 (9.3 to 12.3)
        Visit 1/Day 1: 3 - 6 Years
    10.3 (9.7 to 10.8)
    10.0 (10.0 to 10.0)
    10.0 (10.0 to 10.0)
        Visit 4/Day 15: 3 - 6 Years
    1437.4 (836.1 to 2471.1)
    2275.4 (1518.3 to 3410.3)
    10.0 (10.0 to 10.0)
        Visit 5/Day 29: 3 - 6 Years
    2170.2 (1304.9 to 3609.2)
    3134.8 (2108.4 to 4660.7)
    10.0 (10.0 to 10.0)
        Visit 6/Day 85: 3 - 6 Years
    763.4 (497.7 to 1170.9)
    1073.7 (763.8 to 1509.2)
    10.0 (10.0 to 10.0)
        Visit 7/Day 180: 3 - 6 Years
    468.0 (313.2 to 699.4)
    872.4 (635.4 to 1197.8)
    10.0 (10.0 to 10.0)
        Visit 8/Day 365: 3 - 6 Years
    858.6 (524.5 to 1405.4)
    1382.2 (975.0 to 1959.5)
    10.0 (10.0 to 10.0)
        Visit 1/Day 1: 1 - 2 Years
    10.0 (10.0 to 10.0)
    10.0 (10.0 to 10.0)
    10.4 (9.6 to 11.1)
        Visit 4/Day 15: 1 - 2 Years
    960.3 (462.7 to 1993.1)
    1474.5 (808.7 to 2688.8)
    10.7 (9.3 to 12.3)
        Visit 5/Day 29: 1 - 2 Years
    1439.2 (730.0 to 2837.1)
    2161.7 (1235.0 to 3783.7)
    11.0 (9.6 to 12.5)
        Visit 6/Day 85: 1 - 2 Years
    517.5 (277.9 to 963.8)
    831.1 (500.1 to 1381.1)
    10.0 (10.0 to 10.0)
        Visit 7/Day 180: 1 - 2 Years
    506.0 (272.4 to 940.0)
    820.1 (517.8 to 1298.9)
    10.0 (10.0 to 10.0)
        Visit 8/Day 365: 1 - 2 Years
    814.0 (400.4 to 1654.7)
    1242.6 (703.3 to 2195.8)
    10.8 (9.6 to 12.2)
    No statistical analyses for this end point

    Secondary: 17. Immune Response Measured by CHIKV-specific Neutralizing Antibody Titers pooled by Dose

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    End point title
    		 17. Immune Response Measured by CHIKV-specific Neutralizing Antibody Titers pooled by Dose
    End point description
    Immune Response provided by Geometric Mean Titers (GMTs) by Visit, pooled by Trial Arm up to 12 months post vaccination. (Per-Protocol Analysis)
    End point type
    Secondary
    End point timeframe
    on Day 1, Day 15, Day 29, Day 85, Day 180 and Month 12 post-vaccination
    End point values
    		 CHIKV vaccine Half Dose CHIKV vaccine Full Dose Nimenrix
    Number of subjects analysed
    107
    115
    53
    Units: titer
    geometric mean (confidence interval 95%)
        Visit 1/Day 1
    10.1 (9.9 to 10.3)
    10.0 (10.0 to 10.0)
    10.3 (9.9 to 10.7)
        Visit 4/Day 15
    1073.6 (748.1 to 1540.7)
    1944.8 (1506.5 to 2510.8)
    10.2 (9.8 to 10.8)
        Visit 5/Day 29
    1829.3 (1280.8 to 2612.8)
    2843.6 (2247.1 to 3598.5)
    10.3 (9.9 to 10.8)
        Visit 6/Day 85
    631.4 (463.5 to 860.2)
    1025.9 (824.8 to 1276.2)
    10.0 (10.0 to 10.0)
        Visit 7/Day 180
    508.5 (377.1 to 685.8)
    842.5 (689.1 to 1030.1)
    10.0 (10.0 to 10.0)
        Visit 8/Day 365
    794.5 (566.8 to 1113.7)
    1353.4 (1067.5 to 1715.8)
    10.5 (9.9 to 11.0)
    No statistical analyses for this end point

    Secondary: 18. Percentage of Participants seronegative at baseline with seroconversion as compared to baseline

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    End point title
    		 18. Percentage of Participants seronegative at baseline with seroconversion as compared to baseline
    End point description
    Percentage of participants seronegative at baseline with Seroconversion (defined as >4-fold titer change compared to baseline) by Visit Pooled by Trial Arm (µRPNT Baseline Seronegative Immunogenicity Analysis Population)
    End point type
    Secondary
    End point timeframe
    at Day 15, Day 29, Day 85, Day 180 and Month 12
    End point values
    		 CHIKV vaccine Half Dose CHIKV vaccine Full Dose Nimenrix
    Number of subjects analysed
    109
    116
    53
    Units: percentage of participants
    number (not applicable)
        Visit 4/Day 15
    88.0
    95.7
    0.0
        Visit 5/Day 29
    89.89
    95.7
    0.0
        Visit 6/Day 85
    89.5
    95.7
    0.0
        Visit 7/Day 180
    89.7
    95.7
    0.0
        Visit 8/Day 365
    89.6
    95.7
    0.0
    No statistical analyses for this end point

    Secondary: 19. Percentage of participants seropositive at baseline with seroconversion as compared to baseline

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    End point title
    		 19. Percentage of participants seropositive at baseline with seroconversion as compared to baseline
    End point description
    Percentage of participants seropositive at baseline with Seroconversion (defined as >4-fold titer change compared to baseline) by Visit Pooled by Trial Arm. (µRPNT Baseline Seropositive Immunogenicity Analysis Population)
    End point type
    Secondary
    End point timeframe
    at Day 15, Day 29, Day 85, Day 180 and Month 12
    End point values
    		 CHIKV vaccine Half Dose CHIKV vaccine Full Dose Nimenrix
    Number of subjects analysed
    9
    7
    8
    Units: percentage of participants
    number (not applicable)
        Visit 4/Day 15
    0.0
    0.0
    0.0
        Visit 5/Day 29
    0.0
    0.0
    0.0
        Visit 6/Day 85
    0.0
    0.0
    0.0
        Visit 7/Day 180
    0.0
    0.0
    12.5
        Visit 8/Day 365
    0.0
    0.0
    0.0
    No statistical analyses for this end point

    Secondary: 20. Percentage of participants with seroconversion as compared to baseline stratified by age stratum

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    End point title
    		 20. Percentage of participants with seroconversion as compared to baseline stratified by age stratum
    End point description
    Percentage of participants with Seroconversion (defined as >4-fold titer change compared to baseline) by Visit by Age Group and Trial Arm. (Per-Protocol Analysis Population)
    End point type
    Secondary
    End point timeframe
    at Day 15, Day 29, Day 85, Day 180 and Month 12
    End point values
    		 CHIKV vaccine Half Dose CHIKV vaccine Full Dose Nimenrix
    Number of subjects analysed
    107
    115
    53
    Units: percentage of participants
    number (not applicable)
        Visit 4/Day 15: 7 - 11 Years
    89.7
    100.0
    0.0
        Visit 5/Day 29: 7 - 11 Years
    89.7
    100.0
    0.0
        Visit 6/Day 85: 7 - 11 Years
    89.7
    100.0
    0.0
        Visit 7/Day 180: 7 - 11 Years
    89.7
    100.0
    0.0
        Visit 8/Day 365: 7 - 11 Years
    89.7
    100.0
    0.0
        Visit 4/Day 15: 3 - 6 Years
    92.3
    97.4
    0.0
        Visit 5/Day 29: 3 - 6 Years
    92.5
    97.4
    0.0
        Visit 6/Day 85: 3 - 6 Years
    94.6
    97.4
    0.0
        Visit 7/Day 180: 3 - 6 Years
    95.0
    97.4
    0.0
        Visit 8/Day 365: 3 - 6 Years
    92.5
    97.4
    0.0
        Visit 4/Day 15: 1 - 2 Years
    83.8
    89.7
    0.0
        Visit 5/Day 29: 1 - 2 Years
    86.8
    89.7
    0.0
        Visit 6/Day 85: 1 - 2 Years
    83.3
    90.0
    0.0
        Visit 7/Day 180: 1 - 2 Years
    83.3
    92.3
    0.0
        Visit 8/Day 365: 1 - 2 Years
    85.7
    89.7
    0.0
    No statistical analyses for this end point

    Secondary: 21. Percentage of Participants With Seroconversion as Compared to Baseline by dose

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    End point title
    		 21. Percentage of Participants With Seroconversion as Compared to Baseline by dose
    End point description
    Percentage of participants with Seroconversion (defined as >4-fold titer change compared to baseline) by Visit Pooled by Trial Arm (Per-Protocol Analysis Population)
    End point type
    Secondary
    End point timeframe
    at Day 15, Day 29, Day 85, Day 180 and Month 12
    End point values
    		 CHIKV vaccine Half Dose CHIKV vaccine Full Dose Nimenrix
    Number of subjects analysed
    107
    115
    53
    Units: percentage of participants
    number (not applicable)
        Visit 4/Day 15
    88.6
    95.6
    0.0
        Visit 5/Day 29
    89.7
    95.6
    0.0
        Visit 6/Day 85
    89.2
    95.6
    0.0
        Visit 7/Day 180
    89.5
    96.5
    0.0
        Visit 8/Day 365
    89.4
    95.6
    0.0
    No statistical analyses for this end point

    Secondary: 22. Percentage of participants seronegative at baseline with a seroresponse (defined as PRNT50 ≥150 for baseline negative participants) by dose

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    End point title
    		 22. Percentage of participants seronegative at baseline with a seroresponse (defined as PRNT50 ≥150 for baseline negative participants) by dose
    End point description
    Percentage of Participants with Seroresponse for CHIKV-Specific Neutralizing Antibody Titers (defined as PRNT50 ≥150) by Visit Pooled by Trial Arm. (µRPNT Baseline Seronegative Immunogenicity Analysis Population)
    End point type
    Secondary
    End point timeframe
    on Day 15, Day 29, Day 85, Day 180 and Month 12 post-vaccination
    End point values
    		 CHIKV vaccine Half Dose CHIKV vaccine Full Dose Nimenrix
    Number of subjects analysed
    109
    116
    53
    Units: percentage of participants
    number (not applicable)
        Visit 4/Day 15
    87.0
    95.7
    0.0
        Visit 5/Day 29
    89.0
    95.7
    0.0
        Visit 6/Day 85
    87.6
    95.7
    0.0
        Visit 7/Day 180
    88.8
    95.7
    0.0
        Visit 8/Day 365
    86.8
    94.8
    0.0
    No statistical analyses for this end point

    Secondary: 23. Percentage of participants with a seroresponse stratified by age stratum

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    End point title
    		 23. Percentage of participants with a seroresponse stratified by age stratum
    End point description
    Percentage of Participants with Seroresponse for CHIKV-Specific Neutralizing Antibody Titers (defined as PRNT50 ≥150) by Visit by Age Group and Trial Arm. Per-Protocol Analysis Population
    End point type
    Secondary
    End point timeframe
    on Day 15, Day 29, Day 85, Day 180 and Month 12 post-vaccination
    End point values
    		 CHIKV vaccine Half Dose CHIKV vaccine Full Dose Nimenrix
    Number of subjects analysed
    107
    115
    53
    Units: percentage of participants
    number (not applicable)
        Visit 4/Day 15: 7 - 11 Years
    89.66
    100.00
    0
        Visit 5/Day 29: 7 - 11 Years
    89.66
    100.0
    0
        Visit 6/Day 85: 7 - 11 Years
    89.66
    100.00
    0
        Visit 7/Day 180: 7 - 11 Years
    89.66
    100.00
    0
        Visit 8/Day 365: 7 - 11 Years
    89.66
    97.22
    0
        Visit 4/Day 15: 3 - 6 Years
    92.31
    97.44
    0
        Visit 5/Day 29: 3 - 6 Years
    92.50
    97.44
    0
        Visit 6/Day 85: 3 - 6 Years
    91.89
    97.44
    0
        Visit 7/Day 180: 3 - 6 Years
    92.50
    97.44
    0
        Visit 8/Day 365: 3 - 6 Years
    90.00
    97.44
    0
        Visit 4/Day 15: 1 - 2 Years
    81.08
    89.74
    0
        Visit 5/Day 29: 1 - 2 Years
    84.21
    89.74
    0
        Visit 6/Day 85: 1 - 2 Years
    83.33
    90.00
    0
        Visit 7/Day 180: 1 - 2 Years
    83.33
    92.31
    0
        Visit 8/Day 365: 1 - 2 Years
    80.00
    89.74
    0
    No statistical analyses for this end point

    Secondary: 24. Percentage of participants with a seroresponse stratified by dose

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    End point title
    		 24. Percentage of participants with a seroresponse stratified by dose
    End point description
    Percentage of Participants with Seroresponse for CHIKV-Specific Neutralizing Antibody Titers (defined as PRNT50 ≥150) by Visit Pooled by Trial Arm. (Per-Protocol Analysis Population)
    End point type
    Secondary
    End point timeframe
    on Day 15, Day 29, Day 85, Day 180 and Month 12 post-vaccination
    End point values
    		 CHIKV vaccine Half Dose CHIKV vaccine Full Dose Nimenrix
    Number of subjects analysed
    107
    115
    53
    Units: percentage of participants
    number (not applicable)
        Visit 4/Day 15
    87.62
    95.61
    0
        Visit 5/Day 29
    88.79
    95.61
    0
        Visit 6/Day 85
    88.24
    95.61
    0
        Visit 7/Day 180
    88.57
    96.49
    0
        Visit 8/Day 365
    86.54
    94.74
    0
    No statistical analyses for this end point

    Secondary: 25. Fold change of CHIKV-specific neutralizing antibody titers as compared to baseline in participants seronegative at baseline

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    End point title
    		 25. Fold change of CHIKV-specific neutralizing antibody titers as compared to baseline in participants seronegative at baseline
    End point description
    at Days 15, 29, 85, 180 and at Month 12 post-vaccination
    End point type
    Secondary
    End point timeframe
    Fold Change for CHIKV-Specific Neutralizing Antibody Titers in seronegative Participants by Visit Pooled by Trial Arm. (µRPNT Baseline Seronegative Immunogenicity Analysis Population)
    End point values
    		 CHIKV vaccine Half Dose CHIKV vaccine Full Dose Nimenrix
    Number of subjects analysed
    109
    116
    53
    Units: fold change
    geometric mean (confidence interval 95%)
        Visit 4/Day 15
    103.6 (71.9 to 149.3)
    195.0 (151.4 to 251.2)
    1.0 (0.9 to 1.1)
        Visit 5/Day 29
    182.8 (128.7 to 259.7)
    286.1 (226.8 to 360.8)
    1.0 (0.9 to 1.1)
        Visit 6/Day 85
    62.5 (46.1 to 84.6)
    103.1 (83.1 to 128.1)
    1.0 (0.9 to 1.0)
        Visit 7/Day 180
    50.9 (37.9 to 68.4)
    81.4 (65.9 to 100.5)
    1.0 (0.9 to 1.0)
        Visit 8/Day 365
    79.1 (56.7 to 110.3)
    135.6 (107.2 to 171.5)
    1.0 (0.9 to 1.1)
    No statistical analyses for this end point

    Secondary: 26. Fold change of CHIKV-specific neutralizing antibody titers as compared to baseline in seropositive participants

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    End point title
    		 26. Fold change of CHIKV-specific neutralizing antibody titers as compared to baseline in seropositive participants
    End point description
    Fold Change for CHIKV-Specific Neutralizing Antibody Titers in seropositive Participants by Visit Pooled by Trial Arm.
    End point type
    Secondary
    End point timeframe
    at Days 15, 29, 85, 180 and at Month 12 post-vaccination
    End point values
    		 CHIKV vaccine Half Dose CHIKV vaccine Full Dose Nimenrix
    Number of subjects analysed
    24
    24
    24
    Units: fold change
    geometric mean (confidence interval 95%)
        Visit 4/Day 15
    0.9 (0.7 to 1.1)
    1.4 (0.8 to 2.5)
    1.1 (0.6 to 2.2)
        Visit 5/Day 29
    0.8 (0.6 to 1.1)
    1.9 (1.4 to 2.7)
    1.2 (0.9 to 1.8)
        Visit 6/Day 85
    0.8 (0.6 to 1.2)
    1.9 (1.4 to 2.6)
    1.4 (0.9 to 2.2)
        Visit 7/Day 180
    1.2 (0.8 to 1.8)
    1.1 (0.7 to 1.6)
    1.2 (0.6 to 2.1)
        Visit 8/Day 365
    0.9 (0.6 to 1.3)
    1.2 (0.6 to 2.4)
    1.4 (0.8 to 2.2)
    No statistical analyses for this end point

    Secondary: 27. Fold change of CHIKV-specific neutralizing antibody titers as compared to baseline stratified by age stratum

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    End point title
    		 27. Fold change of CHIKV-specific neutralizing antibody titers as compared to baseline stratified by age stratum
    End point description
    Fold Change for CHIKV-Specific Neutralizing Antibody Titers by Visit by Age Group and Trial Arm.
    End point type
    Secondary
    End point timeframe
    at Days 15, 29, 85, 180 and at Month 12 post-vaccination
    End point values
    		 CHIKV vaccine Half Dose CHIKV vaccine Full Dose Nimenrix
    Number of subjects analysed
    107
    115
    53
    Units: fold change
    geometric mean (confidence interval 95%)
        Visit 4/Day 15: 7 - 11 Years
    83.6 (44.3 to 157.7)
    221.4 (17.6 to 285.7)
    0.9 (0.8 to 1.1)
        Visit 5/Day 29: 7 - 11 Years
    197.9 (94.2 to 415.8)
    344.4 (295.7 to 401.0)
    0.9 (0.8 to 1.1)
        Visit 6/Day 85: 7 - 11 Years
    63.4 (34.8 to 115.8)
    124.1 (100.4 to 153.4)
    0.9 (0.8 to 1.1)
        Visit 7/Day 180: 7 - 11 Years
    57.4 (31.6 to 104.2)
    83.5 (64.8 to 107.7)
    0.9 (0.8 to 1.1)
        Visit 8/Day 365: 7 - 11 Years
    69.3 (37.6 to 127.7)
    145.1 (110.2 to 191.0)
    1.0 (0.8 to 1.2)
        Visit 4/Day 15: 3 - 6 Years
    140.0 (80.9 to 242.2)
    227.5 (151.8 to 341.0)
    1.0 (1.0 to 1.0)
        Visit 5/Day 29: 3 - 6 Years
    211.5 (126.3 to 354.2)
    313.5 (210.8 to 466.1)
    1.0 (1.0 to 1.0)
        Visit 6/Day 85: 3 - 6 Years
    74.2 (48.3 to 114.2)
    107.4 (76.4 to 150.9)
    1.0 (1.0 to 1.0)
        Visit 7/Day 180: 3 - 6 Years
    45.6 (30.4 to 68.4)
    87.2 (63.5 to 119.8)
    1.0 (1.0 to 1.0)
        Visit 8/Day 365: 3 - 6 Years
    83.7 (50.8 to 137.9)
    138.2 (97.5 to 195.9)
    1.0 (1.0 to 1.0)
        Visit 4/Day 15: 1 - 2 Years
    96.0 (46.3 to 199.3)
    147.5 (80.9 to 268.9)
    1.0 (0.9 to 1.2)
        Visit 5/Day 29: 1 - 2 Years
    143.9 (73.0 to 283.7)
    216.2 (123.5 to 378.4)
    1.1 (0.9 to 1.2)
        Visit 6/Day 85: 1 - 2 Years
    51.7 (27.8 to 96.4)
    83.1 (50.0 to 138.1)
    1.0 (0.9 to 1.0)
        Visit 7/Day 180: 1 - 2 Years
    50.6 (27.2 to 94.0)
    82.0 (51.8 to 129.9)
    1.0 (0.9 to 1.0)
        Visit 8/Day 365: 1 - 2 Years
    81.4 (40.0 to 165.5)
    124.3 (70.3 to 219.6)
    1.0 (0.9 to 1.2)
    No statistical analyses for this end point

    Secondary: 28. Fold change of CHIKV-specific neutralizing antibody titers as compared to baseline stratified by dose

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    End point title
    		 28. Fold change of CHIKV-specific neutralizing antibody titers as compared to baseline stratified by dose
    End point description
    Fold Change for CHIKV-Specific Neutralizing Antibody Titers by Visit Pooled by Trial Arm.
    End point type
    Secondary
    End point timeframe
    at Days 15, 29, 85, 180 and at Month 12 post-vaccination
    End point values
    		 CHIKV vaccine Half Dose CHIKV vaccine Full Dose Nimenrix
    Number of subjects analysed
    107
    115
    53
    Units: fold change
    geometric mean (confidence interval 95%)
        Visit 4/Day 15
    106.3 (74.0 to 152.7)
    194.5 (150.6 to 251.1)
    1.0 (0.9 to 1.1)
        Visit 5/Day 29
    181.2 (126.7 to 259.1)
    284.4 (224.7 to 359.9)
    1.0 (0.9 to 1.1)
        Visit 6/Day 85
    62.5 (45.9 to 85.2)
    102.6 (82.5 to 127.6)
    1.0 (0.9 to 1.0)
        Visit 7/Day 180
    50.4 (37.3 to 68.0)
    84.3 (68.9 to 103.0)
    1.0 (0.9 to 1.0)
        Visit 8/Day 365
    78.7 (56.0 to 110.4)
    135.3 (106.7 to 171.6)
    1.0 (0.9 to 1.1)
    No statistical analyses for this end point

    Secondary: 29. Percentage of participants seronegative at baseline reaching an at least 4-fold, 8-fold, 16-fold or 64-fold change in CHIKV-specific neutralizing antibody titers compared to baseline

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    End point title
    		 29. Percentage of participants seronegative at baseline reaching an at least 4-fold, 8-fold, 16-fold or 64-fold change in CHIKV-specific neutralizing antibody titers compared to baseline
    End point description
    Percentage of Participants Reaching a 4-/8-/16-/64-Fold Change in Titers by Visit Pooled by Trial Arm.
    End point type
    Secondary
    End point timeframe
    at Day 15, Day 29, Day 85, Day 180 and Month 12
    End point values
    		 CHIKV vaccine Half Dose CHIKV vaccine Full Dose Nimenrix
    Number of subjects analysed
    109
    116
    53
    Units: percentage of participants
    number (not applicable)
        Visit 4/Day 15: 4-fold change
    87.96
    95.65
    0
        Visit 4/Day 15: 8-fold change
    87.96
    95.65
    0
        Visit 4/Day 15: 16-fold change
    87.04
    95.65
    0
        Visit 4/Day 15: 64-fold change
    76.85
    89.57
    0
        Visit 5/Day 29: 4-fold change
    89.91
    95.69
    0
        Visit 5/Day 29: 8-fold change
    88.99
    95.69
    0
        Visit 5/Day 29: 16-fold change
    88.99
    95.69
    0
        Visit 5/Day 29: 64-fold change
    87.16
    95.69
    0
        Visit 6/Day 85: 4-fold change
    89.52
    95.65
    0
        Visit 6/Day 85: 8-fold change
    89.52
    95.65
    0
        Visit 6/Day 85: 16-fold change
    87.62
    95.65
    0
        Visit 6/Day 85: 64-fold change
    70.48
    80.87
    0
        Visit 7/Day 180: 4-fold change
    89.72
    95.69
    0
        Visit 7/Day 180: 8-fold change
    88.79
    95.69
    0
        Visit 7/Day 180: 16-fold change
    87.85
    95.69
    0
        Visit 7/Day 180: 64-fold change
    55.14
    73.28
    0
        Visit 8/Day 365: 4-fold change
    89.62
    95.65
    0
        Visit 8/Day 365: 8-fold change
    88.68
    95.65
    0
        Visit 8/Day 365: 16-fold change
    85.85
    94.78
    0
        Visit 8/Day 365: 64-fold change
    69.81
    86.96
    0
    No statistical analyses for this end point

    Secondary: 30. Percentage of participants reaching an at least 4-fold, 8-fold, 16-fold or 64-fold change in CHIKV-specific neutralizing antibody titers compared to baseline stratified by age stratum

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    End point title
    		 30. Percentage of participants reaching an at least 4-fold, 8-fold, 16-fold or 64-fold change in CHIKV-specific neutralizing antibody titers compared to baseline stratified by age stratum
    End point description
    Percentage of Participants Reaching a 4-/8-/16-/64-Fold Change in Titers by Visit by Age Group and Trial Arm.
    End point type
    Secondary
    End point timeframe
    at Day 15, Day 29, Day 85, Day 180 and Month 12
    End point values
    		 CHIKV vaccine Half Dose CHIKV vaccine Full Dose Nimenrix
    Number of subjects analysed
    107
    115
    53
    Units: percentage of participants
    number (not applicable)
        Visit 4/Day 15: 4-fold change - 7 - 11 Years
    89.66
    100.00
    0
        Visit 4/Day 15: 8-fold change - 7 - 11 Years
    89.66
    100.00
    0
        Visit 4/Day 15: 16-fold change - 7 - 11 Years
    89.66
    100.00
    0
        Visit 4/Day 15: 64-fold change - 7 - 11 Years
    75.86
    94.44
    0
        Visit 5/Day 29: 4-fold change - 7 - 11 Years
    89.66
    100.00
    0
        Visit 5/Day 29: 8-fold change - 7 - 11 Years
    89.66
    100.00
    0
        Visit 5/Day 29: 16-fold change - 7 - 11 Years
    89.66
    100.00
    0
        Visit 5/Day 29: 64-fold change - 7 - 11 Years
    86.21
    100.00
    0
        Visit 6/Day 85: 4-fold change - 7 - 11 Years
    89.66
    100.00
    0
        Visit 6/Day 85: 8-fold change - 7 - 11 Years
    89.66
    100.00
    0
        Visit 6/Day 85: 16-fold change - 7 - 11 Years
    89.66
    100.00
    0
        Visit 6/Day 85: 64-fold change - 7 - 11 Years
    75.86
    85.71
    0
        Visit 7/Day 180: 4-fold change - 7 - 11 Years
    89.66
    100.00
    0
        Visit 7/Day 180: 8-fold change - 7 - 11 Years
    89.66
    100.00
    0
        Visit 7/Day 180: 16-fold change - 7 - 11 Years
    89.66
    100.00
    0
        Visit 7/Day 180: 64-fold change - 7 - 11 Years
    65.52
    69.44
    0
        Visit 8/Day 365: 4-fold change - 7 - 11 Years
    89.66
    100.00
    0
        Visit 8/Day 365: 8-fold change - 7 - 11 Years
    89.66
    100.00
    0
        Visit 8/Day 365: 16-fold change - 7 - 11 Years
    89.66
    97.22
    0
        Visit 8/Day 365: 64-fold change - 7 - 11 Years
    72.41
    88.89
    0
        Visit 4/Day 15: 4-fold change - 3 - 6 Years
    92.31
    97.44
    0
        Visit 4/Day 15: 8-fold change - 3 - 6 Years
    92.31
    97.44
    0
        Visit 4/Day 15: 16-fold change - 3 - 6 Years
    92.31
    97.44
    0
        Visit 4/Day 15: 64-fold change - 3 - 6 Years
    82.05
    89.74
    0
        Visit 5/Day 29: 4-fold change - 3 - 6 Years
    92.50
    97.44
    0
        Visit 5/Day 29: 8-fold change - 3 - 6 Years
    92.50
    97.44
    0
        Visit 5/Day 29: 16-fold change - 3 - 6 Years
    92.50
    97.44
    0
        Visit 5/Day 29: 64-fold change - 3 - 6 Years
    90.00
    97.44
    0
        Visit 6/Day 85: 4-fold change - 3 - 6 Years
    94.59
    97.44
    0
        Visit 6/Day 85: 8-fold change - 3 - 6 Years
    94.59
    97.44
    0
        Visit 6/Day 85: 16-fold change - 3 - 6 Years
    91.89
    97.44
    0
        Visit 6/Day 85: 64-fold change - 3 - 6 Years
    70.27
    79.49
    0
        Visit 7/Day 180: 4-fold change - 3 - 6 Years
    95.00
    97.44
    0
        Visit 7/Day 180: 8-fold change - 3 - 6 Years
    92.50
    97.44
    0
        Visit 7/Day 180: 16-fold change - 3 - 6 Years
    90.00
    97.44
    0
        Visit 7/Day 180: 64-fold change - 3 - 6 Years
    45.00
    71.79
    0
        Visit 8/Day 365: 4-fold change - 3 - 6 Years
    92.50
    97.44
    0
        Visit 8/Day 365: 8-fold change - 3 - 6 Years
    92.50
    97.44
    0
        Visit 8/Day 365: 16-fold change - 3 - 6 Years
    87.50
    97.44
    0
        Visit 8/Day 365: 64-fold change - 3 - 6 Years
    62.50
    84.62
    0
        Visit 4/Day 15: 4-fold change - 1 -2 Years
    83.78
    89.74
    0
        Visit 4/Day 15: 8-fold change - 1 -2 Years
    83.78
    89.74
    0
        Visit 4/Day 15: 16-fold change - 1 -2 Years
    81.08
    89.74
    0
        Visit 4/Day 15: 64-fold change - 1 -2 Years
    75.68
    84.62
    0
        Visit 5/Day 29: 4-fold change - 1 -2 Years
    86.84
    89.74
    0
        Visit 5/Day 29: 8-fold change - 1 -2 Years
    84.21
    89.74
    0
        Visit 5/Day 29: 16-fold change - 1 -2 Years
    84.21
    89.74
    0
        Visit 5/Day 29: 64-fold change - 1 -2 Years
    84.21
    89.74
    0
        Visit 6/Day 85: 4-fold change - 1 -2 Years
    83.33
    90.00
    0
        Visit 6/Day 85: 8-fold change - 1 -2 Years
    83.33
    90.00
    0
        Visit 6/Day 85: 16-fold change - 1 -2 Years
    83.33
    90.00
    0
        Visit 6/Day 85: 64-fold change - 1 -2 Years
    66.67
    77.50
    0
        Visit 7/Day 180: 4-fold change - 1 -2 Years
    83.33
    92.31
    0
        Visit 7/Day 180: 8-fold change - 1 -2 Years
    83.33
    92.31
    0
        Visit 7/Day 180: 16-fold change - 1 -2 Years
    83.33
    92.31
    0
        Visit 7/Day 180: 64-fold change - 1 -2 Years
    58.33
    79.49
    0
        Visit 8/Day 365: 4-fold change - 1 -2 Years
    85.71
    89.74
    0
        Visit 8/Day 365: 8-fold change - 1 -2 Years
    82.86
    89.74
    0
        Visit 8/Day 365: 16-fold change - 1 -2 Years
    80.00
    89.74
    0
        Visit 8/Day 365: 64-fold change - 1 -2 Years
    74.29
    87.18
    0
    No statistical analyses for this end point

    Secondary: 31. Percentage of Participants Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold change in CHIKV-specific Neutralizing Antibody Titers Compared to Baseline by dose

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    End point title
    		 31. Percentage of Participants Reaching an at Least 4-fold, 8-fold, 16-fold or 64-fold change in CHIKV-specific Neutralizing Antibody Titers Compared to Baseline by dose
    End point description
    Percentage of Participants Reaching a 4-/8-/16-/64-Fold Change in Titers by Visit Pooled by Trial Arm.
    End point type
    Secondary
    End point timeframe
    at Day 15, Day 29, Day 85, Day 180 and Month 12
    End point values
    		 CHIKV vaccine Half Dose CHIKV vaccine Full Dose Nimenrix
    Number of subjects analysed
    107
    115
    53
    Units: percentage of participants
    number (not applicable)
        Visit 4/Day 15: 4-fold change
    88.57
    95.61
    0
        Visit 4/Day 15: 8-fold change
    88.57
    95.61
    0
        Visit 4/Day 15: 16-fold change
    87.62
    95.61
    0
        Visit 4/Day 15: 64-fold change
    78.10
    89.47
    0
        Visit 5/Day 29: 4-fold change
    89.72
    95.61
    0
        Visit 5/Day 29: 8-fold change
    88.79
    95.61
    0
        Visit 5/Day 29: 16-fold change
    88.79
    95.61
    0
        Visit 5/Day 29: 64-fold change
    86.92
    95.61
    0
        Visit 6/Day 85: 4-fold change
    89.22
    95.61
    0
        Visit 6/Day 85: 8-fold change
    89.22
    95.61
    0
        Visit 6/Day 85: 16-fold change
    88.24
    95.61
    0
        Visit 6/Day 85: 64-fold change
    70.59
    80.70
    0
        Visit 7/Day 180: 4-fold change
    89.52
    96.49
    0
        Visit 7/Day 180: 8-fold change
    88.57
    96.49
    0
        Visit 7/Day 180: 16-fold change
    87.62
    96.49
    0
        Visit 7/Day 180: 64-fold change
    55.24
    73.68
    0
        Visit 8/Day 365: 4-fold change
    89.42
    95.61
    0
        Visit 8/Day 365: 8-fold change
    88.46
    95.61
    0
        Visit 8/Day 365: 16-fold change
    85.58
    94.74
    0
        Visit 8/Day 365: 64-fold change
    69.23
    86.84
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    - Up to 14 days post-vaccination: solicited local and systemic AEs - Up to M6 and M12 post-vaccination: Unsolicited AEs - Up to M6 and M12 post-vaccination: SAEs - Within 2 to 21 days post-vaccination: early onset AESI - 22 days post-vaccination till*
    Adverse event reporting additional description
    *trial end: late onset AESI
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.1
    Reporting groups
    Reporting group title
    CHIKV vaccine Half Dose
    Reporting group description
    		 CHIKV vaccine Half Dose formulation (target 3.7 log 10 TCID50 per 0.5 mL)

    Reporting group title
    CHIKV vaccine Full Dose
    Reporting group description
    		 CHIKV vaccine Full Dose formulation (target 4.0 log 10 TCID50 per 0.5 mL)

    Reporting group title
    Nimenrix
    Reporting group description
    		 Nimenrix is a conjugate vaccine indicated for the active immunization of individuals from the age of 6 weeks against invasive meningococcal disease caused by Neisseria meningitidis groups A, C, W-135, and Y. Nimenrix is present as powder and solvent for solution for injection in pre-filled syringe. The reconstituted vaccine is a clear colourless solution. Nimenrix should be used in accordance with available official recommendations. Primary immunization in infants from 6 months of age, children, adolescents and adults: a single 0.5 mL dose should be administered.

    Serious adverse events
    		 CHIKV vaccine Half Dose CHIKV vaccine Full Dose Nimenrix
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 119 (1.68%)
    4 / 124 (3.23%)
    1 / 61 (1.64%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Immune system disorders
    Drug hypersensitivity
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 124 (0.81%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Faecaloma
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 119 (0.00%)
    1 / 124 (0.81%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthmatic crisis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 119 (0.00%)
    2 / 124 (1.61%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis perforated
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 119 (0.84%)
    0 / 124 (0.00%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 119 (0.84%)
    0 / 124 (0.00%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 119 (0.00%)
    0 / 124 (0.00%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 CHIKV vaccine Half Dose CHIKV vaccine Full Dose Nimenrix
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    93 / 119 (78.15%)
    98 / 124 (79.03%)
    48 / 61 (78.69%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    19 / 119 (15.97%)
    22 / 124 (17.74%)
    8 / 61 (13.11%)
         occurrences all number
    23
    24
    9
    General disorders and administration site conditions
    Injection site pain
         subjects affected / exposed
    19 / 119 (15.97%)
    16 / 124 (12.90%)
    7 / 61 (11.48%)
         occurrences all number
    26
    22
    11
    Pyrexia
         subjects affected / exposed
    24 / 119 (20.17%)
    19 / 124 (15.32%)
    6 / 61 (9.84%)
         occurrences all number
    26
    20
    6
    Gastrointestinal disorders
    Diarrhoea
    alternative assessment type: Non-systematic
         subjects affected / exposed
    6 / 119 (5.04%)
    11 / 124 (8.87%)
    7 / 61 (11.48%)
         occurrences all number
    6
    15
    9
    Vomiting
         subjects affected / exposed
    8 / 119 (6.72%)
    12 / 124 (9.68%)
    3 / 61 (4.92%)
         occurrences all number
    8
    13
    4
    Nausea
         subjects affected / exposed
    8 / 119 (6.72%)
    2 / 124 (1.61%)
    1 / 61 (1.64%)
         occurrences all number
    8
    2
    1
    Respiratory, thoracic and mediastinal disorders
    Rhinitis allergic
    alternative assessment type: Non-systematic
         subjects affected / exposed
    11 / 119 (9.24%)
    13 / 124 (10.48%)
    8 / 61 (13.11%)
         occurrences all number
    14
    15
    13
    Allergic cough
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 119 (2.52%)
    1 / 124 (0.81%)
    4 / 61 (6.56%)
         occurrences all number
    4
    1
    4
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    8 / 119 (6.72%)
    4 / 124 (3.23%)
    1 / 61 (1.64%)
         occurrences all number
    8
    4
    1
    Infections and infestations
    Nasopharyngitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    60 / 119 (50.42%)
    59 / 124 (47.58%)
    27 / 61 (44.26%)
         occurrences all number
    103
    126
    52
    Viral infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    6 / 119 (5.04%)
    8 / 124 (6.45%)
    9 / 61 (14.75%)
         occurrences all number
    10
    9
    11
    Gastroenteritis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 119 (1.68%)
    8 / 124 (6.45%)
    2 / 61 (3.28%)
         occurrences all number
    2
    8
    2
    Tonsilitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    6 / 119 (5.04%)
    4 / 124 (3.23%)
    1 / 61 (1.64%)
         occurrences all number
    6
    4
    1
    Metabolism and nutrition disorders
    Decreased appetite
    alternative assessment type: Non-systematic
         subjects affected / exposed
    4 / 119 (3.36%)
    9 / 124 (7.26%)
    1 / 61 (1.64%)
         occurrences all number
    4
    9
    1

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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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