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    Clinical Trial Results:
    A Multicenter, Randomized, Controlled, Double Blinded Pivotal Study to Evaluate Safety and Immunogenicity of a Live-attenuated Chikungunya Virus Vaccine Candidate (VLA1553) in Adolescents Aged 12 Years to <18 Years PIP #: P/0457/2021 and P/0501/2023

    Summary
    EudraCT number
    		 2026-000021-16
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    16 Feb 2024

    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
    VLA1553-321
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04650399
    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
    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
    23 Jan 2025
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Feb 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate immunogenicity and safety of the full dose of the live-attenuated CHIKV vaccine candidate (VLA1553) 28 days following vaccination in adolescents aged 12 years to <18 years after a single immunization.
    Protection of trial subjects
    Informed Consent, Anonymisation of Data
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    14 Feb 2022
    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
    Brazil: 754
    Worldwide total number of subjects
    754
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    754
    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
    		 Overall 947 participants were screened

    Pre-assignment
    Screening details
    		 Out of the 947 screened participants, 6 were re-screened, so 941 unique participants were screened. There were 176 screen failures.

    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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Active
    Arm description
    		 Single intramuscular vaccination on Day 1 with VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate 1x10E4 TCID50 per dose (0.5 mL)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Chikungunya vaccine
    Investigational medicinal product code
    VLA1553
    Other name
    Pharmaceutical forms
    Solution for injection in vial
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Single intramuscular vaccination on Day 1 with VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate 1x10E4 TCID50 per dose (0.5 mL)

    Arm title
    		 Placebo
    Arm description
    		 Single intramuscular vaccination on Day 1 with Phosphate-Buffered Saline (PBS) as placebo (0.5 mL)
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in vial
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Single intramuscular vaccination on Day 1 with Phosphate-Buffered Saline (PBS) as placebo (0.5 mL)

    Number of subjects in period 1
    		Active Placebo
    Started
    502
    252
    Completed
    488
    246
    Not completed
    14
    6
         Consent withdrawn by subject
    6
    3
         Consent withdrawn by parents
    1
    -
         Lost to follow-up
    7
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Active
    Reporting group description
    		 Single intramuscular vaccination on Day 1 with VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate 1x10E4 TCID50 per dose (0.5 mL)

    Reporting group title
    Placebo
    Reporting group description
    		 Single intramuscular vaccination on Day 1 with Phosphate-Buffered Saline (PBS) as placebo (0.5 mL)

    Reporting group values
    		 Active Placebo Total
    Number of subjects
    		 502 252 754
    Age categorical
    Units: Subjects
        12 -< 15 Years
    		 244 129 373
        15 -< 18Years
    		 258 123 381
    Age continuous
    Units: years
        geometric mean (standard deviation)
    		 14.5 ( 1.70 ) 14.4 ( 1.66 ) -
    Gender categorical
    Units: Subjects
        Female
    		 269 137 406
        Male
    		 233 115 348
    Subject analysis sets

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

    Subject analysis set title
    Per-Protocol Analysis
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The PP contains all IMM subjects (IMM population is defined to include all randomized and vaccinated subjects of the immunogenicity subset who have evaluable μPRNT antibody titer results at baseline and at least one post-baseline titer measurement after vaccination.) who have no major protocol deviations that could impact immune response.

    Subject analysis sets values
    		 Safety Analysis Per-Protocol Analysis
    Number of subjects
    754
    351
    Age categorical
    Units: Subjects
        12 -< 15 Years
    373
    167
        15 -< 18Years
    381
    184
    Age continuous
    Units: years
        geometric mean (standard deviation)
    14.5 ( 1.68 )
    14.5 ( 1.71 )
    Gender categorical
    Units: Subjects
        Female
    406
    183
        Male
    348
    168

    End points

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    End points reporting groups
    Reporting group title
    Active
    Reporting group description
    		 Single intramuscular vaccination on Day 1 with VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate 1x10E4 TCID50 per dose (0.5 mL)

    Reporting group title
    Placebo
    Reporting group description
    		 Single intramuscular vaccination on Day 1 with Phosphate-Buffered Saline (PBS) as placebo (0.5 mL)

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

    Subject analysis set title
    Per-Protocol Analysis
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The PP contains all IMM subjects (IMM population is defined to include all randomized and vaccinated subjects of the immunogenicity subset who have evaluable μPRNT antibody titer results at baseline and at least one post-baseline titer measurement after vaccination.) who have no major protocol deviations that could impact immune response.

    Primary: Seroresponse

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    End point title
    		 Seroresponse [1]
    End point description
    Percentage of subjects with seroresponse CHIKV antibody level determined as μPRNT50>= 150 (Micro Plaque Reduction Neutralization Test 50%) for baseline negative subjects 28 days post-vaccination.
    End point type
    Primary
    End point timeframe
    Day 29 after single 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: here a subset for baseline negative subjects was used
    End point values
    		 Active Placebo
    Number of subjects analysed
    251
    42
    Units: percentage of participants
        number (not applicable)
    98.8
    2.4
    No statistical analyses for this end point

    Secondary: CHIKV-specific Antibody Titers as GMTs up to 1 Year

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    End point title
    		 CHIKV-specific Antibody Titers as GMTs up to 1 Year
    End point description
    Immune response as measured by CHIKV-specific neutralizing antibody titers on Day 1, Day 8, Day 29, Day 85, Day 180 (Month 6) and Day 365 (Month 12) post vaccination as determined by μPRNT
    End point type
    Secondary
    End point timeframe
    Day 1, Day 8, Day 29, Day 85, Day 180 (Month 6) and Day 365 (Month 12) post vaccination
    End point values
    		 Active Placebo
    Number of subjects analysed
    251
    42
    Units: units on a scale
    geometric mean (confidence interval 95%)
        Day 1
    10.6 (10.31 to 10.89)
    11.7 (10.46 to 13.17)
        Day 8
    17.6 (15.41 to 20.06)
    10.6 (9.75 to 11.44)
        Day 29
    3855.9 (3432.05 to 4331.98)
    12.3 (9.63 to 15.79)
        Day 85
    1704.30 (1547.68 to 1876.82)
    10.0 (10.0 to 10.0)
        Day 180
    1359.9 (1222.34 to 1512.87)
    10.0 (10.0 to 10.0)
        Day 365
    1283.9 (1145.99 to 1438.45)
    10.0 (10.0 to 10.0)
    No statistical analyses for this end point

    Secondary: Seroresponse up to 1 Year

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    End point title
    		 Seroresponse up to 1 Year
    End point description
    Percentage of subjects with seroresponse defined as μPRNT50 ≥ 150 for μPRNT baseline negative subjects on Day 8, Day 85, Day 180 and Month 12 post-vaccination as determined by μPRNT
    End point type
    Secondary
    End point timeframe
    Day 8, Day 85, Day 180, and Month 12 after vaccination
    End point values
    		 Active Placebo
    Number of subjects analysed
    251
    42
    Units: percentage of participants
    number (not applicable)
        Day 8
    5.7
    0.0
        Day 85
    99.2
    0.0
        Day 180
    98.8
    0.0
        Day 365
    98.3
    0.0
    No statistical analyses for this end point

    Secondary: Seroconversion up to 1 Year Defined as > 4-fold Increase of μPRNT50 Compared to Baseline

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    End point title
    		 Seroconversion up to 1 Year Defined as > 4-fold Increase of μPRNT50 Compared to Baseline
    End point description
    Percentage of subjects with seroconversion defined as > 4-fold increase of μPRNT50 compared to baseline at Day 29, Month 6 and Month 12 as determined by μPRNT assay in µPRNT baseline seronegative subjects
    End point type
    Secondary
    End point timeframe
    12 months after vaccination
    End point values
    		 Active Placebo
    Number of subjects analysed
    251
    42
    Units: precentage of participants
    number (not applicable)
        Day 29
    98.8
    2.38
        Day 180
    99.18
    0.0
        Day 365
    99.15
    0.0
    No statistical analyses for this end point

    Secondary: Fold Change in Neutralizing Antibodies Compared to Baseline

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    End point title
    		 Fold Change in Neutralizing Antibodies Compared to Baseline
    End point description
    Fold change of CHIKV-specific neutralizing antibody titers determined by μPRNT assay in µPRNT baseline seronegative subjects at Days 8, 29, 85, 180 and at Month 12 post-vaccination as compared to baseline
    End point type
    Secondary
    End point timeframe
    up to 12 months after vaccination
    End point values
    		 Active Placebo
    Number of subjects analysed
    251
    42
    Units: fold change
    geometric mean (standard deviation)
        Day 8
    8.18 ( 49.483 )
    0.93 ( 0.201 )
        Day 29
    495.60 ( 379.063 )
    4.05 ( 19.660 )
        Day 85
    202.73 ( 141.663 )
    0.90 ( 0.235 )
        Day 180
    177.17 ( 180.146 )
    0.90 ( 0.235 )
        Day 365
    165.51 ( 147.792 )
    0.91 ( 0.215 )
    No statistical analyses for this end point

    Secondary: percentage of participants reaching a pre-specified change in Neutralizing Antibody Titers at Month 12 Compared to Baseline

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    End point title
    		 percentage of participants reaching a pre-specified change in Neutralizing Antibody Titers at Month 12 Compared to Baseline
    End point description
    Percentage of subjects reaching an at least 4-fold, 8-fold, 16-fold or 64-fold change in CHIKV-specific neutralizing antibody titer compared to baseline as measured by μPRNT assay in µPRNT baseline seronegative subjects
    End point type
    Secondary
    End point timeframe
    12 months after vaccination
    End point values
    		 Active Placebo
    Number of subjects analysed
    251
    42
    Units: percentage of participants
    number (not applicable)
        4-fold change - GMT: reached
    99.15
    0
        8-fold change - GMT: reached
    98.73
    0
        16-fold change - GMT: reached
    98.31
    0
        64-fold change - GMT: reached
    82.2
    0
    No statistical analyses for this end point

    Secondary: Number of Participants With Unsolicited Adverse Events

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    End point title
    		 Number of Participants With Unsolicited Adverse Events
    End point description
    Frequency of unsolicited AEs at Day 29 and Month 6 post-vaccination
    End point type
    Secondary
    End point timeframe
    up to 6 months after vaccination
    End point values
    		 Active Placebo
    Number of subjects analysed
    502
    252
    Units: participants
    number (not applicable)
        Day 29
    196
    81
        Day 180
    309
    148
    No statistical analyses for this end point

    Secondary: Number of Participants With Solicited Adverse Events

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    End point title
    		 Number of Participants With Solicited Adverse Events
    End point description
    Frequency of solicited injection site and systemic adverse events within ten days post-vaccination
    End point type
    Secondary
    End point timeframe
    up to 10 days after vaccination
    End point values
    		 Active Placebo
    Number of subjects analysed
    502
    252
    Units: participants
    number (not applicable)
        Any solicited systemic adverse Event
    319
    107
        Any solicited injection site adverse event
    160
    62
    No statistical analyses for this end point

    Secondary: Number of Participants With Adverse Event of Special Interest

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    End point title
    		 Number of Participants With Adverse Event of Special Interest
    End point description
    Frequency of any Adverse Event of Special Interest: The following cluster of symptoms with or without remissions or exacerbations received particular consideration and were defined as early onset AESI: 1. Fever (≥37.8°C measured axillary); and 2. Acute (poly)arthralgia/arthritis, myalgia, neurological symptoms (e.g., meningoencephalitis, acute encephalitis, headache, seizures), retinitis/uveitis; 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 and ecchymosis; and 3. Onset of symptoms 2 to 21 days after vaccination (i.e., Day 3 to Day 22); and 4. Duration of event ≥3 days, Onset of symptoms 22 days post vaccination or later (Day 23 – study end) was defined as late onset AESI.
    End point type
    Secondary
    End point timeframe
    until 12 month after vaccination
    End point values
    		 Active Placebo
    Number of subjects analysed
    502
    252
    Units: participants
    number (not applicable)
        Early Onset AESI
    17
    2
        Late Onset AESI
    38
    17
    No statistical analyses for this end point

    Secondary: Number of Participants With Serious Adverse Events

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    End point title
    		 Number of Participants With Serious Adverse Events
    End point description
    Frequency and relatedness of any Serious Adverse Event (SAE) during the entire study period
    End point type
    Secondary
    End point timeframe
    until 12 months after vaccination
    End point values
    		 Active Placebo
    Number of subjects analysed
    502
    252
    Units: participants
    number (not applicable)
        Frequency of SAE
    11
    5
        Frequency of related SAE
    1
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    up to 10 days after vaccination - Solicited Adverse Events up to 6 months after vaccinattion - Unsolicited Adverse Events up to 12 months after vaccination - Serious Adverse Events and Adverse Event of Special Interest
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    Active
    Reporting group description
    		 Single intramuscular vaccination on Day 1 with VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate 1x10E4 TCID50 per dose

    Reporting group title
    Placebo
    Reporting group description
    		 Single intramuscular vaccination on Day 1 with Phosphate-Buffered Saline (PBS) as placebo

    Serious adverse events
    		 Active Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    11 / 502 (2.19%)
    5 / 252 (1.98%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Investigations
    Prothrombin time prolonged
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 252 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transaminase increase
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 252 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Arthropod sting
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 252 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower limb fracture
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 252 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Juvenile myoclonic epilepsy
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 252 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seizure
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 252 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 252 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 252 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Suicidal ideation
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 252 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Appendicitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 252 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cat scratch disease
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 252 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dengue fever
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 252 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 252 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 502 (0.00%)
    1 / 252 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 502 (0.20%)
    1 / 252 (0.40%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyperkalemia
         subjects affected / exposed
    1 / 502 (0.20%)
    0 / 252 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Active Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    396 / 502 (78.88%)
    171 / 252 (67.86%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    284 / 502 (56.57%)
    114 / 252 (45.24%)
         occurrences all number
    393
    160
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    117 / 502 (23.31%)
    30 / 252 (11.90%)
         occurrences all number
    123
    32
    Injection site pain
         subjects affected / exposed
    149 / 502 (29.68%)
    55 / 252 (21.83%)
         occurrences all number
    198
    72
    Pyrexia
         subjects affected / exposed
    194 / 502 (38.65%)
    68 / 252 (26.98%)
         occurrences all number
    276
    86
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    99 / 502 (19.72%)
    41 / 252 (16.27%)
         occurrences all number
    108
    49
    Odynophagia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    44 / 502 (8.76%)
    26 / 252 (10.32%)
         occurrences all number
    52
    36
    Vomiting
         subjects affected / exposed
    30 / 502 (5.98%)
    24 / 252 (9.52%)
         occurrences all number
    34
    28
    Respiratory, thoracic and mediastinal disorders
    Cough
    alternative assessment type: Non-systematic
         subjects affected / exposed
    50 / 502 (9.96%)
    26 / 252 (10.32%)
         occurrences all number
    61
    35
    Oropharyngeal pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    24 / 502 (4.78%)
    17 / 252 (6.75%)
         occurrences all number
    25
    17
    Rhinorrhoea
    alternative assessment type: Non-systematic
         subjects affected / exposed
    19 / 502 (3.78%)
    16 / 252 (6.35%)
         occurrences all number
    23
    18
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    74 / 502 (14.74%)
    19 / 252 (7.54%)
         occurrences all number
    75
    20
    Myalgia
         subjects affected / exposed
    162 / 502 (32.27%)
    49 / 252 (19.44%)
         occurrences all number
    186
    61
    Infections and infestations
    Influenza
    alternative assessment type: Non-systematic
         subjects affected / exposed
    40 / 502 (7.97%)
    18 / 252 (7.14%)
         occurrences all number
    47
    18
    Rhinitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    19 / 502 (3.78%)
    14 / 252 (5.56%)
         occurrences all number
    22
    19

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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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    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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