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    Clinical Trial Results:
    Feasibility of Randomizing Danish Citizens Aged 65-79 Years to High-Dose Quadrivalent Influenza Vaccine vs. Standard-Dose Quadrivalent Influenza Vaccine in a Pragmatic Registry-Based Setting

    Summary
    EudraCT number
    		 2021-003170-31
    Trial protocol
    		 DK  
    Global end of trial date
    31 May 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    17 Jun 2023
    First version publication date
    17 Jun 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    QHD00027
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05048589
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Herlev and Gentofte Hospital
    Sponsor organisation address
    Gentofte Hospitalsvej 8, 3.th., Hellerup, Denmark, 2900
    Public contact
    Niklas Dyrby Johansen, Herlev and Gentofte Hospital, +45 20204794, niklas.dyrby.johansen@regionh.dk
    Scientific contact
    Niklas Dyrby Johansen, Herlev and Gentofte Hospital, +45 20204794, niklas.dyrby.johansen@regionh.dk
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    20 Jun 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 May 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    31 May 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Descriptive objective 1: Identifying and recruiting a large sample of Danish citizens aged 65-79 years in the coming 2021/2022 influenza season to assess feasibility, reliability, and validity of the proposed pragmatic RCT study design as assessed by operational endpoints
    Protection of trial subjects
    The trial was approved by the Regional Danish Committee on Biomedical Research Ethics and the Danish Medicines Agency and conducted in accordance with the Declaration of Helsinki. All participants provided written informed consent.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Oct 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 12551
    Worldwide total number of subjects
    12551
    EEA total number of subjects
    12551
    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)
    0
    Adults (18-64 years)
    2
    From 65 to 84 years
    12549
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 12551
    Number of subjects completed
    		 12477

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Consent withdrawn by subject: 72
    Reason: Number of subjects
    		 Protocol deviation: 2
    Period 1
    Period 1 title
    Overall trial period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 High-Dose Quadrivalent Influenza Vaccine
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    High-Dose Quadrivalent Influenza Vaccine
    Investigational medicinal product code
    MA number: 62663, ATC: J07BB02
    Other name
    Efluelda®, Fluzone® High-Dose Quadrivalent
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Single dose vaccine, 60 micrograms of hemagglutinin antigen for each of the 4 influenza strains

    Arm title
    		 Standard-Dose Quadrivalent Influenza Vaccine
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Standard-Dose Quadrivalent Influenza Vaccine
    Investigational medicinal product code
    ATC: J07BB02
    Other name
    Influvactetra, Vaxigriptetra
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Single dose vaccine, 15 micrograms of hemagglutinin antigen for each of the 4 influenza strains

    Number of subjects in period 1 [1]
    		High-Dose Quadrivalent Influenza Vaccine Standard-Dose Quadrivalent Influenza Vaccine
    Started
    6245
    6232
    Completed
    6245
    6232
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Since we are unable to include data for participants excluded due to withdrawn consent and protocol deviations in this report, we had to technically exclude those prior to the baseline period in this system.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    High-Dose Quadrivalent Influenza Vaccine
    Reporting group description
    		 -

    Reporting group title
    Standard-Dose Quadrivalent Influenza Vaccine
    Reporting group description
    		 -

    Reporting group values
    		 High-Dose Quadrivalent Influenza Vaccine Standard-Dose Quadrivalent Influenza Vaccine Total
    Number of subjects
    		 6245 6232 12477
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 0 0 0
        From 65-84 years
    		 6245 6232 12477
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 71.8 ( 3.9 ) 71.7 ( 3.9 ) -
    Gender categorical
    Units: Subjects
        Female
    		 2956 2921 5877
        Male
    		 3289 3311 6600
    Chronic cardiovascular disease
    Units: Subjects
        Chronic cardiovascular disease
    		 1227 1313 2540
        No chronic cardiovascular disease
    		 5018 4919 9937
    Ischemic heart disease
    Units: Subjects
        Ischemic heart disease
    		 450 512 962
        No ischemic heart disease
    		 5795 5720 11515
    Atrial fibrillation
    Units: Subjects
        Atrial fibrillation
    		 458 420 878
        No atrial fibrillation
    		 5787 5812 11599
    Cerebrovascular disease
    Units: Subjects
        Cerebrovascular disease
    		 219 237 456
        No cerebrovascular disease
    		 6026 5995 12021
    Hypertension
    Units: Subjects
        Hypertension
    		 3254 3215 6469
        No hypertension
    		 2991 3017 6008
    Diabetes
    Units: Subjects
        Diabetes
    		 574 588 1162
        No diabetes
    		 5671 5644 11315
    Chronic lung disease
    Units: Subjects
        Chronic lung disease
    		 435 415 850
        No chronic lung disease
    		 5810 5817 11627
    Chronic obstructive pulmonary disease
    Units: Subjects
        Chronic obstructive pulmonary disease
    		 227 190 417
        No chronic obstructive pulmonary disease
    		 6018 6042 12060
    Cancer
    Units: Subjects
        Cancer
    		 695 668 1363
        No cancer
    		 5550 5564 11114
    Immunodeficiency
    Units: Subjects
        Immunodeficiency
    		 244 239 483
        No immunodeficiency
    		 6001 5993 11994
    Subject analysis sets

    Subject analysis set title
    Full analysis set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Full analysis set

    Subject analysis sets values
    		 Full analysis set
    Number of subjects
    12477
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
        Newborns (0-27 days)
    0
        Infants and toddlers (28 days-23 months)
    0
        Children (2-11 years)
    0
        Adolescents (12-17 years)
    0
        Adults (18-64 years)
    0
        From 65-84 years
    12477
        85 years and over
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    ( )
    Gender categorical
    Units: Subjects
        Female
        Male
    Chronic cardiovascular disease
    Units: Subjects
        Chronic cardiovascular disease
    2540
        No chronic cardiovascular disease
    9937
    Ischemic heart disease
    Units: Subjects
        Ischemic heart disease
    962
        No ischemic heart disease
    11515
    Atrial fibrillation
    Units: Subjects
        Atrial fibrillation
    878
        No atrial fibrillation
    11599
    Cerebrovascular disease
    Units: Subjects
        Cerebrovascular disease
    456
        No cerebrovascular disease
    12021
    Hypertension
    Units: Subjects
        Hypertension
    6469
        No hypertension
    6008
    Diabetes
    Units: Subjects
        Diabetes
    1162
        No diabetes
    11315
    Chronic lung disease
    Units: Subjects
        Chronic lung disease
    850
        No chronic lung disease
    11627
    Chronic obstructive pulmonary disease
    Units: Subjects
        Chronic obstructive pulmonary disease
    417
        No chronic obstructive pulmonary disease
    12060
    Cancer
    Units: Subjects
        Cancer
    1363
        No cancer
    11114
    Immunodeficiency
    Units: Subjects
        Immunodeficiency
    483
        No immunodeficiency
    11994

    End points

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    End points reporting groups
    Reporting group title
    High-Dose Quadrivalent Influenza Vaccine
    Reporting group description
    		 -

    Reporting group title
    Standard-Dose Quadrivalent Influenza Vaccine
    Reporting group description
    		 -

    Subject analysis set title
    Full analysis set
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Full analysis set

    Primary: Number of participants included and randomized

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    End point title
    		 Number of participants included and randomized [1]
    End point description
    The trial was a pilot/feasibility trial. This endpoint is a feasibility endpoint describing the total number of participants included and randomized. This endpoint was assigned as the primary endpoint for technical reasons only.
    End point type
    Primary
    End point timeframe
    01/10/2021 to 20/11/2021
    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: The trial was a pilot/feasibility trial with only descriptive endpoints/objectives.
    End point values
    		 Full analysis set
    Number of subjects analysed
    [2]
    Units: Persons
        Feasibility
    12551
    Notes
    [2] - Feasibility endpoint describing the total number of participants included and randomized.
    No statistical analyses for this end point

    Other pre-specified: Number of persons contacted by recruitment letter

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    End point title
    		 Number of persons contacted by recruitment letter
    End point description
    The trial was a pilot/feasibility trial. This endpoint is a feasibility endpoint describing the total number of persons contacted by recruitment letter.
    End point type
    Other pre-specified
    End point timeframe
    24/09/2021 to 01/10/2021
    End point values
    		 Full analysis set
    Number of subjects analysed
    [3]
    Units: Persons
        Feasibility
    34000
    Notes
    [3] - Feasibility endpoint describing the total number of persons contacted by recruitment letter.
    No statistical analyses for this end point

    Other pre-specified: Agreement between randomized assignment and actual received vaccine

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    End point title
    		 Agreement between randomized assignment and actual received vaccine
    End point description
    End point type
    Other pre-specified
    End point timeframe
    The trial was a pilot/feasibility trial. This endpoint is a feasibility endpoint describing the agreement between randomized assignment and actual received vaccine in each randomization group.
    End point values
    		 High-Dose Quadrivalent Influenza Vaccine Standard-Dose Quadrivalent Influenza Vaccine
    Number of subjects analysed
    6245
    6232
    Units: Participants receiving correct vaccine
        Feasibility
    6242
    6226
    No statistical analyses for this end point

    Other pre-specified: Hospitalization for influenza or pneumonia

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    End point title
    		 Hospitalization for influenza or pneumonia
    End point description
    End point type
    Other pre-specified
    End point timeframe
    14 days after vaccination to 31/05/2022
    End point values
    		 High-Dose Quadrivalent Influenza Vaccine Standard-Dose Quadrivalent Influenza Vaccine
    Number of subjects analysed
    6245
    6232
    Units: Participants
        Vaccine effectiveness
    10
    28
    Statistical analysis title
    		 rVE for hospitalization for pneumonia or influenza
    Statistical analysis description
    The trial was a pilot/feasibility trial. Descriptive relative vaccine effectiveness (rVE) estimates were calculated without statistical hypothesis testing.
    Comparison groups
    Standard-Dose Quadrivalent Influenza Vaccine v High-Dose Quadrivalent Influenza Vaccine
    Number of subjects included in analysis
    12477
    Analysis specification
    Pre-specified
    Analysis type
    		 other [4]
    Method
    Parameter type
    		 Relative vaccine effectiveness
    Point estimate
    64.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 24.4
         upper limit
    		 84.6
    Notes
    [4] - Descriptive estimate.

    Other pre-specified: Hospitalization for respiratory disease

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    End point title
    		 Hospitalization for respiratory disease
    End point description
    End point type
    Other pre-specified
    End point timeframe
    14 days after vaccination to 31/05/2022
    End point values
    		 High-Dose Quadrivalent Influenza Vaccine Standard-Dose Quadrivalent Influenza Vaccine
    Number of subjects analysed
    6245
    6232
    Units: Participants
        Vaccine effectiveness
    24
    40
    Statistical analysis title
    		 rVE for hospitalization for respiratory disease
    Statistical analysis description
    The trial was a pilot/feasibility trial. Descriptive relative vaccine effectiveness (rVE) estimates were calculated without statistical hypothesis testing.
    Comparison groups
    High-Dose Quadrivalent Influenza Vaccine v Standard-Dose Quadrivalent Influenza Vaccine
    Number of subjects included in analysis
    12477
    Analysis specification
    Pre-specified
    Analysis type
    		 other [5]
    Method
    Parameter type
    		 Relative vaccine effectiveness
    Point estimate
    40.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.8
         upper limit
    		 65.5
    Notes
    [5] - Descriptive estimate.

    Other pre-specified: Hospitalization for cardio-respiratory disease

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    End point title
    		 Hospitalization for cardio-respiratory disease
    End point description
    End point type
    Other pre-specified
    End point timeframe
    14 days after vaccination to 31/05/2022
    End point values
    		 High-Dose Quadrivalent Influenza Vaccine Standard-Dose Quadrivalent Influenza Vaccine
    Number of subjects analysed
    6245
    6232
    Units: Participants
        Vaccine effectiveness
    103
    117
    Statistical analysis title
    		 rVE for cardiorespiratory hospitalization
    Statistical analysis description
    The trial was a pilot/feasibility trial. Descriptive relative vaccine effectiveness (rVE) estimates were calculated without statistical hypothesis testing.
    Comparison groups
    High-Dose Quadrivalent Influenza Vaccine v Standard-Dose Quadrivalent Influenza Vaccine
    Number of subjects included in analysis
    12477
    Analysis specification
    Pre-specified
    Analysis type
    		 other [6]
    Method
    Parameter type
    		 Relative vaccine effectiveness
    Point estimate
    12.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -15.5
         upper limit
    		 33.3
    Notes
    [6] - Descriptive estimate.

    Other pre-specified: Hospitalization for cardiovascular disease

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    End point title
    		 Hospitalization for cardiovascular disease
    End point description
    End point type
    Other pre-specified
    End point timeframe
    14 days after vaccination to 31/05/2022
    End point values
    		 High-Dose Quadrivalent Influenza Vaccine Standard-Dose Quadrivalent Influenza Vaccine
    Number of subjects analysed
    6245
    6232
    Units: Participants
        Vaccine effectiveness
    82
    81
    Statistical analysis title
    		 rVE for cardiovascular hospitalization
    Statistical analysis description
    The trial was a pilot/feasibility trial. Descriptive relative vaccine effectiveness (rVE) estimates were calculated without statistical hypothesis testing.
    Comparison groups
    High-Dose Quadrivalent Influenza Vaccine v Standard-Dose Quadrivalent Influenza Vaccine
    Number of subjects included in analysis
    12477
    Analysis specification
    Pre-specified
    Analysis type
    		 other [7]
    Method
    Parameter type
    		 Relative vaccine effectiveness
    Point estimate
    -1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -39.1
         upper limit
    		 26.6
    Notes
    [7] - Descriptive estimate.

    Other pre-specified: Hospitalization for any cause

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    End point title
    		 Hospitalization for any cause
    End point description
    End point type
    Other pre-specified
    End point timeframe
    14 days after vaccination to 31/05/2022
    End point values
    		 High-Dose Quadrivalent Influenza Vaccine Standard-Dose Quadrivalent Influenza Vaccine
    Number of subjects analysed
    6245
    6232
    Units: Participants
        Vaccine effectiveness
    513
    550
    Statistical analysis title
    		 rVE for hospitalization for any cause
    Statistical analysis description
    The trial was a pilot/feasibility trial. Descriptive relative vaccine effectiveness (rVE) estimates were calculated without statistical hypothesis testing.
    Comparison groups
    High-Dose Quadrivalent Influenza Vaccine v Standard-Dose Quadrivalent Influenza Vaccine
    Number of subjects included in analysis
    12477
    Analysis specification
    Pre-specified
    Analysis type
    		 other [8]
    Method
    Parameter type
    		 Relative vaccine effectiveness
    Point estimate
    6.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.2
         upper limit
    		 17.6
    Notes
    [8] - Descriptive estimate.

    Other pre-specified: All-cause death

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    End point title
    		 All-cause death
    End point description
    End point type
    Other pre-specified
    End point timeframe
    14 days after vaccination to 31/05/2022
    End point values
    		 High-Dose Quadrivalent Influenza Vaccine Standard-Dose Quadrivalent Influenza Vaccine
    Number of subjects analysed
    6245
    6232
    Units: Participants
        Vaccine effectiveness
    21
    41
    Statistical analysis title
    		 rVE for all-cause death
    Statistical analysis description
    The trial was a pilot/feasibility trial. Descriptive relative vaccine effectiveness (rVE) estimates were calculated without statistical hypothesis testing.
    Comparison groups
    High-Dose Quadrivalent Influenza Vaccine v Standard-Dose Quadrivalent Influenza Vaccine
    Number of subjects included in analysis
    12477
    Analysis specification
    Pre-specified
    Analysis type
    		 other [9]
    Method
    Parameter type
    		 Relative vaccine effectiveness
    Point estimate
    48.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 11.5
         upper limit
    		 71.3
    Notes
    [9] - Descriptive estimate.

    Other pre-specified: Hospitalization for COVID-19

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    End point title
    		 Hospitalization for COVID-19
    End point description
    End point type
    Other pre-specified
    End point timeframe
    14 days after vaccination to 31/05/2022
    End point values
    		 High-Dose Quadrivalent Influenza Vaccine Standard-Dose Quadrivalent Influenza Vaccine
    Number of subjects analysed
    6245
    6232
    Units: Participants
        Vaccine effectiveness
    15
    12
    Statistical analysis title
    		 rVE for hospitalization for COVID-19
    Statistical analysis description
    The trial was a pilot/feasibility trial. Descriptive relative vaccine effectiveness (rVE) estimates were calculated without statistical hypothesis testing.
    Comparison groups
    High-Dose Quadrivalent Influenza Vaccine v Standard-Dose Quadrivalent Influenza Vaccine
    Number of subjects included in analysis
    12477
    Analysis specification
    Pre-specified
    Analysis type
    		 other [10]
    Method
    Parameter type
    		 Relative vaccine effectiveness
    Point estimate
    -24.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -191.9
         upper limit
    		 45.5
    Notes
    [10] - Descriptive estimate.

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    From time of vaccination until approx. 3 months after vaccination.
    Adverse event reporting additional description
    Safety surveillance was performed using a registry-based approach, and after agreement with applicable authorities, only serious adverse events (SAEs), defined in this pragmatic trial as deaths and hospitalizations, were recorded.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 ICD-10
    Dictionary version
    10
    Reporting groups
    Reporting group title
    Standard-Dose Quadrivalent Influenza Vaccine
    Reporting group description
    		 Participants receiving standard-dose quadrivalent influenza vaccine

    Reporting group title
    High-Dose Quadrivalent Influenza Vaccine
    Reporting group description
    		 Participants receiving high-dose quadrivalent influenza vaccine

    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: In agreement with applicable authorities, only serious adverse events were recorded in this pragmatic randomized trial.
    Serious adverse events
    		 Standard-Dose Quadrivalent Influenza Vaccine High-Dose Quadrivalent Influenza Vaccine
    Total subjects affected by serious adverse events
         subjects affected / exposed
    405 / 6229 (6.50%)
    373 / 6248 (5.97%)
         number of deaths (all causes)
    13
    8
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Injury
    Additional description: Injury-related SAEs
         subjects affected / exposed
    98 / 6229 (1.57%)
    94 / 6248 (1.50%)
         occurrences causally related to treatment / all
    0 / 100
    0 / 101
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiovascular disorder
    Additional description: Cardiovascular SAEs
         subjects affected / exposed
    87 / 6229 (1.40%)
    63 / 6248 (1.01%)
         occurrences causally related to treatment / all
    0 / 107
    0 / 71
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Death
    Additional description: Deaths during safety surveillance period
         subjects affected / exposed
    13 / 6229 (0.21%)
    8 / 6248 (0.13%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 8
         deaths causally related to treatment / all
    0 / 8
    0 / 8
    Hyperthermia
    Additional description: Fever, unspecified
         subjects affected / exposed
    1 / 6229 (0.02%)
    1 / 6248 (0.02%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Headache
    Additional description: Headache, unspecified
         subjects affected / exposed
    3 / 6229 (0.05%)
    3 / 6248 (0.05%)
         occurrences causally related to treatment / all
    2 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastrointestinal disorder
    Additional description: Gastrointestinal SAEs
         subjects affected / exposed
    24 / 6229 (0.39%)
    23 / 6248 (0.37%)
         occurrences causally related to treatment / all
    0 / 28
    0 / 23
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Respiratory disorder
    Additional description: Respiratory SAEs
         subjects affected / exposed
    26 / 6229 (0.42%)
    24 / 6248 (0.38%)
         occurrences causally related to treatment / all
    0 / 32
    0 / 27
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chest pain
         subjects affected / exposed
    16 / 6229 (0.26%)
    20 / 6248 (0.32%)
         occurrences causally related to treatment / all
    0 / 19
    1 / 21
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Skin discomfort
    Additional description: Disturbances of skin sensation
         subjects affected / exposed
    3 / 6229 (0.05%)
    0 / 6248 (0.00%)
         occurrences causally related to treatment / all
    1 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Infection
    Additional description: Infection-related SAEs
         subjects affected / exposed
    19 / 6229 (0.31%)
    22 / 6248 (0.35%)
         occurrences causally related to treatment / all
    0 / 25
    0 / 28
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Standard-Dose Quadrivalent Influenza Vaccine High-Dose Quadrivalent Influenza Vaccine
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 6229 (0.00%)
    0 / 6248 (0.00%)

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    19 Oct 2021
    Change from EHR-based to registry-based safety surveillance.

    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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    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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