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    Clinical Trial Results:
    A Multicentre, Randomised, Double-blind, Parallel Group, Placebo-controlled, Phase 3b Study to Evaluate the Potential Effect of Benralizumab on the Humoral Immune Response to the Seasonal Influenza Vaccination in Adolescent and Young Adult Patients with Severe Asthma (ALIZE)

    Summary
    EudraCT number
    		 2016-001717-24
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    24 Jan 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 Oct 2017
    First version publication date
    14 Oct 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    D3250C00033
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02814643
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AstraZeneca AB
    Sponsor organisation address
    151 85, Södertälje, Sweden,
    Public contact
    Mitchell Goldman MD, PhD, AstraZeneca, +1 610 457 5585, Mitchell.Goldman@astrazeneca.com
    Scientific contact
    Mitchell Goldman MD, PhD, AstraZeneca, +1 610 457 5585, Mitchell.Goldman@astrazeneca.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    24 Aug 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Jan 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective was to evaluate the potential effect of benralizumab on the humoral immune response following seasonal influenza virus vaccination in adolescent and young adult patients with severe asthma.
    Protection of trial subjects
    No committees were used for this study. Patients were free to withdraw from the study medication or study assessments at any time without prejudice to further treatment.
    Background therapy
    		 Background asthma medications were to be maintained at stable doses from Visit 1 until the end of the study. If changing the inhaled corticosteroid or long-acting beta2-agonist dose or any other controller medication was judged as necessary by the Investigator or the patient’s healthcare provider, the justification was to have been documented in the source and the change in doses was to have been reflected in the electronic case report form.
    Evidence for comparator
    		 Not applicable.
    Actual start date of recruitment
    01 Jul 2016
    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
    United States: 103
    Worldwide total number of subjects
    103
    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)
    72
    Adults (18-64 years)
    31
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This trial was conducted at 30 trial centres in the United States between 01 July 2016 and 24 January 2017.

    Pre-assignment
    Screening details
    		 The trial duration was up to 23 weeks, consisting of an initial screening period lasting up to 3 weeks, a 12-week treatment period, and a follow-up visit 8 weeks after the last dose of study drug.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    Placebo solution was visually matched with benralizumab solution. As patients on active benralizumab treatment were expected to have lower blood eosinophil counts than patients on placebo, monocyte counts were redacted from central laboratory reports to prevent the Investigator from deducing the patient's study treatment, and centre staff who were directly involved in the patient's management were to remain blinded to any eosinophil, basophil, and monocyte results.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Benralizumab 30mg
    Arm description
    		 Benralizumab 30mg/day subcutaneous
    Arm type
    		 Experimental

    Investigational medicinal product name
    Benralizumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    30 mg/mL solution for injection in accessorised pre-filled syringe, 1 mL fill volume, given every 4 weeks for 3 doses.

    Investigational medicinal product name
    Influenza vaccine
    Investigational medicinal product code
    Other name
    Flulaval Quadrivalent
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    60 mcg hemagglutinin per 0.5 mL dose (15 mcg each of 4 influenza viral strains), given once at Week 8

    Arm title
    		 Placebo
    Arm description
    		 Placebo to benralizumab subcutaneous
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Matching placebo solution for injection in accessorised pre-filled syringe, 1 mL fill volume, given every 4 weeks for 3 doses.

    Investigational medicinal product name
    Influenza vaccine
    Investigational medicinal product code
    Other name
    Flulaval Quadrivalent
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    60 mcg hemagglutinin per 0.5 mL dose (15 mcg each of 4 influenza viral strains), given once at Week 8

    Number of subjects in period 1
    		Benralizumab 30mg Placebo
    Started
    51
    52
    Completed
    50
    49
    Not completed
    1
    3
         Consent withdrawn by subject
    1
    2
         Lost to follow-up
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Benralizumab 30mg
    Reporting group description
    		 Benralizumab 30mg/day subcutaneous

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo to benralizumab subcutaneous

    Reporting group values
    		 Benralizumab 30mg Placebo Total
    Number of subjects
    		 51 52 103
    Age Categorical
    Units: Subjects
        ≥12 to ≤17 years
    		 36 36 72
        ≥18 to ≤21 years
    		 15 16 31
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 16 ( 2.65 ) 15.7 ( 2.99 ) -
    Gender, Male/Female
    Units: Subjects
        Female
    		 21 21 42
        Male
    		 30 31 61
    Race, Customised
    Units: Subjects
        American Indian Or Alaska Native
    		 0 1 1
        Black Or African American
    		 13 13 26
        Other
    		 0 2 2
        White
    		 38 36 74

    End points

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    End points reporting groups
    Reporting group title
    Benralizumab 30mg
    Reporting group description
    		 Benralizumab 30mg/day subcutaneous

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo to benralizumab subcutaneous

    Primary: Postdose strain-specific hemagglutination-inhibition (HAI) antibody geometric mean fold rise from Week 8 to Week 12

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    End point title
    		 Postdose strain-specific hemagglutination-inhibition (HAI) antibody geometric mean fold rise from Week 8 to Week 12
    End point description
    To compare the geometric mean fold rises in influenza strain-specific hemagglutination-inhibition responses from Week 8 to Week 12 between patients receiving benralizumab 30mg and patients receiving placebo.
    End point type
    Primary
    End point timeframe
    4 weeks
    End point values
    		 Benralizumab 30mg Placebo
    Number of subjects analysed
    50
    49
    Units: Geometric mean fold rise
    least squares mean (standard error)
        Influenza A H1N1
    3.6 ( 1.22 )
    3.13 ( 1.22 )
        Influenza A H3N2
    3.25 ( 1.18 )
    3.85 ( 1.18 )
        Influenza B Yamagata lineage
    3.42 ( 1.16 )
    3.17 ( 1.16 )
        Influenza B Victoria lineage
    4.08 ( 1.19 )
    3.27 ( 1.19 )
    Statistical analysis title
    		 Influenza A H1N1
    Comparison groups
    Benralizumab 30mg v Placebo
    Number of subjects included in analysis
    99
    Analysis specification
    Pre-specified
    Analysis type
    Method
    		 ANCOVA
    Parameter type
    		 Geometric least-square mean ratio
    Point estimate
    0.87
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.56
         upper limit
    		 1.35
    Statistical analysis title
    		 Influenza A H3N2
    Comparison groups
    Benralizumab 30mg v Placebo
    Number of subjects included in analysis
    99
    Analysis specification
    Pre-specified
    Analysis type
    Method
    		 ANCOVA
    Parameter type
    		 Geometric least-square mean ratio
    Point estimate
    1.19
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.82
         upper limit
    		 1.71
    Statistical analysis title
    		 Influenza B Yamagata lineage
    Comparison groups
    Benralizumab 30mg v Placebo
    Number of subjects included in analysis
    99
    Analysis specification
    Pre-specified
    Analysis type
    Method
    		 ANCOVA
    Parameter type
    		 Geometric least-square mean ratio
    Point estimate
    0.93
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.67
         upper limit
    		 1.29
    Statistical analysis title
    		 Influenza B Victoria lineage
    Comparison groups
    Benralizumab 30mg v Placebo
    Number of subjects included in analysis
    99
    Analysis specification
    Pre-specified
    Analysis type
    Method
    		 ANCOVA
    Parameter type
    		 Geometric least-square mean ratio
    Point estimate
    0.8
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.54
         upper limit
    		 1.19

    Primary: Postdose strain-specific hemagglutination-inhibition antibody geometric mean titers obtained at Week 12

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    End point title
    		 Postdose strain-specific hemagglutination-inhibition antibody geometric mean titers obtained at Week 12
    End point description
    To compare the geometric mean titers of hemagglutination-inhibition antibody as a measure of influenza strain-specific response at Week 12 between patients receiving benralizumab 30mg and patients receiving placebo.
    End point type
    Primary
    End point timeframe
    12 weeks
    End point values
    		 Benralizumab 30mg Placebo
    Number of subjects analysed
    50
    49
    Units: Geometric mean titer
    least squares mean (standard error)
        Influenza A H1N1
    521.06 ( 1.13 )
    518.6 ( 1.13 )
        Influenza A H3N2
    170.73 ( 1.15 )
    219.35 ( 1.15 )
        Influenza B Yamagata lineage
    61.47 ( 1.13 )
    63.15 ( 1.13 )
        Influenza B Victoria lineage
    53.1 ( 1.14 )
    66.85 ( 1.14 )
    Statistical analysis title
    		 Influenza A H1N1
    Comparison groups
    Benralizumab 30mg v Placebo
    Number of subjects included in analysis
    99
    Analysis specification
    Pre-specified
    Analysis type
    Method
    		 ANCOVA
    Parameter type
    		 Geometric least-square mean ratio
    Point estimate
    1
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.76
         upper limit
    		 1.31
    Statistical analysis title
    		 Influenza A H3N2
    Comparison groups
    Benralizumab 30mg v Placebo
    Number of subjects included in analysis
    99
    Analysis specification
    Pre-specified
    Analysis type
    Method
    		 ANCOVA
    Parameter type
    		 Geometric least-square mean ratio
    Point estimate
    1.28
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.93
         upper limit
    		 1.77
    Statistical analysis title
    		 Influenza B Yamagata lineage
    Comparison groups
    Benralizumab 30mg v Placebo
    Number of subjects included in analysis
    99
    Analysis specification
    Pre-specified
    Analysis type
    Method
    		 ANCOVA
    Parameter type
    		 Geometric least-square mean ratio
    Point estimate
    1.03
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.79
         upper limit
    		 1.34
    Statistical analysis title
    		 Influenza B Victoria lineage
    Comparison groups
    Benralizumab 30mg v Placebo
    Number of subjects included in analysis
    99
    Analysis specification
    Pre-specified
    Analysis type
    Method
    		 ANCOVA
    Parameter type
    		 Geometric least-square mean ratio
    Point estimate
    1.26
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.93
         upper limit
    		 1.7

    Primary: Proportion of patients who experienced a strain-specific postdose antibody response at Week 12 with antibody response defined as a ≥4-fold rise in hemagglutination-inhibition antibody titer from Week 8 to Week 12

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    End point title
    		 Proportion of patients who experienced a strain-specific postdose antibody response at Week 12 with antibody response defined as a ≥4-fold rise in hemagglutination-inhibition antibody titer from Week 8 to Week 12 [1]
    End point description
    To compare the proportions of patients experiencing influenza strain-specific responses as measured by ≥4-fold rises in hemagglutination-inhibition antibody titer from Week 8 to Week 12 between patients receiving benralizumab 30mg and patients receiving placebo.
    End point type
    Primary
    End point timeframe
    4 weeks
    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: No statistical analyses
    End point values
    		 Benralizumab 30mg Placebo
    Number of subjects analysed
    50
    49
    Units: Proportion of patients
    number (confidence interval 90%)
        Influenza A H1N1
    0.44 (0.32 to 0.57)
    0.306 (0.2 to 0.43)
        Influenza A H3N2
    0.5 (0.38 to 0.62)
    0.49 (0.37 to 0.62)
        Influenza B Yamagata lineage
    0.48 (0.36 to 0.6)
    0.49 (0.37 to 0.62)
        Influenza B Victoria lineage
    0.56 (0.43 to 0.68)
    0.408 (0.29 to 0.54)
    No statistical analyses for this end point

    Primary: Proportion of patients who achieved a strain-specific postdose hemagglutination-inhibition antibody titer ≥40 at Week 12

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    End point title
    		 Proportion of patients who achieved a strain-specific postdose hemagglutination-inhibition antibody titer ≥40 at Week 12 [2]
    End point description
    To compare the proportions of patients experiencing influenza strain-specific responses as measured by ≥40-fold rises in hemagglutination-inhibition antibody titer at Week 12 between patients receiving benralizumab 30mg and patients receiving placebo.
    End point type
    Primary
    End point timeframe
    12 weeks
    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: No statistical analyses
    End point values
    		 Benralizumab 30mg Placebo
    Number of subjects analysed
    50
    49
    Units: Proportion of patients
    number (confidence interval 90%)
        Influenza A H1N1
    1 (0.94 to 1)
    1 (0.94 to 1)
        Influenza A H3N2
    0.98 (0.91 to 1)
    0.98 (0.91 to 1)
        Influenza B Yamagata lineage
    0.86 (0.75 to 0.93)
    0.796 (0.68 to 0.88)
        Influenza B Victoria lineage
    0.78 (0.66 to 0.87)
    0.878 (0.77 to 0.95)
    No statistical analyses for this end point

    Secondary: Proportion of patients who achieved a strain-specific postdose hemagglutination inhibition antibody titre ≥320 at Week 12

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    End point title
    		 Proportion of patients who achieved a strain-specific postdose hemagglutination inhibition antibody titre ≥320 at Week 12
    End point description
    To compare the proportions of patients experiencing influenza strain-specific responses as measured by ≥320-fold rises in hemagglutination-inhibition antibody titer at Week 12 between patients receiving benralizumab 30mg and patients receiving placebo.
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 Benralizumab 30mg Placebo
    Number of subjects analysed
    50
    49
    Units: Proportion of patients
    number (confidence interval 90%)
        Influenza A H1N1
    0.84 (0.73 to 0.92)
    0.857 (0.75 to 0.93)
        Influenza A H3N2
    0.5 (0.38 to 0.62)
    0.612 (0.48 to 0.73)
        Influenza B Yamagata lineage
    0.02 (0 to 0.09)
    0.02 (0 to 0.09)
        Influenza B Victoria lineage
    0.08 (0.03 to 0.17)
    0.041 (0.01 to 0.12)
    No statistical analyses for this end point

    Secondary: Postdose strain-specific microneutralisation antibody geometric mean fold rise from Week 8 to Week 12

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    End point title
    		 Postdose strain-specific microneutralisation antibody geometric mean fold rise from Week 8 to Week 12
    End point description
    To compare the geometric mean fold rises in influenza strain-specific microneutralization antibody responses from Week 8 to Week 12 between patients receiving benralizumab 30mg and patients receiving placebo.
    End point type
    Secondary
    End point timeframe
    4 weeks
    End point values
    		 Benralizumab 30mg Placebo
    Number of subjects analysed
    50
    49
    Units: Geometric mean fold rise
    geometric mean (geometric coefficient of variation)
        Influenza A H1N1
    5.1 ( 521.4 )
    4.4 ( 329.4 )
        Influenza A H3N2
    3.2 ( 149.8 )
    3.6 ( 210 )
        Influenza B Yamagata lineage
    2.8 ( 148.9 )
    3.2 ( 141.3 )
        Influenza B Victoria lineage
    3.8 ( 224.1 )
    3.5 ( 195.3 )
    No statistical analyses for this end point

    Secondary: Postdose strain-specific serum microneutralization antibody geometric mean titers obtained at Week 12

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    End point title
    		 Postdose strain-specific serum microneutralization antibody geometric mean titers obtained at Week 12
    End point description
    To compare the geometric mean titers of microneutralization antibody as a measure of influenza strain-specific response at Week 12 between patients receiving benralizumab 30mg and patients receiving placebo.
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 Benralizumab 30mg Placebo
    Number of subjects analysed
    50
    49
    Units: Geometric mean titer
    geometric mean (geometric coefficient of variation)
        Influenza A H1N1
    3774.1 ( 181.7 )
    3969.1 ( 154 )
        Influenza A H3N2
    4307.5 ( 169 )
    4351.3 ( 171 )
        Influenza B Yamagata lineage
    350.2 ( 103.6 )
    336.2 ( 114.3 )
        Influenza B Victoria lineage
    164.5 ( 178.5 )
    234.4 ( 135 )
    No statistical analyses for this end point

    Secondary: Proportion of patients who experience a strain-specific postdose antibody response at Week 12 with antibody response defined as a ≥4-fold rise in microneutralization antibody titer from Week 8 to Week 12

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    End point title
    		 Proportion of patients who experience a strain-specific postdose antibody response at Week 12 with antibody response defined as a ≥4-fold rise in microneutralization antibody titer from Week 8 to Week 12
    End point description
    To compare the proportions of patients experiencing influenza strain-specific responses as measured by ≥4-fold rises in microneutralization antibody titer from Week 8 to Week 12 between patients receiving benralizumab 30mg and patients receiving placebo.
    End point type
    Secondary
    End point timeframe
    4 weeks
    End point values
    		 Benralizumab 30mg Placebo
    Number of subjects analysed
    50
    49
    Units: Proportion of patients
    number (confidence interval 90%)
        Influenza A H1N1
    0.42 (0.3 to 0.55)
    0.408 (0.29 to 0.54)
        Influenza A H3N2
    0.44 (0.32 to 0.57)
    0.429 (0.31 to 0.56)
        Influenza B Yamagata lineage
    0.28 (0.18 to 0.4)
    0.388 (0.27 to 0.52)
        Influenza B Victoria lineage
    0.4 (0.28 to 0.53)
    0.388 (0.27 to 0.52)
    No statistical analyses for this end point

    Secondary: Change from baseline in mean Asthma Control Questionnaire score at Week 12

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    End point title
    		 Change from baseline in mean Asthma Control Questionnaire score at Week 12
    End point description
    To compare the change from baseline at Week 12 in mean Asthma Control Questionnaire score between patients receiving benralizumab 30mg and patients receiving placebo.
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 Benralizumab 30mg Placebo
    Number of subjects analysed
    50
    49
    Units: Difference in score
        arithmetic mean (standard deviation)
    -0.5 ( 1.114 )
    -0.42 ( 0.925 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All adverse events, including serious adverse events, were collected from the time the patient, parent, or legal guardian signed the informed consent/assent throughout the treatment period and including the follow-up period (through Week 20).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    Benralizumab 30mg
    Reporting group description
    		 Benralizumab 30mg/day subcutaneous

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo to benralizumab subcutaneous

    Serious adverse events
    		 Benralizumab 30mg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 51 (0.00%)
    2 / 52 (3.85%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Suicidal ideation
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    		 Benralizumab 30mg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    14 / 51 (27.45%)
    18 / 52 (34.62%)
    Injury, poisoning and procedural complications
    Ligament sprain
         subjects affected / exposed
    2 / 51 (3.92%)
    0 / 52 (0.00%)
         occurrences all number
    2
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 51 (3.92%)
    4 / 52 (7.69%)
         occurrences all number
    3
    4
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    2 / 51 (3.92%)
    0 / 52 (0.00%)
         occurrences all number
    2
    0
    Nausea
         subjects affected / exposed
    1 / 51 (1.96%)
    2 / 52 (3.85%)
         occurrences all number
    1
    2
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    3 / 51 (5.88%)
    3 / 52 (5.77%)
         occurrences all number
    5
    3
    Cough
         subjects affected / exposed
    0 / 51 (0.00%)
    3 / 52 (5.77%)
         occurrences all number
    0
    3
    Oropharyngeal pain
         subjects affected / exposed
    3 / 51 (5.88%)
    2 / 52 (3.85%)
         occurrences all number
    4
    2
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    1 / 51 (1.96%)
    2 / 52 (3.85%)
         occurrences all number
    1
    2
    Musculoskeletal and connective tissue disorders
    Costochondritis
         subjects affected / exposed
    2 / 51 (3.92%)
    0 / 52 (0.00%)
         occurrences all number
    3
    0
    Infections and infestations
    Gastroenteritis viral
         subjects affected / exposed
    3 / 51 (5.88%)
    1 / 52 (1.92%)
         occurrences all number
    3
    1
    Nasopharyngitis
         subjects affected / exposed
    2 / 51 (3.92%)
    4 / 52 (7.69%)
         occurrences all number
    2
    5
    Sinusitis
         subjects affected / exposed
    2 / 51 (3.92%)
    1 / 52 (1.92%)
         occurrences all number
    2
    1
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 51 (5.88%)
    1 / 52 (1.92%)
         occurrences all number
    4
    1
    Viral upper respiratory tract infection
         subjects affected / exposed
    2 / 51 (3.92%)
    0 / 52 (0.00%)
         occurrences all number
    2
    0

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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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