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    Clinical Trial Results:
    A Multicenter, Randomized, Double-blind, Parallel Group, Placebo controlled, Phase IIIb Study to Evaluate the Potential Effect of Tezepelumab on the Humoral Immune Response to Seasonal Quadrivalent Influenza Vaccination in Adolescent and Young Adult Participants with Moderate to Severe Asthma (VECTOR)

    Summary
    EudraCT number
    		 2022-003286-37
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    18 Jul 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 Jan 2023
    First version publication date
    21 Jan 2023
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    D5180C00031
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05062759
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AstraZeneca AB
    Sponsor organisation address
    Södertälje, Södertälje, Sweden, 151 85
    Public contact
    Global Clinical Head, AstraZeneca Clinical Study Information Center, +1 87724094 79, information.center@astrazeneca.com
    Scientific contact
    Global Clinical Head, AstraZeneca Clinical Study Information Center, +1 87724094 79, information.center@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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    22 Jul 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Jul 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the effect of tezepelumab on the humoral immune response following seasonal influenza virus vaccination in adolescent and young adult participants with moderate to severe asthma
    Protection of trial subjects
    This study was performed in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with ICH/GCP, applicable regulatory requirements, and the AstraZeneca policy on Bioethics. The Principal Investigator or designee ensured that each patient (or parent/legally authorised representative) was given full and adequate oral and written information about the nature, purpose, possible risk, and benefit of the study. Informed consent/assent was obtained from all patients (and some parents/legally authorised representatives) before performing any study tests or procedures.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    23 Aug 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
    United States: 70
    Worldwide total number of subjects
    70
    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)
    43
    Adults (18-64 years)
    27
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study was conducted in 15 study centres in the United States between 23 August 2021 and 18 July 2022.

    Pre-assignment
    Screening details
    		 The Screening period was 2 to 3 weeks before randomisation. 81 patients signed informed consent and 70 patients were randomized. Patients were randomised in a 1:1 ratio to receive tezepelumab or placebo. All the study assessments were performed as per the Schedule of Activities.

    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
    		 Investigator, Monitor, Subject, Carer, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Tezepelumab
    Arm description
    		 Patients received at least 1 injection of tezepelumab 210 mg administered subcutaneously every 4 weeks by accessorized pre-filled syringe (APFS).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tezepelumab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Patients received 1 injection of tezepelumab 210mg administered subcutaneously every 4 weeks by APFS.

    Arm title
    		 Placebo
    Arm description
    		 Patients received at least 1 injection of placebo administered subcutaneously every 4 weeks by APFS.
    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
    Patients received 1 injection of placebo administered subcutaneously every 4 weeks by APFS.

    Number of subjects in period 1
    		Tezepelumab Placebo
    Started
    35
    35
    Completed
    34
    34
    Not completed
    1
    1
         Adverse event, serious fatal
    -
    1
         Lost to follow-up
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Tezepelumab
    Reporting group description
    		 Patients received at least 1 injection of tezepelumab 210 mg administered subcutaneously every 4 weeks by accessorized pre-filled syringe (APFS).

    Reporting group title
    Placebo
    Reporting group description
    		 Patients received at least 1 injection of placebo administered subcutaneously every 4 weeks by APFS.

    Reporting group values
    		 Tezepelumab Placebo Total
    Number of subjects
    		 35 35 70
    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)
    		 22 21 43
        Adults (18-64 years)
    		 13 14 27
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 16.3 ( 2.3 ) 16.6 ( 3.1 ) -
    Gender Categorical
    Units: Subjects
        Female
    		 14 11 25
        Male
    		 21 24 45
    Race
    Units: Subjects
        White
    		 24 23 47
        Black or African American
    		 8 12 20
        Asian
    		 1 0 1
        American Indian or Alaska
    		 2 0 2
    Ethnic group
    Units: Subjects
        Hispanic or Latino
    		 8 10 18
        Not Hispanic or Latino
    		 27 25 52

    End points

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    End points reporting groups
    Reporting group title
    Tezepelumab
    Reporting group description
    		 Patients received at least 1 injection of tezepelumab 210 mg administered subcutaneously every 4 weeks by accessorized pre-filled syringe (APFS).

    Reporting group title
    Placebo
    Reporting group description
    		 Patients received at least 1 injection of placebo administered subcutaneously every 4 weeks by APFS.

    Primary: Post-vaccination strain-specific hemagglutination inhibition (HAI) antibody geometric mean fold rises (GMFRs)

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    End point title
    		 Post-vaccination strain-specific hemagglutination inhibition (HAI) antibody geometric mean fold rises (GMFRs)
    End point description
    Effect of tezepelumab on the humoral immune response following seasonal influenza virus vaccination in adolescent and young adult participants with moderate to severe asthma was assessed. Vaccine immunogenicity analysis set consisted of all randomised patients who received the influenza vaccine plus at least 1 dose of tezepelumab or placebo, had pre and post vaccination HAI or Microneutralization antibody measurements, had no influenza infection prior to Visit 7 (Week 16), and had no protocol deviation, judged to have the potential to interfere with the generation or interpretation of an antibody response.
    End point type
    Primary
    End point timeframe
    From Week 12 to Week 16
    End point values
    		 Tezepelumab Placebo
    Number of subjects analysed
    33
    33
    Units: Fold change
    geometric mean (geometric coefficient of variation)
        Influenza A H1N1
    7.34 ( 1.361 )
    4.75 ( 1.455 )
        Influenza B Yamagata Lineage
    1.76 ( 0.955 )
    1.46 ( 0.937 )
        Influenza B Victoria Lineage
    2.94 ( 1.054 )
    2.90 ( 0.841 )
    Statistical analysis title
    		 Influenza A H1N1, Placebo vs Teze
    Statistical analysis description
    Ratio of placebo over tezepelumab. Results based on ANCOVA model
    Comparison groups
    Tezepelumab v Placebo
    Number of subjects included in analysis
    66
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Geometric Least square (LS) mean ratio
    Point estimate
    0.65
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.43
         upper limit
    		 0.98
    Statistical analysis title
    		 Influenza B Yamagata Lineage, Placebo vs Teze
    Statistical analysis description
    Ratio of placebo over tezepelumab. Results based on ANCOVA model
    Comparison groups
    Tezepelumab v Placebo
    Number of subjects included in analysis
    66
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Geometeric LS mean ratio
    Point estimate
    0.83
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.6
         upper limit
    		 1.15
    Statistical analysis title
    		 Influenza B Victoria Lineage, Placebo vs Teze
    Statistical analysis description
    Ratio of placebo over tezepelumab. Results based on ANCOVA model
    Comparison groups
    Tezepelumab v Placebo
    Number of subjects included in analysis
    66
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Geometric LS mean ratio
    Point estimate
    0.99
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.71
         upper limit
    		 1.37

    Primary: Post-vaccination strain-specific microneutralization (MN) antibody GMFRs

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    End point title
    		 Post-vaccination strain-specific microneutralization (MN) antibody GMFRs
    End point description
    Effect of tezepelumab on the humoral immune response following seasonal influenza virus vaccination in adolescent and young adult participants with moderate to severe asthma was assessed. Vaccine immunogenicity analysis set consisted of all randomised patients who received the influenza vaccine plus at least 1 dose of tezepelumab or placebo, had pre and post vaccination HAI or MN antibody measurements, had no influenza infection prior to Visit 7 (Week 16), and had no protocol deviation, judged to have the potential to interfere with the generation or interpretation of an antibody response.
    End point type
    Primary
    End point timeframe
    From Week 12 to Week 16
    End point values
    		 Tezepelumab Placebo
    Number of subjects analysed
    33
    33
    Units: Fold change
    geometric mean (geometric coefficient of variation)
        Influenza A H1N1
    14.56 ( 2.581 )
    10.62 ( 2.409 )
        Influenza A H3N2
    4.73 ( 1.509 )
    5.90 ( 3.180 )
        Influenza B Yamagata Lineage
    4.00 ( 1.541 )
    3.56 ( 2.206 )
        Influenza B Victoria Lineage
    4.08 ( 2.279 )
    5.04 ( 1.723 )
    Statistical analysis title
    		 Influenza A H1N1, Placebo vs Teze
    Statistical analysis description
    Ratio of placebo over tezepelumab. Results based on ANCOVA model
    Comparison groups
    Tezepelumab v Placebo
    Number of subjects included in analysis
    66
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Geometeric LS mean ratio
    Point estimate
    0.73
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.42
         upper limit
    		 1.28
    Statistical analysis title
    		 Influenza A H3N2, Placebo vs Teze
    Statistical analysis description
    Ratio of placebo over tezepelumab. Results based on ANCOVA model
    Comparison groups
    Tezepelumab v Placebo
    Number of subjects included in analysis
    66
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Geometeric LS mean ratio
    Point estimate
    1.25
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.72
         upper limit
    		 2.17
    Statistical analysis title
    		 Influenza B Victoria Lineage, Placebo vs Teze
    Statistical analysis description
    Ratio of placebo over tezepelumab. Results based on ANCOVA model
    Comparison groups
    Tezepelumab v Placebo
    Number of subjects included in analysis
    66
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Geometric LS mean ratio
    Point estimate
    1.23
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.73
         upper limit
    		 2.07
    Statistical analysis title
    		 Influenza B Yamagata Lineage, Placebo vs Teze
    Statistical analysis description
    Ratio of placebo over tezepelumab. Results based on ANCOVA model
    Comparison groups
    Tezepelumab v Placebo
    Number of subjects included in analysis
    66
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Geometeric LS mean ratio
    Point estimate
    0.89
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.54
         upper limit
    		 1.48

    Primary: Post-vaccination strain-specific serum HAI antibody geometric mean titers (GMTs)

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    End point title
    		 Post-vaccination strain-specific serum HAI antibody geometric mean titers (GMTs)
    End point description
    Effect of tezepelumab on the humoral immune response following seasonal influenza virus vaccination in adolescent and young adult participants with moderate to severe asthma was assessed. Vaccine immunogenicity analysis set consisted of all randomised patients who received the influenza vaccine plus at least 1 dose of tezepelumab or placebo, had pre and post vaccination HAI or MN antibody measurements, had no influenza infection prior to Visit 7 (Week 16), and had no protocol deviation, judged to have the potential to interfere with the generation or interpretation of an antibody response.
    End point type
    Primary
    End point timeframe
    Week 16
    End point values
    		 Tezepelumab Placebo
    Number of subjects analysed
    33
    33
    Units: Geometric Mean Titer
    geometric mean (geometric coefficient of variation)
        Influenza A H1N1
    809.23 ( 0.921 )
    596.76 ( 1.076 )
        Influenza B Yamagata Lineage
    167.46 ( 0.925 )
    161.56 ( 0.688 )
        Influenza B Victoria Lineage
    194.68 ( 1.089 )
    200.55 ( 0.948 )
    Statistical analysis title
    		 Influenza A H1N1, Placebo vs Teze
    Statistical analysis description
    Ratio of placebo over tezepelumab. Results based on ANCOVA model
    Comparison groups
    Tezepelumab v Placebo
    Number of subjects included in analysis
    66
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Geometeric LS mean ratio
    Point estimate
    0.74
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.52
         upper limit
    		 1.04
    Statistical analysis title
    		 Influenza B Yamagata Lineage, Placebo vs Teze
    Statistical analysis description
    Ratio of placebo over tezepelumab. Results based on ANCOVA model
    Comparison groups
    Tezepelumab v Placebo
    Number of subjects included in analysis
    66
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Geometeric LS mean ratio
    Point estimate
    0.96
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.72
         upper limit
    		 1.29
    Statistical analysis title
    		 Influenza B Victoria Lineage, Placebo vs Teze
    Statistical analysis description
    Ratio of placebo over tezepelumab. Results based on ANCOVA model
    Comparison groups
    Tezepelumab v Placebo
    Number of subjects included in analysis
    66
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Geometric LS mean ratio
    Point estimate
    1.03
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.73
         upper limit
    		 1.46

    Primary: Post-vaccination strain-specific serum MN antibody GMTs

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    End point title
    		 Post-vaccination strain-specific serum MN antibody GMTs
    End point description
    Effect of tezepelumab on the humoral immune response following seasonal influenza virus vaccination in adolescent and young adult participants with moderate to severe asthma was assessed. Vaccine immunogenicity analysis set consisted of all randomised patients who received the influenza vaccine plus at least 1 dose of tezepelumab or placebo, had pre and post vaccination HAI or MN antibody measurements, had no influenza infection prior to Visit 7 (Week 16), and had no protocol deviation, judged to have the potential to interfere with the generation or interpretation of an antibody response.
    End point type
    Primary
    End point timeframe
    Week 16
    End point values
    		 Tezepelumab Placebo
    Number of subjects analysed
    33
    33
    Units: Geometric Mean Titer
    geometric mean (geometric coefficient of variation)
        Influenza A H1N1
    382.55 ( 1.469 )
    303.63 ( 1.667 )
        Influenza A H3N2
    600.92 ( 2.154 )
    457.33 ( 2.336 )
        Influenza B Yamagata Lineage
    355.44 ( 1.076 )
    366.81 ( 1.270 )
        Influenza B Victoria Lineage
    125.67 ( 4.687 )
    124.35 ( 3.515 )
    Statistical analysis title
    		 Influenza A H1N1, Placebo vs Teze
    Statistical analysis description
    Ratio of placebo over tezepelumab. Results based on ANCOVA model
    Comparison groups
    Tezepelumab v Placebo
    Number of subjects included in analysis
    66
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Geometeric LS mean ratio
    Point estimate
    0.79
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.51
         upper limit
    		 1.25
    Statistical analysis title
    		 Influenza A H3N2, Placebo vs Teze
    Statistical analysis description
    Ratio of placebo over tezepelumab. Results based on ANCOVA model
    Comparison groups
    Tezepelumab v Placebo
    Number of subjects included in analysis
    66
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Geometeric LS mean ratio
    Point estimate
    0.76
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.42
         upper limit
    		 1.28
    Statistical analysis title
    		 Influenza B Victoria Lineage, Placebo vs Teze
    Statistical analysis description
    Ratio of placebo over tezepelumab. Results based on ANCOVA model
    Comparison groups
    Tezepelumab v Placebo
    Number of subjects included in analysis
    66
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Geometric LS mean ratio
    Point estimate
    0.99
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.49
         upper limit
    		 1.99
    Statistical analysis title
    		 Influenza B Yamagata Lineage, Placebo vs Teze
    Statistical analysis description
    Ratio of placebo over tezepelumab. Results based on ANCOVA model
    Comparison groups
    Tezepelumab v Placebo
    Number of subjects included in analysis
    66
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Geometeric LS mean ratio
    Point estimate
    1.03
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.7
         upper limit
    		 1.52

    Primary: Percentage of patients with post-vaccination strain-specific antibody response at Week 16 with antibody response defined as a ≥ 4-fold rise in HAI antibody titer

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    End point title
    		 Percentage of patients with post-vaccination strain-specific antibody response at Week 16 with antibody response defined as a ≥ 4-fold rise in HAI antibody titer [1]
    End point description
    Effect of tezepelumab on the humoral immune response following seasonal influenza virus vaccination in adolescent and young adult participants with moderate to severe asthma was assessed. Vaccine immunogenicity analysis set consisted of all randomised patients who received the influenza vaccine plus at least 1 dose of tezepelumab or placebo, had pre and post vaccination HAI or MN antibody measurements, had no influenza infection prior to Visit 7 (Week 16), and had no protocol deviation, judged to have the potential to interfere with the generation or interpretation of an antibody response.
    End point type
    Primary
    End point timeframe
    Week 16
    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 formal hypothesis testing was performed, as this is a descriptive study
    End point values
    		 Tezepelumab Placebo
    Number of subjects analysed
    33
    33
    Units: Percentage
    number (confidence interval 90%)
        Influenza A H1N1
    78.8 (63.82 to 89.60)
    51.5 (36.07 to 66.74)
        Influenza B Yamagata Lineage
    15.2 (6.17 to 29.25)
    15.2 (6.17 to 29.25)
        Influenza B Victoria Lineage
    30.3 (17.46 to 45.96)
    39.4 (25.11 to 55.18)
    No statistical analyses for this end point

    Primary: Percentage of patients with post-vaccination strain-specific antibody response at Week 16 with antibody response defined as a ≥ 4-fold rise in MN antibody titer

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    End point title
    		 Percentage of patients with post-vaccination strain-specific antibody response at Week 16 with antibody response defined as a ≥ 4-fold rise in MN antibody titer [2]
    End point description
    Effect of tezepelumab on the humoral immune response following seasonal influenza virus vaccination in adolescent and young adult participants with moderate to severe asthma was assessed. Vaccine immunogenicity analysis set consisted of all randomised patients who received the influenza vaccine plus at least 1 dose of tezepelumab or placebo, had pre and post vaccination HAI or MN antibody measurements, had no influenza infection prior to Visit 7 (Week 16), and had no protocol deviation, judged to have the potential to interfere with the generation or interpretation of an antibody response.
    End point type
    Primary
    End point timeframe
    Week 16
    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 formal hypothesis testing was performed, as this is a descriptive study
    End point values
    		 Tezepelumab Placebo
    Number of subjects analysed
    33
    33
    Units: Percentage
    number (confidence interval 90%)
        Influenza A H1N1
    81.8 (67.24 to 91.77)
    75.8 (60.49 to 87.32)
        Influenza A H3N2
    60.6 (44.82 to 74.89)
    51.5 (36.07 to 66.74)
        Influenza B Yamagata Lineage
    51.5 (36.07 to 66.74)
    36.4 (22.50 to 52.16)
        Influenza B Victoria Lineage
    54.5 (38.94 to 69.51)
    63.6 (47.84 to 77.50)
    No statistical analyses for this end point

    Primary: Percentage of patients with post-vaccination strain-specific HAI antibody titer ≥ 40

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    End point title
    		 Percentage of patients with post-vaccination strain-specific HAI antibody titer ≥ 40 [3]
    End point description
    Effect of tezepelumab on the humoral immune response following seasonal influenza virus vaccination in adolescent and young adult participants with moderate to severe asthma was assessed. Vaccine immunogenicity analysis set consisted of all randomised patients who received the influenza vaccine plus at least 1 dose of tezepelumab or placebo, had pre and post vaccination HAI or MN antibody measurements, had no influenza infection prior to Visit 7 (Week 16), and had no protocol deviation, judged to have the potential to interfere with the generation or interpretation of an antibody response.
    End point type
    Primary
    End point timeframe
    Week 16
    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: No formal hypothesis testing was performed, as this is a descriptive study.
    End point values
    		 Tezepelumab Placebo
    Number of subjects analysed
    33
    33
    Units: Percentage
    number (confidence interval 90%)
        Influenza A H1N1
    100 (91.32 to 100.00)
    100 (91.32 to 100.00)
        Influenza B Yamagata Lineage
    97 (86.41 to 99.84)
    100 (91.32 to 100.00)
        Influenza B Victoria Lineage
    100 (91.32 to 100.00)
    97.0 (86.41 to 99.84)
    No statistical analyses for this end point

    Primary: Percentage of patients with post-vaccination strain-specific MN antibody titer ≥ 40

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    End point title
    		 Percentage of patients with post-vaccination strain-specific MN antibody titer ≥ 40 [4]
    End point description
    Effect of tezepelumab on the humoral immune response following seasonal influenza virus vaccination in adolescent and young adult participants with moderate to severe asthma was assessed. Vaccine immunogenicity analysis set consisted of all randomised patients who received the influenza vaccine plus at least 1 dose of tezepelumab or placebo, had pre and post vaccination HAI or MN antibody measurements, had no influenza infection prior to Visit 7 (Week 16), and had no protocol deviation, judged to have the potential to interfere with the generation or interpretation of an antibody response.
    End point type
    Primary
    End point timeframe
    Week 16
    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: No formal hypothesis testing was performed, as this is a descriptive study
    End point values
    		 Tezepelumab Placebo
    Number of subjects analysed
    33
    33
    Units: Percentage
    number (confidence interval 90%)
        Influenza A H1N1
    100 (91.32 to 100.00)
    93.9 (82.13 to 98.91)
        Influenza A H3N2
    93.9 (82.13 to 98.91)
    97 (86.41 to 99.84)
        Influenza B Yamagata Lineage
    97 (86.41 to 99.84)
    100 (91.32 to 100.00)
        Influenza B Victoria Lineage
    78.8 (63.82 to 89.60)
    81.8 (67.24 to 91.77)
    No statistical analyses for this end point

    Secondary: Serum tezepelumab concentrations

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    End point title
    		 Serum tezepelumab concentrations [5]
    End point description
    Tezepelumab serum concentrations were summarized using descriptive statistics at each visit. Pharmacokinetic (PK) analysis set consisted of all patients who received tezepelumab and from whom PK blood samples were obtained and assumed not to be affected by factors such as protocol deviations. Here, the arbitrary value 9999.9999 represent "Not calculated as > 50% of concentrations are below Lower limit of quantification (0.010 ug/mL)"
    End point type
    Secondary
    End point timeframe
    Week 0, Week 12, Week 16 and Week 28
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The Placebo arm did not receive Tezepelumab, therefore serum concentration for tezepelumab cannot be measured in placebo arm.
    End point values
    		 Tezepelumab
    Number of subjects analysed
    32
    Units: microgram/milliliter (μg/mL)
    geometric mean (geometric coefficient of variation)
        Week 0 (n=32)
    9999.9999 ( 9999.9999 )
        Week 12 (n=30)
    27.00 ( 0.5421 )
        Week 16 (n=32)
    20.76 ( 3.6969 )
        Week 28 (n=31)
    2.79 ( 1.0705 )
    No statistical analyses for this end point

    Secondary: Immunogenicity

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    End point title
    		 Immunogenicity
    End point description
    Immunogenicity assessments were performed. ADA prevalence was defined as patients who are ADA positive at any time including baseline. Persistently positive was defined as having at least two post-baseline ADA positive measurements (with ≥16 weeks between first and last positive) or an ADA positive result at the last available post-baseline assessment. Transiently positive was defined as having at least one post-baseline ADA positive measurement and not fulfilling the conditions for persistently positive. Treatment boosted ADA was defined as baseline positive ADA titre that was boosted to a 4-fold or higher-level following treatment. Treatment emergent ADA (ADA incidence) was defined as the sum of treatment induced ADA and treatment boosted ADA. Safety analysis set consisted of all patients who received at least 1 dose of study intervention.
    End point type
    Secondary
    End point timeframe
    From Baseline to Week 28
    End point values
    		 Tezepelumab Placebo
    Number of subjects analysed
    35
    35
    Units: Patients
    number (not applicable)
        ADA prevalence
    0
    4
        Only baseline ADA positive
    0
    0
        Both baseline and post-baseline ADA positive
    0
    0
        Any baseline ADA positive
    0
    0
        Any post-baseline ADA positive
    0
    4
        Treatment-induced ADA positive
    0
    4
        ADA persistently positive
    0
    4
        ADA transiently positive
    0
    0
        Treatment-boosted ADA positive
    0
    0
        TE-ADA positive (ADA incidence)
    0
    4
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the date of the first dose of study drug, throughout the treatment period up to the follow-up period or end of the study visit (Week 28)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.0
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Patients received at least 1 injection of placebo administered subcutaneously every 4 weeks by APFS.

    Reporting group title
    Tezepelumab
    Reporting group description
    		 Patients received at least 1 injection of tezepelumab 210 mg administered subcutaneously every 4 weeks by APFS.

    Serious adverse events
    		 Placebo Tezepelumab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 35 (0.00%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    1
    0
    Injury, poisoning and procedural complications
    Stab wound
         subjects affected / exposed
    1 / 35 (2.86%)
    0 / 35 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Placebo Tezepelumab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    15 / 35 (42.86%)
    14 / 35 (40.00%)
    Injury, poisoning and procedural complications
    Skin laceration
         subjects affected / exposed
    0 / 35 (0.00%)
    2 / 35 (5.71%)
         occurrences all number
    0
    2
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    2 / 35 (5.71%)
    1 / 35 (2.86%)
         occurrences all number
    2
    2
    Infections and infestations
    COVID-19
         subjects affected / exposed
    8 / 35 (22.86%)
    8 / 35 (22.86%)
         occurrences all number
    8
    8
    Acute sinusitis
         subjects affected / exposed
    0 / 35 (0.00%)
    3 / 35 (8.57%)
         occurrences all number
    0
    3
    Ear infection
         subjects affected / exposed
    2 / 35 (5.71%)
    1 / 35 (2.86%)
         occurrences all number
    2
    1
    Pharyngitis
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 35 (0.00%)
         occurrences all number
    2
    0
    Sinusitis
         subjects affected / exposed
    2 / 35 (5.71%)
    0 / 35 (0.00%)
         occurrences all number
    2
    0
    Viral upper respiratory tract infection
         subjects affected / exposed
    2 / 35 (5.71%)
    1 / 35 (2.86%)
         occurrences all number
    2
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    22 Feb 2022
    The primary rationale for this amendment is to introduce a primary database lock after the end of treatment at Visit 7 (Week 16) and to update safety information based on the most recent Investigator’s Brochure, Version 5.0, dated 21 Oct 2021. Additional changes include APFS device malfunction, medical device deficiencies, and Appendix F Medical Device Adverse Events (AEs) to align with International Organisation for Standardisation 14155 and European Medical Device Regulation. In addition, the vaccine immunogenicity analysis set definition was updated to exclude patients who experience influenza infection prior to Visit 7 (Week 16). Other minor changes included clarification of Schedule of Assessments for participants who prematurely discontinue study intervention. In addition, minor formatting and editorial administrative revisions were made throughout the protocol for clarification purposes.

    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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