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    Clinical Trial Results:
    PEANUT ALLERGY ORAL IMMUNOTHERAPY STUDY OF AR101 FOR DESENSITIZATION IN CHILDREN AND ADULTS (THE PALISADE STUDY)

    Summary
    EudraCT number
    		 2015-004257-41
    Trial protocol
    		 SE   DE   GB   DK   IE   NL   ES   IT  
    Global end of trial date
    02 Jul 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Jul 2019
    First version publication date
    11 Jul 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ARC003
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02635776
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Aimmune Therapeutics Inc.
    Sponsor organisation address
    8000 Marina Blvd, Suite 300, Brisbane, United States, 94005
    Public contact
    Clinical Operations, Aimmune Therapeutics, 001 6503963822, amarcantonio@aimmune.com
    Scientific contact
    Clinical Operations, Aimmune Therapeutics, 001 6503963822, amarcantonio@aimmune.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-001734-PIP01-14
    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
    26 Jan 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    21 Dec 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Jul 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective is to demonstrate the efficacy of AR101, a pharmaceutical-grade peanut allergen formulation, through reduction in clinical reactivity to limited amounts of peanut allergen in peanut-allergic children (ages 4-17 years, inclusive).
    Protection of trial subjects
    Education of patients to notify sites of allergic symptoms occuring at home. eDiary for completion at home by patients to measure IP compliance and alert sites of Adverse Events of Interest, including accidental exposure or Epi pen use.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    17 Dec 2015
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy, Safety, Scientific research
    Long term follow-up duration
    		 18 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Netherlands: 4
    Country: Number of subjects enrolled
    Spain: 23
    Country: Number of subjects enrolled
    Sweden: 12
    Country: Number of subjects enrolled
    United Kingdom: 20
    Country: Number of subjects enrolled
    Denmark: 9
    Country: Number of subjects enrolled
    Germany: 27
    Country: Number of subjects enrolled
    Ireland: 16
    Country: Number of subjects enrolled
    Italy: 6
    Country: Number of subjects enrolled
    Canada: 39
    Country: Number of subjects enrolled
    United States: 399
    Worldwide total number of subjects
    555
    EEA total number of subjects
    117
    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)
    328
    Adolescents (12-17 years)
    171
    Adults (18-64 years)
    56
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 842 subjects between the ages of 4 and 55 with suspected peanut allergy were screened for inclusion, of which 555 subjects were randomized and enrolled in the study.

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 AR101
    Arm description
    		 A peanut-derived oral immunotherapy drug
    Arm type
    		 Experimental

    Investigational medicinal product name
    AR101
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral powder
    Routes of administration
    Oral use
    Dosage and administration details
    AR101 drug product was supplied in 2 presentations. These were pull-apart capsules containing 0.5, 1, 10, 20 and 100mg of peanut protein and sealed, foil-laminated sachets containing 300mg of peanut protein. The capsules were used during the Initial Escalation and Up-dosing phases of the study. The sachets were used during the Maintenance phase. These 3 phases are described below: Initial Escalation: Comprised of dose-escalation (from 0.5mg to a maximum of 6 mg at 20 to 30-minute intervals) on Day 1 and confirmation of the tolerability of a single 3 mg dose on Day 2. Up-dosing: Following initial escalation, subjects received daily doses of AR101 and are up-dosed every 2 weeks for approximately 20 weeks. Dosing commenced at 3mg and progressed to 300mg via 10 incremental dosing steps at 2 weekly intervals. Maintenance: All subjects who reach and tolerate 300mg/d will continue to take a daily maintenance dose of 300mg/d for 24 weeks. Maintenance visits occur every 4 weeks.

    Arm title
    		 Placebo
    Arm description
    		 Matching placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Oral powder
    Routes of administration
    Oral use
    Dosage and administration details
    A Placebo matching the AR101 drug product was supplied in 2 presentations. These were pull-apart capsules matching the 0.5, 1, 10, 20 and 100mg peanut capsules but containing no peanut protein and sealed, foil-laminated sachets matching the peanut protein sachets but without any peanut protein. The capsules were used during the Initial Escalation and Up-dosing phases of the study. The sachets were used during the Maintenance phase. These 3 phases are described as for AR101 drug product but utilising the placebo presentations.

    Number of subjects in period 1
    		AR101 Placebo
    Started
    416
    139
    Completed
    314
    128
    Not completed
    102
    11
         Physician decision
    1
    -
         Consent withdrawn by subject
    41
    7
         Adverse event, non-fatal
    51
    3
         Other reasons
    5
    1
         Lost to follow-up
    4
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    AR101
    Reporting group description
    		 A peanut-derived oral immunotherapy drug

    Reporting group title
    Placebo
    Reporting group description
    		 Matching placebo

    Reporting group values
    		 AR101 Placebo Total
    Number of subjects
    		 416 139 555
    Age categorical
    Units: Subjects
        Children (2-11 years)
    		 238 90 328
        Adolescents (12-17 years)
    		 136 35 171
        Adults (18-64 years)
    		 42 14 56
    Gender categorical
    Units: Subjects
        Female
    		 181 56 237
        Male
    		 235 83 318
    Subject analysis sets

    Subject analysis set title
    AR101 ITT Population Ages 4-17
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The pre-specified primary efficacy population includes subjects Ages 4-17 in the ITT Population

    Subject analysis set title
    Placebo ITT Population Ages 4-17
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The pre-specified primary efficacy population includes subjects Ages 4-17 in the ITT Population

    Subject analysis sets values
    		 AR101 ITT Population Ages 4-17 Placebo ITT Population Ages 4-17
    Number of subjects
    372
    124
    Age categorical
    Units: Subjects
        Children (2-11 years)
    238
    89
        Adolescents (12-17 years)
    134
    35
        Adults (18-64 years)
    0
    0
    Age continuous
    Units:
        
    ±
    ±
    Gender categorical
    Units: Subjects
        Female
    164
    48
        Male
    208
    76

    End points

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    End points reporting groups
    Reporting group title
    AR101
    Reporting group description
    		 A peanut-derived oral immunotherapy drug

    Reporting group title
    Placebo
    Reporting group description
    		 Matching placebo

    Subject analysis set title
    AR101 ITT Population Ages 4-17
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The pre-specified primary efficacy population includes subjects Ages 4-17 in the ITT Population

    Subject analysis set title
    Placebo ITT Population Ages 4-17
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    The pre-specified primary efficacy population includes subjects Ages 4-17 in the ITT Population

    Primary: Primary Efficacy End point: Percentage of subjects ages 4-17 who tolerated a single highest dose of at least 1000 mg in the Exit Oral Food Challenge

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    End point title
    		 Primary Efficacy End point: Percentage of subjects ages 4-17 who tolerated a single highest dose of at least 1000 mg in the Exit Oral Food Challenge
    End point description
    End point type
    Primary
    End point timeframe
    Exit oral food challenge (after approximately 1 year of blinded therapy)
    End point values
    		 AR101 ITT Population Ages 4-17 Placebo ITT Population Ages 4-17
    Number of subjects analysed
    372
    124
    Units: Percentage of Patients
    number (confidence interval 95%)
        "Responder "
    50.3 (45.2 to 55.3)
    2.4 (0.8 to 6.9)
    Statistical analysis title
    		 Treatment difference at 1000 mg
    Statistical analysis description
    Farrington-Manning test for the difference (AR101 - Placebo) in percentage of subjects ages 4-17 who tolerated a single highest dose of at least 1000 mg
    Comparison groups
    AR101 ITT Population Ages 4-17 v Placebo ITT Population Ages 4-17
    Number of subjects included in analysis
    496
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Farrington-Manning test
    Parameter type
    		 Risk difference (RD)
    Point estimate
    47.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 38
         upper limit
    		 57.7

    Secondary: Secondary Efficacy End point: Percentage of subjects ages 4-17 who tolerated a single highest dose of at least 600 mg in the Exit Oral Food Challenge

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    End point title
    		 Secondary Efficacy End point: Percentage of subjects ages 4-17 who tolerated a single highest dose of at least 600 mg in the Exit Oral Food Challenge
    End point description
    End point type
    Secondary
    End point timeframe
    Exit oral food challenge (after approximately 1 year of blinded therapy)
    End point values
    		 AR101 ITT Population Ages 4-17 Placebo ITT Population Ages 4-17
    Number of subjects analysed
    372
    124
    Units: Percentage of Patients
    number (confidence interval 95%)
        Responder
    67.2 (62.3 to 71.8)
    4 (1.7 to 9.1)
    Statistical analysis title
    		 Treatment difference at 600 mg
    Statistical analysis description
    Farrington-Manning test for the difference (AR101 - Placebo) in percentage of subjects ages 4-17 who tolerated a single highest dose of at least 600 mg
    Comparison groups
    AR101 ITT Population Ages 4-17 v Placebo ITT Population Ages 4-17
    Number of subjects included in analysis
    496
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Farrington-Manning test
    Parameter type
    		 Risk difference (RD)
    Point estimate
    63.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 53
         upper limit
    		 73.3

    Secondary: Secondary Efficacy End point: Percentage of subjects ages 4-17 who tolerated a single highest dose of at least 300 mg in the Exit Oral Food Challenge

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    End point title
    		 Secondary Efficacy End point: Percentage of subjects ages 4-17 who tolerated a single highest dose of at least 300 mg in the Exit Oral Food Challenge
    End point description
    End point type
    Secondary
    End point timeframe
    Exit oral food challenge (after approximately 1 year of blinded therapy)
    End point values
    		 AR101 ITT Population Ages 4-17 Placebo ITT Population Ages 4-17
    Number of subjects analysed
    372
    124
    Units: Percentage of Patients
    number (confidence interval 95%)
        Responder
    76.6 (72.1 to 80.6)
    8.1 (4.4 to 14.2)
    Statistical analysis title
    		 Treatment difference at 300 mg
    Statistical analysis description
    Farrington-Manning test for the difference (AR101 - Placebo) in percentage of subjects ages 4-17 who tolerated a single highest dose of at least 300 mg
    Comparison groups
    AR101 ITT Population Ages 4-17 v Placebo ITT Population Ages 4-17
    Number of subjects included in analysis
    496
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Farrington-Manning test
    Parameter type
    		 Risk difference (RD)
    Point estimate
    68.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 58.6
         upper limit
    		 78.5

    Secondary: Secondary Efficacy End point: The maximum severity of symptoms in subjects ages 4-17 occurring at any challenge dose of peanut protein during the Exit Oral Food Challenge

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    End point title
    		 Secondary Efficacy End point: The maximum severity of symptoms in subjects ages 4-17 occurring at any challenge dose of peanut protein during the Exit Oral Food Challenge
    End point description
    End point type
    Secondary
    End point timeframe
    Exit oral food challenge (after approximately 1 year of blinded therapy)
    End point values
    		 AR101 ITT Population Ages 4-17 Placebo ITT Population Ages 4-17
    Number of subjects analysed
    372
    124
    Units: Percentage of Patients
    number (not applicable)
        None
    37.6
    2.4
        Mild
    32.0
    28.2
        Moderate
    25.3
    58.9
        Severe or worse
    5.1
    10.5
    Statistical analysis title
    		 Treatment difference in maximum severity
    Statistical analysis description
    Cochran-Mantel-Haenszel test (using equally spaced scores), stratified by region (North America, Europe) for the difference between AR101 and Placebo in maximum severity of symptoms in subjects ages 4-17 occurring at any challenge dose of peanut protein during the Exit Oral Food Challenge
    Comparison groups
    AR101 ITT Population Ages 4-17 v Placebo ITT Population Ages 4-17
    Number of subjects included in analysis
    496
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 < 0.0001
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [1] - Subjects without an Exit Food Challenge were assigned the maximum severity during the Screening Food Challenge, which equates to no change from screening

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Through study completion (approximately 1 year)
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    AR101 Safety Population (Age 4-17)
    Reporting group description
    		 -

    Reporting group title
    Placebo Safety Population (Age 4-17)
    Reporting group description
    		 -

    Serious adverse events
    		 AR101 Safety Population (Age 4-17) Placebo Safety Population (Age 4-17)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    8 / 372 (2.15%)
    1 / 124 (0.81%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Concussion
         subjects affected / exposed
    1 / 372 (0.27%)
    0 / 124 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Humerus fracture
         subjects affected / exposed
    0 / 372 (0.00%)
    1 / 124 (0.81%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    3 / 372 (0.81%)
    0 / 124 (0.00%)
         occurrences causally related to treatment / all
    3 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    2 / 372 (0.54%)
    0 / 124 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    1 / 372 (0.27%)
    0 / 124 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    1 / 372 (0.27%)
    0 / 124 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngitis streptococcal
         subjects affected / exposed
    1 / 372 (0.27%)
    0 / 124 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 AR101 Safety Population (Age 4-17) Placebo Safety Population (Age 4-17)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    367 / 372 (98.66%)
    118 / 124 (95.16%)
    Vascular disorders
    Flushing
         subjects affected / exposed
    49 / 372 (13.17%)
    11 / 124 (8.87%)
         occurrences all number
    194
    13
    Nervous system disorders
    Headache
         subjects affected / exposed
    72 / 372 (19.35%)
    28 / 124 (22.58%)
         occurrences all number
    208
    94
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    88 / 372 (23.66%)
    27 / 124 (21.77%)
         occurrences all number
    189
    47
    Chest discomfort
         subjects affected / exposed
    24 / 372 (6.45%)
    1 / 124 (0.81%)
         occurrences all number
    42
    1
    Ear and labyrinth disorders
    Ear pruritus
         subjects affected / exposed
    25 / 372 (6.72%)
    0 / 124 (0.00%)
         occurrences all number
    110
    0
    Immune system disorders
    Anaphylactic reaction
         subjects affected / exposed
    51 / 372 (13.71%)
    4 / 124 (3.23%)
         occurrences all number
    70
    4
    Seasonal allergy
         subjects affected / exposed
    6 / 372 (1.61%)
    7 / 124 (5.65%)
         occurrences all number
    7
    17
    Eye disorders
    Ocular hyperaemia
         subjects affected / exposed
    34 / 372 (9.14%)
    10 / 124 (8.06%)
         occurrences all number
    64
    11
    Eye pruritus
         subjects affected / exposed
    32 / 372 (8.60%)
    16 / 124 (12.90%)
         occurrences all number
    39
    21
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    194 / 372 (52.15%)
    30 / 124 (24.19%)
         occurrences all number
    1055
    93
    Vomiting
         subjects affected / exposed
    154 / 372 (41.40%)
    30 / 124 (24.19%)
         occurrences all number
    467
    55
    Abdominal pain upper
         subjects affected / exposed
    152 / 372 (40.86%)
    26 / 124 (20.97%)
         occurrences all number
    1201
    85
    Oral pruritus
         subjects affected / exposed
    151 / 372 (40.59%)
    20 / 124 (16.13%)
         occurrences all number
    1629
    21
    Nausea
         subjects affected / exposed
    146 / 372 (39.25%)
    29 / 124 (23.39%)
         occurrences all number
    808
    38
    Paraesthesia oral
         subjects affected / exposed
    65 / 372 (17.47%)
    8 / 124 (6.45%)
         occurrences all number
    762
    15
    Diarrhoea
         subjects affected / exposed
    61 / 372 (16.40%)
    24 / 124 (19.35%)
         occurrences all number
    202
    45
    Abdominal discomfort
         subjects affected / exposed
    60 / 372 (16.13%)
    17 / 124 (13.71%)
         occurrences all number
    367
    27
    Lip swelling
         subjects affected / exposed
    38 / 372 (10.22%)
    5 / 124 (4.03%)
         occurrences all number
    78
    4
    Tongue pruritus
         subjects affected / exposed
    38 / 372 (10.22%)
    7 / 124 (5.65%)
         occurrences all number
    115
    10
    Lip pruritus
         subjects affected / exposed
    36 / 372 (9.68%)
    7 / 124 (5.65%)
         occurrences all number
    106
    6
    Dysphagia
         subjects affected / exposed
    20 / 372 (5.38%)
    3 / 124 (2.42%)
         occurrences all number
    34
    6
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    152 / 372 (40.86%)
    42 / 124 (33.87%)
         occurrences all number
    366
    117
    Throat irritation
         subjects affected / exposed
    152 / 372 (40.86%)
    34 / 124 (27.42%)
         occurrences all number
    1775
    53
    Rhinorrhoea
         subjects affected / exposed
    113 / 372 (30.38%)
    28 / 124 (22.58%)
         occurrences all number
    337
    53
    Sneezing
         subjects affected / exposed
    98 / 372 (26.34%)
    18 / 124 (14.52%)
         occurrences all number
    259
    47
    Throat tightness
         subjects affected / exposed
    86 / 372 (23.12%)
    8 / 124 (6.45%)
         occurrences all number
    350
    4
    Nasal congestion
         subjects affected / exposed
    80 / 372 (21.51%)
    28 / 124 (22.58%)
         occurrences all number
    180
    61
    Oropharyngeal pain
         subjects affected / exposed
    70 / 372 (18.82%)
    19 / 124 (15.32%)
         occurrences all number
    199
    29
    Wheezing
         subjects affected / exposed
    58 / 372 (15.59%)
    15 / 124 (12.10%)
         occurrences all number
    123
    37
    Dyspnoea
         subjects affected / exposed
    44 / 372 (11.83%)
    5 / 124 (4.03%)
         occurrences all number
    77
    4
    Asthma
         subjects affected / exposed
    42 / 372 (11.29%)
    10 / 124 (8.06%)
         occurrences all number
    58
    14
    Rhinitis allergic
         subjects affected / exposed
    32 / 372 (8.60%)
    11 / 124 (8.87%)
         occurrences all number
    60
    36
    Dysphonia
         subjects affected / exposed
    25 / 372 (6.72%)
    2 / 124 (1.61%)
         occurrences all number
    35
    4
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    153 / 372 (41.13%)
    34 / 124 (27.42%)
         occurrences all number
    438
    119
    Urticaria
         subjects affected / exposed
    143 / 372 (38.44%)
    30 / 124 (24.19%)
         occurrences all number
    468
    84
    Rash
         subjects affected / exposed
    81 / 372 (21.77%)
    18 / 124 (14.52%)
         occurrences all number
    146
    42
    Swelling face
         subjects affected / exposed
    39 / 372 (10.48%)
    7 / 124 (5.65%)
         occurrences all number
    84
    8
    Eczema
         subjects affected / exposed
    32 / 372 (8.60%)
    12 / 124 (9.68%)
         occurrences all number
    68
    21
    Erythema
         subjects affected / exposed
    27 / 372 (7.26%)
    5 / 124 (4.03%)
         occurrences all number
    33
    11
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    110 / 372 (29.57%)
    39 / 124 (31.45%)
         occurrences all number
    187
    57
    Nasopharyngitis
         subjects affected / exposed
    57 / 372 (15.32%)
    20 / 124 (16.13%)
         occurrences all number
    79
    35
    Viral infection
         subjects affected / exposed
    50 / 372 (13.44%)
    13 / 124 (10.48%)
         occurrences all number
    76
    14
    Pharyngitis streptococcal
         subjects affected / exposed
    28 / 372 (7.53%)
    5 / 124 (4.03%)
         occurrences all number
    35
    8
    Gastroenteritis
         subjects affected / exposed
    24 / 372 (6.45%)
    5 / 124 (4.03%)
         occurrences all number
    30
    6
    Gastroenteritis viral
         subjects affected / exposed
    24 / 372 (6.45%)
    7 / 124 (5.65%)
         occurrences all number
    34
    9
    Influenza
         subjects affected / exposed
    20 / 372 (5.38%)
    8 / 124 (6.45%)
         occurrences all number
    24
    9
    Otitis media
         subjects affected / exposed
    20 / 372 (5.38%)
    5 / 124 (4.03%)
         occurrences all number
    23
    6
    Rhinitis
         subjects affected / exposed
    20 / 372 (5.38%)
    11 / 124 (8.87%)
         occurrences all number
    33
    15
    Sinusitis
         subjects affected / exposed
    16 / 372 (4.30%)
    7 / 124 (5.65%)
         occurrences all number
    19
    9
    Viral upper respiratory tract infection
         subjects affected / exposed
    15 / 372 (4.03%)
    7 / 124 (5.65%)
         occurrences all number
    20
    11

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 Dec 2015
    Amendment 1 Changes: • Additional secondary endpoints added • Additional exclusion criteria added
    25 Apr 2016
    Amendment 2 Changes: • Additional exploratory endpoints added • Additional exclusion criteria added
    29 Aug 2016
    Amendment 3 Changes: • Exclusion criteria revised • Optional substudy added as an exploratory endpoint (for North America)
    31 Jul 2017
    Amendment 4 Changes: • To incorporate regulatory feedback from participating countries: - Subject continuation provisions prior to enrolling into follow-on study added - Primary and secondary objectives updated - European primary endpoint added • End of trial definition added • Clarified sites for substudy • Clarified adverse event reporting requirements

    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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