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    Clinical Trial Results:
    A Phase 1/2a, Randomized, Double-blind, Placebo-controlled, Dose-escalation Study to Evaluate the Safety, Tolerability, Immunogenicity and Vaccine-like Viral Shedding of MEDI-534, a Live, Attenuated Intranasal Vaccine Against Respiratory Syncytial Virus (RSV) and Parainfluenza Virus Type 3 (PIV3), in Healthy 6 to < 24 Month-old Children and in 2 Month-old Infants

    Summary
    EudraCT number
    2008-002651-24
    Trial protocol
    DE   GB   FI   ES   BE  
    Global end of trial date
    23 Aug 2012

    Results information
    Results version number
    v2(current)
    This version publication date
    30 Apr 2016
    First version publication date
    06 Aug 2015
    Other versions
    v1
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    MI-CP178
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00686075
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    MedImmune, LLC.
    Sponsor organisation address
    One MedImmune Way, Gaithersburg, MD, United States, 20878
    Public contact
    Filip Dubovsky, Vice President, Clinical Development, MedImmune, LLC., dubovskyf@medimmune.com
    Scientific contact
    Filip Dubovsky, Vice President, Clinical Development, MedImmune, LLC., dubovskyf@medimmune.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
    23 Aug 2012
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Aug 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to describe the safety and tolerability of multiple doses of MEDI-534 at 105 or 106 TCID50 in RSV and PIV3 seronegative subjects 6 to < 24 months of age and at dosages of 104, 105, or 106 TCID50 in unscreened infants 2 months of age.
    Protection of trial subjects
    The conduct of this clinical study met all local legal and regulatory requirements. The study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and the International Conference on Harmonization guideline E6: Good Clinical Practice. Participating participant signed informed consent form and could withdraw from the study at any time without any disadvantage and without having to provide a reason for this decision. Only investigators qualified by training and experience were selected as appropriate experts to investigate the study drug.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    11 Jul 2008
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Safety
    Long term follow-up duration
    1 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 390
    Country: Number of subjects enrolled
    Germany: 4
    Country: Number of subjects enrolled
    Brazil: 23
    Country: Number of subjects enrolled
    Finland: 17
    Country: Number of subjects enrolled
    Spain: 142
    Country: Number of subjects enrolled
    Canada: 3
    Country: Number of subjects enrolled
    Australia: 13
    Country: Number of subjects enrolled
    Israel: 18
    Country: Number of subjects enrolled
    South Africa: 110
    Worldwide total number of subjects
    720
    EEA total number of subjects
    163
    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)
    720
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    A total of 720 participants were randomized in the study. An additional 618 participants were screened but not randomized in the study.

    Pre-assignment
    Screening details
    A total of 720 participants were randomized in the study. An additional 618 participants were screened but not randomized in the study.

    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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    MEDI-534, Cohort 1
    Arm description
    Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.
    Arm type
    Experimental

    Investigational medicinal product name
    MEDI-534
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for nasal drops, solution
    Routes of administration
    Nasal use
    Dosage and administration details
    Participants aged 6 to less than (<) 24 months will receive MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.

    Arm title
    Placebo, Cohort 1
    Arm description
    Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal drops, solution
    Routes of administration
    Nasal use
    Dosage and administration details
    Participants aged 6 to <24 months will receive placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.

    Arm title
    MEDI-534, Cohort 2
    Arm description
    Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
    Arm type
    Experimental

    Investigational medicinal product name
    MEDI-534
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for nasal drops, solution
    Routes of administration
    Nasal use
    Dosage and administration details
    Participants aged 6 to <24 months will receive MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.

    Arm title
    Placebo, Cohort 2
    Arm description
    Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal drops, solution
    Routes of administration
    Nasal use
    Dosage and administration details
    Participants aged 6 to <24 months will receive placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.

    Arm title
    MEDI-534, Cohort 3
    Arm description
    Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
    Arm type
    Experimental

    Investigational medicinal product name
    MEDI-534
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for nasal drops, solution
    Routes of administration
    Nasal use
    Dosage and administration details
    Participants aged 2 months will receive MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.

    Arm title
    Placebo, Cohort 3
    Arm description
    Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for nasal drops, solution
    Routes of administration
    Nasal use
    Dosage and administration details
    Participants aged 2 months will receive placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.

    Arm title
    MEDI-534, Cohort 4
    Arm description
    Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
    Arm type
    Experimental

    Investigational medicinal product name
    MEDI-534
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal drops, solution
    Routes of administration
    Nasal use
    Dosage and administration details
    Participants aged 2 months will receive MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.

    Arm title
    Placebo, Cohort 4
    Arm description
    Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for nasal drops, solution
    Routes of administration
    Nasal use
    Dosage and administration details
    Participants aged 2 months will receive placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.

    Arm title
    MEDI-534, Cohort 5
    Arm description
    Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
    Arm type
    Experimental

    Investigational medicinal product name
    MEDI-534
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for nasal drops, solution
    Routes of administration
    Nasal use
    Dosage and administration details
    Participants aged 2 months will receive MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4

    Arm title
    Placebo, Cohort 5
    Arm description
    Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for nasal drops, solution
    Routes of administration
    Nasal use
    Dosage and administration details
    Participants aged 2 months will receive placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.

    Number of subjects in period 1
    MEDI-534, Cohort 1 Placebo, Cohort 1 MEDI-534, Cohort 2 Placebo, Cohort 2 MEDI-534, Cohort 3 Placebo, Cohort 3 MEDI-534, Cohort 4 Placebo, Cohort 4 MEDI-534, Cohort 5 Placebo, Cohort 5
    Started
    79
    81
    80
    80
    40
    40
    82
    78
    81
    79
    Treated
    78
    79
    80
    80
    40
    40
    82
    77
    80
    78
    Completed
    71
    71
    74
    71
    36
    37
    82
    76
    75
    69
    Not completed
    8
    10
    6
    9
    4
    3
    0
    2
    6
    10
         unspecified
             1
             1
             -
             -
             -
             -
             -
             -
             -
             1
         Consent withdrawn by subject
             4
             3
             3
             7
             1
             -
             -
             2
             4
             6
         Lost to follow-up
             3
             6
             3
             2
             3
             3
             -
             -
             2
             3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    MEDI-534, Cohort 1
    Reporting group description
    Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.

    Reporting group title
    Placebo, Cohort 1
    Reporting group description
    Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.

    Reporting group title
    MEDI-534, Cohort 2
    Reporting group description
    Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.

    Reporting group title
    Placebo, Cohort 2
    Reporting group description
    Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.

    Reporting group title
    MEDI-534, Cohort 3
    Reporting group description
    Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.

    Reporting group title
    Placebo, Cohort 3
    Reporting group description
    Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.

    Reporting group title
    MEDI-534, Cohort 4
    Reporting group description
    Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.

    Reporting group title
    Placebo, Cohort 4
    Reporting group description
    Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.

    Reporting group title
    MEDI-534, Cohort 5
    Reporting group description
    Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.

    Reporting group title
    Placebo, Cohort 5
    Reporting group description
    Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.

    Reporting group values
    MEDI-534, Cohort 1 Placebo, Cohort 1 MEDI-534, Cohort 2 Placebo, Cohort 2 MEDI-534, Cohort 3 Placebo, Cohort 3 MEDI-534, Cohort 4 Placebo, Cohort 4 MEDI-534, Cohort 5 Placebo, Cohort 5 Total
    Number of subjects
    79 81 80 80 40 40 82 78 81 79 720
    Age categorical
    Units: Subjects
        6 to 24 Months
    79 81 80 80 0 0 0 0 0 0 320
        2 Months
    0 0 0 0 40 40 82 78 81 79 400
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    9.91 ± 3.7 9.36 ± 4.04 11.39 ± 4.89 3.51 ± 9.5 1.48 ± 0.51 1.53 ± 0.51 1.41 ± 0.52 1.45 ± 0.5 1.52 ± 0.5 1.49 ± 0.5 -
    Gender, Male/Female
    Units: participants
        Female
    40 36 35 40 21 18 47 41 39 43 360
        Male
    39 45 45 40 19 22 35 37 42 36 360

    End points

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    End points reporting groups
    Reporting group title
    MEDI-534, Cohort 1
    Reporting group description
    Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.

    Reporting group title
    Placebo, Cohort 1
    Reporting group description
    Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.

    Reporting group title
    MEDI-534, Cohort 2
    Reporting group description
    Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.

    Reporting group title
    Placebo, Cohort 2
    Reporting group description
    Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.

    Reporting group title
    MEDI-534, Cohort 3
    Reporting group description
    Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.

    Reporting group title
    Placebo, Cohort 3
    Reporting group description
    Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.

    Reporting group title
    MEDI-534, Cohort 4
    Reporting group description
    Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.

    Reporting group title
    Placebo, Cohort 4
    Reporting group description
    Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.

    Reporting group title
    MEDI-534, Cohort 5
    Reporting group description
    Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.

    Reporting group title
    Placebo, Cohort 5
    Reporting group description
    Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.

    Primary: Number of Participants With Solicited Symptoms After Dose 1

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    End point title
    Number of Participants With Solicited Symptoms After Dose 1 [1]
    End point description
    Solicited symptoms were predefined symptoms or events to be specifically inquired about and assessed daily during the 28-day period after vaccine administration. The solicited symptoms included fever greater than or equal to (>=) 100.4 degrees Fahrenheit (F), runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/fussiness, oropharyngeal inflammation (laryngitis), and epistaxis.
    End point type
    Primary
    End point timeframe
    Within 28 days after Dose 1
    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: Statistical data was not planned to be reported for this endpoint.
    End point values
    MEDI-534, Cohort 1 Placebo, Cohort 1 MEDI-534, Cohort 2 Placebo, Cohort 2 MEDI-534, Cohort 3 Placebo, Cohort 3 MEDI-534, Cohort 4 Placebo, Cohort 4 MEDI-534, Cohort 5 Placebo, Cohort 5
    Number of subjects analysed
    78
    79
    80
    80
    40
    40
    82
    77
    80
    78
    Units: participants
        Any solicited symptom
    65
    68
    61
    59
    27
    24
    50
    48
    60
    53
        Fever: 100.4 to 101.4 degrees F
    13
    8
    10
    8
    4
    4
    6
    1
    4
    3
        Fever: 101.5 to 103.1 degrees F
    9
    8
    6
    8
    1
    3
    1
    4
    2
    2
        Fever: 103.2 to 104.9 degrees F
    3
    1
    1
    1
    0
    1
    0
    0
    0
    0
        Fever: greater than (>) 104.9 degrees F
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Runny/stuffy nose
    50
    51
    50
    40
    19
    15
    30
    36
    30
    30
        Cough
    27
    30
    33
    24
    11
    8
    19
    22
    17
    19
        Drowsiness
    26
    29
    21
    21
    10
    9
    15
    13
    16
    22
        Loss of appetite/decreased urine output
    22
    26
    21
    21
    7
    7
    9
    6
    12
    12
        Irritability/fussiness
    40
    46
    41
    44
    16
    14
    29
    18
    41
    32
        Oropharyngeal inflammation
    9
    12
    7
    8
    2
    2
    5
    7
    3
    6
        Epistaxis
    4
    0
    4
    5
    1
    1
    2
    0
    0
    1
    No statistical analyses for this end point

    Primary: Number of Participants With Solicited Symptoms After Dose 2

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    End point title
    Number of Participants With Solicited Symptoms After Dose 2 [2]
    End point description
    Solicited symptoms were predefined symptoms or events to be specifically inquired about and assessed daily during the 28-day period after vaccine administration. The solicited symptoms included fever >=100.4 degrees F, runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/fussiness, oropharyngeal inflammation (laryngitis), and epistaxis.
    End point type
    Primary
    End point timeframe
    Within 28 days after Dose 2
    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: Statistical data was not planned to be reported for this endpoint.
    End point values
    MEDI-534, Cohort 1 Placebo, Cohort 1 MEDI-534, Cohort 2 Placebo, Cohort 2 MEDI-534, Cohort 3 Placebo, Cohort 3 MEDI-534, Cohort 4 Placebo, Cohort 4 MEDI-534, Cohort 5 Placebo, Cohort 5
    Number of subjects analysed
    63
    65
    66
    65
    25
    26
    76
    71
    73
    70
    Units: participants
        Any solicited symptom
    50
    53
    53
    45
    12
    19
    38
    42
    39
    41
        Fever: 100.4 to 101.4 degrees F
    16
    17
    10
    11
    1
    2
    8
    4
    1
    3
        Fever: 101.5 to 103.1 degrees F
    13
    10
    9
    8
    0
    1
    3
    1
    1
    0
        Fever: 103.2 to 104.9 degrees F
    2
    1
    3
    1
    0
    0
    1
    0
    0
    0
        Fever: >104.9 degrees F
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Runny/stuffy nose
    41
    35
    38
    34
    10
    15
    25
    30
    25
    24
        Cough
    16
    23
    28
    22
    2
    7
    15
    21
    20
    20
        Drowsiness
    20
    13
    15
    15
    5
    4
    11
    7
    7
    10
        Loss of appetite/decreased urine output
    16
    17
    14
    17
    3
    4
    9
    11
    9
    9
        Irritability/fussiness
    33
    29
    35
    25
    8
    6
    13
    14
    22
    21
        Oropharyngeal inflammation
    9
    5
    4
    3
    2
    1
    4
    2
    7
    7
        Epistaxis
    4
    4
    2
    4
    1
    0
    0
    1
    1
    0
    No statistical analyses for this end point

    Primary: Number of Participants With Solicited Symptoms After Dose 3

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    End point title
    Number of Participants With Solicited Symptoms After Dose 3 [3]
    End point description
    Solicited symptoms were predefined symptoms or events to be specifically inquired about and assessed daily during the 28-day period after vaccine administration. The solicited symptoms included fever >=100.4 degrees F, runny/stuffy nose, cough, drowsiness, loss of appetite/decreased urine output, irritability/fussiness, oropharyngeal inflammation (laryngitis), and epistaxis.
    End point type
    Primary
    End point timeframe
    Within 28 days after Dose 3
    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: Statistical data was not planned to be reported for this endpoint.
    End point values
    MEDI-534, Cohort 1 Placebo, Cohort 1 MEDI-534, Cohort 2 Placebo, Cohort 2 MEDI-534, Cohort 3 Placebo, Cohort 3 MEDI-534, Cohort 4 Placebo, Cohort 4 MEDI-534, Cohort 5 Placebo, Cohort 5
    Number of subjects analysed
    60
    60
    63
    61
    28
    30
    76
    70
    71
    68
    Units: participants
        Any solicited symptom
    41
    45
    48
    45
    20
    17
    36
    33
    48
    41
        Fever: 100.4 to 101.4 degrees F
    8
    9
    9
    9
    3
    6
    7
    8
    10
    10
        Fever: 101.5 to 103.1 degrees F
    6
    8
    6
    9
    1
    0
    2
    1
    4
    4
        Fever: 103.2 to 104.9 degrees F
    0
    2
    2
    1
    0
    0
    0
    0
    1
    0
        Fever: >104.9 degrees F
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Runny/stuffy nose
    36
    35
    35
    28
    16
    15
    24
    21
    32
    31
        Cough
    22
    14
    20
    17
    10
    10
    14
    15
    25
    23
        Drowsiness
    12
    9
    11
    9
    2
    6
    4
    4
    7
    9
        Loss of appetite/decreased urine output
    13
    15
    8
    11
    8
    4
    8
    10
    11
    11
        Irritability/fussiness
    23
    25
    29
    28
    11
    8
    11
    11
    20
    14
        Oropharyngeal inflammation
    9
    4
    4
    2
    1
    3
    2
    4
    8
    6
        Epistaxis
    2
    1
    2
    4
    0
    2
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After Dose 1

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    End point title
    Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After Dose 1 [4]
    End point description
    An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent adverse events (TEAEs) for Dose 1 are events between administration of Dose 1 and up to 28 days after the dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with unsolicited TEAEs (spontaneously reported events) after Dose 1 were reported.
    End point type
    Primary
    End point timeframe
    Within 28 days after Dose 1
    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: Statistical data was not planned to be reported for this endpoint.
    End point values
    MEDI-534, Cohort 1 Placebo, Cohort 1 MEDI-534, Cohort 2 Placebo, Cohort 2 MEDI-534, Cohort 3 Placebo, Cohort 3 MEDI-534, Cohort 4 Placebo, Cohort 4 MEDI-534, Cohort 5 Placebo, Cohort 5
    Number of subjects analysed
    78
    79
    80
    80
    40
    40
    82
    77
    80
    78
    Units: participants
    51
    51
    47
    35
    15
    15
    20
    26
    29
    21
    No statistical analyses for this end point

    Primary: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After Dose 2

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    End point title
    Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After Dose 2 [5]
    End point description
    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-Emergent Adverse Events (TEAEs) for Dose 2 are events between administration of Dose 2 and up to 28 days after the dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with unsolicited TEAEs (spontaneously reported events) after Dose 2 were reported.
    End point type
    Primary
    End point timeframe
    Within 28 days after Dose 2
    Notes
    [5] - 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: Statistical data was not planned to be reported for this endpoint.
    End point values
    MEDI-534, Cohort 1 Placebo, Cohort 1 MEDI-534, Cohort 2 Placebo, Cohort 2 MEDI-534, Cohort 3 Placebo, Cohort 3 MEDI-534, Cohort 4 Placebo, Cohort 4 MEDI-534, Cohort 5 Placebo, Cohort 5
    Number of subjects analysed
    63
    65
    66
    65
    25
    26
    76
    71
    73
    70
    Units: participants
    31
    41
    31
    27
    9
    10
    21
    21
    25
    24
    No statistical analyses for this end point

    Primary: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After Dose 3

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    End point title
    Number of Participants With Treatment-Emergent Adverse Events (TEAEs) After Dose 3 [6]
    End point description
    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-Emergent Adverse Events (TEAEs) for Dose 3 are events between administration of Dose 3 and up to 28 days after the dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with unsolicited TEAEs (spontaneously reported events) after Dose 3 were reported.
    End point type
    Primary
    End point timeframe
    Within 28 days after Dose 3
    Notes
    [6] - 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: Statistical data was not planned to be reported for this endpoint.
    End point values
    MEDI-534, Cohort 1 Placebo, Cohort 1 MEDI-534, Cohort 2 Placebo, Cohort 2 MEDI-534, Cohort 3 Placebo, Cohort 3 MEDI-534, Cohort 4 Placebo, Cohort 4 MEDI-534, Cohort 5 Placebo, Cohort 5
    Number of subjects analysed
    60
    60
    63
    61
    28
    30
    76
    70
    71
    68
    Units: participants
    34
    35
    33
    25
    11
    10
    25
    22
    29
    27
    No statistical analyses for this end point

    Primary: Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) After Dose 1

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    End point title
    Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) After Dose 1 [7]
    End point description
    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-Emergent Serious Adverse Events (TESAEs) are serious events between administration of Dose 1 and up to 28 days after the dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with unsolicited TESAEs (spontaneously reported events) after Dose 1 were reported.
    End point type
    Primary
    End point timeframe
    Within 28 days after Dose 1
    Notes
    [7] - 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: Statistical data was not planned to be reported for this endpoint.
    End point values
    MEDI-534, Cohort 1 Placebo, Cohort 1 MEDI-534, Cohort 2 Placebo, Cohort 2 MEDI-534, Cohort 3 Placebo, Cohort 3 MEDI-534, Cohort 4 Placebo, Cohort 4 MEDI-534, Cohort 5 Placebo, Cohort 5
    Number of subjects analysed
    78
    79
    80
    80
    40
    40
    82
    77
    80
    78
    Units: participants
    0
    0
    0
    0
    0
    0
    0
    0
    2
    1
    No statistical analyses for this end point

    Primary: Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) After Dose 2

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    End point title
    Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) After Dose 2 [8]
    End point description
    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-Emergent Serious Adverse Events (TESAEs) are serious events between administration of Dose 2 and up to 28 days after the dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with unsolicited TESAEs (spontaneously reported events) after Dose 2 were reported.
    End point type
    Primary
    End point timeframe
    Within 28 days after Dose 2
    Notes
    [8] - 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: Statistical data was not planned to be reported for this endpoint.
    End point values
    MEDI-534, Cohort 1 Placebo, Cohort 1 MEDI-534, Cohort 2 Placebo, Cohort 2 MEDI-534, Cohort 3 Placebo, Cohort 3 MEDI-534, Cohort 4 Placebo, Cohort 4 MEDI-534, Cohort 5 Placebo, Cohort 5
    Number of subjects analysed
    63
    65
    66
    65
    25
    26
    76
    71
    73
    70
    Units: participants
    1
    0
    0
    0
    0
    1
    0
    1
    0
    0
    No statistical analyses for this end point

    Primary: Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) After Dose 3

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    End point title
    Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) After Dose 3 [9]
    End point description
    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-Emergent Serious Adverse Events (TESAEs) are serious events between administration of Dose 3 and up to 28 days after the dose that were absent before treatment or that worsened relative to pretreatment state. Number of participants with unsolicited TESAEs (spontaneously reported events) after Dose 3 were reported.
    End point type
    Primary
    End point timeframe
    Within 28 days after Dose 3
    Notes
    [9] - 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: Statistical data was not planned to be reported for this endpoint.
    End point values
    MEDI-534, Cohort 1 Placebo, Cohort 1 MEDI-534, Cohort 2 Placebo, Cohort 2 MEDI-534, Cohort 3 Placebo, Cohort 3 MEDI-534, Cohort 4 Placebo, Cohort 4 MEDI-534, Cohort 5 Placebo, Cohort 5
    Number of subjects analysed
    60
    60
    63
    61
    28
    30
    76
    70
    71
    68
    Units: participants
    0
    1
    0
    0
    1
    0
    0
    0
    1
    0
    No statistical analyses for this end point

    Primary: Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 1

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    End point title
    Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 1 [10]
    End point description
    An MA-LRI was a healthcare provider-confirmed diagnosis of one or more of the following events: wheezing, pneumonia, croup (laryngotracheobronchitis), rhonchi (not cleared with cough or suctioning), rales (not cleared with cough or suctioning), bronchitis, bronchiolitis, and apnea.
    End point type
    Primary
    End point timeframe
    Within 28 days after Dose 1
    Notes
    [10] - 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: Statistical data was not planned to be reported for this endpoint.
    End point values
    MEDI-534, Cohort 1 Placebo, Cohort 1 MEDI-534, Cohort 2 Placebo, Cohort 2 MEDI-534, Cohort 3 Placebo, Cohort 3 MEDI-534, Cohort 4 Placebo, Cohort 4 MEDI-534, Cohort 5 Placebo, Cohort 5
    Number of subjects analysed
    78
    79
    80
    80
    40
    40
    82
    77
    80
    78
    Units: participants
    2
    2
    4
    4
    0
    0
    1
    0
    0
    2
    No statistical analyses for this end point

    Primary: Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 2

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    End point title
    Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 2 [11]
    End point description
    An MA-LRI was a healthcare provider-confirmed diagnosis of one or more of the following events: wheezing, pneumonia, croup (laryngotracheobronchitis), rhonchi (not cleared with cough or suctioning), rales (not cleared with cough or suctioning), bronchitis, bronchiolitis, and apnea.
    End point type
    Primary
    End point timeframe
    Within 28 days after Dose 2
    Notes
    [11] - 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: Statistical data was not planned to be reported for this endpoint.
    End point values
    MEDI-534, Cohort 1 Placebo, Cohort 1 MEDI-534, Cohort 2 Placebo, Cohort 2 MEDI-534, Cohort 3 Placebo, Cohort 3 MEDI-534, Cohort 4 Placebo, Cohort 4 MEDI-534, Cohort 5 Placebo, Cohort 5
    Number of subjects analysed
    63
    65
    66
    65
    25
    26
    76
    71
    73
    70
    Units: participants
    3
    3
    1
    3
    1
    2
    0
    2
    3
    1
    No statistical analyses for this end point

    Primary: Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 3

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    End point title
    Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) After Dose 3 [12]
    End point description
    An MA-LRI was a healthcare provider-confirmed diagnosis of one or more of the following events: wheezing, pneumonia, croup (laryngotracheobronchitis), rhonchi (not cleared with cough or suctioning), rales (not cleared with cough or suctioning), bronchitis, bronchiolitis, and apnea.
    End point type
    Primary
    End point timeframe
    Within 28 days after Dose 3
    Notes
    [12] - 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: Statistical data was not planned to be reported for this endpoint.
    End point values
    MEDI-534, Cohort 1 Placebo, Cohort 1 MEDI-534, Cohort 2 Placebo, Cohort 2 MEDI-534, Cohort 3 Placebo, Cohort 3 MEDI-534, Cohort 4 Placebo, Cohort 4 MEDI-534, Cohort 5 Placebo, Cohort 5
    Number of subjects analysed
    60
    60
    63
    61
    28
    30
    76
    70
    71
    68
    Units: participants
    3
    0
    7
    3
    2
    2
    1
    1
    7
    4
    No statistical analyses for this end point

    Secondary: Number of Participants who Shed Vaccine-Type Virus

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    End point title
    Number of Participants who Shed Vaccine-Type Virus
    End point description
    Nasal wash specimens were collected to assess vaccine virus recovery in the upper respiratory tract on 7, 12 and 28 days after each dosing.
    End point type
    Secondary
    End point timeframe
    7, 12 and 28 days after Dose 1, 2 and 3
    End point values
    MEDI-534, Cohort 1 Placebo, Cohort 1 MEDI-534, Cohort 2 Placebo, Cohort 2 MEDI-534, Cohort 3 Placebo, Cohort 3 MEDI-534, Cohort 4 Placebo, Cohort 4 MEDI-534, Cohort 5 Placebo, Cohort 5
    Number of subjects analysed
    76
    78
    78
    79
    40
    40
    82
    77
    78
    76
    Units: participants
        Dose 1: Day 7 (n=76,76,78,79,40,39,82,77,78,75)
    33
    0
    41
    0
    22
    0
    50
    0
    52
    0
        Dose 1: Day 12 (n=75,78,78,78,40,40,81,76,78,76)
    21
    0
    14
    0
    16
    0
    29
    0
    22
    0
        Dose 1: Day 28 (n=76,77,77,78,39,40,82,76,77,76)
    2
    0
    1
    0
    3
    0
    4
    0
    5
    0
        Dose 2: Day 7 (n=62,65,65,63,25,26,75,70,72,68)
    9
    0
    6
    0
    5
    0
    20
    0
    13
    0
        Dose 2: Day 12 (n=63,65,65,64,25,25,76,71,72,68)
    2
    0
    1
    0
    3
    0
    7
    0
    4
    0
        Dose 2: Day 28 (n=63,65,65,65,25,26,76,71,73,68)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
        Dose 3: Day 7 (n=58,59,62,59,28,30,75,70,69,68)
    6
    0
    1
    0
    4
    1
    18
    0
    11
    0
        Dose 3: Day 12 (n=59,60,61,61,28,29,76,70,70,68)
    1
    0
    0
    0
    0
    0
    5
    0
    4
    0
        Dose 3: Day 28 (n=60,60,63,61,28,30,76,70,71,68)
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Percentage of Participants With a Seroresponse to Respiratory Syncytial Virus (RSV) and Human Parainfluenza Virus Type 3 (hPIV3) After Dose 3

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    End point title
    Percentage of Participants With a Seroresponse to Respiratory Syncytial Virus (RSV) and Human Parainfluenza Virus Type 3 (hPIV3) After Dose 3
    End point description
    Seroresponse was defined as a >=4-fold rise from Baseline in neutralizing antibody titer, regardless of Baseline serostatus. Respiratory Syncytial Virus (RSV) and hPIV3 antibody titers were determined by using microneutralization assay and hemagglutination inhibition assay, respectively. Clopper-pearson exact confidence interval was reported.
    End point type
    Secondary
    End point timeframe
    Day 28 after Dose 3
    End point values
    MEDI-534, Cohort 1 Placebo, Cohort 1 MEDI-534, Cohort 2 Placebo, Cohort 2 MEDI-534, Cohort 3 Placebo, Cohort 3 MEDI-534, Cohort 4 Placebo, Cohort 4 MEDI-534, Cohort 5 Placebo, Cohort 5
    Number of subjects analysed
    55
    53
    51
    53
    20
    22
    68
    59
    63
    61
    Units: percentage of participants
    number (confidence interval)
        RSV (n=44, 51, 50, 51, 19, 19, 68, 59, 63, 61)
    29.5 (16.8 to 45.2)
    17.6 (8.4 to 30.9)
    36 (22.9 to 50.8)
    25.5 (14.3 to 39.6)
    15.8 (3.4 to 39.6)
    5.3 (0.1 to 26)
    7.4 (2.4 to 16.3)
    3.4 (0.4 to 11.7)
    0 (0 to 5.7)
    0 (0 to 5.9)
        hPIV3 (n=55, 53, 51, 53, 20, 22, 65, 59, 57, 52)
    67.3 (53.3 to 79.3)
    7.5 (2.1 to 18.2)
    86.3 (73.7 to 94.3)
    11.3 (4.3 to 23)
    35 (15.4 to 59.2)
    4.5 (0.1 to 22.8)
    16.9 (8.8 to 28.3)
    5.1 (1.1 to 14.1)
    19.3 (10 to 31.9)
    5.8 (1.2 to 15.9)
    No statistical analyses for this end point

    Secondary: Genotypic Stability of Recovered Vaccine-Type Virus

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    End point title
    Genotypic Stability of Recovered Vaccine-Type Virus
    End point description
    Nasal wash samples with vaccine-type virus were evaluated for genotypic stability, defined as the presence of the entire RSV-Fusion (RSV F) insert based on the RSV F sequence results. If the insert was absent or truncated, the recovered virus was counted as genotypically unstable. Nasal wash samples were categorized as genotypically stable, genotypically unstable or undetermined genotypic stability.
    End point type
    Secondary
    End point timeframe
    Within 28 days after any dose
    End point values
    MEDI-534, Cohort 1 Placebo, Cohort 1 MEDI-534, Cohort 2 Placebo, Cohort 2 MEDI-534, Cohort 3 Placebo, Cohort 3 MEDI-534, Cohort 4 Placebo, Cohort 4 MEDI-534, Cohort 5 Placebo, Cohort 5
    Number of subjects analysed
    53
    0 [13]
    48
    0 [14]
    29
    1
    67
    0 [15]
    60
    0 [16]
    Units: nasal wash samples
        Genotypically stable
    77
    67
    54
    1
    135
    110
        Genotypically unstable
    0
    0
    0
    0
    0
    0
        Undetermined genotypic stability
    4
    0
    5
    0
    6
    7
    Notes
    [13] - No participant was analyzed for this endpoint in this reporting group.
    [14] - No participant was analyzed for this endpoint in this reporting group
    [15] - No participant was analyzed for this endpoint in this reporting group
    [16] - No participant was analyzed for this endpoint in this reporting group
    No statistical analyses for this end point

    Secondary: Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) Through 365 Days After Randomization

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    End point title
    Number of Participants With Medically-Attended Lower Respiratory Illnesses (MA-LRIs) Through 365 Days After Randomization
    End point description
    An MA-LRI was a healthcare provider-confirmed diagnosis of one or more of the following events: wheezing, pneumonia, croup (laryngotracheobronchitis), rhonchi (not cleared with cough or suctioning), rales (not cleared with cough or suctioning), bronchitis, bronchiolitis, and apnea. MA-LRIs occurring within 28 days post any dose and after 28 days post any dose were summarized separately.
    End point type
    Secondary
    End point timeframe
    Day 0 to Day 365
    End point values
    MEDI-534, Cohort 1 Placebo, Cohort 1 MEDI-534, Cohort 2 Placebo, Cohort 2 MEDI-534, Cohort 3 Placebo, Cohort 3 MEDI-534, Cohort 4 Placebo, Cohort 4 MEDI-534, Cohort 5 Placebo, Cohort 5
    Number of subjects analysed
    78
    79
    80
    80
    40
    40
    82
    77
    80
    78
    Units: participants
        Within 28 days post any dose
    8
    5
    12
    10
    3
    4
    2
    3
    10
    7
        After 28 days post any dose
    16
    16
    18
    10
    6
    7
    13
    20
    23
    15
    No statistical analyses for this end point

    Secondary: Number of Participants With Significant New Medical Conditions (SNMCs) Through 365 Days After Randomization

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    End point title
    Number of Participants With Significant New Medical Conditions (SNMCs) Through 365 Days After Randomization
    End point description
    An SNMC was a newly diagnosed medical condition that was of a chronic, ongoing nature and was assessed by the investigator as medically significant. Examples of SNMCs include diabetes, asthma, autoimmune disease (for example, lupus, rheumatoid arthritis), and neurological disease (for example, epilepsy, autism).
    End point type
    Secondary
    End point timeframe
    Day 0 to Day 365
    End point values
    MEDI-534, Cohort 1 Placebo, Cohort 1 MEDI-534, Cohort 2 Placebo, Cohort 2 MEDI-534, Cohort 3 Placebo, Cohort 3 MEDI-534, Cohort 4 Placebo, Cohort 4 MEDI-534, Cohort 5 Placebo, Cohort 5
    Number of subjects analysed
    78
    79
    80
    80
    40
    40
    82
    77
    80
    78
    Units: participants
    0
    0
    1
    1
    0
    0
    3
    1
    1
    1
    No statistical analyses for this end point

    Secondary: Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) Through 365 Days After Randomization

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    End point title
    Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs) Through 365 Days After Randomization
    End point description
    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-Emergent Serious Adverse Events (TESAEs) are serious events after administration of drug which were absent before treatment or that worsened relative to pretreatment state. Number of participants with unsolicited TESAEs (spontaneously reported events) within 365 days after randomization were reported.
    End point type
    Secondary
    End point timeframe
    Day 0 to Day 365
    End point values
    MEDI-534, Cohort 1 Placebo, Cohort 1 MEDI-534, Cohort 2 Placebo, Cohort 2 MEDI-534, Cohort 3 Placebo, Cohort 3 MEDI-534, Cohort 4 Placebo, Cohort 4 MEDI-534, Cohort 5 Placebo, Cohort 5
    Number of subjects analysed
    78
    79
    80
    80
    40
    40
    82
    77
    80
    78
    Units: participants
    6
    5
    5
    1
    1
    2
    3
    4
    9
    3
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Day 0 to Day 365
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    12.0
    Reporting groups
    Reporting group title
    Placebo, Cohort 1
    Reporting group description
    Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.

    Reporting group title
    MEDI-534, Cohort 1
    Reporting group description
    Participants aged 6 to less than (<) 24 months received MEDI-534, 10^5 median tissue culture infectious dose (TCID50) by intranasal route at Month 0, 2, and 4.

    Reporting group title
    Placebo, Cohort 2
    Reporting group description
    Participants aged 6 to <24 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.

    Reporting group title
    MEDI-534, Cohort 2
    Reporting group description
    Participants aged 6 to <24 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.

    Reporting group title
    MEDI-534, Cohort 3
    Reporting group description
    Participants aged 2 months received MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.

    Reporting group title
    Placebo, Cohort 3
    Reporting group description
    Participants aged 2 months received placebo matched to MEDI-534, 10^4 TCID50 by intranasal route at Month 0, 2, and 4.

    Reporting group title
    MEDI-534, Cohort 4
    Reporting group description
    Participants aged 2 months received MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.

    Reporting group title
    Placebo, Cohort 4
    Reporting group description
    Participants aged 2 months received placebo matched to MEDI-534, 10^5 TCID50 by intranasal route at Month 0, 2, and 4.

    Reporting group title
    MEDI-534, Cohort 5
    Reporting group description
    Participants aged 2 months received MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.

    Reporting group title
    Placebo, Cohort 5
    Reporting group description
    Participants aged 2 months received placebo matched to MEDI-534, 10^6 TCID50 by intranasal route at Month 0, 2, and 4.

    Serious adverse events
    Placebo, Cohort 1 MEDI-534, Cohort 1 Placebo, Cohort 2 MEDI-534, Cohort 2 MEDI-534, Cohort 3 Placebo, Cohort 3 MEDI-534, Cohort 4 Placebo, Cohort 4 MEDI-534, Cohort 5 Placebo, Cohort 5
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 79 (6.33%)
    6 / 78 (7.69%)
    1 / 80 (1.25%)
    5 / 80 (6.25%)
    1 / 40 (2.50%)
    2 / 40 (5.00%)
    3 / 82 (3.66%)
    4 / 77 (5.19%)
    9 / 80 (11.25%)
    3 / 78 (3.85%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Thermal burn
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Wheezing
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 78 (1.28%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Febrile convulsion
         subjects affected / exposed
    2 / 79 (2.53%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    1 / 80 (1.25%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    1 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Abscess
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Anal abscess
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    1 / 80 (1.25%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchiolitis
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 78 (1.28%)
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    2 / 82 (2.44%)
    2 / 77 (2.60%)
    2 / 80 (2.50%)
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
    1 / 1
    0 / 2
    0 / 2
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    1 / 40 (2.50%)
    1 / 40 (2.50%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Croup infectious
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 79 (1.27%)
    3 / 78 (3.85%)
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    1 / 77 (1.30%)
    3 / 80 (3.75%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Measles
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    1 / 80 (1.25%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 82 (1.22%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Parainfluenzae virus infection
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 78 (1.28%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 79 (0.00%)
    2 / 78 (2.56%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    1 / 80 (1.25%)
    1 / 78 (1.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    1 / 80 (1.25%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    1 / 80 (1.25%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Streptococcal bacteraemia
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    1 / 77 (1.30%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tonsillitis
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 78 (1.28%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    1 / 80 (1.25%)
    0 / 78 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Placebo, Cohort 1 MEDI-534, Cohort 1 Placebo, Cohort 2 MEDI-534, Cohort 2 MEDI-534, Cohort 3 Placebo, Cohort 3 MEDI-534, Cohort 4 Placebo, Cohort 4 MEDI-534, Cohort 5 Placebo, Cohort 5
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    66 / 79 (83.54%)
    65 / 78 (83.33%)
    55 / 80 (68.75%)
    59 / 80 (73.75%)
    22 / 40 (55.00%)
    27 / 40 (67.50%)
    45 / 82 (54.88%)
    42 / 77 (54.55%)
    50 / 80 (62.50%)
    44 / 78 (56.41%)
    Vascular disorders
    Haematoma
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    1 / 77 (1.30%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Immune system disorders
    Food allergy
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Multiple allergies
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    1 / 80 (1.25%)
    1 / 78 (1.28%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    1
    1
    Seasonal allergy
         subjects affected / exposed
    1 / 79 (1.27%)
    1 / 78 (1.28%)
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    3
    1
    0
    1
    0
    0
    0
    0
    0
    0
    General disorders and administration site conditions
    Feeling hot
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Influenza like illness
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    1 / 78 (1.28%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Injection site pain
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    1 / 80 (1.25%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    1
    0
    0
    0
    0
    Irritability
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 82 (1.22%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Pain
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    1 / 78 (1.28%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Vaccination site pain
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Vessel puncture site haemorrhage
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    1 / 77 (1.30%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 78 (1.28%)
    1 / 80 (1.25%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    3
    1
    0
    0
    0
    0
    0
    0
    0
    Sleep disorder
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Animal bite
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Arthropod bite
         subjects affected / exposed
    1 / 79 (1.27%)
    1 / 78 (1.28%)
    2 / 80 (2.50%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    1 / 80 (1.25%)
    0 / 78 (0.00%)
         occurrences all number
    1
    3
    2
    0
    0
    0
    0
    0
    1
    0
    Contusion
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 78 (0.00%)
    1 / 80 (1.25%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 82 (1.22%)
    2 / 77 (2.60%)
    1 / 80 (1.25%)
    0 / 78 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    1
    2
    1
    0
    Excoriation
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Gingival injury
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Head injury
         subjects affected / exposed
    2 / 79 (2.53%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    4 / 80 (5.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    2
    0
    0
    5
    0
    0
    0
    0
    0
    0
    Joint sprain
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 78 (1.28%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Scratch
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    1 / 77 (1.30%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    2
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Sunburn
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    1 / 77 (1.30%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Tongue injury
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 78 (1.28%)
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    Traumatic haematoma
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    1 / 80 (1.25%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Vaccination complication
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    1 / 82 (1.22%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    1
    0
    0
    0
    Investigations
    Body temperature increased
         subjects affected / exposed
    4 / 79 (5.06%)
    6 / 78 (7.69%)
    6 / 80 (7.50%)
    9 / 80 (11.25%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    1 / 82 (1.22%)
    1 / 77 (1.30%)
    2 / 80 (2.50%)
    2 / 78 (2.56%)
         occurrences all number
    4
    9
    7
    9
    1
    0
    1
    1
    2
    3
    Cardiac murmur
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 78 (1.28%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Occult blood
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    1 / 80 (1.25%)
    0 / 78 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Bronchial hyperreactivity
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    1 / 80 (1.25%)
    0 / 78 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Choking
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    1 / 80 (1.25%)
    0 / 78 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Cough
         subjects affected / exposed
    3 / 79 (3.80%)
    5 / 78 (6.41%)
    3 / 80 (3.75%)
    1 / 80 (1.25%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 82 (1.22%)
    2 / 77 (2.60%)
    3 / 80 (3.75%)
    3 / 78 (3.85%)
         occurrences all number
    5
    5
    3
    1
    0
    0
    1
    2
    3
    4
    Dysphonia
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Hiccups
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Laryngeal stenosis
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Nasal congestion
         subjects affected / exposed
    0 / 79 (0.00%)
    2 / 78 (2.56%)
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    3 / 77 (3.90%)
    1 / 80 (1.25%)
    2 / 78 (2.56%)
         occurrences all number
    0
    2
    0
    1
    1
    0
    0
    3
    2
    2
    Nasal discomfort
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 78 (0.00%)
    1 / 80 (1.25%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Nasal dryness
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    1 / 80 (1.25%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Oropharyngeal pain
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    1 / 77 (1.30%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Pharyngeal erythema
         subjects affected / exposed
    1 / 79 (1.27%)
    1 / 78 (1.28%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Postnasal drip
         subjects affected / exposed
    0 / 79 (0.00%)
    2 / 78 (2.56%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    3
    0
    0
    0
    0
    0
    0
    0
    0
    Respiratory disorder
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 78 (1.28%)
    1 / 80 (1.25%)
    1 / 80 (1.25%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    1
    1
    1
    0
    0
    0
    0
    0
    0
    Respiratory tract congestion
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Rhinitis allergic
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    1 / 80 (1.25%)
    1 / 80 (1.25%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 82 (1.22%)
    0 / 77 (0.00%)
    1 / 80 (1.25%)
    0 / 78 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    0
    1
    0
    1
    0
    Rhinorrhoea
         subjects affected / exposed
    1 / 79 (1.27%)
    3 / 78 (3.85%)
    0 / 80 (0.00%)
    2 / 80 (2.50%)
    3 / 40 (7.50%)
    0 / 40 (0.00%)
    2 / 82 (2.44%)
    0 / 77 (0.00%)
    4 / 80 (5.00%)
    0 / 78 (0.00%)
         occurrences all number
    1
    5
    0
    3
    5
    0
    2
    0
    7
    0
    Rhonchi
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    1 / 77 (1.30%)
    0 / 80 (0.00%)
    1 / 78 (1.28%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    1
    0
    1
    Sinus congestion
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 78 (1.28%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Sneezing
         subjects affected / exposed
    3 / 79 (3.80%)
    0 / 78 (0.00%)
    2 / 80 (2.50%)
    3 / 80 (3.75%)
    3 / 40 (7.50%)
    0 / 40 (0.00%)
    1 / 82 (1.22%)
    0 / 77 (0.00%)
    2 / 80 (2.50%)
    0 / 78 (0.00%)
         occurrences all number
    4
    0
    2
    3
    4
    0
    1
    0
    3
    0
    Throat irritation
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 78 (1.28%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Upper respiratory tract congestion
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 78 (1.28%)
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    0
    0
    0
    0
    Upper respiratory tract inflammation
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    1 / 77 (1.30%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Wheezing
         subjects affected / exposed
    1 / 79 (1.27%)
    2 / 78 (2.56%)
    3 / 80 (3.75%)
    4 / 80 (5.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    2 / 80 (2.50%)
    2 / 78 (2.56%)
         occurrences all number
    1
    2
    3
    4
    0
    0
    0
    0
    2
    2
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    1 / 78 (1.28%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Iron deficiency anaemia
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Leukocytosis
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Lymphadenopathy
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 82 (1.22%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Nervous system disorders
    Febrile convulsion
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    1 / 80 (1.25%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Headache
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    1 / 80 (1.25%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Poor quality sleep
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Eye disorders
    Conjunctival haemorrhage
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    1 / 80 (1.25%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Conjunctivitis
         subjects affected / exposed
    4 / 79 (5.06%)
    6 / 78 (7.69%)
    3 / 80 (3.75%)
    4 / 80 (5.00%)
    4 / 40 (10.00%)
    1 / 40 (2.50%)
    4 / 82 (4.88%)
    7 / 77 (9.09%)
    2 / 80 (2.50%)
    5 / 78 (6.41%)
         occurrences all number
    4
    7
    4
    4
    4
    1
    4
    8
    2
    5
    Conjunctivitis allergic
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    1 / 78 (1.28%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Eye discharge
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 78 (0.00%)
    1 / 80 (1.25%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    2 / 77 (2.60%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    2
    0
    1
    0
    0
    0
    0
    2
    0
    0
    Eye pruritus
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    1 / 77 (1.30%)
    1 / 80 (1.25%)
    0 / 78 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    Eye swelling
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 78 (1.28%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    1 / 77 (1.30%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    1
    0
    0
    Lacrimation increased
         subjects affected / exposed
    2 / 79 (2.53%)
    1 / 78 (1.28%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    1 / 77 (1.30%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    2
    1
    0
    0
    1
    0
    0
    1
    0
    0
    Ocular hyperaemia
         subjects affected / exposed
    0 / 79 (0.00%)
    2 / 78 (2.56%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    1 / 80 (1.25%)
    0 / 78 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    0
    0
    0
    1
    0
    Ear and labyrinth disorders
    Cerumen impaction
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Ear pain
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    1 / 77 (1.30%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    0
    1
    0
    0
    Middle ear effusion
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    1 / 80 (1.25%)
    0 / 80 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    0
    1
    0
    1
    0
    0
    0
    0
    0
    Otorrhoea
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 82 (1.22%)
    0 / 77 (0.00%)
    1 / 80 (1.25%)
    0 / 78 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    1
    0
    Tympanic membrane hyperaemia
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Abdominal pain
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    3 / 77 (3.90%)
    1 / 80 (1.25%)
    0 / 78 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    3
    1
    0
    Abdominal pain upper
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    1 / 82 (1.22%)
    1 / 77 (1.30%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    1
    0
    0
    3
    0
    1
    1
    2
    0
    0
    Constipation
         subjects affected / exposed
    1 / 79 (1.27%)
    2 / 78 (2.56%)
    5 / 80 (6.25%)
    2 / 80 (2.50%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    2 / 82 (2.44%)
    5 / 77 (6.49%)
    4 / 80 (5.00%)
    1 / 78 (1.28%)
         occurrences all number
    1
    3
    6
    3
    1
    0
    2
    5
    4
    1
    Diarrhoea
         subjects affected / exposed
    16 / 79 (20.25%)
    12 / 78 (15.38%)
    17 / 80 (21.25%)
    17 / 80 (21.25%)
    4 / 40 (10.00%)
    3 / 40 (7.50%)
    4 / 82 (4.88%)
    2 / 77 (2.60%)
    7 / 80 (8.75%)
    5 / 78 (6.41%)
         occurrences all number
    26
    14
    24
    23
    4
    5
    5
    2
    7
    7
    Flatulence
         subjects affected / exposed
    1 / 79 (1.27%)
    4 / 78 (5.13%)
    1 / 80 (1.25%)
    4 / 80 (5.00%)
    3 / 40 (7.50%)
    1 / 40 (2.50%)
    1 / 82 (1.22%)
    3 / 77 (3.90%)
    2 / 80 (2.50%)
    1 / 78 (1.28%)
         occurrences all number
    1
    4
    2
    7
    4
    1
    1
    3
    2
    1
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    1 / 82 (1.22%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    2 / 78 (2.56%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    1
    0
    0
    2
    Haematochezia
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    Haemorrhoids
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Infantile colic
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    1 / 77 (1.30%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Intestinal haemorrhage
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    1 / 80 (1.25%)
    0 / 78 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Nausea
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 78 (1.28%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Oral pain
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 78 (1.28%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Regurgitation
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    1 / 78 (1.28%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Stomatitis
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Teething
         subjects affected / exposed
    20 / 79 (25.32%)
    21 / 78 (26.92%)
    15 / 80 (18.75%)
    22 / 80 (27.50%)
    1 / 40 (2.50%)
    1 / 40 (2.50%)
    3 / 82 (3.66%)
    7 / 77 (9.09%)
    3 / 80 (3.75%)
    1 / 78 (1.28%)
         occurrences all number
    53
    40
    39
    44
    1
    1
    4
    8
    4
    1
    Tongue geographic
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Toothache
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    2 / 77 (2.60%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    2
    0
    0
    Umbilical hernia
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    1 / 77 (1.30%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Vomiting
         subjects affected / exposed
    13 / 79 (16.46%)
    8 / 78 (10.26%)
    11 / 80 (13.75%)
    10 / 80 (12.50%)
    4 / 40 (10.00%)
    3 / 40 (7.50%)
    3 / 82 (3.66%)
    3 / 77 (3.90%)
    6 / 80 (7.50%)
    3 / 78 (3.85%)
         occurrences all number
    20
    9
    17
    12
    5
    3
    3
    4
    9
    4
    Vomiting projectile
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 78 (1.28%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Hepatobiliary disorders
    Jaundice
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 78 (1.28%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Blister
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    1 / 77 (1.30%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Dandruff
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    1 / 77 (1.30%)
    1 / 80 (1.25%)
    0 / 78 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    1
    0
    Dermatitis
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    1 / 82 (1.22%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    1
    0
    0
    0
    Dermatitis allergic
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    1 / 80 (1.25%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Dermatitis atopic
         subjects affected / exposed
    1 / 79 (1.27%)
    1 / 78 (1.28%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    2 / 40 (5.00%)
    0 / 40 (0.00%)
    1 / 82 (1.22%)
    2 / 77 (2.60%)
    0 / 80 (0.00%)
    2 / 78 (2.56%)
         occurrences all number
    2
    1
    0
    0
    2
    0
    1
    2
    0
    3
    Dermatitis contact
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    2 / 78 (2.56%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    0
    0
    0
    2
    Dermatitis diaper
         subjects affected / exposed
    9 / 79 (11.39%)
    2 / 78 (2.56%)
    5 / 80 (6.25%)
    5 / 80 (6.25%)
    1 / 40 (2.50%)
    4 / 40 (10.00%)
    2 / 82 (2.44%)
    3 / 77 (3.90%)
    6 / 80 (7.50%)
    2 / 78 (2.56%)
         occurrences all number
    9
    2
    7
    6
    2
    4
    2
    3
    6
    2
    Dry skin
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Ecchymosis
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    Eczema
         subjects affected / exposed
    3 / 79 (3.80%)
    2 / 78 (2.56%)
    0 / 80 (0.00%)
    3 / 80 (3.75%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    5 / 82 (6.10%)
    6 / 77 (7.79%)
    3 / 80 (3.75%)
    2 / 78 (2.56%)
         occurrences all number
    3
    2
    0
    3
    0
    0
    6
    8
    3
    2
    Erythema
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Erythema multiforme
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 78 (1.28%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Heat rash
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    1 / 77 (1.30%)
    1 / 80 (1.25%)
    1 / 78 (1.28%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    1
    1
    1
    Hyperhidrosis
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    1 / 80 (1.25%)
    0 / 78 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Periorbital oedema
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 82 (1.22%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Rash
         subjects affected / exposed
    6 / 79 (7.59%)
    7 / 78 (8.97%)
    5 / 80 (6.25%)
    2 / 80 (2.50%)
    2 / 40 (5.00%)
    2 / 40 (5.00%)
    4 / 82 (4.88%)
    2 / 77 (2.60%)
    5 / 80 (6.25%)
    2 / 78 (2.56%)
         occurrences all number
    6
    7
    6
    2
    2
    2
    4
    2
    5
    4
    Rash erythematous
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    1 / 80 (1.25%)
    0 / 78 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Rash generalised
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Rash papular
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 78 (1.28%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 82 (1.22%)
    0 / 77 (0.00%)
    1 / 80 (1.25%)
    0 / 78 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    1
    0
    1
    0
    Seborrhoea
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    2 / 40 (5.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    0
    0
    0
    0
    0
    Seborrhoeic dermatitis
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 82 (1.22%)
    2 / 77 (2.60%)
    0 / 80 (0.00%)
    1 / 78 (1.28%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    2
    0
    1
    Skin induration
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    1 / 80 (1.25%)
    0 / 78 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Skin irritation
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    1 / 77 (1.30%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Urticaria
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 78 (0.00%)
    1 / 80 (1.25%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Urticaria papular
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    1 / 78 (1.28%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Musculoskeletal and connective tissue disorders
    Pain in extremity
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    1 / 80 (1.25%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    2 / 77 (2.60%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    2
    0
    0
    Torticollis
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    1 / 77 (1.30%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    1 / 80 (1.25%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Weight gain poor
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Infections and infestations
    Acarodermatitis
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 78 (1.28%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Acute sinusitis
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Adenoiditis
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    1 / 80 (1.25%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Adenoviral conjunctivitis
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 78 (1.28%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Adenovirus infection
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 78 (1.28%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Body tinea
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    1 / 80 (1.25%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Bronchiolitis
         subjects affected / exposed
    3 / 79 (3.80%)
    3 / 78 (3.85%)
    6 / 80 (7.50%)
    4 / 80 (5.00%)
    3 / 40 (7.50%)
    2 / 40 (5.00%)
    1 / 82 (1.22%)
    1 / 77 (1.30%)
    6 / 80 (7.50%)
    3 / 78 (3.85%)
         occurrences all number
    3
    3
    6
    4
    3
    2
    1
    1
    7
    3
    Bronchitis
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    3 / 80 (3.75%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    1 / 78 (1.28%)
         occurrences all number
    0
    0
    0
    3
    0
    1
    0
    0
    0
    1
    Candida nappy rash
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    3 / 78 (3.85%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    0
    0
    0
    3
    Candidiasis
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    2 / 40 (5.00%)
    1 / 40 (2.50%)
    1 / 82 (1.22%)
    1 / 77 (1.30%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    0
    0
    0
    2
    1
    1
    1
    0
    0
    Cellulitis
         subjects affected / exposed
    1 / 79 (1.27%)
    1 / 78 (1.28%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Conjunctivitis bacterial
         subjects affected / exposed
    1 / 79 (1.27%)
    2 / 78 (2.56%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    1
    2
    0
    0
    0
    0
    0
    0
    0
    0
    Conjunctivitis infective
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    1 / 80 (1.25%)
    0 / 78 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    1
    0
    Conjunctivitis viral
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 78 (1.28%)
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    1 / 78 (1.28%)
         occurrences all number
    0
    1
    0
    1
    0
    0
    0
    0
    0
    1
    Coxsackie viral infection
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Croup infectious
         subjects affected / exposed
    1 / 79 (1.27%)
    1 / 78 (1.28%)
    1 / 80 (1.25%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    2 / 80 (2.50%)
    0 / 78 (0.00%)
         occurrences all number
    1
    1
    1
    0
    0
    0
    0
    0
    2
    0
    Dermatitis infected
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    1 / 80 (1.25%)
    0 / 78 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Eczema infected
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Enterovirus infection
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 78 (1.28%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    1 / 80 (1.25%)
    0 / 78 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    1
    0
    Exanthema subitum
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    1 / 80 (1.25%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    2 / 82 (2.44%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    2
    0
    0
    0
    Fungal infection
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    1 / 77 (1.30%)
    1 / 80 (1.25%)
    0 / 78 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    1
    1
    0
    Fungal skin infection
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    1 / 77 (1.30%)
    1 / 80 (1.25%)
    1 / 78 (1.28%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    1
    1
    1
    Furuncle
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Gastroenteritis
         subjects affected / exposed
    1 / 79 (1.27%)
    2 / 78 (2.56%)
    2 / 80 (2.50%)
    3 / 80 (3.75%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    3 / 77 (3.90%)
    2 / 80 (2.50%)
    5 / 78 (6.41%)
         occurrences all number
    1
    2
    5
    4
    0
    0
    0
    3
    2
    5
    Gastroenteritis viral
         subjects affected / exposed
    0 / 79 (0.00%)
    3 / 78 (3.85%)
    1 / 80 (1.25%)
    0 / 80 (0.00%)
    1 / 40 (2.50%)
    1 / 40 (2.50%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    3
    1
    0
    1
    1
    0
    0
    0
    0
    Genital candidiasis
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    1 / 78 (1.28%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    Hand-foot-and-mouth disease
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    2 / 80 (2.50%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    0
    0
    0
    0
    0
    Herpangina
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Impetigo
         subjects affected / exposed
    2 / 79 (2.53%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    3
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Influenza
         subjects affected / exposed
    4 / 79 (5.06%)
    1 / 78 (1.28%)
    2 / 80 (2.50%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 82 (1.22%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    4
    1
    2
    0
    0
    0
    1
    0
    0
    0
    Laryngitis
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    2 / 79 (2.53%)
    1 / 78 (1.28%)
    3 / 80 (3.75%)
    1 / 80 (1.25%)
    2 / 40 (5.00%)
    1 / 40 (2.50%)
    5 / 82 (6.10%)
    5 / 77 (6.49%)
    5 / 80 (6.25%)
    7 / 78 (8.97%)
         occurrences all number
    3
    1
    3
    1
    2
    1
    6
    5
    8
    13
    Omphalitis
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 82 (1.22%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Oral candidiasis
         subjects affected / exposed
    4 / 79 (5.06%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    1 / 40 (2.50%)
    2 / 40 (5.00%)
    5 / 82 (6.10%)
    4 / 77 (5.19%)
    4 / 80 (5.00%)
    1 / 78 (1.28%)
         occurrences all number
    5
    0
    0
    0
    1
    2
    5
    4
    4
    2
    Oral herpes
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 78 (1.28%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Otitis externa
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 78 (1.28%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Otitis media
         subjects affected / exposed
    11 / 79 (13.92%)
    11 / 78 (14.10%)
    14 / 80 (17.50%)
    11 / 80 (13.75%)
    2 / 40 (5.00%)
    1 / 40 (2.50%)
    2 / 82 (2.44%)
    1 / 77 (1.30%)
    6 / 80 (7.50%)
    2 / 78 (2.56%)
         occurrences all number
    16
    16
    15
    12
    2
    1
    2
    1
    6
    2
    Otitis media acute
         subjects affected / exposed
    10 / 79 (12.66%)
    7 / 78 (8.97%)
    5 / 80 (6.25%)
    1 / 80 (1.25%)
    0 / 40 (0.00%)
    2 / 40 (5.00%)
    1 / 82 (1.22%)
    0 / 77 (0.00%)
    1 / 80 (1.25%)
    1 / 78 (1.28%)
         occurrences all number
    12
    7
    5
    1
    0
    2
    1
    0
    1
    1
    Paronychia
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Pertussis
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    1 / 80 (1.25%)
    0 / 78 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Pharyngitis
         subjects affected / exposed
    0 / 79 (0.00%)
    4 / 78 (5.13%)
    1 / 80 (1.25%)
    4 / 80 (5.00%)
    2 / 40 (5.00%)
    1 / 40 (2.50%)
    6 / 82 (7.32%)
    3 / 77 (3.90%)
    1 / 80 (1.25%)
    1 / 78 (1.28%)
         occurrences all number
    0
    4
    1
    4
    2
    1
    7
    3
    1
    1
    Pharyngitis streptococcal
         subjects affected / exposed
    2 / 79 (2.53%)
    0 / 78 (0.00%)
    2 / 80 (2.50%)
    1 / 80 (1.25%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    2
    0
    2
    1
    0
    0
    0
    0
    0
    0
    Pharyngotonsillitis
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 78 (1.28%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    Pneumonia
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 78 (1.28%)
    1 / 80 (1.25%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 82 (1.22%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    1 / 78 (1.28%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    1
    0
    0
    1
    Respiratory tract infection
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Respiratory tract infection viral
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    1 / 77 (1.30%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    Rhinitis
         subjects affected / exposed
    2 / 79 (2.53%)
    3 / 78 (3.85%)
    1 / 80 (1.25%)
    1 / 80 (1.25%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    1 / 80 (1.25%)
    0 / 78 (0.00%)
         occurrences all number
    2
    3
    1
    1
    0
    0
    0
    0
    1
    0
    Scarlet fever
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    1 / 80 (1.25%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    Sinusitis
         subjects affected / exposed
    0 / 79 (0.00%)
    4 / 78 (5.13%)
    2 / 80 (2.50%)
    1 / 80 (1.25%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    4
    2
    1
    0
    1
    0
    0
    0
    0
    Skin candida
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 82 (1.22%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    Staphylococcal infection
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Subcutaneous abscess
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    1 / 80 (1.25%)
    0 / 78 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    Tinea infection
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    1 / 80 (1.25%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    0
    0
    0
    0
    0
    Tonsillitis
         subjects affected / exposed
    4 / 79 (5.06%)
    2 / 78 (2.56%)
    3 / 80 (3.75%)
    4 / 80 (5.00%)
    0 / 40 (0.00%)
    1 / 40 (2.50%)
    1 / 82 (1.22%)
    4 / 77 (5.19%)
    0 / 80 (0.00%)
    3 / 78 (3.85%)
         occurrences all number
    4
    2
    5
    5
    0
    1
    1
    5
    0
    3
    Tonsillitis streptococcal
         subjects affected / exposed
    1 / 79 (1.27%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Tracheitis
         subjects affected / exposed
    0 / 79 (0.00%)
    0 / 78 (0.00%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    1 / 40 (2.50%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    26 / 79 (32.91%)
    15 / 78 (19.23%)
    13 / 80 (16.25%)
    22 / 80 (27.50%)
    4 / 40 (10.00%)
    7 / 40 (17.50%)
    15 / 82 (18.29%)
    12 / 77 (15.58%)
    14 / 80 (17.50%)
    14 / 78 (17.95%)
         occurrences all number
    31
    19
    14
    29
    5
    7
    18
    13
    18
    17
    Viral infection
         subjects affected / exposed
    1 / 79 (1.27%)
    4 / 78 (5.13%)
    1 / 80 (1.25%)
    4 / 80 (5.00%)
    0 / 40 (0.00%)
    2 / 40 (5.00%)
    1 / 82 (1.22%)
    1 / 77 (1.30%)
    0 / 80 (0.00%)
    2 / 78 (2.56%)
         occurrences all number
    1
    5
    1
    4
    0
    2
    1
    1
    0
    2
    Viral pharyngitis
         subjects affected / exposed
    1 / 79 (1.27%)
    1 / 78 (1.28%)
    2 / 80 (2.50%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    1 / 82 (1.22%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    1
    1
    2
    0
    0
    0
    1
    0
    0
    0
    Viral rash
         subjects affected / exposed
    1 / 79 (1.27%)
    1 / 78 (1.28%)
    1 / 80 (1.25%)
    1 / 80 (1.25%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    1
    1
    1
    1
    0
    0
    0
    0
    0
    0
    Viral upper respiratory tract infection
         subjects affected / exposed
    5 / 79 (6.33%)
    3 / 78 (3.85%)
    1 / 80 (1.25%)
    1 / 80 (1.25%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    1 / 77 (1.30%)
    1 / 80 (1.25%)
    1 / 78 (1.28%)
         occurrences all number
    5
    3
    1
    1
    0
    0
    0
    1
    1
    1
    Wound infection
         subjects affected / exposed
    0 / 79 (0.00%)
    1 / 78 (1.28%)
    0 / 80 (0.00%)
    0 / 80 (0.00%)
    0 / 40 (0.00%)
    0 / 40 (0.00%)
    0 / 82 (0.00%)
    0 / 77 (0.00%)
    0 / 80 (0.00%)
    0 / 78 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    22 Apr 2008
    The first Amendment updated: 1) Exclusion criterion 9: revised from “Receipt of any live virus vaccine (excluding rotavirus vaccine) within 28 days prior to randomization” to “Receipt of any live virus vaccine (excluding oral polio vaccine and rotavirus vaccine) within 28 days prior to randomization, 2) Exclusion criterion 10: revised from “Receipt of any inactivated (ie, non-live) vaccine or rotavirus vaccine” to “Receipt of any inactivated (ie, non-live) vaccine, oral polio vaccine or rotavirus vaccine”, 3) Exclusion criterion 20: revised to add “for respiratory illness (excludes elective mechanical ventilation during surgery)”, 4) The stratification by region was changed, 5) Updated prohibited concomitant medications, 6) Methods for sample handling, collection, and testing were updated, 7) Updated criteria for interruption of study dosing, 8) Added other analyses and Updated definitions of lower respiratory tract infections criteria in Appendix B (Respiratory Distress Severity Grading Table) of protocols.
    13 Jun 2008
    The second Amendment updated: 1) Inclusion criterion 1: wording was changed from “> 6 month of age” to “≥ 6 months of age”, 2) Exclusion criterion 4: reworded, 3) Clarified 28-day post-dose window for prohibited concomitant medications, 4) The Dose 2 window was expanded from 56 ± 8 days to 56 ± 14 days post Dose 1 and 5) Updated to include criterion 5.
    18 Feb 2009
    The third Amendment updated: 1)Wording “through the end of the RSV season following vaccination or 180 days after the final dose, whichever is later” was changed to “over a 1 year follow-up after receipt of first dose of study vaccine”, 2) The sentence “The study will be initiated in the RSV off season.” was removed (Section 9.1, Overall Study Design and Plan Description, 3) The study flow diagram was updated, 4) The interim analysis description was clarified, 5) Table for schedule of subject evaluations was modified to indicate the timing of 1-year follow-up and to describe that unscheduled illness visits and the Day 28 visit could have been conducted at home. 6) The wording “rectal preferred” was removed and wording was added to describe that axillary temperatures were preferred for daily temperature recording of solicited symptoms post dose, 7) Respiratory syncytial virus and other explanatory text was added to the description of virology testing from nasal wash specimens, 8) The following sentence was added “MA-LRIs that occur during the 28 day post-dosing period are AEs and in addition should be reported as immediately reportable events”, 9) The wording was modified to describe the process for safety review process within MedImmune, 10) The protocol stopping criteria were modified, 11) Significant new medical condition was removed as a primary endpoint and moved to a secondary endpoint, 12) Serious adverse events occurring during the entire study period was added as an additional secondary endpoint.
    18 May 2009
    The fourth Amendment updated: 1) Notification of Sponsor of Serious Adverse Events of protocol amendment, the following sentence was added after the first sentence of the last paragraph “All Grade 4 (Potentially Life Threatening) adverse events, regardless of presumed relationship to study product, will be reported to the US FDA as IND safety reports”.
    03 Nov 2009
    The fifth Amendment updated: 1) Clinical Experience with MEDI-534 of protocol amendment was updated to include the results of preliminary blinded interim analyses of safety results from MI-CP149 and to clarify that the Safety Monitoring Committee reviewed blinded, not unblinded, data, 2) Rationale for Study in protocol was updated to include the results of preliminary blinded interim analyses of safety results from MI-CP149, 3) Interim safety analyses were updated (a) to modify the timing of possible blinded interim safety analyses to after one half of the planned number of subjects in each of Cohorts 1, 2, 3, and 4 reached 28 days post Dose 1, for the purposes of cohort progression and the proof of concept study; and (b) to provide for interim unblinded analyses of virology, immunogenicity, and safety data after all subjects in a cohort reached 28 days post final dose and 4) Interim safety analyses were updated (a) to modify the timing of possible blinded interim safety analyses to after one half of the planned number of subjects in Cohorts 1, 2, 3, and 4 reached 28 days post Dose 1, for the purposes of cohort progression and the proof of concept study; b) to specify the blinded safety data parameters to be reviewed; and c) to clarify that subjects were to be randomized to receive MEDI-534 or placebo.

    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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