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    Clinical Trial Results:
    A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of MEDI8897, a Monoclonal Antibody with an Extended Half-life Against Respiratory Syncytial Virus, in Healthy Late Preterm and Term Infants (MELODY)

    Summary
    EudraCT number
    		 2019-000114-11
    Trial protocol
    		 BE   LV   GB   SE   FR   DE   CZ   LT   EE   FI   PL   AT   ES   BG   IT  
    Global end of trial date
    20 Jun 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Sep 2023
    First version publication date
    22 Sep 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    D5290C00004
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AstraZeneca
    Sponsor organisation address
    950 Wind River Ln, Gaithersburg, United States, MD 20878
    Public contact
    Global Clinical Lead, AstraZeneca, +1 8772409479, information.center@astrazeneca.com
    Scientific contact
    Global Clinical Lead, AstraZeneca, +1 8772409479, information.center@astrazeneca.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-001794-PIP01-15
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    06 Jun 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 Jun 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Jun 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the efficacy of nirsevimab when administered as a single fixed IM dose to term/late preterm infants ≥ 35 weeks 0 days GA and entering their first RSV season, in reducing MA RSV LRTI, compared to placebo
    Protection of trial subjects
    Each subject was assigned a SID to ensure that personally identifiable information was kept separate from the study data. Subject data that were relevant to the trial, eg, demographic information, physical or mental health condition, diagnosis, comorbidities, laboratory test results, etc. were collected with the subject’s informed consent. The IRB/IEC responsible for each site must review and approve the final study protocol, including the final version of the Informed Consent Form and any other written information and/or materials to be provided to the subjects. The IRB/IEC must also approve all advertising used to recruit subjects for the study. Before the study was initiated, AstraZeneca/MedImmune ensured that the national regulatory authority in each country had been notified and their approval had been obtained, as required. AstraZeneca/MedImmune provided safety updates/reports according to local requirements, including suspected unexpected serious adverse reactions where relevant, to regulatory authorities, IRB/IEC, and principal investigators.
    Background therapy
    		 MEDI8897 is a recombinant human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody (mAb) directed against the prefusion conformation of the RSV fusion (F) protein. The antibody has been engineered with a triple amino acid substitution (YTE; M257Y/S259T/T261E [M252Y/S254T/T256E, according to the European Union (EU) numbering system]) in the fragment crystallizable (Fc) region to prolong the t1/2, which is expected to provide protection from serious RSV disease for the duration of the RSV season. MEDI8897 neutralizes RSV by binding the prefusion conformation of the RSV F protein at a site distinct from that bound by palivizumab. In preclinical studies, MEDI8897 was > 150 fold more potent than palivizumab in vitro and approximately 9-fold more potent than palivizumab in vivo in the cotton rat model. MEDI8897 is currently under development by MedImmune for the passive immunization of all infants entering their first RSV season and children with CLD or CHD entering their first and second RSV season for the prevention of LRTI caused by RSV. MEDI8897 may provide a cost effective opportunity to protect all infants from RSV disease based on an improvement in potency and the extended t1/2 that is expected to support once-per-RSV-season dosing.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    23 Jul 2019
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety, Efficacy
    Long term follow-up duration
    		 17 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Austria: 8
    Country: Number of subjects enrolled
    Belgium: 14
    Country: Number of subjects enrolled
    Bulgaria: 131
    Country: Number of subjects enrolled
    Canada: 13
    Country: Number of subjects enrolled
    Czechia: 29
    Country: Number of subjects enrolled
    Estonia: 73
    Country: Number of subjects enrolled
    Finland: 44
    Country: Number of subjects enrolled
    France: 30
    Country: Number of subjects enrolled
    Germany: 58
    Country: Number of subjects enrolled
    Israel: 44
    Country: Number of subjects enrolled
    Italy: 7
    Country: Number of subjects enrolled
    Japan: 147
    Country: Number of subjects enrolled
    Korea, Republic of: 2
    Country: Number of subjects enrolled
    Latvia: 50
    Country: Number of subjects enrolled
    Lithuania: 57
    Country: Number of subjects enrolled
    Mexico: 1
    Country: Number of subjects enrolled
    Panama: 505
    Country: Number of subjects enrolled
    Poland: 58
    Country: Number of subjects enrolled
    Russian Federation: 93
    Country: Number of subjects enrolled
    Spain: 213
    Country: Number of subjects enrolled
    Sweden: 32
    Country: Number of subjects enrolled
    Turkey: 16
    Country: Number of subjects enrolled
    Ukraine: 34
    Country: Number of subjects enrolled
    United Kingdom: 8
    Country: Number of subjects enrolled
    United States: 558
    Country: Number of subjects enrolled
    Argentina: 178
    Country: Number of subjects enrolled
    Australia: 27
    Country: Number of subjects enrolled
    Chile: 45
    Country: Number of subjects enrolled
    Colombia: 54
    Country: Number of subjects enrolled
    New Zealand: 21
    Country: Number of subjects enrolled
    South Africa: 462
    Worldwide total number of subjects
    3012
    EEA total number of subjects
    804
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    655
    Infants and toddlers (28 days-23 months)
    2357
    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
    		 The study was planned to recruit around 3000 infants. The impact of the COVID-19 pandemic on RSV circulation led to the decision to analyze the primary endpoint on the first 1500 subjects (Primary Cohort). Then the study restarted to recruit and the study comprised 2 cohorts: Primary and Safety for a total of 3319 screened subjects

    Pre-assignment
    Screening details
    		 In Primary Cohort: 1626 screened subjects and 136 subjects failing screening criteria. Overall 3319 screened subjects and 307 subjects failing screening criteria.

    Period 1
    Period 1 title
    All Subjects
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Placebo in All Subjects
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Commercially available 0.9% (w/v) saline (sterile for human use)

    Arm title
    		 Medi9987
    Arm description
    		 Medi9987 in All Subjects
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nirsevimab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Single IM dose of 50 mg (if < 5 kg weight at time of dosing) or 100 mg (if ≥ 5 kg weight at time of dosing)

    Number of subjects in period 1
    		Placebo Medi9987
    Started
    1003
    2009
    Completed Day 151 Follow up
    985
    1977
    Completed Day 361 Follow up
    967
    1944
    Completed
    923
    1873
    Not completed
    80
    136
         Adverse event, serious fatal
    -
    5
         Consent withdrawn by subject
    35
    44
         Other
    16
    23
         Covid 19 Pandemic
    1
    3
         Lost to follow-up
    28
    61
    Period 2
    Period 2 title
    Primary Cohort
    Is this the baseline period?
    		 Yes [1]
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Placebo in Primary Cohort
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Commercially available 0.9% (w/v) saline (sterile for human use)

    Arm title
    		 Medi9987
    Arm description
    		 Medi9987 in Primary Cohort
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nirsevimab
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Single IM dose of 50 mg (if < 5 kg weight at time of dosing) or 100 mg (if ≥ 5 kg weight at time of dosing)

    Notes
    [1] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period.
    Justification: Primary cohort is the baseline period for the primary efficacy analysis
    Number of subjects in period 2 [2] [3]
    		Placebo Medi9987
    Started
    496
    994
    Complete Day 151 Follow Up
    488
    977
    Complete Day 361 Follow UP
    453
    914
    Completed
    43
    89
    Not completed
    453
    905
         Adverse event, serious fatal
    -
    4
         Consent withdrawn by subject
    14
    20
         Other
    3
    4
         Ongoing at the DCO
    432
    865
         Covid 19 Pandemic
    1
    3
         Lost to follow-up
    3
    9
    Notes
    [2] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Primary cohort is a subset of the All subjects population
    [3] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: Primary cohort is a subset of the All subjects population

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo in Primary Cohort

    Reporting group title
    Medi9987
    Reporting group description
    		 Medi9987 in Primary Cohort

    Reporting group values
    		 Placebo Medi9987 Total
    Number of subjects
    		 496 994 1490
    Age Categorical
    Age in months at randomization in Primary Cohort
    Units: Subjects
        <= 3 months
    		 285 577 862
        > 3 months - <= 6 months
    		 162 317 479
        >= 6 months
    		 49 100 149
    Age Continuous
    Age (months) at randomization
    Units: months
        arithmetic mean (standard deviation)
    		 3.012 ± 2.2520 2.912 ± 2.946 -
    Gender Categorical
    Gender in the Primary Cohort
    Units: Subjects
        Male
    		 239 530 769
        Female
    		 257 464 721

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo in All Subjects

    Reporting group title
    Medi9987
    Reporting group description
    		 Medi9987 in All Subjects
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo in Primary Cohort

    Reporting group title
    Medi9987
    Reporting group description
    		 Medi9987 in Primary Cohort

    Primary: Incidence of MA RSV LRTI Through 150 Days Post Dose (Primary Cohort)

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    End point title
    		 Incidence of MA RSV LRTI Through 150 Days Post Dose (Primary Cohort)
    End point description
    Primary Endpoint Analysed on Primary Cohort Through 150 Days (N=1490 Participants)
    End point type
    Primary
    End point timeframe
    Through 150 Days Post Dose
    End point values
    		 Placebo Medi9987
    Number of subjects analysed
    496
    994
    Units: Participants
        Observed events through day 150 post dose
    25
    12
        Subjects requiring imputation
    6
    15
        Subjects without event through day 150 post dose
    465
    967
    Statistical analysis title
    		 Relative Risk Reduction Analysis
    Statistical analysis description
    Relative risk reduction of nirsevimab versus placebo, the 95% CI and p-value were estimated based on Poisson regression with robust variance (including stratification factor [age at randomisation] as covariate) obtained after missing data imputation.
    Comparison groups
    Placebo v Medi9987
    Number of subjects included in analysis
    1490
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Poisson Model
    Parameter type
    		 Relative Risk Reduction
    Point estimate
    74.53
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 49.63
         upper limit
    		 87.12

    Secondary: Incidence of MA RSV LRTI with Hospitalisation Through 150 Days Post Dose (Primary Cohort)

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    End point title
    		 Incidence of MA RSV LRTI with Hospitalisation Through 150 Days Post Dose (Primary Cohort)
    End point description
    End point type
    Secondary
    End point timeframe
    Hospitalization Analysed on Primary Cohort Through 150 Days (N=1490 Participants)
    End point values
    		 Placebo Medi9987
    Number of subjects analysed
    496
    994
    Units: Participants
        Observed events through day 150 post dose
    6
    8
        Subjects requiring imputation
    15
    6
        Subjects without event through day 150 post dose
    973
    482
    Statistical analysis title
    		 Relative Risk Reduction Analysis
    Statistical analysis description
    Relative risk reduction of nirsevimab versus placebo, the 95% CI and p-value were estimated based on Poisson regression with robust variance (including study as covariate for pooled studies) obtained after missing data imputation.
    Comparison groups
    Medi9987 v Placebo
    Number of subjects included in analysis
    1490
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0708
    Method
    		 Poisson Regression Model
    Parameter type
    		 Relative Risk Reduction
    Point estimate
    62.15
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.57
         upper limit
    		 86.8

    Other pre-specified: Disease Incidence from the 2nd RSV Season (All Subjects)

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    End point title
    		 Disease Incidence from the 2nd RSV Season (All Subjects)
    End point description
    End point type
    Other pre-specified
    End point timeframe
    From Day 361 to Day 510 Post Dose
    End point values
    		 Placebo Medi9987
    Number of subjects analysed
    967
    1944
    Units: Participants
        MA RSV LRTI (protocol defined)
    10
    19
        MA RSV LRTI hospitalization (protocol defined)
    3
    3
    No statistical analyses for this end point

    Post-hoc: Incidence of MA RSV LRTI Through 150 Days Post Dose (All Subjects)

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    End point title
    		 Incidence of MA RSV LRTI Through 150 Days Post Dose (All Subjects)
    End point description
    Primary Endpoint Analysed on All Subjects Through 150 Days (N=3012 participants)
    End point type
    Post-hoc
    End point timeframe
    Through 150 Days Post Dose
    End point values
    		 Placebo Medi9987
    Number of subjects analysed
    1003
    2009
    Units: Participants
        Observed events
    54
    24
        Subjects requiring imputation
    17
    31
        Subjects without event through day 150 post dose
    932
    1954
    Statistical analysis title
    		 Relative Risk Reduction Analysis
    Statistical analysis description
    Relative risk reduction of nirsevimab versus placebo, the 95% CI and p-value were estimated based on Poisson regression with robust variance (including stratification factor [age at randomisation] as covariate) obtained after missing data imputation.
    Comparison groups
    Placebo v Medi9987
    Number of subjects included in analysis
    3012
    Analysis specification
    Post-hoc
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Poisson regression model
    Parameter type
    		 Relative Risk Reduction (RRR)
    Point estimate
    76.36
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 62.27
         upper limit
    		 85.18

    Post-hoc: Incidence of MA RSV LRTI with Hospitalisation Through 150 Days Post Dose (All Subjects)

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    End point title
    		 Incidence of MA RSV LRTI with Hospitalisation Through 150 Days Post Dose (All Subjects)
    End point description
    Hospitalization Analysed on All Subjects Through 150 Days (N=3012 participants)
    End point type
    Post-hoc
    End point timeframe
    Through 150 Days Post Dose
    End point values
    		 Placebo Medi9987
    Number of subjects analysed
    1003
    2009
    Units: Participants
        Observed events through day 150 post dose
    20
    9
        Subjects requiring imputation
    18
    31
        Subjects without event through day 150 post dose
    965
    1969
    Statistical analysis title
    		 Relative Risk Reduction Analysis
    Statistical analysis description
    RRR of Medi8897 versus placebo; 95% CI and p-value estimated with Poisson regression with robust variance (including stratification factors [age at randomisation] as covariate) obtained after multiple imputation
    Comparison groups
    Placebo v Medi9987
    Number of subjects included in analysis
    3012
    Analysis specification
    Post-hoc
    Analysis type
    		 superiority
    P-value
    		 = 0.0002
    Method
    		 Poisson model
    Parameter type
    		 Relative Risk Reduction (RRR)
    Point estimate
    76.84
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 49.36
         upper limit
    		 89.41

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    through 360 days post dose
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    MedDRA25.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Placebo (All Subjects)

    Reporting group title
    MEDI8897
    Reporting group description
    		 MEDI8897 (All Subjects)

    Serious adverse events
    		 Placebo MEDI8897
    Total subjects affected by serious adverse events
         subjects affected / exposed
    83 / 997 (8.32%)
    149 / 1997 (7.46%)
         number of deaths (all causes)
    0
    5
         number of deaths resulting from adverse events
    0
    4
    Vascular disorders
    Shock
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Kawasaki's disease
         subjects affected / exposed
    1 / 997 (0.10%)
    2 / 1997 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Jaundice neonatal
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 997 (0.10%)
    6 / 1997 (0.30%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fever neonatal
         subjects affected / exposed
    1 / 997 (0.10%)
    1 / 1997 (0.05%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Death
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Immune system disorders
    Milk allergy
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pneumonitis
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchial hyperreactivity
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aspiration
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Apnoea
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Staring
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sleep terror
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Behavioural insomnia of childhood
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Thermal burn
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skull fractured base
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Head injury
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hand fracture
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Concussion
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Accidental exposure to product by child
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Accidental overdose
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Burns third degree
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Pyloric stenosis
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Phenylketonuria
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchogenic cyst
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Febrile convulsion
         subjects affected / exposed
    0 / 997 (0.00%)
    4 / 1997 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Facial paralysis
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Idiopathic generalised epilepsy
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypotonia
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subarachnoid haemorrhage
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    1 / 997 (0.10%)
    2 / 1997 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Hypochromic anaemia
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Colitis
         subjects affected / exposed
    1 / 997 (0.10%)
    1 / 1997 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    0 / 997 (0.00%)
    3 / 1997 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enteritis
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Food poisoning
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Allergic gastroenteritis
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Allergic colitis
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 997 (0.00%)
    2 / 1997 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal obstruction
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Impaired gastric emptying
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Jaundice
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cholelithiasis
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Petechiae
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Scoliosis
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    COVID-19 pneumonia
         subjects affected / exposed
    1 / 997 (0.10%)
    1 / 1997 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess limb
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess neck
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess of external auditory meatus
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adenoviral upper respiratory infection
         subjects affected / exposed
    0 / 997 (0.00%)
    3 / 1997 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacterial sepsis
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Botulism
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchiolitis
         subjects affected / exposed
    17 / 997 (1.71%)
    27 / 1997 (1.35%)
         occurrences causally related to treatment / all
    0 / 18
    0 / 28
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    2 / 997 (0.20%)
    3 / 1997 (0.15%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis viral
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    4 / 997 (0.40%)
    3 / 1997 (0.15%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Conjunctivitis viral
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterovirus infection
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia pyelonephritis
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia urinary tract infection
         subjects affected / exposed
    0 / 997 (0.00%)
    2 / 1997 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Exanthema subitum
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    5 / 997 (0.50%)
    14 / 1997 (0.70%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Gastroenteritis Escherichia coli
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis adenovirus
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis clostridial
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis norovirus
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis rotavirus
         subjects affected / exposed
    1 / 997 (0.10%)
    2 / 1997 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hand-foot-and-mouth disease
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Impetigo
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngitis
         subjects affected / exposed
    3 / 997 (0.30%)
    3 / 1997 (0.15%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 997 (0.00%)
    6 / 1997 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Otitis media acute
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsillitis
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nasopharyngitis
         subjects affected / exposed
    0 / 997 (0.00%)
    2 / 1997 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection viral
         subjects affected / exposed
    1 / 997 (0.10%)
    3 / 1997 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pertussis
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngotonsillitis
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    5 / 997 (0.50%)
    13 / 1997 (0.65%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 14
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia pneumococcal
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia respiratory syncytial viral
         subjects affected / exposed
    1 / 997 (0.10%)
    2 / 1997 (0.10%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia viral
         subjects affected / exposed
    0 / 997 (0.00%)
    2 / 1997 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory syncytial virus bronchiolitis
         subjects affected / exposed
    10 / 997 (1.00%)
    5 / 1997 (0.25%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory syncytial virus bronchitis
         subjects affected / exposed
    2 / 997 (0.20%)
    1 / 1997 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal abscess
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal scalded skin syndrome
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Streptococcal sepsis
         subjects affected / exposed
    1 / 997 (0.10%)
    1 / 1997 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Otitis media
         subjects affected / exposed
    2 / 997 (0.20%)
    0 / 1997 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    5 / 997 (0.50%)
    7 / 1997 (0.35%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 997 (0.20%)
    4 / 1997 (0.20%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tracheobronchitis
         subjects affected / exposed
    2 / 997 (0.20%)
    0 / 1997 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    0 / 997 (0.00%)
    2 / 1997 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 997 (0.00%)
    4 / 1997 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dairy intolerance
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Decreased appetite
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    1 / 997 (0.10%)
    1 / 1997 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Failure to thrive
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Food refusal
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Placebo MEDI8897
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    836 / 997 (83.85%)
    1717 / 1997 (85.98%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Cartilage neoplasm
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Haemangioma
         subjects affected / exposed
    1 / 997 (0.10%)
    9 / 1997 (0.45%)
         occurrences all number
    2
    9
    Haemangioma of skin
         subjects affected / exposed
    1 / 997 (0.10%)
    2 / 1997 (0.10%)
         occurrences all number
    1
    2
    Lipoma
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences all number
    1
    0
    Melanocytic naevus
         subjects affected / exposed
    0 / 997 (0.00%)
    3 / 1997 (0.15%)
         occurrences all number
    0
    3
    Pyogenic granuloma
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences all number
    1
    0
    Skin papilloma
         subjects affected / exposed
    1 / 997 (0.10%)
    2 / 1997 (0.10%)
         occurrences all number
    1
    2
    Vascular disorders
    Cyanosis
         subjects affected / exposed
    1 / 997 (0.10%)
    3 / 1997 (0.15%)
         occurrences all number
    1
    3
    Pallor
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences all number
    1
    0
    Phlebitis
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Surgical and medical procedures
    Clamping of blood vessel
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Circumcision
         subjects affected / exposed
    1 / 997 (0.10%)
    4 / 1997 (0.20%)
         occurrences all number
    1
    4
    Infection prophylaxis
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Scrotal operation
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Skin lesion removal
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    2
    Urethral repair
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences all number
    1
    0
    Oral surgery
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Pregnancy, puerperium and perinatal conditions
    Jaundice neonatal
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences all number
    1
    0
    Small for dates baby
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Umbilical granuloma
         subjects affected / exposed
    3 / 997 (0.30%)
    1 / 1997 (0.05%)
         occurrences all number
    3
    1
    General disorders and administration site conditions
    Secretion discharge
         subjects affected / exposed
    0 / 997 (0.00%)
    2 / 1997 (0.10%)
         occurrences all number
    0
    2
    Asthenia
         subjects affected / exposed
    1 / 997 (0.10%)
    1 / 1997 (0.05%)
         occurrences all number
    1
    1
    Crying
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Developmental delay
         subjects affected / exposed
    0 / 997 (0.00%)
    3 / 1997 (0.15%)
         occurrences all number
    0
    3
    Discomfort
         subjects affected / exposed
    2 / 997 (0.20%)
    10 / 1997 (0.50%)
         occurrences all number
    2
    10
    Fatigue
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Gait disturbance
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Hypothermia
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Influenza like illness
         subjects affected / exposed
    4 / 997 (0.40%)
    2 / 1997 (0.10%)
         occurrences all number
    4
    2
    Injection site induration
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Injection site pain
         subjects affected / exposed
    0 / 997 (0.00%)
    4 / 1997 (0.20%)
         occurrences all number
    0
    4
    Injection site swelling
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Malaise
         subjects affected / exposed
    0 / 997 (0.00%)
    2 / 1997 (0.10%)
         occurrences all number
    0
    2
    Mass
         subjects affected / exposed
    0 / 997 (0.00%)
    2 / 1997 (0.10%)
         occurrences all number
    0
    2
    PFAPA syndrome
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Pain
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences all number
    1
    0
    Peripheral swelling
         subjects affected / exposed
    0 / 997 (0.00%)
    2 / 1997 (0.10%)
         occurrences all number
    0
    2
    Pyrexia
         subjects affected / exposed
    122 / 997 (12.24%)
    290 / 1997 (14.52%)
         occurrences all number
    165
    378
    Vaccination site erythema
         subjects affected / exposed
    0 / 997 (0.00%)
    2 / 1997 (0.10%)
         occurrences all number
    0
    2
    Vaccination site reaction
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Vaccination site swelling
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Vessel puncture site haemorrhage
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Xerosis
         subjects affected / exposed
    1 / 997 (0.10%)
    5 / 1997 (0.25%)
         occurrences all number
    1
    6
    Vaccination site pain
         subjects affected / exposed
    1 / 997 (0.10%)
    3 / 1997 (0.15%)
         occurrences all number
    1
    5
    Immune system disorders
    Allergy to animal
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Allergy to arthropod bite
         subjects affected / exposed
    1 / 997 (0.10%)
    6 / 1997 (0.30%)
         occurrences all number
    1
    6
    Anaphylactic reaction
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences all number
    1
    0
    Drug hypersensitivity
         subjects affected / exposed
    3 / 997 (0.30%)
    9 / 1997 (0.45%)
         occurrences all number
    3
    9
    Dust allergy
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Food allergy
         subjects affected / exposed
    18 / 997 (1.81%)
    30 / 1997 (1.50%)
         occurrences all number
    22
    36
    Hypersensitivity
         subjects affected / exposed
    2 / 997 (0.20%)
    1 / 1997 (0.05%)
         occurrences all number
    2
    1
    Milk allergy
         subjects affected / exposed
    4 / 997 (0.40%)
    7 / 1997 (0.35%)
         occurrences all number
    7
    7
    Multiple allergies
         subjects affected / exposed
    1 / 997 (0.10%)
    2 / 1997 (0.10%)
         occurrences all number
    1
    2
    Reaction to preservatives
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences all number
    1
    0
    Seasonal allergy
         subjects affected / exposed
    6 / 997 (0.60%)
    8 / 1997 (0.40%)
         occurrences all number
    6
    8
    Reproductive system and breast disorders
    Genital discomfort
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences all number
    1
    0
    Acquired hydrocele
         subjects affected / exposed
    0 / 997 (0.00%)
    3 / 1997 (0.15%)
         occurrences all number
    0
    3
    Balanoposthitis
         subjects affected / exposed
    2 / 997 (0.20%)
    6 / 1997 (0.30%)
         occurrences all number
    2
    6
    Breast cyst
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Breast enlargement
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Genital labial adhesions
         subjects affected / exposed
    2 / 997 (0.20%)
    3 / 1997 (0.15%)
         occurrences all number
    2
    3
    Genital ulceration
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences all number
    1
    0
    Penile adhesion
         subjects affected / exposed
    5 / 997 (0.50%)
    6 / 1997 (0.30%)
         occurrences all number
    5
    6
    Penile discharge
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences all number
    1
    0
    Penile erythema
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences all number
    1
    0
    Testicular mass
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences all number
    1
    0
    Vaginal discharge
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences all number
    1
    0
    Vulvovaginal adhesion
         subjects affected / exposed
    0 / 997 (0.00%)
    2 / 1997 (0.10%)
         occurrences all number
    0
    2
    Vulvovaginal erythema
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences all number
    1
    0
    Genital pain
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Respiratory failure
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Respiration abnormal
         subjects affected / exposed
    2 / 997 (0.20%)
    2 / 1997 (0.10%)
         occurrences all number
    2
    2
    Rhinitis allergic
         subjects affected / exposed
    12 / 997 (1.20%)
    13 / 1997 (0.65%)
         occurrences all number
    15
    14
    Aphonia
         subjects affected / exposed
    1 / 997 (0.10%)
    2 / 1997 (0.10%)
         occurrences all number
    1
    2
    Asthma
         subjects affected / exposed
    1 / 997 (0.10%)
    4 / 1997 (0.20%)
         occurrences all number
    1
    6
    Brief resolved unexplained event
         subjects affected / exposed
    1 / 997 (0.10%)
    1 / 1997 (0.05%)
         occurrences all number
    1
    1
    Bronchial hyperreactivity
         subjects affected / exposed
    3 / 997 (0.30%)
    3 / 1997 (0.15%)
         occurrences all number
    3
    3
    Bronchial obstruction
         subjects affected / exposed
    1 / 997 (0.10%)
    4 / 1997 (0.20%)
         occurrences all number
    1
    5
    Bronchospasm
         subjects affected / exposed
    1 / 997 (0.10%)
    2 / 1997 (0.10%)
         occurrences all number
    1
    2
    Catarrh
         subjects affected / exposed
    8 / 997 (0.80%)
    13 / 1997 (0.65%)
         occurrences all number
    12
    13
    Childhood asthma
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Choking
         subjects affected / exposed
    1 / 997 (0.10%)
    2 / 1997 (0.10%)
         occurrences all number
    1
    2
    Cough
         subjects affected / exposed
    58 / 997 (5.82%)
    115 / 1997 (5.76%)
         occurrences all number
    69
    145
    Dysphonia
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Epistaxis
         subjects affected / exposed
    0 / 997 (0.00%)
    4 / 1997 (0.20%)
         occurrences all number
    0
    7
    Hiccups
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Nasal congestion
         subjects affected / exposed
    86 / 997 (8.63%)
    164 / 1997 (8.21%)
         occurrences all number
    113
    208
    Nasal obstruction
         subjects affected / exposed
    5 / 997 (0.50%)
    18 / 1997 (0.90%)
         occurrences all number
    7
    19
    Oropharyngeal pain
         subjects affected / exposed
    2 / 997 (0.20%)
    3 / 1997 (0.15%)
         occurrences all number
    2
    3
    Pharyngeal inflammation
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences all number
    1
    0
    Pneumothorax
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Productive cough
         subjects affected / exposed
    2 / 997 (0.20%)
    1 / 1997 (0.05%)
         occurrences all number
    2
    1
    Rhinalgia
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences all number
    1
    0
    Rhinorrhoea
         subjects affected / exposed
    65 / 997 (6.52%)
    152 / 1997 (7.61%)
         occurrences all number
    85
    216
    Sinus congestion
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences all number
    1
    0
    Sleep apnoea syndrome
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences all number
    1
    0
    Sneezing
         subjects affected / exposed
    0 / 997 (0.00%)
    5 / 1997 (0.25%)
         occurrences all number
    0
    5
    Snoring
         subjects affected / exposed
    0 / 997 (0.00%)
    2 / 1997 (0.10%)
         occurrences all number
    0
    2
    Stridor
         subjects affected / exposed
    0 / 997 (0.00%)
    2 / 1997 (0.10%)
         occurrences all number
    0
    2
    Tachypnoea
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Throat irritation
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Tracheomalacia
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences all number
    1
    0
    Upper airway obstruction
         subjects affected / exposed
    0 / 997 (0.00%)
    2 / 1997 (0.10%)
         occurrences all number
    0
    2
    Upper respiratory tract congestion
         subjects affected / exposed
    3 / 997 (0.30%)
    7 / 1997 (0.35%)
         occurrences all number
    3
    8
    Upper respiratory tract inflammation
         subjects affected / exposed
    2 / 997 (0.20%)
    6 / 1997 (0.30%)
         occurrences all number
    3
    11
    Upper respiratory tract irritation
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Vasomotor rhinitis
         subjects affected / exposed
    5 / 997 (0.50%)
    12 / 1997 (0.60%)
         occurrences all number
    5
    15
    Wheezing
         subjects affected / exposed
    4 / 997 (0.40%)
    5 / 1997 (0.25%)
         occurrences all number
    4
    5
    Psychiatric disorders
    Sleep disorder
         subjects affected / exposed
    1 / 997 (0.10%)
    3 / 1997 (0.15%)
         occurrences all number
    1
    3
    Anxiety
         subjects affected / exposed
    2 / 997 (0.20%)
    3 / 1997 (0.15%)
         occurrences all number
    2
    3
    Irritability
         subjects affected / exposed
    11 / 997 (1.10%)
    22 / 1997 (1.10%)
         occurrences all number
    11
    26
    Poor quality sleep
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Restlessness
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Hepatobiliary disorders
    Hyperbilirubinaemia
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Jaundice
         subjects affected / exposed
    1 / 997 (0.10%)
    7 / 1997 (0.35%)
         occurrences all number
    1
    7
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Body temperature increased
         subjects affected / exposed
    0 / 997 (0.00%)
    5 / 1997 (0.25%)
         occurrences all number
    0
    5
    Blood immunoglobulin E increased
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Blood lead increased
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences all number
    1
    0
    Blood copper increased
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Cardiac murmur
         subjects affected / exposed
    4 / 997 (0.40%)
    5 / 1997 (0.25%)
         occurrences all number
    4
    5
    Cardiac murmur functional
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Echocardiogram abnormal
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences all number
    1
    0
    Platelet count increased
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Liver function test abnormal
         subjects affected / exposed
    0 / 997 (0.00%)
    2 / 1997 (0.10%)
         occurrences all number
    0
    2
    Medical observation normal
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences all number
    1
    0
    Neutrophil count decreased
         subjects affected / exposed
    2 / 997 (0.20%)
    0 / 1997 (0.00%)
         occurrences all number
    2
    0
    Haemoglobin decreased
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences all number
    1
    0
    SARS-CoV-2 test negative
         subjects affected / exposed
    27 / 997 (2.71%)
    48 / 1997 (2.40%)
         occurrences all number
    30
    58
    SARS-CoV-2 test positive
         subjects affected / exposed
    4 / 997 (0.40%)
    3 / 1997 (0.15%)
         occurrences all number
    4
    3
    Transaminases increased
         subjects affected / exposed
    0 / 997 (0.00%)
    2 / 1997 (0.10%)
         occurrences all number
    0
    2
    Urine analysis abnormal
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    Corneal abrasion
         subjects affected / exposed
    0 / 997 (0.00%)
    2 / 1997 (0.10%)
         occurrences all number
    0
    2
    Animal bite
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Animal scratch
         subjects affected / exposed
    0 / 997 (0.00%)
    2 / 1997 (0.10%)
         occurrences all number
    0
    2
    Arthropod bite
         subjects affected / exposed
    22 / 997 (2.21%)
    27 / 1997 (1.35%)
         occurrences all number
    24
    31
    Arthropod sting
         subjects affected / exposed
    2 / 997 (0.20%)
    2 / 1997 (0.10%)
         occurrences all number
    2
    2
    Bone contusion
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Brain contusion
         subjects affected / exposed
    0 / 997 (0.00%)
    2 / 1997 (0.10%)
         occurrences all number
    0
    2
    Burns first degree
         subjects affected / exposed
    1 / 997 (0.10%)
    2 / 1997 (0.10%)
         occurrences all number
    1
    2
    Burns second degree
         subjects affected / exposed
    1 / 997 (0.10%)
    1 / 1997 (0.05%)
         occurrences all number
    1
    1
    Chemical burn
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences all number
    1
    0
    Concussion
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Contusion
         subjects affected / exposed
    3 / 997 (0.30%)
    11 / 1997 (0.55%)
         occurrences all number
    3
    11
    Craniocerebral injury
         subjects affected / exposed
    2 / 997 (0.20%)
    6 / 1997 (0.30%)
         occurrences all number
    2
    6
    Post procedural erythema
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Eye contusion
         subjects affected / exposed
    1 / 997 (0.10%)
    1 / 1997 (0.05%)
         occurrences all number
    1
    1
    Eye injury
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences all number
    1
    0
    Eyelid injury
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Face injury
         subjects affected / exposed
    2 / 997 (0.20%)
    3 / 1997 (0.15%)
         occurrences all number
    2
    3
    Fall
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences all number
    1
    0
    Femur fracture
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Foreign body in ear
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Foreign body in eye
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Foreign body in gastrointestinal tract
         subjects affected / exposed
    1 / 997 (0.10%)
    1 / 1997 (0.05%)
         occurrences all number
    1
    1
    Foreign body in respiratory tract
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Foreign body in throat
         subjects affected / exposed
    0 / 997 (0.00%)
    2 / 1997 (0.10%)
         occurrences all number
    0
    2
    Foreign body ingestion
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences all number
    1
    0
    Gingival injury
         subjects affected / exposed
    1 / 997 (0.10%)
    4 / 1997 (0.20%)
         occurrences all number
    1
    4
    Hand fracture
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Head injury
         subjects affected / exposed
    6 / 997 (0.60%)
    16 / 1997 (0.80%)
         occurrences all number
    7
    17
    Injury
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    2
    Limb injury
         subjects affected / exposed
    3 / 997 (0.30%)
    3 / 1997 (0.15%)
         occurrences all number
    3
    3
    Lip injury
         subjects affected / exposed
    0 / 997 (0.00%)
    2 / 1997 (0.10%)
         occurrences all number
    0
    2
    Mouth injury
         subjects affected / exposed
    0 / 997 (0.00%)
    2 / 1997 (0.10%)
         occurrences all number
    0
    2
    Multiple injuries
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Muscle contusion
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Nail injury
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Nasal injury
         subjects affected / exposed
    0 / 997 (0.00%)
    2 / 1997 (0.10%)
         occurrences all number
    0
    2
    Oral contusion
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Exposure to toxic agent
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Post procedural haemorrhage
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences all number
    1
    0
    Postoperative ileus
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences all number
    1
    0
    Procedural pain
         subjects affected / exposed
    1 / 997 (0.10%)
    2 / 1997 (0.10%)
         occurrences all number
    1
    2
    Radial head dislocation
         subjects affected / exposed
    0 / 997 (0.00%)
    2 / 1997 (0.10%)
         occurrences all number
    0
    2
    Road traffic accident
         subjects affected / exposed
    0 / 997 (0.00%)
    3 / 1997 (0.15%)
         occurrences all number
    0
    3
    Scratch
         subjects affected / exposed
    1 / 997 (0.10%)
    1 / 1997 (0.05%)
         occurrences all number
    1
    1
    Skin abrasion
         subjects affected / exposed
    3 / 997 (0.30%)
    8 / 1997 (0.40%)
         occurrences all number
    3
    8
    Skin injury
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences all number
    1
    0
    Skin laceration
         subjects affected / exposed
    0 / 997 (0.00%)
    2 / 1997 (0.10%)
         occurrences all number
    0
    2
    Skull fracture
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Thermal burn
         subjects affected / exposed
    5 / 997 (0.50%)
    10 / 1997 (0.50%)
         occurrences all number
    5
    11
    Tibia fracture
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Tooth fracture
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Tooth injury
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences all number
    1
    0
    Traumatic haematoma
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Vaccination complication
         subjects affected / exposed
    34 / 997 (3.41%)
    72 / 1997 (3.61%)
         occurrences all number
    47
    90
    Vulvovaginal injury
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Post-traumatic pain
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Congenital, familial and genetic disorders
    Bronchogenic cyst
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Aorta hypoplasia
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Atrial septal defect
         subjects affected / exposed
    0 / 997 (0.00%)
    2 / 1997 (0.10%)
         occurrences all number
    0
    2
    Brachycephaly
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences all number
    1
    0
    Buried penis syndrome
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Telangiectasia congenital
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Congenital nystagmus
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Congenital tongue anomaly
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Congenital torticollis
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences all number
    1
    0
    Congenital vesicoureteric reflux
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Cryptorchism
         subjects affected / exposed
    1 / 997 (0.10%)
    2 / 1997 (0.10%)
         occurrences all number
    1
    2
    Dacryostenosis congenital
         subjects affected / exposed
    3 / 997 (0.30%)
    16 / 1997 (0.80%)
         occurrences all number
    3
    16
    Dermoid cyst
         subjects affected / exposed
    0 / 997 (0.00%)
    2 / 1997 (0.10%)
         occurrences all number
    0
    2
    Developmental hip dysplasia
         subjects affected / exposed
    4 / 997 (0.40%)
    4 / 1997 (0.20%)
         occurrences all number
    4
    4
    Hydrocele
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Klippel-Feil syndrome
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Laryngomalacia
         subjects affected / exposed
    0 / 997 (0.00%)
    4 / 1997 (0.20%)
         occurrences all number
    0
    4
    Macrocephaly
         subjects affected / exposed
    2 / 997 (0.20%)
    0 / 1997 (0.00%)
         occurrences all number
    2
    0
    Mitochondrial encephalomyopathy
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Patent ductus arteriosus
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Phimosis
         subjects affected / exposed
    0 / 997 (0.00%)
    3 / 1997 (0.15%)
         occurrences all number
    0
    3
    Plagiocephaly
         subjects affected / exposed
    4 / 997 (0.40%)
    11 / 1997 (0.55%)
         occurrences all number
    4
    11
    Talipes
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Congenital anomaly
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Vascular malformation
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Ventricular septal defect
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Cardiac disorders
    Left ventricular hypertrophy
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Supraventricular extrasystoles
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Tachycardia
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Sinus tachycardia
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Chorea
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Febrile convulsion
         subjects affected / exposed
    5 / 997 (0.50%)
    4 / 1997 (0.20%)
         occurrences all number
    5
    4
    Gross motor delay
         subjects affected / exposed
    1 / 997 (0.10%)
    3 / 1997 (0.15%)
         occurrences all number
    1
    3
    Head discomfort
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Horner's syndrome
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Hypertonia
         subjects affected / exposed
    1 / 997 (0.10%)
    1 / 1997 (0.05%)
         occurrences all number
    1
    1
    Hypotonia
         subjects affected / exposed
    2 / 997 (0.20%)
    1 / 1997 (0.05%)
         occurrences all number
    2
    1
    Idiopathic partial epilepsy
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences all number
    1
    0
    Motor developmental delay
         subjects affected / exposed
    0 / 997 (0.00%)
    2 / 1997 (0.10%)
         occurrences all number
    0
    2
    Nystagmus
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Post-traumatic epilepsy
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Psychomotor skills impaired
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Seizure
         subjects affected / exposed
    0 / 997 (0.00%)
    2 / 1997 (0.10%)
         occurrences all number
    0
    2
    Seizure like phenomena
         subjects affected / exposed
    1 / 997 (0.10%)
    1 / 1997 (0.05%)
         occurrences all number
    1
    1
    Somnolence
         subjects affected / exposed
    1 / 997 (0.10%)
    2 / 1997 (0.10%)
         occurrences all number
    1
    2
    Speech disorder developmental
         subjects affected / exposed
    0 / 997 (0.00%)
    3 / 1997 (0.15%)
         occurrences all number
    0
    3
    Tremor
         subjects affected / exposed
    0 / 997 (0.00%)
    3 / 1997 (0.15%)
         occurrences all number
    0
    3
    Infant irritability
         subjects affected / exposed
    4 / 997 (0.40%)
    1 / 1997 (0.05%)
         occurrences all number
    4
    1
    Blood and lymphatic system disorders
    Lymphadenitis
         subjects affected / exposed
    1 / 997 (0.10%)
    3 / 1997 (0.15%)
         occurrences all number
    1
    3
    Leukocytosis
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Microcytic anaemia
         subjects affected / exposed
    0 / 997 (0.00%)
    2 / 1997 (0.10%)
         occurrences all number
    0
    2
    Neutropenia
         subjects affected / exposed
    2 / 997 (0.20%)
    2 / 1997 (0.10%)
         occurrences all number
    2
    2
    Normochromic normocytic anaemia
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences all number
    1
    0
    Thrombocytopenia
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Thrombocytosis
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences all number
    1
    0
    Anaemia
         subjects affected / exposed
    8 / 997 (0.80%)
    13 / 1997 (0.65%)
         occurrences all number
    8
    13
    Anaemia neonatal
         subjects affected / exposed
    1 / 997 (0.10%)
    3 / 1997 (0.15%)
         occurrences all number
    1
    3
    Hypochromic anaemia
         subjects affected / exposed
    7 / 997 (0.70%)
    13 / 1997 (0.65%)
         occurrences all number
    8
    13
    Iron deficiency anaemia
         subjects affected / exposed
    8 / 997 (0.80%)
    14 / 1997 (0.70%)
         occurrences all number
    8
    14
    Lymphadenopathy
         subjects affected / exposed
    3 / 997 (0.30%)
    7 / 1997 (0.35%)
         occurrences all number
    3
    7
    Ear and labyrinth disorders
    Cerumen impaction
         subjects affected / exposed
    1 / 997 (0.10%)
    1 / 1997 (0.05%)
         occurrences all number
    1
    1
    Deafness neurosensory
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences all number
    1
    0
    Ear pain
         subjects affected / exposed
    7 / 997 (0.70%)
    12 / 1997 (0.60%)
         occurrences all number
    8
    14
    Excessive cerumen production
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Middle ear effusion
         subjects affected / exposed
    1 / 997 (0.10%)
    1 / 1997 (0.05%)
         occurrences all number
    1
    1
    Motion sickness
         subjects affected / exposed
    0 / 997 (0.00%)
    2 / 1997 (0.10%)
         occurrences all number
    0
    3
    Otorrhoea
         subjects affected / exposed
    1 / 997 (0.10%)
    1 / 1997 (0.05%)
         occurrences all number
    1
    1
    Tympanic membrane hyperaemia
         subjects affected / exposed
    2 / 997 (0.20%)
    0 / 1997 (0.00%)
         occurrences all number
    2
    0
    Eye disorders
    Eye swelling
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences all number
    1
    0
    Astigmatism
         subjects affected / exposed
    1 / 997 (0.10%)
    1 / 1997 (0.05%)
         occurrences all number
    1
    1
    Blepharitis
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Cataract subcapsular
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Conjunctival haemorrhage
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Conjunctival hyperaemia
         subjects affected / exposed
    2 / 997 (0.20%)
    0 / 1997 (0.00%)
         occurrences all number
    2
    0
    Conjunctivitis allergic
         subjects affected / exposed
    2 / 997 (0.20%)
    6 / 1997 (0.30%)
         occurrences all number
    2
    6
    Dacryostenosis acquired
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences all number
    1
    0
    Erythema of eyelid
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Eye discharge
         subjects affected / exposed
    2 / 997 (0.20%)
    6 / 1997 (0.30%)
         occurrences all number
    2
    6
    Pseudostrabismus
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Periorbital oedema
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences all number
    1
    0
    Pupillary disorder
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Strabismus
         subjects affected / exposed
    2 / 997 (0.20%)
    3 / 1997 (0.15%)
         occurrences all number
    2
    3
    Swelling of eyelid
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Eyelid oedema
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Hypermetropia
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Keratitis
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences all number
    1
    0
    Lacrimal structural disorder
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Lacrimation increased
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Ocular hyperaemia
         subjects affected / exposed
    0 / 997 (0.00%)
    4 / 1997 (0.20%)
         occurrences all number
    0
    4
    Pterygium
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    0 / 997 (0.00%)
    5 / 1997 (0.25%)
         occurrences all number
    0
    5
    Abdominal mass
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences all number
    1
    0
    Abdominal pain
         subjects affected / exposed
    3 / 997 (0.30%)
    2 / 1997 (0.10%)
         occurrences all number
    3
    2
    Abdominal pain upper
         subjects affected / exposed
    2 / 997 (0.20%)
    3 / 1997 (0.15%)
         occurrences all number
    2
    3
    Abdominal tenderness
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Aerophagia
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Anal fissure
         subjects affected / exposed
    3 / 997 (0.30%)
    6 / 1997 (0.30%)
         occurrences all number
    3
    6
    Anal polyp
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences all number
    1
    0
    Angular cheilitis
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Infantile colic
         subjects affected / exposed
    11 / 997 (1.10%)
    41 / 1997 (2.05%)
         occurrences all number
    13
    41
    Auriculotemporal syndrome
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences all number
    1
    0
    Cheilitis
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Constipation
         subjects affected / exposed
    38 / 997 (3.81%)
    88 / 1997 (4.41%)
         occurrences all number
    42
    96
    Diarrhoea
         subjects affected / exposed
    89 / 997 (8.93%)
    171 / 1997 (8.56%)
         occurrences all number
    104
    196
    Dyspepsia
         subjects affected / exposed
    0 / 997 (0.00%)
    2 / 1997 (0.10%)
         occurrences all number
    0
    2
    Enteritis
         subjects affected / exposed
    0 / 997 (0.00%)
    3 / 1997 (0.15%)
         occurrences all number
    0
    3
    Enterocolitis
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Epulis
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Faecaloma
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences all number
    1
    0
    Faeces discoloured
         subjects affected / exposed
    2 / 997 (0.20%)
    1 / 1997 (0.05%)
         occurrences all number
    2
    1
    Faeces soft
         subjects affected / exposed
    2 / 997 (0.20%)
    3 / 1997 (0.15%)
         occurrences all number
    2
    3
    Flatulence
         subjects affected / exposed
    4 / 997 (0.40%)
    13 / 1997 (0.65%)
         occurrences all number
    4
    13
    Food protein-induced enterocolitis syndrome
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences all number
    1
    0
    Gastritis
         subjects affected / exposed
    1 / 997 (0.10%)
    1 / 1997 (0.05%)
         occurrences all number
    1
    1
    Gastritis erosive
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Gastrooesophageal reflux disease
         subjects affected / exposed
    14 / 997 (1.40%)
    31 / 1997 (1.55%)
         occurrences all number
    14
    32
    Gingival cyst
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Gingival discomfort
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Gingival pain
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences all number
    3
    0
    Haematemesis
         subjects affected / exposed
    0 / 997 (0.00%)
    3 / 1997 (0.15%)
         occurrences all number
    0
    3
    Haematochezia
         subjects affected / exposed
    5 / 997 (0.50%)
    2 / 1997 (0.10%)
         occurrences all number
    6
    2
    Infant dyschezia
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences all number
    1
    0
    Aphthous ulcer
         subjects affected / exposed
    2 / 997 (0.20%)
    2 / 1997 (0.10%)
         occurrences all number
    2
    2
    Vomiting
         subjects affected / exposed
    32 / 997 (3.21%)
    59 / 1997 (2.95%)
         occurrences all number
    35
    63
    Umbilical hernia
         subjects affected / exposed
    4 / 997 (0.40%)
    14 / 1997 (0.70%)
         occurrences all number
    4
    14
    Infantile spitting up
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences all number
    1
    0
    Inguinal hernia
         subjects affected / exposed
    1 / 997 (0.10%)
    1 / 1997 (0.05%)
         occurrences all number
    1
    1
    Lip ulceration
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences all number
    1
    0
    Melaena
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Mouth ulceration
         subjects affected / exposed
    0 / 997 (0.00%)
    2 / 1997 (0.10%)
         occurrences all number
    0
    2
    Mucous stools
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Oesophageal perforation
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Oral mucosal eruption
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Regurgitation
         subjects affected / exposed
    0 / 997 (0.00%)
    2 / 1997 (0.10%)
         occurrences all number
    0
    2
    Stomatitis
         subjects affected / exposed
    4 / 997 (0.40%)
    7 / 1997 (0.35%)
         occurrences all number
    4
    7
    Teething
         subjects affected / exposed
    70 / 997 (7.02%)
    138 / 1997 (6.91%)
         occurrences all number
    85
    171
    Toothache
         subjects affected / exposed
    1 / 997 (0.10%)
    6 / 1997 (0.30%)
         occurrences all number
    1
    12
    Skin and subcutaneous tissue disorders
    Acne infantile
         subjects affected / exposed
    1 / 997 (0.10%)
    4 / 1997 (0.20%)
         occurrences all number
    1
    4
    Asteatosis
         subjects affected / exposed
    0 / 997 (0.00%)
    4 / 1997 (0.20%)
         occurrences all number
    0
    4
    Blister
         subjects affected / exposed
    1 / 997 (0.10%)
    1 / 1997 (0.05%)
         occurrences all number
    1
    1
    Cafe au lait spots
         subjects affected / exposed
    1 / 997 (0.10%)
    1 / 1997 (0.05%)
         occurrences all number
    1
    1
    Dandruff
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences all number
    1
    0
    Dermatitis
         subjects affected / exposed
    21 / 997 (2.11%)
    44 / 1997 (2.20%)
         occurrences all number
    22
    44
    Dermatitis allergic
         subjects affected / exposed
    5 / 997 (0.50%)
    11 / 1997 (0.55%)
         occurrences all number
    5
    12
    Dermatitis atopic
         subjects affected / exposed
    25 / 997 (2.51%)
    56 / 1997 (2.80%)
         occurrences all number
    28
    59
    Dermatitis contact
         subjects affected / exposed
    16 / 997 (1.60%)
    39 / 1997 (1.95%)
         occurrences all number
    18
    41
    Dermatitis diaper
         subjects affected / exposed
    103 / 997 (10.33%)
    224 / 1997 (11.22%)
         occurrences all number
    118
    267
    Petechiae
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Drug eruption
         subjects affected / exposed
    3 / 997 (0.30%)
    4 / 1997 (0.20%)
         occurrences all number
    3
    4
    Dry skin
         subjects affected / exposed
    19 / 997 (1.91%)
    39 / 1997 (1.95%)
         occurrences all number
    19
    41
    Dyshidrotic eczema
         subjects affected / exposed
    0 / 997 (0.00%)
    2 / 1997 (0.10%)
         occurrences all number
    0
    2
    Eczema
         subjects affected / exposed
    52 / 997 (5.22%)
    90 / 1997 (4.51%)
         occurrences all number
    59
    98
    Eczema asteatotic
         subjects affected / exposed
    1 / 997 (0.10%)
    6 / 1997 (0.30%)
         occurrences all number
    1
    6
    Eczema infantile
         subjects affected / exposed
    9 / 997 (0.90%)
    21 / 1997 (1.05%)
         occurrences all number
    11
    23
    Eczema nummular
         subjects affected / exposed
    0 / 997 (0.00%)
    2 / 1997 (0.10%)
         occurrences all number
    0
    2
    Ephelides
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Erythema
         subjects affected / exposed
    4 / 997 (0.40%)
    3 / 1997 (0.15%)
         occurrences all number
    4
    3
    Erythema toxicum neonatorum
         subjects affected / exposed
    3 / 997 (0.30%)
    5 / 1997 (0.25%)
         occurrences all number
    3
    5
    Haemorrhage subcutaneous
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences all number
    1
    0
    Hand dermatitis
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Idiopathic urticaria
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Ingrowing nail
         subjects affected / exposed
    1 / 997 (0.10%)
    1 / 1997 (0.05%)
         occurrences all number
    1
    1
    Intertrigo
         subjects affected / exposed
    4 / 997 (0.40%)
    2 / 1997 (0.10%)
         occurrences all number
    4
    2
    Keratosis pilaris
         subjects affected / exposed
    2 / 997 (0.20%)
    5 / 1997 (0.25%)
         occurrences all number
    2
    5
    Lichen striatus
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Macule
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Miliaria
         subjects affected / exposed
    37 / 997 (3.71%)
    60 / 1997 (3.00%)
         occurrences all number
    47
    71
    Nail discolouration
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Neurodermatitis
         subjects affected / exposed
    1 / 997 (0.10%)
    2 / 1997 (0.10%)
         occurrences all number
    1
    2
    Papule
         subjects affected / exposed
    2 / 997 (0.20%)
    2 / 1997 (0.10%)
         occurrences all number
    2
    2
    Perioral dermatitis
         subjects affected / exposed
    2 / 997 (0.20%)
    0 / 1997 (0.00%)
         occurrences all number
    2
    0
    Dermatosis
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Pityriasis rosea
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Post inflammatory pigmentation change
         subjects affected / exposed
    0 / 997 (0.00%)
    2 / 1997 (0.10%)
         occurrences all number
    0
    2
    Prurigo
         subjects affected / exposed
    3 / 997 (0.30%)
    6 / 1997 (0.30%)
         occurrences all number
    3
    6
    Rash
         subjects affected / exposed
    48 / 997 (4.81%)
    93 / 1997 (4.66%)
         occurrences all number
    55
    108
    Rash erythematous
         subjects affected / exposed
    1 / 997 (0.10%)
    3 / 1997 (0.15%)
         occurrences all number
    1
    3
    Rash macular
         subjects affected / exposed
    3 / 997 (0.30%)
    2 / 1997 (0.10%)
         occurrences all number
    3
    2
    Rash maculo-papular
         subjects affected / exposed
    8 / 997 (0.80%)
    17 / 1997 (0.85%)
         occurrences all number
    8
    17
    Rash papular
         subjects affected / exposed
    8 / 997 (0.80%)
    15 / 1997 (0.75%)
         occurrences all number
    8
    15
    Rash pruritic
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Seborrhoea
         subjects affected / exposed
    1 / 997 (0.10%)
    3 / 1997 (0.15%)
         occurrences all number
    1
    3
    Seborrhoeic dermatitis
         subjects affected / exposed
    17 / 997 (1.71%)
    40 / 1997 (2.00%)
         occurrences all number
    17
    40
    Skin exfoliation
         subjects affected / exposed
    1 / 997 (0.10%)
    2 / 1997 (0.10%)
         occurrences all number
    1
    2
    Skin hypopigmentation
         subjects affected / exposed
    2 / 997 (0.20%)
    6 / 1997 (0.30%)
         occurrences all number
    2
    6
    Skin irritation
         subjects affected / exposed
    3 / 997 (0.30%)
    15 / 1997 (0.75%)
         occurrences all number
    3
    18
    Thermal burn
         subjects affected / exposed
    5 / 997 (0.50%)
    10 / 1997 (0.50%)
         occurrences all number
    5
    11
    Toxic skin eruption
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Transient neonatal pustular melanosis
         subjects affected / exposed
    2 / 997 (0.20%)
    0 / 1997 (0.00%)
         occurrences all number
    2
    0
    Urticaria
         subjects affected / exposed
    9 / 997 (0.90%)
    21 / 1997 (1.05%)
         occurrences all number
    11
    25
    Urticaria chronic
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Urticaria contact
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences all number
    2
    0
    Xeroderma
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences all number
    1
    0
    Pityriasis alba
         subjects affected / exposed
    4 / 997 (0.40%)
    10 / 1997 (0.50%)
         occurrences all number
    4
    10
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Vesicoureteric reflux
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Dysuria
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Endocrine disorders
    Hypothyroidism
         subjects affected / exposed
    2 / 997 (0.20%)
    0 / 1997 (0.00%)
         occurrences all number
    2
    0
    Musculoskeletal and connective tissue disorders
    Foot deformity
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Diastasis recti abdominis
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Acquired plagiocephaly
         subjects affected / exposed
    3 / 997 (0.30%)
    3 / 1997 (0.15%)
         occurrences all number
    3
    3
    Arthropathy
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences all number
    1
    0
    Growth retardation
         subjects affected / exposed
    1 / 997 (0.10%)
    1 / 1997 (0.05%)
         occurrences all number
    1
    1
    Head deformity
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Limb discomfort
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Musculoskeletal pain
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Posture abnormal
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Rib deformity
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Scoliosis
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Torticollis
         subjects affected / exposed
    1 / 997 (0.10%)
    3 / 1997 (0.15%)
         occurrences all number
    1
    3
    Haematoma muscle
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Infections and infestations
    Abscess
         subjects affected / exposed
    2 / 997 (0.20%)
    2 / 1997 (0.10%)
         occurrences all number
    2
    2
    Abscess jaw
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences all number
    1
    0
    Abscess limb
         subjects affected / exposed
    3 / 997 (0.30%)
    2 / 1997 (0.10%)
         occurrences all number
    3
    2
    Abscess neck
         subjects affected / exposed
    1 / 997 (0.10%)
    1 / 1997 (0.05%)
         occurrences all number
    1
    1
    Acarodermatitis
         subjects affected / exposed
    15 / 997 (1.50%)
    32 / 1997 (1.60%)
         occurrences all number
    20
    39
    Acute sinusitis
         subjects affected / exposed
    3 / 997 (0.30%)
    2 / 1997 (0.10%)
         occurrences all number
    3
    2
    Adenoviral upper respiratory infection
         subjects affected / exposed
    0 / 997 (0.00%)
    6 / 1997 (0.30%)
         occurrences all number
    0
    6
    Adenovirus infection
         subjects affected / exposed
    3 / 997 (0.30%)
    1 / 1997 (0.05%)
         occurrences all number
    3
    1
    Amoebiasis
         subjects affected / exposed
    0 / 997 (0.00%)
    3 / 1997 (0.15%)
         occurrences all number
    0
    3
    Amoebic dysentery
         subjects affected / exposed
    0 / 997 (0.00%)
    2 / 1997 (0.10%)
         occurrences all number
    0
    2
    Anal abscess
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences all number
    1
    0
    Ascariasis
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Asymptomatic COVID-19
         subjects affected / exposed
    7 / 997 (0.70%)
    8 / 1997 (0.40%)
         occurrences all number
    8
    8
    Bacterial disease carrier
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Body tinea
         subjects affected / exposed
    12 / 997 (1.20%)
    20 / 1997 (1.00%)
         occurrences all number
    14
    22
    Borrelia infection
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Bronchiolitis
         subjects affected / exposed
    71 / 997 (7.12%)
    119 / 1997 (5.96%)
         occurrences all number
    86
    139
    Bronchitis
         subjects affected / exposed
    31 / 997 (3.11%)
    60 / 1997 (3.00%)
         occurrences all number
    34
    76
    Bronchitis viral
         subjects affected / exposed
    2 / 997 (0.20%)
    1 / 1997 (0.05%)
         occurrences all number
    3
    1
    Bullous impetigo
         subjects affected / exposed
    1 / 997 (0.10%)
    5 / 1997 (0.25%)
         occurrences all number
    1
    5
    COVID-19
         subjects affected / exposed
    59 / 997 (5.92%)
    97 / 1997 (4.86%)
         occurrences all number
    62
    98
    Candida infection
         subjects affected / exposed
    5 / 997 (0.50%)
    4 / 1997 (0.20%)
         occurrences all number
    5
    5
    Candida nappy rash
         subjects affected / exposed
    3 / 997 (0.30%)
    19 / 1997 (0.95%)
         occurrences all number
    3
    19
    Cellulitis
         subjects affected / exposed
    3 / 997 (0.30%)
    6 / 1997 (0.30%)
         occurrences all number
    3
    6
    Citrobacter infection
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences all number
    1
    0
    Conjunctivitis
         subjects affected / exposed
    56 / 997 (5.62%)
    137 / 1997 (6.86%)
         occurrences all number
    61
    157
    Conjunctivitis bacterial
         subjects affected / exposed
    2 / 997 (0.20%)
    6 / 1997 (0.30%)
         occurrences all number
    3
    6
    Conjunctivitis viral
         subjects affected / exposed
    0 / 997 (0.00%)
    3 / 1997 (0.15%)
         occurrences all number
    0
    3
    Croup infectious
         subjects affected / exposed
    7 / 997 (0.70%)
    17 / 1997 (0.85%)
         occurrences all number
    7
    18
    Gastroenteritis viral
         subjects affected / exposed
    8 / 997 (0.80%)
    21 / 1997 (1.05%)
         occurrences all number
    11
    23
    Dacryocanaliculitis
         subjects affected / exposed
    0 / 997 (0.00%)
    2 / 1997 (0.10%)
         occurrences all number
    0
    2
    Dacryocystitis
         subjects affected / exposed
    3 / 997 (0.30%)
    2 / 1997 (0.10%)
         occurrences all number
    3
    2
    Dermatitis infected
         subjects affected / exposed
    1 / 997 (0.10%)
    1 / 1997 (0.05%)
         occurrences all number
    1
    1
    Dermatophytosis
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences all number
    1
    0
    Diarrhoea infectious
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences all number
    1
    0
    Dysentery
         subjects affected / exposed
    2 / 997 (0.20%)
    1 / 1997 (0.05%)
         occurrences all number
    2
    1
    Ear infection
         subjects affected / exposed
    4 / 997 (0.40%)
    4 / 1997 (0.20%)
         occurrences all number
    5
    4
    Ear infection bacterial
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Ear lobe infection
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences all number
    1
    0
    Eczema infected
         subjects affected / exposed
    1 / 997 (0.10%)
    2 / 1997 (0.10%)
         occurrences all number
    1
    2
    Enterobiasis
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences all number
    1
    0
    Enterovirus infection
         subjects affected / exposed
    1 / 997 (0.10%)
    4 / 1997 (0.20%)
         occurrences all number
    1
    5
    Exanthema subitum
         subjects affected / exposed
    27 / 997 (2.71%)
    30 / 1997 (1.50%)
         occurrences all number
    27
    30
    Eye infection
         subjects affected / exposed
    1 / 997 (0.10%)
    7 / 1997 (0.35%)
         occurrences all number
    1
    9
    Febrile infection
         subjects affected / exposed
    1 / 997 (0.10%)
    2 / 1997 (0.10%)
         occurrences all number
    1
    2
    Folliculitis
         subjects affected / exposed
    4 / 997 (0.40%)
    14 / 1997 (0.70%)
         occurrences all number
    4
    15
    Fungal infection
         subjects affected / exposed
    1 / 997 (0.10%)
    2 / 1997 (0.10%)
         occurrences all number
    1
    2
    Fungal skin infection
         subjects affected / exposed
    19 / 997 (1.91%)
    35 / 1997 (1.75%)
         occurrences all number
    19
    37
    Furuncle
         subjects affected / exposed
    1 / 997 (0.10%)
    3 / 1997 (0.15%)
         occurrences all number
    1
    3
    Gastroenteritis
         subjects affected / exposed
    100 / 997 (10.03%)
    202 / 1997 (10.12%)
         occurrences all number
    113
    246
    Gastroenteritis adenovirus
         subjects affected / exposed
    0 / 997 (0.00%)
    2 / 1997 (0.10%)
         occurrences all number
    0
    2
    Gastroenteritis bacterial
         subjects affected / exposed
    0 / 997 (0.00%)
    2 / 1997 (0.10%)
         occurrences all number
    0
    2
    Gastroenteritis enteroviral
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences all number
    1
    0
    Gastroenteritis rotavirus
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Cystitis
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Joint abscess
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Influenza
         subjects affected / exposed
    1 / 997 (0.10%)
    9 / 1997 (0.45%)
         occurrences all number
    1
    10
    Lice infestation
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Lower respiratory tract infection
         subjects affected / exposed
    34 / 997 (3.41%)
    47 / 1997 (2.35%)
         occurrences all number
    44
    69
    Lower respiratory tract infection viral
         subjects affected / exposed
    12 / 997 (1.20%)
    9 / 1997 (0.45%)
         occurrences all number
    12
    9
    Lyme disease
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Measles
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Mediastinitis
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Meningitis aseptic
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences all number
    1
    0
    Metapneumovirus infection
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Gastrointestinal infection
         subjects affected / exposed
    1 / 997 (0.10%)
    1 / 1997 (0.05%)
         occurrences all number
    1
    2
    Gastrointestinal viral infection
         subjects affected / exposed
    0 / 997 (0.00%)
    3 / 1997 (0.15%)
         occurrences all number
    0
    3
    Genital candidiasis
         subjects affected / exposed
    1 / 997 (0.10%)
    2 / 1997 (0.10%)
         occurrences all number
    1
    2
    Genital infection fungal
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences all number
    1
    0
    Gianotti-Crosti syndrome
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Hand-foot-and-mouth disease
         subjects affected / exposed
    19 / 997 (1.91%)
    42 / 1997 (2.10%)
         occurrences all number
    19
    43
    Helminthic infection
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences all number
    1
    0
    Herpangina
         subjects affected / exposed
    3 / 997 (0.30%)
    5 / 1997 (0.25%)
         occurrences all number
    3
    5
    Herpes ophthalmic
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Hordeolum
         subjects affected / exposed
    2 / 997 (0.20%)
    5 / 1997 (0.25%)
         occurrences all number
    2
    5
    Human herpesvirus 6 infection
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Impetigo
         subjects affected / exposed
    31 / 997 (3.11%)
    43 / 1997 (2.15%)
         occurrences all number
    35
    47
    Infected bite
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Infected dermal cyst
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences all number
    1
    0
    Infected skin ulcer
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Infection
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences all number
    1
    0
    Laryngitis
         subjects affected / exposed
    9 / 997 (0.90%)
    35 / 1997 (1.75%)
         occurrences all number
    9
    37
    Molluscum contagiosum
         subjects affected / exposed
    1 / 997 (0.10%)
    9 / 1997 (0.45%)
         occurrences all number
    1
    10
    Pyoderma streptococcal
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences all number
    1
    0
    Omphalitis
         subjects affected / exposed
    0 / 997 (0.00%)
    2 / 1997 (0.10%)
         occurrences all number
    0
    2
    Oral candidiasis
         subjects affected / exposed
    22 / 997 (2.21%)
    55 / 1997 (2.75%)
         occurrences all number
    23
    60
    Oral fungal infection
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Oral herpes
         subjects affected / exposed
    1 / 997 (0.10%)
    4 / 1997 (0.20%)
         occurrences all number
    1
    4
    Oral infection
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Otitis externa
         subjects affected / exposed
    6 / 997 (0.60%)
    6 / 1997 (0.30%)
         occurrences all number
    6
    6
    Otitis media
         subjects affected / exposed
    76 / 997 (7.62%)
    154 / 1997 (7.71%)
         occurrences all number
    111
    218
    Otitis media acute
         subjects affected / exposed
    44 / 997 (4.41%)
    82 / 1997 (4.11%)
         occurrences all number
    53
    126
    Otitis media chronic
         subjects affected / exposed
    1 / 997 (0.10%)
    2 / 1997 (0.10%)
         occurrences all number
    2
    2
    Parasitic gastroenteritis
         subjects affected / exposed
    2 / 997 (0.20%)
    4 / 1997 (0.20%)
         occurrences all number
    2
    4
    Paronychia
         subjects affected / exposed
    2 / 997 (0.20%)
    11 / 1997 (0.55%)
         occurrences all number
    2
    12
    Periorbital cellulitis
         subjects affected / exposed
    0 / 997 (0.00%)
    2 / 1997 (0.10%)
         occurrences all number
    0
    2
    Pertussis
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Pharyngitis
         subjects affected / exposed
    28 / 997 (2.81%)
    72 / 1997 (3.61%)
         occurrences all number
    28
    80
    Pharyngitis streptococcal
         subjects affected / exposed
    0 / 997 (0.00%)
    2 / 1997 (0.10%)
         occurrences all number
    0
    2
    Pharyngotonsillitis
         subjects affected / exposed
    9 / 997 (0.90%)
    16 / 1997 (0.80%)
         occurrences all number
    9
    16
    Pneumonia
         subjects affected / exposed
    6 / 997 (0.60%)
    11 / 1997 (0.55%)
         occurrences all number
    6
    11
    Pneumonia bacterial
         subjects affected / exposed
    0 / 997 (0.00%)
    2 / 1997 (0.10%)
         occurrences all number
    0
    2
    Pneumonia moraxella
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences all number
    1
    0
    Pulmonary tuberculosis
         subjects affected / exposed
    1 / 997 (0.10%)
    1 / 1997 (0.05%)
         occurrences all number
    1
    1
    Pustule
         subjects affected / exposed
    1 / 997 (0.10%)
    2 / 1997 (0.10%)
         occurrences all number
    1
    2
    Pyelonephritis
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences all number
    1
    0
    Pyoderma
         subjects affected / exposed
    1 / 997 (0.10%)
    3 / 1997 (0.15%)
         occurrences all number
    1
    3
    Nasopharyngitis
         subjects affected / exposed
    237 / 997 (23.77%)
    441 / 1997 (22.08%)
         occurrences all number
    471
    946
    Rash pustular
         subjects affected / exposed
    0 / 997 (0.00%)
    2 / 1997 (0.10%)
         occurrences all number
    0
    2
    Upper respiratory tract infection
         subjects affected / exposed
    316 / 997 (31.70%)
    639 / 1997 (32.00%)
         occurrences all number
    621
    1316
    Respiratory syncytial virus bronchitis
         subjects affected / exposed
    3 / 997 (0.30%)
    0 / 1997 (0.00%)
         occurrences all number
    3
    0
    Respiratory syncytial virus infection
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences all number
    1
    0
    Respiratory tract infection
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Respiratory tract infection viral
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Rhinitis
         subjects affected / exposed
    102 / 997 (10.23%)
    201 / 1997 (10.07%)
         occurrences all number
    146
    272
    Rhinolaryngitis
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Roseola
         subjects affected / exposed
    14 / 997 (1.40%)
    24 / 1997 (1.20%)
         occurrences all number
    14
    24
    Scarlet fever
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Sinusitis
         subjects affected / exposed
    7 / 997 (0.70%)
    9 / 1997 (0.45%)
         occurrences all number
    7
    9
    Sinusitis bacterial
         subjects affected / exposed
    1 / 997 (0.10%)
    1 / 1997 (0.05%)
         occurrences all number
    1
    1
    Skin bacterial infection
         subjects affected / exposed
    0 / 997 (0.00%)
    2 / 1997 (0.10%)
         occurrences all number
    0
    2
    Skin candida
         subjects affected / exposed
    3 / 997 (0.30%)
    9 / 1997 (0.45%)
         occurrences all number
    3
    9
    Skin infection
         subjects affected / exposed
    2 / 997 (0.20%)
    2 / 1997 (0.10%)
         occurrences all number
    3
    2
    Subcutaneous abscess
         subjects affected / exposed
    3 / 997 (0.30%)
    2 / 1997 (0.10%)
         occurrences all number
    3
    2
    Subglottic laryngitis
         subjects affected / exposed
    2 / 997 (0.20%)
    1 / 1997 (0.05%)
         occurrences all number
    3
    1
    Suspected COVID-19
         subjects affected / exposed
    7 / 997 (0.70%)
    10 / 1997 (0.50%)
         occurrences all number
    7
    10
    Tinea capitis
         subjects affected / exposed
    3 / 997 (0.30%)
    1 / 1997 (0.05%)
         occurrences all number
    3
    1
    Tinea cruris
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences all number
    1
    0
    Tinea infection
         subjects affected / exposed
    0 / 997 (0.00%)
    4 / 1997 (0.20%)
         occurrences all number
    0
    4
    Tinea pedis
         subjects affected / exposed
    1 / 997 (0.10%)
    1 / 1997 (0.05%)
         occurrences all number
    1
    1
    Tinea versicolour
         subjects affected / exposed
    1 / 997 (0.10%)
    1 / 1997 (0.05%)
         occurrences all number
    1
    1
    Tonsillitis
         subjects affected / exposed
    7 / 997 (0.70%)
    14 / 1997 (0.70%)
         occurrences all number
    7
    15
    Tracheitis
         subjects affected / exposed
    2 / 997 (0.20%)
    4 / 1997 (0.20%)
         occurrences all number
    2
    4
    Tracheobronchitis
         subjects affected / exposed
    3 / 997 (0.30%)
    2 / 1997 (0.10%)
         occurrences all number
    3
    2
    Respiratory syncytial virus bronchiolitis
         subjects affected / exposed
    14 / 997 (1.40%)
    13 / 1997 (0.65%)
         occurrences all number
    14
    13
    Urinary tract infection
         subjects affected / exposed
    14 / 997 (1.40%)
    22 / 1997 (1.10%)
         occurrences all number
    15
    26
    Vaccination site infection
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Varicella
         subjects affected / exposed
    10 / 997 (1.00%)
    22 / 1997 (1.10%)
         occurrences all number
    10
    22
    Varicella zoster virus infection
         subjects affected / exposed
    1 / 997 (0.10%)
    2 / 1997 (0.10%)
         occurrences all number
    1
    2
    Viral diarrhoea
         subjects affected / exposed
    1 / 997 (0.10%)
    1 / 1997 (0.05%)
         occurrences all number
    1
    1
    Viral infection
         subjects affected / exposed
    21 / 997 (2.11%)
    35 / 1997 (1.75%)
         occurrences all number
    22
    36
    Viral pharyngitis
         subjects affected / exposed
    2 / 997 (0.20%)
    9 / 1997 (0.45%)
         occurrences all number
    2
    9
    Viral rash
         subjects affected / exposed
    30 / 997 (3.01%)
    85 / 1997 (4.26%)
         occurrences all number
    32
    90
    Viral rhinitis
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Viral tonsillitis
         subjects affected / exposed
    1 / 997 (0.10%)
    2 / 1997 (0.10%)
         occurrences all number
    1
    2
    Viral upper respiratory tract infection
         subjects affected / exposed
    60 / 997 (6.02%)
    132 / 1997 (6.61%)
         occurrences all number
    77
    162
    Wound infection
         subjects affected / exposed
    1 / 997 (0.10%)
    0 / 1997 (0.00%)
         occurrences all number
    1
    0
    Urinary tract infection bacterial
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Abnormal weight gain
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Breast milk substitute intolerance
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Dairy intolerance
         subjects affected / exposed
    3 / 997 (0.30%)
    4 / 1997 (0.20%)
         occurrences all number
    3
    4
    Decreased appetite
         subjects affected / exposed
    1 / 997 (0.10%)
    2 / 1997 (0.10%)
         occurrences all number
    1
    2
    Dehydration
         subjects affected / exposed
    5 / 997 (0.50%)
    2 / 1997 (0.10%)
         occurrences all number
    5
    2
    Failure to thrive
         subjects affected / exposed
    3 / 997 (0.30%)
    6 / 1997 (0.30%)
         occurrences all number
    3
    6
    Hyperglycaemia
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Hypoglycaemia
         subjects affected / exposed
    0 / 997 (0.00%)
    2 / 1997 (0.10%)
         occurrences all number
    0
    2
    Iron deficiency
         subjects affected / exposed
    1 / 997 (0.10%)
    1 / 1997 (0.05%)
         occurrences all number
    1
    1
    Lactose intolerance
         subjects affected / exposed
    0 / 997 (0.00%)
    4 / 1997 (0.20%)
         occurrences all number
    0
    4
    Malnutrition
         subjects affected / exposed
    0 / 997 (0.00%)
    5 / 1997 (0.25%)
         occurrences all number
    0
    5
    Poor feeding infant
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Underweight
         subjects affected / exposed
    0 / 997 (0.00%)
    2 / 1997 (0.10%)
         occurrences all number
    0
    2
    Vitamin B12 deficiency
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Vitamin D deficiency
         subjects affected / exposed
    0 / 997 (0.00%)
    1 / 1997 (0.05%)
         occurrences all number
    0
    1
    Weight gain poor
         subjects affected / exposed
    5 / 997 (0.50%)
    7 / 1997 (0.35%)
         occurrences all number
    5
    7

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    01 Feb 2021
    The MELODY study was amended to mitigate for the greatly reduced circulation of RSV due to measures associated with the pandemic and the challenges of operating a trial during the pandemic. In agreement with the FDA at a Type B meeting (02 December 2020) discussing the impact of COVID-19 on the registrational studies/clinical package for the BLA, the MELODY Primary Analysis would be conducted based on the 1490 subjects randomised prior to the pause in enrolment with completion of the full sample size in a complementary Safety Cohort

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    02 Jul 2020
    study enrolment was paused due to the impact of the COVID-19 pandemic.
    09 Apr 2021

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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