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    Clinical Trial Results:
    A Phase IIIb randomized open-label study of nirsevimab (versus no intervention) in preventing hospitalizations due to respiratory syncytial virus in infants (HARMONIE)

    Summary
    EudraCT number
    		 2022-000099-20
    Trial protocol
    		 FR   DE  
    Global end of trial date
    09 Apr 2025

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Oct 2025
    First version publication date
    23 Oct 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    VAS00006
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05437510
    WHO universal trial number (UTN)
    		 U1111-1272-2514
    Sponsors
    Sponsor organisation name
    Sanofi Pasteur
    Sponsor organisation address
    14 Espace Henry Vallée, Lyon, France, 69007
    Public contact
    Trial Transparency Team, Sanofi Pasteur, Contact-US@sanofi.com
    Scientific contact
    Trial Transparency Team, Sanofi Pasteur, Contact-US@sanofi.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    18 Jun 2025
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Apr 2025
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the efficacy of nirsevimab in preventing respiratory syncytial virus (RSV) lower respiratory tract infection (LRTI) hospitalization compared to no intervention.
    Protection of trial subjects
    Vaccinations were performed by qualified and trained study personnel. Participants with allergy to any of the vaccine components were not vaccinated. After vaccination, participants were also kept under clinical observation for 30 minutes to ensure their safety. Appropriate medical equipment were also available on site in case of any immediate allergic reactions.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    08 Aug 2022
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    France: 2177
    Country: Number of subjects enrolled
    Germany: 1789
    Country: Number of subjects enrolled
    United Kingdom: 4091
    Worldwide total number of subjects
    8057
    EEA total number of subjects
    3966
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    1865
    Infants and toddlers (28 days-23 months)
    6192
    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 conducted at 235 investigational sites. Total 8057 participants were enrolled and randomized in 1:1 ratio to nirsevimab or no intervention group between 08 August 2022 to 28 February 2023.

    Pre-assignment
    Screening details
    		 Participants were followed up for safety for 12-months (366 days) (for France, Germany, and United Kingdom[UK] non-reconsented participants) and for 24 months (731 days) (for UK participants who consented to take part into study extension [UK reconsented participants]). As pre-specified in protocol and SAP, results are presented by treatment group.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Nirsevimab
    Arm description
    		 Participants received nirsevimab 50 milligrams (mg) (if weight <5 kilograms [kg]) or 100 mg (if weight ≥5 kg) as a single intramuscular (IM) injection on Day 1.
    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
    Nirsevimab was administered as a single IM injection of 50 mg (if weight <5 kg) or 100 mg (if weight ≥5 kg) on Day 1.

    Arm title
    		 No Intervention
    Arm description
    		 Participants received no RSV preventive intervention on Day 1.
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Nirsevimab No Intervention
    Started
    4038
    4019
    Randomized and treated
    4015
    1 [1]
    Participants Entered Study Extension
    1142 [2]
    1084 [3]
    Completed
    3747
    3631
    Not completed
    291
    388
         Adverse event, non-fatal
    2
    1
         Protocol Deviation
    1
    6
         Withdrawal by Parent/Guardian
    23
    23
         Lost to follow-up
    265
    358
    Notes
    [1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: 1 participant of the no intervention group wrongly received the study intervention.
    [2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: UK participants who consented to take part into optional 12-month study extension.
    [3] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: UK participants who consented to take part into optional 12-month study extension.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Nirsevimab
    Reporting group description
    		 Participants received nirsevimab 50 milligrams (mg) (if weight <5 kilograms [kg]) or 100 mg (if weight ≥5 kg) as a single intramuscular (IM) injection on Day 1.

    Reporting group title
    No Intervention
    Reporting group description
    		 Participants received no RSV preventive intervention on Day 1.

    Reporting group values
    		 Nirsevimab No Intervention Total
    Number of subjects
    		 4038 4019 8057
    Age categorical
    Units: Subjects
    Age Continuous
    Units: months
        arithmetic mean (standard deviation)
    		 4.53 ( 3.342 ) 4.48 ( 3.294 ) -
    Sex: Female, Male
    Units: participants
        Female
    		 1950 1912 3862
        Male
    		 2088 2107 4195
    Race and Ethnicity Not Collected
    Units: Subjects
        Not collected
    		 4038 4019 8057

    End points

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    End points reporting groups
    Reporting group title
    Nirsevimab
    Reporting group description
    		 Participants received nirsevimab 50 milligrams (mg) (if weight <5 kilograms [kg]) or 100 mg (if weight ≥5 kg) as a single intramuscular (IM) injection on Day 1.

    Reporting group title
    No Intervention
    Reporting group description
    		 Participants received no RSV preventive intervention on Day 1.

    Primary: Number of Participants With Respiratory Syncytial Virus Lower Respiratory Tract Infection Hospitalization Through the Respiratory Syncytial Virus Season

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    End point title
    		 Number of Participants With Respiratory Syncytial Virus Lower Respiratory Tract Infection Hospitalization Through the Respiratory Syncytial Virus Season
    End point description
    LRTI included the following common symptoms: clinical finding of rhonchi, rales, crackles, or wheeze; increased respiratory rate at rest (age: <2 months, ≥60 breaths per minute (/min); 2 to 6 months, ≥50 breaths/min; >6 months, ≥40 breaths/min), and hypoxemia (in room air: oxygen saturation <95%). Hospitalization was defined as the decision to admit to in-patient care by the treating physician. RSV season was the period of increased RSV infection. The All Randomized Set consisted of all participants randomly assigned to either the nirsevimab group or the no intervention group.
    End point type
    Primary
    End point timeframe
    From dosing/randomization (Day 1) up to approximately 7 months
    End point values
    		 Nirsevimab No Intervention
    Number of subjects analysed
    4038
    4019
    Units: participants
    11
    64
    Statistical analysis title
    		 Number of RSV LRTI hospitalization
    Statistical analysis description
    The 2-sided 95% confidence interval (CI) for the efficacy was calculated by an exact method assuming a binomial distribution of the number of RSV LRTI hospitalizations in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization.
    Comparison groups
    Nirsevimab v No Intervention
    Number of subjects included in analysis
    8057
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Exact method using binomial distribution
    Parameter type
    		 Efficacy
    Point estimate
    84.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 69.493
         upper limit
    		 92.411

    Secondary: Number of Participants With Very Severe Respiratory Syncytial Virus Lower Respiratory Tract Infection Through the Respiratory Syncytial Virus Season

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    End point title
    		 Number of Participants With Very Severe Respiratory Syncytial Virus Lower Respiratory Tract Infection Through the Respiratory Syncytial Virus Season
    End point description
    LRTI included the following common symptoms: clinical finding of rhonchi, rales, crackles, or wheeze; increased respiratory rate at rest (age: <2 months, ≥60 breaths/min; 2 to 6 months, ≥50 breaths/min; >6 months, ≥40 breaths/min), and hypoxemia (in room air: oxygen saturation <95%). Very severe RSV LRTI was defined as RSV LRTI hospitalization with oxygen saturation <90% (at any time during hospitalization) and oxygen supplementation. Hospitalization was defined as the decision to admit to in-patient care by the treating physician. RSV season was the period of increased RSV infection. The All Randomized Set consisted of all participants randomly assigned to either the nirsevimab group or the no intervention group.
    End point type
    Secondary
    End point timeframe
    From dosing/randomization (Day 1) up to approximately 7 months
    End point values
    		 Nirsevimab No Intervention
    Number of subjects analysed
    4038
    4019
    Units: participants
    5
    21
    Statistical analysis title
    		 Number of very severe RSV LRTI
    Statistical analysis description
    The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of very severe RSV LRTI in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization.
    Comparison groups
    Nirsevimab v No Intervention
    Number of subjects included in analysis
    8057
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0014
    Method
    		 Exact method using binomial distribution
    Parameter type
    		 Efficacy
    Point estimate
    77.71
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 39.249
         upper limit
    		 93.432

    Secondary: Number of Participants With Respiratory Syncytial Virus Lower Respiratory Tract Infection Hospitalization Through the Respiratory Syncytial Virus Season in Each Country

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    End point title
    		 Number of Participants With Respiratory Syncytial Virus Lower Respiratory Tract Infection Hospitalization Through the Respiratory Syncytial Virus Season in Each Country
    End point description
    LRTI included the following common symptoms: clinical finding of rhonchi, rales, crackles, or wheeze; increased respiratory rate at rest (age: <2 months, ≥60 breaths/min; 2 to 6 months, ≥50 breaths/min; >6 months, ≥40 breaths/min), and hypoxemia (in room air: oxygen saturation <95%). Hospitalization was defined as the decision to admit to in-patient care by the treating physician. RSV season was the period of increased RSV infection. Number of participants with RSV LRTI hospitalization through the RSV season in France, UK, and Germany is presented. The All Randomized Set consisted of all participants randomly assigned to either the nirsevimab group or the no intervention group. Here, n=number of participants with data collected for each specified category.
    End point type
    Secondary
    End point timeframe
    From dosing/randomization (Day 1) up to approximately 7 months
    End point values
    		 Nirsevimab No Intervention
    Number of subjects analysed
    4038
    4019
    Units: participants
        France (n=1090, 1087)
    3
    28
        United Kingdom (n=2052, 2039)
    3
    17
        Germany (n=896, 893)
    5
    19
    Statistical analysis title
    		 France: Number of RSV LRTI hospitalization
    Statistical analysis description
    The adjusted 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of RSV LRTI hospitalizations in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization. Adjustment based on Bonferroni-Holm procedure.
    Comparison groups
    Nirsevimab v No Intervention
    Number of subjects included in analysis
    8057
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [1]
    Method
    		 Exact method using binomial distribution
    Parameter type
    		 Efficacy
    Point estimate
    90.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 63.676
         upper limit
    		 98.813
    Notes
    [1] - Adjusted p-value is reported.
    Statistical analysis title
    		 UK: Number of RSV LRTI hospitalization
    Statistical analysis description
    The adjusted 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of RSV LRTI hospitalizations in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization. Adjustment based on Bonferroni-Holm procedure.
    Comparison groups
    Nirsevimab v No Intervention
    Number of subjects included in analysis
    8057
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0036 [2]
    Method
    		 Exact method using binomial distribution
    Parameter type
    		 Efficacy
    Point estimate
    83.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 33.589
         upper limit
    		 97.593
    Notes
    [2] - Adjusted p-value is reported.
    Statistical analysis title
    		 Germany: Number of RSV LRTI hospitalization
    Statistical analysis description
    The adjusted 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of RSV LRTI hospitalizations in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization. Adjustment based on Bonferroni-Holm procedure.
    Comparison groups
    Nirsevimab v No Intervention
    Number of subjects included in analysis
    8057
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0051 [3]
    Method
    		 Exact method using binomial distribution
    Parameter type
    		 Efficacy
    Point estimate
    74.62
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 29.74
         upper limit
    		 92.595
    Notes
    [3] - Adjusted p-value is reported.

    Secondary: Number of Participants With Hospitalization for All-Cause Lower Respiratory Tract Infection Through the Respiratory Syncytial Virus Season

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    End point title
    		 Number of Participants With Hospitalization for All-Cause Lower Respiratory Tract Infection Through the Respiratory Syncytial Virus Season
    End point description
    LRTI included the following common symptoms: clinical finding of rhonchi, rales, crackles, or wheeze; increased respiratory rate at rest (age: <2 months, ≥60 breaths/min; 2 to 6 months, ≥50 breaths/min; >6 months, ≥40 breaths/min), and hypoxemia (in room air: oxygen saturation <95%). Hospitalization was defined as the decision to admit to in-patient care by the treating physician. RSV season was the period of increased RSV infection. Number of participants with hospitalization for all-cause LRTI through the RSV season in France, UK, Germany, and overall is presented. The All Randomized Set consisted of all participants randomly assigned to either the nirsevimab group or the no intervention group. Here, n=number of participants with data collected for each specified category.
    End point type
    Secondary
    End point timeframe
    From dosing/randomization (Day 1) up to approximately 7 months
    End point values
    		 Nirsevimab No Intervention
    Number of subjects analysed
    4038
    4019
    Units: participants
        Overall (n=4038, 4019)
    48
    106
        France (n=1090, 1087)
    24
    44
        United Kingdom (n=2052, 2039)
    17
    39
        Germany (n=896, 893)
    7
    23
    Statistical analysis title
    		 Overall: Number of all-cause LRTI hospitalization
    Statistical analysis description
    The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of all-cause LRTI hospitalizations in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization.
    Comparison groups
    Nirsevimab v No Intervention
    Number of subjects included in analysis
    8057
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Exact method using binomial distribution
    Parameter type
    		 Efficacy
    Point estimate
    57.97
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 40.36
         upper limit
    		 70.76
    Statistical analysis title
    		 Germany: Number of all-cause LRTI hospitalization
    Statistical analysis description
    The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of all-cause LRTI hospitalizations in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization.
    Comparison groups
    Nirsevimab v No Intervention
    Number of subjects included in analysis
    8057
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0037
    Method
    		 Exact method using binomial distribution
    Parameter type
    		 Efficacy
    Point estimate
    70.74
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 29.567
         upper limit
    		 89.396
    Statistical analysis title
    		 UK: Number of all-cause LRTI hospitalization
    Statistical analysis description
    The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of all-cause LRTI hospitalizations in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization.
    Comparison groups
    Nirsevimab v No Intervention
    Number of subjects included in analysis
    8057
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0024
    Method
    		 Exact method using binomial distribution
    Parameter type
    		 Efficacy
    Point estimate
    58.62
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 25.115
         upper limit
    		 78.049
    Statistical analysis title
    		 France: Number of all-cause LRTI hospitalization
    Statistical analysis description
    The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of all-cause LRTI hospitalizations in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization.
    Comparison groups
    Nirsevimab v No Intervention
    Number of subjects included in analysis
    8057
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0039
    Method
    		 Exact method using binomial distribution
    Parameter type
    		 Efficacy
    Point estimate
    52.48
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 20.121
         upper limit
    		 72.36

    Secondary: Number of Participants With Respiratory Syncytial Virus Lower Respiratory Tract Infection Hospitalization Through 151 Days Post-dosing/Randomization

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    End point title
    		 Number of Participants With Respiratory Syncytial Virus Lower Respiratory Tract Infection Hospitalization Through 151 Days Post-dosing/Randomization
    End point description
    LRTI included the following common symptoms: clinical finding of rhonchi, rales, crackles, or wheeze; increased respiratory rate at rest (age: <2 months, ≥60 breaths/min; 2 to 6 months, ≥50 breaths/min; >6 months, ≥40 breaths/min), and hypoxemia (in room air: oxygen saturation <95%). Hospitalization was defined as the decision to admit to in-patient care by the treating physician. Number of participants with RSV LRTI hospitalization through 151 days post-dosing/randomization in France, UK, Germany, and overall is presented. The All Randomized Set consisted of all participants randomly assigned to either the nirsevimab group or the no intervention group. Here, n=number of participants with data collected for each specified category.
    End point type
    Secondary
    End point timeframe
    From dosing/randomization (Day 1) to Day 151
    End point values
    		 Nirsevimab No Intervention
    Number of subjects analysed
    4038
    4019
    Units: participants
        Overall (n=4038, 4019)
    12
    67
        France (n=1090, 1087)
    4
    28
        United Kingdom (n=2052, 2039)
    3
    20
        Germany (n=896, 893)
    5
    19
    Statistical analysis title
    		 Overall: Number of RSV LRTI hospitalization
    Statistical analysis description
    The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of RSV LRTI hospitalizations in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization.
    Comparison groups
    Nirsevimab v No Intervention
    Number of subjects included in analysis
    8057
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Exact method using binomial distribution
    Parameter type
    		 Efficacy
    Point estimate
    82.44
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 67.271
         upper limit
    		 91.357
    Statistical analysis title
    		 Germany: Number of RSV LRTI hospitalization
    Statistical analysis description
    The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of RSV LRTI hospitalizations in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization.
    Comparison groups
    Nirsevimab v No Intervention
    Number of subjects included in analysis
    8057
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0055
    Method
    		 Exact method using binomial distribution
    Parameter type
    		 Efficacy
    Point estimate
    74.36
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 29.006
         upper limit
    		 92.518
    Statistical analysis title
    		 UK: Number of RSV LRTI hospitalization
    Statistical analysis description
    The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of RSV LRTI hospitalizations in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization.
    Comparison groups
    Nirsevimab v No Intervention
    Number of subjects included in analysis
    8057
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0004
    Method
    		 Exact method using binomial distribution
    Parameter type
    		 Efficacy
    Point estimate
    85.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 50.084
         upper limit
    		 97.183
    Statistical analysis title
    		 France: Number of RSV LRTI hospitalization
    Statistical analysis description
    The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of RSV LRTI hospitalizations in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization.
    Comparison groups
    Nirsevimab v No Intervention
    Number of subjects included in analysis
    8057
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Exact method using binomial distribution
    Parameter type
    		 Efficacy
    Point estimate
    86.11
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 60.283
         upper limit
    		 96.459

    Secondary: Number of Participants With Very Severe Respiratory Syncytial Virus Lower Respiratory Tract Infection Through 151 Days Post-dosing/Randomization

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    End point title
    		 Number of Participants With Very Severe Respiratory Syncytial Virus Lower Respiratory Tract Infection Through 151 Days Post-dosing/Randomization
    End point description
    LRTI included the following common symptoms: clinical finding of rhonchi, rales, crackles, or wheeze; increased respiratory rate at rest (age: <2 months, ≥60 breaths/min; 2 to 6 months, ≥50 breaths/min; >6 months, ≥40 breaths/min), and hypoxemia (in room air: oxygen saturation <95%). Very severe RSV LRTI was defined as RSV LRTI hospitalization with oxygen saturation <90% (at any time during hospitalization) and oxygen supplementation. Hospitalization was defined as the decision to admit to in-patient care by the treating physician. Number of participants with very severe RSV LRTI through 151 days post-dosing/randomization in France, UK, Germany, and overall is presented. The All Randomized Set consisted of all participants randomly assigned to either the nirsevimab group or the no intervention group. Here, n=number of participants with data collected for each specified category.
    End point type
    Secondary
    End point timeframe
    From dosing/randomization (Day 1) to Day 151
    End point values
    		 Nirsevimab No Intervention
    Number of subjects analysed
    4038
    4019
    Units: participants
        Overall (n=4038, 4019)
    6
    24
        France (n=1090, 1087)
    2
    9
        United Kingdom (n=2052, 2039)
    1
    11
        Germany (n=896, 893)
    3
    4
    Statistical analysis title
    		 Overall: Number of very severe RSV LRTI
    Statistical analysis description
    The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of very severe RSV LRTI through Day 151 post-dosing/randomization in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization.
    Comparison groups
    Nirsevimab v No Intervention
    Number of subjects included in analysis
    8057
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0013
    Method
    		 Exact method using binomial distribution
    Parameter type
    		 Efficacy
    Point estimate
    75.31
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 38.012
         upper limit
    		 91.747
    Statistical analysis title
    		 France: Number of very severe RSV LRTI
    Statistical analysis description
    The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of very severe RSV LRTI through Day 151 post-dosing/randomization in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization.
    Comparison groups
    Nirsevimab v No Intervention
    Number of subjects included in analysis
    8057
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.062
    Method
    		 Exact method using binomial distribution
    Parameter type
    		 Efficacy
    Point estimate
    78.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.823
         upper limit
    		 97.697
    Statistical analysis title
    		 UK: Number of very severe RSV LRTI
    Statistical analysis description
    The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of very severe RSV LRTI through Day 151 post-dosing/randomization in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization.
    Comparison groups
    Nirsevimab v No Intervention
    Number of subjects included in analysis
    8057
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.006
    Method
    		 Exact method using binomial distribution
    Parameter type
    		 Efficacy
    Point estimate
    91.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 38.156
         upper limit
    		 99.791
    Statistical analysis title
    		 Germany: Number of very severe RSV LRTI
    Statistical analysis description
    The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of very severe RSV LRTI through Day 151 post-dosing/randomization in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization.
    Comparison groups
    Nirsevimab v No Intervention
    Number of subjects included in analysis
    8057
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9851
    Method
    		 Exact method using binomial distribution
    Parameter type
    		 Efficacy
    Point estimate
    26.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -337.329
         upper limit
    		 89.162

    Secondary: Number of Participants With Hospitalization for All-Cause Lower Respiratory Tract Infection Through 151 Days Post-dosing/Randomization

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    End point title
    		 Number of Participants With Hospitalization for All-Cause Lower Respiratory Tract Infection Through 151 Days Post-dosing/Randomization
    End point description
    LRTI included the following common symptoms: clinical finding of rhonchi, rales, crackles, or wheeze; increased respiratory rate at rest (age: <2 months, ≥60 breaths/min; 2 to 6 months, ≥50 breaths/min; >6 months, ≥40 breaths/min), and hypoxemia (in room air: oxygen saturation <95%). Hospitalization was defined as the decision to admit to in-patient care by the treating physician. Number of participants with hospitalization for all-cause LRTI through 151 days post-dosing/randomization in France, UK, Germany, and overall is presented. The All Randomized Set consisted of all participants randomly assigned to either the nirsevimab group or the no intervention group. Here, n=number of participants with data collected for each specified category.
    End point type
    Secondary
    End point timeframe
    From dosing/randomization (Day 1) to Day 151
    End point values
    		 Nirsevimab No Intervention
    Number of subjects analysed
    4038
    4019
    Units: participants
        Overall (n=4038, 4019)
    76
    132
        France (n=1090, 1087)
    32
    48
        United Kingdom (n=2052, 2039)
    35
    58
        Germany (n=896, 893)
    9
    26
    Statistical analysis title
    		 Overall: Number of all-cause LRTI hospitalization
    Statistical analysis description
    The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of hospitalizations for all-cause LRTI through Day 151 post-dosing/randomization in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization.
    Comparison groups
    Nirsevimab v No Intervention
    Number of subjects included in analysis
    8057
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Exact method using binomial distribution
    Parameter type
    		 Efficacy
    Point estimate
    43.62
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 24.677
         upper limit
    		 58.057
    Statistical analysis title
    		 Germany: Number of all-cause LRTI hospitalization
    Statistical analysis description
    The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of hospitalizations for all-cause LRTI through Day 151 post-dosing/randomization in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization.
    Comparison groups
    Nirsevimab v No Intervention
    Number of subjects included in analysis
    8057
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0046
    Method
    		 Exact method using binomial distribution
    Parameter type
    		 Efficacy
    Point estimate
    66.38
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 25.952
         upper limit
    		 86.137
    Statistical analysis title
    		 UK: Number of all-cause LRTI hospitalization
    Statistical analysis description
    The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of hospitalizations for all-cause LRTI through Day 151 post-dosing/randomization in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization.
    Comparison groups
    Nirsevimab v No Intervention
    Number of subjects included in analysis
    8057
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0177
    Method
    		 Exact method using binomial distribution
    Parameter type
    		 Efficacy
    Point estimate
    40.67
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 8.211
         upper limit
    		 62.156
    Statistical analysis title
    		 France: Number of all-cause LRTI hospitalization
    Statistical analysis description
    The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of hospitalizations for all-cause LRTI through Day 151 post-dosing/randomization in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization.
    Comparison groups
    Nirsevimab v No Intervention
    Number of subjects included in analysis
    8057
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0754
    Method
    		 Exact method using binomial distribution
    Parameter type
    		 Efficacy
    Point estimate
    34.78
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.148
         upper limit
    		 59.648

    Secondary: Number of Participants With Immediate Treatment-Emergent Adverse Events (TEAEs)

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    End point title
    		 Number of Participants With Immediate Treatment-Emergent Adverse Events (TEAEs)
    End point description
    An adverse event (AE) was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were either events with the start date and time posterior to the start of the treatment period and up to the end of the treatment period or events with the start date and time prior to the start of the treatment period, whose severity was greater than 1 or missing and stop date is missing or not before the treatment period. Immediate events were recorded to capture medically relevant AEs which occurred within the first 30 minutes after immunization. The Safety Analysis Set (SafAS) consisted of all participants who received nirsevimab in the study and all randomized participants who were randomized to the no intervention group and did not receive nirsevimab inadvertently. As pre-specified in the protocol and SAP, results are presented by treatment group.
    End point type
    Secondary
    End point timeframe
    Up to 30 minutes post-dosing/randomization on Day 1
    End point values
    		 Nirsevimab No Intervention
    Number of subjects analysed
    4016
    4018
    Units: participants
    27
    0
    No statistical analyses for this end point

    Secondary: Number of Participants With Non-Serious Treatment-Emergent Adverse Events

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    End point title
    		 Number of Participants With Non-Serious Treatment-Emergent Adverse Events
    End point description
    An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were either events with the start date and time posterior to the start of the treatment period and up to the end of the treatment period or events with the start date and time prior to the start of the treatment period, whose severity was greater than 1 or missing and stop date was missing or not before the treatment period. The SafAS consisted of all participants who received nirsevimab in the study and all randomized participants who were randomized to the no intervention group and did not receive nirsevimab inadvertently. As pre-specified in the protocol and SAP, results are presented by treatment group.
    End point type
    Secondary
    End point timeframe
    From dosing/randomization (Day 1) to Day 31
    End point values
    		 Nirsevimab No Intervention
    Number of subjects analysed
    4016
    4018
    Units: participants
    1316
    1265
    No statistical analyses for this end point

    Secondary: Number of Participants With Treatment-Emergent Serious Adverse Events (SAEs), Treatment-Emergent Adverse Events of Special Interest (AESIs) and Treatment-Emergent Medically Attended Adverse Events (MAAEs)

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    End point title
    		 Number of Participants With Treatment-Emergent Serious Adverse Events (SAEs), Treatment-Emergent Adverse Events of Special Interest (AESIs) and Treatment-Emergent Medically Attended Adverse Events (MAAEs)
    End point description
    AE:untoward medical occurrence in clinical study participant temporally associated with use of study intervention, whether or not related to it.TEAEs:events with start date/time posterior to start and up to end of treatment period(TP), or events with start date/time prior to start of TP, whose severity was>1/missing;stop date was missing/not before TP.SAE:AE at any dose resulting in death,persistent or significant disability/incapacity,required inpatient hospitalization/prolongation of existing hospitalization,was life-threatening or congenital anomaly/birth defect or medically important event.MAAE:new onset/worsening of condition that prompted participant or participant’s parent/legally acceptable representative to seek unplanned medical advice at physician’s office/Emergency Department.AESI:scientific,medical concern specific to Sponsor’s study intervention/program for which ongoing monitoring and rapid communication by investigator to Sponsor was appropriate. SafAS.
    End point type
    Secondary
    End point timeframe
    From dosing/randomization (Day 1) to Day 366
    End point values
    		 Nirsevimab No Intervention
    Number of subjects analysed
    4016
    4018
    Units: participants
        Treatment-emergent SAEs
    262
    222
        Treatment-emergent AESIs
    11
    3
        Treatment-emergent MAAEs
    3106
    3100
    No statistical analyses for this end point

    Secondary: Number of Participants With Treatment-Related Serious Adverse Event (for United Kingdom Reconsented Participants)

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    End point title
    		 Number of Participants With Treatment-Related Serious Adverse Event (for United Kingdom Reconsented Participants)
    End point description
    An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were either events with start date and time posterior to start of treatment period (TP) and up to end of the TP or events with start date and time prior to start of TP, whose severity was >1 or missing and stop date is missing or not before TP. SAE: AE at any dose resulting in death, persistent or significant disability/incapacity, required inpatient hospitalization/prolongation of existing hospitalization, was life-threatening or congenital anomaly/birth defect or medically important event. A treatment-related TEAE was TEAE considered by the investigator as related or with unknown/missing relationship to treatment for participants who received nirsevimab on Day 1. Analysis was performed on the SafAS. As pre-specified in the protocol and SAP, results are presented by treatment group.
    End point type
    Secondary
    End point timeframe
    From Day 366 to Day 731
    End point values
    		 Nirsevimab No Intervention
    Number of subjects analysed
    1140
    1084
    Units: participants
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Participants With Respiratory Syncytial Virus Lower Respiratory Tract Infection Hospitalization Through 181 Days Post-dosing/Randomization

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    End point title
    		 Number of Participants With Respiratory Syncytial Virus Lower Respiratory Tract Infection Hospitalization Through 181 Days Post-dosing/Randomization
    End point description
    LRTI included the following common symptoms: clinical finding of rhonchi, rales, crackles, or wheeze; increased respiratory rate at rest (age: <2 months, ≥60 breaths/min; 2 to 6 months, ≥50 breaths/min; >6 months, ≥40 breaths/min), and hypoxemia (in room air: oxygen saturation <95%). Hospitalization was defined as the decision to admit to in-patient care by the treating physician. Number of participants with RSV LRTI hospitalization through 181 days post-dosing/randomization in France, UK, Germany, and overall is presented. The All Randomized Set consisted of all participants randomly assigned to either the nirsevimab group or the no intervention group. Here n=number of participants with data collected for each specified category.
    End point type
    Secondary
    End point timeframe
    From dosing/randomization (Day 1) to Day 181
    End point values
    		 Nirsevimab No Intervention
    Number of subjects analysed
    4038
    4019
    Units: participants
        Overall (n=4038, 4019)
    12
    68
        France (n=1090, 1087)
    4
    28
        United Kingdom (n=2052, 2039)
    3
    21
        Germany (n=896, 893)
    5
    19
    Statistical analysis title
    		 Overall: Number of RSV LRTI hospitalization
    Statistical analysis description
    The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of RSV LRTI hospitalizations through Day 181 post-dosing/randomization in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization.
    Comparison groups
    Nirsevimab v No Intervention
    Number of subjects included in analysis
    8057
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Exact method using binomial distribution
    Parameter type
    		 Efficacy
    Point estimate
    82.72
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 67.826
         upper limit
    		 91.49
    Statistical analysis title
    		 UK: Number of RSV LRTI hospitalization
    Statistical analysis description
    The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of RSV LRTI hospitalizations through Day 181 post-dosing/randomization in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization.
    Comparison groups
    Nirsevimab v No Intervention
    Number of subjects included in analysis
    8057
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0002
    Method
    		 Exact method using binomial distribution
    Parameter type
    		 Efficacy
    Point estimate
    85.92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 52.85
         upper limit
    		 97.311
    Statistical analysis title
    		 Germany: Number of RSV LRTI hospitalization
    Statistical analysis description
    The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of RSV LRTI hospitalizations through Day 181 post-dosing/randomization in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization.
    Comparison groups
    Nirsevimab v No Intervention
    Number of subjects included in analysis
    8057
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0054
    Method
    		 Exact method using binomial distribution
    Parameter type
    		 Efficacy
    Point estimate
    74.39
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 29.077
         upper limit
    		 92.525
    Statistical analysis title
    		 France: Number of RSV LRTI hospitalization
    Statistical analysis description
    The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of RSV LRTI hospitalizations through Day 181 post-dosing/randomization in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization.
    Comparison groups
    Nirsevimab v No Intervention
    Number of subjects included in analysis
    8057
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Exact method using binomial distribution
    Parameter type
    		 Efficacy
    Point estimate
    86.13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 60.34
         upper limit
    		 96.464

    Secondary: Number of Participants With Hospitalization for All-Cause Lower Respiratory Tract Infection Through 181 Days Post-dosing/Randomization

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    End point title
    		 Number of Participants With Hospitalization for All-Cause Lower Respiratory Tract Infection Through 181 Days Post-dosing/Randomization
    End point description
    LRTI included the following common symptoms: clinical finding of rhonchi, rales, crackles, or wheeze; increased respiratory rate at rest (age: <2 months, ≥60 breaths/min; 2 to 6 months, ≥50 breaths/min; >6 months, ≥40 breaths/min), and hypoxemia (in room air: oxygen saturation <95%). Hospitalization was defined as the decision to admit to in-patient care by the treating physician. Number of participants with hospitalization for all-cause LRTI through 181 days post-dosing/randomization in France, UK, Germany, and overall is presented. The All Randomized Set consisted of all participants randomly assigned to either the nirsevimab group or the no intervention group. Here, n=number of participants with data collected for each specified category.
    End point type
    Secondary
    End point timeframe
    From dosing/randomization (Day 1) to Day 181
    End point values
    		 Nirsevimab No Intervention
    Number of subjects analysed
    4038
    4019
    Units: participants
        Overall (n=4038, 4019)
    82
    138
        France (n=1090, 1087)
    34
    49
        United Kingdom (n=2052, 2039)
    38
    62
        Germany (n=896, 893)
    10
    27
    Statistical analysis title
    		 Overall:Number of all-cause LRTI hospitalization
    Statistical analysis description
    The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of hospitalizations for all-cause LRTI through day 181 post-dosing/randomization in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization.
    Comparison groups
    Nirsevimab v No Intervention
    Number of subjects included in analysis
    8057
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Exact method using binomial distribution
    Parameter type
    		 Efficacy
    Point estimate
    41.89
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 23.073
         upper limit
    		 56.333
    Statistical analysis title
    		 Germany:Number of all-cause LRTI hospitalization
    Statistical analysis description
    The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of hospitalizations for all-cause LRTI through day 181 post-dosing/randomization in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization.
    Comparison groups
    Nirsevimab v No Intervention
    Number of subjects included in analysis
    8057
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0058
    Method
    		 Exact method using binomial distribution
    Parameter type
    		 Efficacy
    Point estimate
    64.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 23.386
         upper limit
    		 84.478
    Statistical analysis title
    		 UK: Number of all-cause LRTI hospitalization
    Statistical analysis description
    The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of hospitalizations for all-cause LRTI through day 181 post-dosing/randomization in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization.
    Comparison groups
    Nirsevimab v No Intervention
    Number of subjects included in analysis
    8057
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0164
    Method
    		 Exact method using binomial distribution
    Parameter type
    		 Efficacy
    Point estimate
    39.83
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 8.449
         upper limit
    		 60.911
    Statistical analysis title
    		 France: Number of all-cause LRTI hospitalization
    Statistical analysis description
    The 2-sided 95% CI for the efficacy was calculated by an exact method assuming a binomial distribution of the number of hospitalizations for all-cause LRTI through day 181 post-dosing/randomization in the nirsevimab group conditional on the total number in both groups accounting for the follow-up time post-dosing/randomization.
    Comparison groups
    Nirsevimab v No Intervention
    Number of subjects included in analysis
    8057
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1003
    Method
    		 Exact method using binomial distribution
    Parameter type
    		 Efficacy
    Point estimate
    32.19
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.188
         upper limit
    		 57.545

    Secondary: Number of Participants With Respiratory Syncytial Virus Lower Respiratory Tract Infection Hospitalization From Days 181 to 366 Post-dosing/Randomization

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    End point title
    		 Number of Participants With Respiratory Syncytial Virus Lower Respiratory Tract Infection Hospitalization From Days 181 to 366 Post-dosing/Randomization
    End point description
    LRTI included the following common symptoms: clinical finding of rhonchi, rales, crackles, or wheeze; increased respiratory rate at rest (age: <2 months, ≥60 breaths/min; 2 to 6 months, ≥50 breaths/min; >6 months, ≥40 breaths/min), and hypoxemia (in room air: oxygen saturation <95%). Hospitalization was defined as the decision to admit to in-patient care by the treating physician. Number of participants with RSV LRTI hospitalization from Days 181 to 366 post-dosing/randomization (with no RSV LRTI hospitalizations before Day 181) in France, UK, Germany, and overall is presented. The All Randomized Set consisted of all participants randomly assigned to either the nirsevimab group or the no intervention group. Only participants with data collected are reported. Here, n=number of participants with data collected for each specified category.
    End point type
    Secondary
    End point timeframe
    From Day 181 to Day 366
    End point values
    		 Nirsevimab No Intervention
    Number of subjects analysed
    4026
    3951
    Units: participants
        Overall (n=4026, 3951)
    31
    28
        France (n=1086, 1059)
    6
    5
        United Kingdom (n=2049, 2018)
    20
    19
        Germany (n=891, 874)
    5
    4
    No statistical analyses for this end point

    Secondary: Number of Participants With Hospitalization for All-Cause Lower Respiratory Tract Infection From Days 181 to 366 Post-dosing/Randomization

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    End point title
    		 Number of Participants With Hospitalization for All-Cause Lower Respiratory Tract Infection From Days 181 to 366 Post-dosing/Randomization
    End point description
    LRTI included the following common symptoms: clinical finding of rhonchi, rales, crackles, or wheeze; increased respiratory rate at rest (age: <2 months, ≥60 breaths/min; 2 to 6 months, ≥50 breaths/min; >6 months, ≥40 breaths/min), and hypoxemia (in room air: oxygen saturation <95%). Hospitalization was defined as the decision to admit to in-patient care by the treating physician. Number of participants with hospitalization for all-cause LRTI from Days 181 to 366 post-dosing/randomization (with no hospitalizations for all-cause LRTI before Day 181) is presented. The All Randomized Set consisted of all participants randomly assigned to either the nirsevimab group or the no intervention group. Only participants with data collected are reported.
    End point type
    Secondary
    End point timeframe
    From Day 181 to Day 366
    End point values
    		 Nirsevimab No Intervention
    Number of subjects analysed
    3956
    3881
    Units: participants
    68
    55
    No statistical analyses for this end point

    Secondary: Number of Participants With Respiratory Syncytial Virus Lower Respiratory Tract Infection Hospitalization From Days 366 to 731 Post-dosing/Randomization (for United Kingdom Reconsented Participants)

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    End point title
    		 Number of Participants With Respiratory Syncytial Virus Lower Respiratory Tract Infection Hospitalization From Days 366 to 731 Post-dosing/Randomization (for United Kingdom Reconsented Participants)
    End point description
    LRTI included the following common symptoms: clinical finding of rhonchi, rales, crackles, or wheeze; increased respiratory rate at rest (age: <2 months, ≥60 breaths/min; 2 to 6 months, ≥50 breaths/min; >6 months, ≥40 breaths/min), and hypoxemia (in room air: oxygen saturation <95%). Hospitalization was defined as the decision to admit to in-patient care by the treating physician. Number of participants with RSV LRTI hospitalization from Days 366 to 731 post-dosing/randomization (with no RSV LRTI hospitalizations before Day 366) in UK reconsented participants is presented. The All Randomized Set consisted of all participants randomly assigned to either the nirsevimab group or the no intervention group. Only participants with data collected are reported.
    End point type
    Secondary
    End point timeframe
    From Day 366 to Day 731
    End point values
    		 Nirsevimab No Intervention
    Number of subjects analysed
    1132
    1062
    Units: participants
    7
    2
    No statistical analyses for this end point

    Secondary: Number of Participants With Hospitalization for All-Cause Lower Respiratory Tract Infection From Days 366 to 731 Post-dosing/Randomization (for United Kingdom Reconsented Participants)

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    End point title
    		 Number of Participants With Hospitalization for All-Cause Lower Respiratory Tract Infection From Days 366 to 731 Post-dosing/Randomization (for United Kingdom Reconsented Participants)
    End point description
    LRTI included the following common symptoms: clinical finding of rhonchi, rales, crackles, or wheeze; increased respiratory rate at rest (age: <2 months, ≥60 breaths/min; 2 to 6 months, ≥50 breaths/min; >6 months, ≥40 breaths/min), and hypoxemia (in room air: oxygen saturation <95%). Hospitalization was defined as the decision to admit to in-patient care by the treating physician. Number of participants with hospitalization for all-cause LRTI from Days 366 to 731 post-dosing/randomization (with no hospitalizations for all-cause LRTI before Day 366) in UK reconsented participants is presented. The All Randomized Set consisted of all participants randomly assigned to either the nirsevimab group or the no intervention group. Only participants with data collected are reported.
    End point type
    Secondary
    End point timeframe
    From Day 366 to Day 731
    End point values
    		 Nirsevimab No Intervention
    Number of subjects analysed
    1096
    1025
    Units: participants
    18
    10
    No statistical analyses for this end point

    Secondary: Number of Participants With Recurrent Wheeze (for United Kingdom Reconsented Participants)

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    End point title
    		 Number of Participants With Recurrent Wheeze (for United Kingdom Reconsented Participants)
    End point description
    Wheeze was defined as a physician-diagnosed wheeze or asthma or related ear, nose and throat (ENT)/respiratory symptoms at an office visit or an illness for which the child was prescribed medication to treat an ENT/respiratory condition. Recurrent wheeze event was defined as 2 or more protocol-defined wheeze episodes throughout follow-up period. The All Randomized Set consisted of all participants randomly assigned to either the nirsevimab group or the no intervention group. Only participants with data collected are reported.
    End point type
    Secondary
    End point timeframe
    From dosing/randomization (Day 1) to Day 731
    End point values
    		 Nirsevimab No Intervention
    Number of subjects analysed
    928
    888
    Units: participants
    101
    96
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    SAEs and deaths: From dosing/randomization (Day 1) up to end of follow-up (Day 366 for France, Germany, UK non-reconsented participants and Day 731 for UK reconsented participants). Non-serious AEs: From dosing/randomization (Day 1) up to Day 31.
    Adverse event reporting additional description
    Analysis was performed on the SafAS. As pre-specified in the protocol and SAP, results are presented by treatment group. Safety analysis was not planned exclusively for UK reconsented participants, and no separate safety data was collected for this subgroup.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.0
    Reporting groups
    Reporting group title
    No intervention
    Reporting group description
    		 Participants received no RSV preventive intervention on Day 1.

    Reporting group title
    Nirsevimab
    Reporting group description
    		 Participants received nirsevimab 50 mg (if weight <5 kg) or 100 mg (if weight ≥5 kg) as a single IM injection on Day 1.

    Serious adverse events
    		 No intervention Nirsevimab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    222 / 4018 (5.53%)
    262 / 4016 (6.52%)
         number of deaths (all causes)
    0
    1
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acute Myelomonocytic Leukaemia
         subjects affected / exposed
    0 / 4018 (0.00%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Cyanosis
         subjects affected / exposed
    1 / 4018 (0.02%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Kawasaki's Disease
         subjects affected / exposed
    1 / 4018 (0.02%)
    2 / 4016 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Hyperthermia
         subjects affected / exposed
    1 / 4018 (0.02%)
    2 / 4016 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Crying
         subjects affected / exposed
    0 / 4018 (0.00%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Electrocution
         subjects affected / exposed
    0 / 4018 (0.00%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hernia
         subjects affected / exposed
    1 / 4018 (0.02%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypothermia
         subjects affected / exposed
    1 / 4018 (0.02%)
    0 / 4016 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malaise
         subjects affected / exposed
    1 / 4018 (0.02%)
    0 / 4016 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    11 / 4018 (0.27%)
    9 / 4016 (0.22%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Allergy To Vaccine
         subjects affected / exposed
    0 / 4018 (0.00%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alloimmunisation
         subjects affected / exposed
    1 / 4018 (0.02%)
    0 / 4016 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug Hypersensitivity
         subjects affected / exposed
    0 / 4018 (0.00%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Food Allergy
         subjects affected / exposed
    0 / 4018 (0.00%)
    4 / 4016 (0.10%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypersensitivity
         subjects affected / exposed
    1 / 4018 (0.02%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Milk Allergy
         subjects affected / exposed
    1 / 4018 (0.02%)
    0 / 4016 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaphylactic Reaction
         subjects affected / exposed
    2 / 4018 (0.05%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Breast Inflammation
         subjects affected / exposed
    0 / 4018 (0.00%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Testicular Torsion
         subjects affected / exposed
    0 / 4018 (0.00%)
    2 / 4016 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute Respiratory Failure
         subjects affected / exposed
    0 / 4018 (0.00%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Apnoea
         subjects affected / exposed
    3 / 4018 (0.07%)
    0 / 4016 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aspiration
         subjects affected / exposed
    1 / 4018 (0.02%)
    0 / 4016 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Asthma
         subjects affected / exposed
    3 / 4018 (0.07%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    2 / 4018 (0.05%)
    2 / 4016 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Choking
         subjects affected / exposed
    1 / 4018 (0.02%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cough
         subjects affected / exposed
    0 / 4018 (0.00%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Brief Resolved Unexplained Event
         subjects affected / exposed
    1 / 4018 (0.02%)
    0 / 4016 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wheezing
         subjects affected / exposed
    5 / 4018 (0.12%)
    3 / 4016 (0.07%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    0 / 4018 (0.00%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neonatal Respiratory Distress Syndrome
         subjects affected / exposed
    1 / 4018 (0.02%)
    0 / 4016 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Obstructive Sleep Apnoea Syndrome
         subjects affected / exposed
    1 / 4018 (0.02%)
    0 / 4016 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory Depression
         subjects affected / exposed
    1 / 4018 (0.02%)
    0 / 4016 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory Disorder
         subjects affected / exposed
    0 / 4018 (0.00%)
    2 / 4016 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rhinorrhoea
         subjects affected / exposed
    1 / 4018 (0.02%)
    0 / 4016 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsillar Hypertrophy
         subjects affected / exposed
    1 / 4018 (0.02%)
    0 / 4016 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Stereotypy
         subjects affected / exposed
    1 / 4018 (0.02%)
    0 / 4016 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Breath Holding
         subjects affected / exposed
    0 / 4018 (0.00%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Coronavirus Test Positive
         subjects affected / exposed
    0 / 4018 (0.00%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Human Rhinovirus Test Positive
         subjects affected / exposed
    1 / 4018 (0.02%)
    0 / 4016 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Weight Decreased
         subjects affected / exposed
    2 / 4018 (0.05%)
    2 / 4016 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oxygen Saturation Decreased
         subjects affected / exposed
    0 / 4018 (0.00%)
    3 / 4016 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    2 / 4018 (0.05%)
    4 / 4016 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Accidental Exposure To Product
         subjects affected / exposed
    0 / 4018 (0.00%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clavicle Fracture
         subjects affected / exposed
    0 / 4018 (0.00%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Concussion
         subjects affected / exposed
    5 / 4018 (0.12%)
    3 / 4016 (0.07%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Contusion
         subjects affected / exposed
    1 / 4018 (0.02%)
    2 / 4016 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Forearm Fracture
         subjects affected / exposed
    1 / 4018 (0.02%)
    0 / 4016 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foreign Body In Gastrointestinal Tract
         subjects affected / exposed
    0 / 4018 (0.00%)
    2 / 4016 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Foreign Body Ingestion
         subjects affected / exposed
    0 / 4018 (0.00%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hand Fracture
         subjects affected / exposed
    1 / 4018 (0.02%)
    0 / 4016 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Head Injury
         subjects affected / exposed
    1 / 4018 (0.02%)
    5 / 4016 (0.12%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skull Fracture
         subjects affected / exposed
    2 / 4018 (0.05%)
    2 / 4016 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower Limb Fracture
         subjects affected / exposed
    0 / 4018 (0.00%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Overdose
         subjects affected / exposed
    1 / 4018 (0.02%)
    0 / 4016 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Poisoning
         subjects affected / exposed
    1 / 4018 (0.02%)
    0 / 4016 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Road Traffic Accident
         subjects affected / exposed
    1 / 4018 (0.02%)
    0 / 4016 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seroma
         subjects affected / exposed
    0 / 4018 (0.00%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hip Fracture
         subjects affected / exposed
    1 / 4018 (0.02%)
    0 / 4016 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stoma Prolapse
         subjects affected / exposed
    1 / 4018 (0.02%)
    0 / 4016 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thermal Burn
         subjects affected / exposed
    4 / 4018 (0.10%)
    2 / 4016 (0.05%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toxicity To Various Agents
         subjects affected / exposed
    1 / 4018 (0.02%)
    0 / 4016 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Traumatic Haematoma
         subjects affected / exposed
    0 / 4018 (0.00%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper Limb Fracture
         subjects affected / exposed
    0 / 4018 (0.00%)
    1 / 4016 (0.02%)
         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
    Cataract Congenital
         subjects affected / exposed
    0 / 4018 (0.00%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriovenous Malformation
         subjects affected / exposed
    0 / 4018 (0.00%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial Septal Defect
         subjects affected / exposed
    0 / 4018 (0.00%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bicuspid Aortic Valve
         subjects affected / exposed
    0 / 4018 (0.00%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Birth Mark
         subjects affected / exposed
    0 / 4018 (0.00%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Choanal Stenosis
         subjects affected / exposed
    0 / 4018 (0.00%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cleft Palate
         subjects affected / exposed
    0 / 4018 (0.00%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Craniofacial Deformity
         subjects affected / exposed
    0 / 4018 (0.00%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital Megacolon
         subjects affected / exposed
    1 / 4018 (0.02%)
    0 / 4016 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coarctation Of The Aorta
         subjects affected / exposed
    0 / 4018 (0.00%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Factor Viii Deficiency
         subjects affected / exposed
    0 / 4018 (0.00%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydrocele
         subjects affected / exposed
    1 / 4018 (0.02%)
    0 / 4016 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypospadias
         subjects affected / exposed
    0 / 4018 (0.00%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Kabuki Make-Up Syndrome
         subjects affected / exposed
    1 / 4018 (0.02%)
    0 / 4016 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary Sequestration
         subjects affected / exposed
    1 / 4018 (0.02%)
    0 / 4016 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urethral Valves
         subjects affected / exposed
    0 / 4018 (0.00%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyloric Stenosis
         subjects affected / exposed
    0 / 4018 (0.00%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngomalacia
         subjects affected / exposed
    1 / 4018 (0.02%)
    0 / 4016 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac Arrest
         subjects affected / exposed
    0 / 4018 (0.00%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tachycardia
         subjects affected / exposed
    0 / 4018 (0.00%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Altered State Of Consciousness
         subjects affected / exposed
    0 / 4018 (0.00%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lethargy
         subjects affected / exposed
    0 / 4018 (0.00%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infantile Spasms
         subjects affected / exposed
    1 / 4018 (0.02%)
    2 / 4016 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertonia
         subjects affected / exposed
    1 / 4018 (0.02%)
    0 / 4016 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fontanelle Bulging
         subjects affected / exposed
    0 / 4018 (0.00%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile Convulsion
         subjects affected / exposed
    10 / 4018 (0.25%)
    10 / 4016 (0.25%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    2 / 4018 (0.05%)
    3 / 4016 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyskinesia
         subjects affected / exposed
    1 / 4018 (0.02%)
    0 / 4016 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Loss Of Consciousness
         subjects affected / exposed
    1 / 4018 (0.02%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Partial Seizures
         subjects affected / exposed
    0 / 4018 (0.00%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Unresponsive To Stimuli
         subjects affected / exposed
    0 / 4018 (0.00%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tremor
         subjects affected / exposed
    0 / 4018 (0.00%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonic Convulsion
         subjects affected / exposed
    0 / 4018 (0.00%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Status Epilepticus
         subjects affected / exposed
    2 / 4018 (0.05%)
    0 / 4016 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seizure Like Phenomena
         subjects affected / exposed
    0 / 4018 (0.00%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    3 / 4018 (0.07%)
    11 / 4016 (0.27%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Petit Mal Epilepsy
         subjects affected / exposed
    0 / 4018 (0.00%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Hypersplenism
         subjects affected / exposed
    1 / 4018 (0.02%)
    0 / 4016 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eosinophilia
         subjects affected / exposed
    0 / 4018 (0.00%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphadenitis
         subjects affected / exposed
    1 / 4018 (0.02%)
    2 / 4016 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune Thrombocytopenia
         subjects affected / exposed
    1 / 4018 (0.02%)
    0 / 4016 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Hypoacusis
         subjects affected / exposed
    0 / 4018 (0.00%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Deafness
         subjects affected / exposed
    0 / 4018 (0.00%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Eye Movement Disorder
         subjects affected / exposed
    1 / 4018 (0.02%)
    0 / 4016 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye Disorder
         subjects affected / exposed
    1 / 4018 (0.02%)
    0 / 4016 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal Pain Upper
         subjects affected / exposed
    1 / 4018 (0.02%)
    0 / 4016 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    2 / 4018 (0.05%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cyclic Vomiting Syndrome
         subjects affected / exposed
    0 / 4018 (0.00%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diaphragmatic Hernia
         subjects affected / exposed
    0 / 4018 (0.00%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    1 / 4018 (0.02%)
    3 / 4016 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea Haemorrhagic
         subjects affected / exposed
    1 / 4018 (0.02%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysphagia
         subjects affected / exposed
    1 / 4018 (0.02%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enteritis
         subjects affected / exposed
    1 / 4018 (0.02%)
    0 / 4016 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inguinal Hernia
         subjects affected / exposed
    5 / 4018 (0.12%)
    5 / 4016 (0.12%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal Disorder
         subjects affected / exposed
    1 / 4018 (0.02%)
    0 / 4016 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrooesophageal Reflux Disease
         subjects affected / exposed
    2 / 4018 (0.05%)
    2 / 4016 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematemesis
         subjects affected / exposed
    0 / 4018 (0.00%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematochezia
         subjects affected / exposed
    2 / 4018 (0.05%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incarcerated Inguinal Hernia
         subjects affected / exposed
    0 / 4018 (0.00%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Flatulence
         subjects affected / exposed
    1 / 4018 (0.02%)
    0 / 4016 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Protein-Losing Gastroenteropathy
         subjects affected / exposed
    0 / 4018 (0.00%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intussusception
         subjects affected / exposed
    2 / 4018 (0.05%)
    0 / 4016 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal Perforation
         subjects affected / exposed
    0 / 4018 (0.00%)
    1 / 4016 (0.02%)
         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
    3 / 4018 (0.07%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inguinal Hernia, Obstructive
         subjects affected / exposed
    1 / 4018 (0.02%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subileus
         subjects affected / exposed
    1 / 4018 (0.02%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    4 / 4018 (0.10%)
    6 / 4016 (0.15%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Small Intestinal Obstruction
         subjects affected / exposed
    1 / 4018 (0.02%)
    0 / 4016 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholestasis
         subjects affected / exposed
    1 / 4018 (0.02%)
    0 / 4016 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Jaundice
         subjects affected / exposed
    2 / 4018 (0.05%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Dermatitis Allergic
         subjects affected / exposed
    0 / 4018 (0.00%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acne Infantile
         subjects affected / exposed
    1 / 4018 (0.02%)
    0 / 4016 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angioedema
         subjects affected / exposed
    1 / 4018 (0.02%)
    0 / 4016 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urticaria
         subjects affected / exposed
    0 / 4018 (0.00%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rash
         subjects affected / exposed
    3 / 4018 (0.07%)
    0 / 4016 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Petechiae
         subjects affected / exposed
    1 / 4018 (0.02%)
    0 / 4016 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erythema Multiforme
         subjects affected / exposed
    0 / 4018 (0.00%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eczema
         subjects affected / exposed
    0 / 4018 (0.00%)
    2 / 4016 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal Impairment
         subjects affected / exposed
    1 / 4018 (0.02%)
    0 / 4016 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Adrenal Insufficiency
         subjects affected / exposed
    1 / 4018 (0.02%)
    0 / 4016 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Musculoskeletal Discomfort
         subjects affected / exposed
    0 / 4018 (0.00%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Synovitis
         subjects affected / exposed
    1 / 4018 (0.02%)
    0 / 4016 (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
    Cellulitis Orbital
         subjects affected / exposed
    0 / 4018 (0.00%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Covid-19
         subjects affected / exposed
    8 / 4018 (0.20%)
    6 / 4016 (0.15%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bullous Impetigo
         subjects affected / exposed
    0 / 4018 (0.00%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Beta Haemolytic Streptococcal Infection
         subjects affected / exposed
    1 / 4018 (0.02%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacterial Infection
         subjects affected / exposed
    0 / 4018 (0.00%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adenovirus Infection
         subjects affected / exposed
    2 / 4018 (0.05%)
    2 / 4016 (0.05%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abscess Neck
         subjects affected / exposed
    0 / 4018 (0.00%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Conjunctivitis Bacterial
         subjects affected / exposed
    1 / 4018 (0.02%)
    0 / 4016 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coronavirus Infection
         subjects affected / exposed
    2 / 4018 (0.05%)
    6 / 4016 (0.15%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Croup Infectious
         subjects affected / exposed
    3 / 4018 (0.07%)
    5 / 4016 (0.12%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cytomegalovirus Infection
         subjects affected / exposed
    0 / 4018 (0.00%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dermatitis Infected
         subjects affected / exposed
    0 / 4018 (0.00%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dermo-Hypodermitis
         subjects affected / exposed
    1 / 4018 (0.02%)
    0 / 4016 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear Infection
         subjects affected / exposed
    0 / 4018 (0.00%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear Infection Viral
         subjects affected / exposed
    0 / 4018 (0.00%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eczema Herpeticum
         subjects affected / exposed
    1 / 4018 (0.02%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eczema Infected
         subjects affected / exposed
    2 / 4018 (0.05%)
    0 / 4016 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterovirus Infection
         subjects affected / exposed
    0 / 4018 (0.00%)
    1 / 4016 (0.02%)
         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 / 4018 (0.00%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastric Infection
         subjects affected / exposed
    1 / 4018 (0.02%)
    0 / 4016 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    12 / 4018 (0.30%)
    11 / 4016 (0.27%)
         occurrences causally related to treatment / all
    0 / 12
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis Adenovirus
         subjects affected / exposed
    1 / 4018 (0.02%)
    0 / 4016 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis Enteroviral
         subjects affected / exposed
    2 / 4018 (0.05%)
    0 / 4016 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Impetigo
         subjects affected / exposed
    1 / 4018 (0.02%)
    2 / 4016 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis Rotavirus
         subjects affected / exposed
    1 / 4018 (0.02%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis Viral
         subjects affected / exposed
    2 / 4018 (0.05%)
    4 / 4016 (0.10%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal Infection
         subjects affected / exposed
    4 / 4018 (0.10%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal Viral Infection
         subjects affected / exposed
    1 / 4018 (0.02%)
    0 / 4016 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes Simplex
         subjects affected / exposed
    0 / 4018 (0.00%)
    1 / 4016 (0.02%)
         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
    2 / 4018 (0.05%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infection
         subjects affected / exposed
    0 / 4018 (0.00%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infectious Mononucleosis
         subjects affected / exposed
    0 / 4018 (0.00%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    6 / 4018 (0.15%)
    8 / 4016 (0.20%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intervertebral Discitis
         subjects affected / exposed
    1 / 4018 (0.02%)
    0 / 4016 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngitis
         subjects affected / exposed
    3 / 4018 (0.07%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis
         subjects affected / exposed
    0 / 4018 (0.00%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower Respiratory Tract Infection
         subjects affected / exposed
    0 / 4018 (0.00%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung Abscess
         subjects affected / exposed
    0 / 4018 (0.00%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymph Node Abscess
         subjects affected / exposed
    1 / 4018 (0.02%)
    0 / 4016 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mastoiditis
         subjects affected / exposed
    2 / 4018 (0.05%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Localised Infection
         subjects affected / exposed
    0 / 4018 (0.00%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis Enteroviral
         subjects affected / exposed
    1 / 4018 (0.02%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis Neonatal
         subjects affected / exposed
    1 / 4018 (0.02%)
    0 / 4016 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis Viral
         subjects affected / exposed
    1 / 4018 (0.02%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nasopharyngitis
         subjects affected / exposed
    1 / 4018 (0.02%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Norovirus Infection
         subjects affected / exposed
    0 / 4018 (0.00%)
    2 / 4016 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parainfluenzae Virus Infection
         subjects affected / exposed
    0 / 4018 (0.00%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    0 / 4018 (0.00%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteomyelitis Bacterial
         subjects affected / exposed
    1 / 4018 (0.02%)
    0 / 4016 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Otitis Media
         subjects affected / exposed
    1 / 4018 (0.02%)
    2 / 4016 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Otitis Media Acute
         subjects affected / exposed
    2 / 4018 (0.05%)
    0 / 4016 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oral Candidiasis
         subjects affected / exposed
    0 / 4018 (0.00%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Periorbital Cellulitis
         subjects affected / exposed
    1 / 4018 (0.02%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngitis Streptococcal
         subjects affected / exposed
    0 / 4018 (0.00%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    9 / 4018 (0.22%)
    10 / 4016 (0.25%)
         occurrences causally related to treatment / all
    0 / 11
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis Acute
         subjects affected / exposed
    1 / 4018 (0.02%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory Syncytial Virus Infection
         subjects affected / exposed
    2 / 4018 (0.05%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    3 / 4018 (0.07%)
    4 / 4016 (0.10%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rhinitis
         subjects affected / exposed
    1 / 4018 (0.02%)
    2 / 4016 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rhinovirus Infection
         subjects affected / exposed
    3 / 4018 (0.07%)
    3 / 4016 (0.07%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Roseola
         subjects affected / exposed
    0 / 4018 (0.00%)
    2 / 4016 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rotavirus Infection
         subjects affected / exposed
    2 / 4018 (0.05%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Salmonellosis
         subjects affected / exposed
    2 / 4018 (0.05%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory Tract Infection Viral
         subjects affected / exposed
    0 / 4018 (0.00%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal Skin Infection
         subjects affected / exposed
    1 / 4018 (0.02%)
    0 / 4016 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Streptococcal Infection
         subjects affected / exposed
    1 / 4018 (0.02%)
    0 / 4016 (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 / 4018 (0.02%)
    0 / 4016 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subglottic Laryngitis
         subjects affected / exposed
    0 / 4018 (0.00%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suspected Covid-19
         subjects affected / exposed
    0 / 4018 (0.00%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Varicella
         subjects affected / exposed
    0 / 4018 (0.00%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsillitis Bacterial
         subjects affected / exposed
    0 / 4018 (0.00%)
    2 / 4016 (0.05%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper Respiratory Tract Infection
         subjects affected / exposed
    9 / 4018 (0.22%)
    10 / 4016 (0.25%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urachal Abscess
         subjects affected / exposed
    1 / 4018 (0.02%)
    0 / 4016 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary Tract Infection
         subjects affected / exposed
    4 / 4018 (0.10%)
    7 / 4016 (0.17%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    1 / 4018 (0.02%)
    0 / 4016 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsillitis
         subjects affected / exposed
    2 / 4018 (0.05%)
    7 / 4016 (0.17%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral Diarrhoea
         subjects affected / exposed
    0 / 4018 (0.00%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral Infection
         subjects affected / exposed
    7 / 4018 (0.17%)
    11 / 4016 (0.27%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral Pharyngitis
         subjects affected / exposed
    0 / 4018 (0.00%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral Rash
         subjects affected / exposed
    0 / 4018 (0.00%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral Rhinitis
         subjects affected / exposed
    1 / 4018 (0.02%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral Upper Respiratory Tract Infection
         subjects affected / exposed
    4 / 4018 (0.10%)
    2 / 4016 (0.05%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Feeding Disorder
         subjects affected / exposed
    1 / 4018 (0.02%)
    2 / 4016 (0.05%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Failure To Thrive
         subjects affected / exposed
    2 / 4018 (0.05%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    1 / 4018 (0.02%)
    0 / 4016 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Food Refusal
         subjects affected / exposed
    0 / 4018 (0.00%)
    1 / 4016 (0.02%)
         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 / 4018 (0.00%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypophagia
         subjects affected / exposed
    2 / 4018 (0.05%)
    0 / 4016 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Type 1 Diabetes Mellitus
         subjects affected / exposed
    0 / 4018 (0.00%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Weight Gain Poor
         subjects affected / exposed
    1 / 4018 (0.02%)
    1 / 4016 (0.02%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 No intervention Nirsevimab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    279 / 4018 (6.94%)
    324 / 4016 (8.07%)
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    279 / 4018 (6.94%)
    324 / 4016 (8.07%)
         occurrences all number
    298
    345

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    19 Jul 2023
    The purpose of this amendment was to extend the follow-up of HARMONIE participants to 24 months as a result of a post-marketing commitment to the United States Food and Drug Administration to collect data for the evaluation of antibody-dependent enhancement of RSV disease in the second RSV season of neonates and infants who received nirsevimab prior to or during their first RSV season. The HARMONIE study design was updated with the addition of a 12-month follow-up period, including 2 phone calls at Day 546 and Day 731 post-dosing/randomization, in UK participants only. The 12-month extension period was also used as the opportunity to retrospectively collect information on wheeze at Day 366 and Day 731 post-dosing/randomization in UK reconsented participants only.
    01 Feb 2024
    The objectives of this amendment were to extend the time window for signing the addendum to the Inform Consent Form for UK’s participants, to add routine immunization with Beyfortus® as reportable concomitant medications, to clarify the data collection during the 12-month extension period in case of wheeze (including any concomitant medications during wheezing episodes) for UK reconsented participants.
    05 Feb 2024
    The objective of this amendment was to clarify the definition of a wheezing episode.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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