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    Clinical Trial Results:
    A Phase 2, Open-label, Uncontrolled, Single-dose Study to Evaluate the Safety and Tolerability, Pharmacokinetics, and Occurrence of Antidrug Antibody for Nirsevimab in Immunocompromised Children <=24 Months of Age

    Summary
    EudraCT number
    		 2021-003221-30
    Trial protocol
    		 ES   BE   PL  
    Global end of trial date
    17 Feb 2023

    Results information
    Results version number
    		 v2(current)
    This version publication date
    10 Nov 2023
    First version publication date
    11 Aug 2023
    Other versions
    		 v1
    Version creation reason

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    D5290C00008
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04484935
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AstraZeneca
    Sponsor organisation address
    Karlebyhusentren, B674 Astraallen, Södertälje, Sweden, 151 85
    Public contact
    Global Clinical Lead, AstraZeneca, +1 877-240-9479, information.center@astrazeneca.com
    Scientific contact
    Global Clinical Lead, AstraZeneca, +1 877-240-9479, information.center@astrazeneca.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    17 Feb 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Feb 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the safety and tolerability of nirsevimab when administered to immunocompromised children <=24 months of age.
    Protection of trial subjects
    This study was performed in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with International Council for Harmonisation/Good Clinical Practice, applicable regulatory requirements, and the AstraZeneca policy on Bioethics.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    19 Aug 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 6
    Country: Number of subjects enrolled
    Japan: 26
    Country: Number of subjects enrolled
    Poland: 3
    Country: Number of subjects enrolled
    South Africa: 14
    Country: Number of subjects enrolled
    Spain: 10
    Country: Number of subjects enrolled
    Ukraine: 21
    Country: Number of subjects enrolled
    United Kingdom: 1
    Country: Number of subjects enrolled
    United States: 19
    Worldwide total number of subjects
    100
    EEA total number of subjects
    19
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    94
    Children (2-11 years)
    6
    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
    		 This Phase 2, open-label, uncontrolled, single-dose study was conducted at 28 investigational sites in immunocompromised children who were <=24 months of age at the time of enrollment.

    Pre-assignment
    Screening details
    		 This study consisted of a screening period (Visit 1, Day -30 to Day -1); a dosing visit (Visit 2, Day 1) where participants received treatment with nirsevimab and a follow-up period up to Day 361 (Visit 3 to 7). A total of 100 children were enrolled in this study.

    Period 1
    Period 1 title
    Overall study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Nirsevimab 50 mg/100 mg
    Arm description
    		 Participants in their first year of life with a body weight <5 kilogram (kg) received a single fixed intramuscular (IM) dose of 50 milligram (mg) nirsevimab and those with body weight >=5 kg received a single fixed IM dose of 100 mg nirsevimab.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nirsevimab
    Investigational medicinal product code
    Other name
    MEDI8897
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Nirsevimab was administered as an IM injection in the anterolateral aspect of the thigh. Participants with body weight (BW) <5 kg received 50 mg and with BW >=5 kg received 100 mg. The maximum volume administered with each injection was 1.0 milliliter (mL).

    Arm title
    		 Nirsevimab 200 mg
    Arm description
    		 Participants in their second year of life received a single fixed IM dose of 200 mg (2 × 100 mg) of nirsevimab
    Arm type
    		 Experimental

    Investigational medicinal product name
    Nirsevimab
    Investigational medicinal product code
    Other name
    MEDI8897
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Nirsevimab was administered as an IM injection in the anterolateral aspect of the thigh. Participants in their second year received 200 mg dose injection (administered as 2 injections) in each thigh. The maximum volume administered with each injection was 1.0 mL.

    Number of subjects in period 1
    		Nirsevimab 50 mg/100 mg Nirsevimab 200 mg
    Started
    48
    52
    Completed
    45
    49
    Not completed
    3
    3
         Death
    2
    1
         Unspecified
    -
    1
         Lost to follow-up
    1
    -
         Withdrawal by parent/guardian
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Nirsevimab 50 mg/100 mg
    Reporting group description
    		 Participants in their first year of life with a body weight <5 kilogram (kg) received a single fixed intramuscular (IM) dose of 50 milligram (mg) nirsevimab and those with body weight >=5 kg received a single fixed IM dose of 100 mg nirsevimab.

    Reporting group title
    Nirsevimab 200 mg
    Reporting group description
    		 Participants in their second year of life received a single fixed IM dose of 200 mg (2 × 100 mg) of nirsevimab

    Reporting group values
    		 Nirsevimab 50 mg/100 mg Nirsevimab 200 mg Total
    Number of subjects
    		 48 52
    Age Categorical
    Units: Subjects
    Age Continuous
    Units: months
        arithmetic mean (standard deviation)
    		 7.64 ( 3.270 ) 17.90 ( 3.748 ) -
    Gender Categorical
    Units: Subjects
        Female
    		 18 17 35
        Male
    		 30 35 65
    Race
    Units: Subjects
        Asian
    		 16 12 28
        American Indian or Alaskan Native
    		 1 0 1
        Black or African American
    		 9 11 20
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        White
    		 20 25 45
        Other
    		 2 2 4
        Multiple categories checked
    		 0 2 2
    Ethnicity
    Units: Subjects
        Not Hispanic or Latino
    		 44 49 93
        Hispanic or Latino
    		 4 3 7

    End points

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    End points reporting groups
    Reporting group title
    Nirsevimab 50 mg/100 mg
    Reporting group description
    		 Participants in their first year of life with a body weight <5 kilogram (kg) received a single fixed intramuscular (IM) dose of 50 milligram (mg) nirsevimab and those with body weight >=5 kg received a single fixed IM dose of 100 mg nirsevimab.

    Reporting group title
    Nirsevimab 200 mg
    Reporting group description
    		 Participants in their second year of life received a single fixed IM dose of 200 mg (2 × 100 mg) of nirsevimab

    Primary: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious AEs (TESAEs), AEs of Special Interest (AESIs), and New Onset Chronic Disease (NOCDs)

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    End point title
    		 Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious AEs (TESAEs), AEs of Special Interest (AESIs), and New Onset Chronic Disease (NOCDs) [1]
    End point description
    An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment,whether or not considered related to the treatment. TEAEs were AEs whose onset occurred after receiving nirsevimab and within 360 days post dose. A TESAE was any AE that resulted in death, was life-threatening, required inpatient hospitalization, resulted in persistent or significant disability/incapacity, was a congenital abnormality, or was medically significant. AESIs were defined as AEs of immediate (type I) hypersensitivity (including anaphylaxis), thrombocytopenia, and immune complex disease following the administration of nirsevimab based on investigator assessment and Medical Dictionary for Regulatory Activities (MedDRA) preferred term (PT) codes. An NOCD was a newly diagnosed medical condition of a chronic, ongoing nature post administration of treatment. As treated population: All participants who were enrolled and received any dose of nirsevimab.
    End point type
    Primary
    End point timeframe
    TEAEs were collected from the first dose administration (Day 1) up to 360 days post dose
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical analysis was pre-specified for this endpoint.
    End point values
    		 Nirsevimab 50 mg/100 mg Nirsevimab 200 mg
    Number of subjects analysed
    48
    52
    Units: participants
    number (not applicable)
        Any TEAE
    36
    45
        TESAE
    12
    20
        AESI based on investigator assessment
    3
    2
        AESI based on selected MedDRA PT codes
    16
    13
        NOCD
    0
    0
    No statistical analyses for this end point

    Secondary: Serum Concentrations of Nirsevimab

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    End point title
    		 Serum Concentrations of Nirsevimab
    End point description
    Serum concentrations of nirsevimab at selected time points were evaluated to confirm that adequate exposures for protection from respiratory syncitial virus (RSV) lower respiratory tract infection (LRTI) are maintained for at least 5 months after dosing. As treated population: All participants who were enrolled and received any dose of nirsevimab. 99999 = data was below the lower limit of quantification (0.5 microgram [mcg]/mL). n=Only those participants with data available are included in the analysis.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and on Days 8 (for Japanese participants), 31, 151 and 361
    End point values
    		 Nirsevimab 50 mg/100 mg Nirsevimab 200 mg
    Number of subjects analysed
    48
    52
    Units: mcg/mL
    geometric mean (geometric coefficient of variation)
        Baseline (Day 1), n = 48, 52
    99999 ( 99999 )
    99999 ( 99999 )
        Day 8, n = 15, 11
    139.24 ( 22.26 )
    206.76 ( 16.58 )
        Day 31, n = 47, 50
    66.00 ( 141.06 )
    109.77 ( 91.74 )
        Day 151, n = 39, 44
    19.80 ( 101.19 )
    24.14 ( 121.54 )
        Day 361, n = 29, 38
    1.86 ( 119.96 )
    1.93 ( 158.95 )
    No statistical analyses for this end point

    Secondary: Number of Participants With Anti-Drug Antibody (ADA) Response to Nirsevimab

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    End point title
    		 Number of Participants With Anti-Drug Antibody (ADA) Response to Nirsevimab
    End point description
    Blood samples were analyzed for the presence of ADAs for nirsevimab using validated assays. As treated population: All participants who were enrolled and received any dose of nirsevimab.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and on Days 31, 151 and 361
    End point values
    		 Nirsevimab 50 mg/100 mg Nirsevimab 200 mg
    Number of subjects analysed
    48
    52
    Units: participants
    number (not applicable)
        Day 1
    0
    0
        Day 31
    0
    1
        Day 151
    1
    0
        Day 361
    2
    7
    No statistical analyses for this end point

    Secondary: Number of Participants With Medically Attended (MA) RSV LRTI (Inpatient and Outpatient) and Hospitalizations

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    End point title
    		 Number of Participants With Medically Attended (MA) RSV LRTI (Inpatient and Outpatient) and Hospitalizations
    End point description
    Number of participants with LRTI and hospitalizations due to reverse transcriptase-polymerase chain reaction (RT-PCR)-confirmed RSV was assessed. MA RSV LRTI consisted of participants with protocol-defined LRTI, positive central RT-PCR RSV test result, Investigator assessed LRTI at an inpatient or outpatient setting. MA RSV LRTI with hospitalization consisted of participants with protocol-defined LRTI, positive central RT-PCR RSV test result, Investigator assessed LRTI at an inpatient setting. The As-treated population: All participants who were enrolled and received any dose of nirsevimab.
    End point type
    Secondary
    End point timeframe
    Through 150 days post dose
    End point values
    		 Nirsevimab 50 mg/100 mg Nirsevimab 200 mg
    Number of subjects analysed
    48
    52
    Units: participants
    number (not applicable)
        MA RSV LRTI
    0
    0
        MA RSV LRTI with hospitalization
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    TEAEs were collected from the first dose administration (Day 1) up to 360 days post dose
    Adverse event reporting additional description
    As treated population consisted of all participants who were enrolled and received any dose of nirsevimab.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.0
    Reporting groups
    Reporting group title
    Nirsevimab 200 mg
    Reporting group description
    		 Participants in their second year of life received a single fixed IM dose of 200 mg (2 × 100 mg) of nirsevimab.

    Reporting group title
    Nirsevimab 50 mg /100 mg
    Reporting group description
    		 Participants in their first year of life with a body weight <5 kg received a single fixed IM dose of 50 mg nirsevimab and those with body weight >=5 kg received a single fixed IM dose of 100 mg nirsevimab.

    Serious adverse events
    		 Nirsevimab 200 mg Nirsevimab 50 mg /100 mg
    Total subjects affected by serious adverse events
         subjects affected / exposed
    20 / 52 (38.46%)
    12 / 48 (25.00%)
         number of deaths (all causes)
    1
    2
         number of deaths resulting from adverse events
    1
    2
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Tumour haemorrhage
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 52 (1.92%)
    2 / 48 (4.17%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Complication associated with device
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Haemophagocytic lymphohistiocytosis
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transplant rejection
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Graft versus host disease
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Tonsillar hypertrophy
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory distress
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adenoidal hypertrophy
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Gastrostomy failure
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Iatrogenic injury
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Sickle cell disease
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Epilepsy
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intracranial pressure increased
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    2 / 52 (3.85%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemolytic anaemia
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    2 / 52 (3.85%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anaemia
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Intestinal obstruction
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Volvulus
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatic cytolysis
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Nephrotic syndrome
         subjects affected / exposed
    2 / 52 (3.85%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Adrenal insufficiency
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Gastroenteritis Escherichia coli
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 48 (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
    1 / 52 (1.92%)
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia pyelonephritis
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterobacter sepsis
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device related sepsis
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Candida sepsis
         subjects affected / exposed
    0 / 52 (0.00%)
    2 / 48 (4.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    3 / 52 (5.77%)
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacterial infection
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacteraemia
         subjects affected / exposed
    2 / 52 (3.85%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal viral infection
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Klebsiella sepsis
         subjects affected / exposed
    2 / 52 (3.85%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Klebsiella bacteraemia
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Giardiasis
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    3 / 52 (5.77%)
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Lower respiratory tract infection viral
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urethritis
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal bacteraemia
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Serratia sepsis
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Sepsis
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rhinovirus infection
         subjects affected / exposed
    0 / 52 (0.00%)
    2 / 48 (4.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory syncytial virus infection
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative wound infection
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia viral
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    4 / 52 (7.69%)
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oral herpes
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral upper respiratory tract infection
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral diarrhoea
         subjects affected / exposed
    0 / 52 (0.00%)
    2 / 48 (4.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection bacterial
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Feeding intolerance
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyponatraemia
         subjects affected / exposed
    0 / 52 (0.00%)
    1 / 48 (2.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malnutrition
         subjects affected / exposed
    1 / 52 (1.92%)
    0 / 48 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Nirsevimab 200 mg Nirsevimab 50 mg /100 mg
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    45 / 52 (86.54%)
    36 / 48 (75.00%)
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    3 / 52 (5.77%)
    1 / 48 (2.08%)
         occurrences all number
    3
    1
    Febrile neutropenia
         subjects affected / exposed
    2 / 52 (3.85%)
    3 / 48 (6.25%)
         occurrences all number
    4
    4
    Anaemia
         subjects affected / exposed
    3 / 52 (5.77%)
    3 / 48 (6.25%)
         occurrences all number
    3
    3
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    13 / 52 (25.00%)
    13 / 48 (27.08%)
         occurrences all number
    27
    25
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    10 / 52 (19.23%)
    8 / 48 (16.67%)
         occurrences all number
    15
    11
    Abdominal pain
         subjects affected / exposed
    3 / 52 (5.77%)
    1 / 48 (2.08%)
         occurrences all number
    3
    1
    Vomiting
         subjects affected / exposed
    13 / 52 (25.00%)
    8 / 48 (16.67%)
         occurrences all number
    16
    13
    Constipation
         subjects affected / exposed
    2 / 52 (3.85%)
    4 / 48 (8.33%)
         occurrences all number
    3
    5
    Respiratory, thoracic and mediastinal disorders
    Rhinorrhoea
         subjects affected / exposed
    7 / 52 (13.46%)
    6 / 48 (12.50%)
         occurrences all number
    9
    11
    Nasal congestion
         subjects affected / exposed
    3 / 52 (5.77%)
    1 / 48 (2.08%)
         occurrences all number
    3
    1
    Cough
         subjects affected / exposed
    4 / 52 (7.69%)
    6 / 48 (12.50%)
         occurrences all number
    5
    6
    Skin and subcutaneous tissue disorders
    Dermatitis diaper
         subjects affected / exposed
    8 / 52 (15.38%)
    5 / 48 (10.42%)
         occurrences all number
    8
    6
    Dry skin
         subjects affected / exposed
    1 / 52 (1.92%)
    4 / 48 (8.33%)
         occurrences all number
    1
    4
    Eczema infantile
         subjects affected / exposed
    0 / 52 (0.00%)
    4 / 48 (8.33%)
         occurrences all number
    0
    4
    Rash
         subjects affected / exposed
    1 / 52 (1.92%)
    4 / 48 (8.33%)
         occurrences all number
    1
    6
    Urticaria
         subjects affected / exposed
    0 / 52 (0.00%)
    3 / 48 (6.25%)
         occurrences all number
    0
    3
    Infections and infestations
    COVID-19
         subjects affected / exposed
    12 / 52 (23.08%)
    4 / 48 (8.33%)
         occurrences all number
    12
    4
    Ear infection
         subjects affected / exposed
    3 / 52 (5.77%)
    0 / 48 (0.00%)
         occurrences all number
    5
    0
    Conjunctivitis
         subjects affected / exposed
    2 / 52 (3.85%)
    4 / 48 (8.33%)
         occurrences all number
    3
    5
    Rhinitis
         subjects affected / exposed
    5 / 52 (9.62%)
    2 / 48 (4.17%)
         occurrences all number
    5
    2
    Otitis media acute
         subjects affected / exposed
    4 / 52 (7.69%)
    2 / 48 (4.17%)
         occurrences all number
    5
    9
    Otitis media
         subjects affected / exposed
    6 / 52 (11.54%)
    5 / 48 (10.42%)
         occurrences all number
    7
    7
    Nasopharyngitis
         subjects affected / exposed
    6 / 52 (11.54%)
    6 / 48 (12.50%)
         occurrences all number
    9
    13
    Lower respiratory tract infection
         subjects affected / exposed
    3 / 52 (5.77%)
    3 / 48 (6.25%)
         occurrences all number
    3
    3
    Hand-foot-and-mouth disease
         subjects affected / exposed
    3 / 52 (5.77%)
    2 / 48 (4.17%)
         occurrences all number
    3
    2
    Gastrointestinal viral infection
         subjects affected / exposed
    4 / 52 (7.69%)
    0 / 48 (0.00%)
         occurrences all number
    9
    0
    Gastroenteritis viral
         subjects affected / exposed
    4 / 52 (7.69%)
    3 / 48 (6.25%)
         occurrences all number
    4
    5
    Gastroenteritis
         subjects affected / exposed
    6 / 52 (11.54%)
    1 / 48 (2.08%)
         occurrences all number
    7
    2
    Upper respiratory tract infection
         subjects affected / exposed
    18 / 52 (34.62%)
    18 / 48 (37.50%)
         occurrences all number
    33
    49
    Viral upper respiratory tract infection
         subjects affected / exposed
    3 / 52 (5.77%)
    4 / 48 (8.33%)
         occurrences all number
    3
    7

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    24 Apr 2020
    New section and appendix required per protocol template for studies that include laboratory assessments.
    17 Dec 2020
    Clarified inclusion criteria and target population. Added 'clinical laboratory tests' and 'ethical conduct' sections and added Ethics and Regulatory Review at the end of section 7.3. Removed 'placebo' from 'Dose Preparation Steps and Treatment Administration' section as it is not applicable to the study, updated arm description. Removed ‘as needed’ from the visit number description for LRTI and Skin Reactions. Clarified LRTI, added sample storage and destruction details. Clarified that analyses were to be performed using an updated version of the RSV neutralizing antibodies assay previously described. Updates made to clarify Palivizumab use during the study.
    23 Jun 2021
    Pharmacokinetic endpoints revised to include only concentration of nirsevimab. Duration of use for prescription and over-the-counter medications deleted from the description of exploratory objective related to healthcare resource utilization. Additional countries added to study description. Revision of sample size. Addition of interim analysis. Text added that data were to be summarized for the overall study population, as well as for Japan only. Clinical chemistry and hematology removed from visit schedule. Study Visit 3 replaced with telephone call, consecutive visits renumbered appropriately. Estimated volume of blood to be collected was revised. IDMC added, description of hypersensitivity and thrombocytopenia revised to be more specific. Description of Japan-specific regulations removed.

    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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