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    Clinical Trial Results:
    Multi-center, Open-label, Uncontrolled Clinical Study of Palivizumab in Japanese Newborns, Infants and Young Children at the Age of 24 Months or Less with Immunocompromised Medical Conditions

    Summary
    EudraCT number
    2014-004491-31
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    25 Apr 2012

    Results information
    Results version number
    v1(current)
    This version publication date
    20 Apr 2016
    First version publication date
    14 Jun 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    M12-420
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01466062
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    AbbVie
    Sponsor organisation address
    1 North Waukegan Road, North Chicago, IL, United States, 60064
    Public contact
    Global Medical Information, AbbVie, 001 800-633-9110,
    Scientific contact
    Shigeki Hashimoto, AbbVie, shigeki.hashimoto@abbvie.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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    25 Apr 2012
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Apr 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate safety, efficacy and pharmacokinetics of palivizumab in children at the age of 24 months or less with immunocompromised medical conditions.
    Protection of trial subjects
    Participant's parent or legal guardian read and understood information provided about the study and gave written permission.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    22 Aug 2011
    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
    Japan: 28
    Worldwide total number of subjects
    28
    EEA total number of subjects
    0
    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)
    28
    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
    -

    Pre-assignment
    Screening details
    The study included a screening period of 4 weeks.

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

    Arms
    Arm title
    Palivizumab
    Arm description
    15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
    Arm type
    Experimental

    Investigational medicinal product name
    Palivizumab
    Investigational medicinal product code
    Other name
    ABT-315, Synagis
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Palivizumab administered by intramuscular injection

    Number of subjects in period 1
    Palivizumab
    Started
    28
    Completed
    26
    Not completed
    2
         Adverse event
             1
         Consent withdrawn by subject
             1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Palivizumab
    Reporting group description
    15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.

    Reporting group values
    Palivizumab Total
    Number of subjects
    28
    Age categorical
    Units: Subjects
    Age Continuous
    Units: months
        arithmetic mean (standard deviation)
    14.2 ± 6.2 -
    Gender, Male/Female
    Units: participants
        Female
    11 11
        Male
    17 17

    End points

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    End points reporting groups
    Reporting group title
    Palivizumab
    Reporting group description
    15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.

    Primary: Serum Palivizumab Trough Concentrations at Day 1, Day 31, and Day 121

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    End point title
    Serum Palivizumab Trough Concentrations at Day 1, Day 31, and Day 121 [1]
    End point description
    Serum trough concentrations of palivizumab were assessed at Screening, at Day 31 (30 days after the 1st dose) and Day 121 (30 days after the 4th dose). N=number of non-missing observations.
    End point type
    Primary
    End point timeframe
    Day 1 (Screening), Day 31, Day 121
    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: Descriptive data are summarized for this end point per protocol.
    End point values
    Palivizumab
    Number of subjects analysed
    28 [2]
    Units: µg/mL
    arithmetic mean (standard deviation)
        Day 1 (Screening); n=28
    0 ± 0
        Day 31; n=28
    59 ± 12.9
        Day 121; n=26
    91.8 ± 40.6
    Notes
    [2] - All participants
    No statistical analyses for this end point

    Secondary: Percentage of Participants Requiring Hospitalization For Respiratory Syncytial Virus (RSV) Infection

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    End point title
    Percentage of Participants Requiring Hospitalization For Respiratory Syncytial Virus (RSV) Infection
    End point description
    End point type
    Secondary
    End point timeframe
    From the first administration of palivizumab to 30 days after the last administration of palivizumab. Mean (SD) duration of treatment was 183 (37.29) days.
    End point values
    Palivizumab
    Number of subjects analysed
    28 [3]
    Units: percentage of participants
        number (confidence interval 95%)
    0 (0 to 12.3)
    Notes
    [3] - All participants
    No statistical analyses for this end point

    Secondary: Percentage of Participants Who Required Treatment for Respiratory Syncytial Virus (RSV) Infection

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    End point title
    Percentage of Participants Who Required Treatment for Respiratory Syncytial Virus (RSV) Infection
    End point description
    Percentage of participants who required any of the investigated treatments (admission in the intensive care unit [ICU], oxygen supplementation, mechanical ventilation, extracorporeal membrane oxygenation, continuous positive airway pressure and other mechanical respiratory support) for disease caused by RSV infection after the initial dose to 30 days after the last dose of the study drug.
    End point type
    Secondary
    End point timeframe
    From the first administration of palivizumab to 30 days after the last administration of palivizumab. Mean (SD) duration of treatment was 183 (37.29) days.
    End point values
    Palivizumab
    Number of subjects analysed
    28 [4]
    Units: percentage of participants
    number (confidence interval 95%)
        Intensive-care unit
    0 (0 to 12.3)
        Oxygen supplementation
    0 (0 to 12.3)
        Mechanical ventilation
    0 (0 to 12.3)
        Extracorporeal membrane oxygenation
    0 (0 to 12.3)
        Continuous positive airway pressure
    0 (0 to 12.3)
        Other mechanical respiratory support
    0 (0 to 12.3)
    Notes
    [4] - All participants
    No statistical analyses for this end point

    Secondary: Duration of Hospitalization Caused by Respiratory Syncytial Virus (RSV) Infection

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    End point title
    Duration of Hospitalization Caused by Respiratory Syncytial Virus (RSV) Infection
    End point description
    Number of days of hospitalization caused by RSV infection.
    End point type
    Secondary
    End point timeframe
    From the first administration of palivizumab to 30 days after the last administration of palivizumab. Mean (SD) duration of treatment was 183 (37.29) days.
    End point values
    Palivizumab
    Number of subjects analysed
    0 [5]
    Units: days
        number (not applicable)
    Notes
    [5] - No subject had RSV infection from first dose of palivizumab to 30 days after administration
    No statistical analyses for this end point

    Secondary: Duration of Required Treatment for Respiratory Syncytial Virus (RSV) Infection

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    End point title
    Duration of Required Treatment for Respiratory Syncytial Virus (RSV) Infection
    End point description
    Duration (days) of requirement for any of the investigated treatments (admission in the intensive care unit [ICU], oxygen supplementation, mechanical ventilation, extracorporeal membrane oxygenation, continuous positive airway pressure and other mechanical respiratory support) for disease caused by RSV infection after the initial dose to 30 days after the last dose of the study drug.
    End point type
    Secondary
    End point timeframe
    From the first administration of palivizumab to 30 days after the last administration of palivizumab. Mean (SD) duration of treatment was 183 (37.29) days.
    End point values
    Palivizumab
    Number of subjects analysed
    0 [6]
    Units: days
        number (not applicable)
    Notes
    [6] - No subject had RSV infection from first dose of palivizumab to 30 days after administration
    No statistical analyses for this end point

    Secondary: Number of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuations Due to AEs

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    End point title
    Number of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuations Due to AEs
    End point description
    An adverse event (AE) is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with treatment. If an adverse event meets any of the following criteria, it is considered a serious adverse event (SAE): results in death or is life-threatening, results in admission or prolongation of hospitalization, results in congenital anomaly or persistent or significant disability/incapacity, or is an important medical event requiring medical or surgical intervention to prevent serious outcome. AEs were categorized by severity (mild, moderate, severe) and relationship to treatment (probably, possibly, probably not, not related). Please see Adverse Events section below for more details.
    End point type
    Secondary
    End point timeframe
    From the first administration of palivizumab to 100 days after the last administration of palivizumab. Mean (SD) duration of treatment was 183 (37.29) days.
    End point values
    Palivizumab
    Number of subjects analysed
    28 [7]
    Units: participants
    number (not applicable)
        Any AE
    27
        Any AE at least "possibly" drug related
    0
        Any AE at least "probably not" drug related
    7
        Any "severe" AE
    2
        Any SAE
    7
        Any AE leading to discontinuation of study drug
    1
        Any AE leading to death
    0
        Death
    0
    Notes
    [7] - All participants
    No statistical analyses for this end point

    Secondary: Mean Baseline and Mean Change From Baseline in Systolic/Diastolic Blood Pressure at Day 121

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    End point title
    Mean Baseline and Mean Change From Baseline in Systolic/Diastolic Blood Pressure at Day 121
    End point description
    N=number of participants with measurements at given time points.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1), Day 121 (30 days after the 4th dose)
    End point values
    Palivizumab
    Number of subjects analysed
    28 [8]
    Units: mm Hg
    arithmetic mean (standard deviation)
        Baseline Systolic Blood Pressure (SBP); n=26
    96.1 ± 9.44
        Change from Baseline in SBP at Day 121; n=26
    -2.4 ± 10.23
        Baseline Diastolic Blood Pressure (DBP); n=25
    55 ± 9.16
        Change from Baseline in DBP at Day 121; n=25
    3 ± 14.56
    Notes
    [8] - All participants
    No statistical analyses for this end point

    Secondary: Mean Baseline and Mean Change From Baseline in Body Temperature at Day 121

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    End point title
    Mean Baseline and Mean Change From Baseline in Body Temperature at Day 121
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1), Day 121 (30 days after the 4th dose)
    End point values
    Palivizumab
    Number of subjects analysed
    26 [9]
    Units: degrees Celcius
    arithmetic mean (standard deviation)
        Baseline Body Temperature (BT)
    36.77 ± 0.346
        Change from Baseline in BT at Day 12
    -0.11 ± 0.4
    Notes
    [9] - All participants with measurements at given time points
    No statistical analyses for this end point

    Secondary: Mean Baseline and Mean Change From Baseline in Respiratory Rate at Day 121

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    End point title
    Mean Baseline and Mean Change From Baseline in Respiratory Rate at Day 121
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1), Day 121 (30 days after the 4th dose)
    End point values
    Palivizumab
    Number of subjects analysed
    26 [10]
    Units: respirations per minute
    arithmetic mean (standard deviation)
        Baseline Respiratory Rate (RR)
    33.4 ± 8.59
        Change from Baseline in RR at Day 121
    1.5 ± 8.21
    Notes
    [10] - All participants with measurements at given time points
    No statistical analyses for this end point

    Secondary: Mean Baseline and Mean Change From Baseline in Pulse Rate at Day 121

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    End point title
    Mean Baseline and Mean Change From Baseline in Pulse Rate at Day 121
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1), Day 121 (30 days after the 4th dose)
    End point values
    Palivizumab
    Number of subjects analysed
    26 [11]
    Units: beats per minute
    arithmetic mean (standard deviation)
        Baseline Pulse Rate (PR)
    126.6 ± 21.91
        Change from Baseline PR at Day 121
    -6.7 ± 26.66
    Notes
    [11] - All participants with measurements at given time points
    No statistical analyses for this end point

    Secondary: Mean Baseline and Mean Change From Baseline in Body Weight at Day 121

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    End point title
    Mean Baseline and Mean Change From Baseline in Body Weight at Day 121
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1), Day 121 (30 days after the 4th dose)
    End point values
    Palivizumab
    Number of subjects analysed
    26 [12]
    Units: kilograms
    arithmetic mean (standard deviation)
        Baseline Body Weight (BW)
    8.76 ± 1.9
        Change from Baseline in BW at Day 121
    1.23 ± 0.71
    Notes
    [12] - All participants with measurements at given time points
    No statistical analyses for this end point

    Secondary: Hematology: Mean Baseline and Mean Change From Baseline in Hemoglobin at Day 121

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    End point title
    Hematology: Mean Baseline and Mean Change From Baseline in Hemoglobin at Day 121
    End point description
    Normal range for hemoglobin varied by the monthly age of the participant.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1), Day 121 (30 days after the 4th dose)
    End point values
    Palivizumab
    Number of subjects analysed
    25 [13]
    Units: g/dL
    arithmetic mean (standard deviation)
        Baseline Hemoglobin
    11.57 ± 1.56
        Change from Baseline in Hemoglobin at Day 121
    0.14 ± 1.87
    Notes
    [13] - All participants with measurements at given time points
    No statistical analyses for this end point

    Secondary: Hematology: Mean Baseline and Mean Change From Baseline in Hematocrit at Day 121

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    End point title
    Hematology: Mean Baseline and Mean Change From Baseline in Hematocrit at Day 121
    End point description
    Normal range for hematocrit varied by the monthly age of the participant.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1), Day 121 (30 days after the 4th dose)
    End point values
    Palivizumab
    Number of subjects analysed
    25 [14]
    Units: percentage of red blood cells
    arithmetic mean (standard deviation)
        Baseline Hematocrit
    34.32 ± 4.72
        Change from Baseline in Hematocrit at Day 121
    0.96 ± 5.43
    Notes
    [14] - All participants with measurements at given time points
    No statistical analyses for this end point

    Secondary: Hematology: Mean Baseline and Mean Change From Baseline in White Blood Cells (WBC), Neutrophils, Eosinophils, Basophils, Lymphocytes, and Monocytes at Day 121

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    End point title
    Hematology: Mean Baseline and Mean Change From Baseline in White Blood Cells (WBC), Neutrophils, Eosinophils, Basophils, Lymphocytes, and Monocytes at Day 121
    End point description
    Normal ranges for WBC, neutrophils, eosinophils, basophils, lymphocytes, and monocytes varied by the monthly age of the participant.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1), Day 121 (30 days after the 4th dose)
    End point values
    Palivizumab
    Number of subjects analysed
    28 [15]
    Units: cells *10^3/µL
    arithmetic mean (standard deviation)
        Baseline White Blood Cells (WBC); n=25
    6.74 ± 3.93
        Change from Baseline in WBC at Day 121; n=25
    0.24 ± 2.53
        Baseline (BL) Neutrophils; n=24
    2.6 ± 2.17
        Change from BL in Neutrophils at Day 121; n=24
    -0.05 ± 1.6
        Baseline Eosinophils; n=24
    0.25 ± 0.26
        Change from BL in Eosinophils at Day 121; n=24
    0 ± 0.31
        Baseline Basophils; n=24
    0.04 ± 0.05
        Change from Baseline in Basophils at Day 121; n=24
    0.02 ± 0.07
        Baseline Lymphocytes; n=24
    3.36 ± 2.35
        Change from BL in Lymphocytes at Day 121; n=24
    0.31 ± 1.69
        Baseline Monocytes; n=24
    0.51 ± 0.44
        Change from Baseline in Monocytes at Day 121; n=24
    -0.02 ± 0.38
    Notes
    [15] - All participants with measurements at given time points
    No statistical analyses for this end point

    Secondary: Hematology: Mean Baseline and Mean Change From Baseline in Red Blood Cells (RBC) and Platelet Count at Day 121

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    End point title
    Hematology: Mean Baseline and Mean Change From Baseline in Red Blood Cells (RBC) and Platelet Count at Day 121
    End point description
    Normal ranges for RBC and platelet count varied by the monthly age of the participant.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1), Day 121 (30 days after the 4th dose)
    End point values
    Palivizumab
    Number of subjects analysed
    25 [16]
    Units: cells *10^4/µL
    arithmetic mean (standard deviation)
        Baseline Red Blood Cells (RBC)
    410.6 ± 70.83
        Change from Baseline in RBC at Day 121
    22.3 ± 74.74
        Baseline Platelet Count
    31.29 ± 19.8
        Change from Baseline in Platelet Count at Day 121
    1.72 ± 18.35
    Notes
    [16] - All participants with measurements at given time points
    No statistical analyses for this end point

    Secondary: Blood Chemistry: Mean Baseline and Change From Baseline in Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), and Alanine Aminotransferase (ALT) at Day 121

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    End point title
    Blood Chemistry: Mean Baseline and Change From Baseline in Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), and Alanine Aminotransferase (ALT) at Day 121
    End point description
    Normal ranges for ALP, AST, and ALT varied by the monthly age of the participant.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1), Day 121 (30 days after the 4th dose)
    End point values
    Palivizumab
    Number of subjects analysed
    24 [17]
    Units: U/L
    arithmetic mean (standard deviation)
        Baseline ALP
    943 ± 519.1
        Change from Baseline in ALP at Day 121
    -18 ± 368.35
        Baseline AST
    39.08 ± 12.95
        Change from Baseline in AST at Day 121
    1.54 ± 8.09
        Baseline ALT
    31.13 ± 25.7
        Change from Baseline in ALT at Day 121
    -3.17 ± 14.07
    Notes
    [17] - All participants with measurements at given time points
    No statistical analyses for this end point

    Secondary: Blood Chemistry: Mean Baseline and Change From Baseline in Total Bilirubin, Blood Urea Nitrogen (BUN), Creatinine, and C-reactive Protein (CRP) at Day 121

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    End point title
    Blood Chemistry: Mean Baseline and Change From Baseline in Total Bilirubin, Blood Urea Nitrogen (BUN), Creatinine, and C-reactive Protein (CRP) at Day 121
    End point description
    Normal ranges for total bilirubin, BUN, creatinine, and CRP varied by the monthly age of the participant.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1), Day 121 (30 days after the 4th dose)
    End point values
    Palivizumab
    Number of subjects analysed
    24 [18]
    Units: mg/dL
    arithmetic mean (standard deviation)
        Baseline Total Bilirubin
    0.3 ± 0.14
        Change from Baseline in Total Bilirubin at Day 121
    0.04 ± 0.15
        Baseline BUN
    11.46 ± 4.52
        Change from Baseline in BUN at Day 121
    0.87 ± 4.64
        Baseline Creatinine
    0.23 ± 0.04
        Change from Baseline in Creatinine at Day 121
    0.01 ± 0.04
        Baseline CRP
    0.29 ± 0.42
        Change from Baseline in CRP at Day 121
    0.03 ± 0.62
    Notes
    [18] - All participants with measurements at given time points
    No statistical analyses for this end point

    Secondary: Urinalysis: Presence of Urine Protein, Glucose, and Occult Blood at Screening and Day 121

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    End point title
    Urinalysis: Presence of Urine Protein, Glucose, and Occult Blood at Screening and Day 121
    End point description
    The values -, -/+, 1+, 2+, 3+, and 4+ represent a range from none (-) to highest (4+) presence of protein, glucose, and occult blood in the urine. Table presents the number of participants with each value. Those categories with 0 participants to report at either time point are not included in the table below.
    End point type
    Secondary
    End point timeframe
    Screening, Day 121 (30 days after the 4th dose)
    End point values
    Palivizumab
    Number of subjects analysed
    28 [19]
    Units: participants
    number (not applicable)
        Protein "-" at Screening; n=24
    21
        Protein "+/-" at Screening; n=24
    3
        Protein "-" at Day 121; n=22
    21
        Protein "+/-" at Day 121; n=22
    1
        Glucose "-" at Screening; n=24
    24
        Glucose "-" at Day 121; n=22
    22
        Occult Blood "-" at Screening; n=24
    21
        Occult Blood "+/-" at Screening; n=24
    2
        Occult Blood "1+" at Screening; n=24
    1
        Occult Blood "-" at Day 121; n=22
    21
        Occult Blood "+/-" at Day 121; n=22
    0
        Occult Blood "1+" at Day 121; n=22
    1
    Notes
    [19] - All participants with measurements at given time points
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AEs:from time of initial study drug administration (Day 1) to 100 days after final administration of the study drug. SAEs:from screening period until 100 days after final administration of study drug. Mean (SD) duration of treatment was 183 (37.29) days.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    14.1
    Reporting groups
    Reporting group title
    Palivizumab
    Reporting group description
    15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.

    Serious adverse events
    Palivizumab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 28 (25.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Nervous system disorders
    Encephalopathy
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Duodenal stenosis
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Enterocolitis
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal perforation
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Croup infectious
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Bronchitis
         subjects affected / exposed
    2 / 28 (7.14%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Pneumonia bacterial
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Peritonitis
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    3 / 28 (10.71%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Palivizumab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    26 / 28 (92.86%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Skin papilloma
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences all number
    3
    Immune system disorders
    Hypogammaglobulinaemia
         subjects affected / exposed
    4 / 28 (14.29%)
         occurrences all number
    8
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences all number
    1
    Injury, poisoning and procedural complications
    Arthropod sting
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences all number
    1
    Contusion
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences all number
    1
    Subcutaneous haematoma
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences all number
    1
    Thermal burn
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences all number
    1
    Investigations
    Neutrophil count decreased
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences all number
    1
    Bacterial test positive
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences all number
    1
    Antithrombin III decreased
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences all number
    1
    White blood cells urine positive
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences all number
    1
    Congenital, familial and genetic disorders
    Antithrombin III deficiency
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences all number
    1
    Rhinorrhoea
         subjects affected / exposed
    2 / 28 (7.14%)
         occurrences all number
    2
    Respiratory depression
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences all number
    1
    Bronchitis chronic
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Hypercoagulation
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences all number
    2
    Febrile neutropenia
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences all number
    1
    Iron deficiency anaemia
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences all number
    1
    Thrombocytopenia
         subjects affected / exposed
    4 / 28 (14.29%)
         occurrences all number
    10
    Leukopenia
         subjects affected / exposed
    3 / 28 (10.71%)
         occurrences all number
    23
    Anaemia
         subjects affected / exposed
    4 / 28 (14.29%)
         occurrences all number
    18
    Nervous system disorders
    Febrile convulsion
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences all number
    2
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    2 / 28 (7.14%)
         occurrences all number
    2
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    2 / 28 (7.14%)
         occurrences all number
    2
    Enterocolitis
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences all number
    1
    Dyspepsia
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences all number
    1
    Rectal prolapse
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences all number
    1
    Constipation
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences all number
    1
    Renal and urinary disorders
    Azotaemia
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences all number
    1
    Hepatobiliary disorders
    Hepatic function abnormal
         subjects affected / exposed
    4 / 28 (14.29%)
         occurrences all number
    5
    Skin and subcutaneous tissue disorders
    Dermatitis atopic
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences all number
    1
    Dermatitis diaper
         subjects affected / exposed
    5 / 28 (17.86%)
         occurrences all number
    5
    Dermatitis contact
         subjects affected / exposed
    2 / 28 (7.14%)
         occurrences all number
    3
    Eczema
         subjects affected / exposed
    6 / 28 (21.43%)
         occurrences all number
    6
    Eczema asteatotic
         subjects affected / exposed
    3 / 28 (10.71%)
         occurrences all number
    3
    Dry skin
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences all number
    1
    Eczema infantile
         subjects affected / exposed
    3 / 28 (10.71%)
         occurrences all number
    3
    Hyperkeratosis palmaris and plantaris
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences all number
    1
    Rash
         subjects affected / exposed
    5 / 28 (17.86%)
         occurrences all number
    6
    Musculoskeletal and connective tissue disorders
    Muscular weakness
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Hypoalbuminaemia
         subjects affected / exposed
    2 / 28 (7.14%)
         occurrences all number
    2
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    2 / 28 (7.14%)
         occurrences all number
    2
    Conjunctivitis infective
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences all number
    1
    Gastroenteritis viral
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences all number
    1
    Cystitis
         subjects affected / exposed
    2 / 28 (7.14%)
         occurrences all number
    2
    Exanthema subitum
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences all number
    2
    Gastroenteritis
         subjects affected / exposed
    6 / 28 (21.43%)
         occurrences all number
    8
    Molluscum contagiosum
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences all number
    1
    Influenza
         subjects affected / exposed
    6 / 28 (21.43%)
         occurrences all number
    7
    Impetigo
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences all number
    1
    Nasopharyngitis
         subjects affected / exposed
    4 / 28 (14.29%)
         occurrences all number
    4
    Otitis media acute
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences all number
    1
    Otitis media
         subjects affected / exposed
    2 / 28 (7.14%)
         occurrences all number
    2
    Pharyngitis
         subjects affected / exposed
    3 / 28 (10.71%)
         occurrences all number
    4
    Pseudomonas infection
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences all number
    1
    Respiratory tract infection
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences all number
    2
    Sinusitis
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences all number
    1
    Rhinitis
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences all number
    1
    Rotavirus infection
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences all number
    1
    Tinea cruris
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences all number
    1
    Tonsillitis
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences all number
    1
    Upper respiratory tract infection
         subjects affected / exposed
    7 / 28 (25.00%)
         occurrences all number
    16
    Viral infection
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences all number
    1
    Upper respiratory tract infection bacterial
         subjects affected / exposed
    1 / 28 (3.57%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    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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