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    Clinical Trial Results:
    A Phase 3 Study of MEDI-524 (Motavizumab), an Enhanced Potency Humanized Respiratory Syncytial Virus (RSV) Monoclonal Antibody, for the Prevention of RSV Disease Among Native American Infants in the Southwestern United States

    Summary
    EudraCT number
    2012-000825-33
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    27 Dec 2010

    Results information
    Results version number
    v1(current)
    This version publication date
    10 Feb 2016
    First version publication date
    10 Feb 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MI-CP117
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00121108
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    MedImmune LLC
    Sponsor organisation address
    One MedImmune Way, Gaithersburg, United States, MD 20878
    Public contact
    Hasan S Jafri, MD, MedImmune LLC, clinicaltrialenquiries@medimmune.com
    Scientific contact
    Hasan S Jafri, MD, MedImmune LLC, clinicaltrialenquiries@medimmune.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    EMEA-000352-PIP01-08
    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
    27 Dec 2010
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Dec 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study was to assess the safety and efficacy of motavizumab compared to placebo when administered monthly by intramuscular (IM) injection for the reduction of the incidence of respiratory syncytial virus (RSV) hospitalization among otherwise healthy Native American infants during their first RSV season.
    Protection of trial subjects
    The conduct of this clinical study met all local legal and regulatory requirements. The study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and the International Conference on Harmonization guideline E6: Good Clinical Practice. Participating participant signed informed consent form and could withdraw from the study at any time without any disadvantage and without having to provide a reason for this decision. Only investigators qualified by training and experience were selected as appropriate experts to investigate the study drug.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    15 Nov 2004
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Efficacy
    Long term follow-up duration
    3 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 2127
    Worldwide total number of subjects
    2127
    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)
    841
    Infants and toddlers (28 days-23 months)
    1286
    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
    A total of 2127 participants (710 placebo, 1417 motavizumab) were randomized at 11 sites in the southwestern United States. The number of subjects randomized ranged from 11 to 511 participants per site. Four sites randomized less than 100 participants.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo
    Arm description
    Placebo of comparable volume to motavizumab given at 15 milligram per kilogram (mg/kg) administered intramuscularly every 30 days for a maximum of 5 injections during the respiratory syncytial virus (RSV) season.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Placebo of comparable volume to motavizumab given at 15 mg/kg administered intramuscularly every 30 days for a maximum of 5 injections during the RSV season.

    Arm title
    Motavizumab
    Arm description
    Motavizumab 15 mg/kg administered intramuscularly every 30 days for a maximum of 5 injections during the RSV season.
    Arm type
    Experimental

    Investigational medicinal product name
    Motavizumab
    Investigational medicinal product code
    MEDI-524
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Motavizumab 15 mg/kg administered intramuscularly every 30 days for a maximum of 5 injections during the RSV season.

    Number of subjects in period 1
    Placebo Motavizumab
    Started
    710
    1417
    Completed
    589
    1192
    Not completed
    121
    225
         Adverse event, serious fatal
    5
    8
         Consent withdrawn by subject
    106
    195
         Lost to follow-up
    10
    22

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Placebo of comparable volume to motavizumab given at 15 milligram per kilogram (mg/kg) administered intramuscularly every 30 days for a maximum of 5 injections during the respiratory syncytial virus (RSV) season.

    Reporting group title
    Motavizumab
    Reporting group description
    Motavizumab 15 mg/kg administered intramuscularly every 30 days for a maximum of 5 injections during the RSV season.

    Reporting group values
    Placebo Motavizumab Total
    Number of subjects
    710 1417 2127
    Age categorical
    Units: Subjects
    Age Continuous |
    Units: months
        arithmetic mean (standard deviation)
    2.13 ± 1.89 2.08 ± 1.92 -
    Gender, Male/Female
    Units: Participants
        Male
    367 707 1074
        Female
    343 710 1053

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Placebo of comparable volume to motavizumab given at 15 milligram per kilogram (mg/kg) administered intramuscularly every 30 days for a maximum of 5 injections during the respiratory syncytial virus (RSV) season.

    Reporting group title
    Motavizumab
    Reporting group description
    Motavizumab 15 mg/kg administered intramuscularly every 30 days for a maximum of 5 injections during the RSV season.

    Subject analysis set title
    Intent-to-treat (ITT) population analysis: Placebo
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Placebo of comparable volume to motavizumab given at 15 mg/kg administered intramuscularly every 30 days for a maximum of 5 injections during the RSV season. For ITT analyses, the study start (Day 0) was defined as the day of randomization.

    Subject analysis set title
    ITT Population Analysis: Motavizumab
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Motavizumab 15 mg/kg administered intramuscularly every 30 days for a maximum of 5 injections during the RSV season. For ITT analyses, the study start (Day 0) was defined as the day of randomization.

    Subject analysis set title
    Safety Analysis: Placebo
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Placebo of comparable volume to motavizumab given at 15 mg/kg administered intramuscularly every 30 days for a maximum of 5 injections during the RSV season.

    Subject analysis set title
    Safety Analysis: Motavizumab
    Subject analysis set type
    Safety analysis
    Subject analysis set description
    Motavizumab 15 mg/kg administered intramuscularly every 30 days for a maximum of 5 injections during the RSV season.

    Subject analysis set title
    Evaluable Population for Any Dose ADA
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Evaluable population for any dose anti-drug antibody (ADA) included participants who received at least 1 dose of motavizumab prior to the collection of ADA sample. Participants who received any motavizumab were counted in the motavizumab group. Only ADA samples collected after the receipt of motavizumab were included in the analysis.

    Subject analysis set title
    Evaluable Population for PK: Baseline
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Evaluable population for pharmacokinetic (PK) defined as participants in Seasons 1-3 who were randomized to receive motavizumab, received at least 4 doses. For PK analyses, the study start (Day 0) was defined as the day of the first dose of study product.

    Subject analysis set title
    Evaluable Population for PK
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Evaluable population for PK defined as participants (in Seasons 1 through 3) who were randomized to receive motavizumab, received at least 4 doses, and had a post-baseline PK measurement available.

    Primary: Number of Participants Hospitalized With RSV

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    End point title
    Number of Participants Hospitalized With RSV
    End point description
    Respiratory hospitalizations with a positive result for real-time reverse transcriptase-polymerase chain reaction (RT-PCR) RSV diagnostic test performed on samples collected within 3 days before or after hospital admission (or date of deterioration, for nosocomial respiratory hospitalizations) were counted in the primary analysis as RSV hospitalizations. Participants were included in the treatment group corresponding to their randomized treatment group. For ITT analyses, the study start (Day 0) was defined as the day of randomization.
    End point type
    Primary
    End point timeframe
    Day 0 through Day 150
    End point values
    Placebo Motavizumab
    Number of subjects analysed
    710
    1417
    Units: participants
    80
    21
    Statistical analysis title
    Statistical analysis title 1
    Comparison groups
    Placebo v Motavizumab
    Number of subjects included in analysis
    2127
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    Fisher exact
    Parameter type
    Relative risk
    Point estimate
    0.13
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.08
         upper limit
    0.21

    Secondary: Number of Participants With an Outpatient Medically Attended Lower Respiratory Illness (MA-LRI) that was Positive for RSV in Seasons 1-4

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    End point title
    Number of Participants With an Outpatient Medically Attended Lower Respiratory Illness (MA-LRI) that was Positive for RSV in Seasons 1-4
    End point description
    An RSV outpatient MA-LRI was defined as an outpatient medically attended event designated by the investigator as a lower respiratory illness with a positive RSV RT-PCR performed in the central laboratory. Participants were included in the treatment group corresponding to their randomized treatment group. For ITT analyses, the study start (Day 0) was defined as the day of randomization.
    End point type
    Secondary
    End point timeframe
    Day 0 through Day 150
    End point values
    Placebo Motavizumab
    Number of subjects analysed
    710
    1417
    Units: participants
    71
    41
    Statistical analysis title
    Statistical analysis title 1
    Comparison groups
    Placebo v Motavizumab
    Number of subjects included in analysis
    2127
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    < 0.001
    Method
    Fisher exact
    Parameter type
    Relative risk
    Point estimate
    0.29
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.2
         upper limit
    0.42

    Secondary: Number of Participants with Medically Attended Otitis Media (OM) in Seasons 1-4

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    End point title
    Number of Participants with Medically Attended Otitis Media (OM) in Seasons 1-4
    End point description
    Number of participants with any diagnosis of otitis media (OM; including events with only red tympanic membrane and events with perforation or middle ear effusion). Participants were included in the treatment group corresponding to their randomized treatment group. For ITT analyses, the study start (Day 0) was defined as the day of randomization.
    End point type
    Secondary
    End point timeframe
    Day 0 through Day 150
    End point values
    Placebo Motavizumab
    Number of subjects analysed
    710
    1417
    Units: participants
    275
    532
    No statistical analyses for this end point

    Secondary: Frequency of Participants with Events of Medically Attended Otitis Media (MA-OM)

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    End point title
    Frequency of Participants with Events of Medically Attended Otitis Media (MA-OM)
    End point description
    A new onset of medically attended OM is defined as a physician-diagnosed OM in either ear after a normal middle ear exam or an episode of acute OM => 21 days after the onset date of the previous episode. Participants were included in the treatment group corresponding to their randomized treatment group. For ITT analyses, the study start (Day 0) was defined as the day of randomization.
    End point type
    Secondary
    End point timeframe
    Seasons 1-4
    End point values
    Placebo Motavizumab
    Number of subjects analysed
    710
    1417
    Units: participants
        MA-OM: 0
    435
    885
        MA-OM: 1
    190
    372
        MA-OM: 2
    55
    114
        MA-OM: 3
    26
    32
        MA-OM: >3
    4
    14
    Statistical analysis title
    Statistical analysis title 1
    Comparison groups
    Placebo v Motavizumab
    Number of subjects included in analysis
    2127
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.521
    Method
    Cochran-Mantel-Haenszel
    Confidence interval

    Secondary: Frequency of Participants with Medically Attended (MA) Wheezing Events

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    End point title
    Frequency of Participants with Medically Attended (MA) Wheezing Events
    End point description
    New wheezing episodes were recorded as those that occurred >2 weeks after the diagnosis of the previous episode and the medical opinion of the investigator was that the wheezing did not represent a persistence of the previous episode. Participants were included in the treatment group corresponding to their randomized treatment group. For ITT analyses, the study start (Day 0) was defined as the day of randomization.
    End point type
    Secondary
    End point timeframe
    Randomization to 3 years old
    End point values
    Placebo Motavizumab
    Number of subjects analysed
    710
    1417
    Units: participants
        MA-wheezing: 0
    384
    908
        MA-wheezing: 1
    182
    288
        MA-wheezing: 2
    72
    109
        MA-wheezing: 3
    34
    44
        MA-wheezing: 4
    18
    27
        MA-wheezing: >=5
    20
    41
    No statistical analyses for this end point

    Secondary: Number of Participants with Anti-Motavizumab Antibodies (Seasons 1-3)

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    End point title
    Number of Participants with Anti-Motavizumab Antibodies (Seasons 1-3)
    End point description
    Serum samples with a titer >= 1:30 were considered to be positive for anti-motavizumab antibodies. If the Day 120 sample was positive for anti-motavizumab antibodies, the sample taken prior to Dose 1 was screened for anti-motavizumab antibodies and a confirmatory test was performed on the Day 120 sample. None of the pre-Dose 1 samples were positive for anti-motavizumab antibodies. Results for participants who received any motavizumab were presented.
    End point type
    Secondary
    End point timeframe
    Day 120
    End point values
    Evaluable Population for Any Dose ADA
    Number of subjects analysed
    722
    Units: participants
    3
    No statistical analyses for this end point

    Secondary: Baseline Serum Concentration of Motavizumab Determined in Participants Enrolled in Seasons 1-3

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    End point title
    Baseline Serum Concentration of Motavizumab Determined in Participants Enrolled in Seasons 1-3
    End point description
    Participants with a serum concentration < limit of quantitation (LOQ) (LOQ = 1.56 microgram per milliliter [mcg/mL]) at a time point were assigned a value of zero for that time point in the summaries. No imputations were done for missing data. Participants in Seasons 1-3 who were randomized to receive motavizumab, received at least 4 doses, and had a post-baseline pharmacokinetic (PK) measurement available. Results for participants who received any motavizumab were presented.
    End point type
    Secondary
    End point timeframe
    Day 0
    End point values
    Evaluable Population for PK: Baseline
    Number of subjects analysed
    495
    Units: microgram per milliliter
        arithmetic mean (standard deviation)
    0.003212 ± 0.07147
    No statistical analyses for this end point

    Secondary: Incidence of Participants with Medically Attended (MA) Wheezing Events

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    End point title
    Incidence of Participants with Medically Attended (MA) Wheezing Events
    End point description
    New wheezing episodes were recorded as those that occurred >2 weeks after the diagnosis of the previous episode and the medical opinion of the investigator was that the wheezing did not represent a persistence of the previous episode. Participants were included in the treatment group corresponding to their randomized treatment group. Medically attended wheezing events were analyzed using >=1 MA wheezing events and >=3 MA wheezing events over a 12 month period. For ITT analyses, the study start (Day 0) was defined as the day of randomization.
    End point type
    Secondary
    End point timeframe
    Randomization to third birthday
    End point values
    Placebo Motavizumab
    Number of subjects analysed
    710
    1417
    Units: participants
        >=1 MA Wheezing: Randomization - 3 year old
    326
    509
        >=1 MA Wheezing: >study day 150 - 3 year old
    207
    383
        >=1 MA Wheezing: 1 - 3 year old
    179
    342
        >=1 MA Wheezing: 1 - <2 year old
    136
    278
        >=1 MA Wheezing: 2 - 3 year old
    77
    143
        >=3 MA Wheezing: Randomization - 3 year old
    51
    83
        >=3 MA Wheezing: >study day 150 - 3 year old
    27
    51
        >=3 MA Wheezing: 1 - 3 year old
    16
    35
        >=3 MA Wheezing: 1 - <2 year old
    10
    20
        >=3 MA Wheezing: 2 - 3 year old
    4
    12
    No statistical analyses for this end point

    Secondary: Trough Serum Concentration of Motavizumab Determined in Participants Enrolled in Seasons 1-3

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    End point title
    Trough Serum Concentration of Motavizumab Determined in Participants Enrolled in Seasons 1-3
    End point description
    Participants with a serum concentration < LOQ (LOQ = 1.56 mcg/mL) at a time point were assigned a value of zero for that time point in the summaries. No imputations were done for missing data. Results for participants who received any motavizumab were presented.
    End point type
    Secondary
    End point timeframe
    30 days post Dose 4
    End point values
    Evaluable Population for PK
    Number of subjects analysed
    509
    Units: mcg/mL
        arithmetic mean (standard deviation)
    86.46 ± 31.77
    No statistical analyses for this end point

    Secondary: Incidence of Participants with Serious Early Childhood Wheezing (SECW) Events

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    End point title
    Incidence of Participants with Serious Early Childhood Wheezing (SECW) Events
    End point description
    Serious early childhood wheezing was defined as: a)Three or more medically attended wheezing events over a 12 month period occurring any time from the first through the third birthday, or b) A need for one or more courses of systemic steroids for a treatment of a medically attended wheezing event from the first through the third birthday, or c) A need for asthma-controller medication over a 12 month period for at least 3 consecutive months (>= 90 days) or 5 cumulative months (>=150 days) any time from the first through the third birthday, or d) At least one inpatient wheezing event from the first through the third birthday. For ITT analyses, the study start (Day 0) was defined as the day of randomization.
    End point type
    Secondary
    End point timeframe
    Randomization to third birthday
    End point values
    Placebo Motavizumab
    Number of subjects analysed
    710
    1417
    Units: participants
        SECW: 1st through 3 year
    90
    190
        SECW: 1st up to 2 year
    69
    143
        SECW: 2nd through 3 year
    35
    79
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Day 0 - Day 150
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    11.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Placebo of comparable volume to motavizumab given at 15 milligram per kilogram (mg/kg) administered intramuscularly every 30 days for a maximum of 5 injections during the respiratory syncytial virus (RSV) season.

    Reporting group title
    Motavizumab
    Reporting group description
    Motavizumab 15 mg/kg administered intramuscularly every 30 days for a maximum of 5 injections during the RSV season.

    Serious adverse events
    Placebo Motavizumab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    148 / 708 (20.90%)
    212 / 1414 (14.99%)
         number of deaths (all causes)
    2
    4
         number of deaths resulting from adverse events
    0
    0
    Vascular disorders
    Vena cava thrombosis
         subjects affected / exposed
    0 / 708 (0.00%)
    1 / 1414 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Drug hypersensitivity
         subjects affected / exposed
    0 / 708 (0.00%)
    1 / 1414 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypersensitivity
         subjects affected / exposed
    0 / 708 (0.00%)
    4 / 1414 (0.28%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Milk allergy
         subjects affected / exposed
    0 / 708 (0.00%)
    1 / 1414 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Social circumstances
    Victim of child abuse
         subjects affected / exposed
    0 / 708 (0.00%)
    1 / 1414 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Jaundice neonatal
         subjects affected / exposed
    0 / 708 (0.00%)
    1 / 1414 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Fever neonatal
         subjects affected / exposed
    4 / 708 (0.56%)
    10 / 1414 (0.71%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    3 / 708 (0.42%)
    8 / 1414 (0.57%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Head injury
         subjects affected / exposed
    0 / 708 (0.00%)
    3 / 1414 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Postoperative fever
         subjects affected / exposed
    0 / 708 (0.00%)
    1 / 1414 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skull fracture
         subjects affected / exposed
    0 / 708 (0.00%)
    1 / 1414 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thermal burn
         subjects affected / exposed
    0 / 708 (0.00%)
    2 / 1414 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Bacterial test
         subjects affected / exposed
    0 / 708 (0.00%)
    1 / 1414 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood culture positive
         subjects affected / exposed
    1 / 708 (0.14%)
    0 / 1414 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laboratory test interference
         subjects affected / exposed
    1 / 708 (0.14%)
    0 / 1414 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Medical observation
         subjects affected / exposed
    2 / 708 (0.28%)
    0 / 1414 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Congenital, familial and genetic disorders
    Benign familial neonatal convulsions
         subjects affected / exposed
    0 / 708 (0.00%)
    1 / 1414 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Combined immunodeficiency
         subjects affected / exposed
    0 / 708 (0.00%)
    1 / 1414 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fallot's tetralogy
         subjects affected / exposed
    0 / 708 (0.00%)
    1 / 1414 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Microvillous inclusion disease
         subjects affected / exposed
    0 / 708 (0.00%)
    1 / 1414 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asphyxia
         subjects affected / exposed
    1 / 708 (0.14%)
    0 / 1414 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Asthma
         subjects affected / exposed
    0 / 708 (0.00%)
    3 / 1414 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchial hyperreactivity
         subjects affected / exposed
    2 / 708 (0.28%)
    0 / 1414 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cough
         subjects affected / exposed
    0 / 708 (0.00%)
    1 / 1414 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonitis
         subjects affected / exposed
    3 / 708 (0.42%)
    2 / 1414 (0.14%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Convulsion
         subjects affected / exposed
    2 / 708 (0.28%)
    5 / 1414 (0.35%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyskinesia
         subjects affected / exposed
    1 / 708 (0.14%)
    0 / 1414 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile convulsion
         subjects affected / exposed
    1 / 708 (0.14%)
    1 / 1414 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoxic encephalopathy
         subjects affected / exposed
    0 / 708 (0.00%)
    1 / 1414 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subdural hygroma
         subjects affected / exposed
    0 / 708 (0.00%)
    1 / 1414 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    1 / 708 (0.14%)
    0 / 1414 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    0 / 708 (0.00%)
    2 / 1414 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stomatitis
         subjects affected / exposed
    0 / 708 (0.00%)
    1 / 1414 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hyperbilirubinaemia
         subjects affected / exposed
    6 / 708 (0.85%)
    10 / 1414 (0.71%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperbilirubinaemia neonatal
         subjects affected / exposed
    1 / 708 (0.14%)
    0 / 1414 (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 / 708 (0.28%)
    1 / 1414 (0.07%)
         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 / 708 (0.00%)
    1 / 1414 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erythema
         subjects affected / exposed
    0 / 708 (0.00%)
    1 / 1414 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erythema multiforme
         subjects affected / exposed
    0 / 708 (0.00%)
    1 / 1414 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urticaria
         subjects affected / exposed
    0 / 708 (0.00%)
    1 / 1414 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Craniosynostosis
         subjects affected / exposed
    0 / 708 (0.00%)
    1 / 1414 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscle twitching
         subjects affected / exposed
    0 / 708 (0.00%)
    1 / 1414 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Synostosis
         subjects affected / exposed
    0 / 708 (0.00%)
    1 / 1414 (0.07%)
         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
    1 / 708 (0.14%)
    2 / 1414 (0.14%)
         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 / 708 (0.28%)
    1 / 1414 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Bacterial pyelonephritis
         subjects affected / exposed
    3 / 708 (0.42%)
    3 / 1414 (0.21%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchiolitis
         subjects affected / exposed
    35 / 708 (4.94%)
    29 / 1414 (2.05%)
         occurrences causally related to treatment / all
    0 / 36
    0 / 32
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    1 / 708 (0.14%)
    3 / 1414 (0.21%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchopneumonia
         subjects affected / exposed
    0 / 708 (0.00%)
    1 / 1414 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 708 (0.00%)
    2 / 1414 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Croup infectious
         subjects affected / exposed
    1 / 708 (0.14%)
    2 / 1414 (0.14%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia urinary tract infection
         subjects affected / exposed
    0 / 708 (0.00%)
    2 / 1414 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    16 / 708 (2.26%)
    31 / 1414 (2.19%)
         occurrences causally related to treatment / all
    0 / 16
    0 / 32
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Gastroenteritis rotavirus
         subjects affected / exposed
    0 / 708 (0.00%)
    3 / 1414 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    0 / 708 (0.00%)
    5 / 1414 (0.35%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Groin abscess
         subjects affected / exposed
    1 / 708 (0.14%)
    0 / 1414 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    1 / 708 (0.14%)
    3 / 1414 (0.21%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Klebsiella sepsis
         subjects affected / exposed
    0 / 708 (0.00%)
    1 / 1414 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Lobar pneumonia
         subjects affected / exposed
    3 / 708 (0.42%)
    5 / 1414 (0.35%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    4 / 708 (0.56%)
    8 / 1414 (0.57%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 9
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection viral
         subjects affected / exposed
    1 / 708 (0.14%)
    0 / 1414 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis candida
         subjects affected / exposed
    0 / 708 (0.00%)
    1 / 1414 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis pneumococcal
         subjects affected / exposed
    0 / 708 (0.00%)
    1 / 1414 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nasopharyngitis
         subjects affected / exposed
    0 / 708 (0.00%)
    1 / 1414 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oral herpes
         subjects affected / exposed
    0 / 708 (0.00%)
    1 / 1414 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Perineal abscess
         subjects affected / exposed
    0 / 708 (0.00%)
    1 / 1414 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    20 / 708 (2.82%)
    36 / 1414 (2.55%)
         occurrences causally related to treatment / all
    0 / 21
    0 / 39
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia bacterial
         subjects affected / exposed
    1 / 708 (0.14%)
    0 / 1414 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia haemophilus
         subjects affected / exposed
    0 / 708 (0.00%)
    2 / 1414 (0.14%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia influenzal
         subjects affected / exposed
    2 / 708 (0.28%)
    3 / 1414 (0.21%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia pneumococcal
         subjects affected / exposed
    0 / 708 (0.00%)
    1 / 1414 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia respiratory syncytial viral
         subjects affected / exposed
    6 / 708 (0.85%)
    1 / 1414 (0.07%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia viral
         subjects affected / exposed
    0 / 708 (0.00%)
    1 / 1414 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    2 / 708 (0.28%)
    4 / 1414 (0.28%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory syncytial virus bronchiolitis
         subjects affected / exposed
    39 / 708 (5.51%)
    16 / 1414 (1.13%)
         occurrences causally related to treatment / all
    0 / 40
    0 / 17
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory syncytial virus infection
         subjects affected / exposed
    4 / 708 (0.56%)
    3 / 1414 (0.21%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    0 / 708 (0.00%)
    1 / 1414 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 708 (0.14%)
    7 / 1414 (0.50%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 708 (0.00%)
    3 / 1414 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection bacterial
         subjects affected / exposed
    0 / 708 (0.00%)
    1 / 1414 (0.07%)
         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
    6 / 708 (0.85%)
    5 / 1414 (0.35%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral pharyngitis
         subjects affected / exposed
    0 / 708 (0.00%)
    1 / 1414 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral upper respiratory tract infection
         subjects affected / exposed
    1 / 708 (0.14%)
    1 / 1414 (0.07%)
         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: 1%
    Non-serious adverse events
    Placebo Motavizumab
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    685 / 708 (96.75%)
    1354 / 1414 (95.76%)
    Investigations
    Cardiac murmur
         subjects affected / exposed
    12 / 708 (1.69%)
    35 / 1414 (2.48%)
         occurrences all number
    12
    35
    Congenital, familial and genetic disorders
    Dacryostenosis congenital
         subjects affected / exposed
    4 / 708 (0.56%)
    23 / 1414 (1.63%)
         occurrences all number
    4
    24
    Respiratory, thoracic and mediastinal disorders
    Bronchial hyperreactivity
         subjects affected / exposed
    12 / 708 (1.69%)
    18 / 1414 (1.27%)
         occurrences all number
    13
    19
    Respiratory disorder
         subjects affected / exposed
    47 / 708 (6.64%)
    93 / 1414 (6.58%)
         occurrences all number
    49
    104
    Cough
         subjects affected / exposed
    65 / 708 (9.18%)
    149 / 1414 (10.54%)
         occurrences all number
    70
    171
    Nasal congestion
         subjects affected / exposed
    55 / 708 (7.77%)
    128 / 1414 (9.05%)
         occurrences all number
    58
    140
    Rhinorrhoea
         subjects affected / exposed
    71 / 708 (10.03%)
    118 / 1414 (8.35%)
         occurrences all number
    77
    123
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    137 / 708 (19.35%)
    271 / 1414 (19.17%)
         occurrences all number
    153
    303
    Eye discharge
         subjects affected / exposed
    12 / 708 (1.69%)
    21 / 1414 (1.49%)
         occurrences all number
    12
    21
    General disorders and administration site conditions
    Irritability
         subjects affected / exposed
    19 / 708 (2.68%)
    33 / 1414 (2.33%)
         occurrences all number
    20
    33
    Pyrexia
         subjects affected / exposed
    161 / 708 (22.74%)
    307 / 1414 (21.71%)
         occurrences all number
    195
    364
    Ear and labyrinth disorders
    Cerumen impaction
         subjects affected / exposed
    40 / 708 (5.65%)
    81 / 1414 (5.73%)
         occurrences all number
    41
    94
    Ear pain
         subjects affected / exposed
    8 / 708 (1.13%)
    24 / 1414 (1.70%)
         occurrences all number
    8
    24
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    57 / 708 (8.05%)
    97 / 1414 (6.86%)
         occurrences all number
    61
    107
    Abdominal pain
         subjects affected / exposed
    13 / 708 (1.84%)
    26 / 1414 (1.84%)
         occurrences all number
    13
    26
    Diarrhoea
         subjects affected / exposed
    106 / 708 (14.97%)
    196 / 1414 (13.86%)
         occurrences all number
    130
    230
    Enteritis
         subjects affected / exposed
    4 / 708 (0.56%)
    17 / 1414 (1.20%)
         occurrences all number
    4
    17
    Gastrooesophageal reflux disease
         subjects affected / exposed
    10 / 708 (1.41%)
    19 / 1414 (1.34%)
         occurrences all number
    10
    19
    Teething
         subjects affected / exposed
    86 / 708 (12.15%)
    167 / 1414 (11.81%)
         occurrences all number
    96
    178
    Vomiting
         subjects affected / exposed
    23 / 708 (3.25%)
    49 / 1414 (3.47%)
         occurrences all number
    24
    50
    Hepatobiliary disorders
    Jaundice
         subjects affected / exposed
    31 / 708 (4.38%)
    45 / 1414 (3.18%)
         occurrences all number
    31
    46
    Skin and subcutaneous tissue disorders
    Dermatitis
         subjects affected / exposed
    20 / 708 (2.82%)
    39 / 1414 (2.76%)
         occurrences all number
    21
    39
    Dermatitis atopic
         subjects affected / exposed
    21 / 708 (2.97%)
    24 / 1414 (1.70%)
         occurrences all number
    23
    26
    Dermatitis contact
         subjects affected / exposed
    12 / 708 (1.69%)
    18 / 1414 (1.27%)
         occurrences all number
    12
    18
    Dermatitis diaper
         subjects affected / exposed
    151 / 708 (21.33%)
    299 / 1414 (21.15%)
         occurrences all number
    186
    360
    Eczema
         subjects affected / exposed
    55 / 708 (7.77%)
    80 / 1414 (5.66%)
         occurrences all number
    62
    87
    Dry skin
         subjects affected / exposed
    21 / 708 (2.97%)
    39 / 1414 (2.76%)
         occurrences all number
    22
    40
    Rash
         subjects affected / exposed
    57 / 708 (8.05%)
    135 / 1414 (9.55%)
         occurrences all number
    62
    146
    Rash generalised
         subjects affected / exposed
    3 / 708 (0.42%)
    18 / 1414 (1.27%)
         occurrences all number
    3
    18
    Seborrhoeic dermatitis
         subjects affected / exposed
    18 / 708 (2.54%)
    45 / 1414 (3.18%)
         occurrences all number
    18
    47
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    11 / 708 (1.55%)
    18 / 1414 (1.27%)
         occurrences all number
    12
    18
    Infections and infestations
    Bronchiolitis
         subjects affected / exposed
    87 / 708 (12.29%)
    132 / 1414 (9.34%)
         occurrences all number
    101
    146
    Candida nappy rash
         subjects affected / exposed
    30 / 708 (4.24%)
    52 / 1414 (3.68%)
         occurrences all number
    30
    54
    Croup infectious
         subjects affected / exposed
    10 / 708 (1.41%)
    27 / 1414 (1.91%)
         occurrences all number
    10
    28
    Bronchitis
         subjects affected / exposed
    6 / 708 (0.85%)
    19 / 1414 (1.34%)
         occurrences all number
    8
    20
    Impetigo
         subjects affected / exposed
    9 / 708 (1.27%)
    16 / 1414 (1.13%)
         occurrences all number
    9
    17
    Gastroenteritis
         subjects affected / exposed
    115 / 708 (16.24%)
    196 / 1414 (13.86%)
         occurrences all number
    130
    223
    Gastroenteritis viral
         subjects affected / exposed
    10 / 708 (1.41%)
    22 / 1414 (1.56%)
         occurrences all number
    12
    24
    Lower respiratory tract infection
         subjects affected / exposed
    53 / 708 (7.49%)
    66 / 1414 (4.67%)
         occurrences all number
    58
    70
    Lobar pneumonia
         subjects affected / exposed
    10 / 708 (1.41%)
    14 / 1414 (0.99%)
         occurrences all number
    11
    14
    Oral candidiasis
         subjects affected / exposed
    70 / 708 (9.89%)
    118 / 1414 (8.35%)
         occurrences all number
    75
    128
    Nasopharyngitis
         subjects affected / exposed
    14 / 708 (1.98%)
    38 / 1414 (2.69%)
         occurrences all number
    14
    42
    Otitis externa
         subjects affected / exposed
    4 / 708 (0.56%)
    19 / 1414 (1.34%)
         occurrences all number
    4
    19
    Otitis media acute
         subjects affected / exposed
    10 / 708 (1.41%)
    17 / 1414 (1.20%)
         occurrences all number
    10
    17
    Otitis media
         subjects affected / exposed
    270 / 708 (38.14%)
    522 / 1414 (36.92%)
         occurrences all number
    386
    742
    Skin candida
         subjects affected / exposed
    11 / 708 (1.55%)
    20 / 1414 (1.41%)
         occurrences all number
    11
    21
    Respiratory tract infection viral
         subjects affected / exposed
    17 / 708 (2.40%)
    30 / 1414 (2.12%)
         occurrences all number
    17
    32
    Pneumonia
         subjects affected / exposed
    45 / 708 (6.36%)
    97 / 1414 (6.86%)
         occurrences all number
    50
    103
    Viral infection
         subjects affected / exposed
    80 / 708 (11.30%)
    175 / 1414 (12.38%)
         occurrences all number
    98
    217
    Urinary tract infection
         subjects affected / exposed
    18 / 708 (2.54%)
    22 / 1414 (1.56%)
         occurrences all number
    18
    26
    Upper respiratory tract infection
         subjects affected / exposed
    461 / 708 (65.11%)
    903 / 1414 (63.86%)
         occurrences all number
    752
    1560
    Viral skin infection
         subjects affected / exposed
    15 / 708 (2.12%)
    31 / 1414 (2.19%)
         occurrences all number
    15
    32
    Viral upper respiratory tract infection
         subjects affected / exposed
    32 / 708 (4.52%)
    76 / 1414 (5.37%)
         occurrences all number
    33
    78

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    13 Jan 2005
    The major changes were below: Updated for clinical experience with MEDI-524. Updated study objective and overview as - increased monitoring for RSV hospitalizations and medically attended outpatient LRI; the addition of monitoring for non-medically attended wheezing episodes in children who have experienced 3 prior medically attended wheezing episodes while on the study. 1) Routine Visits: Timing of the screening visit was changed from Day 0" to "within 60 days before Study Day 0. 2) Follow-up/Evaluations of Lower Respiratory infection (LRI), Wheezing, OM and Respiratory Hospitalizations. 3) Safety Assessment: This was modified as the point of contact for serious adverse event reporting and as the party responsible for the day-today safety monitoring of the study.
    01 Jul 2005
    The overall reason for the amendment was to include the following changes 1) Study Design Changes: Dosing with study drug was changed; The sample size was changed; The time period for enrolment was changed; A futility assessment was added; An additional analysis was added, to determine if RSV immunoprophylaxis during the first RSV season; comparison of the incidence and frequency of wheezing and LRI were changed; The time period for collection of the following information was changed.
    26 May 2006
    The overall reason for the amendment was to include the following changes 1) Regarding comparison of the incidence and frequency of medically attended LRIs and wheezing was reworded to only assess LRIs. 2) An assessment of the blinded events rates was to be conducted after the third season to determine if a fourth season of enrollment was needed to achieve primary and secondary objectives. 3) Respiratory Secretions for RSV Detection: all future testing of respiratory secretions for RSV be conducted by qPCR.
    06 Jun 2006
    The overall reason for the amendment was to include the following changes 1) Routine Visits and Follow-up through Study Day 150: This was updated to add that cord blood can only be used to obtain Study Day 0 results if the child was enrolled by 7 days of age. 2) Final Visit for Patients who prematurely discontinue from the Study: This was revised to clarify that the investigator, not the sponsor, is responsible for requesting permission to continue follow-up.
    06 Jun 2007
    The overall reason for the amendment was to include the following changes 1) Rationale for Study: To detail the conduct and rationale of an interim analysis and possible unbinding of data. 2) Secondary Objectives: “the incidence of asthma in children at 5 years of age who received motavizumab or placebo,” and renumbering the objectives based on collection of the data. 3) Blinding: This was revised by removing all reference to the DMC, and adding details of the potential unbinding to analyse primary endpoints and secondary endpoints of medically attended LRI and OM, pharmacokinetics, immunogenicity. 4) Administration of Study Drug: This was revised by clarifying when it may be appropriate for subsequent injections to be given in the same site. 5) Routine Visits and Follow-up through Study Day 150: Pre-dose vital sign measurement was extended to within 60 minutes prior to drug dose. 6) Pulmonary Function Measures: revised by specifying that pulmonary function tests will continue unless the analysis of wheezing through 3 years suggests that evaluating. 7) Safety Management during the Study was included. 8) Sample Size: revised to reflect the updated protocol strategy of conducting an interim analysis.
    18 Dec 2008
    The overall reason for the amendment was to include the following changes 1) Secondary Objectives: changed from “in first Respiratory Syncytia Virus (RSV) season” to “through Day 150”; added “in patients enrolled in seasons 1-3 only”; changed “3 years of follow-up” to “3 years of age”. 2) Changes in Study design and eligibility criteria. 3) Follow-up/Evaluation of LRI, Wheezing, OM, and Respiratory Hospitalizations. 4) Final Visit for Patients who Prematurely Discontinue from the Study changed assessment of medically attended acute Lower Respiratory infection (LRI) to occur if discontinuation occurs prior to Study Day 150 but not if discontinuation occurs prior to 3 years of age. 5) Added “central RT-PCR” were added to specify the type of RSV test and changed “within 3 days of hospitalization”. 6) Clarified that the IHS physician are primary care physicians. 7) A note was added that Respiratory Secretions for RSV Detection. 8) Routine Laboratory Evaluations: Clarified that blood samples will only be collected in seasons 1, 2, and 3. 9) Medically Attended Acute Respiratory Illnesses: Clarified that patients in seasons 1 and 2 will be followed for 3 years on study. 10) Wheezing Episode Changed from 5 years to 3 years; Changed “research assistant” to “study staff member”. 11) Pharmacokinetic and Immunologic Evaluations. 12) Pulmonary Function Test (PFT) measures were deleted. 13) Completion of Primary Study and Loss to Follow-up. 14) Study Reporting Period for Serious Adverse Events. 15) Interruption of Discontinuation of Study Dosing in Individual Patients: Changed from 5 years to 3 years of age. 16) Secondary Endpoints: Clarified that 150 days is from randomization and change 3 years of follow-up to 3 years of age and delete the asthma assessment at age 5.

    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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