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    Clinical Trial Results:
    A Prospective, International, Multicenter, Open-Label, Non-Controlled Study of Safety and Effectiveness of Palivizumab, in Children at High Risk of Severe Respiratory Syncytial Virus (RSV) Infection in the Russian Federation and the Republic of Belarus

    Summary
    EudraCT number
    		 2016-000221-39
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    13 Jul 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Jan 2018
    First version publication date
    25 Jan 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    M15-539
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02968173
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AbbVie Deutschland GmbH & Co.KG
    Sponsor organisation address
    AbbVie House, Vanwall Business Park, Vanwall Road, Maidenhead, Berkshire, United Kingdom, SL6-4UB
    Public contact
    Joaquin Valdes MD, AbbVie, joaquin.m.valdes@abbvie.com
    Scientific contact
    Joaquin Valdes MD, AbbVie, joaquin.m.valdes@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
    13 Jul 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Jul 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To collect further data on safety and effectiveness of the liquid formulation of palivizumab (Synagis®) administered as monthly intramuscular injections among preterm infants, infants with chronic lung disease (CLD) of prematurity and infants with hemodynamically significant congenital heart disease (CHD)
    Protection of trial subjects
    Participant and/or legal guardian read and understood the information provided about the study and gave written permission.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    09 Nov 2016
    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
    Belarus: 7
    Country: Number of subjects enrolled
    Russian Federation: 43
    Worldwide total number of subjects
    50
    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)
    50
    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
    		 Subjects were screened for adherence in inclusion/exclusion criteria at The Baseline (Enrollment) Visit.

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

    Arms
    Arm title
    		 Children at High Risk of Severe RSV Infection
    Arm description
    		 A single intramuscular (IM) injection of palivizumab every 30 days beginning at Day 0 for a total of 3-5 injections determined by when in the RSV season a subject was enrolled.
    Arm type
    		 Experimental

    Investigational medicinal product name
    palivizumab
    Investigational medicinal product code
    Other name
    Synagis
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    All subjects were to receive 15 mg/kg of the liquid formulation of palivizumab administered by IM injection by the research staff or designee (health care professional) at the study site every 30 days for a minimum of 3 doses and a maximum of 5 doses.

    Number of subjects in period 1
    		Children at High Risk of Severe RSV Infection
    Started
    50
    Completed
    49
    Not completed
    1
         Consent withdrawn by subject
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Children at High Risk of Severe RSV Infection
    Reporting group description
    		 A single intramuscular (IM) injection of palivizumab every 30 days beginning at Day 0 for a total of 3-5 injections determined by when in the RSV season a subject was enrolled.

    Reporting group values
    		 Children at High Risk of Severe RSV Infection Total
    Number of subjects
    		 50 50
    Age categorical
    Units: Subjects
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    		 6.22 ( 4.428 ) -
    Gender categorical
    Units: Subjects
        Female
    		 24 24
        Male
    		 26 26

    End points

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    End points reporting groups
    Reporting group title
    Children at High Risk of Severe RSV Infection
    Reporting group description
    		 A single intramuscular (IM) injection of palivizumab every 30 days beginning at Day 0 for a total of 3-5 injections determined by when in the RSV season a subject was enrolled.

    Primary: Percentage of Subjects With RSV Hospitalization

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    End point title
    		 Percentage of Subjects With RSV Hospitalization [1]
    End point description
    An RSV hospitalization is defined as either 1) a respiratory/cardiac hospitalization with a positive RSV test, 2) new onset of respiratory/cardiac symptoms in an already hospitalized child, with an objective measure of worsening respiratory/cardiac status and a positive RSV test, or 3) deaths, which can be demonstrated as caused by RSV (by autopsy or clinical history and virologic evidence).
    End point type
    Primary
    End point timeframe
    Approximately 6 months
    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 statistics are presented, per protocol.
    End point values
    		 Children at High Risk of Severe RSV Infection
    Number of subjects analysed
    50
    Units: percentage of subjects
        number (confidence interval 95%)
    0.0 (0.0 to 7.1)
    No statistical analyses for this end point

    Secondary: Total Number of RSV-Hospitalization Days

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    End point title
    		 Total Number of RSV-Hospitalization Days
    End point description
    All secondary outcome measures were dependent on RSV hospitalization. Since no subjects experienced an RSV hospitalization during the study, an evaluation of these outcome measures was not applicable.
    End point type
    Secondary
    End point timeframe
    Approximately 6 months
    End point values
    		 Children at High Risk of Severe RSV Infection
    Number of subjects analysed
    0 [2]
    Units: days
    Notes
    [2] - no subjects experienced an RSV hospitalization during the study
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Who Received Supplemental Oxygen While Hospitalized

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    End point title
    		 Percentage of Subjects Who Received Supplemental Oxygen While Hospitalized
    End point description
    Increased supplemental oxygen is defined as a new requirement or an increase in supplemental oxygen from prior to the onset of cardiac/respiratory symptoms. All secondary outcome measures were dependent on RSV hospitalization. Since no subjects experienced an RSV hospitalization during the study, an evaluation of these outcome measures was not applicable.
    End point type
    Secondary
    End point timeframe
    Approximately 6 months
    End point values
    		 Children at High Risk of Severe RSV Infection
    Number of subjects analysed
    0 [3]
    Units: percentage of subjects
        number (not applicable)
    Notes
    [3] - no subjects experienced an RSV hospitalization during the study
    No statistical analyses for this end point

    Secondary: Total RSV-hospitalization Days With Increased Supplemental Oxygen Requirement

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    End point title
    		 Total RSV-hospitalization Days With Increased Supplemental Oxygen Requirement
    End point description
    Increased supplemental oxygen is defined as a new requirement or an increase in supplemental oxygen from prior to the onset of cardiac/respiratory symptoms. All secondary outcome measures were dependent on RSV hospitalization. Since no subjects experienced an RSV hospitalization during the study, an evaluation of these outcome measures was not applicable.
    End point type
    Secondary
    End point timeframe
    Approximately 6 months
    End point values
    		 Children at High Risk of Severe RSV Infection
    Number of subjects analysed
    0 [4]
    Units: days
    Notes
    [4] - no subjects experienced an RSV hospitalization during the study
    No statistical analyses for this end point

    Secondary: Number of Intensive Care Unit (ICU) Admissions During RSV-hospitalization

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    End point title
    		 Number of Intensive Care Unit (ICU) Admissions During RSV-hospitalization
    End point description
    All secondary outcome measures were dependent on RSV hospitalization. Since no subjects experienced an RSV hospitalization during the study, an evaluation of these outcome measures was not applicable.
    End point type
    Secondary
    End point timeframe
    Approximately 6 months
    End point values
    		 Children at High Risk of Severe RSV Infection
    Number of subjects analysed
    0 [5]
    Units: ICU admissions
    Notes
    [5] - no subjects experienced an RSV hospitalization during the study
    No statistical analyses for this end point

    Secondary: Total Days of RSV-ICU Stay

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    End point title
    		 Total Days of RSV-ICU Stay
    End point description
    All secondary outcome measures were dependent on RSV hospitalization. Since no subjects experienced an RSV hospitalization during the study, an evaluation of these outcome measures was not applicable.
    End point type
    Secondary
    End point timeframe
    Approximately 6 months
    End point values
    		 Children at High Risk of Severe RSV Infection
    Number of subjects analysed
    0 [6]
    Units: days
    Notes
    [6] - no subjects experienced an RSV hospitalization during the study
    No statistical analyses for this end point

    Secondary: Percentage of Subjects Who Received Mechanical Ventilation

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    End point title
    		 Percentage of Subjects Who Received Mechanical Ventilation
    End point description
    All secondary outcome measures were dependent on RSV hospitalization. Since no subjects experienced an RSV hospitalization during the study, an evaluation of these outcome measures was not applicable.
    End point type
    Secondary
    End point timeframe
    Approximately 6 months
    End point values
    		 Children at High Risk of Severe RSV Infection
    Number of subjects analysed
    0 [7]
    Units: percentage of subjects
        number (not applicable)
    Notes
    [7] - no subjects experienced an RSV hospitalization during the study
    No statistical analyses for this end point

    Secondary: Total Days of Mechanical Ventilation During RSV-hospitalization

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    End point title
    		 Total Days of Mechanical Ventilation During RSV-hospitalization
    End point description
    All secondary outcome measures were dependent on RSV hospitalization. Since no participants experienced an RSV hospitalization during the study, an evaluation of these outcome measures was not applicable.
    End point type
    Secondary
    End point timeframe
    Approximately 6 months
    End point values
    		 Children at High Risk of Severe RSV Infection
    Number of subjects analysed
    0 [8]
    Units: days
    Notes
    [8] - no subjects experienced an RSV hospitalization during the study
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    From first dose of study treatment through the last prophylaxis visit (up to Day 120 [±5 days]) + 30 days (+5 days) and 100 days (+5 days
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    PALIVIZUMAB TEAE Within 30 Days
    Reporting group description
    		 A single IM injection of palivizumab every 30 days beginning at Day 0 for a total of 3-5 injections determined by when in the RSV season a subject was enrolled. Treatment-emergent adverse events (TEAEs) are defined as those that began after the first dose of study drug but within 30 days (+ 30 day assessment period) after the last dose of study drug.

    Reporting group title
    PALIVIZUMAB TEAE Within 100 Days
    Reporting group description
    		 A single IM injection of palivizumab every 30 days beginning at Day 0 for a total of 3-5 injections determined by when in the RSV season a subject was enrolled. TEAEs are defined as those that began after the first dose of study drug but within 100 days (+ 100 day assessment period) after the last dose of study drug.

    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: No subjects had a non-serious adverse event above the 5% threshold.
    Serious adverse events
    		 PALIVIZUMAB TEAE Within 30 Days PALIVIZUMAB TEAE Within 100 Days
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 50 (12.00%)
    6 / 50 (12.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Haemangioma
         subjects affected / exposed
    1 / 50 (2.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Tachycardia paroxysmal
         subjects affected / exposed
    1 / 50 (2.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 50 (2.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis viral
         subjects affected / exposed
    1 / 50 (2.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nasopharyngitis
         subjects affected / exposed
    1 / 50 (2.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 50 (2.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory tract infection viral
         subjects affected / exposed
    1 / 50 (2.00%)
    1 / 50 (2.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 PALIVIZUMAB TEAE Within 30 Days PALIVIZUMAB TEAE Within 100 Days
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 50 (0.00%)

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    25 May 2016
    Protocol Amendment 1 modified the study objective to reflect the large amount of data already available for the study drug.

    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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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