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    Clinical Trial Results:
    A Prospective, Multicenter, Open-label, Non-comparative Study of Safety and Efficacy of Synagis® in Children at High Risk of Severe Respiratory Syncytial Virus Infection in the Russian Federation

    Summary
    EudraCT number
    2014-004527-42
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    13 Jul 2010

    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
    W10-664
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01006629
    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
    Global Medical Information, AbbVie, 001 800-633-9110,
    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 2010
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Jul 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    100 Russian children of 2 years of age and less in high-risk populations (preterm infants [less than or equal to 35 weeks gestational age], infants with bronchopulmonary dysplasia [BPD], and infants with hemodynamically significant congenital heart disease [HSCHD]) will receive palivizumab (Synagis) 15 mg/kg intramuscularly as prophylaxis to severe respiratory syncytial virus (RSV) infection in order to study the safety and efficacy of the drug in Russian subjects.
    Protection of trial subjects
    The investigator or his/her representative explained the nature of the study to the subject's parent(s), and answered all questions regarding this study. Prior to any study-related procedures being performed on the subject, the Informed Consent Form was reviewed, signed and dated by the subject's parent(s), the person who administered the informed consent and an impartial witness (a person not involved in the study team at the site and not an Abbott employee). For subjects with two parents, at least one had to sign the consent, stating that the other parent did not object. Participant cards were provided to the subject's parent(s) after the informed consent process, providing contact information for the investigator as well as additional relevant information regarding their child's participation in the study.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    05 Nov 2009
    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
    Russian Federation: 100
    Worldwide total number of subjects
    100
    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)
    1
    Infants and toddlers (28 days-23 months)
    99
    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
    Subjects were enrolled into the study in 3 geographic areas of the Russian Federation. Recruitment began in November 2009 and ended in December 2009. Subjects at high risk of severe RSV infection (including preterm infants, infants with BPD, and infants with HSCHD) were identified as candidates for the study on the basis of routine assessments.

    Pre-assignment
    Screening details
    Screening assessments were conducted at Visit 1 (Day 0) prior to enrollment and study drug administration.

    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
    Palivizumab 15 mg/kg intramuscularly every 30 days for 3 to 5 injections
    Arm type
    Experimental

    Investigational medicinal product name
    Palivizumab
    Investigational medicinal product code
    Other name
    ABT-315 (MEDI-493), Synagis 15 mg/kg intramuscularly
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    palivizumab 15 mg/kg intramuscularly

    Number of subjects in period 1
    Palivizumab
    Started
    100
    Completed
    94
    Not completed
    6
         Parent refused to continue participation
             1
         Parent unable to perform site visit
             4
         Adverse event, non-fatal
             1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Palivizumab
    Reporting group description
    Palivizumab 15 mg/kg intramuscularly every 30 days for 3 to 5 injections

    Reporting group values
    Palivizumab Total
    Number of subjects
    100 100
    Age, Customized
    Units: participants
        Between 0 and 3 months
    28 28
        Between 4 and 6 months
    24 24
        Between 7 and 9 months
    14 14
        Between 10 and 12 months
    7 7
        Between 13 and 15 months
    8 8
        Between 16 and 18 months
    10 10
        Between 19 and 21 months
    5 5
        Between 22 and 24 months
    4 4
    Age Continuous
    Units: months
        arithmetic mean (standard deviation)
    8.2 ± 6.3 -
    Gender, Male/Female
    Units: participants
        Female
    52 52
        Male
    48 48
    Gestational Age, categorical
    Units: Subjects
        Less than 29 weeks gestational age
    23 23
        Between 29 and 32 weeks gestational age
    22 22
        Between 33 and 35 weeks gestational age
    22 22
        Greater than 35 weeks gestational age
    33 33
    Infants born <= 35 weeks gestational age and <= 6 months of age at enrollment
    Units: Subjects
        Yes
    33 33
        No
    67 67
    Infants <= 24 months of age at enrollment and with a diagnosis of BPD
    Units: Subjects
        Yes
    46 46
        No
    54 54
    Infants <= 24 months of age at enrollment and with HSCHD
    Units: Subjects
        Yes
    30 30
        No
    70 70
    Gestational Age
    Gestational age is defined as the time from mother's last menstrual period until birth.
    Units: weeks
        arithmetic mean (standard deviation)
    33.4 ± 5.1 -

    End points

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    End points reporting groups
    Reporting group title
    Palivizumab
    Reporting group description
    Palivizumab 15 mg/kg intramuscularly every 30 days for 3 to 5 injections

    Primary: Frequency of adverse events

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    End point title
    Frequency of adverse events [1]
    End point description
    Treatment-emergent adverse events were defined as those occurring after study drug initiation and within 30 and 100 days after the last dose of study drug. The number of subjects experiencing a serious or nonserious treatment-emergent adverse event within 30 days after the last dose of study drug is summarized. See the Reported Adverse Events section for details.
    End point type
    Primary
    End point timeframe
    Through 30 days following the last injection of palivizumab
    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 were summarized for this endpoint per protocol.
    End point values
    Palivizumab
    Number of subjects analysed
    100
    Units: participants
        number (not applicable)
    41
    No statistical analyses for this end point

    Primary: Number of hospitalizations due to respiratory syncytial virus (RSV)

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    End point title
    Number of hospitalizations due to respiratory syncytial virus (RSV) [2]
    End point description
    Number of subjects experiencing an RSV hospitalization
    End point type
    Primary
    End point timeframe
    Through 30 days following the last injection of palivizumab
    Notes
    [2] - 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 were summarized for this endpoint per protocol.
    End point values
    Palivizumab
    Number of subjects analysed
    100
    Units: participants
        number (confidence interval 95%)
    0 (0 to 3.6)
    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
    All secondary outcome measures were related to hospitalization due to RSV infection. No RSV hospitalizations occurred during the study; therefore, evaluation of the secondary outcome measures was not possible.
    End point type
    Secondary
    End point timeframe
    Through 30 days following the last injection of palivizumab
    End point values
    Palivizumab
    Number of subjects analysed
    0 [3]
    Units: days
        arithmetic mean (standard deviation)
    ±
    Notes
    [3] - No RSV hospitalizations occurred; therefore, evaluation of the end point was not possible.
    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 related to hospitalization due to RSV infection. No RSV hospitalizations occurred during the study; therefore, evaluation of the secondary outcome measures was not possible.
    End point type
    Secondary
    End point timeframe
    Through 30 days following the last injection of palivizumab
    End point values
    Palivizumab
    Number of subjects analysed
    0 [4]
    Units: days
        arithmetic mean (standard deviation)
    ±
    Notes
    [4] - No RSV hospitalizations occurred; therefore, evaluation of the end point was not possible.
    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
    Outcome measure refers to the number of subjects admitted to the ICU during RSV hospitalization. No RSV hospitalizations occurred during the study; therefore, evaluation of the secondary outcome measures was not possible.
    End point type
    Secondary
    End point timeframe
    Through 30 days following the last injection of palivizumab
    End point values
    Palivizumab
    Number of subjects analysed
    0 [5]
    Units: participants
        number (not applicable)
    Notes
    [5] - No RSV hospitalizations occurred; therefore, evaluation of the end point was not possible.
    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 related to hospitalization due to RSV infection. No RSV hospitalizations occurred during the study; therefore, evaluation of the secondary outcome measures was not possible.
    End point type
    Secondary
    End point timeframe
    Through 30 days following the last injection of palivizumab
    End point values
    Palivizumab
    Number of subjects analysed
    0 [6]
    Units: days
        arithmetic mean (standard deviation)
    ±
    Notes
    [6] - No RSV hospitalizations occurred; therefore, evaluation of the end point was not possible.
    No statistical analyses for this end point

    Secondary: Number of Subjects Who Received Mechanical Ventilation During RSV Hospitalization

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    End point title
    Number of Subjects Who Received Mechanical Ventilation During RSV Hospitalization
    End point description
    All secondary outcome measures were related to hospitalization due to RSV infection. No RSV hospitalizations occurred during the study; therefore, evaluation of the secondary outcome measures was not possible.
    End point type
    Secondary
    End point timeframe
    Through 30 days following the last injection of palivizumab
    End point values
    Palivizumab
    Number of subjects analysed
    0 [7]
    Units: participants
        number (not applicable)
    Notes
    [7] - No RSV hospitalizations occurred; therefore, evaluation of the end point was not possible.
    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 related to hospitalization due to RSV infection. No RSV hospitalizations occurred during the study; therefore, evaluation of the secondary outcome measures was not possible.
    End point type
    Secondary
    End point timeframe
    Through 30 days following the last injection of palivizumab
    End point values
    Palivizumab
    Number of subjects analysed
    0 [8]
    Units: days
        arithmetic mean (standard deviation)
    ±
    Notes
    [8] - No RSV hospitalizations occurred; therefore, evaluation of the end point was not possible.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From date of first dose of study drug through 100 days after the last dose of study drug
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    13.0
    Reporting groups
    Reporting group title
    Palivizumab
    Reporting group description
    Palivizumab 15 mg/kg intramuscularly every 30 days for 3 to 5 injections

    Serious adverse events
    Palivizumab
    Total subjects affected by serious adverse events
         subjects affected / exposed
    10 / 100 (10.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Cardiac disorders
    Supraventricular tachycardia
         subjects affected / exposed
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Enteritis
         subjects affected / exposed
    3 / 100 (3.00%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    4 / 100 (4.00%)
         occurrences causally related to treatment / all
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    Tonsillitis
         subjects affected / exposed
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 1
         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
    34 / 100 (34.00%)
    Injury, poisoning and procedural complications
    Thermal burn
         subjects affected / exposed
    1 / 100 (1.00%)
         occurrences all number
    1
    Investigations
    Blood pressure increased
         subjects affected / exposed
    1 / 100 (1.00%)
         occurrences all number
    1
    Cardiac disorders
    Arrhythmia
         subjects affected / exposed
    1 / 100 (1.00%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Rhinorrhoea
         subjects affected / exposed
    1 / 100 (1.00%)
         occurrences all number
    1
    Bronchopulmonary dysplasia
         subjects affected / exposed
    3 / 100 (3.00%)
         occurrences all number
    3
    Tonsillar hypertrophy
         subjects affected / exposed
    1 / 100 (1.00%)
         occurrences all number
    1
    Immune system disorders
    Food allergy
         subjects affected / exposed
    1 / 100 (1.00%)
         occurrences all number
    1
    Eye disorders
    Glaucoma
         subjects affected / exposed
    1 / 100 (1.00%)
         occurrences all number
    1
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 100 (1.00%)
         occurrences all number
    1
    Psychiatric disorders
    Nervousness
         subjects affected / exposed
    2 / 100 (2.00%)
         occurrences all number
    2
    Gastrointestinal disorders
    Anal stenosis
         subjects affected / exposed
    1 / 100 (1.00%)
         occurrences all number
    1
    Teething
         subjects affected / exposed
    2 / 100 (2.00%)
         occurrences all number
    2
    Skin and subcutaneous tissue disorders
    Dermatitis contact
         subjects affected / exposed
    1 / 100 (1.00%)
         occurrences all number
    1
    Dermatitis atopic
         subjects affected / exposed
    2 / 100 (2.00%)
         occurrences all number
    2
    Dermatitis allergic
         subjects affected / exposed
    1 / 100 (1.00%)
         occurrences all number
    1
    Infections and infestations
    Ascariasis
         subjects affected / exposed
    1 / 100 (1.00%)
         occurrences all number
    1
    Bronchiolitis
         subjects affected / exposed
    1 / 100 (1.00%)
         occurrences all number
    1
    Bronchitis
         subjects affected / exposed
    3 / 100 (3.00%)
         occurrences all number
    4
    Ear infection
         subjects affected / exposed
    2 / 100 (2.00%)
         occurrences all number
    2
    Dacryocystitis
         subjects affected / exposed
    1 / 100 (1.00%)
         occurrences all number
    1
    Gastroenteritis
         subjects affected / exposed
    1 / 100 (1.00%)
         occurrences all number
    1
    Nasopharyngitis
         subjects affected / exposed
    2 / 100 (2.00%)
         occurrences all number
    3
    Pharyngitis
         subjects affected / exposed
    1 / 100 (1.00%)
         occurrences all number
    1
    Gastrointestinal infection
         subjects affected / exposed
    1 / 100 (1.00%)
         occurrences all number
    1
    Respiratory tract infection
         subjects affected / exposed
    2 / 100 (2.00%)
         occurrences all number
    2
    Rhinitis
         subjects affected / exposed
    19 / 100 (19.00%)
         occurrences all number
    21
    Respiratory tract infection viral
         subjects affected / exposed
    2 / 100 (2.00%)
         occurrences all number
    3
    Upper respiratory tract infection
         subjects affected / exposed
    8 / 100 (8.00%)
         occurrences all number
    10

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    14 May 2009
    The purpose of this amendment is to change the first month of enrollment from October to November as well as to clarify to several Inclusion/Exclusion Criteria, Prior and Concomitant therapies and also correct any typographical errors, and make several administrative changes/additions.

    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.
    This study had no control group; relative comparisons are only possible with current product information for palivizumab. No RSV hospitalizations occurred during the study; therefore, secondary outcome measures could not be evaluated.
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