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    Clinical Trial Results:
    A Phase 2b Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of MEDI8897, a Monoclonal Antibody with an Extended Half-life Against Respiratory Syncytial Virus, in Healthy Preterm Infants

    Summary
    EudraCT number
    2016-001677-33
    Trial protocol
    GB   ES   CZ   HU   BG   PL   FR   BE   SE   EE   LV   FI   LT   IT  
    Global end of trial date
    06 Dec 2018

    Results information
    Results version number
    v3(current)
    This version publication date
    12 Oct 2019
    First version publication date
    21 Jun 2019
    Other versions
    v1 , v2
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    D5290C00003
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02878330
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    MedImmune, LLC
    Sponsor organisation address
    One MedImmune Way, Gaithersburg, Maryland, United States, 20878
    Public contact
    M. Pamela Griffin, MedImmune, LLC, +1 301-398-4059, information.center@astrazeneca.com
    Scientific contact
    M. Pamela Griffin, MedImmune, LLC, +1 301-398-4059, information.center@astrazeneca.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    EMEA-001784-PIP01-15
    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
    14 Feb 2019
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Dec 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study was to assess the efficacy of MEDI8897 for the reduction of medically attended lower respiratory tract infection (LRTI) due to reverse transcriptase-polymerase chain reaction (RT-PCR)-confirmed respiratory syncytial virus (RSV), compared to placebo.
    Protection of trial subjects
    The conduct of this clinical study met all local and regulatory requirements. The study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and are consistent with International Conference on Harmonization guideline: Good Clinical Practice, and applicable regulatory requirements. Participants signed an 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
    03 Nov 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 2
    Country: Number of subjects enrolled
    Bulgaria: 141
    Country: Number of subjects enrolled
    Canada: 3
    Country: Number of subjects enrolled
    Czech Republic: 24
    Country: Number of subjects enrolled
    Estonia: 19
    Country: Number of subjects enrolled
    Finland: 7
    Country: Number of subjects enrolled
    France: 38
    Country: Number of subjects enrolled
    Hungary: 120
    Country: Number of subjects enrolled
    Italy: 72
    Country: Number of subjects enrolled
    Latvia: 12
    Country: Number of subjects enrolled
    Lithuania: 5
    Country: Number of subjects enrolled
    Poland: 38
    Country: Number of subjects enrolled
    Spain: 128
    Country: Number of subjects enrolled
    Sweden: 17
    Country: Number of subjects enrolled
    Turkey: 60
    Country: Number of subjects enrolled
    United Kingdom: 15
    Country: Number of subjects enrolled
    United States: 287
    Country: Number of subjects enrolled
    Argentina: 7
    Country: Number of subjects enrolled
    Australia: 13
    Country: Number of subjects enrolled
    Brazil: 26
    Country: Number of subjects enrolled
    Chile: 156
    Country: Number of subjects enrolled
    New Zealand: 13
    Country: Number of subjects enrolled
    South Africa: 250
    Worldwide total number of subjects
    1453
    EEA total number of subjects
    638
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    221
    Infants and toddlers (28 days-23 months)
    1232
    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
    The study was conducted from 03-Nov-2016 to 06-Dec-2018.

    Pre-assignment
    Screening details
    A total of 1540 participants were screened, out of which 1453 participants were randomized in the study.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo
    Arm description
    Participants received a single intramuscular (IM) dose of placebo matched to MEDI8897 on Day 1 of the study.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Sterile concentrate
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular (IM) dose of placebo matched to MEDI8897 on Day 1 of the study.

    Arm title
    MEDI8897 50 mg
    Arm description
    Participants received a single IM dose of MEDI8897 50 milligrams (mg) on Day 1 of the study.
    Arm type
    Experimental

    Investigational medicinal product name
    MEDI8897 50 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Sterile concentrate
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular (IM) dose of 50 milligrams (mg) MEDI8897 on Day 1 of the study.

    Number of subjects in period 1
    Placebo MEDI8897 50 mg
    Started
    484
    969
    Completed
    455
    913
    Not completed
    29
    56
         Death
    3
    2
         Not specified
    4
    7
         Consent withdrawn by subject
    11
    21
         Lost to follow-up
    11
    26

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Participants received a single intramuscular (IM) dose of placebo matched to MEDI8897 on Day 1 of the study.

    Reporting group title
    MEDI8897 50 mg
    Reporting group description
    Participants received a single IM dose of MEDI8897 50 milligrams (mg) on Day 1 of the study.

    Reporting group values
    Placebo MEDI8897 50 mg Total
    Number of subjects
    484 969 1453
    Age Categorical
    Units: Subjects
        In utero
    0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0
        Newborns (0-27 days)
    83 138 221
        Infants and toddlers (28 days-23 months)
    401 831 1232
        Children (2-11 years)
    0 0 0
        Adolescents (12-17 years)
    0 0 0
        Adults (18-64 years)
    0 0 0
        From 65-84 years
    0 0 0
        85 years and over
    0 0 0
    Age Continuous
    Units: months
        arithmetic mean (standard deviation)
    3.28 ± 2.31 3.29 ± 2.22 -
    Gender Categorical
    Units: Subjects
        Female
    224 468 692
        Male
    260 501 761
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    91 225 316
        Not Hispanic or Latino
    393 743 1136
        Unknown or Not Reported
    0 1 1
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    1 0 1
        Asian
    10 5 15
        Native Hawaiian or Other Pacific Islander
    3 8 11
        Black or African American
    67 189 256
        White
    355 693 1048
        More than one race
    5 12 17
        Other
    43 61 104
        Unknown or Not Reported
    0 1 1

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Participants received a single intramuscular (IM) dose of placebo matched to MEDI8897 on Day 1 of the study.

    Reporting group title
    MEDI8897 50 mg
    Reporting group description
    Participants received a single IM dose of MEDI8897 50 milligrams (mg) on Day 1 of the study.

    Primary: Number of Participants With Medically Attended Respiratory Syncytial Virus (RSV) Confirmed Lower Respiratory Tract Infection (LRTI)

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    End point title
    Number of Participants With Medically Attended Respiratory Syncytial Virus (RSV) Confirmed Lower Respiratory Tract Infection (LRTI)
    End point description
    Medically attended RSV LRTI is determined based on objective clinical LRTI criteria and RSV test results which are analysed from respiratory secretions using RSV real time reverse transcriptase-polymerase chain reaction (RT-PCR) assay for detection of RSV A or RSV B subtypes. The criteria for LRTI is documented physical exam findings of rhonchi, rales, crackles, or wheeze and any of following: increased respiratory rate at rest (for age < 2 months: >= 60 breaths/min; 2–6 months: >= 50 breaths/min; and for > 6 months – 2 years, >= 40 breaths/min), or hypoxemia (in room air - oxygen saturation < 95% at altitudes <= 1800 meters or < 92% at altitudes > 1800 meters), or clinical signs of severe respiratory disease or dehydration secondary to inadequate oral intake due to respiratory distress. The intent-to-treat (ITT) population was analysed for this end point, which included all participants who were randomised in the study and analysed according to their randomised treatment group.
    End point type
    Primary
    End point timeframe
    From Day 1 through Day 151
    End point values
    Placebo MEDI8897 50 mg
    Number of subjects analysed
    484
    969
    Units: Participants
    46
    25
    Statistical analysis title
    Statistical Analysis
    Comparison groups
    Placebo v MEDI8897 50 mg
    Number of subjects included in analysis
    1453
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.0001
    Method
    Poisson regression
    Parameter type
    Relative Risk Reduction
    Point estimate
    70.1
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    52.3
         upper limit
    81.2

    Secondary: Number of Participants Hopitalized Due to Respiratory Syncytial Virus (RSV) Confirmed Lower Respiartory Tract Infection (LRTI)

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    End point title
    Number of Participants Hopitalized Due to Respiratory Syncytial Virus (RSV) Confirmed Lower Respiartory Tract Infection (LRTI)
    End point description
    A RSV hospitalization is defined as either 1) a respiratory hospitalization with a positive RSV test within 2 days of hospitalization (primary) or 2) new onset of respiratory symptoms in an already hospitalized child, with an objective measure of worsening respiratory status and positive RSV test (nosocomial). The ITT population was analysed for this end point, which included all participants who were randomised in the study and analysed according to their randomised treatment group.
    End point type
    Secondary
    End point timeframe
    From Day 1 through Day 151
    End point values
    Placebo MEDI8897 50 mg
    Number of subjects analysed
    484
    969
    Units: Participants
    20
    8
    Statistical analysis title
    Statistical Analysis
    Comparison groups
    Placebo v MEDI8897 50 mg
    Number of subjects included in analysis
    1453
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    = 0.0002
    Method
    Poisson regression
    Parameter type
    Relative Risk Reduction
    Point estimate
    78.4
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    51.9
         upper limit
    90.3

    Secondary: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)

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    End point title
    Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
    End point description
    An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug. As-treated population was analysed for this end point, which included all randomised participants who received any study drug and analysed according to the study drug they actually received.
    End point type
    Secondary
    End point timeframe
    From Day 1 through Day 361
    End point values
    Placebo MEDI8897 50 mg
    Number of subjects analysed
    479
    968
    Units: Participants
        TEAEs
    416
    834
        TESAEs
    81
    108
    No statistical analyses for this end point

    Secondary: Number of Participants With Adverse Events of Special Interest (AESIs) and New Onset Chronic Diseases (NOCDs)

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    End point title
    Number of Participants With Adverse Events of Special Interest (AESIs) and New Onset Chronic Diseases (NOCDs)
    End point description
    An AESI was one of scientific and medical interest specific to understanding of study drug and may have required close monitoring and rapid communication by investigator to the sponsor. An AESI may be serious or non-serious. A NOCD is a newly diagnosed medical condition that is of a chronic, ongoing nature. It is observed after receiving study drug and is assessed by investigator as medically significant. As-treated population was analysed for this end point, which included all randomised participants who received any study drug and analysed according to the study drug they actually received.
    End point type
    Secondary
    End point timeframe
    From Day 1 through Day 361
    End point values
    Placebo MEDI8897 50 mg
    Number of subjects analysed
    479
    968
    Units: Participants
        AESIs
    3
    5
        NOCDs
    4
    4
    No statistical analyses for this end point

    Secondary: Serum Concentration of MEDI8897

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    End point title
    Serum Concentration of MEDI8897 [1]
    End point description
    As-treated population was analysed for this end point, which included all randomised participants who received any study drug and analysed according to the study drug they actually received. Here 'n' denotes number of participants analysed for specified time point.
    End point type
    Secondary
    End point timeframe
    Days 91, 151, and 361
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Serum concentration of MEDI8897 is only applicable to the MEDI8897 arm group and not to the Placebo arm group.
    End point values
    MEDI8897 50 mg
    Number of subjects analysed
    968
    Units: mcg/mL
    arithmetic mean (standard deviation)
        Day 91 (n= 883)
    35.9 ± 10.9
        Day 151 (n= 849)
    18.9 ± 7.4
        Day 361 (n= 771)
    2.1 ± 1.1
    No statistical analyses for this end point

    Secondary: Elimination half-life (t1/2) of MEDI8897

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    End point title
    Elimination half-life (t1/2) of MEDI8897 [2]
    End point description
    Terminal elimination half-life (t½) is the time required for half of the drug to be eliminated from the serum. As-treated population was analysed for this end point, which included all randomised participants who received any study drug and analysed according to the study drug they actually received. Participants with sufficient additional pharmacokinetics (PK) samples from unscheduled visits were analysed for this end point.
    End point type
    Secondary
    End point timeframe
    Day 91 through Day 361
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Elimination half-life is only applicable to the MEDI8897 arm group and not to the Placebo arm group.
    End point values
    MEDI8897 50 mg
    Number of subjects analysed
    48
    Units: Days
        arithmetic mean (standard deviation)
    59.3 ± 9.6
    No statistical analyses for this end point

    Secondary: Number of Participants With Positive Anti-drug Antibodies to MEDI8897

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    End point title
    Number of Participants With Positive Anti-drug Antibodies to MEDI8897
    End point description
    The number of participants with positive serum antibodies to MEDI8897 are reported. As-treated population was analysed for this end point, which included all randomised participants who received any study drug and analysed according to the study drug they actually received. Here 'n' denotes number of participants analysed for specified time point.
    End point type
    Secondary
    End point timeframe
    Days 91, 151, and 361
    End point values
    Placebo MEDI8897 50 mg
    Number of subjects analysed
    479
    968
    Units: Participants
        Day 91 (n= 455, 890)
    4
    11
        Day 151 (n= 445, 867)
    6
    17
        Day 361 (n= 418, 847)
    8
    30
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From Day 1 through Day 361
    Adverse event reporting additional description
    As-treated population was analysed for this end point, which included all randomised participants who received any study drug and analysed according to the study drug they actually received.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    MEDI8897 50 mg
    Reporting group description
    Participants received a single IM dose of MEDI8897 50 mg on Day 1 of the study.

    Reporting group title
    PLACEBO
    Reporting group description
    Participants received a single IM dose of placebo matched to MEDI8897 on Day 1 of the study.

    Serious adverse events
    MEDI8897 50 mg PLACEBO
    Total subjects affected by serious adverse events
         subjects affected / exposed
    108 / 968 (11.16%)
    81 / 479 (16.91%)
         number of deaths (all causes)
    2
    3
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Eyelid haemangioma
         subjects affected / exposed
    1 / 968 (0.10%)
    0 / 479 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Drug hypersensitivity
         subjects affected / exposed
    1 / 968 (0.10%)
    0 / 479 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Death
         subjects affected / exposed
    1 / 968 (0.10%)
    0 / 479 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pyrexia
         subjects affected / exposed
    3 / 968 (0.31%)
    1 / 479 (0.21%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Irritability
         subjects affected / exposed
    0 / 968 (0.00%)
    1 / 479 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Penile adhesion
         subjects affected / exposed
    0 / 968 (0.00%)
    1 / 479 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Exposure to toxic agent
         subjects affected / exposed
    1 / 968 (0.10%)
    0 / 479 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fall
         subjects affected / exposed
    1 / 968 (0.10%)
    0 / 479 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Palate injury
         subjects affected / exposed
    0 / 968 (0.00%)
    1 / 479 (0.21%)
         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
    2 / 968 (0.21%)
    0 / 479 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Cardiac arrest
         subjects affected / exposed
    1 / 968 (0.10%)
    0 / 479 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    1 / 968 (0.10%)
    0 / 479 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure congestive
         subjects affected / exposed
    1 / 968 (0.10%)
    0 / 479 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myocarditis
         subjects affected / exposed
    0 / 968 (0.00%)
    1 / 479 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pericardial effusion
         subjects affected / exposed
    0 / 968 (0.00%)
    1 / 479 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Congenital, familial and genetic disorders
    Muscular dystrophy
         subjects affected / exposed
    1 / 968 (0.10%)
    0 / 479 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia neonatal
         subjects affected / exposed
    0 / 968 (0.00%)
    1 / 479 (0.21%)
         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
    Apnoea
         subjects affected / exposed
    1 / 968 (0.10%)
    1 / 479 (0.21%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Asthma
         subjects affected / exposed
    1 / 968 (0.10%)
    0 / 479 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngeal stenosis
         subjects affected / exposed
    0 / 968 (0.00%)
    1 / 479 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia aspiration
         subjects affected / exposed
    2 / 968 (0.21%)
    0 / 479 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary vein stenosis
         subjects affected / exposed
    1 / 968 (0.10%)
    0 / 479 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    0 / 968 (0.00%)
    1 / 479 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Febrile convulsion
         subjects affected / exposed
    1 / 968 (0.10%)
    0 / 479 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypotonia
         subjects affected / exposed
    0 / 968 (0.00%)
    1 / 479 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infantile spasms
         subjects affected / exposed
    0 / 968 (0.00%)
    1 / 479 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intraventricular haemorrhage
         subjects affected / exposed
    0 / 968 (0.00%)
    1 / 479 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    0 / 968 (0.00%)
    1 / 479 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Deafness bilateral
         subjects affected / exposed
    1 / 968 (0.10%)
    0 / 479 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 968 (0.10%)
    0 / 479 (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
    2 / 968 (0.21%)
    1 / 479 (0.21%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dysphagia
         subjects affected / exposed
    1 / 968 (0.10%)
    0 / 479 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enteritis
         subjects affected / exposed
    1 / 968 (0.10%)
    1 / 479 (0.21%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 968 (0.10%)
    0 / 479 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incarcerated umbilical hernia
         subjects affected / exposed
    1 / 968 (0.10%)
    0 / 479 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    1 / 968 (0.10%)
    6 / 479 (1.25%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malabsorption
         subjects affected / exposed
    1 / 968 (0.10%)
    0 / 479 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    2 / 968 (0.21%)
    0 / 479 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Jaundice
         subjects affected / exposed
    1 / 968 (0.10%)
    0 / 479 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Nephrolithiasis
         subjects affected / exposed
    2 / 968 (0.21%)
    0 / 479 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Dermatitis allergic
         subjects affected / exposed
    0 / 968 (0.00%)
    1 / 479 (0.21%)
         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
    2 / 968 (0.21%)
    1 / 479 (0.21%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    1 / 968 (0.10%)
    0 / 479 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Abscess limb
         subjects affected / exposed
    1 / 968 (0.10%)
    0 / 479 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adenovirus infection
         subjects affected / exposed
    0 / 968 (0.00%)
    1 / 479 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Anal abscess
         subjects affected / exposed
    1 / 968 (0.10%)
    0 / 479 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchiolitis
         subjects affected / exposed
    20 / 968 (2.07%)
    21 / 479 (4.38%)
         occurrences causally related to treatment / all
    0 / 22
    0 / 26
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    14 / 968 (1.45%)
    11 / 479 (2.30%)
         occurrences causally related to treatment / all
    0 / 16
    0 / 11
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Croup infectious
         subjects affected / exposed
    2 / 968 (0.21%)
    0 / 479 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cytomegalovirus infection
         subjects affected / exposed
    0 / 968 (0.00%)
    1 / 479 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    9 / 968 (0.93%)
    4 / 479 (0.84%)
         occurrences causally related to treatment / all
    0 / 9
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis Escherichia coli
         subjects affected / exposed
    0 / 968 (0.00%)
    1 / 479 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis adenovirus
         subjects affected / exposed
    1 / 968 (0.10%)
    0 / 479 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis rotavirus
         subjects affected / exposed
    0 / 968 (0.00%)
    2 / 479 (0.42%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis salmonella
         subjects affected / exposed
    1 / 968 (0.10%)
    1 / 479 (0.21%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    1 / 968 (0.10%)
    1 / 479 (0.21%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    0 / 968 (0.00%)
    1 / 479 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngitis
         subjects affected / exposed
    1 / 968 (0.10%)
    0 / 479 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    14 / 968 (1.45%)
    13 / 479 (2.71%)
         occurrences causally related to treatment / all
    0 / 14
    0 / 18
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection viral
         subjects affected / exposed
    5 / 968 (0.52%)
    3 / 479 (0.63%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis
         subjects affected / exposed
    0 / 968 (0.00%)
    1 / 479 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis bacterial
         subjects affected / exposed
    0 / 968 (0.00%)
    1 / 479 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Otitis media
         subjects affected / exposed
    2 / 968 (0.21%)
    0 / 479 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritonsillar abscess
         subjects affected / exposed
    0 / 968 (0.00%)
    1 / 479 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngitis
         subjects affected / exposed
    1 / 968 (0.10%)
    0 / 479 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    13 / 968 (1.34%)
    10 / 479 (2.09%)
         occurrences causally related to treatment / all
    0 / 13
    0 / 12
         deaths causally related to treatment / all
    0 / 0
    0 / 2
    Pneumonia bacterial
         subjects affected / exposed
    0 / 968 (0.00%)
    1 / 479 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia parainfluenzae viral
         subjects affected / exposed
    0 / 968 (0.00%)
    1 / 479 (0.21%)
         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
    2 / 968 (0.21%)
    2 / 479 (0.42%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia viral
         subjects affected / exposed
    7 / 968 (0.72%)
    2 / 479 (0.42%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pseudomonal bacteraemia
         subjects affected / exposed
    0 / 968 (0.00%)
    1 / 479 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory syncytial virus bronchiolitis
         subjects affected / exposed
    1 / 968 (0.10%)
    2 / 479 (0.42%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Salmonellosis
         subjects affected / exposed
    1 / 968 (0.10%)
    0 / 479 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    2 / 968 (0.21%)
    1 / 479 (0.21%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis neonatal
         subjects affected / exposed
    1 / 968 (0.10%)
    0 / 479 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal scalded skin syndrome
         subjects affected / exposed
    0 / 968 (0.00%)
    1 / 479 (0.21%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsillitis
         subjects affected / exposed
    1 / 968 (0.10%)
    0 / 479 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 968 (0.31%)
    3 / 479 (0.63%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 968 (0.00%)
    4 / 479 (0.84%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral upper respiratory tract infection
         subjects affected / exposed
    1 / 968 (0.10%)
    0 / 479 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    MEDI8897 50 mg PLACEBO
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    804 / 968 (83.06%)
    402 / 479 (83.92%)
    Injury, poisoning and procedural complications
    Arthropod bite
         subjects affected / exposed
    14 / 968 (1.45%)
    6 / 479 (1.25%)
         occurrences all number
    14
    6
    Vaccination complication
         subjects affected / exposed
    23 / 968 (2.38%)
    15 / 479 (3.13%)
         occurrences all number
    28
    19
    Congenital, familial and genetic disorders
    Plagiocephaly
         subjects affected / exposed
    15 / 968 (1.55%)
    3 / 479 (0.63%)
         occurrences all number
    15
    3
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    37 / 968 (3.82%)
    15 / 479 (3.13%)
         occurrences all number
    45
    17
    Nasal congestion
         subjects affected / exposed
    71 / 968 (7.33%)
    24 / 479 (5.01%)
         occurrences all number
    83
    27
    Nasal obstruction
         subjects affected / exposed
    23 / 968 (2.38%)
    17 / 479 (3.55%)
         occurrences all number
    23
    17
    Rhinorrhoea
         subjects affected / exposed
    63 / 968 (6.51%)
    29 / 479 (6.05%)
         occurrences all number
    75
    34
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    29 / 968 (3.00%)
    17 / 479 (3.55%)
         occurrences all number
    29
    17
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    109 / 968 (11.26%)
    63 / 479 (13.15%)
         occurrences all number
    133
    75
    Psychiatric disorders
    Irritability
         subjects affected / exposed
    11 / 968 (1.14%)
    7 / 479 (1.46%)
         occurrences all number
    20
    14
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    5 / 968 (0.52%)
    10 / 479 (2.09%)
         occurrences all number
    5
    10
    Constipation
         subjects affected / exposed
    34 / 968 (3.51%)
    21 / 479 (4.38%)
         occurrences all number
    36
    24
    Diarrhoea
         subjects affected / exposed
    98 / 968 (10.12%)
    49 / 479 (10.23%)
         occurrences all number
    113
    55
    Gastrooesophageal reflux disease
         subjects affected / exposed
    37 / 968 (3.82%)
    22 / 479 (4.59%)
         occurrences all number
    38
    22
    Teething
         subjects affected / exposed
    62 / 968 (6.40%)
    32 / 479 (6.68%)
         occurrences all number
    72
    35
    Umbilical hernia
         subjects affected / exposed
    11 / 968 (1.14%)
    3 / 479 (0.63%)
         occurrences all number
    11
    3
    Vomiting
         subjects affected / exposed
    40 / 968 (4.13%)
    15 / 479 (3.13%)
         occurrences all number
    46
    17
    Skin and subcutaneous tissue disorders
    Dermatitis
         subjects affected / exposed
    20 / 968 (2.07%)
    15 / 479 (3.13%)
         occurrences all number
    26
    15
    Dermatitis diaper
         subjects affected / exposed
    76 / 968 (7.85%)
    36 / 479 (7.52%)
         occurrences all number
    94
    44
    Dermatitis atopic
         subjects affected / exposed
    30 / 968 (3.10%)
    8 / 479 (1.67%)
         occurrences all number
    34
    9
    Eczema
         subjects affected / exposed
    34 / 968 (3.51%)
    15 / 479 (3.13%)
         occurrences all number
    34
    15
    Rash
         subjects affected / exposed
    43 / 968 (4.44%)
    17 / 479 (3.55%)
         occurrences all number
    49
    18
    Seborrhoeic dermatitis
         subjects affected / exposed
    17 / 968 (1.76%)
    7 / 479 (1.46%)
         occurrences all number
    17
    8
    Infections and infestations
    Acarodermatitis
         subjects affected / exposed
    13 / 968 (1.34%)
    8 / 479 (1.67%)
         occurrences all number
    15
    8
    Bronchitis
         subjects affected / exposed
    91 / 968 (9.40%)
    49 / 479 (10.23%)
         occurrences all number
    150
    77
    Bronchiolitis
         subjects affected / exposed
    83 / 968 (8.57%)
    42 / 479 (8.77%)
         occurrences all number
    104
    60
    Candida nappy rash
         subjects affected / exposed
    12 / 968 (1.24%)
    6 / 479 (1.25%)
         occurrences all number
    14
    6
    Conjunctivitis
         subjects affected / exposed
    86 / 968 (8.88%)
    39 / 479 (8.14%)
         occurrences all number
    94
    44
    Croup infectious
         subjects affected / exposed
    12 / 968 (1.24%)
    6 / 479 (1.25%)
         occurrences all number
    13
    7
    Exanthema subitum
         subjects affected / exposed
    21 / 968 (2.17%)
    11 / 479 (2.30%)
         occurrences all number
    22
    11
    Ear infection
         subjects affected / exposed
    23 / 968 (2.38%)
    13 / 479 (2.71%)
         occurrences all number
    34
    21
    Gastroenteritis
         subjects affected / exposed
    115 / 968 (11.88%)
    44 / 479 (9.19%)
         occurrences all number
    138
    49
    Fungal skin infection
         subjects affected / exposed
    5 / 968 (0.52%)
    8 / 479 (1.67%)
         occurrences all number
    5
    8
    Gastroenteritis viral
         subjects affected / exposed
    13 / 968 (1.34%)
    5 / 479 (1.04%)
         occurrences all number
    15
    5
    Hand-foot-and-mouth disease
         subjects affected / exposed
    36 / 968 (3.72%)
    14 / 479 (2.92%)
         occurrences all number
    36
    14
    Impetigo
         subjects affected / exposed
    12 / 968 (1.24%)
    6 / 479 (1.25%)
         occurrences all number
    12
    6
    Laryngitis
         subjects affected / exposed
    24 / 968 (2.48%)
    10 / 479 (2.09%)
         occurrences all number
    31
    10
    Lower respiratory tract infection
         subjects affected / exposed
    75 / 968 (7.75%)
    46 / 479 (9.60%)
         occurrences all number
    103
    65
    Nasopharyngitis
         subjects affected / exposed
    164 / 968 (16.94%)
    94 / 479 (19.62%)
         occurrences all number
    264
    158
    Lower respiratory tract infection viral
         subjects affected / exposed
    9 / 968 (0.93%)
    6 / 479 (1.25%)
         occurrences all number
    9
    8
    Oral candidiasis
         subjects affected / exposed
    36 / 968 (3.72%)
    26 / 479 (5.43%)
         occurrences all number
    39
    26
    Otitis media
         subjects affected / exposed
    63 / 968 (6.51%)
    42 / 479 (8.77%)
         occurrences all number
    87
    63
    Otitis media acute
         subjects affected / exposed
    51 / 968 (5.27%)
    24 / 479 (5.01%)
         occurrences all number
    82
    33
    Rhinitis
         subjects affected / exposed
    111 / 968 (11.47%)
    50 / 479 (10.44%)
         occurrences all number
    145
    61
    Pharyngitis
         subjects affected / exposed
    57 / 968 (5.89%)
    27 / 479 (5.64%)
         occurrences all number
    68
    32
    Upper respiratory tract infection
         subjects affected / exposed
    392 / 968 (40.50%)
    169 / 479 (35.28%)
         occurrences all number
    734
    337
    Tonsillitis
         subjects affected / exposed
    16 / 968 (1.65%)
    5 / 479 (1.04%)
         occurrences all number
    16
    6
    Urinary tract infection
         subjects affected / exposed
    12 / 968 (1.24%)
    7 / 479 (1.46%)
         occurrences all number
    12
    7
    Varicella
         subjects affected / exposed
    19 / 968 (1.96%)
    11 / 479 (2.30%)
         occurrences all number
    19
    11
    Viral rash
         subjects affected / exposed
    32 / 968 (3.31%)
    15 / 479 (3.13%)
         occurrences all number
    34
    16
    Viral upper respiratory tract infection
         subjects affected / exposed
    48 / 968 (4.96%)
    34 / 479 (7.10%)
         occurrences all number
    75
    57

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    25 Jan 2018
    The interim analysis was removed from the study. The two-sided significance level of α was changed from α equal to (=) 0.049 to α = 0.05. The p value required to achieve statistical significance of less than (<) 0.049 has returned to (less than or equal to) <= 0.05. A decision was made to conduct a primary analysis rather than an interim analysis and a text was added to explain that the primary analysis would now include all efficacy data from all randomized participants through Day 151 and all available safety data up to and beyond Day 151 at the time of the final data cut-off date.

    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
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
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