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    Clinical Trial Results:
    Phase 3B Recombinant Antihemophilic Factor Manufactured and Formulated without Added Human or Animal Proteins (rAHF-PFM): Evaluation of Immunogenicity, Efficacy, and Safety in Previously Untreated Patients with Hemophilia A

    Due to the EudraCT – Results system being out of service between 31 July 2015 and 12 January 2016, these results have been published in compliance with revised timelines.
    Summary
    EudraCT number
    2004-001623-38
    Trial protocol
    AT  
    Global end of trial date
    11 Sep 2009

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

    Trial information

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    Trial identification
    Sponsor protocol code
    060103
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Baxter Innovations GmbH
    Sponsor organisation address
    Industriestrasse 67, Vienna, Austria, A-1221
    Public contact
    Clinical Trial Registries and Results Disclosure, Baxter Innovations GmbH, ClinicalTrialsDisclosure@baxalta.com
    Scientific contact
    Clinical Trial Registries and Results Disclosure, Baxter Innovations GmbH, ClinicalTrialsDisclosure@baxalta.com
    Sponsor organisation name
    Baxter Healthcare Corporation
    Sponsor organisation address
    One Baxter Way, Westlake Village, United States, CA 91362-3811
    Public contact
    Clinical Trial Registries and Results Disclosure, Baxter Healthcare Corporation, ClinicalTrialsDisclosure@baxalta.com
    Scientific contact
    Clinical Trial Registries and Results Disclosure, Baxter Healthcare Corporation, ClinicalTrialsDisclosure@baxalta.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?
    Yes
    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
    11 Sep 2009
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    11 Sep 2009
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Sep 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objectives of study 060103 were: To assess the immunogenicity of rAHF-PFM by determining the risk of FVIII inhibitor development; To assess in vivo incremental recovery of rAHF-PFM at the first study visit, at every other interval study visit, and at the study termination visit; To evaluate the hemostatic efficacy of rAHF-PFM in the management and prevention of acute bleeding events; To evaluate the hemostatic efficacy of rAHF-PFM during perioperative management, if surgery was required; To assess the safety of rAHF-PFM; To assess the incidence of the development of antibodies to CHO protein, murine IgG, and human VWF.
    Protection of trial subjects
    This study was conducted in accordance with this protocol, the ICH Guideline for Good Clinical Practice, Title 21 of the U.S. Code of Federal Regulations, the European Directive, and the Declaration of Helsinki.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    01 Apr 2004
    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
    Italy: 2
    Country: Number of subjects enrolled
    United States: 35
    Country: Number of subjects enrolled
    United Kingdom: 2
    Country: Number of subjects enrolled
    Austria: 2
    Country: Number of subjects enrolled
    Canada: 3
    Country: Number of subjects enrolled
    Spain: 2
    Country: Number of subjects enrolled
    France: 4
    Country: Number of subjects enrolled
    Germany: 5
    Worldwide total number of subjects
    55
    EEA total number of subjects
    17
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    8
    Infants and toddlers (28 days-23 months)
    47
    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
    Recruitment was conducted in the U.S., Canada, and Europe at 24 study sites.

    Pre-assignment
    Screening details
    Participants screened for maximum 21 days. Study was not randomized; it was an open-label evaluation. Prior to initial infusion, a minimum washout period of 3 days was required. 11 participants who enrolled did not receive any rAHF-PFM infusions (3 withdrew consent, 6 screen failures, 1 non-compliance with screening, 1 pre-existing low hemoglobin)

    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
    PUPs
    Arm description
    All treated subjects
    Arm type
    Experimental

    Investigational medicinal product name
    rAHF-PFM
    Investigational medicinal product code
    ADVATE
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    rAHF-PFM was to be dosed according to a therapeutic regimen which was determined by the investigator (ie: standard regimen [25 to 50 IU/kg body weight, 3 to 4 times per week]; a modified prophylactic regimen [dose and frequency selected by investigator] or on–demand treatment [dose selected by investigator]). The dosing regimen used to treat BEs was at the discretion of the investigator and in accordance with the institution’s standard of care for the type of BE diagnosed.

    Number of subjects in period 1
    PUPs
    Started
    55
    Completed
    44
    Not completed
    11
         Inclusion not met- baseline FVIII value
             1
         Physician decision
             1
         Enrolled in another study
             1
         Consent withdrawn by subject
             6
         Met exclusion criteria
             1
         Lost to follow-up
             1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    PUPs
    Reporting group description
    All treated subjects

    Reporting group values
    PUPs Total
    Number of subjects
    55 55
    Age categorical
    Age categorical description
    Units: participants
        <6 months
    21 21
        6-12 months
    26 26
        ≥13 months
    8 8
    Gender categorical
    Gender categorical description
    Units: Subjects
        Female
    0 0
        Male
    55 55

    End points

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    End points reporting groups
    Reporting group title
    PUPs
    Reporting group description
    All treated subjects

    Subject analysis set title
    Did not Develop Factor VIII Inhibitor
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Subjects in Immunogenicity Analysis Set who did not develop Factor VIII Inhibitor

    Subject analysis set title
    Developed Factor VIII Inhibitor
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Subjects in Immunogenicity Analysis Set who developed Factor VIII Inhibitor

    Primary: Factor VIII Inhibitor Development

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    End point title
    Factor VIII Inhibitor Development [1]
    End point description
    Percentage of treated participants who developed factor VIII inhibitors
    End point type
    Primary
    End point timeframe
    Assessed during study period which was to be at least 75 exposure days or 3 years (whichever came first)
    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: Per protocol, descriptive statistics were collected for this endpoint.
    End point values
    PUPs
    Number of subjects analysed
    55
    Units: percentage
        number (confidence interval 95%)
    29.1 (17.1 to 41.1)
    No statistical analyses for this end point

    Secondary: Bleeding Episodes Treated With 1 to ≥4 Infusions

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    End point title
    Bleeding Episodes Treated With 1 to ≥4 Infusions
    End point description
    The number of bleeding episodes treated with 1, 2, 3, or ≥4 infusions of rAHF-PFM to achieve adequate hemostasis
    End point type
    Secondary
    End point timeframe
    Reported during study period which was to be at least 75 exposure days or 3 years (whichever came first)
    End point values
    PUPs
    Number of subjects analysed
    44
    Units: Bleeding episodes
        1 infusion
    356
        2 infusions
    107
        3 infusions
    35
        4 or more infusions
    19
    No statistical analyses for this end point

    Secondary: Assessment of Hemostasis for Treatment of Bleeding Episodes

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    End point title
    Assessment of Hemostasis for Treatment of Bleeding Episodes
    End point description
    Number of rAHF-PFM-treated bleeding episodes with treater assessment of hemostasis (4-point ordinal scale): Excellent: Full pain relief & bleeding cessation within ~8 hrs of 1 infusion. Additional infusions may have been given to maintain hemostasis; Good: Definite pain relief and/or improvement in bleeding within ~8 hrs after infusion. Possibly requires >1 infusion for complete resolution; Fair: Probable or slight relief of pain & slight improvement in bleeding within ~8 hrs after infusion. Requires >1 infusion for complete resolution; or None: No improvement or condition worsens.
    End point type
    Secondary
    End point timeframe
    Reported during study period which was to be at least 75 exposure days or 3 years (whichever came first)
    End point values
    PUPs
    Number of subjects analysed
    44
    Units: bleeding episodes
        Excellent
    258
        Good
    177
        Fair
    30
        None
    1
        Unknown/not assessed
    51
    No statistical analyses for this end point

    Secondary: Annualized Rate of Bleeding Episodes

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    End point title
    Annualized Rate of Bleeding Episodes
    End point description
    Number of bleeding episodes per subject annualized over 1 year for all etiologies
    End point type
    Secondary
    End point timeframe
    Reported during study period which was to be at least 75 exposure days or 3 years (whichever came first)
    End point values
    PUPs
    Number of subjects analysed
    43
    Units: bleeding episodes per subject per year
        median (full range (min-max))
    4.95 (1.01 to 32.7)
    No statistical analyses for this end point

    Secondary: Weekly rAHF-PFM Utilization

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    End point title
    Weekly rAHF-PFM Utilization
    End point description
    Weight-Adjusted Weekly Dose for Prophylaxis, On-Demand Treatment, and Perioperative Management. rAHF-PFM dose determined by the investigator (ie: standard regimen [25-50 IU/kg body weight, 3-4 times per week]; modified prophylactic regimen [dose and frequency selected by investigator] or on–demand treatment [dose selected by investigator]). Dosing to treat BEs was at investigator's discretion and in accordance with institution’s standard of care. rAHF-PFM was administered I.V. via bolus infusion, except for perioperative management when it was given either by continuous or bolus infusion.
    End point type
    Secondary
    End point timeframe
    Reported during study period which was to be at least 75 exposure days or 3 years (whichever came first)
    End point values
    PUPs
    Number of subjects analysed
    36
    Units: IU/kg
    median (full range (min-max))
        During Prophylaxis (n=36)
    87.1 (6.5 to 352.3)
        During On-Demand Treatment (n=47)
    12.5 (2.4 to 176.8)
        During Perioperative Management (n=25)
    606.4 (256.5 to 1951)
    No statistical analyses for this end point

    Secondary: In Vivo Incremental Recovery

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    End point title
    In Vivo Incremental Recovery
    End point description
    Change in factor VIII concentration from pre- to post-infusion at initial and termination study visits.
    End point type
    Secondary
    End point timeframe
    30 minutes pre-infusion to 30 minutes post-infusion
    End point values
    PUPs
    Number of subjects analysed
    4
    Units: IU/dL per IU/kg
    median (full range (min-max))
        Initial Visit (n=4)
    1.81 (0.74 to 1.92)
        Termination Visit (n=12)
    1.71 (1.32 to 2.11)
    No statistical analyses for this end point

    Secondary: Assessment of Intra-operative Hemostasis

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    End point title
    Assessment of Intra-operative Hemostasis
    End point description
    Number of surgical procedures managed with rAHF-PFM and with surgeon's assessment of hemostasis based on a 4-point ordinal scale: Excellent: ≤ average predicted blood loss for matched procedures in healthy individuals Good: > average predicted blood loss, but ≤ maximal predicted blood loss for matched procedures in healthy individuals Fair: > maximal predicted blood loss for matched procedures in healthy individuals, and hemostasis was achieved None: uncontrolled hemostasis with proper dosing, necessitating a change in treatment regimen
    End point type
    Secondary
    End point timeframe
    Assessed at the time of discharge from recovery room
    End point values
    PUPs
    Number of subjects analysed
    22
    Units: Procedures
        Excellent
    18
        Good
    4
        Not Applicable
    0
        Not Done
    0
    No statistical analyses for this end point

    Secondary: Assessment of Postoperative Hemostasis

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    End point title
    Assessment of Postoperative Hemostasis
    End point description
    Number of surgical procedures managed with rAHF-PFM and with investigator's assessment of hemostasis based on a 4-point ordinal scale: Excellent: hemostasis was as good as or better than other licensed factor VIII products for matched procedure Good: hemostasis was probably as good as other licensed factor VIII products for matched procedure Fair: hemostasis was clearly < optimal for matched procedure, without need to change regimen None: bleeding from inadequate response with proper dosing, necessitating a change in regimen
    End point type
    Secondary
    End point timeframe
    Assessed at the time of discharge from hospital or clinic
    End point values
    PUPs
    Number of subjects analysed
    27
    Units: Procedures
        Excellent
    23
        Good
    2
        Not Applicable
    1
        Not Done
    1
    No statistical analyses for this end point

    Secondary: Assessment of Blood Loss During Surgical Procedures

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    End point title
    Assessment of Blood Loss During Surgical Procedures
    End point description
    Percentage of actual intraoperative blood loss compared to preoperatively predicted average and maximal blood loss in hemostatically normal matched individuals (from institutional blood bank records)
    End point type
    Secondary
    End point timeframe
    Predicted volumes preoperatively estimated and actual volumes intraoperatively recorded
    End point values
    PUPs
    Number of subjects analysed
    27
    Units: Percentage Blood Loss
    median (full range (min-max))
        Blood loss as percentage of predicted average
    50 (0 to 250)
        Blood loss as percentage of predicted maximal
    20 (0 to 100)
    No statistical analyses for this end point

    Secondary: Adverse Events Deemed Related to Treatment

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    End point title
    Adverse Events Deemed Related to Treatment
    End point description
    Number of participants who reported AEs deemed related to treatment with rAHF-PFM
    End point type
    Secondary
    End point timeframe
    Reported during the study period which was to be at least 75 exposure days or 3 years (whichever came first)
    End point values
    PUPs
    Number of subjects analysed
    55
    Units: Percentage of Participants
    20
    No statistical analyses for this end point

    Secondary: Development of Antibodies to Heterologous Proteins

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    End point title
    Development of Antibodies to Heterologous Proteins
    End point description
    Number of treated participants who developed antibodies to heterologous proteins (ie, Chinese Hamster Ovary Cell Protein, Murine IgG, or Recombinant Human VWF)
    End point type
    Secondary
    End point timeframe
    Assessed at baseline, throughout the duration of the study, which was to be at least 75 exposure days or 3 years (whichever came first), and at the termination visit.
    End point values
    PUPs
    Number of subjects analysed
    55
    Units: Percentage of Participants
        Antibodies to Chinese Hamster Ovary Cell Protein
    0
        Antibodies to Murine IgG
    0
        Antibodies to Recombinant Human VWF (n=54)
    0
    No statistical analyses for this end point

    Post-hoc: Factor VIII Inhibitor Risk Factor: Genetic Risk Factor- Family History of Inhibitors

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    End point title
    Factor VIII Inhibitor Risk Factor: Genetic Risk Factor- Family History of Inhibitors
    End point description
    Number of treated participants who developed an inhibitor
    End point type
    Post-hoc
    End point timeframe
    Duration of study which was to be at least 75 exposure days or 3 years (whichever came first)
    End point values
    Did not Develop Factor VIII Inhibitor Developed Factor VIII Inhibitor
    Number of subjects analysed
    34
    16
    Units: Participants
        Has Family History of Inhibitors
    6
    8
        Unknown Family History of Inhibitors
    2
    1
        No Family History of Inhibitors
    26
    7
    Statistical analysis title
    Statistical analysis 1
    Comparison groups
    Did not Develop Factor VIII Inhibitor v Developed Factor VIII Inhibitor
    Number of subjects included in analysis
    50
    Analysis specification
    Post-hoc
    Analysis type
    Method
    Parameter type
    Odds ratio (OR)
    Point estimate
    4.95
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.29
         upper limit
    19.06

    Post-hoc: Factor VIII Inhibitor Risk Factor: Race

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    End point title
    Factor VIII Inhibitor Risk Factor: Race
    End point description
    Number of treated participants who developed an inhibitor
    End point type
    Post-hoc
    End point timeframe
    Duration of study which was to be at least 75 exposure days or 3 years (whichever came first)
    End point values
    Did not Develop Factor VIII Inhibitor Developed Factor VIII Inhibitor
    Number of subjects analysed
    34
    16
    Units: Participants
        Non-Caucasian
    8
    9
        Caucasian
    26
    7
    Statistical analysis title
    Statistical analysis 1
    Comparison groups
    Did not Develop Factor VIII Inhibitor v Developed Factor VIII Inhibitor
    Number of subjects included in analysis
    50
    Analysis specification
    Post-hoc
    Analysis type
    Method
    Parameter type
    Odds ratio (OR)
    Point estimate
    4.18
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.18
         upper limit
    14.82

    Post-hoc: Factor VIII Inhibitor Risk Factor: Number of Participants with Intensive Treatment and High Dose (≤20 Exposure Days (EDs))

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    End point title
    Factor VIII Inhibitor Risk Factor: Number of Participants with Intensive Treatment and High Dose (≤20 Exposure Days (EDs))
    End point description
    Immunogenicity Analysis Set- Participants with 5 consecutive study days of a mean infusion dose of FVIII >50 IU/kg within ≤20 EDs who developed an inhibitor
    End point type
    Post-hoc
    End point timeframe
    Duration of study which was to be at least 75 exposure days or 3 years (whichever came first)
    End point values
    Did not Develop Factor VIII Inhibitor Developed Factor VIII Inhibitor
    Number of subjects analysed
    34
    16
    Units: Participants
        Received intensive treatment & high dose
    4
    6
        No intensive treatment & high dose
    30
    10
    Statistical analysis title
    Statistical analysis 1
    Comparison groups
    Did not Develop Factor VIII Inhibitor v Developed Factor VIII Inhibitor
    Number of subjects included in analysis
    50
    Analysis specification
    Post-hoc
    Analysis type
    Method
    Parameter type
    Odds ratio (OR)
    Point estimate
    4.5
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    1.05
         upper limit
    19.25

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Study period was to be at least 75 exposure days or 3 years (whichever came first)
    Adverse event reporting additional description
    Median days on study was 498 (range: 82 to 1360) days. Median days of rAHF-PFM exposure was 76 (range: 1 to 414) exposure days.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    12.1
    Reporting groups
    Reporting group title
    PUPs
    Reporting group description
    Reporting group 1 description

    Serious adverse events
    PUPs
    Total subjects affected by serious adverse events
         subjects affected / exposed
    28 / 55 (50.91%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Vascular disorders
    Haematoma
         subjects affected / exposed
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    Mouth injury
         subjects affected / exposed
    2 / 55 (3.64%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Contusion
         subjects affected / exposed
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Head injury
         subjects affected / exposed
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Tongue injury
         subjects affected / exposed
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Skin laceration
         subjects affected / exposed
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Bronchial hyperreactivity
         subjects affected / exposed
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Cough
         subjects affected / exposed
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Wheezing
         subjects affected / exposed
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Blood and lymphatic system disorders
    Coagulopathy
         subjects affected / exposed
    2 / 55 (3.64%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Factor VIII inhibition
         subjects affected / exposed
    16 / 55 (29.09%)
         occurrences causally related to treatment / all
    16 / 16
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    2 / 55 (3.64%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Catheter site haematoma
         subjects affected / exposed
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Musculoskeletal and connective tissue disorders
    Haemarthrosis
         subjects affected / exposed
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Bacteraemia
         subjects affected / exposed
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Bronchitis
         subjects affected / exposed
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Catheter bacteraemia
         subjects affected / exposed
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Catheter related infection
         subjects affected / exposed
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory syncytial virus infection
         subjects affected / exposed
    1 / 55 (1.82%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    PUPs
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    52 / 55 (94.55%)
    Injury, poisoning and procedural complications
    Procedural pain
         subjects affected / exposed
    9 / 55 (16.36%)
         occurrences all number
    11
    Arthropod bite
         subjects affected / exposed
    4 / 55 (7.27%)
         occurrences all number
    5
    Mouth injury
         subjects affected / exposed
    3 / 55 (5.45%)
         occurrences all number
    4
    Skin laceration
         subjects affected / exposed
    3 / 55 (5.45%)
         occurrences all number
    3
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    10 / 55 (18.18%)
         occurrences all number
    13
    Iron deficiency anaemia
         subjects affected / exposed
    5 / 55 (9.09%)
         occurrences all number
    8
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    23 / 55 (41.82%)
         occurrences all number
    65
    Rhinorrhoea
         subjects affected / exposed
    22 / 55 (40.00%)
         occurrences all number
    54
    Nasal congestion
         subjects affected / exposed
    15 / 55 (27.27%)
         occurrences all number
    48
    Wheezing
         subjects affected / exposed
    6 / 55 (10.91%)
         occurrences all number
    10
    Oropharyngeal pain
         subjects affected / exposed
    3 / 55 (5.45%)
         occurrences all number
    4
    Eye disorders
    Conjuctivitis
         subjects affected / exposed
    9 / 55 (16.36%)
         occurrences all number
    12
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    3 / 55 (5.45%)
         occurrences all number
    3
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    39 / 55 (70.91%)
         occurrences all number
    137
    Pain
         subjects affected / exposed
    4 / 55 (7.27%)
         occurrences all number
    6
    Gastrointestinal disorders
    Diarrhea
         subjects affected / exposed
    20 / 55 (36.36%)
         occurrences all number
    31
    Vomiting
         subjects affected / exposed
    17 / 55 (30.91%)
         occurrences all number
    29
    Abdominal pain
         subjects affected / exposed
    3 / 55 (5.45%)
         occurrences all number
    5
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    13 / 55 (23.64%)
         occurrences all number
    18
    Dermatitis diaper
         subjects affected / exposed
    7 / 55 (12.73%)
         occurrences all number
    8
    Urticaria
         subjects affected / exposed
    5 / 55 (9.09%)
         occurrences all number
    5
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    3 / 55 (5.45%)
         occurrences all number
    4
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    28 / 55 (50.91%)
         occurrences all number
    80
    Ear infection
         subjects affected / exposed
    20 / 55 (36.36%)
         occurrences all number
    44
    Upper respiratory tract infection
         subjects affected / exposed
    16 / 55 (29.09%)
         occurrences all number
    35
    Otitis media
         subjects affected / exposed
    7 / 55 (12.73%)
         occurrences all number
    13
    Hand-foot-and-mouth disease
         subjects affected / exposed
    5 / 55 (9.09%)
         occurrences all number
    5
    Bronchitis
         subjects affected / exposed
    4 / 55 (7.27%)
         occurrences all number
    10
    Influenza
         subjects affected / exposed
    4 / 55 (7.27%)
         occurrences all number
    8
    Pharyngitis
         subjects affected / exposed
    4 / 55 (7.27%)
         occurrences all number
    4
    Rhinitis
         subjects affected / exposed
    4 / 55 (7.27%)
         occurrences all number
    14
    Varicella
         subjects affected / exposed
    4 / 55 (7.27%)
         occurrences all number
    4
    Croup infectious
         subjects affected / exposed
    3 / 55 (5.45%)
         occurrences all number
    3
    Gasteroenteritis
         subjects affected / exposed
    3 / 55 (5.45%)
         occurrences all number
    3
    Viral infection
         subjects affected / exposed
    3 / 55 (5.45%)
         occurrences all number
    5

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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