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    Clinical Trial Results:
    An Open-Label, Uncontrolled 4-Week Study to Assess the Safety, Efficacy and Pharmacokinetics of Allegra® (Dry Syrup Formulation) 15 mg or 30 mg Twice Daily in Pediatric Patients With Atopic Dermatitis

    Summary
    EudraCT number
    2017-000251-74
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    08 Aug 2011

    Results information
    Results version number
    v1(current)
    This version publication date
    19 Jul 2017
    First version publication date
    19 Jul 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    SFY10718
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01244230
    WHO universal trial number (UTN)
    U1111-1115-4048
    Sponsors
    Sponsor organisation name
    Sanofi aventis recherche & développement
    Sponsor organisation address
    1 avenue Pierre Brossolette, Chilly-Mazarin, France, 91380
    Public contact
    Trial Transparency Team, Sanofi Aventis Recherche & Developpement, Contact-US@sanofi.com
    Scientific contact
    Trial Transparency Team, Sanofi Aventis Recherche & Developpement, Contact-US@sanofi.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    02 Sep 2011
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Aug 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the safety of fexofenadine hydrochloride (HCl) (dry syrup formulation) when administered for 4 weeks at doses of 15 mg or 30 mg twice daily to pediatric subjects 6 months through 11 years of age with atopic dermatitis (AD).
    Protection of trial subjects
    The study was conducted by investigators experienced in the treatment of pediatric subjects. The parent(s) or guardian(s) as well as the children were fully informed of all pertinent aspects of the clinical trial as well as the possibility to discontinue at any time. In addition to the consent form for the parent(s)/guardian(s), an assent form in child-appropriate language was provided and explained to the child. Repeated invasive procedures were minimized. The number of blood samples as well as the amount of blood drawn were adjusted according to age and weight. A topical anesthesia may have been used to minimize distress and discomfort.
    Background therapy
    Standard topical treatment of 0.1% hydrocortisone butyrate ointment was applied to the tested sites (except for the face and scalp) by simple application method up to 4 weeks during main treatment period (not specified in extension phase).
    Evidence for comparator
    -
    Actual start date of recruitment
    09 Nov 2010
    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
    Japan: 103
    Worldwide total number of subjects
    103
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    49
    Children (2-11 years)
    54
    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 at 13 centers in Japan from 09 November 2010 to 19 May 2011.

    Pre-assignment
    Screening details
    Out of 115 subjects screened, 12 were screen failures, 103 subjects were enrolled and treated in this study. The study had two treatment periods: 4-weeks main treatment period and an 8-weeks extension treatment period. Subjects who completed 4-weeks main treatment period and required continuous treatment, entered the extension treatment period.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Age 6 Months to <2 Years
    Arm description
    Subjects aged 6 months to <2 years, received one sachet of 15 mg fexofenadine HCl with water or suspended in water or lukewarm water twice daily (in the morning and evening) up to 12 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    Fexofenadine HCl
    Investigational medicinal product code
    M016455
    Other name
    Allegra®
    Pharmaceutical forms
    Powder for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    One sachet of 15 mg fexofenadine HCl with water or suspended in water or lukewarm water twice daily (in the morning and evening).

    Arm title
    Age 2 to <7 Years
    Arm description
    Subjects aged 2 to <7 years, received one sachet of 30 mg fexofenadine HCl (if body weight >10.5 kg) or 15 mg fexofenadine HCl (if body weight <=10.5 kg) with water or suspended in water or lukewarm water twice daily (in the morning and evening) up to 12 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    Fexofenadine HCl
    Investigational medicinal product code
    M016455
    Other name
    Allegra®
    Pharmaceutical forms
    Powder for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    One sachet of 30 mg fexofenadine HCl or 15 mg fexofenadine HCl with water or suspended in water or lukewarm water twice daily (in the morning and evening).

    Arm title
    Age 7 to 11 Years
    Arm description
    Subjects aged 7 to 11 years, received one sachet of 30 mg fexofenadine HCl (if body weight >10.5 kg) or 15 mg fexofenadine HCl (if body weight <=10.5 kg) with water or suspended in water or lukewarm water twice daily (in the morning and evening) up to 12 weeks.
    Arm type
    Experimental

    Investigational medicinal product name
    Fexofenadine HCl
    Investigational medicinal product code
    M016455
    Other name
    Allegra®
    Pharmaceutical forms
    Powder for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    One sachet of 30 mg fexofenadine HCl or 15 mg fexofenadine HCl with water or suspended in water or lukewarm water twice daily (in the morning and evening).

    Number of subjects in period 1
    Age 6 Months to <2 Years Age 2 to <7 Years Age 7 to 11 Years
    Started
    49
    31
    23
    Completed 4-Week Main Treatment Period
    49
    31
    23
    Entered 8-Week Extension Period
    37
    21
    20
    Completed
    36
    21
    20
    Not completed
    13
    10
    3
         Did not enter 8-week extension phase
    12
    10
    3
         Consent withdrawn by subject
    1
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Age 6 Months to <2 Years
    Reporting group description
    Subjects aged 6 months to <2 years, received one sachet of 15 mg fexofenadine HCl with water or suspended in water or lukewarm water twice daily (in the morning and evening) up to 12 weeks.

    Reporting group title
    Age 2 to <7 Years
    Reporting group description
    Subjects aged 2 to <7 years, received one sachet of 30 mg fexofenadine HCl (if body weight >10.5 kg) or 15 mg fexofenadine HCl (if body weight <=10.5 kg) with water or suspended in water or lukewarm water twice daily (in the morning and evening) up to 12 weeks.

    Reporting group title
    Age 7 to 11 Years
    Reporting group description
    Subjects aged 7 to 11 years, received one sachet of 30 mg fexofenadine HCl (if body weight >10.5 kg) or 15 mg fexofenadine HCl (if body weight <=10.5 kg) with water or suspended in water or lukewarm water twice daily (in the morning and evening) up to 12 weeks.

    Reporting group values
    Age 6 Months to <2 Years Age 2 to <7 Years Age 7 to 11 Years Total
    Number of subjects
    49 31 23 103
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    0.5 ± 0.5 4 ± 1.4 8.6 ± 1.2 -
    Gender categorical
    Units: Subjects
        Female
    23 10 10 43
        Male
    26 21 13 60

    End points

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    End points reporting groups
    Reporting group title
    Age 6 Months to <2 Years
    Reporting group description
    Subjects aged 6 months to <2 years, received one sachet of 15 mg fexofenadine HCl with water or suspended in water or lukewarm water twice daily (in the morning and evening) up to 12 weeks.

    Reporting group title
    Age 2 to <7 Years
    Reporting group description
    Subjects aged 2 to <7 years, received one sachet of 30 mg fexofenadine HCl (if body weight >10.5 kg) or 15 mg fexofenadine HCl (if body weight <=10.5 kg) with water or suspended in water or lukewarm water twice daily (in the morning and evening) up to 12 weeks.

    Reporting group title
    Age 7 to 11 Years
    Reporting group description
    Subjects aged 7 to 11 years, received one sachet of 30 mg fexofenadine HCl (if body weight >10.5 kg) or 15 mg fexofenadine HCl (if body weight <=10.5 kg) with water or suspended in water or lukewarm water twice daily (in the morning and evening) up to 12 weeks.

    Primary: Number of Subjects With Adverse Events (AEs) up to 4 Weeks

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    End point title
    Number of Subjects With Adverse Events (AEs) up to 4 Weeks [1]
    End point description
    AEs were any unfavorable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the subject during the study. Analysis was performed on safety population defined as all treated subjects.
    End point type
    Primary
    End point timeframe
    From first dose of study drug up to 4 weeks
    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:  As the endpoint is descriptive in nature, no statistical analysis is provided. 
    End point values
    Age 6 Months to <2 Years Age 2 to <7 Years Age 7 to 11 Years
    Number of subjects analysed
    49
    31
    23
    Units: subjects
    30
    22
    6
    No statistical analyses for this end point

    Primary: Number of Subjects With Potentially Clinically Significant Laboratory Abnormalities up to 4 Weeks: Safety Population

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    End point title
    Number of Subjects With Potentially Clinically Significant Laboratory Abnormalities up to 4 Weeks: Safety Population [2]
    End point description
    Laboratory parameters used were related to renal functions (creatinine) and liver functions (alanine transaminase, aspartate aminotransferase, bilirubin). Subjects with potentially clinically significant laboratory abnormalities were as determined by sponsor. Analysis was performed on safety population defined as all treated subjects.
    End point type
    Primary
    End point timeframe
    Baseline up to 4 weeks
    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:  As the endpoint is descriptive in nature, no statistical analysis is provided. 
    End point values
    Age 6 Months to <2 Years Age 2 to <7 Years Age 7 to 11 Years
    Number of subjects analysed
    49
    31
    23
    Units: subjects
        Creatinine
    5
    0
    1
        Alanine Transaminase
    0
    1
    0
        Aspartate Aminotransferase
    0
    1
    0
        Bilirubin
    0
    0
    0
    No statistical analyses for this end point

    Primary:  Number of Subjects With Potentially Clinically Significant Laboratory Abnormalities up to 4 Weeks: For Subjects Aged 2 to 11 Years

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    End point title
     Number of Subjects With Potentially Clinically Significant Laboratory Abnormalities up to 4 Weeks: For Subjects Aged 2 to 11 Years [3] [4]
    End point description
    Laboratory parameters used were related to hematology (hemoglobin, hematocrit, red blood cell count, platelets count, white blood cell count), renal functions (blood urea nitrogen) and liver functions (alkaline phosphatase). Subjects with potentially clinically significant laboratory abnormalities were as determined by sponsor. Analysis was performed on a subset of safety population (defined as all treated subjects) consisted of subjects aged 2 to 11 years.
    End point type
    Primary
    End point timeframe
    Baseline up to 4 weeks
    Notes
    [3] - 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:  As the endpoint is descriptive in nature, no statistical analysis is provided. 
    [4] - 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: For this endpoint, data was reported only for the subjects above 2 years of age. 
    End point values
    Age 2 to <7 Years Age 7 to 11 Years
    Number of subjects analysed
    31
    23
    Units: subjects
        Hemoglobin
    1
    0
        Hematocrit
    10
    3
        Red Blood Cell Count
    0
    0
        Platelets
    0
    0
        White Blood Cell Count
    0
    1
        Blood Urea Nitrogen
    0
    0
        Alkaline Phosphatase
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects With Adverse Events (AEs) up to 12 Weeks

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    End point title
    Number of Subjects With Adverse Events (AEs) up to 12 Weeks
    End point description
    AEs were any unfavorable and unintended sign, symptom, syndrome, or illness observed by the investigator or reported by the subject during the study. Analysis was performed on safety population defined as all treated subjects.
    End point type
    Secondary
    End point timeframe
    From first dose of study drug up to 12 weeks
    End point values
    Age 6 Months to <2 Years Age 2 to <7 Years Age 7 to 11 Years
    Number of subjects analysed
    49
    31
    23
    Units: subjects
    38
    28
    10
    No statistical analyses for this end point

    Secondary:  Number of Subjects With Potentially Clinically Significant Laboratory Abnormalities up to 12 Weeks: Safety Population

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    End point title
     Number of Subjects With Potentially Clinically Significant Laboratory Abnormalities up to 12 Weeks: Safety Population
    End point description
    Laboratory parameters used were related to renal functions (creatinine) and liver functions (alanine transaminase, aspartate aminotransferase, bilirubin). Subjects with potentially clinically significant laboratory abnormalities were as determined by sponsor. Analysis was performed on safety population defined as all treated subjects.
    End point type
    Secondary
    End point timeframe
    Baseline up to 12 weeks
    End point values
    Age 6 Months to <2 Years Age 2 to <7 Years Age 7 to 11 Years
    Number of subjects analysed
    49
    31
    23
    Units: subjects
        Creatinine
    9
    0
    1
        Alanine Transaminase
    0
    1
    0
        Aspartate Aminotransferase
    0
    1
    0
        Bilirubin
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of Subjects With Potentially Clinically Significant Laboratory Abnormalities up to 12 Weeks: For Subjects Aged 2 to 11 Years

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    End point title
    Number of Subjects With Potentially Clinically Significant Laboratory Abnormalities up to 12 Weeks: For Subjects Aged 2 to 11 Years [5]
    End point description
    Laboratory parameters used were related to hematology (hemoglobin, hematocrit, red blood cell count, platelets count, white blood cell count), renal functions (blood urea nitrogen) and liver functions (alkaline phosphatase). Subjects with potentially clinically significant laboratory abnormalities were as determined by sponsor. Analysis was performed on a subset of safety population (defined as all treated subjects) consisted of subjects aged 2 to 11 years.
    End point type
    Secondary
    End point timeframe
    Baseline up to 12 weeks
    Notes
    [5] - 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: For this endpoint, data was reported only for the subjects above 2 years of age. 
    End point values
    Age 2 to <7 Years Age 7 to 11 Years
    Number of subjects analysed
    31
    23
    Units: subjects
        Hemoglobin
    1
    0
        Hematocrit
    10
    5
        Red Blood Cell Count
    0
    0
        Platelets
    0
    0
        White Blood Cell Count
    0
    1
        Blood Urea Nitrogen
    0
    0
        Alkaline Phosphatase
    0
    0
    No statistical analyses for this end point

    Secondary: Change From Baseline in Main Itching Scores Through Week 4

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    End point title
    Change From Baseline in Main Itching Scores Through Week 4
    End point description
    The intensity of itching was assessed using itching scores on a 5-point scale ranging from 0 (hardly feels itchy) to 4 (unbearable itchiness/can hardly sleep due to itchiness). A higher score indicated worse disease status, and a negative change from baseline indicated improvement. Analysis was performed on modified intention-to-treat (mITT) population defined as all registered subjects whose main itching scores, both baseline and post treatment, were available.
    End point type
    Secondary
    End point timeframe
    Baseline through Week 4
    End point values
    Age 6 Months to <2 Years Age 2 to <7 Years Age 7 to 11 Years
    Number of subjects analysed
    49
    31
    23
    Units: scores on a scale
        arithmetic mean (standard deviation)
    -0.46 ± 0.55
    -0.51 ± 0.54
    -0.39 ± 0.47
    No statistical analyses for this end point

    Secondary: Change From Baseline in Pruritus Intensity Scores at Week 2 and Week 4

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    End point title
    Change From Baseline in Pruritus Intensity Scores at Week 2 and Week 4
    End point description
    The pruritus intensity score were assessed by the investigator or sub-investigator. The intensity of pruritus was evaluated using pruritus intensity scores on a 5-point scale, ranging from 0 (no pruritus) to 4 (severe). A higher score indicated worse disease status, and a negative change from baseline indicated improvement. Analysis was performed on mITT population defined as all registered subjects whose pruritus intensity scores both baseline and post treatment were available.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 2 and Week 4
    End point values
    Age 6 Months to <2 Years Age 2 to <7 Years Age 7 to 11 Years
    Number of subjects analysed
    49
    31
    23
    Units: scores on a scale
    arithmetic mean (standard deviation)
        Week 2
    -0.5 ± 0.7
    -0.4 ± 0.9
    -0.5 ± 0.6
        Week 4
    -0.7 ± 0.9
    -0.8 ± 1.1
    -0.9 ± 1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All AEs were collected from signature of the informed consent form up to the final visit (Day 89) regardless of seriousness or relationship to investigational product.
    Adverse event reporting additional description
    Reported AEs are treatment-emergent adverse events that is AEs that developed/worsened during the ‘on treatment period’ (time from first dose of study drug up to 5 days after the last dose of study drug).
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    14.0
    Reporting groups
    Reporting group title
    Age 6 Months to <2 Years
    Reporting group description
    Subjects aged 6 months to <2 years, received one sachet of 15 mg fexofenadine HCl with water or suspended in water or lukewarm water twice daily (in the morning and evening) up to 12 weeks.

    Reporting group title
    Age 2 to <7 Years
    Reporting group description
    Subjects aged 2 to <7 years received one sachet of 30 mg fexofenadine HCl (if body weight >10.5 kg) or 15 mg fexofenadine HCl (if body weight <=10.5 kg) with water or suspended in water or lukewarm water twice daily (in the morning and evening) up to 12 weeks.

    Reporting group title
    Age 7 to 11 Years
    Reporting group description
    Subjects aged 7 to 11 years received one sachet of 30 mg fexofenadine HCl (if body weight >10.5 kg) or 15 mg fexofenadine HCl (if body weight <=10.5 kg) with water or suspended in water or lukewarm water twice daily (in the morning and evening) up to 12 weeks.

    Serious adverse events
    Age 6 Months to <2 Years Age 2 to <7 Years Age 7 to 11 Years
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 31 (0.00%)
    0 / 23 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 31 (0.00%)
    0 / 23 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Age 6 Months to <2 Years Age 2 to <7 Years Age 7 to 11 Years
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    38 / 49 (77.55%)
    28 / 31 (90.32%)
    10 / 23 (43.48%)
    Injury, poisoning and procedural complications
    Arthropod Sting
         subjects affected / exposed
    3 / 49 (6.12%)
    0 / 31 (0.00%)
    0 / 23 (0.00%)
         occurrences all number
    3
    0
    0
    Contusion
         subjects affected / exposed
    1 / 49 (2.04%)
    1 / 31 (3.23%)
    0 / 23 (0.00%)
         occurrences all number
    1
    2
    0
    Face Injury
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 31 (0.00%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    0
    Thermal Burn
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 31 (0.00%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    0
    Investigations
    White Blood Cell Count Decreased
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 31 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Upper Respiratory Tract Inflammation
         subjects affected / exposed
    12 / 49 (24.49%)
    8 / 31 (25.81%)
    2 / 23 (8.70%)
         occurrences all number
    15
    9
    2
    Cough
         subjects affected / exposed
    0 / 49 (0.00%)
    2 / 31 (6.45%)
    1 / 23 (4.35%)
         occurrences all number
    0
    2
    1
    Oropharyngeal Pain
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 31 (3.23%)
    0 / 23 (0.00%)
         occurrences all number
    0
    1
    0
    Immune system disorders
    Food Allergy
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 31 (0.00%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    0
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    3 / 49 (6.12%)
    0 / 31 (0.00%)
    0 / 23 (0.00%)
         occurrences all number
    4
    0
    0
    Conjunctivitis Allergic
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 31 (3.23%)
    1 / 23 (4.35%)
         occurrences all number
    0
    1
    1
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    2 / 49 (4.08%)
    2 / 31 (6.45%)
    1 / 23 (4.35%)
         occurrences all number
    2
    2
    1
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    0 / 49 (0.00%)
    4 / 31 (12.90%)
    0 / 23 (0.00%)
         occurrences all number
    0
    4
    0
    Constipation
         subjects affected / exposed
    2 / 49 (4.08%)
    1 / 31 (3.23%)
    0 / 23 (0.00%)
         occurrences all number
    2
    1
    0
    Diarrhoea
         subjects affected / exposed
    2 / 49 (4.08%)
    1 / 31 (3.23%)
    0 / 23 (0.00%)
         occurrences all number
    2
    1
    0
    Colitis
         subjects affected / exposed
    0 / 49 (0.00%)
    2 / 31 (6.45%)
    0 / 23 (0.00%)
         occurrences all number
    0
    2
    0
    Aphthous Stomatitis
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 31 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    0
    1
    Dental Caries
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 31 (3.23%)
    0 / 23 (0.00%)
         occurrences all number
    0
    1
    0
    Dyspepsia
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 31 (0.00%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    0
    Enterocolitis
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 31 (3.23%)
    0 / 23 (0.00%)
         occurrences all number
    0
    1
    0
    Skin and subcutaneous tissue disorders
    Urticaria
         subjects affected / exposed
    2 / 49 (4.08%)
    1 / 31 (3.23%)
    0 / 23 (0.00%)
         occurrences all number
    2
    1
    0
    Heat Rash
         subjects affected / exposed
    2 / 49 (4.08%)
    0 / 31 (0.00%)
    0 / 23 (0.00%)
         occurrences all number
    2
    0
    0
    Dermatitis Allergic
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 31 (3.23%)
    0 / 23 (0.00%)
         occurrences all number
    0
    1
    0
    Dermatitis Atopic
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 31 (3.23%)
    0 / 23 (0.00%)
         occurrences all number
    0
    1
    0
    Dermatitis Diaper
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 31 (0.00%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    0
    Eczema
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 31 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    0
    1
    Erythema
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 31 (0.00%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    0
    Skin Exfoliation
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 31 (0.00%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    18 / 49 (36.73%)
    5 / 31 (16.13%)
    4 / 23 (17.39%)
         occurrences all number
    27
    8
    4
    Gastroenteritis
         subjects affected / exposed
    4 / 49 (8.16%)
    2 / 31 (6.45%)
    3 / 23 (13.04%)
         occurrences all number
    4
    2
    3
    Bronchitis
         subjects affected / exposed
    5 / 49 (10.20%)
    1 / 31 (3.23%)
    1 / 23 (4.35%)
         occurrences all number
    5
    1
    1
    Influenza
         subjects affected / exposed
    2 / 49 (4.08%)
    2 / 31 (6.45%)
    0 / 23 (0.00%)
         occurrences all number
    2
    3
    0
    Impetigo
         subjects affected / exposed
    2 / 49 (4.08%)
    1 / 31 (3.23%)
    0 / 23 (0.00%)
         occurrences all number
    3
    1
    0
    Otitis Media
         subjects affected / exposed
    2 / 49 (4.08%)
    0 / 31 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    2
    0
    1
    Exanthema Subitum
         subjects affected / exposed
    2 / 49 (4.08%)
    0 / 31 (0.00%)
    0 / 23 (0.00%)
         occurrences all number
    2
    0
    0
    Hand-Foot-And-Mouth Disease
         subjects affected / exposed
    2 / 49 (4.08%)
    0 / 31 (0.00%)
    0 / 23 (0.00%)
         occurrences all number
    2
    0
    0
    Herpangina
         subjects affected / exposed
    2 / 49 (4.08%)
    0 / 31 (0.00%)
    0 / 23 (0.00%)
         occurrences all number
    2
    0
    0
    Tonsillitis
         subjects affected / exposed
    0 / 49 (0.00%)
    2 / 31 (6.45%)
    0 / 23 (0.00%)
         occurrences all number
    0
    2
    0
    Varicella
         subjects affected / exposed
    2 / 49 (4.08%)
    0 / 31 (0.00%)
    0 / 23 (0.00%)
         occurrences all number
    2
    0
    0
    Adenoviral Conjunctivitis
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 31 (3.23%)
    0 / 23 (0.00%)
         occurrences all number
    0
    1
    0
    Erythema Infectiosum
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 31 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    0
    1
    Gastroenteritis Viral
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 31 (3.23%)
    0 / 23 (0.00%)
         occurrences all number
    0
    1
    0
    Genital Candidiasis
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 31 (0.00%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    0
    Hordeolum
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 31 (3.23%)
    0 / 23 (0.00%)
         occurrences all number
    0
    1
    0
    Lice Infestation
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 31 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    0
    1
    Mumps
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 31 (3.23%)
    0 / 23 (0.00%)
         occurrences all number
    0
    1
    0
    Oral Herpes
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 31 (3.23%)
    0 / 23 (0.00%)
         occurrences all number
    0
    1
    0
    Pharyngitis
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 31 (0.00%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    0
    Pharyngotonsillitis
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 31 (3.23%)
    0 / 23 (0.00%)
         occurrences all number
    0
    1
    0
    Pneumonia
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 31 (0.00%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    0
    Respiratory Syncytial Virus Bronchitis
         subjects affected / exposed
    1 / 49 (2.04%)
    0 / 31 (0.00%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    0
    Streptococcal Infection
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 31 (3.23%)
    0 / 23 (0.00%)
         occurrences all number
    0
    1
    0
    Vulvovaginitis
         subjects affected / exposed
    0 / 49 (0.00%)
    1 / 31 (3.23%)
    0 / 23 (0.00%)
         occurrences all number
    0
    1
    0

    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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