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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 Perennial Allergic Rhinitis.

    Summary
    EudraCT number
    		 2017-000239-15
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    13 Aug 2011

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Jun 2017
    First version publication date
    25 Jun 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    SFY10717
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01244217
    WHO universal trial number (UTN)
    		 U1111-1115-3842
    Sponsors
    Sponsor organisation name
    Sanofi Aventis Recherche & Developpement
    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
    08 Sep 2011
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    13 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 perennial allergic rhinitis (PAR).
    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
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    27 Oct 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: 109
    Worldwide total number of subjects
    109
    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)
    7
    Children (2-11 years)
    102
    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 15 centres in Japan from 27 October 2010 to 16 May 2011.

    Pre-assignment
    Screening details
    		 Out of 199 subjects screened, 90 were screen failures and 109 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
    7
    51
    51
    Completed 4-Week Main Treatment Period
    7
    51
    51
    Entered 8-Week Extension Period
    6
    46
    50
    Completed
    6
    46
    49
    Not completed
    1
    5
    2
         Consent withdrawn by subject
    -
    -
    1
         Did not enter 8-week extension phase
    1
    5
    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
    		 7 51 51 109
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 1 ± 0 4.4 ± 1.3 8.8 ± 1.3 -
    Gender categorical
    Units: Subjects
        Female
    		 3 18 16 37
        Male
    		 4 33 35 72

    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/ guardian during the study. Safety population consisted of 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
    7
    51
    51
    Units: subjects
    2
    39
    28
    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
    7
    51
    51
    Units: subjects
        Creatinine
    0
    2
    0
        Alanine Transaminase
    0
    0
    0
        Aspartate Aminotransferase
    0
    0
    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
    51
    51
    Units: subjects
        Hemoglobin
    1
    1
        Hematocrit
    10
    4
        Red Blood Cell Count
    0
    0
        Platelets
    0
    0
        White Blood Cell Count
    0
    0
        Blood Urea Nitrogen
    0
    0
        Alkaline Phosphatase
    0
    0
    No statistical analyses for this end point

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

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    End point title
    		 Number of Subjects With Adverse Events 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/ guardian during the study. Safety population consisted of 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
    7
    51
    51
    Units: subjects
    6
    46
    38
    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
    7
    51
    51
    Units: subjects
        Creatinine
    0
    2
    1
        Alanine Transaminase
    0
    0
    0
        Aspartate Aminotransferase
    0
    0
    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
    51
    51
    Units: subjects
        Hemoglobin
    1
    1
        Hematocrit
    18
    7
        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 Average Total Nasal Symptom Scores (TNSS) Through Week 4 on Subject Diary

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    End point title
    		 Change From Baseline in Average Total Nasal Symptom Scores (TNSS) Through Week 4 on Subject Diary [6]
    End point description
    Subject’s guardian assessed nasal symptoms using assessment criteria of nasal symptom severity. The guardian observed child’s condition as well as listening to child’s complaints about nasal symptoms, and then entered nasal symptom scores in subject's diary. TNSS was assessed based on the scores of 3 individual nasal symptoms as: paroxysmal sneezing, nasal discharge and nasal congestion. Each symptom was scored on a 5-point scale ranges from 0=no symptoms to 4=severe symptoms. TNSS was derived from the sum of scores from each individual symptoms and ranges from 0=best outcome to 12=worst outcome. 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 total scores of 3 nasal symptoms for subjects aged 2 years & older or nasal findings for subjects aged <2 years both baseline & post treatment were available.
    End point type
    Secondary
    End point timeframe
    Baseline through Week 4
    Notes
    [6] - 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
    51
    51
    Units: scores on a scale
        arithmetic mean (standard deviation)
    -1.63 ± 1.99
    -1.92 ± 1.77
    No statistical analyses for this end point

    Secondary: Change From Baseline in Total Nasal Symptom Severity Scores (TNSSS) Assessed by Investigator or Sub-Investigator at Week 2 and 4

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    End point title
    		 Change From Baseline in Total Nasal Symptom Severity Scores (TNSSS) Assessed by Investigator or Sub-Investigator at Week 2 and 4 [7]
    End point description
    TNSSS was assessed by the investigator, sub-investigator and was based on the scores of 3 individual nasal symptoms (paroxysmal sneezing, nasal discharge, and nasal congestion), in view of physical examinations and nasal findings. Each symptom was scored on a 5-point scale ranges from 0=no symptoms to 4=severe symptoms. TNSS was derived from the sum of scores from each individual symptoms and ranges from 0=best outcome to 12=worst outcome. 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 total scores of 3 nasal symptoms for subjects aged 2 years & older or nasal findings for subjects aged <2 years both baseline & post treatment were available.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 2, Week 4
    Notes
    [7] - 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
    51
    51
    Units: scores on scale
    arithmetic mean (standard deviation)
        Week 2
    -1.3 ± 2
    -1.7 ± 1.8
        Week 4
    -2.4 ± 1.8
    -2.4 ± 2.3
    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 adverse events 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
    0 / 7 (0.00%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    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
    6 / 7 (85.71%)
    46 / 51 (90.20%)
    38 / 51 (74.51%)
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 7 (14.29%)
    7 / 51 (13.73%)
    2 / 51 (3.92%)
         occurrences all number
    1
    7
    2
    Chest Discomfort
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
         occurrences all number
    0
    2
    0
    Immune system disorders
    Seasonal Allergy
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 51 (1.96%)
    1 / 51 (1.96%)
         occurrences all number
    0
    1
    1
    Respiratory, thoracic and mediastinal disorders
    Epistaxis
         subjects affected / exposed
    0 / 7 (0.00%)
    9 / 51 (17.65%)
    1 / 51 (1.96%)
         occurrences all number
    0
    10
    2
    Cough
         subjects affected / exposed
    1 / 7 (14.29%)
    2 / 51 (3.92%)
    1 / 51 (1.96%)
         occurrences all number
    1
    2
    1
    Pharyngeal Erythema
         subjects affected / exposed
    0 / 7 (0.00%)
    2 / 51 (3.92%)
    0 / 51 (0.00%)
         occurrences all number
    0
    2
    0
    Allergic Bronchitis
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    0
    1
    Oropharyngeal Pain
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    0
    1
    Investigations
    White Blood Cell Count Decreased
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
         occurrences all number
    0
    1
    0
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    0
    1
    Ear Abrasion
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    0
    1
    Foreign Body
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
         occurrences all number
    0
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 7 (0.00%)
    3 / 51 (5.88%)
    1 / 51 (1.96%)
         occurrences all number
    0
    3
    1
    Somnolence
         subjects affected / exposed
    0 / 7 (0.00%)
    2 / 51 (3.92%)
    1 / 51 (1.96%)
         occurrences all number
    0
    2
    1
    Blood and lymphatic system disorders
    Lymphadenitis
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
         occurrences all number
    0
    1
    0
    Ear and labyrinth disorders
    Tympanic Membrane Disorder
         subjects affected / exposed
    0 / 7 (0.00%)
    2 / 51 (3.92%)
    0 / 51 (0.00%)
         occurrences all number
    0
    2
    0
    Ear Pain
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
         occurrences all number
    0
    1
    0
    External Ear Pain
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
         occurrences all number
    0
    1
    0
    Eye disorders
    Conjunctivitis Allergic
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 51 (1.96%)
    1 / 51 (1.96%)
         occurrences all number
    0
    1
    1
    Chalazion
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
         occurrences all number
    0
    1
    0
    Keratitis
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    0
    1
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    0 / 7 (0.00%)
    6 / 51 (11.76%)
    1 / 51 (1.96%)
         occurrences all number
    0
    6
    1
    Diarrhoea
         subjects affected / exposed
    0 / 7 (0.00%)
    6 / 51 (11.76%)
    0 / 51 (0.00%)
         occurrences all number
    0
    6
    0
    Abdominal Pain
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 51 (1.96%)
    2 / 51 (3.92%)
         occurrences all number
    0
    1
    2
    Cheilitis
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 51 (1.96%)
    1 / 51 (1.96%)
         occurrences all number
    0
    1
    1
    Constipation
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 51 (1.96%)
    1 / 51 (1.96%)
         occurrences all number
    0
    1
    1
    Abdominal Pain Lower
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
         occurrences all number
    0
    1
    0
    Abdominal Pain Upper
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
         occurrences all number
    0
    1
    0
    Dental Caries
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
         occurrences all number
    0
    1
    0
    Nausea
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Dermatitis
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    0
    1
    Dermatitis Allergic
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
         occurrences all number
    0
    1
    0
    Rash
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    0
    Urticaria
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
         occurrences all number
    0
    1
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    4 / 7 (57.14%)
    26 / 51 (50.98%)
    22 / 51 (43.14%)
         occurrences all number
    5
    38
    32
    Influenza
         subjects affected / exposed
    1 / 7 (14.29%)
    6 / 51 (11.76%)
    10 / 51 (19.61%)
         occurrences all number
    1
    6
    10
    Acute Sinusitis
         subjects affected / exposed
    0 / 7 (0.00%)
    5 / 51 (9.80%)
    5 / 51 (9.80%)
         occurrences all number
    0
    8
    6
    Bronchitis
         subjects affected / exposed
    0 / 7 (0.00%)
    3 / 51 (5.88%)
    3 / 51 (5.88%)
         occurrences all number
    0
    3
    3
    Gastroenteritis
         subjects affected / exposed
    1 / 7 (14.29%)
    2 / 51 (3.92%)
    2 / 51 (3.92%)
         occurrences all number
    1
    2
    2
    Acute Tonsillitis
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 51 (1.96%)
    2 / 51 (3.92%)
         occurrences all number
    0
    1
    2
    Erythema Infectiosum
         subjects affected / exposed
    0 / 7 (0.00%)
    2 / 51 (3.92%)
    0 / 51 (0.00%)
         occurrences all number
    0
    2
    0
    Impetigo
         subjects affected / exposed
    0 / 7 (0.00%)
    2 / 51 (3.92%)
    0 / 51 (0.00%)
         occurrences all number
    0
    2
    0
    Otitis Externa
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 51 (1.96%)
    1 / 51 (1.96%)
         occurrences all number
    0
    1
    1
    Otitis Media
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 51 (1.96%)
    1 / 51 (1.96%)
         occurrences all number
    0
    1
    2
    Bacterial Diarrhoea
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
         occurrences all number
    0
    1
    0
    Enteritis Infectious
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
         occurrences all number
    0
    1
    0
    Furuncle
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
         occurrences all number
    0
    1
    0
    Gastroenteritis Viral
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
         occurrences all number
    0
    1
    0
    Hand-Foot-And-Mouth Disease
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
         occurrences all number
    0
    1
    0
    Mumps
         subjects affected / exposed
    1 / 7 (14.29%)
    0 / 51 (0.00%)
    0 / 51 (0.00%)
         occurrences all number
    1
    0
    0
    Nasal Vestibulitis
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
         occurrences all number
    0
    1
    0
    Oral Herpes
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
         occurrences all number
    0
    1
    0
    Otitis Media Acute
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
         occurrences all number
    0
    1
    0
    Pharyngitis
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    0
    1
    Varicella
         subjects affected / exposed
    0 / 7 (0.00%)
    1 / 51 (1.96%)
    0 / 51 (0.00%)
         occurrences all number
    0
    1
    0
    Metabolism and nutrition disorders
    Decreased Appetite
         subjects affected / exposed
    0 / 7 (0.00%)
    0 / 51 (0.00%)
    1 / 51 (1.96%)
         occurrences all number
    0
    0
    1

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

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