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    Clinical Trial Results:
    Double-blind, double-dummy, multi-center, randomized parallel group study to demonstrate therapeutic equivalence of Salmeterol/Fluticasone DPI HEXAL versus SeretideTM 100 AccuhalerTM over a period of 12 weeks in pediatric patients with persistent moderate asthma

    Summary
    EudraCT number
    		 2007-005630-36
    Trial protocol
    		 LT   PL  
    Global end of trial date
    22 Feb 2010

    Results information
    Results version number
    		 v2(current)
    This version publication date
    24 Mar 2016
    First version publication date
    05 Aug 2015
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Information about articel 46 was wrong

    Trial information

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    Trial identification
    Sponsor protocol code
    2006-57-DPI-2
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    HEXAL AG
    Sponsor organisation address
    Industriestraße 25, Holzkirchen, Germany, 83607
    Public contact
    Head of Clinical Research Department, Hexal AG, 0049 80249080,
    Scientific contact
    Head of Clinical Research Department, Hexal AG, 0049 80249080,
    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
    26 Nov 2010
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 Feb 2010
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Feb 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective of this study was to evaluate the long-term efficacy and safety of Salmeterol/Fluticasone DPI HEXAL compared to SeretideTM 100 AccuhalerTM in pediatric patients suffering from persistent moderate asthma.
    Protection of trial subjects
    Safety assessments included adverse events (AEs), physical examination, ECG, vital signs and clinical laboratory data. This study was conducted in accordance with International Conference on Harmonisation of Good Clinical Practice, the principles of the Declaration of Helsinki, as well as other applicable local ethical and legal requirements.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    22 Jul 2009
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Lithuania: 34
    Country: Number of subjects enrolled
    Poland: 71
    Country: Number of subjects enrolled
    Romania: 13
    Country: Number of subjects enrolled
    Ukraine: 100
    Worldwide total number of subjects
    218
    EEA total number of subjects
    118
    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)
    0
    Children (2-11 years)
    218
    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
    		 Double-blind, double-dummy, multi-center, randomized, parallel group study in pediatric patients with persistent moderate asthma.

    Pre-assignment
    Screening details
    		 A total number of 229 patients where screened and 218 patients were randomized. The study consisted of a 2-week run-in wash-out period and a 12-week blinded treatment period. A screening visit (Visit -1) was followed by a 2-week run-in wash-out period during which all asthma treatments except reliever medication were to be stopped.

    Pre-assignment period milestones
    Number of subjects started
    		 229 [1]
    Number of subjects completed
    		 218

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Ineligibility: 8
    Reason: Number of subjects
    		 Other reason: 1
    Reason: Number of subjects
    		 Consent withdrawn by subject: 2
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 11 Patients dropped out according to protocol.
    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Salmeterol/Fluticasone DPI HEXAL
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Salmeterol/Fluticasone DPI HEXAL
    Investigational medicinal product code
    Other name
    NA
    Pharmaceutical forms
    Pressurised inhalation
    Routes of administration
    Inhalation use
    Dosage and administration details
    Salmeterol/Fluticasone DPI HEXAL (50 μg salmeterol/100 μg fluticasone per actuation), one actuation two times per day

    Arm title
    		 Seretide 100 Accuhaler
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Seretide 100 Accuhaler
    Investigational medicinal product code
    Other name
    NA
    Pharmaceutical forms
    Pressurised inhalation
    Routes of administration
    Inhalation use
    Dosage and administration details
    Seretide 100 Accuhaler (50 μg salmeterol/100 μg fluticasone per actuation), one actuation two times per day

    Number of subjects in period 1
    		Salmeterol/Fluticasone DPI HEXAL Seretide 100 Accuhaler
    Started
    110
    108
    Completed
    108
    106
    Not completed
    2
    2
         Consent withdrawn by subject
    1
    1
         Lost to follow-up
    1
    -
         Protocol deviation
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Salmeterol/Fluticasone DPI HEXAL
    Reporting group description
    		 -

    Reporting group title
    Seretide 100 Accuhaler
    Reporting group description
    		 -

    Reporting group values
    		 Salmeterol/Fluticasone DPI HEXAL Seretide 100 Accuhaler Total
    Number of subjects
    		 110 108 218
    Age Categorical
    Age Categorical Characteristic
    Units: Subjects
        In Utero
    		 0 0 0
        Preterm newborn- gestational age < 37 wk
    		 0 0 0
        Newborns (0-27days)
    		 0 0 0
        Infants and toddlers (28days – 23months)
    		 0 0 0
        Children (2-11 years)
    		 110 108 218
        Adolescents (12-17 year)
    		 0 0 0
        From 18 - 64 years
    		 0 0 0
        From 65 – 84 years
    		 0 0 0
        Over 85 years
    		 0 0 0
    Age Continuous
    Age Continuous Characteristic
    Units: Years
        arithmetic mean (standard deviation)
    		 8.1 ( 2 ) 8.5 ( 1.8 ) -
    Gender Categorical
    Gender Categorical Characteristic
    Units: Subjects
        Female
    		 38 39 77
        Male
    		 72 69 141

    End points

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    End points reporting groups
    Reporting group title
    Salmeterol/Fluticasone DPI HEXAL
    Reporting group description
    		 -

    Reporting group title
    Seretide 100 Accuhaler
    Reporting group description
    		 -

    Subject analysis set title
    Salmeterol/Fluticasone DPI HEXAL (6-11 years) - Safety Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The analysis set consists of all patients who were randomized and received at least one dose of IP.

    Subject analysis set title
    Seretide 100 Accuhaler (4-5 years) - Safety Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The analysis set consists of all patients who were randomized and received at least one dose of IP.

    Subject analysis set title
    Salmeterol/Fluticasone DPI HEXAL (4-5 years) - Safety Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The analysis set consists of all patients who were randomized and received at least one dose of IP.

    Subject analysis set title
    Seretide 100 Accuhaler (4-5 years) - FAS
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The analysis set consists of all patients who were included in the Safety Set and had clinic FEV1 data after the baseline visit.

    Subject analysis set title
    Salmeterol/Fluticasone DPI HEXAL (6-11 years) - FAS
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The analysis set consists of all patients who were included in the Safety Set and had clinic FEV1 data after the baseline visit.

    Subject analysis set title
    Seretide 100 Accuhaler (6-11 years) - Safety Set
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The analysis set consists of all patients who were randomized and received at least one dose of IP.

    Subject analysis set title
    Salmeterol/Fluticasone DPI HEXAL (4-5 years) - FAS
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The analysis set consists of all patients who were included in the SS and had clinic FEV1 data after the baseline visit.

    Subject analysis set title
    Salmeterol/Fluticasone DPI HEXAL (6-11 years) - PPS
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The analysis set consists of all patients who were included in the FAS and completed the study and had no major protocol violations.

    Subject analysis set title
    Seretide 100 Accuhaler (6-11 years) - FAS
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The analysis set consists of all patients who were included in the Safety Set and had clinic FEV1 data after the baseline visit.

    Subject analysis set title
    Seretide 100 Accuhaler (6-11 years) - PPS
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The analysis set consists of all patients who were included in the FAS and completed the study and had no major protocol violations.

    Primary: Relative Change in FEV1 from baseline to the end of treatment period

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    End point title
    		 Relative Change in FEV1 from baseline to the end of treatment period
    End point description
    The change in FEV1 from baseline at the end of the 12- week treatment period. Missing values of the primary endpoint ‘relative change in FEV1’ were replaced using the last-value carried- forward strategy as follows: in case if both pre–dose FEV1 values was missing at Visit 6/ET, the last value observed under treatment before Visit 6/ET was imputed as Visit 6/ET value. If there is no such last value under treatment, no imputation was made. If there is only one assessment of FEV1 pre-dose values at Visit 0 or Visit 6/ET is done, the available value was used for analysis.
    End point type
    Primary
    End point timeframe
    End of 12 weeks treatment period
    End point values
    		 Salmeterol/Fluticasone DPI HEXAL (6-11 years) - PPS Seretide 100 Accuhaler (6-11 years) - PPS
    Number of subjects analysed
    96
    98
    Units: Litre
    arithmetic mean (standard deviation)
        Baseline, FEV1
    1.377 ( 0.296 )
    1.402 ( 0.275 )
        Endpoint, FEV1
    1.853 ( 0.439 )
    1.865 ( 0.4 )
        Relative Change from Baseline (%)
    35.4 ( 21.37 )
    33.9 ( 19.97 )
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    An Analysis of Covariance (ANCOVA) using treatment and centre as factors and baseline FEV1 (mean of the 2 pre-dose values at Visit 0) and age as co-variables was performed on the change.
    Comparison groups
    Salmeterol/Fluticasone DPI HEXAL (6-11 years) - PPS v Seretide 100 Accuhaler (6-11 years) - PPS
    Number of subjects included in analysis
    194
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.646
    Method
    		 ANCOVA
    Parameter type
    		 Mean Difference
    Point estimate
    0.011932
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.039171
         upper limit
    		 0.063036

    Primary: The area under the 4-hour serial FEV1 curve (AUC0-4) at the end of the 12-week treatment period (Visit 6) relative to the mean FEV1 value at Visit 6 pre-inhalation

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    End point title
    		 The area under the 4-hour serial FEV1 curve (AUC0-4) at the end of the 12-week treatment period (Visit 6) relative to the mean FEV1 value at Visit 6 pre-inhalation
    End point description
    The area under the 4-hour serial FEV1 curve (AUC0-4) at the end of the 12-week treatment period (Visit 6) relative to the mean FEV1 value at Visit 6 pre-inhalation. Missing values of the second primary endpoint ‘FEV1 AUC(0-4)’ were replaced using linear interpolation.
    End point type
    Primary
    End point timeframe
    At the end of the double blind treatment period
    End point values
    		 Salmeterol/Fluticasone DPI HEXAL (6-11 years) - PPS Seretide 100 Accuhaler (6-11 years) - PPS
    Number of subjects analysed
    96
    98
    Units: Litre
    arithmetic mean (standard deviation)
        FEV1 pre-IP Inhalation
    1.853 ( 0.439 )
    1.865 ( 0.4 )
        AUC(0—4)/4 (L) at V6/ET
    1.92 ( 0.45 )
    1.959 ( 0.423 )
        Ratio of AUC(0—4)/4 and FEV1 pre-IP Inhalation
    1.039 ( 0.059 )
    1.052 ( 0.081 )
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    An Analysis of Covariance (ANCOVA) was performed using treatment and centre as factors, age and log transformed pre-inhalation FEV1 as co-variables.
    Comparison groups
    Salmeterol/Fluticasone DPI HEXAL (6-11 years) - PPS v Seretide 100 Accuhaler (6-11 years) - PPS
    Number of subjects included in analysis
    194
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.142
    Method
    		 ANCOVA
    Parameter type
    		 Ratio
    Point estimate
    0.987814
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.971726
         upper limit
    		 1.004169

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the first intake of investigational product (IP) till the patient’s last study visit.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    12.1
    Reporting groups
    Reporting group title
    Salmeterol/Fluticasone DPI HEXAL (4-5 years) - Safety Set
    Reporting group description
    		 -

    Reporting group title
    Seretide 100 Accuhaler (4-5 years) - Safety Set
    Reporting group description
    		 -

    Reporting group title
    Seretide 100 Accuhaler (6-11 years) - Safety Set
    Reporting group description
    		 -

    Reporting group title
    Salmeterol/Fluticasone DPI HEXAL (6-11 years) - Safety Set
    Reporting group description
    		 -

    Serious adverse events
    		 Salmeterol/Fluticasone DPI HEXAL (4-5 years) - Safety Set Seretide 100 Accuhaler (4-5 years) - Safety Set Seretide 100 Accuhaler (6-11 years) - Safety Set Salmeterol/Fluticasone DPI HEXAL (6-11 years) - Safety Set
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    2 / 102 (1.96%)
    0 / 100 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    1 / 102 (0.98%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    1 / 102 (0.98%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Respiratory tract infection
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    1 / 102 (0.98%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory tract infection viral
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    1 / 102 (0.98%)
    0 / 100 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Salmeterol/Fluticasone DPI HEXAL (4-5 years) - Safety Set Seretide 100 Accuhaler (4-5 years) - Safety Set Seretide 100 Accuhaler (6-11 years) - Safety Set Salmeterol/Fluticasone DPI HEXAL (6-11 years) - Safety Set
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 10 (40.00%)
    4 / 6 (66.67%)
    39 / 102 (38.24%)
    48 / 100 (48.00%)
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    1 / 102 (0.98%)
    0 / 100 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Weight increased
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    1 / 102 (0.98%)
    0 / 100 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Injury, poisoning and procedural complications
    Traumatic arthritis
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    1 / 102 (0.98%)
    0 / 100 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 6 (16.67%)
    1 / 102 (0.98%)
    0 / 100 (0.00%)
         occurrences all number
    0
    1
    3
    0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 6 (16.67%)
    0 / 102 (0.00%)
    3 / 100 (3.00%)
         occurrences all number
    0
    1
    0
    4
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    0 / 102 (0.00%)
    1 / 100 (1.00%)
         occurrences all number
    0
    0
    0
    1
    Diarrhoea
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    0 / 102 (0.00%)
    1 / 100 (1.00%)
         occurrences all number
    0
    0
    0
    1
    Dyspepsia
         subjects affected / exposed
    1 / 10 (10.00%)
    1 / 6 (16.67%)
    1 / 102 (0.98%)
    2 / 100 (2.00%)
         occurrences all number
    1
    1
    1
    4
    Gastritis
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 6 (0.00%)
    0 / 102 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Gastrointestinal disorder
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    1 / 102 (0.98%)
    1 / 100 (1.00%)
         occurrences all number
    0
    0
    1
    1
    Toothache
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    0 / 102 (0.00%)
    1 / 100 (1.00%)
         occurrences all number
    0
    0
    0
    1
    Vomiting
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    0 / 102 (0.00%)
    1 / 100 (1.00%)
         occurrences all number
    0
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    0 / 102 (0.00%)
    3 / 100 (3.00%)
         occurrences all number
    0
    0
    0
    3
    Cough
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    0 / 102 (0.00%)
    2 / 100 (2.00%)
         occurrences all number
    0
    0
    0
    2
    Nasal septum deviation
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    0 / 102 (0.00%)
    1 / 100 (1.00%)
         occurrences all number
    0
    0
    0
    1
    Dysphonia
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    1 / 102 (0.98%)
    2 / 100 (2.00%)
         occurrences all number
    0
    0
    1
    2
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 6 (16.67%)
    0 / 102 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Musculoskeletal and connective tissue disorders
    Growth retardation
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    0 / 102 (0.00%)
    3 / 100 (3.00%)
         occurrences all number
    0
    0
    0
    3
    Jaw cyst
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    1 / 102 (0.98%)
    0 / 100 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Infections and infestations
    Acute tonsillitis
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    0 / 102 (0.00%)
    1 / 100 (1.00%)
         occurrences all number
    0
    0
    0
    1
    Bronchitis
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    0 / 102 (0.00%)
    2 / 100 (2.00%)
         occurrences all number
    0
    0
    0
    2
    Bronchopneumonia
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    1 / 102 (0.98%)
    0 / 100 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Ear lobe infection
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    0 / 102 (0.00%)
    1 / 100 (1.00%)
         occurrences all number
    0
    0
    0
    1
    Herpes dermatitis
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    0 / 102 (0.00%)
    1 / 100 (1.00%)
         occurrences all number
    0
    0
    0
    1
    Influenza
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    3 / 102 (2.94%)
    3 / 100 (3.00%)
         occurrences all number
    0
    0
    3
    3
    Nasopharyngitis
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 6 (0.00%)
    3 / 102 (2.94%)
    7 / 100 (7.00%)
         occurrences all number
    1
    0
    4
    7
    Laryngitis
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    0 / 102 (0.00%)
    1 / 100 (1.00%)
         occurrences all number
    0
    0
    0
    1
    Pharyngitis
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 6 (16.67%)
    9 / 102 (8.82%)
    5 / 100 (5.00%)
         occurrences all number
    0
    1
    9
    5
    Respiratory tract infection
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    4 / 102 (3.92%)
    8 / 100 (8.00%)
         occurrences all number
    0
    0
    5
    11
    Respiratory tract infection viral
         subjects affected / exposed
    1 / 10 (10.00%)
    1 / 6 (16.67%)
    9 / 102 (8.82%)
    6 / 100 (6.00%)
         occurrences all number
    1
    1
    9
    6
    Rhinitis
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    4 / 102 (3.92%)
    5 / 100 (5.00%)
         occurrences all number
    0
    0
    4
    6
    Sinusitis
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    0 / 102 (0.00%)
    1 / 100 (1.00%)
         occurrences all number
    0
    0
    0
    1
    Skin infection
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    1 / 102 (0.98%)
    0 / 100 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Tracheitis
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    0 / 102 (0.00%)
    1 / 100 (1.00%)
         occurrences all number
    0
    0
    0
    1
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 10 (10.00%)
    1 / 6 (16.67%)
    3 / 102 (2.94%)
    2 / 100 (2.00%)
         occurrences all number
    1
    1
    3
    3
    Urinary tract infection
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    0 / 102 (0.00%)
    2 / 100 (2.00%)
         occurrences all number
    0
    0
    0
    2
    Varicella
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 6 (16.67%)
    0 / 102 (0.00%)
    1 / 100 (1.00%)
         occurrences all number
    0
    1
    0
    1
    Viral rhinitis
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    2 / 102 (1.96%)
    3 / 100 (3.00%)
         occurrences all number
    0
    0
    2
    4
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    4 / 102 (3.92%)
    2 / 100 (2.00%)
         occurrences all number
    0
    0
    5
    2

    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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    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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