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    Clinical Trial Results:
    A phase III, randomised, observer-blind, multicentre study to evaluate the immunogenicity and safety of a 2-dose vaccination with the new process manufactured adjuvanted pandemic H1N1 influenza candidate vaccine in children aged 3 to 9 years old.

    Summary
    EudraCT number
    		 2009-015960-32
    Trial protocol
    		 CZ  
    Global end of trial date
    14 Jan 2011

    Results information
    Results version number
    		 v2(current)
    This version publication date
    15 Dec 2022
    First version publication date
    23 May 2015
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Correction of full data set and alignment between registries.

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    113810
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01014091
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline Biologicals
    Sponsor organisation address
    Rue de l’Institut 89, Rixensart, Belgium, B-1330
    Public contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.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
    31 May 2011
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    14 Jan 2011
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Jan 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate whether the humoral immune response of the 3.75 µg dosage with AS03A H1N1 candidate vaccine meets or exceeds the CHMP criteria at 21 days post-dose 2 vaccination. To evaluate whether the humoral immune response of the 1.9 µg dosage with AS03B H1N1 candidate vaccine meets or exceeds the CHMP criteria at 21 days post-dose 2 vaccination.
    Protection of trial subjects
    The vaccines were observed closely for at least 60 minutes following the administration of the vaccine with appropriate medical treatment readily available in case of a rare anaphylactic reaction. Vaccines were administered by qualified and trained personnel. Vaccines were administered only to eligible subjects that had no contraindications to any components of the vaccines.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    07 Dec 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
    Czech Republic: 60
    Worldwide total number of subjects
    60
    EEA total number of subjects
    60
    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)
    60
    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
    		 -

    Pre-assignment
    Screening details
    		 From a total of 60 subjects enrolled in the study only 58 were vaccinated.

    Pre-assignment period milestones
    Number of subjects started
    		 60
    Number of subjects completed
    		 58

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Unvaccinated: 2
    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Subject
    Blinding implementation details
    Data was collected in an observer-blind manner. By observer-blind, it was meant that during the course of the study, the vaccine recipient and those responsible for the evaluation of any study endpoint (e.g. safety, reactogenicity) were all unaware of which vaccine was administered. To do so, vaccine preparation and administration was done by authorized medical personnel who did not participate in any of the study clinical evaluation assay.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 GSK2340272A F1 Y3-5 Group
    Arm description
    		 Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
    Arm type
    		 Experimental

    Investigational medicinal product name
    GSK2340272A vaccine
    Investigational medicinal product code
    Other name
    GSK pandemic vaccine
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    The vaccine was administered intramuscularly in the deltoid of the arm.

    Arm title
    		 GSK2340272A F1 Y6-9 Group
    Arm description
    		 Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
    Arm type
    		 Experimental

    Investigational medicinal product name
    GSK2340272A vaccine
    Investigational medicinal product code
    Other name
    GSK pandemic vaccine
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    The vaccine was administered intramuscularly in the deltoid of the arm.

    Arm title
    		 GSK2340272A F2 Y3-5 Group
    Arm description
    		 Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
    Arm type
    		 Experimental

    Investigational medicinal product name
    GSK2340272A vaccine
    Investigational medicinal product code
    Other name
    GSK pandemic vaccine
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    The vaccine was administered intramuscularly in the deltoid of the arm.

    Arm title
    		 GSK2340272A F2 Y6-9 Group
    Arm description
    		 Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
    Arm type
    		 Experimental

    Investigational medicinal product name
    GSK2340272A vaccine
    Investigational medicinal product code
    Other name
    GSK pandemic vaccine
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    The vaccine was administered intramuscularly in the deltoid of the arm.

    Arm title
    		 GSK2340272A F3 Y3-5 Group
    Arm description
    		 Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
    Arm type
    		 Experimental

    Investigational medicinal product name
    GSK2340272A vaccine
    Investigational medicinal product code
    Other name
    GSK pandemic vaccine
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    The vaccine was administered intramuscularly in the deltoid of the arm.

    Arm title
    		 GSK2340272A F3 Y6-9 Group
    Arm description
    		 Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
    Arm type
    		 Experimental

    Investigational medicinal product name
    GSK2340272A vaccine
    Investigational medicinal product code
    Other name
    GSK pandemic vaccine
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    The vaccine was administered intramuscularly in the deltoid of the arm.

    Number of subjects in period 1 [1]
    		GSK2340272A F1 Y3-5 Group GSK2340272A F1 Y6-9 Group GSK2340272A F2 Y3-5 Group GSK2340272A F2 Y6-9 Group GSK2340272A F3 Y3-5 Group GSK2340272A F3 Y6-9 Group
    Started
    7
    13
    5
    15
    6
    12
    Completed
    7
    13
    5
    15
    6
    12
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: From a total of 60 subjects enrolled in this study, two subjects were excluded from the TVC because the study vaccine dose was notadministrated although a subject number was allocated.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    GSK2340272A F1 Y3-5 Group
    Reporting group description
    		 Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.

    Reporting group title
    GSK2340272A F1 Y6-9 Group
    Reporting group description
    		 Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.

    Reporting group title
    GSK2340272A F2 Y3-5 Group
    Reporting group description
    		 Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.

    Reporting group title
    GSK2340272A F2 Y6-9 Group
    Reporting group description
    		 Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.

    Reporting group title
    GSK2340272A F3 Y3-5 Group
    Reporting group description
    		 Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.

    Reporting group title
    GSK2340272A F3 Y6-9 Group
    Reporting group description
    		 Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.

    Reporting group values
    		 GSK2340272A F1 Y3-5 Group GSK2340272A F1 Y6-9 Group GSK2340272A F2 Y3-5 Group GSK2340272A F2 Y6-9 Group GSK2340272A F3 Y3-5 Group GSK2340272A F3 Y6-9 Group Total
    Number of subjects
    		 7 13 5 15 6 12 58
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 4.1 ± 0.9 7.5 ± 1.2 3.8 ± 0.84 7.3 ± 0.9 3.8 ± 0.98 7.6 ± 0.9 -
    Gender categorical
    Units: Subjects
        Female
    		 3 7 2 4 1 3 20
        Male
    		 4 6 3 11 5 9 38

    End points

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    End points reporting groups
    Reporting group title
    GSK2340272A F1 Y3-5 Group
    Reporting group description
    		 Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.

    Reporting group title
    GSK2340272A F1 Y6-9 Group
    Reporting group description
    		 Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.

    Reporting group title
    GSK2340272A F2 Y3-5 Group
    Reporting group description
    		 Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.

    Reporting group title
    GSK2340272A F2 Y6-9 Group
    Reporting group description
    		 Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.

    Reporting group title
    GSK2340272A F3 Y3-5 Group
    Reporting group description
    		 Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.

    Reporting group title
    GSK2340272A F3 Y6-9 Group
    Reporting group description
    		 Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.

    Subject analysis set title
    GSK2340272A Formulation 1 Group
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects received 2 doses of Flu vaccine formulation 1 according to a 0, 21-day schedule. Enrolment was further stratified by age: 3 – 5 years and 6 – 9 years.

    Subject analysis set title
    GSK2340272A Formulation 2 Group
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects received 2 doses of Flu vaccine formulation 2 according to a 0, 21-day schedule. Enrolment was further stratified by age: 3 – 5 years and 6 – 9 years.

    Subject analysis set title
    GSK2340272A Formulation 3 Group
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects received 2 doses of Flu vaccine formulation 3 according to a 0, 21-day schedule. Enrolment was further stratified by age: 3 – 5 years and 6 – 9 years.

    Primary: Haemagglutination inhibition (HI) antibody titers against vaccine H1N1 antigen

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    End point title
    		 Haemagglutination inhibition (HI) antibody titers against vaccine H1N1 antigen [1]
    End point description
    Humoral immune response in terms of vaccine H1N1 haemagglutination inhibition (HI) antibodies against A/California/7/2009 (H1N1)v-like virus (Flu A/CAL/7/09) has been assessed. Antibody titers were presented as geometric mean titers (GMTs). The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects who received 2 doses of study vaccine and for whom assay results were available for antibodies against H1N1 antigen for any blood sample taken up to Month 7 after first vaccine dose.
    End point type
    Primary
    End point timeframe
    At Day 42
    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: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 GSK2340272A Formulation 1 Group GSK2340272A Formulation 2 Group GSK2340272A Formulation 3 Group
    Number of subjects analysed
    13
    9
    12
    Units: Titers
    geometric mean (confidence interval 95%)
        Flu A/CAL/7/09
    954.6 (730 to 1248.4)
    838.1 (647 to 1085.5)
    359.1 (219.8 to 586.9)
    No statistical analyses for this end point

    Primary: Number of seropositive subjects for HI antibodies

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    End point title
    		 Number of seropositive subjects for HI antibodies [2]
    End point description
    A seropositive subject was defined as a subject with a serum HI titer equal to or above (≥) 1:10. The flu strain assessed was Flu A/CAL/7/09. The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 doses of study vaccine and for whom assay results were available for antibodies against H1N1 antigen for any blood sample taken up to Month 7 after first vaccine dose.
    End point type
    Primary
    End point timeframe
    At Day 42
    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: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 GSK2340272A Formulation 1 Group GSK2340272A Formulation 2 Group GSK2340272A Formulation 3 Group
    Number of subjects analysed
    13
    9
    12
    Units: Subjects
        Flu A/CAL/7/09 (N=13; 9; 12)
    13
    9
    12
    No statistical analyses for this end point

    Primary: Number of seroconverted subjects in terms of HI antibodies

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    End point title
    		 Number of seroconverted subjects in terms of HI antibodies [3]
    End point description
    Seroconversion (SCR) was defined as: For initially seronegative subjects [pre-vaccination titer below (<) 1:10], a post-vaccination titer ≥ 1:40. For initially seropositive subjects (pre-vaccination titer ≥ 1:10), at least a 4-fold increase in post-vaccination titer. The flu strain assessed was Flu A/CAL/7/09. The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 doses of study vaccine and for whom assay results were available for antibodies against H1N1 antigen for any blood sample taken up to Month 7 after first vaccine dose.
    End point type
    Primary
    End point timeframe
    At Day 42
    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: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 GSK2340272A Formulation 1 Group GSK2340272A Formulation 2 Group GSK2340272A Formulation 3 Group
    Number of subjects analysed
    13
    9
    12
    Units: Subjects
        Flu A/CAL/7/09
    13
    9
    12
    No statistical analyses for this end point

    Primary: Number of seroprotected subjects for HI antibodies

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    End point title
    		 Number of seroprotected subjects for HI antibodies [4]
    End point description
    A seroprotected subject was defined as a vaccinated subject with a serum HI titer ≥ 1:40, which is usually accepted as indicating protection. The flu strain assessed was Flu A/CAL/7/09. The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 doses of study vaccine and for whom assay results were available for antibodies against H1N1 antigen for any blood sample taken up to Month 7 after first vaccine dose.
    End point type
    Primary
    End point timeframe
    At Day 42
    Notes
    [4] - 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: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 GSK2340272A Formulation 1 Group GSK2340272A Formulation 2 Group GSK2340272A Formulation 3 Group
    Number of subjects analysed
    13
    9
    12
    Units: Subjects
        Flu A/CAL/7/09
    13
    9
    12
    No statistical analyses for this end point

    Primary: Geometric mean fold increase (GMFR) for serum HI antibody titer

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    End point title
    		 Geometric mean fold increase (GMFR) for serum HI antibody titer [5]
    End point description
    GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09. The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 doses of study vaccine and for whom assay results were available for antibodies against H1N1 antigen for any blood sample taken up to Month 7 after first vaccine dose.
    End point type
    Primary
    End point timeframe
    At Day 42
    Notes
    [5] - 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: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 GSK2340272A Formulation 1 Group GSK2340272A Formulation 2 Group GSK2340272A Formulation 3 Group
    Number of subjects analysed
    13
    9
    12
    Units: Fold increase
    geometric mean (confidence interval 95%)
        Flu A/CAL/7/09
    64 (25.9 to 158.2)
    71.9 (24.4 to 212.1)
    40.3 (27 to 60.3)
    No statistical analyses for this end point

    Secondary: HI antibody titers against vaccine H1N1 antigen

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    End point title
    		 HI antibody titers against vaccine H1N1 antigen
    End point description
    Humoral immune response in terms of vaccine H1N1 haemagglutination inhibition (HI) antibodies against A/California/7/2009 (H1N1)v-like virus (Flu A/CAL/7/09) has been assessed. Antibody titers were presented as geometric mean titers (GMTs). The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 doses of study vaccine and for whom assay results were available for antibodies against H1N1 antigen for any blood sample taken up to Month 7 after first vaccine dose.
    End point type
    Secondary
    End point timeframe
    At Day 0, Day 21 and Month 7
    End point values
    		 GSK2340272A Formulation 1 Group GSK2340272A Formulation 2 Group GSK2340272A Formulation 3 Group
    Number of subjects analysed
    13
    9
    12
    Units: Titers
    geometric mean (confidence interval 95%)
        Flu A/CAL/7/09, Day 0
    14.9 (6.9 to 32)
    11.7 (4.2 to 32.1)
    8.9 (4.9 to 16.2)
        Flu A/CAL/7/09, Day 21
    429.1 (268.9 to 684.6)
    285.3 (137.7 to 591.1)
    123.2 (40.5 to 374.9)
        Flu A/CAL/7/09, Month 7
    155.9 (104.1 to 233.6)
    108.7 (61.2 to 192.9)
    84.8 (53.7 to 134.1)
    No statistical analyses for this end point

    Secondary: Number of seropositive subjects for HI antibodies

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    End point title
    		 Number of seropositive subjects for HI antibodies
    End point description
    A seropositive subject was defined as a subject with a serum HI titer equal to or above (≥) 1:10. The flu strain assessed was Flu A/CAL/7/09. The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 doses of study vaccine and for whom assay results were available for antibodies against H1N1 antigen for any blood sample taken up to Month 7 after first vaccine dose.
    End point type
    Secondary
    End point timeframe
    At Day 0, Day 21 and Month 7
    End point values
    		 GSK2340272A Formulation 1 Group GSK2340272A Formulation 2 Group GSK2340272A Formulation 3 Group
    Number of subjects analysed
    13
    9
    12
    Units: Subjects
        Flu A/CAL/7/09, Day 0
    6
    3
    4
        Flu A/CAL/7/09, Day 21
    13
    9
    12
        Flu A/CAL/7/09, Month 7
    13
    9
    12
    No statistical analyses for this end point

    Secondary: Number of seroconverted subjects in terms of HI antibodies

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    End point title
    		 Number of seroconverted subjects in terms of HI antibodies
    End point description
    Seroconversion (SCR) was defined as: For initially seronegative subjects (pre-vaccination titer below < 1:10), a post-vaccination titer ≥ 1:40. For initially seropositive subjects (pre-vaccination titer ≥ 1:10), at least a 4-fold increase in post-vaccination titer. The flu strain assessed was Flu A/CAL/7/09. The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 doses of study vaccine and for whom assay results were available for antibodies against H1N1 antigen for any blood sample taken up to Month 7 after first vaccine dose.
    End point type
    Secondary
    End point timeframe
    At Day 21 and Month 7
    End point values
    		 GSK2340272A Formulation 1 Group GSK2340272A Formulation 2 Group GSK2340272A Formulation 3 Group
    Number of subjects analysed
    13
    9
    12
    Units: Subjects
        Flu A/CAL/7/09, Day 21
    13
    8
    9
        Flu A/CAL/7/09, Month 7
    12
    7
    10
    No statistical analyses for this end point

    Secondary: Number of seroprotected subjects for HI antibodies

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    End point title
    		 Number of seroprotected subjects for HI antibodies
    End point description
    A seroprotected subject was defined as a vaccinated subject with a serum HI titer ≥ 1:40, which is usually accepted as indicating protection. The flu strain assessed was Flu A/CAL/7/09. The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 doses of study vaccine and for whom assay results were available for antibodies against H1N1 antigen for any blood sample taken up to Month 7 after first vaccine dose.
    End point type
    Secondary
    End point timeframe
    At Day 0, Day 21 and Month 7
    End point values
    		 GSK2340272A Formulation 1 Group GSK2340272A Formulation 2 Group GSK2340272A Formulation 3 Group
    Number of subjects analysed
    13
    9
    12
    Units: Subjects
        Flu A/CAL/7/09, Day 0
    6
    2
    2
        Flu A/CAL/7/09, Day 21
    13
    9
    9
        Flu A/CAL/7/09, Month 7
    13
    8
    11
    No statistical analyses for this end point

    Secondary: Geometric mean fold increase (GMFR) for serum HI antibody titer

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    End point title
    		 Geometric mean fold increase (GMFR) for serum HI antibody titer
    End point description
    GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09. The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects who received 2 doses of study vaccine and for whom assay results were available for antibodies against H1N1 antigen for any blood sample taken up to Month 7 after first vaccine dose.
    End point type
    Secondary
    End point timeframe
    At Day 21 and Month 7
    End point values
    		 GSK2340272A Formulation 1 Group GSK2340272A Formulation 2 Group GSK2340272A Formulation 3 Group
    Number of subjects analysed
    13
    9
    12
    Units: Fold increase
    geometric mean (confidence interval 95%)
        Flu A/CAL/7/09, Day 21
    28.8 (16.4 to 50.5)
    24.5 (10 to 59.7)
    13.8 (7.2 to 26.5)
        Flu A/CAL/7/09, Month 7
    10.5 (6 to 18.3)
    9.3 (3.6 to 23.9)
    9.5 (5.9 to 15.3)
    No statistical analyses for this end point

    Secondary: Number of subjects with any and grade 3 solicited local symptoms

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    End point title
    		 Number of subjects with any and grade 3 solicited local symptoms
    End point description
    Assessed solicited local symptoms were pain, redness and swelling. Any = incidence of a particular symptom regardless of intensity grade or relationship to vaccinations. Grade 3 pain (children below 6 years of age) = cried when limb was moved/spontaneously painful. Grade 3 pain (children above 6 years of age) = significant pain at rest; pain that prevented normal everyday activities. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site. The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.
    End point type
    Secondary
    End point timeframe
    During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
    End point values
    		 GSK2340272A F1 Y3-5 Group GSK2340272A F1 Y6-9 Group GSK2340272A F2 Y3-5 Group GSK2340272A F2 Y6-9 Group GSK2340272A F3 Y3-5 Group GSK2340272A F3 Y6-9 Group
    Number of subjects analysed
    7
    13
    5
    15
    6
    12
    Units: Subjects
        Any Pain Dose 1
    6
    13
    3
    12
    1
    6
        Grade 3 Pain Dose 1
    0
    0
    0
    0
    0
    0
        Any Redness Dose 1
    5
    6
    1
    5
    2
    4
        Grade 3 Redness Dose 1
    0
    1
    0
    0
    0
    0
        Any Swelling Dose 1
    4
    6
    1
    6
    1
    2
        Grade 3 Swelling Dose 1
    0
    2
    0
    0
    0
    0
        Any Pain Dose 2
    5
    12
    3
    12
    1
    4
        Grade 3 Pain Dose 2
    0
    1
    0
    0
    0
    0
        Any Redness Dose 2
    4
    6
    2
    4
    3
    4
        Grade 3 Redness Dose 2
    0
    1
    0
    0
    1
    0
        Any Swelling Dose 2
    5
    9
    1
    5
    2
    3
        Grade 3 Swelling Dose 2
    0
    2
    0
    1
    1
    0
        Any Pain Across doses
    6
    13
    4
    13
    2
    6
        Grade 3 Pain Across doses
    0
    1
    0
    0
    0
    0
        Any Redness Across doses
    5
    9
    3
    8
    3
    7
        Grade 3 Redness Across doses
    0
    1
    0
    0
    1
    0
        Any Swelling Across doses
    6
    10
    2
    8
    3
    3
        Grade 3 Swelling Across doses
    0
    3
    0
    1
    1
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with any, grade 3 and related solicited general symptoms

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    End point title
    		 Number of subjects with any, grade 3 and related solicited general symptoms
    End point description
    Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = incidence of a particular symptom regardless of intensity grade or relationship to vaccinations. Grade 3 drowsiness = drowsiness which prevented normal everyday activities. Grade 3 irritability = crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as causally related to the vaccination. The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.
    End point type
    Secondary
    End point timeframe
    During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
    End point values
    		 GSK2340272A Formulation 1 Group GSK2340272A Formulation 2 Group GSK2340272A Formulation 3 Group
    Number of subjects analysed
    7
    5
    6
    Units: Subjects
        Any Drowsiness Dose 1
    3
    2
    3
        Grade 3 Drowsiness Dose 1
    0
    0
    0
        Related Drowsiness Dose 1
    0
    0
    0
        Any Irritability Dose 1
    2
    2
    0
        Grade 3 Irritability Dose 1
    0
    0
    0
        Related Irritability Dose 1
    0
    0
    0
        Any Loss of appetite Dose 1
    2
    0
    0
        Grade 3 Loss of appetite Dose 1
    0
    0
    0
        Related Loss of appetite Dose 1
    0
    0
    0
        Any Temperature Dose 1
    2
    0
    1
        Grade 3 Temperature Dose 1
    2
    0
    0
        Related Temperature Dose 1
    1
    0
    0
        Any Drowsiness Dose 2
    1
    0
    2
        Grade 3 Drowsiness Dose 2
    0
    0
    0
        Related Drowsiness Dose 2
    0
    0
    0
        Any Irritability Dose 2
    1
    1
    0
        Grade 3 Irritability Dose 2
    0
    0
    0
        Related Irritability Dose 2
    1
    0
    0
        Any Loss of appetite Dose 2
    1
    0
    0
        Grade 3 Loss of appetite Dose 2
    0
    0
    0
        Related Loss of appetite Dose 2
    0
    0
    0
        Any Temperature Dose 2
    0
    0
    1
        Grade 3 Temperature Dose 2
    0
    0
    0
        Related Temperature Dose 2
    0
    0
    0
        Any Drowsiness Across doses
    4
    2
    3
        Grade 3 Drowsiness Across doses
    0
    0
    0
        Related Drowsiness Across doses
    0
    0
    0
        Any Irritability Across doses
    3
    2
    0
        Grade 3 Irritability Across doses
    0
    0
    0
        Related Irritability Across doses
    1
    0
    0
        Any Loss of appetite Across doses
    3
    0
    0
        Grade 3 Loss of appetite Across doses
    0
    0
    0
        Related Loss of appetite Across doses
    0
    0
    0
        Any Temperature Across doses
    2
    0
    2
        Grade 3 Temperature Across doses
    2
    0
    0
        Related Temperature Across doses
    1
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with any, grade 3 and related solicited general symptoms

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    End point title
    		 Number of subjects with any, grade 3 and related solicited general symptoms
    End point description
    Assessed solicited general symptoms were fatigue, gastrointestinal, headache and temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = incidence of a particular symptom regardless of intensity grade or relationship to vaccinations. Grade 3 = symptom which prevented normal everyday activity. Related = symptom assessed by the investigator as causally related to the vaccination. Grade 3 fever = fever > 39.0 °C. The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.
    End point type
    Secondary
    End point timeframe
    During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
    End point values
    		 GSK2340272A Formulation 1 Group GSK2340272A Formulation 2 Group GSK2340272A Formulation 3 Group
    Number of subjects analysed
    13
    15
    12
    Units: Subjects
        Any Fatigue, D1
    5
    5
    8
        Grade 3 Fatigue, D1
    0
    0
    0
        Related Fatigue, D1
    3
    0
    2
        Any Gastrointestinal, D1
    3
    2
    2
        Grade 3 Gastrointestinal, D1
    0
    0
    0
        Related Gastrointestinal, D1
    1
    0
    0
        Any Headache, D1
    7
    5
    5
        Grade 3 Headache, D1
    0
    0
    0
        Related Headache, D1
    1
    0
    1
        Any Temperature/(Axillary), D1
    1
    1
    1
        Grade 3 Temperature/(Axillary), D1
    0
    0
    0
        Related Temperature/(Axillary), D1
    1
    0
    1
        Any Fatigue, D2
    6
    7
    1
        Grade 3 Fatigue, D2
    0
    2
    0
        Related Fatigue, D2
    2
    2
    1
        Any Gastrointestinal, D2
    4
    3
    0
        Grade 3 Gastrointestinal, D2
    0
    0
    0
        Related Gastrointestinal, D2
    2
    0
    0
        Any Headache, D2
    6
    9
    0
        Grade 3 Headache, D2
    1
    1
    0
        Related Headache, D2
    3
    2
    0
        Any Temperature/(Axillary), D2
    4
    1
    0
        Grade 3 Temperature/(Axillary), D2
    0
    0
    0
        Related Temperature/(Axillary), D2
    3
    1
    0
        Any Fatigue, Across doses
    6
    9
    8
        Grade 3 Fatigue, Across doses
    0
    2
    0
        Related Fatigue, Across doses
    3
    2
    3
        Any Gastrointestinal, Across doses
    4
    3
    2
        Grade 3 Gastrointestinal, Across doses
    0
    0
    0
        Related Gastrointestinal, Across doses
    2
    0
    0
        Any Headache, Across doses
    10
    9
    5
        Grade 3 Headache, Across doses
    1
    1
    0
        Related Headache, Across doses
    3
    2
    1
        Any Temperature/(Axillary), Across doses
    4
    2
    1
        Grade 3 Temperature/(Axillary), Across doses
    0
    0
    0
        Related Temperature/(Axillary), Across doses
    3
    1
    1
    No statistical analyses for this end point

    Secondary: Number of subjects with medically-attended events (MAEs)

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    End point title
    		 Number of subjects with medically-attended events (MAEs)
    End point description
    MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination. The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.
    End point type
    Secondary
    End point timeframe
    During the entire study period (from Month 0 up to Month 12)
    End point values
    		 GSK2340272A F1 Y3-5 Group GSK2340272A F1 Y6-9 Group GSK2340272A F2 Y3-5 Group GSK2340272A F2 Y6-9 Group GSK2340272A F3 Y3-5 Group GSK2340272A F3 Y6-9 Group
    Number of subjects analysed
    7
    13
    5
    15
    6
    12
    Units: Subjects
        Any MAEs
    4
    11
    5
    11
    6
    10
    No statistical analyses for this end point

    Secondary: Number of subjects with adverse events of specific interest (AESIs)/potential immune-mediated disease (pIMDs)

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    End point title
    		 Number of subjects with adverse events of specific interest (AESIs)/potential immune-mediated disease (pIMDs)
    End point description
    Adverse events of specific interest (AESI) were defined as AEs including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration. Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology. The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.
    End point type
    Secondary
    End point timeframe
    During the entire study period (from Month 0 up to Month 12)
    End point values
    		 GSK2340272A F1 Y3-5 Group GSK2340272A F1 Y6-9 Group GSK2340272A F2 Y3-5 Group GSK2340272A F2 Y6-9 Group GSK2340272A F3 Y3-5 Group GSK2340272A F3 Y6-9 Group
    Number of subjects analysed
    7
    13
    5
    15
    6
    12
    Units: Subjects
        Any AESI(s)/pIMD(s)
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with unsolicited adverse events (AEs)

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    End point title
    		 Number of subjects with unsolicited adverse events (AEs)
    End point description
    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination. The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.
    End point type
    Secondary
    End point timeframe
    Within the 42-day (Days 0-41) post-vaccination period
    End point values
    		 GSK2340272A F1 Y3-5 Group GSK2340272A F1 Y6-9 Group GSK2340272A F2 Y3-5 Group GSK2340272A F2 Y6-9 Group GSK2340272A F3 Y3-5 Group GSK2340272A F3 Y6-9 Group
    Number of subjects analysed
    7
    13
    5
    15
    6
    12
    Units: Subjects
        Any AEs
    1
    2
    0
    2
    2
    2
        Grade 3 AEs
    0
    1
    0
    0
    0
    0
        Related AEs
    0
    1
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with serious adverse events (SAEs)

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    End point title
    		 Number of subjects with serious adverse events (SAEs)
    End point description
    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects with at least 1 vaccine administration documented.
    End point type
    Secondary
    End point timeframe
    During the entire study period (from Month 0 to Month 12)
    End point values
    		 GSK2340272A F1 Y3-5 Group GSK2340272A F1 Y6-9 Group GSK2340272A F2 Y3-5 Group GSK2340272A F2 Y6-9 Group GSK2340272A F3 Y3-5 Group GSK2340272A F3 Y6-9 Group
    Number of subjects analysed
    7
    13
    5
    15
    6
    12
    Units: Subjects
        Any SAEs
    0
    1
    1
    1
    0
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited local and general symptoms: 7-day follow-up period after each vaccination; Unsolicited adverse events (AEs): during a 21-day follow-up period after each vaccination; Serious adverse events (SAEs): during the entire study period;
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.0
    Reporting groups
    Reporting group title
    GSK2340272A F2 Y3-5 Group
    Reporting group description
    		 Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.

    Reporting group title
    GSK2340272A F1 Y6-9 Group
    Reporting group description
    		 Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.

    Reporting group title
    GSK2340272A F2 Y6-9 Group
    Reporting group description
    		 Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.

    Reporting group title
    GSK2340272A F1 Y3-5 Group
    Reporting group description
    		 Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.

    Reporting group title
    GSK2340272A F3 Y6-9 Group
    Reporting group description
    		 Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.

    Reporting group title
    GSK2340272A F3 Y3-5 Group
    Reporting group description
    		 Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.

    Serious adverse events
    		 GSK2340272A F2 Y3-5 Group GSK2340272A F1 Y6-9 Group GSK2340272A F2 Y6-9 Group GSK2340272A F1 Y3-5 Group GSK2340272A F3 Y6-9 Group GSK2340272A F3 Y3-5 Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 5 (20.00%)
    1 / 13 (7.69%)
    1 / 15 (6.67%)
    0 / 7 (0.00%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Muscle injury
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 13 (7.69%)
    0 / 15 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Contusion
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
    0 / 7 (0.00%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 13 (0.00%)
    1 / 15 (6.67%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Adenoidal hypertrophy
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Acute tonsillitis
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 13 (7.69%)
    0 / 15 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 13 (7.69%)
    0 / 15 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 GSK2340272A F2 Y3-5 Group GSK2340272A F1 Y6-9 Group GSK2340272A F2 Y6-9 Group GSK2340272A F1 Y3-5 Group GSK2340272A F3 Y6-9 Group GSK2340272A F3 Y3-5 Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 5 (80.00%)
    13 / 13 (100.00%)
    15 / 15 (100.00%)
    7 / 7 (100.00%)
    11 / 12 (91.67%)
    6 / 6 (100.00%)
    General disorders and administration site conditions
    Pain
    alternative assessment type: Systematic
         subjects affected / exposed
    4 / 5 (80.00%)
    13 / 13 (100.00%)
    13 / 15 (86.67%)
    6 / 7 (85.71%)
    6 / 12 (50.00%)
    2 / 6 (33.33%)
         occurrences all number
    4
    13
    13
    6
    6
    2
    Redness
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 5 (60.00%)
    9 / 13 (69.23%)
    8 / 15 (53.33%)
    5 / 7 (71.43%)
    7 / 12 (58.33%)
    3 / 6 (50.00%)
         occurrences all number
    3
    9
    8
    5
    7
    3
    Swelling
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 5 (40.00%)
    10 / 13 (76.92%)
    8 / 15 (53.33%)
    6 / 7 (85.71%)
    3 / 12 (25.00%)
    3 / 6 (50.00%)
         occurrences all number
    2
    10
    8
    6
    3
    3
    Drowsiness
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 5 (40.00%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
    4 / 7 (57.14%)
    0 / 12 (0.00%)
    3 / 6 (50.00%)
         occurrences all number
    2
    0
    0
    4
    0
    3
    Irritability
    alternative assessment type: Systematic
         subjects affected / exposed
    2 / 5 (40.00%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
    3 / 7 (42.86%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    2
    0
    0
    3
    0
    0
    Loss of appetite
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
    3 / 7 (42.86%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    3
    0
    0
    Temperature/(Axillary)
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
    2 / 7 (28.57%)
    0 / 12 (0.00%)
    2 / 6 (33.33%)
         occurrences all number
    0
    0
    0
    2
    0
    2
    Fatigue
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 5 (0.00%)
    6 / 13 (46.15%)
    9 / 15 (60.00%)
    0 / 7 (0.00%)
    8 / 12 (66.67%)
    0 / 6 (0.00%)
         occurrences all number
    0
    6
    9
    0
    8
    0
    Gastrointestinal
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 5 (0.00%)
    4 / 13 (30.77%)
    3 / 15 (20.00%)
    0 / 7 (0.00%)
    2 / 12 (16.67%)
    0 / 6 (0.00%)
         occurrences all number
    0
    4
    3
    0
    2
    0
    Headache
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 5 (0.00%)
    10 / 13 (76.92%)
    9 / 15 (60.00%)
    0 / 7 (0.00%)
    5 / 12 (41.67%)
    0 / 6 (0.00%)
         occurrences all number
    0
    10
    9
    0
    5
    0
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 13 (7.69%)
    0 / 15 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    0
    0
    0
    1
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 13 (0.00%)
    1 / 15 (6.67%)
    0 / 7 (0.00%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    1
    0
    1
    0
    Diarrhoea
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
    0 / 7 (0.00%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    0 / 5 (0.00%)
    4 / 13 (30.77%)
    2 / 15 (13.33%)
    2 / 7 (28.57%)
    1 / 12 (8.33%)
    4 / 6 (66.67%)
         occurrences all number
    0
    4
    2
    2
    1
    4
    Otitis media
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 13 (7.69%)
    0 / 15 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    2 / 6 (33.33%)
         occurrences all number
    0
    1
    0
    0
    0
    2
    Rhinitis
         subjects affected / exposed
    2 / 5 (40.00%)
    0 / 13 (0.00%)
    1 / 15 (6.67%)
    1 / 7 (14.29%)
    2 / 12 (16.67%)
    1 / 6 (16.67%)
         occurrences all number
    2
    0
    1
    1
    2
    1
    Tonsillitis
         subjects affected / exposed
    1 / 5 (20.00%)
    4 / 13 (30.77%)
    2 / 15 (13.33%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    0 / 6 (0.00%)
         occurrences all number
    1
    4
    2
    0
    0
    0
    Tracheitis
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
    1 / 7 (14.29%)
    1 / 12 (8.33%)
    2 / 6 (33.33%)
         occurrences all number
    1
    0
    0
    1
    1
    2
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 13 (0.00%)
    0 / 15 (0.00%)
    0 / 7 (0.00%)
    0 / 12 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Viral infection
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 13 (7.69%)
    0 / 15 (0.00%)
    0 / 7 (0.00%)
    1 / 12 (8.33%)
    0 / 6 (0.00%)
         occurrences all number
    0
    1
    0
    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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    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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