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    Clinical Trial Results:
    A Phase IV, open label, randomized, monocentric study to evaluate immunogenicity and safety of GSK Biologicals' seasonal (2010-2011) influenza vaccine FluarixTM in adolescents previously vaccinated with GSK Biologicals' H1N1 vaccine (PandemrixTM).

    Summary
    EudraCT number
    		 2010-020331-39
    Trial protocol
    		 FI  
    Global end of trial date
    07 Jul 2011

    Results information
    Results version number
    		 v3(current)
    This version publication date
    07 Jul 2022
    First version publication date
    07 Mar 2015
    Other versions
    		 v1 , v2
    Version creation reason
    • Correction of full data set
    Correction of full data set and alignment between registries.

    Trial information

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    Trial identification
    Sponsor protocol code
    114452
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01190215
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline Biologicals
    Sponsor organisation address
    Rue Fleming 20, Wavre, Belgium, 1300
    Public contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089904466, 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
    29 Sep 2011
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    07 Jul 2011
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Jul 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate HI immune response against the H1N1 strain 28 days following vaccination with TIV vaccine (Fluarix) in subjects previously vaccinated with 1 dose of H1N1 adjuvanted vaccine (Pandemrix) in the TIV Group.
    Protection of trial subjects
    All subjects were supervised for 30 min after vaccination with appropriate medical treatment readily available. Vaccines were administered by qualified and trained personnel. Only eligible subjects that had no contraindications to any components of the vaccines were vaccinated. Subjects were followed-up until Month 6 after each/last vaccination.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    21 Dec 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
    Finland: 77
    Worldwide total number of subjects
    77
    EEA total number of subjects
    77
    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)
    0
    Adolescents (12-17 years)
    77
    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
    		 During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.

    Period 1
    Period 1 title
    Up to Day 28
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Fluarix Group
    Arm description
    		 Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Biological: Fluarix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One Intramuscular injection

    Arm title
    		 Havrix Group
    Arm description
    		 Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Biological: Havrix Junior
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Two Intramuscular injections

    Number of subjects in period 1
    		Fluarix Group Havrix Group
    Started
    38
    39
    Completed
    38
    39
    Period 2
    Period 2 title
    Up to Month 6
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Fluarix Group
    Arm description
    		 Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Biological: Fluarix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.

    Investigational medicinal product name
    Biological: Havrix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.

    Arm title
    		 Havrix Group
    Arm description
    		 Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Biological: Havrix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.

    Number of subjects in period 2
    		Fluarix Group Havrix Group
    Started
    38
    39
    Completed
    36
    39
    Not completed
    2
    0
         Lost to follow-up
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Fluarix Group
    Reporting group description
    		 Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.

    Reporting group title
    Havrix Group
    Reporting group description
    		 Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.

    Reporting group values
    		 Fluarix Group Havrix Group Total
    Number of subjects
    		 38 39 77
    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)
    		 14.6 ( 2.22 ) 14.7 ( 2.28 ) -
    Gender categorical
    Units: Subjects
        Female
    		 22 19 41
        Male
    		 16 20 36

    End points

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    End points reporting groups
    Reporting group title
    Fluarix Group
    Reporting group description
    		 Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.

    Reporting group title
    Havrix Group
    Reporting group description
    		 Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
    Reporting group title
    Fluarix Group
    Reporting group description
    		 Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.

    Reporting group title
    Havrix Group
    Reporting group description
    		 Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.

    Primary: Geometric mean antibody titres for haemagglutination inhibition (HI) antibodies against Fluarix vaccine containing H1N1 strain.

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    End point title
    		 Geometric mean antibody titres for haemagglutination inhibition (HI) antibodies against Fluarix vaccine containing H1N1 strain. [1]
    End point description
    Fluarix vaccine strain was Flu A/California/7/2009 (H1N1). Day 28 data were presented only for the Fluarix Group. Titres were expressed as geometric mean antibody titre.
    End point type
    Primary
    End point timeframe
    At Day 0 and Day 28
    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 scope of this primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 Fluarix Group Havrix Group
    Number of subjects analysed
    33
    39
    Units: Titres
    geometric mean (confidence interval 95%)
        Flu A/Cal/7/09 H1N1 [Day 0]
    150.1 (105.8 to 213)
    150.3 (106 to 213.3)
        Flu A/Cal/7/09 H1N1 [Day 28]
    646.8 (534.6 to 782.6)
    0 (0 to 0)
    No statistical analyses for this end point

    Primary: Number of seropositive subjects for haemagglutination inhibition (HI) antibodies against Fluarix vaccine containing H1N1 strain.

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    End point title
    		 Number of seropositive subjects for haemagglutination inhibition (HI) antibodies against Fluarix vaccine containing H1N1 strain. [2]
    End point description
    Fluarix vaccine strain was Flu A/California/7/2009 (H1N1). Seropositivity was assessed for subjects with an antibody titre assay cut-off value equal to or above 1:10. Day 28 data was presented only for the Fluarix Group.
    End point type
    Primary
    End point timeframe
    At Day 0 and Day 28
    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 scope of this primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 Fluarix Group Havrix Group
    Number of subjects analysed
    33
    39
    Units: Subjects
        Flu A/Cal/7/09 H1N1 [Day 0]
    33
    39
        Flu A/Cal/7/09 H1N1 [Day 28]
    33
    0
    No statistical analyses for this end point

    Primary: Number of seroconverted subjects for haemagglutination inhibition (HI) antibodies against Fluarix vaccine containing H1N1 strain.

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    End point title
    		 Number of seroconverted subjects for haemagglutination inhibition (HI) antibodies against Fluarix vaccine containing H1N1 strain. [3] [4]
    End point description
    Fluarix vaccine strain was Flu A/California/7/2009 (H1N1). A seroconverted subject was a subject who had either a pre-vaccination (Day 0) titre less than (< ) 1:10 and a post-vaccination titre greater than or equal to ( ≥) 1:40 or a pre-vaccination titre ≥ 1:10 and at least a 4-fold increase in post-vaccination titre. Day 28 data were presented for the Fluarix Group only.
    End point type
    Primary
    End point timeframe
    At Day 28
    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 scope of this primary endpoint was descriptive, no statistical analyses were conducted.
    [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: Day 28 data were presented for the Fluarix Group only.
    End point values
    		 Fluarix Group
    Number of subjects analysed
    33
    Units: Subjects
        Flu A/California/7/2009
    16
    No statistical analyses for this end point

    Primary: Number of seroprotected subjects for haemagglutination inhibition (HI) antibodies against Fluarix vaccine containing H1N1 strain.

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    End point title
    		 Number of seroprotected subjects for haemagglutination inhibition (HI) antibodies against Fluarix vaccine containing H1N1 strain. [5]
    End point description
    Fluarix vaccine strain was Flu A/California/7/2009 (H1N1). A seroprotected subject was a subject with a serum HI titre ≥ 1:40 that usually is accepted as indicating protection. Day 28 data were presented for the Fluarix Group only.
    End point type
    Primary
    End point timeframe
    At Day 0 and Day 28
    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 scope of this primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 Fluarix Group Havrix Group
    Number of subjects analysed
    33
    39
    Units: Subjects
        Flu A/Cal/7/09 H1N1 [Day 0]
    31
    36
        Flu A/Cal/7/09 H1N1 [Day 28]
    33
    0
    No statistical analyses for this end point

    Primary: Mean geometric increase (MGI) for haemagglutination inhibition (HI) antibodies against Fluarix vaccine containing H1N1 strain.

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    End point title
    		 Mean geometric increase (MGI) for haemagglutination inhibition (HI) antibodies against Fluarix vaccine containing H1N1 strain. [6] [7]
    End point description
    Fluarix vaccine strain was Flu A/California/7/2009 (H1N1). MGI is defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titre to the pre-vaccination (Day 0) reciprocal HI titre. Day 28 data were presented for the Fluarix Group only.
    End point type
    Primary
    End point timeframe
    At Day 28
    Notes
    [6] - 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 scope of this primary endpoint was descriptive, no statistical analyses were conducted.
    [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: Day 28 data were presented for the Fluarix Group only.
    End point values
    		 Fluarix Group
    Number of subjects analysed
    33
    Units: Ratio
    geometric mean (confidence interval 95%)
        Flu A/Cal/7/09 H1N1
    4.3 (2.9 to 6.4)
    No statistical analyses for this end point

    Secondary: Geometric mean antibody titres for haemagglutination inhibition (HI) antibodies against all Fluarix vaccine strains.

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    End point title
    		 Geometric mean antibody titres for haemagglutination inhibition (HI) antibodies against all Fluarix vaccine strains.
    End point description
    Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008. Day 28 data were presented for the Fluarix Group only. Titres were expressed as geometric mean antibody titres (GMTs). Only data for the Flu A/California/7/2009 (H1N1) strain were presented for the Havrix Group.
    End point type
    Secondary
    End point timeframe
    At Day 0 and Day 28
    End point values
    		 Fluarix Group Havrix Group
    Number of subjects analysed
    33
    39
    Units: Titres
    geometric mean (confidence interval 95%)
        Flu A/Cal/7/09 H1N1 [Day 0]
    150.1 (105.8 to 213)
    150.3 (106 to 213.3)
        Flu A/Cal/7/09 H1N1 [Day 28]
    646.8 (534.6 to 782.6)
    0 (0 to 0)
        Flu B/Bri/60/08 Victoria [Day 0]
    22.2 (14.7 to 33.5)
    21 (14.8 to 30)
        Flu B/Bri/60/08 Victoria [Day 28]
    320.1 (216.8 to 472.6)
    0 (0 to 0)
        Flu A/Vic/210/09 H3N2 [Day 0]
    20 (13 to 30.8)
    279.2 (202.1 to 385.8)
        Flu A/Vic/210/09 H3N2 [Day 28]
    20.3 (13.9 to 29.8)
    0 (0 to 0)
    No statistical analyses for this end point

    Secondary: Geometric mean antibody titres for haemagglutination inhibition (HI) antibodies against all Fluarix vaccine strains.

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    End point title
    		 Geometric mean antibody titres for haemagglutination inhibition (HI) antibodies against all Fluarix vaccine strains.
    End point description
    Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008. Only data for the Flu A/California/7/2009 (H1N1) strain were presented for the Havrix Group. Titres were expressed as geometric mean antibody titres (GMTs).
    End point type
    Secondary
    End point timeframe
    At Day 0 and at Month 6
    End point values
    		 Fluarix Group Havrix Group
    Number of subjects analysed
    35
    37
    Units: Titres
    geometric mean (confidence interval 95%)
        Flu B/Bri/60/08 Victoria [Day 0]
    22.9 (15.6 to 33.8)
    0 (0 to 0)
        Flu B/Bri/60/08 Victoria [Month 6]
    242.4 (173.9 to 337.8)
    0 (0 to 0)
        Flu A/Cal/7/09 H1N1 [Day 0]
    169.7 (116.2 to 247.8)
    152.7 (105.6 to 220.8)
        Flu A/Cal/7/09 H1N1 [Month 6]
    346.4 (273.4 to 438.8)
    131.4 (92.5 to 186.6)
        Flu A/Vic/210/09 H3N2 [Day 0]
    17.9 (12.7 to 25.3)
    0 (0 to 0)
        Flu A/Vic/210/09 H3N2 [Month 6]
    160.1 (118.1 to 217)
    0 (0 to 0)
    No statistical analyses for this end point

    Secondary: Number of seropositive subjects for haemagglutination inhibition (HI) antibodies against all Fluarix vaccine strains.

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    End point title
    		 Number of seropositive subjects for haemagglutination inhibition (HI) antibodies against all Fluarix vaccine strains.
    End point description
    Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008. Seropositivity was assessed for subjects with an antibody titre assay cut-off value equal to or above 1:10. Day 28 data were presented for the Fluarix Group only.
    End point type
    Secondary
    End point timeframe
    At Day 0 and Day 28
    End point values
    		 Fluarix Group Havrix Group
    Number of subjects analysed
    33
    39
    Units: Subjects
        Flu A/Cal/7/09 H1N1 [Day 0]
    33
    39
        Flu A/Cal/7/09 H1N1 [Day 28]
    33
    0
        Flu B/Bri/60/08 Victoria [Day 0]
    26
    31
        Flu B/Bri/60/08 Victoria [Day 28]
    33
    0
        Flu A/Vic/210/09 H3N2 [Day 0]
    24
    28
        Flu A/Vic/210/09 H3N2 [Day 28]
    33
    0
    No statistical analyses for this end point

    Secondary: Number of seropositive subjects for haemagglutination inhibition (HI) antibodies against all Fluarix vaccine strains.

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    End point title
    		 Number of seropositive subjects for haemagglutination inhibition (HI) antibodies against all Fluarix vaccine strains.
    End point description
    Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008. Seropositivity was assessed for subjects with an antibody titre assay cut-off equal to or above 1:10. Only data for the Flu A/California/7/2009 (H1N1) strain were presented for the Havrix Group.
    End point type
    Secondary
    End point timeframe
    At Day 0 and at Month 6
    End point values
    		 Fluarix Group Havrix Group
    Number of subjects analysed
    35
    37
    Units: Subjects
        Flu B/Bri/60/08 Victoria [Day 0]
    29
    0
        Flu B/Bri/60/08 Victoria [Month 6]
    35
    0
        Flu A/Cal/7/09 H1N1 [Day 0]
    35
    37
        Flu A/Cal/7/09 H1N1 [Month 6]
    35
    37
        Flu A/Vic/210/09 H3N2 [Day 0]
    25
    0
        Flu A/Vic/210/09 H3N2 [Month 6]
    35
    0
    No statistical analyses for this end point

    Secondary: Number of seroconverted subjects for haemagglutination inhibition (HI) antibodies against all Fluarix vaccine strains.

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    End point title
    		 Number of seroconverted subjects for haemagglutination inhibition (HI) antibodies against all Fluarix vaccine strains. [8]
    End point description
    Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008. A seroconverted subject was a subject who had either a pre-vaccination (Day 0) titre less than (< ) 1:10 and a post-vaccination titre greater than or equal to ( ≥) 1:40 or a pre-vaccination titre ≥ 1:10 and at least a 4-fold increase in post-vaccination titre. Day 28 data were presented for the Fluarix Group only.
    End point type
    Secondary
    End point timeframe
    At Day 28
    Notes
    [8] - 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: Day 28 data were presented for the Fluarix Group only.
    End point values
    		 Fluarix Group
    Number of subjects analysed
    33
    Units: Subjects
        Flu A/Cal/7/09 H1N1
    16
        Flu B/Bri/60/08 Victoria
    28
        Flu A/Vic/210/09 H3N2
    29
    No statistical analyses for this end point

    Secondary: Number of seroconverted subjects for haemagglutination inhibition (HI) antibodies against all Fluarix vaccine strains.

    		 Close Top of page
    End point title
    		 Number of seroconverted subjects for haemagglutination inhibition (HI) antibodies against all Fluarix vaccine strains.
    End point description
    Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008. A seroconverted subject was a subject who had either a pre-vaccination (Day 0) titre < 1:10 and a post-vaccination titre ≥ 1:40 or a pre-vaccination titre ≥ 1:10 and at least a 4-fold increase in post-vaccination titre. Only data for the Flu A/California/7/2009 (H1N1) strain were presented for the Havrix Group.
    End point type
    Secondary
    End point timeframe
    At Month 6
    End point values
    		 Fluarix Group Havrix Group
    Number of subjects analysed
    35
    37
    Units: Subjects
        Flu B/Bri/60/08 Victoria
    29
    0
        Flu A/Cal/7/09 H1N1
    8
    2
        Flu A/Vic/210/09 H3N2
    30
    0
    No statistical analyses for this end point

    Secondary: Number of seroprotected subjects for haemagglutination inhibition (HI) antibodies against all Fluarix vaccine strains.

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    End point title
    		 Number of seroprotected subjects for haemagglutination inhibition (HI) antibodies against all Fluarix vaccine strains.
    End point description
    Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008. A seroprotected subject was a subject with a serum HI titre ≥ 1:40 that usually is accepted as indicating protection. Day 28 data were presented for the Fluarix Group only.
    End point type
    Secondary
    End point timeframe
    At Day 0 and Day 28
    End point values
    		 Fluarix Group Havrix Group
    Number of subjects analysed
    33
    39
    Units: Subjects
        Flu A/Cal/7/09 H1N1 [Day 0]
    31
    36
        Flu A/Cal/7/09 H1N1 [Day 28]
    33
    0
        Flu B/Bri/60/08 Victoria [Day 0]
    13
    11
        Flu B/Bri/60/08 Victoria [Day 28]
    33
    0
        Flu A/Vic/210/09 H3N2 [Day 0]
    12
    16
        Flu A/Vic/210/09 H3N2 [Day 28]
    33
    0
    No statistical analyses for this end point

    Secondary: Number of seroprotected subjects for haemagglutination inhibition (HI) antibodies against all Fluarix vaccine strains.

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    End point title
    		 Number of seroprotected subjects for haemagglutination inhibition (HI) antibodies against all Fluarix vaccine strains.
    End point description
    Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008. A seroprotected subject was a subject with a serum HI titre ≥ 1:40 that usually is accepted as indicating protection. Only data for the Flu A/California/7/2009 (H1N1) strain were presented for the Havrix Group.
    End point type
    Secondary
    End point timeframe
    At Day 0 and Month 6
    End point values
    		 Fluarix Group Havrix Group
    Number of subjects analysed
    35
    37
    Units: Subjects
        Flu B/Bri/60/08 Victoria [Day 0]
    13
    0
        Flu B/Bri/60/08 Victoria [Month 6]
    33
    0
        Flu A/Cal/7/09 H1N1 [Day 0]
    33
    34
        Flu A/Cal/7/09 H1N1 [Month 6]
    35
    34
        Flu A/Vic/210/09 H3N2 [Day 0]
    13
    0
        Flu A/Vic/210/09 H3N2 [Month 6]
    34
    0
    No statistical analyses for this end point

    Secondary: Mean geometric increase (MGI) for haemagglutination inhibition (HI) antibodies against all Fluarix vaccine strains.

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    End point title
    		 Mean geometric increase (MGI) for haemagglutination inhibition (HI) antibodies against all Fluarix vaccine strains. [9]
    End point description
    Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008. MGI is defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titre to the pre-vaccination (Day 0) reciprocal HI titre. Day 28 data were presented for the Fluarix Group only.
    End point type
    Secondary
    End point timeframe
    At Day 28
    Notes
    [9] - 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: Day 28 data were presented for the Fluarix Group only.
    End point values
    		 Fluarix Group
    Number of subjects analysed
    33
    Units: Ratio
    geometric mean (confidence interval 95%)
        Flu A/Cal/7/09 H1N1
    4.3 (2.9 to 6.4)
        Flu B/Bri/60/08 Victoria
    14.4 (9.4 to 22)
        Flu A/Vic/210/09 H3N2
    14 (9.3 to 21.1)
    No statistical analyses for this end point

    Secondary: Mean geometric increase (MGI) for haemagglutination inhibition (HI) antibodies against all Fluarix vaccine strains.

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    End point title
    		 Mean geometric increase (MGI) for haemagglutination inhibition (HI) antibodies against all Fluarix vaccine strains.
    End point description
    Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008. MGI is defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titre to the pre-vaccination (Day 0) reciprocal HI titre. Only data for the Flu A/California/7/2009 (H1N1) strain were presented for the Havrix Group.
    End point type
    Secondary
    End point timeframe
    At Month 6
    End point values
    		 Fluarix Group Havrix Group
    Number of subjects analysed
    35
    37
    Units: Ratio
    geometric mean (confidence interval 95%)
        Flu B/Bri/60/08 Victoria
    10.6 (7.5 to 14.9)
    0 (0 to 0)
        Flu A/Cal/7/09 H1N1
    2 (1.6 to 2.7)
    0.9 (0.7 to 1.1)
        Flu A/Vic/210/09 H3N2
    8.9 (6.6 to 12)
    0 (0 to 0)
    No statistical analyses for this end point

    Secondary: Geometric mean antibody titres for neutralising antibodies against all Fluarix vaccine strains.

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    End point title
    		 Geometric mean antibody titres for neutralising antibodies against all Fluarix vaccine strains.
    End point description
    Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Perth/16/09(H3N2) and B/Brisbane/60/2008. Day 28 data were presented for the Fluarix Group only. Titres were expressed as geometric mean antibody titres (GMTs).
    End point type
    Secondary
    End point timeframe
    At Day 0 and at Day 28
    End point values
    		 Fluarix Group Havrix Group
    Number of subjects analysed
    33
    39
    Units: Titre
    geometric mean (confidence interval 95%)
        Flu B/Bri/60/08 Victoria [Day 0]
    26 (20.2 to 33.6)
    24.5 (18.9 to 31.9)
        Flu B/Bri/60/08 Victoria [Day 28]
    257.9 (158.5 to 419.5)
    0 (0 to 0)
        Flu A/Cal/7/09 H1N1 [Day 0]
    119.7 (95.2 to 150.5)
    137.7 (108 to 175.5)
        Flu A/Cal/7/09 H1N1 [Day 28]
    1512.4 (1077.9 to 2122.1)
    0 (0 to 0)
        Flu A/Per/16/09 H3N2 [Day 0]
    69.8 (50.5 to 96.5)
    72.6 (55.2 to 95.5)
        Flu A/Per/16/09 H3N2 [Day 28]
    614.5 (371.4 to 1016.7)
    0 (0 to 0)
    No statistical analyses for this end point

    Secondary: Geometric mean antibody titres for neutralising antibodies against all Fluarix vaccine strains.

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    End point title
    		 Geometric mean antibody titres for neutralising antibodies against all Fluarix vaccine strains.
    End point description
    Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Perth/16/09 (H3N2) and B/Brisbane/60/2008. Titres were expressed as geometric mean antibody titres (GMTs). Only data for the Flu A/California/7/2009 (H1N1) strain were presented for the Havrix Group.
    End point type
    Secondary
    End point timeframe
    At Day 0 and at Month 6
    End point values
    		 Fluarix Group Havrix Group
    Number of subjects analysed
    35
    37
    Units: Titre
    geometric mean (confidence interval 95%)
        Flu B/Bri/60/08 Victoria [Day 0]
    25.1 (19.7 to 32.1)
    0 (0 to 0)
        Flu B/Bri/60/08 Victoria [Month 6]
    199.5 (145.8 to 273)
    0 (0 to 0)
        Flu A/Cal/7/09 H1N1 [Day 0]
    119.4 (94.5 to 150.8)
    138.3 (107.5 to 178)
        Flu A/Cal/7/09 H1N1 [Month 6]
    390.6 (291.4 to 523.8)
    115.3 (82.4 to 161.4)
        Flu A/Per/16/09 H3N2 [Day 0]
    62.5 (49.5 to 78.8)
    0 (0 to 0)
        Flu A/Per/16/09 H3N2 [Month 6]
    266.8 (173.6 to 410.1)
    0 (0 to 0)
    No statistical analyses for this end point

    Secondary: Number of seroconverted subjects for neutralising antibodies against all Fluarix vaccine strains.

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    End point title
    		 Number of seroconverted subjects for neutralising antibodies against all Fluarix vaccine strains. [10]
    End point description
    A seroconverted subject for neutralising antibodies was a subject with a minimum 4-fold increase in titre at post-vaccination. Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Perth/16/09 (H3N2) and B/Brisbane/60/2008. Day 28 data were presented for the Fluarix Group only.
    End point type
    Secondary
    End point timeframe
    At Day 28
    Notes
    [10] - 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: Day 28 data were presented for the Fluarix Group only.
    End point values
    		 Fluarix Group
    Number of subjects analysed
    33
    Units: Subjects
        Flu B/Bri/60/08 Victoria
    25
        Flu A/Cal/7/09 H1N1
    29
        Flu A/Per/16/09 H3N2
    22
    No statistical analyses for this end point

    Secondary: Number of seroconverted subjects for neutralising antibodies against all Fluarix vaccine strains.

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    End point title
    		 Number of seroconverted subjects for neutralising antibodies against all Fluarix vaccine strains.
    End point description
    A seroconverted subject for neutralising antibodies was a subject with a minimum 4-fold increase in titre at post-vaccination. Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Perth/16/09 (H3N2) and B/Brisbane/60/2008. At Month 6, only data for the Flu A/California/7/2009 (H1N1) strain were presented for the Havrix Group.
    End point type
    Secondary
    End point timeframe
    At Month 6
    End point values
    		 Fluarix Group Havrix Group
    Number of subjects analysed
    35
    37
    Units: Subjects
        Flu B/Bri/60/08 Victoria
    28
    0
        Flu A/Cal/7/09 H1N1
    13
    2
        Flu A/Per/16/09 H3N2
    17
    0
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any and Grade 3 solicited local symptoms.

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    End point title
    		 Number of subjects reporting any and Grade 3 solicited local symptoms.
    End point description
    Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any solicited local symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling above 50 millimetres.
    End point type
    Secondary
    End point timeframe
    Within 7 days (Day 0 – Day 6) after vaccination
    End point values
    		 Fluarix Group Havrix Group
    Number of subjects analysed
    38
    39
    Units: Subjects
        Any pain
    35
    24
        Grade 3 pain
    2
    0
        Any redness
    6
    5
        Grade 3 redness
    0
    0
        Any swelling
    5
    0
        Grade 3 swelling
    1
    0
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any and Grade 3 solicited general symptoms.

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    End point title
    		 Number of subjects reporting any and Grade 3 solicited general symptoms.
    End point description
    Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering, sweating, temperature (temperature = axillary temperature equal to or above 37.5 degrees Celsius). Any = occurrence of any solicited general symptom regardless of intensity grade or relation to vaccination. Grade 3 symptom = general symptom that prevented normal activity. Grade 3 temperature = axillary temperature above 39.0 degrees Celsius.
    End point type
    Secondary
    End point timeframe
    Within 7 days (Day 0 – Day 6) after vaccination
    End point values
    		 Fluarix Group Havrix Group
    Number of subjects analysed
    38
    39
    Units: Subjects
        Any arthralgia
    4
    5
        Grade 3 arthralgia
    0
    0
        Any fatigue
    25
    24
        Grade 3 fatigue
    1
    1
        Any gastrointestinal symptoms
    8
    3
        Grade 3 gastrointestinal symptoms
    2
    0
        Any headache
    24
    16
        Grade 3 headache
    1
    0
        Any myalgia
    16
    16
        Grade 3 myalgia
    0
    1
        Any shivering
    18
    9
        Grade 3 shivering
    0
    0
        Any sweating
    9
    4
        Grade 3 sweating
    0
    0
        Any temperature >= 37.5°C
    4
    1
        Grade 3 temperature > 39.0°C
    0
    0
    No statistical analyses for this end point

    Secondary: Number of days with any solicited local symptoms.

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    End point title
    		 Number of days with any solicited local symptoms.
    End point description
    Solicited local symptoms assessed were pain, redness and swelling. Inter-quartile range assessed was the 25th percentile and the 75th percentile.
    End point type
    Secondary
    End point timeframe
    Within 7 days (Day 0 – Day 6) after vaccination
    End point values
    		 Fluarix Group Havrix Group
    Number of subjects analysed
    38
    39
    Units: Days
    median (inter-quartile range (Q1-Q3))
        Pain
    2 (1 to 3)
    2 (1 to 2.5)
        Redness
    2 (1 to 2)
    1 (1 to 2)
        Swelling
    2 (2 to 3)
    0 (0 to 0)
    No statistical analyses for this end point

    Secondary: Number of days with grade 3 solicited local symptoms.

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    End point title
    		 Number of days with grade 3 solicited local symptoms.
    End point description
    Solicited local symptoms assessed were pain and swelling. Grade 3 redness/swelling = redness/swelling above 50 millimetres. Inter-quartile range assessed was the 25th percentile and the 75th percentile.
    End point type
    Secondary
    End point timeframe
    Within 7 days (Day 0 – Day 6) after vaccination
    End point values
    		 Fluarix Group Havrix Group
    Number of subjects analysed
    38
    39
    Units: Days
    median (inter-quartile range (Q1-Q3))
        Pain
    1 (1 to 1)
    0 (0 to 0)
        Swelling
    1 (1 to 1)
    0 (0 to 0)
    No statistical analyses for this end point

    Secondary: Number of days with any solicited general symptoms.

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    End point title
    		 Number of days with any solicited general symptoms.
    End point description
    Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering, sweating, temperature (temperature = axillary temperature equal to or above 37.5 degrees Celsius). Inter-quartile range assessed was the 25th percentile and the 75th percentile.
    End point type
    Secondary
    End point timeframe
    Within 7 days (Day 0 – Day 6) after vaccination
    End point values
    		 Fluarix Group Havrix Group
    Number of subjects analysed
    38
    39
    Units: Days
    median (inter-quartile range (Q1-Q3))
        Arthralgia
    2 (1.5 to 4)
    1 (1 to 2)
        Fatigue
    2 (1 to 4)
    2 (1 to 3)
        Gastrointestinal
    1 (1 to 2)
    1 (1 to 3)
        Headache
    2 (1 to 3)
    1 (1 to 2)
        Myalgia
    2 (1.5 to 3.5)
    2 (1 to 3)
        Sweating
    1 (1 to 1)
    2 (2 to 2.5)
        Shivering
    2 (1 to 4)
    1 (1 to 1)
        Temperature
    1 (1 to 1.5)
    1 (1 to 1)
    No statistical analyses for this end point

    Secondary: Number of days with grade 3 solicited general symptoms.

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    End point title
    		 Number of days with grade 3 solicited general symptoms.
    End point description
    Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache and myalgia. Grade 3 symptom = general symptom that prevented normal activity. Inter-quartile range assessed was the 25th percentile and the 75th percentile.
    End point type
    Secondary
    End point timeframe
    Within 7 days (Day 0 – Day 6) after vaccination
    End point values
    		 Fluarix Group Havrix Group
    Number of subjects analysed
    38
    39
    Units: Days
    median (inter-quartile range (Q1-Q3))
        Fatigue
    1 (1 to 1)
    1 (1 to 1)
        Gastrointestinal
    1 (1 to 1)
    0 (0 to 0)
        Headache
    1 (1 to 1)
    0 (0 to 0)
        Myalgia
    0 (0 to 0)
    1 (1 to 1)
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any, grade 3 and related unsolicited adverse events (AEs).

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    End point title
    		 Number of subjects reporting any, grade 3 and related unsolicited adverse events (AEs).
    End point description
    An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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. Grade 3 = event that prevented normal, everyday activities. Related = event assessed by the investigator as causally related to the study vaccination.
    End point type
    Secondary
    End point timeframe
    Within 28 days (Day 0 – Day 27) after vaccination
    End point values
    		 Fluarix Group Havrix Group
    Number of subjects analysed
    38
    39
    Units: Subjects
        Any
    12
    11
        Grade 3
    1
    2
        Related to vaccination
    4
    1
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects reporting medically-attended events (MAEs).
    End point description
    For each solicited and unsolicited symptom the subject experienced, the subject was asked if they received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel for any reason.
    End point type
    Secondary
    End point timeframe
    Within the 28-day (Days 0-27) post-vaccination period
    End point values
    		 Fluarix Group Havrix Group
    Number of subjects analysed
    38
    39
    Units: Subjects
        MAEs Number
    1
    3
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects reporting medically-attended events (MAEs).
    End point description
    For each solicited and unsolicited symptom the subject experienced, the subject was asked if they received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel for any reason.
    End point type
    Secondary
    End point timeframe
    During the entire study period (Up to Month 6)
    End point values
    		 Fluarix Group Havrix Group
    Number of subjects analysed
    38
    39
    Units: Subjects
        MAE(s) Number
    2
    4
    No statistical analyses for this end point

    Secondary: Number of subjects reporting adverse events of specific interest (AESIs)/potential immune mediated diseases (pIMDs).

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    End point title
    		 Number of subjects reporting adverse events of specific interest (AESIs)/potential immune mediated diseases (pIMDs).
    End point description
    Potential Immune-Mediated Diseases (pIMDs) or Adverse events of specific interest (AESI), are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.
    End point type
    Secondary
    End point timeframe
    During the entire study period (Up to Month 6)
    End point values
    		 Fluarix Group Havrix Group
    Number of subjects analysed
    38
    39
    Units: Subjects
        AESIs/pIMDs Number
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects reporting adverse events of special interest.

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    End point title
    		 Number of subjects reporting adverse events of special interest.
    End point description
    Adverse events of special interest for safety monitoring includes both convulsion and anaphylaxis.
    End point type
    Secondary
    End point timeframe
    During the entire study period (Up to Month 6)
    End point values
    		 Fluarix Group Havrix Group
    Number of subjects analysed
    38
    39
    Units: Subjects
        AEs of special interest Number
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects reporting serious adverse events (SAEs).

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    End point title
    		 Number of subjects reporting serious adverse events (SAEs).
    End point description
    SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
    End point type
    Secondary
    End point timeframe
    Within the 28-day (Days 0-27) post-vaccination period
    End point values
    		 Fluarix Group Havrix Group
    Number of subjects analysed
    38
    39
    Units: Subjects
        Any SAE(s)
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects reporting serious adverse events (SAEs).

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    End point title
    		 Number of subjects reporting serious adverse events (SAEs).
    End point description
    SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
    End point type
    Secondary
    End point timeframe
    During the entire study period (Up to Month 6)
    End point values
    		 Fluarix Group Havrix Group
    Number of subjects analysed
    38
    39
    Units: Subjects
        Any SAE(s)
    1
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Serious adverse events were assessed up to Day 28 and during the entire study period, up to Month 6. Systematically and non-systematically assessed frequent adverse events were assessed during the 7 day and 28 day post-vaccination period respectively.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.0
    Reporting groups
    Reporting group title
    Havrix Group
    Reporting group description
    		 Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.

    Reporting group title
    Fluarix Group
    Reporting group description
    		 Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.

    Serious adverse events
    		 Havrix Group Fluarix Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 38 (2.63%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Infections and infestations
    Acute tonsillitis
         subjects affected / exposed
    0 / 39 (0.00%)
    1 / 38 (2.63%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Havrix Group Fluarix Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    34 / 39 (87.18%)
    37 / 38 (97.37%)
    Nervous system disorders
    Headache (AE)
         subjects affected / exposed
    2 / 39 (5.13%)
    1 / 38 (2.63%)
         occurrences all number
    2
    1
    General disorders and administration site conditions
    Pain
    alternative assessment type: Systematic
         subjects affected / exposed
    24 / 39 (61.54%)
    35 / 38 (92.11%)
         occurrences all number
    24
    35
    Redness
    alternative assessment type: Systematic
         subjects affected / exposed
    5 / 39 (12.82%)
    6 / 38 (15.79%)
         occurrences all number
    5
    6
    Swelling
    alternative assessment type: Systematic
         subjects affected / exposed
    0 / 39 (0.00%)
    5 / 38 (13.16%)
         occurrences all number
    0
    5
    Arthralgia
    alternative assessment type: Systematic
         subjects affected / exposed
    5 / 39 (12.82%)
    4 / 38 (10.53%)
         occurrences all number
    5
    4
    Fatigue
    alternative assessment type: Systematic
         subjects affected / exposed
    24 / 39 (61.54%)
    25 / 38 (65.79%)
         occurrences all number
    24
    25
    Gastrointestinal symptoms
    alternative assessment type: Systematic
         subjects affected / exposed
    3 / 39 (7.69%)
    8 / 38 (21.05%)
         occurrences all number
    3
    8
    Headache (Solicited Symptom)
    alternative assessment type: Systematic
         subjects affected / exposed
    16 / 39 (41.03%)
    24 / 38 (63.16%)
         occurrences all number
    16
    24
    Myalgia
    alternative assessment type: Systematic
         subjects affected / exposed
    16 / 39 (41.03%)
    16 / 38 (42.11%)
         occurrences all number
    16
    16
    Shivering
    alternative assessment type: Systematic
         subjects affected / exposed
    9 / 39 (23.08%)
    18 / 38 (47.37%)
         occurrences all number
    9
    18
    Sweating
    alternative assessment type: Systematic
         subjects affected / exposed
    4 / 39 (10.26%)
    9 / 38 (23.68%)
         occurrences all number
    4
    9
    Temperature
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 39 (2.56%)
    4 / 38 (10.53%)
         occurrences all number
    1
    4
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    2 / 39 (5.13%)
    1 / 38 (2.63%)
         occurrences all number
    2
    1
    Musculoskeletal and connective tissue disorders
    Neck pain
         subjects affected / exposed
    0 / 39 (0.00%)
    2 / 38 (5.26%)
         occurrences all number
    0
    2
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 39 (5.13%)
    3 / 38 (7.89%)
         occurrences all number
    2
    3

    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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