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    Clinical Trial Results:
    A Phase III, open-label, non-randomised, multi-centre, single dose study to assess the immunogenicity and safety of GSK Biologicals' Quadrivalent Split Virion Influenza Vaccine (GSK2321138A) Influsplit Tetra (Fluarix Tetra) (2013/2014 season) injected intramuscularly in adults (18 to 60 years) and in the elderly (over 60 years)

    Summary
    EudraCT number
    		 2013-001094-25
    Trial protocol
    		 DE  
    Global end of trial date
    05 Aug 2013

    Results information
    Results version number
    		 v3(current)
    This version publication date
    16 Apr 2023
    First version publication date
    25 Apr 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
    200188
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01878812
    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, 44 2089904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 44 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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    13 Aug 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    05 Aug 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Aug 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the humoral response [(anti- Haemagglutinin (HA) antibodies tested by Haemagglutination Inhibition (HI)] against each vaccine strain in adults 18-60 years and >60 years of age, 21 days after vaccination with Fluarix/Influsplit Tetra 2013/2014.
    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 for xx days after each/last vaccination.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    11 Jul 2013
    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
    Germany: 117
    Worldwide total number of subjects
    117
    EEA total number of subjects
    117
    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)
    0
    Adults (18-64 years)
    60
    From 65 to 84 years
    57
    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
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Fluarix/Influsplit Tetra Adult Group
    Arm description
    		 Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Fluarix/Influsplit Tetra (2013-2014 season)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 dose administered intramuscularly in the deltoid region of non-dominant arm

    Arm title
    		 Fluarix/Influsplit Tetra Elderly Group
    Arm description
    		 Subjects >60 years of age receiving Fluarix/Influsplit Tetra 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Fluarix/Influsplit Tetra (2013-2014 season)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 dose administered intramuscularly in the deltoid region of non-dominant arm

    Number of subjects in period 1
    		Fluarix/Influsplit Tetra Adult Group Fluarix/Influsplit Tetra Elderly Group
    Started
    60
    57
    Completed
    60
    57

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Fluarix/Influsplit Tetra Adult Group
    Reporting group description
    		 Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.

    Reporting group title
    Fluarix/Influsplit Tetra Elderly Group
    Reporting group description
    		 Subjects >60 years of age receiving Fluarix/Influsplit Tetra 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.

    Reporting group values
    		 Fluarix/Influsplit Tetra Adult Group Fluarix/Influsplit Tetra Elderly Group Total
    Number of subjects
    		 60 57 117
    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)
    		 38.7 ± 12.24 70.6 ± 6.81 -
    Gender categorical
    Units: Subjects
        Female
    		 32 31 63
        Male
    		 28 26 54

    End points

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    End points reporting groups
    Reporting group title
    Fluarix/Influsplit Tetra Adult Group
    Reporting group description
    		 Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.

    Reporting group title
    Fluarix/Influsplit Tetra Elderly Group
    Reporting group description
    		 Subjects >60 years of age receiving Fluarix/Influsplit Tetra 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.

    Primary: Anti-HI antibody titers against 4 strains of influenza disease

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    End point title
    		 Anti-HI antibody titers against 4 strains of influenza disease [1]
    End point description
    The strains assessed were: Flu A/Christchurch/16/2010 H1N1 HI, Flu A/Texas/50/2012 H3N2 HI, Flu B/Massachusetts/2/2012 Yamagata HI, (referred to as Flu B/Mass/2/2012 Yamagata) ,Flu B/Brisbane/60/2008 Victoria HI. Titers are presented as geometric mean titers (GMTs).
    End point type
    Primary
    End point timeframe
    At Days 0 and 21
    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 for this endpoint was descriptive, hence no statistical hypotesis test was performed.
    End point values
    		 Fluarix/Influsplit Tetra Adult Group Fluarix/Influsplit Tetra Elderly Group
    Number of subjects analysed
    60
    56
    Units: Titers
    geometric mean (confidence interval 95%)
        Flu A/Christchurch/16/2010 H1N1, Day 0 [N=60,56]
    29.8 (20.7 to 42.8)
    14.9 (10.9 to 20.4)
        Flu A/Texas/50/2012 H3N2, Day 0 [N=60,56]
    13.1 (10.1 to 17)
    13.5 (10.1 to 18.1)
        Flu B/Mass/2/2012 Yamagata, Day 0 [N=60,56]
    151 (111.3 to 204.7)
    110.4 (88.5 to 137.6)
        Flu B/Brisbane/60/2008 Victoria, Day 0 [N=60,56]
    58.5 (44.4 to 77.1)
    56.6 (44.6 to 71.7)
        Flu A/Christchurch/16/2010 H1N1, Day 21 [N=60,56]
    505 (400.1 to 637.4)
    230.3 (160.7 to 330.2)
        Flu A/Texas/50/2012 H3N2, Day 21 [N=60,56]
    94 (74.1 to 119.3)
    77.9 (58.5 to 103.9)
        Flu B/Mass/2/2012 Yamagata, Day 21 [N=60,56]
    792.6 (661.6 to 949.5)
    535 (442.2 to 647.2)
        Flu B/Brisbane/60/2008 Victoria, Day 21 [N=60,56]
    346.9 (288 to 417.9)
    239.2 (193.3 to 296)
    No statistical analyses for this end point

    Primary: Number of seroprotected subjects against 4 strains of influenza disease

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    End point title
    		 Number of seroprotected subjects against 4 strains of influenza disease [2]
    End point description
    The strains are: Flu A/Christchurch/16/2010 H1N1 HI, Flu A/Texas/50/2012 H3N2 HI, Flu B/Massachusetts/2/2012 Yamagata HI,(referred to as Flu B/Mass/2/2012 Yamagata), Flu B/Brisbane/60/2008 Victoria HI. A seroprotected subject is defined as a subject with serum HI titre ≥ 1:40.
    End point type
    Primary
    End point timeframe
    At Day 21
    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 for this endpoint was descriptive, hence no statistical hypotesis test was performed.
    End point values
    		 Fluarix/Influsplit Tetra Adult Group Fluarix/Influsplit Tetra Elderly Group
    Number of subjects analysed
    60
    56
    Units: Subjects
        Flu A/Christchurch/16/2010 H1N1, Day 0 [N=60,56]
    29
    12
        Flu A/Christchurch/16/2010 H1N1, Day 21 [N=60,56]
    60
    49
        Flu A/Texas/50/2012 H3N2, Day 0 [N=60,56]
    12
    15
        Flu A/Texas/50/2012 H3N2, Day 21 [N=60,56]
    54
    40
        Flu B/Mass/2/2012 Yamagata, Day 0 [N=60,56]
    56
    52
        Flu B/Mass/2/2012 Yamagata, Day 21 [N=60,56]
    60
    56
        Flu B/Brisbane/60/2008 Victoria, Day 0 [N=60,56]
    43
    40
        Flu B/Brisbane/60/2008 Victoria, Day 21 [N=60,56]
    60
    55
    No statistical analyses for this end point

    Primary: Number of seroconverted subjects against 4 strains of influenza disease

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    End point title
    		 Number of seroconverted subjects against 4 strains of influenza disease [3]
    End point description
    The strains are: Flu A/Christchurch/16/2010 H1N1 HI,(referred to as Flu A/Christch/16/2010 H1N1), Flu A/Texas/50/2012 H3N2 HI, Flu B/Massachusetts/2/2012 Yamagata HI, (referred to as Flu B/Mass/2/2012 Yamagata), Flu B/Brisbane/60/2008 Victoria HI. A seroconverted subject is defined as a subject with either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least 4-fold increase in post-vaccination titer.
    End point type
    Primary
    End point timeframe
    At Day 21
    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 for this endpoint was descriptive, hence no statistical hypotesis test was performed.
    End point values
    		 Fluarix/Influsplit Tetra Adult Group Fluarix/Influsplit Tetra Elderly Group
    Number of subjects analysed
    60
    56
    Units: Subjects
        Flu A/Christch/16/2010 H1N1, Day 21 [N=60,56]
    48
    43
        Flu A/Texas/50/2012 H3N2, Day 21 [N=60,56]
    41
    27
        Flu B/Mass/2/2012 Yamagata, Day 21 [N=60,56]
    35
    32
        Flu B/Brisbane/60/2008 Victoria, Day 21 [N=60,56]
    37
    24
    No statistical analyses for this end point

    Primary: Mean geometric increase (MGI) for HI antibody titer against the 4 flu strains of influenza disease

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    End point title
    		 Mean geometric increase (MGI) for HI antibody titer against the 4 flu strains of influenza disease [4]
    End point description
    The strains are: Flu A/Christchurch/16/2010 H1N1 HI, (referred to as Flu A/Christch/16/2010 H1N1), Flu A/Texas/50/2012 H3N2 HI, Flu B/Massachusetts/2/2012 Yamagata HI, (referred to as Flu B/Mass/2/2012 Yamagata) Flu B/Brisbane/60/2008 Victoria HI. MGI was defined as the fold increase in serum HI geometric mean titers post-vaccination compared to Day 0.
    End point type
    Primary
    End point timeframe
    At Day 21
    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 for this endpoint was descriptive, hence no statistical hypotesis test was performed.
    End point values
    		 Fluarix/Influsplit Tetra Adult Group Fluarix/Influsplit Tetra Elderly Group
    Number of subjects analysed
    60
    56
    Units: Fold increase
    geometric mean (confidence interval 95%)
        Flu A/Christch/16/2010 H1N1, Day 21 [N=60,56]
    17 (11.6 to 24.8)
    15.4 (10.5 to 22.6)
        Flu A/Texas/50/2012 H3N2, Day 21 [N=60,56]
    7.2 (5.5 to 9.3)
    5.8 (4.3 to 7.8)
        Flu B/Mass/2/2012 Yamagata, Day 21 [N=60,56]
    5.3 (3.8 to 7.2)
    4.8 (3.9 to 6.1)
        Flu B/Brisbane/60/2008 Victoria, Day 21 [N=60,56]
    5.9 (4.4 to 7.9)
    4.2 (3.2 to 5.7)
    No statistical analyses for this end point

    Primary: Seroprotection Powers (SPP) for HI antibody titer against the 4 flu strains of influenza disease

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    End point title
    		 Seroprotection Powers (SPP) for HI antibody titer against the 4 flu strains of influenza disease [5]
    End point description
    The strains are: Flu A/Christchurch/16/2010 H1N1 HI, (referred to as Flu A/Christch/16/2010 H1N1), Flu A/Texas/50/2012 H3N2 HI, Flu B/Massachusetts/2/2012 Yamagata HI, (referred to as Flu B/Mass/2/2012 Yamagata), Flu B/Brisbane/60/2008 Victoria HI. SPP is defined as the percentage of subjects who had a pre-vaccination titer < 1:40 and a post-vaccination titer ≥ 1:40.
    End point type
    Primary
    End point timeframe
    During a 4-day follow-up period after vaccination (i.e. day of vaccination and 3 subsequent days)
    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 for this endpoint was descriptive, hence no statistical hypotesis test was performed.
    End point values
    		 Fluarix/Influsplit Tetra Adult Group Fluarix/Influsplit Tetra Elderly Group
    Number of subjects analysed
    48
    44
    Units: Percentage of Subjects
    number (not applicable)
        Flu A/Christch/16/2010 H1N1, Day 21 [N=31,44]
    100
    84.1
        Flu A/Texas/50/2012 H3N2, Day 21 [N=48,41]
    87.5
    61.0
        Flu B/Mass/2/2012 Yamagata, Day 21 [N=17, 16]
    100
    93.8
        Flu B/Brisbane/60/2008 Victoria, Day 21 [N=4,4]
    100
    100
    No statistical analyses for this end point

    Secondary: Number of subjects with solicited local symptoms

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    End point title
    		 Number of subjects with solicited local symptoms
    End point description
    Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 ecchymosis/induration/redness/swelling = ecchymosis/induration/redness/swelling spreading beyond 100 millimeters (mm) of injection site.
    End point type
    Secondary
    End point timeframe
    During a 21-day follow-up period after vaccination (i.e. day of vaccination and 20 subsequent days)
    End point values
    		 Fluarix/Influsplit Tetra Adult Group Fluarix/Influsplit Tetra Elderly Group
    Number of subjects analysed
    60
    57
    Units: Subjects
        Any Ecchymosis
    0
    0
        Grade 3 Ecchymosis
    0
    0
        Any Induration
    6
    5
        Grade 3 Induration
    0
    0
        Any Pain
    37
    19
        Grade 3 Pain
    1
    0
        Any Redness
    3
    6
        Grade 3 Redness
    0
    0
        Any Swelling
    3
    2
        Grade 3 Swelling
    0
    0
    No statistical analyses for this end point

    Secondary: Number of days of solicited local symptoms

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    End point title
    		 Number of days of solicited local symptoms
    End point description
    Assessed solicited local symptoms were ecchymosis, induration, pain, redness and swelling. The number of days is expressed as a mean value.
    End point type
    Secondary
    End point timeframe
    During the entire study period (Days 0 to 21)
    End point values
    		 Fluarix/Influsplit Tetra Adult Group Fluarix/Influsplit Tetra Elderly Group
    Number of subjects analysed
    37
    19
    Units: Days
    arithmetic mean (confidence interval 95%)
        Induration [N=6;5]
    1.8 (1 to 2)
    2.2 (2 to 3)
        Pain [N=37;19]
    2.2 (2 to 3)
    1.9 (1 to 2)
        Redness [N=3;6]
    2 (1 to 3)
    1.5 (1 to 2)
        Swelling [N=3;2]
    2.7 (2 to 3)
    2 (2 to 2)
    No statistical analyses for this end point

    Secondary: Number of subjects with solicited general symptoms

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    End point title
    		 Number of subjects with solicited general symptoms
    End point description
    Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering, sweating and temperature [defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)],. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
    End point type
    Secondary
    End point timeframe
    During a 4-day follow-up period after vaccination (i.e. day of vaccination and 3 subsequent days)
    End point values
    		 Fluarix/Influsplit Tetra Adult Group Fluarix/Influsplit Tetra Elderly Group
    Number of subjects analysed
    60
    57
    Units: Subjects
        Any Arthralgia
    3
    6
        Grade 3 Arthralgia
    1
    0
        Related Arthralgia
    1
    4
        Any Fatigue
    10
    4
        Grade 3 Fatigue
    1
    0
        Related Fatigue
    8
    2
        Any Gastrointestinal symptoms
    3
    2
        Grade 3 Gastrointestinal symptoms
    0
    0
        Related Gastrointestinal symptoms
    0
    1
        Any Headache
    9
    5
        Grade 3 Headache
    1
    0
        Related Headache
    4
    4
        Any Myalgia
    14
    7
        Grade 3 Myalgia
    1
    0
        Related Myalgia
    12
    5
        Any Sweating
    2
    0
        Grade 3 Sweating
    1
    0
        Related Sweating
    1
    0
        Any Shivering
    3
    2
        Grade 3 Shivering
    1
    0
        Related Shivering
    3
    2
        Any Temperature
    0
    0
        Grade 3 Temperature
    0
    0
        Related Temperature
    0
    0
    No statistical analyses for this end point

    Secondary: Number of days of solicited general symptoms

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    End point title
    		 Number of days of solicited general symptoms
    End point description
    Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering, sweating and temperature [defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. The number of days is expressed as a mean value.
    End point type
    Secondary
    End point timeframe
    During a 4-day follow-up period after vaccination (i.e. day of vaccination and 3 subsequent days)
    End point values
    		 Fluarix/Influsplit Tetra Adult Group Fluarix/Influsplit Tetra Elderly Group
    Number of subjects analysed
    14
    7
    Units: Days
    arithmetic mean (inter-quartile range (Q1-Q3))
        Arthralgia [N=3;6]
    2.7 (2 to 3)
    1.8 (1 to 2)
        Fatigue [N=10;4]
    1.6 (1 to 2)
    2.8 (2 to 3.5)
        Gastrointestinal symptoms [N=3;2]
    2 (1 to 3)
    2.5 (1 to 4)
        Headache [N=9;5]
    1.9 (1 to 2)
    1.4 (1 to 2)
        Myalgia [N=14;7]
    1.8 (1 to 2)
    2 (1 to 2)
        Sweating [N=3;2]
    1.7 (1 to 3)
    2 (2 to 2)
        Shivering [N=2;0]
    2 (1 to 3)
    0 (0 to 0)
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects with any, grade 3 and related 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.
    End point type
    Secondary
    End point timeframe
    During a 4-day follow-up period after vaccination (i.e. day of vaccination and 3 subsequent days)
    End point values
    		 Fluarix/Influsplit Tetra Adult Group Fluarix/Influsplit Tetra Elderly Group
    Number of subjects analysed
    60
    57
    Units: Subjects
        Subjects with grade 3 AE(s)
    1
    0
        Subjects with related AE(s)
    0
    0
        Subjects with any AE(s)
    6
    9
    No statistical analyses for this end point

    Secondary: Number of subjects with any, grade 3 and related serious adverse events (SAEs).

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    End point title
    		 Number of subjects with any, grade 3 and related 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.
    End point type
    Secondary
    End point timeframe
    At Days 0 and 21
    End point values
    		 Fluarix/Influsplit Tetra Adult Group Fluarix/Influsplit Tetra Elderly Group
    Number of subjects analysed
    60
    57
    Units: Subjects
        Subjects with any SAE(s), n (%)
    0
    0
        Subjects with related SAE(s)
    0
    0
    No statistical analyses for this end point

    Secondary: Anti-HI antibody titers against 4 strains of influenza virus by vaccination status

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    End point title
    		 Anti-HI antibody titers against 4 strains of influenza virus by vaccination status
    End point description
    The strains are: Flu A/Christchurch/16/2010 H1N1 HI, (referred to as Flu A/Christch/16/2010 H1N1), Flu A/Texas/50/2012 H3N2 HI, Flu B/Massachusetts/2/2012 Yamagata HI, (referred to as Flu B/Mass/2/2012 Yamagata), Flu B/Brisbane/60/2008 Victoria HI. Titers are presented as geometric mean titers (GMTs). Vaccination status is presented as Y = vaccinated or N = not vaccinated during the 2012-2013 season.
    End point type
    Secondary
    End point timeframe
    At Days 0 and 21
    End point values
    		 Fluarix/Influsplit Tetra Adult Group Fluarix/Influsplit Tetra Elderly Group
    Number of subjects analysed
    60
    56
    Units: Titers
    geometric mean (confidence interval 95%)
        Flu A/Christch/16/2010 H1N1, Day 0,Y [N=12,24]
    65.4 (31.9 to 134.1)
    16.1 (10.5 to 24.7)
        Flu A/Christch/16/2010 H1N1, Day 0,N [N=48,32]
    24.5 (16.2 to 36.8)
    14.1 (8.9 to 22.4)
        Flu A/Texas/50/2012 H3N2, Day 0, Y [N=12.24]
    21.8 (9.5 to 50)
    15 (9.4 to 23.8)
        Flu A/Texas/50/2012 H3N2, Day 0, N [N=48,32]
    11.5 (8.9 to 15)
    12.6 (8.5 to 18.6)
        Flu B/Mass/2/2012 Yamagata, Day 0,Y [N=12,24]
    174.4 (88.4 to 343.8)
    111.6 (83.7 to 148.7)
        Flu B/Mass/2/2012 Yamagata, Day 0,N [N=48,32]
    145.6 (102.4 to 207.1)
    109.5 (78.4 to 152.8)
        Flu B/Brisbane/60/2008 Victoria, Day 0,Y [N=12,24]
    113.2 (67.2 to 190.8)
    62.7 (44.5 to 88.2)
        Flu B/Brisbane/60/2008 Victoria, Day 0,N [N=48,32]
    49.6 (36.4 to 67.6)
    52.4 (37.2 to 73.6)
        Flu A/Christch/16/2010 H1N1, Day 21,Y [N=12,24]
    570.2 (362.2 to 897.4)
    198.6 (111.2 to 355)
        Flu A/Christch/16/2010 H1N1, Day 21,N [N=48,32]
    489.9 (372.2 to 644.9)
    257.4 (159.1 to 416.2)
        Flu A/Texas/50/2012 H3N2, Day 21,Y [N=12,24]
    119.9 (67.8 to 211.9)
    68.2 (44.9 to 103.7)
        Flu A/Texas/50/2012 H3N2, Day 21,N [N=48,32]
    88.5 (67.6 to 115.8)
    86.1 (57.3 to 129.6)
        Flu B/Mass/2/2012 Yamagata, Day 21,Y [N=12,24]
    522.9 (316.8 to 863)
    415.2 (305.8 to 563.6)
        Flu B/Mass/2/2012 Yamagata, Day 21,N [N=48,32]
    879.5 (729.8 to 1059.9)
    647 (511.9 to 817.8)
        Flu B/Brisbane/60/2008 Victoria,Day 21,Y [N=12,24]
    269 (188.1 to 384.8)
    162.2 (117.9 to 223.2)
        Flu B/Brisbane/60/2008 Victoria,Day 21,N [N=48,32]
    369.7 (297.6 to 459.1)
    320 (248.3 to 412.5)
    No statistical analyses for this end point

    Secondary: Number of seroprotected subjects against 4 strains of influenza virus by vaccination status

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    End point title
    		 Number of seroprotected subjects against 4 strains of influenza virus by vaccination status
    End point description
    The strains are: Flu A/Christchurch/16/2010 H1N1 HI, (referred to as Flu A/Christch/16/2010 H1N1), Flu A/Texas/50/2012 H3N2 HI, Flu B/Massachusetts/2/2012 Yamagata HI, (referred to as Flu B/Mass/2/2012 Yamagata), Flu B/Brisbane/60/2008 Victoria HI. A seroprotected subject is defined as a subject with serum HI titre ≥ 1:40. Vaccination status is presented as Y = vaccinated or N = not vaccinated during the 2012-2013 season.
    End point type
    Secondary
    End point timeframe
    At Day 21
    End point values
    		 Fluarix/Influsplit Tetra Adult Group Fluarix/Influsplit Tetra Elderly Group
    Number of subjects analysed
    60
    56
    Units: Subjects
        Flu A/Christch/16/2010 H1N1, Day 0,Y [N=12,24]
    9
    5
        Flu A/Christch/16/2010 H1N1, Day 0,N [N=48,32]
    20
    7
        Flu A/Texas/50/2012 H3N2, Day 0, N [N=12,24]
    4
    7
        Flu A/Texas/50/2012 H3N2, Day 0, N [N=48,32]
    8
    8
        Flu B/Mass/2/2012 Yamagata, Day 0,Y [N=12,24]
    11
    23
        Flu B/Mass/2/2012 Yamagata, Day 0,N [N=48,32]
    45
    29
        Flu B/Brisbane/60/2008 Victoria, Day 0,Y [N=12,24]
    11
    20
        Flu B/Brisbane/60/2008 Victoria, Day 0,N [N=48,32]
    32
    20
        Flu A/Christch/16/2010 H1N1, Day 21,Y [N=12,24]
    12
    21
        Flu A/Christch/16/2010 H1N1, Day 21,N [N=48,32]
    48
    28
        Flu A/Texas/50/2012 H3N2, Day 21,Y [N=12,24]
    11
    18
        Flu A/Texas/50/2012 H3N2, Day 21,N [N=48,32]
    43
    22
        Flu B/Mass/2/2012 Yamagata, Day 21,Y [N=12,24]
    12
    24
        Flu B/Mass/2/2012 Yamagata, Day 21,N [N=48,32]
    48
    32
        Flu B/Brisbane/60/2008 Victoria,Day 21,Y [N=12,24]
    12
    23
        Flu B/Brisbane/60/2008 Victoria,Day 21,N [N=48,32]
    48
    32
    No statistical analyses for this end point

    Secondary: Number of seroconverted subjects against 4 strains of influenza virus by vaccination status

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    End point title
    		 Number of seroconverted subjects against 4 strains of influenza virus by vaccination status
    End point description
    The strains are: Flu A/Christchurch/16/2010 H1N1 HI, (referred to as Flu A/Christch/16/2010 H1N1), Flu A/Texas/50/2012 H3N2 HI, Flu B/Massachusetts/2/2012 Yamagata HI, (referred to as Flu B/Mass/2/2012 Yamagata), Flu B/Brisbane/60/2008 Victoria HI. A seroconverted subject is defined as a subject with either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least 4-fold increase in post-vaccination titer. Vaccination status is presented as Y = vaccinated or N = not vaccinated during the 2012-2013 season.
    End point type
    Secondary
    End point timeframe
    At Day 21
    End point values
    		 Fluarix/Influsplit Tetra Adult Group Fluarix/Influsplit Tetra Elderly Group
    Number of subjects analysed
    60
    56
    Units: Subjects
        Flu A/Christch/16/2010 H1N1, Day 21,Y [N=12,24]
    8
    18
        Flu A/Christch/16/2010 H1N1, Day 21,N [N=60,57]
    40
    25
        Flu A/Texas/50/2012 H3N2, Day 21,Y [N=12,24]
    7
    10
        Flu A/Texas/50/2012 H3N2, Day 21,N [N=60,57]
    34
    17
        Flu B/Mass/2/2012 Yamagata, Day 21,Y [N=12,24]
    3
    10
        Flu B/Mass/2/2012 Yamagata, Day 21,N [N=60,57]
    32
    22
        Flu B/Brisbane/60/2008 Victoria,Day 21,Y [N=12,24]
    2
    4
        Flu B/Brisbane/60/2008 Victoria,Day 21,N [N=60,57]
    35
    20
    No statistical analyses for this end point

    Secondary: Mean geometric increase (MGI) for HI antibody titer against the 4 flu strains of influenza virus by vaccination status

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    End point title
    		 Mean geometric increase (MGI) for HI antibody titer against the 4 flu strains of influenza virus by vaccination status
    End point description
    The strains are: Flu A/Christchurch/16/2010 H1N1 HI, (referred to as Flu A/Christch/16/2010 H1N1), Flu A/Texas/50/2012 H3N2 HI, Flu B/Massachusetts/2/2012 Yamagata HI, (referred to as Flu B/Mass/2/2012 Yamagata), Flu B/Brisbane/60/2008 Victoria HI. MGI was defined as the fold increase in serum HI geometric mean titers post-vaccination compared to Day 0. Vaccination status is presented as Y = vaccinated or N = not vaccinated during the 2012-2013 season.
    End point type
    Secondary
    End point timeframe
    At Day 21
    End point values
    		 Fluarix/Influsplit Tetra Adult Group Fluarix/Influsplit Tetra Elderly Group
    Number of subjects analysed
    60
    56
    Units: Titers
    geometric mean (confidence interval 95%)
        Flu A/Christch/16/2010 H1N1, Day 21,Y [N=12,24]
    8.7 (3.3 to 23.2)
    12.4 (7.1 to 21.6)
        Flu A/Christch/16/2010 H1N1, Day 21,N [N=48,32]
    20 (13.2 to 30.3)
    18.2 (10.6 to 31.4)
        Flu A/Texas/50/2012 H3N2, Day 21,Y [N=12,24]
    5.5 (2.5 to 12)
    4.6 (2.9 to 7.2)
        Flu A/Texas/50/2012 H3N2, Day 21,N [N=48,32]
    7.7 (5.8 to 10.1)
    6.9 (4.5 to 10.4)
        Flu B/Mass/2/2012 Yamagata, Day 21,Y [N=12,24]
    3 (1.6 to 5.7)
    3.7 (2.7 to 5.2)
        Flu B/Mass/2/2012 Yamagata, Day 21,N [N=48,32]
    6 (4.2 to 8.6)
    5.9 (4.4 to 7.9)
        Flu B/Brisbane/60/2008 Victoria,Day 21,Y [N=12,24]
    2.4 (1.6 to 3.6)
    2.6 (1.7 to 3.9)
        Flu B/Brisbane/60/2008 Victoria,Day 21,N [N=48,32]
    7.4 (5.4 to 10.3)
    6.1 (4.2 to 8.9)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited symptoms: Days 0-4 post-vaccination, unsolicited AEs: days 0-21 post-vaccination, SAEs: the entire study duration (Days 0-21 post-vaccination).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10
    Reporting groups
    Reporting group title
    Fluarix/Influsplit Tetra Elderly Group
    Reporting group description
    		 Subjects >60 years of age receiving Fluarix/Influsplit Tetra 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.

    Reporting group title
    Fluarix/Influsplit Tetra Adult Group
    Reporting group description
    		 Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.

    Serious adverse events
    		 Fluarix/Influsplit Tetra Elderly Group Fluarix/Influsplit Tetra Adult Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 57 (0.00%)
    0 / 60 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Fluarix/Influsplit Tetra Elderly Group Fluarix/Influsplit Tetra Adult Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    24 / 57 (42.11%)
    46 / 60 (76.67%)
    General disorders and administration site conditions
    Induration
         subjects affected / exposed
    5 / 57 (8.77%)
    6 / 60 (10.00%)
         occurrences all number
    5
    6
    Pain
         subjects affected / exposed
    19 / 57 (33.33%)
    37 / 60 (61.67%)
         occurrences all number
    19
    37
    Redness
         subjects affected / exposed
    6 / 57 (10.53%)
    3 / 60 (5.00%)
         occurrences all number
    6
    3
    Swelling
         subjects affected / exposed
    2 / 57 (3.51%)
    3 / 60 (5.00%)
         occurrences all number
    2
    3
    Arthralgia
         subjects affected / exposed
    6 / 57 (10.53%)
    3 / 60 (5.00%)
         occurrences all number
    6
    3
    Fatigue
         subjects affected / exposed
    4 / 57 (7.02%)
    10 / 60 (16.67%)
         occurrences all number
    4
    10
    Gastrointestinal symptoms
         subjects affected / exposed
    2 / 57 (3.51%)
    3 / 60 (5.00%)
         occurrences all number
    2
    3
    Headache
         subjects affected / exposed
    5 / 57 (8.77%)
    9 / 60 (15.00%)
         occurrences all number
    5
    9
    Myalgia
         subjects affected / exposed
    7 / 57 (12.28%)
    14 / 60 (23.33%)
         occurrences all number
    7
    14
    Sweating
         subjects affected / exposed
    2 / 57 (3.51%)
    3 / 60 (5.00%)
         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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