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    Clinical Trial Results:
    A Phase III, open-label, non-randomised, multi-centre, single dose study to assess immunogenicity and safety of Fluarix / Influsplit SSW 2013/2014 injected intramuscularly in adults (18 to 60 years of age) and in the elderly (over 60 years of age)

    Summary
    EudraCT number
    2013-000855-42
    Trial protocol
    DE  
    Global end of trial date
    02 Aug 2013

    Results information
    Results version number
    v2(current)
    This version publication date
    28 May 2016
    First version publication date
    19 Mar 2015
    Other versions
    v1
    Version creation reason
    • Correction of full data set
    Typos/information were corrected in endpoint description for 1 primary endpoint (GMT) and in the reporting groups for the secondary endpoints.

    Trial information

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    Trial identification
    Sponsor protocol code
    200160
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01884519
    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
    09 Aug 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    02 Aug 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    02 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 SSW 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
    12 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: 120
    Worldwide total number of subjects
    120
    EEA total number of subjects
    120
    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)
    120
    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
    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 18-60 Years Group
    Arm description
    Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
    Arm type
    Experimental

    Investigational medicinal product name
    Fluarix/Influsplit SSW® (2013-2014 season)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.

    Arm title
    Fluarix/Influsplit > 60 Years Group
    Arm description
    Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
    Arm type
    Experimental

    Investigational medicinal product name
    Fluarix/Influsplit SSW® (2013-2014 season)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.

    Number of subjects in period 1
    Fluarix/Influsplit 18-60 Years Group Fluarix/Influsplit > 60 Years Group
    Started
    60
    60
    Completed
    60
    60

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Fluarix/Influsplit 18-60 Years Group
    Reporting group description
    Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.

    Reporting group title
    Fluarix/Influsplit > 60 Years Group
    Reporting group description
    Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.

    Reporting group values
    Fluarix/Influsplit 18-60 Years Group Fluarix/Influsplit > 60 Years Group Total
    Number of subjects
    60 60 120
    Age categorical
    Units: Subjects
        In utero
    0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0
        Newborns (0-27 days)
    0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0
        Children (2-11 years)
    0 0 0
        Adolescents (12-17 years)
    0 0 0
        Adults (18-64 years)
    60 60 120
        From 65-84 years
    0 0 0
        85 years and over
    0 0 0
    Age continuous
    Units: years
        geometric mean (standard deviation)
    42.6 ± 11.5 68.2 ± 5.49 -
    Gender categorical
    Units: Subjects
        Female
    38 34 72
        Male
    22 26 48

    End points

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    End points reporting groups
    Reporting group title
    Fluarix/Influsplit 18-60 Years Group
    Reporting group description
    Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.

    Reporting group title
    Fluarix/Influsplit > 60 Years Group
    Reporting group description
    Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.

    Subject analysis set title
    Fluarix/Influsplit > 60 Years Group with Vaccination
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Subjects aged >60 years of age receiving Fluarix/Influsplit SSW 2013-2014

    Subject analysis set title
    Fluarix/Influsplit > 60 Years Group without Vaccination
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Subjects aged >60 years of age not receiving Fluarix/Influsplit SSW 2013-2014

    Subject analysis set title
    Fluarix/Influsplit 18-60 years Group with Vaccination
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Fluarix/Influsplit 18-60 years Group with Vaccination: Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0 and who had received an influenza vaccine during the 2 influenza seasonal prior to season 2012-2013. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.

    Subject analysis set title
    Fluarix/Influsplit 18-60 years Group without Vaccination
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Fluarix/Influsplit 18-60 years Group without Vaccination: Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0 and who had not received an influenza vaccine during the 2 influenza seasonal prior to season 2012-2013. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.

    Primary: Humoral immune response in terms of Haemagglutination Inhibition (HI) antibody titers against each of the three vaccine influenza strains

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    End point title
    Humoral immune response in terms of Haemagglutination Inhibition (HI) antibody titers against each of the three vaccine influenza strains [1]
    End point description
    HI Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).
    End point type
    Primary
    End point timeframe
    At Day 0 and Day 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 of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    Fluarix/Influsplit 18-60 Years Group Fluarix/Influsplit > 60 Years Group
    Number of subjects analysed
    60
    60
    Units: Titer
    geometric mean (confidence interval 95%)
        H1N1, Day 0
    27.3 (20.3 to 36.8)
    15.7 (12.1 to 20.4)
        H1N1, Day 21
    444.6 (335.6 to 588.9)
    197 (142.6 to 272.1)
        H3N2, Day 0
    15.8 (11.9 to 21.1)
    14.2 (11 to 18.4)
        H3N2, Day 21
    73.8 (57.8 to 94.2)
    80 (58.4 to 109.5)
        Yamagata, Day 0
    105 (83.6 to 131.8)
    95.2 (77.5 to 116.9)
        Yamagata, Day 21
    424.6 (347.6 to 518.8)
    327.5 (266.2 to 402.9)
    No statistical analyses for this end point

    Primary: Number of subjects who were seroprotected for anti-HI antibodies against each of the three vaccine influenza strains.

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    End point title
    Number of subjects who were seroprotected for anti-HI antibodies against each of the three vaccine influenza strains. [2]
    End point description
    A seroprotected subject was defined as a vaccinated subject. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).
    End point type
    Primary
    End point timeframe
    At Day 0 and 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 of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    Fluarix/Influsplit 18-60 Years Group Fluarix/Influsplit > 60 Years Group
    Number of subjects analysed
    60
    60
    Units: Subjects
        H1N1, Day 0
    25
    14
        H1N1, Day 21
    58
    56
        H3N2, Day 0
    12
    12
        H3N2, Day 21
    50
    44
        Yamagata, Day 0
    53
    55
        Yamagata, Day 21
    60
    60
    No statistical analyses for this end point

    Primary: Number of seroconverted subjects for anti-HIA antibodies against each of the three vaccine influenza strains.

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    End point title
    Number of seroconverted subjects for anti-HIA antibodies against each of the three vaccine influenza strains. [3]
    End point description
    A seroconverted subjects was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).
    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 of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    Fluarix/Influsplit 18-60 Years Group Fluarix/Influsplit > 60 Years Group
    Number of subjects analysed
    60
    60
    Units: Subjects
        H1N1
    44
    46
        H3N2
    31
    29
        Yamagata
    30
    23
    No statistical analyses for this end point

    Primary: Mean geometric increase (MGI) for haemagglutination inhibition (HI) antibody titer against each of the three vaccine influenza strains.

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    End point title
    Mean geometric increase (MGI) for haemagglutination inhibition (HI) antibody titer against each of the three vaccine influenza strains. [4]
    End point description
    MGI was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).
    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 of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    Fluarix/Influsplit 18-60 Years Group Fluarix/Influsplit > 60 Years Group
    Number of subjects analysed
    60
    60
    Units: Fold increase
    geometric mean (confidence interval 95%)
        H1N1
    16.3 (10.8 to 24.5)
    12.6 (8.7 to 18.2)
        H3N2
    4.7 (3.4 to 6.4)
    5.6 (4 to 7.9)
        Yamagata
    4 (3.1 to 5.3)
    3.4 (2.7 to 4.3)
    No statistical analyses for this end point

    Primary: Number of subjects with seroprotection power (SPP) for HI antibody titer against each of the three vaccine Influenza strains above the cut-off value.

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    End point title
    Number of subjects with seroprotection power (SPP) for HI antibody titer against each of the three vaccine Influenza strains above the cut-off value. [5]
    End point description
    SPP was defined as the number of vaccinated subjects with a pre-vaccination titer < 1:40 and a post-vaccination titer ≥ 1:40. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).
    End point type
    Primary
    End point timeframe
    At Day 21
    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
    Fluarix/Influsplit 18-60 Years Group Fluarix/Influsplit > 60 Years Group
    Number of subjects analysed
    48
    48
    Units: Subjects
        H1N1 [N=35,46]
    33
    42
        H3N2 [N=48,48]
    38
    32
        Yamagata [N=7,5]
    7
    5
    No statistical analyses for this end point

    Secondary: Humoral immune response in terms of HI antibody titers against each of the three vaccine influenza strains

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    End point title
    Humoral immune response in terms of HI antibody titers against each of the three vaccine influenza strains
    End point description
    HI antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata). This outcome measure was assessed by influenza vaccination status in subjects (18-60 years and >60 years) who had and who had not received an influenza vaccine during the 2 influenza seasons prior to season 2012/2013.
    End point type
    Secondary
    End point timeframe
    At Days 0 and 21
    End point values
    Fluarix/Influsplit > 60 Years Group with Vaccination Fluarix/Influsplit > 60 Years Group without Vaccination Fluarix/Influsplit 18-60 years Group with Vaccination Fluarix/Influsplit 18-60 years Group without Vaccination
    Number of subjects analysed
    29
    31
    20
    40
    Units: Titer
    geometric mean (confidence interval 95%)
        H1N1, Day 0
    16.3 (10.5 to 25.2)
    15.1 (10.9 to 21)
    28.7 (17.2 to 48.1)
    26.6 (18.2 to 38.9)
        H1N1, Day 21
    158.2 (99.1 to 252.5)
    241.9 (152.7 to 383.3)
    348.8 (200.3 to 607.4)
    501.9 (361 to 698)
        H3N2, Day 0
    17.3 (11.4 to 26.2)
    11.8 (8.6 to 16.2)
    18.6 (10.8 to 32)
    14.6 (10.3 to 20.8)
        H3N2, Day 21
    58.6 (39.9 to 86.2)
    106.9 (65.6 to 174.3)
    60.6 (39.3 to 93.5)
    81.4 (60 to 110.4)
        Yamagata, Day 0
    110.6 (84.6 to 144.5)
    82.7 (60.3 to 113.4)
    109.3 (74.3 to 160.9)
    102.9 (76.7 to 138)
        Yamagata, Day 21
    237.3 (184.2 to 305.8)
    442.6 (328.9 to 595.7)
    355 (247.3 to 509.5)
    464.4 (362.9 to 594.2)
    No statistical analyses for this end point

    Secondary: Number of subjects who were seroprotected for anti-HI antibodies against each of the three vaccine influenza strains.

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    End point title
    Number of subjects who were seroprotected for anti-HI antibodies against each of the three vaccine influenza strains.
    End point description
    A seroprotected subject was defined as the number of a vaccinated subjects with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata). This outcome measure was assessed by influenza vaccination status in subjects (18-60 years and >60 years) who had and who had not received an influenza vaccine during the 2 influenza seasons prior to season 2012/2013.
    End point type
    Secondary
    End point timeframe
    At Day 0 and Day 21
    End point values
    Fluarix/Influsplit > 60 Years Group with Vaccination Fluarix/Influsplit > 60 Years Group without Vaccination Fluarix/Influsplit 18-60 years Group with Vaccination Fluarix/Influsplit 18-60 years Group without Vaccination
    Number of subjects analysed
    29
    31
    20
    40
    Units: Subjects
        H1N1, Day 0
    8
    6
    9
    16
        H1N1, Day 21
    26
    30
    19
    39
        H3N2, Day 0
    6
    6
    5
    7
        H3N2, Day 21
    20
    24
    16
    34
        Yamagata, Day 0
    29
    26
    18
    35
        Yamagata, Day 21
    29
    31
    20
    40
    No statistical analyses for this end point

    Secondary: Number of seroconverted subjects for anti-HA antibodies against each of the three vaccine influenza strains.

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    End point title
    Number of seroconverted subjects for anti-HA antibodies against each of the three vaccine influenza strains.
    End point description
    A seroconverted subjects was defined as a vaccinated subjects with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata). This outcome measure was assessed by influenza vaccination status in subjects (18-60 years and >60 years) who had and who had not received an influenza vaccine during the 2 influenza seasons prior to season 2012/2013.
    End point type
    Secondary
    End point timeframe
    At Day 21
    End point values
    Fluarix/Influsplit > 60 Years Group with Vaccination Fluarix/Influsplit > 60 Years Group without Vaccination Fluarix/Influsplit 18-60 years Group with Vaccination Fluarix/Influsplit 18-60 years Group without Vaccination
    Number of subjects analysed
    29
    31
    20
    40
    Units: Subjects
        H1N1
    20
    26
    13
    31
        H3N2
    10
    19
    8
    23
        Yamagata
    5
    18
    6
    24
    No statistical analyses for this end point

    Secondary: Mean geometric increase (MGI) for haemagglutination inhibition (HI) antibody titer against each of the three vaccine influenza strains.

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    End point title
    Mean geometric increase (MGI) for haemagglutination inhibition (HI) antibody titer against each of the three vaccine influenza strains.
    End point description
    MGI was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata). This outcome measure was assessed by influenza vaccination status in subjects (18-60 years and >60 years) who had and who had not received an influenza vaccine during the 2 influenza seasons prior to season 2012/2013.
    End point type
    Secondary
    End point timeframe
    At Day 21
    End point values
    Fluarix/Influsplit > 60 Years Group with Vaccination Fluarix/Influsplit > 60 Years Group without Vaccination Fluarix/Influsplit 18-60 years Group with Vaccination Fluarix/Influsplit 18-60 years Group without Vaccination
    Number of subjects analysed
    29
    31
    20
    40
    Units: Fold increase
    geometric mean (confidence interval 95%)
        H1N1
    9.7 (5.5 to 17)
    16 (9.7 to 26.5)
    12.1 (5.8 to 25.4)
    18.9 (11.4 to 31.4)
        H3N2
    3.4 (2.4 to 4.8)
    9.1 (5.3 to 15.5)
    3.3 (2 to 5.2)
    5.6 (3.7 to 8.3)
        Yamagata
    2.1 (1.7 to 2.7)
    5.4 (3.9 to 7.4)
    3.2 (2 to 5.2)
    4.5 (3.2 to 6.3)
    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 ecchymosis, induration, pain, redness and swelling. Any was defined as any solicited local symptom reported irrespective of intensity. Grade 3 pain was defined as pain that prevented normal everyday activities. Grade 3 ecchymosis, induration, redness and swelling was greater than 100 millimeters (mm) i.e. >100mm.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Days 0-3) post-vaccination period
    End point values
    Fluarix/Influsplit 18-60 Years Group Fluarix/Influsplit > 60 Years Group
    Number of subjects analysed
    60
    60
    Units: Subjects
        Any Ecchymosis
    0
    0
        Grade 3 Ecchymosis
    0
    0
        Any Induration
    0
    2
        Grade 3 Induration
    0
    0
        Any Pain
    38
    15
        Grade 3 Pain
    0
    0
        Any Redness
    8
    3
        Grade 3 Redness
    0
    0
        Any Swelling
    6
    2
        Grade 3 Swelling
    0
    0
    No statistical analyses for this end point

    Secondary: Duration of solicited local symptoms.

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    End point title
    Duration of solicited local symptoms.
    End point description
    Duration was defined as number of days with any grade of local symptoms.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Days 0-3) post-vaccination period
    End point values
    Fluarix/Influsplit 18-60 Years Group Fluarix/Influsplit > 60 Years Group
    Number of subjects analysed
    38
    15
    Units: Days
    median (full range (min-max))
        Induration [N=0,2]
    0 (0 to 0)
    1.5 (1 to 2)
        Pain [N=38, 15]
    2 (1 to 4)
    2 (1 to 4)
        Redness [N=8,3]
    2 (1 to 4)
    2 (2 to 4)
        Swelling [N=6,2]
    1 (1 to 4)
    2 (2 to 2)
    No statistical analyses for this end point

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

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    End point title
    Number of subjects reporting any, grade 3 and related solicited general symptoms.
    End point description
    Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering, increased sweating and fever [axillary temperature above 37.5 degrees Celsius (°C)]. Gastrointestinal symptoms included nausea, vomiting, diarrhea and/or abdominal pain. Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 fever = axillary temperature above 39.0°C
    End point type
    Secondary
    End point timeframe
    During the 4-day (Days 0-3) post-vaccination period
    End point values
    Fluarix/Influsplit 18-60 Years Group Fluarix/Influsplit > 60 Years Group
    Number of subjects analysed
    60
    60
    Units: Subjects
        Any Arthralgia
    5
    5
        Grade 3 Arthralgia
    0
    0
        Related Arthralgia
    4
    3
        Any Fatigue
    10
    7
        Grade 3 Fatigue
    0
    0
        Related Fatigue
    6
    4
        Any Gastrointestinal symptoms
    4
    1
        Grade 3 Gastrointestinal symptoms
    0
    0
        Related Gastrointestinal symptoms
    3
    1
        Any Headache
    10
    5
        Grade 3 Headache
    2
    0
        Related Headache
    9
    5
        Any Myalgia
    14
    5
        Grade 3 Myalgia
    0
    0
        Related Myalgia
    12
    4
        Any Shivering
    4
    0
        Grade 3 Shivering
    0
    0
        Related Shivering
    4
    0
        Any Sweating
    3
    7
        Grade 3 Sweating
    0
    0
        Related Sweating
    1
    4
        Any Fever ( ≥37.5°C)
    0
    1
        Grade 3 Fever (>39.0°C)
    0
    0
        Related Fever
    0
    1
    No statistical analyses for this end point

    Secondary: Duration of solicited general symptoms.

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    End point title
    Duration of solicited general symptoms.
    End point description
    Duration was defined as number of days with any grade of general symptoms.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Days 0-3) post-vaccination period
    End point values
    Fluarix/Influsplit 18-60 Years Group Fluarix/Influsplit > 60 Years Group
    Number of subjects analysed
    14
    7
    Units: Days
    median (full range (min-max))
        Arthralgia [N=5,5]
    1 (1 to 4)
    1 (1 to 4)
        Fatigue [N=10, 7]
    1 (1 to 2)
    2 (1 to 4)
        Gastrointestinal symptoms [N=4,1]
    1 (1 to 1)
    3 (3 to 3)
        Headache [N=10,5]
    1.5 (1 to 3)
    1 (1 to 2)
        Myalgia [N=14,5]
    1 (1 to 4)
    2 (1 to 3)
        Sweating [N=3,7]
    1 (1 to 1)
    1 (1 to 4)
        Shivering [N=4,0]
    1 (1 to 1)
    0 (0 to 0)
        Fever (Axillary) [N=0,1]
    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
    Unsolicited AE covers any AE 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 occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination.
    End point type
    Secondary
    End point timeframe
    During the 21-day (Days 0-20) post-vaccination period
    End point values
    Fluarix/Influsplit 18-60 Years Group Fluarix/Influsplit > 60 Years Group
    Number of subjects analysed
    60
    60
    Units: Subjects
        Any Unsolicted AEs
    5
    3
        Grade 3 Unsolicted AEs
    0
    0
        Related Unsolicted AEs
    0
    1
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any and related serious adverse events (SAEs)

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    End point title
    Number of subjects reporting any and related serious adverse events (SAEs)
    End point description
    A serious adverse event was any untoward medical occurrence that: resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.
    End point type
    Secondary
    End point timeframe
    During the entire study period (Days 0-180)
    End point values
    Fluarix/Influsplit 18-60 Years Group Fluarix/Influsplit > 60 Years Group
    Number of subjects analysed
    60
    60
    Units: Subjects
        Any SAEs
    0
    0
        Related SAEs
    0
    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: From Day 0 to Day 180; Solicited local and general symptoms: During the 4-day (Days 0-3) post-vaccination period; Unsolicited symptoms: During the 21-day (Day 0-20) post-vaccination period
    Adverse event reporting additional description
    For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated Cohort who had the symptom sheet completed.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    10
    Reporting groups
    Reporting group title
    Fluarix/Influsplit > 60 Years Group
    Reporting group description
    -

    Reporting group title
    Fluarix/Influsplit 18-60 Years Group
    Reporting group description
    -

    Serious adverse events
    Fluarix/Influsplit > 60 Years Group Fluarix/Influsplit 18-60 Years Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 60 (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 > 60 Years Group Fluarix/Influsplit 18-60 Years Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    25 / 60 (41.67%)
    38 / 60 (63.33%)
    General disorders and administration site conditions
    Pain
         subjects affected / exposed
    15 / 60 (25.00%)
    38 / 60 (63.33%)
         occurrences all number
    15
    38
    Redness
         subjects affected / exposed
    3 / 60 (5.00%)
    8 / 60 (13.33%)
         occurrences all number
    3
    8
    Swelling
         subjects affected / exposed
    2 / 60 (3.33%)
    6 / 60 (10.00%)
         occurrences all number
    2
    6
    Arthralgia
         subjects affected / exposed
    5 / 60 (8.33%)
    5 / 60 (8.33%)
         occurrences all number
    5
    5
    Fatigue
         subjects affected / exposed
    7 / 60 (11.67%)
    10 / 60 (16.67%)
         occurrences all number
    7
    10
    Gastrointestinal symptoms
         subjects affected / exposed
    1 / 60 (1.67%)
    4 / 60 (6.67%)
         occurrences all number
    1
    4
    Headache
         subjects affected / exposed
    5 / 60 (8.33%)
    10 / 60 (16.67%)
         occurrences all number
    5
    10
    Myalgia
         subjects affected / exposed
    5 / 60 (8.33%)
    14 / 60 (23.33%)
         occurrences all number
    5
    14
    Shivering
         subjects affected / exposed
    0 / 60 (0.00%)
    4 / 60 (6.67%)
         occurrences all number
    0
    4
    Sweating
         subjects affected / exposed
    7 / 60 (11.67%)
    3 / 60 (5.00%)
         occurrences all number
    7
    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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