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    Clinical Trial Results:
    Estudio fase I, abierto, multicéntrico para evaluar la seguridad e inmunogenicidad de la vacuna antigripal estacional trivalente (GSK2186877A) adyuvada con varias dosis de AS03, administrada en niños sanos de entre 6 y 35 meses de edad.

    Summary
    EudraCT number
    		 2010-018392-22
    Trial protocol
    		 ES  
    Global end of trial date
    13 Dec 2010

    Results information
    Results version number
    		 v1
    This version publication date
    13 May 2016
    First version publication date
    01 Feb 2015
    Other versions
    		 v2 , v3

    Trial information

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    Trial identification
    Sponsor protocol code
    114182
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01096056
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline Biologicals
    Sponsor organisation address
    Rue de l’Institut 89, Rixensart, Belgium, B-1330
    Public contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    22 Feb 2011
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    13 Dec 2010
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Dec 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Evaluar la reactogenicidad de la vacuna antigripal estacional trivalente adyuvada con varias dosis de AS03, a partir de la incidencia de fiebre de grado &#8805;2* notificada durante el periodo de seguimiento de 7 días después de cada vacunación. * temperatura axilar >38°C
    Protection of trial subjects
    As with all injectable vaccines, appropriate medical treatment was always readily available in case of anaphylactic reactions following the administration of the vaccine. For this reason, the vaccinee remained under medical supervision for 30 minutes after vaccination.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 Apr 2010
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy
    Long term follow-up duration
    		 6 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 40
    Worldwide total number of subjects
    40
    EEA total number of subjects
    40
    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)
    40
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 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
    		 Influenza vaccine GSK2186877A formulation 1 Group
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Biological: Influenza vaccine GSK2186877A formulation 1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received 2 doses of influenza vaccine GSK2186877A formulation 1 at Day 0 and Day 21 and 1 dose of Fluarix vaccine at Month 6.

    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 received 2 doses of influenza vaccine GSK2186877A formulation 1 at Day 0 and Day 21 and 1 dose of Fluarix vaccine at Month 6.

    Arm title
    		 Influenza vaccine GSK2186877A formulation 2 Group
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Biological: Influenza vaccine GSK2186877A formulation 2
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received 1 dose of influenza vaccine GSK2186877A formulation 2 at Day 0 and 1 dose of Fluarix vaccine at Month 6.

    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 received 1 dose of influenza vaccine GSK2186877A formulation 2 at Day 0 and 1 dose of Fluarix vaccine at Month 6.

    Number of subjects in period 1
    		Influenza vaccine GSK2186877A formulation 1 Group Influenza vaccine GSK2186877A formulation 2 Group
    Started
    20
    20
    Completed
    20
    19
    Not completed
    0
    1
         Lost to follow-up
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Influenza vaccine GSK2186877A formulation 1 Group
    Reporting group description
    		 -

    Reporting group title
    Influenza vaccine GSK2186877A formulation 2 Group
    Reporting group description
    		 -

    Reporting group values
    		 Influenza vaccine GSK2186877A formulation 1 Group Influenza vaccine GSK2186877A formulation 2 Group Total
    Number of subjects
    		 20 20 40
    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: months
        arithmetic mean (standard deviation)
    		 23.2 ± 9.82 18.6 ± 7.46 -
    Gender categorical
    Units: Subjects
        Female
    		 11 7 18
        Male
    		 9 13 22

    End points

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    End points reporting groups
    Reporting group title
    Influenza vaccine GSK2186877A formulation 1 Group
    Reporting group description
    		 -

    Reporting group title
    Influenza vaccine GSK2186877A formulation 2 Group
    Reporting group description
    		 -

    Primary: Number of subjects reporting fever grade 2 or higher

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    End point title
    		 Number of subjects reporting fever grade 2 or higher [1]
    End point description
    Fever grade greater than or equal to 2 i.e. ≥2 was defined as axillary temperature >38 degree centigrade (°C).
    End point type
    Primary
    End point timeframe
    Within 7 days following any vaccination with New generation influenza vaccine GSK2186877A
    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
    		 Influenza vaccine GSK2186877A formulation 1 Group Influenza vaccine GSK2186877A formulation 2 Group
    Number of subjects analysed
    20
    20
    Units: Subjects
        Temperature [Units:subjects]
    11
    7
    No statistical analyses for this end point

    Secondary: Haemagglutination Inhibition (HI) antibody titers

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    End point title
    		 Haemagglutination Inhibition (HI) antibody titers
    End point description
    Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains included Flu A/CAL/7/09 H1N1, Flu A/Uru/716/07 H3N2 and FluB/Bri/60/08 Victoria antigens.
    End point type
    Secondary
    End point timeframe
    At Day 0 and Day 42
    End point values
    		 Influenza vaccine GSK2186877A formulation 1 Group Influenza vaccine GSK2186877A formulation 2 Group
    Number of subjects analysed
    20
    20
    Units: Units:Titers
    geometric mean (confidence interval 95%)
        Flu A/CAL/7/09 H1N1 strain at Day 0 (N=20;20)
    13.7 (6.5 to 28.9)
    35.4 (13.6 to 92.6)
        Flu A/CAL/7/09 H1N1 strain at Day 42 (N=20;19)
    905.2 (649 to 1262.6)
    617.1 (251 to 1516.8)
        Flu A/Uru/716/07 H3N2 strain at Day 0 (N=20;20)
    14.9 (6.6 to 33.5)
    7.6 (4.1 to 13.9)
        Flu A/Uru/716/07 H3N2 strain at Day 42 (N=20;19)
    722.5 (473.8 to 1101.7)
    160 (86.3 to 296.7)
        FluB/Bri/60/08 Victoria strain at Day 0 (N=20;20)
    5.9 (4.1 to 8.5)
    5.9 (4.1 to 8.5)
        FluB/Bri/60/08 Victoria strain at Day 42 (N=20;19)
    460.5 (320.4 to 661.8)
    63.1 (30.9 to 128.8)
    No statistical analyses for this end point

    Secondary: The number of subjects seropositive to HI antibodies

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    End point title
    		 The number of subjects seropositive to HI antibodies
    End point description
    A seropositive subject was defined as a subject with antibody titer greater than or equal to 1:10. The vaccine strains included Flu A/CAL/7/09 H1N1, Flu A/Uru/716/07 H3N2 and FluB/Bri/60/08 Victoria antigens.
    End point type
    Secondary
    End point timeframe
    At Day 0 and Day 42
    End point values
    		 Influenza vaccine GSK2186877A formulation 1 Group Influenza vaccine GSK2186877A formulation 2 Group
    Number of subjects analysed
    20
    20
    Units: Subjects
        Flu A/CAL/7/09 H1N1 strain at Day 0 (N=20;20)
    6
    10
        Flu A/CAL/7/09 H1N1 strain at Day 42 (N=20;19)
    20
    19
        Flu A/Uru/716/07 H3N2 strain at Day 0 (N=20;20)
    6
    2
        Flu A/Uru/716/07 H3N2 strain at Day 42 (N=20;19)
    20
    19
        FluB/Bri/60/08 Victoria strain at Day 0 (N=20;20)
    1
    1
        FluB/Bri/60/08 Victoria strain at Day 42 (N=20;19)
    20
    19
    No statistical analyses for this end point

    Secondary: The number of subjects seroprotected to HI antibodies

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    End point title
    		 The number of subjects seroprotected to HI antibodies
    End point description
    A seroprotected subject was defined as a subject with a serum HI titre greater than or equal to 1:40 that usually is accepted as indicating protection. The vaccine strains included Flu A/CAL/7/09 H1N1, Flu A/Uru/716/07 H3N2 and FluB/Bri/60/08 Victoria antigens.
    End point type
    Secondary
    End point timeframe
    At Day 0 and Day 42
    End point values
    		 Influenza vaccine GSK2186877A formulation 1 Group Influenza vaccine GSK2186877A formulation 2 Group
    Number of subjects analysed
    20
    20
    Units: Subjects
        Flu A/CAL/7/09 H1N1 strain at Day 0 (N=20;20)
    6
    10
        Flu A/CAL/7/09 H1N1 strain at Day 42 (N=20;19)
    20
    19
        Flu A/Uru/716/07 H3N2 strain at Day 0 (N=20;20)
    6
    2
        Flu A/Uru/716/07 H3N2 strain at Day 42 (N=20;19)
    20
    19
        FluB/Bri/60/08 Victoria strain at Day 0 (N=20;20)
    1
    1
        FluB/Bri/60/08 Victoria strain at Day 42 (N=20;19)
    20
    14
    No statistical analyses for this end point

    Secondary: The number of subjects seroconverted to HI antibodies

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    End point title
    		 The number of subjects seroconverted to HI antibodies
    End point description
    A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains included Flu A/CAL/7/09 H1N1, Flu A/Uru/716/07 H3N2 and FluB/Bri/60/08 Victoria antigens.
    End point type
    Secondary
    End point timeframe
    Day 42
    End point values
    		 Influenza vaccine GSK2186877A formulation 1 Group Influenza vaccine GSK2186877A formulation 2 Group
    Number of subjects analysed
    20
    19
    Units: Subjects
        Flu A/CAL/7/09 H1N1 strain
    20
    19
        Flu A/Uru/716/07 H3N2 strain
    20
    19
        FluB/Bri/60/08 Victoria strain
    20
    14
    No statistical analyses for this end point

    Secondary: HI antibody Geometric mean fold rise (GMFR)

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    End point title
    		 HI antibody Geometric mean fold rise (GMFR)
    End point description
    GMFR was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The vaccine strains included Flu A/CAL/7/09 H1N1, Flu A/Uru/716/07 H3N2 and FluB/Bri/60/08 Victoria antigens.
    End point type
    Secondary
    End point timeframe
    Day 42
    End point values
    		 Influenza vaccine GSK2186877A formulation 1 Group Influenza vaccine GSK2186877A formulation 2 Group
    Number of subjects analysed
    20
    19
    Units: Units:fold increase
    geometric mean (confidence interval 95%)
        Flu A/CAL/7/09 H1N1 strain
    66.3 (38.8 to 113.3)
    19.6 (13.4 to 28.5)
        Flu A/Uru/716/07 H3N2 strain
    48.5 (28 to 84.1)
    20.7 (14.8 to 28.8)
        FluB/Bri/60/08 Victoria strain
    77.4 (59.4 to 101)
    10.5 (6.3 to 17.6)
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any and grade 3 solicited local Adverse Events (AEs)

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    End point title
    		 Number of subjects reporting any and grade 3 solicited local Adverse Events (AEs)
    End point description
    Grade 3 redness and swelling was > 50 millimeter (mm) and grade 3 pain was subjects crying when limb was moved/spontaneously painful. Any was occurrence of any local symptom regardless of their intensity grade.
    End point type
    Secondary
    End point timeframe
    Within 7 days following any vaccination with New generation influenza vaccine GSK2186877A
    End point values
    		 Influenza vaccine GSK2186877A formulation 1 Group Influenza vaccine GSK2186877A formulation 2 Group
    Number of subjects analysed
    20
    20
    Units: Subjects
        Any pain
    10
    6
        Grade 3 pain
    0
    0
        Any redness
    7
    2
        Grade 3 redness
    0
    0
        Any swelling
    6
    1
        Grade 3 swelling
    0
    0
    No statistical analyses for this end point

    Secondary: Duration of solicited local AEs

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    End point title
    		 Duration of solicited local AEs
    End point description
    Duration was defined as number of days with any grade of local symptoms following each dose of New generation influenza vaccine GSK2186877A. Dose 1 application of vaccine involved Influenza vaccine GSK2186877A formulation 1 Group and Influenza vaccine GSK2186877A formulation 2 Group while Dose 2 involved only Influenza vaccine GSK2186877A formulation 1 Group.
    End point type
    Secondary
    End point timeframe
    Within 7 days following any vaccination with New generation influenza vaccine GSK2186877A
    End point values
    		 Influenza vaccine GSK2186877A formulation 1 Group Influenza vaccine GSK2186877A formulation 2 Group
    Number of subjects analysed
    7
    6
    Units: Units:Days
    median (full range (min-max))
        Pain [Dose 1] (N=6;6)
    1 (1 to 2)
    1 (1 to 2)
        Pain [Dose 2] (N=7;0)
    2 (1 to 2)
    0 (0 to 0)
        Redness [Dose 1] (N=2;2)
    3.5 (2 to 5)
    1 (1 to 1)
        Redness [Dose 2] (N=6;0)
    2.5 (2 to 3)
    0 (0 to 0)
        Swelling [Dose 1] (N=1;1)
    3 (3 to 3)
    1 (1 to 1)
        Swelling [Dose 2] (N=5;0)
    3 (2 to 4)
    0 (0 to 0)
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects reporting any, grade 3 and related solicited general AEs
    End point description
    Any temperature was defined as axillary temperature ≥37.5°C, grade 3 temperature was axillary temperature >39.0°C. For other symptoms, any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination. Grade 3 drowsiness was defined as general symptom that prevented normal activity, grade 3 irritability was crying that cannot be comforted/prevented normal activity, grade 3 loss of appetite was not eating at all and grade 3 vomiting was defined as ≥3 episode of vomiting/day. Related was symptom assessed by the investigator as causally related to vaccination.
    End point type
    Secondary
    End point timeframe
    Within 7 days following any vaccination with New generation influenza vaccine GSK2186877A
    End point values
    		 Influenza vaccine GSK2186877A formulation 1 Group Influenza vaccine GSK2186877A formulation 2 Group
    Number of subjects analysed
    20
    20
    Units: Subjects
        Any drowsiness
    6
    7
        Grade 3 drowsiness
    0
    1
        Related drowsiness
    3
    3
        Any irritability
    7
    9
        Grade 3 irritability
    1
    1
        Related irritability
    4
    4
        Any loss of appetite
    12
    5
        Grade 3 loss of appetite
    0
    1
        Related loss of appetite
    5
    3
        Any temperature
    14
    12
        Grade 3 temperature
    2
    1
        Related temperature
    9
    9
        Any vomiting
    7
    4
        Grade 3 vomiting
    2
    1
        Related vomiting
    2
    0
    No statistical analyses for this end point

    Secondary: Duration of solicited general AEs

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    End point title
    		 Duration of solicited general AEs
    End point description
    Duration was defined as number of days with any grade of local symptoms following each dose of New generation influenza vaccine GSK2186877A. Dose 1 application of vaccine involved subjects in Influenza vaccine GSK2186877A formulation 1 Group and Influenza vaccine GSK2186877A formulation 2 Group while Dose 2 application of vaccine involved only subjects in the Influenza vaccine GSK2186877A formulation 1 Group.
    End point type
    Secondary
    End point timeframe
    Within 7 days following any vaccination with New generation influenza vaccine GSK2186877A
    End point values
    		 Influenza vaccine GSK2186877A formulation 1 Group Influenza vaccine GSK2186877A formulation 2 Group
    Number of subjects analysed
    9
    12
    Units: Units:Days
    median (full range (min-max))
        Drowsiness [Dose 1] (N=4;7)
    1.5 (1 to 3)
    2 (1 to 6)
        Drowsiness [Dose 2] (N=4;0)
    2 (1 to 4)
    0 (0 to 0)
        Irritability [Dose 1] (N=4;9)
    2.5 (1 to 4)
    2 (1 to 6)
        Irritability [Dose 2] (N=4;0)
    1 (1 to 2)
    0 (0 to 0)
        Loss of appetite [Dose 1] (N=9;5)
    1 (1 to 3)
    2 (1 to 4)
        Loss of appetite [Dose 2] (N=5;0)
    5 (1 to 6)
    0 (0 to 0)
        Temperature [Dose 1] (N=7;12)
    1 (1 to 5)
    1 (1 to 6)
        Temperature [Dose 2] (N=9;0)
    1 (1 to 4)
    0 (0 to 0)
        Vomiting [Dose 1] (N=5;4)
    1 (1 to 1)
    1 (1 to 2)
        Vomiting [Dose 2] (N=3;0)
    1 (1 to 2)
    0 (0 to 0)
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any, grade 3 and related unsolicited AEs

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    End point title
    		 Number of subjects reporting any, grade 3 and related unsolicited 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 event that prevented normal activities and Related was defined as unsolicited AE assessed by the investigator to be causally related to the study vaccination.
    End point type
    Secondary
    End point timeframe
    Within 21 days after any vaccination with New generation influenza vaccine GSK2186877A
    End point values
    		 Influenza vaccine GSK2186877A formulation 1 Group Influenza vaccine GSK2186877A formulation 2 Group
    Number of subjects analysed
    20
    20
    Units: Subjects
        Any AE(s)
    14
    12
        Grade 3 AE(s)
    1
    0
        Related AE(s)
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any, grade 3 and related AEs with a medically attended visit (MAEs)

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    End point title
    		 Number of subjects reporting any, grade 3 and related AEs with a medically attended visit (MAEs)
    End point description
    For each solicited and unsolicited AE the subject experienced, the subject was asked if they had received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination, grade 3 was defined as symptom that prevented normal activity and related was symptom assessed by the investigator as causally related to the study vaccination.
    End point type
    Secondary
    End point timeframe
    Day 0 up to Month 7
    End point values
    		 Influenza vaccine GSK2186877A formulation 1 Group Influenza vaccine GSK2186877A formulation 2 Group
    Number of subjects analysed
    20
    20
    Units: Subjects
        Any MAE(s)
    18
    20
        Grade 3 MAE(s)
    3
    3
        Related MAE(s)
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any potential Immune-Mediated-Diseases (pIMDs)

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    End point title
    		 Number of subjects reporting any potential Immune-Mediated-Diseases (pIMDs)
    End point description
    pIMDs 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
    Day 0 up to Month 7
    End point values
    		 Influenza vaccine GSK2186877A formulation 1 Group Influenza vaccine GSK2186877A formulation 2 Group
    Number of subjects analysed
    20
    20
    Units: Subjects
        Any pIMD [Units:Subjects]
    0
    0
    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
    SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are 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 event assessed by the investigator as causally related to the study vaccination.
    End point type
    Secondary
    End point timeframe
    Day 0 up to Month 7
    End point values
    		 Influenza vaccine GSK2186877A formulation 1 Group Influenza vaccine GSK2186877A formulation 2 Group
    Number of subjects analysed
    20
    20
    Units: Subjects
        Any SAE (s)
    0
    3
        Related SAE(s)
    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 were assessed from day 0 up to month 7. Systematically assessed frequent adverse events (AEs) and Non-systematically assessed frequent AEs were assessed during 7 day and 21 day post vaccination period.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    13.1
    Reporting groups
    Reporting group title
    Influenza vaccine GSK2186877A formulation 1 Group
    Reporting group description
    		 Subjects aged 6 to 35 months received 2 doses of new generation influenza vaccine GSK2186877A formulation 1 at Day 0 and Day 21 and 1 dose of Fluarix vaccine at Month 6.

    Reporting group title
    Influenza vaccine GSK2186877A formulation 2 Group
    Reporting group description
    		 Subjects aged 6 to 35 months received 1 dose of new generation influenza vaccine GSK2186877A formulation 2 at Day 0 and 1 dose of Fluarix vaccine at Month 6.

    Serious adverse events
    		 Influenza vaccine GSK2186877A formulation 1 Group Influenza vaccine GSK2186877A formulation 2 Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 20 (0.00%)
    3 / 20 (15.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Nervous system disorders
    Syncope
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Bronchopneumonia
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsillitis
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         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
    		 Influenza vaccine GSK2186877A formulation 1 Group Influenza vaccine GSK2186877A formulation 2 Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    14 / 20 (70.00%)
    12 / 20 (60.00%)
    Vascular disorders
    Haematoma
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Pain
    alternative assessment type: Systematic
         subjects affected / exposed
    10 / 20 (50.00%)
    6 / 20 (30.00%)
         occurrences all number
    10
    6
    Redness
    alternative assessment type: Systematic
         subjects affected / exposed
    7 / 20 (35.00%)
    2 / 20 (10.00%)
         occurrences all number
    7
    2
    Swelling
    alternative assessment type: Systematic
         subjects affected / exposed
    6 / 20 (30.00%)
    1 / 20 (5.00%)
         occurrences all number
    6
    1
    Drowsiness
    alternative assessment type: Systematic
         subjects affected / exposed
    6 / 20 (30.00%)
    7 / 20 (35.00%)
         occurrences all number
    6
    7
    Irritability
    alternative assessment type: Systematic
         subjects affected / exposed
    7 / 20 (35.00%)
    9 / 20 (45.00%)
         occurrences all number
    7
    9
    Loss of appetite
    alternative assessment type: Systematic
         subjects affected / exposed
    12 / 20 (60.00%)
    5 / 20 (25.00%)
         occurrences all number
    12
    5
    Temperature
    alternative assessment type: Systematic
         subjects affected / exposed
    14 / 20 (70.00%)
    12 / 20 (60.00%)
         occurrences all number
    14
    12
    Vomiting (silicited general symptom)
    alternative assessment type: Systematic
         subjects affected / exposed
    7 / 20 (35.00%)
    4 / 20 (20.00%)
         occurrences all number
    7
    4
    Pyrexia
         subjects affected / exposed
    5 / 20 (25.00%)
    0 / 20 (0.00%)
         occurrences all number
    5
    0
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Teething
         subjects affected / exposed
    1 / 20 (5.00%)
    2 / 20 (10.00%)
         occurrences all number
    1
    2
    Toothache
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Vomiting (unsolicited AE)
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 20 (10.00%)
    2 / 20 (10.00%)
         occurrences all number
    2
    2
    Bronchial hyperreactivity
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Hiccups
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Dermatitis diaper
         subjects affected / exposed
    1 / 20 (5.00%)
    2 / 20 (10.00%)
         occurrences all number
    1
    2
    Rash
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    5 / 20 (25.00%)
    7 / 20 (35.00%)
         occurrences all number
    5
    7
    Otits media acute
         subjects affected / exposed
    3 / 20 (15.00%)
    0 / 20 (0.00%)
         occurrences all number
    3
    0
    Gastroenteritis
         subjects affected / exposed
    1 / 20 (5.00%)
    2 / 20 (10.00%)
         occurrences all number
    1
    2
    Nasopharyngitis
         subjects affected / exposed
    2 / 20 (10.00%)
    0 / 20 (0.00%)
         occurrences all number
    2
    0
    Bronchitis
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    Cellulitis
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Otitis media
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Pharyngitis
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    Tonsillitis
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 20 (5.00%)
         occurrences all number
    1
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    16 Jun 2010
    The reactogenicity data were collected in 20 subjects having received the first dose of GSK’s seasonal influenza vaccine 7.5 µg HA per strain + AS03C and they suggest a trend towards an increase of fever after the first dose compared to the data that were collected during the first study phase in the 7.5 µg HA per strain + AS03D group. The observed incidence of any reported fever (≥37,5°; axillary measurement) after the first dose is 60% in TIV-AS03C group compared to 35% in the TIV-AS03D group. Importantly, the incidence of grade 3 temperature (axillary temperature ≥ 39.1°C) was low (5.0%-one children among the 20 recruited), and the majority of fever episodes were short (1 day) and did not require medical attention. The follow-up for the participants already enrolled will be continued according to the protocol including assessment of all safety, reactogenicity and immunogenicity end-points. However according to the recommendations of the internal Vaccine Safety Monitoring Board, any further vaccination was suspended (i.e. the administration of the second dose of TIV-AS03C and the further enrolment in the group TIV-AS03B). Also the protocol was amended to proceed with an early analysis of the immunogenicty results of children who received 2 doses of the TIV-AS03D vaccine to evaluate the possible impact of high initial priming status which can contribute to the present findings and to evaluate how best to plan the further booster phase.

    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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