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    Clinical Trial Results:
    A Phase III, double-blind, randomised, controlled, multi-country, multi-centre study to evaluate the immunogenicity and safety of GSK Biologicals’ quadrivalent influenza vaccine candidate, GSK2282512A (FLU Q-QIV), compared to GSK Biologicals’ trivalent influenza vaccine Fluarix®, administered intramuscularly to children 6 to 35 months of age.

    Summary
    EudraCT number
    		 2013-003155-38
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    19 Jun 2013

    Results information
    Results version number
    		 v2(current)
    This version publication date
    25 Jun 2022
    First version publication date
    04 Jul 2015
    Other versions
    		 v1
    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
    250116926
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01711736
    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
    23 Sep 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    21 Feb 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    19 Jun 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    •To assess the immunogenicity of FLU Q-QIV based on Center for Biologics Evaluation and Research’s (CBER)’s Seroconversion Rate (SCR) criterion for each of the four strains in children 6 to 35 months of age, approximately 28 days after completion of dosing (approximately Day 28 and Day 56 for primed and unprimed subjects, respectively). Criterion for determination of effective immunisation: The lower limit of the two-sided 95% confidence interval (CI) for SCR should be ≥ 40% for each strain. •To describe the reactogenicity of FLU Q-QIV and Fluarix in terms of solicited local and general adverse events (AEs), during a 7-day follow-up period.
    Protection of trial subjects
    The vaccine recipients were observed closely for at least 30 minutes following the administration of vaccine, with appropriate medical treatment readily available in case of a rare anaphylactic reaction following the administration of vaccines.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Nov 2012
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    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
    Canada: 146
    Country: Number of subjects enrolled
    Honduras: 210
    Country: Number of subjects enrolled
    Dominican Republic: 250
    Worldwide total number of subjects
    606
    EEA total number of subjects
    0
    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)
    402
    Children (2-11 years)
    204
    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
    		 Primed subjects: Received 2 doses of seasonal influenza vaccine separated by at least one month during the last season or had received at least 1 dose prior to last season. Unprimed subjects: Did not receive any seasonal influenza vaccine in the past or received only 1 dose for the first time in the last influenza season.

    Pre-assignment
    Screening details
    		 5 subjects enrolled in the study were allocated subject numbers but the study vaccine dose was not administered.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor
    Blinding implementation details
    Data were collected in a double-blind manner. The laboratory in charge of the laboratory testing was blinded to the treatment, and codes were used to link the subject and study (without any link to the treatment attributed to the subject) to each sample.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 GSK2282512A Group
    Arm description
    		 Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine. Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age).
    Arm type
    		 Experimental

    Investigational medicinal product name
    FLU Q-QIV (Quadrivalent influenza vaccine)
    Investigational medicinal product code
    GSK2282512A
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 or 2 doses administered intramuscularly (IM) in deltoid muscle or anterolateral thigh on Day 0 (primed subjects) and on Day 0 and Day 28 (unprimed subjects) respectively.

    Arm title
    		 Fluarix Group
    Arm description
    		 Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine. Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age).
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Fluarix™
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 or 2 doses administered IM in deltoid muscle or anterolateral thigh, on Day 0 (primed subjects) and on Day 0 and Day 28 (unprimed subjects) respectively.

    Number of subjects in period 1 [1]
    		GSK2282512A Group Fluarix Group
    Started
    299
    302
    Completed
    287
    294
    Not completed
    12
    8
         Consent withdrawn by subject
    6
    6
         Migrated/moved from study area
    2
    1
         Lost to follow-up
    4
    1
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 5 subjects enrolled in the study were allocated subject numbers but the study vaccine dose was not administered.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    GSK2282512A Group
    Reporting group description
    		 Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine. Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age).

    Reporting group title
    Fluarix Group
    Reporting group description
    		 Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine. Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age).

    Reporting group values
    		 GSK2282512A Group Fluarix Group Total
    Number of subjects
    		 299 302 601
    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)
    		 18.2 ( 8.17 ) 18.1 ( 8.34 ) -
    Gender categorical
    Units: Subjects
        Female
    		 155 146 301
        Male
    		 144 156 300

    End points

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    End points reporting groups
    Reporting group title
    GSK2282512A Group
    Reporting group description
    		 Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine. Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age).

    Reporting group title
    Fluarix Group
    Reporting group description
    		 Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine. Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age).

    Primary: Number of seroconverted subjects for anti- Haemagglutination Inhibition (HI) antibodies against each of the four vaccine influenza strains of quadrivalent influenza GSK2282512A vaccine.

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    End point title
    		 Number of seroconverted subjects for anti- Haemagglutination Inhibition (HI) antibodies against each of the four vaccine influenza strains of quadrivalent influenza GSK2282512A vaccine. [1] [2]
    End point description
    A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 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/CAL/7/09 (H1N1), Flu A/Victoria/361/11 (H3N2), Flu B/Hubei-Wujiagang/158/09 (Yamagata) and Flu B/Bri/60/08 (Victoria). This outcome concerns solely subjects in the GSK2282512A Group.
    End point type
    Primary
    End point timeframe
    At Day 28 for primed subjects and at Day 56 for unprimed subjects.
    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.
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This outcome concerns solely subjects in the GSK2282512A Group.
    End point values
    		 GSK2282512A Group
    Number of subjects analysed
    284
    Units: Subjects
        [H1N1, Day 28 = primed and Day 56 = unprimed]
    244
        [H3N2, Day 28 = primed and Day 56 = unprimed]
    205
        [Yamagata, Day 28 = primed and Day 56 = unprimed]
    224
        [Victoria, Day 28 = primed and Day 56 = unprimed]
    210
    No statistical analyses for this end point

    Primary: 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. [3]
    End point description
    Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of the specified solicited local symptom regardless of its intensity. Grade 3 pain was defined as pain that prevented normal everyday activities. Grade 3 swelling was greater than 100 millimeters (mm) i.e. >100mm.
    End point type
    Primary
    End point timeframe
    During the 7-day (Days 0-6) post-vaccination period.
    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
    		 GSK2282512A Group Fluarix Group
    Number of subjects analysed
    291
    297
    Units: Subjects
        Any Pain
    95
    91
        Grade 3 Pain
    7
    3
        Any Redness
    6
    6
        Grade 3 Redness
    0
    0
        Any Swelling
    5
    6
        Grade 3 Swelling
    0
    0
    No statistical analyses for this end point

    Primary: Number of subjects reporting any, grade 3 and related solicited general symptoms (excluding fever).

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    End point title
    		 Number of subjects reporting any, grade 3 and related solicited general symptoms (excluding fever). [4]
    End point description
    Solicited general symptoms assessed were drowsiness, irritability/fussiness and loss of appetite. Any was defined as any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related was defined as symptoms assessed by the investigator to have a causal relationship to vaccination. Grade 3 irritability/fussiness was defined as crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite was defined as not eating at all. Grade 3 drowsiness was defined as drowsiness that prevented normal activity.
    End point type
    Primary
    End point timeframe
    During the 7-day (Days 0-6) post-vaccination period.
    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
    		 GSK2282512A Group Fluarix Group
    Number of subjects analysed
    290
    296
    Units: Subjects
        Any Drowsiness
    93
    88
        Grade 3 Drowsiness
    9
    9
        Related Drowsiness
    79
    80
        Any Irritability/fussiness
    118
    123
        Grade 3 Irritability/fussiness
    15
    14
        Related Irritability/fussiness
    104
    106
        Any Loss of appetite
    99
    100
        Grade 3 Loss of appetite
    16
    14
        Related Loss of appetite
    84
    83
    No statistical analyses for this end point

    Primary: Number of subjects reporting any, grade 3 and related fever.

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    End point title
    		 Number of subjects reporting any, grade 3 and related fever. [5]
    End point description
    Any fever was defined as any fever ≥38.0 degrees Celsius (°C) irrespective of intensity and relationship to vaccination. Related was defined as symptoms assessed by the investigator to have a causal relationship to vaccination. Grade 3 fever was defined as fever ≥39.0 °C.
    End point type
    Primary
    End point timeframe
    During the 7-day (Days 0-6) post-vaccination period.
    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
    		 GSK2282512A Group Fluarix Group
    Number of subjects analysed
    290
    296
    Units: Subjects
        Any Fever
    61
    60
        Grade 3 Fever
    23
    13
        Related Fever
    49
    48
    No statistical analyses for this end point

    Secondary: Haemagglutination inhibition (HI) antibody titers against each of the four vaccine influenza strains.

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    End point title
    		 Haemagglutination inhibition (HI) antibody titers against each of the four vaccine influenza strains.
    End point description
    HI antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains assessed were Flu A/CAL/7/09 (H1N1), Flu A/Victoria/361/11 (H3N2), Flu B/Hubei-Wujiagang/158/09 (Yamagata) and Flu B/Bri/60/08 (Victoria).
    End point type
    Secondary
    End point timeframe
    At Day 0 (for all subjects) and 28 days after the last vaccine dose (at Day 28 for primed subjects and at Day 56 for unprimed subjects).
    End point values
    		 GSK2282512A Group Fluarix Group
    Number of subjects analysed
    284
    287
    Units: Titers
    geometric mean (confidence interval 95%)
        [H1N1, Day 0]
    9.6 (8.1 to 11.3)
    9.8 (8.3 to 11.6)
        [H1N1, Day 28 = primed and Day 56 = unprimed]
    157.1 (132.8 to 185.9)
    61.2 (49.2 to 76.2)
        [H3N2, Day 0]
    17.4 (14.1 to 21.5)
    13.8 (11.4 to 16.8)
        [H3N2, Day 28 = primed and Day 56 = unprimed]
    159.4 (129.4 to 196.3)
    103 (83.7 to 126.7)
        [Yamagata, Day 0]
    7.7 (6.9 to 8.7)
    7.2 (6.5 to 8)
        [Yamagata, Day 28 = primed and Day 56 = unprimed]
    114.2 (100 to 130.5)
    107.2 (92.2 to 124.6)
        [Victoria, Day 0]
    10.6 (9.1 to 12.4)
    9.3 (8 to 10.7)
        [Victoria, Day 28 = primed and Day 56 = unprimed]
    111.4 (91.9 to 135.2)
    15.6 (13.3 to 18.5)
    No statistical analyses for this end point

    Secondary: Number of seroconverted subjects for anti- Haemagglutination Inhibition (HI) antibodies against each of the four vaccine influenza strains of Fluarix vaccine.

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    End point title
    		 Number of seroconverted subjects for anti- Haemagglutination Inhibition (HI) antibodies against each of the four vaccine influenza strains of Fluarix vaccine. [6]
    End point description
    A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 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/CAL/7/09 (H1N1), Flu A/Victoria/361/11 (H3N2), Flu B/Hubei-Wujiagang/158/09 (Yamagata) and Flu B/Bri/60/08 (Victoria). This outcome concerns solely subjects in the Fluarix Group.
    End point type
    Secondary
    End point timeframe
    At Day 28 for primed subjects and at Day 56 for unprimed subjects.
    Notes
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This outcome concerns solely subjects in the Fluarix Group.
    End point values
    		 Fluarix Group
    Number of subjects analysed
    287
    Units: Subjects
        [H1N1, Day 28 = primed and Day 56 = unprimed]
    154
        [H3N2, Day 28 = primed and Day 56 = unprimed]
    160
        [Yamagata, Day 28 = primed and Day 56 = unprimed]
    222
        [Victoria, Day 28 = primed and Day 56 = unprimed]
    28
    No statistical analyses for this end point

    Secondary: Number of subjects who were seroprotected for haemagglutination inhibition (HI) antibodies against each of the four vaccine influenza strains.

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    End point title
    		 Number of subjects who were seroprotected for haemagglutination inhibition (HI) antibodies against each of the four vaccine influenza strains.
    End point description
    A seroprotected subject was defined as a vaccinated subject 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/CAL/7/09 (H1N1), Flu A/Victoria/361/11 (H3N2), Flu B/Hubei-Wujiagang/158/09 (Yamagata) and Flu B/Bri/60/08 (Victoria).
    End point type
    Secondary
    End point timeframe
    At Day 0 (for all subjects) and Day 28 after last vaccine dose (Day 28 for primed subjects and Day 56 for unprimed subjects).
    End point values
    		 GSK2282512A Group Fluarix Group
    Number of subjects analysed
    284
    287
    Units: Subjects
        [H1N1, Day 0]
    46
    47
        [H1N1, Day 28 = primed and Day 56 = unprimed]
    254
    169
        [H3N2, Day 0]
    93
    74
        [H3N2, Day 28 = primed and Day 56 = unprimed]
    231
    191
        [Yamagata, Day 0]
    26
    24
        [Yamagata, Day 28 = primed and Day 56 = unprimed]
    242
    229
        [Victoria, Day 0]
    56
    45
        [Victoria, Day 28 = primed and Day 56 = unprimed]
    216
    74
    No statistical analyses for this end point

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

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    End point title
    		 Mean geometric increase (MGI) for haemagglutination inhibition (HI) antibody titer against each of the four vaccine influenza strains.
    End point description
    MGI was defined as the fold increase in serum haemagglutination inhibition (HI) GMTs post-vaccination compared to pre-vaccination (Day 0). The vaccine strains assessed were Flu A/CAL/7/09 (H1N1), Flu A/Victoria/361/11 (H3N2), Flu B/Hubei-Wujiagang/158/09 (Yamagata) and Flu B/Bri/60/08 (Victoria).
    End point type
    Secondary
    End point timeframe
    28 days after the last vaccine dose (at Day 28 for primed subjects and at Day 56 for unprimed subjects).
    End point values
    		 GSK2282512A Group Fluarix Group
    Number of subjects analysed
    284
    287
    Units: Fold increase
    geometric mean (confidence interval 95%)
        [H1N1, Day 28 = primed and Day 56 = unprimed]
    16.4 (14.3 to 18.7)
    6.2 (5.3 to 7.3)
        [H3N2, Day 28 = primed and Day 56 = unprimed]
    9.1 (8 to 10.5)
    7.5 (6.4 to 8.7)
        [Yamagata, Day 28 = primed and Day 56 = unprimed]
    14.8 (12.8 to 17.1)
    14.8 (12.8 to 17.2)
        [Victoria, Day 28 = primed and Day 56 = unprimed]
    10.5 (9.2 to 11.9)
    1.7 (1.5 to 1.9)
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any, grade 3 and related fever.

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    End point title
    		 Number of subjects reporting any, grade 3 and related fever.
    End point description
    Any fever was defined as any fever ≥38.0 °C irrespective of intensity and relationship to vaccination. Related was defined as symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 fever was defined as fever ≥39.0 °C.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Days 0-3) post-vaccination period.
    End point values
    		 GSK2282512A Group Fluarix Group
    Number of subjects analysed
    290
    296
    Units: Subjects
        Any Fever
    46
    42
        Grade 3 Fever
    16
    8
        Related Fever
    39
    38
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any Medically Attended Adverse Events (MAEs).

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    End point title
    		 Number of subjects reporting any Medically Attended Adverse Events (MAEs).
    End point description
    MAEs were defined as adverse events with medically-attended visits that were not routine visits for physical examination or vaccination, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any was defined as any occurrence of MAE(s).
    End point type
    Secondary
    End point timeframe
    During the entire study period (Day 0 to Day 180).
    End point values
    		 GSK2282512A Group Fluarix Group
    Number of subjects analysed
    299
    302
    Units: Subjects
        Any MAE(s)
    156
    156
    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
    Potential immune-mediated diseases (pIMDs) were defined as a subset of adverse events that included both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which might or might not have an autoimmune aetiology. Any pIMD was defined as at least one pIMD experienced by the study subject.
    End point type
    Secondary
    End point timeframe
    During the entire study period (Day 0 to Day 180).
    End point values
    		 GSK2282512A Group Fluarix Group
    Number of subjects analysed
    299
    302
    Units: Subjects
        Any pIMD(s)
    0
    2
        Related pIMD(s)
    0
    0
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects reporting any, grade 3 and related unsolicited adverse events (AEs).
    End point description
    An unsolicited AE was defined as an untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product 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 occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.
    End point type
    Secondary
    End point timeframe
    During the 28-day (Days 0-27) post-vaccination period.
    End point values
    		 GSK2282512A Group Fluarix Group
    Number of subjects analysed
    299
    302
    Units: Subjects
        Any Unsolicited AEs
    142
    165
        Grade 3 Unsolicited AEs
    9
    5
        Related Unsolicited AEs
    17
    13
    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 defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of 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 (Day 0 – Day 180).
    End point values
    		 GSK2282512A Group Fluarix Group
    Number of subjects analysed
    299
    302
    Units: Subjects
        Any SAEs
    9
    8
        Related SAEs
    1
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Serious Adverse Events: From Day 0 to Day 180; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period; Unsolicited adverse events: During the 28-day (Days 0-27) 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
    16.0
    Reporting groups
    Reporting group title
    Fluarix Group
    Reporting group description
    		 Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine. Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age).

    Reporting group title
    GSK2282512A Group
    Reporting group description
    		 Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine. Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age).

    Serious adverse events
    		 Fluarix Group GSK2282512A Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    8 / 302 (2.65%)
    9 / 299 (3.01%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Nervous system disorders
    Febrile convulsion
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 302 (0.00%)
    1 / 299 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Colitis ulcerative
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 302 (0.00%)
    1 / 299 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intestinal obstruction
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchial hyperreactivity
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia aspiration
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 302 (0.00%)
    1 / 299 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Bronchiolitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 302 (0.66%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis rotavirus
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 302 (0.66%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Amoebic dysentery
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 302 (0.00%)
    1 / 299 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacterial pyelonephritis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 302 (0.00%)
    1 / 299 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blastocystis infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dengue fever
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 302 (0.00%)
    1 / 299 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Otitis media acute
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peritonitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngitis streptococcal
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 302 (0.00%)
    1 / 299 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory syncytial virus bronchiolitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rotavirus infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 302 (0.00%)
    1 / 299 (0.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic shock
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsillitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 302 (0.33%)
    0 / 299 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 302 (0.33%)
    1 / 299 (0.33%)
         occurrences causally related to treatment / all
    0 / 1
    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
    		 Fluarix Group GSK2282512A Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    200 / 302 (66.23%)
    211 / 299 (70.57%)
    General disorders and administration site conditions
    Pain
         subjects affected / exposed [1]
    91 / 297 (30.64%)
    95 / 291 (32.65%)
         occurrences all number
    91
    95
    Drowsiness
         subjects affected / exposed [2]
    88 / 296 (29.73%)
    93 / 290 (32.07%)
         occurrences all number
    88
    93
    Irritability/fussiness
         subjects affected / exposed [3]
    123 / 296 (41.55%)
    118 / 290 (40.69%)
         occurrences all number
    123
    118
    Loss of appetite
         subjects affected / exposed [4]
    100 / 296 (33.78%)
    99 / 290 (34.14%)
         occurrences all number
    100
    99
    Fever (Days 0-6)
         subjects affected / exposed [5]
    60 / 296 (20.27%)
    61 / 290 (21.03%)
         occurrences all number
    60
    61
    Fever (Days 0-3)
         subjects affected / exposed [6]
    42 / 296 (14.19%)
    46 / 290 (15.86%)
         occurrences all number
    42
    46
    Gastrointestinal disorders
    Diarrhoea
    alternative assessment type: Non-systematic
         subjects affected / exposed
    38 / 302 (12.58%)
    38 / 299 (12.71%)
         occurrences all number
    38
    38
    Infections and infestations
    Nasopharyngitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    90 / 302 (29.80%)
    78 / 299 (26.09%)
         occurrences all number
    90
    78
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Subjects who missed reporting symptoms (solicited/unsolicited or concomitant medications) were treated as subjects without symptoms (solicited/unsolicited or concomitant medications, respectively).
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Subjects who missed reporting symptoms (solicited/unsolicited or concomitant medications) were treated as subjects without symptoms (solicited/unsolicited or concomitant medications, respectively).
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Subjects who missed reporting symptoms (solicited/unsolicited or concomitant medications) were treated as subjects without symptoms (solicited/unsolicited or concomitant medications, respectively).
    [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Subjects who missed reporting symptoms (solicited/unsolicited or concomitant medications) were treated as subjects without symptoms (solicited/unsolicited or concomitant medications, respectively).
    [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Subjects who missed reporting symptoms (solicited/unsolicited or concomitant medications) were treated as subjects without symptoms (solicited/unsolicited or concomitant medications, respectively).
    [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Subjects who missed reporting symptoms (solicited/unsolicited or concomitant medications) were treated as subjects without symptoms (solicited/unsolicited or concomitant medications, respectively).

    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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