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    Clinical Trial Results:
    A phase IIa, observer-blind, multi-country, multicentre, randomised study to evaluate the immunogenicity, safety and reactogenicity of the GlaxoSmithKline Biologicals’ quadrivalent influenza vaccine (QIV) adjuvanted with various doses of the AS03 (GSK2584786A), administered in children aged 6 to 35 months, and compared to non-adjuvanted QIV and Fluarix™.

    Summary
    EudraCT number
    		 2010-020312-12
    Trial protocol
    		 ES   FI  
    Global end of trial date
    22 Mar 2011

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 Apr 2016
    First version publication date
    15 May 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    114294
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01195779
    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 Mar 2011
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 Mar 2011
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Mar 2011
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To identify the optimal formulation (combination of HA dosage and AS03 dosage) of the FLU D-QIV-AS03 vaccine compared to non-adjuvanted QIV, given intramuscularly in children aged 6-35 months, based on immunogenicity (HI GMTs and neutralising antibodies GMTs for the four vaccine strains and frequency of influenza-specific CD4 T lymphocytes identified as producing immune markers like IFN-gamma, IL-2, IL-13, CD40L, or TNF-alpha upon in vitro stimulation 28 days following last dose of study vaccine) and reactogenicity (incidence of fever grade ≥2 within 7-days follow-up period after any vaccination). Criteria: An overall desirability index based on both the immunogenicity and the reactogenicity endpoints will be computed for each formulation to identify the combination(s) having the most desirable profile.
    Protection of trial subjects
    The vaccinees were be observed closely for at least 30 minutes, with appropriate medical treatment readily available in case of anaphylaxis following the administration of vaccines. Vaccines were administered by qualified and trained personnel. Vaccines were administered only to eligible subjects that had no contraindications to any components of the vaccines.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Sep 2010
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 4
    Worldwide total number of subjects
    4
    EEA total number of subjects
    4
    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)
    3
    Children (2-11 years)
    1
    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
    		 Note that only 4 of 1120 planned subjects were enrolled in the study before early termination.

    Pre-assignment
    Screening details
    		 Four subjects who were already enrolled in the study were followed for safety assessment until Day 180, i.e. during 6 months after vaccination (and not until Day 365 as it was planned in the protocol), because they only received a single dose of the study vaccines.

    Period 1
    Period 1 title
    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
    Observer-blind controlled study

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 GSK2584786A 1-A3 Group
    Arm description
    		 Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
    Arm type
    		 Experimental

    Investigational medicinal product name
    GSK Biologicals' influenza vaccine GSK2584786A, different formulations
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 Dose at Day 0 into the deltoid muscle.

    Arm title
    		 GSK2584786A 2-B1 Group
    Arm description
    		 Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
    Arm type
    		 Experimental

    Investigational medicinal product name
    GSK Biologicals' influenza vaccine GSK2584786A, different formulations
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    2 Doses at Days 0 and 28 into the deltoid muscle.

    Arm title
    		 GSK2584786A 2-B3 Group
    Arm description
    		 Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
    Arm type
    		 Experimental

    Investigational medicinal product name
    GSK Biologicals' influenza vaccine GSK2584786A, different formulations
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    2 Doses at Days 0 and 28 into the deltoid muscle.

    Arm title
    		 Fluarix Group
    Arm description
    		 Subjects received 2 doses of GSK Biologicals’ Fluarix vaccine (GSK2321138A).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Fluarix™
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    2 Doses at Days 0 and 28 into the deltoid muscle.

    Number of subjects in period 1
    		GSK2584786A 1-A3 Group GSK2584786A 2-B1 Group GSK2584786A 2-B3 Group Fluarix Group
    Started
    1
    1
    1
    1
    Completed
    1
    1
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    GSK2584786A 1-A3 Group
    Reporting group description
    		 Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.

    Reporting group title
    GSK2584786A 2-B1 Group
    Reporting group description
    		 Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.

    Reporting group title
    GSK2584786A 2-B3 Group
    Reporting group description
    		 Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.

    Reporting group title
    Fluarix Group
    Reporting group description
    		 Subjects received 2 doses of GSK Biologicals’ Fluarix vaccine (GSK2321138A).

    Reporting group values
    		 GSK2584786A 1-A3 Group GSK2584786A 2-B1 Group GSK2584786A 2-B3 Group Fluarix Group Total
    Number of subjects
    		 1 1 1 1 4
    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)
    		 28 ( 0 ) 17 ( 0 ) 14 ( 0 ) 14 ( 0 ) -
    Gender categorical
    Units: Subjects
        Female
    		 0 1 0 1 2
        Male
    		 1 0 1 0 2

    End points

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    End points reporting groups
    Reporting group title
    GSK2584786A 1-A3 Group
    Reporting group description
    		 Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.

    Reporting group title
    GSK2584786A 2-B1 Group
    Reporting group description
    		 Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.

    Reporting group title
    GSK2584786A 2-B3 Group
    Reporting group description
    		 Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.

    Reporting group title
    Fluarix Group
    Reporting group description
    		 Subjects received 2 doses of GSK Biologicals’ Fluarix vaccine (GSK2321138A).

    Primary: Serum HI antibody titre against each of the 4 vaccine strains

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    End point title
    		 Serum HI antibody titre against each of the 4 vaccine strains [1]
    End point description
    Data were not analyzed due to study early termination.
    End point type
    Primary
    End point timeframe
    At Day 28/56.
    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 data were not analyzed due to the study early termination.
    End point values
    		 GSK2584786A 1-A3 Group GSK2584786A 2-B1 Group GSK2584786A 2-B3 Group Fluarix Group
    Number of subjects analysed
    0 [2]
    0 [3]
    0 [4]
    0 [5]
    Units: Titre
        median (standard deviation)
    ( )
    ( )
    ( )
    ( )
    Notes
    [2] - Data were not analyzed
    [3] - Data were not analyzed
    [4] - Data were not analyzed
    [5] - Data were not analyzed
    No statistical analyses for this end point

    Secondary: Number of subjects with unsolicited adverse events (AEs)

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    End point title
    		 Number of subjects with unsolicited adverse events (AEs)
    End point description
    End point type
    Secondary
    End point timeframe
    Within the 28-day (Days 0-27) post-vaccination period
    End point values
    		 GSK2584786A 1-A3 Group GSK2584786A 2-B1 Group GSK2584786A 2-B3 Group Fluarix Group
    Number of subjects analysed
    1
    1
    1
    1
    Units: Subjects
        Any AEs
    0
    1
    1
    1
    No statistical analyses for this end point

    Secondary: Number of subjects with serious adverse events (SAEs)

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    End point title
    		 Number of subjects with serious adverse events (SAEs)
    End point description
    End point type
    Secondary
    End point timeframe
    Up to study end at Day 180
    End point values
    		 GSK2584786A 1-A3 Group GSK2584786A 2-B1 Group GSK2584786A 2-B3 Group Fluarix Group
    Number of subjects analysed
    1
    1
    1
    1
    Units: Subjects
        SAEs
    0
    0
    0
    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
    End point type
    Secondary
    End point timeframe
    During the 7-day (Days 0-6) post-vaccination period following each dose
    End point values
    		 GSK2584786A 1-A3 Group GSK2584786A 2-B1 Group GSK2584786A 2-B3 Group Fluarix Group
    Number of subjects analysed
    1
    1
    1
    1
    Units: Subjects
        Any Drowsiness
    1
    0
    0
    0
        Grade 3 Drowsiness
    0
    0
    0
    0
        Related Drowsiness
    0
    0
    0
    0
        Any Fever
    0
    0
    0
    0
        Grade 3 Fever
    0
    0
    0
    0
        Related Fever
    0
    0
    0
    0
        Any Irritability/Fussiness
    1
    0
    0
    0
        Grade 3 Irritability/Fussiness
    0
    0
    0
    0
        Related Irritability/Fussiness
    0
    0
    0
    0
        Any Loss of appetite
    0
    0
    0
    0
        Grade 3 Loss of appetite
    0
    0
    0
    0
        Related Loss of appetite
    0
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AEs: Days 0-27 post-vaccination. SAEs up to Day 180 post-vaccination.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.0
    Reporting groups
    Reporting group title
    GSK2584786A 1-A3 Group
    Reporting group description
    		 Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.

    Reporting group title
    GSK2584786A 2-B1 Group
    Reporting group description
    		 Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.

    Reporting group title
    GSK2584786A 2-B3 Group
    Reporting group description
    		 Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.

    Reporting group title
    Fluarix Group
    Reporting group description
    		 Subjects received 2 doses of GSK Biologicals’ Fluarix vaccine.

    Serious adverse events
    		 GSK2584786A 1-A3 Group GSK2584786A 2-B1 Group GSK2584786A 2-B3 Group Fluarix Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 GSK2584786A 1-A3 Group GSK2584786A 2-B1 Group GSK2584786A 2-B3 Group Fluarix Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 1 (100.00%)
    1 / 1 (100.00%)
    1 / 1 (100.00%)
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 1 (100.00%)
    1 / 1 (100.00%)
         occurrences all number
    0
    0
    1
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 1 (100.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 1 (100.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 1 (100.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Bronchitis
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 1 (100.00%)
         occurrences all number
    0
    0
    0
    1
    Herpes zoster
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    0 / 1 (0.00%)
    1 / 1 (100.00%)
         occurrences all number
    0
    0
    0
    1

    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? Yes
    Date
    Interruption
    Restart date
    22 Mar 2011
    Since only 4 subjects were recruited in the study, the study was interrupted for logistical reasons.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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