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    Clinical Trial Results:
    Estudio fase III, no aleatorizado, abierto para evaluar la seguridad e inmunogenicidad de la vacuna H1N1 adyuvada con AS03A administrada como primovacunación y booster en sujetos entre 3 y 17 años de edad.

    Summary
    EudraCT number
    		 2009-013785-52
    Trial protocol
    		 ES  
    Global end of trial date
    27 Nov 2010

    Results information
    Results version number
    		 v1
    This version publication date
    22 Mar 2016
    First version publication date
    29 May 2015
    Other versions
    		 v2

    Trial information

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    Trial identification
    Sponsor protocol code
    113528
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00964158
    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)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000725-PIP01-09
    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
    06 Apr 2011
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    27 Nov 2010
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Nov 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    • To evaluate whether the haemagglutination inhibition (HI) immune response to the vaccine-homologous virus of the Flu Pan vaccine meets or exceeds the European Medicines Agency (EMEA) Committee for Medicinal Products for Human Use (CHMP) criteria* 21 days post dose 2 vaccination. The CHMP criteria are fulfilled if the point estimate for seroconversion rate (SCR) is > 40%, the point estimate for seroprotection rate (SPR) is > 70% and the point estimate for seroconversion factor (SCF) is > 2.5.
    Protection of trial subjects
    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
    10 Sep 2009
    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: 210
    Worldwide total number of subjects
    210
    EEA total number of subjects
    210
    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)
    210
    Children (2-11 years)
    0
    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 (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
    		 Flu Pan 3-5 Years Group
    Arm description
    		 Subjects received 2 primary doses of Flu Pan vaccine according to a 0, 21-day schedule, at 3 to 5 years old.
    Arm type
    		 Experimental

    Investigational medicinal product name
    GSK2340272A vaccine
    Investigational medicinal product code
    Other name
    Pandemic influenza vaccine
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Two primary intramuscular (IM) injections and a booster IM injection administered in the deltoid region of the arm.

    Arm title
    		 Flu Pan 6-9 Years Group
    Arm description
    		 Subjects received 2 primary doses of Flu Pan vaccine according to a 0, 21-day schedule, at 6 to 9 years old.
    Arm type
    		 Experimental

    Investigational medicinal product name
    GSK2340272A vaccine
    Investigational medicinal product code
    Other name
    Pandemic influenza vaccine
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Two primary intramuscular (IM) injections and a booster IM injection administered in the deltoid region of the arm.

    Arm title
    		 Flu Pan 10-17 Years Group
    Arm description
    		 Subjects received 2 primary doses of Flu Pan vaccine according to a 0, 21-day schedule, at 10 to 17 years old.
    Arm type
    		 Experimental

    Investigational medicinal product name
    GSK2340272A vaccine
    Investigational medicinal product code
    Other name
    Pandemic influenza vaccine
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Two primary intramuscular (IM) injections and a booster IM injection administered in the deltoid region of the arm.

    Number of subjects in period 1
    		Flu Pan 3-5 Years Group Flu Pan 6-9 Years Group Flu Pan 10-17 Years Group
    Started
    53
    57
    100
    Completed
    53
    56
    92
    Not completed
    0
    1
    8
         Consent withdrawn by subject
    -
    1
    8

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Flu Pan 3-5 Years Group
    Reporting group description
    		 Subjects received 2 primary doses of Flu Pan vaccine according to a 0, 21-day schedule, at 3 to 5 years old.

    Reporting group title
    Flu Pan 6-9 Years Group
    Reporting group description
    		 Subjects received 2 primary doses of Flu Pan vaccine according to a 0, 21-day schedule, at 6 to 9 years old.

    Reporting group title
    Flu Pan 10-17 Years Group
    Reporting group description
    		 Subjects received 2 primary doses of Flu Pan vaccine according to a 0, 21-day schedule, at 10 to 17 years old.

    Reporting group values
    		 Flu Pan 3-5 Years Group Flu Pan 6-9 Years Group Flu Pan 10-17 Years Group Total
    Number of subjects
    		 53 57 100 210
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 3.5 ± 0.7 7.5 ± 1.18 13.3 ± 2.23 -
    Gender categorical
    Units: Subjects
        Female
    		 31 25 61 117
        Male
    		 22 32 39 93

    End points

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    End points reporting groups
    Reporting group title
    Flu Pan 3-5 Years Group
    Reporting group description
    		 Subjects received 2 primary doses of Flu Pan vaccine according to a 0, 21-day schedule, at 3 to 5 years old.

    Reporting group title
    Flu Pan 6-9 Years Group
    Reporting group description
    		 Subjects received 2 primary doses of Flu Pan vaccine according to a 0, 21-day schedule, at 6 to 9 years old.

    Reporting group title
    Flu Pan 10-17 Years Group
    Reporting group description
    		 Subjects received 2 primary doses of Flu Pan vaccine according to a 0, 21-day schedule, at 10 to 17 years old.

    Subject analysis set title
    Flu Pan Group
    Subject analysis set type
    		 Sub-group analysis
    Subject analysis set description
    Subjects received 2 primary doses of Flu Pan vaccine according to a 0, 21-day schedule.

    Primary: Haemagglutination inhibition (HI) antibody titers against H1N1 strain contained in the Fluarix vaccine

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    End point title
    		 Haemagglutination inhibition (HI) antibody titers against H1N1 strain contained in the Fluarix vaccine [1]
    End point description
    End point type
    Primary
    End point timeframe
    At Day 0 and Day 42
    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 scope of this primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 Flu Pan Group
    Number of subjects analysed
    198
    Units: Titers
    geometric mean (confidence interval 95%)
        Flu A/CAL/7/2009, Day 0 [N=198]
    7.8 (6.8 to 9)
        Flu A/CAL/7/2009, Day 42 [N=194]
    1538.5 (1419 to 1668.2)
    No statistical analyses for this end point

    Primary: Number of subjects with HI antibody titers ≥ 1:10

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    End point title
    		 Number of subjects with HI antibody titers ≥ 1:10 [2]
    End point description
    End point type
    Primary
    End point timeframe
    At Day 0 and Day 42
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 Flu Pan Group
    Number of subjects analysed
    198
    Units: Subjects
        Flu A/CAL/7/2009, Day 0 [N=198]
    40
        Flu A/CAL/7/2009, Day 42 [N=194]
    194
    No statistical analyses for this end point

    Primary: Number of seroconverted subjects in terms of HI antibodies

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    End point title
    		 Number of seroconverted subjects in terms of HI antibodies [3]
    End point description
    Fluarix vaccine strain was Flu A/California/7/2009 (H1N1). A seroconverted subject was a subject who had either a pre-vaccination (Day 0) titre less than (<) 1:10 and a post-vaccination titre greater than or equal to (≥) 1:40 or a pre-vaccination titre ≥ 1:10 and at least a 4-fold increase in post-vaccination titre.
    End point type
    Primary
    End point timeframe
    At Day 42
    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 scope of this primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 Flu Pan Group
    Number of subjects analysed
    194
    Units: Subjects
        Flu A/CAL/7/2009 [Day 42]
    191
    No statistical analyses for this end point

    Primary: Number of seroprotected subjects for HI antibodies

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    End point title
    		 Number of seroprotected subjects for HI antibodies [4]
    End point description
    Fluarix vaccine strain was Flu A/California/7/2009 (H1N1). A seroprotected subject was a subject with a serum HI titre ≥ 1:40 that usually is accepted as indicating protection.
    End point type
    Primary
    End point timeframe
    At Day 42
    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 scope of this primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 Flu Pan Group
    Number of subjects analysed
    194
    Units: Subjects
        Flu A/CAL/7/2009 [Day 42]
    194
    No statistical analyses for this end point

    Primary: Seroconversion factor for HI antibody titre

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    End point title
    		 Seroconversion factor for HI antibody titre [5]
    End point description
    Fluarix vaccine strain was Flu A/California/7/2009 (H1N1). Serconversion factor was defined as a serum HI GMTs post-vaccination compared to pre-vaccination. The criterion is fulfilled if the point estimate for SCF was > 2.5 in subjects 18 to 60 years of age.
    End point type
    Primary
    End point timeframe
    At Day 42
    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 scope of this primary endpoint was descriptive, no statistical analyses were conducted.
    End point values
    		 Flu Pan Group
    Number of subjects analysed
    194
    Units: Fold increase
    geometric mean (confidence interval 95%)
        Flu A/CAL/7/09 [Day 42]
    208.5 (179 to 242.9)
    No statistical analyses for this end point

    Secondary: HI antibody titers

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    End point title
    		 HI antibody titers
    End point description
    End point type
    Secondary
    End point timeframe
    At Day 0, Day 21, Day 42 and Month 12
    End point values
    		 Flu Pan Group
    Number of subjects analysed
    210
    Units: Titers
    geometric mean (confidence interval 95%)
        Flu A/CAL/7/2009 Day 0 [N=179]
    7.8 (6.8 to 9)
        Flu A/CAL/7/2009 Day 21 [N=178]
    455.6 (399.9 to 519.1)
        Flu A/CAL/7/2009 Day 42 [N=173]
    1538.5 (1419 to 1668.2)
        Flu A/CAL/7/2009 Month 12 [N=179]
    167.3 (147.2 to 190.2)
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-HIs antibody concentrations ≥ 1:10

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    End point title
    		 Number of subjects with anti-HIs antibody concentrations ≥ 1:10
    End point description
    End point type
    Secondary
    End point timeframe
    At Day 0, Day 21, Day 42 and Month 12
    End point values
    		 Flu Pan Group
    Number of subjects analysed
    210
    Units: Subjects
        Flu A/CAL/7/2009 Day 0 [N=179]
    28
        Flu A/CAL/7/2009 Day 21 [N=178]
    178
        Flu A/CAL/7/2009 Day 42 [N=173]
    173
        Flu A/CAL/7/2009 Month 12 [N=179]
    179
    No statistical analyses for this end point

    Secondary: Number of seroconverted subjects for HI antibodies

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    End point title
    		 Number of seroconverted subjects for HI antibodies
    End point description
    End point type
    Secondary
    End point timeframe
    At Day 0, Day 21, Day 42 and Month 12
    End point values
    		 Flu Pan Group
    Number of subjects analysed
    179
    Units: Subjects
        Flu A/CAL/7/09 Day 21 [N=178]
    176
        Flu A/CAL/7/09 Day 42 [N=173]
    170
        Flu A/CAL/7/09 Month 12 [N=179]
    172
    No statistical analyses for this end point

    Secondary: Number of seroprotected subjects for HI antibodies

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    End point title
    		 Number of seroprotected subjects for HI antibodies
    End point description
    End point type
    Secondary
    End point timeframe
    At Day 0, Day 21, Day 42 and Month 12
    End point values
    		 Flu Pan Group
    Number of subjects analysed
    179
    Units: Subjects
        Flu A/CAL/7/09 Day 0 [N=179]
    15
        Flu A/CAL/7/09 Day 21 [N=178]
    178
        Flu A/CAL/7/09 Day 42 [N=173]
    173
        Flu A/CAL/7/09 Month 12 [N=179]
    178
    No statistical analyses for this end point

    Secondary: Seroconversion factor for HI antibody titer

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    End point title
    		 Seroconversion factor for HI antibody titer
    End point description
    End point type
    Secondary
    End point timeframe
    At Day 21, Day 42 and Month 12
    End point values
    		 Flu Pan Group
    Number of subjects analysed
    179
    Units: Fold increase
    geometric mean (confidence interval 95%)
        Flu A/CAL/7/09 Day 21 [N=178]
    49.1 (42.6 to 56.7)
        Flu A/CAL/7/09 Day 42 [N=173]
    161.2 (138.5 to 187.6)
        Flu A/CAL/7/09 Month 12 [N=179]
    23.7 (20.6 to 27.3)
    No statistical analyses for this end point

    Secondary: Serum neutralising antibody titres

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    End point title
    		 Serum neutralising antibody titres
    End point description
    End point type
    Secondary
    End point timeframe
    At Day 0, Day 21, Day 42 and Month 12
    End point values
    		 Flu Pan Group
    Number of subjects analysed
    90
    Units: Titers
    geometric mean (confidence interval 95%)
        Flu A/Neth/602/09 Day 0 [N=90]
    5.2 (4.3 to 6.3)
        Flu A/Neth/602/09 Day 21 [N=90]
    112.6 (83 to 152.8)
        Flu A/Neth/602/09 Day 42 [N=87]
    847.2 (671.1 to 1069.6)
        Flu A/Neth/602/09 Month 12 [N=85]
    172 (141.9 to 208.4)
    No statistical analyses for this end point

    Secondary: Number of seroconverted subjects in terms of H1N1 neutralizing antibodies

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    End point title
    		 Number of seroconverted subjects in terms of H1N1 neutralizing antibodies
    End point description
    End point type
    Secondary
    End point timeframe
    At Day 21, Day 42 and Month 12
    End point values
    		 Flu Pan Group
    Number of subjects analysed
    88
    Units: Subjects
        Flu A/Neth/602/09 Day 21 [N=88]
    76
        Flu A/Neth/602/09 Day 42 [N=85]
    85
        Flu A/Neth/602/09 Month 12 [N=83]
    79
    No statistical analyses for this end point

    Secondary: Number of subjects with solicited local symptoms

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    End point title
    		 Number of subjects with solicited local symptoms
    End point description
    End point type
    Secondary
    End point timeframe
    During a 7-day follow-up period, i.e., day of vaccination and 6 subsequent days after each vaccination on Day 0 and Day 21
    End point values
    		 Flu Pan 3-5 Years Group Flu Pan 6-9 Years Group Flu Pan 10-17 Years Group
    Number of subjects analysed
    53
    57
    98
    Units: Subjects
        Pain, Dose 1 [N=53,57,98]
    40
    54
    9
        Grade 3 Pain, Dose 1 [N=53,57,98]
    2
    3
    8
        Redness, Dose 1 [N=53,57,98]
    15
    14
    2
        Grade 3 Redness, Dose 1 [N=53,57,98]
    0
    2
    6
        Swelling, Dose 1 [N=53,57,98]
    18
    16
    4
        Grade 3 Swelling, Dose 1 [N=53,57,98]
    1
    3
    6
        Pain, Dose 2 [N=52,57,93]
    44
    55
    9
        Grade 3 Pain, Dose 2 [N=52,57,93]
    5
    8
    1
        Redness, Dose 2 [N=52,57,93]
    18
    19
    2
        Grade 3 Redness, Dose 2 [N=52,57,93]
    4
    2
    2
        Swelling, Dose 2 [N=52,57,93]
    16
    26
    5
        Grade 3 Swelling, Dose 2 [N=52,57,93]
    2
    1
    2
    No statistical analyses for this end point

    Secondary: Number of subjects with solicited general symptoms

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    End point title
    		 Number of subjects with solicited general symptoms [6]
    End point description
    End point type
    Secondary
    End point timeframe
    During a 7-day follow-up period, i.e., day of vaccination and 6 subsequent days after each vaccination on Day 0 and Day 21 in the Flu Pan 3-5 Years Group
    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: The solicited general symptoms were different for the above 6 years old groups, hence they are presented separately.
    End point values
    		 Flu Pan 3-5 Years Group
    Number of subjects analysed
    53
    Units: Subjects
        Any Diarrhea [N=53] Dose 1
    2
        Grade 3 Diarrhea [N=53] Dose 1
    0
        Related Diarrhea [N=53] Dose 1
    1
        Any Drowsiness [N=53] Dose 1
    1
        Grade 3 Drowsiness [N=53] Dose 1
    0
        Related Drowsiness [N=53] Dose 1
    8
        Any Irritability [N=53] Dose 1
    1
        Grade 3 Irritability [N=53] Dose 1
    0
        Related Irritability [N=53] Dose 1
    1
        Any Loss of appetite [N=53] Dose 1
    1
        Grade 3 Loss of appetite [N=53] Dose 1
    0
        Related Loss of appetite [N=53] Dose 1
    8
        Any Shivering [N=53] Dose 1
    5
        Grade 3 Shivering [N=53] Dose 1
    0
        Related Shivering [N=53] Dose 1
    2
        Any Sweating [N=53] Dose 1
    4
        Grade 3 Sweating [N=53] Dose 1
    0
        Related Sweating [N=53] Dose 1
    1
        Any Temperature [N=53] Dose 1
    1
        Grade 3 Temperature [N=53] Dose 1
    1
        Related Temperature [N=53] Dose 1
    8
        Any Diarrhea [N=52] Dose 2
    6
        Grade 3 Diarrhea [N=52] Dose 2
    0
        Related Diarrhea [N=52] Dose 2
    3
        Any Drowsiness [N=52] Dose 2
    1
        Grade 3 Drowsiness [N=52] Dose 2
    2
        Related Drowsiness [N=52] Dose 2
    1
        Any Irritability [N=52] Dose 2
    1
        Grade 3 Irritability [N=52] Dose 2
    3
        Related Irritability [N=52] Dose 2
    1
        Any Loss of appetite [N=52] Dose 2
    2
        Grade 3 Loss of appetite [N=52] Dose 2
    3
        Related Loss of appetite [N=52] Dose 2
    1
        Any Shivering [N=52] Dose 2
    6
        Grade 3 Shivering [N=52] Dose 2
    1
        Related Shivering [N=52] Dose 2
    5
        Any Sweating [N=52] Dose 2
    6
        Grade 3 Sweating [N=52] Dose 2
    0
        Related Sweating [N=52] Dose 2
    4
        Any Temperature [N=52] Dose 2
    2
        Grade 3 Temperature [N=52] Dose 2
    2
        Related Temperature [N=52] Dose 2
    2
        Any Diarrhea [N=53] Across doses
    8
        Grade 3 Diarrhea [N=53] Across doses
    0
        Related Diarrhea [N=53] Across doses
    4
        Any Drowsiness [N=53] Across doses
    2
        Grade 3 Drowsiness [N=53] Across doses
    2
        Related Drowsiness [N=53] Across doses
    1
        Any Irritability [N=53] Across doses
    2
        Grade 3 Irritability [N=53] Across doses
    3
        Related Irritability [N=53] Across doses
    1
        Any Loss of appetite [N=53] Across doses
    2
        Grade 3 Loss of appetite [N=53] Across doses
    3
        Related Loss of appetite [N=53] Across doses
    2
        Any Shivering [N=53] Across doses
    1
        Grade 3 Shivering [N=53] Across doses
    1
        Related Shivering [N=53] Across doses
    7
        Any Sweating [N=53] Across doses
    1
        Grade 3 Sweating [N=53] Across doses
    0
        Related Sweating [N=53] Across doses
    5
        Any Temperature [N=53] Across doses
    3
        Grade 3 Temperature [N=53] Across doses
    3
        Related Temperature [N=53] Across doses
    2
    No statistical analyses for this end point

    Secondary: Number of subjects with solicited general symptoms

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    End point title
    		 Number of subjects with solicited general symptoms [7]
    End point description
    End point type
    Secondary
    End point timeframe
    During a 7-day follow-up period, i.e., day of vaccination and 6 subsequent days after each vaccination on Day 0 and Day 21 in the Flu Pan 6-9 Years Group and Flu Pan 10-17 Years Group
    Notes
    [7] - 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: The solicited general symptoms were different for the above 6 years old groups, hence they are presented separately.
    End point values
    		 Flu Pan 6-9 Years Group Flu Pan 10-17 Years Group
    Number of subjects analysed
    57
    98
    Units: Subjects
        Any Arthralgia, Dose 1
    9
    26
        Grade 3 Arthralgia, Dose 1
    0
    1
        Related Arthralgia, Dose 1
    8
    26
        Any Fatigue, Dose 1
    21
    44
        Grade 3 Fatigue, Dose 1
    1
    4
        Related Fatigue, Dose 1
    20
    40
        Any Gastrointestinal, Dose 1
    13
    12
        Grade 3 Gastrointestinal, Dose 1
    2
    1
        Related Gastrointestinal, Dose 1
    9
    6
        Any Headache, Dose 1
    25
    48
        Grade 3 Headache, Dose 1
    2
    3
        Related Headache, Dose 1
    24
    41
        Any Myalgia, Dose 1
    15
    35
        Grade 3 Myalgia, Dose 1
    2
    2
        Related Myalgia, Dose 1
    13
    34
        Any Shivering, Dose 1
    7
    19
        Grade 3 Shivering, Dose 1
    0
    0
        Related Shivering, Dose 1
    4
    14
        Any Sweating, Dose 1
    2
    8
        Grade 3 Sweating, Dose 1
    0
    0
        Related Sweating, Dose 1
    1
    5
        Any Temperature/Axillary, Dose 1
    13
    17
        Grade 3 Temperature/Axillary, Dose 1
    0
    0
        Related Temperature/Axillary, Dose 1
    10
    15
        Any Arthralgia, Dose 2
    13
    34
        Grade 3 Arthralgia, Dose 2
    1
    1
        Related Arthralgia, Dose 2
    13
    32
        Any Fatigue, Dose 2
    29
    50
        Grade 3 Fatigue, Dose 2
    3
    5
        Related Fatigue, Dose2
    28
    48
        Any Gastrointestinal, Dose 2
    9
    10
        Grade 3 Gastrointestinal, Dose 2
    0
    0
        Related Gastrointestinal, Dose 2
    8
    6
        Any Headache, Dose 2
    26
    51
        Grade 3 Headache, Dose 2
    4
    5
        Related Headache, Dose 2
    26
    50
        Any Myalgia, Dose 2
    16
    47
        Grade 3 Myalgia, Dose 2
    1
    2
        Related Myalgia, Dose 2
    16
    44
        Any Shivering, Dose 2
    14
    27
        Grade 3 Shivering, Dose 2
    0
    1
        Related Shivering, Dose 2
    13
    25
        Any Sweating, Dose 2
    7
    8
        Grade 3 Sweating, Dose 2
    0
    0
        Related Sweating, Dose 2
    4
    7
        Any Temperature/Axillary, Dose 2
    20
    23
        Grade 3 Temperature/Axillary, Dose 2
    1
    1
        Related Temperature/Axillary, Dose 2
    19
    16
    No statistical analyses for this end point

    Secondary: Number of subjects with medically-attended events (MAEs)

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    End point title
    		 Number of subjects with medically-attended events (MAEs)
    End point description
    End point type
    Secondary
    End point timeframe
    During the entire study period
    End point values
    		 Flu Pan 3-5 Years Group Flu Pan 6-9 Years Group Flu Pan 10-17 Years Group
    Number of subjects analysed
    53
    57
    100
    Units: Subjects
        MAEs
    36
    21
    33
    No statistical analyses for this end point

    Secondary: Number of subjects with adverse events of specific interest (AESIs)/potential immune-mediated disease (pIMDs)

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    End point title
    		 Number of subjects with adverse events of specific interest (AESIs)/potential immune-mediated disease (pIMDs)
    End point description
    End point type
    Secondary
    End point timeframe
    During the entire study period
    End point values
    		 Flu Pan 3-5 Years Group Flu Pan 6-9 Years Group Flu Pan 10-17 Years Group
    Number of subjects analysed
    53
    57
    100
    Units: Subjects
        AESI(s)/pIMD(s)
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with normal or abnormal values of biochemical parameters

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    End point title
    		 Number of subjects with normal or abnormal values of biochemical parameters
    End point description
    Biochemical parameters assessed were Alanine Amino Trasferase (ALAT), Aspartate Amino Transferase (ASAT), Bilirubin, Creatinine and Blood Urea Nitrogen (BUN).
    End point type
    Secondary
    End point timeframe
    During the entire study period
    End point values
    		 Flu Pan 3-5 Years Group Flu Pan 6-9 Years Group Flu Pan 10-17 Years Group
    Number of subjects analysed
    53
    57
    97
    Units: Subjects
        ALAT, Unknown, Day 0 [N=30,38,59]
    0
    0
    0
        ALAT, Below, Day 0 [N=30,38,59]
    0
    0
    0
        ALAT, Within, Day 0 [N=30,38,59]
    30
    38
    59
        ALAT, Above, Day 0 [N=30,38,59]
    0
    0
    0
        ALAT, Unknown, Day 21 [N=53,57,97]
    1
    0
    2
        ALAT, Below, Day 21 [N=53,57,97]
    0
    0
    0
        ALAT, Within, Day 21 [N=53,57,97]
    52
    57
    94
        ALAT, Above, Day 21 [N=53,57,97]
    0
    0
    1
        ALAT, Unknown, Day 42 [N=52,56,93]
    2
    1
    0
        ALAT, Below, Day 42 [N=52,56,93]
    0
    0
    0
        ALAT, Within, Day 42 [N=52,56,93]
    50
    55
    91
        ALAT, Above, Day 42 [N=52,56,93]
    0
    0
    2
        ASAT, Unknown, Day 0 [N=30,38,59]
    0
    0
    0
        ASAT, Below, Day 0 [N=30,38,59]
    0
    0
    0
        ASAT, Within, Day 0 [N=30,38,59]
    28
    38
    58
        ASAT, Above, Day 0 [N=30,38,59]
    2
    0
    1
        ASAT, Unknown, Day 21 [N=53,57,97]
    2
    1
    2
        ASAT, Below, Day 21 [N=53,57,97]
    0
    0
    0
        ASAT, Within, Day 21 [N=53,57,97]
    50
    56
    94
        ASAT, Above, Day 21 [N=53,57,97]
    1
    0
    1
        ASAT, Unknown, Day 42 [N=52,56,93]
    2
    1
    0
        ASAT, Below, Day 42 [N=52,56,93]
    0
    0
    0
        ASAT, Within, Day 42 [N=52,56,93]
    50
    55
    91
        ASAT, Above, Day 42 [N=52,56,93]
    0
    0
    2
        BILI, Unknown, Day 0 [N=30,38,59]
    0
    0
    0
        BILI, Below, Day 0 [N=30,38,59]
    0
    0
    0
        BILI, Within, Day 0 [N=30,38,59]
    30
    38
    57
        BILI, Above, Day 0 [N=30,38,59]
    0
    0
    2
        BILI, Unknown, Day 21 [N=53,57,97]
    1
    0
    2
        BILI, Below, Day 21 [N=53,57,97]
    0
    0
    0
        BILI, Within, Day 21 [N=53,57,97]
    52
    57
    90
        BILI, Above, Day 21 [N=53,57,97]
    0
    0
    5
        BILI, Unknown, Day 42 [N=52,56,93]
    2
    1
    0
        BILI, Below, Day 42 [N=52,56,93]
    0
    0
    0
        BILI, Within, Day 42 [N=52,56,93]
    50
    55
    90
        BILI, Above, Day 42 [N=52,56,93]
    0
    0
    3
        CREA, Unknown, Day 0 [N=30,38,59]
    0
    0
    0
        CREA, Below, Day 0 [N=30,38,59]
    1
    0
    1
        CREA, Within, Day 0 [N=30,38,59]
    28
    33
    54
        CREA, Above, Day 0 [N=30,38,59]
    1
    5
    4
        CREA, Unknown, Day 21 [N=53,57,97]
    1
    0
    2
        CREA, Below, Day 21 [N=53,57,97]
    7
    2
    1
        CREA, Within, Day 21 [N=53,57,97]
    44
    53
    90
        CREA, Above, Day 21 [N=53,57,97]
    1
    2
    4
        CREA, Unknown, Day 42 [N=52,56,93]
    2
    1
    0
        CREA, Below, Day 42 [N=52,56,93]
    5
    2
    2
        CREA, Within, Day 42 [N=52,56,93]
    45
    52
    85
        CREA, Above, Day 42 [N=52,56,93]
    0
    1
    6
        BUN, Unknown, Day 0 [N=30,38,59]
    0
    0
    0
        BUN, Below, Day 0 [N=30,38,59]
    0
    0
    0
        BUN, Within, Day 0 [N=30,38,59]
    28
    37
    57
        BUN, Above, Day 0 [N=30,38,59]
    2
    1
    2
        BUN, Unknown, Day 21 [N=53,57,97]
    1
    0
    2
        BUN, Below, Day 21 [N=53,57,97]
    1
    0
    0
        BUN, Within, Day 21 [N=53,57,97]
    49
    52
    92
        BUN, Above, Day 21 [N=53,57,97]
    2
    5
    3
        BUN, Unknown, Day 42 [N=52,56,93]
    2
    1
    0
        BUN, Below, Day 42 [N=52,56,93]
    0
    0
    0
        BUN, Within, Day 42 [N=52,56,93]
    47
    47
    89
        BUN, Above, Day 42 [N=52,56,93]
    3
    8
    4
    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
    During a 21-day follow-up period after the first vaccination
    End point values
    		 Flu Pan 3-5 Years Group Flu Pan 6-9 Years Group Flu Pan 10-17 Years Group
    Number of subjects analysed
    53
    57
    100
    Units: Subjects
        Any AE(s)
    29
    22
    30
        Grade 3 AE(s)
    4
    2
    1
        Related AE(s)
    2
    4
    6
    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
    During the 83-day period following first vaccination and the 62-day period following second vaccination
    End point values
    		 Flu Pan 3-5 Years Group Flu Pan 6-9 Years Group Flu Pan 10-17 Years Group
    Number of subjects analysed
    53
    57
    100
    Units: Subjects
        Any AE(s)
    37
    26
    41
        Grade 3 AE(s)
    8
    4
    7
        Related AE(s)
    2
    4
    6
    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
    During the entire study period
    End point values
    		 Flu Pan 3-5 Years Group Flu Pan 6-9 Years Group Flu Pan 10-17 Years Group
    Number of subjects analysed
    53
    57
    100
    Units: Subjects
        SAEs
    0
    0
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    13.1
    Reporting groups
    Reporting group title
    Flu Pan 3-5 Years Group
    Reporting group description
    		 -

    Reporting group title
    Flu Pan 6-9 Years Group
    Reporting group description
    		 -

    Reporting group title
    Flu Pan 10-17 Years Group
    Reporting group description
    		 -

    Serious adverse events
    		 Flu Pan 3-5 Years Group Flu Pan 6-9 Years Group Flu Pan 10-17 Years Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 57 (0.00%)
    1 / 100 (1.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Blood and lymphatic system disorders
    Bone marrow failure
         subjects affected / exposed
    0 / 53 (0.00%)
    0 / 57 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Flu Pan 3-5 Years Group Flu Pan 6-9 Years Group Flu Pan 10-17 Years Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    37 / 53 (69.81%)
    26 / 57 (45.61%)
    41 / 100 (41.00%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 53 (5.66%)
    0 / 57 (0.00%)
    5 / 100 (5.00%)
         occurrences all number
    3
    0
    5
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    4 / 53 (7.55%)
    1 / 57 (1.75%)
    0 / 100 (0.00%)
         occurrences all number
    4
    1
    0
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    3 / 53 (5.66%)
    1 / 57 (1.75%)
    0 / 100 (0.00%)
         occurrences all number
    3
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    5 / 53 (9.43%)
    3 / 57 (5.26%)
    4 / 100 (4.00%)
         occurrences all number
    5
    3
    4
    Nasal congestion
         subjects affected / exposed
    0 / 53 (0.00%)
    3 / 57 (5.26%)
    0 / 100 (0.00%)
         occurrences all number
    0
    3
    0
    Oropharyngeal pain
         subjects affected / exposed
    0 / 53 (0.00%)
    3 / 57 (5.26%)
    0 / 100 (0.00%)
         occurrences all number
    0
    3
    0
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    11 / 53 (20.75%)
    3 / 57 (5.26%)
    14 / 100 (14.00%)
         occurrences all number
    11
    3
    14
    Gastroenteritis
         subjects affected / exposed
    4 / 53 (7.55%)
    1 / 57 (1.75%)
    3 / 100 (3.00%)
         occurrences all number
    4
    1
    3
    Laryngitis
         subjects affected / exposed
    5 / 53 (9.43%)
    2 / 57 (3.51%)
    0 / 100 (0.00%)
         occurrences all number
    5
    2
    0
    Tonsillitis
         subjects affected / exposed
    0 / 53 (0.00%)
    1 / 57 (1.75%)
    5 / 100 (5.00%)
         occurrences all number
    0
    1
    5
    Pharyngitis
         subjects affected / exposed
    5 / 53 (9.43%)
    1 / 57 (1.75%)
    0 / 100 (0.00%)
         occurrences all number
    5
    1
    0
    Ear infection
         subjects affected / exposed
    4 / 53 (7.55%)
    0 / 57 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    4
    0
    0
    Otitis media
         subjects affected / exposed
    3 / 53 (5.66%)
    0 / 57 (0.00%)
    0 / 100 (0.00%)
         occurrences all number
    3
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    29 Apr 2010
    Amendment 5 Due to recent developments in the pandemic situation and following the feedback from the European authorities, the follow-up study FLU D-PAN H1N1-037 is no longer planned to be conducted. Therefore the protocol was amended to delete all references to this planned follow-up study. In addition an error from the previous amendment has been corrected (Day 21 timepoint removed from primary endpoint in body of protocol).

    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
    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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