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    Clinical Trial Results:
    A phase II, randomized, observer blind, multicenter study to evaluate the safety and immunogenicity of a single low dose of AS03-adjuvanted, Quebec- or Dresden- manufactured monovalent A/California/7/2009 (H1N1)v-like vaccine in children 3 to less than 10 years old

    Summary
    EudraCT number
    		 2011-003512-23
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    31 Jan 2011

    Results information
    Results version number
    		 v2(current)
    This version publication date
    28 May 2023
    First version publication date
    23 Jul 2015
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Results have been amended to account for consistency with other registries.

    Trial information

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    Trial identification
    Sponsor protocol code
    114495
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01161160
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline Biologicals
    Sponsor organisation address
    Rue de l’Institut 89, Rixensart, Belgium, B-1330
    Public contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 44 2089904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 44 2089904466, GSKClinicalSupportHD@gsk.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    09 May 2011
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    23 Aug 2010
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Jan 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess whether vaccination with 1 dose of 0.9 µg monovalent A/California/7/2009 (H1N1)v-like HA antigen produced in Quebec adjuvanted with AS03B and 1 dose of monovalent A/California/7/2009 (H1N1)v-like HA antigen produced in Dresden adjuvanted with AS03B; results in an immune response to the vaccine-homologous virus that meets or exceeds the U.S Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER) and the European Medicines Agency (EMA), Committee for Medicinal Products for Human Use (CHMP) guidance targets for pandemic vaccine serocon-version rate (SCR), rate of induction of vaccine-homologous reciprocal hemagglutination inhibition (HI) titers >= 40 (potential seroprotection rate [SPR]) and geo-metric mean fold rise (GMFR) 21 days after vaccination in children 3 to < 10 years of age.
    Protection of trial subjects
    All subjects were supervised closely for at least 30 minutes following vaccination with appropriate medical treatment readily available. 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. Subjects were followed-up from the time the subject consents to participate in the study until she/he is discharged.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    25 Jul 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
    Philippines: 102
    Country: Number of subjects enrolled
    Thailand: 107
    Worldwide total number of subjects
    209
    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)
    0
    Children (2-11 years)
    209
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind [1]
    Roles blinded
    		 Assessor, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Arepanrix 1/2 Group
    Arm description
    		 Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Arepanrix
    Investigational medicinal product code
    GSK2340274A
    Other name
    Q-PAN H1N1-AS03 (FluQ)
    Pharmaceutical forms
    Emulsion for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.

    Arm title
    		 Pandemrix 1/2 Group
    Arm description
    		 Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Pandemrix
    Investigational medicinal product code
    GSK2340272A
    Other name
    D-PAN H1N1-AS03 (FluD)
    Pharmaceutical forms
    Emulsion for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.

    Arm title
    		 Arepanrix Group
    Arm description
    		 Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Arepanrix
    Investigational medicinal product code
    GSK2340274A
    Other name
    Q-PAN H1N1-AS03 (FluD)
    Pharmaceutical forms
    Emulsion for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.

    Notes
    [1] - The roles blinded appear to be inconsistent with a double blind trial.
    Justification: This is an observer-blind study which means that during the course of the study, the vaccine recipient (subject) and those responsible for the evaluation of any study endpoint, were all unaware of which vaccine was administered to a particular subject. To do so, vaccine preparation and vaccination was done by authorized medical personnel who did not participate in any of the study clinical evaluation (i.e. assessor).
    Number of subjects in period 1
    		Arepanrix 1/2 Group Pandemrix 1/2 Group Arepanrix Group
    Started
    76
    75
    58
    Completed
    76
    75
    58

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Arepanrix 1/2 Group
    Reporting group description
    		 Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.

    Reporting group title
    Pandemrix 1/2 Group
    Reporting group description
    		 Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.

    Reporting group title
    Arepanrix Group
    Reporting group description
    		 Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.

    Reporting group values
    		 Arepanrix 1/2 Group Pandemrix 1/2 Group Arepanrix Group Total
    Number of subjects
    		 76 75 58 209
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 76 75 58 209
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 0 0 0 0
        From 65-84 years
    		 0 0 0 0
        85 years and over
    		 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 6 ( 2.03 ) 6 ( 2.02 ) 6 ( 2 ) -
    Gender categorical
    Units: Subjects
        Female
    		 30 38 27 95
        Male
    		 46 37 31 114

    End points

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    End points reporting groups
    Reporting group title
    Arepanrix 1/2 Group
    Reporting group description
    		 Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.

    Reporting group title
    Pandemrix 1/2 Group
    Reporting group description
    		 Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.

    Reporting group title
    Arepanrix Group
    Reporting group description
    		 Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.

    Primary: Number of seroconverted subjects for haemagglutination inhibition (HI) antibodies against Flu A/CAL/7/09 H1N1 strain

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    End point title
    		 Number of seroconverted subjects for haemagglutination inhibition (HI) antibodies against Flu A/CAL/7/09 H1N1 strain [1]
    End point description
    Seroconversion rate (SCR) was defined as the proportion of subjects who had either a pre-vaccination reciprocal HI titre below (<) 10 and a post-vaccination reciprocal titre greater than or equal to (≥) 40, or a pre-vaccination reciprocal HI titre ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titre against the vaccine virus. The Flu strain assessed was A/California/7/2009 (H1N1)v-like virus (Flu A/CAL/7/09), following the Committee for Medicinal Products for Human Use (CHMP) and the Center for Biologics Evaluation and Research (CBER) guidance. The CBER criterion was fulfilled if the lower 95% confidence interval (CI) for SCR was (>) 40%. The CHMP criterion was fulfilled if the point estimate for SCR was > 40%.
    End point type
    Primary
    End point timeframe
    At Day 21
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 Arepanrix 1/2 Group Pandemrix 1/2 Group Arepanrix Group
    Number of subjects analysed
    76
    75
    58
    Units: Subjects
        Flu A/CAL/7/09
    75
    74
    57
    No statistical analyses for this end point

    Primary: Number of seroprotected subjects for HI antibodies against Flu A/CAL/7/09 H1N1 strain

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    End point title
    		 Number of seroprotected subjects for HI antibodies against Flu A/CAL/7/09 H1N1 strain [2]
    End point description
    A seroprotected subject was defined as a vaccinated subject with a serum HI titre greater than or equal to 1:40 that usually is accepted as indicating protection. The Flu strain assessed was Flu A/CAL/7/09, following the CHMP and the CBER guidance. The CBER criterion was fulfilled if the lower limit of the 95% CI for seroprotection (SPR) was > 70%. The CHMP criterion was fulfilled if the post-vaccination point estimate for SPR was > 70%.
    End point type
    Primary
    End point timeframe
    At Day 0
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 Arepanrix 1/2 Group Pandemrix 1/2 Group Arepanrix Group
    Number of subjects analysed
    76
    75
    58
    Units: Subjects
    28
    24
    18
    No statistical analyses for this end point

    Primary: Geometric mean fold rise (GMFR) for HI antibodies against Flu A/CAL/7/09 H1N1 strain

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    End point title
    		 Geometric mean fold rise (GMFR) for HI antibodies against Flu A/CAL/7/09 H1N1 strain [3]
    End point description
    GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The Flu strain assessed was Flu A/CAL/7/09, following the CHMP and the CBER guidance. The CHMP criterion was fulfilled if the point estimate for GMFR was > 2.5.
    End point type
    Primary
    End point timeframe
    At day 21
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 Arepanrix 1/2 Group Pandemrix 1/2 Group Arepanrix Group
    Number of subjects analysed
    76
    75
    58
    Units: Fold increase
    geometric mean (confidence interval 95%)
        Flu A/CAL/7/09
    25.7 (20.7 to 32)
    27.1 (22.4 to 32.8)
    32.2 (24.7 to 42.0)
    No statistical analyses for this end point

    Primary: Number of seroprotected subjects for HI antibodies against Flu A/CAL/7/09 H1N1 strain

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    End point title
    		 Number of seroprotected subjects for HI antibodies against Flu A/CAL/7/09 H1N1 strain [4]
    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. The Flu strain assessed was Flu A/CAL/7/09, following the CHMP and the CBER guidance. The CBER criterion was fulfilled if the lower limit of the 95% CI for seroprotection (SPR) was > 70%. The CHMP criterion was fulfilled if the post-vaccination point estimate for SPR was > 70%.
    End point type
    Primary
    End point timeframe
    At Day 21
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 Arepanrix 1/2 Group Pandemrix 1/2 Group Arepanrix Group
    Number of subjects analysed
    76
    75
    58
    Units: Subjects
    75
    74
    57
    No statistical analyses for this end point

    Secondary: Number of seroconverted subjects for HI antibodies against Flu A/CAL/7/09 H1N1 strain

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    End point title
    		 Number of seroconverted subjects for HI antibodies against Flu A/CAL/7/09 H1N1 strain
    End point description
    Seroconversion rate (SCR) was defined as the proportion of subjects who had either a pre-vaccination reciprocal HI titre < 10 and a post-vaccination reciprocal titre ≥ 40, or a pre-vaccination reciprocal HI titre ≥ 10 and at least a 4-fold increase in post vaccination reciprocal titre against the vaccine virus. The Flu strain assessed was Flu A/CAL/7/09, following the CHMP and the CBER guidance. The CBER criterion was fulfilled if the lower limit of the 95% CI for SCR was > 40%. The CHMP criterion was fulfilled if the post-vaccination point estimate for SCR was > 40%.
    End point type
    Secondary
    End point timeframe
    At Day 182
    End point values
    		 Arepanrix 1/2 Group Pandemrix 1/2 Group Arepanrix Group
    Number of subjects analysed
    73
    74
    58
    Units: Subjects
        Flu A/CAL/7/09
    46
    53
    40
    No statistical analyses for this end point

    Secondary: Number of seroprotected subjects for HI antibodies against Flu A/CAL/7/09 H1N1 strain

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    End point title
    		 Number of seroprotected subjects for HI antibodies against Flu A/CAL/7/09 H1N1 strain
    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. The Flu strain assessed was Flu A/CAL/7/09, following the CHMP and the CBER guidance. The CBER criterion was fulfilled if the lower limit of the 95% CI for seroprotection (SPR) was > 70%. The CHMP criterion was fulfilled if the post-vaccination point estimate for SPR was > 70%.
    End point type
    Secondary
    End point timeframe
    At Day 0 (PRE) and Day 182 (POST)
    End point values
    		 Arepanrix 1/2 Group Pandemrix 1/2 Group Arepanrix Group
    Number of subjects analysed
    73
    74
    58
    Units: Subjects
        Day 0 (PRE)
    27
    24
    18
        Day 182 (POST)
    55
    63
    46
    No statistical analyses for this end point

    Secondary: Geometric mean fold rise (GMFR) for HI antibodies against Flu A/CAL/7/09 H1N1 strain

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    End point title
    		 Geometric mean fold rise (GMFR) for HI antibodies against Flu A/CAL/7/09 H1N1 strain
    End point description
    GMFR, also called seroconversion factor (SCF), was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The Flu strain assessed was Flu A/CAL/7/09, following the CHMP and the CBER guidance. The CHMP criterion was fulfilled if the post-vaccination point estimate for SCF was > 2.5.
    End point type
    Secondary
    End point timeframe
    At Day 182
    End point values
    		 Arepanrix 1/2 Group Pandemrix 1/2 Group Arepanrix Group
    Number of subjects analysed
    73
    74
    58
    Units: Fold increase
    geometric mean (confidence interval 95%)
        Flu A/CAL/7/09
    6.6 (5.4 to 8.2)
    8 (6.4 to 10.1)
    8.9 (6.8 to 11.7)
    No statistical analyses for this end point

    Secondary: Number of subjects with HI antibody titers against Flu A/CAL/7/09 ≥ 1:10

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    End point title
    		 Number of subjects with HI antibody titers against Flu A/CAL/7/09 ≥ 1:10
    End point description
    The cut-off value for the humoral immune response in terms of vaccine H1N1 HI antibodies were equal to or above (≥) 1:10. The Flu strain assessed was Flu A/CAL/7/09, following the CHMP and the CBER guidance.
    End point type
    Secondary
    End point timeframe
    At Day 21
    End point values
    		 Arepanrix 1/2 Group Pandemrix 1/2 Group Arepanrix Group
    Number of subjects analysed
    76
    75
    58
    Units: Subjects
    76
    75
    58
    No statistical analyses for this end point

    Secondary: HI antibody titers against Flu A/CAL/7/09 H1N1 strain

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    End point title
    		 HI antibody titers against Flu A/CAL/7/09 H1N1 strain
    End point description
    Antibody titers were expressed as Geometric mean titers (GMTs), for the seropositivity cut-off value of ≥ 1:10. The Flu strain assessed was Flu A/CAL/7/09, following the CHMP and the CBER guidance.
    End point type
    Secondary
    End point timeframe
    At Day 21
    End point values
    		 Arepanrix 1/2 Group Pandemrix 1/2 Group Arepanrix Group
    Number of subjects analysed
    76
    75
    58
    Units: Titers
        geometric mean (confidence interval 95%)
    448.6 (323.9 to 621.3)
    434.1 (321 to 587)
    418.8 (297.6 to 589.1)
    Statistical analysis title
    		 Adjusted ratios Flu A/CAL/7/09 H1N1.HA antibodies
    Statistical analysis description
    To demonstrate immunological equivalence of HA antigen adjuvanted with AS03B manufactured in Quebec (FluQ) and HA antigen adjuvanted with AS03B manufactured in Dresden (FluD), 21 days after vaccination.
    Comparison groups
    Arepanrix 1/2 Group v Pandemrix 1/2 Group
    Number of subjects included in analysis
    151
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [5]
    Method
    Parameter type
    		 Adjusted GMT ratio
    Point estimate
    0.96
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.73
         upper limit
    		 1.26
    Notes
    [5] - Equivalence criteria were fulfilled if the 2-sided 95% confidence limits on the geometric mean titre (GMT) ratio was within the interval 0.5 to 2.0.

    Secondary: Number of subjects with HI antibody titers against Flu A/CAL/7/09 ≥ 1:10

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    End point title
    		 Number of subjects with HI antibody titers against Flu A/CAL/7/09 ≥ 1:10
    End point description
    The cut-off value for the humoral immune response in terms of vaccine H1N1 HI antibodies were equal to or above (≥) 1:10. The Flu strain assessed was Flu A/CAL/7/09, following the CHMP and the CBER guidance.
    End point type
    Secondary
    End point timeframe
    At Day 182
    End point values
    		 Arepanrix 1/2 Group Pandemrix 1/2 Group Arepanrix Group
    Number of subjects analysed
    73
    74
    58
    Units: Subjects
    72
    72
    58
    No statistical analyses for this end point

    Secondary: HI antibody titers against Flu A/CAL/7/09 H1N1 strain

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    End point title
    		 HI antibody titers against Flu A/CAL/7/09 H1N1 strain
    End point description
    Antibody titers were expressed as GMTs, for the seropositivity cut-off value of ≥ 1:10. The Flu strain assessed was Flu A/CAL/7/09, following the CHMP and the CBER guidance.
    End point type
    Secondary
    End point timeframe
    At Day 182
    End point values
    		 Arepanrix 1/2 Group Pandemrix 1/2 Group Arepanrix Group
    Number of subjects analysed
    73
    74
    58
    Units: Titers
        geometric mean (confidence interval 95%)
    117.4 (84.5 to 163.1)
    128.3 (95.8 to 171.9)
    115.7 (80.7 to 166)
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any and grade 3 solicited local symptoms

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    End point title
    		 Number of subjects reporting any and grade 3 solicited local symptoms
    End point description
    Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain for children less than 6 years= cried when limb was moved/spontaneously painful. Grade 3 pain for children aged 6 to < 10 years= pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
    End point type
    Secondary
    End point timeframe
    During a 7-day (Days 0-6) post-vaccination period
    End point values
    		 Arepanrix 1/2 Group Pandemrix 1/2 Group Arepanrix Group
    Number of subjects analysed
    76
    75
    58
    Units: Subjects
        Any Pain
    41
    41
    23
        Grade 3 Pain
    3
    0
    0
        Any Redness
    0
    1
    0
        Grade 3 Redness
    0
    0
    0
        Any Swelling
    1
    5
    1
        Grade 3 Swelling
    0
    0
    0
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects with any, grade 3 and related solicited general symptoms
    End point description
    Solicited general symptoms assessed were drowsiness, irritability, loss of appetite and fever (Fever = axillary temperature equal to or above 38.0 degrees Celsius (°C)). Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Grade 3 drowsiness= drowsiness that prevented normal activity. Grade 3 irritability= crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite= not eating at all. Grade 3 fever = fever > 39.0 °C or > 40.0 °C. Related= general symptom assessed by the investigator as causally related to the vaccination. This outcome measure refers to subjects aged 3 to 5 years.
    End point type
    Secondary
    End point timeframe
    During the 7-day (Days 0-6) post-vaccination
    End point values
    		 Arepanrix 1/2 Group Pandemrix 1/2 Group Arepanrix Group
    Number of subjects analysed
    33
    31
    24
    Units: Subjects
        Any Drowsiness
    5
    3
    1
        Grade 3 Drowsiness
    0
    0
    0
        Related Drowsiness
    1
    2
    0
        Any Irritability
    2
    7
    1
        Grade 3 Irritability
    0
    0
    0
        Related Irritability
    0
    2
    0
        Any Loss of appetite
    6
    4
    1
        Grade 3 Loss of appetite
    1
    1
    0
        Related Loss of appetite
    1
    2
    0
        Any Fever
    2
    5
    5
        Grade 3 Fever
    1
    2
    1
        Related Fever
    1
    5
    2
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects with any, grade 3 and related solicited general symptoms
    End point description
    Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache, joint pain at other location, muscle aches, shivering, sweating and fever [defined as axillary temperature equal to or above 38.0 degrees Celsius (°C)]. Any = occurrence of any general symptom regardless of intensity grade or relation to vaccination. Grade 3 symptom= symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C, but ≤ 40.0 °C. Related= general symptom assessed by the investigator as causally related to the vaccination. This outcome measure refers to subjects aged 6 to 10 years.
    End point type
    Secondary
    End point timeframe
    During the 7-day (Days 0-6) post-vaccination
    End point values
    		 Arepanrix 1/2 Group Pandemrix 1/2 Group Arepanrix Group
    Number of subjects analysed
    41
    44
    33
    Units: Subjects
        Any Fatigue
    4
    3
    2
        Grade 3 Fatigue
    1
    0
    0
        Related Fatigue
    1
    0
    0
        Any Gastrointestinal
    2
    1
    0
        Grade 3 Gastrointestinal
    1
    0
    0
        Related Gastrointestinal
    0
    0
    0
        Any Headache
    7
    9
    4
        Grade 3 Headache
    1
    0
    0
        Related Headache
    0
    2
    0
        Any Joint pain at other location
    5
    1
    4
        Grade 3 Joint pain at other location
    1
    0
    0
        Related Joint pain at other location
    1
    0
    0
        Any Muscle aches
    6
    7
    5
        Grade 3 Muscle aches
    0
    0
    0
        Related Muscle aches
    1
    1
    0
        Any Shivering
    4
    2
    0
        Grade 3 Shivering
    1
    0
    0
        Related Shivering
    0
    0
    0
        Any Sweating
    2
    1
    0
        Grade 3 Sweating
    1
    0
    0
        Related Sweating
    0
    0
    0
        Any Fever
    4
    0
    0
        Grade 3 Fever
    1
    0
    0
        Related Fever
    1
    0
    0
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects with medically-attended adverse events (MAEs)
    End point description
    MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination. Analysis of intensity and relationship to vaccination of MAEs was not performed.
    End point type
    Secondary
    End point timeframe
    Up to Day 21
    End point values
    		 Arepanrix 1/2 Group Pandemrix 1/2 Group Arepanrix Group
    Number of subjects analysed
    76
    75
    58
    Units: Subjects
        Any MAE(s)
    14
    9
    1
    No statistical analyses for this end point

    Secondary: Number of subjects with MAEs

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    End point title
    		 Number of subjects with MAEs
    End point description
    MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination. Analysis of intensity and relationship to vaccination of MAEs was not performed.
    End point type
    Secondary
    End point timeframe
    During the entire study period (Day 0 to Day 182)
    End point values
    		 Arepanrix 1/2 Group Pandemrix 1/2 Group Arepanrix Group
    Number of subjects analysed
    76
    75
    58
    Units: Subjects
        Any MAE(s)
    29
    29
    18
    No statistical analyses for this end point

    Secondary: Number of subjects with potential immune-mediated diseases (pIMDs)

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    End point title
    		 Number of subjects with potential immune-mediated diseases (pIMDs)
    End point description
    Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
    End point type
    Secondary
    End point timeframe
    Up to Day 21
    End point values
    		 Arepanrix 1/2 Group Pandemrix 1/2 Group Arepanrix Group
    Number of subjects analysed
    76
    75
    58
    Units: Subjects
        pIMDs
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects with pIMDs

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    End point title
    		 Number of subjects with pIMDs
    End point description
    Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
    End point type
    Secondary
    End point timeframe
    During the entire study period (Day 0 to Day 182)
    End point values
    		 Arepanrix 1/2 Group Pandemrix 1/2 Group Arepanrix Group
    Number of subjects analysed
    76
    75
    58
    Units: Subjects
        pIMDs
    0
    0
    0
    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
    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the 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 the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
    End point type
    Secondary
    End point timeframe
    Within the 21-day (Days 0-20) post-vaccination period
    End point values
    		 Arepanrix 1/2 Group Pandemrix 1/2 Group Arepanrix Group
    Number of subjects analysed
    76
    75
    58
    Units: Subjects
        Any AE(s)
    22
    21
    5
    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
    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the 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 the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
    End point type
    Secondary
    End point timeframe
    Within the 42-day (Days 0-41) post-vaccination period
    End point values
    		 Arepanrix 1/2 Group Pandemrix 1/2 Group Arepanrix Group
    Number of subjects analysed
    76
    75
    58
    Units: Subjects
        Any AE(s)
    28
    28
    23
    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
    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
    End point type
    Secondary
    End point timeframe
    Up to 21 days after vaccination
    End point values
    		 Arepanrix 1/2 Group Pandemrix 1/2 Group Arepanrix Group
    Number of subjects analysed
    76
    75
    58
    Units: Subjects
        Any SAE(s)
    0
    0
    0
    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
    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
    End point type
    Secondary
    End point timeframe
    During the entire study period (Days 0 - 182)
    End point values
    		 Arepanrix 1/2 Group Pandemrix 1/2 Group Arepanrix Group
    Number of subjects analysed
    76
    75
    58
    Units: Subjects
        Any SAE(s)
    1
    0
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    SAEs: Day 0 to 182; Unsolicited AEs: During the 42-day (Days 0-41) post-vaccination period; Solicited local and general symptoms: During the 7-day (Days 0-6) post-vaccination period.
    Adverse event reporting additional description
    The solicited local and general symptoms were only collected for those subjects who filled in their symptom sheets. 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
    Arepanrix 1/2 Group
    Reporting group description
    		 Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Arepanrix vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.

    Reporting group title
    Pandemrix 1/2 Group
    Reporting group description
    		 Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 half (1/2) pediatric dose of Pandemrix vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.

    Reporting group title
    Arepanrix Group
    Reporting group description
    		 Healthy male or female children aged 3 to less than (<) 10 years at the time of study vaccination, who received 1 pediatric dose of Arepanrix vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm.

    Serious adverse events
    		 Arepanrix 1/2 Group Pandemrix 1/2 Group Arepanrix Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 75 (0.00%)
    1 / 58 (1.72%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Infections and infestations
    Dengue fever
         subjects affected / exposed
    1 / 76 (1.32%)
    0 / 75 (0.00%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    0 / 76 (0.00%)
    0 / 75 (0.00%)
    1 / 58 (1.72%)
         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
    		 Arepanrix 1/2 Group Pandemrix 1/2 Group Arepanrix Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    52 / 76 (68.42%)
    52 / 75 (69.33%)
    35 / 58 (60.34%)
    General disorders and administration site conditions
    Pyrexia (Days 0-20 post-vaccination period)
         subjects affected / exposed
    2 / 76 (2.63%)
    6 / 75 (8.00%)
    1 / 58 (1.72%)
         occurrences all number
    2
    6
    1
    Pyrexia (Days 0-41 post-vaccination period)
         subjects affected / exposed
    4 / 76 (5.26%)
    9 / 75 (12.00%)
    6 / 58 (10.34%)
         occurrences all number
    4
    9
    6
    Pain
    alternative assessment type: Systematic
         subjects affected / exposed
    41 / 76 (53.95%)
    41 / 75 (54.67%)
    23 / 58 (39.66%)
         occurrences all number
    41
    41
    23
    Swelling
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 76 (1.32%)
    5 / 75 (6.67%)
    1 / 58 (1.72%)
         occurrences all number
    1
    5
    1
    Drowsiness (3-5Y)
    alternative assessment type: Systematic
         subjects affected / exposed [1]
    5 / 33 (15.15%)
    3 / 31 (9.68%)
    1 / 24 (4.17%)
         occurrences all number
    5
    3
    1
    Irritability (3-5Y)
    alternative assessment type: Systematic
         subjects affected / exposed [2]
    2 / 33 (6.06%)
    7 / 31 (22.58%)
    1 / 24 (4.17%)
         occurrences all number
    2
    7
    1
    Loss of appetite (3-5Y)
    alternative assessment type: Systematic
         subjects affected / exposed [3]
    6 / 33 (18.18%)
    4 / 31 (12.90%)
    1 / 24 (4.17%)
         occurrences all number
    6
    4
    1
    Temperature/ (Axillary) (3-5Y)
    alternative assessment type: Systematic
         subjects affected / exposed [4]
    2 / 33 (6.06%)
    5 / 31 (16.13%)
    5 / 24 (20.83%)
         occurrences all number
    2
    5
    5
    Fatigue (6-10Y)
    alternative assessment type: Systematic
         subjects affected / exposed [5]
    4 / 41 (9.76%)
    3 / 44 (6.82%)
    2 / 33 (6.06%)
         occurrences all number
    4
    3
    2
    Headache (6-10Y)
    alternative assessment type: Systematic
         subjects affected / exposed [6]
    7 / 41 (17.07%)
    9 / 44 (20.45%)
    4 / 33 (12.12%)
         occurrences all number
    7
    9
    4
    Joint pain (6-10Y)
    alternative assessment type: Systematic
         subjects affected / exposed [7]
    5 / 41 (12.20%)
    1 / 44 (2.27%)
    4 / 33 (12.12%)
         occurrences all number
    5
    1
    4
    Muscle aches (6-10Y)
    alternative assessment type: Systematic
         subjects affected / exposed [8]
    6 / 41 (14.63%)
    7 / 44 (15.91%)
    5 / 33 (15.15%)
         occurrences all number
    6
    7
    5
    Shivering (6-10Y)
    alternative assessment type: Systematic
         subjects affected / exposed [9]
    4 / 41 (9.76%)
    2 / 44 (4.55%)
    0 / 33 (0.00%)
         occurrences all number
    4
    2
    0
    Temperature/ (Axillary) (6-10Y)
    alternative assessment type: Systematic
         subjects affected / exposed [10]
    4 / 41 (9.76%)
    0 / 44 (0.00%)
    0 / 33 (0.00%)
         occurrences all number
    4
    0
    0
    Eye disorders
    Conjunctivitis (Days 0-41 post-vaccination period)
         subjects affected / exposed
    3 / 76 (3.95%)
    1 / 75 (1.33%)
    3 / 58 (5.17%)
         occurrences all number
    3
    1
    3
    Respiratory, thoracic and mediastinal disorders
    Cough (Days 0-41 post-vaccination period)
         subjects affected / exposed
    2 / 76 (2.63%)
    4 / 75 (5.33%)
    3 / 58 (5.17%)
         occurrences all number
    2
    4
    3
    Infections and infestations
    Upper respiratory tract infection (Days 0-20 post-vaccination period)
         subjects affected / exposed
    5 / 76 (6.58%)
    5 / 75 (6.67%)
    1 / 58 (1.72%)
         occurrences all number
    5
    5
    1
    Nasopharyngitis (Days 0-20 post-vaccination period)
         subjects affected / exposed
    5 / 76 (6.58%)
    1 / 75 (1.33%)
    2 / 58 (3.45%)
         occurrences all number
    5
    1
    2
    Rhinitis (Days 0-20 post-vaccination period)
         subjects affected / exposed
    4 / 76 (5.26%)
    2 / 75 (2.67%)
    0 / 58 (0.00%)
         occurrences all number
    4
    2
    0
    Nasopharyngitis (Days 0-41 post-vaccination period)
         subjects affected / exposed
    7 / 76 (9.21%)
    5 / 75 (6.67%)
    5 / 58 (8.62%)
         occurrences all number
    7
    5
    5
    Upper respiratory tract infection (Days 0-41 post-vaccination period)
         subjects affected / exposed
    6 / 76 (7.89%)
    6 / 75 (8.00%)
    3 / 58 (5.17%)
         occurrences all number
    6
    6
    3
    Rhinitis (Days 0-41 post-vaccination period)
         subjects affected / exposed
    5 / 76 (6.58%)
    2 / 75 (2.67%)
    0 / 58 (0.00%)
         occurrences all number
    5
    2
    0
    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: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom. 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: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom. 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: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom. 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: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom. 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: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom. 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: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom. Subjects who missed reporting symptoms (solicited/unsolicited or concomitant medications) were treated as subjects without symptoms (solicited/unsolicited or concomitant medications, respectively).
    [7] - 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: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom. Subjects who missed reporting symptoms (solicited/unsolicited or concomitant medications) were treated as subjects without symptoms (solicited/unsolicited or concomitant medications, respectively).
    [8] - 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: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom. Subjects who missed reporting symptoms (solicited/unsolicited or concomitant medications) were treated as subjects without symptoms (solicited/unsolicited or concomitant medications, respectively).
    [9] - 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: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom. Subjects who missed reporting symptoms (solicited/unsolicited or concomitant medications) were treated as subjects without symptoms (solicited/unsolicited or concomitant medications, respectively).
    [10] - 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: The analysis was performed on Total Vaccinated cohort which included all subjects with the vaccine administration documented and symptom sheet completed only on subjects that reported the specific symptom. Subjects who missed reporting symptoms (solicited/unsolicited or concomitant medications) were treated as subjects without symptoms (solicited/unsolicited or concomitant medications, respectively).

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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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