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    Clinical Trial Results:
    A Phase II randomized, observer blind, multicenter study of GlaxoSmithKline (GSK) Biologicals’ combined measles-mumps-rubella-varicella vaccine (MMRV) versus ProQuad, according to a one dose schedule, both administered subcutaneously at 12-14 months of age, concomitantly with hepatitis A vaccine (HAV) and pneumococcal conjugate vaccine (PCV) but at separate sites

    Summary
    EudraCT number
    		 2017-000454-18
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    17 Mar 2009

    Results information
    Results version number
    		 v2
    This version publication date
    23 Sep 2018
    First version publication date
    06 Jan 2018
    Other versions
    		 v1 , v3
    Version creation reason
    • Correction of full data set
    Non-serious adverse events section: Value corrected for the row - Total subjects affected by non serious adverse events, subjects affected / exposed

    Trial information

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    Trial identification
    Sponsor protocol code
    110058
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00578175
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline Biologicals
    Sponsor organisation address
    Rue de l'Institut 89, Rixensart, Belgium,
    Public contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, ((44)2089) 904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, ((44)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
    17 Mar 2009
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    24 Feb 2009
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Mar 2009
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    1. To demonstrate non-inferiority of GSK Biologicals’ Refrigerator-stored Priorix-Tetra co-administered with HAV and PCV compared to ProQuad co-administered with HAV and PCV at Day 42 with respect to a. the seroresponse rate for antibodies to varicella virus, measles virus and rubella virus and mumps virus. b. the geometric mean concentration (GMC) for anti-bodies to varicella virus, hepatitis A virus in a subset of subjects and S. pneumoniae serotypes (anti-PS) 4, 6B, 9V, 14, 18C, 19F and 23F in a subset of subjects. 2. To demonstrate non-inferiority of GSK Biologicals’ Freezer-stored Priorix-Tetra co-administered with HAV and PCV compared to ProQuad co-administered with HAV and PCV at Day 42 with respect to a. the seroresponse rate for antibodies to varicella virus, measles virus and rubella virus and mumps virus. b. GMC for antibodies to varicella virus, hepatitis A virus in a subset of subjects and anti-PS serotypes 4, 6B, 9V, 14, 18C, 19F and 23F in a subset of subjects.
    Protection of trial subjects
    The vaccinees were observed closely for at least 30 minutes following the administration of vaccines, with appropriate medical treatment readily available in case of a rare anaphylactic reaction.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    20 Nov 2007
    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
    United States: 1851
    Worldwide total number of subjects
    1851
    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)
    1851
    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
    		 While the total numbers of subjects enrolled in the study was of 1851, the total number of subjects that entered the study was 1783. The remaining 67 subjects received a subject number but no vaccine dose and were therefore excluded from the analysis and group assignment.

    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
    		 Subject, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    Data was collected in an observer-blinded manner.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Refrigerator-stored Priorix-Tetra Group
    Arm description
    		 Subjects received at Day 0 a single dose of refrigerator-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Priorix-Tetra
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Single dose of Priorix-Tetra was administered at Visit 1 (Day 0)

    Investigational medicinal product name
    Prevenar
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Single dose of Prevenar was administered at Visit 1 (Day 0)

    Investigational medicinal product name
    Havrix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    First dose of Havrix was administered at Visit 1 (Day 0) and second dose at Visit 3 (Day 180)

    Arm title
    		 Freezer-stored Priorix-Tetra Group
    Arm description
    		 Subjects received at Day 0 a single dose of freezer-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Priorix-Tetra
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Single dose of Priorix-Tetra was administered at Visit 1 (Day 0)

    Investigational medicinal product name
    Havrix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    First dose of Havrix was administered at Visit 1 (Day 0) and second dose at Visit 3 (Day 180)

    Investigational medicinal product name
    Prevenar
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Single dose of Prevenar was administered at Visit 1 (Day 0)

    Arm title
    		 ProQuad Group
    Arm description
    		 Subjects received at Day 0 a single dose of ProQuad subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    ProQuad
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Single dose of ProQuad was administered at Visit 1 (Day 0)

    Investigational medicinal product name
    Havrix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    First dose of Havrix was administered at Visit 1 (Day 0) and second dose at Visit 3 (Day 180)

    Investigational medicinal product name
    Prevenar
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Single dose of Prevenar was administered at Visit 1 (Day 0)

    Notes
    [1] - The roles blinded appear to be inconsistent with a double blind trial.
    Justification: Data was collected in an observer-blinded manner.
    Number of subjects in period 1 [2]
    		Refrigerator-stored Priorix-Tetra Group Freezer-stored Priorix-Tetra Group ProQuad Group
    Started
    705
    689
    389
    Completed
    635
    646
    365
    Not completed
    70
    43
    24
         Adverse event, non-fatal
    -
    1
    1
         Other reasons
    70
    42
    23
    Notes
    [2] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: While the total numbers of subjects enrolled in the study was of 1851, the total number of subjects that entered the study was 1783. The remaining 67 subjects received a subject number but no vaccine dose and were therefore excluded from the analysis and group assignment.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Refrigerator-stored Priorix-Tetra Group
    Reporting group description
    		 Subjects received at Day 0 a single dose of refrigerator-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.

    Reporting group title
    Freezer-stored Priorix-Tetra Group
    Reporting group description
    		 Subjects received at Day 0 a single dose of freezer-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.

    Reporting group title
    ProQuad Group
    Reporting group description
    		 Subjects received at Day 0 a single dose of ProQuad subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly.

    Reporting group values
    		 Refrigerator-stored Priorix-Tetra Group Freezer-stored Priorix-Tetra Group ProQuad Group Total
    Number of subjects
    		 705 689 389
    Age categorical
    Units: Subjects
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    		 12.3 ( 0.58 ) 12.3 ( 0.59 ) 12.3 ( 0.61 ) -
    Gender categorical
    Units: Subjects
        Female
    		 356 346 186 888
        Male
    		 349 343 203 895

    End points

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    End points reporting groups
    Reporting group title
    Refrigerator-stored Priorix-Tetra Group
    Reporting group description
    		 Subjects received at Day 0 a single dose of refrigerator-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.

    Reporting group title
    Freezer-stored Priorix-Tetra Group
    Reporting group description
    		 Subjects received at Day 0 a single dose of freezer-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.

    Reporting group title
    ProQuad Group
    Reporting group description
    		 Subjects received at Day 0 a single dose of ProQuad subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly.

    Primary: Number of subjects with seroresponse for antibodies to varicella virus (VZV)

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    End point title
    		 Number of subjects with seroresponse for antibodies to varicella virus (VZV) [1]
    End point description
    Seroresponse for antibodies to VZV is defined as the appearance post-vaccination of anti-VZV antibodies [concentration greater than or equal to the threshold of 75 milli-international units per milliliter (mIU/mL)] in the serum of subjects below the assay cut-off value of 25 mIU/mL before vaccination.
    End point type
    Primary
    End point timeframe
    At Day 42 after vaccination
    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 end point was descriptive, no statistical hypothesis test was performed.
    End point values
    		 Refrigerator-stored Priorix-Tetra Group Freezer-stored Priorix-Tetra Group ProQuad Group
    Number of subjects analysed
    622
    630
    347
    Units: Subjects
        Subjects
    355
    440
    301
    No statistical analyses for this end point

    Primary: Concentration of antibodies to varicella virus (VZV)

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    End point title
    		 Concentration of antibodies to varicella virus (VZV) [2]
    End point description
    Concentrations are given as Geometric Mean Concentrations (GMCs).
    End point type
    Primary
    End point timeframe
    At Day 42 after vaccination
    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 end point was descriptive, no statistical hypothesis test was performed.
    End point values
    		 Refrigerator-stored Priorix-Tetra Group Freezer-stored Priorix-Tetra Group ProQuad Group
    Number of subjects analysed
    629
    636
    352
    Units: Milli-international units per milliliter
    geometric mean (confidence interval 95%)
        Milli-international units per milliliter
    83.6 (77.0 to 90.8)
    109.9 (102.1 to 118.3)
    164.3 (152.3 to 177.3)
    No statistical analyses for this end point

    Primary: Number of subjects with seroresponse for antibodies to mumps virus

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    End point title
    		 Number of subjects with seroresponse for antibodies to mumps virus [3]
    End point description
    Seroresponse for antibodies to mumps virus is defined as the appearance post-vaccination of anti-mumps virus antibodies [titer greater than or equal to the threshold of 51 Effective Doses (ED50)] in the serum of subjects below the assay cut-off value of 24 ED50 before vaccination.
    End point type
    Primary
    End point timeframe
    At Day 42 after vaccination
    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 end point was descriptive, no statistical hypothesis test was performed.
    End point values
    		 Refrigerator-stored Priorix-Tetra Group Freezer-stored Priorix-Tetra Group ProQuad Group
    Number of subjects analysed
    532
    531
    276
    Units: Subjects
        Subjects
    491
    498
    256
    No statistical analyses for this end point

    Primary: Number of subjects with seroresponse for antibodies to measles virus

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    End point title
    		 Number of subjects with seroresponse for antibodies to measles virus [4]
    End point description
    Seroresponse for antibodies to measles virus is defined as the appearance post-vaccination of anti-measles virus antibodies [concentration greater than or equal to the threshold of 200 milli-international units per milliliter (mIU/mL)] in the serum of subjects below the assay cut-off value of 150 mIU/mL before vaccination.
    End point type
    Primary
    End point timeframe
    At Day 42 after vaccination
    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 end point was descriptive, no statistical hypothesis test was performed.
    End point values
    		 Refrigerator-stored Priorix-Tetra Group Freezer-stored Priorix-Tetra Group ProQuad Group
    Number of subjects analysed
    626
    636
    350
    Units: Subjects
        Subjects
    616
    633
    342
    No statistical analyses for this end point

    Primary: Number of subjects with seroresponse for antibodies to rubella virus

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    End point title
    		 Number of subjects with seroresponse for antibodies to rubella virus [5]
    End point description
    Seroresponse for antibodies to rubella virus is defined as the appearance post-vaccination of anti-rubella virus antibodies [concentration greater than or equal to the threshold of 10 international units per milliliter (IU/mL)] in the serum of subjects below the assay cut-off value of 4 IU/mL before vaccination.
    End point type
    Primary
    End point timeframe
    At Day 42 after vaccination
    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 end point was descriptive, no statistical hypothesis test was performed.
    End point values
    		 Refrigerator-stored Priorix-Tetra Group Freezer-stored Priorix-Tetra Group ProQuad Group
    Number of subjects analysed
    628
    636
    351
    Units: Subjects
        Subjects
    616
    622
    349
    No statistical analyses for this end point

    Primary: Concentration of antibodies to hepatitis A virus (HAV)

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    End point title
    		 Concentration of antibodies to hepatitis A virus (HAV) [6]
    End point description
    Concentrations are given as Geometric Mean Concentrations (GMCs).
    End point type
    Primary
    End point timeframe
    At Day 42 after vaccination
    Notes
    [6] - 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 end point was descriptive, no statistical hypothesis test was performed.
    End point values
    		 Refrigerator-stored Priorix-Tetra Group Freezer-stored Priorix-Tetra Group ProQuad Group
    Number of subjects analysed
    404
    409
    227
    Units: Milli-international units per milliliter
    geometric mean (confidence interval 95%)
        Milli-international units per milliliter
    40.5 (37.1 to 44.2)
    40.3 (37.0 to 44.0)
    40.0 (35.7 to 44.9)
    No statistical analyses for this end point

    Primary: Concentration of antibodies to S. pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F and 23F

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    End point title
    		 Concentration of antibodies to S. pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F and 23F [7]
    End point description
    Concentrations are given as Geometric Mean Concentrations (GMCs).
    End point type
    Primary
    End point timeframe
    At Day 42 after vaccination
    Notes
    [7] - 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 end point was descriptive, no statistical hypothesis test was performed.
    End point values
    		 Refrigerator-stored Priorix-Tetra Group Freezer-stored Priorix-Tetra Group ProQuad Group
    Number of subjects analysed
    461
    468
    266
    Units: Micrograms per milliliter (µg/mL)
    geometric mean (confidence interval 95%)
        S.Pneu.4 (n= 461, 463, 266)
    3.35 (3.10 to 3.63)
    3.31 (3.04 to 3.59)
    3.02 (2.72 to 3.34)
        S.Pneu.6B (n= 460, 464, 265)
    5.65 (5.16 to 6.19)
    5.91 (5.40 to 6.45)
    5.43 (4.90 to 6.02)
        S.Pneu.9V (n=461, 468, 266)
    5.81 (5.37 to 6.29)
    5.66 (5.23 to 6.13)
    5.54 (5.02 to 6.12)
        S.Pneu.14 (n= 460, 465, 266)
    9.71 (8.99 to 10.50)
    9.54 (8.81 to 10.34)
    8.96 (8.07 to 9.95)
        S.Pneu.18C (n= 458, 465, 263)
    5.50 (5.04 to 6.01)
    5.80 (5.30 to 6.34)
    5.51 (4.95 to 6.12)
        S.Pneu.19F (n= 454, 460, 261)
    2.52 (2.32 to 2.74)
    2.52 (2.32 to 2.73)
    2.31 (2.06 to 2.59)
        S.Pneu.23F (n= 459, 464, 266)
    10.10 (9.22 to 11.06)
    10.85 (9.87 to 11.91)
    9.79 (8.65 to 11.07)
    No statistical analyses for this end point

    Secondary: Antibody titers to mumps virus

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    End point title
    		 Antibody titers to mumps virus
    End point description
    Data are expressed as Geometric Mean Titers (GMTs). The titer is the serum dilution giving a 50 percent reduction of the signal compared to a control without serum.
    End point type
    Secondary
    End point timeframe
    At Day 42 after vaccination
    End point values
    		 Refrigerator-stored Priorix-Tetra Group Freezer-stored Priorix-Tetra Group ProQuad Group
    Number of subjects analysed
    591
    601
    327
    Units: Titer
    geometric mean (confidence interval 95%)
        Titer
    222.4 (202.5 to 244.3)
    224.6 (206.9 to 243.9)
    253.1 (222.7 to 287.7)
    No statistical analyses for this end point

    Secondary: Concentration of antibodies to measles virus

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    End point title
    		 Concentration of antibodies to measles virus
    End point description
    Concentrations are given as Geometric Mean Concentrations (GMCs).
    End point type
    Secondary
    End point timeframe
    At Day 42 after vaccination
    End point values
    		 Refrigerator-stored Priorix-Tetra Group Freezer-stored Priorix-Tetra Group ProQuad Group
    Number of subjects analysed
    626
    636
    350
    Units: Milli-international units per milliliter
    geometric mean (confidence interval 95%)
        Milli-international units per milliliter
    4723.1 (4436.4 to 5028.4)
    4650.3 (4430.9 to 4880.5)
    4207.1 (3823.3 to 4629.3)
    No statistical analyses for this end point

    Secondary: Concentration of antibodies to rubella virus

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    End point title
    		 Concentration of antibodies to rubella virus
    End point description
    Concentrations are given as Geometric Mean Concentrations (GMCs).
    End point type
    Secondary
    End point timeframe
    At Day 42 after vaccination
    End point values
    		 Refrigerator-stored Priorix-Tetra Group Freezer-stored Priorix-Tetra Group ProQuad Group
    Number of subjects analysed
    629
    636
    352
    Units: International units per milliliter
    geometric mean (confidence interval 95%)
        International units per milliliter
    59.9 (55.9 to 64.1)
    57.9 (54.4 to 61.7)
    71.4 (65.5 to 77.8)
    No statistical analyses for this end point

    Secondary: Number of subjects with vaccine response to Havrix

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    End point title
    		 Number of subjects with vaccine response to Havrix
    End point description
    Vaccine response to Havrix is defined as the appearance post-vaccination of anti-hepatitis A virus (anti-HAV) antibodies [concentration greater than or equal to 15 milli-international units per milliliter (mIU/mL)] in the serum of subjects seronegative before vaccination (concentration below the assay cut-off value of 15 mIU/mL) or having a 2-fold increase above the pre-vaccination concentration in subjects who were seropositive before vaccination.
    End point type
    Secondary
    End point timeframe
    At Day 42 after vaccination
    End point values
    		 Refrigerator-stored Priorix-Tetra Group Freezer-stored Priorix-Tetra Group ProQuad Group
    Number of subjects analysed
    404
    409
    227
    Units: Subjects
        Subjects
    344
    345
    195
    No statistical analyses for this end point

    Secondary: Number of subjects with concentration of antibodies to S. pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F and 23F equal or above the cut-off value

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    End point title
    		 Number of subjects with concentration of antibodies to S. pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F and 23F equal or above the cut-off value
    End point description
    Cut-off value assessed include 0.05 micrograms per milliliter (µg/mL).
    End point type
    Secondary
    End point timeframe
    At Day 42 after vaccination
    End point values
    		 Refrigerator-stored Priorix-Tetra Group Freezer-stored Priorix-Tetra Group ProQuad Group
    Number of subjects analysed
    461
    468
    266
    Units: Subjects
        Anti-S.Pneu-4 (n= 461, 463, 266)
    461
    463
    266
        Anti-S.Pneu-6B (n= 460, 464, 265)
    459
    463
    265
        Anti-S.Pneu-9V (n= 461, 468, 266)
    461
    468
    266
        Anti-S.Pneu-14 (n= 460, 465, 266)
    460
    465
    266
        Anti-S.Pneu-18C (n= 458, 465, 263)
    458
    465
    263
        Anti-S.Pneu-19F (n= 454, 460, 261)
    454
    460
    261
        Anti-S.Pneu-23F (n= 459, 464, 266)
    459
    464
    266
    No statistical analyses for this end point

    Secondary: Number of subjects with concentration of antibodies to S. pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F and 23F equal or above the cut-off value

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    End point title
    		 Number of subjects with concentration of antibodies to S. pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F and 23F equal or above the cut-off value
    End point description
    Cut-off value assessed include 0.2 micrograms per milliliter (µg/mL).
    End point type
    Secondary
    End point timeframe
    At Day 42 after vaccination
    End point values
    		 Refrigerator-stored Priorix-Tetra Group Freezer-stored Priorix-Tetra Group ProQuad Group
    Number of subjects analysed
    461
    468
    266
    Units: Subjects
        Anti-S.Pneu-4 (n= 461, 463, 266)
    461
    463
    266
        Anti-S.Pneu-6B (n= 460, 464, 265)
    458
    460
    265
        Anti-S.Pneu-9V (n= 461, 468, 266)
    461
    468
    266
        Anti-S.Pneu-14 (n= 460, 465, 266)
    460
    465
    266
        Anti-S.Pneu-18C (n= 458, 465, 263)
    458
    464
    263
        Anti-S.Pneu-19F (n= 454, 460, 261)
    451
    459
    259
        Anti-S.Pneu-23F (n= 459, 464, 266)
    459
    464
    266
    No statistical analyses for this end point

    Secondary: Number of subjects with concentration of antibodies to S. pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F and 23F equal or above the cut-off value

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    End point title
    		 Number of subjects with concentration of antibodies to S. pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F and 23F equal or above the cut-off value
    End point description
    Cut-off value assessed include 0.5 micrograms per milliliter (µg/mL).
    End point type
    Secondary
    End point timeframe
    At Day 42 after vaccination
    End point values
    		 Refrigerator-stored Priorix-Tetra Group Freezer-stored Priorix-Tetra Group ProQuad Group
    Number of subjects analysed
    461
    468
    266
    Units: Subjects
        Anti-S.Pneu-4 (n= 461, 463, 266)
    456
    459
    265
        Anti-S.Pneu-6B (n= 460, 464, 265)
    453
    459
    264
        Anti-S.Pneu-9V (n= 461, 468, 266)
    459
    466
    266
        Anti-S.Pneu-14 (n= 460, 465, 266)
    459
    464
    266
        Anti-S.Pneu-18C (n= 458, 465, 263)
    458
    463
    263
        Anti-S.Pneu-19F (n= 454, 460, 261)
    431
    448
    249
        Anti-S.Pneu-23F (n= 459, 464, 266)
    458
    462
    266
    No statistical analyses for this end point

    Secondary: Number of subjects with concentration of antibodies to S. pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F and 23F equal or above the cut-off value

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    End point title
    		 Number of subjects with concentration of antibodies to S. pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F and 23F equal or above the cut-off value
    End point description
    Cut-off value assessed include 1.0 micrograms per milliliter (µg/mL).
    End point type
    Secondary
    End point timeframe
    At Day 42 after vaccination
    End point values
    		 Refrigerator-stored Priorix-Tetra Group Freezer-stored Priorix-Tetra Group ProQuad Group
    Number of subjects analysed
    461
    468
    266
    Units: Subjects
        Anti-S.Pneu-4 (n= 461, 463, 266)
    437
    423
    249
        Anti-S.Pneu-6B (n= 460, 464, 265)
    442
    453
    259
        Anti-S.Pneu-9V (n= 461, 468, 266)
    450
    459
    265
        Anti-S.Pneu-14 (n= 460, 465, 266)
    458
    463
    266
        Anti-S.Pneu-18C (n= 458, 465, 263)
    446
    455
    259
        Anti-S.Pneu-19F (n= 454, 460, 261)
    390
    390
    214
        Anti-S.Pneu-23F (n= 459, 464, 266)
    446
    458
    265
    No statistical analyses for this end point

    Secondary: Number of subjects reporting solicited local symptoms

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    End point title
    		 Number of subjects reporting solicited local symptoms
    End point description
    Solicited local symptoms assessed include pain, redness and swelling.
    End point type
    Secondary
    End point timeframe
    During the 4 day follow up period following vaccination
    End point values
    		 Refrigerator-stored Priorix-Tetra Group Freezer-stored Priorix-Tetra Group ProQuad Group
    Number of subjects analysed
    673
    666
    378
    Units: Subjects
        Pain
    136
    114
    65
        Redness
    111
    120
    54
        Swelling
    50
    49
    21
    No statistical analyses for this end point

    Secondary: Number of subjects reporting fever ≥ 38.0°C/100.4°F and > 39.5°C/103.1°F during the 15-day follow up period after vaccination

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    End point title
    		 Number of subjects reporting fever ≥ 38.0°C/100.4°F and > 39.5°C/103.1°F during the 15-day follow up period after vaccination
    End point description
    Fever was measured rectally.
    End point type
    Secondary
    End point timeframe
    During the 15-day follow-up period following vaccination
    End point values
    		 Refrigerator-stored Priorix-Tetra Group Freezer-stored Priorix-Tetra Group ProQuad Group
    Number of subjects analysed
    676
    668
    379
    Units: Subjects
        ≥ 38.0°C/100.4°F
    248
    241
    120
        > 39.5°C/103.1°F
    33
    48
    14
    No statistical analyses for this end point

    Secondary: Number of subjects reporting fever ≥ 38.0°C/100.4°F and > 39.5°C/103.1°F during the 43-day follow-up period after vaccination

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    End point title
    		 Number of subjects reporting fever ≥ 38.0°C/100.4°F and > 39.5°C/103.1°F during the 43-day follow-up period after vaccination
    End point description
    Fever was measured rectally.
    End point type
    Secondary
    End point timeframe
    During the 43-day follow-up period following vaccination
    End point values
    		 Refrigerator-stored Priorix-Tetra Group Freezer-stored Priorix-Tetra Group ProQuad Group
    Number of subjects analysed
    676
    668
    379
    Units: subjects
        ≥ 38.0°C/100.4°F
    312
    301
    162
        > 39.5°C/103.1°F
    52
    71
    24
    No statistical analyses for this end point

    Secondary: Number of subjects reporting investigator-confirmed measles/rubella-like rash

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    End point title
    		 Number of subjects reporting investigator-confirmed measles/rubella-like rash
    End point description
    End point type
    Secondary
    End point timeframe
    During the 43-day follow-up period after vaccination
    End point values
    		 Refrigerator-stored Priorix-Tetra Group Freezer-stored Priorix-Tetra Group ProQuad Group
    Number of subjects analysed
    676
    668
    379
    Units: Subjects
        Subjects
    37
    25
    15
    No statistical analyses for this end point

    Secondary: Number of subjects reporting investigator-confirmed varicella-like rash

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    End point title
    		 Number of subjects reporting investigator-confirmed varicella-like rash
    End point description
    End point type
    Secondary
    End point timeframe
    During the 43-day follow-up period after vaccination
    End point values
    		 Refrigerator-stored Priorix-Tetra Group Freezer-stored Priorix-Tetra Group ProQuad Group
    Number of subjects analysed
    676
    668
    379
    Units: Subjects
        Subjects
    10
    9
    6
    No statistical analyses for this end point

    Secondary: Number of subjects reporting investigator-confirmed parotid/salivary gland swelling

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    End point title
    		 Number of subjects reporting investigator-confirmed parotid/salivary gland swelling
    End point description
    End point type
    Secondary
    End point timeframe
    During the 43-day follow-up period after vaccination
    End point values
    		 Refrigerator-stored Priorix-Tetra Group Freezer-stored Priorix-Tetra Group ProQuad Group
    Number of subjects analysed
    676
    668
    379
    Units: Subjects
        Subjects
    14
    7
    5
    No statistical analyses for this end point

    Secondary: Number of subjects reporting unsolicited adverse events and medically-attended adverse events (excluding rash and parotid/salivary gland swelling)

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    End point title
    		 Number of subjects reporting unsolicited adverse events and medically-attended adverse events (excluding rash and parotid/salivary gland swelling)
    End point description
    Unsolicited adverse event covers any adverse event 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. Medically-attended adverse event covers any adverse event which received medical attention. Medical attention is defined as hospitalization, an emergency room visit or a visit to or from medical personnel.
    End point type
    Secondary
    End point timeframe
    During the 43-day follow-up period after vaccination
    End point values
    		 Refrigerator-stored Priorix-Tetra Group Freezer-stored Priorix-Tetra Group ProQuad Group
    Number of subjects analysed
    705
    689
    389
    Units: Subjects
        Unsolicited adverse events
    338
    332
    191
        Medically-attended adverse events
    217
    213
    124
    No statistical analyses for this end point

    Secondary: Number of subjects reporting new onset chronic illnesses and conditions prompting emergency room visits

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    End point title
    		 Number of subjects reporting new onset chronic illnesses and conditions prompting emergency room visits
    End point description
    New onset chronic illnesses include autoimmune disorders, asthma, type I diabetes and allergies.
    End point type
    Secondary
    End point timeframe
    For approximately 6 months (Day 0-180)
    End point values
    		 Refrigerator-stored Priorix-Tetra Group Freezer-stored Priorix-Tetra Group ProQuad Group
    Number of subjects analysed
    705
    689
    389
    Units: Subjects
        New onsets of chronic diseases
    11
    11
    7
        Emergency room visits
    63
    63
    44
    No statistical analyses for this end point

    Secondary: Number of subjects reporting serious adverse events

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    End point title
    		 Number of subjects reporting serious adverse events
    End point description
    Serious adverse events assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
    End point type
    Secondary
    End point timeframe
    For approximately 6 months (Day 0-180)
    End point values
    		 Refrigerator-stored Priorix-Tetra Group Freezer-stored Priorix-Tetra Group ProQuad Group
    Number of subjects analysed
    705
    689
    389
    Units: Subjects
        Subjects
    14
    20
    7
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited local AEs: during 4-day follow-up period after vaccination. Solicited general & Unsolicited AEs: during 43-day follow-up period after vaccination. SAEs: during the entire study period (approximately 6 months; Day 0 to Day 180).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    12.0
    Reporting groups
    Reporting group title
    Refrigerator-stored Priorix-Tetra Group
    Reporting group description
    		 Subjects received at Day 0 a single dose of refrigerator-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.

    Reporting group title
    Freezer-stored Priorix-Tetra Group
    Reporting group description
    		 Subjects received at Day 0 a single dose of freezer-stored Priorix-Tetra subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly in the left thigh.

    Reporting group title
    Proquad Group
    Reporting group description
    		 Subjects received at Day 0 a single dose of ProQuad subcutaneously in the right upper arm co-administered with a single dose of Havrix and Prevnar intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix intramuscularly.

    Serious adverse events
    		 Refrigerator-stored Priorix-Tetra Group Freezer-stored Priorix-Tetra Group Proquad Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    14 / 705 (1.99%)
    20 / 689 (2.90%)
    7 / 389 (1.80%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Primitive neuroectodermal tumour
         subjects affected / exposed
    0 / 705 (0.00%)
    1 / 689 (0.15%)
    0 / 389 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Accidental drug intake by child
         subjects affected / exposed
    1 / 705 (0.14%)
    0 / 689 (0.00%)
    0 / 389 (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
    Accidental exposure
         subjects affected / exposed
    1 / 705 (0.14%)
    0 / 689 (0.00%)
    0 / 389 (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
    Burns second degree
         subjects affected / exposed
    0 / 705 (0.00%)
    1 / 689 (0.15%)
    0 / 389 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Foreign body trauma
         subjects affected / exposed
    0 / 705 (0.00%)
    0 / 689 (0.00%)
    1 / 389 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thermal burn
         subjects affected / exposed
    0 / 705 (0.00%)
    1 / 689 (0.15%)
    0 / 389 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Febrile convulsion
         subjects affected / exposed
    0 / 705 (0.00%)
    2 / 689 (0.29%)
    0 / 389 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Convulsion
         subjects affected / exposed
    1 / 705 (0.14%)
    0 / 689 (0.00%)
    0 / 389 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Partial seizures
         subjects affected / exposed
    0 / 705 (0.00%)
    1 / 689 (0.15%)
    0 / 389 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 705 (0.00%)
    1 / 689 (0.15%)
    0 / 389 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Dysphagia
         subjects affected / exposed
    1 / 705 (0.14%)
    0 / 689 (0.00%)
    0 / 389 (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
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 705 (0.14%)
    0 / 689 (0.00%)
    0 / 389 (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
    Vomiting
         subjects affected / exposed
    0 / 705 (0.00%)
    1 / 689 (0.15%)
    0 / 389 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Aspiration
         subjects affected / exposed
    0 / 705 (0.00%)
    1 / 689 (0.15%)
    0 / 389 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Atelectasis
         subjects affected / exposed
    1 / 705 (0.14%)
    0 / 689 (0.00%)
    0 / 389 (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
    Asthma
         subjects affected / exposed
    1 / 705 (0.14%)
    1 / 689 (0.15%)
    0 / 389 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchial hyperreactivity
         subjects affected / exposed
    0 / 705 (0.00%)
    2 / 689 (0.29%)
    0 / 389 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    0 / 705 (0.00%)
    1 / 689 (0.15%)
    0 / 389 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory distress
         subjects affected / exposed
    0 / 705 (0.00%)
    1 / 689 (0.15%)
    0 / 389 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Autism spectrum disorder
         subjects affected / exposed
    0 / 705 (0.00%)
    1 / 689 (0.15%)
    0 / 389 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Abscess
         subjects affected / exposed
    0 / 705 (0.00%)
    1 / 689 (0.15%)
    0 / 389 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Acute sinusitis
         subjects affected / exposed
    0 / 705 (0.00%)
    0 / 689 (0.00%)
    1 / 389 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchiolitis
         subjects affected / exposed
    0 / 705 (0.00%)
    0 / 689 (0.00%)
    1 / 389 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    2 / 705 (0.28%)
    0 / 689 (0.00%)
    0 / 389 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Croup infectious
         subjects affected / exposed
    0 / 705 (0.00%)
    1 / 689 (0.15%)
    0 / 389 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ear infection
         subjects affected / exposed
    1 / 705 (0.14%)
    0 / 689 (0.00%)
    0 / 389 (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
    Gastroenteritis
         subjects affected / exposed
    1 / 705 (0.14%)
    2 / 689 (0.29%)
    0 / 389 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis rotavirus
         subjects affected / exposed
    0 / 705 (0.00%)
    0 / 689 (0.00%)
    1 / 389 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Groin abscess
         subjects affected / exposed
    0 / 705 (0.00%)
    2 / 689 (0.29%)
    0 / 389 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Otitis media
         subjects affected / exposed
    1 / 705 (0.14%)
    0 / 689 (0.00%)
    0 / 389 (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
    Periorbital cellulitis
         subjects affected / exposed
    0 / 705 (0.00%)
    0 / 689 (0.00%)
    1 / 389 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Perirectal abscess
         subjects affected / exposed
    0 / 705 (0.00%)
    0 / 689 (0.00%)
    1 / 389 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 705 (0.00%)
    0 / 689 (0.00%)
    2 / 389 (0.51%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia viral
         subjects affected / exposed
    0 / 705 (0.00%)
    1 / 689 (0.15%)
    0 / 389 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory syncytial virus bronchiolitis
         subjects affected / exposed
    1 / 705 (0.14%)
    0 / 689 (0.00%)
    0 / 389 (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
    Respiratory syncytial virus infection
         subjects affected / exposed
    1 / 705 (0.14%)
    0 / 689 (0.00%)
    0 / 389 (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
    Staphylococcal infection
         subjects affected / exposed
    1 / 705 (0.14%)
    1 / 689 (0.15%)
    0 / 389 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Subcutaneous abscess
         subjects affected / exposed
    1 / 705 (0.14%)
    0 / 689 (0.00%)
    0 / 389 (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
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 705 (0.00%)
    1 / 689 (0.15%)
    0 / 389 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    0 / 705 (0.00%)
    1 / 689 (0.15%)
    0 / 389 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypoglycaemia
         subjects affected / exposed
    0 / 705 (0.00%)
    1 / 689 (0.15%)
    0 / 389 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    0 / 705 (0.00%)
    1 / 689 (0.15%)
    0 / 389 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Type 1 diabetes mellitus
         subjects affected / exposed
    0 / 705 (0.00%)
    1 / 689 (0.15%)
    0 / 389 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         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
    		 Refrigerator-stored Priorix-Tetra Group Freezer-stored Priorix-Tetra Group Proquad Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    547 / 705 (77.59%)
    541 / 689 (78.52%)
    297 / 389 (76.35%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Essential thrombocythaemia
         subjects affected / exposed
    0 / 705 (0.00%)
    1 / 689 (0.15%)
    0 / 389 (0.00%)
         occurrences all number
    0
    1
    0
    Vascular disorders
    Haematoma
         subjects affected / exposed
    0 / 705 (0.00%)
    1 / 689 (0.15%)
    0 / 389 (0.00%)
         occurrences all number
    0
    1
    0
    Surgical and medical procedures
    Adenoidectomy
         subjects affected / exposed
    1 / 705 (0.14%)
    0 / 689 (0.00%)
    0 / 389 (0.00%)
         occurrences all number
    1
    0
    0
    Inguinal hernia repair
         subjects affected / exposed
    1 / 705 (0.14%)
    0 / 689 (0.00%)
    0 / 389 (0.00%)
         occurrences all number
    1
    0
    0
    Myringotomy
         subjects affected / exposed
    1 / 705 (0.14%)
    0 / 689 (0.00%)
    0 / 389 (0.00%)
         occurrences all number
    1
    0
    0
    Sinus operation
         subjects affected / exposed
    1 / 705 (0.14%)
    2 / 689 (0.29%)
    2 / 389 (0.51%)
         occurrences all number
    1
    3
    3
    General disorders and administration site conditions
    Adverse drug reaction
         subjects affected / exposed
    0 / 705 (0.00%)
    0 / 689 (0.00%)
    1 / 389 (0.26%)
         occurrences all number
    0
    0
    1
    Discomfort
         subjects affected / exposed
    2 / 705 (0.28%)
    1 / 689 (0.15%)
    1 / 389 (0.26%)
         occurrences all number
    2
    2
    2
    Fatigue
         subjects affected / exposed
    2 / 705 (0.28%)
    2 / 689 (0.29%)
    2 / 389 (0.51%)
         occurrences all number
    2
    2
    2
    Foreign body reaction
         subjects affected / exposed
    0 / 705 (0.00%)
    0 / 689 (0.00%)
    1 / 389 (0.26%)
         occurrences all number
    0
    0
    1
    Gait disturbance
         subjects affected / exposed
    1 / 705 (0.14%)
    1 / 689 (0.15%)
    1 / 389 (0.26%)
         occurrences all number
    1
    1
    1
    Induration
         subjects affected / exposed
    1 / 705 (0.14%)
    0 / 689 (0.00%)
    0 / 389 (0.00%)
         occurrences all number
    1
    0
    0
    Influenza like illness
         subjects affected / exposed
    2 / 705 (0.28%)
    1 / 689 (0.15%)
    0 / 389 (0.00%)
         occurrences all number
    2
    1
    0
    Injection site haematoma
         subjects affected / exposed
    1 / 705 (0.14%)
    2 / 689 (0.29%)
    0 / 389 (0.00%)
         occurrences all number
    1
    2
    0
    Injection site erythema
         subjects affected / exposed
    0 / 705 (0.00%)
    1 / 689 (0.15%)
    0 / 389 (0.00%)
         occurrences all number
    0
    1
    0
    Injection site induration
         subjects affected / exposed
    0 / 705 (0.00%)
    1 / 689 (0.15%)
    0 / 389 (0.00%)
         occurrences all number
    0
    1
    0
    Irritability
         subjects affected / exposed
    25 / 705 (3.55%)
    35 / 689 (5.08%)
    20 / 389 (5.14%)
         occurrences all number
    30
    39
    22
    Local swelling
         subjects affected / exposed
    1 / 705 (0.14%)
    0 / 689 (0.00%)
    0 / 389 (0.00%)
         occurrences all number
    1
    0
    0
    Oedema peripheral
         subjects affected / exposed
    2 / 705 (0.28%)
    2 / 689 (0.29%)
    0 / 389 (0.00%)
         occurrences all number
    2
    2
    0
    Pain
         subjects affected / exposed
    136 / 705 (19.29%)
    116 / 689 (16.84%)
    65 / 389 (16.71%)
         occurrences all number
    137
    117
    65
    Pyrexia
         subjects affected / exposed
    2 / 705 (0.28%)
    1 / 689 (0.15%)
    0 / 389 (0.00%)
         occurrences all number
    2
    1
    0
    Swelling
         subjects affected / exposed
    50 / 705 (7.09%)
    51 / 689 (7.40%)
    21 / 389 (5.40%)
         occurrences all number
    50
    51
    21
    Thirst
         subjects affected / exposed
    1 / 705 (0.14%)
    0 / 689 (0.00%)
    0 / 389 (0.00%)
         occurrences all number
    1
    0
    0
    Immune system disorders
    Food allergy
         subjects affected / exposed
    2 / 705 (0.28%)
    1 / 689 (0.15%)
    0 / 389 (0.00%)
         occurrences all number
    2
    1
    0
    Hypersensitivity
         subjects affected / exposed
    1 / 705 (0.14%)
    0 / 689 (0.00%)
    0 / 389 (0.00%)
         occurrences all number
    1
    0
    0
    Milk allergy
         subjects affected / exposed
    1 / 705 (0.14%)
    0 / 689 (0.00%)
    0 / 389 (0.00%)
         occurrences all number
    1
    0
    0
    Multiple allergies
         subjects affected / exposed
    1 / 705 (0.14%)
    0 / 689 (0.00%)
    3 / 389 (0.77%)
         occurrences all number
    1
    0
    3
    Seasonal allergy
         subjects affected / exposed
    0 / 705 (0.00%)
    1 / 689 (0.15%)
    1 / 389 (0.26%)
         occurrences all number
    0
    1
    1
    Reproductive system and breast disorders
    Balanitis
         subjects affected / exposed
    1 / 705 (0.14%)
    0 / 689 (0.00%)
    0 / 389 (0.00%)
         occurrences all number
    1
    0
    0
    Posthitis
         subjects affected / exposed
    1 / 705 (0.14%)
    0 / 689 (0.00%)
    0 / 389 (0.00%)
         occurrences all number
    1
    0
    0
    Testicular swelling
         subjects affected / exposed
    1 / 705 (0.14%)
    0 / 689 (0.00%)
    0 / 389 (0.00%)
         occurrences all number
    1
    0
    0
    Vulvovaginal adhesion
         subjects affected / exposed
    0 / 705 (0.00%)
    1 / 689 (0.15%)
    0 / 389 (0.00%)
         occurrences all number
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Adenoidal hypertrophy
         subjects affected / exposed
    0 / 705 (0.00%)
    1 / 689 (0.15%)
    0 / 389 (0.00%)
         occurrences all number
    0
    1
    0
    Asthma
         subjects affected / exposed
    0 / 705 (0.00%)
    1 / 689 (0.15%)
    0 / 389 (0.00%)
         occurrences all number
    0
    1
    0
    Bronchial hyperreactivity
         subjects affected / exposed
    6 / 705 (0.85%)
    2 / 689 (0.29%)
    1 / 389 (0.26%)
         occurrences all number
    6
    2
    1
    Bronchospasm
         subjects affected / exposed
    0 / 705 (0.00%)
    0 / 689 (0.00%)
    2 / 389 (0.51%)
         occurrences all number
    0
    0
    2
    Choking
         subjects affected / exposed
    0 / 705 (0.00%)
    1 / 689 (0.15%)
    0 / 389 (0.00%)
         occurrences all number
    0
    1
    0
    Cough
         subjects affected / exposed
    30 / 705 (4.26%)
    23 / 689 (3.34%)
    17 / 389 (4.37%)
         occurrences all number
    31
    24
    19
    Epistaxis
         subjects affected / exposed
    1 / 705 (0.14%)
    2 / 689 (0.29%)
    0 / 389 (0.00%)
         occurrences all number
    2
    2
    0
    Nasal congestion
         subjects affected / exposed
    11 / 705 (1.56%)
    11 / 689 (1.60%)
    4 / 389 (1.03%)
         occurrences all number
    11
    11
    4
    Oropharyngeal blistering
         subjects affected / exposed
    1 / 705 (0.14%)
    0 / 689 (0.00%)
    0 / 389 (0.00%)
         occurrences all number
    1
    0
    0
    Pharyngeal erythema
         subjects affected / exposed
    0 / 705 (0.00%)
    1 / 689 (0.15%)
    0 / 389 (0.00%)
         occurrences all number
    0
    1
    0
    Respiratory disorder
         subjects affected / exposed
    2 / 705 (0.28%)
    1 / 689 (0.15%)
    1 / 389 (0.26%)
         occurrences all number
    2
    1
    1
    Respiratory tract congestion
         subjects affected / exposed
    0 / 705 (0.00%)
    0 / 689 (0.00%)
    1 / 389 (0.26%)
         occurrences all number
    0
    0
    1
    Rhinitis allergic
         subjects affected / exposed
    1 / 705 (0.14%)
    0 / 689 (0.00%)
    0 / 389 (0.00%)
         occurrences all number
    1
    0
    0
    Rhinorrhoea
         subjects affected / exposed
    29 / 705 (4.11%)
    21 / 689 (3.05%)
    24 / 389 (6.17%)
         occurrences all number
    31
    24
    26
    Sinus disorder
         subjects affected / exposed
    1 / 705 (0.14%)
    0 / 689 (0.00%)
    0 / 389 (0.00%)
         occurrences all number
    1
    0
    0
    Sinus congestion
         subjects affected / exposed
    1 / 705 (0.14%)
    0 / 689 (0.00%)
    0 / 389 (0.00%)
         occurrences all number
    1
    0
    0
    Sneezing
         subjects affected / exposed
    1 / 705 (0.14%)
    0 / 689 (0.00%)
    0 / 389 (0.00%)
         occurrences all number
    1
    0
    0
    Tachypnoea
         subjects affected / exposed
    1 / 705 (0.14%)
    0 / 689 (0.00%)
    0 / 389 (0.00%)
         occurrences all number
    1
    0
    0
    Upper respiratory tract congestion
         subjects affected / exposed
    0 / 705 (0.00%)
    1 / 689 (0.15%)
    0 / 389 (0.00%)
         occurrences all number
    0
    1
    0
    Wheezing
         subjects affected / exposed
    6 / 705 (0.85%)
    4 / 689 (0.58%)
    3 / 389 (0.77%)
         occurrences all number
    6
    4
    3
    Psychiatric disorders
    Breath holding
         subjects affected / exposed
    0 / 705 (0.00%)
    1 / 689 (0.15%)
    0 / 389 (0.00%)
         occurrences all number
    0
    1
    0
    Decreased activity
         subjects affected / exposed
    0 / 705 (0.00%)
    0 / 689 (0.00%)
    1 / 389 (0.26%)
         occurrences all number
    0
    0
    1
    Insomnia
         subjects affected / exposed
    1 / 705 (0.14%)
    2 / 689 (0.29%)
    1 / 389 (0.26%)
         occurrences all number
    1
    2
    1
    Listless
         subjects affected / exposed
    0 / 705 (0.00%)
    1 / 689 (0.15%)
    0 / 389 (0.00%)
         occurrences all number
    0
    1
    0
    Reactive attachment disorder of infancy or early childhood
         subjects affected / exposed
    0 / 705 (0.00%)
    1 / 689 (0.15%)
    0 / 389 (0.00%)
         occurrences all number
    0
    1
    0
    Investigations
    Haematocrit decreased
         subjects affected / exposed
    0 / 705 (0.00%)
    1 / 689 (0.15%)
    0 / 389 (0.00%)
         occurrences all number
    0
    1
    0
    Thyroid function test abnormal
         subjects affected / exposed
    0 / 705 (0.00%)
    1 / 689 (0.15%)
    0 / 389 (0.00%)
         occurrences all number
    0
    1
    0
    Injury, poisoning and procedural complications
    Animal bite
         subjects affected / exposed
    0 / 705 (0.00%)
    0 / 689 (0.00%)
    1 / 389 (0.26%)
         occurrences all number
    0
    0
    1
    Arthropod bite
         subjects affected / exposed
    5 / 705 (0.71%)
    7 / 689 (1.02%)
    1 / 389 (0.26%)
         occurrences all number
    5
    7
    1
    Burns second degree
         subjects affected / exposed
    1 / 705 (0.14%)
    1 / 689 (0.15%)
    0 / 389 (0.00%)
         occurrences all number
    1
    1
    0
    Contusion
         subjects affected / exposed
    2 / 705 (0.28%)
    1 / 689 (0.15%)
    2 / 389 (0.51%)
         occurrences all number
    2
    1
    2
    Ear canal abrasion
         subjects affected / exposed
    1 / 705 (0.14%)
    0 / 689 (0.00%)
    0 / 389 (0.00%)
         occurrences all number
    1
    0
    0
    Excoriation
         subjects affected / exposed
    1 / 705 (0.14%)
    0 / 689 (0.00%)
    0 / 389 (0.00%)
         occurrences all number
    1
    0
    0
    Eye injury
         subjects affected / exposed
    0 / 705 (0.00%)
    1 / 689 (0.15%)
    0 / 389 (0.00%)
         occurrences all number
    0
    1
    0
    Eye penetration
         subjects affected / exposed
    1 / 705 (0.14%)
    0 / 689 (0.00%)
    0 / 389 (0.00%)
         occurrences all number
    1
    0
    0
    Face injury
         subjects affected / exposed
    0 / 705 (0.00%)
    0 / 689 (0.00%)
    1 / 389 (0.26%)
         occurrences all number
    0
    0
    1
    Fall
         subjects affected / exposed
    1 / 705 (0.14%)
    0 / 689 (0.00%)
    0 / 389 (0.00%)
         occurrences all number
    1
    0
    0
    Foreign body trauma
         subjects affected / exposed
    1 / 705 (0.14%)
    0 / 689 (0.00%)
    0 / 389 (0.00%)
         occurrences all number
    1
    0
    0
    Head injury
         subjects affected / exposed
    0 / 705 (0.00%)
    2 / 689 (0.29%)
    1 / 389 (0.26%)
         occurrences all number
    0
    2
    1
    Joint sprain
         subjects affected / exposed
    1 / 705 (0.14%)
    0 / 689 (0.00%)
    0 / 389 (0.00%)
         occurrences all number
    1
    0
    0
    Joint dislocation
         subjects affected / exposed
    1 / 705 (0.14%)
    1 / 689 (0.15%)
    0 / 389 (0.00%)
         occurrences all number
    1
    1
    0
    Limb crushing injury
         subjects affected / exposed
    1 / 705 (0.14%)
    1 / 689 (0.15%)
    0 / 389 (0.00%)
         occurrences all number
    1
    1
    0
    Limb injury
         subjects affected / exposed
    0 / 705 (0.00%)
    2 / 689 (0.29%)
    0 / 389 (0.00%)
         occurrences all number
    0
    2
    0
    Road traffic accident
         subjects affected / exposed
    1 / 705 (0.14%)
    0 / 689 (0.00%)
    0 / 389 (0.00%)
         occurrences all number
    1
    0
    0
    Skin laceration
         subjects affected / exposed
    0 / 705 (0.00%)
    2 / 689 (0.29%)
    1 / 389 (0.26%)
         occurrences all number
    0
    2
    1
    Sunburn
         subjects affected / exposed
    0 / 705 (0.00%)
    1 / 689 (0.15%)
    0 / 389 (0.00%)
         occurrences all number
    0
    1
    0
    Thermal burn
         subjects affected / exposed
    1 / 705 (0.14%)
    0 / 689 (0.00%)
    0 / 389 (0.00%)
         occurrences all number
    1
    0
    0
    Tibia fracture
         subjects affected / exposed
    1 / 705 (0.14%)
    0 / 689 (0.00%)
    0 / 389 (0.00%)
         occurrences all number
    1
    0
    0
    Traumatic brain injury
         subjects affected / exposed
    1 / 705 (0.14%)
    1 / 689 (0.15%)
    0 / 389 (0.00%)
         occurrences all number
    1
    1
    0
    Upper limb fracture
         subjects affected / exposed
    0 / 705 (0.00%)
    1 / 689 (0.15%)
    0 / 389 (0.00%)
         occurrences all number
    0
    1
    0
    Congenital, familial and genetic disorders
    Talipes
         subjects affected / exposed
    0 / 705 (0.00%)
    1 / 689 (0.15%)
    1 / 389 (0.26%)
         occurrences all number
    0
    1
    1
    Tibial torsion
         subjects affected / exposed
    0 / 705 (0.00%)
    0 / 689 (0.00%)
    1 / 389 (0.26%)
         occurrences all number
    0
    0
    1
    Nervous system disorders
    Crying
         subjects affected / exposed
    1 / 705 (0.14%)
    1 / 689 (0.15%)
    0 / 389 (0.00%)
         occurrences all number
    1
    1
    0
    Encephalopathy
         subjects affected / exposed
    0 / 705 (0.00%)
    1 / 689 (0.15%)
    0 / 389 (0.00%)
         occurrences all number
    0
    1
    0
    Febrile convulsion
         subjects affected / exposed
    2 / 705 (0.28%)
    0 / 689 (0.00%)
    1 / 389 (0.26%)
         occurrences all number
    2
    0
    1
    Hypersomnia
         subjects affected / exposed
    0 / 705 (0.00%)
    0 / 689 (0.00%)
    1 / 389 (0.26%)
         occurrences all number
    0
    0
    1
    Lethargy
         subjects affected / exposed
    1 / 705 (0.14%)
    1 / 689 (0.15%)
    0 / 389 (0.00%)
         occurrences all number
    1
    1
    0
    Poor quality sleep
         subjects affected / exposed
    0 / 705 (0.00%)
    1 / 689 (0.15%)
    1 / 389 (0.26%)
         occurrences all number
    0
    1
    1
    Somnolence
         subjects affected / exposed
    2 / 705 (0.28%)
    2 / 689 (0.29%)
    1 / 389 (0.26%)
         occurrences all number
    2
    2
    1
    Tremor
         subjects affected / exposed
    1 / 705 (0.14%)
    0 / 689 (0.00%)
    0 / 389 (0.00%)
         occurrences all number
    1
    0
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    3 / 705 (0.43%)
    1 / 689 (0.15%)
    1 / 389 (0.26%)
         occurrences all number
    3
    1
    1
    Iron deficiency anaemia
         subjects affected / exposed
    0 / 705 (0.00%)
    2 / 689 (0.29%)
    0 / 389 (0.00%)
         occurrences all number
    0
    2
    0
    Lymphadenopathy
         subjects affected / exposed
    2 / 705 (0.28%)
    3 / 689 (0.44%)
    0 / 389 (0.00%)
         occurrences all number
    2
    3
    0
    Neutropenia
         subjects affected / exposed
    0 / 705 (0.00%)
    1 / 689 (0.15%)
    0 / 389 (0.00%)
         occurrences all number
    0
    1
    0
    Ear and labyrinth disorders
    Cerumen impaction
         subjects affected / exposed
    0 / 705 (0.00%)
    0 / 689 (0.00%)
    1 / 389 (0.26%)
         occurrences all number
    0
    0
    1
    Ear pain
         subjects affected / exposed
    3 / 705 (0.43%)
    1 / 689 (0.15%)
    4 / 389 (1.03%)
         occurrences all number
    3
    1
    4
    Ear haemorrhage
         subjects affected / exposed
    0 / 705 (0.00%)
    0 / 689 (0.00%)
    1 / 389 (0.26%)
         occurrences all number
    0
    0
    1
    Eustachian tube dysfunction
         subjects affected / exposed
    2 / 705 (0.28%)
    1 / 689 (0.15%)
    0 / 389 (0.00%)
         occurrences all number
    2
    1
    0
    Middle ear effusion
         subjects affected / exposed
    0 / 705 (0.00%)
    0 / 689 (0.00%)
    1 / 389 (0.26%)
         occurrences all number
    0
    0
    1
    Otorrhoea
         subjects affected / exposed
    1 / 705 (0.14%)
    0 / 689 (0.00%)
    1 / 389 (0.26%)
         occurrences all number
    1
    0
    1
    Tympanic membrane perforation
         subjects affected / exposed
    0 / 705 (0.00%)
    1 / 689 (0.15%)
    0 / 389 (0.00%)
         occurrences all number
    0
    1
    0
    Eye disorders
    Chalazion
         subjects affected / exposed
    0 / 705 (0.00%)
    0 / 689 (0.00%)
    1 / 389 (0.26%)
         occurrences all number
    0
    0
    1
    Conjunctivitis
         subjects affected / exposed
    17 / 705 (2.41%)
    20 / 689 (2.90%)
    7 / 389 (1.80%)
         occurrences all number
    20
    20
    7
    Eye discharge
         subjects affected / exposed
    0 / 705 (0.00%)
    1 / 689 (0.15%)
    0 / 389 (0.00%)
         occurrences all number
    0
    1
    0
    Eye disorder
         subjects affected / exposed
    0 / 705 (0.00%)
    1 / 689 (0.15%)
    0 / 389 (0.00%)
         occurrences all number
    0
    2
    0
    Eye irritation
         subjects affected / exposed
    0 / 705 (0.00%)
    1 / 689 (0.15%)
    0 / 389 (0.00%)
         occurrences all number
    0
    1
    0
    Eye swelling
         subjects affected / exposed
    2 / 705 (0.28%)
    1 / 689 (0.15%)
    0 / 389 (0.00%)
         occurrences all number
    2
    1
    0
    Lacrimation increased
         subjects affected / exposed
    0 / 705 (0.00%)
    3 / 689 (0.44%)
    1 / 389 (0.26%)
         occurrences all number
    0
    3
    1
    Ocular hyperaemia
         subjects affected / exposed
    1 / 705 (0.14%)
    0 / 689 (0.00%)
    0 / 389 (0.00%)
         occurrences all number
    1
    0
    0
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    0 / 705 (0.00%)
    0 / 689 (0.00%)
    1 / 389 (0.26%)
         occurrences all number
    0
    0
    1
    Abdominal hernia
         subjects affected / exposed
    0 / 705 (0.00%)
    1 / 689 (0.15%)
    0 / 389 (0.00%)
         occurrences all number
    0
    1
    0
    Abdominal pain upper
         subjects affected / exposed
    0 / 705 (0.00%)
    1 / 689 (0.15%)
    0 / 389 (0.00%)
         occurrences all number
    0
    1
    0
    Abdominal pain
         subjects affected / exposed
    0 / 705 (0.00%)
    1 / 689 (0.15%)
    0 / 389 (0.00%)
         occurrences all number
    0
    1
    0
    Anal fissure
         subjects affected / exposed
    0 / 705 (0.00%)
    1 / 689 (0.15%)
    0 / 389 (0.00%)
         occurrences all number
    0
    1
    0
    Aphthous stomatitis
         subjects affected / exposed
    1 / 705 (0.14%)
    0 / 689 (0.00%)
    0 / 389 (0.00%)
         occurrences all number
    1
    0
    0
    Constipation
         subjects affected / exposed
    5 / 705 (0.71%)
    5 / 689 (0.73%)
    3 / 389 (0.77%)
         occurrences all number
    5
    6
    3
    Diarrhoea
         subjects affected / exposed
    37 / 705 (5.25%)
    46 / 689 (6.68%)
    29 / 389 (7.46%)
         occurrences all number
    45
    55
    29
    Faecaloma
         subjects affected / exposed
    0 / 705 (0.00%)
    1 / 689 (0.15%)
    0 / 389 (0.00%)
         occurrences all number
    0
    1
    0
    Flatulence
         subjects affected / exposed
    2 / 705 (0.28%)
    4 / 689 (0.58%)
    1 / 389 (0.26%)
         occurrences all number
    2
    4
    1
    Gastrointestinal pain
         subjects affected / exposed
    0 / 705 (0.00%)
    1 / 689 (0.15%)
    0 / 389 (0.00%)
         occurrences all number
    0
    1
    0
    Haematemesis
         subjects affected / exposed
    1 / 705 (0.14%)
    0 / 689 (0.00%)
    0 / 389 (0.00%)
         occurrences all number
    1
    0
    0
    Gingival pain
         subjects affected / exposed
    1 / 705 (0.14%)
    0 / 689 (0.00%)
    0 / 389 (0.00%)
         occurrences all number
    1
    0
    0
    Gingival swelling
         subjects affected / exposed
    1 / 705 (0.14%)
    0 / 689 (0.00%)
    0 / 389 (0.00%)
         occurrences all number
    1
    0
    0
    Haematochezia
         subjects affected / exposed
    0 / 705 (0.00%)
    0 / 689 (0.00%)
    1 / 389 (0.26%)
         occurrences all number
    0
    0
    1
    Nausea
         subjects affected / exposed
    0 / 705 (0.00%)
    1 / 689 (0.15%)
    0 / 389 (0.00%)
         occurrences all number
    0
    1
    0
    Stomatitis
         subjects affected / exposed
    1 / 705 (0.14%)
    3 / 689 (0.44%)
    0 / 389 (0.00%)
         occurrences all number
    1
    3
    0
    Teething
         subjects affected / exposed
    42 / 705 (5.96%)
    53 / 689 (7.69%)
    28 / 389 (7.20%)
         occurrences all number
    54
    69
    37
    Tooth discolouration
         subjects affected / exposed
    0 / 705 (0.00%)
    1 / 689 (0.15%)
    0 / 389 (0.00%)
         occurrences all number
    0
    1
    0
    Toothache
         subjects affected / exposed
    1 / 705 (0.14%)
    0 / 689 (0.00%)
    0 / 389 (0.00%)
         occurrences all number
    1
    0
    0
    Vomiting
         subjects affected / exposed
    35 / 705 (4.96%)
    25 / 689 (3.63%)
    15 / 389 (3.86%)
         occurrences all number
    42
    30
    15
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    0 / 705 (0.00%)
    0 / 689 (0.00%)
    1 / 389 (0.26%)
         occurrences all number
    0
    0
    1
    Dermatitis
         subjects affected / exposed
    0 / 705 (0.00%)
    1 / 689 (0.15%)
    0 / 389 (0.00%)
         occurrences all number
    0
    1
    0
    Dermatitis diaper
         subjects affected / exposed
    1 / 705 (0.14%)
    1 / 689 (0.15%)
    0 / 389 (0.00%)
         occurrences all number
    1
    1
    0
    Eczema
         subjects affected / exposed
    1 / 705 (0.14%)
    2 / 689 (0.29%)
    1 / 389 (0.26%)
         occurrences all number
    1
    2
    1
    Erythema
         subjects affected / exposed
    114 / 705 (16.17%)
    123 / 689 (17.85%)
    55 / 389 (14.14%)
         occurrences all number
    114
    126
    55
    Ingrowing nail
         subjects affected / exposed
    0 / 705 (0.00%)
    1 / 689 (0.15%)
    0 / 389 (0.00%)
         occurrences all number
    0
    1
    0
    Keratosis pilaris
         subjects affected / exposed
    1 / 705 (0.14%)
    0 / 689 (0.00%)
    0 / 389 (0.00%)
         occurrences all number
    1
    0
    0
    Petechiae
         subjects affected / exposed
    1 / 705 (0.14%)
    0 / 689 (0.00%)
    0 / 389 (0.00%)
         occurrences all number
    1
    0
    0
    Skin discolouration
         subjects affected / exposed
    0 / 705 (0.00%)
    1 / 689 (0.15%)
    1 / 389 (0.26%)
         occurrences all number
    0
    1
    1
    Skin irritation
         subjects affected / exposed
    1 / 705 (0.14%)
    0 / 689 (0.00%)
    1 / 389 (0.26%)
         occurrences all number
    1
    0
    1
    Skin reaction
         subjects affected / exposed
    1 / 705 (0.14%)
    0 / 689 (0.00%)
    1 / 389 (0.26%)
         occurrences all number
    1
    0
    1
    Skin lesion
         subjects affected / exposed
    1 / 705 (0.14%)
    0 / 689 (0.00%)
    0 / 389 (0.00%)
         occurrences all number
    1
    0
    0
    Swelling face
         subjects affected / exposed
    1 / 705 (0.14%)
    0 / 689 (0.00%)
    0 / 389 (0.00%)
         occurrences all number
    1
    0
    0
    Urticaria
         subjects affected / exposed
    1 / 705 (0.14%)
    0 / 689 (0.00%)
    0 / 389 (0.00%)
         occurrences all number
    1
    0
    0
    Musculoskeletal and connective tissue disorders
    Bone swelling
         subjects affected / exposed
    1 / 705 (0.14%)
    0 / 689 (0.00%)
    0 / 389 (0.00%)
         occurrences all number
    1
    0
    0
    Limb discomfort
         subjects affected / exposed
    1 / 705 (0.14%)
    0 / 689 (0.00%)
    0 / 389 (0.00%)
         occurrences all number
    1
    0
    0
    Pain in extremity
         subjects affected / exposed
    3 / 705 (0.43%)
    1 / 689 (0.15%)
    1 / 389 (0.26%)
         occurrences all number
    3
    1
    1
    Infections and infestations
    Acute sinusitis
         subjects affected / exposed
    0 / 705 (0.00%)
    1 / 689 (0.15%)
    0 / 389 (0.00%)
         occurrences all number
    0
    1
    0
    Adenovirus infection
         subjects affected / exposed
    1 / 705 (0.14%)
    0 / 689 (0.00%)
    0 / 389 (0.00%)
         occurrences all number
    1
    0
    0
    African trypanosomiasis
         subjects affected / exposed
    1 / 705 (0.14%)
    0 / 689 (0.00%)
    0 / 389 (0.00%)
         occurrences all number
    1
    0
    0
    Bronchitis
         subjects affected / exposed
    8 / 705 (1.13%)
    7 / 689 (1.02%)
    1 / 389 (0.26%)
         occurrences all number
    8
    7
    1
    Bronchiolitis
         subjects affected / exposed
    2 / 705 (0.28%)
    2 / 689 (0.29%)
    0 / 389 (0.00%)
         occurrences all number
    2
    2
    0
    Candidiasis
         subjects affected / exposed
    2 / 705 (0.28%)
    2 / 689 (0.29%)
    2 / 389 (0.51%)
         occurrences all number
    2
    2
    2
    Cellulitis
         subjects affected / exposed
    0 / 705 (0.00%)
    1 / 689 (0.15%)
    2 / 389 (0.51%)
         occurrences all number
    0
    1
    2
    Conjunctivitis bacterial
         subjects affected / exposed
    0 / 705 (0.00%)
    0 / 689 (0.00%)
    1 / 389 (0.26%)
         occurrences all number
    0
    0
    1
    Conjunctivitis viral
         subjects affected / exposed
    0 / 705 (0.00%)
    0 / 689 (0.00%)
    1 / 389 (0.26%)
         occurrences all number
    0
    0
    1
    Conjunctivitis infective
         subjects affected / exposed
    0 / 705 (0.00%)
    2 / 689 (0.29%)
    0 / 389 (0.00%)
         occurrences all number
    0
    2
    0
    Coxsackie viral infection
         subjects affected / exposed
    1 / 705 (0.14%)
    0 / 689 (0.00%)
    0 / 389 (0.00%)
         occurrences all number
    1
    0
    0
    Croup infectious
         subjects affected / exposed
    1 / 705 (0.14%)
    1 / 689 (0.15%)
    2 / 389 (0.51%)
         occurrences all number
    1
    1
    2
    Diarrhoea infectious
         subjects affected / exposed
    0 / 705 (0.00%)
    1 / 689 (0.15%)
    0 / 389 (0.00%)
         occurrences all number
    0
    1
    0
    Ear infection
         subjects affected / exposed
    6 / 705 (0.85%)
    1 / 689 (0.15%)
    2 / 389 (0.51%)
         occurrences all number
    6
    1
    2
    Erysipelas
         subjects affected / exposed
    0 / 705 (0.00%)
    1 / 689 (0.15%)
    0 / 389 (0.00%)
         occurrences all number
    0
    1
    0
    Eye infection viral
         subjects affected / exposed
    0 / 705 (0.00%)
    1 / 689 (0.15%)
    0 / 389 (0.00%)
         occurrences all number
    0
    1
    0
    Folliculitis
         subjects affected / exposed
    1 / 705 (0.14%)
    0 / 689 (0.00%)
    0 / 389 (0.00%)
         occurrences all number
    1
    0
    0
    Fungal infection
         subjects affected / exposed
    0 / 705 (0.00%)
    0 / 689 (0.00%)
    1 / 389 (0.26%)
         occurrences all number
    0
    0
    1
    Fungal skin infection
         subjects affected / exposed
    0 / 705 (0.00%)
    0 / 689 (0.00%)
    1 / 389 (0.26%)
         occurrences all number
    0
    0
    1
    Furuncle
         subjects affected / exposed
    1 / 705 (0.14%)
    2 / 689 (0.29%)
    0 / 389 (0.00%)
         occurrences all number
    1
    2
    0
    Gastroenteritis
         subjects affected / exposed
    10 / 705 (1.42%)
    12 / 689 (1.74%)
    2 / 389 (0.51%)
         occurrences all number
    11
    12
    2
    Gastroenteritis viral
         subjects affected / exposed
    4 / 705 (0.57%)
    0 / 689 (0.00%)
    4 / 389 (1.03%)
         occurrences all number
    4
    0
    4
    Gingival infection
         subjects affected / exposed
    0 / 705 (0.00%)
    0 / 689 (0.00%)
    1 / 389 (0.26%)
         occurrences all number
    0
    0
    1
    Hand-foot-and-mouth disease
         subjects affected / exposed
    1 / 705 (0.14%)
    2 / 689 (0.29%)
    0 / 389 (0.00%)
         occurrences all number
    1
    2
    0
    Herpangina
         subjects affected / exposed
    2 / 705 (0.28%)
    2 / 689 (0.29%)
    1 / 389 (0.26%)
         occurrences all number
    2
    2
    1
    Hordeolum
         subjects affected / exposed
    1 / 705 (0.14%)
    0 / 689 (0.00%)
    0 / 389 (0.00%)
         occurrences all number
    1
    0
    0
    Impetigo
         subjects affected / exposed
    1 / 705 (0.14%)
    0 / 689 (0.00%)
    0 / 389 (0.00%)
         occurrences all number
    1
    0
    0
    Influenza
         subjects affected / exposed
    1 / 705 (0.14%)
    2 / 689 (0.29%)
    1 / 389 (0.26%)
         occurrences all number
    1
    2
    1
    Infected bites
         subjects affected / exposed
    1 / 705 (0.14%)
    0 / 689 (0.00%)
    0 / 389 (0.00%)
         occurrences all number
    1
    0
    0
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 705 (0.14%)
    0 / 689 (0.00%)
    0 / 389 (0.00%)
         occurrences all number
    1
    0
    0
    Nasopharyngitis
         subjects affected / exposed
    9 / 705 (1.28%)
    10 / 689 (1.45%)
    9 / 389 (2.31%)
         occurrences all number
    9
    11
    10
    Neonatal candida infection
         subjects affected / exposed
    1 / 705 (0.14%)
    0 / 689 (0.00%)
    0 / 389 (0.00%)
         occurrences all number
    1
    0
    0
    Oral candidiasis
         subjects affected / exposed
    0 / 705 (0.00%)
    2 / 689 (0.29%)
    2 / 389 (0.51%)
         occurrences all number
    0
    2
    2
    Oral herpes
         subjects affected / exposed
    0 / 705 (0.00%)
    1 / 689 (0.15%)
    1 / 389 (0.26%)
         occurrences all number
    0
    1
    1
    Otitis media
         subjects affected / exposed
    71 / 705 (10.07%)
    62 / 689 (9.00%)
    34 / 389 (8.74%)
         occurrences all number
    77
    67
    36
    Otitis externa
         subjects affected / exposed
    0 / 705 (0.00%)
    1 / 689 (0.15%)
    1 / 389 (0.26%)
         occurrences all number
    0
    1
    1
    Otitis media acute
         subjects affected / exposed
    13 / 705 (1.84%)
    11 / 689 (1.60%)
    4 / 389 (1.03%)
         occurrences all number
    14
    12
    4
    Paronychia
         subjects affected / exposed
    0 / 705 (0.00%)
    1 / 689 (0.15%)
    1 / 389 (0.26%)
         occurrences all number
    0
    1
    1
    Pharyngitis
         subjects affected / exposed
    20 / 705 (2.84%)
    16 / 689 (2.32%)
    7 / 389 (1.80%)
         occurrences all number
    20
    17
    7
    Pharyngitis streptococcal
         subjects affected / exposed
    0 / 705 (0.00%)
    4 / 689 (0.58%)
    1 / 389 (0.26%)
         occurrences all number
    0
    4
    1
    Pharyngotonsillitis
         subjects affected / exposed
    1 / 705 (0.14%)
    1 / 689 (0.15%)
    0 / 389 (0.00%)
         occurrences all number
    1
    1
    0
    Pneumonia
         subjects affected / exposed
    5 / 705 (0.71%)
    3 / 689 (0.44%)
    1 / 389 (0.26%)
         occurrences all number
    5
    3
    1
    Pneumonia viral
         subjects affected / exposed
    0 / 705 (0.00%)
    0 / 689 (0.00%)
    1 / 389 (0.26%)
         occurrences all number
    0
    0
    1
    Rhinitis
         subjects affected / exposed
    10 / 705 (1.42%)
    6 / 689 (0.87%)
    5 / 389 (1.29%)
         occurrences all number
    10
    6
    5
    Roseola
         subjects affected / exposed
    0 / 705 (0.00%)
    1 / 689 (0.15%)
    1 / 389 (0.26%)
         occurrences all number
    0
    1
    1
    Sinusitis
         subjects affected / exposed
    8 / 705 (1.13%)
    8 / 689 (1.16%)
    5 / 389 (1.29%)
         occurrences all number
    8
    8
    5
    Streptococcal infection
         subjects affected / exposed
    0 / 705 (0.00%)
    2 / 689 (0.29%)
    1 / 389 (0.26%)
         occurrences all number
    0
    2
    1
    Subcutaneous abscess
         subjects affected / exposed
    0 / 705 (0.00%)
    1 / 689 (0.15%)
    0 / 389 (0.00%)
         occurrences all number
    0
    1
    0
    Tonsillitis
         subjects affected / exposed
    0 / 705 (0.00%)
    1 / 689 (0.15%)
    1 / 389 (0.26%)
         occurrences all number
    0
    1
    1
    Tinea pedis
         subjects affected / exposed
    0 / 705 (0.00%)
    1 / 689 (0.15%)
    0 / 389 (0.00%)
         occurrences all number
    0
    1
    0
    Tinea infection
         subjects affected / exposed
    2 / 705 (0.28%)
    0 / 689 (0.00%)
    0 / 389 (0.00%)
         occurrences all number
    2
    0
    0
    Urethritis
         subjects affected / exposed
    1 / 705 (0.14%)
    0 / 689 (0.00%)
    0 / 389 (0.00%)
         occurrences all number
    1
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    49 / 705 (6.95%)
    57 / 689 (8.27%)
    42 / 389 (10.80%)
         occurrences all number
    52
    61
    43
    Urinary tract infection
         subjects affected / exposed
    0 / 705 (0.00%)
    1 / 689 (0.15%)
    0 / 389 (0.00%)
         occurrences all number
    0
    1
    0
    Viraemia
         subjects affected / exposed
    1 / 705 (0.14%)
    0 / 689 (0.00%)
    0 / 389 (0.00%)
         occurrences all number
    1
    0
    0
    Viral infection
         subjects affected / exposed
    22 / 705 (3.12%)
    20 / 689 (2.90%)
    12 / 389 (3.08%)
         occurrences all number
    22
    20
    12
    Viral pharyngitis
         subjects affected / exposed
    3 / 705 (0.43%)
    3 / 689 (0.44%)
    1 / 389 (0.26%)
         occurrences all number
    3
    3
    1
    Viral tonsillitis
         subjects affected / exposed
    1 / 705 (0.14%)
    0 / 689 (0.00%)
    0 / 389 (0.00%)
         occurrences all number
    1
    0
    0
    Viral rash
         subjects affected / exposed
    0 / 705 (0.00%)
    0 / 689 (0.00%)
    2 / 389 (0.51%)
         occurrences all number
    0
    0
    2
    Viral upper respiratory tract infection
         subjects affected / exposed
    2 / 705 (0.28%)
    3 / 689 (0.44%)
    2 / 389 (0.51%)
         occurrences all number
    2
    4
    2
    Wound infection
         subjects affected / exposed
    0 / 705 (0.00%)
    1 / 689 (0.15%)
    0 / 389 (0.00%)
         occurrences all number
    0
    1
    0
    Metabolism and nutrition disorders
    Anorexia
         subjects affected / exposed
    1 / 705 (0.14%)
    2 / 689 (0.29%)
    1 / 389 (0.26%)
         occurrences all number
    1
    2
    1
    Decreased appetite
         subjects affected / exposed
    3 / 705 (0.43%)
    4 / 689 (0.58%)
    3 / 389 (0.77%)
         occurrences all number
    3
    4
    3
    Hyperglycaemia
         subjects affected / exposed
    1 / 705 (0.14%)
    0 / 689 (0.00%)
    0 / 389 (0.00%)
         occurrences all number
    1
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    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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