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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
    		 v3(current)
    This version publication date
    19 Dec 2020
    First version publication date
    06 Jan 2018
    Other versions
    		 v1 , v2
    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
    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
    		 Carer, Assessor, Subject, Monitor, Data analyst
    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).
    Adverse event reporting additional description
    Events collected by systematic assessment are reported for subjects with a symptom diary card available. Events collected by non-systematic method are reported for the Total Vaccinated Cohort. For the systematically assessed non-serious AEs, the occurrence of reported AEs was not available and encoded as equal to the number of subjects affected.
    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
    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 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.

    Serious adverse events
    		 Refrigerator-stored Priorix-Tetra Group Proquad Group Freezer-stored Priorix-Tetra Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    14 / 705 (1.99%)
    7 / 389 (1.80%)
    20 / 689 (2.90%)
         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%)
    0 / 389 (0.00%)
    1 / 689 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         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 / 389 (0.00%)
    0 / 689 (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 / 389 (0.00%)
    0 / 689 (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%)
    0 / 389 (0.00%)
    1 / 689 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Foreign body trauma
         subjects affected / exposed
    0 / 705 (0.00%)
    1 / 389 (0.26%)
    0 / 689 (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
    Thermal burn
         subjects affected / exposed
    0 / 705 (0.00%)
    0 / 389 (0.00%)
    1 / 689 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Febrile convulsion
         subjects affected / exposed
    0 / 705 (0.00%)
    0 / 389 (0.00%)
    2 / 689 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Convulsion
         subjects affected / exposed
    1 / 705 (0.14%)
    0 / 389 (0.00%)
    0 / 689 (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%)
    0 / 389 (0.00%)
    1 / 689 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         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%)
    0 / 389 (0.00%)
    1 / 689 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Dysphagia
         subjects affected / exposed
    1 / 705 (0.14%)
    0 / 389 (0.00%)
    0 / 689 (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 / 389 (0.00%)
    0 / 689 (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%)
    0 / 389 (0.00%)
    1 / 689 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         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%)
    0 / 389 (0.00%)
    1 / 689 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Atelectasis
         subjects affected / exposed
    1 / 705 (0.14%)
    0 / 389 (0.00%)
    0 / 689 (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%)
    0 / 389 (0.00%)
    1 / 689 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchial hyperreactivity
         subjects affected / exposed
    0 / 705 (0.00%)
    0 / 389 (0.00%)
    2 / 689 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    0 / 705 (0.00%)
    0 / 389 (0.00%)
    1 / 689 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory distress
         subjects affected / exposed
    0 / 705 (0.00%)
    0 / 389 (0.00%)
    1 / 689 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Autism spectrum disorder
         subjects affected / exposed
    0 / 705 (0.00%)
    0 / 389 (0.00%)
    1 / 689 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Abscess
         subjects affected / exposed
    0 / 705 (0.00%)
    0 / 389 (0.00%)
    1 / 689 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Acute sinusitis
         subjects affected / exposed
    0 / 705 (0.00%)
    1 / 389 (0.26%)
    0 / 689 (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
    Bronchiolitis
         subjects affected / exposed
    0 / 705 (0.00%)
    1 / 389 (0.26%)
    0 / 689 (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
    Cellulitis
         subjects affected / exposed
    2 / 705 (0.28%)
    0 / 389 (0.00%)
    0 / 689 (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%)
    0 / 389 (0.00%)
    1 / 689 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ear infection
         subjects affected / exposed
    1 / 705 (0.14%)
    0 / 389 (0.00%)
    0 / 689 (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%)
    0 / 389 (0.00%)
    2 / 689 (0.29%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis rotavirus
         subjects affected / exposed
    0 / 705 (0.00%)
    1 / 389 (0.26%)
    0 / 689 (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
    Groin abscess
         subjects affected / exposed
    0 / 705 (0.00%)
    0 / 389 (0.00%)
    2 / 689 (0.29%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Otitis media
         subjects affected / exposed
    1 / 705 (0.14%)
    0 / 389 (0.00%)
    0 / 689 (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%)
    1 / 389 (0.26%)
    0 / 689 (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
    Perirectal abscess
         subjects affected / exposed
    0 / 705 (0.00%)
    1 / 389 (0.26%)
    0 / 689 (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
    Pneumonia
         subjects affected / exposed
    0 / 705 (0.00%)
    2 / 389 (0.51%)
    0 / 689 (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
    Pneumonia viral
         subjects affected / exposed
    0 / 705 (0.00%)
    0 / 389 (0.00%)
    1 / 689 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory syncytial virus bronchiolitis
         subjects affected / exposed
    1 / 705 (0.14%)
    0 / 389 (0.00%)
    0 / 689 (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 / 389 (0.00%)
    0 / 689 (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%)
    0 / 389 (0.00%)
    1 / 689 (0.15%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Subcutaneous abscess
         subjects affected / exposed
    1 / 705 (0.14%)
    0 / 389 (0.00%)
    0 / 689 (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%)
    0 / 389 (0.00%)
    1 / 689 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    0 / 705 (0.00%)
    0 / 389 (0.00%)
    1 / 689 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hypoglycaemia
         subjects affected / exposed
    0 / 705 (0.00%)
    0 / 389 (0.00%)
    1 / 689 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    0 / 705 (0.00%)
    0 / 389 (0.00%)
    1 / 689 (0.15%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Type 1 diabetes mellitus
         subjects affected / exposed
    0 / 705 (0.00%)
    0 / 389 (0.00%)
    1 / 689 (0.15%)
         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
    		 Refrigerator-stored Priorix-Tetra Group Proquad Group Freezer-stored Priorix-Tetra Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    547 / 705 (77.59%)
    297 / 389 (76.35%)
    541 / 689 (78.52%)
    General disorders and administration site conditions
    Pain
         subjects affected / exposed [1]
    136 / 673 (20.21%)
    65 / 378 (17.20%)
    114 / 666 (17.12%)
         occurrences all number
    136
    65
    114
    Redness
         subjects affected / exposed [2]
    111 / 673 (16.49%)
    54 / 378 (14.29%)
    120 / 666 (18.02%)
         occurrences all number
    111
    54
    120
    Swelling
         subjects affected / exposed [3]
    50 / 673 (7.43%)
    21 / 378 (5.56%)
    49 / 666 (7.36%)
         occurrences all number
    50
    21
    49
    Fever
         subjects affected / exposed [4]
    312 / 676 (46.15%)
    163 / 379 (43.01%)
    302 / 668 (45.21%)
         occurrences all number
    312
    163
    302
    Rash
         subjects affected / exposed [5]
    221 / 676 (32.69%)
    128 / 379 (33.77%)
    219 / 668 (32.78%)
         occurrences all number
    221
    128
    219
    Irritability
    alternative assessment type: Non-systematic
         subjects affected / exposed
    25 / 705 (3.55%)
    20 / 389 (5.14%)
    35 / 689 (5.08%)
         occurrences all number
    30
    22
    39
    Gastrointestinal disorders
    Teething
    alternative assessment type: Non-systematic
         subjects affected / exposed
    42 / 705 (5.96%)
    28 / 389 (7.20%)
    53 / 689 (7.69%)
         occurrences all number
    54
    37
    69
    Diarrhoea
    alternative assessment type: Non-systematic
         subjects affected / exposed
    37 / 705 (5.25%)
    29 / 389 (7.46%)
    46 / 689 (6.68%)
         occurrences all number
    45
    29
    55
    Respiratory, thoracic and mediastinal disorders
    Rhinorrhoea
    alternative assessment type: Non-systematic
         subjects affected / exposed
    29 / 705 (4.11%)
    24 / 389 (6.17%)
    21 / 689 (3.05%)
         occurrences all number
    31
    26
    24
    Infections and infestations
    Otitis media
    alternative assessment type: Non-systematic
         subjects affected / exposed
    71 / 705 (10.07%)
    34 / 389 (8.74%)
    62 / 689 (9.00%)
         occurrences all number
    77
    36
    67
    Upper respiratory tract infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    49 / 705 (6.95%)
    42 / 389 (10.80%)
    58 / 689 (8.42%)
         occurrences all number
    52
    43
    61
    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 the Total vaccinated cohort, only on subjects with their symptom dairy cards completed.
    [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 the Total vaccinated cohort, only on subjects with their symptom dairy cards completed.
    [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 the Total vaccinated cohort, only on subjects with their symptom dairy cards completed.
    [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 the Total vaccinated cohort, only on subjects with their symptom dairy cards completed.
    [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 the Total vaccinated cohort, only on subjects with their symptom dairy cards completed.

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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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