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    Clinical Trial Results:
    A phase II, randomized, observer blind, controlled, multicenter study to assess immunogenicity and antibody persistence following vaccination with GSK's candidate combined measles, mumps, and rubella vaccine (MMR) versus M-M-R® II as a first dose, both administered subcutaneously at 12-15 months of age, concomitantly with hepatitis A vaccine (HAV), varicella vaccine (VV) and pneumococcal conjugate vaccine (PCV) but at separate sites.

    Summary
    EudraCT number
    		 2011-005860-31
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    18 Jun 2012

    Results information
    Results version number
    		 v2(current)
    This version publication date
    18 Mar 2018
    First version publication date
    31 Jul 2015
    Other versions
    		 v1
    Version creation reason

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    111870
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00861744
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline Biologicals
    Sponsor organisation address
    Rue de l’Institut 89, Rixensart, Belgium, B-1330
    Public contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, (44)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
    14 Jun 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    21 Jul 2010
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Jun 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess GSK’s candidate MMR vaccine formulated with a range of mumps virus potencies, co-administered with HAV, VV and PCV in contrast to MMR-II co-administered with HAV, VV and PCV with respect to the seroresponse rate for antibodies to measles virus, mumps virus and rubella virus at Day 42.
    Protection of trial subjects
    Vaccines were administered by qualified and trained personnel. Vaccines were administered only to eligible subjects that had no contraindications to any components of the vaccines.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 Jun 2009
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Efficacy
    Long term follow-up duration
    		 23 Months
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 1259
    Worldwide total number of subjects
    1259
    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)
    1259
    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
    		 The study was divided in 3 phases: the active phase (up to Day 42), the extended safety follow-up (ESFU) phase (up to Day 180) and the antibody persistence phase (up to Day 730).

    Pre-assignment
    Screening details
    		 The number of subjects enrolled was 1259. 39 subjects were enrolled in the study but did not receive a subject number and were never vaccinated.

    Pre-assignment period milestones
    Number of subjects started
    		 1259
    Number of subjects completed
    		 1220

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Not allocated to a study group: 35
    Reason: Number of subjects
    		 No vaccine received: 4
    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, Carer, Assessor
    Blinding implementation details
    The study was conducted in an observer blind manner in which the subject and the study personnel involved in the clinical evaluation of the subjects were blinded while other study personnel (investigator) were aware of the treatment allocation.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Priorix 1 Group
    Arm description
    		 Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Priorix
    Investigational medicinal product code
    Other name
    MMR
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injection, one dose, in the right upper arm.

    Investigational medicinal product name
    Varivax
    Investigational medicinal product code
    Other name
    VV
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injection, one dose, in the left upper arm.

    Investigational medicinal product name
    Havrix
    Investigational medicinal product code
    Other name
    HAV
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection, one dose, in the left thigh.

    Investigational medicinal product name
    Prevnar
    Investigational medicinal product code
    Other name
    PCV
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection, one dose, in the right thigh.

    Arm title
    		 Priorix 2 Group
    Arm description
    		 Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Priorix
    Investigational medicinal product code
    Other name
    MMR
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injection, one dose, in the right upper arm.

    Investigational medicinal product name
    Varivax
    Investigational medicinal product code
    Other name
    VV
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injection, one dose, in the left upper arm.

    Investigational medicinal product name
    Havrix
    Investigational medicinal product code
    Other name
    HAV
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection, one dose, in the left thigh.

    Investigational medicinal product name
    Prevnar
    Investigational medicinal product code
    Other name
    PCV
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection, one dose, in the right thigh.

    Arm title
    		 Priorix 3 Group
    Arm description
    		 Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Priorix
    Investigational medicinal product code
    Other name
    MMR
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injection, one dose, in the right upper arm.

    Investigational medicinal product name
    Varivax
    Investigational medicinal product code
    Other name
    VV
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injection, one dose, in the left upper arm.

    Investigational medicinal product name
    Havrix
    Investigational medicinal product code
    Other name
    HAV
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection, one dose, in the left thigh.

    Investigational medicinal product name
    Prevnar
    Investigational medicinal product code
    Other name
    PCV
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection, one dose, in the right thigh.

    Arm title
    		 MMR-II Group
    Arm description
    		 Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Varivax
    Investigational medicinal product code
    Other name
    VV
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injection, one dose, in the left upper arm.

    Investigational medicinal product name
    Havrix
    Investigational medicinal product code
    Other name
    HAV
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection, one dose, in the left thigh.

    Investigational medicinal product name
    M-M-R II
    Investigational medicinal product code
    Other name
    MMR-II
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subcutaneous injection, one dose, in the right upper arm.

    Investigational medicinal product name
    Prevnar
    Investigational medicinal product code
    Other name
    PCV
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscular injection, one dose, in the right thigh.

    Notes
    [1] - The roles blinded appear to be inconsistent with a double blind trial.
    Justification: The study was conducted in an observer blind manner in which the subject and the study personnel involved in the clinical evaluation of the subjects were blinded while other study personnel (investigator) were aware of the treatment allocation.
    Number of subjects in period 1 [2]
    		Priorix 1 Group Priorix 2 Group Priorix 3 Group MMR-II Group
    Started
    304
    304
    304
    308
    Completed
    287
    275
    280
    275
    Not completed
    17
    29
    24
    33
         Consent withdrawn by subject
    10
    6
    6
    19
         Adverse event, non-fatal
    -
    -
    -
    1
         Lost to follow-up
    7
    19
    17
    12
         Blood draws
    -
    -
    -
    1
         Migration from study area
    -
    3
    1
    -
         Protocol deviation
    -
    1
    -
    -
    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: The number of subjects enrolled was 1259. 39 subjects were enrolled in the study but did not receive a subject number and were never vaccinated.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Priorix 1 Group
    Reporting group description
    		 Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.

    Reporting group title
    Priorix 2 Group
    Reporting group description
    		 Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.

    Reporting group title
    Priorix 3 Group
    Reporting group description
    		 Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.

    Reporting group title
    MMR-II Group
    Reporting group description
    		 Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.

    Reporting group values
    		 Priorix 1 Group Priorix 2 Group Priorix 3 Group MMR-II Group Total
    Number of subjects
    		 304 304 304 308
    Age categorical
    Units: Subjects
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    		 12.4 ( 0.75 ) 12.4 ( 0.73 ) 12.2 ( 0.56 ) 12.4 ( 0.75 ) -
    Gender categorical
    Units: Subjects
        Female
    		 156 144 157 139 596
        Male
    		 148 160 147 169 624

    End points

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    End points reporting groups
    Reporting group title
    Priorix 1 Group
    Reporting group description
    		 Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.

    Reporting group title
    Priorix 2 Group
    Reporting group description
    		 Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.

    Reporting group title
    Priorix 3 Group
    Reporting group description
    		 Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.

    Reporting group title
    MMR-II Group
    Reporting group description
    		 Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.

    Primary: Number of subjects with Anti-measles virus antibody concentration equal to or above the cut-off-value.

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    End point title
    		 Number of subjects with Anti-measles virus antibody concentration equal to or above the cut-off-value. [1]
    End point description
    Anti-measles virus antibody cut-off-value assessed was ≥ 200 milli-International Units per milliliter (mIU/mL). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-measles virus antibody concentrations <150 mIU/mL prior to vaccination.
    End point type
    Primary
    End point timeframe
    At Day 42 after administration of a dose of Priorix vaccine.
    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
    		 Priorix 1 Group Priorix 2 Group Priorix 3 Group MMR-II Group
    Number of subjects analysed
    247
    240
    240
    249
    Units: Subjects
        Subjects
    245
    236
    236
    248
    No statistical analyses for this end point

    Primary: Number of subjects with Anti-mumps virus antibody titer equal to or above the cut-off-value.

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    End point title
    		 Number of subjects with Anti-mumps virus antibody titer equal to or above the cut-off-value. [2]
    End point description
    Anti-mumps virus antibody cut-off-value assessed was ≥ 51 Estimated Dose 50 (ED50). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-measles virus antibody concentrations <24 ED50 prior to vaccination.
    End point type
    Primary
    End point timeframe
    At Day 42 after administration of a dose of Priorix vaccine.
    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
    		 Priorix 1 Group Priorix 2 Group Priorix 3 Group MMR-II Group
    Number of subjects analysed
    193
    202
    195
    192
    Units: Subjects
        Subjects
    175
    183
    175
    175
    No statistical analyses for this end point

    Primary: Number of subjects with Anti-rubella virus antibody concentrations equal to or above the cut-off-value.

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    End point title
    		 Number of subjects with Anti-rubella virus antibody concentrations equal to or above the cut-off-value. [3]
    End point description
    Anti-rubella virus antibody cut-off-value assessed was ≥ 10 International Units per milliliter (IU/mL).
    End point type
    Primary
    End point timeframe
    At Day 42 after administration of a dose of Priorix vaccine.
    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
    		 Priorix 1 Group Priorix 2 Group Priorix 3 Group MMR-II Group
    Number of subjects analysed
    247
    238
    239
    249
    Units: Subjects
        Subjects
    244
    235
    233
    249
    No statistical analyses for this end point

    Secondary: Number of subjects with Anti-varicella antibody concentration equal to or above the cut-off-value.

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    End point title
    		 Number of subjects with Anti-varicella antibody concentration equal to or above the cut-off-value.
    End point description
    Anti-varicella virus antibody cut-off-value assessed was ≥ 75 milli-International Units per milliliter (mIU/mL).
    End point type
    Secondary
    End point timeframe
    At Day 42 after administration of a dose of Varivax vaccine.
    End point values
    		 Priorix 1 Group Priorix 2 Group Priorix 3 Group MMR-II Group
    Number of subjects analysed
    245
    238
    240
    246
    Units: Subjects
        Subjects
    240
    230
    230
    241
    No statistical analyses for this end point

    Secondary: Anti-measles virus antibody concentrations

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    End point title
    		 Anti-measles virus antibody concentrations
    End point description
    Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-measles virus antibody concentrations <150 mIU/mL prior to vaccination.
    End point type
    Secondary
    End point timeframe
    At Day 42 after administration of a dose of Priorix vaccine.
    End point values
    		 Priorix 1 Group Priorix 2 Group Priorix 3 Group MMR-II Group
    Number of subjects analysed
    247
    240
    240
    249
    Units: mIU/mL
    geometric mean (confidence interval 95%)
        mIU/mL
    2798.7 (2544.8 to 3077.9)
    2878.2 (2607.0 to 3177.7)
    2593.1 (2350.3 to 2861.1)
    2949.5 (2698.4 to 3224.0)
    No statistical analyses for this end point

    Secondary: Anti-mumps virus antibody concentrations

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    End point title
    		 Anti-mumps virus antibody concentrations
    End point description
    Antibody concentrations are expressed as Geometric Mean Titer (GMT). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with antibody titer < 24 ED50 prior to vaccination.
    End point type
    Secondary
    End point timeframe
    At Day 42 after administration of a dose of Priorix vaccine.
    End point values
    		 Priorix 1 Group Priorix 2 Group Priorix 3 Group MMR-II Group
    Number of subjects analysed
    193
    202
    195
    192
    Units: Titers
    geometric mean (confidence interval 95%)
        Titers
    242.0 (204.5 to 286.5)
    265.0 (221.8 to 316.5)
    253.4 (213.4 to 300.9)
    267.6 (224.2 to 319.5)
    No statistical analyses for this end point

    Secondary: Anti-rubella virus antibody concentrations

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    End point title
    		 Anti-rubella virus antibody concentrations
    End point description
    Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in IU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-rubella virus antibody concentrations <4 IU/mL prior to vaccination.
    End point type
    Secondary
    End point timeframe
    At Day 42 after administration of a dose of Priorix vaccine.
    End point values
    		 Priorix 1 Group Priorix 2 Group Priorix 3 Group MMR-II Group
    Number of subjects analysed
    247
    238
    239
    249
    Units: IU/mL
    geometric mean (confidence interval 95%)
        IU/mL
    72.2 (65.6 to 79.6)
    77.7 (70.4 to 85.7)
    68.2 (61.8 to 75.3)
    89.4 (81.4 to 98.2)
    No statistical analyses for this end point

    Secondary: Anti-S. pneumoniae antibody concentrations (by serotype).

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    End point title
    		 Anti-S. pneumoniae antibody concentrations (by serotype).
    End point description
    Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in µg/mL.
    End point type
    Secondary
    End point timeframe
    At Day 42 after vaccination
    End point values
    		 Priorix 1 Group Priorix 2 Group Priorix 3 Group MMR-II Group
    Number of subjects analysed
    128
    127
    128
    126
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Anti-S.PNEU-4
    3.57 (3.04 to 4.20)
    3.72 (3.21 to 4.31)
    3.40 (2.88 to 4.00)
    3.80 (3.17 to 4.56)
        Anti-S. PNEU-6B
    5.68 (4.78 to 6.76)
    5.87 (5.02 to 6.87)
    5.41 (4.66 to 6.28)
    7.22 (6.28 to 8.29)
        Anti-S.PNEU 9V
    6.56 (5.66 to 7.60)
    7.30 (6.35 to 8.38)
    5.81 (4.97 to 6.78)
    7.80 (6.81 to 8.93)
        Anti-S.PNEU-14
    9.23 (8.03 to 10.61)
    8.33 (7.30 to 9.51)
    7.58 (6.55 to 8.76)
    7.97 (6.95 to 9.14)
        Anti-S.PNEU-18 C
    6.20 (5.30 to 7.26)
    6.62 (5.76 to 7.60)
    6.15 (5.25 to 7.21)
    6.73 (5.74 to 7.91)
        Anti-S.PNEU-19 F
    2.42 (2.05 to 2.85)
    2.46 (2.11 to 2.88)
    2.34 (2.00 to 2.73)
    2.59 (2.23 to 3.00)
        Anti-S.PNEU-23 F
    9.34 (7.76 to 11.25)
    9.27 (7.82 to 10.99)
    8.33 (6.88 to 10.10)
    11.49 (9.67 to 13.66)
    No statistical analyses for this end point

    Secondary: Anti-varicella antibody concentrations.

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    End point title
    		 Anti-varicella antibody concentrations.
    End point description
    Antibody concentrations are expressed as Geometric Mean Titers (GMT). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with antibody concentration < 25 mIU/mL prior to vaccination.
    End point type
    Secondary
    End point timeframe
    At Day 42 after administration of a dose of Varivax vaccine.
    End point values
    		 Priorix 1 Group Priorix 2 Group Priorix 3 Group MMR-II Group
    Number of subjects analysed
    245
    238
    240
    246
    Units: mIU/mL
    geometric mean (confidence interval 95%)
        mIU/mL
    245.5 (229.0 to 263.3)
    235.2 (217.4 to 254.4)
    236.0 (218.0 to 255.5)
    255.9 (240.4 to 272.4)
    No statistical analyses for this end point

    Secondary: Anti-hepatitis A virus antibody concentrations.

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    End point title
    		 Anti-hepatitis A virus antibody concentrations.
    End point description
    Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-hepatitis A virus antibody concentrations <15 mIU/mL prior to vaccination.
    End point type
    Secondary
    End point timeframe
    At Day 42 after administration of a dose of Havrix vaccine.
    End point values
    		 Priorix 1 Group Priorix 2 Group Priorix 3 Group MMR-II Group
    Number of subjects analysed
    117
    112
    111
    124
    Units: mIU/mL
    geometric mean (confidence interval 95%)
        mIU/mL
    33.8 (28.8 to 39.6)
    39.2 (33.1 to 46.5)
    39.4 (32.7 to 47.5)
    42.1 (35.8 to 49.6)
    No statistical analyses for this end point

    Secondary: Number of subjects with Anti-hepatitis A antibody concentrations equal to or above the cut-off-value.

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    End point title
    		 Number of subjects with Anti-hepatitis A antibody concentrations equal to or above the cut-off-value.
    End point description
    Anti-hepatitis A antibody cut-off-value assessed was ≥15 milli-International Units per milliliter (mIU/mL).
    End point type
    Secondary
    End point timeframe
    At Day 42 after administration of a dose of Havrix vaccine.
    End point values
    		 Priorix 1 Group Priorix 2 Group Priorix 3 Group MMR-II Group
    Number of subjects analysed
    117
    112
    111
    124
    Units: Subjects
        Subjects
    98
    99
    94
    110
    No statistical analyses for this end point

    Secondary: Anti-S. pneumoniae antibody concentrations (by serotype).

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    End point title
    		 Anti-S. pneumoniae antibody concentrations (by serotype).
    End point description
    Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in µg/mL.
    End point type
    Secondary
    End point timeframe
    At Day 0 before vaccination
    End point values
    		 Priorix 1 Group Priorix 2 Group Priorix 3 Group MMR-II Group
    Number of subjects analysed
    129
    130
    130
    119
    Units: µg/mL
    geometric mean (confidence interval 95%)
        Anti-S.PNEU-4
    0.54 (0.46 to 0.65)
    0.61 (0.52 to 0.72)
    0.67 (0.58 to 0.78)
    0.67 (0.56 to 0.81)
        Anti-S.PNEU-6B
    0.53 (0.43 to 0.66)
    0.57 (0.46 to 0.70)
    0.52 (0.43 to 0.64)
    0.67 (0.56 to 0.80)
        Anti-S.PNEU-9V
    1.01 (0.85 to 1.20)
    1.13 (0.97 to 1.32)
    1.04 (0.88 to 1.23)
    1.26 (1.06 to 1.49)
        Anti-S.PNEU-14
    3.01 (2.60 to 3.47)
    2.82 (2.42 to 3.28)
    2.54 (2.21 to 2.92)
    2.76 (2.38 to 3.20)
        Anti-S.PNEU-18C
    0.88 (0.74 to 1.03)
    0.97 (0.83 to 1.13)
    0.97 (0.83 to 1.14)
    1.00 (0.86 to 1.15)
        Anti-S.PNEU-19F
    0.40 (0.32 to 0.50)
    0.40 (0.33 to 0.50)
    0.44 (0.36 to 0.53)
    0.45 (0.37 to 0.56)
        Anti-S.PNEU-23 F
    0.64 (0.51 to 0.82)
    0.63 (0.51 to 0.77)
    0.65 (0.52 to 0.81)
    0.85 (0.67 to 1.08)
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-measles virus antibody concentration equal to or above the cut-off-value

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    End point title
    		 Number of subjects with anti-measles virus antibody concentration equal to or above the cut-off-value
    End point description
    Anti-measles virus antibody cut-off-value assessed was ≥ 200 milli-International Units per milliliter (mIU/mL).
    End point type
    Secondary
    End point timeframe
    At 1 year post-vaccination
    End point values
    		 Priorix 1 Group Priorix 2 Group Priorix 3 Group MMR-II Group
    Number of subjects analysed
    213
    215
    218
    210
    Units: Subjects
        Subjects
    211
    211
    218
    209
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-measles virus antibody concentration equal to or above the cut-off-value

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    End point title
    		 Number of subjects with anti-measles virus antibody concentration equal to or above the cut-off-value
    End point description
    Anti-measles virus antibody cut-off-value assessed was ≥ 200 milli-International Units per milliliter (mIU/mL).
    End point type
    Secondary
    End point timeframe
    At 2 years post-vaccination
    End point values
    		 Priorix 1 Group Priorix 2 Group Priorix 3 Group MMR-II Group
    Number of subjects analysed
    171
    159
    169
    166
    Units: Subjects
        Subjects
    171
    159
    168
    166
    No statistical analyses for this end point

    Secondary: Anti-measles virus antibody concentrations

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    End point title
    		 Anti-measles virus antibody concentrations
    End point description
    Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-measles virus antibody concentrations <150 mIU/mL prior to vaccination.
    End point type
    Secondary
    End point timeframe
    At 2 years post-vaccination
    End point values
    		 Priorix 1 Group Priorix 2 Group Priorix 3 Group MMR-II Group
    Number of subjects analysed
    171
    159
    169
    166
    Units: mIU/mL
    geometric mean (confidence interval 95%)
        mIU/mL
    3361.1 (2922.3 to 3865.6)
    3963.8 (3479.3 to 4515.7)
    3360.3 (2923.3 to 3862.7)
    4022.1 (3507.7 to 4611.9)
    No statistical analyses for this end point

    Secondary: Anti-measles virus antibody concentrations

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    End point title
    		 Anti-measles virus antibody concentrations
    End point description
    Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-measles virus antibody concentrations <150 mIU/mL prior to vaccination.
    End point type
    Secondary
    End point timeframe
    At 1 year post-vaccination
    End point values
    		 Priorix 1 Group Priorix 2 Group Priorix 3 Group MMR-II Group
    Number of subjects analysed
    213
    215
    218
    210
    Units: mIU/mL
    geometric mean (confidence interval 95%)
        mIU/mL
    3224.3 (2840.1 to 3660.5)
    3708.2 (3226.2 to 4262.2)
    3534.7 (3139.9 to 3979.1)
    3828.1 (3371.3 to 4346.7)
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects reporting investigator-confirmed measles/rubella-like rash and varicella-like rash.
    End point description
    End point type
    Secondary
    End point timeframe
    During the 43-day (Days 0-42) post-vaccination period
    End point values
    		 Priorix 1 Group Priorix 2 Group Priorix 3 Group MMR-II Group
    Number of subjects analysed
    283
    275
    283
    277
    Units: Subjects
        Varicella like
    0
    4
    0
    0
        Measles/Rubella like
    6
    7
    5
    5
    No statistical analyses for this end point

    Secondary: Number of subjects reporting febrile convulsions

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    End point title
    		 Number of subjects reporting febrile convulsions
    End point description
    Timing of febrile convulsions: events occured on Day 29 in the Priorix 2 Group and Day 0 in the MMR II Group. All cases of febrile convulsions were case of meningism.
    End point type
    Secondary
    End point timeframe
    During the 43-day (Days 0-42) post-vaccination period
    End point values
    		 Priorix 1 Group Priorix 2 Group Priorix 3 Group MMR-II Group
    Number of subjects analysed
    283
    275
    283
    277
    Units: Subjects
        Subjects
    0
    1
    0
    1
    No statistical analyses for this end point

    Secondary: Anti-mumps virus antibody titers (enhanced Plaque Reduction Neutralization (PRN))

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    End point title
    		 Anti-mumps virus antibody titers (enhanced Plaque Reduction Neutralization (PRN))
    End point description
    Antibody titers were expressed as Geometric Mean Titer (GMT). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with antibody titer < 24 ED50 prior to vaccination.
    End point type
    Secondary
    End point timeframe
    At 1 year post-vaccination
    End point values
    		 Priorix 1 Group Priorix 2 Group Priorix 3 Group MMR-II Group
    Number of subjects analysed
    189
    186
    189
    183
    Units: Titers
    geometric mean (confidence interval 95%)
        Titers
    162.8 (141.8 to 186.9)
    188.3 (162.4 to 218.3)
    176.2 (152.6 to 203.3)
    185.5 (163.5 to 210.6)
    No statistical analyses for this end point

    Secondary: Number of subjects reporting other rash.

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    End point title
    		 Number of subjects reporting other rash.
    End point description
    Other rash = not confirmed by the investigator to be either measles/rubella-like or varicella-like in nature
    End point type
    Secondary
    End point timeframe
    During the 43-day (Days 0-42) post-vaccination period
    End point values
    		 Priorix 1 Group Priorix 2 Group Priorix 3 Group MMR-II Group
    Number of subjects analysed
    283
    275
    283
    277
    Units: Subjects
        Localized or generalized
    72
    74
    60
    60
        With fever
    26
    29
    23
    23
        Grade 3
    11
    10
    6
    6
        Related
    9
    14
    6
    6
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-mumps virus antibody titers above the cut-off value (enhanced PRN)

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    End point title
    		 Number of subjects with anti-mumps virus antibody titers above the cut-off value (enhanced PRN)
    End point description
    Anti-mumps virus antibody cut-off-value assessed was ≥ 51 ED50.
    End point type
    Secondary
    End point timeframe
    At 1 year post-vaccination
    End point values
    		 Priorix 1 Group Priorix 2 Group Priorix 3 Group MMR-II Group
    Number of subjects analysed
    189
    186
    189
    183
    Units: Subjects
        Subjects
    169
    170
    171
    170
    No statistical analyses for this end point

    Secondary: Number of subjects with Anti-rubella virus antibody concentrations equal to or above the cut-off-value.

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    End point title
    		 Number of subjects with Anti-rubella virus antibody concentrations equal to or above the cut-off-value.
    End point description
    Anti-rubella virus antibody cut-off-value assessed was ≥ 10 International Units per milliliter (IU/mL). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-rubella virus antibody concentrations <4 IU/mL prior to vaccination.
    End point type
    Secondary
    End point timeframe
    At 1 year post-vaccination
    End point values
    		 Priorix 1 Group Priorix 2 Group Priorix 3 Group MMR-II Group
    Number of subjects analysed
    213
    214
    218
    210
    Units: Subjects
        Subjects
    212
    213
    217
    210
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-rubella virus antibody concentrations equal to or above the cut-off-value.

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    End point title
    		 Number of subjects with anti-rubella virus antibody concentrations equal to or above the cut-off-value.
    End point description
    Anti-rubella virus antibody cut-off-value assessed was ≥ 10 International Units per milliliter (IU/mL).
    End point type
    Secondary
    End point timeframe
    At 2 years post-vaccination
    End point values
    		 Priorix 1 Group Priorix 2 Group Priorix 3 Group MMR-II Group
    Number of subjects analysed
    171
    158
    168
    166
    Units: Subjects
        Subjects
    171
    158
    168
    166
    No statistical analyses for this end point

    Secondary: Anti-rubella virus antibody concentrations

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    End point title
    		 Anti-rubella virus antibody concentrations
    End point description
    Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in IU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-rubella virus antibody concentrations <4 IU/mL prior to vaccination.
    End point type
    Secondary
    End point timeframe
    At 1 year post-vaccination
    End point values
    		 Priorix 1 Group Priorix 2 Group Priorix 3 Group MMR-II Group
    Number of subjects analysed
    213
    214
    218
    210
    Units: IU/mL
    geometric mean (confidence interval 95%)
        IU/mL
    138.1 (125.3 to 152.2)
    145.4 (132.0 to 160.1)
    136.5 (123.5 to 150.9)
    166.8 (151.5 to 183.6)
    No statistical analyses for this end point

    Secondary: Anti-rubella virus antibody concentrations

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    End point title
    		 Anti-rubella virus antibody concentrations
    End point description
    Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in IU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-rubella virus antibody concentrations <4 IU/mL prior to vaccination.
    End point type
    Secondary
    End point timeframe
    At 2 years post-vaccination
    End point values
    		 Priorix 1 Group Priorix 2 Group Priorix 3 Group MMR-II Group
    Number of subjects analysed
    171
    158
    168
    166
    Units: IU/mL
    geometric mean (confidence interval 95%)
        IU/mL
    78.0 (69.7 to 87.2)
    79.5 (71.7 to 88.2)
    81.7 (73.8 to 90.4)
    93.1 (83.6 to 103.6)
    No statistical analyses for this end point

    Secondary: Number of subjects reporting fever.

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    End point title
    		 Number of subjects reporting fever.
    End point description
    fever is assessed for temperature ≥38°C/100.4°F and >39.5°C/103.1°F as measured rectally.
    End point type
    Secondary
    End point timeframe
    During the 15-day (Days 0-14) and 43 days (Days 0-42) post-vaccination period
    End point values
    		 Priorix 1 Group Priorix 2 Group Priorix 3 Group MMR-II Group
    Number of subjects analysed
    283
    275
    283
    277
    Units: Subjects
        Day 15 (N= 283; 275; 283; 277) ≥38.0°C
    65
    79
    64
    56
        Day 15 (N= 283; 275; 283; 277) >39.5°C
    10
    7
    9
    8
        Day 43 (N= 283; 275; 283; 277) ≥38.0°C
    103
    104
    104
    85
        Day 43 (N= 283; 275; 283; 277) >39.5°C
    20
    14
    18
    13
    No statistical analyses for this end point

    Secondary: Number of subjects with solicited local symptoms.

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    End point title
    		 Number of subjects with solicited local symptoms.
    End point description
    Solicited local symptoms assessed were pain, redness and swelling.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Days 0-3) post-vaccination period
    End point values
    		 Priorix 1 Group Priorix 2 Group Priorix 3 Group MMR-II Group
    Number of subjects analysed
    282
    274
    282
    274
    Units: Subjects
        Pain
    70
    70
    79
    67
        Redness
    45
    47
    41
    47
        Swelling
    20
    26
    19
    15
    No statistical analyses for this end point

    Secondary: Number of subjects reporting Medically attended visit (MAEs)

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    End point title
    		 Number of subjects reporting Medically attended visit (MAEs)
    End point description
    MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.
    End point type
    Secondary
    End point timeframe
    During the 43-day (Days 0-42) post-vaccination period
    End point values
    		 Priorix 1 Group Priorix 2 Group Priorix 3 Group MMR-II Group
    Number of subjects analysed
    304
    304
    304
    308
    Units: Subjects
        Subjects
    99
    99
    97
    107
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects with unsolicited adverse events (AEs).
    End point description
    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
    End point type
    Secondary
    End point timeframe
    During the 43-day (Days 0-42) post-vaccination period
    End point values
    		 Priorix 1 Group Priorix 2 Group Priorix 3 Group MMR-II Group
    Number of subjects analysed
    304
    304
    304
    308
    Units: Subjects
        Subjects
    170
    153
    164
    169
    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
    Swelling with accompanying general symptoms
    End point type
    Secondary
    End point timeframe
    During the 43-day (Days 0-42) post-vaccination period
    End point values
    		 Priorix 1 Group Priorix 2 Group Priorix 3 Group MMR-II Group
    Number of subjects analysed
    283
    275
    283
    277
    Units: Subjects
        Subjects
    3
    3
    5
    2
    No statistical analyses for this end point

    Secondary: Number of subjects with solicited general symptoms.

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    End point title
    		 Number of subjects with solicited general symptoms.
    End point description
    Assessed solicited general symptoms were drowsiness, irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade.
    End point type
    Secondary
    End point timeframe
    During the 15-day (Days 0-14) post-vaccination period
    End point values
    		 Priorix 1 Group Priorix 2 Group Priorix 3 Group MMR-II Group
    Number of subjects analysed
    283
    275
    283
    277
    Units: Subjects
        Any drowsiness
    133
    106
    113
    109
        Any irritability
    180
    141
    150
    153
        Any loss of appetite
    111
    77
    110
    94
    No statistical analyses for this end point

    Secondary: Number of subjects reporting new onset chronic illnesses (NOCIs).

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    End point title
    		 Number of subjects reporting new onset chronic illnesses (NOCIs).
    End point description
    NOCIs included autoimmune disorders, asthma, type I diabetes, allergies.
    End point type
    Secondary
    End point timeframe
    From Day 0 to Day 180 after vaccination
    End point values
    		 Priorix 1 Group Priorix 2 Group Priorix 3 Group MMR-II Group
    Number of subjects analysed
    304
    304
    304
    308
    Units: Subjects
        Subjects
    5
    2
    4
    2
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects reporting serious adverse events (SAEs)
    End point description
    SAEs assessed include medical occurrences that result in death, are 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
    From Day 0 to Day 180 after vaccination
    End point values
    		 Priorix 1 Group Priorix 2 Group Priorix 3 Group MMR-II Group
    Number of subjects analysed
    304
    304
    304
    308
    Units: Subjects
        Subjects
    1
    6
    7
    9
    No statistical analyses for this end point

    Secondary: Number of subjects reporting serious adverse events (SAEs).

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    End point title
    		 Number of subjects reporting serious adverse events (SAEs).
    End point description
    SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are congenital anomaly/birth defect in the offspring of a study subject.
    End point type
    Secondary
    End point timeframe
    From Day 180 to Day 730 after vaccination
    End point values
    		 Priorix 1 Group Priorix 2 Group Priorix 3 Group MMR-II Group
    Number of subjects analysed
    304
    304
    304
    308
    Units: Subjects
        Subjects
    0
    0
    0
    1
    No statistical analyses for this end point

    Secondary: Number of subjects reporting conditions prompting emergency room (ER) visits.

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    End point title
    		 Number of subjects reporting conditions prompting emergency room (ER) visits.
    End point description
    End point type
    Secondary
    End point timeframe
    From Day 0 to Day 180 after vaccination
    End point values
    		 Priorix 1 Group Priorix 2 Group Priorix 3 Group MMR-II Group
    Number of subjects analysed
    304
    304
    304
    308
    Units: Subjects
        Subjects
    27
    28
    22
    26
    No statistical analyses for this end point

    Secondary: Anti-mumps virus antibody titers (unenhanced PRN)

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    End point title
    		 Anti-mumps virus antibody titers (unenhanced PRN)
    End point description
    Antibody titers were expressed as Geometric Mean Titer (GMT).
    End point type
    Secondary
    End point timeframe
    At 1 year post-vaccination
    End point values
    		 Priorix 1 Group Priorix 2 Group Priorix 3 Group MMR-II Group
    Number of subjects analysed
    196
    205
    211
    195
    Units: Titer
    geometric mean (confidence interval 95%)
        Titer
    31.0 (24.1 to 39.9)
    46.1 (36.2 to 58.7)
    39.3 (31.0 to 50.0)
    46.6 (36.6 to 59.3)
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-mumps virus antibody titers above the cut-off value (unenhanced PRN)

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    End point title
    		 Number of subjects with anti-mumps virus antibody titers above the cut-off value (unenhanced PRN)
    End point description
    Anti-mumps virus antibody cut-off-value assessed was ≥ 4 Estimated Dose 50 (ED50).
    End point type
    Secondary
    End point timeframe
    At 1 year post-vaccination
    End point values
    		 Priorix 1 Group Priorix 2 Group Priorix 3 Group MMR-II Group
    Number of subjects analysed
    196
    205
    211
    195
    Units: Subjects
        Subjects
    173
    186
    184
    173
    No statistical analyses for this end point

    Secondary: Anti-mumps virus antibody titers (unenhanced PRN)

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    End point title
    		 Anti-mumps virus antibody titers (unenhanced PRN)
    End point description
    Antibody concentrations are expressed as Geometric Mean Titer (GMT).
    End point type
    Secondary
    End point timeframe
    At 2 years post-vaccination
    End point values
    		 Priorix 1 Group Priorix 2 Group Priorix 3 Group MMR-II Group
    Number of subjects analysed
    157
    144
    157
    152
    Units: Titer
    geometric mean (confidence interval 95%)
        Titer
    43.4 (33.4 to 56.3)
    48.9 (37.7 to 63.5)
    57.4 (45.7 to 72.2)
    60.7 (47.6 to 77.5)
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-mumps virus antibody titers above the cut-off value (unenhanced PRN)

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    End point title
    		 Number of subjects with anti-mumps virus antibody titers above the cut-off value (unenhanced PRN)
    End point description
    Anti-mumps virus antibody cut-off-value assessed was ≥ 4 Estimated Dose 50 (ED50).
    End point type
    Secondary
    End point timeframe
    At 2 years post-vaccination
    End point values
    		 Priorix 1 Group Priorix 2 Group Priorix 3 Group MMR-II Group
    Number of subjects analysed
    157
    144
    157
    152
    Units: Subjects
        Subjects
    144
    134
    152
    144
    No statistical analyses for this end point

    Secondary: Anti-mumps virus antibody concentrations (Pharmaceutical Product Development (PPD) ELISA)

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    End point title
    		 Anti-mumps virus antibody concentrations (Pharmaceutical Product Development (PPD) ELISA)
    End point description
    Antibody concentrations are expressed as Geometric Mean Concentrations (GMC) in ELISA units per milliliter (EU/mL). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-rubella virus antibody concentrations <5 EU/mL prior to vaccination.
    End point type
    Secondary
    End point timeframe
    At 1 year post-vaccination
    End point values
    		 Priorix 1 Group Priorix 2 Group Priorix 3 Group MMR-II Group
    Number of subjects analysed
    170
    173
    179
    170
    Units: EU/mL
    geometric mean (confidence interval 95%)
        EU/mL
    47.3 (39.2 to 57.1)
    42.9 (36.4 to 50.6)
    42.5 (35.9 to 50.3)
    58.6 (50.6 to 67.8)
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-mumps virus antibody concentrations above the cut-off value (PPD ELISA)

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    End point title
    		 Number of subjects with anti-mumps virus antibody concentrations above the cut-off value (PPD ELISA)
    End point description
    Anti-mumps virus antibody cut-off-value assessed was ≥ 10 ELISA units per milliliter (EU/mL)
    End point type
    Secondary
    End point timeframe
    At 1 year post-vaccination
    End point values
    		 Priorix 1 Group Priorix 2 Group Priorix 3 Group MMR-II Group
    Number of subjects analysed
    170
    173
    179
    170
    Units: Subjects
        Subjects
    155
    159
    162
    164
    No statistical analyses for this end point

    Secondary: Anti-mumps virus antibody concentrations (PPD ELISA)

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    End point title
    		 Anti-mumps virus antibody concentrations (PPD ELISA)
    End point description
    Antibody concentrations are expressed as Geometric Mean Concentrations (GMC) in ELISA units per milliliter (EU/mL). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-rubella virus antibody concentrations <5 EU/mL prior to vaccination.
    End point type
    Secondary
    End point timeframe
    At 2 years post-vaccination
    End point values
    		 Priorix 1 Group Priorix 2 Group Priorix 3 Group MMR-II Group
    Number of subjects analysed
    136
    130
    141
    140
    Units: EU/mL
    geometric mean (confidence interval 95%)
        EU/mL
    47.8 (40.2 to 56.9)
    50.2 (42.1 to 59.9)
    54.0 (46.1 to 63.3)
    59.2 (50.1 to 70.0)
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-mumps virus antibody concentrations above the cut-off value (PPD ELISA)

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    End point title
    		 Number of subjects with anti-mumps virus antibody concentrations above the cut-off value (PPD ELISA)
    End point description
    Anti-mumps virus antibody cut-off-value assessed was ≥ 10 ELISA units per milliliter (EU/mL)
    End point type
    Secondary
    End point timeframe
    At 2 years post-vaccination
    End point values
    		 Priorix 1 Group Priorix 2 Group Priorix 3 Group MMR-II Group
    Number of subjects analysed
    136
    130
    141
    140
    Units: Subjects
        Subjects
    128
    125
    136
    134
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited symptoms: During the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: During the 43-day (Days 0-42) post vaccination period. SAEs: the entire study period (Day 0-Day 730).
    Adverse event reporting additional description
    Solicited symptoms were only assessed on subjects returning the symptom sheet.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    Priorix 1 Group
    Reporting group description
    		 Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.

    Reporting group title
    Priorix 2 Group
    Reporting group description
    		 Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.

    Reporting group title
    Priorix 3 Group
    Reporting group description
    		 Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.

    Reporting group title
    MMR-II Group
    Reporting group description
    		 Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.

    Serious adverse events
    		 Priorix 1 Group Priorix 2 Group Priorix 3 Group MMR-II Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 304 (0.33%)
    6 / 304 (1.97%)
    7 / 304 (2.30%)
    10 / 308 (3.25%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Nephroblastoma
         subjects affected / exposed
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    1 / 308 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vascular disorders
    Extremity necrosis
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 304 (0.33%)
    0 / 304 (0.00%)
    0 / 308 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Ataxia
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 304 (0.33%)
    0 / 304 (0.00%)
    0 / 308 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Febrile convulsion
         subjects affected / exposed
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    1 / 308 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Idiopathic thrombocytopenic purpura
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 304 (0.33%)
    0 / 304 (0.00%)
    0 / 308 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Leukocytosis
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 304 (0.33%)
    0 / 304 (0.00%)
    0 / 308 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Lymphadenitis
         subjects affected / exposed
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    1 / 304 (0.33%)
    0 / 308 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Influenza like illness
         subjects affected / exposed
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    1 / 308 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    1 / 304 (0.33%)
    0 / 308 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Intussusception
         subjects affected / exposed
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    1 / 304 (0.33%)
    0 / 308 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Bronchial hyperreactivity
         subjects affected / exposed
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    1 / 308 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    2 / 308 (0.65%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nasal congestion
         subjects affected / exposed
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    1 / 308 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Petechiae
         subjects affected / exposed
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    1 / 304 (0.33%)
    0 / 308 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Rash
         subjects affected / exposed
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    1 / 308 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Bronchiolitis
         subjects affected / exposed
    1 / 304 (0.33%)
    1 / 304 (0.33%)
    0 / 304 (0.00%)
    2 / 308 (0.65%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    1 / 304 (0.33%)
    1 / 308 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    1 / 304 (0.33%)
    0 / 308 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Coxsackie viral infection
         subjects affected / exposed
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    1 / 304 (0.33%)
    0 / 308 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    1 / 304 (0.33%)
    0 / 308 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    H1n1 influenza
         subjects affected / exposed
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    1 / 308 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    1 / 308 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pharyngotonsillitis
         subjects affected / exposed
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    1 / 308 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    1 / 304 (0.33%)
    1 / 308 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia respiratory syncytial viral
         subjects affected / exposed
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    1 / 308 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory syncytial virus infection
         subjects affected / exposed
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    1 / 308 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal infection
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 304 (0.33%)
    0 / 304 (0.00%)
    0 / 308 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    1 / 308 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    1 / 308 (0.32%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Priorix 1 Group Priorix 2 Group Priorix 3 Group MMR-II Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    240 / 304 (78.95%)
    216 / 304 (71.05%)
    219 / 304 (72.04%)
    221 / 308 (71.75%)
    Vascular disorders
    Pallor
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 304 (0.33%)
    0 / 304 (0.00%)
    0 / 308 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Surgical and medical procedures
    Sinus operation
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 304 (0.33%)
    1 / 304 (0.33%)
    0 / 308 (0.00%)
         occurrences all number
    0
    1
    1
    0
    General disorders and administration site conditions
    Chest discomfort
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    0 / 308 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Crying
         subjects affected / exposed
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    1 / 304 (0.33%)
    0 / 308 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Discomfort
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 304 (0.00%)
    1 / 304 (0.33%)
    0 / 308 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Hyperpyrexia
         subjects affected / exposed
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    1 / 304 (0.33%)
    0 / 308 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Influenza like illness
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    1 / 308 (0.32%)
         occurrences all number
    1
    0
    0
    1
    Injection site bruising
         subjects affected / exposed
    3 / 304 (0.99%)
    0 / 304 (0.00%)
    1 / 304 (0.33%)
    2 / 308 (0.65%)
         occurrences all number
    3
    0
    1
    2
    Injection site erythema
         subjects affected / exposed
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    2 / 308 (0.65%)
         occurrences all number
    0
    0
    0
    2
    Injection site induration
         subjects affected / exposed
    1 / 304 (0.33%)
    1 / 304 (0.33%)
    0 / 304 (0.00%)
    0 / 308 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Injection site mass
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 304 (0.33%)
    0 / 304 (0.00%)
    1 / 308 (0.32%)
         occurrences all number
    0
    1
    0
    1
    Injection site reaction
         subjects affected / exposed
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    1 / 304 (0.33%)
    0 / 308 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Injection site swelling
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 304 (0.33%)
    0 / 304 (0.00%)
    2 / 308 (0.65%)
         occurrences all number
    0
    1
    0
    2
    Local swelling
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 304 (0.00%)
    1 / 304 (0.33%)
    0 / 308 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Oedema peripheral
         subjects affected / exposed
    1 / 304 (0.33%)
    1 / 304 (0.33%)
    0 / 304 (0.00%)
    1 / 308 (0.32%)
         occurrences all number
    1
    1
    0
    1
    Pain
         subjects affected / exposed
    72 / 304 (23.68%)
    70 / 304 (23.03%)
    79 / 304 (25.99%)
    68 / 308 (22.08%)
         occurrences all number
    72
    70
    79
    69
    Pyrexia
         subjects affected / exposed
    1 / 304 (0.33%)
    1 / 304 (0.33%)
    0 / 304 (0.00%)
    0 / 308 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Swelling
         subjects affected / exposed
    22 / 304 (7.24%)
    26 / 304 (8.55%)
    20 / 304 (6.58%)
    15 / 308 (4.87%)
         occurrences all number
    22
    26
    20
    15
    Vessel puncture site bruise
         subjects affected / exposed
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    1 / 304 (0.33%)
    0 / 308 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    0 / 304 (0.00%)
    2 / 304 (0.66%)
    1 / 304 (0.33%)
    2 / 308 (0.65%)
         occurrences all number
    0
    2
    2
    2
    Milk allergy
         subjects affected / exposed
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    1 / 308 (0.32%)
         occurrences all number
    0
    0
    0
    1
    Multiple allergies
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 304 (0.33%)
    1 / 304 (0.33%)
    0 / 308 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Seasonal allergy
         subjects affected / exposed
    1 / 304 (0.33%)
    1 / 304 (0.33%)
    1 / 304 (0.33%)
    1 / 308 (0.32%)
         occurrences all number
    1
    1
    1
    1
    Reproductive system and breast disorders
    Genital cyst
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 304 (0.33%)
    0 / 304 (0.00%)
    0 / 308 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Gynaecomastia
         subjects affected / exposed
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    1 / 304 (0.33%)
    0 / 308 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Penile adhesion
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    0 / 308 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Vaginal discharge
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 304 (0.33%)
    0 / 304 (0.00%)
    0 / 308 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Adenoidal hypertrophy
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 304 (0.33%)
    0 / 304 (0.00%)
    0 / 308 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Asthma
         subjects affected / exposed
    3 / 304 (0.99%)
    0 / 304 (0.00%)
    2 / 304 (0.66%)
    0 / 308 (0.00%)
         occurrences all number
    3
    0
    2
    0
    Bronchial hyperreactivity
         subjects affected / exposed
    2 / 304 (0.66%)
    1 / 304 (0.33%)
    3 / 304 (0.99%)
    4 / 308 (1.30%)
         occurrences all number
    2
    1
    3
    4
    Cough
         subjects affected / exposed
    25 / 304 (8.22%)
    21 / 304 (6.91%)
    16 / 304 (5.26%)
    19 / 308 (6.17%)
         occurrences all number
    28
    24
    17
    19
    Dyspnoea
         subjects affected / exposed
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    1 / 304 (0.33%)
    0 / 308 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Epistaxis
         subjects affected / exposed
    1 / 304 (0.33%)
    1 / 304 (0.33%)
    0 / 304 (0.00%)
    0 / 308 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Increased upper airway secretion
         subjects affected / exposed
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    1 / 304 (0.33%)
    0 / 308 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Nasal congestion
         subjects affected / exposed
    7 / 304 (2.30%)
    13 / 304 (4.28%)
    9 / 304 (2.96%)
    10 / 308 (3.25%)
         occurrences all number
    8
    13
    9
    11
    Nasal disorder
         subjects affected / exposed
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    1 / 308 (0.32%)
         occurrences all number
    0
    0
    0
    1
    Oropharyngeal pain
         subjects affected / exposed
    2 / 304 (0.66%)
    0 / 304 (0.00%)
    2 / 304 (0.66%)
    0 / 308 (0.00%)
         occurrences all number
    2
    0
    2
    0
    Respiratory disorder
         subjects affected / exposed
    1 / 304 (0.33%)
    1 / 304 (0.33%)
    0 / 304 (0.00%)
    0 / 308 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Rhinitis allergic
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 304 (0.33%)
    1 / 304 (0.33%)
    1 / 308 (0.32%)
         occurrences all number
    0
    1
    1
    1
    Rhinorrhoea
         subjects affected / exposed
    22 / 304 (7.24%)
    17 / 304 (5.59%)
    21 / 304 (6.91%)
    13 / 308 (4.22%)
         occurrences all number
    27
    22
    25
    13
    Stridor
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 304 (0.33%)
    0 / 304 (0.00%)
    0 / 308 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Tonsillar hypertrophy
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 304 (0.33%)
    0 / 304 (0.00%)
    0 / 308 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Wheezing
         subjects affected / exposed
    2 / 304 (0.66%)
    4 / 304 (1.32%)
    4 / 304 (1.32%)
    1 / 308 (0.32%)
         occurrences all number
    2
    4
    4
    1
    Psychiatric disorders
    Aggression
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    0 / 308 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Insomnia
         subjects affected / exposed
    2 / 304 (0.66%)
    2 / 304 (0.66%)
    0 / 304 (0.00%)
    0 / 308 (0.00%)
         occurrences all number
    2
    3
    0
    0
    Irritability
         subjects affected / exposed
    181 / 304 (59.54%)
    142 / 304 (46.71%)
    150 / 304 (49.34%)
    153 / 308 (49.68%)
         occurrences all number
    185
    142
    152
    154
    Middle insomnia
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    0 / 308 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Investigations
    Bacterial test negative
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    0 / 308 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Blood iron decreased
         subjects affected / exposed
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    1 / 308 (0.32%)
         occurrences all number
    0
    0
    0
    1
    Cardiac murmur
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    0 / 308 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Injury, poisoning and procedural complications
    Accidental exposure to product by child
         subjects affected / exposed
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    1 / 304 (0.33%)
    0 / 308 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Arthropod bite
         subjects affected / exposed
    1 / 304 (0.33%)
    2 / 304 (0.66%)
    1 / 304 (0.33%)
    2 / 308 (0.65%)
         occurrences all number
    1
    2
    1
    2
    Arthropod sting
         subjects affected / exposed
    2 / 304 (0.66%)
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    0 / 308 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Burns second degree
         subjects affected / exposed
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    1 / 304 (0.33%)
    0 / 308 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Concussion
         subjects affected / exposed
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    1 / 308 (0.32%)
         occurrences all number
    0
    0
    0
    1
    Contusion
         subjects affected / exposed
    4 / 304 (1.32%)
    1 / 304 (0.33%)
    0 / 304 (0.00%)
    1 / 308 (0.32%)
         occurrences all number
    4
    1
    0
    1
    Corneal abrasion
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 304 (0.33%)
    0 / 304 (0.00%)
    0 / 308 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Excoriation
         subjects affected / exposed
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    1 / 304 (0.33%)
    0 / 308 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Fall
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    0 / 308 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Head injury
         subjects affected / exposed
    2 / 304 (0.66%)
    2 / 304 (0.66%)
    2 / 304 (0.66%)
    5 / 308 (1.62%)
         occurrences all number
    3
    2
    5
    5
    Laceration
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 304 (0.33%)
    0 / 304 (0.00%)
    1 / 308 (0.32%)
         occurrences all number
    0
    1
    0
    1
    Lip injury
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    0 / 308 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Mouth injury
         subjects affected / exposed
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    1 / 304 (0.33%)
    0 / 308 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Muscle strain
         subjects affected / exposed
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    1 / 308 (0.32%)
         occurrences all number
    0
    0
    0
    1
    Thermal burn
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    1 / 308 (0.32%)
         occurrences all number
    1
    0
    0
    1
    Tongue injury
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 304 (0.33%)
    0 / 304 (0.00%)
    0 / 308 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Wound
         subjects affected / exposed
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    1 / 308 (0.32%)
         occurrences all number
    0
    0
    0
    1
    Congenital, familial and genetic disorders
    Laryngomalacia
         subjects affected / exposed
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    1 / 308 (0.32%)
         occurrences all number
    0
    0
    0
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    1 / 308 (0.32%)
         occurrences all number
    0
    0
    0
    1
    Drooling
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    0 / 308 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Lethargy
         subjects affected / exposed
    1 / 304 (0.33%)
    1 / 304 (0.33%)
    0 / 304 (0.00%)
    1 / 308 (0.32%)
         occurrences all number
    2
    1
    0
    1
    Somnolence
         subjects affected / exposed
    133 / 304 (43.75%)
    106 / 304 (34.87%)
    113 / 304 (37.17%)
    109 / 308 (35.39%)
         occurrences all number
    133
    106
    114
    110
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 304 (0.33%)
    1 / 304 (0.33%)
    2 / 308 (0.65%)
         occurrences all number
    0
    1
    1
    2
    Iron deficiency anaemia
         subjects affected / exposed
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    1 / 304 (0.33%)
    1 / 308 (0.32%)
         occurrences all number
    0
    0
    1
    1
    Leukocytosis
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    1 / 308 (0.32%)
         occurrences all number
    1
    0
    0
    1
    Lymphadenopathy
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 304 (0.00%)
    1 / 304 (0.33%)
    2 / 308 (0.65%)
         occurrences all number
    1
    0
    1
    2
    Ear and labyrinth disorders
    Auricular pseudocyst
         subjects affected / exposed
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    1 / 308 (0.32%)
         occurrences all number
    0
    0
    0
    1
    Cerumen impaction
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 304 (0.33%)
    2 / 304 (0.66%)
    2 / 308 (0.65%)
         occurrences all number
    0
    1
    2
    2
    Ear pain
         subjects affected / exposed
    1 / 304 (0.33%)
    1 / 304 (0.33%)
    3 / 304 (0.99%)
    2 / 308 (0.65%)
         occurrences all number
    1
    1
    3
    2
    Eustachian tube dysfunction
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 304 (0.33%)
    0 / 304 (0.00%)
    0 / 308 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Tympanic membrane perforation
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    0 / 308 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Eye disorders
    Conjunctivitis
         subjects affected / exposed
    9 / 304 (2.96%)
    3 / 304 (0.99%)
    0 / 304 (0.00%)
    4 / 308 (1.30%)
         occurrences all number
    9
    3
    0
    4
    Dark circles under eyes
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    0 / 308 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Eye allergy
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 304 (0.33%)
    0 / 304 (0.00%)
    0 / 308 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Eye swelling
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 304 (0.33%)
    0 / 304 (0.00%)
    0 / 308 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Lacrimation increased
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    1 / 308 (0.32%)
         occurrences all number
    1
    0
    0
    1
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 304 (0.33%)
    0 / 304 (0.00%)
    0 / 308 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Abdominal distension
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 304 (0.33%)
    0 / 304 (0.00%)
    0 / 308 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Abdominal pain upper
         subjects affected / exposed
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    1 / 304 (0.33%)
    0 / 308 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Aphthous stomatitis
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 304 (0.33%)
    0 / 304 (0.00%)
    0 / 308 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Bowel movement irregularity
         subjects affected / exposed
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    1 / 308 (0.32%)
         occurrences all number
    0
    0
    0
    1
    Colitis
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    0 / 308 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Constipation
         subjects affected / exposed
    3 / 304 (0.99%)
    1 / 304 (0.33%)
    4 / 304 (1.32%)
    3 / 308 (0.97%)
         occurrences all number
    3
    1
    5
    3
    Diarrhoea
         subjects affected / exposed
    25 / 304 (8.22%)
    24 / 304 (7.89%)
    19 / 304 (6.25%)
    21 / 308 (6.82%)
         occurrences all number
    29
    29
    21
    22
    Diarrhoea haemorrhagic
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 304 (0.33%)
    0 / 304 (0.00%)
    0 / 308 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Dysphagia
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    0 / 308 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Enteritis
         subjects affected / exposed
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    1 / 304 (0.33%)
    0 / 308 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Faeces discoloured
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 304 (0.33%)
    0 / 304 (0.00%)
    0 / 308 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Flatulence
         subjects affected / exposed
    2 / 304 (0.66%)
    1 / 304 (0.33%)
    2 / 304 (0.66%)
    2 / 308 (0.65%)
         occurrences all number
    3
    1
    3
    2
    Gastritis
         subjects affected / exposed
    1 / 304 (0.33%)
    1 / 304 (0.33%)
    0 / 304 (0.00%)
    0 / 308 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    0 / 308 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Proctalgia
         subjects affected / exposed
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    1 / 304 (0.33%)
    0 / 308 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Stomatitis
         subjects affected / exposed
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    1 / 304 (0.33%)
    0 / 308 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Teething
         subjects affected / exposed
    35 / 304 (11.51%)
    35 / 304 (11.51%)
    37 / 304 (12.17%)
    35 / 308 (11.36%)
         occurrences all number
    40
    41
    47
    40
    Tongue disorder
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    0 / 308 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Tooth discolouration
         subjects affected / exposed
    1 / 304 (0.33%)
    2 / 304 (0.66%)
    1 / 304 (0.33%)
    2 / 308 (0.65%)
         occurrences all number
    1
    2
    2
    7
    Vomiting
         subjects affected / exposed
    13 / 304 (4.28%)
    11 / 304 (3.62%)
    13 / 304 (4.28%)
    12 / 308 (3.90%)
         occurrences all number
    15
    13
    14
    13
    Skin and subcutaneous tissue disorders
    Blister
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 304 (0.00%)
    1 / 304 (0.33%)
    0 / 308 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Dermatitis
         subjects affected / exposed
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    1 / 304 (0.33%)
    0 / 308 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Dermatitis atopic
         subjects affected / exposed
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    1 / 308 (0.32%)
         occurrences all number
    0
    0
    0
    1
    Dermatitis diaper
         subjects affected / exposed
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    1 / 304 (0.33%)
    1 / 308 (0.32%)
         occurrences all number
    0
    0
    1
    1
    Eczema
         subjects affected / exposed
    1 / 304 (0.33%)
    1 / 304 (0.33%)
    0 / 304 (0.00%)
    1 / 308 (0.32%)
         occurrences all number
    1
    1
    0
    1
    Erythema
         subjects affected / exposed
    46 / 304 (15.13%)
    48 / 304 (15.79%)
    43 / 304 (14.14%)
    49 / 308 (15.91%)
         occurrences all number
    46
    49
    43
    49
    Hyperhidrosis
         subjects affected / exposed
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    2 / 304 (0.66%)
    0 / 308 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Petechiae
         subjects affected / exposed
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    1 / 304 (0.33%)
    0 / 308 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Pruritus
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 304 (0.33%)
    0 / 304 (0.00%)
    0 / 308 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Rash
         subjects affected / exposed
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    1 / 304 (0.33%)
    0 / 308 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Rash macular
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    0 / 308 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Seborrhoea
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 304 (0.33%)
    0 / 304 (0.00%)
    0 / 308 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Seborrhoeic dermatitis
         subjects affected / exposed
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    1 / 304 (0.33%)
    0 / 308 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Skin discolouration
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    0 / 308 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Renal and urinary disorders
    Ketonuria
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    0 / 308 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Knee deformity
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 304 (0.00%)
    1 / 304 (0.33%)
    0 / 308 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Musculoskeletal pain
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 304 (0.33%)
    0 / 304 (0.00%)
    0 / 308 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Pain in extremity
         subjects affected / exposed
    2 / 304 (0.66%)
    0 / 304 (0.00%)
    1 / 304 (0.33%)
    1 / 308 (0.32%)
         occurrences all number
    2
    0
    1
    1
    Infections and infestations
    Abscess
         subjects affected / exposed
    1 / 304 (0.33%)
    1 / 304 (0.33%)
    0 / 304 (0.00%)
    1 / 308 (0.32%)
         occurrences all number
    1
    1
    0
    1
    Acarodermatitis
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 304 (0.33%)
    0 / 304 (0.00%)
    0 / 308 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Acute sinusitis
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 304 (0.33%)
    1 / 304 (0.33%)
    0 / 308 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Acute tonsillitis
         subjects affected / exposed
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    1 / 304 (0.33%)
    0 / 308 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Bacteraemia
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    0 / 308 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Body tinea
         subjects affected / exposed
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    1 / 304 (0.33%)
    0 / 308 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Bronchiolitis
         subjects affected / exposed
    3 / 304 (0.99%)
    1 / 304 (0.33%)
    2 / 304 (0.66%)
    5 / 308 (1.62%)
         occurrences all number
    3
    1
    2
    5
    Bronchitis
         subjects affected / exposed
    2 / 304 (0.66%)
    0 / 304 (0.00%)
    1 / 304 (0.33%)
    3 / 308 (0.97%)
         occurrences all number
    2
    0
    1
    3
    Bronchitis viral
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 304 (0.33%)
    0 / 304 (0.00%)
    0 / 308 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Candidiasis
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    2 / 308 (0.65%)
         occurrences all number
    1
    0
    0
    2
    Cellulitis
         subjects affected / exposed
    0 / 304 (0.00%)
    2 / 304 (0.66%)
    1 / 304 (0.33%)
    1 / 308 (0.32%)
         occurrences all number
    0
    2
    1
    1
    Conjunctivitis infective
         subjects affected / exposed
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    1 / 304 (0.33%)
    0 / 308 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Croup infectious
         subjects affected / exposed
    4 / 304 (1.32%)
    3 / 304 (0.99%)
    6 / 304 (1.97%)
    3 / 308 (0.97%)
         occurrences all number
    5
    3
    6
    3
    Ear infection
         subjects affected / exposed
    3 / 304 (0.99%)
    1 / 304 (0.33%)
    1 / 304 (0.33%)
    3 / 308 (0.97%)
         occurrences all number
    3
    1
    1
    3
    Enterovirus infection
         subjects affected / exposed
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    1 / 304 (0.33%)
    0 / 308 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Fungal infection
         subjects affected / exposed
    2 / 304 (0.66%)
    2 / 304 (0.66%)
    0 / 304 (0.00%)
    1 / 308 (0.32%)
         occurrences all number
    2
    2
    0
    1
    Gastroenteritis
         subjects affected / exposed
    2 / 304 (0.66%)
    5 / 304 (1.64%)
    2 / 304 (0.66%)
    5 / 308 (1.62%)
         occurrences all number
    2
    5
    2
    5
    Gastroenteritis viral
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 304 (0.33%)
    2 / 304 (0.66%)
    0 / 308 (0.00%)
         occurrences all number
    0
    1
    2
    0
    Gingivitis
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 304 (0.33%)
    0 / 304 (0.00%)
    0 / 308 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Hand-foot-and-mouth disease
         subjects affected / exposed
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    1 / 308 (0.32%)
         occurrences all number
    0
    0
    0
    1
    Herpangina
         subjects affected / exposed
    2 / 304 (0.66%)
    1 / 304 (0.33%)
    1 / 304 (0.33%)
    0 / 308 (0.00%)
         occurrences all number
    2
    1
    1
    0
    Hordeolum
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    0 / 308 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Impetigo
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 304 (0.33%)
    0 / 304 (0.00%)
    0 / 308 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Infected bites
         subjects affected / exposed
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    1 / 308 (0.32%)
         occurrences all number
    0
    0
    0
    1
    Influenza
         subjects affected / exposed
    1 / 304 (0.33%)
    3 / 304 (0.99%)
    2 / 304 (0.66%)
    0 / 308 (0.00%)
         occurrences all number
    1
    3
    2
    0
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    1 / 308 (0.32%)
         occurrences all number
    0
    0
    0
    1
    Molluscum contagiosum
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 304 (0.33%)
    0 / 304 (0.00%)
    1 / 308 (0.32%)
         occurrences all number
    0
    1
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    10 / 304 (3.29%)
    8 / 304 (2.63%)
    13 / 304 (4.28%)
    9 / 308 (2.92%)
         occurrences all number
    11
    9
    14
    9
    Oral candidiasis
         subjects affected / exposed
    3 / 304 (0.99%)
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    0 / 308 (0.00%)
         occurrences all number
    3
    0
    0
    0
    Oral herpes
         subjects affected / exposed
    2 / 304 (0.66%)
    0 / 304 (0.00%)
    1 / 304 (0.33%)
    0 / 308 (0.00%)
         occurrences all number
    2
    0
    1
    0
    Otitis externa
         subjects affected / exposed
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    1 / 304 (0.33%)
    0 / 308 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Otitis media
         subjects affected / exposed
    25 / 304 (8.22%)
    25 / 304 (8.22%)
    29 / 304 (9.54%)
    24 / 308 (7.79%)
         occurrences all number
    25
    26
    31
    26
    Otitis media acute
         subjects affected / exposed
    9 / 304 (2.96%)
    10 / 304 (3.29%)
    8 / 304 (2.63%)
    5 / 308 (1.62%)
         occurrences all number
    10
    13
    8
    5
    Otitis media chronic
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 304 (0.33%)
    0 / 304 (0.00%)
    1 / 308 (0.32%)
         occurrences all number
    0
    1
    0
    2
    Paronychia
         subjects affected / exposed
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    1 / 304 (0.33%)
    0 / 308 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Pharyngitis
         subjects affected / exposed
    12 / 304 (3.95%)
    7 / 304 (2.30%)
    10 / 304 (3.29%)
    6 / 308 (1.95%)
         occurrences all number
    12
    7
    10
    6
    Pharyngitis streptococcal
         subjects affected / exposed
    1 / 304 (0.33%)
    4 / 304 (1.32%)
    1 / 304 (0.33%)
    3 / 308 (0.97%)
         occurrences all number
    1
    4
    1
    3
    Pneumonia
         subjects affected / exposed
    3 / 304 (0.99%)
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    0 / 308 (0.00%)
         occurrences all number
    3
    0
    0
    0
    Pneumonia bacterial
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    0 / 308 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Respiratory syncytial virus bronchitis
         subjects affected / exposed
    2 / 304 (0.66%)
    1 / 304 (0.33%)
    0 / 304 (0.00%)
    0 / 308 (0.00%)
         occurrences all number
    2
    1
    0
    0
    Respiratory syncytial virus infection
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 304 (0.33%)
    0 / 304 (0.00%)
    0 / 308 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Rhinitis
         subjects affected / exposed
    7 / 304 (2.30%)
    4 / 304 (1.32%)
    6 / 304 (1.97%)
    4 / 308 (1.30%)
         occurrences all number
    7
    5
    8
    4
    Sinusitis
         subjects affected / exposed
    3 / 304 (0.99%)
    5 / 304 (1.64%)
    4 / 304 (1.32%)
    3 / 308 (0.97%)
         occurrences all number
    3
    5
    5
    3
    Skin infection
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 304 (0.33%)
    0 / 304 (0.00%)
    1 / 308 (0.32%)
         occurrences all number
    0
    1
    0
    1
    Staphylococcal infection
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 304 (0.33%)
    0 / 304 (0.00%)
    1 / 308 (0.32%)
         occurrences all number
    0
    1
    0
    1
    Streptococcal infection
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 304 (0.33%)
    0 / 304 (0.00%)
    0 / 308 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Subcutaneous abscess
         subjects affected / exposed
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    1 / 308 (0.32%)
         occurrences all number
    0
    0
    0
    1
    Tonsillitis
         subjects affected / exposed
    0 / 304 (0.00%)
    2 / 304 (0.66%)
    1 / 304 (0.33%)
    0 / 308 (0.00%)
         occurrences all number
    0
    2
    1
    0
    Upper respiratory tract infection
         subjects affected / exposed
    40 / 304 (13.16%)
    22 / 304 (7.24%)
    39 / 304 (12.83%)
    43 / 308 (13.96%)
         occurrences all number
    40
    25
    40
    46
    Urinary tract infection
         subjects affected / exposed
    0 / 304 (0.00%)
    1 / 304 (0.33%)
    1 / 304 (0.33%)
    1 / 308 (0.32%)
         occurrences all number
    0
    1
    1
    1
    Viral infection
         subjects affected / exposed
    7 / 304 (2.30%)
    8 / 304 (2.63%)
    9 / 304 (2.96%)
    11 / 308 (3.57%)
         occurrences all number
    7
    8
    9
    11
    Viral pharyngitis
         subjects affected / exposed
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    1 / 304 (0.33%)
    0 / 308 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Viral rash
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    0 / 308 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Viral upper respiratory tract infection
         subjects affected / exposed
    1 / 304 (0.33%)
    1 / 304 (0.33%)
    0 / 304 (0.00%)
    0 / 308 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Vulvovaginitis
         subjects affected / exposed
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    1 / 308 (0.32%)
         occurrences all number
    0
    0
    0
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    111 / 304 (36.51%)
    77 / 304 (25.33%)
    110 / 304 (36.18%)
    95 / 308 (30.84%)
         occurrences all number
    112
    78
    111
    96
    Dehydration
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    0 / 308 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Feeding disorder of infancy or early childhood
         subjects affected / exposed
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    1 / 308 (0.32%)
         occurrences all number
    0
    0
    0
    1
    Lactose intolerance
         subjects affected / exposed
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    1 / 304 (0.33%)
    1 / 308 (0.32%)
         occurrences all number
    0
    0
    1
    1
    Polydipsia
         subjects affected / exposed
    1 / 304 (0.33%)
    0 / 304 (0.00%)
    0 / 304 (0.00%)
    0 / 308 (0.00%)
         occurrences all number
    1
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    29 Jun 2010
    •Update Sponsor contact details for reporting SAEs and for emergency unblinding. •Clarify the timeframe to which medications, treatments and/or vaccinations are to be recorded in the eCRF. •Clarify the that the second dose of Havrix is not a part of the study procedures, but is recorded in the eCRF.
    29 Apr 2011
    Clarify/require the collection of any subsequent MMR vaccinations through visit 5. Change/update the interim analysis from a yearly persistence analysis to a 2 year analysis.

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

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

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