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    Clinical Trial Results:
    A phase IIIA, randomized, observer-blind, controlled, multinational study to evaluate the immunogenicity and safety of GSK Biologicals' MMR vaccine (209762) (Priorix) at an end of shelf-life potency compared to Merck & Co., Inc.’s MMR vaccine (M-M-R II), when both are co-administered with Varivax, Havrix and Prevnar 13 (subset of children), and given on a two-dose schedule to healthy children in their second year of life

    Summary
    EudraCT number
    		 2011-004905-26
    Trial protocol
    		 FI   CZ   ES  
    Global end of trial date
    18 Aug 2015

    Results information
    Results version number
    		 v2(current)
    This version publication date
    04 Aug 2018
    First version publication date
    15 Jan 2017
    Other versions
    		 v1
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    115649
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01681992
    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 Disclosure Advisor, GlaxoSmithKline Biologicals, 44 2089904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Disclosure Advisor, GlaxoSmithKline Biologicals, 44 2089904466, GSKClinicalSupportHD@gsk.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    14 Sep 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Aug 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    1. To demonstrate non-inferiority of Inv_MMR_Min vaccine compared to pooled Com_MMR vaccine in terms of seroresponse rates & GMCs for antibodies to MMR viruses at Day 42. 2. To demonstrate an acceptable immune response of Inv_MMR_Min & Inv_MMR_Med vaccine in terms of seroresponse rates for MMR viruses at Day 42. 3. To demonstrate non-inferiority of Inv_MMR_Min vaccine compared to pooled Com_MMR vaccine in terms of seroresponse rates & GMTs for antibodies to mumps virus (by PRNT) at Day 42. 4. To demonstrate non-inferiority of Inv_MMR_Med vaccine compared to pooled Com_MMR vaccine in terms of seroresponse rates & GMCs for antibodies to MMR viruses at Day 42. 5. To demonstrate non-inferiority of Inv_MMR_Med vaccine compared to pooled Com_MMR vaccine in terms of seroresponse rates & GMTs for antibodies to mumps virus (by PRNT) at Day 42.
    Protection of trial subjects
    All subjects were observed closely for at least 30 minutes following the administration of vaccines with appropriate medical treatment readily available in case of a rare anaphylactic reaction.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    10 Oct 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Czech Republic: 700
    Country: Number of subjects enrolled
    Finland: 421
    Country: Number of subjects enrolled
    Malaysia: 134
    Country: Number of subjects enrolled
    Spain: 1300
    Country: Number of subjects enrolled
    Thailand: 966
    Country: Number of subjects enrolled
    United States: 1017
    Worldwide total number of subjects
    4538
    EEA total number of subjects
    2421
    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)
    4538
    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
    		 US sub-cohort: Subjects recruited in US and received Inv_MMR_Min or Inv_MMR_Med or Com_MMR (Lot 1 or 2) co-administered with Varivax (VV), Havrix (HAV) and Prevnar 13 (PCV-13) at Day 0. Non-US sub-cohort: Subjects recruited outside US and received Inv_MMR_Min or Inv_MMR_Med or Com_MMR (Lot 1 or 2) co-administered with VV and HAV at Day 0.

    Pre-assignment
    Screening details
    		 4538 subjects were registered in the study. 3 subjects were excluded because of invalid Informed Consent Forms and 19 subjects received a subject number but were not vaccinated. Therefore, the number of subjects started is 4516.

    Pre-assignment period milestones
    Number of subjects started
    		 4538
    Number of subjects completed
    		 4516

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Subject number allocated but not vaccinated: 19
    Reason: Number of subjects
    		 Invalid Informed Consent Forms: 3
    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind [1]
    Roles blinded
    		 Subject, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    The study was conducted in a double-blind fashion with regard to the two Inv_MMR vaccine lots (Inv_MMR_Min and Inv_MMR_Med) and in an observer-blind fashion for the lots of Inv_MMR vaccine versus the pooled Com_MMR vaccine lots. By observer-blind, it is meant that during the course of the study, the vaccine recipient and those responsible for the evaluation of any study endpoint were all unaware of which vaccine was administered.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Inv_MMR_Min Group
    Arm description
    		 Subjects received one dose of GlaxoSmithKline (GSK) Biologicals’ measles, mumps, rubella (MMR) vaccine, Priorix (Inv_MMR), from a minimum potency lot (Inv_MMR_Min), co-administered with Varivax (VV) and Havrix (HAV) vaccines at Day 0. All US subjects were also co-administered Prevnar 13 (PCV-13) vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv_MMR vaccine (Inv_MMR_Release), for the second dose. Inv_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Priorix
    Investigational medicinal product code
    Other name
    GSK Biologicals’ live attenuated measles, mumps, rubella vaccine
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received one dose of either minimum (Inv_MMR_Min) or medium (Inv_MMR_Med) potency lot at Day 0 and a dose of separate potency lot (Inv_MMR_Release) at Day 42, administered subcutaneously in the triceps region of the left arm.

    Investigational medicinal product name
    Varivax
    Investigational medicinal product code
    Other name
    Merck & Co., Inc.’s varicella virus vaccine, live
    Pharmaceutical forms
    Powder and solvent for solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received one dose co-administered subcutaneously with the study vaccines (Priorix and M-M-R II), in the triceps region of right arm, at Day 0.

    Investigational medicinal product name
    Havrix
    Investigational medicinal product code
    Other name
    GSK Biologicals’ hepatitis A vaccine, inactivated
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received one dose co-administered intramuscularly with the study vaccines (Priorix and M-M-R II), in the anterolateral region of the right thigh, at Day 0.

    Investigational medicinal product name
    Prevnar 13
    Investigational medicinal product code
    Other name
    Pfizer Inc.’s pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein)
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    US Subjects received one dose co-administered intramuscularly with the study vaccines (Priorix and M-M-R II), in the anterolateral region of the left thigh, at Day 0.

    Arm title
    		 Inv_MMR_Med Group
    Arm description
    		 Subjects received one dose of GlaxoSmithKline (GSK) Biologicals’ measles, mumps, rubella (MMR) vaccine, Priorix (Inv_MMR), from a mid-range or medium potency lot (Inv_MMR_Med), co-administered with Varivax (VV) and Havrix (HAV) vaccines at Day 0. All US subjects were also co-administered Prevnar 13 (PCV-13) vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv_MMR vaccine (Inv_MMR_Release), for the second dose. Inv_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Priorix
    Investigational medicinal product code
    Other name
    GSK Biologicals’ live attenuated measles, mumps, rubella vaccine
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received one dose of either minimum (Inv_MMR_Min) or medium (Inv_MMR_Med) potency lot at Day 0 and a dose of separate potency lot (Inv_MMR_Release) at Day 42, administered subcutaneously in the triceps region of the left arm.

    Investigational medicinal product name
    Havrix
    Investigational medicinal product code
    Other name
    GSK Biologicals’ hepatitis A vaccine, inactivated
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received one dose co-administered intramuscularly with the study vaccines (Priorix and M-M-R II), in the anterolateral region of the right thigh, at Day 0.

    Investigational medicinal product name
    Prevnar 13
    Investigational medicinal product code
    Other name
    Pfizer Inc.’s pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein)
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    US Subjects received one dose co-administered intramuscularly with the study vaccines (Priorix and M-M-R II), in the anterolateral region of the left thigh, at Day 0.

    Investigational medicinal product name
    Varivax
    Investigational medicinal product code
    Other name
    Merck & Co., Inc.’s varicella virus vaccine, live
    Pharmaceutical forms
    Powder and solvent for solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received one dose co-administered subcutaneously with the study vaccines (Priorix and M-M-R II), in the triceps region of right arm, at Day 0.

    Arm title
    		 Com_MMR Group
    Arm description
    		 Subjects received one dose of M-M-R II (Com_MMR) vaccine (Lot 1 or Lot 2), co-administered with Varivax (VV) and Havrix (HAV) vaccines at Day 0. All US subjects were also co-administered Prevnar 13 (PCV-13) vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    M-M-R II
    Investigational medicinal product code
    Other name
    Merck & Co., Inc.’s measles, mumps, rubella virus vaccine, live
    Pharmaceutical forms
    Powder and solvent for suspension for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received two doses of either Lot 1 or Lot 2, one at Day 0 and one at Day 42, administered subcutaneously in the triceps region of the left arm.

    Investigational medicinal product name
    Varivax
    Investigational medicinal product code
    Other name
    Merck & Co., Inc.’s varicella virus vaccine, live
    Pharmaceutical forms
    Powder and solvent for solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received one dose co-administered subcutaneously with the study vaccines (Priorix and M-M-R II), in the triceps region of right arm, at Day 0.

    Investigational medicinal product name
    Havrix
    Investigational medicinal product code
    Other name
    GSK Biologicals’ hepatitis A vaccine, inactivated
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received one dose co-administered intramuscularly with the study vaccines (Priorix and M-M-R II), in the anterolateral region of the right thigh, at Day 0.

    Investigational medicinal product name
    Prevnar 13
    Investigational medicinal product code
    Other name
    Pfizer Inc.’s pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein)
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    US Subjects received one dose co-administered intramuscularly with the study vaccines (Priorix and M-M-R II), in the anterolateral region of the left thigh, at Day 0.

    Notes
    [1] - The roles blinded appear to be inconsistent with a double blind trial.
    Justification: The study was conducted in a double-blind fashion with regard to the two Inv_MMR vaccine lots (Inv_MMR_Min and Inv_MMR_Med) and in an observer-blind fashion for the lots of Inv_MMR vaccine versus the pooled Com_MMR vaccine lots.
    Number of subjects in period 1 [2]
    		Inv_MMR_Min Group Inv_MMR_Med Group Com_MMR Group
    Started
    1493
    1497
    1526
    Completed
    1427
    1427
    1443
    Not completed
    66
    70
    83
         Consent withdrawn by subject
    27
    30
    25
         Adverse event, non-fatal
    3
    2
    3
         As Per Sponsor Decision
    -
    -
    1
         Lost to follow-up
    36
    38
    53
         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: 4538 subjects were registered in the study. 3 subjects were excluded because of invalid Informed Consent Forms and 19 subjects received a subject number but were not vaccinated. Therefore, the number of subjects started is 4516.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Inv_MMR_Min Group
    Reporting group description
    		 Subjects received one dose of GlaxoSmithKline (GSK) Biologicals’ measles, mumps, rubella (MMR) vaccine, Priorix (Inv_MMR), from a minimum potency lot (Inv_MMR_Min), co-administered with Varivax (VV) and Havrix (HAV) vaccines at Day 0. All US subjects were also co-administered Prevnar 13 (PCV-13) vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv_MMR vaccine (Inv_MMR_Release), for the second dose. Inv_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.

    Reporting group title
    Inv_MMR_Med Group
    Reporting group description
    		 Subjects received one dose of GlaxoSmithKline (GSK) Biologicals’ measles, mumps, rubella (MMR) vaccine, Priorix (Inv_MMR), from a mid-range or medium potency lot (Inv_MMR_Med), co-administered with Varivax (VV) and Havrix (HAV) vaccines at Day 0. All US subjects were also co-administered Prevnar 13 (PCV-13) vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv_MMR vaccine (Inv_MMR_Release), for the second dose. Inv_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.

    Reporting group title
    Com_MMR Group
    Reporting group description
    		 Subjects received one dose of M-M-R II (Com_MMR) vaccine (Lot 1 or Lot 2), co-administered with Varivax (VV) and Havrix (HAV) vaccines at Day 0. All US subjects were also co-administered Prevnar 13 (PCV-13) vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.

    Reporting group values
    		 Inv_MMR_Min Group Inv_MMR_Med Group Com_MMR Group Total
    Number of subjects
    		 1493 1497 1526
    Age categorical
    Units: Subjects
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    		 12.6 ± 0.9 12.6 ± 0.9 12.6 ± 0.9 -
    Gender categorical
    Units: Subjects
        Female
    		 704 718 758 2180
        Male
    		 789 779 768 2336
    Race/Ethnicity, Customized
    Units: Subjects
        African Heritage / African American
    		 45 53 46 144
        American Indian or Alaskan Native
    		 2 1 1 4
        Asian - Central/South Asian Heritage
    		 1 0 2 3
        Asian - East Asian Heritage
    		 3 0 1 4
        Asian - South East Asian Heritage
    		 362 366 367 1095
        Native Hawaiian or Other Pacific Islander
    		 0 1 0 1
        White - Arabic / North African Heritage
    		 8 8 8 24
        White - Caucasian / European Heritage
    		 1017 1022 1052 3091
        Other
    		 55 46 49 150

    End points

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    End points reporting groups
    Reporting group title
    Inv_MMR_Min Group
    Reporting group description
    		 Subjects received one dose of GlaxoSmithKline (GSK) Biologicals’ measles, mumps, rubella (MMR) vaccine, Priorix (Inv_MMR), from a minimum potency lot (Inv_MMR_Min), co-administered with Varivax (VV) and Havrix (HAV) vaccines at Day 0. All US subjects were also co-administered Prevnar 13 (PCV-13) vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv_MMR vaccine (Inv_MMR_Release), for the second dose. Inv_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.

    Reporting group title
    Inv_MMR_Med Group
    Reporting group description
    		 Subjects received one dose of GlaxoSmithKline (GSK) Biologicals’ measles, mumps, rubella (MMR) vaccine, Priorix (Inv_MMR), from a mid-range or medium potency lot (Inv_MMR_Med), co-administered with Varivax (VV) and Havrix (HAV) vaccines at Day 0. All US subjects were also co-administered Prevnar 13 (PCV-13) vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv_MMR vaccine (Inv_MMR_Release), for the second dose. Inv_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.

    Reporting group title
    Com_MMR Group
    Reporting group description
    		 Subjects received one dose of M-M-R II (Com_MMR) vaccine (Lot 1 or Lot 2), co-administered with Varivax (VV) and Havrix (HAV) vaccines at Day 0. All US subjects were also co-administered Prevnar 13 (PCV-13) vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.

    Primary: Percentage of subjects with anti-measles virus antibody concentration equal to or above the cut-off-value (by enzyme-linked immunosorbent assay [ELISA])

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    End point title
    		 Percentage of subjects with anti-measles virus antibody concentration equal to or above the cut-off-value (by enzyme-linked immunosorbent assay [ELISA])
    End point description
    For measles virus, a seroresponse was defined as post-vaccination anti-measles virus antibody concentration equal or above [≥] 200 mIU/mL (ELISA) among subjects who were seronegative (antibody concentration less than [<] 150 mIU/mL) before dose 1. Criteria to demonstrate an acceptable immune response of Inv_MMR_Min/Inv_MMR_Med vaccine in terms of seroresponse rate for measles virus at Day 42: The lower limit of the two-sided 97.5% CI for the seroresponse rate of Inv_MMR_Min/Inv_MMR_Med was to be ≥ 90% for antibodies to measles virus.
    End point type
    Primary
    End point timeframe
    At Day 42
    End point values
    		 Inv_MMR_Min Group Inv_MMR_Med Group Com_MMR Group
    Number of subjects analysed
    1361
    1366
    1378
    Units: Percentage of subjects
    number (confidence interval 97.5%)
        Anti-measles ≥ 150 mIU/mL
    90.9 (89.0 to 92.6)
    94.3 (92.7 to 95.6)
    96.5 (95.2 to 97.5)
        Anti-measles ≥ 200 mIU/mL
    90.8 (88.9 to 92.5)
    94.2 (92.6 to 95.5)
    96.3 (95.0 to 97.3)
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Non-inferiority of Inv_MMR_Min vaccine compared to Com_MMR vaccine in terms of seroresponse rate to measles virus at Day 42.
    Comparison groups
    Inv_MMR_Min Group v Com_MMR Group
    Number of subjects included in analysis
    2739
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    Method
    Parameter type
    		 Difference in seroresponse rate
    Point estimate
    -5.48
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 -7.65
         upper limit
    		 -3.43
    Notes
    [1] - The lower limit of the 2-sided 97.5% confidence interval (CI) on the group difference (Inv_MMR_Min minus Com_MMR) in seroresponse rate should be ≥ -5% for antibodies to measles virus when tested with ELISA.
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    Non-inferiority of Inv_MMR_Med vaccine compared to Com_MMR vaccine in terms of seroresponse rate to measles virus at Day 42.
    Comparison groups
    Com_MMR Group v Inv_MMR_Med Group
    Number of subjects included in analysis
    2744
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [2]
    Method
    Parameter type
    		 Difference in seroresponse rate
    Point estimate
    -2.08
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 -3.96
         upper limit
    		 -0.27
    Notes
    [2] - The lower limit of the 2-sided 97.5% confidence interval (CI) on the group difference (Inv_MMR_Med minus Com_MMR) in seroresponse rate should be ≥ -5% for antibodies to measles virus when tested with ELISA.

    Primary: Percentage of subjects with anti-mumps virus antibody concentration equal to or above the cut-off-value (by ELISA)

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    End point title
    		 Percentage of subjects with anti-mumps virus antibody concentration equal to or above the cut-off-value (by ELISA)
    End point description
    For mumps virus, a seroresponse was defined as post-vaccination anti-mumps virus antibody concentration ≥ 10 EU/mL (ELISA) among subjects who were seronegative (antibody concentration < 5 EU/mL) before dose 1. Criteria to demonstrate an acceptable immune response of Inv_MMR_Min/Inv_MMR_Med vaccine in terms of seroresponse rate for mumps virus at Day 42: The lower limit of the two-sided 97.5% CI for the seroresponse rate of Inv_MMR_Min/Inv_MMR_Med was to be ≥ 90% for antibodies to mumps virus.
    End point type
    Primary
    End point timeframe
    At Day 42
    End point values
    		 Inv_MMR_Min Group Inv_MMR_Med Group Com_MMR Group
    Number of subjects analysed
    1161
    1131
    1155
    Units: Percentage of subjects
    number (confidence interval 97.5%)
        Anti-mumps ≥ 5 EU/mL
    99.1 (98.2 to 99.6)
    99.0 (98.1 to 99.6)
    99.2 (98.4 to 99.7)
        Anti-mumps ≥ 10 EU/mL
    97.4 (96.2 to 98.3)
    97.3 (96.0 to 98.2)
    97.8 (96.7 to 98.7)
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    Non-inferiority of Inv_MMR_Med vaccine compared to Com_MMR vaccine in terms of seroresponse rate to mumps virus at Day 42.
    Comparison groups
    Com_MMR Group v Inv_MMR_Med Group
    Number of subjects included in analysis
    2286
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [3]
    Method
    Parameter type
    		 Difference in seroresponse rate
    Point estimate
    -0.58
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 -2.11
         upper limit
    		 0.91
    Notes
    [3] - The lower limit of the 2-sided 97.5% CI on the group difference (Inv_MMR_Med minus Com_MMR) in seroresponse rate should be ≥ -5% for antibodies to mumps virus when tested with ELISA.
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Non-inferiority of Inv_MMR_Min vaccine compared to Com_MMR vaccine in terms of seroresponse rate to mumps virus at Day 42.
    Comparison groups
    Com_MMR Group v Inv_MMR_Min Group
    Number of subjects included in analysis
    2316
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [4]
    Method
    Parameter type
    		 Difference in seroresponse rate
    Point estimate
    -0.42
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 -1.91
         upper limit
    		 1.04
    Notes
    [4] - The lower limit of the 2-sided 97.5% CI on the group difference (Inv_MMR_Min minus Com_MMR) in seroresponse rate should be ≥ -5% for antibodies to mumps virus when tested with ELISA.

    Primary: Percentage of subjects with anti-mumps virus antibody concentration equal to or above the cut-off-value (by Plaque Reduction Neutralization Test [PRNT])

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    End point title
    		 Percentage of subjects with anti-mumps virus antibody concentration equal to or above the cut-off-value (by Plaque Reduction Neutralization Test [PRNT])
    End point description
    For mumps virus as measured by PRNT, a seroresponse was defined as post-vaccination anti-mumps virus antibody concentration ≥ 4 End point Dilution 50% (ED50) (PRNT) among subjects who were seronegative (antibody concentration < 2.5 ED50) before dose 1.
    End point type
    Primary
    End point timeframe
    At Day 42
    End point values
    		 Inv_MMR_Min Group Inv_MMR_Med Group Com_MMR Group
    Number of subjects analysed
    1252
    1265
    1287
    Units: Percentage of subjects
    number (confidence interval 95%)
        ≥ 2.5 ED50
    79.1 (76.7 to 81.3)
    81.6 (79.3 to 83.7)
    87.5 (85.6 to 89.2)
        ≥ 4 ED50
    71.2 (68.6 to 73.7)
    73.4 (70.8 to 75.8)
    80.6 (78.3 to 82.7)
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Non-inferiority of Inv_MMR_Min vaccine compared to Com_MMR vaccine in terms of seroresponse rate to mumps virus at Day 42.
    Comparison groups
    Inv_MMR_Min Group v Com_MMR Group
    Number of subjects included in analysis
    2539
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [5]
    Method
    Parameter type
    		 Difference in seroresponse rate
    Point estimate
    -9.41
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 -13.2
         upper limit
    		 -5.62
    Notes
    [5] - The lower limit of the 2-sided 97.5% CI on the group difference (Inv_MMR_Min minus Com_MMR) in seroresponse rate should be ≥ -10% for antibodies to mumps virus when tested with PRNT.
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    Non-inferiority of Inv_MMR_Med vaccine compared to Com_MMR vaccine in terms of seroresponse rate to mumps virus at Day 42.
    Comparison groups
    Inv_MMR_Med Group v Com_MMR Group
    Number of subjects included in analysis
    2552
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [6]
    Method
    Parameter type
    		 Difference in seroresponse rate
    Point estimate
    -7.22
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 -10.94
         upper limit
    		 -3.49
    Notes
    [6] - The lower limit of the 2-sided 97.5% CI on the group difference (Inv_MMR_Med minus Com_MMR) in seroresponse rate should be ≥ -10% for antibodies to mumps virus when tested with PRNT.

    Primary: Percentage of subjects with anti-rubella virus antibody concentration equal to or above the cut-off-value (by ELISA)

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    End point title
    		 Percentage of subjects with anti-rubella virus antibody concentration equal to or above the cut-off-value (by ELISA)
    End point description
    For rubella virus, a seroresponse was defined as post-vaccination anti-rubella virus antibody concentration ≥ 10 IU/mL (ELISA) among subjects who were seronegative (antibody concentration < 4 IU/mL) before dose 1. Criteria to demonstrate an acceptable immune response of Inv_MMR_Min/Inv_MMR_Med vaccine in terms of seroresponse rate for rubella virus at Day 42: The lower limit of the two-sided 97.5% CI for the seroresponse rate of Inv_MMR_Min/Inv_MMR_Med was to be ≥ 90% for antibodies to mumps virus.
    End point type
    Primary
    End point timeframe
    At Day 42
    End point values
    		 Inv_MMR_Min Group Inv_MMR_Med Group Com_MMR Group
    Number of subjects analysed
    1359
    1366
    1376
    Units: Percentage of subjects
    number (confidence interval 97.5%)
        ≥ 4 IU/mL
    99.3 (98.6 to 99.7)
    99.5 (98.9 to 99.8)
    99.5 (98.9 to 99.8)
        ≥ 10 IU/mL
    96.8 (95.5 to 97.7)
    97.3 (96.1 to 98.2)
    98.5 (97.6 to 99.1)
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    Non-inferiority of Inv_MMR_Med vaccine compared to Com_MMR vaccine in terms of seroresponse rate to rubella virus at Day 42.
    Comparison groups
    Com_MMR Group v Inv_MMR_Med Group
    Number of subjects included in analysis
    2742
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [7]
    Method
    Parameter type
    		 Difference in seroresponse rate
    Point estimate
    -1.18
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 -2.5
         upper limit
    		 0.05
    Notes
    [7] - The lower limit of the 2-sided 97.5% CI on the group difference (Inv_MMR_Med minus Com_MMR) in seroresponse rate should be ≥ -5% for antibodies to rubella virus when tested with ELISA.
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Non-inferiority of Inv_MMR_Min vaccine compared to Com_MMR vaccine in terms of seroresponse rate to rubella virus at Day 42.
    Comparison groups
    Com_MMR Group v Inv_MMR_Min Group
    Number of subjects included in analysis
    2735
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [8]
    Method
    Parameter type
    		 Difference in seroresponse rate
    Point estimate
    -1.71
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 -3.11
         upper limit
    		 -0.42
    Notes
    [8] - The lower limit of the 2-sided 97.5% CI on the group difference (Inv_MMR_Min minus Com_MMR) in seroresponse rate should be ≥ -5% for antibodies to rubella virus when tested with ELISA.

    Primary: Anti-measles virus antibody concentrations (by ELISA)

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    End point title
    		 Anti-measles virus antibody concentrations (by ELISA)
    End point description
    Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) in mIU/mL.
    End point type
    Primary
    End point timeframe
    At Day 42
    End point values
    		 Inv_MMR_Min Group Inv_MMR_Med Group Com_MMR Group
    Number of subjects analysed
    1361
    1366
    1378
    Units: mIU/mL
    geometric mean (confidence interval 97.5%)
        mIU/mL
    2209.9 (2041.3 to 2392.4)
    2540.9 (2368.8 to 2725.5)
    2787.7 (2619.5 to 2966.7)
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Non-inferiority of Inv_MMR_Min vaccine compared to COM_MMR vaccine in terms of GMCs for anti-measles antibodies at Day 42.
    Comparison groups
    Com_MMR Group v Inv_MMR_Min Group
    Number of subjects included in analysis
    2739
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [9]
    Method
    		 ANOVA
    Parameter type
    		 Adjusted GMC ratio
    Point estimate
    0.79
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 0.72
         upper limit
    		 0.88
    Notes
    [9] - The lower limit of the 2-sided 97.5% CI on the group ratio of GMCs (Inv_MMR_Min over pooled Com_MMR) should to be ≥ 0.67 for antibodies to measles virus when tested with ELISA.
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    Non-inferiority of Inv_MMR_Med vaccine compared to COM_MMR vaccine in terms of GMCs for anti-measles antibodies at Day 42.
    Comparison groups
    Inv_MMR_Med Group v Com_MMR Group
    Number of subjects included in analysis
    2744
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [10]
    Method
    		 ANOVA
    Parameter type
    		 Adjusted GMC ratio
    Point estimate
    0.91
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 0.83
         upper limit
    		 1.01
    Notes
    [10] - The lower limit of the 2-sided 97.5% CI on the group ratio of GMCs (Inv_MMR_Med over pooled Com_MMR) should to be ≥ 0.67 for antibodies to measles virus when tested with ELISA.

    Primary: Anti-mumps virus antibody concentrations (by ELISA)

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    End point title
    		 Anti-mumps virus antibody concentrations (by ELISA)
    End point description
    Antibody concentrations were expressed as GMCs in EU/mL.
    End point type
    Primary
    End point timeframe
    At Day 42
    End point values
    		 Inv_MMR_Min Group Inv_MMR_Med Group Com_MMR Group
    Number of subjects analysed
    1161
    1131
    1155
    Units: EU/mL
    geometric mean (confidence interval 97.5%)
        EU/mL
    58.7 (55.5 to 62.1)
    60.2 (56.8 to 63.7)
    71.6 (67.7 to 75.8)
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    Non-inferiority of Inv_MMR_Med vaccine compared to COM_MMR vaccine in terms of GMCs for anti-mumps antibodies at Day 42.
    Comparison groups
    Inv_MMR_Med Group v Com_MMR Group
    Number of subjects included in analysis
    2286
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [11]
    Method
    		 ANOVA
    Parameter type
    		 Adjusted GMC ratio
    Point estimate
    0.84
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 0.78
         upper limit
    		 0.91
    Notes
    [11] - The lower limit of the 2-sided 97.5% CI on the group ratio of GMCs (Inv_MMR_Med over pooled Com_MMR) should to be ≥ 0.67 for antibodies to mumps virus when tested with ELISA.
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Non-inferiority of Inv_MMR_Min vaccine compared to COM_MMR vaccine in terms of GMCs for anti-mumps antibodies at Day 42.
    Comparison groups
    Inv_MMR_Min Group v Com_MMR Group
    Number of subjects included in analysis
    2316
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [12]
    Method
    		 ANOVA
    Parameter type
    		 Adjusted GMC ratio
    Point estimate
    0.82
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 0.76
         upper limit
    		 0.89
    Notes
    [12] - The lower limit of the 2-sided 97.5% CI on the group ratio of GMCs (Inv_MMR_Min over pooled Com_MMR) should to be ≥ 0.67 for antibodies to mumps virus when tested with ELISA.

    Primary: Anti-mumps virus antibody concentrations (by PRNT)

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    End point title
    		 Anti-mumps virus antibody concentrations (by PRNT)
    End point description
    Antibody concentrations were expressed as Geometric Mean Titers (GMTs).
    End point type
    Primary
    End point timeframe
    At Day 42
    End point values
    		 Inv_MMR_Min Group Inv_MMR_Med Group Com_MMR Group
    Number of subjects analysed
    1252
    1265
    1287
    Units: Titers
    geometric mean (confidence interval 95%)
        Titers
    9.8 (9.0 to 10.6)
    10.7 (9.9 to 11.5)
    16.3 (15.1 to 17.7)
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    Non-inferiority of Inv_MMR_Med vaccine compared to COM_MMR vaccine in terms of GMCs for anti-mumps antibodies at Day 42.
    Comparison groups
    Inv_MMR_Med Group v Com_MMR Group
    Number of subjects included in analysis
    2552
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [13]
    Method
    		 ANOVA
    Parameter type
    		 Adjusted GMT ratio
    Point estimate
    0.65
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 0.57
         upper limit
    		 0.74
    Notes
    [13] - The lower limit of the 2-sided 97.5% CI on the group ratio of GMCs (Inv_MMR_Med over pooled Com_MMR) should to be ≥ 0.67 for antibodies to mumps virus when tested with PRNT.
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Non-inferiority of Inv_MMR_Min vaccine compared to COM_MMR vaccine in terms of GMCs for anti-mumps antibodies at Day 42.
    Comparison groups
    Inv_MMR_Min Group v Com_MMR Group
    Number of subjects included in analysis
    2539
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [14]
    Method
    		 ANOVA
    Parameter type
    		 Adjusted GMT ratio
    Point estimate
    0.6
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 0.53
         upper limit
    		 0.68
    Notes
    [14] - The lower limit of the 2-sided 97.5% CI on the group ratio of GMCs (Inv_MMR_Min over pooled Com_MMR) should to be ≥ 0.67 for antibodies to mumps virus when tested with PRNT.

    Primary: Anti-rubella virus antibody concentrations (by ELISA)

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    End point title
    		 Anti-rubella virus antibody concentrations (by ELISA)
    End point description
    Antibody concentrations were expressed as GMCs in IU/mL.
    End point type
    Primary
    End point timeframe
    At Day 42
    End point values
    		 Inv_MMR_Min Group Inv_MMR_Med Group Com_MMR Group
    Number of subjects analysed
    1359
    1366
    1376
    Units: IU/mL
    geometric mean (confidence interval 97.5%)
        IU/mL
    57.0 (54.1 to 60.0)
    56.9 (54.2 to 59.8)
    64.4 (61.4 to 67.5)
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Non-inferiority of Inv_MMR_Min vaccine compared to COM_MMR vaccine in terms of GMCs for anti-rubella antibodies at Day 42.
    Comparison groups
    Com_MMR Group v Inv_MMR_Min Group
    Number of subjects included in analysis
    2735
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [15]
    Method
    		 ANOVA
    Parameter type
    		 Adjusted GMC ratio
    Point estimate
    0.89
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 0.83
         upper limit
    		 0.95
    Notes
    [15] - The lower limit of the 2-sided 97.5% CI on the group ratio of GMCs (Inv_MMR_Min over pooled Com_MMR) should to be ≥ 0.67 for antibodies to rubella virus when tested with ELISA.
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    Non-inferiority of Inv_MMR_Med vaccine compared to COM_MMR vaccine in terms of GMCs for anti-rubella antibodies at Day 42.
    Comparison groups
    Com_MMR Group v Inv_MMR_Med Group
    Number of subjects included in analysis
    2742
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [16]
    Method
    		 ANOVA
    Parameter type
    		 Adjusted GMC ratio
    Point estimate
    0.88
    Confidence interval
         level
    		 97.5%
         sides
    2-sided
         lower limit
    		 0.83
         upper limit
    		 0.95
    Notes
    [16] - The lower limit of the 2-sided 97.5% CI on the group ratio of GMCs (Inv_MMR_Med over pooled Com_MMR) should to be ≥ 0.67 for antibodies to rubella virus when tested with ELISA.

    Secondary: Percentage of subjects with anti-measles virus antibody concentration equal to or above the cut-off-value (by ELISA)

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    End point title
    		 Percentage of subjects with anti-measles virus antibody concentration equal to or above the cut-off-value (by ELISA)
    End point description
    For measles virus, a seroresponse was defined as post-vaccination anti-measles virus antibody concentration ≥ 200 mIU/mL (ELISA) among subjects who were seronegative (antibody concentration < 150 mIU/mL) before dose 1.
    End point type
    Secondary
    End point timeframe
    At Day 84
    End point values
    		 Inv_MMR_Min Group Inv_MMR_Med Group Com_MMR Group
    Number of subjects analysed
    245
    258
    257
    Units: Percentage of subjects
    number (confidence interval 95%)
        ≥ 150 mIU/mL
    99.6 (97.7 to 100)
    98.8 (96.6 to 99.8)
    98.8 (96.6 to 99.8)
        ≥ 200 mIU/mL
    99.6 (97.7 to 100)
    98.4 (96.1 to 99.6)
    98.4 (96.1 to 99.6)
    No statistical analyses for this end point

    Secondary: Percentage of subjects with anti-mumps virus antibody concentration equal to or above the cut-off-value (by ELISA)

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    End point title
    		 Percentage of subjects with anti-mumps virus antibody concentration equal to or above the cut-off-value (by ELISA)
    End point description
    For mumps virus, a seroresponse was defined as post-vaccination anti-mumps virus antibody concentration ≥ 10 EU/mL (ELISA) among subjects who were seronegative (antibody concentration < 5 EU/mL) before dose 1.
    End point type
    Secondary
    End point timeframe
    At Day 84
    End point values
    		 Inv_MMR_Min Group Inv_MMR_Med Group Com_MMR Group
    Number of subjects analysed
    216
    199
    212
    Units: Percentage of subjects
    number (confidence interval 95%)
        ≥ 5 EU/mL
    99.1 (96.7 to 99.9)
    100 (98.2 to 100)
    99.1 (96.6 to 99.9)
        ≥ 10 EU/mL
    99.1 (96.7 to 99.9)
    100 (98.2 to 100)
    98.6 (95.9 to 99.7)
    No statistical analyses for this end point

    Secondary: Percentage of subjects with anti-rubella virus antibody concentration equal to or above the cut-off-value (by ELISA)

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    End point title
    		 Percentage of subjects with anti-rubella virus antibody concentration equal to or above the cut-off-value (by ELISA)
    End point description
    For rubella virus, a seroresponse was defined as post-vaccination anti-rubella virus antibody concentration ≥ 10 IU/mL (ELISA) among subjects who were seronegative (antibody concentration < 4 IU/mL) before dose 1.
    End point type
    Secondary
    End point timeframe
    At Day 84
    End point values
    		 Inv_MMR_Min Group Inv_MMR_Med Group Com_MMR Group
    Number of subjects analysed
    245
    259
    255
    Units: Percentage of subjects
    number (confidence interval 95%)
        ≥ 4 IU/mL
    100 (98.5 to 100)
    100 (98.6 to 100)
    100 (98.6 to 100)
        ≥ 10 IU/mL
    99.6 (97.7 to 100)
    99.6 (97.9 to 100)
    99.6 (97.8 to 100)
    No statistical analyses for this end point

    Secondary: Anti-measles virus antibody concentrations (by ELISA)

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    End point title
    		 Anti-measles virus antibody concentrations (by ELISA)
    End point description
    Antibody concentrations were expressed as GMCs in mIU/mL.
    End point type
    Secondary
    End point timeframe
    At Day 84
    End point values
    		 Inv_MMR_Min Group Inv_MMR_Med Group Com_MMR Group
    Number of subjects analysed
    245
    258
    257
    Units: mIU/mL
    geometric mean (confidence interval 95%)
        mIU/mL
    4803.5 (4290.4 to 5378.0)
    4557.7 (4061.5 to 5114.4)
    4453.9 (3951.9 to 5019.8)
    No statistical analyses for this end point

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

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    End point title
    		 Anti-mumps virus antibody concentrations (by ELISA)
    End point description
    Antibody concentrations were expressed as GMCs in EU/mL.
    End point type
    Secondary
    End point timeframe
    At Day 84
    End point values
    		 Inv_MMR_Min Group Inv_MMR_Med Group Com_MMR Group
    Number of subjects analysed
    216
    199
    212
    Units: EU/mL
    geometric mean (confidence interval 95%)
        EU/mL
    88.9 (80.4 to 98.3)
    94.1 (85.3 to 103.8)
    86.4 (77.4 to 96.5)
    No statistical analyses for this end point

    Secondary: Anti-rubella virus antibody concentrations (by ELISA)

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    End point title
    		 Anti-rubella virus antibody concentrations (by ELISA)
    End point description
    Antibody concentrations were expressed as GMCs in IU/mL.
    End point type
    Secondary
    End point timeframe
    At Day 84
    End point values
    		 Inv_MMR_Min Group Inv_MMR_Med Group Com_MMR Group
    Number of subjects analysed
    245
    259
    255
    Units: IU/mL
    geometric mean (confidence interval 95%)
        IU/mL
    112.7 (104.1 to 122.0)
    110.7 (102.9 to 119.1)
    110.9 (101.8 to 120.8)
    No statistical analyses for this end point

    Secondary: Number of subjects with any solicited local adverse events (AEs) post dose 1

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    End point title
    		 Number of subjects with any solicited local adverse events (AEs) post dose 1
    End point description
    Assessed solicited local AEs were pain, redness and swelling. Any = Occurrence of the AE regardless of intensity grade or relation to vaccination.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Days 0-3) post-vaccination period
    End point values
    		 Inv_MMR_Min Group Inv_MMR_Med Group Com_MMR Group
    Number of subjects analysed
    1453
    1464
    1482
    Units: Participants
        Any pain
    261
    262
    301
        Any redness
    232
    256
    286
        Any swelling
    89
    97
    122
    No statistical analyses for this end point

    Secondary: Number of subjects with any solicited local AEs post dose 2

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    End point title
    		 Number of subjects with any solicited local AEs post dose 2
    End point description
    Assessed solicited local AEs were pain, redness and swelling. Any = Occurrence of the AE regardless of intensity grade or relation to vaccination.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Days 0-3) post-vaccination period
    End point values
    		 Inv_MMR_Min Group Inv_MMR_Med Group Com_MMR Group
    Number of subjects analysed
    1427
    1440
    1456
    Units: Participants
        Any pain
    170
    183
    196
        Any redness
    159
    196
    217
        Any swelling
    67
    91
    96
    No statistical analyses for this end point

    Secondary: Number of subjects with any solicited general AEs post dose 1

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    End point title
    		 Number of subjects with any solicited general AEs post dose 1
    End point description
    Assessed solicited general AEs were drowsiness, irritability/fussiness and loss of appetite. Any = Occurrence of the AE regardless of intensity grade or relation to vaccination.
    End point type
    Secondary
    End point timeframe
    During the 15-day (Days 0-14) post-vaccination period
    End point values
    		 Inv_MMR_Min Group Inv_MMR_Med Group Com_MMR Group
    Number of subjects analysed
    1454
    1466
    1486
    Units: Participants
        Any drowsiness
    551
    565
    582
        Any irritability / fussiness
    749
    792
    788
        Any loss of appetite
    570
    589
    591
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any fever post dose 1

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    End point title
    		 Number of subjects reporting any fever post dose 1
    End point description
    Any fever = Fever (axillary) ≥ 38°C.
    End point type
    Secondary
    End point timeframe
    During the 43-day (Days 0-42) post-vaccination period
    End point values
    		 Inv_MMR_Min Group Inv_MMR_Med Group Com_MMR Group
    Number of subjects analysed
    1454
    1466
    1486
    Units: Participants
        Participants
    582
    617
    618
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any fever post dose 2

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    End point title
    		 Number of subjects reporting any fever post dose 2
    End point description
    Any fever = Fever (axillary) ≥ 38°C.
    End point type
    Secondary
    End point timeframe
    During the 43-day (Days 0-42) post-vaccination period
    End point values
    		 Inv_MMR_Min Group Inv_MMR_Med Group Com_MMR Group
    Number of subjects analysed
    1426
    1443
    1455
    Units: Participants
        Participants
    458
    471
    499
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any rash post dose 1

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    End point title
    		 Number of subjects reporting any rash post dose 1
    End point description
    Assessed were any localized or generalized rash, rash with fever, varicella-like rash and measles/rubella-like rash. Any = Occurrence of the 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
    		 Inv_MMR_Min Group Inv_MMR_Med Group Com_MMR Group
    Number of subjects analysed
    1454
    1466
    1486
    Units: Participants
        Any localized or generalized
    328
    322
    333
        Any with fever
    115
    133
    131
        Any varicella like
    57
    53
    45
        Any measles/rubella like
    53
    61
    68
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any rash post dose 2

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    End point title
    		 Number of subjects reporting any rash post dose 2
    End point description
    Assessed were any localized or generalized rash, rash with fever, varicella-like rash and measles/rubella-like rash. Any = Occurrence of the 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
    		 Inv_MMR_Min Group Inv_MMR_Med Group Com_MMR Group
    Number of subjects analysed
    1426
    1443
    1455
    Units: Participants
        Any localized or generalized
    129
    150
    141
        Any with fever
    52
    63
    53
        Any varicella like
    0
    0
    1
        Any measles/rubella like
    22
    14
    14
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any MMR specific solicited general AEs post dose 1

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    End point title
    		 Number of subjects reporting any MMR specific solicited general AEs post dose 1
    End point description
    Assessed MMR specific solicited general AEs were any suspected signs of meningism including febrile convulsions and parotid/salivary gland swelling. Any = Occurrence of the 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
    		 Inv_MMR_Min Group Inv_MMR_Med Group Com_MMR Group
    Number of subjects analysed
    1454
    1466
    1486
    Units: Participants
        Any parotid gland swelling
    3
    2
    3
        Any febrile convulsion
    3
    4
    3
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any MMR specific solicited general AEs post dose 2

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    End point title
    		 Number of subjects reporting any MMR specific solicited general AEs post dose 2
    End point description
    Assessed MMR specific solicited general AEs were any suspected signs of meningism including febrile convulsions and parotid/salivary gland swelling. Any = Occurrence of the 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
    		 Inv_MMR_Min Group Inv_MMR_Med Group Com_MMR Group
    Number of subjects analysed
    1426
    1443
    1455
    Units: Participants
        Any parotid gland swelling
    1
    2
    0
        Any febrile convulsion
    2
    6
    4
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any unsolicited AES post dose 1

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    End point title
    		 Number of subjects reporting any unsolicited AES post dose 1
    End point description
    Unsolicited AE was defined as any AE reported in reported in addition to those solicited during the clinical study and any solicited AE with onset outside the specified period of follow-up for solicited AEs. Any = Occurrence of the 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
    		 Inv_MMR_Min Group Inv_MMR_Med Group Com_MMR Group
    Number of subjects analysed
    1493
    1497
    1526
    Units: Participants
        Participants
    762
    794
    777
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any unsolicited AES post dose 2

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    End point title
    		 Number of subjects reporting any unsolicited AES post dose 2
    End point description
    Unsolicited AE was defined as any AE reported in reported in addition to those solicited during the clinical study and any solicited AE with onset outside the specified period of follow-up for solicited AEs. Any = Occurrence of the 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
    		 Inv_MMR_Min Group Inv_MMR_Med Group Com_MMR Group
    Number of subjects analysed
    1449
    1464
    1483
    Units: Participants
        Participants
    667
    703
    690
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any AEs of specific interest

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    End point title
    		 Number of subjects reporting any AEs of specific interest
    End point description
    AEs of specific interest included new onset chronic disease (NOCD) (e.g., autoimmune disorders, asthma, type I diabetes, vasculitis, celiac disease, conditions associated with sub-acute or chronic thrombocytopenia and allergies) and AEs prompting emergency room (ER) visits.
    End point type
    Secondary
    End point timeframe
    From Day 0 through the end of the study (Day 222)
    End point values
    		 Inv_MMR_Min Group Inv_MMR_Med Group Com_MMR Group
    Number of subjects analysed
    1493
    1497
    1526
    Units: Participants
        Any NOCD
    35
    39
    33
        Any AE prompting ER visit
    348
    361
    347
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects reporting any serious adverse events (SAEs)
    End point description
    SAEs assessed include any untoward medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of existing hospitalization or resulted in disability/incapacity.
    End point type
    Secondary
    End point timeframe
    From Day 0 through the end of the study (Day 222)
    End point values
    		 Inv_MMR_Min Group Inv_MMR_Med Group Com_MMR Group
    Number of subjects analysed
    1493
    1497
    1526
    Units: Participants
        Participants
    91
    102
    92
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Inv_MMR_Min Group
    Reporting group description
    		 Subjects received one dose of Inv_MMR, from a minimum potency lot (Inv_MMR_Min), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv_MMR vaccine (Inv_MMR_Release), for the second dose. Inv_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.

    Reporting group title
    Inv_MMR_Med Group
    Reporting group description
    		 Subjects received one dose of Inv_MMR, from a mid-range or medium potency lot (Inv_MMR_Med), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose from a separate lot of the Inv_MMR vaccine (Inv_MMR_Release), for the second dose. Inv_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.

    Reporting group title
    Com_MMR Group
    Reporting group description
    		 Subjects received one dose of Com_MMR vaccine (Lot 1 or Lot 2), co-administered with VV and HAV vaccines at Day 0. All US subjects were also co-administered PCV-13 vaccine. Approximately 6 weeks later, at Day 42, subjects were administered a dose of Com_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com_MMR and VV vaccines were administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.

    Serious adverse events
    		 Inv_MMR_Min Group Inv_MMR_Med Group Com_MMR Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    91 / 1493 (6.10%)
    102 / 1497 (6.81%)
    92 / 1526 (6.03%)
         number of deaths (all causes)
    1
    0
    1
         number of deaths resulting from adverse events
    0
    0
    0
    Vascular disorders
    Circulatory collapse
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Phlebitis superficial
         subjects affected / exposed
    1 / 1493 (0.07%)
    0 / 1497 (0.00%)
    0 / 1526 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thrombophlebitis
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Drowning
         subjects affected / exposed
    1 / 1493 (0.07%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
    Influenza like illness
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    1 / 1493 (0.07%)
    4 / 1497 (0.27%)
    1 / 1526 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    1 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Immune system disorders
    Allergy to arthropod bite
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Apnoea
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Aspiration
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Asthma
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Atelectasis
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchial hyperreactivity
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    1 / 1526 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchospasm
         subjects affected / exposed
    2 / 1493 (0.13%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory distress
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    1 / 1526 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Wheezing
         subjects affected / exposed
    1 / 1493 (0.07%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Accidental poisoning
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Burns second degree
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chest injury
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Child maltreatment syndrome
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Concussion
         subjects affected / exposed
    1 / 1493 (0.07%)
    0 / 1497 (0.00%)
    0 / 1526 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Contusion
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    1 / 1526 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Face injury
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    1 / 1493 (0.07%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Foreign body
         subjects affected / exposed
    1 / 1493 (0.07%)
    0 / 1497 (0.00%)
    0 / 1526 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Head injury
         subjects affected / exposed
    1 / 1493 (0.07%)
    1 / 1497 (0.07%)
    1 / 1526 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Joint dislocation
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Laceration
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    1 / 1526 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Limb crushing injury
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Mouth injury
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Multiple injuries
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Poisoning
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thermal burn
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    3 / 1526 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Toxicity to various agents
         subjects affected / exposed
    1 / 1493 (0.07%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Supraventricular tachycardia
         subjects affected / exposed
    1 / 1493 (0.07%)
    0 / 1497 (0.00%)
    0 / 1526 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Burning sensation
         subjects affected / exposed
    1 / 1493 (0.07%)
    0 / 1497 (0.00%)
    0 / 1526 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Epilepsy
         subjects affected / exposed
    1 / 1493 (0.07%)
    0 / 1497 (0.00%)
    0 / 1526 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Febrile convulsion
         subjects affected / exposed
    7 / 1493 (0.47%)
    13 / 1497 (0.87%)
    8 / 1526 (0.52%)
         occurrences causally related to treatment / all
    0 / 8
    0 / 15
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intracranial pressure increased
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    2 / 1493 (0.13%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Haemolytic anaemia
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hypochromic anaemia
         subjects affected / exposed
    1 / 1493 (0.07%)
    0 / 1497 (0.00%)
    0 / 1526 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Iron deficiency anaemia
         subjects affected / exposed
    0 / 1493 (0.00%)
    3 / 1497 (0.20%)
    2 / 1526 (0.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Leukopenia
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Thrombocytopenia
         subjects affected / exposed
    1 / 1493 (0.07%)
    0 / 1497 (0.00%)
    0 / 1526 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Anal fistula
         subjects affected / exposed
    1 / 1493 (0.07%)
    0 / 1497 (0.00%)
    0 / 1526 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Constipation
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    0 / 1493 (0.00%)
    3 / 1497 (0.20%)
    4 / 1526 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Food poisoning
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastritis
         subjects affected / exposed
    3 / 1493 (0.20%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Intestinal haemorrhage
         subjects affected / exposed
    1 / 1493 (0.07%)
    0 / 1497 (0.00%)
    0 / 1526 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Perianal erythema
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Teething
         subjects affected / exposed
    1 / 1493 (0.07%)
    0 / 1497 (0.00%)
    0 / 1526 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    1 / 1526 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Liver disorder
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Angioedema
         subjects affected / exposed
    1 / 1493 (0.07%)
    0 / 1497 (0.00%)
    0 / 1526 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Henoch-schonlein purpura
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Petechiae
         subjects affected / exposed
    1 / 1493 (0.07%)
    0 / 1497 (0.00%)
    0 / 1526 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rash
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rash maculo-papular
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Stevens-johnson syndrome
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Toxic skin eruption
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urticaria
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Juvenile idiopathic arthritis
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Synovitis
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    1 / 1526 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Adenovirus infection
         subjects affected / exposed
    1 / 1493 (0.07%)
    0 / 1497 (0.00%)
    0 / 1526 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Anal abscess
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Atypical pneumonia
         subjects affected / exposed
    1 / 1493 (0.07%)
    0 / 1497 (0.00%)
    0 / 1526 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bacteraemia
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    1 / 1526 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchiolitis
         subjects affected / exposed
    6 / 1493 (0.40%)
    7 / 1497 (0.47%)
    2 / 1526 (0.13%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 7
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    4 / 1493 (0.27%)
    10 / 1497 (0.67%)
    8 / 1526 (0.52%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 10
    0 / 8
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchitis viral
         subjects affected / exposed
    1 / 1493 (0.07%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Campylobacter gastroenteritis
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 1493 (0.07%)
    2 / 1497 (0.13%)
    2 / 1526 (0.13%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cellulitis orbital
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Clostridium difficile colitis
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Conjunctivitis
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Croup infectious
         subjects affected / exposed
    2 / 1493 (0.13%)
    3 / 1497 (0.20%)
    4 / 1526 (0.26%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cystitis klebsiella
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Dengue fever
         subjects affected / exposed
    1 / 1493 (0.07%)
    0 / 1497 (0.00%)
    0 / 1526 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Diarrhoea infectious
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    3 / 1526 (0.20%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ear infection
         subjects affected / exposed
    2 / 1493 (0.13%)
    0 / 1497 (0.00%)
    0 / 1526 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Empyema
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Encephalitis
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    1 / 1526 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Encephalitis brain stem
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Enterococcal bacteraemia
         subjects affected / exposed
    1 / 1493 (0.07%)
    0 / 1497 (0.00%)
    0 / 1526 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Escherichia urinary tract infection
         subjects affected / exposed
    1 / 1493 (0.07%)
    0 / 1497 (0.00%)
    0 / 1526 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Exanthema subitum
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    16 / 1493 (1.07%)
    19 / 1497 (1.27%)
    10 / 1526 (0.66%)
         occurrences causally related to treatment / all
    0 / 16
    0 / 19
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis bacterial
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis rotavirus
         subjects affected / exposed
    6 / 1493 (0.40%)
    3 / 1497 (0.20%)
    7 / 1526 (0.46%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 3
    0 / 7
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis salmonella
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    2 / 1526 (0.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    2 / 1493 (0.13%)
    0 / 1497 (0.00%)
    0 / 1526 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hand-foot-and-mouth disease
         subjects affected / exposed
    2 / 1493 (0.13%)
    2 / 1497 (0.13%)
    4 / 1526 (0.26%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Herpangina
         subjects affected / exposed
    2 / 1493 (0.13%)
    1 / 1497 (0.07%)
    3 / 1526 (0.20%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    3 / 1493 (0.20%)
    2 / 1497 (0.13%)
    2 / 1526 (0.13%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Laryngitis
         subjects affected / exposed
    2 / 1493 (0.13%)
    1 / 1497 (0.07%)
    4 / 1526 (0.26%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Laryngotracheitis obstructive
         subjects affected / exposed
    1 / 1493 (0.07%)
    0 / 1497 (0.00%)
    0 / 1526 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 1493 (0.07%)
    0 / 1497 (0.00%)
    0 / 1526 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Meningitis
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nail bed infection
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nasopharyngitis
         subjects affected / exposed
    2 / 1493 (0.13%)
    3 / 1497 (0.20%)
    1 / 1526 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nosocomial infection
         subjects affected / exposed
    1 / 1493 (0.07%)
    0 / 1497 (0.00%)
    0 / 1526 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Otitis media
         subjects affected / exposed
    3 / 1493 (0.20%)
    3 / 1497 (0.20%)
    2 / 1526 (0.13%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Otitis media acute
         subjects affected / exposed
    1 / 1493 (0.07%)
    1 / 1497 (0.07%)
    1 / 1526 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Otitis media viral
         subjects affected / exposed
    1 / 1493 (0.07%)
    0 / 1497 (0.00%)
    0 / 1526 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Otosalpingitis
         subjects affected / exposed
    1 / 1493 (0.07%)
    0 / 1497 (0.00%)
    0 / 1526 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Periorbital cellulitis
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pharyngitis
         subjects affected / exposed
    3 / 1493 (0.20%)
    2 / 1497 (0.13%)
    0 / 1526 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pharyngotonsillitis
         subjects affected / exposed
    2 / 1493 (0.13%)
    5 / 1497 (0.33%)
    1 / 1526 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    7 / 1493 (0.47%)
    14 / 1497 (0.94%)
    10 / 1526 (0.66%)
         occurrences causally related to treatment / all
    0 / 7
    0 / 14
    0 / 10
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia bacterial
         subjects affected / exposed
    1 / 1493 (0.07%)
    2 / 1497 (0.13%)
    1 / 1526 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia respiratory syncytial viral
         subjects affected / exposed
    3 / 1493 (0.20%)
    1 / 1497 (0.07%)
    2 / 1526 (0.13%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia viral
         subjects affected / exposed
    2 / 1493 (0.13%)
    6 / 1497 (0.40%)
    1 / 1526 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 7
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    1 / 1493 (0.07%)
    0 / 1497 (0.00%)
    0 / 1526 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    1 / 1493 (0.07%)
    0 / 1497 (0.00%)
    0 / 1526 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory syncytial virus bronchiolitis
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory syncytial virus bronchitis
         subjects affected / exposed
    0 / 1493 (0.00%)
    2 / 1497 (0.13%)
    1 / 1526 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory syncytial virus infection
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    1 / 1526 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Rhinitis
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 1493 (0.07%)
    0 / 1497 (0.00%)
    0 / 1526 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sinusitis
         subjects affected / exposed
    1 / 1493 (0.07%)
    1 / 1497 (0.07%)
    1 / 1526 (0.07%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Skin candida
         subjects affected / exposed
    1 / 1493 (0.07%)
    0 / 1497 (0.00%)
    0 / 1526 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal bacteraemia
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Staphylococcal infection
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Subcutaneous abscess
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Tonsillitis
         subjects affected / exposed
    2 / 1493 (0.13%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 1493 (0.13%)
    3 / 1497 (0.20%)
    3 / 1526 (0.20%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    2 / 1493 (0.13%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    3 / 1493 (0.20%)
    1 / 1497 (0.07%)
    2 / 1526 (0.13%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Viral pharyngitis
         subjects affected / exposed
    1 / 1493 (0.07%)
    0 / 1497 (0.00%)
    0 / 1526 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Viral tonsillitis
         subjects affected / exposed
    1 / 1493 (0.07%)
    0 / 1497 (0.00%)
    0 / 1526 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Wound infection
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    4 / 1493 (0.27%)
    7 / 1497 (0.47%)
    6 / 1526 (0.39%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 7
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Electrolyte imbalance
         subjects affected / exposed
    1 / 1493 (0.07%)
    0 / 1497 (0.00%)
    0 / 1526 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolic acidosis
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    2 / 1526 (0.13%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Type 1 diabetes mellitus
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Inv_MMR_Min Group Inv_MMR_Med Group Com_MMR Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1299 / 1493 (87.01%)
    1311 / 1497 (87.58%)
    1330 / 1526 (87.16%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Brain neoplasm
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences all number
    0
    1
    0
    Haemangioma
         subjects affected / exposed
    1 / 1493 (0.07%)
    0 / 1497 (0.00%)
    0 / 1526 (0.00%)
         occurrences all number
    1
    0
    0
    Melanocytic naevus
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences all number
    0
    0
    1
    Pyogenic granuloma
         subjects affected / exposed
    1 / 1493 (0.07%)
    0 / 1497 (0.00%)
    0 / 1526 (0.00%)
         occurrences all number
    1
    0
    0
    Vascular disorders
    Flushing
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences all number
    0
    0
    1
    Haematoma
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences all number
    0
    0
    1
    Pregnancy, puerperium and perinatal conditions
    Abortion
         subjects affected / exposed
    1 / 1493 (0.07%)
    0 / 1497 (0.00%)
    0 / 1526 (0.00%)
         occurrences all number
    1
    0
    0
    Perinatal brain damage
         subjects affected / exposed
    1 / 1493 (0.07%)
    0 / 1497 (0.00%)
    0 / 1526 (0.00%)
         occurrences all number
    1
    0
    0
    General disorders and administration site conditions
    Adverse drug reaction
         subjects affected / exposed
    1 / 1493 (0.07%)
    0 / 1497 (0.00%)
    0 / 1526 (0.00%)
         occurrences all number
    1
    0
    0
    Application site erythema
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    2 / 1526 (0.13%)
         occurrences all number
    0
    1
    2
    Application site hypersensitivity
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences all number
    0
    0
    1
    Crying
         subjects affected / exposed
    4 / 1493 (0.27%)
    4 / 1497 (0.27%)
    5 / 1526 (0.33%)
         occurrences all number
    5
    4
    7
    Decreased activity
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences all number
    0
    1
    0
    Discomfort
         subjects affected / exposed
    0 / 1493 (0.00%)
    2 / 1497 (0.13%)
    0 / 1526 (0.00%)
         occurrences all number
    0
    2
    0
    Fatigue
         subjects affected / exposed
    2 / 1493 (0.13%)
    2 / 1497 (0.13%)
    1 / 1526 (0.07%)
         occurrences all number
    2
    3
    1
    Feeling hot
         subjects affected / exposed
    2 / 1493 (0.13%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences all number
    2
    1
    0
    Gait disturbance
         subjects affected / exposed
    1 / 1493 (0.07%)
    1 / 1497 (0.07%)
    1 / 1526 (0.07%)
         occurrences all number
    1
    1
    1
    Influenza like illness
         subjects affected / exposed
    1 / 1493 (0.07%)
    1 / 1497 (0.07%)
    1 / 1526 (0.07%)
         occurrences all number
    1
    1
    1
    Injection site bruising
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    2 / 1526 (0.13%)
         occurrences all number
    0
    0
    3
    Injection site erythema
         subjects affected / exposed
    11 / 1493 (0.74%)
    15 / 1497 (1.00%)
    9 / 1526 (0.59%)
         occurrences all number
    11
    15
    9
    Injection site haematoma
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    3 / 1526 (0.20%)
         occurrences all number
    0
    0
    3
    Injection site haemorrhage
         subjects affected / exposed
    0 / 1493 (0.00%)
    3 / 1497 (0.20%)
    0 / 1526 (0.00%)
         occurrences all number
    0
    3
    0
    Injection site induration
         subjects affected / exposed
    2 / 1493 (0.13%)
    4 / 1497 (0.27%)
    2 / 1526 (0.13%)
         occurrences all number
    2
    4
    2
    Injection site inflammation
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences all number
    0
    0
    1
    Injection site mass
         subjects affected / exposed
    1 / 1493 (0.07%)
    0 / 1497 (0.00%)
    0 / 1526 (0.00%)
         occurrences all number
    1
    0
    0
    Injection site nodule
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences all number
    0
    1
    0
    Injection site pain
         subjects affected / exposed
    2 / 1493 (0.13%)
    1 / 1497 (0.07%)
    1 / 1526 (0.07%)
         occurrences all number
    2
    1
    1
    Injection site papule
         subjects affected / exposed
    1 / 1493 (0.07%)
    0 / 1497 (0.00%)
    0 / 1526 (0.00%)
         occurrences all number
    1
    0
    0
    Injection site reaction
         subjects affected / exposed
    1 / 1493 (0.07%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences all number
    1
    1
    0
    Injection site swelling
         subjects affected / exposed
    3 / 1493 (0.20%)
    5 / 1497 (0.33%)
    2 / 1526 (0.13%)
         occurrences all number
    3
    5
    2
    Injection site urticaria
         subjects affected / exposed
    1 / 1493 (0.07%)
    0 / 1497 (0.00%)
    0 / 1526 (0.00%)
         occurrences all number
    1
    0
    0
    Local swelling
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    1 / 1526 (0.07%)
         occurrences all number
    0
    1
    1
    Malaise
         subjects affected / exposed
    3 / 1493 (0.20%)
    2 / 1497 (0.13%)
    2 / 1526 (0.13%)
         occurrences all number
    3
    3
    4
    Mass
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences all number
    0
    0
    1
    Pain
         subjects affected / exposed
    334 / 1493 (22.37%)
    336 / 1497 (22.44%)
    378 / 1526 (24.77%)
         occurrences all number
    431
    445
    500
    Peripheral swelling
         subjects affected / exposed
    1 / 1493 (0.07%)
    0 / 1497 (0.00%)
    0 / 1526 (0.00%)
         occurrences all number
    1
    0
    0
    Pyrexia
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    1 / 1526 (0.07%)
         occurrences all number
    0
    1
    1
    Swelling
         subjects affected / exposed
    123 / 1493 (8.24%)
    152 / 1497 (10.15%)
    170 / 1526 (11.14%)
         occurrences all number
    156
    188
    218
    Vaccination site erythema
         subjects affected / exposed
    7 / 1493 (0.47%)
    6 / 1497 (0.40%)
    8 / 1526 (0.52%)
         occurrences all number
    7
    6
    8
    Vaccination site haematoma
         subjects affected / exposed
    1 / 1493 (0.07%)
    0 / 1497 (0.00%)
    0 / 1526 (0.00%)
         occurrences all number
    1
    0
    0
    Vaccination site pain
         subjects affected / exposed
    1 / 1493 (0.07%)
    0 / 1497 (0.00%)
    0 / 1526 (0.00%)
         occurrences all number
    1
    0
    0
    Vaccination site rash
         subjects affected / exposed
    1 / 1493 (0.07%)
    0 / 1497 (0.00%)
    0 / 1526 (0.00%)
         occurrences all number
    1
    0
    0
    Vaccination site reaction
         subjects affected / exposed
    1 / 1493 (0.07%)
    0 / 1497 (0.00%)
    0 / 1526 (0.00%)
         occurrences all number
    1
    0
    0
    Vaccination site swelling
         subjects affected / exposed
    1 / 1493 (0.07%)
    1 / 1497 (0.07%)
    1 / 1526 (0.07%)
         occurrences all number
    1
    1
    1
    Vessel puncture site haemorrhage
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences all number
    0
    1
    0
    Immune system disorders
    Allergy to animal
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences all number
    0
    1
    0
    Drug hypersensitivity
         subjects affected / exposed
    1 / 1493 (0.07%)
    2 / 1497 (0.13%)
    3 / 1526 (0.20%)
         occurrences all number
    1
    2
    3
    Food allergy
         subjects affected / exposed
    1 / 1493 (0.07%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences all number
    1
    1
    0
    Hypersensitivity
         subjects affected / exposed
    2 / 1493 (0.13%)
    0 / 1497 (0.00%)
    0 / 1526 (0.00%)
         occurrences all number
    2
    0
    0
    Milk allergy
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences all number
    0
    0
    1
    Multiple allergies
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    1 / 1526 (0.07%)
         occurrences all number
    0
    1
    1
    Seasonal allergy
         subjects affected / exposed
    1 / 1493 (0.07%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences all number
    1
    0
    1
    Reproductive system and breast disorders
    Balanoposthitis
         subjects affected / exposed
    2 / 1493 (0.13%)
    3 / 1497 (0.20%)
    1 / 1526 (0.07%)
         occurrences all number
    2
    3
    2
    Genital erythema
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences all number
    0
    0
    1
    Genital labial adhesions
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences all number
    0
    1
    0
    Penile adhesion
         subjects affected / exposed
    2 / 1493 (0.13%)
    0 / 1497 (0.00%)
    2 / 1526 (0.13%)
         occurrences all number
    2
    0
    2
    Penile erythema
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences all number
    0
    0
    1
    Perineal erythema
         subjects affected / exposed
    1 / 1493 (0.07%)
    0 / 1497 (0.00%)
    0 / 1526 (0.00%)
         occurrences all number
    1
    0
    0
    Scrotal swelling
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences all number
    0
    1
    0
    Testicular pain
         subjects affected / exposed
    1 / 1493 (0.07%)
    0 / 1497 (0.00%)
    0 / 1526 (0.00%)
         occurrences all number
    1
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 1493 (0.07%)
    5 / 1497 (0.33%)
    3 / 1526 (0.20%)
         occurrences all number
    2
    5
    3
    Bronchial hyperreactivity
         subjects affected / exposed
    7 / 1493 (0.47%)
    4 / 1497 (0.27%)
    8 / 1526 (0.52%)
         occurrences all number
    8
    5
    9
    Bronchospasm
         subjects affected / exposed
    7 / 1493 (0.47%)
    3 / 1497 (0.20%)
    2 / 1526 (0.13%)
         occurrences all number
    7
    3
    2
    Catarrh
         subjects affected / exposed
    1 / 1493 (0.07%)
    2 / 1497 (0.13%)
    2 / 1526 (0.13%)
         occurrences all number
    1
    2
    3
    Cough
         subjects affected / exposed
    59 / 1493 (3.95%)
    64 / 1497 (4.28%)
    75 / 1526 (4.91%)
         occurrences all number
    68
    74
    84
    Dysphonia
         subjects affected / exposed
    0 / 1493 (0.00%)
    3 / 1497 (0.20%)
    0 / 1526 (0.00%)
         occurrences all number
    0
    3
    0
    Epistaxis
         subjects affected / exposed
    2 / 1493 (0.13%)
    4 / 1497 (0.27%)
    2 / 1526 (0.13%)
         occurrences all number
    3
    4
    2
    Lower respiratory tract congestion
         subjects affected / exposed
    1 / 1493 (0.07%)
    0 / 1497 (0.00%)
    0 / 1526 (0.00%)
         occurrences all number
    1
    0
    0
    Nasal congestion
         subjects affected / exposed
    9 / 1493 (0.60%)
    12 / 1497 (0.80%)
    10 / 1526 (0.66%)
         occurrences all number
    9
    12
    12
    Oropharyngeal pain
         subjects affected / exposed
    1 / 1493 (0.07%)
    3 / 1497 (0.20%)
    3 / 1526 (0.20%)
         occurrences all number
    1
    3
    6
    Productive cough
         subjects affected / exposed
    0 / 1493 (0.00%)
    2 / 1497 (0.13%)
    0 / 1526 (0.00%)
         occurrences all number
    0
    3
    0
    Respiratory tract congestion
         subjects affected / exposed
    1 / 1493 (0.07%)
    0 / 1497 (0.00%)
    0 / 1526 (0.00%)
         occurrences all number
    1
    0
    0
    Rhinitis allergic
         subjects affected / exposed
    4 / 1493 (0.27%)
    0 / 1497 (0.00%)
    6 / 1526 (0.39%)
         occurrences all number
    4
    0
    6
    Rhinorrhoea
         subjects affected / exposed
    32 / 1493 (2.14%)
    25 / 1497 (1.67%)
    39 / 1526 (2.56%)
         occurrences all number
    39
    33
    41
    Sinus congestion
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences all number
    0
    0
    1
    Sinus disorder
         subjects affected / exposed
    1 / 1493 (0.07%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences all number
    1
    0
    1
    Sleep apnoea syndrome
         subjects affected / exposed
    1 / 1493 (0.07%)
    0 / 1497 (0.00%)
    0 / 1526 (0.00%)
         occurrences all number
    1
    0
    0
    Sneezing
         subjects affected / exposed
    2 / 1493 (0.13%)
    2 / 1497 (0.13%)
    0 / 1526 (0.00%)
         occurrences all number
    2
    2
    0
    Throat irritation
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences all number
    0
    1
    0
    Wheezing
         subjects affected / exposed
    3 / 1493 (0.20%)
    9 / 1497 (0.60%)
    7 / 1526 (0.46%)
         occurrences all number
    3
    9
    7
    Psychiatric disorders
    Agitation
         subjects affected / exposed
    1 / 1493 (0.07%)
    0 / 1497 (0.00%)
    0 / 1526 (0.00%)
         occurrences all number
    1
    0
    0
    Bruxism
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences all number
    0
    0
    1
    Insomnia
         subjects affected / exposed
    1 / 1493 (0.07%)
    2 / 1497 (0.13%)
    0 / 1526 (0.00%)
         occurrences all number
    1
    2
    0
    Irritability
         subjects affected / exposed
    757 / 1493 (50.70%)
    795 / 1497 (53.11%)
    793 / 1526 (51.97%)
         occurrences all number
    781
    815
    815
    Mood altered
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences all number
    0
    0
    1
    Nervousness
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences all number
    0
    1
    0
    Restlessness
         subjects affected / exposed
    1 / 1493 (0.07%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences all number
    2
    0
    1
    Tearfulness
         subjects affected / exposed
    1 / 1493 (0.07%)
    0 / 1497 (0.00%)
    0 / 1526 (0.00%)
         occurrences all number
    1
    0
    0
    Product issues
    Device occlusion
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences all number
    0
    1
    0
    Investigations
    Blood alkaline phosphatase increased
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences all number
    0
    0
    1
    Body temperature increased
         subjects affected / exposed
    1 / 1493 (0.07%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences all number
    1
    1
    0
    Cardiac murmur
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences all number
    0
    0
    1
    Gastric ph decreased
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences all number
    0
    1
    0
    Haemoglobin decreased
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences all number
    0
    0
    1
    Staphylococcus test positive
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences all number
    0
    1
    0
    Injury, poisoning and procedural complications
    Accidental exposure to product
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences all number
    0
    0
    1
    Animal bite
         subjects affected / exposed
    1 / 1493 (0.07%)
    0 / 1497 (0.00%)
    2 / 1526 (0.13%)
         occurrences all number
    1
    0
    2
    Arthropod bite
         subjects affected / exposed
    24 / 1493 (1.61%)
    21 / 1497 (1.40%)
    12 / 1526 (0.79%)
         occurrences all number
    29
    23
    13
    Arthropod sting
         subjects affected / exposed
    3 / 1493 (0.20%)
    2 / 1497 (0.13%)
    1 / 1526 (0.07%)
         occurrences all number
    3
    2
    1
    Burns second degree
         subjects affected / exposed
    0 / 1493 (0.00%)
    3 / 1497 (0.20%)
    1 / 1526 (0.07%)
         occurrences all number
    0
    3
    1
    Contusion
         subjects affected / exposed
    8 / 1493 (0.54%)
    7 / 1497 (0.47%)
    9 / 1526 (0.59%)
         occurrences all number
    9
    8
    9
    Ear canal abrasion
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences all number
    0
    0
    1
    Excoriation
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    1 / 1526 (0.07%)
         occurrences all number
    0
    1
    1
    Exposure to communicable disease
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences all number
    0
    1
    0
    Exposure to toxic agent
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences all number
    0
    1
    0
    Eye injury
         subjects affected / exposed
    0 / 1493 (0.00%)
    2 / 1497 (0.13%)
    1 / 1526 (0.07%)
         occurrences all number
    0
    2
    1
    Eyelid injury
         subjects affected / exposed
    0 / 1493 (0.00%)
    2 / 1497 (0.13%)
    1 / 1526 (0.07%)
         occurrences all number
    0
    2
    1
    Face injury
         subjects affected / exposed
    0 / 1493 (0.00%)
    3 / 1497 (0.20%)
    0 / 1526 (0.00%)
         occurrences all number
    0
    3
    0
    Fall
         subjects affected / exposed
    3 / 1493 (0.20%)
    4 / 1497 (0.27%)
    7 / 1526 (0.46%)
         occurrences all number
    5
    4
    8
    Foot fracture
         subjects affected / exposed
    1 / 1493 (0.07%)
    0 / 1497 (0.00%)
    0 / 1526 (0.00%)
         occurrences all number
    1
    0
    0
    Foreign body
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences all number
    0
    0
    1
    Head injury
         subjects affected / exposed
    8 / 1493 (0.54%)
    7 / 1497 (0.47%)
    7 / 1526 (0.46%)
         occurrences all number
    8
    7
    7
    Injury
         subjects affected / exposed
    2 / 1493 (0.13%)
    2 / 1497 (0.13%)
    4 / 1526 (0.26%)
         occurrences all number
    2
    2
    4
    Joint dislocation
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences all number
    0
    1
    0
    Laceration
         subjects affected / exposed
    3 / 1493 (0.20%)
    6 / 1497 (0.40%)
    7 / 1526 (0.46%)
         occurrences all number
    3
    6
    7
    Limb injury
         subjects affected / exposed
    1 / 1493 (0.07%)
    1 / 1497 (0.07%)
    1 / 1526 (0.07%)
         occurrences all number
    1
    1
    1
    Lip injury
         subjects affected / exposed
    2 / 1493 (0.13%)
    4 / 1497 (0.27%)
    1 / 1526 (0.07%)
         occurrences all number
    2
    4
    1
    Mouth injury
         subjects affected / exposed
    2 / 1493 (0.13%)
    1 / 1497 (0.07%)
    1 / 1526 (0.07%)
         occurrences all number
    2
    1
    1
    Procedural vomiting
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences all number
    0
    0
    1
    Radial head dislocation
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    2 / 1526 (0.13%)
         occurrences all number
    0
    0
    2
    Radius fracture
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences all number
    0
    0
    1
    Road traffic accident
         subjects affected / exposed
    1 / 1493 (0.07%)
    0 / 1497 (0.00%)
    2 / 1526 (0.13%)
         occurrences all number
    1
    0
    2
    Skin abrasion
         subjects affected / exposed
    2 / 1493 (0.13%)
    5 / 1497 (0.33%)
    5 / 1526 (0.33%)
         occurrences all number
    2
    5
    5
    Skin wound
         subjects affected / exposed
    1 / 1493 (0.07%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences all number
    1
    1
    0
    Thermal burn
         subjects affected / exposed
    2 / 1493 (0.13%)
    4 / 1497 (0.27%)
    4 / 1526 (0.26%)
         occurrences all number
    2
    4
    4
    Tibia fracture
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences all number
    0
    0
    1
    Tongue injury
         subjects affected / exposed
    1 / 1493 (0.07%)
    2 / 1497 (0.13%)
    0 / 1526 (0.00%)
         occurrences all number
    1
    2
    0
    Tooth fracture
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences all number
    0
    0
    1
    Tooth injury
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    2 / 1526 (0.13%)
         occurrences all number
    0
    1
    2
    Vaccination complication
         subjects affected / exposed
    0 / 1493 (0.00%)
    3 / 1497 (0.20%)
    2 / 1526 (0.13%)
         occurrences all number
    0
    3
    2
    Wound
         subjects affected / exposed
    4 / 1493 (0.27%)
    10 / 1497 (0.67%)
    5 / 1526 (0.33%)
         occurrences all number
    4
    10
    5
    Congenital, familial and genetic disorders
    Dermoid cyst
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences all number
    0
    0
    1
    Inborn error of metabolism
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences all number
    0
    0
    1
    Keratosis follicular
         subjects affected / exposed
    1 / 1493 (0.07%)
    0 / 1497 (0.00%)
    0 / 1526 (0.00%)
         occurrences all number
    1
    0
    0
    Naevus flammeus
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences all number
    0
    0
    1
    Phimosis
         subjects affected / exposed
    0 / 1493 (0.00%)
    2 / 1497 (0.13%)
    1 / 1526 (0.07%)
         occurrences all number
    0
    2
    1
    Talipes
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences all number
    0
    1
    0
    Cardiac disorders
    Arrhythmia
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences all number
    0
    0
    1
    Nervous system disorders
    Aphonia
         subjects affected / exposed
    1 / 1493 (0.07%)
    1 / 1497 (0.07%)
    1 / 1526 (0.07%)
         occurrences all number
    1
    1
    1
    Cerebrovascular accident
         subjects affected / exposed
    1 / 1493 (0.07%)
    0 / 1497 (0.00%)
    0 / 1526 (0.00%)
         occurrences all number
    1
    0
    0
    Drooling
         subjects affected / exposed
    1 / 1493 (0.07%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences all number
    1
    0
    1
    Headache
         subjects affected / exposed
    1 / 1493 (0.07%)
    0 / 1497 (0.00%)
    0 / 1526 (0.00%)
         occurrences all number
    1
    0
    0
    Language disorder
         subjects affected / exposed
    1 / 1493 (0.07%)
    0 / 1497 (0.00%)
    0 / 1526 (0.00%)
         occurrences all number
    1
    0
    0
    Lethargy
         subjects affected / exposed
    1 / 1493 (0.07%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences all number
    2
    1
    0
    Poor quality sleep
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    1 / 1526 (0.07%)
         occurrences all number
    0
    1
    1
    Psychomotor hyperactivity
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences all number
    0
    0
    1
    Sleep phase rhythm disturbance
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences all number
    0
    0
    1
    Somnolence
         subjects affected / exposed
    551 / 1493 (36.91%)
    567 / 1497 (37.88%)
    582 / 1526 (38.14%)
         occurrences all number
    552
    569
    582
    Syncope
         subjects affected / exposed
    1 / 1493 (0.07%)
    0 / 1497 (0.00%)
    0 / 1526 (0.00%)
         occurrences all number
    1
    0
    0
    Tongue biting
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences all number
    0
    0
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    6 / 1493 (0.40%)
    5 / 1497 (0.33%)
    4 / 1526 (0.26%)
         occurrences all number
    6
    5
    4
    Hypochromic anaemia
         subjects affected / exposed
    1 / 1493 (0.07%)
    0 / 1497 (0.00%)
    0 / 1526 (0.00%)
         occurrences all number
    1
    0
    0
    Iron deficiency anaemia
         subjects affected / exposed
    0 / 1493 (0.00%)
    3 / 1497 (0.20%)
    1 / 1526 (0.07%)
         occurrences all number
    0
    3
    1
    Lymphadenitis
         subjects affected / exposed
    2 / 1493 (0.13%)
    2 / 1497 (0.13%)
    2 / 1526 (0.13%)
         occurrences all number
    2
    2
    2
    Lymphadenopathy
         subjects affected / exposed
    8 / 1493 (0.54%)
    5 / 1497 (0.33%)
    2 / 1526 (0.13%)
         occurrences all number
    8
    5
    2
    Thrombocytosis
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences all number
    0
    1
    0
    Ear and labyrinth disorders
    Cerumen impaction
         subjects affected / exposed
    2 / 1493 (0.13%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences all number
    2
    1
    0
    Ear disorder
         subjects affected / exposed
    1 / 1493 (0.07%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences all number
    1
    0
    1
    Ear pain
         subjects affected / exposed
    6 / 1493 (0.40%)
    7 / 1497 (0.47%)
    6 / 1526 (0.39%)
         occurrences all number
    6
    7
    6
    Middle ear inflammation
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences all number
    0
    1
    0
    Otorrhoea
         subjects affected / exposed
    1 / 1493 (0.07%)
    1 / 1497 (0.07%)
    3 / 1526 (0.20%)
         occurrences all number
    1
    1
    4
    Tympanic membrane perforation
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    2 / 1526 (0.13%)
         occurrences all number
    0
    0
    2
    Eye disorders
    Blepharitis
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences all number
    0
    1
    0
    Conjunctival hyperaemia
         subjects affected / exposed
    1 / 1493 (0.07%)
    0 / 1497 (0.00%)
    0 / 1526 (0.00%)
         occurrences all number
    1
    0
    0
    Conjunctivitis allergic
         subjects affected / exposed
    0 / 1493 (0.00%)
    2 / 1497 (0.13%)
    0 / 1526 (0.00%)
         occurrences all number
    0
    3
    0
    Eye discharge
         subjects affected / exposed
    1 / 1493 (0.07%)
    2 / 1497 (0.13%)
    3 / 1526 (0.20%)
         occurrences all number
    1
    2
    3
    Eye oedema
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences all number
    0
    0
    1
    Eye swelling
         subjects affected / exposed
    1 / 1493 (0.07%)
    0 / 1497 (0.00%)
    0 / 1526 (0.00%)
         occurrences all number
    1
    0
    0
    Eyelid bleeding
         subjects affected / exposed
    1 / 1493 (0.07%)
    0 / 1497 (0.00%)
    0 / 1526 (0.00%)
         occurrences all number
    1
    0
    0
    Eyelid cyst
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences all number
    0
    1
    0
    Eyelid oedema
         subjects affected / exposed
    0 / 1493 (0.00%)
    2 / 1497 (0.13%)
    0 / 1526 (0.00%)
         occurrences all number
    0
    2
    0
    Keratitis
         subjects affected / exposed
    1 / 1493 (0.07%)
    0 / 1497 (0.00%)
    0 / 1526 (0.00%)
         occurrences all number
    1
    0
    0
    Lacrimation increased
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences all number
    0
    1
    0
    Ocular hyperaemia
         subjects affected / exposed
    1 / 1493 (0.07%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences all number
    1
    1
    0
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    0 / 1493 (0.00%)
    2 / 1497 (0.13%)
    0 / 1526 (0.00%)
         occurrences all number
    0
    2
    0
    Abdominal distension
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences all number
    0
    1
    0
    Abdominal pain
         subjects affected / exposed
    3 / 1493 (0.20%)
    2 / 1497 (0.13%)
    3 / 1526 (0.20%)
         occurrences all number
    3
    3
    3
    Abdominal pain upper
         subjects affected / exposed
    1 / 1493 (0.07%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences all number
    1
    1
    0
    Anal fissure
         subjects affected / exposed
    3 / 1493 (0.20%)
    3 / 1497 (0.20%)
    3 / 1526 (0.20%)
         occurrences all number
    3
    3
    3
    Aphthous ulcer
         subjects affected / exposed
    6 / 1493 (0.40%)
    7 / 1497 (0.47%)
    3 / 1526 (0.20%)
         occurrences all number
    6
    7
    3
    Cheilitis
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences all number
    0
    0
    1
    Colitis
         subjects affected / exposed
    0 / 1493 (0.00%)
    2 / 1497 (0.13%)
    0 / 1526 (0.00%)
         occurrences all number
    0
    2
    0
    Constipation
         subjects affected / exposed
    11 / 1493 (0.74%)
    11 / 1497 (0.73%)
    6 / 1526 (0.39%)
         occurrences all number
    11
    13
    6
    Diarrhoea
         subjects affected / exposed
    73 / 1493 (4.89%)
    71 / 1497 (4.74%)
    75 / 1526 (4.91%)
         occurrences all number
    83
    76
    80
    Dyspepsia
         subjects affected / exposed
    0 / 1493 (0.00%)
    2 / 1497 (0.13%)
    1 / 1526 (0.07%)
         occurrences all number
    0
    2
    1
    Enteritis
         subjects affected / exposed
    19 / 1493 (1.27%)
    21 / 1497 (1.40%)
    19 / 1526 (1.25%)
         occurrences all number
    19
    23
    20
    Enterocolitis
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences all number
    0
    1
    0
    Faeces discoloured
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences all number
    0
    0
    1
    Flatulence
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences all number
    0
    1
    0
    Food poisoning
         subjects affected / exposed
    1 / 1493 (0.07%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences all number
    1
    0
    1
    Functional gastrointestinal disorder
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences all number
    0
    0
    1
    Gastritis
         subjects affected / exposed
    2 / 1493 (0.13%)
    0 / 1497 (0.00%)
    3 / 1526 (0.20%)
         occurrences all number
    2
    0
    3
    Gastrooesophageal reflux disease
         subjects affected / exposed
    2 / 1493 (0.13%)
    2 / 1497 (0.13%)
    2 / 1526 (0.13%)
         occurrences all number
    2
    2
    2
    Gingival disorder
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences all number
    0
    0
    1
    Gingival pain
         subjects affected / exposed
    4 / 1493 (0.27%)
    4 / 1497 (0.27%)
    2 / 1526 (0.13%)
         occurrences all number
    5
    4
    2
    Glossodynia
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences all number
    0
    1
    0
    Haematochezia
         subjects affected / exposed
    1 / 1493 (0.07%)
    1 / 1497 (0.07%)
    2 / 1526 (0.13%)
         occurrences all number
    1
    1
    3
    Haemorrhoids
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences all number
    0
    0
    1
    Inguinal hernia
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences all number
    0
    1
    0
    Lip disorder
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences all number
    0
    0
    1
    Lip ulceration
         subjects affected / exposed
    1 / 1493 (0.07%)
    0 / 1497 (0.00%)
    0 / 1526 (0.00%)
         occurrences all number
    1
    0
    0
    Malocclusion
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences all number
    0
    0
    1
    Mouth ulceration
         subjects affected / exposed
    1 / 1493 (0.07%)
    1 / 1497 (0.07%)
    2 / 1526 (0.13%)
         occurrences all number
    1
    1
    2
    Nausea
         subjects affected / exposed
    1 / 1493 (0.07%)
    2 / 1497 (0.13%)
    2 / 1526 (0.13%)
         occurrences all number
    1
    2
    2
    Noninfective gingivitis
         subjects affected / exposed
    1 / 1493 (0.07%)
    0 / 1497 (0.00%)
    0 / 1526 (0.00%)
         occurrences all number
    2
    0
    0
    Oral disorder
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences all number
    0
    0
    1
    Palatal ulcer
         subjects affected / exposed
    1 / 1493 (0.07%)
    0 / 1497 (0.00%)
    0 / 1526 (0.00%)
         occurrences all number
    1
    0
    0
    Periodontal disease
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences all number
    0
    0
    1
    Protein-losing gastroenteropathy
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences all number
    0
    1
    0
    Regurgitation
         subjects affected / exposed
    2 / 1493 (0.13%)
    0 / 1497 (0.00%)
    0 / 1526 (0.00%)
         occurrences all number
    2
    0
    0
    Salivary gland enlargement
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences all number
    0
    1
    0
    Salivary hypersecretion
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences all number
    0
    1
    0
    Stomatitis
         subjects affected / exposed
    3 / 1493 (0.20%)
    6 / 1497 (0.40%)
    3 / 1526 (0.20%)
         occurrences all number
    3
    6
    3
    Teething
         subjects affected / exposed
    62 / 1493 (4.15%)
    71 / 1497 (4.74%)
    64 / 1526 (4.19%)
         occurrences all number
    86
    104
    82
    Tongue blistering
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences all number
    0
    1
    0
    Tooth discolouration
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences all number
    0
    1
    0
    Tooth disorder
         subjects affected / exposed
    3 / 1493 (0.20%)
    2 / 1497 (0.13%)
    0 / 1526 (0.00%)
         occurrences all number
    4
    2
    0
    Toothache
         subjects affected / exposed
    22 / 1493 (1.47%)
    17 / 1497 (1.14%)
    17 / 1526 (1.11%)
         occurrences all number
    31
    21
    22
    Vomiting
         subjects affected / exposed
    43 / 1493 (2.88%)
    42 / 1497 (2.81%)
    48 / 1526 (3.15%)
         occurrences all number
    55
    45
    51
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences all number
    0
    1
    0
    Angioedema
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences all number
    0
    0
    1
    Dermal cyst
         subjects affected / exposed
    1 / 1493 (0.07%)
    0 / 1497 (0.00%)
    0 / 1526 (0.00%)
         occurrences all number
    1
    0
    0
    Dermatitis
         subjects affected / exposed
    9 / 1493 (0.60%)
    9 / 1497 (0.60%)
    17 / 1526 (1.11%)
         occurrences all number
    9
    10
    17
    Dermatitis allergic
         subjects affected / exposed
    0 / 1493 (0.00%)
    2 / 1497 (0.13%)
    1 / 1526 (0.07%)
         occurrences all number
    0
    2
    1
    Dermatitis atopic
         subjects affected / exposed
    15 / 1493 (1.00%)
    14 / 1497 (0.94%)
    13 / 1526 (0.85%)
         occurrences all number
    16
    16
    15
    Dermatitis contact
         subjects affected / exposed
    3 / 1493 (0.20%)
    2 / 1497 (0.13%)
    3 / 1526 (0.20%)
         occurrences all number
    3
    2
    3
    Dermatitis diaper
         subjects affected / exposed
    12 / 1493 (0.80%)
    18 / 1497 (1.20%)
    21 / 1526 (1.38%)
         occurrences all number
    12
    19
    21
    Ecchymosis
         subjects affected / exposed
    1 / 1493 (0.07%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences all number
    1
    1
    0
    Eczema
         subjects affected / exposed
    16 / 1493 (1.07%)
    7 / 1497 (0.47%)
    7 / 1526 (0.46%)
         occurrences all number
    16
    7
    9
    Erythema
         subjects affected / exposed
    288 / 1493 (19.29%)
    331 / 1497 (22.11%)
    362 / 1526 (23.72%)
         occurrences all number
    394
    455
    505
    Erythema multiforme
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences all number
    0
    1
    0
    Ingrowing nail
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences all number
    0
    0
    1
    Intertrigo
         subjects affected / exposed
    3 / 1493 (0.20%)
    2 / 1497 (0.13%)
    2 / 1526 (0.13%)
         occurrences all number
    4
    2
    2
    Macule
         subjects affected / exposed
    2 / 1493 (0.13%)
    0 / 1497 (0.00%)
    0 / 1526 (0.00%)
         occurrences all number
    2
    0
    0
    Miliaria
         subjects affected / exposed
    6 / 1493 (0.40%)
    4 / 1497 (0.27%)
    4 / 1526 (0.26%)
         occurrences all number
    6
    4
    4
    Nail disorder
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences all number
    0
    1
    0
    Onychomadesis
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    2 / 1526 (0.13%)
         occurrences all number
    0
    1
    2
    Petechiae
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences all number
    0
    0
    1
    Prurigo
         subjects affected / exposed
    1 / 1493 (0.07%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences all number
    1
    1
    0
    Pruritus
         subjects affected / exposed
    0 / 1493 (0.00%)
    3 / 1497 (0.20%)
    0 / 1526 (0.00%)
         occurrences all number
    0
    3
    0
    Rash macular
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences all number
    0
    0
    1
    Rash maculo-papular
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences all number
    0
    1
    0
    Rash papular
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences all number
    0
    0
    1
    Rash vesicular
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences all number
    0
    1
    0
    Seborrhoeic dermatitis
         subjects affected / exposed
    2 / 1493 (0.13%)
    1 / 1497 (0.07%)
    1 / 1526 (0.07%)
         occurrences all number
    2
    1
    1
    Skin burning sensation
         subjects affected / exposed
    1 / 1493 (0.07%)
    0 / 1497 (0.00%)
    0 / 1526 (0.00%)
         occurrences all number
    1
    0
    0
    Skin discolouration
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences all number
    0
    0
    1
    Skin irritation
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    2 / 1526 (0.13%)
         occurrences all number
    0
    0
    2
    Skin lesion
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences all number
    0
    2
    0
    Skin ulcer
         subjects affected / exposed
    0 / 1493 (0.00%)
    2 / 1497 (0.13%)
    0 / 1526 (0.00%)
         occurrences all number
    0
    2
    0
    Skin warm
         subjects affected / exposed
    1 / 1493 (0.07%)
    2 / 1497 (0.13%)
    0 / 1526 (0.00%)
         occurrences all number
    1
    2
    0
    Spider naevus
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences all number
    0
    0
    1
    Swelling face
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences all number
    0
    0
    1
    Urticaria
         subjects affected / exposed
    4 / 1493 (0.27%)
    5 / 1497 (0.33%)
    3 / 1526 (0.20%)
         occurrences all number
    4
    5
    3
    Musculoskeletal and connective tissue disorders
    Foot deformity
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences all number
    0
    1
    0
    Myalgia
         subjects affected / exposed
    1 / 1493 (0.07%)
    0 / 1497 (0.00%)
    0 / 1526 (0.00%)
         occurrences all number
    1
    0
    0
    Neck mass
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences all number
    0
    1
    0
    Pain in extremity
         subjects affected / exposed
    2 / 1493 (0.13%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences all number
    2
    1
    0
    Synovitis
         subjects affected / exposed
    3 / 1493 (0.20%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences all number
    4
    0
    1
    Infections and infestations
    Abscess
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    2 / 1526 (0.13%)
         occurrences all number
    0
    0
    2
    Acarodermatitis
         subjects affected / exposed
    1 / 1493 (0.07%)
    0 / 1497 (0.00%)
    0 / 1526 (0.00%)
         occurrences all number
    1
    0
    0
    Acute sinusitis
         subjects affected / exposed
    2 / 1493 (0.13%)
    0 / 1497 (0.00%)
    0 / 1526 (0.00%)
         occurrences all number
    2
    0
    0
    Adenoiditis
         subjects affected / exposed
    1 / 1493 (0.07%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences all number
    1
    0
    1
    Adenoviral conjunctivitis
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences all number
    0
    0
    1
    Adenovirus infection
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences all number
    0
    1
    0
    Angular cheilitis
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences all number
    0
    1
    0
    Body tinea
         subjects affected / exposed
    1 / 1493 (0.07%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences all number
    1
    0
    1
    Bronchiolitis
         subjects affected / exposed
    18 / 1493 (1.21%)
    22 / 1497 (1.47%)
    21 / 1526 (1.38%)
         occurrences all number
    22
    22
    22
    Bronchitis
         subjects affected / exposed
    81 / 1493 (5.43%)
    96 / 1497 (6.41%)
    77 / 1526 (5.05%)
         occurrences all number
    92
    115
    95
    Bronchitis viral
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    1 / 1526 (0.07%)
         occurrences all number
    0
    1
    1
    Bullous impetigo
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences all number
    0
    1
    0
    Burn infection
         subjects affected / exposed
    1 / 1493 (0.07%)
    0 / 1497 (0.00%)
    0 / 1526 (0.00%)
         occurrences all number
    1
    0
    0
    Campylobacter gastroenteritis
         subjects affected / exposed
    0 / 1493 (0.00%)
    2 / 1497 (0.13%)
    2 / 1526 (0.13%)
         occurrences all number
    0
    2
    2
    Campylobacter infection
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences all number
    0
    1
    0
    Candida infection
         subjects affected / exposed
    6 / 1493 (0.40%)
    9 / 1497 (0.60%)
    7 / 1526 (0.46%)
         occurrences all number
    7
    9
    7
    Candida nappy rash
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences all number
    0
    1
    0
    Cellulitis
         subjects affected / exposed
    0 / 1493 (0.00%)
    2 / 1497 (0.13%)
    3 / 1526 (0.20%)
         occurrences all number
    0
    2
    3
    Conjunctivitis
         subjects affected / exposed
    63 / 1493 (4.22%)
    79 / 1497 (5.28%)
    79 / 1526 (5.18%)
         occurrences all number
    67
    90
    87
    Conjunctivitis bacterial
         subjects affected / exposed
    1 / 1493 (0.07%)
    0 / 1497 (0.00%)
    0 / 1526 (0.00%)
         occurrences all number
    1
    0
    0
    Conjunctivitis viral
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences all number
    0
    1
    0
    Coxsackie viral infection
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    2 / 1526 (0.13%)
         occurrences all number
    0
    0
    2
    Croup infectious
         subjects affected / exposed
    4 / 1493 (0.27%)
    11 / 1497 (0.73%)
    12 / 1526 (0.79%)
         occurrences all number
    4
    11
    13
    Cryptosporidiosis infection
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences all number
    0
    0
    1
    Cystitis
         subjects affected / exposed
    1 / 1493 (0.07%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences all number
    1
    0
    1
    Ear infection
         subjects affected / exposed
    19 / 1493 (1.27%)
    19 / 1497 (1.27%)
    12 / 1526 (0.79%)
         occurrences all number
    19
    20
    13
    Eczema impetiginous
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences all number
    0
    1
    0
    Enterobiasis
         subjects affected / exposed
    0 / 1493 (0.00%)
    2 / 1497 (0.13%)
    0 / 1526 (0.00%)
         occurrences all number
    0
    2
    0
    Enterovirus infection
         subjects affected / exposed
    3 / 1493 (0.20%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences all number
    3
    1
    0
    Erythema infectiosum
         subjects affected / exposed
    1 / 1493 (0.07%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences all number
    1
    0
    1
    Exanthema subitum
         subjects affected / exposed
    2 / 1493 (0.13%)
    5 / 1497 (0.33%)
    1 / 1526 (0.07%)
         occurrences all number
    2
    5
    1
    Eye infection
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences all number
    0
    1
    0
    Folliculitis
         subjects affected / exposed
    3 / 1493 (0.20%)
    0 / 1497 (0.00%)
    0 / 1526 (0.00%)
         occurrences all number
    3
    0
    0
    Fungal infection
         subjects affected / exposed
    2 / 1493 (0.13%)
    0 / 1497 (0.00%)
    0 / 1526 (0.00%)
         occurrences all number
    2
    0
    0
    Fungal skin infection
         subjects affected / exposed
    1 / 1493 (0.07%)
    3 / 1497 (0.20%)
    0 / 1526 (0.00%)
         occurrences all number
    1
    3
    0
    Furuncle
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences all number
    0
    1
    0
    Gastritis viral
         subjects affected / exposed
    3 / 1493 (0.20%)
    0 / 1497 (0.00%)
    2 / 1526 (0.13%)
         occurrences all number
    4
    0
    2
    Gastroenteritis
         subjects affected / exposed
    88 / 1493 (5.89%)
    95 / 1497 (6.35%)
    93 / 1526 (6.09%)
         occurrences all number
    93
    107
    100
    Gastroenteritis norovirus
         subjects affected / exposed
    0 / 1493 (0.00%)
    2 / 1497 (0.13%)
    0 / 1526 (0.00%)
         occurrences all number
    0
    2
    0
    Gastroenteritis salmonella
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    1 / 1526 (0.07%)
         occurrences all number
    0
    1
    1
    Gastroenteritis viral
         subjects affected / exposed
    7 / 1493 (0.47%)
    6 / 1497 (0.40%)
    9 / 1526 (0.59%)
         occurrences all number
    7
    6
    9
    Genital candidiasis
         subjects affected / exposed
    2 / 1493 (0.13%)
    0 / 1497 (0.00%)
    0 / 1526 (0.00%)
         occurrences all number
    2
    0
    0
    Gingivitis
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    2 / 1526 (0.13%)
         occurrences all number
    0
    0
    2
    Hand-foot-and-mouth disease
         subjects affected / exposed
    10 / 1493 (0.67%)
    23 / 1497 (1.54%)
    10 / 1526 (0.66%)
         occurrences all number
    10
    23
    11
    Herpangina
         subjects affected / exposed
    9 / 1493 (0.60%)
    8 / 1497 (0.53%)
    8 / 1526 (0.52%)
         occurrences all number
    9
    8
    8
    Herpes virus infection
         subjects affected / exposed
    1 / 1493 (0.07%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences all number
    1
    0
    1
    Hordeolum
         subjects affected / exposed
    3 / 1493 (0.20%)
    3 / 1497 (0.20%)
    1 / 1526 (0.07%)
         occurrences all number
    3
    3
    1
    Impetigo
         subjects affected / exposed
    6 / 1493 (0.40%)
    7 / 1497 (0.47%)
    9 / 1526 (0.59%)
         occurrences all number
    6
    7
    9
    Infected bite
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    1 / 1526 (0.07%)
         occurrences all number
    0
    1
    1
    Influenza
         subjects affected / exposed
    7 / 1493 (0.47%)
    11 / 1497 (0.73%)
    10 / 1526 (0.66%)
         occurrences all number
    8
    13
    10
    Laryngitis
         subjects affected / exposed
    34 / 1493 (2.28%)
    34 / 1497 (2.27%)
    27 / 1526 (1.77%)
         occurrences all number
    35
    37
    30
    Lice infestation
         subjects affected / exposed
    0 / 1493 (0.00%)
    4 / 1497 (0.27%)
    0 / 1526 (0.00%)
         occurrences all number
    0
    4
    0
    Localised infection
         subjects affected / exposed
    2 / 1493 (0.13%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences all number
    2
    0
    1
    Lower respiratory tract infection
         subjects affected / exposed
    4 / 1493 (0.27%)
    4 / 1497 (0.27%)
    5 / 1526 (0.33%)
         occurrences all number
    4
    5
    5
    Lower respiratory tract infection viral
         subjects affected / exposed
    1 / 1493 (0.07%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences all number
    1
    1
    0
    Mastitis
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences all number
    0
    1
    0
    Molluscum contagiosum
         subjects affected / exposed
    1 / 1493 (0.07%)
    0 / 1497 (0.00%)
    0 / 1526 (0.00%)
         occurrences all number
    1
    0
    0
    Mycoplasma infection
         subjects affected / exposed
    5 / 1493 (0.33%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences all number
    5
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    148 / 1493 (9.91%)
    176 / 1497 (11.76%)
    134 / 1526 (8.78%)
         occurrences all number
    177
    210
    154
    Oral candidiasis
         subjects affected / exposed
    7 / 1493 (0.47%)
    1 / 1497 (0.07%)
    8 / 1526 (0.52%)
         occurrences all number
    7
    1
    8
    Oral fungal infection
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences all number
    0
    0
    1
    Oral herpes
         subjects affected / exposed
    3 / 1493 (0.20%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences all number
    3
    1
    0
    Orchitis
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences all number
    0
    0
    1
    Otitis externa
         subjects affected / exposed
    5 / 1493 (0.33%)
    3 / 1497 (0.20%)
    3 / 1526 (0.20%)
         occurrences all number
    5
    3
    3
    Otitis media
         subjects affected / exposed
    95 / 1493 (6.36%)
    99 / 1497 (6.61%)
    116 / 1526 (7.60%)
         occurrences all number
    120
    117
    143
    Otitis media acute
         subjects affected / exposed
    46 / 1493 (3.08%)
    49 / 1497 (3.27%)
    57 / 1526 (3.74%)
         occurrences all number
    55
    60
    65
    Parasitic gastroenteritis
         subjects affected / exposed
    1 / 1493 (0.07%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences all number
    1
    0
    1
    Paronychia
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    2 / 1526 (0.13%)
         occurrences all number
    0
    1
    2
    Periorbital cellulitis
         subjects affected / exposed
    1 / 1493 (0.07%)
    0 / 1497 (0.00%)
    0 / 1526 (0.00%)
         occurrences all number
    1
    0
    0
    Pharyngitis
         subjects affected / exposed
    50 / 1493 (3.35%)
    53 / 1497 (3.54%)
    55 / 1526 (3.60%)
         occurrences all number
    61
    56
    57
    Pharyngitis streptococcal
         subjects affected / exposed
    2 / 1493 (0.13%)
    1 / 1497 (0.07%)
    1 / 1526 (0.07%)
         occurrences all number
    2
    1
    1
    Pharyngotonsillitis
         subjects affected / exposed
    14 / 1493 (0.94%)
    15 / 1497 (1.00%)
    17 / 1526 (1.11%)
         occurrences all number
    15
    16
    17
    Pneumonia
         subjects affected / exposed
    5 / 1493 (0.33%)
    8 / 1497 (0.53%)
    9 / 1526 (0.59%)
         occurrences all number
    5
    8
    9
    Pneumonia mycoplasmal
         subjects affected / exposed
    1 / 1493 (0.07%)
    1 / 1497 (0.07%)
    1 / 1526 (0.07%)
         occurrences all number
    1
    1
    1
    Pneumonia viral
         subjects affected / exposed
    1 / 1493 (0.07%)
    0 / 1497 (0.00%)
    0 / 1526 (0.00%)
         occurrences all number
    1
    0
    0
    Pseudocroup
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences all number
    0
    1
    0
    Pyelonephritis
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences all number
    0
    1
    0
    Pyoderma
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences all number
    0
    1
    0
    Respiratory syncytial virus bronchiolitis
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences all number
    0
    0
    1
    Respiratory syncytial virus infection
         subjects affected / exposed
    1 / 1493 (0.07%)
    4 / 1497 (0.27%)
    2 / 1526 (0.13%)
         occurrences all number
    1
    4
    2
    Respiratory tract infection
         subjects affected / exposed
    24 / 1493 (1.61%)
    24 / 1497 (1.60%)
    22 / 1526 (1.44%)
         occurrences all number
    25
    28
    30
    Respiratory tract infection viral
         subjects affected / exposed
    4 / 1493 (0.27%)
    9 / 1497 (0.60%)
    7 / 1526 (0.46%)
         occurrences all number
    5
    10
    11
    Rhinitis
         subjects affected / exposed
    37 / 1493 (2.48%)
    49 / 1497 (3.27%)
    30 / 1526 (1.97%)
         occurrences all number
    53
    56
    33
    Rhinovirus infection
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences all number
    0
    1
    0
    Roseola
         subjects affected / exposed
    1 / 1493 (0.07%)
    3 / 1497 (0.20%)
    0 / 1526 (0.00%)
         occurrences all number
    1
    3
    0
    Salmonellosis
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences all number
    0
    0
    1
    Scarlet fever
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences all number
    0
    0
    1
    Sinusitis
         subjects affected / exposed
    11 / 1493 (0.74%)
    10 / 1497 (0.67%)
    7 / 1526 (0.46%)
         occurrences all number
    12
    10
    7
    Sinusitis bacterial
         subjects affected / exposed
    2 / 1493 (0.13%)
    0 / 1497 (0.00%)
    0 / 1526 (0.00%)
         occurrences all number
    2
    0
    0
    Skin bacterial infection
         subjects affected / exposed
    1 / 1493 (0.07%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences all number
    1
    1
    0
    Skin candida
         subjects affected / exposed
    1 / 1493 (0.07%)
    0 / 1497 (0.00%)
    0 / 1526 (0.00%)
         occurrences all number
    1
    0
    0
    Skin infection
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences all number
    0
    1
    0
    Staphylococcal abscess
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences all number
    0
    0
    1
    Staphylococcal infection
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences all number
    0
    1
    0
    Streptococcal infection
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    1 / 1526 (0.07%)
         occurrences all number
    0
    1
    1
    Subcutaneous abscess
         subjects affected / exposed
    2 / 1493 (0.13%)
    1 / 1497 (0.07%)
    3 / 1526 (0.20%)
         occurrences all number
    2
    1
    3
    Superinfection bacterial
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences all number
    0
    0
    1
    Tonsillitis
         subjects affected / exposed
    34 / 1493 (2.28%)
    24 / 1497 (1.60%)
    34 / 1526 (2.23%)
         occurrences all number
    36
    27
    36
    Tonsillitis bacterial
         subjects affected / exposed
    1 / 1493 (0.07%)
    0 / 1497 (0.00%)
    0 / 1526 (0.00%)
         occurrences all number
    1
    0
    0
    Tooth abscess
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences all number
    0
    1
    0
    Tracheitis
         subjects affected / exposed
    1 / 1493 (0.07%)
    3 / 1497 (0.20%)
    2 / 1526 (0.13%)
         occurrences all number
    1
    3
    2
    Tracheobronchitis
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences all number
    0
    0
    1
    Upper respiratory tract infection
         subjects affected / exposed
    350 / 1493 (23.44%)
    354 / 1497 (23.65%)
    365 / 1526 (23.92%)
         occurrences all number
    475
    473
    485
    Upper respiratory tract infection bacterial
         subjects affected / exposed
    2 / 1493 (0.13%)
    0 / 1497 (0.00%)
    0 / 1526 (0.00%)
         occurrences all number
    2
    0
    0
    Urinary tract infection
         subjects affected / exposed
    4 / 1493 (0.27%)
    2 / 1497 (0.13%)
    4 / 1526 (0.26%)
         occurrences all number
    5
    3
    5
    Varicella
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    1 / 1526 (0.07%)
         occurrences all number
    0
    1
    1
    Viral infection
         subjects affected / exposed
    45 / 1493 (3.01%)
    51 / 1497 (3.41%)
    57 / 1526 (3.74%)
         occurrences all number
    50
    57
    61
    Viral pharyngitis
         subjects affected / exposed
    5 / 1493 (0.33%)
    2 / 1497 (0.13%)
    3 / 1526 (0.20%)
         occurrences all number
    5
    2
    3
    Viral rash
         subjects affected / exposed
    1 / 1493 (0.07%)
    0 / 1497 (0.00%)
    0 / 1526 (0.00%)
         occurrences all number
    1
    0
    0
    Viral rhinitis
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    3 / 1526 (0.20%)
         occurrences all number
    0
    1
    3
    Viral tonsillitis
         subjects affected / exposed
    1 / 1493 (0.07%)
    1 / 1497 (0.07%)
    1 / 1526 (0.07%)
         occurrences all number
    1
    1
    1
    Viral upper respiratory tract infection
         subjects affected / exposed
    2 / 1493 (0.13%)
    6 / 1497 (0.40%)
    11 / 1526 (0.72%)
         occurrences all number
    2
    6
    12
    Vulvitis
         subjects affected / exposed
    1 / 1493 (0.07%)
    0 / 1497 (0.00%)
    0 / 1526 (0.00%)
         occurrences all number
    1
    0
    0
    Vulvovaginitis
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences all number
    0
    0
    1
    Wound infection
         subjects affected / exposed
    1 / 1493 (0.07%)
    0 / 1497 (0.00%)
    0 / 1526 (0.00%)
         occurrences all number
    1
    0
    0
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    571 / 1493 (38.25%)
    593 / 1497 (39.61%)
    593 / 1526 (38.86%)
         occurrences all number
    575
    595
    593
    Dehydration
         subjects affected / exposed
    1 / 1493 (0.07%)
    1 / 1497 (0.07%)
    0 / 1526 (0.00%)
         occurrences all number
    1
    1
    0
    Disaccharide metabolism disorder
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences all number
    0
    0
    1
    Failure to thrive
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    2 / 1526 (0.13%)
         occurrences all number
    0
    0
    2
    Feeding disorder
         subjects affected / exposed
    1 / 1493 (0.07%)
    0 / 1497 (0.00%)
    0 / 1526 (0.00%)
         occurrences all number
    1
    0
    0
    Hyposideraemia
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    1 / 1526 (0.07%)
         occurrences all number
    0
    1
    1
    Lactase deficiency
         subjects affected / exposed
    0 / 1493 (0.00%)
    0 / 1497 (0.00%)
    1 / 1526 (0.07%)
         occurrences all number
    0
    0
    1
    Lactose intolerance
         subjects affected / exposed
    0 / 1493 (0.00%)
    1 / 1497 (0.07%)
    2 / 1526 (0.13%)
         occurrences all number
    0
    1
    2

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Feb 2014
    • At CBER’s request, the US non post dose 2 sub cohort was eliminated. This sub cohort was previously defined as any child enrolled in the US after the target enrollment of 1000 US children was met. These children would not have been required to have a blood sample taken post dose 2 as post dose 2 immunogenicity testing was only required in 1000 children. At CBER’s request, the serologic response after each dose of both Merck’s MMR-II and GSK’s investigational vaccine will be evaluated in all US children. In the event that the pre-specified criteria for seroresponse are not met, U.S. children will be offered vaccination with MMR-II to assure protection from measles, mumps and rubella diseases. • Vaccination against influenza and haemophilus influenza type B can be given at any time before, during, or after the study, including the day of study vaccination. This is to correct a prior exclusion criterion which stated that it could be given at any time during the study. The intent has always been to allow these vaccinations at any time regardless of whether or not it was before, during or after the study period. • For other MMR US Phase III studies, CBER has requested that all conditions leading to non-routine medically attended visits be collected for the entire study in the eCRF. It has been clarified throughout the protocol that From Visit 1 (Day 0) to study end (Day 180), all medically attended events will be recorded in the eCRF. Subjects’ routine ‘well child’ doctor visits will not be recorded in the eCRF.
    19 May 2015
    • Serological assays for the determination of antibodies against measles, rubella and varicella viruses will now be performed by a new 3rd party Contract Research Organization (CRO) named NEOMED-LABS Inc. Initially the testing was planned to be performed by GSK Biologicals’ laboratory in Rixensart. The assays have been transferred to GSK Biologicals’ laboratory in Laval. As of April 1st 2015, the GSK Biologicals’ laboratory in Laval became part of Neomed. The only change between GSK Biologicals’ laboratory in Laval and NEOMED-LABS Inc. is the name of the laboratory: assays and facilities remain the same. • Due to a delay in the availability of serologic data for the mumps Plaque Reduction Neutralization Test (PRNT) data analysis for this study will be conducted as follows: Part 1 will include a summary of measles, mumps and rubella Enzyme-Linked Immunosorbent Assay (ELISA) results post dose 1 (Day 42) and post dose 2 (Day 84). Part 2 will include a full immunogenicity analysis for post dose 1 (Day 42) and post dose 2 (Day 84) including mumps PRNT results post dose 1, and all safety data.

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

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