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    Clinical Trial Results:
    A phase IIIA, randomized, observer-blind, controlled, multinational consistency study to evaluate the immunogenicity and safety of GSK Biologicals' MMR vaccine (209762) (Priorix®) compared to Merck & Co., Inc.’s MMR vaccine (M-M-R®II), as a first dose, both co-administered with Varivax, Havrix and Prevnar 13 (subset of children) to healthy children 12 to 15 months of age.

    Summary
    EudraCT number
    		 2011-004891-12
    Trial protocol
    		 EE   FI   ES  
    Global end of trial date
    16 Apr 2015

    Results information
    Results version number
    		 v1
    This version publication date
    30 Jul 2016
    First version publication date
    30 Jul 2016
    Other versions
    		 v2

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    115648
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01702428
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline Biologicals
    Sponsor organisation address
    Rue de l’Institut 89, Rixensart, Belgium, B-1330
    Public contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 44 2089904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 44 2089904466, GSKClinicalSupportHD@gsk.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Interim
    Date of interim/final analysis
    18 Apr 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    25 Nov 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Apr 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    •To demonstrate the consistency of three manufacturing lots of Inv_MMR vaccine in terms of seroresponse rates to measles, mumps and rubella viruses at Day 42. •To demonstrate the consistency of three manufacturing lots of Inv_MMR vaccine in terms of geometric mean concentrations (GMCs) for antibodies to measles, mumps and rubella viruses at Day 42. •To demonstrate the non-inferiority of Inv_MMR (for the three pooled lots) compared to Com_MMR (for the two pooled lots) vaccine in terms of seroresponse rates for measles, mumps and rubella viruses at Day 42. •To demonstrate non-inferiority of Inv_MMR (for the three pooled lots) compared to Com_MMR (for the two pooled lots) vaccine in terms of GMCs for antibodies to measles, mumps and rubella viruses at Day 42. •To demonstrate an acceptable immune response for Inv_MMR in terms of seroresponse rates for measles, mumps and rubella viruses 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
    09 Nov 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
    Spain: 256
    Country: Number of subjects enrolled
    Estonia: 501
    Country: Number of subjects enrolled
    Finland: 1350
    Country: Number of subjects enrolled
    Mexico: 394
    Country: Number of subjects enrolled
    United States: 2515
    Worldwide total number of subjects
    5016
    EEA total number of subjects
    2107
    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)
    5016
    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
    		 13 subjects from 5016 were allocated subject number but no study vaccine was administered. Therefore, the number of subjects started is 5003.

    Pre-assignment
    Screening details
    		 The subjects were observed closely for at least 30 minutes following the administration of vaccine(s), with appropriate medical treatment readily available in case of a rare anaphylactic reaction.

    Period 1
    Period 1 title
    Day-42 (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 INV_MMR _Lot1 Group
    Arm description
    		 Subjects received 1 dose of INV_MMR lot 1 vaccine (i.e., MMR_MMR_L1) co administered with Varivax and Havrix vaccines at Visit 1 (Day 0). All US subjects were also given Prevnar 13. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. 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 measles, mumps and rubella vaccine live (GSK 209762)
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received 1 dose of MMR vaccine which was administered subcutaneously in the triceps region of the left arm.

    Investigational medicinal product name
    Varivax
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received 1 dose of varicella vaccine which was administered subcutaneously in the triceps region of the right arm.

    Investigational medicinal product name
    Havrix 720 Junior
    Investigational medicinal product code
    Other name
    HEPATITIS A VIRUS HM175 STRAIN (INACTIVATED)
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received 1 dose of HAV vaccine which was administered intramuscularly in the anterolateral region of the right thigh.

    Investigational medicinal product name
    Prevnar 13
    Investigational medicinal product code
    Other name
    PCV 13
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    US subjects received 1 dose of PCV vaccine which was administered intramuscularly in the anterolateral region of the left thigh.

    Arm title
    		 INV_MMR _Lot2 Group
    Arm description
    		 Subjects received 1 dose of INV_MMR lot 2 vaccine (i.e., MMR_MMR_L2) co administered with Varivax and Havrix vaccines at Visit 1 (Day 0). All US subjects were also given Prevnar 13. The MMR vaccine was administered subcutaneously in the in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. 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 measles, mumps and rubella vaccine live (GSK 209762)
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received 1 dose of MMR vaccine which was administered subcutaneously in the triceps region of the left arm.

    Investigational medicinal product name
    Varivax
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received 1 dose of varicella vaccine which was administered subcutaneously in the triceps region of the right arm.

    Investigational medicinal product name
    Havrix 720 Junior
    Investigational medicinal product code
    Other name
    HEPATITIS A VIRUS HM175 STRAIN (INACTIVATED)
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received 1 dose of HAV vaccine which was administered intramuscularly in the anterolateral region of the right thigh.

    Investigational medicinal product name
    Prevnar 13
    Investigational medicinal product code
    Other name
    PCV 13
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    US subjects received 1 dose of PCV vaccine which was administered intramuscularly in the anterolateral region of the left thigh.

    Arm title
    		 INV_MMR _Lot3 Group
    Arm description
    		 Subjects received 1 dose of INV_MMR lot 3 vaccine (i.e., MMR_MMR_L3) co-administered with Varivax and Havrix vaccines at Visit 1 (Day 0). All US subjects were also given Prevnar 13. The MMR vaccine was administered subcutaneously in the in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. 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 measles, mumps and rubella vaccine live (GSK 209762)
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received 1 dose of MMR vaccine which was administered subcutaneously in the triceps region of the left arm.

    Investigational medicinal product name
    Varivax
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received 1 dose of varicella vaccine which was administered subcutaneously in the triceps region of the right arm.

    Investigational medicinal product name
    Havrix 720 Junior
    Investigational medicinal product code
    Other name
    HEPATITIS A VIRUS HM175 STRAIN (INACTIVATED)
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received 1 dose of HAV vaccine which was administered intramuscularly in the anterolateral region of the right thigh.

    Investigational medicinal product name
    Prevnar 13
    Investigational medicinal product code
    Other name
    PCV 13
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    US subjects received 1 dose of PCV vaccine which was administered intramuscularly in the anterolateral region of the left thigh.

    Arm title
    		 INV_MMR Group
    Arm description
    		 This group included subjects from INV_MMR _L1, INV_MMR _L2 and INV_MMR _L3 groups for whom pooled analysis was conducted in addition to lot-to-lot consistency.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Priorix
    Investigational medicinal product code
    Other name
    GSK Biologicals measles, mumps and rubella vaccine live (GSK 209762)
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received 1 dose of MMR vaccine which was administered subcutaneously in the triceps region of the left arm.

    Arm title
    		 COM_MMR Group
    Arm description
    		 Subjects in this group received one dose of COM_MMR from Lot 1 and Lot 2 for whom pooled analysis was conducted.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    M-M-R VaxPro
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for suspension for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received 1 dose of MMR vaccine which was administered subcutaneously in the triceps region of the left arm.

    Investigational medicinal product name
    Varivax
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Subjects received 1 dose of varicella vaccine which was administered subcutaneously in the triceps region of the right arm.

    Investigational medicinal product name
    Havrix 720 Junior
    Investigational medicinal product code
    Other name
    HEPATITIS A VIRUS HM175 STRAIN (INACTIVATED)
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received 1 dose of HAV vaccine which was administered intramuscularly in the anterolateral region of the right thigh.

    Investigational medicinal product name
    Prevnar 13
    Investigational medicinal product code
    Other name
    PCV 13
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    US subjects received 1 dose of PCV vaccine which was administered intramuscularly in the anterolateral region of the left thigh.

    Number of subjects in period 1
    		INV_MMR _Lot1 Group INV_MMR _Lot2 Group INV_MMR _Lot3 Group INV_MMR Group COM_MMR Group
    Started
    1239
    1232
    1243
    3714
    1289
    Completed
    1199
    1192
    1211
    3602
    1258
    Not completed
    40
    40
    32
    112
    31
         Consent withdrawn by subject
    19
    19
    13
    51
    8
         Adverse event, non-fatal
    2
    -
    -
    2
    -
         Migrated/moved from study area
    4
    1
    3
    -
    2
         Lost to follow-up
    13
    20
    16
    57
    21
         Protocol deviation
    2
    -
    -
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups [1]
    Reporting group title
    INV_MMR _Lot1 Group
    Reporting group description
    		 Subjects received 1 dose of INV_MMR lot 1 vaccine (i.e., MMR_MMR_L1) co administered with Varivax and Havrix vaccines at Visit 1 (Day 0). All US subjects were also given Prevnar 13. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV 13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.

    Reporting group title
    INV_MMR _Lot2 Group
    Reporting group description
    		 Subjects received 1 dose of INV_MMR lot 2 vaccine (i.e., MMR_MMR_L2) co administered with Varivax and Havrix vaccines at Visit 1 (Day 0). All US subjects were also given Prevnar 13. The MMR vaccine was administered subcutaneously in the in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV 13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.

    Reporting group title
    INV_MMR _Lot3 Group
    Reporting group description
    		 Subjects received 1 dose of INV_MMR lot 3 vaccine (i.e., MMR_MMR_L3) co-administered with Varivax and Havrix vaccines at Visit 1 (Day 0). All US subjects were also given Prevnar 13. The MMR vaccine was administered subcutaneously in the in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV 13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.

    Reporting group title
    INV_MMR Group
    Reporting group description
    		 This group included subjects from INV_MMR _L1, INV_MMR _L2 and INV_MMR _L3 groups for whom pooled analysis was conducted in addition to lot-to-lot consistency.

    Reporting group title
    COM_MMR Group
    Reporting group description
    		 Subjects in this group received one dose of COM_MMR from Lot 1 and Lot 2 for whom pooled analysis was conducted.

    Notes
    [1] - The number of subjects reported to be in the baseline period is not equal to the worldwide number of subjects enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 13 subjects from 5016 were allocated subject number but no study vaccine was administered. Therefore, the number of subjects started is 5003.
    Reporting group values
    		 INV_MMR _Lot1 Group INV_MMR _Lot2 Group INV_MMR _Lot3 Group INV_MMR Group COM_MMR Group Total
    Number of subjects
    		 1239 1232 1243 3714 1289
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    		 12.3 ± 0.7 12.3 ± 0.7 12.3 ± 0.7 12.3 ± 0.7 12.3 ± 0.7 -
    Gender categorical
    Units: Subjects
        Female
    		 607 594 615 1816 618 2434
        Male
    		 632 638 628 1898 671 2569

    End points

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    End points reporting groups
    Reporting group title
    INV_MMR _Lot1 Group
    Reporting group description
    		 Subjects received 1 dose of INV_MMR lot 1 vaccine (i.e., MMR_MMR_L1) co administered with Varivax and Havrix vaccines at Visit 1 (Day 0). All US subjects were also given Prevnar 13. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV 13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.

    Reporting group title
    INV_MMR _Lot2 Group
    Reporting group description
    		 Subjects received 1 dose of INV_MMR lot 2 vaccine (i.e., MMR_MMR_L2) co administered with Varivax and Havrix vaccines at Visit 1 (Day 0). All US subjects were also given Prevnar 13. The MMR vaccine was administered subcutaneously in the in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV 13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.

    Reporting group title
    INV_MMR _Lot3 Group
    Reporting group description
    		 Subjects received 1 dose of INV_MMR lot 3 vaccine (i.e., MMR_MMR_L3) co-administered with Varivax and Havrix vaccines at Visit 1 (Day 0). All US subjects were also given Prevnar 13. The MMR vaccine was administered subcutaneously in the in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV 13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.

    Reporting group title
    INV_MMR Group
    Reporting group description
    		 This group included subjects from INV_MMR _L1, INV_MMR _L2 and INV_MMR _L3 groups for whom pooled analysis was conducted in addition to lot-to-lot consistency.

    Reporting group title
    COM_MMR Group
    Reporting group description
    		 Subjects in this group received one dose of COM_MMR from Lot 1 and Lot 2 for whom pooled analysis was conducted.

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

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    End point title
    		 Number of subjects with anti-measles virus antibody concentration equal to or above the cut-off-value [1]
    End point description
    Seroresponse was defined as post-vaccination anti-measles virus antibody concentration ≥200 milli International Unit/Milliliter (mIU/mL) among children who were seronegative (antibody concentration <150 mIU/mL) before vaccination.
    End point type
    Primary
    End point timeframe
    At Day 42
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups.
    End point values
    		 INV_MMR _Lot1 Group INV_MMR _Lot2 Group INV_MMR _Lot3 Group
    Number of subjects analysed
    1083
    1069
    1096
    Units: Subjects
        Anti-measles ≥ 150 mIU/mL
    1064
    1057
    1075
        Anti-measles ≥ 200 mIU/mL
    1062
    1054
    1072
    Statistical analysis title
    		 Serostatus for Anti-Measles antibodies
    Comparison groups
    INV_MMR _Lot1 Group v INV_MMR _Lot2 Group
    Number of subjects included in analysis
    2152
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in seroresponse rate
    Point estimate
    -0.54
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.69
         upper limit
    		 0.58
    Statistical analysis title
    		 Serostatus for Anti-Measles antibodies
    Comparison groups
    INV_MMR _Lot1 Group v INV_MMR _Lot3 Group
    Number of subjects included in analysis
    2179
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in seroresponse rate
    Point estimate
    0.25
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.98
         upper limit
    		 1.5
    Statistical analysis title
    		 Serostatus for Anti-measles antibodies
    Comparison groups
    INV_MMR _Lot2 Group v INV_MMR _Lot3 Group
    Number of subjects included in analysis
    2165
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in seroresponse rate
    Point estimate
    0.79
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.35
         upper limit
    		 1.98

    Primary: Anti-measles Virus Antibody Concentrations

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    End point title
    		 Anti-measles Virus Antibody Concentrations [2]
    End point description
    Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in mIU/mL.
    End point type
    Primary
    End point timeframe
    At Day 42
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups.
    End point values
    		 INV_MMR _Lot1 Group INV_MMR _Lot2 Group INV_MMR _Lot3 Group
    Number of subjects analysed
    1083
    1069
    1096
    Units: Titers
    geometric mean (confidence interval 95%)
        Anti-Measles antibody concentration
    2970.3 (2813.2 to 3136.2)
    3023.6 (2864.5 to 3191.6)
    3058.3 (2893.9 to 3232)
    Statistical analysis title
    		 GMC ratio for Anti-measles antibodies
    Statistical analysis description
    Ratio order: INV_MMR _Lot1 / INV_MMR _ Lot2
    Comparison groups
    INV_MMR _Lot1 Group v INV_MMR _Lot2 Group
    Number of subjects included in analysis
    2152
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Adjusted GMC ratio
    Point estimate
    0.99
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.91
         upper limit
    		 1.06
    Statistical analysis title
    		 GMC ratio for Anti-measles antibodies
    Statistical analysis description
    Ratio order: INV_MMR _ Lot1 / Inv_ MMR_ Lot3
    Comparison groups
    INV_MMR _Lot1 Group v INV_MMR _Lot3 Group
    Number of subjects included in analysis
    2179
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Adjusted GMC ratio
    Point estimate
    0.97
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.9
         upper limit
    		 1.05
    Statistical analysis title
    		 GMC ratio for Anti-measles antibodies
    Statistical analysis description
    Ratio order: INV_MMR _ Lot2 / INV_MMR _ Lot1
    Comparison groups
    INV_MMR _Lot2 Group v INV_MMR _Lot1 Group
    Number of subjects included in analysis
    2152
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Adjusted GMC ratio
    Point estimate
    1.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.94
         upper limit
    		 1.09
    Statistical analysis title
    		 GMC ratio for Anti-measles antibodies
    Statistical analysis description
    Ratio order: INV_MMR _ Lot2 / INV_MMR _ Lot3
    Comparison groups
    INV_MMR _Lot2 Group v INV_MMR _Lot3 Group
    Number of subjects included in analysis
    2165
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Adjusted GMC ratio
    Point estimate
    0.99
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.91
         upper limit
    		 1.06
    Statistical analysis title
    		 GMC ratio for Anti-measles antibodies
    Statistical analysis description
    Ratio order: INV_MMR _ Lot3 / INV_MMR _ Lot1
    Comparison groups
    INV_MMR _Lot1 Group v INV_MMR _Lot3 Group
    Number of subjects included in analysis
    2179
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Adjusted GMC ratio
    Point estimate
    1.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.95
         upper limit
    		 1.11
    Statistical analysis title
    		 GMC ratio for Anti-measles antibodies
    Statistical analysis description
    Ratio order: INV_MMR _ Lot3 / INV_MMR _ Lot2
    Comparison groups
    INV_MMR _Lot2 Group v INV_MMR _Lot3 Group
    Number of subjects included in analysis
    2165
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Adjusted GMC ratio
    Point estimate
    1.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.94
         upper limit
    		 1.09

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

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    End point title
    		 Number of subjects with anti-mumps virus antibody concentration equal to or above the cut-off-value [3]
    End point description
    Seroresponse was defined as post-vaccination anti-mumps virus antibody concentration ≥10 EL.U/mL among children who were seronegative (antibody concentrations < 5 EL.U/mL before vaccination.
    End point type
    Primary
    End point timeframe
    At Day 42
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups.
    End point values
    		 INV_MMR _Lot1 Group INV_MMR _Lot2 Group INV_MMR _Lot3 Group
    Number of subjects analysed
    1062
    1047
    1078
    Units: Subjects
        Anti-mumps ≥ 5 EL.U/mL
    1059
    1040
    1069
        Anti-mumps ≥ 10 EL.U/mL
    1047
    1032
    1056
    Statistical analysis title
    		 Serostatus for Anti-mumps antibodies
    Comparison groups
    INV_MMR _Lot1 Group v INV_MMR _Lot2 Group
    Number of subjects included in analysis
    2109
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in seroresponse rate
    Point estimate
    0.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.05
         upper limit
    		 1.09
    Statistical analysis title
    		 Serostatus for Anti-mumps antibodies
    Comparison groups
    INV_MMR _Lot1 Group v INV_MMR _Lot3 Group
    Number of subjects included in analysis
    2140
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in seroresponse rate
    Point estimate
    0.63
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.5
         upper limit
    		 1.81
    Statistical analysis title
    		 Serostatus for Anti-mumps antibodies
    Comparison groups
    INV_MMR _Lot2 Group v INV_MMR _Lot3 Group
    Number of subjects included in analysis
    2125
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in seroresponse rate
    Point estimate
    0.61
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.53
         upper limit
    		 1.79

    Primary: Anti-mumps virus antibody concentration

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    End point title
    		 Anti-mumps virus antibody concentration [4]
    End point description
    Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in mIU/mL.
    End point type
    Primary
    End point timeframe
    At Day 42
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups.
    End point values
    		 INV_MMR _Lot1 Group INV_MMR _Lot2 Group INV_MMR _Lot3 Group
    Number of subjects analysed
    1062
    1047
    1078
    Units: Titers
    geometric mean (confidence interval 95%)
        Anti-Mumps antibody concentration
    71.7 (68.3 to 75.2)
    76.9 (73.2 to 80.8)
    69 (65.5 to 72.7)
    Statistical analysis title
    		 GMC ratio for Anti-mumps antibodies
    Statistical analysis description
    Ratio order: INV_MMR _ Lot1 /MMR_Lot2
    Comparison groups
    INV_MMR _Lot1 Group v INV_MMR _Lot2 Group
    Number of subjects included in analysis
    2109
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Adjusted GMC ratio
    Point estimate
    0.93
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.87
         upper limit
    		 1
    Statistical analysis title
    		 GMC ratio for Anti-mumps antibodies
    Statistical analysis description
    Ratio order: INV_MMR _ Lot1 /MMR_ Lot3
    Comparison groups
    INV_MMR _Lot1 Group v INV_MMR _Lot3 Group
    Number of subjects included in analysis
    2140
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Adjusted GMC ratio
    Point estimate
    1.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.97
         upper limit
    		 1.11
    Statistical analysis title
    		 GMC ratio for Anti-mumps antibodies
    Statistical analysis description
    Ratio order: INV_MMR _ Lot2 /MMR_ Lot1
    Comparison groups
    INV_MMR _Lot1 Group v INV_MMR _Lot2 Group
    Number of subjects included in analysis
    2109
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Adjusted GMC ratio
    Point estimate
    1.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1
         upper limit
    		 1.15
    Statistical analysis title
    		 GMC ratio for Anti-mumps antibodies
    Statistical analysis description
    Ratio order: INV_MMR _ Lot2 /MMR_ Lot3
    Comparison groups
    INV_MMR _Lot2 Group v INV_MMR _Lot3 Group
    Number of subjects included in analysis
    2125
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Adjusted GMC ratio
    Point estimate
    1.11
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.04
         upper limit
    		 1.19
    Statistical analysis title
    		 GMC ratio for Anti-mumps antibodies
    Statistical analysis description
    Ratio order: INV_MMR _ Lot3 /MMR_ Lot1
    Comparison groups
    INV_MMR _Lot3 Group v INV_MMR _Lot1 Group
    Number of subjects included in analysis
    2140
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Adjusted GMC ratio
    Point estimate
    0.96
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.9
         upper limit
    		 1.03
    Statistical analysis title
    		 GMC ratio for Anti-mumps antibodies
    Statistical analysis description
    Ratio order: INV_MMR _ Lot3 /MMR_ Lot2
    Comparison groups
    INV_MMR _Lot3 Group v INV_MMR _Lot2 Group
    Number of subjects included in analysis
    2125
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Adjusted GMC ratio
    Point estimate
    0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.84
         upper limit
    		 0.96

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

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    End point title
    		 Number of subjects with anti-rubella virus antibody concentration equal to or above the cut-off-value [5]
    End point description
    Seroresponse was defined as post-vaccination anti-rubella virus antibody concentration ≥ 10 IU/mL among children who were seronegative (antibody concentrations < 4 IU/mL) before vaccination.
    End point type
    Primary
    End point timeframe
    At Day 42
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups.
    End point values
    		 INV_MMR _Lot1 Group INV_MMR _Lot2 Group INV_MMR _Lot3 Group
    Number of subjects analysed
    1083
    1067
    1095
    Units: Subjects
        Anti-rubella ≥ 4 IU/mL
    1077
    1064
    1088
        Anti-rubella ≥ 10 IU/mL
    1053
    1036
    1070
    Statistical analysis title
    		 Serostatus for Anti-rubella antibodies
    Comparison groups
    INV_MMR _Lot1 Group v INV_MMR _Lot2 Group
    Number of subjects included in analysis
    2150
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in seroresponse rate
    Point estimate
    0.14
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.3
         upper limit
    		 1.58
    Statistical analysis title
    		 Serostatus for Anti-rubella antibodies
    Comparison groups
    INV_MMR _Lot1 Group v INV_MMR _Lot3 Group
    Number of subjects included in analysis
    2178
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in seroresponse rate
    Point estimate
    -0.49
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.86
         upper limit
    		 0.86
    Statistical analysis title
    		 Serostatus for Anti-rubella antibodies
    Comparison groups
    INV_MMR _Lot3 Group v INV_MMR _Lot2 Group
    Number of subjects included in analysis
    2162
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in seroresponse rate
    Point estimate
    -0.62
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.02
         upper limit
    		 0.74

    Primary: Anti-rubella virus antibody concentration

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    End point title
    		 Anti-rubella virus antibody concentration [6]
    End point description
    Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in mIU/mL.
    End point type
    Primary
    End point timeframe
    At Day 42
    Notes
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups.
    End point values
    		 INV_MMR _Lot1 Group INV_MMR _Lot2 Group INV_MMR _Lot3 Group
    Number of subjects analysed
    1083
    1067
    1095
    Units: Titers
    geometric mean (confidence interval 95%)
        Anti-Rubella antibody concentration
    57.2 (54.4 to 60.1)
    53.1 (50.5 to 55.7)
    57 (54.3 to 59.8)
    Statistical analysis title
    		 GMC ratio for Anti-rubella antibodies
    Statistical analysis description
    Ratio order: INV_MMR _ Lot1 / INV_MMR _Lot2
    Comparison groups
    INV_MMR _Lot1 Group v INV_MMR _Lot2 Group
    Number of subjects included in analysis
    2150
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Adjusted GMC ratio
    Point estimate
    1.08
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.01
         upper limit
    		 1.15
    Statistical analysis title
    		 GMC ratio for Anti-rubella antibodies
    Statistical analysis description
    Ratio order: INV_MMR _ Lot1 / INV_MMR _ Lot3
    Comparison groups
    INV_MMR _Lot1 Group v INV_MMR _Lot3 Group
    Number of subjects included in analysis
    2178
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Adjusted GMC ratio
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.94
         upper limit
    		 1.07
    Statistical analysis title
    		 GMC ratio for Anti-rubella antibodies
    Statistical analysis description
    Ratio order: INV_MMR _ Lot2 / INV_MMR _ Lot1
    Comparison groups
    INV_MMR _Lot1 Group v INV_MMR _Lot2 Group
    Number of subjects included in analysis
    2150
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Adjusted GMC ratio
    Point estimate
    0.93
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.87
         upper limit
    		 0.99
    Statistical analysis title
    		 GMC ratio for Anti-rubella antibodies
    Statistical analysis description
    Ratio order: INV_MMR _ Lot2 / INV_MMR _ Lot3
    Comparison groups
    INV_MMR _Lot2 Group v INV_MMR _Lot3 Group
    Number of subjects included in analysis
    2162
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Adjusted GMC ratio
    Point estimate
    0.93
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.87
         upper limit
    		 0.99
    Statistical analysis title
    		 GMC ratio for Anti-rubella antibodies
    Statistical analysis description
    Ratio order: INV_MMR _ Lot3 / INV_MMR _ Lot1
    Comparison groups
    INV_MMR _Lot3 Group v INV_MMR _Lot1 Group
    Number of subjects included in analysis
    2178
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Adjusted GMC ratio
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.93
         upper limit
    		 1.07
    Statistical analysis title
    		 GMC ratio for Anti-rubella antibodies
    Statistical analysis description
    Ratio order: INV_MMR _ Lot3 / INV_MMR _ Lot2
    Comparison groups
    INV_MMR _Lot3 Group v INV_MMR _Lot2 Group
    Number of subjects included in analysis
    2162
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Adjusted GMC ratio
    Point estimate
    1.08
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.01
         upper limit
    		 1.15

    Primary: Number of subjects with anti-measles virus antibody concentration equal to or above the cut-off-value in pooled MMR groups

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    End point title
    		 Number of subjects with anti-measles virus antibody concentration equal to or above the cut-off-value in pooled MMR groups [7]
    End point description
    Seroresponse was defined as post-vaccination anti-measles virus antibody concentration ≥ 200 milli International Unit/Milliliter (mIU/mL) among children who were seronegative (antibody concentration < 150 mIU/mL) before vaccination.
    End point type
    Primary
    End point timeframe
    At Day 42
    Notes
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups.
    End point values
    		 INV_MMR Group COM_MMR Group
    Number of subjects analysed
    3248
    1137
    Units: Subjects
        Anti-measles ≥ 150 mIU/mL
    3196
    1115
        Anti-measles ≥ 200 mIU/mL
    3188
    1114
    Statistical analysis title
    		 Serostatus for Anti-measles antibodies
    Comparison groups
    INV_MMR Group v COM_MMR Group
    Number of subjects included in analysis
    4385
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in seroresponse rate
    Point estimate
    0.18
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.68
         upper limit
    		 1.25

    Primary: Anti-measles Virus Antibody Concentrations in pooled MMR groups

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    End point title
    		 Anti-measles Virus Antibody Concentrations in pooled MMR groups [8]
    End point description
    Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in mIU/mL.
    End point type
    Primary
    End point timeframe
    At Day 42
    Notes
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups.
    End point values
    		 INV_MMR Group COM_MMR Group
    Number of subjects analysed
    3248
    1137
    Units: Titers
    geometric mean (confidence interval 95%)
        Anti-Measles antibody concentration
    3017.4 (2923.9 to 3113.8)
    3074.4 (2911 to 3246.9)
    Statistical analysis title
    		 GMC ratio for Anti-measles antibodies
    Comparison groups
    INV_MMR Group v COM_MMR Group
    Number of subjects included in analysis
    4385
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Adjusted GMC ratio
    Point estimate
    0.98
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.93
         upper limit
    		 1.05

    Primary: Number of subjects with anti-mumps virus antibody concentration equal to or above the cut-off-value in pooled MMR groups

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    End point title
    		 Number of subjects with anti-mumps virus antibody concentration equal to or above the cut-off-value in pooled MMR groups [9]
    End point description
    Seroresponse was defined as post-vaccination anti-mumps virus antibody concentration ≥ 10 EL.U/mL among children who were seronegative (antibody concentrations < 5 EL.U/mL.
    End point type
    Primary
    End point timeframe
    At Day 42
    Notes
    [9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups.
    End point values
    		 INV_MMR Group COM_MMR Group
    Number of subjects analysed
    3187
    1107
    Units: Subjects
        Anti-mumps ≥ 5 EL.U/mL
    3168
    1099
        Anti-mumps ≥ 10 EL.U/mL
    3135
    1080
    Statistical analysis title
    		 Serostatus for Anti-mumps antibodies
    Comparison groups
    INV_MMR Group v COM_MMR Group
    Number of subjects included in analysis
    4294
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in seroresponse rate
    Point estimate
    0.81
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.1
         upper limit
    		 1.96

    Primary: Anti-mumps virus antibody concentration in pooled MMR groups

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    End point title
    		 Anti-mumps virus antibody concentration in pooled MMR groups [10]
    End point description
    Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in mIU/mL.
    End point type
    Primary
    End point timeframe
    At Day 42
    Notes
    [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups.
    End point values
    		 INV_MMR Group COM_MMR Group
    Number of subjects analysed
    3187
    1107
    Units: Titers
    geometric mean (confidence interval 95%)
        Anti-Mumps antibody concentration
    72.4 (70.4 to 74.5)
    69.1 (65.7 to 72.7)
    Statistical analysis title
    		 GMC ratio for Anti-mumps antibodies
    Comparison groups
    INV_MMR Group v COM_MMR Group
    Number of subjects included in analysis
    4294
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Adjusted GMC ratio
    Point estimate
    1.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.99
         upper limit
    		 1.11

    Primary: Number of subjects with anti-rubella virus antibody concentration equal to or above the cut-off-value in pooled MMR groups

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    End point title
    		 Number of subjects with anti-rubella virus antibody concentration equal to or above the cut-off-value in pooled MMR groups [11]
    End point description
    Seroresponse was defined as post-vaccination anti-rubella virus antibody concentration ≥ 10 IU/mL among children who were seronegative (antibody concentrations < 4 IU/mL) before vaccination.
    End point type
    Primary
    End point timeframe
    At Day 42
    Notes
    [11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups.
    End point values
    		 INV_MMR Group COM_MMR Group
    Number of subjects analysed
    3245
    1135
    Units: Subjects
        Anti-rubella ≥ 4 IU/mL
    3229
    1130
        Anti-rubella ≥ 10 IU/mL
    3159
    1118
    Statistical analysis title
    		 Serostatus for Anti-rubella antibodies
    Comparison groups
    INV_MMR Group v COM_MMR Group
    Number of subjects included in analysis
    4380
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in seroresponse rate
    Point estimate
    -1.15
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2
         upper limit
    		 -0.15

    Primary: Anti-rubella virus antibody concentration in pooled MMR groups

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    End point title
    		 Anti-rubella virus antibody concentration in pooled MMR groups [12]
    End point description
    Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in mIU/mL.
    End point type
    Primary
    End point timeframe
    At Day 42
    Notes
    [12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The results in this study were tabulated by age group and study period. Hence for each related endpoint, they are presented for only the respective groups in the baseline period, while the results for multiple endpoints account for all baseline groups.
    End point values
    		 INV_MMR Group COM_MMR Group
    Number of subjects analysed
    3245
    1135
    Units: Titers
    geometric mean (confidence interval 95%)
        Anti-Rubella antibody concentration
    55.7 (54.2 to 57.3)
    64 (61.1 to 67)
    Statistical analysis title
    		 GMC ratio for Anti-rubella antibodies
    Comparison groups
    INV_MMR Group v COM_MMR Group
    Number of subjects included in analysis
    4380
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Adjusted GMC ratio
    Point estimate
    0.87
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.83
         upper limit
    		 0.92

    Secondary: Number of subjects with solicited local symptoms

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    End point title
    		 Number of subjects with solicited local symptoms
    End point description
    Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 Pain = cried when limb was moved/spontaneously painful.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Days 0-3) post-vaccination period
    End point values
    		 INV_MMR _Lot1 Group INV_MMR _Lot2 Group INV_MMR _Lot3 Group INV_MMR Group COM_MMR Group
    Number of subjects analysed
    1186
    1175
    1194
    3555
    1242
    Units: Subjects
        Any Pain
    331
    315
    273
    919
    349
        Grade 3 Pain
    6
    9
    9
    24
    12
        Any Redness
    296
    273
    301
    870
    313
        Grade 3 Redness
    6
    2
    6
    14
    8
        Any Swelling
    116
    99
    103
    318
    133
        Grade 3 Swelling
    1
    5
    6
    12
    5
    No statistical analyses for this end point

    Secondary: Number of subjects with solicited general symptoms

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    End point title
    		 Number of subjects with solicited general symptoms
    End point description
    Assessed solicited general symptoms were drowsiness, irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 Drowsiness = drowsiness that prevented normal activity. Grade 3 Irritability/Fussiness = crying that could not be comforted/ prevented normal activity. Grade 3 Loss of appetite = did not eat at all.
    End point type
    Secondary
    End point timeframe
    During the 15-day (Days 0-14) post-vaccination period
    End point values
    		 INV_MMR _Lot1 Group INV_MMR _Lot2 Group INV_MMR _Lot3 Group INV_MMR Group COM_MMR Group
    Number of subjects analysed
    1190
    1176
    1200
    3566
    1243
    Units: Subjects
        Any Drowsiness
    533
    535
    533
    1601
    586
        Grade 3 Drowsiness
    23
    39
    23
    85
    22
        Any Irritability / fussiness
    764
    729
    765
    2258
    819
        Grade 3 Irritability / fussiness
    56
    63
    57
    176
    58
        Any Loss of appetite
    546
    536
    526
    1608
    548
        Grade 3 Loss of appetite
    24
    29
    19
    72
    31
    No statistical analyses for this end point

    Secondary: Number of subjects reporting fever

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    End point title
    		 Number of subjects reporting fever
    End point description
    Fever was assessed for temperature ≥ 38°C/100.4°F and > 39.5°C/103.1°F as measured rectally.
    End point type
    Secondary
    End point timeframe
    During the 43 days (Days 0-42) post-vaccination period
    End point values
    		 INV_MMR _Lot1 Group INV_MMR _Lot2 Group INV_MMR _Lot3 Group INV_MMR Group COM_MMR Group
    Number of subjects analysed
    1190
    1176
    1200
    3566
    1243
    Units: Subjects
        Any Fever
    404
    422
    418
    1244
    412
        Grade 3 Fever
    36
    37
    32
    105
    32
    No statistical analyses for this end point

    Secondary: Number of subjects reporting MMR specific solicited general symptoms

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    End point title
    		 Number of subjects reporting MMR specific solicited general symptoms
    End point description
    Assessed MMR specific symptoms were rash, parotid gland swelling, and any suspected signs of meningism including febrile convulsions. Any = occurrence of the symptom regardless of intensity grade. Grade 3 Parotid/salivary gland swelling = Swelling accompanied with general symptoms. Grade 3 Febrile convulsion = Prevented normal, everyday activities. Related = symptom assessed by the investigator as causally related to study vaccination.
    End point type
    Secondary
    End point timeframe
    During the 43 days (Days 0-42) post-vaccination period
    End point values
    		 INV_MMR _Lot1 Group INV_MMR _Lot2 Group INV_MMR _Lot3 Group INV_MMR Group COM_MMR Group
    Number of subjects analysed
    1190
    1176
    1200
    3566
    1243
    Units: Subjects
        Any Febrile convulsion
    4
    1
    5
    10
    3
        Grade 3 Febrile convulsion
    2
    0
    2
    4
    0
        Related Febrile convulsion
    1
    1
    2
    4
    2
        Any Parotid/ salivary gland swelling
    0
    0
    0
    0
    0
        Grade 3 Parotid/ salivary gland swelling
    0
    0
    0
    0
    0
        Related Parotid/ salivary gland swelling
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects reporting investigator-confirmed rash

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    End point title
    		 Number of subjects reporting investigator-confirmed rash
    End point description
    Assessed any rash, measles/rubella-like rash and varicella-like rash. Grade 3 Measles/rubella/varicella-like rash = rash with more than 150 lesions. Other Grade 3 Rash = rash that prevented normal, everyday activities.
    End point type
    Secondary
    End point timeframe
    During the 43 days (Days 0-42) post-vaccination period
    End point values
    		 INV_MMR _Lot1 Group INV_MMR _Lot2 Group INV_MMR _Lot3 Group INV_MMR Group COM_MMR Group
    Number of subjects analysed
    1190
    1176
    1200
    3566
    1243
    Units: Subjects
        Any Localized or generalized
    352
    331
    360
    1043
    378
        Any With fever
    106
    123
    118
    347
    104
        Any Varicella like
    87
    78
    85
    250
    85
        Any Measles/ Rubella like
    71
    88
    76
    235
    77
        Any Grade 3
    33
    37
    36
    106
    25
        Localized Any
    230
    224
    251
    705
    266
        Localized Administration site
    10
    16
    12
    38
    16
        Localized Other site
    225
    213
    242
    680
    252
        Localized With fever
    48
    67
    67
    182
    54
        Localized Varicella like
    68
    57
    55
    180
    61
        Localized Measles/ Rubella like
    25
    34
    34
    93
    35
        Localized Grade 3
    6
    10
    9
    25
    5
        Generalized Any
    143
    138
    133
    414
    143
        Generalized With fever
    66
    65
    55
    186
    55
        Generalized Varicella like
    20
    23
    31
    74
    25
        Generalized Measles/ Rubella like
    47
    55
    44
    146
    42
        Generalized Grade 3
    29
    27
    27
    83
    20
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Serious Adverse Events: From Day 0 through the end of study (Day-42); Solicited local and general symptoms: During the 4-day (Days 0-3) and 15 days (Day 0-14) post-vaccination period; Unsolicited adverse events: During the 43-days post-vaccination period.
    Adverse event reporting additional description
    The analysis of the solicited symptoms was based on the Total Vaccinated cohort which included only children/doses with documented safety data (i.e., symptom screen/sheet completed).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    INV_MMR _Lot1 Group
    Reporting group description
    		 Subjects received 1 dose of INV_MMR lot 1 vaccine (i.e., MMR_MMR_L1) co administered with Varivax and Havrix vaccines at Visit 1 (Day 0). All US subjects were also given Prevnar 13. The MMR vaccine was administered subcutaneously in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV 13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.

    Reporting group title
    INV_MMR _Lot2 Group
    Reporting group description
    		 Subjects received 1 dose of INV_MMR lot 2 vaccine (i.e., MMR_MMR_L2) co administered with Varivax and Havrix vaccines at Visit 1 (Day 0). All US subjects were also given Prevnar 13. The MMR vaccine was administered subcutaneously in the in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV 13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.

    Reporting group title
    INV_MMR _Lot3 Group
    Reporting group description
    		 Subjects received 1 dose of INV_MMR lot 3 vaccine (i.e., MMR_MMR_L3) co-administered with Varivax and Havrix vaccines at Visit 1 (Day 0). All US subjects were also given Prevnar 13. The MMR vaccine was administered subcutaneously in the in the triceps region of the left arm while the VV vaccine was administered subcutaneously in the triceps region of the right arm. HAV and PCV 13 vaccines were administered intramuscularly in the anterolateral region of the right and left thigh, respectively.

    Reporting group title
    INV_MMR Group
    Reporting group description
    		 This group included subjects from INV_MMR _L1, INV_MMR _L2 and INV_MMR _L3 groups for whom pooled analysis was conducted in addition to lot-to-lot consistency.

    Reporting group title
    COM_MMR Group
    Reporting group description
    		 Subjects in this group received one dose of COM_MMR from Lot 1 and Lot 2 for whom pooled analysis was conducted.

    Serious adverse events
    		 INV_MMR _Lot1 Group INV_MMR _Lot2 Group INV_MMR _Lot3 Group INV_MMR Group COM_MMR Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 1190 (0.00%)
    0 / 1176 (0.00%)
    0 / 1200 (0.00%)
    0 / 3566 (0.00%)
    0 / 1243 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 INV_MMR _Lot1 Group INV_MMR _Lot2 Group INV_MMR _Lot3 Group INV_MMR Group COM_MMR Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    764 / 1190 (64.20%)
    729 / 1176 (61.99%)
    765 / 1200 (63.75%)
    2258 / 3566 (63.32%)
    819 / 1243 (65.89%)
    General disorders and administration site conditions
    Pain
         subjects affected / exposed [1]
    331 / 1186 (27.91%)
    315 / 1175 (26.81%)
    273 / 1194 (22.86%)
    919 / 3555 (25.85%)
    349 / 1242 (28.10%)
         occurrences all number
    331
    315
    273
    919
    349
    Redness
         subjects affected / exposed [2]
    296 / 1186 (24.96%)
    273 / 1175 (23.23%)
    301 / 1194 (25.21%)
    870 / 3555 (24.47%)
    313 / 1242 (25.20%)
         occurrences all number
    296
    273
    301
    870
    313
    Swelling
         subjects affected / exposed [3]
    116 / 1186 (9.78%)
    99 / 1175 (8.43%)
    103 / 1194 (8.63%)
    318 / 3555 (8.95%)
    133 / 1242 (10.71%)
         occurrences all number
    116
    99
    103
    318
    133
    Drowsiness
         subjects affected / exposed
    533 / 1190 (44.79%)
    535 / 1176 (45.49%)
    533 / 1200 (44.42%)
    1601 / 3566 (44.90%)
    586 / 1243 (47.14%)
         occurrences all number
    533
    535
    533
    1601
    586
    Irritability / fussiness
         subjects affected / exposed
    764 / 1190 (64.20%)
    729 / 1176 (61.99%)
    765 / 1200 (63.75%)
    2258 / 3566 (63.32%)
    819 / 1243 (65.89%)
         occurrences all number
    764
    729
    765
    2258
    819
    Loss of appetite
         subjects affected / exposed
    546 / 1190 (45.88%)
    536 / 1176 (45.58%)
    526 / 1200 (43.83%)
    1608 / 3566 (45.09%)
    548 / 1243 (44.09%)
         occurrences all number
    546
    536
    526
    1608
    548
    Fever
         subjects affected / exposed
    404 / 1190 (33.95%)
    422 / 1176 (35.88%)
    418 / 1200 (34.83%)
    1244 / 3566 (34.89%)
    412 / 1243 (33.15%)
         occurrences all number
    404
    422
    418
    1244
    412
    Localized rash
         subjects affected / exposed
    230 / 1190 (19.33%)
    224 / 1176 (19.05%)
    251 / 1200 (20.92%)
    705 / 3566 (19.77%)
    266 / 1243 (21.40%)
         occurrences all number
    230
    224
    251
    705
    266
    Generalized rash
         subjects affected / exposed
    143 / 1190 (12.02%)
    138 / 1176 (11.73%)
    133 / 1200 (11.08%)
    414 / 3566 (11.61%)
    143 / 1243 (11.50%)
         occurrences all number
    143
    138
    133
    414
    143
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.

    More information

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

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

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