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    Clinical Trial Results:
    Immunogenicity and safety study of GSK Biologicals’ combined measles-mumps-rubella vaccine in subjects seven years and older (209762).

    Summary
    EudraCT number
    		 2011-003672-36
    Trial protocol
    		 SK   EE  
    Global end of trial date
    17 Sep 2015

    Results information
    Results version number
    		 v1
    This version publication date
    15 Jan 2017
    First version publication date
    15 Jan 2017
    Other versions
    		 v2

    Trial information

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    Trial identification
    Sponsor protocol code
    115231
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02058563
    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
    Final
    Date of interim/final analysis
    08 Jul 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    24 May 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Sep 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate the non-inferiority of INV_MMR vaccine to COM_MMR vaccine in terms of Geometric Mean Concentration (GMCs) for anti measles, anti mumps and anti rubella antibodies at Day 42. Criteria for the determination of non-inferiority for measles, mumps, and rubella viruses: Lower limit (LL) of the 2-sided 95% Confidence Interval (CI) on GMC ratio (INV_MMR over COM_MMR) is equal to or above 0.67 for anti-measles, anti-mumps, and anti rubella antibodies.
    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
    17 Jul 2014
    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
    Estonia: 109
    Country: Number of subjects enrolled
    Slovakia: 216
    Country: Number of subjects enrolled
    United States: 671
    Worldwide total number of subjects
    996
    EEA total number of subjects
    325
    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)
    0
    Children (2-11 years)
    250
    Adolescents (12-17 years)
    84
    Adults (18-64 years)
    661
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 996 subjects were enrolled and 994 were vaccinated. Of the 994 vaccinated subjects, 83 subjects from 2 US site s were excluded due to significant GCP concerns, resulting in 911 subjects in the Total vaccinated cohort considered for the analysis.

    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.

    Pre-assignment period milestones
    Number of subjects started
    		 996
    Number of subjects completed
    		 911

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 excluded due to GCP concerns: 83
    Reason: Number of subjects
    		 subjects non vaccinated: 2
    Period 1
    Period 1 title
    Overall study period (Day 0 to Day 180) (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor
    Blinding implementation details
    Data will be collected in an observer-blind manner. 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 (e.g. safety, reactogenicity, and efficacy) will all be unaware of which vaccine was administered. To do so, vaccine preparation and administration will be done by authorized medical personnel who will not participate in any of the study clinical evaluations.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 INV_MMR Group
    Arm description
    		 Subjects received one dose of INV_MMR (Priorix®) vaccine at Visit 1 (Day 0).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Priorix
    Investigational medicinal product code
    209762
    Other name
    MEASLES VIRUS SCHWARZ STRAIN (LIVE, ATTENUATED); INV_MMR
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    A single vaccination was given on study Day 0 in the “triceps” region of the upper arm.

    Arm title
    		 COM_MMR Group
    Arm description
    		 Subjects received one dose of COM_MMR (M-M-R®II ) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
    Arm type
    		 Active comparator

    Investigational medicinal product name
    M-M-R VAXPRO
    Investigational medicinal product code
    Other name
    COM_MMR
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    A single vaccination was given on study Day 0 in the “triceps” region of the upper arm.

    Number of subjects in period 1 [1]
    		INV_MMR Group COM_MMR Group
    Started
    454
    457
    Completed
    426
    433
    Not completed
    28
    24
         Consent withdrawn by subject
    1
    1
         Patient incarcerated
    -
    1
         Lost to follow-up
    26
    22
         Vaccinated later as new subject
    1
    -
    Notes
    [1] - 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: A total of 996 subjects were enrolled and 994 were vaccinated. Of the 994 vaccinated subjects, 83 subjects from 2 US sites were excluded due to significant GCP concerns, resulting in 911 subjects in the Total vaccinated cohort considered for the analysis.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    INV_MMR Group
    Reporting group description
    		 Subjects received one dose of INV_MMR (Priorix®) vaccine at Visit 1 (Day 0).

    Reporting group title
    COM_MMR Group
    Reporting group description
    		 Subjects received one dose of COM_MMR (M-M-R®II ) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).

    Reporting group values
    		 INV_MMR Group COM_MMR Group Total
    Number of subjects
    		 454 457
    Age categorical
    Units: Subjects
    Age continuous
    Age continuous description
    Units: years
        arithmetic mean (standard deviation)
    		 25.9 ± 13.9 25.6 ± 13.8 -
    Gender categorical
    Gender categorical description
    Units: Subjects
        Female
    		 250 252 502
        Male
    		 204 205 409
    Race/Ethnicity, Customized
    Units: Subjects
        African Heritage/African American
    		 108 103 211
        American Indian or Alaskan native
    		 2 4 6
        Asian - Central/South Asian heritage
    		 1 0 1
        Asian - East Asian heritage
    		 1 0 1
        Asian - Japanese heritage
    		 0 1 1
        Asian - South East Asian heritage
    		 0 0 0
        Native Hawaiian or other Pacific Islander
    		 1 0 1
        White - Arabic/North African heritage
    		 0 1 1
        White - Caucasian/European heritage
    		 334 344 678
        Other
    		 7 4 11

    End points

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    End points reporting groups
    Reporting group title
    INV_MMR Group
    Reporting group description
    		 Subjects received one dose of INV_MMR (Priorix®) vaccine at Visit 1 (Day 0).

    Reporting group title
    COM_MMR Group
    Reporting group description
    		 Subjects received one dose of COM_MMR (M-M-R®II ) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).

    Primary: Anti-measles virus antibody Concentrations

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    End point title
    		 Anti-measles virus antibody Concentrations
    End point description
    Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in milli International Units per milliliter (mIU/mL). Seropositivity was defined as subjects with anti-measles virus antibody concentration equal or greater than 150 mIU/mL.
    End point type
    Primary
    End point timeframe
    At Day 42
    End point values
    		 INV_MMR Group COM_MMR Group
    Number of subjects analysed
    433
    436
    Units: mIU/mL
        geometric mean (confidence interval 95%)
    1795.6 (1641.1 to 1964.7)
    1783.3 (1624.6 to 1957.4)
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Non-inferiority of INV_MMR vaccine to COM_MMR vaccine in terms of Geometric Mean Concentration (GMCs) for anti measles, anti mumps and anti rubella antibodies at Day 42.The 95% CI for adjusted geometric mean concentrations (GMCs) and the adjusted GMC ratio were obtained using an ANCOVA model on the logarithm-transformed concentrations including the vaccine group (for adjusted GMC ratio) as fixed effect, gender, age and country groups as continuous effects and the pre-vaccination log-transformed
    Comparison groups
    COM_MMR Group v INV_MMR Group
    Number of subjects included in analysis
    869
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    Method
    Parameter type
    		 Adjusted GMC ratio
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.91
         upper limit
    		 1.11
    Notes
    [1] - Criteria for the determination of non-inferiority for measles, mumps, and rubella viruses: Lower limit (LL) of the 2-sided 95% Confidence Interval (CI) on GMC ratio ((INV_MMR over COM_MMR) was to be equal to or above 0.67 for anti-measles, anti-mumps, and anti rubella antibodies. Number of subjects in INV-MMR Group and in COM-MMR Group considered for calculating the adjusted GMC ratio, are 432 and 435 and adjusted GMCs = 1790.2 (LL=1669.6;UL=1919.5) and 1781.5 (LL=1661.8;UL=1909.7) respectively

    Primary: Anti-mumps virus antibody Concentrations

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    End point title
    		 Anti-mumps virus antibody Concentrations
    End point description
    Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in EU/mL. Seropositivity was defined as subjects with anti-mumps virus antibody concentration equal or greater than 5 EU/mL.
    End point type
    Primary
    End point timeframe
    At Day 42
    End point values
    		 INV_MMR Group COM_MMR Group
    Number of subjects analysed
    433
    436
    Units: EU/mL
        geometric mean (confidence interval 95%)
    110.6 (102.1 to 119.8)
    110.2 (101.9 to 119.2)
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Non-inferiority of INV_MMR vaccine to COM_MMR vaccine in terms of Geometric Mean Concentration (GMCs) for anti measles, anti mumps and anti rubella antibodies at Day 42.The 95% CI for adjusted geometric mean concentrations (GMCs) and the adjusted GMC ratio were obtained using an ANCOVA model on the logarithm-transformed concentrations including the vaccine group (for adjusted GMC ratio) as fixed effect, gender, age and country groups as continuous effects and the pre-vaccination log-transformed.
    Comparison groups
    COM_MMR Group v INV_MMR Group
    Number of subjects included in analysis
    869
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [2]
    Method
    Parameter type
    		 Adjusted GMC ratio
    Point estimate
    1.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.96
         upper limit
    		 1.16
    Notes
    [2] - Criteria for the determination of non-inferiority for measles, mumps, and rubella viruses: Lower limit (LL) of the 2-sided 95% Confidence Interval (CI) on GMC ratio (INV_MMR over COM_MMR) was to be equal to or above 0.67 for anti-measles, anti-mumps, and anti rubella antibodies. Number of subjects in INV-MMR Group and in COM-MMR Group considered for calculating the adjusted GMC ratio, are 432 and 435 and adjusted GMCs = 113.5 (LL=106.0;UL=121.6) and 107.8 (LL=100.7;UL=115.4) respectively.

    Primary: Anti-rubella virus antibody Concentrations

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    End point title
    		 Anti-rubella virus antibody Concentrations
    End point description
    Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in IU/mL. Seropositivity was defined as subjects with anti-rubella virus antibody concentration equal or greater than 4 IU/mL.
    End point type
    Primary
    End point timeframe
    At Day 42
    End point values
    		 INV_MMR Group COM_MMR Group
    Number of subjects analysed
    433
    436
    Units: IU/mL
    geometric mean (confidence interval 95%)
        Reporting groups
    75.3 (70.3 to 80.6)
    75.6 (70.8 to 80.7)
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Non-inferiority of INV_MMR vaccine to COM_MMR vaccine in terms of Geometric Mean Concentration (GMCs) for anti measles, anti mumps and anti rubella antibodies at Day 42.The 95% CI for adjusted geometric mean concentrations (GMCs) and the adjusted GMC ratio were obtained using an ANCOVA model on the logarithm-transformed concentrations including the vaccine group (for adjusted GMC ratio) as fixed effect, gender, age and country groups as continuous effects and the pre-vaccination log-transformed
    Comparison groups
    COM_MMR Group v INV_MMR Group
    Number of subjects included in analysis
    869
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [3]
    Method
    Parameter type
    		 Adjusted GMC ratio
    Point estimate
    1.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.93
         upper limit
    		 1.11
    Notes
    [3] - Criteria for the determination of non-inferiority for measles, mumps, and rubella viruses: Lower limit (LL) of the 2-sided 95% Confidence Interval (CI) on GMC ratio (INV_MMR over COM_MMR) was to be equal to or above 0.67 for anti-measles, anti-mumps, and anti rubella antibodies. Number of subjects in the INV-MMR Group and in the COM-MMR Group considered for calculating the adjusted GMC ratio, are 432 and 435 and adjusted GMCs = 76.1 (LL=71.5;UL=81.0) and 74.6 (LL=70.2;UL=79.4) respectively.

    Secondary: Number of subjects with anti-measles virus antibody concentration equal to or above the threshold of 200 mIU/mL (seroresponse rate)

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    End point title
    		 Number of subjects with anti-measles virus antibody concentration equal to or above the threshold of 200 mIU/mL (seroresponse rate)
    End point description
    Seroresponse was defined as: Anti-measles virus antibody concentration equal to or above the threshold of 200 mIU/mL after administration of INV_MMR vaccine vs. COM_MMR at Day 42
    End point type
    Secondary
    End point timeframe
    At Day 42
    End point values
    		 INV_MMR Group COM_MMR Group
    Number of subjects analysed
    433
    436
    Units: Subjects
    428
    432
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-mumps virus antibody concentration equal to or above the threshold of 10 EU/mL (seroresponse rate).

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    End point title
    		 Number of subjects with anti-mumps virus antibody concentration equal to or above the threshold of 10 EU/mL (seroresponse rate).
    End point description
    Seroresponse was defined as: Anti-mumps virus antibody concentration equal to or above the threshold of 10 EU/mL after administration of INV_MMR vaccine vs. COM_MMR at Day 42.
    End point type
    Secondary
    End point timeframe
    At Day 42
    End point values
    		 INV_MMR Group COM_MMR Group
    Number of subjects analysed
    433
    436
    Units: Subjects
    426
    434
    No statistical analyses for this end point

    Secondary: Number of subjects with anti-rubella virus antibody concentration equal to or above the threshold of 10 IU/mL (seroresponse rate).

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    End point title
    		 Number of subjects with anti-rubella virus antibody concentration equal to or above the threshold of 10 IU/mL (seroresponse rate).
    End point description
    Seroresponse was defined as: Anti-rubella virus antibody concentration equal to or above the threshold of 10 IU/mL after administration of INV_MMR vaccine vs. COM_MMR at Day 42.
    End point type
    Secondary
    End point timeframe
    At Day 42
    End point values
    		 INV_MMR Group COM_MMR Group
    Number of subjects analysed
    433
    436
    Units: Subjects
    431
    435
    No statistical analyses for this end point

    Secondary: Number of subjects who achieved a 4-fold or greater rise in anti-measles, anti-mumps and anti-rubella virus antibody concentrations.

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    End point title
    		 Number of subjects who achieved a 4-fold or greater rise in anti-measles, anti-mumps and anti-rubella virus antibody concentrations.
    End point description
    For subjects with seronegative status at pre-vaccination, a 4-fold rise in antibody concentration is defined as 4 times the cut-off level of the assay. Cut-off levels for anti-measles, anti-mumps and anti-rubella virus antibody concentrations are 150 m IU/mL, 5 EU/mL and 4 IU/mL.
    End point type
    Secondary
    End point timeframe
    At Day 42
    End point values
    		 INV_MMR Group COM_MMR Group
    Number of subjects analysed
    432
    435
    Units: Subjects
        Anti-measles
    42
    48
        Anti-mumps
    152
    128
        Anti-rubella
    179
    161
    No statistical analyses for this end point

    Secondary: Number of subjects with solicited local symptoms

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    End point title
    		 Number of subjects with solicited local symptoms
    End point description
    Assessed solicited local symptoms were pain, redness and swelling. Any = Occurrence of any local symptom regardless of its intensity grade. Grade 3 Pain = Significant pain at rest. Prevented normal every day activities. Grade 3 redness = redness with surface diameter >50mm. Grade 3 swelling = swelling with surface diameter >50mm.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Days 0-3) post-vaccination period
    End point values
    		 INV_MMR Group COM_MMR Group
    Number of subjects analysed
    433
    445
    Units: Subjects
        Any injection site redness
    53
    52
        Grade 3 injection site redness
    0
    0
        Any injection site swelling
    23
    29
        Grade 3 injection site swelling
    0
    0
        Any injection site pain
    51
    51
        Grade 3 injection site pain
    1
    0
    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:Any fever (≥38°C) = occurrence of any fever regardless of its intensity grade or relationship to vaccination. Grade3 fever = fever >39.5°C. . Related = symptom assessed by the investigator as causally related to study vaccination.The preferred route for recording temperature in this study was oral.
    End point type
    Secondary
    End point timeframe
    During the 43 days (Days 0-42) post-vaccination period.
    End point values
    		 INV_MMR Group COM_MMR Group
    Number of subjects analysed
    431
    445
    Units: Subjects
        Any
    13
    23
        Grade 3
    1
    6
        Related
    2
    6
    No statistical analyses for this end point

    Secondary: Number of subjects reporting solicited general symptoms as parotid/salivary gland swelling and any sign of meningism /seizure.

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    End point title
    		 Number of subjects reporting solicited general symptoms as parotid/salivary gland swelling and any sign of meningism /seizure.
    End point description
    Assessed MMR specific symptoms were parotid/salivary gland swelling and any sign of meningism /seizure. Parotid/salivary gland swelling: Any = occurrence of any general symptom regardless of its intensity grade or relationship to vaccination; Grade 3 Parotid/salivary gland swelling = Swelling accompanied with general symptoms. Meningism /seizure: Any= occurrence of any general symptom regardless of its intensity grade or relationship to vaccination; Grade-3 meningism /seizure= Prevented normal, everyday activities (In adults/adolescents, such an AE could, for example, prevented attendance at work/school and could necessitated the administration of corrective therapy). Related symptom = 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 Group COM_MMR Group
    Number of subjects analysed
    431
    445
    Units: Subjects
        Any parotid/salivary gland swelling
    1
    1
        Grade 3 parotid/salivary gland swelling
    1
    0
        Related parotid/salivary gland swelling
    0
    0
        Any meningism/seizure
    1
    1
        Grade 3 meningism/seizure
    1
    0
        Related meningism/seizure
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects reporting unsolicited AEs

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    End point title
    		 Number of subjects reporting unsolicited AEs
    End point description
    Any untoward medical occurrence in a patient or clinical investigation child, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product
    End point type
    Secondary
    End point timeframe
    During the 43 days (Days 0-42) post-vaccination period.
    End point values
    		 INV_MMR Group COM_MMR Group
    Number of subjects analysed
    454
    457
    Units: Subjects
    95
    82
    No statistical analyses for this end point

    Secondary: Number of subjects reporting solicited rash symptom.

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    End point title
    		 Number of subjects reporting solicited rash symptom.
    End point description
    Assessed any rash, Grade 3, Related, Localized rash, Generalized rash,measles/rubella-rash. Any= occurrence of any general symptom regardless of its intensity grade or relationship to vaccination. Grade3 rash/exanthema= Rash which prevented normal, everyday activities (In adults/adolescents, such an AE could, for example, prevented attendance at work/school and could necessitated the administration of corrective therapy). Grade 3 measles/rubella/varicella-like rash = Rash with more than150 lesions. 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 Group COM_MMR Group
    Number of subjects analysed
    431
    445
    Units: Subjects
        Any
    9
    5
        Grade 3
    0
    0
        Related
    6
    2
        Localized rash
    8
    3
        Generalized rash
    1
    2
        Rash type - measles/rubella-rash
    0
    2
        Rash type - others
    9
    3
    No statistical analyses for this end point

    Secondary: Number of subjects reporting solicited joint pain (arthralgia/arthritis)

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    End point title
    		 Number of subjects reporting solicited joint pain (arthralgia/arthritis)
    End point description
    Assessed any, Grade-3, Related. Any= occurrence of any general symptom regardless of its intensity grade or relationship to vaccination Grade3 joint pain (arthralgia/arthritis)= Pain which prevented normal, everyday activities (In adults/adolescents, such an AE could, for example, prevented attendance at work/school and could necessitated the administration of corrective therapy). 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 Group COM_MMR Group
    Number of subjects analysed
    431
    445
    Units: subjects
        Any
    8
    4
        Grade 3
    0
    0
        Related
    3
    1
    No statistical analyses for this end point

    Secondary: Number of subjects reporting NOCDs

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    End point title
    		 Number of subjects reporting NOCDs
    End point description
    Occurrence of new onset chronic diseases (NOCDs)
    End point type
    Secondary
    End point timeframe
    Day 0 through the end of the study (Day 180)
    End point values
    		 INV_MMR Group COM_MMR Group
    Number of subjects analysed
    454
    457
    Units: Subjects
    2
    1
    No statistical analyses for this end point

    Secondary: Number of subjects reporting adverse events prompting ER visits

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    End point title
    		 Number of subjects reporting adverse events prompting ER visits
    End point description
    Occurrence of AEs prompting emergency room (ER) visits.
    End point type
    Secondary
    End point timeframe
    Day 0 through the end of the study (Day 180)
    End point values
    		 INV_MMR Group COM_MMR Group
    Number of subjects analysed
    454
    457
    Units: Subjects
    14
    9
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects reporting serious adverse events (SAEs)
    End point description
    A serious adverse event (SAE) is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity.
    End point type
    Secondary
    End point timeframe
    Day 0 through the end of the study (Day 180)
    End point values
    		 INV_MMR Group COM_MMR Group
    Number of subjects analysed
    454
    457
    Units: Subjects
    3
    7
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Serious Adverse Events: From Day 0 to Day 180
    Adverse event reporting additional description
    The frequent adverse event data is currently being re-analyzed and the record will be updated once it becomes available.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    COM_MMR Group
    Reporting group description
    		 Subjects received one dose of COM_MMR (M-M-R®II) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).

    Reporting group title
    INV_MMR Group
    Reporting group description
    		 Subjects received one dose of INV_MMR (Priorix®) vaccine at Visit 1 (Day 0).

    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: The frequent adverse event data is currently being re-analyzed and the record will be updated once it becomes available.
    Serious adverse events
    		 COM_MMR Group INV_MMR Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 457 (1.53%)
    3 / 454 (0.66%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer
         subjects affected / exposed
    1 / 457 (0.22%)
    0 / 454 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Jaw fracture
         subjects affected / exposed
    1 / 457 (0.22%)
    0 / 454 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tendon injury
         subjects affected / exposed
    0 / 457 (0.00%)
    1 / 454 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
         subjects affected / exposed
    2 / 457 (0.44%)
    0 / 454 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 457 (0.22%)
    0 / 454 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal pain lower
         subjects affected / exposed
    0 / 457 (0.00%)
    1 / 454 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis relapsing
         subjects affected / exposed
    1 / 457 (0.22%)
    0 / 454 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Biliary colic
         subjects affected / exposed
    0 / 457 (0.00%)
    1 / 454 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Psychogenic seizure
         subjects affected / exposed
    0 / 457 (0.00%)
    1 / 454 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pyelonephritis
         subjects affected / exposed
    1 / 457 (0.22%)
    0 / 454 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 COM_MMR Group INV_MMR Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 457 (0.00%)
    0 / 454 (0.00%)

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 Nov 2013
    The study has been changed in design based on the United States (US) Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) feedback, highlighting the heterogeneous nature of the study population in terms of prior vaccination with a measles-containing vaccine and the possibility of providing 1 or 2 doses of measles, mumps and rubella vaccine (MMR) as part of this study. The study has therefore been simplified to evaluate the administration of 1 dose of MMR vaccine only. Prior receipt of at least 1 dose of MMR has been added as a study inclusion criterion. Whereas children 7 17 years of age will be excluded if they have received more than 1 dose of MMR vaccine, adults 18 years of age and older will be able to enroll with a verbal or written history of 1 or more doses of MMR vaccine. Prior MMR vaccination status will be recorded at baseline. Due to CBER’s request to add a confirmatory objective for geometric mean concentration (GMC) ratio, the sample size has been increased in order to maintain statistical power. Since the change in study design includes only a one-dose cohort, all assessments and schedules in the study now refer to a single vaccination at Day 0, a safety follow up visit (Visit 2) at Day 42, and a phone contact at Day 180. In the interest of safety, definitions and categories of solicited local and general adverse events have been refined. The protocol has also been revised to include the offer of a rescue plan for subjects that fail to meet the seroresponse threshold for antibodies to measles, mumps or rubella virus components. Descriptive secondary statistical analyses have been added.
    29 Sep 2014
    The Dominican Republic will not be participating in the study as originally planned; therefore, all references to that country are deleted. Based on PAREXEL’s site assessment and feasibility, the ex-United States (US) sites are willing and able to adjust their enrollment goals to include the pediatric subjects originally allocated to the Dominican Republic. Consequently, changes are made to pediatric enrollment figures for ex-US sites. Exclusion criterion 7 was amended to include more specific instructions regarding the administration of live influenza vaccine during the study. Minor administrative changes have been made to align this protocol with other protocols in the MMR program. These include changes to clarify the recording of adverse events and concomitant medication/vaccination, amending Table 14 for the recording of AEs, SAEs, and pregnancy; and clarification of the recording of rash events.
    08 Mar 2015
    Due to a delay in the availability of serologic data, the study team has decided to conduct one final analysis at study end, therefore eliminating the two-step analysis.

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

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