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

    Summary
    EudraCT number
    		 2011-006161-18
    Trial protocol
    		 EE   FI  
    Global end of trial date
    22 Dec 2015

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

    Trial information

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    Trial identification
    Sponsor protocol code
    115650
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02184572
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline Biologicals
    Sponsor organisation address
    Rue de l'Institut 89, Rixensart, Belgium,
    Public contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    22 Dec 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Dec 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    • To demonstrate the safety profile (fever >39.0°C (>102.2°F)) of Inv_MMR compared to Com_MMR (pooled lots) when co-administered with VV and HAV (to all children) and PCV-13 (only to children enrolled in the US). • To demonstrate the safety profile (fever ≥38.0°C (≥100.4°F)) of Inv_MMR compared to Com_MMR (pooled lots) when co-administered with VV and HAV (to all children) and PCV-13 (children enrolled in the US).
    Protection of trial subjects
    All subjects were supervised for at least 30 min after vaccination/product administration with appropriate medical treatment readily available. Vaccines/products were administered by qualified and trained personnel. Vaccines/products were administered only to eligible subjects that had no contraindications to any components of the vaccines/products.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    25 Aug 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: 240
    Country: Number of subjects enrolled
    Finland: 220
    Country: Number of subjects enrolled
    Puerto Rico: 23
    Country: Number of subjects enrolled
    Taiwan: 185
    Country: Number of subjects enrolled
    United States: 1075
    Worldwide total number of subjects
    1743
    EEA total number of subjects
    460
    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)
    1743
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 US sub-cohort: Subjects recruited in US received INV_MMR (Priorix®)or COM_MMR (M-M-R®II/M-M-R Vax Pro™) co-administered with Varivax®, Havrix® & Prevnar 13 vaccines (Day 0). Non-US sub-cohort: Subjects recruited outside the US received INV_MMR (Priorix®) or COM_MMR (M-M-R®II/M-M-R Vax Pro™) co-administered with Varivax® & Havrix® vaccines (Day 0).

    Pre-assignment period milestones
    Number of subjects started
    		 1742 [1]
    Number of subjects completed
    		 1736

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Subject no. allocated vaccine not administered: 6
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Out of 1743 subjects enrolled, 1 subject was removed from the study.
    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor
    Blinding implementation details
    Observer blinded study

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 INV_MMR
    Arm description
    		 Subjects received 1 dose of the study vaccine Priorix® co administered with Varivax® and Havrix® vaccines at Day 0. Subjects recruited in the US also received Prevnar 13® at Day 0.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Priorix®
    Investigational medicinal product code
    Other name
    GSK Biologicals' measles, mumps, and rubella vaccine live
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    1 dose administered subcutaneously (SC) in the tricep region of left arm.

    Investigational medicinal product name
    Havrix®
    Investigational medicinal product code
    SUB38555
    Other name
    Havrix junior 720 (GSK Biological Hepatitis A virus antigen (HAV))
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 dose administered intramuscularly (IM) in the anterolateral region of the right thigh at Visit 1 (Day 0), with either Inv_MMR vaccine or one of the two Com_MMR vaccine lots.

    Investigational medicinal product name
    Varivax®
    Investigational medicinal product code
    SUB25312
    Other name
    Merck & Co. Inc.'s Live attenuated Varicella
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 dose administered SC in the tricep region of right arm at Visit 1 (Day 0), with either Priorix® vaccine or one of the two M-M-R®II vaccine lots.

    Investigational medicinal product name
    Prevnar 13®
    Investigational medicinal product code
    Other name
    Pfizer Inc.'s Pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) (PCV-13)
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 dose administered IM in the anterolateral region of the left thigh at Visit 1 (Day 0), with either Inv_MMR vaccine or one of the two Com_MMR vaccine lots in US children only.

    Arm title
    		 COM_MMR
    Arm description
    		 Subjects received 1 dose of the licensed vaccine M-M-R®II or M-M-R Vax Pro™ Lot 1 or Lot 2 co administered with Varivax® and Havrix® vaccines at Day 0. Subjects recruited in the US also received Prevnar 13® at Day 0.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    M-M-R®II
    Investigational medicinal product code
    Other name
    M-M-R Vax Pro®
    Pharmaceutical forms
    Powder and solvent for suspension for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    1 dose administered SC in the tricep region of left arm.

    Investigational medicinal product name
    Havrix®
    Investigational medicinal product code
    SUB38555
    Other name
    Havrix junior 720 (GSK Biological Hepatitis A virus antigen (HAV))
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 dose administered intramuscularly (IM) in the anterolateral region of the right thigh at Visit 1 (Day 0), with either Inv_MMR vaccine or one of the two Com_MMR vaccine lots.

    Investigational medicinal product name
    Varivax®
    Investigational medicinal product code
    SUB25312
    Other name
    Merck & Co. Inc.'s Live attenuated Varicella
    Pharmaceutical forms
    Powder and solvent for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 dose administered SC in the tricep region of right arm at Visit 1 (Day 0), with either Priorix® vaccine or one of the two M-M-R®II vaccine lots.

    Investigational medicinal product name
    Prevnar 13®
    Investigational medicinal product code
    Other name
    Pfizer Inc.'s Pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) (PCV-13)
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 dose administered IM in the anterolateral region of the left thigh at Visit 1 (Day 0), with either Inv_MMR vaccine or one of the two Com_MMR vaccine lots in US children only.

    Number of subjects in period 1 [2]
    		INV_MMR COM_MMR
    Started
    1163
    573
    Completed
    1116
    543
    Not completed
    47
    30
         Consent withdrawn by subject
    14
    9
         Loss Of Kaiser Insurance
    1
    -
         2nd blooddraw & diary card incomplete
    1
    -
         Traveling Outside The Country
    1
    -
         Lost to follow-up
    29
    21
         Family Out Of Country Until 9/29/2015
    1
    -
    Notes
    [2] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Out of 1743 subjects enrolled, 6 subjects with an allocated subject number did not receive the study vaccine dose and 1 subject was removed from the study.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    INV_MMR
    Reporting group description
    		 Subjects received 1 dose of the study vaccine Priorix® co administered with Varivax® and Havrix® vaccines at Day 0. Subjects recruited in the US also received Prevnar 13® at Day 0.

    Reporting group title
    COM_MMR
    Reporting group description
    		 Subjects received 1 dose of the licensed vaccine M-M-R®II or M-M-R Vax Pro™ Lot 1 or Lot 2 co administered with Varivax® and Havrix® vaccines at Day 0. Subjects recruited in the US also received Prevnar 13® at Day 0.

    Reporting group values
    		 INV_MMR COM_MMR Total
    Number of subjects
    		 1163 573
    Age categorical
    Units: Subjects
    Age continuous
    Age continuous description
    Units: months
        arithmetic mean (standard deviation)
    		 12.3 ( 0.7 ) 12.3 ( 0.7 ) -
    Gender categorical
    Gender categorical description
    Units: Subjects
        Female
    		 551 270 821
        Male
    		 612 303 915
    Race/Ethnicity, Customized
    Units: Subjects
        African Heritage / African American
    		 64 38 102
        American Indian or Alaskan Native
    		 29 16 45
        Asian - Central/South Asian Heritage
    		 8 5 13
        Asian - East Asian Heritage
    		 131 65 196
        Asian - Japanese Heritage
    		 2 0 2
        Asian - South East Asian Heritage
    		 28 12 40
        Native Hawaiian or Other Pacific Islander
    		 1 2 3
        White - Arabic / North African Heritage
    		 3 3 6
        White - Caucasian / European Heritage
    		 808 385 1193
        Other
    		 89 47 136

    End points

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    End points reporting groups
    Reporting group title
    INV_MMR
    Reporting group description
    		 Subjects received 1 dose of the study vaccine Priorix® co administered with Varivax® and Havrix® vaccines at Day 0. Subjects recruited in the US also received Prevnar 13® at Day 0.

    Reporting group title
    COM_MMR
    Reporting group description
    		 Subjects received 1 dose of the licensed vaccine M-M-R®II or M-M-R Vax Pro™ Lot 1 or Lot 2 co administered with Varivax® and Havrix® vaccines at Day 0. Subjects recruited in the US also received Prevnar 13® at Day 0.

    Primary: Number of subjects reporting fever after MMR (Priorix® or M-M-R®II ) vaccination

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    End point title
    		 Number of subjects reporting fever after MMR (Priorix® or M-M-R®II ) vaccination
    End point description
    Fever was assessed for temperature equal to/above (≥) 38°C and above (>) 39.0°C. The safety profile for fever was assessed based on the group difference (INV_MMR minus COM_MMR) in incidence of fever equal to or below the cut-off value.
    End point type
    Primary
    End point timeframe
    During Day 5 to Day 12 post-vaccination period
    End point values
    		 INV_MMR COM_MMR
    Number of subjects analysed
    1125
    556
    Units: Subjects
        ≥38 °C
    205
    95
        >39.0 °C
    47
    17
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Null hypotheses: UL of the group difference (INV_MMR minus COM_MMR) in incidence of 95% CI is equal to or below (≤) 10% for Fever ≥38°C and equal to or below (≤) 5% for Fever >39.0°C.
    Comparison groups
    INV_MMR v COM_MMR
    Number of subjects included in analysis
    1681
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    Method
    Parameter type
    		 Difference in percentage between groups
    Point estimate
    1.14
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.84
         upper limit
    		 4.89
    Notes
    [1] - Power obtained using PASS 2005 (Likelihood Score [Miettinen and Nurminen approach]), [Miettinen, 1985]), one-sided non-inferiority test for the difference of two independent proportions, under the alternative associated to the reference value & one-sided alpha=2.5%. The global power for these objectives was 90.3%
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    Null hypotheses: UL of the group difference (INV_MMR minus COM_MMR) in incidence of 95% CI is equal to or below (≤) 10% for Fever ≥38°C and equal to or below (≤) 5% for Fever >39.0°C.
    Comparison groups
    INV_MMR v COM_MMR
    Number of subjects included in analysis
    1681
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [2]
    Method
    Parameter type
    		 Difference in percentage between groups
    Point estimate
    1.12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.92
         upper limit
    		 2.9
    Notes
    [2] - Power obtained using PASS 2005 (Likelihood Score [Miettinen and Nurminen approach]), [Miettinen, 1985]), one-sided non-inferiority test for the difference of two independent proportions, under the alternative associated to the reference value & one-sided alpha=2.5%. The global power for these objectives was 90.3%.

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

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    End point title
    		 Number of subjects with anti-measles virus antibody concentration equal to or above the cut-off-value
    End point description
    Seroresponse was defined as post-vaccination anti-measles virus antibody concentration ≥200 mIU/mL (ELISA, Enzygnost) among children who were seronegative (antibody concentration <150 mIU/mL) before vaccination.
    End point type
    Secondary
    End point timeframe
    At Day 42 post vaccination
    End point values
    		 INV_MMR COM_MMR
    Number of subjects analysed
    1042
    522
    Units: subjects
        ≥150 mIU/ml
    1035
    505
        ≥200 mIU/ml
    1032
    504
    No statistical analyses for this end point

    Secondary: Evaluation of immunogenicity in terms of anti-measles virus antibody concentrations

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    End point title
    		 Evaluation of immunogenicity in terms of anti-measles virus antibody concentrations
    End point description
    Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. Analyses included initially seronegative subjects only.
    End point type
    Secondary
    End point timeframe
    At Day 42 post vaccination
    End point values
    		 INV_MMR COM_MMR
    Number of subjects analysed
    1042
    522
    Units: mIU/mL
        geometric mean (confidence interval 95%)
    2751.2 (2617.6 to 2891.7)
    3134 (2879.6 to 3410.8)
    No statistical analyses for this end point

    Secondary: 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
    End point description
    For mumps virus, a seroresponse was defined as post-vaccination anti-mumps virus antibody concentration ³10 EU/mL (ELISA, PPD) among children who were seronegative (antibody concentration <5 EU/mL) before vaccination.
    End point type
    Secondary
    End point timeframe
    At Day 42 post vaccination
    End point values
    		 INV_MMR COM_MMR
    Number of subjects analysed
    963
    484
    Units: Subjects
        ≥5 EU/ml
    961
    481
        ≥10 EU/ml
    957
    474
    No statistical analyses for this end point

    Secondary: Evaluation of immunogenicity in terms of anti-mumps virus antibody concentrations

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    End point title
    		 Evaluation of immunogenicity in terms of anti-mumps virus antibody concentrations
    End point description
    Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. Analyses included initially seronegative subjects only.
    End point type
    Secondary
    End point timeframe
    At Day 42 post vaccination
    End point values
    		 INV_MMR COM_MMR
    Number of subjects analysed
    963
    484
    Units: mIU/mL
        geometric mean (confidence interval 95%)
    86 (82 to 90.3)
    82.6 (76.5 to 89.2)
    No statistical analyses for this end point

    Secondary: 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
    End point description
    For rubella virus, a seroresponse was defined as post-vaccination anti-rubella virus antibody concentration ³10 IU/mL (ELISA, Enzygnost) among children who were seronegative (antibody concentration <4 IU/mL) before vaccination.
    End point type
    Secondary
    End point timeframe
    At Day 42 post vaccination
    End point values
    		 INV_MMR COM_MMR
    Number of subjects analysed
    1042
    522
    Units: subjects
        ≥10 IU/ml
    997
    513
        ≥4 IU/ml
    1038
    521
    No statistical analyses for this end point

    Secondary: Evaluation of immunogenicity in terms of anti-rubella virus antibody concentrations

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    End point title
    		 Evaluation of immunogenicity in terms of anti-rubella virus antibody concentrations
    End point description
    Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. Analyses included initially seronegative subjects only.
    End point type
    Secondary
    End point timeframe
    At Day 42 post vaccination
    End point values
    		 INV_MMR COM_MMR
    Number of subjects analysed
    1042
    522
    Units: mIU/mL
        geometric mean (confidence interval 95%)
    45 (42.8 to 47.2)
    66.8 (62.2 to 71.6)
    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 their 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 COM_MMR
    Number of subjects analysed
    1122
    554
    Units: Subjects
        Any pain
    311
    132
        Grade 3 pain
    6
    2
        Any redness
    259
    138
        Grade 3 redness (>20 mm)
    7
    8
        Any swelling
    95
    59
        Grade 3 swelling (>20 mm)
    2
    3
    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/fussiness, and loss of appetite. Any= occurrence of any general symptom regardless of intensity grade or relationship to vaccination, Grade 3 drowsiness = symptom that prevented normal activity, Grade 3 irritability/fussiness =crying that could not be comforted/ symptom that 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 COM_MMR
    Number of subjects analysed
    1125
    556
    Units: Subjects
        Any drowsiness
    526
    239
        Grade 3 drowsiness
    31
    13
        Any irritability/fussiness
    721
    346
        Grade 3 irritability/fussiness
    41
    20
        Any loss of appetite
    492
    233
        Grade 3 loss of appetite
    20
    10
    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
    End point type
    Secondary
    End point timeframe
    During the 43-day (Days 0-42) post-vaccination period
    End point values
    		 INV_MMR COM_MMR
    Number of subjects analysed
    1125
    556
    Units: Subjects
        ≥38 °C
    349
    180
        >39.5 °C
    45
    15
    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 parotid gland swelling and any suspected signs of meningism including febrile convulsions. Any = occurrence of any general symptom regardless of intensity grade or relationship to vaccination, Grade 3 Febrile convulsion = Prevented everyday activity, Grade 3 Parotid gland = Swelling with accompanied general symptoms, Related = event assessed by the investigator as causally related to the study vaccination.
    End point type
    Secondary
    End point timeframe
    During the 43-day (Days 0-42) post-vaccination period
    End point values
    		 INV_MMR COM_MMR
    Number of subjects analysed
    1125
    556
    Units: Subjects
        Any febrile convulsion
    2
    0
        Grade 3 febrile convulsion
    1
    0
        Related febrile convulsion
    1
    0
        Any parotid gland swelling
    0
    0
        Grade 3 parotid gland swelling
    0
    0
        Related parotid gland swelling
    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, Grade 3, Related, Localized rash, Generalized rash, measles/rubella-rash. Grade 3 Measles/rubella/varicella-like rash = Rash with more than150 lesions .Other Grade 3 Rash = Rash that prevented normal, everyday activities. Related = Rash assessed by the investigator as causally related to study vaccination.
    End point type
    Secondary
    End point timeframe
    During the 43-day (Days 0-42) post-vaccination period
    End point values
    		 INV_MMR COM_MMR
    Number of subjects analysed
    1125
    556
    Units: Subjects
        Any localized or generalized
    274
    153
        Any with fever
    99
    49
        Any varicella like
    39
    23
        Any measles/rubella like
    65
    26
        Any grade 3
    22
    8
        Any related
    70
    37
        Localized any
    185
    98
        Localized administration site
    8
    4
        Localized other site
    177
    96
        Localized with fever
    53
    26
        Localized varicella like
    26
    14
        Localized measles/rubella like
    22
    12
        Localized grade 3
    2
    1
        Localized related
    24
    21
        Generalized any
    108
    65
        Generalized with fever
    48
    25
        Generalized varicella like
    13
    9
        Generalized measles/rubella like
    45
    16
        Generalized grade 3
    20
    7
        Generalized related
    47
    20
    No statistical analyses for this end point

    Secondary: Number of subjects reporting unsolicited adverse events

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    End point title
    		 Number of subjects reporting unsolicited adverse events
    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-day (Days 0-42) post-vaccination period
    End point values
    		 INV_MMR COM_MMR
    Number of subjects analysed
    1163
    573
    Units: Subjects
    597
    278
    No statistical analyses for this end point

    Secondary: Number of subjects reporting new onset chronic diseases (NOCDs)

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    End point title
    		 Number of subjects reporting new onset chronic diseases (NOCDs)
    End point description
    End point type
    Secondary
    End point timeframe
    Day 0 through the end of the study (Day 180)
    End point values
    		 INV_MMR COM_MMR
    Number of subjects analysed
    1163
    573
    Units: Subjects
    29
    11
    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 COM_MMR
    Number of subjects analysed
    1163
    573
    Units: Subjects
    166
    55
    No statistical analyses for this end point

    Secondary: Number of subjects reporting AEs leading to a medically attended visit

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    End point title
    		 Number of subjects reporting AEs leading to a medically attended visit
    End point description
    An event for which the child received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (e.g., nurse practitioner or physician assistant or medical doctor) for any reason.
    End point type
    Secondary
    End point timeframe
    Day 0 through the end of the study (Day 180)
    End point values
    		 INV_MMR COM_MMR
    Number of subjects analysed
    1163
    573
    Units: Subjects
    717
    319
    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 resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization or resulted 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 COM_MMR
    Number of subjects analysed
    1163
    573
    Units: Subjects
    24
    9
    No statistical analyses for this end point

    Secondary: Number of subjects reporting measles-like illness

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    End point title
    		 Number of subjects reporting measles-like illness
    End point description
    Measles-like illness was defined as the occurrence of the following signs and symptoms in the absence of another confirmed diagnosis: maculopapular rash, fever (≥38°C), and at least one symptom of cough, coryza, conjunctivitis, or diarrhea, with fever or rash occurring between Day 5 and Day 12 inclusive. Other event must be one of cough, coryza, conjunctivitis, or diarrhea.
    End point type
    Secondary
    End point timeframe
    Between Day 5 and Day 12 (inclusive) post-vaccination
    End point values
    		 INV_MMR COM_MMR
    Number of subjects analysed
    1163
    573
    Units: Subjects
        Measles-like illness
    18
    5
        Maculopapular rash plus fever and one other event
    26
    9
        Maculopapular rash and fever
    89
    44
    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 (SAE) =Entire study period (180 days).
    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
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    INV_MMR Group
    Reporting group description
    		 Subjects received 1 dose of the study vaccine Priorix® co administered with Varivax® and Havrix® vaccines at Day 0. Subjects recruited in the US also received Prevnar 13® at Day 0.

    Reporting group title
    COM_MMR Group
    Reporting group description
    		 Subjects received 1 dose of the licensed vaccine M-M-R®II or M-M-R Vax Pro™ Lot 1 or Lot 2 co administered with Varivax® and Havrix® vaccines at Day 0. Subjects recruited in the US also received Prevnar 13® at 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
    		 INV_MMR Group COM_MMR Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    24 / 1163 (2.06%)
    9 / 573 (1.57%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Limb injury
         subjects affected / exposed
    1 / 1163 (0.09%)
    0 / 573 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Febrile convulsion
         subjects affected / exposed
    1 / 1163 (0.09%)
    0 / 573 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lethargy
         subjects affected / exposed
    1 / 1163 (0.09%)
    0 / 573 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    1 / 1163 (0.09%)
    0 / 573 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Immune thrombocytopenic purpura
         subjects affected / exposed
    0 / 1163 (0.00%)
    1 / 573 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leukopenia
         subjects affected / exposed
    1 / 1163 (0.09%)
    0 / 573 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastritis
         subjects affected / exposed
    0 / 1163 (0.00%)
    1 / 573 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Bronchial hyperreactivity
         subjects affected / exposed
    0 / 1163 (0.00%)
    1 / 573 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Obstructive airways disorder
         subjects affected / exposed
    1 / 1163 (0.09%)
    0 / 573 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory distress
         subjects affected / exposed
    1 / 1163 (0.09%)
    1 / 573 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Joint effusion
         subjects affected / exposed
    1 / 1163 (0.09%)
    0 / 573 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Acute sinusitis
         subjects affected / exposed
    1 / 1163 (0.09%)
    0 / 573 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacterial infection
         subjects affected / exposed
    0 / 1163 (0.00%)
    1 / 573 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchiolitis
         subjects affected / exposed
    1 / 1163 (0.09%)
    1 / 573 (0.17%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    1 / 1163 (0.09%)
    2 / 573 (0.35%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    1 / 1163 (0.09%)
    0 / 573 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Croup infectious
         subjects affected / exposed
    1 / 1163 (0.09%)
    0 / 573 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Exanthema subitum
         subjects affected / exposed
    1 / 1163 (0.09%)
    0 / 573 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fungal skin infection
         subjects affected / exposed
    0 / 1163 (0.00%)
    1 / 573 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 1163 (0.09%)
    0 / 573 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis norovirus
         subjects affected / exposed
    1 / 1163 (0.09%)
    0 / 573 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis salmonella
         subjects affected / exposed
    1 / 1163 (0.09%)
    0 / 573 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    1 / 1163 (0.09%)
    0 / 573 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hand-foot-and-mouth disease
         subjects affected / exposed
    1 / 1163 (0.09%)
    0 / 573 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza
         subjects affected / exposed
    0 / 1163 (0.00%)
    1 / 573 (0.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Laryngitis
         subjects affected / exposed
    1 / 1163 (0.09%)
    0 / 573 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Otitis media
         subjects affected / exposed
    1 / 1163 (0.09%)
    0 / 573 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parainfluenzae virus infection
         subjects affected / exposed
    1 / 1163 (0.09%)
    0 / 573 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Periorbital cellulitis
         subjects affected / exposed
    1 / 1163 (0.09%)
    0 / 573 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    4 / 1163 (0.34%)
    1 / 573 (0.17%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia respiratory syncytial viral
         subjects affected / exposed
    1 / 1163 (0.09%)
    0 / 573 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory syncytial virus infection
         subjects affected / exposed
    1 / 1163 (0.09%)
    0 / 573 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Salmonellosis
         subjects affected / exposed
    1 / 1163 (0.09%)
    0 / 573 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Staphylococcal infection
         subjects affected / exposed
    1 / 1163 (0.09%)
    0 / 573 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsillitis
         subjects affected / exposed
    1 / 1163 (0.09%)
    0 / 573 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 1163 (0.09%)
    0 / 573 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    3 / 1163 (0.26%)
    0 / 573 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    1 / 1163 (0.09%)
    0 / 573 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypovolaemia
         subjects affected / exposed
    1 / 1163 (0.09%)
    0 / 573 (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
    		 INV_MMR Group COM_MMR Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 1163 (0.00%)
    0 / 573 (0.00%)

    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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