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    Clinical Trial Results:
    Measles-mumps-rubella vaccine at 6 months of age, immunology, and childhood morbidity in a high-income setting

    Summary
    EudraCT number
    		 2016-001901-18
    Trial protocol
    		 DK  
    Global end of trial date
    07 Jan 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Jan 2023
    First version publication date
    22 Jan 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    LGS.MMR.01.2016.2022
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    The Danish National University Hospital "Rigshospitalet"
    Sponsor organisation address
    9-Blegdamsvej, Copenhagen, Denmark,
    Public contact
    The Child and Adolescent Clinic, The Danish National University Hospital "Rigshospitalet", 35453545 35459727, lone.graff.stensballe@regionh.dk
    Scientific contact
    The Child and Adolescent Clinic, The Danish National University Hospital "Rigshospitalet", 35453545 35459727, lone.graff.stensballe@regionh.dk
    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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    06 Jan 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    07 Jan 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Jan 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Aim in relation to the specific effect of the MMR vaccine. Sub-group study among 500 children. 1. To measure the level of specific immunity, measured as level of measles neutralising antibodies by plaque-reduction neutralisation test 1 month after experimental MMR vaccination at 6 months of age. Aim in relation to the potential non-specific, heterologous effect of the MMR vaccine. 6426 children. 2. To test if MMR administered to healthy Danish children at 6 months of age decreases non-measles childhood morbidity defined as hospitalisation for infection between 6 and 12 months of age before the third DTaKPHib is scheduled according to the Danish child vaccination programme.
    Protection of trial subjects
    Data Safety Monitoring Board and Danish Patient Insurance Act
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Feb 2019
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 6540
    Worldwide total number of subjects
    6540
    EEA total number of subjects
    6540
    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)
    6540
    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
    		 Child examination

    Period 1
    Period 1 title
    Randomisation and allocation (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Data analyst, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 MMRvaxpro vaccine
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    M-M-Rvaxpro
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    0.5ml standard dose

    Arm title
    		 Placebo
    Arm description
    		 Solvent only
    Arm type
    		 Placebo

    Investigational medicinal product name
    M-M-R VaxPro solvent only
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Injection
    Dosage and administration details
    0.5 ml IM

    Number of subjects in period 1
    		MMRvaxpro vaccine Placebo
    Started
    3266
    3274
    Completed
    3264
    3272
    Not completed
    2
    2
         Consent withdrawn by subject
    2
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    MMRvaxpro vaccine
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 Solvent only

    Reporting group values
    		 MMRvaxpro vaccine Placebo Total
    Number of subjects
    		 3266 3274 6540
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 3266 3274 6540
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 0 0 0
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 1572 1578 3150
        Male
    		 1694 1696 3390
    Subject analysis sets

    Subject analysis set title
    MMRvaxpro vaccine
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    MMRvaxpro ITT

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Placebo ITT

    Subject analysis sets values
    		 MMRvaxpro vaccine Placebo
    Number of subjects
    3264
    3272
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
    3264
    3272
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Units:
        
    ±
    ±
    Gender categorical
    Units: Subjects
        Female
    1571
    1576
        Male
    1693
    1696

    End points

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    End points reporting groups
    Reporting group title
    MMRvaxpro vaccine
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 Solvent only

    Subject analysis set title
    MMRvaxpro vaccine
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    MMRvaxpro ITT

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Placebo ITT

    Primary: Immunogenicity

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    End point title
    		 Immunogenicity
    End point description
    Since we received the PRNT results very recently, the results submitted may need further validation
    End point type
    Primary
    End point timeframe
    One month after randomisation
    End point values
    		 MMRvaxpro vaccine Placebo
    Number of subjects analysed
    290 [1]
    358 [2]
    Units: international unit(s)/litre
        geometric mean (confidence interval 95%)
    121.6 (104.0 to 142.2)
    32.6 (29.1 to 36.6)
    Notes
    [1] - Subset of participants with bleedings and intervention MMR, 290 had valid PRNT results at visit 2
    [2] - Subset of participants with bleedings and intervention placebo, 358 had valid PRNT results at visit2
    Statistical analysis title
    		 Linear regression
    Comparison groups
    MMRvaxpro vaccine v Placebo
    Number of subjects included in analysis
    648
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Geometric mean ratio
    Point estimate
    3.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3
         upper limit
    		 4.4

    Primary: Hospitalisation for infection

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    End point title
    		 Hospitalisation for infection
    End point description
    End point type
    Primary
    End point timeframe
    From randomisation to 12 months of age
    End point values
    		 MMRvaxpro vaccine Placebo MMRvaxpro vaccine Placebo
    Number of subjects analysed
    3264
    3272
    3264
    3272
    Units: Hospital contact for infection
    786
    762
    786
    762
    Statistical analysis title
    		 Cox regression
    Comparison groups
    MMRvaxpro vaccine v Placebo
    Number of subjects included in analysis
    6536
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    1.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.91
         upper limit
    		 1.18

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Six weeks after randomisation
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 ICD
    Dictionary version
    10
    Reporting groups
    Reporting group title
    MMRvaxpro vaccine
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 Solvent only

    Serious adverse events
    		 MMRvaxpro vaccine Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    16 / 3266 (0.49%)
    9 / 3274 (0.27%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Nervous system disorders
    Hospitalisation
         subjects affected / exposed
    2 / 3266 (0.06%)
    2 / 3274 (0.06%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Hospitalisation
         subjects affected / exposed
    2 / 3266 (0.06%)
    1 / 3274 (0.03%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Hospitalisation
         subjects affected / exposed
    10 / 3266 (0.31%)
    4 / 3274 (0.12%)
         occurrences causally related to treatment / all
    0 / 10
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Hospitalisation
         subjects affected / exposed
    2 / 3266 (0.06%)
    2 / 3274 (0.06%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 MMRvaxpro vaccine Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1941 / 3266 (59.43%)
    1947 / 3274 (59.47%)
    Nervous system disorders
    Neurological symptom
         subjects affected / exposed
    8 / 3266 (0.24%)
    9 / 3274 (0.27%)
         occurrences all number
    8
    9
    Blood and lymphatic system disorders
    Lymph node palpable
         subjects affected / exposed
    6 / 3266 (0.18%)
    0 / 3274 (0.00%)
         occurrences all number
    6
    0
    Eye disorders
    Eye disorder
         subjects affected / exposed
    20 / 3266 (0.61%)
    31 / 3274 (0.95%)
         occurrences all number
    20
    32
    Gastrointestinal disorders
    Gastrointestinal disorder
         subjects affected / exposed
    578 / 3266 (17.70%)
    589 / 3274 (17.99%)
         occurrences all number
    751
    770
    Respiratory, thoracic and mediastinal disorders
    Respiratory disorder
         subjects affected / exposed
    1446 / 3266 (44.27%)
    1461 / 3274 (44.62%)
         occurrences all number
    2200
    2324
    Skin and subcutaneous tissue disorders
    Skin disorder
         subjects affected / exposed
    736 / 3266 (22.54%)
    696 / 3274 (21.26%)
         occurrences all number
    842
    794
    Renal and urinary disorders
    Urogenital disorder
         subjects affected / exposed
    6 / 3266 (0.18%)
    9 / 3274 (0.27%)
         occurrences all number
    6
    9
    Musculoskeletal and connective tissue disorders
    musculoskeletal symptoms
         subjects affected / exposed
    2 / 3266 (0.06%)
    2 / 3274 (0.06%)
         occurrences all number
    3
    2
    Infections and infestations
    fever, uncomfortable
         subjects affected / exposed
    911 / 3266 (27.89%)
    927 / 3274 (28.31%)
         occurrences all number
    1123
    1098

    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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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