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    Clinical Trial Results:
    A phase IIIB, partially blind, randomized study to evaluate the immunogenicity and safety of GlaxoSmithKline Biologicals’ measles-mumps-rubella-varicella vaccine (MeMuRu-OKA) given to healthy children during the second year of life following a 4-week and a 12-month interval between two doses

    Summary
    EudraCT number
    		 2004-004371-11
    Trial protocol
    		 DE   BE  
    Global end of trial date
    23 May 2007

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 May 2016
    First version publication date
    07 Jun 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    103388 & 104690
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00127010
    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, 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
    23 May 2007
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    23 May 2007
    Global end of trial reached?
    Yes
    Global end of trial date
    23 May 2007
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the immunogenicity of a 4-week interval and a 12-month interval between two doses of MeMuRu-OKA 42-56 days after the second dose for all antigens.
    Protection of trial subjects
    The subjects were observed closely for at least 30 minutes, with appropriate medical treatment readily available in case of a rare anaphylactic reaction following the administration of vaccines.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    23 Nov 2005
    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
    Belgium: 44
    Country: Number of subjects enrolled
    Germany: 386
    Country: Number of subjects enrolled
    Netherlands: 130
    Worldwide total number of subjects
    560
    EEA total number of subjects
    560
    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)
    560
    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
    		 One subject from the total number of 560 subjects had a subject number allocated but no study vaccine administered and therefore not included in "Started".

    Pre-assignment
    Screening details
    		 During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Subject
    Blinding implementation details
    The study was open with respect to the 2 groups randomized to a 4-week interval schedule versus the group with a 12-month interval schedule and single-blind with respect to the group randomized to a 4-week interval schedule of MMRV versus group receiving MMR up to Week 10, when they were offered licensed varicella vaccine, to be administered outside of the study.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 MMRV/4W Group
    Arm description
    		 Subjects received two doses of MMRV vaccine 4 weeks apart (Day 0 and Week 4).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Priorix™-Tetra
    Investigational medicinal product code
    MeMuRu-OKA
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Two doses of Priorix™-Tetra vaccine (MMRV) 4 weeks apart (Day 0 and Week 4) administered subcutaneously in the left deltoid region.

    Arm title
    		 MMRV/12M Group
    Arm description
    		 Subjects received two doses of Priorix™-Tetra vaccine (MMRV) 12 months apart (Day 0 and Month 12).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Priorix™-Tetra
    Investigational medicinal product code
    MeMuRu-OKA
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Two doses of Priorix™-Tetra vaccine (MMRV) 12 months apart (Day 0 and Month 12) administered subcutaneously in the left deltoid region.

    Arm title
    		 MMR Group
    Arm description
    		 Subjects received two doses of Priorix™ vaccine (MMR) 4 weeks apart (Day 0 and Week 4)
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Priorix™
    Investigational medicinal product code
    MeMuRu
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Intramuscular use, Subcutaneous use
    Dosage and administration details
    Two doses of Priorix™ vaccine (MMR) 4 weeks apart (Day 0 and Week 4) administered subcutaneously in the left deltoid region.

    Number of subjects in period 1 [1]
    		MMRV/4W Group MMRV/12M Group MMR Group
    Started
    188
    184
    187
    Completed
    181
    180
    184
    Not completed
    7
    4
    3
         Adverse event, serious fatal
    -
    -
    1
         Consent withdrawn by subject
    5
    2
    1
         Adverse event, non-fatal
    1
    -
    -
         Lost to follow-up
    1
    2
    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: One subject from the total number of 560 subjects had a subject number allocated but no study vaccine administered and therefore not included in "Started".

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    MMRV/4W Group
    Reporting group description
    		 Subjects received two doses of MMRV vaccine 4 weeks apart (Day 0 and Week 4).

    Reporting group title
    MMRV/12M Group
    Reporting group description
    		 Subjects received two doses of Priorix™-Tetra vaccine (MMRV) 12 months apart (Day 0 and Month 12).

    Reporting group title
    MMR Group
    Reporting group description
    		 Subjects received two doses of Priorix™ vaccine (MMR) 4 weeks apart (Day 0 and Week 4)

    Reporting group values
    		 MMRV/4W Group MMRV/12M Group MMR Group Total
    Number of subjects
    		 188 184 187 559
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    		 12 ( 0.83 ) 12 ( 0.84 ) 12.1 ( 0.9 ) -
    Gender categorical
    Units: Subjects
        Female
    		 92 96 92 280
        Male
    		 96 88 95 279

    End points

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    End points reporting groups
    Reporting group title
    MMRV/4W Group
    Reporting group description
    		 Subjects received two doses of MMRV vaccine 4 weeks apart (Day 0 and Week 4).

    Reporting group title
    MMRV/12M Group
    Reporting group description
    		 Subjects received two doses of Priorix™-Tetra vaccine (MMRV) 12 months apart (Day 0 and Month 12).

    Reporting group title
    MMR Group
    Reporting group description
    		 Subjects received two doses of Priorix™ vaccine (MMR) 4 weeks apart (Day 0 and Week 4)

    Primary: Number of subjects seroconverted for measles, mumps, rubella and varicella antibodies above the cut-off value.

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    End point title
    		 Number of subjects seroconverted for measles, mumps, rubella and varicella antibodies above the cut-off value. [1] [2]
    End point description
    Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination. The cut-off values for seroconversion was 150 mIU/mL, 231 U/mL, 4 IU/mL and 1:4 dilution for measles, mumps, rubella and varicella, respectively. This outcome measure concerns the MMRV/4W Group and MMRV/12M Group.
    End point type
    Primary
    End point timeframe
    Approximately 42-56 days after the second dose of MMRV vaccine (Week 10 for the MMRV/4W Groups and Month 13.5 for the MMRV/12M Group).
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This outcome measure concerns the MMRV/4W Group and MMRV/12M Group.
    End point values
    		 MMRV/4W Group MMRV/12M Group
    Number of subjects analysed
    110
    137
    Units: Subjects
        anti-measles ≥ 150 mIU/mL
    108
    124
        anti-mumps ≥ 231 U/ML
    105
    124
        anti-rubella ≥ 4 IU/mL
    110
    124
        IgG varicella antibodies ≥ 1:4 dilution
    101
    116
    No statistical analyses for this end point

    Secondary: Number of subjects seroconverted for measles, mumps, rubella and varicella antibodies above the cut-off value.

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    End point title
    		 Number of subjects seroconverted for measles, mumps, rubella and varicella antibodies above the cut-off value. [3]
    End point description
    Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination. The cut-off values for seroconversion was 150 mIU/mL, 231 U/mL, 4 IU/mL and 1:4 dilution for measles, mumps, rubella and varicella, respectively. This outcome measure concerns the MMRV/12M Group only.
    End point type
    Secondary
    End point timeframe
    At 42-56 days after the first dose of MMRV vaccine.
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This outcome measure concerns the MMRV/12M Group only.
    End point values
    		 MMRV/12M Group
    Number of subjects analysed
    137
    Units: Subjects
        anti-measles ≥ 150 mIU/mL
    134
        anti-mumps ≥ 231 U/ML
    125
        anti-rubella ≥ 4 IU/mL
    133
        IgG varicella antibodies ≥ 1:4 dilution
    127
    No statistical analyses for this end point

    Secondary: Number of subjects seroconverted for measles, mumps, rubella and varicella antibodies above the cut-off value.

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    End point title
    		 Number of subjects seroconverted for measles, mumps, rubella and varicella antibodies above the cut-off value. [4]
    End point description
    Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination. The cut-off values for seroconversion was 150 mIU/mL, 231 U/mL, 4 IU/mL and 1:4 dilution for measles, mumps, rubella and varicella, respectively. This outcome measure concerns the MMRV/4W Group only.
    End point type
    Secondary
    End point timeframe
    At 28-30 days after the first dose of MMRV vaccine.
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This outcome measure concerns the MMRV/4W Group only.
    End point values
    		 MMRV/4W Group
    Number of subjects analysed
    110
    Units: Subjects
        anti-measles ≥ 150 mIU/mL
    108
        anti-mumps ≥ 231 U/ML
    78
        anti-rubella ≥ 4 IU/mL
    107
        IgG varicella antibodies ≥ 1:4 dilution
    101
    No statistical analyses for this end point

    Secondary: Number of subjects seroconverted for measles, mumps and rubella antibodies above the cut-off value.

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    End point title
    		 Number of subjects seroconverted for measles, mumps and rubella antibodies above the cut-off value. [5]
    End point description
    Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination. The cut-off values for seroconversion was 150 mIU/mL, 231 U/mL and 4 IU/mL for measles, mumps and rubella, respectively. This outcome measure concerns the MMR Group only.
    End point type
    Secondary
    End point timeframe
    At 28-30 days after the first dose and 42-56 days after the second dose of MMR vaccine.
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This outcome measure concerns the MMR Group only.
    End point values
    		 MMR Group
    Number of subjects analysed
    107
    Units: Subjects
        anti-measles ≥ 150 mIU/mL; D28-30
    96
        anti-measles ≥ 150 mIU/mL; D42-56
    104
        anti-mumps ≥ 231 U/ML; D28-30
    76
        anti-mumps ≥ 231 U/ML; D42-56
    101
        anti-rubella ≥ 4 IU/mL; D28-30
    98
        anti-rubella ≥ 4 IU/mL; D42-56
    107
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any and grade 3 solicited local symptoms

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    End point title
    		 Number of subjects reporting any and grade 3 solicited local symptoms
    End point description
    Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.
    End point type
    Secondary
    End point timeframe
    Within 4 days after each vaccination (Day 0-3)
    End point values
    		 MMRV/4W Group MMRV/12M Group MMR Group
    Number of subjects analysed
    182
    176
    184
    Units: Subjects
        Any Pain; Dose 1
    21
    31
    21
        Grade 3 Pain; Dose 1
    0
    1
    0
        Any Redness; Dose 1
    34
    43
    41
        Grade 3 Redness; Dose 1
    1
    0
    1
        Any Swelling; Dose 1
    10
    14
    16
        Grade 3 Swelling; Dose 1
    0
    0
    0
        Any Pain; Dose 2
    11
    17
    11
        Grade 3 Pain; Dose 2
    0
    2
    1
        Any Redness; Dose 2
    36
    32
    32
        Grade 3 Redness; Dose 2
    1
    1
    1
        Any Swelling; Dose 2
    13
    12
    14
        Grade 3 Swelling; Dose 2
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any, grade 3 and related fever

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    End point title
    		 Number of subjects reporting any, grade 3 and related fever
    End point description
    Any fever was defined as fever ≥ 38.0°C and grade 3 fever > 39.5°C after vaccination. Related fever was defined as fever assessed by the investigator as related to the vaccination.
    End point type
    Secondary
    End point timeframe
    During the 15-day (Day 0-14) post-vaccination period following each dose.
    End point values
    		 MMRV/4W Group MMRV/12M Group MMR Group
    Number of subjects analysed
    183
    179
    185
    Units: Subjects
        Any temperature; Dose 1
    117
    88
    86
        Grade 3 temperature; Dose 1
    29
    18
    17
        Related temperature; Dose 1
    69
    64
    51
        Any temperature; Dose 2
    80
    52
    63
        Grade 3 temperature; Dose 2
    8
    7
    13
        Related temperature; Dose 2
    40
    28
    36
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any, grade 3 and related solicited general symptoms

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    End point title
    		 Number of subjects reporting any, grade 3 and related solicited general symptoms
    End point description
    Assessed solicited general symptoms were fever, meningism, parotid gland swelling and rash. Any = occurrence of the symptom regardless of intensity grade. Grade 3 parotid / salivary gland swelling = swelling with accompanying general symptoms and grade 3 rash = intensity > 150 lesions. Related = symptom assessed by the investigator as related to the vaccination.
    End point type
    Secondary
    End point timeframe
    During the 29-day (Day 0-28) post-vaccination period following each dose.
    End point values
    		 MMRV/4W Group MMRV/12M Group MMR Group
    Number of subjects analysed
    183
    179
    185
    Units: Subjects
        Any temperature; Dose 1
    124
    100
    99
        Grade 3 temperture; Dose 1
    37
    31
    27
        Related temperature; Dose 1
    72
    67
    54
        Any Meningism; Dose 1
    0
    0
    1
        Grade 3 Meningism; Dose 1
    0
    0
    0
        Related Meningism; Dose 1
    0
    0
    0
        Any Parotid gland swelling; Dose 1
    0
    1
    0
        Grade 3 Parotid gland swelling; Dose 1
    0
    0
    0
        Related Parotid gland swelling; Dose 1
    0
    1
    0
        Any Rash; Dose 1
    29
    33
    35
        Grade 3 Rash; Dose 1
    3
    2
    5
        Related Rash; Dose 1
    4
    6
    0
        Any temperature; Dose 2
    92
    66
    87
        Grade 3 temperature; Dose 2
    12
    12
    30
        Related temperature; Dose 2
    40
    28
    40
        Any Meningism; Dose 2
    0
    0
    1
        Grade 3 Meningism; Dose 2
    0
    0
    1
        Related Meningism; Dose 2
    0
    0
    0
        Any Parotid gland swelling; Dose 2
    0
    2
    0
        Grade 3 Parotid gland swelling; Dose 2
    0
    1
    0
        Related Parotid gland swelling; Dose 2
    0
    1
    0
        Any Rash; Dose 2
    14
    8
    23
        Grade 3 Rash; Dose 2
    1
    1
    6
        Related 3 Rash; Dose 2
    2
    0
    4
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any, grade 3 and related solicited general symptoms

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    End point title
    		 Number of subjects reporting any, grade 3 and related solicited general symptoms
    End point description
    Assessed solicited general symptoms were fever, meningism, parotid gland swelling and rash. Any = occurrence of the symptom regardless of intensity grade. Grade 3 parotid / salivary gland swelling = swelling with accompanying general symptoms and grade 3 rash = intensity > 150 lesions. Related = symptom assessed by the investigator as related to the vaccination. This outcome measure is not applicable to subjects in MMRV/4W Group and MMR Group for Dose 1 as these subjects were administered the study vaccine during this outcome measure time frame.
    End point type
    Secondary
    End point timeframe
    During the 43-day (Day 0-42) post-vaccination period following each dose.
    End point values
    		 MMRV/4W Group MMRV/12M Group MMR Group
    Number of subjects analysed
    181
    179
    183
    Units: Subjects
        Any temperature; Dose 1
    0
    106
    0
        Grade 3 temperature; Dose 1
    0
    36
    0
        Related temperature; Dose 1
    0
    67
    0
        Any Meningism; Dose 1
    0
    1
    0
        Grade 3 Meningism; Dose 1
    0
    0
    0
        Related Meningism; Dose 1
    0
    0
    0
        Any Parotid gland swelling; Dose 1
    0
    1
    0
        Grade 3 Parotid gland swelling; Dose 1
    0
    0
    0
        Related Parotid gland swelling; Dose 1
    0
    1
    0
        Any Rash; Dose 1
    0
    37
    0
        Grade 3 Rash; Dose 1
    0
    3
    0
        Related Rash; Dose 1
    0
    6
    0
        Any temperature; Dose 2
    104
    76
    97
        Grade 3 temperature; Dose 2
    19
    18
    33
        Related temperature; Dose 2
    40
    30
    40
        Any Meningism; Dose 2
    0
    0
    1
        Grade 3 Meningism; Dose 2
    0
    0
    1
        Related Meningism; Dose 2
    0
    0
    0
        Any Parotid gland swelling; Dose 2
    0
    2
    0
        Grade 3 Parotid gland swelling; Dose 2
    0
    1
    0
        Related Parotid gland swelling; Dose 2
    0
    1
    0
        Any Rash; Dose 2
    19
    10
    26
        Grade 3 Rash; Dose 2
    1
    1
    6
        Related Rash; Dose 2
    2
    0
    4
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any unsolicted adverse event

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    End point title
    		 Number of subjects reporting any unsolicted adverse event
    End point description
    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined as an adverse event (AE) reported in addition to those solicited during the clinical study. Also any ‘solicited’ symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.
    End point type
    Secondary
    End point timeframe
    Within 29 days after Dose 1.
    End point values
    		 MMRV/4W Group MMRV/12M Group MMR Group
    Number of subjects analysed
    184
    161
    185
    Units: Subjects
        any AE(s)
    86
    74
    77
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any unsolicited adverse event

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    End point title
    		 Number of subjects reporting any unsolicited adverse event
    End point description
    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined as an adverse event (AE) reported in addition to those solicited during the clinical study. Also any ‘solicited’ symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.
    End point type
    Secondary
    End point timeframe
    Within 43 days after Dose 1.
    End point values
    		 MMRV/4W Group MMRV/12M Group MMR Group
    Number of subjects analysed
    188
    184
    187
    Units: Subjects
        Any AE(s)
    87
    83
    79
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any unsolicited adverse event

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    End point title
    		 Number of subjects reporting any unsolicited adverse event
    End point description
    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined as an adverse event (AE) reported in addition to those solicited during the clinical study. Also any ‘solicited’ symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.
    End point type
    Secondary
    End point timeframe
    Within 43 days after Dose 2.
    End point values
    		 MMRV/4W Group MMRV/12M Group MMR Group
    Number of subjects analysed
    184
    161
    185
    Units: Subjects
        Any AE(s)
    70
    51
    89
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects with serious adverse events (SAEs)
    End point description
    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or congenital anomaly/birth defect in the offspring of a study subject.
    End point type
    Secondary
    End point timeframe
    During the entire study period (Month 0 - Month 13.5)
    End point values
    		 MMRV/4W Group MMRV/12M Group MMR Group
    Number of subjects analysed
    184
    161
    185
    Units: Subjects
        Any SAE(s)
    2
    10
    10
    No statistical analyses for this end point

    Secondary: Antibody titers against measles, mumps, rubella and varicella viruses

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    End point title
    		 Antibody titers against measles, mumps, rubella and varicella viruses
    End point description
    Antibody titers were summarized by geometric mean titers (GMTs) with their 95% CIs.
    End point type
    Secondary
    End point timeframe
    One year post Dose 2 in Groups MMRV/4W and MMR (Month 13.5) and one year post Dose 1 in MMRV/12M Group (Month 12).
    End point values
    		 MMRV/4W Group MMRV/12M Group MMR Group
    Number of subjects analysed
    110
    137
    107
    Units: mIU/mL
    geometric mean (confidence interval 95%)
        anti-measles
    4086.9 (3401.4 to 4910.7)
    3759.3 (3105.9 to 4550.2)
    1960.4 (1559.4 to 2464.5)
        anti-mumps
    1066.9 (864.5 to 1316.6)
    1116.1 (926 to 1345.3)
    1045.3 (847.7 to 1289)
        anti-rubella
    98.7 (83.5 to 116.8)
    101.1 (86.2 to 118.6)
    107.6 (91.5 to 126.6)
        IgG varicella antibodies
    310.7 (237.4 to 406.7)
    128 (91.3 to 179.5)
    0 (0 to 0)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited local symptoms: within 4 days after each vaccination, solicited general symptoms: during the 29-day and during the 43-day post-vaccination after each dose. Unsolicited AEs: 43 days after Dose 1&2. SAEs: Month 0 - Month 13.5
    Adverse event reporting additional description
    The number of occurrences reported for solicited symptoms, adverse events, and serious adverse events were not available for posting. The number of subjects affected by each specific event was indicated as the number of occurrences.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    11
    Reporting groups
    Reporting group title
    MMRV/4W Group
    Reporting group description
    		 Subjects received two doses of MMRV vaccine 4 weeks apart (Day 0 and Week 4).

    Reporting group title
    MMRV/12M Group
    Reporting group description
    		 Subjects received two doses of Priorix™-Tetra vaccine (MMRV) 12 months apart (Day 0 and Month 12).

    Reporting group title
    MMR Group
    Reporting group description
    		 Subjects received two doses of Priorix™ vaccine (MMR) 4 weeks apart (Day 0 and Week 4)

    Serious adverse events
    		 MMRV/4W Group MMRV/12M Group MMR Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 188 (1.06%)
    10 / 184 (5.43%)
    10 / 187 (5.35%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Brain contusion
    alternative assessment type: Non-systematic
         subjects affected / exposed [1]
    0 / 184 (0.00%)
    1 / 161 (0.62%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Drug toxicity
    alternative assessment type: Non-systematic
         subjects affected / exposed [2]
    0 / 184 (0.00%)
    0 / 161 (0.00%)
    1 / 185 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Febrile convulsion
    alternative assessment type: Non-systematic
         subjects affected / exposed [3]
    0 / 184 (0.00%)
    2 / 161 (1.24%)
    1 / 185 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Convulsion
    alternative assessment type: Non-systematic
         subjects affected / exposed [4]
    0 / 184 (0.00%)
    0 / 161 (0.00%)
    1 / 185 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Gait disturbance
    alternative assessment type: Non-systematic
         subjects affected / exposed [5]
    0 / 184 (0.00%)
    1 / 161 (0.62%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Lymphadenitis
    alternative assessment type: Non-systematic
         subjects affected / exposed [6]
    0 / 184 (0.00%)
    0 / 161 (0.00%)
    1 / 185 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Concussion
         subjects affected / exposed [7]
    0 / 184 (0.00%)
    1 / 161 (0.62%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Bronchitis chronic
    alternative assessment type: Non-systematic
         subjects affected / exposed [8]
    0 / 184 (0.00%)
    1 / 161 (0.62%)
    1 / 185 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
    alternative assessment type: Non-systematic
         subjects affected / exposed [9]
    1 / 184 (0.54%)
    1 / 161 (0.62%)
    2 / 185 (1.08%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis rotavirus
    alternative assessment type: Non-systematic
         subjects affected / exposed [10]
    0 / 184 (0.00%)
    1 / 161 (0.62%)
    2 / 185 (1.08%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchitis
    alternative assessment type: Non-systematic
         subjects affected / exposed [11]
    0 / 184 (0.00%)
    1 / 161 (0.62%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Gastroenteritis
    alternative assessment type: Non-systematic
         subjects affected / exposed [12]
    0 / 184 (0.00%)
    1 / 161 (0.62%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infectious mononucleosis
    alternative assessment type: Non-systematic
         subjects affected / exposed [13]
    0 / 184 (0.00%)
    1 / 161 (0.62%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Otitis media
    alternative assessment type: Non-systematic
         subjects affected / exposed [14]
    1 / 184 (0.54%)
    0 / 161 (0.00%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pseudocroup
    alternative assessment type: Non-systematic
         subjects affected / exposed [15]
    0 / 184 (0.00%)
    1 / 161 (0.62%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
    alternative assessment type: Non-systematic
         subjects affected / exposed [16]
    0 / 184 (0.00%)
    1 / 161 (0.62%)
    0 / 185 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Type 1 diabetes mellitus
    alternative assessment type: Non-systematic
         subjects affected / exposed [17]
    0 / 184 (0.00%)
    0 / 161 (0.00%)
    1 / 185 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Subjects who missed reporting symptoms (solicited/unsolicited or concomitant medications) were treated as subjects without symptoms (solicited/unsolicited or concomitant medications, respectively).
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Subjects who missed reporting symptoms (solicited/unsolicited or concomitant medications) were treated as subjects without symptoms (solicited/unsolicited or concomitant medications, respectively).
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Subjects who missed reporting symptoms (solicited/unsolicited or concomitant medications) were treated as subjects without symptoms (solicited/unsolicited or concomitant medications, respectively).
    [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Subjects who missed reporting symptoms (solicited/unsolicited or concomitant medications) were treated as subjects without symptoms (solicited/unsolicited or concomitant medications, respectively).
    [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Subjects who missed reporting symptoms (solicited/unsolicited or concomitant medications) were treated as subjects without symptoms (solicited/unsolicited or concomitant medications, respectively).
    [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Subjects who missed reporting symptoms (solicited/unsolicited or concomitant medications) were treated as subjects without symptoms (solicited/unsolicited or concomitant medications, respectively).
    [7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Subjects who missed reporting symptoms (solicited/unsolicited or concomitant medications) were treated as subjects without symptoms (solicited/unsolicited or concomitant medications, respectively).
    [8] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Subjects who missed reporting symptoms (solicited/unsolicited or concomitant medications) were treated as subjects without symptoms (solicited/unsolicited or concomitant medications, respectively).
    [9] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Subjects who missed reporting symptoms (solicited/unsolicited or concomitant medications) were treated as subjects without symptoms (solicited/unsolicited or concomitant medications, respectively).
    [10] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Subjects who missed reporting symptoms (solicited/unsolicited or concomitant medications) were treated as subjects without symptoms (solicited/unsolicited or concomitant medications, respectively).
    [11] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Subjects who missed reporting symptoms (solicited/unsolicited or concomitant medications) were treated as subjects without symptoms (solicited/unsolicited or concomitant medications, respectively).
    [12] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Subjects who missed reporting symptoms (solicited/unsolicited or concomitant medications) were treated as subjects without symptoms (solicited/unsolicited or concomitant medications, respectively).
    [13] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Subjects who missed reporting symptoms (solicited/unsolicited or concomitant medications) were treated as subjects without symptoms (solicited/unsolicited or concomitant medications, respectively).
    [14] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Subjects who missed reporting symptoms (solicited/unsolicited or concomitant medications) were treated as subjects without symptoms (solicited/unsolicited or concomitant medications, respectively).
    [15] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Subjects who missed reporting symptoms (solicited/unsolicited or concomitant medications) were treated as subjects without symptoms (solicited/unsolicited or concomitant medications, respectively).
    [16] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Subjects who missed reporting symptoms (solicited/unsolicited or concomitant medications) were treated as subjects without symptoms (solicited/unsolicited or concomitant medications, respectively).
    [17] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
    Justification: Subjects who missed reporting symptoms (solicited/unsolicited or concomitant medications) were treated as subjects without symptoms (solicited/unsolicited or concomitant medications, respectively).
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 MMRV/4W Group MMRV/12M Group MMR Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    124 / 188 (65.96%)
    106 / 184 (57.61%)
    99 / 187 (52.94%)
    Injury, poisoning and procedural complications
    Upper respiratory tract infection; Dose 1
    Additional description: Within 43 days after Dose 1
         subjects affected / exposed
    12 / 188 (6.38%)
    19 / 184 (10.33%)
    7 / 187 (3.74%)
         occurrences all number
    12
    19
    7
    General disorders and administration site conditions
    Pain; Dose 1
         subjects affected / exposed [18]
    21 / 182 (11.54%)
    31 / 176 (17.61%)
    21 / 184 (11.41%)
         occurrences all number
    21
    31
    21
    Redness; Dose 1
         subjects affected / exposed [19]
    34 / 182 (18.68%)
    43 / 176 (24.43%)
    41 / 184 (22.28%)
         occurrences all number
    34
    43
    41
    Swelling; Dose 1
         subjects affected / exposed [20]
    10 / 182 (5.49%)
    14 / 176 (7.95%)
    16 / 184 (8.70%)
         occurrences all number
    10
    14
    16
    Pain; Dose 2
         subjects affected / exposed [21]
    11 / 179 (6.15%)
    17 / 156 (10.90%)
    11 / 180 (6.11%)
         occurrences all number
    11
    17
    11
    Redness; Dose 2
         subjects affected / exposed [22]
    36 / 179 (20.11%)
    32 / 156 (20.51%)
    32 / 180 (17.78%)
         occurrences all number
    36
    32
    32
    Swelling; Dose 2
         subjects affected / exposed [23]
    13 / 179 (7.26%)
    12 / 156 (7.69%)
    14 / 180 (7.78%)
         occurrences all number
    13
    12
    14
    Fever; Dose 1 (D0-28)
    Additional description: Reported during the 29-day (Day 0-28) post-vaccination period following dose 1.
         subjects affected / exposed [24]
    124 / 183 (67.76%)
    100 / 179 (55.87%)
    99 / 185 (53.51%)
         occurrences all number
    124
    100
    99
    Rash; Dose 1 (D0-28)
    Additional description: Reported during the 29-day (Day 0-28) post-vaccination period following dose 1.
         subjects affected / exposed [25]
    29 / 183 (15.85%)
    33 / 179 (18.44%)
    35 / 185 (18.92%)
         occurrences all number
    29
    33
    35
    Fever; Dose 2 (D0-42)
    Additional description: Reported during the 43-day (Day 0-42) post-vaccination period following dose 2.
         subjects affected / exposed [26]
    104 / 181 (57.46%)
    76 / 155 (49.03%)
    97 / 183 (53.01%)
         occurrences all number
    104
    76
    97
    Rash; Dose 2 (D0-42)
    Additional description: Reported during the 43-day (Day 0-42) post-vaccination period following dose 2.
         subjects affected / exposed [27]
    19 / 181 (10.50%)
    10 / 155 (6.45%)
    26 / 183 (14.21%)
         occurrences all number
    19
    10
    26
    Fever; Dose 2 (D0-28)
    Additional description: Reported during the 29-day (Day 0-28) post-vaccination period following dose 2.
         subjects affected / exposed [28]
    92 / 181 (50.83%)
    66 / 155 (42.58%)
    87 / 183 (47.54%)
         occurrences all number
    92
    66
    87
    Rash; Dose 2 (D0-28)
    Additional description: Reported during the 29-day (Day 0-28) post-vaccination period following dose 2.
         subjects affected / exposed [29]
    14 / 181 (7.73%)
    8 / 155 (5.16%)
    23 / 183 (12.57%)
         occurrences all number
    14
    8
    23
    Fever; Dose 1 (D0-42)
    Additional description: Reported during the 43-day post-vaccination period following dose 1.This symptom was reported by subjects in the MMRV/12M Group only & is not applicable to subjects in MMRV/4W & MMR Groups due to another vaccination planned for these subjects.
         subjects affected / exposed [30]
    0 / 188 (0.00%)
    106 / 179 (59.22%)
    0 / 187 (0.00%)
         occurrences all number
    0
    106
    0
    Rash; Dose 1 (D0-42)
    Additional description: Reported during the 43-day post-vaccination period following dose 1.This symptom was reported by subjects in the MMRV/12M Group only & is not applicable to subjects in MMRV/4W & MMR Groups due to another vaccination planned for these subjects.
         subjects affected / exposed [31]
    0 / 188 (0.00%)
    37 / 179 (20.67%)
    0 / 187 (0.00%)
         occurrences all number
    0
    37
    0
    Gastrointestinal disorders
    Teething; Dose 2
    Additional description: Within 43 days after Dose 2
    alternative assessment type: Non-systematic
         subjects affected / exposed [32]
    10 / 184 (5.43%)
    0 / 161 (0.00%)
    7 / 185 (3.78%)
         occurrences all number
    10
    0
    7
    Respiratory, thoracic and mediastinal disorders
    Cough; Dose 1
    Additional description: Within 43 days after Dose 1
         subjects affected / exposed
    16 / 188 (8.51%)
    5 / 184 (2.72%)
    5 / 187 (2.67%)
         occurrences all number
    16
    5
    5
    Infections and infestations
    Gastroenteritis; Dose 1
    Additional description: Within 43 days after Dose 1
         subjects affected / exposed
    8 / 188 (4.26%)
    14 / 184 (7.61%)
    10 / 187 (5.35%)
         occurrences all number
    8
    14
    10
    Rhinitis; Dose 1
    Additional description: Within 43 days after Dose 1
         subjects affected / exposed
    10 / 188 (5.32%)
    8 / 184 (4.35%)
    10 / 187 (5.35%)
         occurrences all number
    10
    8
    10
    Bronchitis; Dose 1
    Additional description: Within 43 days after Dose 1
         subjects affected / exposed
    5 / 188 (2.66%)
    16 / 184 (8.70%)
    9 / 187 (4.81%)
         occurrences all number
    5
    16
    9
    Nasopharyngitis; Dose 1
    Additional description: Within 43 days after Dose 1
         subjects affected / exposed
    8 / 188 (4.26%)
    0 / 184 (0.00%)
    12 / 187 (6.42%)
         occurrences all number
    8
    0
    12
    Gastroenteritis; Dose 2
    Additional description: Within 43 days after Dose 2
    alternative assessment type: Non-systematic
         subjects affected / exposed [33]
    14 / 184 (7.61%)
    6 / 161 (3.73%)
    11 / 185 (5.95%)
         occurrences all number
    14
    6
    11
    Upper respiratory tract infection; Dose 2
    Additional description: Within 43 days after Dose 2
    alternative assessment type: Non-systematic
         subjects affected / exposed [34]
    8 / 184 (4.35%)
    9 / 161 (5.59%)
    9 / 185 (4.86%)
         occurrences all number
    8
    9
    9
    Bronchitis; Dose 2
    Additional description: Within 43 days after Dose 2
    alternative assessment type: Non-systematic
         subjects affected / exposed [35]
    6 / 184 (3.26%)
    7 / 161 (4.35%)
    11 / 185 (5.95%)
         occurrences all number
    6
    7
    11
    Nasopharyngitis; Dose 2
    Additional description: Within 43 days after Dose 2
    alternative assessment type: Non-systematic
         subjects affected / exposed [36]
    7 / 184 (3.80%)
    5 / 161 (3.11%)
    10 / 185 (5.41%)
         occurrences all number
    7
    5
    10
    Otitis media; Dose 1
    Additional description: Within 43 days after Dose 1
    alternative assessment type: Non-systematic
         subjects affected / exposed
    9 / 188 (4.79%)
    10 / 184 (5.43%)
    9 / 187 (4.81%)
         occurrences all number
    9
    10
    9
    Otitis media; Dose 2
    Additional description: Within 43 days after Dose 2
    alternative assessment type: Non-systematic
         subjects affected / exposed [37]
    5 / 184 (2.72%)
    6 / 161 (3.73%)
    11 / 185 (5.95%)
         occurrences all number
    5
    6
    11
    Notes
    [18] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Subjects who missed reporting symptoms (solicited/unsolicited or concomitant medications) were treated as subjects without symptoms (solicited/unsolicited or concomitant medications, respectively).
    [19] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Subjects who missed reporting symptoms (solicited/unsolicited or concomitant medications) were treated as subjects without symptoms (solicited/unsolicited or concomitant medications, respectively).
    [20] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Subjects who missed reporting symptoms (solicited/unsolicited or concomitant medications) were treated as subjects without symptoms (solicited/unsolicited or concomitant medications, respectively).
    [21] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Subjects who missed reporting symptoms (solicited/unsolicited or concomitant medications) were treated as subjects without symptoms (solicited/unsolicited or concomitant medications, respectively).
    [22] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Subjects who missed reporting symptoms (solicited/unsolicited or concomitant medications) were treated as subjects without symptoms (solicited/unsolicited or concomitant medications, respectively).
    [23] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Subjects who missed reporting symptoms (solicited/unsolicited or concomitant medications) were treated as subjects without symptoms (solicited/unsolicited or concomitant medications, respectively).
    [24] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Subjects who missed reporting symptoms (solicited/unsolicited or concomitant medications) were treated as subjects without symptoms (solicited/unsolicited or concomitant medications, respectively).
    [25] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Subjects who missed reporting symptoms (solicited/unsolicited or concomitant medications) were treated as subjects without symptoms (solicited/unsolicited or concomitant medications, respectively).
    [26] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Subjects who missed reporting symptoms (solicited/unsolicited or concomitant medications) were treated as subjects without symptoms (solicited/unsolicited or concomitant medications, respectively).
    [27] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Subjects who missed reporting symptoms (solicited/unsolicited or concomitant medications) were treated as subjects without symptoms (solicited/unsolicited or concomitant medications, respectively).
    [28] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Subjects who missed reporting symptoms (solicited/unsolicited or concomitant medications) were treated as subjects without symptoms (solicited/unsolicited or concomitant medications, respectively).
    [29] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Subjects who missed reporting symptoms (solicited/unsolicited or concomitant medications) were treated as subjects without symptoms (solicited/unsolicited or concomitant medications, respectively).
    [30] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Subjects who missed reporting symptoms (solicited/unsolicited or concomitant medications) were treated as subjects without symptoms (solicited/unsolicited or concomitant medications, respectively).
    [31] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Subjects who missed reporting symptoms (solicited/unsolicited or concomitant medications) were treated as subjects without symptoms (solicited/unsolicited or concomitant medications, respectively).
    [32] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Subjects who missed reporting symptoms (solicited/unsolicited or concomitant medications) were treated as subjects without symptoms (solicited/unsolicited or concomitant medications, respectively).
    [33] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Subjects who missed reporting symptoms (solicited/unsolicited or concomitant medications) were treated as subjects without symptoms (solicited/unsolicited or concomitant medications, respectively).
    [34] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Subjects who missed reporting symptoms (solicited/unsolicited or concomitant medications) were treated as subjects without symptoms (solicited/unsolicited or concomitant medications, respectively).
    [35] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Subjects who missed reporting symptoms (solicited/unsolicited or concomitant medications) were treated as subjects without symptoms (solicited/unsolicited or concomitant medications, respectively).
    [36] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Subjects who missed reporting symptoms (solicited/unsolicited or concomitant medications) were treated as subjects without symptoms (solicited/unsolicited or concomitant medications, respectively).
    [37] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: Subjects who missed reporting symptoms (solicited/unsolicited or concomitant medications) were treated as subjects without symptoms (solicited/unsolicited or concomitant medications, respectively).

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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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