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    Clinical Trial Results:
    A Phase IIIb, open, randomized study to evaluate non-inferiority of GSK Biologicals’ measles-mumps-rubella-varicella vaccine versus co-administration of GSK Biologicals’ Priorix™ and Varilrix™ in healthy children during their second year of life.

    Summary
    EudraCT number
    		 2011-004485-15
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    27 May 2010

    Results information
    Results version number
    		 v1
    This version publication date
    27 Apr 2016
    First version publication date
    30 Jul 2015
    Other versions
    		 v2

    Trial information

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    Trial identification
    Sponsor protocol code
    110876
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00751348
    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
    15 Oct 2010
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    27 May 2010
    Global end of trial reached?
    Yes
    Global end of trial date
    27 May 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate the non-inferiority of GSK Biologicals’ combined measles-mumps-rubella-varicella (MeMuRu-Oka) vaccine to Priorix and Varilrix vaccines administered as concomitant, separate injections in terms of measles, mumps, rubella, and varicella zoster virus (VZV) seroconversion rates 42-56 days after vaccination
    Protection of trial subjects
    The subjects were observed closely for at least 30 minutes following the administration of vaccine(s), with appropriate medical treatment readily available in case of a rare anaphylactic reaction.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    16 Oct 2008
    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
    Korea, Republic of: 474
    Worldwide total number of subjects
    474
    EEA total number of subjects
    0
    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)
    474
    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
    		 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 Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 MMRV Group
    Arm description
    		 Subjects received one dose of MMRV vaccine at Day 0.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Priorix-Tetra
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    One dose of MMRV vaccine was administered in the deltoid region of the left upper arm at Day 0.

    Arm title
    		 MMR+V Group
    Arm description
    		 Subjects received one dose of MMR vaccine and one dose of V vaccine at Day 0.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Priorix™
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    One dose of MMR vaccine was administered in the deltoid region of the left upper arm.

    Investigational medicinal product name
    Varilrix™
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    One dose of varicella vaccine was administered in the deltoid region of the right upper arm at Day 0.

    Number of subjects in period 1
    		MMRV Group MMR+V Group
    Started
    313
    161
    Completed
    307
    159
    Not completed
    6
    2
         Consent withdrawn by subject
    5
    2
         Migration from study area
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    MMRV Group
    Reporting group description
    		 Subjects received one dose of MMRV vaccine at Day 0.

    Reporting group title
    MMR+V Group
    Reporting group description
    		 Subjects received one dose of MMR vaccine and one dose of V vaccine at Day 0.

    Reporting group values
    		 MMRV Group MMR+V Group Total
    Number of subjects
    		 313 161 474
    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)
    		 12.4 ( 1.4 ) 12.5 ( 1.65 ) -
    Gender categorical
    Units: Subjects
        Female
    		 128 76 204
        Male
    		 185 85 270

    End points

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    End points reporting groups
    Reporting group title
    MMRV Group
    Reporting group description
    		 Subjects received one dose of MMRV vaccine at Day 0.

    Reporting group title
    MMR+V Group
    Reporting group description
    		 Subjects received one dose of MMR vaccine and one dose of V vaccine at Day 0.

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

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    End point title
    		 Number of subjects seroconverted for measles, mumps, rubella, and VZV antibodies above the cut-off values.
    End point description
    Seroconversion was defined as the appearance of antibodies (i.e. titer ≥ cut-off value) in the sera of subjects seronegative (i.e. titer < cut-off value) before vaccination. Cut-off values are the following: • Anti-measles concentration ≥ 150 mIU/mL • Anti-mumps concentration ≥ 231 U/mL • Anti-rubella concentration ≥ 4 IU/mL • Anti-VZV titer ≥ 1:4 dilution
    End point type
    Primary
    End point timeframe
    At 42-days after vaccination.
    End point values
    		 MMRV Group MMR+V Group
    Number of subjects analysed
    300
    157
    Units: Subjects
        Anti-Measles (N=300; 156)
    294
    155
        Anti-Mumps (N=295; 154)
    262
    145
        Anti-Rubella (N=298; 157)
    297
    157
        Anti-VZV (N=283; 151)
    280
    151
    Statistical analysis title
    		 Non-inferiority - vaccine response to anti-measles
    Statistical analysis description
    Non-inferiority of MMRV vaccine vs MMR and V administered as concomitant vaccine 42-56 days after vaccination at Day 0 in terms of anti-measles seroconversion rates. Non-inferiority with respect to seroconversion rates for measles 42-56 days after vaccination was concluded if the lower limit of the two-sided standardized asymptotic 95% confidence interval (CI) for the group difference (MMRV Group minus MMR+V Group) in seroconversion rate for anti-measles was above -10%.
    Comparison groups
    MMRV Group v MMR+V Group
    Number of subjects included in analysis
    457
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.05 [1]
    Method
    		 Fisher exact
    Parameter type
    		 Difference in percentage
    Point estimate
    -1.36
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.77
         upper limit
    		 1.66
    Variability estimate
    Standard deviation
    Notes
    [1] - The p-values for all reactogenicity comparisons were calculated using a two-sided Fisher Exact test.
    Statistical analysis title
    		 Non-inferiority - vaccine response to anti-mumps
    Statistical analysis description
    Non-inferiority of MMRV vaccine vs MMR and V administered as concomitant vaccine 42-56 days after vaccination at Day 0 in terms of anti-mumps seroconversion rates. Non-inferiority with respect to seroconversion rates for mumps 42-56 days after vaccination was concluded if the lower limit of the two-sided standardized asymptotic 95% confidence interval (CI) for the group difference (MMRV Group minus MMR+V Group) in seroconversion rate for anti-mumps was above -10%.
    Comparison groups
    MMRV Group v MMR+V Group
    Number of subjects included in analysis
    457
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.05 [2]
    Method
    		 Fisher exact
    Parameter type
    		 Difference in percentage
    Point estimate
    -5.34
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.4
         upper limit
    		 0.38
    Variability estimate
    Standard deviation
    Notes
    [2] - The p-values for all reactogenicity comparisons were calculated using a two-sided Fisher Exact test.
    Statistical analysis title
    		 Non-inferiority - vaccine response to anti-rubella
    Statistical analysis description
    Non-inferiority of MMRV vaccine vs MMR and V administered as concomitant vaccine 42-56 days after vaccination at Day 0 in terms of of anti-rubella seroconversion rates. Non-inferiority with respect to seroconversion rates for rubella 42-56 days after vaccination was concluded if the lower limit of the two-sided standardized asymptotic 95% confidence interval (CI) for the group difference (MMRV Group minus MMR+V Group) in seroconversion rate for anti-rubella was above -10%.
    Comparison groups
    MMRV Group v MMR+V Group
    Number of subjects included in analysis
    457
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.05 [3]
    Method
    		 Fisher exact
    Parameter type
    		 Difference in percentage
    Point estimate
    -0.34
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.88
         upper limit
    		 2.06
    Variability estimate
    Standard deviation
    Notes
    [3] - The p-values for all reactogenicity comparisons were calculated using a two-sided Fisher Exact test.
    Statistical analysis title
    		 Non-inferiority - vaccine response to anti-VZV
    Statistical analysis description
    Non-inferiority of MMRV vaccine vs MMR and V administered as concomitant vaccine 42-56 days after vaccination at Day 0 in terms of of anti-varicella zoster virus (VZV) seroconversion rates. Non-inferiority with respect to seroconversion rates for VZV 42-56 days after vaccination was concluded if the lower limit of the two-sided standardized asymptotic 95% confidence interval (CI) for the group difference (MMRV Group minus MMR+V Group) in seroconversion rate for anti-VZV was above -10%.
    Comparison groups
    MMRV Group v MMR+V Group
    Number of subjects included in analysis
    457
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.05 [4]
    Method
    		 Fisher exact
    Parameter type
    		 Difference in percentage
    Point estimate
    -1.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.07
         upper limit
    		 1.44
    Variability estimate
    Standard deviation
    Notes
    [4] - The p-values for all reactogenicity comparisons were calculated using a two-sided Fisher Exact test.

    Secondary: Antibody concentrations against measles.

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    End point title
    		 Antibody concentrations against measles.
    End point description
    Antibody titers were summarized by Geometric Mean Concentrations (GMCs) with their 95% CIs.
    End point type
    Secondary
    End point timeframe
    At 42-days after vaccination.
    End point values
    		 MMRV Group MMR+V Group
    Number of subjects analysed
    300
    156
    Units: mIU/mL
    geometric mean (confidence interval 95%)
        Anti-Measles (N=300; 156)
    4978.6 (4579.8 to 5412.1)
    3433.6 (3116.3 to 3783.2)
    No statistical analyses for this end point

    Secondary: Antibody concentrations against mumps.

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    End point title
    		 Antibody concentrations against mumps.
    End point description
    Antibody titers were summarized by Geometric Mean Concentrations (GMCs) with their 95% CIs.
    End point type
    Secondary
    End point timeframe
    At 42-days after vaccination.
    End point values
    		 MMRV Group MMR+V Group
    Number of subjects analysed
    295
    154
    Units: U/mL
    geometric mean (confidence interval 95%)
        Anti-Mumps (N=295; 154)
    1012.3 (894.4 to 1145.7)
    934.3 (805.2 to 1084.1)
    No statistical analyses for this end point

    Secondary: Antibody concentrations against rubella.

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    End point title
    		 Antibody concentrations against rubella.
    End point description
    Antibody titers were summarized by Geometric Mean Concentrations (GMCs) with their 95% CIs.
    End point type
    Secondary
    End point timeframe
    At 42-days after vaccination.
    End point values
    		 MMRV Group MMR+V Group
    Number of subjects analysed
    298
    157
    Units: IU/mL
    geometric mean (confidence interval 95%)
        Anti-Rubella (N=298; 157)
    63.4 (57.9 to 69.4)
    75.7 (68 to 84.3)
    No statistical analyses for this end point

    Secondary: Antibody titers against varicela viruses.

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    End point title
    		 Antibody titers against varicela viruses.
    End point description
    Antibody titers were summarized by Geometric Mean Titers (GMTs) with their 95% CIs.
    End point type
    Secondary
    End point timeframe
    At 42-days after vaccination.
    End point values
    		 MMRV Group MMR+V Group
    Number of subjects analysed
    283
    151
    Units: Titres
    geometric mean (confidence interval 95%)
        Anti-VZV (N=283; 151)
    134.1 (117 to 153.7)
    129.2 (109.8 to 152)
    No statistical analyses for this end point

    Secondary: Number of subjects with any and Grade 3 solicited local symptoms.

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    End point title
    		 Number of subjects with any and Grade 3 solicited local symptoms.
    End point description
    Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = Cry when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.
    End point type
    Secondary
    End point timeframe
    Within 4-days (Days 0-3) post-vaccination period.
    End point values
    		 MMRV Group MMR+V Group
    Number of subjects analysed
    310
    159
    Units: Subjects
        Any Pain
    15
    10
        Grade 3 Pain
    0
    0
        Any Redness
    26
    21
        Grade 3 Redness
    0
    1
        Any Swelling
    5
    5
        Grade 3 Swelling
    0
    0
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects with any, grade 3 and related solicited general symptoms.
    End point description
    Solicited general symptoms assessed were fever (defined as rectal temperature ≥38°C), rash, meningism and parotid gland swelling. Any was defined as incidence of the specified symptoms regardless of intensity or relationship to study vaccine. Grade 3 rash was defined as more than 150 lesions. Grade 3 fever was defined as fever (rectal temperature) >39.5°C. Grade 3 meningism and parotid gland swelling was defined as meningism/parotid gland swelling symptom which prevented normal everyday activities. Related = general symptom assessed by the investigator as causally related to the vaccination.
    End point type
    Secondary
    End point timeframe
    During the 43-day (Days 0-42) post-vaccination period.
    End point values
    		 MMRV Group MMR+V Group
    Number of subjects analysed
    310
    159
    Units: Subjects
        Any temperature
    202
    82
        Grade 3 temperature
    53
    19
        Related temperature
    31
    12
        Any Rash
    33
    16
        Grade 3 Rash
    0
    0
        Related Rash
    3
    1
        Any Meningism
    2
    0
        Grade 3 Meningism
    0
    0
        Related Meningism
    0
    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 any unsolicited adverse events (AEs).

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    End point title
    		 Number of subjects reporting any unsolicited adverse events (AEs).
    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. 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 the 43-day (Days 0-42) post-vaccination period.
    End point values
    		 MMRV Group MMR+V Group
    Number of subjects analysed
    313
    161
    Units: Subjects
        Any AE(s)
    194
    88
    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 resulted in death, were life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.
    End point type
    Secondary
    End point timeframe
    From the study dose until study end (Day 0 to Day 43-57).
    End point values
    		 MMRV Group MMR+V Group
    Number of subjects analysed
    313
    161
    Units: Subjects
        Any SAE(s)
    25
    12
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Serious Adverse Events: entire study period (Day 0 to Day 43-57); Solicited local: During the 4-day (Days 0-3) post vaccination period; Unsolicited symptoms and solicited general symptoms: Within 43 day post vaccination period.
    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
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    13.0
    Reporting groups
    Reporting group title
    MMRV Group
    Reporting group description
    		 -

    Reporting group title
    MMR+V Group
    Reporting group description
    		 -

    Serious adverse events
    		 MMRV Group MMR+V Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    25 / 313 (7.99%)
    12 / 161 (7.45%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Road traffic accident
         subjects affected / exposed
    1 / 313 (0.32%)
    0 / 161 (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
    2 / 313 (0.64%)
    0 / 161 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 313 (0.32%)
    0 / 161 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    1 / 313 (0.32%)
    1 / 161 (0.62%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Hepatitis
         subjects affected / exposed
    0 / 313 (0.00%)
    1 / 161 (0.62%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Acute tonsillitis
         subjects affected / exposed
    1 / 313 (0.32%)
    0 / 161 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchiolitis
         subjects affected / exposed
    3 / 313 (0.96%)
    2 / 161 (1.24%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchopneumonia
         subjects affected / exposed
    6 / 313 (1.92%)
    3 / 161 (1.86%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Croup infectious
         subjects affected / exposed
    2 / 313 (0.64%)
    0 / 161 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    5 / 313 (1.60%)
    6 / 161 (3.73%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis norovirus
         subjects affected / exposed
    1 / 313 (0.32%)
    0 / 161 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis rotavirus
         subjects affected / exposed
    2 / 313 (0.64%)
    0 / 161 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hand-foot-and-mouth disease
         subjects affected / exposed
    0 / 313 (0.00%)
    1 / 161 (0.62%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpangina
         subjects affected / exposed
    1 / 313 (0.32%)
    0 / 161 (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 / 313 (0.32%)
    0 / 161 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Otitis media acute
         subjects affected / exposed
    3 / 313 (0.96%)
    1 / 161 (0.62%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngitis
         subjects affected / exposed
    5 / 313 (1.60%)
    1 / 161 (0.62%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngotonsillitis
         subjects affected / exposed
    4 / 313 (1.28%)
    1 / 161 (0.62%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 313 (0.32%)
    1 / 161 (0.62%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rhinitis
         subjects affected / exposed
    1 / 313 (0.32%)
    0 / 161 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 313 (0.00%)
    1 / 161 (0.62%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral rash
         subjects affected / exposed
    1 / 313 (0.32%)
    0 / 161 (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
    Hypophagia
         subjects affected / exposed
    0 / 313 (0.00%)
    1 / 161 (0.62%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Iron deficiency
         subjects affected / exposed
    0 / 313 (0.00%)
    1 / 161 (0.62%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 MMRV Group MMR+V Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    202 / 313 (64.54%)
    88 / 161 (54.66%)
    General disorders and administration site conditions
    Pain
    alternative assessment type: Systematic
         subjects affected / exposed [1]
    15 / 310 (4.84%)
    10 / 159 (6.29%)
         occurrences all number
    15
    10
    Redness
    alternative assessment type: Systematic
         subjects affected / exposed [2]
    26 / 310 (8.39%)
    21 / 159 (13.21%)
         occurrences all number
    26
    21
    Fever
    alternative assessment type: Systematic
         subjects affected / exposed [3]
    202 / 310 (65.16%)
    82 / 159 (51.57%)
         occurrences all number
    202
    82
    Rash
    alternative assessment type: Systematic
         subjects affected / exposed [4]
    33 / 310 (10.65%)
    16 / 159 (10.06%)
         occurrences all number
    33
    16
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    63 / 313 (20.13%)
    25 / 161 (15.53%)
         occurrences all number
    63
    25
    Nasopharyngitis
         subjects affected / exposed
    31 / 313 (9.90%)
    14 / 161 (8.70%)
         occurrences all number
    31
    14
    Gastroenteritis
         subjects affected / exposed
    28 / 313 (8.95%)
    13 / 161 (8.07%)
         occurrences all number
    28
    13
    Pharyngitis
         subjects affected / exposed
    27 / 313 (8.63%)
    10 / 161 (6.21%)
         occurrences all number
    27
    10
    Bronchitis
         subjects affected / exposed
    26 / 313 (8.31%)
    11 / 161 (6.83%)
         occurrences all number
    26
    11
    Bronchiolitis
         subjects affected / exposed
    21 / 313 (6.71%)
    11 / 161 (6.83%)
         occurrences all number
    21
    11
    Pharyngotonsillitis
         subjects affected / exposed
    21 / 313 (6.71%)
    10 / 161 (6.21%)
         occurrences all number
    21
    10
    Otitis media acute
         subjects affected / exposed
    13 / 313 (4.15%)
    9 / 161 (5.59%)
         occurrences all number
    13
    9
    Notes
    [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: For the analysis of solicited symptom, missing or non-evaluable measurements were not replaced. Therefore the analysis of the solicited symptoms based on the Total Vaccinated cohort included only subjects with documented safety data (i.e. symptom screen/sheet completed).
    [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: For the analysis of solicited symptom, missing or non-evaluable measurements were not replaced. Therefore the analysis of the solicited symptoms based on the Total Vaccinated cohort included only subjects with documented safety data (i.e. symptom screen/sheet completed).
    [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal.
    Justification: For the analysis of solicited symptom, missing or non-evaluable measurements were not replaced. Therefore the analysis of the solicited symptoms based on the Total Vaccinated cohort included only subjects with documented safety data (i.e. symptom screen/sheet completed).
    [4] - 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: For the analysis of solicited symptom, missing or non-evaluable measurements were not replaced. Therefore the analysis of the solicited symptoms based on the Total Vaccinated cohort included only subjects with documented safety data (i.e. symptom screen/sheet completed).

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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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