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    Clinical Trial Results:
    A phase II, randomized, double-blind study of Priorix-Tetra (combined measles-mumps-rubella-varicella vaccine), one lot using new measles and rubella working seeds and one lot using old working seeds, in healthy subjects aged 11 to 21 months

    Summary
    EudraCT number
    		 2011-005881-38
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    13 Dec 2010

    Results information
    Results version number
    		 v2(current)
    This version publication date
    12 Aug 2022
    First version publication date
    30 Jul 2015
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Correction of full data set and alignment between registries.

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    108760
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00892775
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline Biologicals
    Sponsor organisation address
    Rue de l’Institut 89, Rixensart, Belgium, B-1330
    Public contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 44 2089904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 44 2089904466, GSKClinicalSupportHD@gsk.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    17 Sep 2010
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    17 Sep 2010
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Dec 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate the non-inferiority of MeMuRu-OKAnew WS to MeMuRu-OKA in terms of seroconversion rate to the measles, mumps, rubella, varicella components after the first dose. Criterion for non-inferiority (43 days after dose 1): For each antibody to mumps (ELISA), measles (ELISA), rubella (ELISA), varicella (IFA), lower limit of the standardized asymptotic 95% confidence interval (CI) for the group difference (MeMuRu OKAnew WS minus MeMuRu-OKA) in the percentage of subjects with seroconversion is -10% (clinical limit for non-inferiority).
    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
    03 Jun 2009
    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
    Singapore: 250
    Country: Number of subjects enrolled
    Taiwan: 251
    Worldwide total number of subjects
    501
    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)
    501
    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
    		 Three subjects were enrolled but not vaccinated, of which one subject was assigned to the Priorix-Tetra new WS Group, and remaining two subjects were not assigned a treatment group.

    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
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Priorix-Tetra new WS Group
    Arm description
    		 Subjects received 2 doses of Priorix-Tetra vaccine formulated with new measles and rubella working seeds at Day 0 and Week 12.
    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
    Two doses of MMRVnew WS vaccine administered by subcutaneous injections in the upper arm.

    Arm title
    		 Priorix-Tetra current WS Group
    Arm description
    		 Subjects received 2 doses of Priorix-Tetra vaccine manufactured with current working seed virus at Day 0 and Week 12.
    Arm type
    		 Active comparator

    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
    Two doses of MMRV vaccine administered subcutaneously in the upper arm.

    Number of subjects in period 1 [1]
    		Priorix-Tetra new WS Group Priorix-Tetra current WS Group
    Started
    332
    166
    Completed
    327
    165
    Not completed
    5
    1
         Consent withdrawn by subject
    -
    1
         Migrated/moved from study area
    1
    -
         The subject had difficulty with blood drawing
    1
    -
         Because of H1N1 the parents give up participating
    1
    -
         Lost to follow-up
    1
    -
         Protocol deviation
    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: Three subjects were enrolled but not vaccinated, of which one subject was assigned to the Priorix-Tetra new WS Group, and remaining two subjects were not assigned a treatment group.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Priorix-Tetra new WS Group
    Reporting group description
    		 Subjects received 2 doses of Priorix-Tetra vaccine formulated with new measles and rubella working seeds at Day 0 and Week 12.

    Reporting group title
    Priorix-Tetra current WS Group
    Reporting group description
    		 Subjects received 2 doses of Priorix-Tetra vaccine manufactured with current working seed virus at Day 0 and Week 12.

    Reporting group values
    		 Priorix-Tetra new WS Group Priorix-Tetra current WS Group Total
    Number of subjects
    		 332 166 498
    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)
    		 332 166 498
        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
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    		 13 ( 1.94 ) 12.9 ( 1.7 ) -
    Gender categorical
    Units: Subjects
        Female
    		 166 84 250
        Male
    		 166 82 248

    End points

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    End points reporting groups
    Reporting group title
    Priorix-Tetra new WS Group
    Reporting group description
    		 Subjects received 2 doses of Priorix-Tetra vaccine formulated with new measles and rubella working seeds at Day 0 and Week 12.

    Reporting group title
    Priorix-Tetra current WS Group
    Reporting group description
    		 Subjects received 2 doses of Priorix-Tetra vaccine manufactured with current working seed virus at Day 0 and Week 12.

    Primary: Number of subjects seroconverted for measles, mumps, rubella and varicella antibodies greater than or equal to (>=) the cut-off value

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    End point title
    		 Number of subjects seroconverted for measles, mumps, rubella and varicella antibodies greater than or equal to (>=) the cut-off value
    End point description
    Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. The cut-off values for seroconversion were 150 milli international units per milliliter (mIU/mL), 231 units per milliliter (U/mL), 4 international units per milliliter (IU/mL) and 1:4 dilution for measles, mumps, rubella and varicella, respectively.
    End point type
    Primary
    End point timeframe
    At 42-56 days after the first dose of study vaccine (Week 6)
    End point values
    		 Priorix-Tetra new WS Group Priorix-Tetra current WS Group
    Number of subjects analysed
    314
    157
    Units: Subjects
        Anti-measles ≥ 150 mIU/mL
    312
    157
        Anti-mumps ≥ 231 U/ML
    279
    142
        Anti-rubella ≥ 4 IU/mL
    313
    157
        IgG varicella antibodies ≥ 1:4 dilution
    284
    131
    Statistical analysis title
    		 Priorix-Tetra New WS vs Priorix-Tetra Current WS
    Statistical analysis description
    Non-inferiority of GSK Biologicals’ MMRV new formulation vaccine (Priorix-Tetra new WS) compared to Priorix-Tetra current WS vaccine after the first dose in terms of anti-measles seroconversion rates, 42 – 56 days after the first dose. Non-inferiority with respect to seroconversion rates for measles 42-56 days after vaccination was concluded if the lower limit of the 95% CI around the difference in seroconversion rates between groups would be [–10%] or higher.
    Comparison groups
    Priorix-Tetra current WS Group v Priorix-Tetra new WS Group
    Number of subjects included in analysis
    471
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    -0.64
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.29
         upper limit
    		 1.76
    Statistical analysis title
    		 Priorix-Tetra New WS vs Priorix-Tetra Current WS
    Statistical analysis description
    Non-inferiority of GSK Biologicals’ MMRV new formulation vaccine (Priorix-Tetra new WS) compared to Priorix-Tetra current WS vaccine after the first dose in terms of anti-mumps seroconversion rates, 42 – 56 days after the first dose. Non-inferiority with respect to seroconversion rates for mumps 42-56 days after vaccination was concluded if the lower limit of the 95% CI around the difference in seroconversion rates between groups would be [–10%] or higher.
    Comparison groups
    Priorix-Tetra new WS Group v Priorix-Tetra current WS Group
    Number of subjects included in analysis
    471
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    -0.74
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -6.14
         upper limit
    		 5.58
    Statistical analysis title
    		 Priorix-Tetra New WS vs Priorix-Tetra Current WS
    Statistical analysis description
    Non-inferiority of GSK Biologicals’ MMRV new formulation vaccine (Priorix-Tetra new WS) compared to Priorix-Tetra current WS vaccine after the first dose in terms of anti-rubella seroconversion rates, 42 – 56 days after the first dose. Non-inferiority with respect to seroconversion rates for rubella 42-56 days after vaccination was concluded if the lower limit of the 95% CI around the difference in seroconversion rates between groups would be [–10%] or higher.
    Comparison groups
    Priorix-Tetra new WS Group v Priorix-Tetra current WS Group
    Number of subjects included in analysis
    471
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    -0.32
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.78
         upper limit
    		 2.08
    Statistical analysis title
    		 Priorix-Tetra New WS vs Priorix-Tetra Current WS
    Statistical analysis description
    Non-inferiority of GSK Biologicals’ MMRV new formulation vaccine (Priorix-Tetra new WS) compared to Priorix-Tetra current WS vaccine after the first dose in terms of anti-varicella seroconversion rates, 42 – 56 days after the first dose. Non-inferiority with respect to seroconversion rates for varicella 42-56 days after vaccination was concluded if the lower limit of the 95% CI around the difference in seroconversion rates between groups would be [–10%] or higher.
    Comparison groups
    Priorix-Tetra new WS Group v Priorix-Tetra current WS Group
    Number of subjects included in analysis
    471
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    4.69
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.72
         upper limit
    		 10.34

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

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    End point title
    		 Number of subjects seroconverted for measles, mumps, rubella and varicella antibodies >= the cut-off value
    End point description
    Seroconversion was defined as the appearance of antibodies 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.
    End point type
    Secondary
    End point timeframe
    At 42-56 days after the second dose of study vaccine (Week 18)
    End point values
    		 Priorix-Tetra new WS Group Priorix-Tetra current WS Group
    Number of subjects analysed
    308
    156
    Units: Subjects
        Anti-measles ≥ 150 mIU/mL
    308
    156
        Anti-mumps ≥ 231 U/ML
    307
    155
        Anti-rubella ≥ 4 IU/mL
    308
    156
        IgG varicella antibodies ≥ 1:4 dilution
    286
    138
    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
    At 42-56 days after the first and second dose of study vaccine(s)
    End point values
    		 Priorix-Tetra new WS Group Priorix-Tetra current WS Group
    Number of subjects analysed
    314
    157
    Units: Titres
    geometric mean (confidence interval 95%)
        Anti-Measles (mIU/mL); Dose 1 [N=314,157]
    3291.2 (3054 to 3546.8)
    3460.1 (3145.6 to 3806)
        Anti-Mumps (U/mL); Dose 1 [N=311, 157]
    924.4 (821.9 to 1039.7)
    994.4 (851.7 to 1161)
        Anti-Rubella (IU/mL); Dose 1 [N=314, 157]
    71.7 (66.1 to 77.9)
    66.6 (59.3 to 74.9)
        Anti-Varicella (1/dil); Dose 1 [N=291, 141]
    104.8 (90.8 to 120.9)
    69.6 (53.6 to 90.2)
        Anti-Measles (mIU/mL); Dose 2 [N= 308, 156]
    4247.6 (3911.5 to 4612.6)
    4297.1 (3867.9 to 4774)
        Anti-Mumps (U/mL); Dose 2 [N=307, 155]
    3379.5 (3121.3 to 3659)
    3216.2 (2870.9 to 3603)
        Anti-Rubella (IU/mL); Dose 2 [N= 308, 156]
    125.7 (117.4 to 134.5)
    115.2 (104.2 to 127.4)
        Anti-Varicella (1/dil); Dose 2 [N= 286, 138]
    6570.6 (5746.7 to 7512.7)
    5134.8 (4153.8 to 6347.4)
    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 = Cried 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 after each vaccination (Days 0-3)
    End point values
    		 Priorix-Tetra new WS Group Priorix-Tetra current WS Group
    Number of subjects analysed
    330
    166
    Units: Subjects
        Any Pain; Dose 1 [N=330, 166]
    62
    28
        Grade 3 Pain; Dose 1 [N=330, 166]
    0
    0
        Any Redness; Dose 1 [N=330, 166]
    92
    44
        Grade 3 Redness; Dose 1 [N=330, 166]
    2
    3
        Any Swelling; Dose 1 [N=330, 166]
    22
    11
        Grade 3 Swelling; Dose 1 [N=330, 166]
    0
    0
        Any Pain; Dose 2 [N=327, 164]
    46
    24
        Grade 3 Pain; Dose 2 [N=327, 164]
    0
    0
        Any Redness; Dose 2 [N=327, 164]
    79
    43
        Grade 3 Redness; Dose 2 [N=327, 164]
    4
    5
        Any Swelling; Dose 2 [N=327, 164]
    37
    25
        Grade 3 Swelling; Dose 2 [N=327, 164]
    1
    0
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects reporting any and grade 3 solicited general symptoms
    End point description
    Assessed solicited general symptoms were meningism and parotid gland swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 meningism and parotid gland swelling = meningism/parotid gland swelling which prevented normal everyday activities.
    End point type
    Secondary
    End point timeframe
    Within 43 days (Days 0-42) after each vaccination
    End point values
    		 Priorix-Tetra new WS Group Priorix-Tetra current WS Group
    Number of subjects analysed
    330
    166
    Units: Subjects
        Any Meningism; Dose 1 [N=330, 166]
    2
    1
        Grade 3 Meningism; Dose 1 [N=330, 166]
    0
    0
        Any Parotid gland; Dose 1 [N=330, 166]
    0
    0
        Grade 3 Parotid gland; Dose 1 [N=330, 166]
    0
    0
        Any Meningism; Dose 2 [N=327, 164]
    2
    0
        Grade 3 Meningism; Dose 2 [N=327, 164]
    1
    0
        Any Parotid gland; Dose 2 [N=327, 164]
    0
    0
        Grade 3 Parotid gland; Dose 2 [N=327, 164]
    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 greater than (>) 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
    Within 43 days (Days 0-42) after each vaccination
    End point values
    		 Priorix-Tetra new WS Group Priorix-Tetra current WS Group
    Number of subjects analysed
    330
    166
    Units: Subjects
        Any temperature; Dose 1 [N=330, 166]
    231
    104
        Grade 3 temperature; Dose 1 [N=330, 166]
    54
    23
        Related temperature; Dose 1 [N=330, 166]
    160
    70
        Any temperature; Dose 2 [N=327, 164]
    115
    62
        Grade 3 temperature; Dose 2 [N=327, 164]
    31
    13
        Related temperature; Dose 2 [N=327, 164]
    29
    28
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any (local or general), grade 3 and related rashes

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    End point title
    		 Number of subjects reporting any (local or general), grade 3 and related rashes
    End point description
    Rash was defined as: 1) measles/ rubella rashes (macular or maculo-papular rashes): presence of macules, discolored small patches or spots of the skin, neither elevated nor depressed below the skin’s surface; 2) varicella rash (maculo-papulo-vesicular): simultaneous presence of macules, papules and vesicles raised above the skin’s surface; 3) other types of rash (heat rash, diaper rash etc.). Any rash = occurrence of rash regardless of intensity grade or relationship to vaccination Grade 3 rash >= 150 lesions and Related = rash assessed by the investigator as related to the vaccination.
    End point type
    Secondary
    End point timeframe
    Within 43 days (Days 0-42) after each vaccination
    End point values
    		 Priorix-Tetra new WS Group Priorix-Tetra current WS Group
    Number of subjects analysed
    330
    166
    Units: Subjects
        Any, rash type; Dose 1 [N=330, 166]
    88
    42
        Grade 3 rash type; Dose 1 [N=330, 166]
    9
    6
        Related rash type; Dose 1 [N=330, 166]
    37
    23
        Any, rash type; Dose 2 [N=327, 164]
    40
    17
        Grade 3 rash type; Dose 2 [N=327, 164]
    6
    1
        Related rash type; Dose 2 [N=327, 164]
    12
    7
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any, grade 3 and related unsolicited adverse event (AEs)

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    End point title
    		 Number of subjects reporting any, grade 3 and related unsolicited adverse event (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. Also any ‘solicited’ symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. Grade 3 was defined as an event that prevented normal activity and Related was defined as an event assessed by the investigator as causally related to the study vaccination.
    End point type
    Secondary
    End point timeframe
    Within 43 days (Days 0-42) after first vaccination dose
    End point values
    		 Priorix-Tetra new WS Group Priorix-Tetra current WS Group
    Number of subjects analysed
    332
    166
    Units: Subjects
        Any AE(s)
    165
    73
        Grade 3 AE(s)
    8
    5
        Related AE(s)
    21
    8
    No statistical analyses for this end point

    Secondary: Number of subjects reporting any, grade 3 and related unsolicited adverse event (AEs)

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    End point title
    		 Number of subjects reporting any, grade 3 and related unsolicited adverse event (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. Also any ‘solicited’ symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. Grade 3 was defined as an event that prevented normal activity and Related was defined as an event assessed by the investigator as causally related to the study vaccination.
    End point type
    Secondary
    End point timeframe
    Within 43 days (Days 86-128) after second vaccination dose
    End point values
    		 Priorix-Tetra new WS Group Priorix-Tetra current WS Group
    Number of subjects analysed
    332
    166
    Units: Subjects
        Any AE(s)
    146
    76
        Grade 3 AE(s)
    6
    6
        Related AE(s)
    10
    6
    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 included medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject.
    End point type
    Secondary
    End point timeframe
    From first study dose (Day 0) until study end (Week 18)
    End point values
    		 Priorix-Tetra new WS Group Priorix-Tetra current WS Group
    Number of subjects analysed
    332
    166
    Units: Subjects
        Any SAE(s)
    27
    12
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited local symptoms were collected within 4 days after each vaccination.Solicited general symptoms & unsolicited AEs were collected within 43 days after each vaccination. SAEs were collected throughout the entire study period.
    Adverse event reporting additional description
    The number of occurrences reported for serious adverse events were not available for posting. The number of subjects affected by each specific event was indicated as the number of occurrences. The solicited local and general symptoms were only collected for those subjects who filled-in their symptom sheets.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.0
    Reporting groups
    Reporting group title
    Priorix-Tetra new WS Group
    Reporting group description
    		 Subjects received 2 doses of vaccine formulated with new measles and rubella working seeds at Day 0 and Week 12.

    Reporting group title
    Priorix-Tetra current WS Group
    Reporting group description
    		 Subjects received 2 doses of Priorix-Tetra vaccine manufactured with current working seed virus at Day 0 and Week 12

    Serious adverse events
    		 Priorix-Tetra new WS Group Priorix-Tetra current WS Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    27 / 332 (8.13%)
    12 / 166 (7.23%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Investigations
    Band neutrophil count increased
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 332 (0.00%)
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Head injury
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 332 (0.30%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Kawasaki’s disease
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 332 (0.30%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Febrile convulsion
    alternative assessment type: Non-systematic
         subjects affected / exposed
    4 / 332 (1.20%)
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Hypochromic anaemia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 332 (0.30%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Conjunctivitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 332 (0.00%)
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Enterocolitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 332 (0.60%)
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal discomfort
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 332 (0.30%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Constipation
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 332 (0.00%)
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastritis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 332 (0.00%)
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Balanoposthitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 332 (0.00%)
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Testicular retraction
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 332 (0.00%)
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 332 (0.30%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Dermatitis diaper
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 332 (0.00%)
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Bronchiolitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    4 / 332 (1.20%)
    4 / 166 (2.41%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute tonsillitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    4 / 332 (1.20%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 332 (0.60%)
    2 / 166 (1.20%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchopneumonia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 332 (0.60%)
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Croup infectious
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 332 (0.60%)
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpangina
    alternative assessment type: Non-systematic
         subjects affected / exposed
    2 / 332 (0.60%)
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Otitis media acute
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 332 (0.90%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    3 / 332 (0.90%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis salmonella
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 332 (0.30%)
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hand-foot-and-mouth disease
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 332 (0.30%)
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Adenovirus infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 332 (0.30%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis orbital
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 332 (0.00%)
    1 / 166 (0.60%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Encephalitis viral
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 332 (0.30%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Enterovirus infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 332 (0.30%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Exanthema subitum
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 332 (0.30%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis norovirus
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 332 (0.30%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pharyngitis
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 332 (0.30%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 332 (0.30%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper respiratory tract infection
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 332 (0.30%)
    0 / 166 (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
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 332 (0.30%)
    0 / 166 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Viral rash
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 332 (0.30%)
    0 / 166 (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
    Hypovolaemia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 332 (0.00%)
    1 / 166 (0.60%)
         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
    		 Priorix-Tetra new WS Group Priorix-Tetra current WS Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    246 / 332 (74.10%)
    117 / 166 (70.48%)
    General disorders and administration site conditions
    Pain; Dose 1
         subjects affected / exposed [1]
    62 / 330 (18.79%)
    28 / 166 (16.87%)
         occurrences all number
    62
    28
    Redness; Dose 1
         subjects affected / exposed [2]
    92 / 330 (27.88%)
    44 / 166 (26.51%)
         occurrences all number
    92
    44
    Swelling; Dose 1
         subjects affected / exposed [3]
    22 / 330 (6.67%)
    11 / 166 (6.63%)
         occurrences all number
    22
    11
    Pain; Dose 2
         subjects affected / exposed [4]
    46 / 327 (14.07%)
    24 / 164 (14.63%)
         occurrences all number
    46
    24
    Redness; Dose 2
         subjects affected / exposed [5]
    79 / 327 (24.16%)
    43 / 164 (26.22%)
         occurrences all number
    79
    43
    Swelling; Dose 2
         subjects affected / exposed [6]
    37 / 327 (11.31%)
    25 / 164 (15.24%)
         occurrences all number
    37
    25
    Gastrointestinal disorders
    Diarrhoea; Dose 1
    alternative assessment type: Non-systematic
         subjects affected / exposed
    17 / 332 (5.12%)
    11 / 166 (6.63%)
         occurrences all number
    17
    11
    Respiratory, thoracic and mediastinal disorders
    Rhinorrhoea; Dose 1
    alternative assessment type: Non-systematic
         subjects affected / exposed
    31 / 332 (9.34%)
    10 / 166 (6.02%)
         occurrences all number
    31
    10
    Cough; Dose 1
    alternative assessment type: Non-systematic
         subjects affected / exposed
    24 / 332 (7.23%)
    10 / 166 (6.02%)
         occurrences all number
    24
    10
    Cough; Dose 2
    alternative assessment type: Non-systematic
         subjects affected / exposed
    24 / 332 (7.23%)
    12 / 166 (7.23%)
         occurrences all number
    24
    12
    Rhinorrhoea; Dose 2
    alternative assessment type: Non-systematic
         subjects affected / exposed
    24 / 332 (7.23%)
    10 / 166 (6.02%)
         occurrences all number
    24
    10
    Skin and subcutaneous tissue disorders
    Rash; Dose 1
    alternative assessment type: Non-systematic
         subjects affected / exposed [7]
    88 / 330 (26.67%)
    42 / 166 (25.30%)
         occurrences all number
    88
    42
    Rash; Dose 2
    alternative assessment type: Non-systematic
         subjects affected / exposed [8]
    40 / 327 (12.23%)
    17 / 164 (10.37%)
         occurrences all number
    40
    17
    Infections and infestations
    Fever; Dose 1
    alternative assessment type: Non-systematic
         subjects affected / exposed [9]
    231 / 330 (70.00%)
    104 / 166 (62.65%)
         occurrences all number
    231
    104
    Fever; Dose 2
    alternative assessment type: Non-systematic
         subjects affected / exposed [10]
    115 / 327 (35.17%)
    62 / 164 (37.80%)
         occurrences all number
    115
    62
    Upper respiratory tract infection; Dose 1
    alternative assessment type: Non-systematic
         subjects affected / exposed
    50 / 332 (15.06%)
    22 / 166 (13.25%)
         occurrences all number
    50
    22
    Upper respiratory tract infection; Dose 2
    alternative assessment type: Non-systematic
         subjects affected / exposed
    30 / 332 (9.04%)
    31 / 166 (18.67%)
         occurrences all number
    30
    31
    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: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets 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: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets 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: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets 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: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
    [5] - 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: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
    [6] - 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: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
    [7] - 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: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
    [8] - 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: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
    [9] - 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: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets completed.
    [10] - 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: The analysis was performed on the Total vaccinated cohort, only on subjects with their symptom sheets 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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