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    Clinical Trial Results:
    A phase IIIb, open, randomised, multicentre, primary study in healthy children, to establish the non-inferiority of GlaxoSmithKline (GSK) Biologicals’ MeMuRu-OKA vaccine (administered at 9 and 15 months of age) versus Priorix™ (9 months of age) and Priorix™ co-administered with Varilrix™ at 15 months of age (comparator) and also to evaluate the non-inferiority of Priorix™ (9 months of age) and MeMuRu-OKA vaccine (15 months of age) versus the comparator, all administered subcutaneously as two-dose primary vaccination course

    Summary
    EudraCT number
    		 2011-005882-19
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    21 Feb 2011

    Results information
    Results version number
    		 v2(current)
    This version publication date
    24 May 2023
    First version publication date
    29 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
    109995
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00969436
    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
    07 Oct 2011
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    21 Feb 2011
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Feb 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    • To demonstrate the non-inferiority of two doses of GSK Biologicals’ measles-mumps-rubella-varicella vaccine (MeMuRu-OKA) compared to Priorix followed by Priorix co-administered with Varilrix (the current standard of care in India) in terms of measles, mumps, rubella and varicella seroconversion rates, 42 – 56 days after the second dose. • To demonstrate the non-inferiority of GSK Biologicals’ Priorix followed by MeMuRu-OKA vaccine compared to Priorix followed by Priorix co-administered with Varilrix (the current standard of care in India) in terms of measles, mumps, rubella and varicella seroconversion rates, 42 – 56 days after the second dose.
    Protection of trial subjects
    All subjects were supervised for at least 30 min after vaccination/product administration with appropriate medical treatment readily available in case of a rare anaphylactic reaction following the administration of vaccines. Vaccines/products were administered by qualified and trained personnel.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    09 Nov 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
    India: 450
    Worldwide total number of subjects
    450
    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)
    450
    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
    		 Priorix-Tetra Group
    Arm description
    		 Subjects received 2 doses of Priorix-Tetra vaccine, 1 at Day 0 and 1 at Month 6, administered subcutaneously in the left anterolateral thigh.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Priorix-Tetra
    Investigational medicinal product code
    Other name
    MMRV
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Priorix-Tetra vaccine was administered subcutaneously in the left anterolateral thigh.

    Arm title
    		 Priorix/Priorix-Tetra Group
    Arm description
    		 Subjects received 1 dose of Priorix vaccine at Day 0 and 1 dose of Priorix-Tetra vaccine at Month 6, both administered subcutaneously in the left anterolateral thigh.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Priorix
    Investigational medicinal product code
    Other name
    MMR
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Priorix vaccine was administered subcutaneously in the left anterolateral thigh.

    Investigational medicinal product name
    Priorix-Tetra
    Investigational medicinal product code
    Other name
    MMRV
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Priorix-Tetra vaccine was administered subcutaneously in the left anterolateral thigh.

    Arm title
    		 Control Group
    Arm description
    		 Subjects received 1 dose of Priorix vaccine at Day 0 and 1 dose of Priorix vaccine co-administered with Varilrix vaccine at Month 6, administered subcutaneously in the left and right anterolateral thigh.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Priorix
    Investigational medicinal product code
    Other name
    MMR
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Priorix vaccine was administered subcutaneously in the left anterolateral thigh.

    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
    Varilrix vaccine was administered subcutaneously in the right anterolateral thigh.

    Number of subjects in period 1
    		Priorix-Tetra Group Priorix/Priorix-Tetra Group Control Group
    Started
    180
    180
    90
    Completed
    155
    159
    79
    Not completed
    25
    21
    11
         Consent withdrawn by subject
    3
    -
    2
         Parents personal problem
    -
    -
    1
         Migrated/moved from study area
    12
    10
    2
         Subject took other vaccine hence eliminated
    1
    -
    -
         Lost to follow-up
    8
    8
    5
         Father was admitted in serious health problem
    -
    -
    1
         Protocol deviation
    1
    3
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Priorix-Tetra Group
    Reporting group description
    		 Subjects received 2 doses of Priorix-Tetra vaccine, 1 at Day 0 and 1 at Month 6, administered subcutaneously in the left anterolateral thigh.

    Reporting group title
    Priorix/Priorix-Tetra Group
    Reporting group description
    		 Subjects received 1 dose of Priorix vaccine at Day 0 and 1 dose of Priorix-Tetra vaccine at Month 6, both administered subcutaneously in the left anterolateral thigh.

    Reporting group title
    Control Group
    Reporting group description
    		 Subjects received 1 dose of Priorix vaccine at Day 0 and 1 dose of Priorix vaccine co-administered with Varilrix vaccine at Month 6, administered subcutaneously in the left and right anterolateral thigh.

    Reporting group values
    		 Priorix-Tetra Group Priorix/Priorix-Tetra Group Control Group Total
    Number of subjects
    		 180 180 90 450
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 180 180 90 450
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 0 0 0 0
        From 65-84 years
    		 0 0 0 0
        85 years and over
    		 0 0 0 0
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    		 9 ± 0 9 ± 0.11 9 ± 0 -
    Gender categorical
    Units: Subjects
        Female
    		 79 89 49 217
        Male
    		 101 91 41 233
    Race/Ethnicity
    Units: Subjects
        Asian - central/south Asian heritage
    		 177 175 88 440
        Asian - south east Asian heritage
    		 2 5 2 9
        American Indian or Alaskan native
    		 1 0 0 1

    End points

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    End points reporting groups
    Reporting group title
    Priorix-Tetra Group
    Reporting group description
    		 Subjects received 2 doses of Priorix-Tetra vaccine, 1 at Day 0 and 1 at Month 6, administered subcutaneously in the left anterolateral thigh.

    Reporting group title
    Priorix/Priorix-Tetra Group
    Reporting group description
    		 Subjects received 1 dose of Priorix vaccine at Day 0 and 1 dose of Priorix-Tetra vaccine at Month 6, both administered subcutaneously in the left anterolateral thigh.

    Reporting group title
    Control Group
    Reporting group description
    		 Subjects received 1 dose of Priorix vaccine at Day 0 and 1 dose of Priorix vaccine co-administered with Varilrix vaccine at Month 6, administered subcutaneously in the left and right anterolateral thigh.

    Primary: Number of subjects seroconverted for measles, mumps, rubella and varicella antibodies

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    End point title
    		 Number of subjects seroconverted for measles, mumps, rubella and varicella antibodies
    End point description
    Seroconversion was defined as the appearance of antibodies [i.e. concentration/titre greater than or equal to (≥) the cut-off value] 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 for immunoglobulin G (IgG) varicella antibodies 1:4 dilution for measles, mumps, rubella and varicella, respectively.
    End point type
    Primary
    End point timeframe
    At 42 – 56 days after the second vaccination dose at week 30
    End point values
    		 Priorix-Tetra Group Priorix/Priorix-Tetra Group Control Group
    Number of subjects analysed
    150
    153
    73
    Units: Subjects
        Anti-measles ≥ 150 mIU/mL [N=149, 153, 72]
    149
    153
    72
        Anti-mumps ≥ 231 U/ML [N=149, 152, 72]
    149
    152
    72
        Anti-rubella ≥ 4 IU/mL [N=150, 152, 73]
    150
    152
    73
        IgG varicella antibodies ≥ 1:4 [N= 138, 143, 72]
    138
    141
    69
    Statistical analysis title
    		 Non-inferiority of 2 doses MMRV vs Control group
    Statistical analysis description
    Non-inferiority of 2 doses of MMRV vaccine compared to MMR vaccine followed by MMR vaccine co-administered with V vaccine in terms of anti-measles seroconversion rates. Non-inferiority with respect to seroconversion rates for measles 42-56 days after second vaccination dose was concluded if the lower limit (LL) of the two-sided standardised asymptotic 95% CI on the difference in the seroconversion rates between the two groups (MMRV Group minus Control Group) was greater than or equal to -10%.
    Comparison groups
    Priorix-Tetra Group v Control Group
    Number of subjects included in analysis
    223
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.52
         upper limit
    		 5.09
    Statistical analysis title
    		 Non-inferiority of 2 doses MMRV vs Control group
    Statistical analysis description
    Non-inferiority of 2 doses of MMRV vaccine compared to MMR vaccine followed by MMR vaccine co-administered with V vaccine in terms of anti-mumps seroconversion rates. Non-inferiority with respect to seroconversion rates for mumps 42-56 days after second vaccination dose was concluded if the LL of the two-sided standardised asymptotic 95% CI on the difference in the seroconversion rates between the two groups (MMRV Group minus Control Group) was greater than or equal to -10%.
    Comparison groups
    Control Group v Priorix-Tetra Group
    Number of subjects included in analysis
    223
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.52
         upper limit
    		 5.09
    Statistical analysis title
    		 Non-inferiority of 2 doses MMRV vs Control group
    Statistical analysis description
    Non-inferiority of 2 doses of MMRV vaccine compared to MMR vaccine followed by MMR vaccine co-administered with V vaccine in terms of anti-rubella seroconversion rates. Non-inferiority with respect to seroconversion rates for rubella 42-56 days after second vaccination dose was concluded if the LL of the two-sided standardised asymptotic 95% CI on the difference in the seroconversion rates between the two groups (MMRV Group minus Control Group) was greater than or equal to -10%.
    Comparison groups
    Priorix-Tetra Group v Control Group
    Number of subjects included in analysis
    223
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.51
         upper limit
    		 5.02
    Statistical analysis title
    		 Non-inferiority of 2 doses MMRV vs Control group
    Statistical analysis description
    Non-inferiority of 2 doses of MMRV vaccine compared to MMR vaccine followed by MMR vaccine co-administered with V vaccine in terms of anti-varicella seroconversion rates. Non-inferiority with respect to seroconversion rates for varicella 42-56 days after second vaccination dose was concluded if the LL of the two-sided standardised asymptotic 95% CI on the difference in the seroconversion rates between the two groups (MMRV Group minus Control Group) was greater than or equal to -10%.
    Comparison groups
    Priorix-Tetra Group v Control Group
    Number of subjects included in analysis
    223
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    4.17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.37
         upper limit
    		 11.57
    Statistical analysis title
    		 Non-inferiority of MMR/MMRV vs Control group
    Statistical analysis description
    Non-inferiority of MMR vaccine followed by MMRV vaccine compared to MMR vaccine followed by MMR vaccine co-administered with V vaccine in terms of anti-measles seroconversion rates. Non-inferiority with respect to seroconversion rates for measles 42-56 days after second vaccination dose was concluded if the LL of the 2-sided standardised asymptotic 95% CI on the difference in the seroconversion rates between the 2 groups (MMR/MMRV Group minus Control Group) was ≥ -10%.
    Comparison groups
    Control Group v Priorix/Priorix-Tetra Group
    Number of subjects included in analysis
    226
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.46
         upper limit
    		 5.09
    Statistical analysis title
    		 Non-inferiority of MMR/MMRV vs Control group
    Statistical analysis description
    Non-inferiority of MMR vaccine followed by MMRV vaccine compared to MMR vaccine followed by MMR vaccine co-administered with V vaccine in terms of anti-mumps seroconversion rates. Non-inferiority with respect to seroconversion rates for mumps 42-56 days after second vaccination dose was concluded if the LL of the 2-sided standardised asymptotic 95% CI on the difference in the seroconversion rates between the 2 groups (MMR/MMRV Group minus Control Group) was ≥ -10%.
    Comparison groups
    Control Group v Priorix/Priorix-Tetra Group
    Number of subjects included in analysis
    226
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.48
         upper limit
    		 5.09
    Statistical analysis title
    		 Non-inferiority of MMR/MMRV vs Control group
    Statistical analysis description
    Non-inferiority of MMR vaccine followed by MMRV vaccine compared to MMR vaccine followed by MMR vaccine co-administered with V vaccine in terms of anti-rubella seroconversion rates. Non-inferiority with respect to seroconversion rates for rubella 42-56 days after second vaccination dose was concluded if the LL of the 2-sided standardised asymptotic 95% CI on the difference in the seroconversion rates between the 2 groups (MMR/MMRV Group minus Control Group) was ≥ -10%.
    Comparison groups
    Priorix/Priorix-Tetra Group v Control Group
    Number of subjects included in analysis
    226
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.48
         upper limit
    		 5.02
    Statistical analysis title
    		 Non-inferiority of MMR/MMRV vs Control group
    Statistical analysis description
    Non-inferiority of MMR vaccine followed by MMRV vaccine compared to MMR vaccine followed by MMR vaccine co-administered with V vaccine in terms of anti-varicella seroconversion rates. Non-inferiority with respect to seroconversion rates for varicella 42-56 days after second vaccination dose was concluded if the LL of the 2-sided standardised asymptotic 95% CI on the difference in the seroconversion rates between the 2 groups (MMR/MMRV Group minus Control Group) was ≥ -10%.
    Comparison groups
    Priorix/Priorix-Tetra Group v Control Group
    Number of subjects included in analysis
    226
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    2.77
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.59
         upper limit
    		 10.29

    Secondary: Number of seroconverted subjects for measles, mumps, rubella and varicella antibodies

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    End point title
    		 Number of seroconverted subjects for measles, mumps, rubella and varicella antibodies
    End point description
    Seroconversion was defined as the appearance of antibodies (i.e. concentration/titre ≥ 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 for IgG varicella antibodies 1:4 dilution for measles, mumps, rubella and varicella, respectively.
    End point type
    Secondary
    End point timeframe
    Approximately 42 to 56 days after the first vaccine dose at week 6
    End point values
    		 Priorix-Tetra Group Priorix/Priorix-Tetra Group Control Group
    Number of subjects analysed
    149
    153
    73
    Units: Subjects
        Anti-measles ≥ 150 mIU/mL [N= 148, 153, 72]
    138
    135
    63
        Anti-mumps ≥ 231 U/ML [N= 144, 152, 72]
    124
    128
    60
        Anti-rubella ≥ 4 IU/mL [N= 149, 152, 73]
    147
    151
    73
        IgG varicella antibodies ≥ 1:4 [N= 138, 142, 72]
    130
    4
    1
    No statistical analyses for this end point

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

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    End point title
    		 Antibody concentrations against measles, mumps, rubella and varicella viruses
    End point description
    Antibody concentrations were summarized by geometric mean concentrations (GMCs) with their 95% confidence intervals (CIs).
    End point type
    Secondary
    End point timeframe
    At 42 – 56 days after the first (at Week 6) and second (at Week 30) vaccination dose
    End point values
    		 Priorix-Tetra Group Priorix/Priorix-Tetra Group Control Group
    Number of subjects analysed
    150
    153
    73
    Units: mIU/mL
    geometric mean (confidence interval 95%)
        Anti-measles; W6 [N= 148, 153, 72]
    2013.6 (1662.2 to 2439.3)
    1180.4 (963 to 1446.7)
    1200 (887.9 to 1621.8)
        Anti-mumps; W6 [N= 144, 152, 72]
    991.9 (819.7 to 1200.3)
    746.6 (628 to 887.6)
    775.1 (600.9 to 999.7)
        Anti-rubella; W6 [N= 149, 152, 73]
    45.4 (38.3 to 53.7)
    63.8 (55.9 to 72.8)
    62 (51.3 to 74.9)
        IgG varicella antibodies; W6 [N= 138, 142, 72]
    120.5 (90.8 to 160)
    2.2 (2 to 2.4)
    2.2 (1.8 to 2.6)
        Anti-measles; W30 [N=149, 153, 72]
    4471.3 (3975.3 to 5029.2)
    3358.7 (3017.5 to 3738.4)
    2495 (2064.5 to 3015.2)
        Anti-mumps; W30 [N=149, 152, 72]
    6428 (5774.9 to 7154.9)
    10108.5 (9223.9 to 11078)
    4925.3 (4200.9 to 5774.7)
        Anti-rubella; W30 [N=150, 152, 73]
    148.4 (136.1 to 161.8)
    164.8 (152.1 to 178.6)
    173 (153 to 195.6)
        IgG varicella antibodies; W30 [N= 138, 143, 72]
    5318.5 (4318.7 to 6549.8)
    198 (158.2 to 247.7)
    128 (91.7 to 178.7)
    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
    During the 4-day (Days 0-3) post-vaccination period following each dose (Dose 1 and Dose 2)
    End point values
    		 Priorix-Tetra Group Priorix/Priorix-Tetra Group Control Group
    Number of subjects analysed
    174
    172
    84
    Units: Subjects
        Any Pain; Dose 1 [N= 174, 172, 84]
    20
    12
    9
        Grade 3 Pain; Dose 1 [N= 174, 172, 84]
    0
    0
    0
        Any Redness; Dose 1 [N= 174, 172, 84]
    15
    8
    3
        Grade 3 Redness; Dose 1 [N= 174, 172, 84]
    0
    0
    0
        Any Swelling; Dose 1 [N= 174, 172, 84]
    8
    5
    3
        Grade 3 Swelling; Dose 1 [N= 174, 172, 84]
    0
    0
    0
        Any Pain; Dose 2 [N= 155, 159, 79]
    9
    10
    3
        Grade 3 Pain; Dose 2 [N= 155, 159, 79]
    0
    0
    0
        Any Redness; Dose 2 [N= 155, 159, 79]
    10
    6
    0
        Grade 3 Redness; Dose 2 [N= 155, 159, 79]
    3
    0
    0
        Any Swelling; Dose 2 [N= 155, 159, 79]
    9
    6
    0
        Grade 3 Swelling; Dose 2 [N= 155, 159, 79]
    0
    0
    0
    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 meningism and parotid gland swelling. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 (G3) meningism and parotid gland swelling = meningism/parotid gland swelling which prevented normal everyday activities. Related (Rel) = symptom assessed by the investigator as related to the vaccination.
    End point type
    Secondary
    End point timeframe
    During the 43-day (Days 0-42) post-vaccination period following each dose (Dose 1 and Dose 2)
    End point values
    		 Priorix-Tetra Group Priorix/Priorix-Tetra Group Control Group
    Number of subjects analysed
    174
    172
    83
    Units: Subjects
        Any Meningism; D1 [N= 174, 172, 83]
    0
    0
    0
        G3 Meningism; D1 [N= 174, 172, 83]
    0
    0
    0
        Rel Meningism; D1 [N= 174, 172, 83]
    0
    0
    0
        Any Parotid gland swelling; D1 [N= 174, 172, 83]
    0
    0
    0
        G3 Parotid gland swelling; D1 [N= 174, 172, 83]
    0
    0
    0
        Rel Parotid gland swelling; D1 [N= 174, 172, 83]
    0
    0
    0
        Any Meningism; D2 [N= 155, 159, 79]
    0
    0
    0
        G3 Meningism; D2 [N= 155, 159, 79]
    0
    0
    0
        Rel Meningism; D2 [N= 155, 159, 79]
    0
    0
    0
        Any Parotid gland swelling; D2 [N= 155, 159, 79]
    0
    0
    0
        G3 Parotid gland swelling; D2 [N= 155, 159, 79]
    0
    0
    0
        Rel Parotid gland swelling; D2 [N= 155, 159, 79]
    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 43-day (Days 0-42) post-vaccination period following each dose (Dose 1 and Dose 2)
    End point values
    		 Priorix-Tetra Group Priorix/Priorix-Tetra Group Control Group
    Number of subjects analysed
    174
    172
    83
    Units: Subjects
        Any temperature; Dose 1 [N= 174, 172, 83]
    76
    70
    27
        Grade 3 temperature; Dose 1 [N= 174, 172, 83]
    11
    5
    1
        Related temperature; Dose 1 [N= 174, 172, 83]
    53
    48
    15
        Any temperature; Dose 2 [N= 155, 159, 79]
    41
    37
    22
        Grade 3 temperature; Dose 2 [N= 155, 159, 79]
    2
    6
    2
        Related temperature; Dose 2 [N= 155, 159, 79]
    22
    21
    10
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects reporting any, grade 3 and related rash
    End point description
    Any rash was defined as incidence of a rash regardless of intensity grade or relationship to vaccination and grade 3 rash greater than (>) 150 lesions. Related rash was defined as rash 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 following each dose (Dose 1 and Dose 2)
    End point values
    		 Priorix-Tetra Group Priorix/Priorix-Tetra Group Control Group
    Number of subjects analysed
    174
    172
    83
    Units: Subjects
        Any Rash; Dose 1 [N= 174, 172, 83]
    1
    2
    1
        Grade 3 Rash; Dose 1 [N= 174, 172, 83]
    0
    0
    0
        Related Rash; Dose 1 [N= 174, 172, 83]
    1
    0
    0
        Any Rash; Dose 2 [N= 155, 159, 79]
    0
    1
    0
        Grade 3 Rash; Dose 2 [N= 155, 159, 79]
    0
    0
    0
        Related Rash; Dose 2 [N= 155, 159, 79]
    0
    0
    0
    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 adverse event (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 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-day (Days 0-42) after the first and second vaccination dose
    End point values
    		 Priorix-Tetra Group Priorix/Priorix-Tetra Group Control Group
    Number of subjects analysed
    180
    180
    90
    Units: Subjects
        Any AE(s); Dose 1
    37
    39
    18
        Any AE(s); Dose 2
    19
    18
    11
    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
    From the first study dose up to study end (Month 0 to Month 7.5 approximately)
    End point values
    		 Priorix-Tetra Group Priorix/Priorix-Tetra Group Control Group
    Number of subjects analysed
    180
    180
    90
    Units: Subjects
        Any SAE(s)
    7
    6
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited local and general symptoms were collected during the 4-day and 43-day after each vaccination dose, respectively. Unsolicited AEs were collected during the 43-day after each vaccination dose. SAEs were collected from Month 0 to Month 7.5.
    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
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.0
    Reporting groups
    Reporting group title
    Priorix-Tetra Group
    Reporting group description
    		 Subjects received 2 doses of Priorix-Tetra vaccine, 1 at Day 0 and 1 at Month 6, administered subcutaneously in the left anterolateral thigh.

    Reporting group title
    Priorix/Priorix-Tetra Group
    Reporting group description
    		 Subjects received 1 dose of Priorix vaccine at Day 0 and 1 dose of Priorix-Tetra vaccine at Month 6, both administered subcutaneously in the left anterolateral thigh.

    Reporting group title
    Control Group
    Reporting group description
    		 Subjects received 1 dose of Priorix vaccine at Day 0 and 1 dose of Priorix vaccine co-administered with Varilrix vaccine at Month 6, administered subcutaneously in the left and right anterolateral thigh.

    Serious adverse events
    		 Priorix-Tetra Group Priorix/Priorix-Tetra Group Control Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 180 (3.89%)
    6 / 180 (3.33%)
    0 / 90 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Nervous system disorders
    Febrile convulsion
         subjects affected / exposed
    0 / 180 (0.00%)
    1 / 180 (0.56%)
    0 / 90 (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
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    1 / 180 (0.56%)
    0 / 180 (0.00%)
    0 / 90 (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
    Respiratory, thoracic and mediastinal disorders
    Pneumonitis
         subjects affected / exposed
    1 / 180 (0.56%)
    0 / 180 (0.00%)
    0 / 90 (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
    Upper respiratory tract inflammation
         subjects affected / exposed
    0 / 180 (0.00%)
    1 / 180 (0.56%)
    0 / 90 (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
    Wheezing
         subjects affected / exposed
    1 / 180 (0.56%)
    0 / 180 (0.00%)
    0 / 90 (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
    Infections and infestations
    Gastroenteritis
         subjects affected / exposed
    2 / 180 (1.11%)
    3 / 180 (1.67%)
    0 / 90 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    2 / 180 (1.11%)
    1 / 180 (0.56%)
    0 / 90 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Viral infection
         subjects affected / exposed
    1 / 180 (0.56%)
    1 / 180 (0.56%)
    0 / 90 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Bronchiolitis
         subjects affected / exposed
    0 / 180 (0.00%)
    1 / 180 (0.56%)
    0 / 90 (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
    Pneumonia
         subjects affected / exposed
    0 / 180 (0.00%)
    1 / 180 (0.56%)
    0 / 90 (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
         subjects affected / exposed
    0 / 180 (0.00%)
    1 / 180 (0.56%)
    0 / 90 (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
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Priorix-Tetra Group Priorix/Priorix-Tetra Group Control Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    114 / 180 (63.33%)
    116 / 180 (64.44%)
    55 / 90 (61.11%)
    General disorders and administration site conditions
    Pain; Dose 1
    alternative assessment type: Systematic
         subjects affected / exposed
    20 / 180 (11.11%)
    12 / 180 (6.67%)
    9 / 90 (10.00%)
         occurrences all number
    20
    12
    9
    Redness; Dose 1
    alternative assessment type: Systematic
         subjects affected / exposed [1]
    15 / 174 (8.62%)
    8 / 172 (4.65%)
    3 / 84 (3.57%)
         occurrences all number
    15
    8
    3
    Pain; Dose 2
    alternative assessment type: Systematic
         subjects affected / exposed [2]
    9 / 155 (5.81%)
    10 / 159 (6.29%)
    3 / 79 (3.80%)
         occurrences all number
    9
    10
    3
    Redness; Dose 2
    alternative assessment type: Systematic
         subjects affected / exposed [3]
    10 / 155 (6.45%)
    6 / 159 (3.77%)
    0 / 79 (0.00%)
         occurrences all number
    10
    6
    0
    Swelling; Dose 2
    alternative assessment type: Systematic
         subjects affected / exposed [4]
    9 / 155 (5.81%)
    6 / 159 (3.77%)
    0 / 79 (0.00%)
         occurrences all number
    9
    6
    0
    Fever; Dose 1
    alternative assessment type: Systematic
         subjects affected / exposed [5]
    76 / 174 (43.68%)
    70 / 172 (40.70%)
    27 / 83 (32.53%)
         occurrences all number
    76
    70
    27
    Fever; Dose 2
    alternative assessment type: Systematic
         subjects affected / exposed [6]
    41 / 155 (26.45%)
    37 / 159 (23.27%)
    22 / 79 (27.85%)
         occurrences all number
    41
    37
    22
    Respiratory, thoracic and mediastinal disorders
    Cough; Dose 1
         subjects affected / exposed
    6 / 180 (3.33%)
    10 / 180 (5.56%)
    6 / 90 (6.67%)
         occurrences all number
    6
    10
    6
    Infections and infestations
    Rhinitis; Dose 1
         subjects affected / exposed
    7 / 180 (3.89%)
    9 / 180 (5.00%)
    6 / 90 (6.67%)
         occurrences all number
    7
    9
    6
    Nasopharyngitis; Dose 1
         subjects affected / exposed
    4 / 180 (2.22%)
    8 / 180 (4.44%)
    6 / 90 (6.67%)
         occurrences all number
    4
    8
    6
    Upper respiratory tract infection; Dose 1
         subjects affected / exposed
    10 / 180 (5.56%)
    7 / 180 (3.89%)
    1 / 90 (1.11%)
         occurrences all number
    10
    7
    1
    Rhinitis; Dose 2
         subjects affected / exposed
    6 / 180 (3.33%)
    7 / 180 (3.89%)
    5 / 90 (5.56%)
         occurrences all number
    6
    7
    5
    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 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 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 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 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: 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 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: 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 completed).

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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