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    Clinical Trial Results:
    A phase III, open-label, randomised multicentre study to evaluate the immunogenicity and safety of a booster dose of GlaxoSmithKline Biologicals’ dTpa-IPV vaccine (Boostrix Polio) compared with Sanofi Pasteur MSD’s dTpa-IPV vaccine (Repevax), when co-administered with GSK Biologicals’ MMR vaccine (Priorix) in 3 and 4-year-old healthy children.

    Summary
    EudraCT number
    		 2009-012202-39
    Trial protocol
    		 GB  
    Global end of trial date

    Results information
    Results version number
    		 v3(current)
    This version publication date
    02 Apr 2023
    First version publication date
    06 Jun 2015
    Other versions
    		 v1 , v2
    Version creation reason

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    111763
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01245049
    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, 0044 2089904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 0044 2089904466, GSKClinicalSupportHD@gsk.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000500-PIP01-08
    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
    Interim
    Date of interim/final analysis
    27 Mar 2012
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    27 Mar 2012
    Global end of trial reached?
    No
    General information about the trial
    Main objective of the trial
    • To demonstrate that GSK Biologicals’ dTpa-IPV vaccine is non-inferior to Sanofi Pasteur MSD’s dTpa-IPV vaccine in terms of percentages of subjects with immune response to the diphtheria, tetanus and polio antigens, one month after booster vaccination. • To demonstrate that GSK Biologicals’ dTpa-IPV vaccine given as a single booster dose in this study is non-inferior to GSK Biologicals’ DTPa vaccine (Infanrix) given as a primary series in the German household contact study APV-039 in terms of anti-PT, anti-FHA and anti-PRN geometric mean concentrations (GMCs), one month after booster vaccination.
    Protection of trial subjects
    The vaccine was administered with caution to subjects with thrombocytopenia or a bleeding disorder since bleeding may have occurred following an intramuscular administration to these subjects. Firm pressure was applied to the injection site (without rubbing) for at least two minutes.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    06 Apr 2011
    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
    United Kingdom: 385
    Worldwide total number of subjects
    385
    EEA total number of subjects
    385
    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)
    0
    Children (2-11 years)
    385
    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
    		 2 subjects did not receive vaccination.

    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
    		 Boostrix Polio Group
    Arm description
    		 Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix and Polio vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix Polio vaccine co-administered with Priorix vaccine at Day 0. Boostrix Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Priorix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 dose of Boostrix Polio co-administered with Priorix.

    Investigational medicinal product name
    Boostrix Polio
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 dose of Boostrix Polio co-administered with Priorix.

    Arm title
    		 Repevax Group
    Arm description
    		 Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix and Polio vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax vaccine co-administered with Priorix vaccine at Day 0. Repevax vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Priorix
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 dose of Repevax co-administered with Priorix.

    Investigational medicinal product name
    Repevax
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 dose of Repevax Polio co-administered with Priorix.

    Number of subjects in period 1
    		Boostrix Polio Group Repevax Group
    Started
    255
    130
    Completed
    254
    126
    Not completed
    1
    4
         Consent withdrawn by subject
    -
    1
         Lost to follow-up
    -
    2
         Migrated/moved from study area
    -
    1
         Lost to follow-up
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Boostrix Polio Group
    Reporting group description
    		 Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix and Polio vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix Polio vaccine co-administered with Priorix vaccine at Day 0. Boostrix Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm.

    Reporting group title
    Repevax Group
    Reporting group description
    		 Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix and Polio vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax vaccine co-administered with Priorix vaccine at Day 0. Repevax vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm.

    Reporting group values
    		 Boostrix Polio Group Repevax Group Total
    Number of subjects
    		 255 130 385
    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)
    		 0 0 0
        Children (2-11 years)
    		 255 130 385
        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: years
        arithmetic mean (standard deviation)
    		 3.1 ( 0.2 ) 3.1 ( 0.2 ) -
    Gender categorical
    Units: Subjects
        Female
    		 123 65 188
        Male
    		 132 65 197

    End points

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    End points reporting groups
    Reporting group title
    Boostrix Polio Group
    Reporting group description
    		 Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix and Polio vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix Polio vaccine co-administered with Priorix vaccine at Day 0. Boostrix Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm.

    Reporting group title
    Repevax Group
    Reporting group description
    		 Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix and Polio vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax vaccine co-administered with Priorix vaccine at Day 0. Repevax vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm.

    Primary: Number of subjects with a booster response to diphtheria (D) and tetanus (T) antibodies

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    End point title
    		 Number of subjects with a booster response to diphtheria (D) and tetanus (T) antibodies
    End point description
    Booster response was defined as: For initially seronegative subjects [i.e. pre-vaccination concentration below (<) cut-off value of 0.1 international units per milliliter (IU/mL)], antibody concentrations at least four times the assay cut-off [post vaccination concentration greater than or equal to (≥) 0.4 IU/ml]; For initially seropositive subjects (pre-vaccination concentration ≥ 0.1 IU/ml), an increase in antibody concentrations of at least four times the Pre booster vaccination concentration.
    End point type
    Primary
    End point timeframe
    At Month 1, one month after the booster vaccination
    End point values
    		 Boostrix Polio Group Repevax Group
    Number of subjects analysed
    177
    90
    Units: Subject
        Anti-D [N=177;90]
    176
    90
        Anti-T [N=176;90]
    173
    90
    Statistical analysis title
    		 Non-inferiority in terms of booster response to D
    Comparison groups
    Repevax Group v Boostrix Polio Group
    Number of subjects included in analysis
    267
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    Method
    		 Standardized asymptotic
    Parameter type
    		 Percentage difference
    Point estimate
    0.56
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.55
         upper limit
    		 3.14
    Notes
    [1] - To assess the Non-inferiority of the Boostrix Polio Group compared to the Repevax Group in terms of booster response to diphtheria, standardized asymptotic 95% CI for the groups’difference [Repevax Group minus Boostrix Polio Group] was computed. Non-inferiority criterion: Upper limit of the 95% CI of the groups’ difference in booster response rate lesser than or equal to (≤) 10%.
    Statistical analysis title
    		 Non-inferiority in terms of booster response to T
    Comparison groups
    Boostrix Polio Group v Repevax Group
    Number of subjects included in analysis
    267
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [2]
    Method
    Parameter type
    		 Percentage difference
    Point estimate
    1.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.43
         upper limit
    		 4.9
    Notes
    [2] - To assess the Non-inferiority of the Boostrix Polio Group compared to the Repevax Group in terms of booster response to tetanus, standardized asymptotic 95% CI for the groups’ difference [Repevax Group minus Boostrix Polio Group] was computed. Non-inferiority criterion: Upper limit of the 95% CI of the groups’ difference in booster response rate ≤10%

    Primary: Anti-pertussis toxoid (anti-PT), anti-filamentous haemagglutinin (anti-FHA) and anti-pertactin (anti-PRN) antibody concentrations

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    End point title
    		 Anti-pertussis toxoid (anti-PT), anti-filamentous haemagglutinin (anti-FHA) and anti-pertactin (anti-PRN) antibody concentrations [3]
    End point description
    Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
    End point type
    Primary
    End point timeframe
    At Month 1, one month after the booster vaccination
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 Boostrix Polio Group Repevax Group
    Number of subjects analysed
    195
    96
    Units: EU/mL
    geometric mean (confidence interval 95%)
        Anti-PT POST [N=194;96]
    70.1 (62.2 to 79)
    47.8 (39.9 to 57.3)
        Anti-FHA POST [N=195;95]
    358.3 (312.5 to 410.8)
    164.8 (138.5 to 196.1)
        Anti-PRN POST [N=195;94]
    151.4 (127.5 to 179.6)
    209.8 (168.5 to 261.3)
    No statistical analyses for this end point

    Primary: Anti-Polio virus type 1, 2 and 3 antibody titers

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    End point title
    		 Anti-Polio virus type 1, 2 and 3 antibody titers
    End point description
    Antibody titers were presented as geometric mean titers (GMTs).
    End point type
    Primary
    End point timeframe
    At Month 1, one month after the booster vaccination
    End point values
    		 Boostrix Polio Group Repevax Group
    Number of subjects analysed
    160
    81
    Units: Titers
    geometric mean (confidence interval 95%)
        Anti-Polio 1, POST (N=157,75)
    2183.3 (1812.4 to 2630.1)
    1876.1 (1472.8 to 2389.7)
        Anti-Polio 2, POST (N=124,71)
    2693.1 (2176.3 to 3332.5)
    2203.8 (1681 to 2889.4)
        Anti-Polio 3, POST (N=159,81)
    3762.4 (3080.9 to 4594.6)
    4185.1 (3318.3 to 5278.3)
    Statistical analysis title
    		 Immune response difference to anti-Polio 1 antigen
    Comparison groups
    Boostrix Polio Group v Repevax Group
    Number of subjects included in analysis
    241
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [4]
    Method
    		 ANCOVA
    Parameter type
    		 Difference in adjusted GMT ratio
    Point estimate
    0.91
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.65
         upper limit
    		 1.28
    Notes
    [4] - Non-inferiority in terms of response to the poliovirus types 1, 2 and 3 was demonstrated if the upper limit of the 95% confidence interval (CI) on the ratio of geometric mean titres (GMTs) [Repevax Group divided by Boostrix-Polio Group] was ≤ 2.
    Statistical analysis title
    		 Immune response difference to anti-Polio 2 antigen
    Comparison groups
    Boostrix Polio Group v Repevax Group
    Number of subjects included in analysis
    241
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [5]
    Method
    		 ANCOVA
    Parameter type
    		 Difference in adjusted GMT ratio
    Point estimate
    0.78
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.54
         upper limit
    		 1.12
    Notes
    [5] - Non-inferiority in terms of response to the poliovirus types 1, 2 and 3 was demonstrated if the upper limit of the 95% confidence interval (CI) on the ratio of geometric mean titres (GMTs) [Repevax Group divided by Boostrix-Polio Group] was ≤ 2.
    Statistical analysis title
    		 Immune response difference to anti-Polio 3 antigen
    Comparison groups
    Boostrix Polio Group v Repevax Group
    Number of subjects included in analysis
    241
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [6]
    Method
    		 ANCOVA
    Parameter type
    		 Difference in adjusted GMT ratio
    Point estimate
    1.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.93
         upper limit
    		 1.84
    Notes
    [6] - Non-inferiority in terms of response to the poliovirus types 1, 2 and 3 was demonstrated if the upper limit of the 95% confidence interval (CI) on the ratio of geometric mean titres (GMTs) [Repevax Group divided by Boostrix-Polio Group] was ≤ 2.

    Secondary: Number of seropositive subjects for anti-pertussis toxoid (anti-PT), anti-filamentous haemagglutinin (anti-FHA) and anti-pertactin (anti-PRN)

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    End point title
    		 Number of seropositive subjects for anti-pertussis toxoid (anti-PT), anti-filamentous haemagglutinin (anti-FHA) and anti-pertactin (anti-PRN)
    End point description
    A seropositive subject for anti-PT, anti-FHA and anti-PRN was a subject whose antibody concentration was ≥ 5 EL.U/mL.
    End point type
    Secondary
    End point timeframe
    Month 0 (PRE) before booster vaccination and Month 1 (POST) after the booster vaccination
    End point values
    		 Boostrix Polio Group Repevax Group
    Number of subjects analysed
    195
    96
    Units: Subject
        Anti-PT PRE [N=171;90]
    31
    18
        Anti-PT POST [N=194;96]
    194
    96
        Anti-FHA PRE [N=174;85]
    112
    60
        Anti-FHA POST [N=195;95]
    195
    95
        Anti-PRN PRE [N=175;91]
    61
    37
        Anti-PRN POST [N=195;94]
    194
    94
    No statistical analyses for this end point

    Secondary: Number of seroprotected subjects for anti-D and anti-T

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    End point title
    		 Number of seroprotected subjects for anti-D and anti-T
    End point description
    A seroprotected subject was defined a subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 international units per millilitre (IU/mL).
    End point type
    Secondary
    End point timeframe
    Month 0 (PRE) before booster vaccination and Month 1 (POST) after the booster vaccination
    End point values
    		 Boostrix Polio Group Repevax Group
    Number of subjects analysed
    195
    96
    Units: Subject
        Anti-D PRE [N=177;90]
    136
    75
        Anti-D POST [N=195;96]
    195
    96
        Anti-T PRE [N=177;90]
    116
    63
        Anti-T POST [N=194;96]
    194
    96
    No statistical analyses for this end point

    Secondary: Anti-D and anti-T antibody concentrations

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    End point title
    		 Anti-D and anti-T antibody concentrations
    End point description
    Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL.
    End point type
    Secondary
    End point timeframe
    Month 0 (PRE) before booster vaccination and Month 1 (POST) after the booster vaccination
    End point values
    		 Boostrix Polio Group Repevax Group
    Number of subjects analysed
    195
    96
    Units: IU/mL
    geometric mean (confidence interval 95%)
        Anti-D PRE [N=177;90]
    0.228 (0.194 to 0.267)
    0.259 (0.209 to 0.32)
        Anti-D POST [N=195;96]
    8.113 (7.259 to 9.068)
    11.948 (10.003 to 14.271)
        Anti-T PRE [N=177;90]
    0.209 (0.173 to 0.253)
    0.241 (0.184 to 0.315)
        Anti-T POST [N=194;96]
    6.787 (5.961 to 7.727)
    9.194 (7.565 to 11.175)
    No statistical analyses for this end point

    Secondary: Number of seroconverted subjects for anti-measles

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    End point title
    		 Number of seroconverted subjects for anti-measles
    End point description
    Seroconversion for anti-measles was defined as the appearance of antibodies after vaccination in subjects who were initially seronegative [with antibody concentrations ≥ 150 milli-international units per millilitre (mIU/mL)].
    End point type
    Secondary
    End point timeframe
    Month 0 (PRE) before booster vaccination and Month 1 (POST) after the booster vaccination
    End point values
    		 Boostrix Polio Group Repevax Group
    Number of subjects analysed
    4
    2
    Units: Subject
        Anti-measles PRE [N=4;2]
    0
    0
        Anti-measles POST [N=4;2]
    4
    2
    No statistical analyses for this end point

    Secondary: Number of seroconverted subjects for anti-mumps

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    End point title
    		 Number of seroconverted subjects for anti-mumps
    End point description
    Seroconversion for anti-mumps was defined as the appearance of antibodies after vaccination in subjects who were initially seronegative [with antibody concentrations ≥ 231 units per millilitre (U/mL)].
    End point type
    Secondary
    End point timeframe
    Month 0 (PRE) before booster vaccination and Month 1 (POST) after the booster vaccination
    End point values
    		 Boostrix Polio Group Repevax Group
    Number of subjects analysed
    16
    7
    Units: Subjects
        Anti-mumps PRE [N=16;7]
    0
    0
        Anti-mumps POST [N=11;6]
    11
    6
    No statistical analyses for this end point

    Secondary: Number of subjects with a booster response to PT, FHA and PRN antigens

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    End point title
    		 Number of subjects with a booster response to PT, FHA and PRN antigens
    End point description
    Booster response was defined as: For initially seronegative subjects (pre-vaccination concentration < 5 EL.U/mL), antibody concentrations at least four times the assay cut-off (post vaccination concentration ≥ 20 EL.U/mL); For initially seropositive subjects (with pre-vaccination concentration ≥ 5 EL.U/mL and < 20 EL.U/mL), an increase in antibody concentrations of at least four times the Pre booster vaccination concentration; For initially seropositive subjects (with pre-vaccination concentration ≥ 20 EL.U/mL), an increase in antibody concentrations of at least two times the Pre booster vaccination concentration.
    End point type
    Secondary
    End point timeframe
    At Month 1, one month after the booster vaccination
    End point values
    		 Boostrix Polio Group Repevax Group
    Number of subjects analysed
    175
    90
    Units: Subjects
        Anti-PT [N=170;90]
    154
    73
        Anti-FHA [N=174;85]
    165
    79
        Anti-PRN [N= 175;89]
    169
    89
    No statistical analyses for this end point

    Secondary: Number of subjects with any solicited local symptoms

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    End point title
    		 Number of subjects with any solicited local symptoms
    End point description
    Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Days 0-3) follow-up period after booster vaccination
    End point values
    		 Boostrix Polio Group Repevax Group
    Number of subjects analysed
    255
    125
    Units: Subjects
        Any Pain (N=255;125)
    127
    70
        Any Redness (N=255;125)
    146
    73
        Any Swelling (N=255;125)
    92
    53
    No statistical analyses for this end point

    Secondary: Number of subjects with any solicited general symptoms

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    End point title
    		 Number of subjects with any solicited general symptoms
    End point description
    Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Days 0-3) follow-up period after booster vaccination
    End point values
    		 Boostrix Polio Group Repevax Group
    Number of subjects analysed
    255
    125
    Units: Subjects
        Drowsiness [N=255;125]
    77
    39
        Irritability [N=255;125]
    107
    49
        Loss of appetite [N=255;125]
    67
    30
        Temperature [N=255;125]
    18
    9
    No statistical analyses for this end point

    Secondary: Number of subjects with any unsolicited adverse events (AEs)

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    End point title
    		 Number of subjects with 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 and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
    End point type
    Secondary
    End point timeframe
    During the 31-day (Days 0-30) follow-up period after booster vaccination
    End point values
    		 Boostrix Polio Group Repevax Group
    Number of subjects analysed
    255
    130
    Units: Subjects
        AEs [N=255;130]
    88
    36
    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 or result in disability/incapacity.
    End point type
    Secondary
    End point timeframe
    During the entire study period (From Day 0 to Month 1)
    End point values
    		 Boostrix Polio Group Repevax Group
    Number of subjects analysed
    225
    130
    Units: Subjects
        SAEs [N=255;130]
    1
    0
    No statistical analyses for this end point

    Secondary: Number of seropositive subjects for anti-measles antibody

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    End point title
    		 Number of seropositive subjects for anti-measles antibody
    End point description
    A seropositive subject was defined as a subject with anti-measles antibody titers ≥150 mIU/mL.
    End point type
    Secondary
    End point timeframe
    Month 0 (PRE) before booster vaccination and Month 1 (POST) after the booster vaccination
    End point values
    		 Boostrix Polio Group Repevax Group
    Number of subjects analysed
    159
    76
    Units: Subjects
        Anti-Measles, PRE (N=159;76)
    155
    74
        Anti-Measles, POST (N=136;68)
    136
    68
    No statistical analyses for this end point

    Secondary: Number of seropositive subjects for anti-mumps antibody

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    End point title
    		 Number of seropositive subjects for anti-mumps antibody
    End point description
    A seropositive subject was defined as a subject with anti-mumps antibody titers ≥231 U/mL.
    End point type
    Secondary
    End point timeframe
    Month 0 (PRE) before booster vaccination and Month 1 (POST) after the booster vaccination
    End point values
    		 Boostrix Polio Group Repevax Group
    Number of subjects analysed
    156
    76
    Units: Subjects
        Anti-Mumps, PRE (N=156;76)
    140
    69
        Anti-Mumps, POST (N=133;68)
    133
    68
    No statistical analyses for this end point

    Secondary: Number of seropositive subjects for anti-rubella antibody

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    End point title
    		 Number of seropositive subjects for anti-rubella antibody
    End point description
    A seropositive subject was defined as a subject with anti-rubella antibody titers ≥4 IU/mL.
    End point type
    Secondary
    End point timeframe
    Month 0 (PRE) before booster vaccination and Month 1 (POST) after the booster vaccination
    End point values
    		 Boostrix Polio Group Repevax Group
    Number of subjects analysed
    158
    76
    Units: Subjects
        Anti-Rubella, PRE (N=158;76)
    158
    76
        Anti-Rubella, POST (N=134;68)
    134
    68
    No statistical analyses for this end point

    Secondary: Anti-mumps antibody concentrations

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    End point title
    		 Anti-mumps antibody concentrations
    End point description
    Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in U/mL.
    End point type
    Secondary
    End point timeframe
    Month 0 (PRE) before booster vaccination and Month 1 (POST) after the booster vaccination
    End point values
    		 Boostrix Polio Group Repevax Group
    Number of subjects analysed
    156
    76
    Units: U/mL
    geometric mean (confidence interval 95%)
        Anti-Mumps, PRE (N=156;76)
    1035.3 (869.8 to 1232.3)
    971.7 (752.1 to 1255.5)
        Anti-Mumps, POST (N=133;68)
    6801.9 (6155 to 7516.8)
    6219.4 (5365.8 to 7208.8)
    No statistical analyses for this end point

    Secondary: Anti-measles antibody concentrations

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    End point title
    		 Anti-measles antibody concentrations
    End point description
    Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL.
    End point type
    Secondary
    End point timeframe
    Month 0 (PRE) before booster vaccination and Month 1 (POST) after the booster vaccination
    End point values
    		 Boostrix Polio Group Repevax Group
    Number of subjects analysed
    159
    76
    Units: mIU/mL
    geometric mean (confidence interval 95%)
        Anti-Measles, PRE (N=159;76)
    2644 (2261.3 to 3091.6)
    2702.6 (2146 to 3403.6)
        Anti-Measles, POST (N=136;68)
    3817.7 (3422.3 to 4258.8)
    3798 (3262.6 to 4421.1)
    No statistical analyses for this end point

    Secondary: Anti-rubella antibody concentrations

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    End point title
    		 Anti-rubella antibody concentrations
    End point description
    Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL.
    End point type
    Secondary
    End point timeframe
    Month 0 (PRE) before booster vaccination and Month 1 (POST) after the booster vaccination
    End point values
    		 Boostrix Polio Group Repevax Group
    Number of subjects analysed
    158
    76
    Units: IU/mL
    geometric mean (confidence interval 95%)
        Anti-Rubella, PRE (N=158;76)
    66.5 (59.1 to 74.8)
    72.6 (59.8 to 88.1)
        Anti-Rubella, POST (N=134;68)
    134.3 (120.7 to 149.4)
    130.3 (111.7 to 152)
    No statistical analyses for this end point

    Secondary: Number of subjects with booster response for Polio 1, 2 and 3 antigens

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    End point title
    		 Number of subjects with booster response for Polio 1, 2 and 3 antigens
    End point description
    Booster response defined as: For initially seronegative subjects, antibody titers at least four times the cut-off (post-vaccination titer ≥ 32); For initially seropositive subjects, an increase in antibody titers of at least four times the Pre booster vaccination titer.
    End point type
    Secondary
    End point timeframe
    At Month 1, one month after the booster vaccination
    End point values
    		 Boostrix Polio Group Repevax Group
    Number of subjects analysed
    131
    68
    Units: Subjects
        Anti-Polio 1 (N=131;63)
    129
    63
        Anti-Polio 2 (N=100;61)
    99
    59
        Anti-Polio 3 (N=126;68)
    124
    68
    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: during the 4 day- (Day 0-Day 3) after vaccination; Unsolicited adverse events: during the 31 day (Day 0-Day 30) after vaccination; Serious adverse events: during the entire study period (from Month 0 to Month 1).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.1
    Reporting groups
    Reporting group title
    Boostrix Polio Group
    Reporting group description
    		 Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix and Polio vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Boostrix Polio vaccine co-administered with Priorix vaccine at Day 0. Boostrix Polio vaccine was administered intramuscularly in the deltoid muscle of the left arm, while Priorix vaccine was administered subcutaneously in the deltoid region of the right arm or as an intramuscular injection into the deltoid muscle of the right arm.

    Reporting group title
    Repevax Group
    Reporting group description
    		 Healthy male or female children of 3 or 4 years of age, who were previously vaccinated with 3 doses of Infanrix and Polio vaccines in the German household contact study (APV-039), additionally received 1 booster dose of Repevax vaccine co-administered with Priorix vaccine at Day 0. Repevax vaccine was administered intramuscularly in the deltoid muscle of the arm, while Priorix vaccine was administered subcutaneously in the deltoid region of the right arn or as an intramuscular injection into the deltoid muscle of the right arm.

    Serious adverse events
    		 Boostrix Polio Group Repevax Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 255 (0.39%)
    0 / 130 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Pneumonia
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 255 (0.39%)
    0 / 130 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Boostrix Polio Group Repevax Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    215 / 255 (84.31%)
    108 / 130 (83.08%)
    General disorders and administration site conditions
    Pain
         subjects affected / exposed [1]
    127 / 255 (49.80%)
    70 / 125 (56.00%)
         occurrences all number
    127
    70
    Swelling
    alternative assessment type: Non-systematic
         subjects affected / exposed [2]
    92 / 255 (36.08%)
    53 / 125 (42.40%)
         occurrences all number
    92
    53
    Redness
         subjects affected / exposed [3]
    146 / 255 (57.25%)
    73 / 125 (58.40%)
         occurrences all number
    146
    73
    Drowsiness
         subjects affected / exposed [4]
    77 / 255 (30.20%)
    39 / 125 (31.20%)
         occurrences all number
    77
    39
    Irritability
         subjects affected / exposed [5]
    107 / 255 (41.96%)
    49 / 125 (39.20%)
         occurrences all number
    107
    49
    Temperature/(Axillary)
         subjects affected / exposed [6]
    18 / 255 (7.06%)
    9 / 125 (7.20%)
         occurrences all number
    18
    9
    Loss of appetite
         subjects affected / exposed [7]
    67 / 255 (26.27%)
    30 / 125 (24.00%)
         occurrences all number
    67
    30
    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: Assessment for this event for this phase was performed solely 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: Assessment for this event for this phase was performed solely 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: Assessment for this event for this phase was performed solely 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: Assessment for this event for this phase was performed solely 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: Assessment for this event for this phase was performed solely 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: Assessment for this event for this phase was performed solely 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: Assessment for this event for this phase was performed solely on subjects with their symptom sheets 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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