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    Clinical Trial Results:
    A phase IIIb, 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 (Tetravac), when co-administered with MMRV (Priorix Tetra) in 5 to 6-year-old healthy children.

    Summary
    EudraCT number
    2008-006124-64
    Trial protocol
    IT  
    Global end of trial date
    18 Nov 2009

    Results information
    Results version number
    v3(current)
    This version publication date
    13 May 2018
    First version publication date
    20 Feb 2015
    Other versions
    v1 , v2
    Version creation reason
    • Correction of full data set
    Minor corrections of the full study results.

    Trial information

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    Trial identification
    Sponsor protocol code
    111815
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT00871000
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline Biologicals
    Sponsor organisation address
    Rue de l’Institut 89, Rixensart, Belgium, B-1330
    Public contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    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
    Final
    Date of interim/final analysis
    29 Jun 2010
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    18 Nov 2009
    Global end of trial reached?
    Yes
    Global end of trial date
    18 Nov 2009
    Was the trial ended prematurely?
    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 seroprotection rates against diphtheria, tetanus and poliovirus types 1, 2 and 3, one month after vaccination.
    Protection of trial subjects
    As with all injectable vaccines, appropriate medical treatment was always readily available in case of anaphylactic reactions following the administration of the vaccine. For this reason, the vaccinee remained under medical supervision for 30 minutes after vaccination
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    15 Apr 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
    Italy: 303
    Worldwide total number of subjects
    303
    EEA total number of subjects
    303
    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)
    303
    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 Study (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, between and including 5 to 6 years of age, who were primed with three doses of Infanrix vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio vaccine co-administered with a single dose of Priorix Tetra vaccine at Day 0. Boostrix Polio vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra vaccine was administered subcutaneously in the deltoid region of the right upper arm
    Arm type
    Experimental

    Investigational medicinal product name
    Boostrix Polio
    Investigational medicinal product code
    Other name
    dTpa-IPV, GSK Biologicals' combined reduced-antigen-content diphteria, tetanus, acellular pertussis and inactivated poliovirus vaccine
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Single dose, intramuscular administration in the deltoid region of the left upper arm at Day 0.

    Investigational medicinal product name
    Priorix Tetra
    Investigational medicinal product code
    Other name
    MMRV, GSK Biologicals' live attenuated measles-mumps-rubella-varicella vaccine
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Single dose, subcutaneous administration in the deltoid region of the right upper arm at Day 0.

    Arm title
    Tetravac Group
    Arm description
    Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac vaccine co-administered with a single dose of Priorix Tetra vaccine at Day 0. Tetravac vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra vaccine was administered subcutaneously in the deltoid region of the right upper arm.
    Arm type
    Active comparator

    Investigational medicinal product name
    Priorix Tetra
    Investigational medicinal product code
    Other name
    MMRV, GSK Biologicals' live attenuated measles-mumps-rubella-varicella vaccine
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Single dose, subcutaneous administration in the deltoid region of the right upper arm at Day 0.

    Investigational medicinal product name
    Tetravac
    Investigational medicinal product code
    Other name
    dTpa-IPV, GSK Biologicals' combined reduced-antigen-content diphteria, tetanus, acellular pertussis and inactivated poliovirus vaccine
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Single dose, intramuscular administration in the deltoid region of the left upper arm at Day 0.

    Number of subjects in period 1
    Boostrix Polio Group Tetravac Group
    Started
    151
    152
    Completed
    150
    152
    Not completed
    1
    0
         Consent withdrawn by subject
    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, between and including 5 to 6 years of age, who were primed with three doses of Infanrix vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio vaccine co-administered with a single dose of Priorix Tetra vaccine at Day 0. Boostrix Polio vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra vaccine was administered subcutaneously in the deltoid region of the right upper arm

    Reporting group title
    Tetravac Group
    Reporting group description
    Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac vaccine co-administered with a single dose of Priorix Tetra vaccine at Day 0. Tetravac vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra vaccine was administered subcutaneously in the deltoid region of the right upper arm.

    Reporting group values
    Boostrix Polio Group Tetravac Group Total
    Number of subjects
    151 152 303
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
        Newborns (0-27 days)
    0
        Infants and toddlers (28 days-23 months)
    0
        Children (2-11 years)
    0
        Adolescents (12-17 years)
    0
        Adults (18-64 years)
    0
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Units: years
        geometric mean (standard deviation)
    5 ± 0.14 5 ± 0.14 -
    Gender categorical
    Units: Subjects
        Female
    81 68 149
        Male
    70 84 154
    Race/Ethnicity
    Units: Subjects
        African heritage/African American
    1 0 1
        Asian-Central/South Asian heritage
    1 4 5
        White-Arabic/North African heritage
    2 0 2
        White-Caucasian/European heritage
    147 147 294
        Not specified
    0 1 1

    End points

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    End points reporting groups
    Reporting group title
    Boostrix Polio Group
    Reporting group description
    Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio vaccine co-administered with a single dose of Priorix Tetra vaccine at Day 0. Boostrix Polio vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra vaccine was administered subcutaneously in the deltoid region of the right upper arm

    Reporting group title
    Tetravac Group
    Reporting group description
    Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac vaccine co-administered with a single dose of Priorix Tetra vaccine at Day 0. Tetravac vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra vaccine was administered subcutaneously in the deltoid region of the right upper arm.

    Primary: Anti-diphtheria (anti-D) and anti-tetanus (anti-T) antibody concentrations

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    End point title
    Anti-diphtheria (anti-D) and anti-tetanus (anti-T) antibody concentrations [1]
    End point description
    Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL). The reference cut-off value was greater than or equal to (≥) 0.1 IU/mL.
    End point type
    Primary
    End point timeframe
    At 1 Month post-vaccination
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    Boostrix Polio Group Tetravac Group
    Number of subjects analysed
    139
    144
    Units: IU/mL
    geometric mean (confidence interval 95%)
        Anti-D
    9.207 (8.057 to 10.522)
    21.393 (19.165 to 23.88)
        Anti-T
    12.527 (10.957 to 14.323)
    11.07 (9.872 to 12.413)
    No statistical analyses for this end point

    Primary: Anti-poliovirus types 1, 2 and 3 antibody titres

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    End point title
    Anti-poliovirus types 1, 2 and 3 antibody titres [2]
    End point description
    Antibody titers were presented as geometric mean titers (GMTs) for the assay cut-off ≥ the value of 8.
    End point type
    Primary
    End point timeframe
    At 1 Month post-vaccination
    Notes
    [2] - 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 Tetravac Group
    Number of subjects analysed
    139
    144
    Units: Titers
    geometric mean (confidence interval 95%)
        Anti-Polio 1 [N=139;144]
    1145.6 (978.7 to 1340.9)
    948 (817.5 to 1099.4)
        Anti-Polio 2 [N=139;144]
    1076.4 (908.7 to 1274.9)
    1315.3 (1123.1 to 1540.3)
        Anti-Polio 3 [N=138;144]
    1937.8 (1631.4 to 2301.8)
    1657.3 (1385.5 to 1982.6)
    No statistical analyses for this end point

    Primary: Number of seropositive subjects for anti-D and anti-T antibodies

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    End point title
    Number of seropositive subjects for anti-D and anti-T antibodies
    End point description
    A seropositive subject was defined as a subject with anti-D and anti-T concentrations ≥ 0.1 IU/mL. Antibody concentrations have been assessed by enzyme-linked immunosorbent assay (ELISA).
    End point type
    Primary
    End point timeframe
    At 1 Month post-vaccination
    End point values
    Boostrix Polio Group Tetravac Group
    Number of subjects analysed
    139
    144
    Units: Subjects
        Anti-D
    139
    144
        Anti-T
    139
    144
    Statistical analysis title
    Seroprotection in terms of anti-D antibodies
    Statistical analysis description
    To demonstrate that GSK Biologicals’ Boostrix Polio™ vaccine is non-inferior to Sanofi-Pasteur-MSD’s Tetravac™ vaccine, in terms of seroprotection rates against diphtheria, one month after vaccination.
    Comparison groups
    Boostrix Polio Group v Tetravac Group
    Number of subjects included in analysis
    283
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [3]
    Method
    Parameter type
    Difference in seroprotection rate
    Point estimate
    0
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.61
         upper limit
    2.7
    Notes
    [3] - Non-inferiority in terms of seroprotection rates against diphtheria was demonstrated if the upper limit of the standardised asymptotic 95% confidence interval (CI) on the group difference [Tetravac Group minus Boostrix Polio Group] in the percentage of subjects with anti-diphtheria antibody concentrations ≥ 0.1 IU/mL was ≤ 10%.
    Statistical analysis title
    Seroprotection in terms of anti-T antibodies
    Statistical analysis description
    To demonstrate that GSK Biologicals’ Boostrix Polio™ vaccine is non-inferior to Sanofi-Pasteur-MSD’s Tetravac™ vaccine, in terms of seroprotection rates against tetanus, one month after vaccination.
    Comparison groups
    Boostrix Polio Group v Tetravac Group
    Number of subjects included in analysis
    283
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [4]
    Method
    Parameter type
    Difference in seroprotection rate
    Point estimate
    0
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.61
         upper limit
    2.7
    Notes
    [4] - Non-inferiority in terms of seroprotection rates against tetanus was demonstrated if the upper limit of the standardised asymptotic 95% confidence interval (CI) on the group difference [Tetravac Group minus Boostrix Polio Group] in the percentage of subjects with anti-tetanus antibody concentrations ≥ 0.1 IU/mL was ≤ 10%.

    Primary: Number of seroprotected subjects against polio types 1, 2 and 3

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    End point title
    Number of seroprotected subjects against polio types 1, 2 and 3
    End point description
    A seroprotected subject was defined as a subject with anti-polio types 1, 2 and 3 titers ≥ the value of 8. Antibody titers have been assessed by neutralization assay.
    End point type
    Primary
    End point timeframe
    At 1 Month post-vaccination
    End point values
    Boostrix Polio Group Tetravac Group
    Number of subjects analysed
    139
    144
    Units: Subjects
        Anti-Polio 1 [N=139;144]
    139
    144
        Anti-Polio 2 [N=139;144]
    139
    144
        Anti-Polio 3 [N=138;144]
    138
    144
    Statistical analysis title
    Seroprotection in terms of anti-Polio 1 antibodies
    Statistical analysis description
    To demonstrate that GSK Biologicals’ Boostrix Polio™ vaccine is non-inferior to Sanofi-Pasteur-MSD’s Tetravac™ vaccine, in terms of seroprotection rates against poliovirus type 1, one month after vaccination.
    Comparison groups
    Boostrix Polio Group v Tetravac Group
    Number of subjects included in analysis
    283
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [5]
    Method
    Parameter type
    Difference in seroprotection rate
    Point estimate
    0
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.61
         upper limit
    2.7
    Notes
    [5] - Non-inferiority in terms of seroprotection rates against poliovirus type 1 was demonstrated if the upper limit of the standardised asymptotic 95% confidence interval (CI) on the group difference [Tetravac Group minus Boostrix Polio Group] in the percentage of subjects with anti-poliovirus type 1 antibody titers ≥ 8 was ≤ 10%.
    Statistical analysis title
    Seroprotection in terms of anti-Polio 2 antibodies
    Statistical analysis description
    To demonstrate that GSK Biologicals’ Boostrix Polio™ vaccine is non-inferior to Sanofi-Pasteur-MSD’s Tetravac™ vaccine, in terms of seroprotection rates against poliovirus type 2, one month after vaccination
    Comparison groups
    Boostrix Polio Group v Tetravac Group
    Number of subjects included in analysis
    283
    Analysis specification
    Pre-specified
    Analysis type
    [6]
    Method
    Parameter type
    Difference in seroprotection rate
    Point estimate
    0
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.61
         upper limit
    2.7
    Notes
    [6] - Non-inferiority in terms of seroprotection rates against poliovirus type 2 was demonstrated if the upper limit of the standardised asymptotic 95% confidence interval (CI) on the group difference [Tetravac Group minus Boostrix Polio Group] in the percentage of subjects with anti-poliovirus type 2 antibody titers ≥ 8 was ≤ 10%.
    Statistical analysis title
    Seroprotection in terms of anti-Polio 3 antibodies
    Statistical analysis description
    To demonstrate that GSK Biologicals’ Boostrix Polio™ vaccine is non-inferior to Sanofi-Pasteur-MSD’s Tetravac™ vaccine, in terms of seroprotection rates against poliovirus type 3, one month after vaccination
    Comparison groups
    Boostrix Polio Group v Tetravac Group
    Number of subjects included in analysis
    283
    Analysis specification
    Pre-specified
    Analysis type
    non-inferiority [7]
    Method
    Parameter type
    Difference in seroprotection rate
    Point estimate
    0
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -2.61
         upper limit
    2.72
    Notes
    [7] - Non-inferiority in terms of seroprotection rates against poliovirus type 1 was demonstrated if the upper limit of the standardised asymptotic 95% confidence interval (CI) on the group difference [Tetravac Group minus Boostrix Polio Group] in the percentage of subjects with anti-poliovirus type 3 antibody titers ≥ 8 was ≤ 10%.

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

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    End point title
    Anti-pertussis toxoid (anti-PT), anti-filamentous hemagglutinin (anti-FHA) and anti-pertactin (anti-PRN) antibody concentrations
    End point description
    Antibody concentrations were presented as geometric mean concentrations, expressed in ELISA units per milliliter (EL.U/mL). The reference cut-off value was ≥ 5 EL.U/mL.
    End point type
    Secondary
    End point timeframe
    At 1 Month post-vaccination
    End point values
    Boostrix Polio Group Tetravac Group
    Number of subjects analysed
    139
    144
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        Anti-PT
    59.8 (52.2 to 68.5)
    75.9 (65.7 to 87.7)
        Anti-FHA
    556.2 (491.4 to 629.5)
    613.5 (547 to 688.2)
        Anti-PRN
    354.8 (280.2 to 449.4)
    7.8 (6.5 to 9.2)
    No statistical analyses for this end point

    Secondary: Number of seroprotected subjects against diphteria (D) and tetanus (T) antigens

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    End point title
    Number of seroprotected subjects against diphteria (D) and tetanus (T) antigens
    End point description
    A seroprotected subject was defined as a subject with anti-D and anti-T concentrations ≥ 1.0 IU/mL. Antibody concentrations have been assessed by ELISA.
    End point type
    Secondary
    End point timeframe
    At 1 Month post-vaccination
    End point values
    Boostrix Polio Group Tetravac Group
    Number of subjects analysed
    139
    144
    Units: Subjects
        Anti-D
    138
    144
        Anti-T
    137
    143
    No statistical analyses for this end point

    Secondary: Number of seropositive subjects for anti-measles, anti-mumps, anti-rubella and anti-varicella.

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    End point title
    Number of seropositive subjects for anti-measles, anti-mumps, anti-rubella and anti-varicella.
    End point description
    Seropositivity was defined as subjects with antibody concentrations: ≥ 150 milli-international units per milliliter (mIU/mL), ≥ 231 units per milliliter (U/mL), ≥ 4 international units per milliliter (IU/mL) and ≥ 50 mIU/mL for anti-measles, anti-mumps, anti-rubella and anti-varicella antibodies, respectively.
    End point type
    Secondary
    End point timeframe
    At 1 Month post-vaccination
    End point values
    Boostrix Polio Group Tetravac Group
    Number of subjects analysed
    139
    146
    Units: Subjects
        Anti- measles
    139
    146
        Anti-mumps
    139
    144
        Anti-rubella
    139
    145
        Anti- varicella
    135
    140
    No statistical analyses for this end point

    Secondary: Anti-measles and anti-varicella antibody concentrations.

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    End point title
    Anti-measles and anti-varicella antibody concentrations.
    End point description
    Antibody concentrations were assessed by ELISA, presented as geometric mean concentrations (GMCs) and expressed in mIU/mL.
    End point type
    Secondary
    End point timeframe
    At 1 Month post-vaccination
    End point values
    Boostrix Polio Group Tetravac Group
    Number of subjects analysed
    139
    146
    Units: mIU/mL
    geometric mean (confidence interval 95%)
        Anti- measles
    2743.9 (2411.4 to 3122.2)
    2863 (2534.6 to 3233.9)
        Anti- varicella
    856.7 (671.8 to 1092.4)
    909.9 (721 to 1148.2)
    No statistical analyses for this end point

    Secondary: Number of subjects with booster responses to anti-diphtheria and anti-tetanus.

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    End point title
    Number of subjects with booster responses to anti-diphtheria and anti-tetanus.
    End point description
    Booster responses to anti-D and anti-T were defined as: For initially seronegative subjects (pre-vaccination concentration < cut-off of 0.1 IU/mL), antibody concentrations at least four times the assay cut-off (post-vaccination concentration ≥ 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-vaccination concentration.
    End point type
    Secondary
    End point timeframe
    At 1 Month post-vaccination
    End point values
    Boostrix Polio Group Tetravac Group
    Number of subjects analysed
    137
    143
    Units: Subjects
        Ant-D [N=136;143]
    130
    136
        Anti-T [N=137;143]
    137
    142
    No statistical analyses for this end point

    Secondary: Number of subjects with booster responses to anti-poliovirus types 1, 2 and 3.

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    End point title
    Number of subjects with booster responses to anti-poliovirus types 1, 2 and 3.
    End point description
    Booster response to the poliovirus antigens was defined as: For initially seronegative subjects (pre-vaccination antibody titre < cut-off of 8), antibody titre ≥ 32. For initially seropositive subjects (pre-vaccination antibody titres ≥ 8), an increase in antibody titres of at least four times the pre-vaccination titre.
    End point type
    Secondary
    End point timeframe
    At 1 Month post-vaccination
    End point values
    Boostrix Polio Group Tetravac Group
    Number of subjects analysed
    139
    144
    Units: Subjects
        Anti-Polio 1 [N=139;144]
    115
    112
        Anti-Polio 2 [N=139;143]
    113
    122
        Anti-Polio 3 [N=138;144]
    126
    127
    No statistical analyses for this end point

    Secondary: Number of subjects with booster responses to anti-PT, anti-FHA and anti-PRN.

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    End point title
    Number of subjects with booster responses to anti-PT, anti-FHA and anti-PRN.
    End point description
    Booster response to the PT, FHA and PRN antigens was defined as: For initially seronegative subjects (pre-vaccination concentration < cut-off of 5 EL.U/mL), antibody concentrations at least four times the 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-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-vaccination concentration.
    End point type
    Secondary
    End point timeframe
    At 1 Month post-vaccination
    End point values
    Boostrix Polio Group Tetravac Group
    Number of subjects analysed
    137
    143
    Units: Subjects
        Anti-PT [N=137;141]
    123
    130
        Anti-FHA [N=136;140]
    129
    134
        Anti-PRN [N=137;143]
    129
    0
    No statistical analyses for this end point

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

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    End point title
    Number of seroconverted subjects for anti-measles, anti-mumps, anti-rubella and anti-varicella
    End point description
    Seroconversion for anti-measles, anti-mumps, anti-rubella and anti-varicella was defined as the appearance of antibodies after vaccination in subjects who were seronegative before vaccination. There were no seronegative subjects for anti-rubella antibodies, prior to vaccination.
    End point type
    Secondary
    End point timeframe
    At 1 Month post-vaccination
    End point values
    Boostrix Polio Group Tetravac Group
    Number of subjects analysed
    36
    34
    Units: Subjects
        Anti-measles [N=2;1]
    2
    1
        Anti-mumps [N=13;13]
    13
    12
        Anti-rubella [N=0;0]
    0
    0
        Anti-varicellas [N=36;34]
    35
    32
    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) post-vaccination period
    End point values
    Boostrix Polio Group Tetravac Group
    Number of subjects analysed
    151
    152
    Units: Subjects
        Pain
    96
    96
        Redness
    58
    66
        Swelling
    55
    62
    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 fatigue, gastrointestinal, headache 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) post-vaccination period
    End point values
    Boostrix Polio Group Tetravac Group
    Number of subjects analysed
    151
    152
    Units: Subjects
        Fatigue
    40
    36
        Gastrointestinal
    23
    15
        Headache
    18
    20
        Temperature
    32
    30
    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 days (Days 0-30) post-vaccination period
    End point values
    Boostrix Polio Group Tetravac Group
    Number of subjects analysed
    151
    152
    Units: Subjects
        Subjects with any AE(s)
    23
    20
    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 whole study period
    End point values
    Boostrix Polio Group Tetravac Group
    Number of subjects analysed
    151
    152
    Units: Subjects
        Subjects with any SAE(s)
    0
    0
    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 assessed by ELISA, presented as geometric mean concentrations (GMCs) and expressed in U/mL.
    End point type
    Secondary
    End point timeframe
    At 1 Month post-vaccination
    End point values
    Boostrix Polio Group Tetravac Group
    Number of subjects analysed
    139
    146
    Units: U/mL
    geometric mean (confidence interval 95%)
        Anti-mumps
    4141.3 (3590.5 to 4776.5)
    3837.6 (3275.1 to 4496.7)
    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 assessed by ELISA, presented as geometric mean concentrations (GMCs) and expressed in IU/mL.
    End point type
    Secondary
    End point timeframe
    At 1 Month post-vaccination
    End point values
    Boostrix Polio Group Tetravac Group
    Number of subjects analysed
    139
    146
    Units: IU/mL
    geometric mean (confidence interval 95%)
        Anti-rubella
    154.5 (141.3 to 168.9)
    162.5 (145.8 to 181)
    No statistical analyses for this end point

    Secondary: Number of seropositive subjects for anti-PT, anti-FHA and anti-PRN antibodies

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    End point title
    Number of seropositive subjects for anti-PT, anti-FHA and anti-PRN antibodies
    End point description
    A seropositive subject was defined as a subject with anti-PT, anti-FHA and anti-PRN concentrations ≥ 5.0 IU/mL. Antibody concentrations have been assessed by ELISA.
    End point type
    Secondary
    End point timeframe
    At Month 1 post-vaccination
    End point values
    Boostrix Polio Group Tetravac Group
    Number of subjects analysed
    139
    144
    Units: Subjects
        Anti-PT
    139
    144
        Anti-FHA
    139
    144
        Anti-PRN
    138
    87
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited symptoms: 4-day follow-up period after vaccination (Day 0 - Day 3); Unsolicited AEs: 31-day follow-up period after vaccination (Day 0 - Day 30); SAEs: throughout the study.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    13
    Reporting groups
    Reporting group title
    Tetravac Group
    Reporting group description
    Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac vaccine co-administered with a single dose of Priorix Tetra vaccine at Day 0. Tetravac vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra vaccine was administered subcutaneously in the deltoid region of the right upper arm.

    Reporting group title
    Boostrix Group
    Reporting group description
    Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio vaccine co-administered with a single dose of Priorix Tetra vaccine at Day 0. Boostrix Polio vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra vaccine was administered subcutaneously in the deltoid region of the right upper arm.

    Serious adverse events
    Tetravac Group Boostrix Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 152 (0.00%)
    0 / 151 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Tetravac Group Boostrix Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    117 / 152 (76.97%)
    117 / 151 (77.48%)
    General disorders and administration site conditions
    Pain
         subjects affected / exposed
    96 / 152 (63.16%)
    96 / 151 (63.58%)
         occurrences all number
    96
    96
    Redness
         subjects affected / exposed
    66 / 152 (43.42%)
    58 / 151 (38.41%)
         occurrences all number
    66
    58
    Swelling
         subjects affected / exposed
    62 / 152 (40.79%)
    55 / 151 (36.42%)
         occurrences all number
    62
    55
    Fatigue
         subjects affected / exposed
    36 / 152 (23.68%)
    40 / 151 (26.49%)
         occurrences all number
    36
    40
    Gastrointestinal
         subjects affected / exposed
    15 / 152 (9.87%)
    23 / 151 (15.23%)
         occurrences all number
    15
    23
    Headache
         subjects affected / exposed
    20 / 152 (13.16%)
    18 / 151 (11.92%)
         occurrences all number
    20
    18
    Temperature
         subjects affected / exposed
    30 / 152 (19.74%)
    32 / 151 (21.19%)
         occurrences all number
    30
    32

    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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