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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
    		 v1
    This version publication date
    27 Apr 2016
    First version publication date
    06 Jun 2015
    Other versions
    		 v2 , v3

    Trial information

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    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
    		 -

    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
    		 Subjects received 1 booster dose of Boostrix Polio vaccine co-administered with Priorix
    Arm type
    		 Experimental

    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™.

    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™.

    Arm title
    		 Repevax Group
    Arm description
    		 Subjects received 1 booster dose of Repevax vaccine co-administered with Priorix vaccine
    Arm type
    		 Active comparator

    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™.

    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™.

    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
    		 Subjects received 1 booster dose of Boostrix Polio vaccine co-administered with Priorix

    Reporting group title
    Repevax Group
    Reporting group description
    		 Subjects received 1 booster dose of Repevax vaccine co-administered with Priorix vaccine

    Reporting group values
    		 Boostrix Polio Group Repevax Group Total
    Number of subjects
    		 255 130 385
    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
        arithmetic mean (standard deviation)
    		 3.1 ± 0.25 3.1 ± 0.24 -
    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
    		 Subjects received 1 booster dose of Boostrix Polio vaccine co-administered with Priorix

    Reporting group title
    Repevax Group
    Reporting group description
    		 Subjects received 1 booster dose of Repevax vaccine co-administered with Priorix vaccine

    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, antibody concentrations at least four times the assay cut-off; for initially seropositive subjects, an increase in antibody concentrations of at least four times the Pre booster vaccination concentration.
    End point type
    Primary
    End point timeframe
    One month after 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
    Boostrix Polio Group v Repevax 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 ≤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: Concentrations for anti-pertussis toxoid (anti-PT), anti-filamentous haemagglutinin (anti-FHA) and anti-pertactin (anti-PRN).

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    End point title
    		 Concentrations for anti-pertussis toxoid (anti-PT), anti-filamentous haemagglutinin (anti-FHA) and anti-pertactin (anti-PRN). [3]
    End point description
    End point type
    Primary
    End point timeframe
    Before (PRE) and one month after (POST) 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 PRE [N=171;90]
    3.4 (3 to 3.9)
    3.2 (2.9 to 3.6)
        Anti-PT POST [N=194;96]
    70.1 (62.2 to 79)
    47.8 (39.9 to 57.3)
        Anti-FHA PRE [N=174;85]
    12.9 (10 to 16.6)
    10.7 (7.9 to 14.5)
        Anti-FHA POST [N=195;95]
    358.3 (312.5 to 410.8)
    164.8 (138.5 to 196.1)
        Anti-PRN PRE [N=175;91]
    4.3 (3.8 to 5)
    4.3 (3.7 to 5)
        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

    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
    Before (PRE) and one month after (POST) 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 antibody concentrations ≥ 0.1 international units per millilitre (IU/mL).
    End point type
    Secondary
    End point timeframe
    Before (PRE) and one month after (POST) 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: Concentrations for anti-D and anti-T.

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    End point title
    		 Concentrations for anti-D and anti-T.
    End point description
    End point type
    Secondary
    End point timeframe
    Before (PRE) and one month after (POST) 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
    A converted subject was defined an initially seronegative subject with antibody concentrations ≥ 150 milli-international units per millilitre (mIU/mL).
    End point type
    Secondary
    End point timeframe
    Before (PRE) and one month after (POST) 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: Concentrations for anti-measles

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    End point title
    		 Concentrations for anti-measles
    End point description
    End point type
    Secondary
    End point timeframe
    Before (PRE) and one month after (POST) the booster vaccination.
    End point values
    		 Boostrix Polio Group Repevax Group
    Number of subjects analysed
    4
    2
    Units: mIU/mL
    geometric mean (confidence interval 95%)
        Anti-measles PRE [N=4;2]
    75 (75 to 75)
    75 (75 to 75)
        Anti-measles POST [N=4;2]
    1937.2 (597.6 to 6279.9)
    2662.6 (0.9 to 7909745)
    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
    A converted subject was defined an initially seronegative subject with antibody concentrations ≥ 231 units per millilitre (U/mL).
    End point type
    Secondary
    End point timeframe
    Before (PRE) and one month after (POST) 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: Concentrations for anti-mumps

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    End point title
    		 Concentrations for anti-mumps
    End point description
    End point type
    Secondary
    End point timeframe
    Before (PRE) and one month after (POST) the booster vaccination.
    End point values
    		 Boostrix Polio Group Repevax Group
    Number of subjects analysed
    16
    7
    Units: U/mL
    geometric mean (confidence interval 95%)
        Anti-mumps PRE [N=16;7]
    115.5 (115.5 to 115.5)
    115.5 (115.5 to 115.5)
        Anti-mumps POST [N=11;6]
    4131.9 (2453 to 6959.7)
    3671.2 (1642.9 to 8203.7)
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects with a booster response to PT, FHA and PRN antibodies.
    End point description
    Booster response was defined as: for initially seronegative subjects, antibody concentrations at least four times the assay cut-off; for initially seropositive subjects, an increase in antibody concentrations of at least four times the Pre booster vaccination concentration.
    End point type
    Secondary
    End point timeframe
    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 solicited local symptoms.

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    End point title
    		 Number of subjects with solicited local symptoms.
    End point description
    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
        Pain [N=255;125]
    134
    72
        Redness [N=255;125]
    156
    77
        Swelling [N=255;125]
    99
    54
    No statistical analyses for this end point

    Secondary: Number of subjects with solicited general symptoms.

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    End point title
    		 Number of subjects with solicited general symptoms.
    End point description
    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 unsolicited adverse events (AEs).

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    End point title
    		 Number of subjects with unsolicited adverse events (AEs).
    End point description
    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
    End point type
    Secondary
    End point timeframe
    During the entire study period.
    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

    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 event from the booster dose up to study end
    Assessment type
    		 Non-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
    		 Subjects received 1 booster dose of Boostrix Polio vaccine co-administered with Priorix

    Reporting group title
    Repevax Group
    Reporting group description
    		 Subjects received 1 booster dose of Repevax vaccine co-administered with Priorix vaccine

    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
         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
    156 / 255 (61.18%)
    77 / 130 (59.23%)
    General disorders and administration site conditions
    Pain
    alternative assessment type: Systematic
         subjects affected / exposed
    134 / 255 (52.55%)
    72 / 130 (55.38%)
         occurrences all number
    134
    72
    Redness
    alternative assessment type: Systematic
         subjects affected / exposed
    156 / 255 (61.18%)
    77 / 130 (59.23%)
         occurrences all number
    156
    77
    Swelling
         subjects affected / exposed
    99 / 255 (38.82%)
    54 / 130 (41.54%)
         occurrences all number
    99
    54
    Drowsiness
    alternative assessment type: Systematic
         subjects affected / exposed
    77 / 255 (30.20%)
    39 / 130 (30.00%)
         occurrences all number
    77
    39
    Irritability
    alternative assessment type: Systematic
         subjects affected / exposed
    107 / 255 (41.96%)
    49 / 130 (37.69%)
         occurrences all number
    107
    49
    Loss of appetite
    alternative assessment type: Systematic
         subjects affected / exposed
    67 / 255 (26.27%)
    30 / 130 (23.08%)
         occurrences all number
    67
    30
    Temperature/(Axillary)
    alternative assessment type: Systematic
         subjects affected / exposed
    18 / 255 (7.06%)
    9 / 130 (6.92%)
         occurrences all number
    18
    9

    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
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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