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    Clinical Trial Results:
    A phase IV, single-blind, randomized, multicenter study to assess the immunogenicity and safety of GSK Biologicals’ dTpa vaccine (Boostrix) using a new syringe presentation in healthy adolescents aged 10–15 years

    Summary
    EudraCT number
    		 2013-003768-30
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    03 Sep 2012

    Results information
    Results version number
    		 v3(current)
    This version publication date
    31 Mar 2023
    First version publication date
    13 May 2015
    Other versions
    		 v1 , v2
    Version creation reason
    • Correction of full data set
    Correction of full data set and alignment between registries.

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    114778
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01362322
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline Biologicals
    Sponsor organisation address
    Rue de l’Institut 89, Rixensart, Belgium,
    Public contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 44 2089904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 44 2089904466, GSKClinicalSupportHD@gsk.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    10 Jan 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    03 Sep 2012
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Sep 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate that Boostrix administered using the new syringe presentation is non-inferior to Boostrix administered using the previous syringe presentation, in terms of immune response to all vaccine antigens, one month after booster vaccination.
    Protection of trial subjects
    All subjects were supervised after vaccination/product administration with appropriate medical treatment readily available. Vaccines were administered by qualified and trained personnel. Vaccines were administered only to eligible subjects that had no contraindications to any components of the vaccines.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    05 Jul 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
    Mexico: 376
    Country: Number of subjects enrolled
    Chile: 295
    Worldwide total number of subjects
    671
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    671
    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
    		 Single blind
    Roles blinded
    		 Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Boostrix New Group
    Arm description
    		 Subjects, aged 10 to 15 years, received one dose of Boostrix vaccine administered using a new syringe presentation (prefilled syringes from a different manufacturer) in the deltoid of the non-dominant arm, at Day 0.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Boostrix
    Investigational medicinal product code
    Other name
    dTpa
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose of vaccine, in a new syringe presentation, was administered in the deltoid of the non-dominant arm, at Day 0.

    Arm title
    		 Boostrix Prev Group
    Arm description
    		 Subjects, aged 10 to 15 years, received one dose of Boostrix vaccine administered using a previous syringe presentation (single dose vial or a prefilled disposable syringe without a needle) in the deltoid of the non-dominant arm, at Day 0.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Boostrix
    Investigational medicinal product code
    Other name
    dTpa
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose of vaccine, in a previous syringe presentation, was administered in the deltoid of the non-dominant arm, at Day 0.

    Number of subjects in period 1
    		Boostrix New Group Boostrix Prev Group
    Started
    335
    336
    Completed
    330
    329
    Not completed
    5
    7
         Consent withdrawn by subject
    3
    1
         Lost to follow-up
    2
    6

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Boostrix New Group
    Reporting group description
    		 Subjects, aged 10 to 15 years, received one dose of Boostrix vaccine administered using a new syringe presentation (prefilled syringes from a different manufacturer) in the deltoid of the non-dominant arm, at Day 0.

    Reporting group title
    Boostrix Prev Group
    Reporting group description
    		 Subjects, aged 10 to 15 years, received one dose of Boostrix vaccine administered using a previous syringe presentation (single dose vial or a prefilled disposable syringe without a needle) in the deltoid of the non-dominant arm, at Day 0.

    Reporting group values
    		 Boostrix New Group Boostrix Prev Group Total
    Number of subjects
    		 335 336 671
    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)
    		 335 336 671
        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)
    		 11.9 ± 1.59 11.9 ± 1.61 -
    Gender categorical
    Units: Subjects
        Female
    		 179 178 357
        Male
    		 156 158 314

    End points

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    End points reporting groups
    Reporting group title
    Boostrix New Group
    Reporting group description
    		 Subjects, aged 10 to 15 years, received one dose of Boostrix vaccine administered using a new syringe presentation (prefilled syringes from a different manufacturer) in the deltoid of the non-dominant arm, at Day 0.

    Reporting group title
    Boostrix Prev Group
    Reporting group description
    		 Subjects, aged 10 to 15 years, received one dose of Boostrix vaccine administered using a previous syringe presentation (single dose vial or a prefilled disposable syringe without a needle) in the deltoid of the non-dominant arm, at Day 0.

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

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    End point title
    		 Anti-diphteria (anti-D) and anti-tetanus (anti-T) antibody concentrations
    End point description
    Concentrations are presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).
    End point type
    Primary
    End point timeframe
    At Month 1
    End point values
    		 Boostrix New Group Boostrix Prev Group
    Number of subjects analysed
    321
    319
    Units: IU/mL
    geometric mean (confidence interval 95%)
        Anti-D
    6.784 (6.178 to 7.45)
    6.493 (5.915 to 7.128)
        Anti-T
    18.937 (17.313 to 20.713)
    18.515 (16.851 to 20.342)
    Statistical analysis title
    		 Adjusted ratios of GMCs for anti-D
    Statistical analysis description
    Analysis was performed to demonstrate that the Boostrix vaccine administered using the new-syringe presentation was non-inferior to Boostrix vaccine administered using the previous-syringe, in terms of immune response to diphteria vaccine antigens, one month after booster vaccination.
    Comparison groups
    Boostrix New Group v Boostrix Prev Group
    Number of subjects included in analysis
    640
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    Method
    		 ANCOVA
    Parameter type
    		 Adjusted Ratio
    Point estimate
    0.96
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.85
         upper limit
    		 1.09
    Notes
    [1] - The upper limit (UL) of the 95% confidence interval (CI) on the geometric mean concentration (GMC) ratios [Boostrix-Prev Group over Boostrix-New Group] for anti-diphtheria (anti-D)antibodies was lesser than or equal to (≤) 1.5 (clinical limit for non-inferiority).
    Statistical analysis title
    		 Adjusted ratios of GMCs for anti-T
    Statistical analysis description
    Analysis was performed to demonstrate that the Boostrix vaccine administered using the new-syringe presentation was non-inferior to Boostrix vaccine administered using the previous-syringe, in terms of immune response to tetanus vaccine antigens, one month after booster vaccination.
    Comparison groups
    Boostrix New Group v Boostrix Prev Group
    Number of subjects included in analysis
    640
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [2]
    Method
    		 ANCOVA
    Parameter type
    		 Adjusted Ratio
    Point estimate
    0.97
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.86
         upper limit
    		 1.1
    Notes
    [2] - The upper limit (UL) of the 95% confidence interval (CI) on the geometric mean concentration (GMC) ratios [Boostrix-Prev Group over Boostrix-New Group] for anti-tetanus (anti-T) antibodies was ≤ 1.5 (clinical limit for non-inferiority).

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

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    End point title
    		 Anti-pertussis toxoid (anti-PT), anti-filamentous haemagglutinin (anti-FHA), anti-pertactin (anti-PRN) antibody concentrations
    End point description
    Concentrations are 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
    End point values
    		 Boostrix New Group Boostrix Prev Group
    Number of subjects analysed
    321
    319
    Units: EU/mL
    geometric mean (confidence interval 95%)
        Anti-PT [N=318;318]
    140.2 (126 to 156.1)
    125.9 (112.7 to 140.7)
        Anti-FHA [N=319;319]
    1080.2 (995.2 to 1172.5)
    1013.7 (940 to 1093.2)
        Anti-PRN [N=321;318]
    652.4 (572.1 to 743.9)
    619.2 (546 to 702.2)
    Statistical analysis title
    		 Adjusted ratios of GMCs for anti-PT
    Statistical analysis description
    Analysis was performed to demonstrate that the Boostrix vaccine administered using the new-syringe presentation was non-inferior to Boostrix vaccine administered using the previous-syringe, in terms of immune response to pertussis toxoid vaccine antigens, one month after booster vaccination.
    Comparison groups
    Boostrix New Group v Boostrix Prev Group
    Number of subjects included in analysis
    640
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [3]
    Method
    		 ANCOVA
    Parameter type
    		 Adjusted Ratio
    Point estimate
    0.92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.82
         upper limit
    		 1.04
    Notes
    [3] - The upper limit (UL) of the 95% confidence interval (CI) on the geometric mean concentration (GMC) ratios [Boostrix-Prev Group over Boostrix-New Group] for anti-pertussis toxoid (anti-PT) antibodies was ≤ 1.5 (clinical limit for non-inferiority).
    Statistical analysis title
    		 Adjusted ratios of GMCs for anti-FHA
    Statistical analysis description
    Analysis was performed to demonstrate that the Boostrix vaccine administered using the new-syringe presentation was non-inferior to Boostrix vaccine administered using the previous-syringe, in terms of immune response to filamentous haemagglutinin vaccine antigens, one month after booster vaccination.
    Comparison groups
    Boostrix New Group v Boostrix Prev Group
    Number of subjects included in analysis
    640
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [4]
    Method
    		 ANCOVA
    Parameter type
    		 Adjusted Ratio
    Point estimate
    0.92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.83
         upper limit
    		 1.03
    Notes
    [4] - The upper limit (UL) of the 95% confidence interval (CI) on the geometric mean concentration (GMC) ratios [Boostrix-Prev Group over Boostrix-New Group] for anti-filamentous haemagglutinin (anti-FHA) antibodies was ≤ 1.5 (clinical limit for non-inferiority).
    Statistical analysis title
    		 Adjusted ratios of GMCs for anti-PRN
    Statistical analysis description
    Analysis was performed to demonstrate that the Boostrix vaccine administered using the new-syringe presentation was non-inferior to Boostrix vaccine administered using the previous-syringe, in terms of immune response to pertactin vaccine antigens, one month after booster vaccination.
    Comparison groups
    Boostrix New Group v Boostrix Prev Group
    Number of subjects included in analysis
    640
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [5]
    Method
    		 ANCOVA
    Parameter type
    		 Adjusted Ratio
    Point estimate
    0.98
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.85
         upper limit
    		 1.13
    Notes
    [5] - The upper limit (UL) of the 95% confidence interval (CI) on the geometric mean concentration (GMC) ratios [Boostrix-Prev Group over Boostrix-New Group] for anti-pertactin (anti-PRN) antibodies was ≤ 1.5 (clinical limit for non-inferiority).

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

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    End point title
    		 Anti-diphteria (anti-D) and anti-tetanus (anti-T) antibody concentrations [6]
    End point description
    Concentrations are presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).
    End point type
    Primary
    End point timeframe
    At Day 0
    Notes
    [6] - 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 New Group Boostrix Prev Group
    Number of subjects analysed
    321
    319
    Units: IU/mL
    geometric mean (confidence interval 95%)
        Anti-D
    0.472 (0.403 to 0.553)
    0.456 (0.392 to 0.53)
        Anti-T
    0.956 (0.835 to 1.095)
    0.899 (0.789 to 1.026)
    No statistical analyses for this end point

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

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    End point title
    		 Anti-pertussis toxoid (anti-PT), anti-filamentous haemagglutinin (anti-FHA), anti-pertactin (anti-PRN) antibody concentrations [7]
    End point description
    Concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL).
    End point type
    Primary
    End point timeframe
    At Day 0
    Notes
    [7] - 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 New Group Boostrix Prev Group
    Number of subjects analysed
    320
    319
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        Anti-PT PRE [N=320;319]
    7.5 (6.6 to 8.7)
    7.2 (6.3 to 8.2)
        Anti-FHA PRE [N=316;315]
    48.9 (43.3 to 55.2)
    49.4 (43.6 to 56)
        Anti-PRN PRE [N=321;319]
    14 (12.3 to 15.9)
    13.4 (11.9 to 15)
    No statistical analyses for this end point

    Secondary: Number of seropositive subjects against Diphtheria(D) and Tetanus(T) antigens

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    End point title
    		 Number of seropositive subjects against Diphtheria(D) and Tetanus(T) antigens
    End point description
    A seroprotected subject was defined as a subject whose antibody concentration was greater than or equal to (≥) 0.1. international units per milliliter (IU/mL), as assessed by the Enzyme Linked Immunosorbent Assay (ELISA).
    End point type
    Secondary
    End point timeframe
    At Day 0 (PRE) and at Month 1 (POST)
    End point values
    		 Boostrix New Group Boostrix Prev Group
    Number of subjects analysed
    321
    319
    Units: subjects
        Anti-D PRE
    284
    286
        Anti-D POST
    320
    319
        Anti-T PRE
    311
    314
        Anti-T POST
    321
    319
    No statistical analyses for this end point

    Secondary: Number of seroprotected subjects against Diphtheria(D) and Tetanus(T) antigens

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    End point title
    		 Number of seroprotected subjects against Diphtheria(D) and Tetanus(T) antigens
    End point description
    A seroprotected subject is defined as a vaccinated subject with anti-D and anti-T antibody concentration greater than or equal to ( ≥) 1 international units per milliliter (IU/mL).
    End point type
    Secondary
    End point timeframe
    At Day 0 (PRE) vaccine and at Month 1 (POST)
    End point values
    		 Boostrix New Group Boostrix Prev Group
    Number of subjects analysed
    321
    319
    Units: subjects
        Anti-D PRE
    83
    89
        Anti-D POST
    315
    310
        Anti-T PRE
    151
    143
        Anti-T POST
    321
    319
    No statistical analyses for this end point

    Secondary: Number of seropositive subjects with anti-pertussis toxoid (anti-PT), anti-filamentous haemagglutin (anti-FHA) and anti-pertactin (anti-PRN) antibody concentrations

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    End point title
    		 Number of seropositive subjects with anti-pertussis toxoid (anti-PT), anti-filamentous haemagglutin (anti-FHA) and anti-pertactin (anti-PRN) antibody concentrations
    End point description
    A seroprotected subject was defined as a subject whose antibody concentration was greater than or equal to (≥) 5 Enzyme Linked Immunosorbent Assay (ELISA) units per milliliter (EL.U/mL).
    End point type
    Secondary
    End point timeframe
    At Day 0 (PRE) vaccine and at Month 1 (POST)
    End point values
    		 Boostrix New Group Boostrix Prev Group
    Number of subjects analysed
    321
    319
    Units: subjects
        Anti-PT PRE [N=320;319]
    175
    175
        Anti-PT POST [N=318;318]
    316
    315
        Anti-FHA PRE [N=316;315]
    310
    310
        Anti-FHA POST [N=319;319]
    319
    319
        Anti-PRN PRE [N=321;319]
    269
    272
        Anti-PRN POST [N=321;318]
    321
    318
    No statistical analyses for this end point

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

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    End point title
    		 Number of subjects with booster response to diphtheria (D) and tetanus (T) antibodies
    End point description
    Booster response to the diphtheria and tetanus antigens, was defined as: for initially seronegative subjects (pre-vaccination concentration <0.1 IU/mL): antibody concentrations at least 4 times the 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 4 times the pre-vaccination concentration.
    End point type
    Secondary
    End point timeframe
    At Month 1
    End point values
    		 Boostrix New Group Boostrix Prev Group
    Number of subjects analysed
    321
    319
    Units: subjects
        Anti-D
    257
    252
        Anti-T
    266
    270
    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 to the PT, FHA and PRN antigens, was defined as: for initially seronegative subjects: antibody concentrations at least 4 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 4 times the pre-vaccination concentration; and for initially seropositive subjects with pre-vaccination concentration ≥ 20 EL.U/mL: an increase in antibody concentrations of at least 2 times the pre-vaccination concentration.
    End point type
    Secondary
    End point timeframe
    At Month 1
    End point values
    		 Boostrix New Group Boostrix Prev Group
    Number of subjects analysed
    321
    318
    Units: subjects
        Anti-PT [N=317;318]
    298
    295
        Anti-FHA [N=314;315]
    305
    304
        Anti-PRN [N=321;318]
    315
    317
    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
    Within 4 days (Days 0-3) post vaccination period
    End point values
    		 Boostrix New Group Boostrix Prev Group
    Number of subjects analysed
    330
    329
    Units: subjects
        Any Pain
    237
    248
        Any Redness
    113
    94
        Any Swelling
    98
    90
    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, temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], headache and gastrointestinal symptoms. Gastrointestinal symptoms included Nausea, Vomiting, Diarrhea and or Abdominal pain. Any = occurrence of the symptom regardless of intensity grade.
    End point type
    Secondary
    End point timeframe
    Within 4 days (Days 0-3) post vaccination period
    End point values
    		 Boostrix New Group Boostrix Prev Group
    Number of subjects analysed
    330
    329
    Units: subjects
        Any Fatigue
    83
    86
        Any Gastrointestinal symptoms
    32
    42
        Any Headache
    88
    108
        Any Temperature
    9
    6
    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
    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
    Within 31 days (Days 0-30) post vaccination period
    End point values
    		 Boostrix New Group Boostrix Prev Group
    Number of subjects analysed
    335
    336
    Units: subjects
        Any unsolicited AEs
    44
    45
    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 (Day 0 - Month 1)
    End point values
    		 Boostrix New Group Boostrix Prev Group
    Number of subjects analysed
    335
    336
    Units: subjects
        Any SAEs
    1
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited symptoms during the 4-day post-vaccination period (Day 0 - Day 3), Unsolicited AEs during the 31-day post-vaccination period (Day 0 - Day 30), SAEs during the entire period (Day 0 - Month 1).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    Boostrix Prev Group
    Reporting group description
    		 Subjects, aged 10 to 15 years, received one dose of Boostrix vaccine administered using a previous syringe presentation (single dose vial or a prefilled disposable syringe without a needle) in the deltoid of the non-dominant arm, at Day 0.

    Reporting group title
    Boostrix New Group
    Reporting group description
    		 Subjects, aged 10 to 15 years, received one dose of Boostrix vaccine administered using a new syringe presentation (prefilled syringes from a different manufacturer) in the deltoid of the non-dominant arm, at Day 0.

    Serious adverse events
    		 Boostrix Prev Group Boostrix New Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 336 (0.00%)
    1 / 335 (0.30%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Injury
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 336 (0.00%)
    1 / 335 (0.30%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Boostrix Prev Group Boostrix New Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    279 / 336 (83.04%)
    263 / 335 (78.51%)
    General disorders and administration site conditions
    Pain
         subjects affected / exposed
    248 / 336 (73.81%)
    237 / 335 (70.75%)
         occurrences all number
    248
    237
    Redness
         subjects affected / exposed
    94 / 336 (27.98%)
    113 / 335 (33.73%)
         occurrences all number
    94
    113
    Swelling
         subjects affected / exposed
    90 / 336 (26.79%)
    98 / 335 (29.25%)
         occurrences all number
    90
    98
    Fatigue
         subjects affected / exposed
    86 / 336 (25.60%)
    83 / 335 (24.78%)
         occurrences all number
    86
    83
    Gastrointestinal symptoms
         subjects affected / exposed
    42 / 336 (12.50%)
    32 / 335 (9.55%)
         occurrences all number
    42
    32
    Headache
         subjects affected / exposed
    109 / 336 (32.44%)
    89 / 335 (26.57%)
         occurrences all number
    110
    90

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    29 May 2012
    At the European Medicines Agency’s (EMA) request, GSK Biologicals has updated its procedure for emergency unblinding during the conduct of a clinical study. According to the revised procedure, the responsibility and the decision to break the treatment code in emergency situations resides solely with the investigator and consequently, the investigator will have full authority to break the treatment code. The Emergency unblinding is not applicable for open and single blind studies anymore. Therefore the section has been deleted.

    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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