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    Clinical Trial Results:
    A phase III, open, randomised, multicentre study to assess the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals’ combined reduced antigen content diphtheria-tetanus toxoids and acellular pertussis vaccine (Boostrix™) and the Chinese DT vaccine, when administered as booster vaccination in healthy children aged 6-8 years who were previously vaccinated with four doses of combined diphtheria-tetanus-pertussis (DTP) vaccine in the first two years of life.

    Summary
    EudraCT number
    		 2016-000644-34
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    12 May 2007

    Results information
    Results version number
    		 v1(current)
    This version publication date
    23 Jul 2016
    First version publication date
    23 Jul 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    108638
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00452686
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline Biologicals
    Sponsor organisation address
    Rue de l’Institut 89, Rixensart, Belgium, B-1330
    Public contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, +44 2089904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, +44 2089904466, GSKClinicalSupportHD@gsk.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    19 Sep 2007
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    12 May 2007
    Global end of trial reached?
    Yes
    Global end of trial date
    12 May 2007
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    One month after the booster dose: To evaluate the immunogenicity of GSK Biologicals’ dTpa vaccine, in terms of antibody response to all vaccine antigens. To assess the immunogenicity of the Chinese DT vaccine in terms of antibody response to diphtheria and tetanus toxoids
    Protection of trial subjects
    The vaccinees will be observed closely for at least 30 minutes following the administration of vaccine, with appropriate medical treatment readily available in case of a rare anaphylactic reaction.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    30 Mar 2007
    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
    China: 660
    Worldwide total number of subjects
    660
    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)
    660
    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 Group
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Boostrix™
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received a single booster dose of Boostrix™ vaccine as an intramuscular injection into the left deltoid muscle.

    Arm title
    		 DT Group
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Chinese DT vaccine (adsorbed diphtheria and tetanus toxoid (DT) vaccine)
    Investigational medicinal product code
    Other name
    WIBP DT
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received a single booster dose of Wuhan Institute of Biological Products’ (WIBP) adsorbed diphtheria and tetanus toxoid vaccine (DT) as an intramuscular injection into the left deltoid muscle.

    Number of subjects in period 1
    		Boostrix Group DT Group
    Started
    330
    330
    Completed
    329
    330
    Not completed
    1
    0
         Migrated/moved from study area
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Boostrix Group
    Reporting group description
    		 -

    Reporting group title
    DT Group
    Reporting group description
    		 -

    Reporting group values
    		 Boostrix Group DT Group Total
    Number of subjects
    		 330 330 660
    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)
    		 6.3 ( 0.46 ) 6.3 ( 0.46 ) -
    Gender categorical
    Units: Subjects
        Female
    		 131 133 264
        Male
    		 199 197 396

    End points

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    End points reporting groups
    Reporting group title
    Boostrix Group
    Reporting group description
    		 -

    Reporting group title
    DT Group
    Reporting group description
    		 -

    Primary: Number of seroprotected subjects against anti-diphtheria (anti-D) and anti-tetanus (anti-T) antigens.

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    End point title
    		 Number of seroprotected subjects against anti-diphtheria (anti-D) and anti-tetanus (anti-T) antigens. [1]
    End point description
    A seroprotected subject, is a subject whose anti-D/anti-T antibody concentrations are greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).
    End point type
    Primary
    End point timeframe
    At Month 1
    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 Group DT Group
    Number of subjects analysed
    161
    162
    Units: Subjects
        Anti-D at Month 1
    161
    161
        Anti-T at Month 1
    161
    162
    No statistical analyses for this end point

    Primary: Number of subjects with booster response to anti-pertussis toxoid (anti-PT), anti-filamentous haemagglutinin (anti-FHA) and anti-pertactin (anti-PRN)

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    End point title
    		 Number of subjects with booster response to anti-pertussis toxoid (anti-PT), anti-filamentous haemagglutinin (anti-FHA) and anti-pertactin (anti-PRN) [2]
    End point description
    Booster response was defined as Anti-PT and anti-FHA antibody concentrations ≥ 20 ELISA units per millilitre (EL.U/mL), and at least a four-fold increase in anti-PRN antibody concentrations from pre-vaccination to post-vaccination time points.
    End point type
    Primary
    End point timeframe
    At Month 1
    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 Group DT Group
    Number of subjects analysed
    161
    162
    Units: Subjects
        Anti-PT
    148
    22
        Anti-FHA
    159
    89
        Anti-PRN
    135
    7
    No statistical analyses for this end point

    Primary: Anti-D and anti-T antibody concentrations

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    End point title
    		 Anti-D and anti-T antibody concentrations [3]
    End point description
    End point type
    Primary
    End point timeframe
    At Month 1
    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 Group DT Group
    Number of subjects analysed
    161
    162
    Units: IU/mL
    geometric mean (confidence interval 95%)
        Anti-D at Month 1
    1.06 (0.985 to 1.141)
    1.039 (0.968 to 1.116)
        Anti-T at Month 1
    3.305 (3.119 to 3.502)
    2.496 (2.34 to 2.663)
    No statistical analyses for this end point

    Primary: Anti-PT, anti-FHA and anti-PRN antibody concentrations

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    End point title
    		 Anti-PT, anti-FHA and anti-PRN antibody concentrations [4]
    End point description
    End point type
    Primary
    End point timeframe
    At Month 1
    Notes
    [4] - 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 Group DT Group
    Number of subjects analysed
    161
    162
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        Anti-PT at Month 1
    56.7 (50.5 to 63.6)
    11.9 (11 to 12.9)
        Anti-FHA at Month 1
    330.8 (288.2 to 379.7)
    23 (20 to 26.5)
        Anti-PRN at Month 1
    168.3 (147.4 to 192.3)
    14.8 (13.2 to 16.7)
    No statistical analyses for this end point

    Secondary: Number of seropositive subjects for anti-Pt, anti-FHA, and anti-PRN with an antibody concentration ≥20 ELISA-Units per milliliter (EL.U/mL)

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    End point title
    		 Number of seropositive subjects for anti-Pt, anti-FHA, and anti-PRN with an antibody concentration ≥20 ELISA-Units per milliliter (EL.U/mL)
    End point description
    End point type
    Secondary
    End point timeframe
    At Month 0
    End point values
    		 Boostrix Group DT Group
    Number of subjects analysed
    161
    162
    Units: Subjects
        Anti-PT at Month 0
    7
    9
        Anti-FHA at Month 0
    69
    65
        Anti-PRN at Month 0
    67
    59
    No statistical analyses for this end point

    Secondary: Number of seroprotected subjects with anti-D/anti-T antibody concentrations ≥ 0.1 IU/mL

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    End point title
    		 Number of seroprotected subjects with anti-D/anti-T antibody concentrations ≥ 0.1 IU/mL
    End point description
    A seroprotected subject, is a subject whose anti-D/anti-T antibody concentrations are greater than or equal to (≥) 0.1 international units per millilitre (IU/mL).
    End point type
    Secondary
    End point timeframe
    At Month 0
    End point values
    		 Boostrix Group DT Group
    Number of subjects analysed
    161
    162
    Units: Subjects
        Anti-D at Month 0
    109
    117
        Anti-T at Month 0
    127
    135
    No statistical analyses for this end point

    Secondary: Anti-D/anti-T antibody concentrations

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    End point title
    		 Anti-D/anti-T antibody concentrations
    End point description
    End point type
    Secondary
    End point timeframe
    At Month 0
    End point values
    		 Boostrix Group DT Group
    Number of subjects analysed
    161
    162
    Units: IU/mL
    geometric mean (confidence interval 95%)
        Anti-D at Month 0
    0.109 (0.098 to 0.12)
    0.115 (0.105 to 0.126)
        Anti-T at Month 0
    0.199 (0.171 to 0.23)
    0.23 (0.199 to 0.266)
    No statistical analyses for this end point

    Secondary: Anti-PT, anti-FHA and anti-PRN antibody concentrations

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    End point title
    		 Anti-PT, anti-FHA and anti-PRN antibody concentrations
    End point description
    End point type
    Secondary
    End point timeframe
    At Month 0
    End point values
    		 Boostrix Group DT Group
    Number of subjects analysed
    161
    162
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        Anti-PT at Month 0
    10.5 (10.1 to 11)
    10.5 (10.2 to 10.9)
        Anti-FHA at Month 0
    18.1 (16 to 20.4)
    17.7 (15.7 to 19.9)
        Anti-PRN at Month 0
    17.1 (15 to 19.4)
    15.2 (13.5 to 17.1)
    No statistical analyses for this end point

    Secondary: Number of subjects with solicited local and general symptoms

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    End point title
    		 Number of subjects with solicited local and general symptoms
    End point description
    Solicited local symptoms assessed were pain, redness and swelling. Solicited general symptoms assessed were fatigue, fever (≥37.1 °C), gastrointestinal, headache.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Day 0-Day 3) follow-up period after the booster dose
    End point values
    		 Boostrix Group DT Group
    Number of subjects analysed
    330
    330
    Units: Subjects
        Pain
    63
    67
        Redness
    49
    50
        Swelling
    39
    28
        Fatigue
    13
    11
        Fever
    55
    45
        Gastrointestinal
    11
    13
        Headache
    10
    15
    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 (Day 0-Day 30) follow-up period after the booster dose
    End point values
    		 Boostrix Group DT Group
    Number of subjects analysed
    330
    330
    Units: Subjects
        Any AE(s)
    30
    40
    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 (from Month 0 to Month 1).
    End point values
    		 Boostrix Group DT Group
    Number of subjects analysed
    330
    330
    Units: Subjects
        Any SAE(s)
    0
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited local/general symptoms: During the 4-day (Day 0-Day 3) follow-up period after the booster dose. Unsolicited AE(s): During the 31-day (Day 0-Day 30) follow-up period after the booster dose. SAE(s): During the entire study period.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10.0
    Reporting groups
    Reporting group title
    Boostrix Group
    Reporting group description
    		 -

    Reporting group title
    DT Group
    Reporting group description
    		 -

    Serious adverse events
    		 Boostrix Group DT Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 330 (0.00%)
    1 / 330 (0.30%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Gastrointestinal disorders
    Food poisoning
         subjects affected / exposed
    0 / 330 (0.00%)
    1 / 330 (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 Group DT Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    63 / 330 (19.09%)
    67 / 330 (20.30%)
    General disorders and administration site conditions
    Pain
         subjects affected / exposed
    63 / 330 (19.09%)
    67 / 330 (20.30%)
         occurrences all number
    63
    67
    Redness
         subjects affected / exposed
    49 / 330 (14.85%)
    50 / 330 (15.15%)
         occurrences all number
    49
    50
    Swelling
         subjects affected / exposed
    39 / 330 (11.82%)
    28 / 330 (8.48%)
         occurrences all number
    39
    28
    Fever/axillary
         subjects affected / exposed
    55 / 330 (16.67%)
    45 / 330 (13.64%)
         occurrences all number
    55
    45

    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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    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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