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    Clinical Trial Results:
    An open, phase IV, non-randomised, single-centre study with two study groups to assess the immunogenicity and reactogenicity of a booster dose of GlaxoSmithKline (GSK) Biologicals' combined reduced antigen content diphtheria-tetanus toxoids and acellular pertussis vaccine (Boostrix), when administered in young adults, 10 years after previous booster vaccination in study 263855/004 (dTpa-004).

    Summary
    EudraCT number
    		 2007-003248-31
    Trial protocol
    		 FI  
    Global end of trial date
    30 Apr 2008

    Results information
    Results version number
    		 v3(current)
    This version publication date
    08 May 2021
    First version publication date
    06 Jun 2015
    Other versions
    		 v1 , v2
    Version creation reason
    • Correction of full data set
    Results have been amended to account for consistency with other registries.

    Trial information

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    Trial identification
    Sponsor protocol code
    110806
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00610168
    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)
    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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    01 Oct 2008
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Apr 2008
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Apr 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate that a booster dose of dTpa vaccine, administered to young adults 10 years after a previous dose of the dTpa vaccine, elicited seroprotective antibody concentrations in at least 80% of the subjects against diphtheria and in at least 90% of the subjects against tetanus one month after the booster dose.
    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
    23 Jan 2008
    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
    Finland: 82
    Worldwide total number of subjects
    82
    EEA total number of subjects
    82
    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)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    82
    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 (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Boostrix I Group
    Arm description
    		 Subjects who had received the dTpa vaccine in the primary study (263855/004)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Boostrix™
    Investigational medicinal product code
    Other name
    dTPa vaccine
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received a single booster dose of dTpa vaccine administered intramuscularly in the deltoid region of the non-dominant arm.

    Arm title
    		 Boostrix II Group
    Arm description
    		 Subjects who had received the Td + pa vaccines in the primary study (263855/004)
    Arm type
    		 Experimental

    Investigational medicinal product name
    Boostrix™
    Investigational medicinal product code
    Other name
    dTPa vaccine
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received a single booster dose of dTpa vaccine administered intramuscularly in the deltoid region of the non-dominant arm.

    Number of subjects in period 1
    		Boostrix I Group Boostrix II Group
    Started
    75
    7
    Completed
    73
    7
    Not completed
    2
    0
         Consent withdrawn by subject
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Boostrix I Group
    Reporting group description
    		 Subjects who had received the dTpa vaccine in the primary study (263855/004)

    Reporting group title
    Boostrix II Group
    Reporting group description
    		 Subjects who had received the Td + pa vaccines in the primary study (263855/004)

    Reporting group values
    		 Boostrix I Group Boostrix II Group Total
    Number of subjects
    		 75 7 82
    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)
    		 21.1 ± 0.31 21.1 ± 0.38 -
    Gender categorical
    Units: Subjects
        Female
    		 66 6 72
        Male
    		 9 1 10

    End points

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    End points reporting groups
    Reporting group title
    Boostrix I Group
    Reporting group description
    		 Subjects who had received the dTpa vaccine in the primary study (263855/004)

    Reporting group title
    Boostrix II Group
    Reporting group description
    		 Subjects who had received the Td + pa vaccines in the primary study (263855/004)

    Subject analysis set title
    Boostrix Pooled Group
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    For safety assessment, the 2 groups (Boostrix I Group + Boostrix II Group) were pooled (Pooled Group).

    Primary: Number of subjects with anti-diphtheria (Anti-DT) and anti-tetanus toxoids (Anti-TT) antibody concentrations equal to or above (≥) 0.1 international units per milliliter (IU/mL) and ≥ 1 IU/mL

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    End point title
    		 Number of subjects with anti-diphtheria (Anti-DT) and anti-tetanus toxoids (Anti-TT) antibody concentrations equal to or above (≥) 0.1 international units per milliliter (IU/mL) and ≥ 1 IU/mL [1]
    End point description
    The primary efficacy results were reported for the Boostrix I Group one month after the booster dose
    End point type
    Primary
    End point timeframe
    Prior to and one month after the booster vaccination in all subjects
    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 I Group Boostrix II Group
    Number of subjects analysed
    74
    7
    Units: Subjects
        Anti-diphtheria ≥ 0.1 IU/mL Pre [N=74;7]
    61
    5
        Anti-diphtheria ≥ 0.1 IU/mL Post [N=73;7]
    73
    7
        Anti-diphtheria ≥ 1 IU/mL Pre [N=74;7]
    17
    0
        Anti-diphtheria ≥ 1 IU/mL Post [N=73;7]
    68
    7
        Anti-tetanus ≥ 0.1 IU/mL Pre [N=74;7]
    72
    7
        Anti-tetanus ≥ 0.1 IU/mL Post [N=73;7]
    73
    7
        Anti-tetanus ≥ 1 IU/mL Pre [N=74;7]
    44
    4
        Anti-tetanus ≥ 1 IU/mL Post [N=73;7]
    71
    7
    No statistical analyses for this end point

    Secondary: Anti-diphtheria (Anti-DT) and anti-tetanus toxoids (Anti-TT) antibody concentrations

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    End point title
    		 Anti-diphtheria (Anti-DT) and anti-tetanus toxoids (Anti-TT) antibody concentrations
    End point description
    End point type
    Secondary
    End point timeframe
    Prior to and one month after the booster vaccination
    End point values
    		 Boostrix I Group Boostrix II Group
    Number of subjects analysed
    74
    7
    Units: IU/mL
    geometric mean (confidence interval 95%)
        Anti-diphtheria Pre [N=74;7]
    0.318 (0.24 to 0.421)
    0.196 (0.068 to 0.568)
        Anti-diphtheria Post [N=73;7]
    5.994 (4.679 to 7.68)
    3.226 (1.741 to 5.975)
        Anti-tetanus Pre [N=74;7]
    1.246 (0.956 to 1.623)
    0.989 (0.498 to 1.961)
        Anti-tetanus Post [N=73;7]
    9.596 (7.986 to 11.531)
    8.975 (5.277 to 15.264)
    No statistical analyses for this end point

    Secondary: Number of seropositive subjects with anti-pertussis toxoid (anti-PT), anti-filamentous haemagglutinin (anti-FHA) and anti-pertactin (anti-PRN) antibody concentrations ≥ 5 ELISA unit per milli-liter (EL.U/ml)

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    End point title
    		 Number of seropositive subjects with anti-pertussis toxoid (anti-PT), anti-filamentous haemagglutinin (anti-FHA) and anti-pertactin (anti-PRN) antibody concentrations ≥ 5 ELISA unit per milli-liter (EL.U/ml)
    End point description
    End point type
    Secondary
    End point timeframe
    Prior to and one month after the booster vaccination
    End point values
    		 Boostrix I Group Boostrix II Group
    Number of subjects analysed
    75
    7
    Units: Subjects
        Anti-PT Pre [N=75;7]
    46
    7
        Anti-PT Post [N=73;7]
    73
    7
        Anti-FHA Pre [N=75;7]
    75
    7
        Anti-FHA Post [N=73;7]
    73
    7
        Anti-PRN Pre [N=75;7]
    72
    7
        Anti-PRN Post [N=73;7]
    73
    7
    No statistical analyses for this end point

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

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    End point title
    		 Anti-pertussis toxoid (anti-PT), anti-filamentous haemagglutinin (anti-FHA) and anti-pertactin (anti-PRN) antibody concentrations
    End point description
    End point type
    Secondary
    End point timeframe
    Prior to and one month after the booster vaccination
    End point values
    		 Boostrix I Group Boostrix II Group
    Number of subjects analysed
    75
    7
    Units: EL.U/ml
    geometric mean (confidence interval 95%)
        Anti-PT Pre [N=75;7]
    9.1 (6.9 to 11.9)
    12.5 (8.8 to 17.9)
        Anti-PT Post [N=73;7]
    90.3 (73.9 to 110.5)
    116.5 (56.5 to 240.5)
        Anti-FHA Pre [N=75;7]
    63.8 (53.1 to 76.8)
    118.8 (80.6 to 175.1)
        Anti-FHA Post [N=73;7]
    793.4 (670.3 to 939.2)
    584.3 (248.3 to 1374.9)
        Anti-PRN Pre [N=75;7]
    36.9 (27.7 to 49.2)
    41.8 (20.3 to 85.9)
        Anti-PRN Post [N=73;7]
    548.1 (456.9 to 657.5)
    685.3 (243.5 to 1928.4)
    No statistical analyses for this end point

    Secondary: Number of subjects with vaccine 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 vaccine response to anti-pertussis toxoid (anti-PT), anti-filamentous haemagglutinin (anti-FHA) and anti-pertactin (anti-PRN)
    End point description
    Booster response was defined as appearance of antibodies in subjects who were seronegative at the pre-vaccination time point (i.e. with concentrations < 5 El.U/mL) or at least 2-fold increase of prevaccination antibody concentrations in subjects who were seropositive at the pre-vaccination time point (i.e. with concentrations ≥5 El.U/mL.
    End point type
    Secondary
    End point timeframe
    One month after booster vaccination
    End point values
    		 Boostrix I Group Boostrix II Group
    Number of subjects analysed
    73
    7
    Units: Subjects
        Anti-PT [N=73;7]
    72
    7
        Anti-FHA [N=73;7]
    71
    6
        Anti-PRN [N=73;7]
    68
    7
    No statistical analyses for this end point

    Secondary: Number of subjects with any and Grade 3 solicited local symptoms

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    End point title
    		 Number of subjects with any and Grade 3 solicited local symptoms
    End point description
    Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Day 0–3) follow-up period after booster vaccination.
    End point values
    		 Boostrix Pooled Group
    Number of subjects analysed
    81
    Units: Subjects
        Any pain
    76
        Grade 3 pain
    8
        Any redness
    48
        Grade 3 redness
    14
        Any swelling
    46
        Grade 3 swelling
    15
    No statistical analyses for this end point

    Secondary: Number of subjects with any, Grade 3 and related solicited general symptoms

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    End point title
    		 Number of subjects with any, Grade 3 and related solicited general symptoms
    End point description
    Assessed solicited general symptoms were fatigue, fever [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)], headache and gastrointestinal symptoms. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Day 0–3) follow-up period after booster vaccination.
    End point values
    		 Boostrix Pooled Group
    Number of subjects analysed
    81
    Units: Subjects
        Any Fatigue
    44
        Grade 3 Fatigue
    2
        Related Fatigue
    36
        Any Fever
    7
        Grade 3 Fever
    0
        Related Fever
    7
        Any Gastrointestinal
    14
        Grade 3 Gastrointestinal
    1
        Related Gastrointestinal
    8
        Any Headache
    27
        Grade 3 Headache
    0
        Related Headache
    22
    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.
    End point type
    Secondary
    End point timeframe
    During the 31-day (Day 0–30) follow-up period after booster vaccination
    End point values
    		 Boostrix Pooled Group
    Number of subjects analysed
    82
    Units: Subjects
        AEs
    26
    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
    From Month 0 to Month 1
    End point values
    		 Boostrix Pooled Group
    Number of subjects analysed
    82
    Units: Subjects
        SAEs
    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 post vaccination period. Unsolicited AE(s): during the 31-day post vaccination period. SAEs: during the entire study period (from Month 0 to Month 1).
    Adverse event reporting additional description
    The occurrence of reported AEs (all/related) was not available and is encoded as equal to the number of subjects affected.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    11.0
    Reporting groups
    Reporting group title
    Pooled Group
    Reporting group description
    		 -

    Serious adverse events
    		 Pooled Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 82 (1.22%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Respiratory, thoracic and mediastinal disorders
    Hyperventilation
         subjects affected / exposed
    1 / 82 (1.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Pooled Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    78 / 82 (95.12%)
    General disorders and administration site conditions
    Pain
    alternative assessment type: Systematic
         subjects affected / exposed
    76 / 82 (92.68%)
         occurrences all number
    76
    Redness
    alternative assessment type: Systematic
         subjects affected / exposed
    48 / 82 (58.54%)
         occurrences all number
    48
    Swelling
    alternative assessment type: Systematic
         subjects affected / exposed
    46 / 82 (56.10%)
         occurrences all number
    46
    Fatigue
    alternative assessment type: Systematic
         subjects affected / exposed
    44 / 82 (53.66%)
         occurrences all number
    44
    Fever (Axillary)
    alternative assessment type: Systematic
         subjects affected / exposed
    7 / 82 (8.54%)
         occurrences all number
    7
    Gastrointestinal
    alternative assessment type: Systematic
         subjects affected / exposed
    14 / 82 (17.07%)
         occurrences all number
    14
    Headache
    alternative assessment type: Systematic
         subjects affected / exposed
    27 / 82 (32.93%)
         occurrences all number
    27
    Infections and infestations
    Influenza
         subjects affected / exposed
    6 / 82 (7.32%)
         occurrences all number
    6

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    22 Nov 2007
    Amendment 1 The immunity to pertussis induced by vaccination is known to wane over time. The necessity to maintain a sufficient immunity to pertussis disease throughout adulthood via regular boosters is being considered. One practical way to achieve this would be to use the opportunity of the currently generally recommended dT decennial booster to add on a pertussis booster, using the dTpa vaccine. The persistence of the immune response in adolescents and adults has been studied up to five years after dTpa booster vaccination. Data currently suggest that sufficient immunity is still present at that time. This study is a follow-up of study 263855/004 (dTpa-004), in which healthy adolescents aged of 10 to 14 years received a dTpa booster. The purpose of this study is to evaluate in these subjects, 10 years later, the persistence of antibodies against all the vaccine antigens, and to evaluate the immunogenicity and reactogenicity of a second dTpa booster dose.

    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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    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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