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    Clinical Trial Results:
    A phase III, single-group, open-label study to assess the safety and reactogenicity of GSK Biologicals’ combined reduced-antigen-content diphtheria-tetanus-acellular pertussis (dTpa) vaccine Boostrix administered as a booster vaccine dose in healthy Vietnamese children.

    Summary
    EudraCT number
    		 2013-003859-37
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    10 May 2014

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

    Trial information

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    Trial identification
    Sponsor protocol code
    115739
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    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
    24 Jul 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    10 May 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    10 May 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the safety and reactogenicity of the study vaccine in terms of solicited symptoms, unsolicited symptoms and serious adverse events (SAEs).
    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
    22 Feb 2014
    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
    Vietnam: 302
    Worldwide total number of subjects
    302
    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)
    302
    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
    		 Out of the 302 subjects enrolled into the study, 2 were excluded due to developing allergic reactions and hence only 300 started the study.

    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.

    Pre-assignment period milestones
    Number of subjects started
    		 302
    Number of subjects completed
    		 300

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Excluded due to allergic reaction: 2
    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Boostrix Group
    Arm description
    		 Subjects received a single dose of Boostrix vaccine at 6-10 years of age.
    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
    Single-dose administered, on day 0, intramuscularly in the deltoid region of non-dominant arm.

    Number of subjects in period 1 [1]
    		Boostrix Group
    Started
    300
    Completed
    300
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Two subjects were excluded from the study due to an allergic reaction.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Boostrix Group
    Reporting group description
    		 Subjects received a single dose of Boostrix vaccine at 6-10 years of age.

    Reporting group values
    		 Boostrix Group Total
    Number of subjects
    		 300 300
    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)
    		 7.9 ( 1.38 ) -
    Gender categorical
    Units: Subjects
        Female
    		 151 151
        Male
    		 149 149
    Race/Ethnicity
    Units: Subjects
        Asian-South East Asian heritage
    		 300 300

    End points

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    End points reporting groups
    Reporting group title
    Boostrix Group
    Reporting group description
    		 Subjects received a single dose of Boostrix vaccine at 6-10 years of age.

    Primary: Numbers of subjects with any and grade 3 solicited local symptoms

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    End point title
    		 Numbers of subjects with any and grade 3 solicited local symptoms [1]
    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 100 millimeters (mm) of injection site. Relationship analysis was not performed.
    End point type
    Primary
    End point timeframe
    Within 4 days (Days 0-3) post vaccination period
    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
    Number of subjects analysed
    300
    Units: subjects
        Any Pain
    105
        Any Redness
    55
        Any Swelling
    40
        Grade 3 Pain
    1
        Grade 3 Redness
    1
        Grade 3 Swelling
    3
    No statistical analyses for this end point

    Primary: 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 [2]
    End point description
    Assessed solicited general symptoms were fatigue, gastrointestinal symptoms, headache and temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. 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
    Primary
    End point timeframe
    Within 4 days (Days 0-3) post vaccination period
    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
    Number of subjects analysed
    300
    Units: subjects
        Any Fatigue
    42
        Any Gastrointestinal symptoms
    15
        Any Headache
    33
        Any Temperature
    14
        Grade 3 Fatigue
    1
        Grade 3 Gastrointestinal symptoms
    0
        Grade 3 Headache
    0
        Grade 3 Temperature
    0
        Related Fatigue
    40
        Related Gastrointestinal symptoms
    14
        Related Headache
    33
        Related Temperature
    13
    No statistical analyses for this end point

    Primary: Number of subjects with unsolicited adverse events (AEs)

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    End point title
    		 Number of subjects with unsolicited adverse events (AEs) [3]
    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
    Primary
    End point timeframe
    Within 31 days (Days 0-30) post vaccination period
    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
    Number of subjects analysed
    300
    Units: subjects
        Any unsolicited AEs
    19
    No statistical analyses for this end point

    Primary: Number of subjects with serious adverse events (SAEs)

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    End point title
    		 Number of subjects with serious adverse events (SAEs) [4]
    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
    Primary
    End point timeframe
    During the entire study period (From Day 0 to Day 30)
    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
    Number of subjects analysed
    300
    Units: subjects
        Any SAEs
    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 (Days 0-3) post-vaccination period, Unsolicited AEs during the 31-day (Days 0-30) post-vaccination period, SAEs during the entire study period (from Day 0 to Day 30).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.0
    Reporting groups
    Reporting group title
    Boostrix Group
    Reporting group description
    		 Subjects received a single dose of Boostrix vaccine at 6-10 years of age.

    Serious adverse events
    		 Boostrix Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 300 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Boostrix Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    133 / 300 (44.33%)
    General disorders and administration site conditions
    Pain
         subjects affected / exposed
    105 / 300 (35.00%)
         occurrences all number
    105
    Redness
         subjects affected / exposed
    55 / 300 (18.33%)
         occurrences all number
    55
    Swelling
         subjects affected / exposed
    40 / 300 (13.33%)
         occurrences all number
    40
    Fatigue
         subjects affected / exposed
    42 / 300 (14.00%)
         occurrences all number
    42
    Gastrointestinal symptoms
         subjects affected / exposed
    15 / 300 (5.00%)
         occurrences all number
    15
    Headache
         subjects affected / exposed
    33 / 300 (11.00%)
         occurrences all number
    33

    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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    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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