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

    Summary
    EudraCT number
    2015-003405-42
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    31 Aug 2018

    Results information
    Results version number
    v1(current)
    This version publication date
    21 Sep 2019
    First version publication date
    21 Sep 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    201532
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03311659
    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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    10 Mar 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Aug 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Aug 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the immune response to the dTpa vaccine in terms of seroprotection status for antibodies against diphtheria and tetanus antigens and in terms of seropositivity status for antibodies against the pertussis antigens [pertussis toxoid (PT), filamentous haemagglutinin (FHA) and pertactin (PRN)], one month after vaccination.
    Protection of trial subjects
    Appropriate medical treatment was readily available in case of anaphylactic reactions following the administration of the vaccine. For this reason, the vaccinee remained under medical supervision for 30 minutes after vaccination.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    26 Jan 2018
    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
    Russian Federation: 447
    Worldwide total number of subjects
    447
    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)
    130
    Adolescents (12-17 years)
    92
    Adults (18-64 years)
    113
    From 65 to 84 years
    101
    85 years and over
    11

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    Out of 448 enrolled subjects, only 447 were vaccinated. One subject was withdrawn prior to vaccination.

    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
    dTpa group
    Arm description
    Healthy female and male subjects with age 4 years and above and who received a single dose of Boostrix vaccine at Day 1.
    Arm type
    Other

    Investigational medicinal product name
    Boostrix
    Investigational medicinal product code
    Other name
    SB263855
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    1 dose at Day 1

    Number of subjects in period 1
    dTpa group
    Started
    447
    Completed
    446
    Not completed
    1
         Protocol deviation
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    dTpa group
    Reporting group description
    Healthy female and male subjects with age 4 years and above and who received a single dose of Boostrix vaccine at Day 1.

    Reporting group values
    dTpa group Total
    Number of subjects
    447 447
    Age categorical
    Units: Subjects
        In utero
    0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0
        Newborns (0-27 days)
    0 0
        Infants and toddlers (28 days-23 months)
    0 0
        Children (2-11 years)
    130 130
        Adolescents (12-17 years)
    92 92
        Adults (18-64 years)
    113 113
        From 65 to 84 years
    101 101
        85 years and over
    11 11
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    32.7 ± 27.29 -
    Sex: Female, Male
    Units: Subjects
        Female
    241 241
        Male
    206 206
    Race/Ethnicity, Customized
    Units: Subjects
        White-Caucasian/ European heritage
    447 447

    End points

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    End points reporting groups
    Reporting group title
    dTpa group
    Reporting group description
    Healthy female and male subjects with age 4 years and above and who received a single dose of Boostrix vaccine at Day 1.

    Primary: Number of seroprotected subjects for anti-diphtheria (anti-D)

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    End point title
    Number of seroprotected subjects for anti-diphtheria (anti-D) [1]
    End point description
    A seroprotected subject was a subject whose anti-D concentrations are greater than or equal to (≥) 0.1 International units per milliliter (IU/ml). Seroprotection was assessed by enzyme-linked immunosorbent assay (ELISA) method. In addition, sera with ELISA concentrations <0.1 IU/ml were tested for neutralising antibodies using a Vero-cell neutralisation assay. Both the ELISA test (antibody concentrations ≥ 0.1 IU/ml) and Vero-cell test (antibody concentration ≥ 0.01 IU/ml) defined the seroprotection status for the primary endpoint.
    End point type
    Primary
    End point timeframe
    At Day 31
    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: This endpoint was descriptive, hence no statistical analyses were available. 
    End point values
    dTpa group
    Number of subjects analysed
    441
    Units: Participants
        Anti-D antibody ≥ 0.1 IU/ml [N=438]
    437
        Anti-D antibody ≥ 0.01 IU/ml [N=438]
    1
    No statistical analyses for this end point

    Primary: Number of seroprotected subjects for anti-tetanus (anti-T)

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    End point title
    Number of seroprotected subjects for anti-tetanus (anti-T) [2]
    End point description
    A seroprotected subject was a subject whose anti-T concentrations are greater than or equal to (≥) 0.1 International units per milliliter (IU/ml). Seroprotection was assessed by enzyme-linked immunosorbent assay (ELISA) method.
    End point type
    Primary
    End point timeframe
    At Day 31
    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: This endpoint was descriptive, hence no statistical analyses were available. 
    End point values
    dTpa group
    Number of subjects analysed
    441
    Units: Participants
        Anti-T antibody
    439
    No statistical analyses for this end point

    Primary: 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) [3]
    End point description
    A seropositive subject was a subject whose antibody concentration was greater than or equal to the assay cut-off value. Assay cut-off was 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA and 2.187 IU/mL for anti-PRN respectively.
    End point type
    Primary
    End point timeframe
    At Day 31
    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: This endpoint was descriptive, hence no statistical analyses were available. 
    End point values
    dTpa group
    Number of subjects analysed
    442
    Units: Participants
        Anti-PT antibody [N=440]
    430
        Anti-FHA antibody [N=442]
    442
        Anti-PRN antibody [N=436]
    431
    No statistical analyses for this end point

    Secondary: Number of subjects with a booster response to diphtheria and tetanus antigens, one month after vaccination

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    End point title
    Number of subjects with a booster response to diphtheria and tetanus antigens, one month after vaccination
    End point description
    Booster response to diphtheria (D) and tetanus (T) antigens was defined as: for subjects with pre-vaccination antibody concentration <0.1 IU/ml (i.e. below the seroprotection cut-off), antibody concentrations at least ≥0.4 IU/ml, one month after vaccination, and for subjects with pre-vaccination antibody concentration ≥0.1 IU/ml (i.e. equal or above the seroprotection cut-off), an increase in antibody concentrations of at least four times the pre-vaccination concentration, one month after vaccination. Seronegative (S-) subjects are those who have antibody concentration less than (<) 0.1 IU/mL and seropositive (S+) subjects are those who have antibody concentration ≥ 0.1 IU/mL prior to vaccination.
    End point type
    Secondary
    End point timeframe
    At Day 31
    End point values
    dTpa group
    Number of subjects analysed
    441
    Units: Participants
        Anti-D antibody, S- [N=33]
    26
        Anti-D antibody, S+ [N=398]
    282
        Anti-D antibody, Overall [N=431]
    308
        Anti-T antibody, S- [N=43]
    38
        Anti-T antibody, S+ [N=398]
    338
        Anti-T antibody, Overall [N=441]
    376
    No statistical analyses for this end point

    Secondary: Number of subjects with a booster response to the PT, FHA and PRN antigens, one month after vaccination

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    End point title
    Number of subjects with a booster response to the PT, FHA and PRN antigens, one month after vaccination
    End point description
    Booster response to PT, FHA and PRN antigens was defined as: for subjects with pre-vaccination antibody concentration below (<) the assay cut-off, post-vaccination antibody concentration ≥ 4 times the assay cut-off; for subjects with pre-vaccination antibody concentration between the assay cut-off and <4 times the assay cut-off, post-vaccination antibody concentration ≥ 4 times the pre-vaccination antibody concentration; and for subjects with pre-vaccination antibody concentration ≥ 4 times the assay cut-off, post-vaccination antibody concentration ≥ 2 times the pre-vaccination antibody concentration. Seronegative (S-) subjects are those who have antibody concentration less than (<) assay cut-off and seropositive (S+) subjects are those who have antibody concentration ≥ assay cut-off prior to vaccination. Assay cut-off was 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA and 2.187 IU/mL for anti-PRN respectively.
    End point type
    Secondary
    End point timeframe
    At Day 31
    End point values
    dTpa group
    Number of subjects analysed
    442
    Units: Participants
        Anti-PT antibody, S- {N=158]
    138
        Anti-PT antibody, S+ (< 4*assay cut-off) [N=159]
    140
        Anti-PT antibody, S+ (≥ 4*assay cut-off) [N=121]
    97
        Anti-PT antibody, Overall [N=438]
    375
        Anti-FHA antibody, S- [N=8]
    8
        Anti-FHA antibody, S+ (< 4*assay cut-off) [N=57]
    57
        Anti-FHA antibody, S+ (≥ 4*assay cut-off) [N=377]
    345
        Anti-FHA antibody, Overall [N=442]
    410
        Anti-PRN antibody, S- [N=68]
    57
        Anti-PRN antibody, S+ (< 4*assay cut-off) [N=121]
    114
        Anti-PRN antibody, S+ (≥ 4*assay cut-off) [N=245]
    225
        Anti-PRN, Overall [N=434]
    396
    No statistical analyses for this end point

    Secondary: Anti-D, anti-T, anti-PT, anti-FHA and anti-PRN antibody concentrations, one month after vaccination

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    End point title
    Anti-D, anti-T, anti-PT, anti-FHA and anti-PRN antibody concentrations, one month after vaccination
    End point description
    Antibody concentrations are presented as Geometric Mean Concentrations (GMCs) and expressed in International Units per milliliter (IU/mL). The cut-off for the assays were: 0.057 IU/mL for anti-D, 0.043 IU/mL for anti-T, 2.693 IU/mL for anti-PT, 2.046 IU/mL for anti-FHA and 2.187 IU/mL for anti-PRN, respectively.
    End point type
    Secondary
    End point timeframe
    At Day 31
    End point values
    dTpa group
    Number of subjects analysed
    442
    Units: IU/mL
    geometric mean (confidence interval 95%)
        Anti-D antibody
    6.287 (5.643 to 7.004)
        Anti-T antibody
    13.507 (12.138 to 15.031)
        Anti-PT antibody
    59.279 (52.907 to 66.418)
        Anti-FHA antibody
    396.938 (362.876 to 434.197)
        Anti-PRN antibody
    249.638 (213.233 to 292.258)
    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
    Assessed solicited local symptoms were pain, redness, swelling. Any = Occurrence of any local symptom regardless of its intensity grade. Any redness and swelling were defined as greater than (>) 0 millimeters (mm) diameter for all subjects.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Day 1–4) follow-up period after vaccination.
    End point values
    dTpa group
    Number of subjects analysed
    447
    Units: Participants
        Pain
    284
        Redness
    207
        Swelling
    174
    No statistical analyses for this end point

    Secondary: Number of subjects aged below 6 years with solicited general symptoms

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    End point title
    Number of subjects aged below 6 years with solicited general symptoms
    End point description
    Assessed solicited general symptoms were Drowsiness, Irritability/Fussiness, Loss of appetite and Fever. Any = Occurrence of any general symptom regardless of its intensity grade and relationship to the study vaccination. Fever was defined as temperature ≥38.0 degrees Celsius (°C). The location for measuring temperature was the axilla.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Day 1–4) follow-up period after vaccination.
    End point values
    dTpa group
    Number of subjects analysed
    18
    Units: Participants
        Drowsiness
    1
        Irritability/Fussiness
    5
        Loss of appetite
    3
        Fever ( ≥ 38°C)
    0
    No statistical analyses for this end point

    Secondary: Number of subjects aged above and equal to 6 years with solicited general symptoms

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    End point title
    Number of subjects aged above and equal to 6 years with solicited general symptoms
    End point description
    Assessed solicited general symptoms were Fatigue, Gastrointestinal symptoms (included nausea, vomiting, diarrhoea and/or abdominal pain), Headache and Fever. Any = Occurence of any general symptom regardless of its intensity grade and relationship to the study vaccination. Fever was defined as axilla temperature ≥ 38 degrees Celsius (°C).
    End point type
    Secondary
    End point timeframe
    During the 4-day (Day 1–4) follow-up period after vaccination.
    End point values
    dTpa group
    Number of subjects analysed
    429
    Units: Participants
        Fatigue
    126
        Gastrointestinal symptoms
    34
        Headache
    107
        Fever ( ≥ 38°C), Overall
    10
    No statistical analyses for this end point

    Secondary: Number of subjects with large swelling reactions

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    End point title
    Number of subjects with large swelling reactions
    End point description
    Large injection site reaction for subjects <6 years of age defined as a swelling with a diameter of >50 mm and for subjects >=6 years of age swelling with a diameter of >100 mm, noticeable diffuse swelling or noticeable increase in limb circumference. Any = Occurence of any large swelling regardless of its intensity grade and relationship to the study vaccination.
    End point type
    Secondary
    End point timeframe
    During the 4-day (Day 1–4) follow-up period after vaccination.
    End point values
    dTpa group
    Number of subjects analysed
    447
    Units: Participants
    1
    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
    Any unsolicited AE was defined as any AE reported in addition to those solicited during the clinical study. Also any ‘solicited’ symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event.
    End point type
    Secondary
    End point timeframe
    During the 31-day (Day 1–31) follow-up period after vaccination
    End point values
    dTpa group
    Number of subjects analysed
    447
    Units: Participants
    52
    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
    A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject.
    End point type
    Secondary
    End point timeframe
    From Day 1 to Day 31
    End point values
    dTpa group
    Number of subjects analysed
    447
    Units: Participants
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Unsolicited adverse events (AEs) during the 31-day follow-up period after vaccination. Serious adverse events were reported during the whole study period (from Day 1 up to study conclusion at Day 31).
    Adverse event reporting additional description
    Solicited adverse events were not reported in this section. They were defined for both age strata (subjects less than 6 years and subjects equal or greater than 6 years), and then, analyzed per age stratum. Please refer to the outcomes section for the results.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    dTpa group
    Reporting group description
    Healthy female and male subjects with age 4 years and above and who received a single dose of Boostrix vaccine at Day 1.

    Serious adverse events
    dTpa group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 447 (0.22%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Infections and infestations
    Pneumonia bacterial
         subjects affected / exposed
    1 / 447 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    dTpa group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    52 / 447 (11.63%)
    Injury, poisoning and procedural complications
    Joint injury
         subjects affected / exposed
    1 / 447 (0.22%)
         occurrences all number
    1
    Investigations
    Blood pressure increased
         subjects affected / exposed
    1 / 447 (0.22%)
         occurrences all number
    2
    Body temperature increased
         subjects affected / exposed
    2 / 447 (0.45%)
         occurrences all number
    2
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    6 / 447 (1.34%)
         occurrences all number
    6
    Nasal congestion
         subjects affected / exposed
    1 / 447 (0.22%)
         occurrences all number
    1
    Oropharyngeal pain
         subjects affected / exposed
    6 / 447 (1.34%)
         occurrences all number
    6
    Rhinorrhoea
         subjects affected / exposed
    2 / 447 (0.45%)
         occurrences all number
    2
    Sneezing
         subjects affected / exposed
    1 / 447 (0.22%)
         occurrences all number
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    12 / 447 (2.68%)
         occurrences all number
    12
    Somnolence
         subjects affected / exposed
    1 / 447 (0.22%)
         occurrences all number
    1
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 447 (0.22%)
         occurrences all number
    1
    Chills
         subjects affected / exposed
    1 / 447 (0.22%)
         occurrences all number
    1
    Fatigue
         subjects affected / exposed
    1 / 447 (0.22%)
         occurrences all number
    1
    Induration
         subjects affected / exposed
    1 / 447 (0.22%)
         occurrences all number
    1
    Injection site oedema
         subjects affected / exposed
    1 / 447 (0.22%)
         occurrences all number
    1
    Injection site lymphadenopathy
         subjects affected / exposed
    1 / 447 (0.22%)
         occurrences all number
    1
    Pyrexia
         subjects affected / exposed
    3 / 447 (0.67%)
         occurrences all number
    3
    Vaccination site erythema
         subjects affected / exposed
    1 / 447 (0.22%)
         occurrences all number
    1
    Injection site pruritus
         subjects affected / exposed
    2 / 447 (0.45%)
         occurrences all number
    2
    Vaccination site haematoma
         subjects affected / exposed
    1 / 447 (0.22%)
         occurrences all number
    1
    Psychiatric disorders
    Irritability
         subjects affected / exposed
    1 / 447 (0.22%)
         occurrences all number
    1
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    1 / 447 (0.22%)
         occurrences all number
    1
    Abdominal pain
         subjects affected / exposed
    1 / 447 (0.22%)
         occurrences all number
    1
    Nausea
         subjects affected / exposed
    3 / 447 (0.67%)
         occurrences all number
    3
    Diarrhoea
         subjects affected / exposed
    1 / 447 (0.22%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    1 / 447 (0.22%)
         occurrences all number
    1
    Erythema
         subjects affected / exposed
    1 / 447 (0.22%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Arthritis reactive
         subjects affected / exposed
    1 / 447 (0.22%)
         occurrences all number
    1
    Arthropathy
         subjects affected / exposed
    1 / 447 (0.22%)
         occurrences all number
    1
    Muscular weakness
         subjects affected / exposed
    1 / 447 (0.22%)
         occurrences all number
    1
    Myalgia
         subjects affected / exposed
    1 / 447 (0.22%)
         occurrences all number
    1
    Musculoskeletal pain
         subjects affected / exposed
    1 / 447 (0.22%)
         occurrences all number
    1
    Infections and infestations
    Bronchitis
         subjects affected / exposed
    1 / 447 (0.22%)
         occurrences all number
    1
    Conjunctivitis
         subjects affected / exposed
    1 / 447 (0.22%)
         occurrences all number
    1
    Ear infection
         subjects affected / exposed
    1 / 447 (0.22%)
         occurrences all number
    1
    Nasopharyngitis
         subjects affected / exposed
    3 / 447 (0.67%)
         occurrences all number
    3
    Pharyngitis
         subjects affected / exposed
    2 / 447 (0.45%)
         occurrences all number
    2
    Pneumonia bacterial
         subjects affected / exposed
    1 / 447 (0.22%)
         occurrences all number
    1
    Oral herpes
         subjects affected / exposed
    1 / 447 (0.22%)
         occurrences all number
    1
    Rhinitis
         subjects affected / exposed
    7 / 447 (1.57%)
         occurrences all number
    7
    Respiratory tract infection viral
         subjects affected / exposed
    1 / 447 (0.22%)
         occurrences all number
    1
    Sinusitis
         subjects affected / exposed
    1 / 447 (0.22%)
         occurrences all number
    1
    Tonsillitis
         subjects affected / exposed
    1 / 447 (0.22%)
         occurrences all number
    1
    Varicella
         subjects affected / exposed
    1 / 447 (0.22%)
         occurrences all number
    1
    Tracheitis
         subjects affected / exposed
    3 / 447 (0.67%)
         occurrences all number
    3

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    02 Feb 2017
    The protocol has been amended to implement the following changes: • The age at inclusion to study has been changed from 3 to 4 years of age in order to be in compliant with Boostrix’s approved EU label wherein it is indicated for booster vaccination in individuals aged four years and older. • Wording “parents/Legally Acceptable Representative(s) (LAR[s])” is replaced by the wording “parents/adoptive parents”. As per Russian legislation, only parents or adoptive parents can give consent for the enrolment of their child in a clinical trial. No other person is allowed to give consent on behalf of a minor to participate in a clinical trial. • The age groups are amended according to the approved Boostrix EU label and physiological particularities i.e, from 3-9 to 4-9 years (children), 10-19 to 10-17 years (adolescents), 20-64 to 18-64 years (adults) and ≥ 65 years (elderly population). • To reflect the upgrade to new version for protocol (15.0), ICF (8.0), eCRF, SPM and overall changes in the functions. • The inclusion criteria has been amended in order to clarify the following, - Children from four to seven years of age who have received diphtheria, tetanus and pertussis vaccination prior to study enrolment as per local recommendations will be enrolled - Subjects eight years of age and older who have received diphtheria, tetanus and pertussis vaccination to the best of their/subjects’ parent(s)/subjects’ adoptive parent(s) knowledge and did not receive an additional diphtheria, tetanus or pertussis vaccination within 5 years prior to enrolment in the study will be enrolled.
    07 Aug 2017
    This protocol amendment was developed after the comments from the Russian regulatory authorities [Ministry of Health (MoH)]. Adjustments to the text were made in certain sections for better readability and to clarify the inclusion and exclusion criteria for enrolment of subjects and the conduct of the study. In addition, adjustments for the reporting period and assessment of adverse events in the safety sections were made for consistency. Typos and errors were corrected throughout the document. The newly re-developed and re-validated GSK’s DTPa ELISA cut-offs were updated as per the most recent CBER recommendation (2017).
    31 Oct 2017
    This protocol amendment was developed in order to accommodate older adults (approximately 58 years old and older) who were born before national recommendations in Russia for infant DTP vaccination, as well as those born when DTP vaccination coverage was low. The protocol amendment would also clarify inconsistencies present in the Protocol Amendment 2, between the English version and the Russian version. Following which, adjustments to the text were made in the inclusion criteria to clarify the enrolment of subjects for age group eight years and above. The wording parent(s)/adoptive parent(s) were aligned according to the local regulations. References for laboratory assays were updated and certain sections were modified to align with the rest of the document.

    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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