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    Clinical Trial Results:
    A phase II, randomised, observer-blind, controlled, study to assess the reactogenicity and safety of a single intramuscular dose of GlaxoSmithKline (GSK) Biologicals’ investigational respiratory syncytial virus (RSV) vaccine (GSK3003891A) in 18 to 45 year-old healthy non-pregnant women.

    Summary
    EudraCT number
    2015-005742-58
    Trial protocol
    BE  
    Global end of trial date
    28 Jun 2016

    Results information
    Results version number
    v1(current)
    This version publication date
    29 Jun 2017
    First version publication date
    29 Jun 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    204813
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02753413
    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?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    09 Sep 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 Jun 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Jun 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the reactogenicity and safety of a single dose of the investigational RSV vaccine in healthy non-pregnant women during the study period.
    Protection of trial subjects
    All subjects were supervised closely for at least 30 minutes following vaccination 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. Subjects were followed-up for one month (minimum 30 days) following administration of the study vaccine.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    26 Apr 2016
    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
    Belgium: 102
    Worldwide total number of subjects
    102
    EEA total number of subjects
    102
    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)
    102
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    A total of 102 subject numbers were screened, but only 100 subjects were randomized and received vaccination.

    Pre-assignment
    Screening details
    NA

    Period 1
    Period 1 title
    Overall Period
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Single blind
    Roles blinded
    Subject
    Blinding implementation details
    Given the different appearance and presentation of the investigational RSV vaccine, and Boostrix, double blinding was not possible and data was collected in an observer-blind manner: during the course of the study, the vaccine recipient and those responsible for the evaluation of any study endpoint were unaware of which vaccine was administered. Vaccine preparation and administration was done by authorised medical personnel who did not participate in any of the study clinical evaluation assays.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    GSK3003891A Group
    Arm description
    Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the investigational GSK3003891A vaccine, intramuscularly in the deltoid region of the arm, at Day 0
    Arm type
    Experimental

    Investigational medicinal product name
    GSK3003891A
    Investigational medicinal product code
    Other name
    60 µg PreF
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects were administered one dose of the investigational GSK3003891A vaccine, intramuscularly in the deltoid region of the arm, at Day 0.

    Arm title
    Boostrix Group
    Arm description
    Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the comparator Boostrix™ vaccine, intramuscularly in the deltoid region of the arm, at Day 0.
    Arm type
    Active comparator

    Investigational medicinal product name
    Boostrix™
    Investigational medicinal product code
    Other name
    dTpa
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects were administered one dose of the comparator Boostrix™ vaccine, intramuscularly in the deltoid region of the arm, at Day 0.

    Number of subjects in period 1 [1]
    GSK3003891A Group Boostrix Group
    Started
    49
    51
    Completed
    49
    51
    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: A total of 102 subject numbers were screened, but only 100 subjects were randomized and received vaccination.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    GSK3003891A Group
    Reporting group description
    Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the investigational GSK3003891A vaccine, intramuscularly in the deltoid region of the arm, at Day 0

    Reporting group title
    Boostrix Group
    Reporting group description
    Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the comparator Boostrix™ vaccine, intramuscularly in the deltoid region of the arm, at Day 0.

    Reporting group values
    GSK3003891A Group Boostrix Group Total
    Number of subjects
    49 51 100
    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)
    25.8 ± 5.9 25.6 ± 6.1 -
    Gender categorical
    Units: Subjects
        Female
    49 51 100
        Male
    0 0 0

    End points

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    End points reporting groups
    Reporting group title
    GSK3003891A Group
    Reporting group description
    Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the investigational GSK3003891A vaccine, intramuscularly in the deltoid region of the arm, at Day 0

    Reporting group title
    Boostrix Group
    Reporting group description
    Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the comparator Boostrix™ vaccine, intramuscularly in the deltoid region of the arm, at Day 0.

    Primary: Number of subjects with abnormal biochemical laboratory parameter values by maximum grading

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    End point title
    Number of subjects with abnormal biochemical laboratory parameter values by maximum grading [1]
    End point description
    Among biochemical parameters tested were ALT, AST and CRE, graded by FDA toxicity grading for biochemistry parameters. Assessed grades were unknown, grade 0 [G0], grade 1 [G1] (mild), grade 2 [G2] (moderate), grade 3 [G3] (severe) and grade 4 [G4] (potentially life threatening), as compared to baseline at Day 0.
    End point type
    Primary
    End point timeframe
    From Day 7 up to Day 30
    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 scope of this primary end point was descriptive, no statistical hypothesis test was performed.
    End point values
    GSK3003891A Group Boostrix Group
    Number of subjects analysed
    49
    51
    Units: Subjects
        ALT, Unknown-Unknown [N=0;1]
    0
    1
        ALT, Unknown-G0 [N=0;1]
    0
    0
        ALT, Unknown-G1 [N=0;1]
    0
    0
        ALT, Unknown-G2 [N=0;1]
    0
    0
        ALT, Unknown-G3 [N=0;1]
    0
    0
        ALT, Unknown-G4 [N=0;1]
    0
    0
        ALT, G0-Unknown [N=49;50]
    0
    0
        ALT, G0-G0 [N=49;50]
    48
    49
        ALT, G0-G1 [N=49;50]
    1
    1
        ALT, G0-G2 [N=49;50]
    0
    0
        ALT, G0-G3 [N=49;50]
    0
    0
        ALT, G0-G4 [N=49;50]
    0
    0
        AST, G0-Unknown [N=48;51]
    0
    0
        AST, G0-G0 [N=48;51]
    47
    49
        AST, G0-G1 [N=48;51]
    1
    2
        AST, G0-G2 [N=48;51]
    0
    0
        AST, G0-G3 [N=48;51]
    0
    0
        AST, G0-G4 [N=48;51]
    0
    0
        AST, G1-Unknown [N=1;0]
    0
    0
        AST, G1-G0 [N=1;0]
    0
    0
        AST, G1-G1 [N=1;0]
    1
    0
        AST, G1-G2 [N=1;0]
    0
    0
        AST, G1-G3 [N=1;0]
    0
    0
        AST, G1-G4 [N=1;0]
    0
    0
        CRE, G0-Unknown [N=49;51]
    0
    0
        CRE, G0-G0 [N=49;51]
    49
    51
        CRE, G0-G1 [N=49;51]
    0
    0
        CRE, G0-G2 [N=49;51]
    0
    0
        CRE, G0-G3 [N=49;51]
    0
    0
        CRE, G0-G4 [N=49;51]
    0
    0
    No statistical analyses for this end point

    Primary: Number of subjects with abnormal haematological laboratory parameter values by maximum grading

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    End point title
    Number of subjects with abnormal haematological laboratory parameter values by maximum grading [2]
    End point description
    Among haematological parameters tested were EOS, decreased Hgb and LYM graded by FDA toxicity grading for haematology parameters. Assessed grades were unknown, grade 0 [G0], grade 1 [G1] (mild), grade 2 [G2] (moderate), grade 3 [G3] (severe) and grade 4 [G4] (potentially life threatening), as compared to baseline at Day 0.
    End point type
    Primary
    End point timeframe
    From Day 7 up to Day 30
    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 scope of this primary end point was descriptive, no statistical hypothesis test was performed.
    End point values
    GSK3003891A Group Boostrix Group
    Number of subjects analysed
    49
    51
    Units: Subjects
        EOS, G0-Unknown [N=49;51]
    0
    0
        EOS, G0-G0 [N=49;51]
    48
    49
        EOS, G0-G1 [N=49;51]
    1
    2
        EOS, G0-G2 [N=49;51]
    0
    0
        EOS, G0-G3 [N=49;51]
    0
    0
        EOS, G0-G4 [N=49;51]
    0
    0
        Hgb/D, G0-Unknown [N=47;49]
    0
    0
        Hgb/D, G0-G0 [N=47;49]
    45
    46
        Hgb/D, G0-G1 [N=47;49]
    2
    3
        Hgb/D, G0-G2 [N=47;49]
    0
    0
        Hgb/D, G0-G3 [N=47;49]
    0
    0
        Hgb/D, G0-G4 [N=47;49]
    0
    0
        Hgb/D, G1-Unknown [N=2;1]
    0
    0
        Hgb/D, G1-G0 [N=2;1]
    0
    1
        Hgb/D, G1-G1 [N=2;1]
    2
    0
        Hgb/D, G1-G2 [N=2;1]
    0
    0
        Hgb/D, G1-G3 [N=2;1]
    0
    0
        Hgb/D, G1-G4 [N=2;1]
    0
    0
        Hgb/D, G4-Unknown [N=0;1]
    0
    0
        Hgb/D, G4-G0 [N=0;1]
    0
    0
        Hgb/D, G4-G1 [N=0;1]
    0
    0
        Hgb/D, G4-G2 [N=0;1]
    0
    0
        Hgb/D, G4-G3 [N=0;1]
    0
    0
        Hgb/D, G4-G4 [N=0;1]
    0
    1
        LYM, G0-Unknown [N=49;51]
    0
    0
        LYM, G0-G0 [N=49;51]
    49
    48
        LYM, G0-G1 [N=49;51]
    0
    2
        LYM, G0-G2 [N=49;51]
    0
    1
        LYM, G0-G3 [N=49;51]
    0
    0
        LYM, G0-G4 [N=49;51]
    0
    0
    No statistical analyses for this end point

    Primary: Number of subjects with abnormal haematological laboratory parameter values by maximum grading

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    End point title
    Number of subjects with abnormal haematological laboratory parameter values by maximum grading [3]
    End point description
    Among haematological parameters tested were NEU, PLT, decreased WBC and increased WBC/I, graded by FDA toxicity grading for haematology parameters. Assessed grades were unknown, grade 0 [G0], grade 1 [G1] (mild), grade 2 [G2] (moderate), grade 3 [G3] (severe) and grade 4 [G4] (potentially life threatening), as compared to baseline at Day 0.
    End point type
    Primary
    End point timeframe
    From Day 7 up to Day 30
    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 scope of this primary end point was descriptive, no statistical hypothesis test was performed.
    End point values
    GSK3003891A Group Boostrix Group
    Number of subjects analysed
    49
    51
    Units: Subjects
        NEU, G0-Unknown [N=47;49]
    0
    0
        NEU, G0-G0 [N=47;49]
    46
    47
        NEU, G0-G1 [N=47;49]
    1
    2
        NEU, G0-G2 [N=47;49]
    0
    0
        NEU, G0-G3 [N=47;49]
    0
    0
        NEU, G0-G4 [N=47;49]
    0
    0
        NEU, G1-Unknown [N=2;2]
    0
    0
        NEU, G1-G0 [N=2;2]
    0
    2
        NEU, G1-G1 [N=2;2]
    1
    0
        NEU, G1-G2 [N=2;2]
    1
    0
        NEU, G1-G3 [N=2;2]
    0
    0
        NEU, G1-G4 [N=2;2]
    0
    0
        PLT, G0-Unknown [N=49;51]
    0
    0
        PLT, G0-G0 [N=49;51]
    49
    49
        PLT, G0-G1 [N=49;51]
    0
    2
        PLT, G0-G2 [N=49;51]
    0
    0
        PLT, G0-G3 [N=49;51]
    0
    0
        PLT, G0-G4 [N=49;51]
    0
    0
        WBC/D, G0-Unknown [N=49;51]
    0
    0
        WBC/D, G0-G0 [N=49;51]
    49
    50
        WBC/D, G0-G1 [N=49;51]
    0
    1
        WBC/D, G0-G2 [N=49;51]
    0
    0
        WBC/D, G0-G3 [N=49;51]
    0
    0
        WBC/D, G0-G4 [N=49;51]
    0
    0
        WBC/I, G0-Unknown [N=49;50]
    0
    0
        WBC/I, G0-G0 [N=49;50]
    47
    49
        WBC/I, G0-G1 [N=49;50]
    2
    1
        WBC/I, G0-G2 [N=49;50]
    0
    0
        WBC/I, G0-G3 [N=49;50]
    0
    0
        WBC/I, G0-G4 [N=49;50]
    0
    0
        WBC/I, G1-Unknown [N=0;1]
    0
    0
        WBC/I, G1-G0 [N=0;1]
    0
    1
        WBC/I, G1-G1 [N=0;1]
    0
    0
        WBC/I, G1-G2 [N=0;1]
    0
    0
        WBC/I, G1-G3 [N=0;1]
    0
    0
        WBC/I, G1-G4 [N=0;1]
    0
    0
    No statistical analyses for this end point

    Primary: Number of subjects with haematology change from baseline by maximum grade

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    End point title
    Number of subjects with haematology change from baseline by maximum grade [4]
    End point description
    Assessed laboratory parameter changed from baseline was haemoglobin (Hgb). FDA grading for Hgb (change from baseline) was not applicable a baseline.
    End point type
    Primary
    End point timeframe
    From Day 7 up 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 scope of this primary end point was descriptive, no statistical hypothesis test was performed.
    End point values
    GSK3003891A Group Boostrix Group
    Number of subjects analysed
    49
    51
    Units: Subjects
        Hgb, G0
    15
    15
        Hgb, G1
    34
    35
        Hgb, G2
    0
    1
        Hgb, G3
    0
    0
        Hgb, G4
    0
    0
    No statistical analyses for this end point

    Primary: Number of subjects with solicited local symptoms

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    End point title
    Number of subjects with solicited local symptoms [5]
    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 millimetres (mm) of injection site. All solicited local symptoms are considered as related to the vaccination.
    End point type
    Primary
    End point timeframe
    During a 7-day follow-up period (from Day 0 to Day 6) after vaccination
    Notes
    [5] - 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 scope of this primary end point was descriptive, no statistical hypothesis test was performed.
    End point values
    GSK3003891A Group Boostrix Group
    Number of subjects analysed
    49
    51
    Units: Subjects
        Any Pain
    27
    46
        Grade 3 Pain
    1
    1
        Any Redness
    0
    1
        Grade 3 Redness
    0
    1
        Any Swelling
    0
    1
        Grade 3 Swelling
    0
    0
    No statistical analyses for this end point

    Primary: Number of subjects with solicited general symptoms

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    End point title
    Number of subjects with solicited general symptoms [6]
    End point description
    Assessed solicited general symptoms were fatigue, temperature (defined as oral temperature equal to or above [≥] 37.5 degrees Celsius [°C] for oral, axillary or tympanic route), gastrointestinal symptoms (gastro) including nausea, vomiting, diarrhoea and/or abdominal pain; and headache. Any = occurrence of the symptom regardless of intensity grade and relationship to the vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever ≥ 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination.
    End point type
    Primary
    End point timeframe
    During a 7-day follow-up period (from Day 0 to Day 6) after vaccination
    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 scope of this primary end point was descriptive, no statistical hypothesis test was performed.
    End point values
    GSK3003891A Group Boostrix Group
    Number of subjects analysed
    49
    51
    Units: Subjects
        Any Fatigue
    20
    23
        Grade 3 Fatigue
    4
    1
        Related Fatigue
    15
    15
        Any Gastro.
    14
    14
        Grade 3 Gastro.
    2
    1
        Related Gastro.
    8
    9
        Any Headache
    14
    17
        Grade 3 Headache
    3
    1
        Related Headache
    5
    9
        Any temperature
    2
    2
        Grade 3 Temperature
    0
    0
        Related temperature
    0
    2
    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) [7]
    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 out-side 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
    Primary
    End point timeframe
    During a 30-day follow-up period (from Day 0 to Day 29) after vaccination
    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 scope of this primary end point was descriptive, no statistical hypothesis test was performed.
    End point values
    GSK3003891A Group Boostrix Group
    Number of subjects analysed
    49
    51
    Units: Subjects
        Any AE(S)
    23
    28
    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) [8]
    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
    From vaccination (Day 0) up to study end (Day 30)
    Notes
    [8] - 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 scope of this primary end point was descriptive, no statistical hypothesis test was performed.
    End point values
    GSK3003891A Group Boostrix Group
    Number of subjects analysed
    49
    51
    Units: Subjects
        Any SAE(s)
    0
    0
    No statistical analyses for this end point

    Primary: Number of subjects with Abnormal Biochemical Laboratory Values.

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    End point title
    Number of subjects with Abnormal Biochemical Laboratory Values. [9]
    End point description
    Among analysed biochemical parameters were alanine aminotransferase [ALT], aspartate aminotransferase [AST] and creatinine [CRE]. Biochemical value ranges assessed were below, within or above, as compared to baseline at Day 0.
    End point type
    Primary
    End point timeframe
    At Day 7
    Notes
    [9] - 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 scope of this primary end point was descriptive, no statistical hypothesis test was performed.
    End point values
    GSK3003891A Group Boostrix Group
    Number of subjects analysed
    49
    51
    Units: Subjects
        ALT, Within-Bellow [N=49;51]
    0
    0
        ALT, Within-Within [N=49;51]
    48
    50
        ALT, Within-Above [N=49;51]
    1
    1
        AST, Within-Below [N=48;51]
    0
    0
        AST, Within-Within [N=48;51]
    48
    48
        AST, Within-Above [N=48;51]
    0
    3
        AST, Above-Below [N==1;0]
    0
    0
        AST, Above-Within [N=1;0]
    0
    0
        AST, Above-Above [N=1;0]
    1
    0
        CRE, Within-Bellow [N=49;51]
    0
    0
        CRE, Within-Within [N=49;51]
    49
    51
        CRE, Within-Above [N=49;51]
    0
    0
    No statistical analyses for this end point

    Primary: Number of subjects with Abnormal Biochemical Laboratory Values.

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    End point title
    Number of subjects with Abnormal Biochemical Laboratory Values. [10]
    End point description
    Among analysed biochemical parameters were alanine aminotransferase [ALT], aspartate aminotransferase [AST] and creatinine [CRE]. Biochemical value ranges assessed were below, within or above, as compared to baseline at Day 0.
    End point type
    Primary
    End point timeframe
    At Day 30
    Notes
    [10] - 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 scope of this primary end point was descriptive, no statistical hypothesis test was performed.
    End point values
    GSK3003891A Group Boostrix Group
    Number of subjects analysed
    49
    51
    Units: Subjects
        ALT, Within-Bellow [N=49;51]
    0
    0
        ALT, Within-Within [N=49;51]
    48
    51
        ALT, Within-Above [N=49;51]
    1
    0
        AST, Within-Below [N=48;51]
    0
    0
        AST, Within-Within [N=48;51]
    47
    51
        AST, Within-Above [N=48;51]
    1
    0
        AST, Above-Below [N=1;0]
    0
    0
        AST, Above-Within [N=1;0]
    0
    0
        AST, Above-Above [N=1;0]
    1
    0
        CRE, Within-Bellow [N=49;51]
    0
    0
        CRE, Within-Within [N=49;51]
    49
    51
        CRE, Within-Above [N=49;51]
    0
    0
    No statistical analyses for this end point

    Primary: Number of subjects with Abnormal Haematological Laboratory Values.

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    End point title
    Number of subjects with Abnormal Haematological Laboratory Values. [11]
    End point description
    Among analysed haematological parameters were eosinophils [EOS], haemoglobin [Hgb], leukocytes (white blood cells) [WBC], lymphocytes [LYM], neutrophils [NEU] and platelets [PLT]. Haematological value ranges assessed were below, within or above, as compared to baseline at Day 0. This outcome presents values for EOS, Hgb and WBC.
    End point type
    Primary
    End point timeframe
    At Day 7
    Notes
    [11] - 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 scope of this primary end point was descriptive, no statistical hypothesis test was performed.
    End point values
    GSK3003891A Group Boostrix Group
    Number of subjects analysed
    48
    50
    Units: Subjects
        EOS, Within-Bellow [N=48;47]
    0
    0
        EOS, Within-Within [N=48;47]
    46
    45
        EOS, Within-Above [N=48;47]
    2
    2
        EOS, Above-Below [N=1;4]
    0
    0
        EOS, Above-Within [N=1;4]
    0
    2
        EOS, Above-Above [N=1;4]
    1
    2
        Hgb, Below-Below [N=1;1]
    0
    1
        Hgb, Below-Within [N=1;1]
    1
    0
        Hgb, Below-Above [N=1;1]
    0
    0
        Hgb, Within-Bellow [N=48;50]
    1
    0
        Hgb, Within-Within [N=48;50]
    47
    50
        Hgb, Within-Above [N=48;50]
    0
    0
        WBC, Within-Bellow [N=48;50]
    0
    0
        WBC, Within-Within [N=48;50]
    46
    47
        WBC, Within-Above [N=48;50]
    2
    1
        WBC, Above-Below [N=1;3]
    0
    0
        WBC, Above-Within [N=1;3]
    1
    2
        WBC, Above-Above [N=1;3]
    0
    1
    No statistical analyses for this end point

    Primary: Number of subjects with Abnormal Haematological Laboratory Values.

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    End point title
    Number of subjects with Abnormal Haematological Laboratory Values. [12]
    End point description
    Among analysed haematological parameters were eosinophils [EOS], haemoglobin [Hgb], leukocytes (white blood cells) [WBC], lymphocytes [LYM], neutrophils [NEU] and platelets [PLT]. Haematological value ranges assessed were below, within or above, as compared to baseline at Day 0. This outcome presents values for EOS, Hgb and WBC.
    End point type
    Primary
    End point timeframe
    At Day 30
    Notes
    [12] - 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 scope of this primary end point was descriptive, no statistical hypothesis test was performed.
    End point values
    GSK3003891A Group Boostrix Group
    Number of subjects analysed
    48
    50
    Units: Subjects
        EOS, Within-Bellow [N=48;47]
    0
    0
        EOS, Within-Within [N=48;47]
    41
    44
        EOS, Within-Above [N=48;47]
    7
    3
        EOS, Above-Below [N=1;4]
    0
    0
        EOS, Above-Within [N=1;4]
    0
    3
        EOS, Above-Above [N=1;4]
    1
    1
        Hgb, Below-Below [N=1;1]
    0
    1
        Hgb, Below-Within [N=1;1]
    1
    0
        Hgb, Below-Above [N=1;1]
    0
    0
        Hgb, Within-Bellow [N=48;50]
    0
    0
        Hgb, Within-Within [N=48;50]
    48
    50
        Hgb, Within-Above [N=48;50]
    0
    0
        WBC, Within-Bellow [N=48;48]
    0
    1
        WBC, Within-Within [N=48;48]
    47
    45
        WBC, Within-Above [N=48;48]
    1
    2
        WBC, Above-Below [N=1;3]
    0
    0
        WBC, Above-Within [N=1;3]
    1
    3
        WBC, Above-Above [N=1;3]
    0
    0
    No statistical analyses for this end point

    Primary: Number of subjects with Abnormal Haematological Laboratory Values.

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    End point title
    Number of subjects with Abnormal Haematological Laboratory Values. [13]
    End point description
    Among analysed haematological parameters were eosinophils [EOS], haemoglobin [Hgb], leukocytes (white blood cells) [WBC], lymphocytes [LYM], neutrophils [NEU] and platelets [PLT]. Haematological value ranges assessed were below, within or above, as compared to baseline at Day 0. This outcome presents values for LYM, NEU and PLT
    End point type
    Primary
    End point timeframe
    At Day 7
    Notes
    [13] - 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 scope of this primary end point was descriptive, no statistical hypothesis test was performed.
    End point values
    GSK3003891A Group Boostrix Group
    Number of subjects analysed
    48
    50
    Units: Subjects
        LYM, Below-Below [N=0;2]
    0
    0
        LYM, Below-Within [N=0;2]
    0
    2
        LYM, Below-Above [N=0;2]
    0
    0
        LYM, Within-Bellow [N=46;48]
    1
    1
        LYM, Within-Within [N=46;48]
    42
    45
        LYM, Within-Above [N=46;48]
    3
    2
        LYM, Above-Below [N=3;1]
    0
    0
        LYM, Above-Within [N=3;1]
    1
    1
        LYM, Above-Above [N=3;1]
    2
    0
        NEU, Below-Below [N=1;0]
    0
    0
        NEU, Below-Within [N=1;0]
    1
    0
        NEU, Below-Above [N=1;0]
    0
    0
        NEU, Within-Bellow [N=47;48]
    3
    2
        NEU, Within-Within [N=47;48]
    44
    44
        NEU, Within-Above [N=47;48]
    0
    2
        NEU, Above-Below [N=1;3]
    0
    0
        NEU, Above-Within [N=1;3]
    0
    1
        NEU, Above-Above [N=1;3]
    1
    2
        PLT, Within-Bellow [N=48;50]
    1
    1
        PLT, Within-Within [N=48;50]
    47
    47
        PLT, Within-Above [N=48;50]
    0
    2
        PLT, Above-Below [N=1;1]
    0
    0
        PLT, Above-Within [N=1;1]
    0
    0
        PLT, Above-Above [N=1;1]
    1
    1
    No statistical analyses for this end point

    Primary: Number of subjects with Abnormal Haematological Laboratory Values.

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    End point title
    Number of subjects with Abnormal Haematological Laboratory Values. [14]
    End point description
    Among analysed haematological parameters were eosinophils [EOS], haemoglobin [Hgb], leukocytes (white blood cells) [WBC], lymphocytes [LYM], neutrophils [NEU] and platelets [PLT]. Haematological value ranges assessed were below, within or above, as compared to baseline at Day 0. This outcome presents values for LYM, NEU and PLT.
    End point type
    Primary
    End point timeframe
    At Day 30
    Notes
    [14] - 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 scope of this primary end point was descriptive, no statistical hypothesis test was performed.
    End point values
    GSK3003891A Group Boostrix Group
    Number of subjects analysed
    48
    50
    Units: Subjects
        LYM, Below-Below [N=0;2]
    0
    0
        LYM, Below-Within [N=0;2]
    0
    2
        LYM, Below-Above [N=0;2]
    0
    0
        LYM, Within-Bellow [N=46;48]
    1
    0
        LYM, Within-Within [N=46;48]
    44
    46
        LYM, Within-Above [N=46;48]
    1
    2
        LYM, Above-Below [N=3;1]
    0
    0
        LYM, Above-Within [N=3;1]
    2
    1
        LYM, Above-Above [N=3;1]
    1
    0
        NEU, Below-Below [N=1;0]
    0
    0
        NEU, Below-Within [N=1;0]
    1
    0
        NEU, Below-Above [N=1;0]
    0
    0
        NEU, Within-Bellow [N=47;48]
    0
    0
        NEU, Within-Within [N=47;48]
    46
    48
        NEU, Within-Above [N=47;48]
    1
    0
        NEU, Above-Below [N=1;3]
    0
    0
        NEU, Above-Within [N=1;3]
    1
    3
        NEU, Above-Above [N=1;3]
    0
    0
        PLT, Within-Bellow [N=48;50]
    1
    2
        PLT, Within-Within [N=48;50]
    47
    48
        PLT, Within-Above [N=48;50]
    0
    0
        PLT, Above-Below [N=1;1]
    0
    0
        PLT, Above-Within [N=1;1]
    1
    0
        PLT, Above-Above [N=1;1]
    0
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited and unsolicited AEs during the 30-Day follow-up period after vaccination; SAEs from Day 0 up to study end Day 30.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    GSK3003891A Group
    Reporting group description
    Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the investigational GSK3003891A vaccine, intramuscularly in the deltoid region of the arm, at Day 0

    Reporting group title
    Boostrix Group
    Reporting group description
    Healthy, non-pregnant women, aged 18-45 at the time of vaccination, were administered one dose of the comparator Boostrix™ vaccine, intramuscularly in the deltoid region of the arm, at Day 0

    Serious adverse events
    GSK3003891A Group Boostrix Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 49 (0.00%)
    0 / 51 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    GSK3003891A Group Boostrix Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    27 / 49 (55.10%)
    46 / 51 (90.20%)
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    2 / 49 (4.08%)
    4 / 51 (7.84%)
         occurrences all number
    2
    4
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    4 / 49 (8.16%)
    0 / 51 (0.00%)
         occurrences all number
    4
    0
    Headache
         subjects affected / exposed
    18 / 49 (36.73%)
    25 / 51 (49.02%)
         occurrences all number
    18
    25
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    20 / 49 (40.82%)
    24 / 51 (47.06%)
         occurrences all number
    20
    24
    Pain
         subjects affected / exposed
    27 / 49 (55.10%)
    46 / 51 (90.20%)
         occurrences all number
    27
    46
    Pyrexia
         subjects affected / exposed
    2 / 49 (4.08%)
    3 / 51 (5.88%)
         occurrences all number
    2
    3
    Gastrointestinal disorders
    Gastrointestinal disorder
         subjects affected / exposed
    14 / 49 (28.57%)
    14 / 51 (27.45%)
         occurrences all number
    14
    14
    Nausea
         subjects affected / exposed
    1 / 49 (2.04%)
    3 / 51 (5.88%)
         occurrences all number
    1
    3
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    1 / 49 (2.04%)
    4 / 51 (7.84%)
         occurrences all number
    1
    4
    Pharyngitis
         subjects affected / exposed
    3 / 49 (6.12%)
    1 / 51 (1.96%)
         occurrences all number
    3
    1

    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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