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    Clinical Trial Results:
    A Phase II, randomised, observer-blind, controlled, multi-country study to assess the safety, reactogenicity and immunogenicity of a single intramuscular dose of different formulations of GlaxoSmithKline (GSK) Biologicals’ investigational RSV vaccine (GSK3003891A), in healthy women aged 18 to 45 years

    Summary
    EudraCT number
    2014-002688-14
    Trial protocol
    CZ   DE  
    Global end of trial date
    21 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
    201510
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT02360475
    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
    08 Nov 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    02 Jul 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Jun 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the reactogenicity and the safety of a single intramuscular dose of the investigational RSV vaccines, in healthy, non-pregnant women, during the first 30 days after vaccination. To evaluate the functional antibody titres induced by a single intramuscular dose of the investigational RSV vac-cines, in healthy, non-pregnant women, 30 days after vaccination.
    Protection of trial subjects
    The body temperature of the subject was determined prior to study vaccination. If a subject had fever on the day of planned vaccination, the vaccination visit was rescheduled. 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. Subjects were followed for one year following administration of the study vaccine.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    20 Mar 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Czech Republic: 125
    Country: Number of subjects enrolled
    Germany: 126
    Country: Number of subjects enrolled
    Australia: 125
    Country: Number of subjects enrolled
    United States: 131
    Worldwide total number of subjects
    507
    EEA total number of subjects
    251
    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)
    507
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    A total of 507 subjects were screened, but only 500 subjects received vaccination.

    Pre-assignment
    Screening details
    NA

    Period 1
    Period 1 title
    Overall study (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 vaccines, 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.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    GSK3003891A 30 Non-adjuvanted Group
    Arm description
    Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of the non-adjuvanted 30 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
    Arm type
    Experimental

    Investigational medicinal product name
    GSK3003891A non-adjuvanted 30 µg PreF
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received a single dose of GSK3003891A non-adjuvanted 30 µg PreF vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.

    Arm title
    GSK3003891A 60 Non-adjuvanted Group
    Arm description
    Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of non-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
    Arm type
    Experimental

    Investigational medicinal product name
    GSK3003891A 60 PreF Group
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solution for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received a single dose of GSK3003891A non-adjuvanted 60 µg PreF vaccine, intramuscularly in the deltoid region of the non-dominant arm, at Day 0.

    Arm title
    GSK3003891A 60 Adjuvanted Group
    Arm description
    Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of aluminium-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
    Arm type
    Experimental

    Investigational medicinal product name
    GSK3003891A 60 PreF-Al Group
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received a single dose of RSV GSK3003891A aluminium-adjuvanted 60 µg Pref vaccine, intramuscularly in the deltoid region of the non-dominant arm, at Day 0.

    Arm title
    Boostrix Group
    Arm description
    Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of Boostrix™ vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.
    Arm type
    Active comparator

    Investigational medicinal product name
    Boostrix™
    Investigational medicinal product code
    Other name
    dTpa/Tdap
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Subjects received a single dose of Boostrix™ vaccine, intramuscularly in the deltoid region of the non-dominant arm, at Day 0.

    Number of subjects in period 1 [1]
    GSK3003891A 30 Non-adjuvanted Group GSK3003891A 60 Non-adjuvanted Group GSK3003891A 60 Adjuvanted Group Boostrix Group
    Started
    126
    124
    125
    125
    Completed
    122
    111
    117
    120
    Not completed
    4
    13
    8
    5
         Migrated/moved from study area
    -
    -
    -
    1
         Consent withdrawn by subject
    -
    1
    2
    -
         Lost to follow-up
    4
    12
    6
    4
    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 507 subjects were screened, but only 500 subjects received vaccination.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    GSK3003891A 30 Non-adjuvanted Group
    Reporting group description
    Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of the non-adjuvanted 30 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.

    Reporting group title
    GSK3003891A 60 Non-adjuvanted Group
    Reporting group description
    Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of non-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.

    Reporting group title
    GSK3003891A 60 Adjuvanted Group
    Reporting group description
    Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of aluminium-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.

    Reporting group title
    Boostrix Group
    Reporting group description
    Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of Boostrix™ vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.

    Reporting group values
    GSK3003891A 30 Non-adjuvanted Group GSK3003891A 60 Non-adjuvanted Group GSK3003891A 60 Adjuvanted Group Boostrix Group Total
    Number of subjects
    126 124 125 125 500
    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)
    29.2 ± 7.5 29.5 ± 8.2 29.1 ± 7.4 29.2 ± 7.9 -
    Gender categorical
    Units: Subjects
        Female
    126 124 125 125 500
        Male
    0 0 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    GSK3003891A 30 Non-adjuvanted Group
    Reporting group description
    Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of the non-adjuvanted 30 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.

    Reporting group title
    GSK3003891A 60 Non-adjuvanted Group
    Reporting group description
    Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of non-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.

    Reporting group title
    GSK3003891A 60 Adjuvanted Group
    Reporting group description
    Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of aluminium-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.

    Reporting group title
    Boostrix Group
    Reporting group description
    Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of Boostrix™ vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.

    Primary: Number of subjects with solicited local symptoms

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    End point title
    Number of subjects with 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 = Significant pain at rest, pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling with a maximum diameter greater than 100 millimeters (mm).
    End point type
    Primary
    End point timeframe
    During the 7-day (Days 0-6) 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 scope of this primary end point was descriptive, no statistical hypothesis test was performed.
    End point values
    GSK3003891A 30 Non-adjuvanted Group GSK3003891A 60 Non-adjuvanted Group GSK3003891A 60 Adjuvanted Group Boostrix Group
    Number of subjects analysed
    124
    119
    124
    124
    Units: Subjects
        Any Pain
    62
    68
    104
    104
        Grade 3 Pain
    1
    2
    9
    3
        Any Redness
    6
    3
    8
    6
        Grade 3 Redness
    0
    0
    0
    0
        Any Swelling
    7
    6
    12
    5
        Grade 3 Swelling
    0
    0
    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 [2]
    End point description
    Assessed solicited general symptoms (symp.) were headache, fever [defined as oral temperature (temp.) equal to or above 37.5 degrees Celsius (°C)], fatigue, gastrointestinal (Gastro.) symptoms [nausea, vomiting, diarrhoea and/or abdominal pain]. Any = occurrence of the symptom regardless of intensity grade and relationship. Grade 3 (G3) 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 the 7-day (Days 0-6) 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 scope of this primary end point was descriptive, no statistical hypothesis test was performed.
    End point values
    GSK3003891A 30 Non-adjuvanted Group GSK3003891A 60 Non-adjuvanted Group GSK3003891A 60 Adjuvanted Group Boostrix Group
    Number of subjects analysed
    124
    119
    124
    124
    Units: Subjects
        Any Fatigue
    53
    50
    56
    45
        G3 Fatigue
    8
    1
    4
    2
        Related Fatigue
    44
    41
    50
    39
        Any Gastro. symp.
    16
    19
    23
    20
        G3 Gastro. symp.
    1
    2
    1
    0
        Related Gastro. symp.
    9
    14
    21
    17
        Any Headache
    47
    44
    53
    39
        G3 Headache
    3
    2
    5
    3
        Related Headache
    37
    33
    39
    33
        Any Temp.
    7
    9
    12
    7
        G3 Temp.
    0
    0
    0
    0
        Related Temp.
    5
    8
    11
    6
    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. "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 the 30-Day (Days 0-29) 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 scope of this primary end point was descriptive, no statistical hypothesis test was performed.
    End point values
    GSK3003891A 30 Non-adjuvanted Group GSK3003891A 60 Non-adjuvanted Group GSK3003891A 60 Adjuvanted Group Boostrix Group
    Number of subjects analysed
    126
    124
    125
    125
    Units: Subjects
        Any AE(s)
    35
    38
    34
    37
    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
    From vaccination at Day 0, up to Day 30 post-vaccination
    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 30 Non-adjuvanted Group GSK3003891A 60 Non-adjuvanted Group GSK3003891A 60 Adjuvanted Group Boostrix Group
    Number of subjects analysed
    126
    124
    125
    125
    Units: Subjects
        Any SAE(s)
    1
    1
    0
    0
    No statistical analyses for this end point

    Primary: Titres of RSV-A neutralizing antibodies

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    End point title
    Titres of RSV-A neutralizing antibodies [5]
    End point description
    RSV-A neutralizing antibody titres, expressed as Geometric Mean Titres (GMTs). Seropositive subjects were defined as subjects whose antibody titre was greater than or equal to (≥) the cut-off 8 serum dilution that induced 60 % inhibition in plaque forming units (ED60).
    End point type
    Primary
    End point timeframe
    At Day 0 pre-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 30 Non-adjuvanted Group GSK3003891A 60 Non-adjuvanted Group GSK3003891A 60 Adjuvanted Group Boostrix Group
    Number of subjects analysed
    117
    117
    118
    118
    Units: Titers
    geometric mean (confidence interval 95%)
        anti-RSV A neutralizing antibodies
    397.1 (330.7 to 476.7)
    326.3 (277.1 to 384.4)
    444.2 (370.4 to 532.6)
    423.7 (360.2 to 498.4)
    No statistical analyses for this end point

    Primary: Titres of RSV-A neutralizing antibodies

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    End point title
    Titres of RSV-A neutralizing antibodies [6]
    End point description
    RSV-A neutralizing antibody titres, expressed as Geometric Mean Titres (GMTs). Seropositive subjects were defined as subjects whose antibody titre was greater than or equal to (≥) the cut-off 8 serum dilution that induced 60 % inhibition in plaque forming units (ED60).
    End point type
    Primary
    End point timeframe
    At Day 30 post-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 30 Non-adjuvanted Group GSK3003891A 60 Non-adjuvanted Group GSK3003891A 60 Adjuvanted Group Boostrix Group
    Number of subjects analysed
    117
    117
    118
    118
    Units: Titers
    geometric mean (confidence interval 95%)
        anti-RSV A neutralizing antibodies
    1237 (1094.8 to 1397.6)
    1278.7 (1141.6 to 1432.2)
    1442.5 (1287.4 to 1616.2)
    387.1 (328.4 to 456.3)
    No statistical analyses for this end point

    Secondary: Titres of RSV-A neutralizing antibodies

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    End point title
    Titres of RSV-A neutralizing antibodies
    End point description
    RSV-A neutralizing antibody titres, expressed as Geometric Mean Titres (GMTs), were greater than or equal to (≥) the cut-off 8 serum dilution inducing 60% inhibition in plaque forming units (ED60).
    End point type
    Secondary
    End point timeframe
    At Day 60 (D60) and 90 (D90) post-vaccination
    End point values
    GSK3003891A 30 Non-adjuvanted Group GSK3003891A 60 Non-adjuvanted Group GSK3003891A 60 Adjuvanted Group Boostrix Group
    Number of subjects analysed
    112
    111
    110
    111
    Units: Titers
    geometric mean (confidence interval 95%)
        anti-RSV A, D60 [N=109;111;108;111]
    947.2 (832.9 to 1077.1)
    882.9 (781.9 to 996.9)
    1055.7 (926.1 to 1203.4)
    358.8 (297.8 to 432.3)
        anti-RSV A, D90 [N=112;111;110;111]
    837.7 (738.9 to 949.7)
    774.5 (682.6 to 878.7)
    897.5 (782.8 to 1029.2)
    358.3 (291.9 to 439.9)
    No statistical analyses for this end point

    Secondary: Concentrations of Palivizumab competing antibodies (PCA)

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    End point title
    Concentrations of Palivizumab competing antibodies (PCA)
    End point description
    Palivizumab competing antibody concentrations, expressed as Geometric Mean Concentrations (GMCs), were greater than or equal to 3.34 micrograms per millilitre (µg/mL).
    End point type
    Secondary
    End point timeframe
    At Day 0 (D0) pre-vaccination, Day 30 (D30), Day 60 (D60) and Day 90 (D90) post-vaccination
    End point values
    GSK3003891A 30 Non-adjuvanted Group GSK3003891A 60 Non-adjuvanted Group GSK3003891A 60 Adjuvanted Group Boostrix Group
    Number of subjects analysed
    115
    111
    116
    111
    Units: µg/mL
    geometric mean (confidence interval 95%)
        anti-PCA, D0 [N=110;107;105;110]
    5.4 (4.7 to 6.3)
    5.2 (4.4 to 6)
    4.6 (4 to 5.4)
    5.7 (4.8 to 6.7)
        anti-PCA, D30 [N=115;116;116;109]
    79.9 (72.1 to 88.6)
    88.6 (79.9 to 98.2)
    97.2 (89.1 to 105.9)
    6.1 (5.3 to 7.1)
        anti-PCA,D60 [N=109;111;108;111]
    65.9 (57.8 to 75.1)
    68.4 (61.5 to 75.9)
    74.1 (66.6 to 82.3)
    5.8 (5 to 6.7)
        anti-PCA, D90 [N=112;111;110;109]
    60.4 (54 to 67.6)
    62.5 (56.7 to 68.9)
    66.1 (59.9 to 73)
    7.5 (6.6 to 8.6)
    No statistical analyses for this end point

    Secondary: Number of subjects with SAEs

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    End point title
    Number of subjects with SAEs
    End point description
    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
    Up to study end at Day 360
    End point values
    GSK3003891A 30 Non-adjuvanted Group GSK3003891A 60 Non-adjuvanted Group GSK3003891A 60 Adjuvanted Group Boostrix Group
    Number of subjects analysed
    126
    124
    125
    125
    Units: Subjects
        Any SAE(s)
    3
    3
    6
    2
    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: within the 30-day (Days 0-29) post-vaccination period; SAEs: from Day 0 up to study end at Day 360.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    GSK3003891A 30 Non-adjuvanted Group
    Reporting group description
    Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of the non-adjuvanted 30 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.

    Reporting group title
    GSK3003891A 60 Non-adjuvanted Group
    Reporting group description
    Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of non-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.

    Reporting group title
    GSK3003891A 60 Adjuvanted Group
    Reporting group description
    Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of aluminium-adjuvanted 60 µg investigational GSK3003891A vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.

    Reporting group title
    Boostrix Group
    Reporting group description
    Healthy non-pregnant female subjects between and including 18 and 45 years of age at the time of vaccination received a single dose of Boostrix™ vaccine, intramuscularly, in the deltoid region of the non-dominant arm, at Day 0.

    Serious adverse events
    GSK3003891A 30 Non-adjuvanted Group GSK3003891A 60 Non-adjuvanted Group GSK3003891A 60 Adjuvanted Group Boostrix Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 126 (2.38%)
    3 / 124 (2.42%)
    6 / 125 (4.80%)
    2 / 125 (1.60%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Multiple injuries
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 124 (0.00%)
    0 / 125 (0.00%)
    1 / 125 (0.80%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal injury
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 124 (0.81%)
    0 / 125 (0.00%)
    0 / 125 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Fibula fracture
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 124 (0.00%)
    1 / 125 (0.80%)
    0 / 125 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Incisional hernia
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 124 (0.00%)
    1 / 125 (0.80%)
    0 / 125 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Tibia fracture
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 124 (0.00%)
    1 / 125 (0.80%)
    0 / 125 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 124 (0.00%)
    1 / 125 (0.80%)
    0 / 125 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Obliterative bronchiolitis
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 124 (0.00%)
    0 / 125 (0.00%)
    0 / 125 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Transient ischaemic attack
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 124 (0.81%)
    0 / 125 (0.00%)
    0 / 125 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
         subjects affected / exposed
    0 / 126 (0.00%)
    1 / 124 (0.81%)
    1 / 125 (0.80%)
    0 / 125 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Suicide attempt
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 124 (0.00%)
    0 / 125 (0.00%)
    0 / 125 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Colitis
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 124 (0.00%)
    1 / 125 (0.80%)
    0 / 125 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Umbilical hernia
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 124 (0.00%)
    1 / 125 (0.80%)
    0 / 125 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Jaw cyst
         subjects affected / exposed
    1 / 126 (0.79%)
    0 / 124 (0.00%)
    0 / 125 (0.00%)
    0 / 125 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia bacterial
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 124 (0.00%)
    0 / 125 (0.00%)
    1 / 125 (0.80%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    0 / 126 (0.00%)
    0 / 124 (0.00%)
    1 / 125 (0.80%)
    0 / 125 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    GSK3003891A 30 Non-adjuvanted Group GSK3003891A 60 Non-adjuvanted Group GSK3003891A 60 Adjuvanted Group Boostrix Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    93 / 126 (73.81%)
    88 / 124 (70.97%)
    112 / 125 (89.60%)
    109 / 125 (87.20%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    49 / 126 (38.89%)
    45 / 124 (36.29%)
    56 / 125 (44.80%)
    41 / 125 (32.80%)
         occurrences all number
    49
    45
    56
    41
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    53 / 126 (42.06%)
    50 / 124 (40.32%)
    56 / 125 (44.80%)
    45 / 125 (36.00%)
         occurrences all number
    53
    50
    56
    45
    Pain
         subjects affected / exposed
    62 / 126 (49.21%)
    68 / 124 (54.84%)
    104 / 125 (83.20%)
    104 / 125 (83.20%)
         occurrences all number
    62
    68
    104
    104
    Pyrexia
         subjects affected / exposed
    7 / 126 (5.56%)
    10 / 124 (8.06%)
    12 / 125 (9.60%)
    8 / 125 (6.40%)
         occurrences all number
    7
    10
    12
    8
    Swelling
         subjects affected / exposed
    7 / 126 (5.56%)
    6 / 124 (4.84%)
    12 / 125 (9.60%)
    5 / 125 (4.00%)
         occurrences all number
    7
    6
    12
    5
    Gastrointestinal disorders
    Gastrointestinal disorder
         subjects affected / exposed
    16 / 126 (12.70%)
    19 / 124 (15.32%)
    23 / 125 (18.40%)
    20 / 125 (16.00%)
         occurrences all number
    16
    19
    23
    20
    Skin and subcutaneous tissue disorders
    Erythema
         subjects affected / exposed
    6 / 126 (4.76%)
    3 / 124 (2.42%)
    8 / 125 (6.40%)
    6 / 125 (4.80%)
         occurrences all number
    6
    3
    8
    6
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 126 (1.59%)
    7 / 124 (5.65%)
    3 / 125 (2.40%)
    6 / 125 (4.80%)
         occurrences all number
    2
    7
    3
    6

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 Feb 2015
    Following US Food and Drug Administration (FDA) feedback on the RSV F-020 (201510) protocol, the following changes were implemented:  Addition of a one-year safety phone call to collect information about any serious adverse events (SAEs) and pregnancies that may have occurred between Visit 4 (Day 90) and the Phone contact (Day 360).  Section 8.1.4 has been updated to clarify that clinical safety laboratory testing is not required per protocol unless the investigator believes it is warranted. Any abnormal laboratory findings (e.g. clinical chemistry, haematology, urinalysis) or other abnormal assessments that are judged by the investigator to be clinically significant will be recorded as AE or SAE if they meet the definition of an AE or SAE. In addition, the list of contributing authors was updated.

    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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