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    Clinical Trial Results:
    A Phase I/II randomized observer-blind placebo controlled study to evaluate the safety, reactogenicity and immunogenicity of different dose levels of GSK Biologicals’ investigational unadjuvanted RSV Maternal vaccine (GSK3888550A) compared to placebo when administered to healthy non-pregnant women aged 18-45 years

    Summary
    EudraCT number
    2018-001340-62
    Trial protocol
    FI   DE  
    Global end of trial date
    06 Sep 2019

    Results information
    Results version number
    v2(current)
    This version publication date
    22 Nov 2020
    First version publication date
    18 Apr 2020
    Other versions
    v1
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    208068
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT03674177
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline
    Sponsor organisation address
    Rue de l’Institut 89, Rixensart, Belgium, B-1330
    Public contact
    GSK Response Center, GlaxoSmithKline, 044 2089-904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    GSK Response Center, GlaxoSmithKline, 044 2089-904466, GSKClinicalSupportHD@gsk.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    08 Nov 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    16 Apr 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Sep 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the safety and reactogenicity of three dose levels (30, 60, 120 µg) of the RSV maternal investigational vaccine administered as a single intramuscular injection, as compared to placebo up to 1 month post vaccination (Day 31).
    Protection of trial subjects
    As this was the first time this vaccine was tested in humans, appropriate safety monitoring was planned for this study. The study enrolled in a two-step fashion with a pause in enrollment when the first 60 subjects (approximately 15 subjects per study group) had been vaccinated until the re-view of Day 8 and Day 31 post-vaccination safety data by an unblinded GSK internal Safety Review Committee (iSRC) was completed. The enrollment/vaccination of the remaining subjects started following the favourable outcome of the iSRC safety reviews. In step 1, for the first 30 subjects there was a minimum interval of 60 minutes between vaccinations and vaccination was limited to 10 subjects per day across all sites. In addition to the above, all subjects remained under observation at the vaccination centre for at least 60 minutes after vaccination with appropriate medical treatment readily available. Vaccines were administered by qualified and trained personnel, and only to eligible subjects that have no contraindications to any components of the vaccine. Subjects were followed for about 6 months after vaccination.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    30 Oct 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
    Finland: 61
    Country: Number of subjects enrolled
    Germany: 211
    Country: Number of subjects enrolled
    United States: 230
    Worldwide total number of subjects
    502
    EEA total number of subjects
    272
    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)
    502
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    The study was conducted at 11 centers in 3 countries: 4 in Finland, 5 in Germany and 2 in the USA.

    Pre-assignment
    Screening details
    Among 579 screened subjects in this study, 77 subjects were screen failure. 502 subjects were enrolled.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor, Data analyst, Assessor
    Blinding implementation details
    This is an observer blind study. In this study, the subject and study site personnel involved in the clinical evaluations of the subjects are blinded while other study personnel may be aware of the treatment assignments.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    RSV MAT formulation 1 Group
    Arm description
    Subjects receive a single dose (30 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
    Arm type
    Experimental

    Investigational medicinal product name
    GSK3888550A RSV Maternal vaccine formulation 1
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Single dose(30 µg) administered intramuscularly at Day 1 in the deltoid region of the non-dominant arm

    Arm title
    RSV MAT formulation 2 Group
    Arm description
    Subjects receive a single dose (60 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
    Arm type
    Experimental

    Investigational medicinal product name
    GSK3888550A RSV Maternal vaccine formulation 2 Group
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Single dose(60 µg) administered intramuscularly at Day 1 in the deltoid region of the non-dominant arm

    Arm title
    RSV MAT formulation 3 Group
    Arm description
    Subjects receive a single dose (120 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm
    Arm type
    Experimental

    Investigational medicinal product name
    GSK3888550A RSV Maternal vaccine formulation 3 Group
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Single dose(120 µg) administered intramuscularly at Day 1 in the deltoid region of the non-dominant arm

    Arm title
    Control Group
    Arm description
    Subjects receive a single placebo saline injection at Day 1, intramuscularly into the deltoid region of the non-dominant arm
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo (Normal Saline)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Single dose administered intramuscularly at Day 1 in the deltoid region of the non-dominant arm

    Number of subjects in period 1
    RSV MAT formulation 1 Group RSV MAT formulation 2 Group RSV MAT formulation 3 Group Control Group
    Started
    124
    126
    126
    126
    Completed
    122
    125
    126
    124
    Not completed
    2
    1
    0
    2
         Lost to follow-up
    2
    1
    -
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    RSV MAT formulation 1 Group
    Reporting group description
    Subjects receive a single dose (30 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm

    Reporting group title
    RSV MAT formulation 2 Group
    Reporting group description
    Subjects receive a single dose (60 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm

    Reporting group title
    RSV MAT formulation 3 Group
    Reporting group description
    Subjects receive a single dose (120 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm

    Reporting group title
    Control Group
    Reporting group description
    Subjects receive a single placebo saline injection at Day 1, intramuscularly into the deltoid region of the non-dominant arm

    Reporting group values
    RSV MAT formulation 1 Group RSV MAT formulation 2 Group RSV MAT formulation 3 Group Control Group Total
    Number of subjects
    124 126 126 126 502
    Age categorical
    Units: Subjects
        In utero
    0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0 0 0
        Newborns (0-27 days)
    0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0 0 0
        Children (2-11 years)
    0 0 0 0 0
        Adolescents (12-17 years)
    0 0 0 0 0
        Adults (18-64 years)
    124 126 126 126 502
        From 65-84 years
    0 0 0 0 0
        85 years and over
    0 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    32.5 ± 7.4 32.1 ± 7.9 31.5 ± 7.6 32.2 ± 7.1 -
    Sex: Female, Male
    Units:
        Female
    124 126 126 126 502
        Male
    0 0 0 0 0
    Race/Ethnicity, Customized
    Units: Subjects
        ASIAN
    1 1 2 5 9
        BLACK OR AFRICAN AMERICAN
    5 5 4 7 21
        OTHER
    3 0 3 0 6
        WHITE
    115 120 117 114 466

    End points

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    End points reporting groups
    Reporting group title
    RSV MAT formulation 1 Group
    Reporting group description
    Subjects receive a single dose (30 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm

    Reporting group title
    RSV MAT formulation 2 Group
    Reporting group description
    Subjects receive a single dose (60 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm

    Reporting group title
    RSV MAT formulation 3 Group
    Reporting group description
    Subjects receive a single dose (120 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm

    Reporting group title
    Control Group
    Reporting group description
    Subjects receive a single placebo saline injection at Day 1, intramuscularly into the deltoid region of the non-dominant arm

    Primary: Number of Subjects With Any and Grade 3 Solicited Local Adverse events (AE) during a 7-day follow-up period

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    End point title
    Number of Subjects With Any and Grade 3 Solicited Local Adverse events (AE) during a 7-day follow-up period [1]
    End point description
    Assessed solicited local symptoms include pain, redness and swelling, at the injection site. Any = occurrence of the AE regardless of intensity grade. Any Redness and swelling symptom = symptom reported with a surface diameter greater than 20 millimeters. Grade 3 pain = significant pain at rest, pain that prevented normal every day activity. Grade 3 redness/swelling = symptom reported with a surface diameter greater than 100 millimeters. The analysis was performed on the Exposed Set, which included all subjects with the study vaccine administration documented.
    End point type
    Primary
    End point timeframe
    During a 7-day follow-up period (i.e., on the day of vaccination and 6 subsequent days)
    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: No statistical analyses as there are no confirmatory analysis
    End point values
    RSV MAT formulation 1 Group RSV MAT formulation 2 Group RSV MAT formulation 3 Group Control Group
    Number of subjects analysed
    124
    125
    126
    126
    Units: Participants
        Pain
    59
    64
    67
    20
        Grade 3 Pain
    1
    1
    0
    0
        Redness
    8
    14
    10
    1
        Grade 3 Redness
    0
    0
    0
    0
        Swelling
    5
    7
    6
    0
        Grade 3 Swelling
    0
    0
    1
    0
    No statistical analyses for this end point

    Primary: Number of Subjects With Any, Grade 3 and related Solicited general Adverse events (AE) during a 7-day follow-up period

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    End point title
    Number of Subjects With Any, Grade 3 and related Solicited general Adverse events (AE) during a 7-day follow-up period [2]
    End point description
    Assessed solicited general symptoms include fatigue, gastrointestinal symptoms (nausea, vomiting, diarrhea and/or abdominal pain), headache and fever. Any Fatigue, gastrointestinal symptoms and headache = occurrence of the symptom regardless of intensity grade and relationship. Any Fever = temperature higher than or equal to 38.0 degrees Celsius (°C), or 100.4 degrees Fahrenheit (°F). Grade 3 Fatigue, gastrointestinal symptoms and headache = symptoms that prevented normal activities. Grade 3 Fever = temperature higher than 39.0 degrees Celsius (°C), or 102.2 degrees Fahrenheit (°F). Related fatigue, gastrointestinal symptoms, headache and fever(>38°C) = symptoms assessed by the investigator as related to the vaccination. The analysis was performed on the Exposed Set, which included all subjects with the study vaccine administration documented.
    End point type
    Primary
    End point timeframe
    During a 7-day follow-up period (i.e., on the day of vaccination and 6 subsequent days)
    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: No statistical analyses as there are no confirmatory analysis
    End point values
    RSV MAT formulation 1 Group RSV MAT formulation 2 Group RSV MAT formulation 3 Group Control Group
    Number of subjects analysed
    124
    125
    126
    126
    Units: Participants
        Any Fatigue
    41
    49
    41
    38
        Grade 3 Fatigue
    3
    5
    3
    4
        Related Fatigue
    25
    34
    25
    27
        Any Gastrointestinal symptoms
    30
    29
    23
    27
        Grade 3 Gastrointestinal symptoms
    2
    2
    2
    1
        Related Gastrointestinal symptoms
    12
    16
    13
    17
        Any Headache
    37
    51
    60
    32
        Grade 3 Headache
    3
    6
    2
    3
        Related Headache
    17
    25
    34
    17
        Any Fever
    2
    0
    4
    0
        Grade 3 Fever
    0
    0
    0
    0
        Related Fever
    0
    0
    2
    0
    No statistical analyses for this end point

    Primary: Number of subjects with any unsolicited AEs during a 30-day follow-up period

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    End point title
    Number of subjects with any unsolicited AEs during a 30-day follow-up period [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 is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. The analysis was performed on the Exposed Set, which included all vaccinated subjects.
    End point type
    Primary
    End point timeframe
    During a 30-day follow-up period after vaccination (i.e., on the day of vaccination and 29 subsequent days)
    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: No statistical analyses as there are no confirmatory analysis
    End point values
    RSV MAT formulation 1 Group RSV MAT formulation 2 Group RSV MAT formulation 3 Group Control Group
    Number of subjects analysed
    124
    126
    126
    126
    Units: Participants
        Any unsolicited adverse event
    45
    43
    48
    44
    No statistical analyses for this end point

    Primary: Number of subjects with serious adverse events (SAEs) during a 30-day follow-up period

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    End point title
    Number of subjects with serious adverse events (SAEs) during a 30-day follow-up period [4]
    End point description
    Assessed SAEs include any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, or results in disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a study subject. The analysis was performed on the Exposed Set, which included all vaccinated subjects.
    End point type
    Primary
    End point timeframe
    From Day 1 (vaccination) up to Day 30 (i.e., on the day of vaccination and 29 subsequent days)
    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: No statistical analyses as there are no confirmatory analysis
    End point values
    RSV MAT formulation 1 Group RSV MAT formulation 2 Group RSV MAT formulation 3 Group Control Group
    Number of subjects analysed
    124
    126
    126
    126
    Units: Participants
        Any serious adverse event
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Number of subjects with hematological laboratory results change with respect to normal laboratory ranges and versus baseline, at Day 8

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    End point title
    Number of subjects with hematological laboratory results change with respect to normal laboratory ranges and versus baseline, at Day 8 [5]
    End point description
    Assessed hematological laboratory parameters include Eosinophils, Hemoglobin, Lymphocytes, Neutrophils, Platelets, White blood cells (WBC). Hematological abnormalities refer to range indicator at timing, categorized as BELOW, WITHIN or ABOVE normal ranges, and compared to baseline range indicator i.e. BELOW(SCR), WITHIN(SCR) or ABOVE(SCR). [e.g. WBC, BELOW(SCR), BELOW = WBC BELOW normal ranges at baseline versus BELOW normal ranges at Day 8]. The analysis was performed on the Exposed Set, which included all vaccinated subjects with available results for the specified laboratory parameter and time point.
    End point type
    Primary
    End point timeframe
    At Day 8
    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: No statistical analyses as there are no confirmatory analysis
    End point values
    RSV MAT formulation 1 Group RSV MAT formulation 2 Group RSV MAT formulation 3 Group Control Group
    Number of subjects analysed
    122
    122
    125
    125
    Units: Participants
        Eosinophils, BELOW(SCR), BELOW (N-6,5,7,10)
    2
    3
    3
    8
        Eosinophils, BELOW(SCR), WITHIN(N-6,5,7,10)
    4
    2
    4
    2
        Eosinophils, WITHIN(SCR), BELOW(N-112,113,117,113)
    3
    1
    3
    3
        Eosinophils,WITHIN(SCR),WITHIN (N-112,113,117,113)
    108
    109
    112
    110
        Eosinophils,WITHIN(SCR),ABOVE(N-112,113,117,113)
    1
    3
    2
    0
        Eosinophils, ABOVE(SCR), WITHIN (N-4,3,0,2)
    2
    0
    0
    1
        Eosinophils, ABOVE(SCR), ABOVE (N-4,3,0,2)
    2
    3
    0
    1
        Hemoglobin, BELOW(SCR), BELOW (N-7,3,1,2)
    5
    2
    1
    0
        Hemoglobin, BELOW(SCR), WITHIN(N-7,3,1,2)
    2
    1
    0
    2
        Hemoglobin,WITHIN(SCR), BELOW (N-115,117,122,122)
    2
    2
    1
    5
        Hemoglobin, WITHIN(SCR), WITHIN(N-115,117,122,122)
    112
    115
    120
    117
        Hemoglobin,WITHIN(SCR),ABOVE (N-115,117,122,122)
    1
    0
    1
    0
        Hemoglobin,ABOVE(SCR),WITHIN (N-0,2,2,1)
    0
    1
    2
    0
        Hemoglobin,ABOVE(SCR),ABOVE (N-0,2,2,1)
    0
    1
    0
    1
        Lymphocytes, BELOW(SCR), WITHIN (N-0,2,2,0)
    0
    2
    2
    0
        Lymphocytes,WITHIN(SCR),BELOW (N-120,118,122,124)
    1
    1
    1
    1
        Lymphocytes,WITHIN(SCR),WITHIN (N-120,118,122,124)
    119
    116
    119
    121
        Lymphocytes,WITHIN(SCR),ABOVE (N-120,118,122,124)
    0
    1
    2
    2
        Lymphocytes, ABOVE(SCR), WITHIN (N-2,1,0,1)
    1
    0
    0
    0
        Lymphocytes, ABOVE(SCR), ABOVE (N-2,1,0,1)
    1
    1
    0
    1
        Neutrophils, BELOW(SCR), WITHIN (N-1,1,0,1)
    1
    1
    0
    1
        Neutrophils,WITHIN(SCR),BELOW (N-120,119,120,120)
    2
    4
    2
    1
        Neutrophils,WITHIN(SCR),WITHIN (N-120,119,120,120)
    117
    111
    117
    118
        Neutrophils,WITHIN(SCR),ABOVE (N-120,119,120,120)
    1
    4
    1
    1
        Neutrophils, ABOVE(SCR), WITHIN (N-1,1,4,4)
    1
    1
    1
    3
        Neutrophils, ABOVE(SCR), ABOVE (N-1,1,4,4)
    0
    0
    3
    1
        Platelets, BELOW(SCR), BELOW (N-0,0,1,2)
    0
    0
    0
    1
        Platelets, BELOW(SCR), WITHIN (N-0,0,1,2)
    0
    0
    1
    1
        Platelets, WITHIN(SCR), BELOW (N-118,117,119,116)
    1
    0
    0
    0
        Platelets, WITHIN(SCR), WITHIN (N-118,117,119,116)
    116
    112
    115
    114
        Platelets, WITHIN(SCR), ABOVE (N-118,117,119,116)
    1
    5
    4
    2
        Platelets, ABOVE(SCR), WITHIN (N-4,5,5,7)
    3
    2
    3
    3
        Platelets, ABOVE(SCR), ABOVE (N-4,5,5,7)
    1
    3
    2
    4
        WBC, BELOW(SCR), BELOW (N-3,2,5,5)
    0
    1
    1
    5
        WBC, BELOW(SCR), WITHIN (N-3,2,5,5)
    3
    1
    4
    0
        WBC, WITHIN(SCR), BELOW (N-118,117,116,115)
    5
    4
    5
    0
        WBC, WITHIN(SCR), WITHIN (N-118,117,116,115)
    111
    108
    108
    115
        WBC, WITHIN(SCR), ABOVE (N-118,117,116,115)
    2
    5
    3
    0
        WBC, ABOVE(SCR), WITHIN (N-1,3,4,5)
    0
    1
    1
    5
        WBC, ABOVE(SCR), ABOVE (N-1,3,4,5)
    1
    2
    3
    0
    No statistical analyses for this end point

    Primary: Number of subjects with hematological laboratory results change with respect to normal laboratory ranges and versus baseline, at Day 31

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    End point title
    Number of subjects with hematological laboratory results change with respect to normal laboratory ranges and versus baseline, at Day 31 [6]
    End point description
    Assessed hematological laboratory parameters include Eosinophils, Hemoglobin, Lymphocytes, Neutrophils, Platelets, White blood cells (WBC). Hematological abnormalities refer to range indicator at timing, categorized as BELOW, WITHIN or ABOVE normal ranges, and compared to baseline range indicator i.e. BELOW(SCR), WITHIN(SCR) or ABOVE(SCR) [e.g. WBC, BELOW(SCR), BELOW = WBC BELOW normal ranges at baseline versus BELOW normal ranges at Day 31]. The analysis was performed on the Exposed Set, which included all vaccinated subjects with available results for the specified laboratory parameter and time point.
    End point type
    Primary
    End point timeframe
    At Day 31
    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: No statistical analyses as there are no confirmatory analysis
    End point values
    RSV MAT formulation 1 Group RSV MAT formulation 2 Group RSV MAT formulation 3 Group Control Group
    Number of subjects analysed
    121
    124
    125
    125
    Units: Participants
        Eosinophils, BELOW(SCR), BELOW (N-7,6,8,11)
    3
    3
    6
    8
        Eosinophils, BELOW(SCR), WITHIN (N-7,6,8,11)
    4
    3
    2
    3
        Eosinophils,WITHIN(SCR),BELOW (N-110,115,117,112)
    4
    2
    1
    1
        Eosinophils,WITHIN(SCR),WITHIN(N-110,115,117,112)
    105
    112
    115
    110
        Eosinophils,WITHIN(SCR),ABOVE (N-110,115,117,112)
    1
    1
    1
    1
        Eosinophils, ABOVE(SCR), WITHIN (N-4,3,0,2)
    2
    1
    0
    1
        Eosinophils, ABOVE(SCR), ABOVE (N-4,3,0,2)
    2
    2
    0
    1
        Hemoglobin, BELOW(SCR), BELOW (N-7,3,1,2)
    6
    1
    1
    2
        Hemoglobin, BELOW(SCR), WITHIN (N-7,3,1,2)
    1
    2
    0
    0
        Hemoglobin, WITHIN(SCR), BELOW (N-114,118,122,122)
    2
    4
    1
    3
        Hemoglobin, WITHIN(SCR), WITHIN(N-114,118,122,122)
    112
    114
    121
    119
        Hemoglobin, ABOVE(SCR), WITHIN (N-0,3,2,1)
    0
    2
    1
    0
        Hemoglobin, ABOVE(SCR), ABOVE (N-0,3,2,1)
    0
    1
    1
    1
        Lymphocytes, BELOW(SCR), BELOW (N-0,2,2,0)
    0
    1
    0
    0
        Lymphocytes, BELOW(SCR), WITHIN (N-0,2,2,0)
    0
    1
    2
    0
        Lymphocytes, WITHIN(SCR), BELOW(N-119,120,123,124)
    0
    1
    3
    2
        Lymphocytes,WITHIN(SCR),WITHIN(N-119,120,123,124)
    119
    119
    119
    119
        Lymphocytes,WITHIN(SCR),ABOVE (N-119,120,123,124)
    0
    0
    1
    3
        Lymphocytes, ABOVE(SCR), WITHIN (N-2,2,0,1)
    2
    1
    0
    0
        Lymphocytes, ABOVE(SCR), ABOVE (N-2,2,0,1)
    0
    1
    0
    1
        Neutrophils, BELOW(SCR), BELOW (N-1,1,0,1)
    1
    0
    0
    0
        Neutrophils,BELOW(SCR),WITHIN(N-1,1,0,1)
    0
    1
    0
    1
        Neutrophils,WITHIN(SCR),BELOW(N-119,122,121,120)
    2
    2
    3
    1
        Neutrophils,WITHIN(SCR),WITHIN (N-119,122,121,120)
    116
    117
    114
    116
        Neutrophils,WITHIN(SCR),ABOVE (N-119,122,121,120)
    1
    3
    4
    3
        Neutrophils, ABOVE(SCR), WITHIN (N-1,1,4,4)
    1
    0
    4
    4
        Neutrophils, ABOVE(SCR), ABOVE (N-1,1,4,4)
    0
    1
    0
    0
        Platelets, BELOW(SCR), BELOW (N-0,0,1,2)
    0
    0
    0
    1
        Platelets, BELOW(SCR), WITHIN (N-0,0,1,2)
    0
    0
    1
    1
        Platelets, WITHIN(SCR), BELOW (N-117,119,119,116)
    0
    0
    2
    0
        Platelets, WITHIN(SCR), WITHIN (N-117,119,119,116)
    115
    115
    111
    113
        Platelets, WITHIN(SCR), ABOVE (N-117,119,119,116)
    2
    4
    6
    3
        Platelets, ABOVE(SCR), WITHIN (N-4,5,5,7)
    3
    1
    3
    2
        Platelets, ABOVE(SCR), ABOVE (N-4,5,5,7)
    1
    4
    2
    5
        WBC, BELOW(SCR), BELOW (N-3,2,4,5)
    2
    1
    2
    4
        WBC, BELOW(SCR), WITHIN (N-3,2,4,5)
    1
    1
    2
    1
        WBC, WITHIN(SCR), BELOW (N-117,119,117,115)
    3
    5
    9
    1
        WBC, WITHIN(SCR), WITHIN (N-117,119,117,115)
    109
    107
    105
    110
        WBC, WITHIN(SCR), ABOVE (N-117,119,117,115)
    5
    7
    3
    4
        WBC, ABOVE(SCR), WITHIN (N-1,3,4,5)
    1
    0
    4
    5
        WBC, ABOVE(SCR), ABOVE (N-1,3,4,5)
    0
    3
    0
    0
    No statistical analyses for this end point

    Primary: Number of subjects with biochemical laboratory results change with respect to normal laboratory ranges and versus baseline, at Day 8

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    End point title
    Number of subjects with biochemical laboratory results change with respect to normal laboratory ranges and versus baseline, at Day 8 [7]
    End point description
    Assessed biochemical laboratory parameters include alanine aminotransferase (ALT), aspartate aminotransferase (AST), blood urea nitrogen (BUN) and creatinine. Biochemical abnormalities refer to range indicator at timing, categorized as BELOW, WITHIN or ABOVE normal ranges, and compared to baseline range indicator i.e. BELOW(SCR), WITHIN(SCR) or ABOVE(SCR)[e.g. ALT, BELOW(SCR), BELOW = ALT BELOW normal ranges at baseline versus BELOW normal ranges at Day 8]. The analysis was performed on the Exposed Set, which included all vaccinated subjects with available results for the specified laboratory parameter and time point.
    End point type
    Primary
    End point timeframe
    At Day 8
    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: No statistical analyses as there are no confirmatory analysis
    End point values
    RSV MAT formulation 1 Group RSV MAT formulation 2 Group RSV MAT formulation 3 Group Control Group
    Number of subjects analysed
    123
    124
    126
    126
    Units: Participants
        ALT, BELOW(SCR), WITHIN (N-0,2,0,0)
    0
    2
    0
    0
        ALT, WITHIN(SCR), WITHIN (N-115,116,123,115)
    114
    109
    120
    111
        ALT, WITHIN(SCR), ABOVE (N-115,116,123,115)
    1
    7
    3
    4
        ALT, ABOVE(SCR), WITHIN (N-8,6,3,10)
    3
    6
    3
    3
        ALT, ABOVE(SCR), ABOVE (N-8,6,3,10)
    5
    0
    0
    7
        AST, BELOW(SCR), WITHIN (N-1,1,2,0)
    1
    1
    2
    0
        AST, WITHIN(SCR), BELOW (N-119,122,120,118)
    0
    1
    0
    0
        AST, WITHIN(SCR), WITHIN (N-119,122,120,118)
    116
    115
    116
    116
        AST, WITHIN(SCR), ABOVE (N-119,122,120,118)
    3
    6
    4
    2
        AST, ABOVE(SCR), WITHIN (N-3,1,4,7)
    3
    1
    3
    6
        AST, ABOVE(SCR), ABOVE (N-3,1,4,7)
    0
    0
    1
    1
        BUN, BELOW(SCR), BELOW (N-4,4,7,1)
    3
    2
    3
    1
        BUN, BELOW(SCR), WITHIN (N-4,4,7,1)
    1
    2
    4
    0
        BUN, WITHIN(SCR), BELOW (N-116,119,115,123)
    1
    2
    2
    1
        BUN, WITHIN(SCR), WITHIN (N-116,119,115,123)
    113
    115
    113
    121
        BUN, WITHIN(SCR), ABOVE (N-116,119,115,123)
    2
    2
    0
    1
        BUN, ABOVE(SCR), WITHIN (N-3,1,3,2)
    2
    0
    3
    2
        BUN, ABOVE(SCR), ABOVE (N-3,1,3,2)
    1
    1
    0
    0
        Creatinine, BELOW(SCR), BELOW (N-2,3,4,4)
    0
    1
    1
    4
        Creatinine, BELOW(SCR), WITHIN (N-2,3,4,4)
    2
    2
    3
    0
        Creatinine, WITHIN(SCR), BELOW (N-119,121,121,121)
    1
    0
    1
    3
        Creatinine,WITHIN(SCR),WITHIN(N-119,121,121,121)
    117
    118
    119
    118
        Creatinine, WITHIN(SCR), ABOVE (N-119,121,121,121)
    1
    3
    1
    0
        Creatinine, ABOVE(SCR), WITHIN (N-2,0,1,1)
    2
    0
    1
    0
        Creatinine, ABOVE(SCR), ABOVE (N-2,0,1,1)
    0
    0
    0
    1
    No statistical analyses for this end point

    Primary: Number of subjects with biochemical laboratory results change with respect to normal laboratory ranges and versus baseline, at Day 31

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    End point title
    Number of subjects with biochemical laboratory results change with respect to normal laboratory ranges and versus baseline, at Day 31 [8]
    End point description
    Assessed biochemical laboratory parameters include alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine and blood urea nitrogen (BUN). Biochemical abnormalities refer to range indicator at timing, categorized as BELOW, WITHIN or ABOVE normal ranges, and compared to baseline range indicator i.e. BELOW(SCR), WITHIN(SCR) or ABOVE(SCR) [e.g. ALT, BELOW(SCR), BELOW = ALT BELOW normal ranges at baseline versus BELOW normal ranges at Day 31]. The analysis was performed on the Exposed Set, which included all vaccinated subjects with available results for the specified laboratory parameter and time point.
    End point type
    Primary
    End point timeframe
    At Day 31
    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: No statistical analyses as there are no confirmatory analysis
    End point values
    RSV MAT formulation 1 Group RSV MAT formulation 2 Group RSV MAT formulation 3 Group Control Group
    Number of subjects analysed
    123
    124
    126
    126
    Units: Participants
        ALT, BELOW(SCR), BELOW (N-0,2,0,0)
    0
    1
    0
    0
        ALT, BELOW(SCR), WITHIN (N-0,2,0,0)
    0
    1
    0
    0
        ALT, WITHIN(SCR), BELOW (N-115,116,123,116)
    0
    0
    1
    0
        ALT, WITHIN(SCR), WITHIN (N-115,116,123,116)
    112
    113
    121
    110
        ALT, WITHIN(SCR), ABOVE (N-115,116,123,116)
    3
    3
    1
    6
        ALT, ABOVE(SCR), WITHIN (N-8,6,3,10)
    4
    5
    3
    6
        ALT, ABOVE(SCR), ABOVE (N-8,6,3,10)
    4
    1
    0
    4
        AST, BELOW(SCR), WITHIN (N-1,1,2,0)
    1
    1
    2
    0
        AST, WITHIN(SCR), BELOW (N-119,122,120,119)
    0
    0
    0
    1
        AST, WITHIN(SCR), WITHIN (N-119,122,120,119)
    115
    118
    120
    114
        AST, WITHIN(SCR), ABOVE (N-119,122,120,119)
    4
    4
    0
    4
        AST, ABOVE(SCR), WITHIN (N-3,1,4,7)
    3
    1
    3
    6
        AST, ABOVE(SCR), ABOVE (N-3,1,4,7)
    0
    0
    1
    1
        BUN, BELOW(SCR), BELOW (N-4,4,7,1)
    2
    2
    2
    1
        BUN, BELOW(SCR), WITHIN (N-4,4,7,1)
    2
    2
    5
    0
        BUN, WITHIN(SCR), BELOW (N-116,119,116,123)
    2
    2
    0
    2
        BUN, WITHIN(SCR), WITHIN (N-116,119,116,123)
    113
    117
    115
    120
        BUN, WITHIN(SCR), ABOVE (N-116,119,116,123)
    1
    0
    1
    1
        BUN, ABOVE(SCR), WITHIN (N-3,1,3,2)
    3
    0
    3
    2
        BUN, ABOVE(SCR), ABOVE (N-3,1,3,2)
    0
    1
    0
    0
        Creatinine, BELOW(SCR), BELOW (N-2,3,4,4)
    0
    0
    0
    3
        Creatinine, BELOW(SCR), WITHIN (N-2,3,4,4)
    2
    3
    4
    1
        Creatinine, WITHIN(SCR), BELOW (N-119,121,121,121)
    0
    1
    0
    2
        Creatinine,WITHIN(SCR),WITHIN (N-119,121,121,121)
    118
    116
    117
    116
        Creatinine, WITHIN(SCR), ABOVE (N-119,121,121,121)
    1
    4
    4
    3
        Creatinine, ABOVE(SCR), WITHIN (N-2,0,1,1)
    1
    0
    1
    0
        Creatinine, ABOVE(SCR), ABOVE (N-2,0,1,1)
    1
    0
    0
    1
    No statistical analyses for this end point

    Primary: Number of subjects with hematological laboratory results versus baseline, by maximum grading, at Day 8

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    End point title
    Number of subjects with hematological laboratory results versus baseline, by maximum grading, at Day 8 [9]
    End point description
    Assessed hematological laboratory parameters include Eosinophils, Hemoglobin, Lymphocytes Decrease(Lym Dec), Neutrophils Decrease(Neu Dec), Platelets Decrease(Dec), WBC Decrease(Dec) and WBC Increase(Inc), as graded by the Food and Drug Administration [FDA] Guidance for Industry "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Assessed grades at specified time point, are Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe and Grade 4 = life threatening, as compared to the baseline status of the same parameter, at baseline [e.g. WBC decrease-Grade 1(SCR)-Grade 1 = WBC decrease Grade 1 at baseline versus Grade 1 at Day 8]. "Any" corresponding to any grade and "Grade 0" to normal ranges. The analysis was performed on the Exposed Set, which included all vaccinated subjects with available results for the specified laboratory parameter and time point.
    End point type
    Primary
    End point timeframe
    At Day 8
    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: No statistical analyses as there are no confirmatory analysis
    End point values
    RSV MAT formulation 1 Group RSV MAT formulation 2 Group RSV MAT formulation 3 Group Control Group
    Number of subjects analysed
    122
    122
    125
    125
    Units: Participants
        Eosinophils, Any(SCR), GRADE 0(N-122,121,124,125)
    121
    120
    124
    125
        Eosinophils, Any(SCR), GRADE 1(N-122,121,124,125)
    1
    0
    0
    0
        Eosinophils, Any(SCR), GRADE 2(N-122,121,124,125)
    0
    1
    0
    0
        Eosinophils,Grade0(SCR),GRADE 0(N-120,120,124,123)
    119
    120
    124
    123
        Eosinophils,Grade0(SCR),GRADE 1(N-120,120,124,123)
    1
    0
    0
    0
        Eosinophils,Grade1(SCR),GRADE 0(N=2,1,0,2)
    2
    0
    0
    2
        Eosinophils, Grade 1(SCR), GRADE 2 (N-2,1,0,2)
    0
    1
    0
    0
        Hemoglobin, Any(SCR), GRADE 0 (N-122,122,125,125)
    110
    111
    114
    110
        Hemoglobin, Any(SCR), GRADE 1 (N-122,122,125,125)
    11
    9
    10
    15
        Hemoglobin, Any(SCR), GRADE 2 (N-122,122,125,125)
    1
    2
    1
    0
        Hemoglobin,Grade 0(SCR),GRADE 0(N-110,111,115,116)
    106
    107
    110
    106
        Hemoglobin,Grade 0(SCR),GRADE 1(N-110,111,115,116)
    4
    4
    5
    10
        Hemoglobin, Grade 1(SCR), GRADE 0 (N-11,11,10,9)
    4
    4
    4
    4
        Hemoglobin, Grade 1(SCR), GRADE 1 (N-11,11,10,9)
    7
    5
    5
    5
        Hemoglobin, Grade 1(SCR), GRADE 2 (N-11,11,10,9)
    0
    2
    1
    0
        Hemoglobin, Grade 2(SCR), GRADE 2 (N-1,0,0,0)
    1
    0
    0
    0
        Lym Dec, Any(SCR), GRADE 0 (N-122,121,124,125)
    120
    118
    122
    122
        Lym Dec, Any(SCR), GRADE 1 (N-122,121,124,125)
    1
    2
    2
    3
        Lym Dec, Any(SCR), GRADE 2 (N-122,121,124,125)
    1
    1
    0
    0
        Lym Dec, Grade 0(SCR), GRADE 0 (N-122,119,120,120)
    120
    117
    118
    120
        Lym Dec, Grade 0(SCR), GRADE 1 (N-122,119,120,120)
    1
    1
    2
    0
        Lym Dec, Grade 0(SCR), GRADE 2 (N-122,119,120,120)
    1
    1
    0
    0
        Lym Dec, Grade 1(SCR), GRADE 0 (N-0,2,3,5)
    0
    1
    3
    2
        Lym Dec, Grade 1(SCR), GRADE 1 (N-0,2,3,5)
    0
    1
    0
    3
        Lym Dec, Grade 2(SCR), GRADE 0 (N-0,0,1,0)
    0
    0
    1
    0
        Neu Dec, Any(SCR), GRADE 0 (N-122,121,124,125)
    112
    113
    116
    118
        Neu Dec, Any(SCR), GRADE 1 (N-122,121,124,125)
    10
    5
    8
    6
        Neu Dec, Any(SCR), GRADE 2 (N-122,121,124,125)
    0
    3
    0
    1
        Neu Dec, Grade 0(SCR), GRADE 0 (N-117,115,119,119)
    109
    109
    111
    115
        Neu Dec, Grade 0(SCR), GRADE 1 (N-117,115,119,119)
    8
    4
    8
    4
        Neu Dec, Grade 0(SCR), GRADE 2 (N-117,115,119,119)
    0
    2
    0
    0
        Neu Dec, Grade 1(SCR), GRADE 0 (N-4,6,5,6)
    3
    4
    5
    3
        Neu Dec, Grade 1(SCR), GRADE 1 (N-4,6,5,6)
    1
    1
    0
    2
        Neu Dec, Grade 1(SCR), GRADE 2 (N-4,6,5,6)
    0
    1
    0
    1
        Neu Dec, Grade 2(SCR), GRADE 1 (N-1,0,0,0)
    1
    0
    0
    0
        Platelet Dec,Any(SCR),GRADE 0(N-122,122,125,125)
    121
    122
    125
    125
        Platelet Dec,Any(SCR),GRADE1(N-122,122,125,125)
    1
    0
    0
    0
        Platelet Dec,Grade0(SCR),GRADE0(N-122,122,125,123)
    121
    122
    125
    123
        Platelet Dec,Grade0(SCR),GRADE1(N-122,122,125,123)
    1
    0
    0
    0
        Platelet Dec, Grade 1(SCR), GRADE 0 (N-0,0,0,2)
    0
    0
    0
    2
        WBC Dec, Any(SCR), GRADE 0 (N-122,122,125,125)
    121
    119
    125
    124
        WBC Dec, Any(SCR), GRADE 1 (N-122,122,125,125)
    1
    3
    0
    1
        WBC Dec, Grade 0(SCR), GRADE 0 (N-121,121,124,121)
    120
    118
    124
    120
        WBC Dec, Grade 0(SCR), GRADE 1 (N-121,121,124,121)
    1
    3
    0
    1
        WBC Dec, Grade 1(SCR), GRADE 0 (N-1,1,1,4)
    1
    1
    1
    4
        WBC Inc, Any(SCR), GRADE 0 (N-122,122,125,125)
    119
    118
    121
    125
        WBC Inc, Any(SCR), GRADE 1 (N-122,122,125,125)
    3
    3
    4
    0
        WBC Inc, Any(SCR), GRADE 2 (N-122,122,125,125)
    0
    1
    0
    0
        WBC Inc, Grade 0(SCR), GRADE 0 (N-119,118,121,122)
    118
    116
    120
    122
        WBC Inc, Grade 0(SCR), GRADE 1 (N-119,118,121,122)
    1
    2
    1
    0
        WBC Inc, Grade 1(SCR), GRADE 0 (N-3,4,4,3)
    1
    2
    1
    3
        WBC Inc, Grade 1(SCR), GRADE 1 (N-3,4,4,3)
    2
    1
    3
    0
        WBC Inc, Grade 1(SCR), GRADE 2 (N-3,4,4,3)
    0
    1
    0
    0
    No statistical analyses for this end point

    Primary: Number of subjects with hematological laboratory results versus baseline, by maximum grading, at Day 31

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    End point title
    Number of subjects with hematological laboratory results versus baseline, by maximum grading, at Day 31 [10]
    End point description
    Assessed hematological laboratory parameters include Eosinophils, Hemoglobin, Lymphocytes Decrease(Lym Dec), Neutrophils Decrease(Neu Dec), Platelets Decrease(Dec), WBC Decrease(Dec) and WBC Increase(Inc), as graded by the Food and Drug Administration [FDA] Guidance for Industry "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Assessed grades at specified time point, are Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe and Grade 4 = life threatening, as compared to the baseline status of the same parameter, at baseline [e.g. WBC decrease-Grade 1(SCR)-Grade 1 = WBC decrease Grade 1 at baseline versus Grade 1 at Day 31]. "Any" corresponding to any grade and "Grade 0" to normal ranges. The analysis was performed on the Exposed Set, which included all vaccinated subjects with available results for the specified laboratory parameter and time point.
    End point type
    Primary
    End point timeframe
    At Day 31
    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: No statistical analyses as there are no confirmatory analysis
    End point values
    RSV MAT formulation 1 Group RSV MAT formulation 2 Group RSV MAT formulation 3 Group Control Group
    Number of subjects analysed
    121
    124
    125
    125
    Units: Participants
        Eosinophils,Any(SCR),GRADE 0 (N-121,124,125,125)
    118
    122
    125
    125
        Eosinophils,Any(SCR),GRADE 1 (N-121,124,125,125)
    3
    2
    0
    0
        Eosinophils,Grade 0(SCR),GRADE0(N-119,123,125,123)
    117
    122
    125
    123
        Eosinophils,Grade 0(SCR),GRADE1(N-119,123,125,123)
    2
    1
    0
    0
        Eosinophils,Grade 1(SCR),GRADE 0(N-2,1,0,2)
    1
    0
    0
    2
        Eosinophils,Grade 1(SCR),GRADE 1(N-2,1,0,2)
    1
    1
    0
    0
        Hemoglobin,Any(SCR),GRADE 0 (N-121,124,125,125)
    108
    115
    112
    114
        Hemoglobin,Any(SCR),GRADE 1 (N-121,124,125,125)
    11
    7
    13
    8
        Hemoglobin,Any(SCR),GRADE 2 (N-121,124,125,125)
    2
    2
    0
    3
        Hemoglobin,Grade 0(SCR),GRADE 0(N-110,113,115,116)
    106
    112
    109
    111
        Hemoglobin,Grade 0(SCR),GRADE 1(N-110,113,115,116)
    4
    1
    6
    3
        Hemoglobin,Grade 0(SCR),GRADE 2(N-110,113,115,116)
    0
    0
    0
    2
        Hemoglobin,Grade 1(SCR),GRADE 0(N-10,11,10,9)
    2
    3
    3
    3
        Hemoglobin,Grade 1(SCR),GRADE 1(N-10,11,10,9)
    7
    6
    7
    5
        Hemoglobin,Grade 1(SCR),GRADE 2(N-10,11,10,9)
    1
    2
    0
    1
        Hemoglobin,Grade 2(SCR),GRADE 2(N-1,0,0,0)
    1
    0
    0
    0
        Lym Dec,Any(SCR),GRADE 0(N-121,124,125,125)
    119
    119
    121
    120
        Lym Dec, Any(SCR), GRADE 1(N-121,124,125,125)
    2
    5
    4
    4
        Lym Dec, Any(SCR), GRADE 2(N-121,124,125,125)
    0
    0
    0
    1
        Lym Dec, Grade 0(SCR), GRADE 0(N-121,122,121,120)
    119
    118
    117
    117
        Lym Dec, Grade 0(SCR), GRADE 1(N-121,122,121,120)
    2
    4
    4
    3
        Lym Dec, Grade 1(SCR), GRADE 0(N-0,2,3,5)
    0
    1
    3
    3
        Lym Dec, Grade 1(SCR), GRADE 1(N-0,2,3,5)
    0
    1
    0
    1
        Lym Dec, Grade 1(SCR), GRADE 2(N-0,2,3,5)
    0
    0
    0
    1
        Lym Dec, Grade 2(SCR), GRADE 0(N-0,0,1,0)
    0
    0
    1
    0
        Neu Dec, Any(SCR), GRADE 0(N-121,124,125,125)
    111
    115
    114
    116
        Neu Dec, Any(SCR), GRADE 1(N-121,124,125,125)
    8
    7
    10
    8
        Neu Dec, Any(SCR), GRADE 2(N-121,124,125,125)
    1
    2
    1
    1
        Neu Dec, Any(SCR), GRADE 3(N-121,124,125,125)
    1
    0
    0
    0
        Neu Dec, Grade 0(SCR), GRADE 0(N-117,118,120,119)
    109
    112
    109
    114
        Neu Dec, Grade 0(SCR), GRADE 1(N-117,118,120,119)
    7
    5
    10
    4
        Neu Dec,Grade 0(SCR), GRADE 2(N-117,118,120,119)
    0
    1
    1
    1
        Neu Dec,Grade 0(SCR), GRADE 3(N-117,118,120,119)
    1
    0
    0
    0
        Neu Dec,Grade 1(SCR), GRADE 0(N-3,6,5,6)
    2
    3
    5
    2
        Neu Dec,Grade 1(SCR), GRADE 1(N-3,6,5,6)
    1
    2
    0
    4
        Neu Dec,Grade 1(SCR), GRADE 2(N-3,6,5,6)
    0
    1
    0
    0
        Neu Dec,Grade 2(SCR), GRADE 2(N-1,0,0,0)
    1
    0
    0
    0
        Platelet Dec,Any(SCR),GRADE0(N-121,124,125,125)
    121
    124
    125
    125
        Platelet Dec,Grade0(SCR),GRADE0(N-121,124,125,123)
    121
    124
    125
    123
        Platelet Dec,Grade 1(SCR),GRADE0(N-0,0,0,2)
    0
    0
    0
    2
        WBC Dec, Any(SCR), GRADE 0(N-121,124,125,125)
    119
    122
    121
    123
        WBC Dec, Any(SCR), GRADE 1(N-121,124,125,125)
    2
    2
    4
    2
        WBC Dec, Grade 0(SCR), GRADE 0(N-120,123,124,121)
    119
    121
    120
    120
        WBC Dec, Grade 0(SCR), GRADE 1(N-120,123,124,121)
    1
    2
    4
    1
        WBC Dec, Grade 1(SCR), GRADE 0(N-1,1,1,4)
    0
    1
    1
    3
        WBC Dec, Grade 1(SCR), GRADE 1(N-1,1,1,4)
    1
    0
    0
    1
        WBC Inc, Any(SCR), GRADE 0(N-121,124,125,125)
    120
    116
    122
    122
        WBC Inc, Any(SCR), GRADE 1(N-121,124,125,125)
    1
    8
    3
    3
        WBC Inc, Grade 0(SCR), GRADE 0(N-118,120,121,122)
    118
    115
    118
    119
        WBC Inc, Grade 0(SCR), GRADE 1(N-118,120,121,122)
    0
    5
    3
    3
        WBC Inc, Grade 1(SCR), GRADE 0(N-3,4,4,3)
    2
    1
    4
    3
        WBC Inc, Grade 1(SCR), GRADE 1(N-3,4,4,3)
    1
    3
    0
    0
    No statistical analyses for this end point

    Primary: Number of subjects with biochemical laboratory results versus baseline, by maximum grading, at Day 8

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    End point title
    Number of subjects with biochemical laboratory results versus baseline, by maximum grading, at Day 8 [11]
    End point description
    Assessed biochemical laboratory parameters include alanine aminotransferase (ALT), aspartate aminotransferase (AST), blood urea nitrogen (BUN) and creatinine, as graded by the Food and Drug Administration [FDA] Guidance for Industry "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Assessed grades at specified time point, are Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe and Grade 4 = life threatening, as compared to the baseline status of the same parameter, at baseline [e.g. ALT-Grade 1(SCR)-Grade 1 = ALT Grade 1 at baseline versus Grade 1 at Day 8]. "Any" corresponding to any grade and "Grade 0" to normal ranges. Increase By Factor = IBF The analysis was performed on the Exposed Set, which included all vaccinated subjects with available results for the specified laboratory parameter and time point.
    End point type
    Primary
    End point timeframe
    At Day 8
    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: No statistical analyses as there are no confirmatory analysis
    End point values
    RSV MAT formulation 1 Group RSV MAT formulation 2 Group RSV MAT formulation 3 Group Control Group
    Number of subjects analysed
    123
    124
    126
    126
    Units: Participants
        ALT-IBF, Any(SCR), GRADE 0(N-123,124,126,125)
    118
    119
    124
    117
        ALT-IBF, Any(SCR), GRADE 1(N-123,124,126,125)
    5
    3
    1
    7
        ALT-IBF, Any(SCR), GRADE 2(N-123,124,126,125)
    0
    1
    1
    0
        ALT-IBF, Any(SCR), GRADE 3(N-123,124,126,125)
    0
    1
    0
    1
        ALT-IBF, Grade 0(SCR), GRADE 0(N-116,120,123,116)
    115
    115
    121
    114
        ALT-IBF, Grade 0(SCR), GRADE 1(N-116,120,123,116)
    1
    3
    1
    2
        ALT-IBF, Grade 0(SCR), GRADE 2(N-116,120,123,116)
    0
    1
    1
    0
        ALT-IBF, Grade 0(SCR), GRADE 3(N-116,120,123,116)
    0
    1
    0
    0
        ALT-IBF, Grade 1(SCR), GRADE 0(N-6,4,3,9)
    3
    4
    3
    3
        ALT-IBF, Grade 1(SCR), GRADE 1(N-6,4,3,9)
    3
    0
    0
    5
        ALT-IBF, Grade 1(SCR), GRADE 3(N-6,4,3,9)
    0
    0
    0
    1
        ALT-IBF, Grade 2(SCR), GRADE 1(N-1,0,0,0)
    1
    0
    0
    0
        AST-IBF, Any(SCR), GRADE 0(N-123,124,126,125)
    123
    120
    124
    122
        AST-IBF, Any(SCR), GRADE 1(N-123,124,126,125)
    0
    3
    2
    3
        AST-IBF, Any(SCR), GRADE 3(N-123,124,126,125)
    0
    1
    0
    0
        AST-IBF, Grade 0(SCR), GRADE 0(N-120,123,125,121)
    120
    119
    124
    119
        AST-IBF, Grade 0(SCR), GRADE 1(N-120,123,125,121)
    0
    3
    1
    2
        AST-IBF, Grade 0(SCR), GRADE 3(N-120,123,125,121)
    0
    1
    0
    0
        AST-IBF, Grade 1(SCR), GRADE 0(N-3,1,1,4)
    3
    1
    0
    3
        AST-IBF, Grade 1(SCR), GRADE 1(N-3,1,1,4)
    0
    0
    1
    1
        BUN, Any(SCR), GRADE 0(N-123,124,125,126)
    122
    123
    124
    125
        BUN, Any(SCR), GRADE 1(N-123,124,125,126)
    1
    1
    1
    0
        BUN, Any(SCR), GRADE 2(N-123,124,125,126)
    0
    0
    0
    1
        BUN, Grade 0(SCR), GRADE 0(N-123,124,124,126)
    122
    123
    123
    124
        BUN, Grade 0(SCR), GRADE 1(N-123,124,124,126)
    1
    1
    1
    0
        BUN, Grade 0(SCR), GRADE 2(N-123,124,124,126)
    0
    0
    0
    1
        BUN, Grade 1(SCR), GRADE 0(N-0,0,1,0)
    0
    0
    1
    0
        BUN, Grade 2(SCR), GRADE 0(N-0,0,0,1)
    0
    0
    0
    1
        Creatinine, Any(SCR), GRADE 0 (N-123,124,126,126)
    122
    124
    126
    126
        Creatinine,Any(SCR), GRADE 3(N-123,124,126,126)
    1
    0
    0
    0
        Creatinine,Grade 0(SCR),GRADE 0(N-123,124,126,126)
    122
    124
    126
    126
        Creatinine,Grade 0(SCR),GRADE 3(N-123,124,126,126)
    1
    0
    0
    0
    No statistical analyses for this end point

    Primary: Number of subjects with biochemical laboratory results versus baseline, by maximum grading, at Day 31

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    End point title
    Number of subjects with biochemical laboratory results versus baseline, by maximum grading, at Day 31 [12]
    End point description
    Assessed biochemical laboratory parameters include alanine aminotransferase (ALT), aspartate aminotransferase (AST), blood urea nitrogen (BUN) and creatinine, as graded by the Food and Drug Administration [FDA] Guidance for Industry "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials. Assessed grades at specified time point, are Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe and Grade 4 = life threatening, as compared to the baseline status of the same parameter, at baseline [e.g. ALT-Grade 1(SCR)-Grade 1 = ALT Grade 1 at baseline versus Grade 1 at Day 31]. "Any" corresponding to any grade and "Grade 0" to normal ranges. Increase By Factor = IBF The analysis was performed on the Exposed Set, which included all vaccinated subjects with available results for the specified laboratory parameter and time point.
    End point type
    Primary
    End point timeframe
    At Day 31
    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: No statistical analyses as there are no confirmatory analysis
    End point values
    RSV MAT formulation 1 Group RSV MAT formulation 2 Group RSV MAT formulation 3 Group Control Group
    Number of subjects analysed
    123
    124
    126
    126
    Units: Participants
        ALT-IBF, Any(SCR), GRADE 0(N-123,124,126,126)
    117
    121
    125
    118
        ALT-IBF, Any(SCR), GRADE 1(N-123,124,126,126)
    6
    3
    1
    6
        ALT-IBF, Any(SCR), GRADE 2(N-123,124,126,126)
    0
    0
    0
    2
        ALT-IBF, Grade 0(SCR), GRADE 0(N-116,120,123,117)
    113
    117
    122
    112
        ALT-IBF, Grade 0(SCR), GRADE 1(N-116,120,123,117)
    3
    3
    1
    4
        ALT-IBF, Grade 0(SCR), GRADE 2(N-116,120,123,117)
    0
    0
    0
    1
        ALT-IBF, Grade 1(SCR), GRADE 0(N-6,4,3,9)
    4
    4
    3
    6
        ALT-IBF, Grade 1(SCR), GRADE 1(N-6,4,3,9)
    2
    0
    0
    2
        ALT-IBF, Grade 1(SCR), GRADE 2(N-6,4,3,9)
    0
    0
    0
    1
        ALT-IBF, Grade 2(SCR), GRADE 1(N-1,0,0,0)
    1
    0
    0
    0
        AST-IBF, Any(SCR), GRADE 0(N-123,124,126,126)
    121
    122
    125
    121
        AST-IBF, Any(SCR), GRADE 1(N-123,124,126,126)
    2
    2
    1
    3
        AST-IBF, Any(SCR), GRADE 2(N-123,124,126,126)
    0
    0
    0
    2
        AST-IBF, Grade 0(SCR), GRADE 0(N-120,123,125,122)
    118
    121
    125
    118
        AST-IBF, Grade 0(SCR), GRADE 1(N-120,123,125,122)
    2
    2
    0
    3
        AST-IBF, Grade 0(SCR), GRADE 2(N-120,123,125,122)
    0
    0
    0
    1
        AST-IBF, Grade 1(SCR), GRADE 0(N-3,1,1,4)
    3
    1
    0
    3
        AST-IBF, Grade 1(SCR), GRADE 1(N-3,1,1,4)
    0
    0
    1
    0
        AST-IBF, Grade 1(SCR), GRADE 2(N-3,1,1,4)
    0
    0
    0
    1
        BUN, Any(SCR), GRADE 0(N-123,124,126,126)
    123
    123
    126
    125
        BUN, Any(SCR), GRADE 1(N-123,124,126,126)
    0
    0
    0
    1
        BUN, Any(SCR), GRADE 2(N-123,124,126,126)
    0
    1
    0
    0
        BUN, Grade 0(SCR), GRADE 0(N-123,124,125,125)
    123
    123
    125
    124
        BUN, Grade 0(SCR), GRADE 1(N-123,124,125,125)
    0
    0
    0
    1
        BUN, Grade 0(SCR), GRADE 2(N-123,124,125,125)
    0
    1
    0
    0
        BUN, Grade 1(SCR), GRADE 0(N-0,0,1,0)
    0
    0
    1
    0
        BUN, Grade 2(SCR), GRADE 0(N-0,0,0,1)
    0
    0
    0
    1
        Creatinine,Any(SCR),GRADE 0(N-123,124,126,126)
    123
    124
    126
    126
        Creatinine,Grade 0(SCR),GRADE 0(N-123,124,126,126)
    123
    124
    126
    126
    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
    Assessed SAEs include any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, or results in disability/incapacity, or is a congenital anomaly/birth defect in the offspring of a study subject. The analysis was performed on the Exposed Set, which included all vaccinated subjects.
    End point type
    Secondary
    End point timeframe
    From Day 1 (vaccination) up to Day 91 and up to Day 181
    End point values
    RSV MAT formulation 1 Group RSV MAT formulation 2 Group RSV MAT formulation 3 Group Control Group
    Number of subjects analysed
    124
    126
    126
    126
    Units: Participants
        SAE - Day 91
    0
    0
    1
    1
        SAE - Day 181
    0
    0
    1
    2
    No statistical analyses for this end point

    Secondary: Neutralizing antibody (Nab) titers against RSV serotype A

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    End point title
    Neutralizing antibody (Nab) titers against RSV serotype A
    End point description
    Anti RSV-A neutralizing antibody titers are given as geometric mean titers (GMTs) and expressed as Estimated Dose: serum dilution giving a 60% reduction of the signal compared to a control without serum (ED60), calculated on subjects with anti-RSV-A neutralizing antibody titer equal to or above the assay cut-off 18 ED60. The analysis was performed on the Per-protocol set which included all vaccinated subjects, meeting all protocol requirements and for whom immunogenicity results were available for the specified assay at the corresponding time-point.
    End point type
    Secondary
    End point timeframe
    At pre-vaccination at screening (PRE), 7 days post vaccination (Day 8), 30 days post vaccination (Day 31), 60 days post vaccination (Day 61) and 90 days post vaccination (Day 91)
    End point values
    RSV MAT formulation 1 Group RSV MAT formulation 2 Group RSV MAT formulation 3 Group Control Group
    Number of subjects analysed
    123
    125
    126
    126
    Units: Titers
    geometric mean (confidence interval 95%)
        PRE (N-123,125,126,126)
    851.1 (732.88 to 988.3)
    921.6 (795.52 to 1067.64)
    868.8 (754.18 to 1000.78)
    746.2 (639.96 to 870.02)
        Day 8 (N-120,119,120,123)
    6720.1 (5861.07 to 7705.03)
    9843.6 (8170.69 to 11858.92)
    12638.3 (10883.83 to 14675.63)
    790.8 (665.49 to 939.62)
        Day 31 (N-121,121,124,122)
    5327.6 (4640.84 to 6116.06)
    7323.3 (6236 to 8600.25)
    7943.4 (6942.16 to 9089.07)
    762.9 (638.74 to 911.18)
        Day 61 (N-121,121,124,120)
    5268.4 (4639.84 to 5982.16)
    6783.1 (5782.42 to 7956.92)
    7575.8 (6633.19 to 8652.41)
    875.6 (734.11 to 1044.4)
        Day 91 (N-116,119,123,118)
    4110.7 (3564.87 to 4740.12)
    5186.7 (4357.63 to 6173.57)
    5067.9 (4451.73 to 5769.4)
    840.0 (717.87 to 982.93)
    No statistical analyses for this end point

    Secondary: Anti-RSVPreF3 Immunoglobulin G (IgG) antibody concentrations

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    End point title
    Anti-RSVPreF3 Immunoglobulin G (IgG) antibody concentrations
    End point description
    Concentrations are presented as geometric mean concentrations (GMCs), expressed in Enzyme Linked Immunosorbent Assay (ELISA) units per millilitre (EL.U/mL), calculated on subjects with anti-RSVPreF3 antibody concentration equal to or above the assay cut-off 25 EL.U/mL. The analysis was performed on the Per-protocol set which included all vaccinated subjects, meeting all protocol requirements and for whom immunogenicity results were available for the specified assay at the corresponding time-point.
    End point type
    Secondary
    End point timeframe
    At pre-vaccination at screening (PRE), 7 days post vaccination (Day 8), 30 days post vaccination (Day 31), 60 days post vaccination (Day 61) and 90 days post vaccination (Day 91)
    End point values
    RSV MAT formulation 1 Group RSV MAT formulation 2 Group RSV MAT formulation 3 Group Control Group
    Number of subjects analysed
    123
    125
    126
    126
    Units: EL.U/mL
    geometric mean (confidence interval 95%)
        PRE (N-123,125,126,126)
    6753 (6032.53 to 7560.61)
    6447 (5822.74 to 7138.39)
    6738 (5954.89 to 7625.01)
    5583 (5014.96 to 6215.1)
        Day 8 (N-120,119,120,123)
    83187 (75159.55 to 92072.87)
    111915 (97936.91 to 127887.72)
    145984 (131579.66 to 161966.03)
    5902 (5270.51 to 6609.37)
        Day 31 (N-121,121,124,123)
    66153 (58990.44 to 74184.52)
    85096 (75185.08 to 96313.02)
    94360 (86517.06 to 102912.86)
    5856 (5165.49 to 6639.47)
        Day 61 (N-121,121,124,120)
    55170 (49687.49 to 61258)
    65007 (57805.13 to 73106.25)
    71401 (66038.58 to 77198.53)
    6100 (5355.93 to 6948.09)
        Day 91 (N-116,119,123,118)
    39602 (34650.65 to 45261.85)
    47629 (41925.98 to 54108.51)
    51424 (46747.32 to 56569.61)
    6692 (5722.81 to 7825)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited adverse events were collected during the 7-day follow-up period and unsolicited adverse events during the 30-day follow-up period. Serious adverse events were collected from Day 1 up to Day 181.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    RSV MAT formulation 1 Group
    Reporting group description
    Subjects receive a single dose (30 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm

    Reporting group title
    RSV MAT formulation 2 Group
    Reporting group description
    Subjects receive a single dose (60 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm

    Reporting group title
    RSV MAT formulation 3 Group
    Reporting group description
    Subjects receive a single dose (120 µg) injection of the investigational RSV maternal vaccine (GSK3888550A) at Day 1, intramuscularly into the deltoid region of the non-dominant arm

    Reporting group title
    Control Group
    Reporting group description
    Subjects receive a single placebo saline injection at Day 1, intramuscularly into the deltoid region of the non-dominant arm

    Serious adverse events
    RSV MAT formulation 1 Group RSV MAT formulation 2 Group RSV MAT formulation 3 Group Control Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 126 (0.00%)
    1 / 126 (0.79%)
    2 / 126 (1.59%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Gastrointestinal disorders
    Umbilical hernia
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 126 (0.00%)
    1 / 126 (0.79%)
    0 / 126 (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
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
    1 / 126 (0.79%)
         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
    Diverticulitis
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
    1 / 126 (0.79%)
         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
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    RSV MAT formulation 1 Group RSV MAT formulation 2 Group RSV MAT formulation 3 Group Control Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    94 / 124 (75.81%)
    96 / 126 (76.19%)
    105 / 126 (83.33%)
    83 / 126 (65.87%)
    Vascular disorders
    Flushing
         subjects affected / exposed
    0 / 124 (0.00%)
    1 / 126 (0.79%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Hypertension
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    0
    1
    Peripheral coldness
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 126 (0.00%)
    1 / 126 (0.79%)
    0 / 126 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Immune system disorders
    Hypersensitivity
         subjects affected / exposed
    0 / 124 (0.00%)
    2 / 126 (1.59%)
    0 / 126 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    2
    0
    1
    Food allergy
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    1
    0
    0
    0
    General disorders and administration site conditions
    Injection site pain
         subjects affected / exposed
    59 / 124 (47.58%)
    64 / 126 (50.79%)
    67 / 126 (53.17%)
    20 / 126 (15.87%)
         occurrences all number
    59
    64
    67
    20
    Fatigue
         subjects affected / exposed
    42 / 124 (33.87%)
    49 / 126 (38.89%)
    41 / 126 (32.54%)
    38 / 126 (30.16%)
         occurrences all number
    43
    49
    41
    38
    Injection site inflammation
         subjects affected / exposed
    8 / 124 (6.45%)
    14 / 126 (11.11%)
    10 / 126 (7.94%)
    1 / 126 (0.79%)
         occurrences all number
    8
    14
    10
    1
    Injection site swelling
         subjects affected / exposed
    5 / 124 (4.03%)
    7 / 126 (5.56%)
    6 / 126 (4.76%)
    0 / 126 (0.00%)
         occurrences all number
    5
    7
    6
    0
    Pyrexia
         subjects affected / exposed
    2 / 124 (1.61%)
    0 / 126 (0.00%)
    4 / 126 (3.17%)
    1 / 126 (0.79%)
         occurrences all number
    2
    0
    4
    1
    Injection site bruising
         subjects affected / exposed
    2 / 124 (1.61%)
    1 / 126 (0.79%)
    1 / 126 (0.79%)
    2 / 126 (1.59%)
         occurrences all number
    2
    1
    1
    2
    Chills
         subjects affected / exposed
    0 / 124 (0.00%)
    1 / 126 (0.79%)
    1 / 126 (0.79%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Peripheral swelling
         subjects affected / exposed
    0 / 124 (0.00%)
    1 / 126 (0.79%)
    1 / 126 (0.79%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Axillary pain
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 126 (0.00%)
    2 / 126 (1.59%)
    0 / 126 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Influenza like illness
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Feeling cold
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    0
    1
    Feeling hot
         subjects affected / exposed
    0 / 124 (0.00%)
    1 / 126 (0.79%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Injection site induration
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 126 (0.00%)
    1 / 126 (0.79%)
    0 / 126 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Injury associated with device
         subjects affected / exposed
    0 / 124 (0.00%)
    1 / 126 (0.79%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Pain
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 126 (0.00%)
    1 / 126 (0.79%)
    0 / 126 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Swelling
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 126 (0.00%)
    1 / 126 (0.79%)
    0 / 126 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Vaccination site bruising
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    0
    1
    Vaccination site haematoma
         subjects affected / exposed
    0 / 124 (0.00%)
    1 / 126 (0.79%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    1 / 124 (0.81%)
    2 / 126 (1.59%)
    2 / 126 (1.59%)
    1 / 126 (0.79%)
         occurrences all number
    2
    2
    2
    1
    Breast swelling
         subjects affected / exposed
    0 / 124 (0.00%)
    1 / 126 (0.79%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Genital pain
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    0
    1
    Menstrual disorder
         subjects affected / exposed
    0 / 124 (0.00%)
    1 / 126 (0.79%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Injury, poisoning and procedural complications
    Dental restoration failure
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 126 (0.00%)
    1 / 126 (0.79%)
    0 / 126 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hand fracture
         subjects affected / exposed
    0 / 124 (0.00%)
    1 / 126 (0.79%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Ligament rupture
         subjects affected / exposed
    0 / 124 (0.00%)
    1 / 126 (0.79%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Skin abrasion
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 126 (0.00%)
    1 / 126 (0.79%)
    0 / 126 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    0
    1
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    0
    1
    Haemoglobin decreased
         subjects affected / exposed
    0 / 124 (0.00%)
    1 / 126 (0.79%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Transaminases increased
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    0
    1
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    4 / 124 (3.23%)
    1 / 126 (0.79%)
    4 / 126 (3.17%)
    1 / 126 (0.79%)
         occurrences all number
    4
    1
    4
    1
    Cough
         subjects affected / exposed
    1 / 124 (0.81%)
    3 / 126 (2.38%)
    3 / 126 (2.38%)
    1 / 126 (0.79%)
         occurrences all number
    1
    3
    3
    1
    Rhinorrhoea
         subjects affected / exposed
    1 / 124 (0.81%)
    1 / 126 (0.79%)
    0 / 126 (0.00%)
    2 / 126 (1.59%)
         occurrences all number
    1
    1
    0
    2
    Nasal congestion
         subjects affected / exposed
    1 / 124 (0.81%)
    1 / 126 (0.79%)
    0 / 126 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    1
    1
    0
    1
    Paranasal sinus discomfort
         subjects affected / exposed
    0 / 124 (0.00%)
    1 / 126 (0.79%)
    1 / 126 (0.79%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Asthma
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    0
    1
    Dyspnoea
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 126 (0.00%)
    1 / 126 (0.79%)
    0 / 126 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Sneezing
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 126 (0.00%)
    1 / 126 (0.79%)
    0 / 126 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Blood and lymphatic system disorders
    Lymphadenopathy
         subjects affected / exposed
    1 / 124 (0.81%)
    2 / 126 (1.59%)
    3 / 126 (2.38%)
    1 / 126 (0.79%)
         occurrences all number
    1
    2
    3
    1
    Lymphadenitis
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 126 (0.00%)
    1 / 126 (0.79%)
    0 / 126 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Neutropenia
         subjects affected / exposed
    0 / 124 (0.00%)
    1 / 126 (0.79%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    43 / 124 (34.68%)
    53 / 126 (42.06%)
    63 / 126 (50.00%)
    38 / 126 (30.16%)
         occurrences all number
    50
    57
    70
    50
    Dizziness
         subjects affected / exposed
    1 / 124 (0.81%)
    1 / 126 (0.79%)
    1 / 126 (0.79%)
    2 / 126 (1.59%)
         occurrences all number
    1
    1
    1
    2
    Paraesthesia
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 126 (0.00%)
    2 / 126 (1.59%)
    1 / 126 (0.79%)
         occurrences all number
    1
    0
    2
    1
    Nerve compression
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Dysaesthesia
         subjects affected / exposed
    0 / 124 (0.00%)
    1 / 126 (0.79%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Neuralgia
         subjects affected / exposed
    0 / 124 (0.00%)
    1 / 126 (0.79%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Poor quality sleep
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 126 (0.00%)
    1 / 126 (0.79%)
    0 / 126 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Sciatica
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    0
    1
    Thermohyperaesthesia
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 126 (0.00%)
    1 / 126 (0.79%)
    0 / 126 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    1
    0
    0
    0
    External ear pain
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    0
    1
    Hyperacusis
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    0
    1
    Vertigo
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 126 (0.00%)
    1 / 126 (0.79%)
    0 / 126 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Gastrointestinal disorders
    Gastrointestinal disorder
         subjects affected / exposed
    30 / 124 (24.19%)
    29 / 126 (23.02%)
    23 / 126 (18.25%)
    27 / 126 (21.43%)
         occurrences all number
    30
    29
    23
    27
    Diarrhoea
         subjects affected / exposed
    2 / 124 (1.61%)
    1 / 126 (0.79%)
    0 / 126 (0.00%)
    2 / 126 (1.59%)
         occurrences all number
    2
    1
    0
    2
    Nausea
         subjects affected / exposed
    1 / 124 (0.81%)
    1 / 126 (0.79%)
    0 / 126 (0.00%)
    2 / 126 (1.59%)
         occurrences all number
    2
    1
    0
    2
    Abdominal pain
         subjects affected / exposed
    0 / 124 (0.00%)
    2 / 126 (1.59%)
    1 / 126 (0.79%)
    1 / 126 (0.79%)
         occurrences all number
    0
    2
    1
    1
    Constipation
         subjects affected / exposed
    2 / 124 (1.61%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Abdominal pain upper
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 126 (0.00%)
    1 / 126 (0.79%)
    0 / 126 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Food poisoning
         subjects affected / exposed
    0 / 124 (0.00%)
    1 / 126 (0.79%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Gastrointestinal pain
         subjects affected / exposed
    0 / 124 (0.00%)
    1 / 126 (0.79%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Vomiting
         subjects affected / exposed
    0 / 124 (0.00%)
    1 / 126 (0.79%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Hepatobiliary disorders
    Hypertransaminasaemia
         subjects affected / exposed
    0 / 124 (0.00%)
    1 / 126 (0.79%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Hyperhidrosis
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 126 (0.00%)
    1 / 126 (0.79%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    1
    1
    Urticaria
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Acne
         subjects affected / exposed
    0 / 124 (0.00%)
    1 / 126 (0.79%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Night sweats
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 126 (0.00%)
    1 / 126 (0.79%)
    0 / 126 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Perioral dermatitis
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    0
    1
    Rash
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 126 (0.00%)
    1 / 126 (0.79%)
    0 / 126 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Skin exfoliation
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 126 (0.00%)
    1 / 126 (0.79%)
    0 / 126 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    4 / 124 (3.23%)
    3 / 126 (2.38%)
    0 / 126 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    4
    3
    0
    1
    Pain in extremity
         subjects affected / exposed
    4 / 124 (3.23%)
    1 / 126 (0.79%)
    1 / 126 (0.79%)
    2 / 126 (1.59%)
         occurrences all number
    4
    1
    1
    2
    Arthralgia
         subjects affected / exposed
    2 / 124 (1.61%)
    2 / 126 (1.59%)
    3 / 126 (2.38%)
    1 / 126 (0.79%)
         occurrences all number
    2
    2
    3
    1
    Myalgia
         subjects affected / exposed
    1 / 124 (0.81%)
    2 / 126 (1.59%)
    1 / 126 (0.79%)
    1 / 126 (0.79%)
         occurrences all number
    1
    2
    1
    1
    Muscle spasms
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
    2 / 126 (1.59%)
         occurrences all number
    1
    0
    0
    2
    Musculoskeletal pain
         subjects affected / exposed
    0 / 124 (0.00%)
    2 / 126 (1.59%)
    0 / 126 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    2
    0
    1
    Neck pain
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 126 (0.00%)
    2 / 126 (1.59%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    3
    1
    Muscular weakness
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 126 (0.00%)
    1 / 126 (0.79%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    1
    1
    Joint swelling
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Muscle tightness
         subjects affected / exposed
    0 / 124 (0.00%)
    1 / 126 (0.79%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Musculoskeletal discomfort
         subjects affected / exposed
    0 / 124 (0.00%)
    1 / 126 (0.79%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Pain in jaw
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 126 (0.00%)
    1 / 126 (0.79%)
    0 / 126 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Spinal pain
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    0
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 126 (0.00%)
    1 / 126 (0.79%)
    0 / 126 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    7 / 124 (5.65%)
    7 / 126 (5.56%)
    10 / 126 (7.94%)
    4 / 126 (3.17%)
         occurrences all number
    8
    7
    11
    4
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 124 (1.61%)
    4 / 126 (3.17%)
    4 / 126 (3.17%)
    3 / 126 (2.38%)
         occurrences all number
    2
    4
    4
    3
    Sinusitis
         subjects affected / exposed
    2 / 124 (1.61%)
    1 / 126 (0.79%)
    1 / 126 (0.79%)
    0 / 126 (0.00%)
         occurrences all number
    2
    1
    1
    0
    Urinary tract infection
         subjects affected / exposed
    2 / 124 (1.61%)
    1 / 126 (0.79%)
    0 / 126 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    2
    1
    0
    1
    Gastroenteritis
         subjects affected / exposed
    1 / 124 (0.81%)
    2 / 126 (1.59%)
    0 / 126 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    1
    3
    0
    1
    Gastroenteritis viral
         subjects affected / exposed
    0 / 124 (0.00%)
    2 / 126 (1.59%)
    1 / 126 (0.79%)
    1 / 126 (0.79%)
         occurrences all number
    0
    2
    1
    1
    Viral upper respiratory tract infection
         subjects affected / exposed
    1 / 124 (0.81%)
    1 / 126 (0.79%)
    0 / 126 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    1
    1
    0
    1
    Influenza
         subjects affected / exposed
    0 / 124 (0.00%)
    1 / 126 (0.79%)
    1 / 126 (0.79%)
    1 / 126 (0.79%)
         occurrences all number
    0
    1
    1
    1
    Bronchitis
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 126 (0.00%)
    1 / 126 (0.79%)
    0 / 126 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Rhinitis
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    1
    0
    0
    1
    Laryngitis
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Oral herpes
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Respiratory tract infection
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Viral infection
         subjects affected / exposed
    1 / 124 (0.81%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Bacterial vaginosis
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    0
    1
    Conjunctivitis bacterial
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    0
    1
    Cystitis
         subjects affected / exposed
    0 / 124 (0.00%)
    1 / 126 (0.79%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Gastroenteritis norovirus
         subjects affected / exposed
    0 / 124 (0.00%)
    1 / 126 (0.79%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Infection
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    0
    1
    Infectious mononucleosis
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 126 (0.00%)
    1 / 126 (0.79%)
    0 / 126 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Nasal herpes
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 126 (0.00%)
    1 / 126 (0.79%)
    0 / 126 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Pharyngitis
         subjects affected / exposed
    0 / 124 (0.00%)
    1 / 126 (0.79%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Pharyngitis streptococcal
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 126 (0.00%)
    0 / 126 (0.00%)
    1 / 126 (0.79%)
         occurrences all number
    0
    0
    0
    1
    Viral pharyngitis
         subjects affected / exposed
    0 / 124 (0.00%)
    0 / 126 (0.00%)
    1 / 126 (0.79%)
    0 / 126 (0.00%)
         occurrences all number
    0
    0
    1
    0

    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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