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    Clinical Trial Results:
    A phase II, controlled, randomized, single centre, single blind study to evaluate the immunogenicity, safety and reactogenicity of the low dose influenza vaccine with various doses of AS03 adjuvant compared to Fluarix™ (GlaxoSmithKline Biologicals) administered intramuscularly in subjects aged 18-59 years old.

    Summary
    EudraCT number
    		 2006-003769-15
    Trial protocol
    		 BE  
    Global end of trial date
    29 Nov 2006

    Results information
    Results version number
    		 v2(current)
    This version publication date
    07 Apr 2021
    First version publication date
    04 Dec 2014
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Minor corrections in safety section.

    Trial information

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    Trial identification
    Sponsor protocol code
    108656
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT00374842
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline Biologicals
    Sponsor organisation address
    Rue de l'Institut 89, Rixensart, Belgium, 1330
    Public contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 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
    30 Nov 2006
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Nov 2006
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the humoral immune response (anti-haemagglutinin antibody titres) elicited by the low dose influenza vaccine adjuvanted with AS03 (full or half dose of AS03) and by Fluarix given intramuscularly in subjects aged 18-59 years old, 21 days following vaccination.
    Protection of trial subjects
    As with all injectable vaccines, appropriate medical treatment was always readily available in case of anaphylactic reactions following the administration of the vaccine. For this reason, the vaccine remained under medical supervision for 30 minutes after vaccination. Subjects were instructed to contact the investigator should they manifest any signs or symptoms they perceive as serious.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 Oct 2006
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 300
    Worldwide total number of subjects
    300
    EEA total number of subjects
    300
    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)
    300
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 A total of 300 subjects were enrolled in the study. Study duration was of approximately 1 month (30 days) for all subjects.

    Pre-assignment
    Screening details
    		 -

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

    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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 GSK1247446A Formulation 1 Group
    Arm description
    		 Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a full dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
    Arm type
    		 Experimental

    Investigational medicinal product name
    GlaxoSmithKline Biologicals low dose influenza vaccine adjuvanted with AS03 (full dose of AS03)
    Investigational medicinal product code
    FLU-LD
    Other name
    GSK1247446A
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Low-dose GlaxoSmithKline Biologicals’ GSK1247446A influenza vaccine

    Arm title
    		 GSK1247446A Formulation 2 Group
    Arm description
    		 Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a half dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
    Arm type
    		 Experimental

    Investigational medicinal product name
    GlaxoSmithKline Biologicals low dose influenza vaccine adjuvanted with AS03 (half dose of AS03)
    Investigational medicinal product code
    FLU-LD
    Other name
    GSK1247446A
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Low-dose GlaxoSmithKline Biologicals’ GSK1247446A influenza vaccine

    Arm title
    		 Fluarix Group
    Arm description
    		 Subjects aged 18 - 59 years at the time of enrolment received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Fluarix™
    Investigational medicinal product code
    Other name
    Alpharix
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    Intramuscularly in the deltoid region of the non-dominant arm.

    Number of subjects in period 1
    		GSK1247446A Formulation 1 Group GSK1247446A Formulation 2 Group Fluarix Group
    Started
    100
    100
    100
    Completed
    100
    100
    100

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    GSK1247446A Formulation 1 Group
    Reporting group description
    		 Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a full dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

    Reporting group title
    GSK1247446A Formulation 2 Group
    Reporting group description
    		 Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a half dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

    Reporting group title
    Fluarix Group
    Reporting group description
    		 Subjects aged 18 - 59 years at the time of enrolment received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

    Reporting group values
    		 GSK1247446A Formulation 1 Group GSK1247446A Formulation 2 Group Fluarix Group Total
    Number of subjects
    		 100 100 100 300
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0
        Newborns (0-27 days)
    		 0
        Infants and toddlers (28 days-23 months)
    		 0
        Children (2-11 years)
    		 0
        Adolescents (12-17 years)
    		 0
        Adults (18-64 years)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        geometric mean (standard deviation)
    		 37.3 ( 13.94 ) 35 ( 13.26 ) 37.7 ( 13.75 ) -
    Gender categorical
    Units: Subjects
        Female
    		 65 60 57 182
        Male
    		 35 40 43 118

    End points

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    End points reporting groups
    Reporting group title
    GSK1247446A Formulation 1 Group
    Reporting group description
    		 Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a full dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

    Reporting group title
    GSK1247446A Formulation 2 Group
    Reporting group description
    		 Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a half dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

    Reporting group title
    Fluarix Group
    Reporting group description
    		 Subjects aged 18 - 59 years at the time of enrolment received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

    Primary: Titers of serum haemagglutination-inhibition (HI) antibodies against each of the 3 influenza strains assessed.

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    End point title
    		 Titers of serum haemagglutination-inhibition (HI) antibodies against each of the 3 influenza strains assessed. [1]
    End point description
    Influenza strains assessed were the A/New Caledonia (A/CAL), A/Wisconsin (A/WIS), B/Malaysia (B/MAL) strains. Titers were presented as geometric mean titers (GMTs) calculated on subjects with available results, and expressed in haemagglutination-inhibition unit (HIU), e. g. the dilution of a serum haemagglutination-inhibition containing the specific antibody each of the assessed influenza strains at which the solution retained the minimum level of activity needed to neutralize or precipitate the corresponding influenzae antigen. The seropositivity cut-off value of the assay was 10 HIU.
    End point type
    Primary
    End point timeframe
    At Day 0 and at Day 21.
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 GSK1247446A Formulation 1 Group GSK1247446A Formulation 2 Group Fluarix Group
    Number of subjects analysed
    99
    99
    98
    Units: HIU
    geometric mean (confidence interval 95%)
        A/CAL, Day 0
    31.9 (23.5 to 43.4)
    36.1 (26.9 to 48.5)
    26.1 (20.5 to 33.2)
        A/CAL, Day 21
    475.4 (352.2 to 641.6)
    399 (294.7 to 540.2)
    380.6 (274.2 to 528.4)
        A/WIS, Day 0
    16.8 (13.1 to 21.5)
    19.9 (15.2 to 25.9)
    14.7 (11.6 to 18.6)
        A/WIS, Day 21
    276.2 (223.5 to 341.3)
    241.9 (192.9 to 303.4)
    172.3 (136.4 to 217.6)
        B/MAL, Day 0
    20.4 (15.9 to 26.1)
    22.2 (17.6 to 27.9)
    26.5 (20.9 to 33.6)
        B/MAL, Day 21
    268.6 (221.3 to 326)
    301.5 (246.1 to 369.4)
    219.2 (171.4 to 280.2)
    No statistical analyses for this end point

    Primary: Number of seroprotected subjects against each of the 3 influenza strains assessed.

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    End point title
    		 Number of seroprotected subjects against each of the 3 influenza strains assessed. [2]
    End point description
    A seroprotected subject was a subject whose antibody titer against each of the influenza strains assessed (A/New Caledonia (A/CAL), A/Wisconsin (A/WIS) and B/Malaysia (B/MAL) strains) was equal to or higher than (>=) the assay seroprotection cut-off value of 40 haemagglutination-inhibition units (HIU) (e. g. the dilution of a serum haemagglutination-inhibition containing the specific antibody each of the assessed influenza strains at which the solution retained the minimum level of activity needed to neutralize or precipitate the corresponding influenzae antigen).
    End point type
    Primary
    End point timeframe
    At Day 0 and at Day 21.
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 GSK1247446A Formulation 1 Group GSK1247446A Formulation 2 Group Fluarix Group
    Number of subjects analysed
    99
    99
    98
    Units: Subjects
        A/CAL, Day 0
    41
    55
    35
        A/CAL, Day 21
    95
    97
    93
        A/WIS, Day 0
    32
    37
    25
        A/WIS, Day 21
    97
    97
    93
        B/MAL, Day 0
    31
    39
    44
        B/MAL, Day 21
    97
    98
    94
    No statistical analyses for this end point

    Primary: Number of seroconverted subjects against each of the 3 influenza strains assessed

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    End point title
    		 Number of seroconverted subjects against each of the 3 influenza strains assessed [3]
    End point description
    Influenza strains assessed were the A/New Caledonia (A/CAL), A/Wisconsin (A/WIS), and B/Malaysia (B/MAL) strains. A seroconverted subject was a subject who had either a pre-vaccination serum HI antibody titer lower than 10 haemagglutination-inhibition units (HIU) (e. g. the dilution of a serum haemagglutination-inhibition containing the specific antibody each of the assessed influenza strains at which the solution retained the minimum level of activity needed to neutralize or precipitate the corresponding influenzae antigen) and a post-vaccination titer higher than or equal to 40 HIU, or a pre-vaccination titer >= 10 and at least a four-fold increase in post- vaccination titer.
    End point type
    Primary
    End point timeframe
    At Day 21.
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 GSK1247446A Formulation 1 Group GSK1247446A Formulation 2 Group Fluarix Group
    Number of subjects analysed
    99
    99
    98
    Units: Subjects
        A/CAL, Day 21
    69
    64
    66
        A/WIS, Day 21
    88
    79
    73
        B/MAL, Day 21
    76
    82
    65
    No statistical analyses for this end point

    Primary: Seroconversion factor against each of the 3 Influenza strains assessed.

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    End point title
    		 Seroconversion factor against each of the 3 Influenza strains assessed. [4]
    End point description
    Influenza strains assessed were the A/New Caledonia (A/CAL), A/Wisconsin (A/WIS), and B/Malaysia (B/MAL) strains. The seroconversion factor (SCF) was defined as a ratio, as the fold increase in serum haemagglutination-inhibition geometric mean titers (GMTs) post-vaccination compared to Day 0 (with GMTs in the above calculation expressed in haemagglutination-inhibition units (HIU) [e. g. the dilution of a serum haemagglutination-inhibition containing the specific antibody each of the assessed influenza strains at which the solution retained the minimum level of activity needed to neutralize or precipitate the corresponding influenza antigen]).
    End point type
    Primary
    End point timeframe
    At Day 21.
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed.
    End point values
    		 GSK1247446A Formulation 1 Group GSK1247446A Formulation 2 Group Fluarix Group
    Number of subjects analysed
    99
    99
    98
    Units: Fold increase
    geometric mean (confidence interval 95%)
        A/CAL, Day 21
    14.9 (10.4 to 21.3)
    11 (7.7 to 15.9)
    14.6 (9.9 to 21.6)
        A/WIS, Day 21
    16.5 (13 to 20.9)
    12.2 (9.2 to 16.1)
    11.7 (8.8 to 15.6)
        B/MAL, Day 21
    13.2 (10 to 17.4)
    13.6 (10.2 to 18)
    8.3 (6.2 to 11)
    No statistical analyses for this end point

    Secondary: Number of subjects with any and grade 3 solicited local symptoms

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    End point title
    		 Number of subjects with any and grade 3 solicited local symptoms
    End point description
    Assessed solicited local symptoms were ecchymosis, pain, redness and swelling the site of injection. Any = occurrence of a solicited local symptom regardless of intensity grade. Grade 3 pain = Pain which prevented normal activity. Grade 3 ecchymosis/redness/swelling = ecchymosis/redness/swelling at injection site with a diameter larger than (>) 50 millimeters (mm). All solicited local symptoms assessed were considered by the investigator as causally related to the study vaccination.
    End point type
    Secondary
    End point timeframe
    Within the 7-day follow-up period (Days 0-6) after vaccination
    End point values
    		 GSK1247446A Formulation 1 Group GSK1247446A Formulation 2 Group Fluarix Group
    Number of subjects analysed
    100
    100
    100
    Units: Subjects
        Any ecchymosis
    6
    11
    6
        Grade 3 ecchymosis (> 50 mm)
    0
    0
    0
        Any pain
    92
    89
    64
        Grade 3 pain
    10
    0
    0
        Any redness
    24
    12
    15
        Grade 3 redness (> 50 mm)
    6
    2
    1
        Any swelling
    28
    17
    7
        Grade 3 swelling (> 50 mm)
    7
    4
    2
    No statistical analyses for this end point

    Secondary: Number of subjects with any, grade 3 and related solicited general symptoms

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    End point title
    		 Number of subjects with any, grade 3 and related solicited general symptoms
    End point description
    Assessed solicited general symptoms were arthralgia, fatigue, fever (axillary temperature higher than or equal to (>=) 37.5 degrees Celsius (°C)), headache, muscle aches, and shivering. Any = Occurrence of a particular symptom regardless of intensity or relationship to vaccination. Grade 3 symptom = Symptom which prevented normal activity. Related = Symptom assessed by the investigator as causally related to the study vaccination. Grade 3 fever = axillary temperature higher than 39.0°C.
    End point type
    Secondary
    End point timeframe
    Within the 7-day follow-up period (Days 0-6) after vaccination
    End point values
    		 GSK1247446A Formulation 1 Group GSK1247446A Formulation 2 Group Fluarix Group
    Number of subjects analysed
    100
    100
    100
    Units: Subjects
        Any arthralgia
    32
    14
    7
        Grade 3 arthralgia
    3
    1
    0
        Related arthralgia
    32
    13
    5
        Any fatigue
    60
    42
    28
        Grade 3 fatigue
    6
    2
    1
        Related fatigue
    59
    39
    26
        Axillary fever (>= 37.5°C)
    30
    12
    2
        Grade 3 axillary fever (> 39.0°C)
    2
    0
    0
        Related axillary fever (>= 37.5°C)
    30
    12
    2
        Any headache
    51
    40
    29
        Grade 3 headache
    9
    6
    3
        Related headache
    50
    35
    23
        Any muscle aches
    48
    30
    12
        Grade 3 muscle aches
    4
    2
    0
        Related muscle aches
    47
    29
    11
        Any shivering
    33
    13
    5
        Grade 3 shivering
    2
    2
    0
        Related shivering
    33
    13
    5
    No statistical analyses for this end point

    Secondary: Number of subjects with any, grade 3 and related unsolicited adverse events (AEs)

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    End point title
    		 Number of subjects with any, grade 3 and related unsolicited adverse events (AEs)
    End point description
    An unsolicited AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product. Any AE = any occurrence of an AE, regardless of intensity or relationship to study vaccination. Grade 3 = an event that prevented normal activity. Related = event assessed by the investigator as causally related to the study vaccination.
    End point type
    Secondary
    End point timeframe
    Within the 30-day follow-up period (Days 0-29) after vaccination
    End point values
    		 GSK1247446A Formulation 1 Group GSK1247446A Formulation 2 Group Fluarix Group
    Number of subjects analysed
    100
    100
    100
    Units: Subjects
        Subject(s) with any unsolicited AE(s)
    55
    47
    35
        Subject(s) with Grade 3 unsolicited AE(s)
    11
    5
    6
        Subject(s) with related unsolicited AE(s)
    33
    22
    16
    No statistical analyses for this end point

    Secondary: Number of subjects with any and related serious adverse events (SAEs)

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    End point title
    		 Number of subjects with any and related serious adverse events (SAEs)
    End point description
    SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE = any occurrence of an SAE, regardless of relationship to study vaccination. A related SAE = an SAE assessed by the investigator as causally related to the study vaccination.
    End point type
    Secondary
    End point timeframe
    From study start to study end, from Day 0 to Day 30
    End point values
    		 GSK1247446A Formulation 1 Group GSK1247446A Formulation 2 Group Fluarix Group
    Number of subjects analysed
    100
    100
    100
    Units: Subjects
        Subject(s) with any SAE(s)
    1
    0
    0
        Subject(s) with related SAE(s)
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited symptoms: within the 7-day (Days 0-6) follow-up period after vaccination. Unsolicited adverse events: Within the 30-day (Days 0-29) follow-up period after vaccination. Serious adverse events: From study start to study end (Days 0-30)
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10
    Reporting groups
    Reporting group title
    GSK1247446A Formulation 2 Group
    Reporting group description
    		 Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a half dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

    Reporting group title
    Fluarix Group
    Reporting group description
    		 Subjects aged 18 - 59 years at the time of enrolment received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

    Reporting group title
    GSK1247446A Formulation 1 Group
    Reporting group description
    		 Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a full dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

    Serious adverse events
    		 GSK1247446A Formulation 2 Group Fluarix Group GSK1247446A Formulation 1 Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    1 / 100 (1.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Injury, poisoning and procedural complications
    Post procedural nausea
         subjects affected / exposed
    0 / 100 (0.00%)
    0 / 100 (0.00%)
    1 / 100 (1.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 GSK1247446A Formulation 2 Group Fluarix Group GSK1247446A Formulation 1 Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    95 / 100 (95.00%)
    81 / 100 (81.00%)
    98 / 100 (98.00%)
    Nervous system disorders
    Headache (unsolicited AE)
         subjects affected / exposed
    6 / 100 (6.00%)
    2 / 100 (2.00%)
    9 / 100 (9.00%)
         occurrences all number
    6
    2
    9
    Blood and lymphatic system disorders
    Lymphadenopathy
         subjects affected / exposed
    2 / 100 (2.00%)
    0 / 100 (0.00%)
    5 / 100 (5.00%)
         occurrences all number
    2
    0
    5
    General disorders and administration site conditions
    Ecchymosis
    alternative assessment type: Systematic
         subjects affected / exposed
    11 / 100 (11.00%)
    6 / 100 (6.00%)
    6 / 100 (6.00%)
         occurrences all number
    11
    6
    6
    Pain
    alternative assessment type: Systematic
         subjects affected / exposed
    89 / 100 (89.00%)
    64 / 100 (64.00%)
    92 / 100 (92.00%)
         occurrences all number
    89
    64
    92
    Redness
    alternative assessment type: Systematic
         subjects affected / exposed
    12 / 100 (12.00%)
    15 / 100 (15.00%)
    24 / 100 (24.00%)
         occurrences all number
    12
    15
    24
    Swelling
    alternative assessment type: Systematic
         subjects affected / exposed
    17 / 100 (17.00%)
    7 / 100 (7.00%)
    28 / 100 (28.00%)
         occurrences all number
    17
    7
    28
    Arthralgia
    alternative assessment type: Systematic
         subjects affected / exposed
    14 / 100 (14.00%)
    7 / 100 (7.00%)
    32 / 100 (32.00%)
         occurrences all number
    14
    7
    32
    Fatigue
    alternative assessment type: Systematic
         subjects affected / exposed
    42 / 100 (42.00%)
    28 / 100 (28.00%)
    60 / 100 (60.00%)
         occurrences all number
    42
    28
    60
    Headache (solicited general symptom AE)
    alternative assessment type: Systematic
         subjects affected / exposed
    40 / 100 (40.00%)
    29 / 100 (29.00%)
    51 / 100 (51.00%)
         occurrences all number
    40
    29
    51
    Muscle aches
    alternative assessment type: Systematic
         subjects affected / exposed
    30 / 100 (30.00%)
    12 / 100 (12.00%)
    48 / 100 (48.00%)
         occurrences all number
    30
    12
    48
    Shivering
    alternative assessment type: Systematic
         subjects affected / exposed
    13 / 100 (13.00%)
    5 / 100 (5.00%)
    33 / 100 (33.00%)
         occurrences all number
    13
    5
    33
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    3 / 100 (3.00%)
    2 / 100 (2.00%)
    7 / 100 (7.00%)
         occurrences all number
    3
    2
    7
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    8 / 100 (8.00%)
    11 / 100 (11.00%)
    15 / 100 (15.00%)
         occurrences all number
    8
    11
    15

    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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