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    Clinical Trial Results:
    A phase 3, randomized, double-blind, multi-country study to evaluate consistency, safety, and reactogenicity of 3 lots of RSVPreF3 OA investigational vaccine administrated as a single dose in adults aged 60 years and above.

    Summary
    EudraCT number
    		 2021-002225-18
    Trial protocol
    		 SE  
    Global end of trial date
    30 Jun 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Feb 2023
    First version publication date
    15 Feb 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    217131
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05059301
    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, 20 8664357343, GSKClinicalSupportHD@gsk.com
    Scientific contact
    GSK Response Center, GlaxoSmithKline, 20 8664357343, 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
    05 Sep 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Jun 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate the lot to lot consistency of 3 lots of the RSVPreF3 OA investigational vaccine in terms of immunogenicity.
    Protection of trial subjects
    Study participants must be observed closely for at least 30 minutes after the administration of the study intervention. Appropriate medical treatment must be readily available during the observation period in case of anaphylaxis.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Oct 2021
    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
    Canada: 322
    Country: Number of subjects enrolled
    Sweden: 254
    Country: Number of subjects enrolled
    United States: 194
    Worldwide total number of subjects
    770
    EEA total number of subjects
    254
    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)
    180
    From 65 to 84 years
    573
    85 years and over
    17

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Out of 770 participants enrolled 757 received the study vaccine and were included in the Exposed Set.

    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
    		 Investigator, Monitor, Carer, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 RSV OA_Lot 1
    Arm description
    		 Participants received 1 dose of a combination of the RSVPreF3 antigen Lot 1 and AS01E adjuvant Lot A at Day 1 and were followed up until the study end (Month 6).
    Arm type
    		 Experimental

    Investigational medicinal product name
    RSVPreF3 OA investigational vaccine - Lot 1 + AS01E adjuvant - Lot A
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and suspension for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose of RSVPreF3 Lot 1 vaccine reconstituted with 0.5 mL AS01E Lot A adjuvant administered intramuscularly in the deltoid region of the non-dominant arm.

    Arm title
    		 RSV OA_Lot 2
    Arm description
    		 Participants received 1 dose of a combination of the RSVPreF3 antigen Lot 2 and AS01E adjuvant Lot B at Day 1 and were followed up until the study end (Month 6).
    Arm type
    		 Experimental

    Investigational medicinal product name
    RSVPreF3 OA investigational vaccine - Lot 2 + AS01E adjuvant - Lot B
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and suspension for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose of RSVPreF3 Lot 2 vaccine reconstituted with 0.5 mL AS01E Lot B adjuvant administered intramuscularly in the deltoid region of the non-dominant arm.

    Arm title
    		 RSV OA_Lot 3
    Arm description
    		 Participants received 1 dose of a combination of the RSVPreF3 antigen Lot 3 and AS01E adjuvant Lot C at Day 1 and were followed up until the study end (Month 6).
    Arm type
    		 Experimental

    Investigational medicinal product name
    RSVPreF3 OA investigational vaccine - Lot 3 + AS01E adjuvant - Lot C
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and suspension for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose of RSVPreF3 Lot 3 vaccine reconstituted with 0.5 mL AS01E Lot C adjuvant administered intramuscularly in the deltoid region of the non-dominant arm.

    Number of subjects in period 1 [1]
    		RSV OA_Lot 1 RSV OA_Lot 2 RSV OA_Lot 3
    Started
    251
    253
    253
    Completed
    249
    248
    248
    Not completed
    2
    5
    5
         Adverse event, serious fatal
    -
    2
    2
         Lost to follow-up
    2
    3
    3
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Out of 770 participants enrolled 757 received the study vaccine and were included in the Exposed Set.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    RSV OA_Lot 1
    Reporting group description
    		 Participants received 1 dose of a combination of the RSVPreF3 antigen Lot 1 and AS01E adjuvant Lot A at Day 1 and were followed up until the study end (Month 6).

    Reporting group title
    RSV OA_Lot 2
    Reporting group description
    		 Participants received 1 dose of a combination of the RSVPreF3 antigen Lot 2 and AS01E adjuvant Lot B at Day 1 and were followed up until the study end (Month 6).

    Reporting group title
    RSV OA_Lot 3
    Reporting group description
    		 Participants received 1 dose of a combination of the RSVPreF3 antigen Lot 3 and AS01E adjuvant Lot C at Day 1 and were followed up until the study end (Month 6).

    Reporting group values
    		 RSV OA_Lot 1 RSV OA_Lot 2 RSV OA_Lot 3 Total
    Number of subjects
    		 251 253 253 757
    Age categorical
    Units: Subjects
        <65 years
    		 60 59 58 177
        >=65 years
    		 191 194 195 580
    Age Continuous
    Units: Years
        arithmetic mean (standard deviation)
    		 69.7 ( 6.6 ) 70.1 ( 6.6 ) 69.9 ( 6.6 ) -
    Sex: Female, Male
    Units: Subjects
        FEMALE
    		 131 131 109 371
        MALE
    		 120 122 144 386
    Race/Ethnicity, Customized
    Units: Subjects
        ASIAN
    		 6 10 10 26
        BLACK OR AFRICAN AMERICAN
    		 6 3 4 13
        NATIVE HAWAIIAN/OTHER PACIFIC ISLANDER
    		 0 1 0 1
        OTHER: Not specified
    		 8 8 6 22
        WHITE
    		 231 231 233 695

    End points

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    End points reporting groups
    Reporting group title
    RSV OA_Lot 1
    Reporting group description
    		 Participants received 1 dose of a combination of the RSVPreF3 antigen Lot 1 and AS01E adjuvant Lot A at Day 1 and were followed up until the study end (Month 6).

    Reporting group title
    RSV OA_Lot 2
    Reporting group description
    		 Participants received 1 dose of a combination of the RSVPreF3 antigen Lot 2 and AS01E adjuvant Lot B at Day 1 and were followed up until the study end (Month 6).

    Reporting group title
    RSV OA_Lot 3
    Reporting group description
    		 Participants received 1 dose of a combination of the RSVPreF3 antigen Lot 3 and AS01E adjuvant Lot C at Day 1 and were followed up until the study end (Month 6).

    Primary: RSVPreF3 specific immunoglobin (Ig)G antibody concentrations expressed as group geometric mean concentration (GMC)

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    End point title
    		 RSVPreF3 specific immunoglobin (Ig)G antibody concentrations expressed as group geometric mean concentration (GMC)
    End point description
    Enzyme-linked immunosorbent assay (ELISA) was used to assess the concentrations of IgG antibodies against RSV PreF3 in serum samples. The analysis was performed on the Per Protocol set (PPS) which consisted of all eligible subjects who received the study intervention as per protocol, had immunogenicity results pre- and post dose, complied with blood draw intervals, without intercurrent conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination.
    End point type
    Primary
    End point timeframe
    At 30 days post-vaccination (Day 31)
    End point values
    		 RSV OA_Lot 1 RSV OA_Lot 2 RSV OA_Lot 3
    Number of subjects analysed
    234
    237
    237
    Units: ELISA Units/milliliter
        geometric mean (confidence interval 95%)
    86039.9 (78541.5 to 94254.3)
    80518 (73150 to 88628.2)
    94260.9 (86042.2 to 103264.7)
    Statistical analysis title
    		 RSVPreF3 OA lot-to-lot consistency
    Statistical analysis description
    To demonstrate the clinical equivalence of RSV OA_Lot 1 versus RSV OA_Lot 2 in terms of RSV PreF3 IgG concentrations expressed as group GMC ratio at one month post vaccination. The 2-sided 95% CI for group GMC ratio was derived from an ANCOVA model on log10 transformed RSV PreF3 IgG antibody titers. The ANCOVA model included the treatment group and the age category (age at vaccination: 60-69, 70-79 or >=80 years) and the center as fixed effects and the pre-dose log10 titer as covariate.
    Comparison groups
    RSV OA_Lot 1 v RSV OA_Lot 2
    Number of subjects included in analysis
    471
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [1]
    Method
    Parameter type
    		 Adjusted group GMC ratio
    Point estimate
    1.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.94
         upper limit
    		 1.21
    Notes
    [1] - Clinical equivalence is demonstrated if the 2 sided 95% confidence interval (CI) of the GMC ratios (RSV OA_Lot 1 divided by RSV OA_Lot 2) is within the pre defined limit of [0.67, 1.5].
    Statistical analysis title
    		 RSVPreF3 OA lot-to-lot consistency
    Statistical analysis description
    To demonstrate the clinical equivalence of RSV OA_Lot 1 versus RSV OA_Lot 3 in terms of RSV PreF3 IgG concentrations expressed as group GMC ratio at one month post vaccination. The 2-sided 95% CI for group GMC ratio was derived from an ANCOVA model on log10 transformed RSV PreF3 IgG antibody titers. The ANCOVA model included the treatment group and the age category (age at vaccination: 60-69, 70-79 or >=80 years) and the center as fixed effects and the pre-dose log10 titer as covariate.
    Comparison groups
    RSV OA_Lot 1 v RSV OA_Lot 3
    Number of subjects included in analysis
    471
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [2]
    Method
    Parameter type
    		 Adjusted group GMC ratio
    Point estimate
    0.92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.81
         upper limit
    		 1.04
    Notes
    [2] - Clinical equivalence is demonstrated if the 2 sided 95% confidence interval (CI) of the GMC ratios (RSV OA_Lot 1 divided by RSV OA_Lot 3) is within the pre defined limit of [0.67, 1.5].
    Statistical analysis title
    		 RSVPreF3 OA lot-to-lot consistency
    Statistical analysis description
    To demonstrate the clinical equivalence of RSV OA_Lot 2 versus RSV OA_Lot 3 in terms of RSV PreF3 IgG concentrations expressed as group GMC ratio at one month post vaccination. The 2-sided 95% CI for group GMC ratio was derived from an ANCOVA model on log10 transformed RSV PreF3 IgG antibody titers. The ANCOVA model included the treatment group and the age category (age at vaccination: 60-69, 70-79 or >=80 years) and the center as fixed effects and the pre-dose log10 titer as covariate.
    Comparison groups
    RSV OA_Lot 2 v RSV OA_Lot 3
    Number of subjects included in analysis
    474
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [3]
    Method
    Parameter type
    		 Adjusted group GMC ratio
    Point estimate
    0.87
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.77
         upper limit
    		 0.99
    Notes
    [3] - Clinical equivalence is demonstrated if the 2 sided 95% confidence interval (CI) of the GMC ratios (RSV OA_Lot 2 divided by RSV OA_Lot 3) is within the pre defined limit of [0.67, 1.5].

    Secondary: RSVPreF3 specific IgG antibody concentrations expressed as mean geometric increase (MGI)

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    End point title
    		 RSVPreF3 specific IgG antibody concentrations expressed as mean geometric increase (MGI)
    End point description
    MGI was defined as the geometric mean of the within participant ratios of the post-vaccination RSV PreF3 IgG concentration over the pre-vaccination RSV PreF3 IgG concentration. The analysis was performed on the PPS which consisted of all eligible subjects who received the study intervention as per protocol, had immunogenicity results pre- and post dose, complied with blood draw intervals, without intercurrent conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination.
    End point type
    Secondary
    End point timeframe
    At 30 days post-vaccination (Day 31)
    End point values
    		 RSV OA_Lot 1 RSV OA_Lot 2 RSV OA_Lot 3
    Number of subjects analysed
    234
    237
    237
    Units: Ratio
        geometric mean (confidence interval 95%)
    11.84 (10.53 to 13.31)
    11.29 (10.12 to 12.6)
    12.46 (11.13 to 13.94)
    No statistical analyses for this end point

    Secondary: Percentage of participants reporting solicited administration site events

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    End point title
    		 Percentage of participants reporting solicited administration site events
    End point description
    Solicited administration site adverse events (AEs) assessed were erythema, pain and swelling. Any = occurrence of the adverse event regardless of intensity grade. The analysis was performed on participants of the Exposed Set (ES) who had their diary cards completed. The ES included all subjects who received the study intervention.
    End point type
    Secondary
    End point timeframe
    Within 4 days (the day of vaccination and 3 subsequent days) after study intervention administration 
    End point values
    		 RSV OA_Lot 1 RSV OA_Lot 2 RSV OA_Lot 3
    Number of subjects analysed
    249
    251
    252
    Units: Percentage of participants
    number (confidence interval 95%)
        Erythema
    12.4 (8.6 to 17.2)
    11.6 (7.9 to 16.2)
    13.5 (9.5 to 18.3)
        Pain
    58.2 (51.8 to 64.4)
    65.7 (59.5 to 71.6)
    62.7 (56.4 to 68.7)
        Swelling
    6.8 (4 to 10.7)
    7.6 (4.6 to 11.6)
    7.9 (4.9 to 12)
    No statistical analyses for this end point

    Secondary: Percentage of participants reporting solicited systemic events

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    End point title
    		 Percentage of participants reporting solicited systemic events
    End point description
    Solicited systemic events assessed were arthralgia, fatigue, fever [defined as temperature equal to or above (>=) 38 degrees Celsius (°C)/100.4 degrees Fahrenheit (°F)], headache and myalgia. Any = occurrence of the adverse event regardless of intensity grade or relation to study vaccination. The analysis was performed on participants of the Exposed Set (ES) who had their diary cards completed. The ES included all subjects who received the study intervention.
    End point type
    Secondary
    End point timeframe
    Within 4 days (the day of vaccination and 3 subsequent days) after study intervention administration 
    End point values
    		 RSV OA_Lot 1 RSV OA_Lot 2 RSV OA_Lot 3
    Number of subjects analysed
    249
    251
    252
    Units: Percentage of participants
    number (confidence interval 95%)
        Arthralgia
    13.3 (9.3 to 18.1)
    13.9 (9.9 to 18.9)
    14.7 (10.6 to 19.7)
        Fatigue
    28.1 (22.6 to 34.1)
    25.9 (20.6 to 31.8)
    27.8 (22.3 to 33.7)
        Fever
    2 (0.7 to 4.6)
    1.6 (0.4 to 4)
    2.8 (1.1 to 5.6)
        Headache
    25.7 (20.4 to 31.6)
    23.5 (18.4 to 29.2)
    22.2 (17.2 to 27.9)
        Myalgia
    31.3 (25.6 to 37.5)
    34.3 (28.4 to 40.5)
    33.7 (27.9 to 39.9)
    No statistical analyses for this end point

    Secondary: Percentage of participants reporting at least one unsolicited adverse event

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    End point title
    		 Percentage of participants reporting at least one unsolicited adverse event
    End point description
    An unsolicited AE is any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited AE. Unsolicited AEs include serious, non-serious AEs and potential immune-mediated diseases (pIMDs). The analysis was performed on the ES, which included all subjects who received the study intervention.
    End point type
    Secondary
    End point timeframe
    Within 30 days (the day of vaccination and 29 subsequent days) after study intervention administration 
    End point values
    		 RSV OA_Lot 1 RSV OA_Lot 2 RSV OA_Lot 3
    Number of subjects analysed
    251
    253
    253
    Units: Percentage of participants
        number (confidence interval 95%)
    14.7 (10.6 to 19.7)
    14.6 (10.5 to 19.6)
    13.4 (9.5 to 18.3)
    No statistical analyses for this end point

    Secondary: Percentage of participants reporting at least one serious adverse event (SAE) 

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    End point title
    		 Percentage of participants reporting at least one serious adverse event (SAE) 
    End point description
    An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. The analysis was performed on the ES, which included all subjects who received the study intervention.
    End point type
    Secondary
    End point timeframe
    From Day 1 up to study end (6 months after vaccination)
    End point values
    		 RSV OA_Lot 1 RSV OA_Lot 2 RSV OA_Lot 3
    Number of subjects analysed
    251
    253
    253
    Units: Percentage of Participants
        number (confidence interval 95%)
    3.2 (1.4 to 6.2)
    2.4 (0.9 to 5.1)
    2.8 (1.1 to 5.6)
    No statistical analyses for this end point

    Secondary: Percentage of participants reporting at least onepotential immune-mediated disease (pIMD)

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    End point title
    		 Percentage of participants reporting at least onepotential immune-mediated disease (pIMD)
    End point description
    pIMDs are a subset of AEs of special interest that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology. The analysis was performed on the ES, which included all subjects who received the study intervention.
    End point type
    Secondary
    End point timeframe
    From Day 1 up to study end (6 months after vaccination)
    End point values
    		 RSV OA_Lot 1 RSV OA_Lot 2 RSV OA_Lot 3
    Number of subjects analysed
    251
    253
    253
    Units: Percentage of participants
        number (confidence interval 95%)
    0.8 (0.1 to 2.8)
    0.4 (0 to 2.2)
    1.2 (0.2 to 3.4)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected from Day 1 to Study end (6 months after vaccination).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.0
    Reporting groups
    Reporting group title
    RSV OA_Lot 1
    Reporting group description
    		 Participants received 1 dose of a combination of the RSVPreF3 antigen Lot 1 and AS01E adjuvant Lot A at Day 1 and were followed up until the study end (Month 6).

    Reporting group title
    RSV OA_Lot 2
    Reporting group description
    		 Participants received 1 dose of a combination of the RSVPreF3 antigen Lot 2 and AS01E adjuvant Lot B at Day 1 and were followed up until the study end (Month 6).

    Reporting group title
    RSV OA_Lot 3
    Reporting group description
    		 Participants received 1 dose of a combination of the RSVPreF3 antigen Lot 3 and AS01E adjuvant Lot C at Day 1 and were followed up until the study end (Month 6).

    Serious adverse events
    		 RSV OA_Lot 1 RSV OA_Lot 2 RSV OA_Lot 3
    Total subjects affected by serious adverse events
         subjects affected / exposed
    8 / 251 (3.19%)
    6 / 253 (2.37%)
    7 / 253 (2.77%)
         number of deaths (all causes)
    0
    2
    2
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Metastases to liver
         subjects affected / exposed
    1 / 251 (0.40%)
    0 / 253 (0.00%)
    0 / 253 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metastases to lymph nodes
         subjects affected / exposed
    1 / 251 (0.40%)
    0 / 253 (0.00%)
    0 / 253 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pancreatic carcinoma
         subjects affected / exposed
    1 / 251 (0.40%)
    0 / 253 (0.00%)
    0 / 253 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Prostate cancer
         subjects affected / exposed
    1 / 251 (0.40%)
    0 / 253 (0.00%)
    0 / 253 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Squamous cell carcinoma of the hypopharynx
         subjects affected / exposed
    0 / 251 (0.00%)
    1 / 253 (0.40%)
    0 / 253 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    1 / 251 (0.40%)
    0 / 253 (0.00%)
    0 / 253 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    0 / 251 (0.00%)
    1 / 253 (0.40%)
    1 / 253 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    1 / 251 (0.40%)
    0 / 253 (0.00%)
    1 / 253 (0.40%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    0 / 251 (0.00%)
    0 / 253 (0.00%)
    1 / 253 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Myocardial infarction
         subjects affected / exposed
    0 / 251 (0.00%)
    1 / 253 (0.40%)
    0 / 253 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Nervous system disorders
    Ischaemic stroke
         subjects affected / exposed
    1 / 251 (0.40%)
    0 / 253 (0.00%)
    0 / 253 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Syncope
         subjects affected / exposed
    0 / 251 (0.00%)
    0 / 253 (0.00%)
    1 / 253 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Sudden cardiac death
         subjects affected / exposed
    0 / 251 (0.00%)
    1 / 253 (0.40%)
    0 / 253 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary embolism
         subjects affected / exposed
    1 / 251 (0.40%)
    0 / 253 (0.00%)
    2 / 253 (0.79%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 251 (0.00%)
    0 / 253 (0.00%)
    1 / 253 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pleural effusion
         subjects affected / exposed
    0 / 251 (0.00%)
    0 / 253 (0.00%)
    1 / 253 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    Pulmonary oedema
         subjects affected / exposed
    0 / 251 (0.00%)
    0 / 253 (0.00%)
    1 / 253 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    1 / 251 (0.40%)
    0 / 253 (0.00%)
    0 / 253 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Urethral stenosis
         subjects affected / exposed
    0 / 251 (0.00%)
    1 / 253 (0.40%)
    0 / 253 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    COVID-19
         subjects affected / exposed
    1 / 251 (0.40%)
    0 / 253 (0.00%)
    0 / 253 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Large intestine infection
         subjects affected / exposed
    0 / 251 (0.00%)
    1 / 253 (0.40%)
    0 / 253 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 251 (0.00%)
    1 / 253 (0.40%)
    0 / 253 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 251 (0.40%)
    0 / 253 (0.00%)
    0 / 253 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Gout
         subjects affected / exposed
    0 / 251 (0.00%)
    1 / 253 (0.40%)
    0 / 253 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Malnutrition
         subjects affected / exposed
    0 / 251 (0.00%)
    1 / 253 (0.40%)
    0 / 253 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 RSV OA_Lot 1 RSV OA_Lot 2 RSV OA_Lot 3
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    181 / 251 (72.11%)
    192 / 253 (75.89%)
    195 / 253 (77.08%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast cancer
         subjects affected / exposed
    0 / 251 (0.00%)
    1 / 253 (0.40%)
    0 / 253 (0.00%)
         occurrences all number
    0
    1
    0
    Vascular disorders
    Haematoma
         subjects affected / exposed
    1 / 251 (0.40%)
    0 / 253 (0.00%)
    0 / 253 (0.00%)
         occurrences all number
    1
    0
    0
    General disorders and administration site conditions
    Injection site pain
         subjects affected / exposed
    145 / 251 (57.77%)
    165 / 253 (65.22%)
    159 / 253 (62.85%)
         occurrences all number
    145
    165
    160
    Fatigue
         subjects affected / exposed
    70 / 251 (27.89%)
    66 / 253 (26.09%)
    72 / 253 (28.46%)
         occurrences all number
    70
    66
    72
    Injection site erythema
         subjects affected / exposed
    32 / 251 (12.75%)
    29 / 253 (11.46%)
    37 / 253 (14.62%)
         occurrences all number
    32
    29
    37
    Injection site swelling
         subjects affected / exposed
    17 / 251 (6.77%)
    20 / 253 (7.91%)
    20 / 253 (7.91%)
         occurrences all number
    17
    20
    20
    Pyrexia
         subjects affected / exposed
    8 / 251 (3.19%)
    9 / 253 (3.56%)
    9 / 253 (3.56%)
         occurrences all number
    8
    9
    9
    Chest discomfort
         subjects affected / exposed
    1 / 251 (0.40%)
    1 / 253 (0.40%)
    0 / 253 (0.00%)
         occurrences all number
    1
    1
    0
    Chills
         subjects affected / exposed
    0 / 251 (0.00%)
    2 / 253 (0.79%)
    0 / 253 (0.00%)
         occurrences all number
    0
    2
    0
    Malaise
         subjects affected / exposed
    0 / 251 (0.00%)
    1 / 253 (0.40%)
    1 / 253 (0.40%)
         occurrences all number
    0
    1
    1
    Chest pain
         subjects affected / exposed
    0 / 251 (0.00%)
    1 / 253 (0.40%)
    0 / 253 (0.00%)
         occurrences all number
    0
    1
    0
    Influenza like illness
         subjects affected / exposed
    0 / 251 (0.00%)
    1 / 253 (0.40%)
    0 / 253 (0.00%)
         occurrences all number
    0
    1
    0
    Pain
         subjects affected / exposed
    0 / 251 (0.00%)
    1 / 253 (0.40%)
    0 / 253 (0.00%)
         occurrences all number
    0
    1
    0
    Tenderness
         subjects affected / exposed
    1 / 251 (0.40%)
    0 / 253 (0.00%)
    0 / 253 (0.00%)
         occurrences all number
    1
    0
    0
    Peripheral swelling
         subjects affected / exposed
    0 / 251 (0.00%)
    0 / 253 (0.00%)
    1 / 253 (0.40%)
         occurrences all number
    0
    0
    1
    Vaccination site pain
         subjects affected / exposed
    0 / 251 (0.00%)
    0 / 253 (0.00%)
    1 / 253 (0.40%)
         occurrences all number
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    3 / 251 (1.20%)
    3 / 253 (1.19%)
    1 / 253 (0.40%)
         occurrences all number
    3
    3
    1
    Asthma
         subjects affected / exposed
    1 / 251 (0.40%)
    0 / 253 (0.00%)
    1 / 253 (0.40%)
         occurrences all number
    1
    0
    1
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 251 (0.00%)
    0 / 253 (0.00%)
    2 / 253 (0.79%)
         occurrences all number
    0
    0
    2
    Cough
         subjects affected / exposed
    0 / 251 (0.00%)
    0 / 253 (0.00%)
    2 / 253 (0.79%)
         occurrences all number
    0
    0
    2
    Rhinorrhoea
         subjects affected / exposed
    1 / 251 (0.40%)
    0 / 253 (0.00%)
    1 / 253 (0.40%)
         occurrences all number
    1
    0
    1
    Catarrh
         subjects affected / exposed
    0 / 251 (0.00%)
    1 / 253 (0.40%)
    0 / 253 (0.00%)
         occurrences all number
    0
    1
    0
    Dysphonia
         subjects affected / exposed
    1 / 251 (0.40%)
    0 / 253 (0.00%)
    0 / 253 (0.00%)
         occurrences all number
    1
    0
    0
    Nasal discomfort
         subjects affected / exposed
    0 / 251 (0.00%)
    1 / 253 (0.40%)
    0 / 253 (0.00%)
         occurrences all number
    0
    1
    0
    Nasal obstruction
         subjects affected / exposed
    0 / 251 (0.00%)
    1 / 253 (0.40%)
    0 / 253 (0.00%)
         occurrences all number
    0
    1
    0
    Pulmonary mass
         subjects affected / exposed
    0 / 251 (0.00%)
    1 / 253 (0.40%)
    0 / 253 (0.00%)
         occurrences all number
    0
    1
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 251 (0.40%)
    1 / 253 (0.40%)
    0 / 253 (0.00%)
         occurrences all number
    1
    1
    0
    Investigations
    Computerised tomogram head abnormal
         subjects affected / exposed
    0 / 251 (0.00%)
    1 / 253 (0.40%)
    0 / 253 (0.00%)
         occurrences all number
    0
    1
    0
    Injury, poisoning and procedural complications
    Procedural pain
         subjects affected / exposed
    0 / 251 (0.00%)
    2 / 253 (0.79%)
    0 / 253 (0.00%)
         occurrences all number
    0
    2
    0
    Fall
         subjects affected / exposed
    1 / 251 (0.40%)
    0 / 253 (0.00%)
    0 / 253 (0.00%)
         occurrences all number
    1
    0
    0
    Fibula fracture
         subjects affected / exposed
    1 / 251 (0.40%)
    0 / 253 (0.00%)
    0 / 253 (0.00%)
         occurrences all number
    1
    0
    0
    Foreign body in respiratory tract
         subjects affected / exposed
    0 / 251 (0.00%)
    1 / 253 (0.40%)
    0 / 253 (0.00%)
         occurrences all number
    0
    1
    0
    Injury
         subjects affected / exposed
    1 / 251 (0.40%)
    0 / 253 (0.00%)
    0 / 253 (0.00%)
         occurrences all number
    1
    0
    0
    Muscle strain
         subjects affected / exposed
    0 / 251 (0.00%)
    1 / 253 (0.40%)
    0 / 253 (0.00%)
         occurrences all number
    0
    1
    0
    Skin laceration
         subjects affected / exposed
    1 / 251 (0.40%)
    0 / 253 (0.00%)
    0 / 253 (0.00%)
         occurrences all number
    1
    0
    0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    0 / 251 (0.00%)
    1 / 253 (0.40%)
    0 / 253 (0.00%)
         occurrences all number
    0
    1
    0
    Palpitations
         subjects affected / exposed
    1 / 251 (0.40%)
    0 / 253 (0.00%)
    0 / 253 (0.00%)
         occurrences all number
    1
    0
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    65 / 251 (25.90%)
    62 / 253 (24.51%)
    57 / 253 (22.53%)
         occurrences all number
    68
    64
    59
    Dizziness
         subjects affected / exposed
    1 / 251 (0.40%)
    1 / 253 (0.40%)
    1 / 253 (0.40%)
         occurrences all number
    1
    1
    1
    Migraine
         subjects affected / exposed
    0 / 251 (0.00%)
    1 / 253 (0.40%)
    2 / 253 (0.79%)
         occurrences all number
    0
    1
    2
    Ophthalmic migraine
         subjects affected / exposed
    0 / 251 (0.00%)
    0 / 253 (0.00%)
    1 / 253 (0.40%)
         occurrences all number
    0
    0
    1
    Sciatica
         subjects affected / exposed
    1 / 251 (0.40%)
    0 / 253 (0.00%)
    0 / 253 (0.00%)
         occurrences all number
    1
    0
    0
    Blood and lymphatic system disorders
    Lymphadenopathy
         subjects affected / exposed
    0 / 251 (0.00%)
    0 / 253 (0.00%)
    1 / 253 (0.40%)
         occurrences all number
    0
    0
    1
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 251 (0.40%)
    0 / 253 (0.00%)
    0 / 253 (0.00%)
         occurrences all number
    1
    0
    0
    Vertigo positional
         subjects affected / exposed
    0 / 251 (0.00%)
    0 / 253 (0.00%)
    1 / 253 (0.40%)
         occurrences all number
    0
    0
    1
    Eye disorders
    Age-related macular degeneration
         subjects affected / exposed
    0 / 251 (0.00%)
    0 / 253 (0.00%)
    1 / 253 (0.40%)
         occurrences all number
    0
    0
    1
    Ocular hyperaemia
         subjects affected / exposed
    0 / 251 (0.00%)
    1 / 253 (0.40%)
    0 / 253 (0.00%)
         occurrences all number
    0
    1
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    2 / 251 (0.80%)
    0 / 253 (0.00%)
    1 / 253 (0.40%)
         occurrences all number
    2
    0
    1
    Abdominal pain upper
         subjects affected / exposed
    0 / 251 (0.00%)
    1 / 253 (0.40%)
    1 / 253 (0.40%)
         occurrences all number
    0
    1
    1
    Nausea
         subjects affected / exposed
    1 / 251 (0.40%)
    1 / 253 (0.40%)
    0 / 253 (0.00%)
         occurrences all number
    1
    1
    0
    Abdominal discomfort
         subjects affected / exposed
    0 / 251 (0.00%)
    1 / 253 (0.40%)
    0 / 253 (0.00%)
         occurrences all number
    0
    1
    0
    Abdominal distension
         subjects affected / exposed
    0 / 251 (0.00%)
    0 / 253 (0.00%)
    1 / 253 (0.40%)
         occurrences all number
    0
    0
    1
    Dyspepsia
         subjects affected / exposed
    0 / 251 (0.00%)
    0 / 253 (0.00%)
    1 / 253 (0.40%)
         occurrences all number
    0
    0
    1
    Glossodynia
         subjects affected / exposed
    0 / 251 (0.00%)
    1 / 253 (0.40%)
    0 / 253 (0.00%)
         occurrences all number
    0
    1
    0
    Oral mucosal blistering
         subjects affected / exposed
    1 / 251 (0.40%)
    0 / 253 (0.00%)
    0 / 253 (0.00%)
         occurrences all number
    1
    0
    0
    Oral pain
         subjects affected / exposed
    0 / 251 (0.00%)
    1 / 253 (0.40%)
    0 / 253 (0.00%)
         occurrences all number
    0
    1
    0
    Toothache
         subjects affected / exposed
    0 / 251 (0.00%)
    1 / 253 (0.40%)
    0 / 253 (0.00%)
         occurrences all number
    0
    1
    0
    Vomiting
         subjects affected / exposed
    0 / 251 (0.00%)
    1 / 253 (0.40%)
    0 / 253 (0.00%)
         occurrences all number
    0
    1
    0
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    2 / 251 (0.80%)
    2 / 253 (0.79%)
    3 / 253 (1.19%)
         occurrences all number
    2
    2
    3
    Erythema
         subjects affected / exposed
    0 / 251 (0.00%)
    1 / 253 (0.40%)
    1 / 253 (0.40%)
         occurrences all number
    0
    1
    1
    Psoriasis
         subjects affected / exposed
    0 / 251 (0.00%)
    0 / 253 (0.00%)
    2 / 253 (0.79%)
         occurrences all number
    0
    0
    2
    Dermatitis contact
         subjects affected / exposed
    0 / 251 (0.00%)
    1 / 253 (0.40%)
    0 / 253 (0.00%)
         occurrences all number
    0
    1
    0
    Hyperhidrosis
         subjects affected / exposed
    1 / 251 (0.40%)
    0 / 253 (0.00%)
    0 / 253 (0.00%)
         occurrences all number
    1
    0
    0
    Rash
         subjects affected / exposed
    0 / 251 (0.00%)
    1 / 253 (0.40%)
    0 / 253 (0.00%)
         occurrences all number
    0
    1
    0
    Rosacea
         subjects affected / exposed
    1 / 251 (0.40%)
    0 / 253 (0.00%)
    0 / 253 (0.00%)
         occurrences all number
    1
    0
    0
    Renal and urinary disorders
    Chronic kidney disease
         subjects affected / exposed
    0 / 251 (0.00%)
    0 / 253 (0.00%)
    1 / 253 (0.40%)
         occurrences all number
    0
    0
    1
    Pollakiuria
         subjects affected / exposed
    1 / 251 (0.40%)
    0 / 253 (0.00%)
    0 / 253 (0.00%)
         occurrences all number
    1
    0
    0
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    78 / 251 (31.08%)
    87 / 253 (34.39%)
    86 / 253 (33.99%)
         occurrences all number
    78
    87
    86
    Arthralgia
         subjects affected / exposed
    34 / 251 (13.55%)
    36 / 253 (14.23%)
    39 / 253 (15.42%)
         occurrences all number
    34
    37
    39
    Back pain
         subjects affected / exposed
    1 / 251 (0.40%)
    1 / 253 (0.40%)
    1 / 253 (0.40%)
         occurrences all number
    1
    1
    1
    Bursitis
         subjects affected / exposed
    1 / 251 (0.40%)
    1 / 253 (0.40%)
    0 / 253 (0.00%)
         occurrences all number
    1
    1
    0
    Pain in extremity
         subjects affected / exposed
    0 / 251 (0.00%)
    2 / 253 (0.79%)
    0 / 253 (0.00%)
         occurrences all number
    0
    2
    0
    Arthritis
         subjects affected / exposed
    0 / 251 (0.00%)
    0 / 253 (0.00%)
    1 / 253 (0.40%)
         occurrences all number
    0
    0
    1
    Flank pain
         subjects affected / exposed
    0 / 251 (0.00%)
    1 / 253 (0.40%)
    0 / 253 (0.00%)
         occurrences all number
    0
    1
    0
    Greater trochanteric pain syndrome
         subjects affected / exposed
    0 / 251 (0.00%)
    0 / 253 (0.00%)
    1 / 253 (0.40%)
         occurrences all number
    0
    0
    1
    Musculoskeletal stiffness
         subjects affected / exposed
    1 / 251 (0.40%)
    0 / 253 (0.00%)
    0 / 253 (0.00%)
         occurrences all number
    1
    0
    0
    Muscle spasms
         subjects affected / exposed
    1 / 251 (0.40%)
    0 / 253 (0.00%)
    0 / 253 (0.00%)
         occurrences all number
    1
    0
    0
    Neck pain
         subjects affected / exposed
    0 / 251 (0.00%)
    0 / 253 (0.00%)
    1 / 253 (0.40%)
         occurrences all number
    0
    0
    1
    Osteoarthritis
         subjects affected / exposed
    1 / 251 (0.40%)
    0 / 253 (0.00%)
    0 / 253 (0.00%)
         occurrences all number
    1
    0
    0
    Rotator cuff syndrome
         subjects affected / exposed
    0 / 251 (0.00%)
    0 / 253 (0.00%)
    1 / 253 (0.40%)
         occurrences all number
    0
    0
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    3 / 251 (1.20%)
    2 / 253 (0.79%)
    1 / 253 (0.40%)
         occurrences all number
    3
    2
    1
    Urinary tract infection
         subjects affected / exposed
    3 / 251 (1.20%)
    0 / 253 (0.00%)
    0 / 253 (0.00%)
         occurrences all number
    3
    0
    0
    COVID-19
         subjects affected / exposed
    2 / 251 (0.80%)
    0 / 253 (0.00%)
    0 / 253 (0.00%)
         occurrences all number
    2
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 251 (0.80%)
    0 / 253 (0.00%)
    0 / 253 (0.00%)
         occurrences all number
    2
    0
    0
    Bronchitis
         subjects affected / exposed
    0 / 251 (0.00%)
    1 / 253 (0.40%)
    0 / 253 (0.00%)
         occurrences all number
    0
    1
    0
    Gastroenteritis
         subjects affected / exposed
    0 / 251 (0.00%)
    1 / 253 (0.40%)
    0 / 253 (0.00%)
         occurrences all number
    0
    1
    0
    Gastroenteritis caliciviral
         subjects affected / exposed
    0 / 251 (0.00%)
    0 / 253 (0.00%)
    1 / 253 (0.40%)
         occurrences all number
    0
    0
    1
    Herpes zoster
         subjects affected / exposed
    0 / 251 (0.00%)
    0 / 253 (0.00%)
    1 / 253 (0.40%)
         occurrences all number
    0
    0
    1
    Postoperative wound infection
         subjects affected / exposed
    0 / 251 (0.00%)
    0 / 253 (0.00%)
    1 / 253 (0.40%)
         occurrences all number
    0
    0
    1
    Sinusitis
         subjects affected / exposed
    0 / 251 (0.00%)
    1 / 253 (0.40%)
    0 / 253 (0.00%)
         occurrences all number
    0
    1
    0
    Tooth abscess
         subjects affected / exposed
    0 / 251 (0.00%)
    1 / 253 (0.40%)
    0 / 253 (0.00%)
         occurrences all number
    0
    1
    0

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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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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