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    Clinical Trial Results:
    A Phase III, open-label, randomized, controlled, multicountry study to evaluate the immune response, safety and reactogenicity of an RSVPreF3 OA investigational vaccine when co-administered with FLU aQIV (inactivated influenza vaccine – adjuvanted) in adults aged 65 years and above.

    Summary
    EudraCT number
    		 2022-000623-21
    Trial protocol
    		 ES   BE  
    Global end of trial date
    17 Jul 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Mar 2024
    First version publication date
    15 Mar 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    218350
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    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, 44 8664357343, GSKClinicalSupportHD@gsk.com
    Scientific contact
    GSK Response Center, GlaxoSmithKline, 44 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
    15 Nov 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Jul 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    • To demonstrate the non-inferiority of the FLU vaccine when co administered with the RSVPreF3 OA vaccine compared to the FLU vaccine administered alone. • To demonstrate the non-inferiority of the RSVPreF3 OA vaccine when co-administered with the FLU vaccine compared to the RSVPreF3 OA vaccine administered alone.
    Protection of trial subjects
    Study participants were observed closely for at least 30 minutes after the administration of the study interventions. Appropriate medical treatment was readily available during the observation period in case of anaphylaxis or syncope.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    14 Oct 2022
    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: 121
    Country: Number of subjects enrolled
    Finland: 110
    Country: Number of subjects enrolled
    France: 223
    Country: Number of subjects enrolled
    Spain: 444
    Country: Number of subjects enrolled
    United Kingdom: 147
    Worldwide total number of subjects
    1045
    EEA total number of subjects
    898
    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)
    0
    From 65 to 84 years
    1045
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 All 1045 enrolled participants were randomized to Co-Ad and Control Groups and received at least 1 dose of study intervention and were included in the exposed set.

    Pre-assignment
    Screening details
    		 This study assessed the immunogenicity, safety and reactogenicity of the RSVPreF3 OA vaccine when co-administered with an adjuvanted quadrivalent influenza (FLU-aQIV [FLU]) vaccine, in adults aged 65 years old or above.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Co-Ad Group
    Arm description
    		 Participants received one dose of FLU-aQIV vaccine and one dose of RSVPreF3 OA vaccine, both doses administered at Day 1, and were followed until end of study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    FLU-aQIV vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose of FLU-aQIV vaccine administered intramuscularly.

    Investigational medicinal product name
    RSVPreF3 OA vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose of RSVPreF3 OA vaccine administered intramuscularly.

    Arm title
    		 Control Group
    Arm description
    		 Participants received one dose of FLU-aQIV vaccine at Day 1, followed by one dose of RSVPreF3 OA vaccine at Day 31, and were followed until end of study.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    FLU-aQIV vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose of FLU-aQIV vaccine administered intramuscularly.

    Investigational medicinal product name
    RSVPreF3 OA vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose of RSVPreF3 OA vaccine administered intramuscularly.

    Number of subjects in period 1
    		Co-Ad Group Control Group
    Started
    523
    522
    Completed
    518
    499
    Not completed
    5
    23
         Consent withdrawn by subject
    1
    10
         Adverse event, non-fatal
    -
    8
         Not specified
    2
    2
         Lost to follow-up
    2
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Co-Ad Group
    Reporting group description
    		 Participants received one dose of FLU-aQIV vaccine and one dose of RSVPreF3 OA vaccine, both doses administered at Day 1, and were followed until end of study.

    Reporting group title
    Control Group
    Reporting group description
    		 Participants received one dose of FLU-aQIV vaccine at Day 1, followed by one dose of RSVPreF3 OA vaccine at Day 31, and were followed until end of study.

    Reporting group values
    		 Co-Ad Group Control Group Total
    Number of subjects
    		 523 522 1045
    Age Categorical
    Units: Participants
        <=18 years
    		 0 0 0
        Between 18 and 65 years
    		 0 0 0
        >=65 years
    		 523 522 1045
    Age continuous
    Units: years
        median (standard deviation)
    		 72.1 ( 5.4 ) 72.2 ( 5.2 ) -
    Sex: Female, Male
    Units: Participants
        Female
    		 255 275 530
        Male
    		 268 247 515
    Race/Ethnicity, Customized
    Units: Subjects
        American Indian or Alaska Native
    		 1 2 3
        Asian
    		 0 1 1
        Black or African American
    		 0 1 1
        White
    		 522 516 1038
        Multiple
    		 0 1 1
        Other - Unspecified
    		 0 1 1

    End points

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    End points reporting groups
    Reporting group title
    Co-Ad Group
    Reporting group description
    		 Participants received one dose of FLU-aQIV vaccine and one dose of RSVPreF3 OA vaccine, both doses administered at Day 1, and were followed until end of study.

    Reporting group title
    Control Group
    Reporting group description
    		 Participants received one dose of FLU-aQIV vaccine at Day 1, followed by one dose of RSVPreF3 OA vaccine at Day 31, and were followed until end of study.

    Primary: Titers for Hemagglutination Inhibition (HI) antibodies against 4 FLU vaccine strains expressed as group Geometric Mean Titers (GMTs) at 1 month after FLU vaccine dose

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    End point title
    		 Titers for Hemagglutination Inhibition (HI) antibodies against 4 FLU vaccine strains expressed as group Geometric Mean Titers (GMTs) at 1 month after FLU vaccine dose
    End point description
    HI antibodies assessed were antibodies against the Flu A/Darwin/6/2021 H3N2, Flu A/Victoria/2570/2019 H1N1, Flu B/Austria/1359417/2021 Victoria, and Flu B/Phuket/3073/2013 Yamagata flu strains. Analysis was performed on Per Protocol Set for FLU analysis which included eligible participants who: received at least one control group intervention or all Co-Ad group interventions, had pre- and post-dose immunogenicity results, adhered to specified blood draw intervals, with immunogenicity data available for the specified analysis at the specified time point post-FLU vaccine dose, who lacked interfering medical conditions and avoided prohibited concomitant medication/vaccination.
    End point type
    Primary
    End point timeframe
    At 1 month after the FLU vaccine dose (Day 31 for both groups)
    End point values
    		 Co-Ad Group Control Group
    Number of subjects analysed
    429
    400
    Units: Titers
    geometric mean (confidence interval 95%)
        Flu A/Darwin/6/2021 H3N2 (N=429,400)
    43.8 (38.9 to 49.4)
    57.7 (51.0 to 65.3)
        Flu A/Victoria/2570/2019 H1N1 (N=420,396)
    143.0 (128.6 to 159.0)
    148.5 (133.2 to 165.6)
        Flu B/Austria/1359417/2021 Victoria (N=429,400)
    613.9 (575.1 to 655.2)
    597.5 (558.7 to 639.1)
        Flu B/Phuket/3073/2013 Yamagata (N=428,400)
    406.2 (380.0 to 434.2)
    421.0 (393.0 to 451.0)
    Statistical analysis title
    		 HI GMTs against the Flu A/Darwin/6/2021 H3N2
    Statistical analysis description
    To demonstrate the non-inferiority of the FLU vaccine when co administered with the RSVPreF3 OA vaccine compared to the FLU vaccine administered alone, in terms of HI GMTs against the Flu A/Darwin/6/2021 H3N2 strain, at 1 month post-FLU vaccine dose administration (Day 31 for both groups).
    Comparison groups
    Co-Ad Group v Control Group
    Number of subjects included in analysis
    829
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    1.32
    Confidence interval
         level
    		 0.95%
         sides
    2-sided
         lower limit
    		 1.13
         upper limit
    		 1.53
    Notes
    [1] - The non-inferiority is demonstrated if the upper limit (UL) of the 2-sided 95% confidence interval (CI) of the group GMT ratio (Control group divided by Co-Ad group) for HI antibody titers for the Flu strain is less than or equal (<=) 1.5.
    Statistical analysis title
    		 HI GMTs against the Flu A/Victoria/2570/2019 H1N1
    Statistical analysis description
    To demonstrate the non-inferiority of the FLU vaccine when co administered with the RSVPreF3 OA vaccine compared to the FLU vaccine administered alone, in terms of HI GMTs against the Flu A/Victoria/2570/2019 H1N1 strain, at 1 month post-FLU vaccine dose administration (Day 31 for both groups).
    Comparison groups
    Co-Ad Group v Control Group
    Number of subjects included in analysis
    829
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [2]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    1.04
    Confidence interval
         level
    		 0.95%
         sides
    2-sided
         lower limit
    		 0.91
         upper limit
    		 1.18
    Notes
    [2] - The non-inferiority is demonstrated if the UL of the 2-sided 95% CI of the group GMT ratio (Control group divided by Co-Ad group) for HI antibody titers for the Flu strain is <=1.5.
    Statistical analysis title
    		 HI GMTs against the Flu B/Austria/1359417/2021
    Statistical analysis description
    To demonstrate the non-inferiority of the FLU vaccine when co administered with the RSVPreF3 OA vaccine compared to the FLU vaccine administered alone, in terms of HI GMTs against the Flu B/Austria/1359417/2021 strain, at 1 month post-FLU vaccine dose administration (Day 31 for both groups).
    Comparison groups
    Co-Ad Group v Control Group
    Number of subjects included in analysis
    829
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [3]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    0.97
    Confidence interval
         level
    		 0.95%
         sides
    2-sided
         lower limit
    		 0.9
         upper limit
    		 1.06
    Notes
    [3] - The non-inferiority is demonstrated if the UL of the 2-sided 95% CI of the group GMT ratio (Control group divided by Co-Ad group) for HI antibody titers for the Flu strain is <=1.5.
    Statistical analysis title
    		 HI GMTs against Flu B/Phuket/3073/2013 Yamagata
    Statistical analysis description
    To demonstrate the non-inferiority of the FLU vaccine when co administered with the RSVPreF3 OA vaccine compared to the Flu vaccine administered alone, in terms of HI GMTs against the Flu B/Phuket/3073/2013 Yamagata strain, at 1 month post-FLU vaccine dose administration (Day 31 for both groups).
    Comparison groups
    Co-Ad Group v Control Group
    Number of subjects included in analysis
    829
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [4]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    1.04
    Confidence interval
         level
    		 0.95%
         sides
    2-sided
         lower limit
    		 0.95
         upper limit
    		 1.13
    Notes
    [4] - The non-inferiority is demonstrated if the UL of the 2-sided 95% CI of the group GMT ratio (Control group divided by Co-Ad group) for HI antibody titers for the Flu strain is <=1.5.

    Primary: RSV-A neutralizing antibody titers expressed as GMTs

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    End point title
    		 RSV-A neutralizing antibody titers expressed as GMTs
    End point description
    RSV-A neutralizing antibodies were given as GMTs and expressed as Estimated Dilution 60 (ED60). Analysis was performed on Per Protocol Set for RSV OA analysis which included eligible participants who: received at least one control group intervention or all Co-Ad group interventions, had pre- and post-dose immunogenicity results, adhered to specified blood draw intervals, with immunogenicity data available for the specified analysis at the specified time point post-RSVPreF3 OA vaccine dose, who lacked interfering medical conditions and avoided prohibited concomitant medication/vaccination.
    End point type
    Primary
    End point timeframe
    At 1 month after the RSVPreF3 OA dose (Day 31 for the Co-Ad Group and Day 61 for the Control Group) 
    End point values
    		 Co-Ad Group Control Group
    Number of subjects analysed
    471
    373
    Units: Titers
        geometric mean (confidence interval 95%)
    6673.4 (6057.2 to 7352.4)
    6591.8 (5917.8 to 7342.6)
    Statistical analysis title
    		 RSV-A Group GMT Ratio
    Statistical analysis description
    To demonstrate the non-inferiority of the RSVPreF3 OA vaccine when co-administered with the FLU vaccine compared to the RSVPreF3 OA vaccine administered alone, in terms of RSV-A neutralizing antibody titers, at 1 month after the RSVPreF3 OA vaccine dose (Day 31 for the Co-Ad Group and Day 61 for the Control Group). 
    Comparison groups
    Co-Ad Group v Control Group
    Number of subjects included in analysis
    844
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [5]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    0.99
    Confidence interval
         level
    		 0.95%
         sides
    2-sided
         lower limit
    		 0.87
         upper limit
    		 1.12
    Notes
    [5] - The non-inferiority is demonstrated if the UL of the 2-sided 95% CI of the GMT ratio (Control group divided by Co-Ad group) for RSV-A neutralizing antibody vaccine is <=1.5.

    Primary: RSV-B neutralizing antibody titers expressed as GMTs

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    End point title
    		 RSV-B neutralizing antibody titers expressed as GMTs
    End point description
    RSV B neutralizing antibodies are given as GMTs and expressed as Estimated Dilution 60 (ED60). Analysis was performed on Per Protocol Set for RSV OA analysis which included eligible participants who: received at least one control group intervention or all Co-Ad group interventions, had pre- and post-dose immunogenicity results, adhered to specified blood draw intervals, with immunogenicity data available for the specified analysis at the specified time point post-RSVPreF3 OA vaccine dose, who lacked interfering medical conditions and avoided prohibited concomitant medication/vaccination.
    End point type
    Primary
    End point timeframe
    At 1 month after the RSVPreF3 OA dose (Day 31 for the CoAd Group and Day 61 for the Control Group) 
    End point values
    		 Co-Ad Group Control Group
    Number of subjects analysed
    469
    373
    Units: Titers
        geometric mean (confidence interval 95%)
    7880.1 (7195.4 to 8629.8)
    9134.1 (8255.9 to 10105.7)
    Statistical analysis title
    		 RSV-B Group GMT Ratio
    Statistical analysis description
    To demonstrate the non-inferiority of the RSVPreF3 OA vaccine when co-administered with the FLU vaccine compared to the RSVPreF3 OA vaccine administered alone, in terms of RSV-B neutralizing antibody titers, at 1 month after the RSVPreF3 OA vaccine dose (Day 31 for the CoAd Group and Day 61 for the Control Group).
    Comparison groups
    Co-Ad Group v Control Group
    Number of subjects included in analysis
    842
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [6]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    1.16
    Confidence interval
         level
    		 0.95%
         sides
    2-sided
         lower limit
    		 1.03
         upper limit
    		 1.3
    Notes
    [6] - The non-inferiority is demonstrated if the UL of the 2-sided 95% CI of the GMT ratio (Control group divided by Co-Ad group) for RSV-B neutralizing antibody vaccine is <=1.5.

    Secondary: HI seroconversion rate (SCR) for 4 FLU vaccine strains

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    End point title
    		 HI seroconversion rate (SCR) for 4 FLU vaccine strains
    End point description
    SCR for HI antibody is defined as the percentage of participants who have either a HI predose titer less than (<) 1:10 and a post-dose titer greater than or equal to (>=) 1:40, or a pre-dose titer >= 1:10 and at least a 4-fold increase in post-dose titer. The assessed Flu strains were: Flu A/Darwin/6/2021 H3N2, Flu A/Victoria/2570/2019 H1N1, Flu B/Austria/1359417/2021 Victoria, and Flu B/Phuket/3073/2013 Yamagata. Analysis was performed on Per Protocol Set for FLU analysis which included eligible participants who: received at least one control group intervention or all Co-Ad group interventions, had pre- and post-dose immunogenicity results, adhered to specified blood draw intervals, with immunogenicity data available for the specified analysis at the specified time point post-FLU vaccine dose, who lacked interfering medical conditions and avoided prohibited concomitant medication/vaccination.
    End point type
    Secondary
    End point timeframe
    At 1 month after the FLU vaccine dose (Day 31 for both groups) 
    End point values
    		 Co-Ad Group Control Group
    Number of subjects analysed
    429
    400
    Units: Percentage of participants
    number (confidence interval 95%)
        Flu A/Darwin/6/2021 H3N2 (N=429,400)
    51.7 (46.9 to 56.6)
    62.0 (57.0 to 66.8)
        Flu A/Victoria/2570/2019 H1N1 (N=420,396)
    44.0 (39.2 to 48.9)
    45.7 (40.7 to 50.8)
        Flu B/Austria/1359417/2021 Victoria (N=429,400)
    17.2 (13.8 to 21.2)
    17.5 (13.9 to 21.6)
        Flu B/Phuket/3073/2013 Yamagata (N=428,400)
    18.5 (14.9 to 22.5)
    19.3 (15.5 to 23.5)
    Statistical analysis title
    		 SCR for Flu A/Darwin/6/2021 H3N2
    Statistical analysis description
    To evaluate the non-inferiority of the FLU vaccine when co-administered with the RSVPreF3 OA vaccine compared to the FLU vaccine administered alone as measured by the difference of percentage of participants achieving seroconversion for HI antibody titers against Flu A/Darwin/6/2021 H3N2 strain at 1 month post-FLU vaccine dose administration (Day 31 for both groups).
    Comparison groups
    Co-Ad Group v Control Group
    Number of subjects included in analysis
    829
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [7]
    Method
    Parameter type
    		 Difference of Percentage
    Point estimate
    10.25
    Confidence interval
         level
    		 0.95%
         sides
    2-sided
         lower limit
    		 3.5
         upper limit
    		 16.9
    Notes
    [7] - The non-inferiority is demonstrated if the UL of the 2-sided 95% CI on the group difference (Control group minus Co-Ad group) in terms of SCR is <=10% for anti-HI antibodies.
    Statistical analysis title
    		 SCR for Flu B/Austria/1359417/2021 Victoria
    Statistical analysis description
    To evaluate the non-inferiority of the FLU vaccine when co-administered with the RSVPreF3 OA vaccine compared to the FLU vaccine administered alone as measured by the difference of percentage of participants achieving seroconversion for HI antibody titers against Flu B/Austria/1359417/2021 Victoria at 1 month post-FLU vaccine dose administration (Day 31 for both groups).
    Comparison groups
    Co-Ad Group v Control Group
    Number of subjects included in analysis
    829
    Analysis specification
    Pre-specified
    Analysis type
    		 [8]
    Method
    Parameter type
    		 Difference of Percentage
    Point estimate
    0.25
    Confidence interval
         level
    		 0.95%
         sides
    2-sided
         lower limit
    		 -4.92
         upper limit
    		 5.46
    Notes
    [8] - The non-inferiority is demonstrated if the UL of the 2-sided 95% CI on the group difference (Control group minus Co-Ad group) in terms of SCR is <=10% for anti-HI antibodies.
    Statistical analysis title
    		 SCR for Flu B/Phuket/3073/2013 Yamagata
    Statistical analysis description
    To evaluate the non-inferiority of the FLU vaccine when co-administered with the RSVPreF3 OA vaccine compared to the FLU vaccine administered alone as measured by the difference of percentage of participants achieving seroconversion for HI antibody titers against Flu B/Phuket/3073/2013 Yamagata strain at 1 month post-FLU vaccine dose administration (Day 31 for both groups).
    Comparison groups
    Co-Ad Group v Control Group
    Number of subjects included in analysis
    829
    Analysis specification
    Pre-specified
    Analysis type
    		 [9]
    Method
    Parameter type
    		 Difference of Percentage
    Point estimate
    0.79
    Confidence interval
         level
    		 0.95%
         sides
    2-sided
         lower limit
    		 -4.54
         upper limit
    		 6.17
    Notes
    [9] - The non-inferiority is demonstrated if the UL of the 2-sided 95% CI on the group difference (Control group minus Co-Ad group) in terms of SCR is <=10% for anti-HI antibodies.
    Statistical analysis title
    		 SCR for Flu A/Victoria/2570/2019 H1N1
    Statistical analysis description
    To evaluate the non-inferiority of the FLU vaccine when co-administered with the RSVPreF3 OA vaccine compared to the FLU vaccine administered alone as measured by the difference of percentage of participants achieving seroconversion for HI antibody titers against Flu A/Victoria/2570/2019 H1N1 strain at 1 month post-FLU vaccine dose administration (Day 31 for both groups).
    Comparison groups
    Co-Ad Group v Control Group
    Number of subjects included in analysis
    829
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [10]
    Method
    Parameter type
    		 Difference of Percentage
    Point estimate
    1.66
    Confidence interval
         level
    		 0.95%
         sides
    2-sided
         lower limit
    		 -5.16
         upper limit
    		 8.47
    Notes
    [10] - The non-inferiority is demonstrated if the UL of the 2-sided 95% CI on the group difference (Control group minus Co-Ad group) in terms of SCR is <=10% for anti-HI antibodies.

    Secondary: RSV-A neutralization antibody titers expressed as mean geometric increase (MGI) 

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    End point title
    		 RSV-A neutralization antibody titers expressed as mean geometric increase (MGI) 
    End point description
    MGI was defined as the geometric mean of the within-participant ratios of the post-dose titer over the pre-dose titer. Analysis was performed on Per Protocol Set for RSV OA analysis which included eligible participants who: received at least one control group intervention or all Co-Ad group interventions, had pre- and post-dose immunogenicity results, adhered to specified blood draw intervals, with immunogenicity data available for the specified analysis at the specified time point post-RSVPreF3 OA vaccine dose, who lacked interfering medical conditions and avoided prohibited concomitant medication/vaccination.
    End point type
    Secondary
    End point timeframe
    At 1 month after the RSVPreF3 OA vaccine dose (Day 31 for the Co-Ad Group and Day 61 for the Control Group) compared to pre-vaccination (Day 1 for Co-Ad group and Day 31 for Control group)
    End point values
    		 Co-Ad Group Control Group
    Number of subjects analysed
    471
    373
    Units: Ratio
        geometric mean (confidence interval 95%)
    8.50 (7.79 to 9.27)
    7.58 (6.82 to 8.42)
    No statistical analyses for this end point

    Secondary: RSV-B neutralization antibody titers expressed as MGI

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    End point title
    		 RSV-B neutralization antibody titers expressed as MGI
    End point description
    MGI was defined as the geometric mean of the within-participant ratios of the post-dose titer over the pre-dose titer. Analysis was performed on Per Protocol Set for RSV OA analysis which included eligible participants who: received at least one control group intervention or all Co-Ad group interventions, had pre- and post-dose immunogenicity results, adhered to specified blood draw intervals, with immunogenicity data available for the specified analysis at the specified time point post-RSVPreF3 OA vaccine dose, who lacked interfering medical conditions and avoided prohibited concomitant medication/vaccination.
    End point type
    Secondary
    End point timeframe
    At 1 month after the RSVPreF3 OA vaccine dose (Day 31 for the Co-Ad Group and Day 61 for the Control Group) compared to pre-vaccination (Day 1 for Co-Ad group and Day 31 for Control group)
    End point values
    		 Co-Ad Group Control Group
    Number of subjects analysed
    469
    373
    Units: Ratio
        geometric mean (confidence interval 95%)
    7.11 (6.55 to 7.72)
    7.46 (6.74 to 8.25)
    No statistical analyses for this end point

    Secondary: Titers for HI antibodies against 4 FLU vaccine strains

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    End point title
    		 Titers for HI antibodies against 4 FLU vaccine strains
    End point description
    HI antibodies assessed were antibodies against the Flu A/Darwin/6/2021 H3N2, Flu A/Victoria/2570/2019 H1N1, Flu B/Austria/1359417/2021 Victoria, and Flu B/Phuket/3073/2013 Yamagata flu strains. HI antibodies were expressed as GMT, in titers. Analysis was performed on Per Protocol Set for FLU analysis which included eligible participants who: received at least one control group intervention or all Co-Ad group interventions, had pre- and post-dose immunogenicity results, adhered to specified blood draw intervals, with immunogenicity data available for the specified analysis at the specified time point post-FLU vaccine dose, who lacked interfering medical conditions and avoided prohibited concomitant medication/vaccination
    End point type
    Secondary
    End point timeframe
    At Day 1 (Baseline) and Day 31
    End point values
    		 Co-Ad Group Control Group
    Number of subjects analysed
    469
    449
    Units: Titers
    geometric mean (confidence interval 95%)
        Flu A/Darwin/6/2021 H3N2,Day1(N=469,449)
    9.1 (8.4 to 9.8)
    8.7 (8.1 to 9.4)
        Flu A/Darwin/6/2021 H3N2,Day31(N=442,400)
    45.3 (40.6 to 50.5)
    58.3 (51.6 to 65.8)
        Flu A/Victoria/2570/2019 H1N1,Day1(N=460,446)
    40.0 (35.4 to 45.1)
    43.2 (38.4 to 48.5)
        Flu A/Victoria/2570/2019 H1N1,Day31(N=440,399)
    151.0 (136.4 to 167.2)
    163.8 (147.5 to 181.9)
        FluB/Austria/1359417/2021Victoria,Day1(N=469,449)
    323.6 (300.4 to 348.5)
    327.2 (303.6 to 352.7)
        FluB/Austria/1359417/2021Victoria,Day31(N=442,400)
    614.9 (575.5 to 657.0)
    608.1 (566.8 to 652.5)
        Flu B/Phuket/3073/2013 Yamagata,Day1(N=468,449)
    213.1 (198.5 to 228.7)
    193.2 (179.9 to 207.5)
        Flu B/Phuket/3073/2013 Yamagata,Day31(N=442,400)
    423.0 (394.6 to 453.5)
    417.5 (387.9 to 449.4)
    No statistical analyses for this end point

    Secondary: HI seroprotection rate (SPR) for 4 FLU vaccine strains 

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    End point title
    		 HI seroprotection rate (SPR) for 4 FLU vaccine strains 
    End point description
    SPR for HI antibody was defined as the percentage of participants with a serum HI titer >= 1:40. The assessed Flu strains were: Flu A/Darwin/6/2021 H3N2, Flu A/Victoria/2570/2019 H1N1, Flu B/Austria/1359417/2021 Victoria, and Flu B/Phuket/3073/2013 Yamagata. Analysis was performed on Per Protocol Set for FLU analysis which included eligible participants who: received at least one control group intervention or all Co-Ad group interventions, had pre- and post-dose immunogenicity results, adhered to specified blood draw intervals, with immunogenicity data available for the specified analysis at the specified time point post-FLU vaccine dose, who lacked interfering medical conditions and avoided prohibited concomitant medication/vaccination.
    End point type
    Secondary
    End point timeframe
    At Day 1 (Baseline) and Day 31
    End point values
    		 Co-Ad Group Control Group
    Number of subjects analysed
    469
    449
    Units: Percentage of participants
    number (confidence interval 95%)
        Flu A/Darwin/6/2021 H3N2, Day1 (N=469, 449)
    10.4 (7.8 to 13.6)
    10.7 (8.0 to 13.9)
        Flu A/Darwin/6/2021 H3N2, Day31 (N=442,400)
    63.6 (58.9 to 68.1)
    71.0 (66.3 to 75.4)
        Flu A/Victoria/2570/2019 H1N1, Day1 (N=460,446)
    60.0 (55.4 to 64.5)
    64.3 (59.7 to 68.8)
        Flu A/Victoria/2570/2019 H1N1, Day31 (N=440,399)
    92.0 (89.1 to 94.4)
    95.2 (92.7 to 97.1)
        FluB/Austria/1359417/2021Victoria,Day1(N=469,449)
    99.6 (98.5 to 99.9)
    100 (99.2 to 100)
        FluB/Austria/1359417/2021Victoria,Day31(N=442,400)
    100 (99.2 to 100)
    100 (99.1 to 100)
        Flu B/Phuket/3073/2013 Yamagata,Day1(N=468,449)
    99.8 (98.8 to 100.0)
    98.9 (97.4 to 99.6)
        Flu B/Phuket/3073/2013 Yamagata,Day31(N=442,400)
    100 (99.2 to 100)
    100 (99.1 to 100)
    No statistical analyses for this end point

    Secondary: HI antibody titers for 4 FLU vaccine strains expressed as MGI

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    End point title
    		 HI antibody titers for 4 FLU vaccine strains expressed as MGI
    End point description
    MGI was defined as the geometric mean of the within-participant ratios of the post-dose titer over the pre-dose titer. The assessed Flu strains were: Flu A/Darwin/6/2021 H3N2, Flu A/Victoria/2570/2019 H1N1, Flu B/Austria/1359417/2021 Victoria, and Flu B/Phuket/3073/2013 Yamagata. Analysis was performed on Per Protocol Set for FLU analysis which included eligible participants who: received at least one control group intervention or all Co-Ad group interventions, had pre- and post-dose immunogenicity results, adhered to specified blood draw intervals, with immunogenicity data available for the specified analysis at the specified time point post-FLU vaccine dose, who lacked interfering medical conditions and avoided prohibited concomitant medication/vaccination.
    End point type
    Secondary
    End point timeframe
     At 1 month after the FLU dose (Day 31 for both groups) compared to pre-vaccination (Day 1 for both groups)
    End point values
    		 Co-Ad Group Control Group
    Number of subjects analysed
    429
    400
    Units: Ratio
    geometric mean (confidence interval 95%)
        Flu A/Darwin/6/2021 H3N2 HI (N=429,400)
    5.10 (4.60 to 5.66)
    6.87 (6.12 to 7.71)
        Flu A/Victoria/2570/2019 H1N1 HI (N=420,396)
    3.85 (3.40 to 4.35)
    3.79 (3.34 to 4.31)
        Flu B/Austria/1359417/2021 Victoria HI (N=429,400)
    1.89 (1.77 to 2.03)
    1.84 (1.71 to 1.98)
        Flu B/Phuket/3073/2013 Yamagata HI (N=428,400)
    1.94 (1.82 to 2.07)
    2.11 (1.97 to 2.27)
    No statistical analyses for this end point

    Secondary: Percentage of participants reporting each solicited administration site event after each vaccine dose administration

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    End point title
    		 Percentage of participants reporting each solicited administration site event after each vaccine dose administration
    End point description
    The solicited administration site events after vaccination include erythema, pain and swelling. Analysis was performed on Exposed set which included participants who received a study intervention and with the electronic diary completed post-each vaccination and for whom solicited administration event data was available for specific visit. The Control group received FLU vaccination at Day 1 and RSVPreF3 OA vaccination at Day 31; Co-Ad group received co-administered vaccine (RSVPreF3 OA + FLU) on Day 1. Analysis per group is based on the study intervention administered on specific visit.
    End point type
    Secondary
    End point timeframe
    Within 7 days (the day of vaccination and 6 subsequent days) after each vaccine administration (vaccines administered at Day 1 for CoAd Group and at Day 1 and Day 31 for Control group)
    End point values
    		 Co-Ad Group Control Group
    Number of subjects analysed
    516
    513
    Units: Percentage of participants
    number (confidence interval 95%)
        Erythema, FLU dose given at Day 1 (N=516,513)
    6.6 (4.6 to 9.1)
    5.3 (3.5 to 7.6)
        Erythema, RSV dose given at Day 1 (N=516,0)
    14.1 (11.3 to 17.5)
    0 (0 to 0)
        Erythema, RSV dose given at Day 31 (N=0,451)
    0 (0 to 0)
    12.4 (9.5 to 15.8)
        Pain, FLU dose given at Day 1 (N=516,513)
    51.7 (47.3 to 56.1)
    44.8 (40.5 to 49.3)
        Pain, RSV dose given at Day 1 (N=516,0)
    66.1 (61.8 to 70.2)
    0 (0 to 0)
        Pain, RSV dose given at Day 31 (N=0,451)
    0 (0 to 0)
    58.8 (54.1 to 63.3)
        Swelling, FLU dose given at Day 1 (N=515,513)
    5.2 (3.5 to 7.5)
    6.0 (4.1 to 8.5)
        Swelling, RSV dose given at Day 1 (N=516,0)
    10.5 (8.0 to 13.4)
    0 (0 to 0)
        Swelling, RSV dose given at Day 31 (N=0,451)
    0 (0 to 0)
    8.4 (6.0 to 11.4)
    No statistical analyses for this end point

    Secondary: Percentage of participants reporting each solicited systemic event after each dose administration

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    End point title
    		 Percentage of participants reporting each solicited systemic event after each dose administration
    End point description
    The solicited systemic events after vaccination include fever, headache, fatigue, myalgia and arthralgia. Analysis was performed on Exposed set which included participants who received a study intervention and with the electronic diary completed post-each vaccination and for whom solicited administration event data was available for specific visit. The Control group received FLU vaccination at Day 1 and RSVPreF3 OA vaccination at Day 31; Co-Ad group received co-administered vaccine (RSVPreF3 OA + FLU) on Day 1. Analysis per group is based on the study intervention administered on specific visit.
    End point type
    Secondary
    End point timeframe
    Within 7 days (the day of vaccination and 6 subsequent days) after each vaccine administration (vaccines administered at Day 1 and Day 31 for Co-Ad Group and at Day 1 and Day 31 for Control group)
    End point values
    		 Co-Ad Group Control Group
    Number of subjects analysed
    516
    513
    Units: Percentage of participants
    number (confidence interval 95%)
        Arthralgia, Dosing at Day 1 (N=516,513)
    25.8 (22.1 to 29.8)
    15.6 (12.6 to 19.0)
        Arthralgia, Dosing at Day 31 (N=0,451)
    0 (0 to 0)
    17.1 (13.7 to 20.9)
        Fatigue, Dosing at Day 1 (N=516,513)
    45.7 (41.4 to 50.1)
    28.5 (24.6 to 32.6)
        Fatigue, Dosing at Day 31 (N=0, 451)
    0 (0 to 0)
    30.4 (26.2 to 34.9)
        Fever, Dosing at Day 1 (N=516,513)
    2.1 (1.1 to 3.8)
    0.6 (0.1 to 1.7)
        Fever, Dosing at Day 31 (N=0,451)
    0 (0 to 0)
    1.1 (0.4 to 2.6)
        Headache, Dosing at Day 1 (N=516,513)
    32.2 (28.2 to 36.4)
    19.3 (16.0 to 23.0)
        Headache, Dosing at Day 31 (N=0, 451)
    0 (0 to 0)
    23.9 (20.1 to 28.2)
        Myalgia, Dosing at Day 1 (N=516,513)
    39.0 (34.7 to 43.3)
    23.0 (19.4 to 26.9)
        Myalgia, Dosing at Day 31 (N=0,451)
    0 (0 to 0)
    31.9 (27.6 to 36.5)
    No statistical analyses for this end point

    Secondary: Percentage of participants reporting unsolicited adverse events (AEs) 

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    End point title
    		 Percentage of participants reporting unsolicited adverse events (AEs) 
    End point description
    An unsolicited AEs is an AE that is not included in a list of solicited events using a Participant Electronic Diary. Unsolicited events must be spontaneously communicated by a participant who signs the informed consent. Unsolicited AEs include both serious, non-serious AEs and potential immune-mediated diseases (pIMDs). Analysis was performed on Exposed set which included participants who received at least a study intervention and had data for the assessed timepoint and analysis.
    End point type
    Secondary
    End point timeframe
    Within 30 days (the day of vaccination and 29 subsequent days) after each vaccine administration
    End point values
    		 Co-Ad Group Control Group
    Number of subjects analysed
    523
    522
    Units: Percentage of participants
        number (confidence interval 95%)
    13.6 (10.8 to 16.8)
    24.5 (20.9 to 28.4)
    No statistical analyses for this end point

    Secondary: Percentage of participants reporting at least one Serious Adverse Event (SAEs)

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    End point title
    		 Percentage of participants reporting at least one Serious Adverse Event (SAEs)
    End point description
    An SAE is 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 participant. Analysis was performed on Exposed set which included participants who received at least a study intervention and had data for the assessed timepoint and analysis.
    End point type
    Secondary
    End point timeframe
    From Day 1 until 6 months after last vaccination (Month 6 for the Co-Ad Group, Month 7 for the Control group)
    End point values
    		 Co-Ad Group Control Group
    Number of subjects analysed
    523
    522
    Units: Percentage of participants
        number (confidence interval 95%)
    4.0 (2.5 to 6.1)
    6.9 (4.9 to 9.4)
    No statistical analyses for this end point

    Secondary: Percentage of participants reporting at least one Potential Immune-mediated Disease (pIMDs)

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    End point title
    		 Percentage of participants reporting at least one Potential Immune-mediated Disease (pIMDs)
    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 investigator must exercise his/her medical/scientific judgment to determine whether other diseases have an autoimmune origin (i.e., pathophysiology involving systemic or organ-specific pathogenic autoantibodies) and should also be recorded as a pIMD. Analysis was performed on Exposed set which included participants who received at least a study intervention and had data for the assessed timepoint and analysis.
    End point type
    Secondary
    End point timeframe
    From Day 1 until 6 months after last vaccination (Month 6 for the Co-Ad Group, Month 7 for the Control group)
    End point values
    		 Co-Ad Group Control Group
    Number of subjects analysed
    523
    522
    Units: Percentage of participants
        number (confidence interval 95%)
    0 (0 to 0.7)
    0.6 (0.1 to 1.7)
    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 7-day follow-up period after each vaccination. Unsolicited AEs were collected during 30-day follow-up period after each vaccination. SAEs and pIMDs were collected from Day 1 to 6 months after last vaccination.
    Adverse event reporting additional description
    Solicited and unsolicited events were reported per participant at any dose for the assessed timeframe (within 30 days after any vaccine dose administration) according to occurrence of each event, as pre-specified in Statistical Analysis Plan.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    v26.0
    Reporting groups
    Reporting group title
    Control Group
    Reporting group description
    		 Participants received one dose of FLU-aQIV vaccine at Day 1, followed by one dose of RSVPreF3 OA vaccine at Day 31, and were followed until end of study.

    Reporting group title
    Co-Ad Group
    Reporting group description
    		 Participants received one dose of FLU-aQIV vaccine and one dose of RSVPreF3 OA vaccine, both doses administered at Day 1, and were followed until end of study.

    Serious adverse events
    		 Control Group Co-Ad Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    36 / 522 (6.90%)
    21 / 523 (4.02%)
         number of deaths (all causes)
    6
    0
         number of deaths resulting from adverse events
    0
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Small intestine carcinoma
         subjects affected / exposed
    1 / 522 (0.19%)
    0 / 523 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Adenocarcinoma gastric
         subjects affected / exposed
    1 / 522 (0.19%)
    1 / 523 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Bladder neoplasm
         subjects affected / exposed
    0 / 522 (0.00%)
    1 / 523 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glioblastoma
         subjects affected / exposed
    1 / 522 (0.19%)
    0 / 523 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ocular melanoma
         subjects affected / exposed
    1 / 522 (0.19%)
    0 / 523 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oesophageal neoplasm
         subjects affected / exposed
    0 / 522 (0.00%)
    1 / 523 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Aortic aneurysm
         subjects affected / exposed
    1 / 522 (0.19%)
    0 / 523 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Giant cell arteritis
         subjects affected / exposed
    1 / 522 (0.19%)
    0 / 523 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 522 (0.19%)
    0 / 523 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Haemoptysis
         subjects affected / exposed
    1 / 522 (0.19%)
    0 / 523 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory failure
         subjects affected / exposed
    1 / 522 (0.19%)
    1 / 523 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary arterial hypertension
         subjects affected / exposed
    2 / 522 (0.38%)
    0 / 523 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 2
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    3 / 522 (0.57%)
    1 / 523 (0.19%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 3
    0 / 0
    Hypercapnia
         subjects affected / exposed
    1 / 522 (0.19%)
    0 / 523 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pulmonary embolism
         subjects affected / exposed
    0 / 522 (0.00%)
    1 / 523 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 522 (0.19%)
    0 / 523 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Wound necrosis
         subjects affected / exposed
    1 / 522 (0.19%)
    0 / 523 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Posterior capsule rupture
         subjects affected / exposed
    1 / 522 (0.19%)
    0 / 523 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    1 / 522 (0.19%)
    0 / 523 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    1 / 522 (0.19%)
    2 / 523 (0.38%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute myocardial infarction
         subjects affected / exposed
    1 / 522 (0.19%)
    1 / 523 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arrhythmia
         subjects affected / exposed
    1 / 522 (0.19%)
    1 / 523 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute coronary syndrome
         subjects affected / exposed
    1 / 522 (0.19%)
    0 / 523 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Angina unstable
         subjects affected / exposed
    1 / 522 (0.19%)
    0 / 523 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Stress cardiomyopathy
         subjects affected / exposed
    1 / 522 (0.19%)
    0 / 523 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Right ventricular failure
         subjects affected / exposed
    1 / 522 (0.19%)
    0 / 523 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pericarditis
         subjects affected / exposed
    1 / 522 (0.19%)
    0 / 523 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac failure
         subjects affected / exposed
    0 / 522 (0.00%)
    1 / 523 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebrovascular accident
         subjects affected / exposed
    1 / 522 (0.19%)
    1 / 523 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Encephalopathy
         subjects affected / exposed
    1 / 522 (0.19%)
    0 / 523 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Gastrointestinal disorders
    Intestinal obstruction
         subjects affected / exposed
    1 / 522 (0.19%)
    0 / 523 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inguinal hernia
         subjects affected / exposed
    0 / 522 (0.00%)
    1 / 523 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ascites
         subjects affected / exposed
    1 / 522 (0.19%)
    0 / 523 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    1 / 522 (0.19%)
    1 / 523 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Obstructive pancreatitis
         subjects affected / exposed
    0 / 522 (0.00%)
    1 / 523 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis chronic
         subjects affected / exposed
    0 / 522 (0.00%)
    1 / 523 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Upper gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 522 (0.19%)
    0 / 523 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Hepatobiliary disorders
    Cholecystitis acute
         subjects affected / exposed
    1 / 522 (0.19%)
    0 / 523 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Diabetic foot
         subjects affected / exposed
    1 / 522 (0.19%)
    0 / 523 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 522 (0.19%)
    0 / 523 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endocrine disorders
    Hyperparathyroidism
         subjects affected / exposed
    1 / 522 (0.19%)
    0 / 523 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Spinal stenosis
         subjects affected / exposed
    1 / 522 (0.19%)
    0 / 523 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthralgia
         subjects affected / exposed
    1 / 522 (0.19%)
    1 / 523 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    3 / 522 (0.57%)
    0 / 523 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Infective exacerbation of chronic obstructive airways disease
         subjects affected / exposed
    1 / 522 (0.19%)
    1 / 523 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory syncytial virus infection
         subjects affected / exposed
    1 / 522 (0.19%)
    1 / 523 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    1 / 522 (0.19%)
    1 / 523 (0.19%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacterial disease carrier
         subjects affected / exposed
    0 / 522 (0.00%)
    1 / 523 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Complicated appendicitis
         subjects affected / exposed
    1 / 522 (0.19%)
    0 / 523 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bronchitis
         subjects affected / exposed
    0 / 522 (0.00%)
    2 / 523 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    0 / 522 (0.00%)
    2 / 523 (0.38%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Superinfection
         subjects affected / exposed
    0 / 522 (0.00%)
    1 / 523 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    1 / 522 (0.19%)
    0 / 523 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    1 / 522 (0.19%)
    0 / 523 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retroperitoneal abscess
         subjects affected / exposed
    0 / 522 (0.00%)
    1 / 523 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 522 (0.19%)
    0 / 523 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Infective exacerbation of bronchiectasis
         subjects affected / exposed
    1 / 522 (0.19%)
    0 / 523 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Infected skin ulcer
         subjects affected / exposed
    0 / 522 (0.00%)
    1 / 523 (0.19%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Erysipelas
         subjects affected / exposed
    1 / 522 (0.19%)
    0 / 523 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    1 / 522 (0.19%)
    0 / 523 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Control Group Co-Ad Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    428 / 522 (81.99%)
    427 / 523 (81.64%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Skin papilloma
         subjects affected / exposed
    0 / 522 (0.00%)
    1 / 523 (0.19%)
         occurrences all number
    0
    1
    Vascular disorders
    Haematoma
         subjects affected / exposed
    1 / 522 (0.19%)
    0 / 523 (0.00%)
         occurrences all number
    1
    0
    Hypertension
         subjects affected / exposed
    5 / 522 (0.96%)
    2 / 523 (0.38%)
         occurrences all number
    5
    2
    General disorders and administration site conditions
    Injection site erythema
         subjects affected / exposed
    76 / 522 (14.56%)
    83 / 523 (15.87%)
         occurrences all number
    84
    83
    Injection site swelling
         subjects affected / exposed
    61 / 522 (11.69%)
    67 / 523 (12.81%)
         occurrences all number
    69
    67
    Injection site pain
         subjects affected / exposed
    349 / 522 (66.86%)
    368 / 523 (70.36%)
         occurrences all number
    496
    368
    Fatigue
         subjects affected / exposed
    212 / 522 (40.61%)
    236 / 523 (45.12%)
         occurrences all number
    286
    237
    Administration site erythema
         subjects affected / exposed
    0 / 522 (0.00%)
    1 / 523 (0.19%)
         occurrences all number
    0
    1
    Influenza like illness
         subjects affected / exposed
    4 / 522 (0.77%)
    1 / 523 (0.19%)
         occurrences all number
    5
    1
    Pyrexia
         subjects affected / exposed
    9 / 522 (1.72%)
    14 / 523 (2.68%)
         occurrences all number
    9
    14
    Asthenia
         subjects affected / exposed
    1 / 522 (0.19%)
    0 / 523 (0.00%)
         occurrences all number
    1
    0
    Chills
         subjects affected / exposed
    0 / 522 (0.00%)
    1 / 523 (0.19%)
         occurrences all number
    0
    1
    Inflammation
         subjects affected / exposed
    0 / 522 (0.00%)
    1 / 523 (0.19%)
         occurrences all number
    0
    1
    Injection site haematoma
         subjects affected / exposed
    0 / 522 (0.00%)
    1 / 523 (0.19%)
         occurrences all number
    0
    1
    Administration site pain
         subjects affected / exposed
    0 / 522 (0.00%)
    1 / 523 (0.19%)
         occurrences all number
    0
    1
    Vessel puncture site swelling
         subjects affected / exposed
    1 / 522 (0.19%)
    0 / 523 (0.00%)
         occurrences all number
    1
    0
    Pain
         subjects affected / exposed
    0 / 522 (0.00%)
    1 / 523 (0.19%)
         occurrences all number
    0
    1
    Oedema peripheral
         subjects affected / exposed
    1 / 522 (0.19%)
    0 / 523 (0.00%)
         occurrences all number
    1
    0
    Malaise
         subjects affected / exposed
    1 / 522 (0.19%)
    0 / 523 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    6 / 522 (1.15%)
    1 / 523 (0.19%)
         occurrences all number
    6
    1
    Oropharyngeal pain
         subjects affected / exposed
    3 / 522 (0.57%)
    1 / 523 (0.19%)
         occurrences all number
    3
    1
    Productive cough
         subjects affected / exposed
    2 / 522 (0.38%)
    1 / 523 (0.19%)
         occurrences all number
    2
    1
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    1 / 522 (0.19%)
    1 / 523 (0.19%)
         occurrences all number
    1
    1
    Catarrh
         subjects affected / exposed
    1 / 522 (0.19%)
    0 / 523 (0.00%)
         occurrences all number
    1
    0
    Dyspnoea
         subjects affected / exposed
    1 / 522 (0.19%)
    0 / 523 (0.00%)
         occurrences all number
    1
    0
    Lung disorder
         subjects affected / exposed
    1 / 522 (0.19%)
    0 / 523 (0.00%)
         occurrences all number
    1
    0
    Rhinorrhoea
         subjects affected / exposed
    0 / 522 (0.00%)
    1 / 523 (0.19%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Restlessness
         subjects affected / exposed
    0 / 522 (0.00%)
    1 / 523 (0.19%)
         occurrences all number
    0
    1
    Investigations
    Blood pressure increased
         subjects affected / exposed
    0 / 522 (0.00%)
    1 / 523 (0.19%)
         occurrences all number
    0
    1
    Occult blood positive
         subjects affected / exposed
    1 / 522 (0.19%)
    0 / 523 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    3 / 522 (0.57%)
    1 / 523 (0.19%)
         occurrences all number
    3
    1
    Limb injury
         subjects affected / exposed
    3 / 522 (0.57%)
    0 / 523 (0.00%)
         occurrences all number
    3
    0
    Contusion
         subjects affected / exposed
    0 / 522 (0.00%)
    1 / 523 (0.19%)
         occurrences all number
    0
    1
    Eye injury
         subjects affected / exposed
    1 / 522 (0.19%)
    0 / 523 (0.00%)
         occurrences all number
    1
    0
    Fibula fracture
         subjects affected / exposed
    1 / 522 (0.19%)
    0 / 523 (0.00%)
         occurrences all number
    1
    0
    Head injury
         subjects affected / exposed
    1 / 522 (0.19%)
    0 / 523 (0.00%)
         occurrences all number
    1
    0
    Immunisation reaction
         subjects affected / exposed
    0 / 522 (0.00%)
    1 / 523 (0.19%)
         occurrences all number
    0
    1
    Ligament sprain
         subjects affected / exposed
    1 / 522 (0.19%)
    0 / 523 (0.00%)
         occurrences all number
    2
    0
    Muscle contusion
         subjects affected / exposed
    0 / 522 (0.00%)
    1 / 523 (0.19%)
         occurrences all number
    0
    1
    Procedural pain
         subjects affected / exposed
    0 / 522 (0.00%)
    1 / 523 (0.19%)
         occurrences all number
    0
    1
    Road traffic accident
         subjects affected / exposed
    1 / 522 (0.19%)
    0 / 523 (0.00%)
         occurrences all number
    1
    0
    Vaccination complication
         subjects affected / exposed
    1 / 522 (0.19%)
    0 / 523 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    Arteriosclerosis coronary artery
         subjects affected / exposed
    1 / 522 (0.19%)
    0 / 523 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Dizziness postural
         subjects affected / exposed
    0 / 522 (0.00%)
    1 / 523 (0.19%)
         occurrences all number
    0
    1
    Presyncope
         subjects affected / exposed
    2 / 522 (0.38%)
    0 / 523 (0.00%)
         occurrences all number
    2
    0
    Paraesthesia
         subjects affected / exposed
    1 / 522 (0.19%)
    1 / 523 (0.19%)
         occurrences all number
    1
    1
    Headache
         subjects affected / exposed
    164 / 522 (31.42%)
    167 / 523 (31.93%)
         occurrences all number
    210
    167
    Sciatica
         subjects affected / exposed
    0 / 522 (0.00%)
    1 / 523 (0.19%)
         occurrences all number
    0
    1
    Syncope
         subjects affected / exposed
    0 / 522 (0.00%)
    1 / 523 (0.19%)
         occurrences all number
    0
    1
    Blood and lymphatic system disorders
    Lymphadenitis
         subjects affected / exposed
    0 / 522 (0.00%)
    1 / 523 (0.19%)
         occurrences all number
    0
    1
    Hypochromic anaemia
         subjects affected / exposed
    0 / 522 (0.00%)
    1 / 523 (0.19%)
         occurrences all number
    0
    1
    Eye disorders
    Blepharitis
         subjects affected / exposed
    0 / 522 (0.00%)
    1 / 523 (0.19%)
         occurrences all number
    0
    1
    Neovascular age-related macular degeneration
         subjects affected / exposed
    1 / 522 (0.19%)
    0 / 523 (0.00%)
         occurrences all number
    1
    0
    Glaucoma
         subjects affected / exposed
    1 / 522 (0.19%)
    0 / 523 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    0 / 522 (0.00%)
    1 / 523 (0.19%)
         occurrences all number
    0
    1
    Toothache
         subjects affected / exposed
    1 / 522 (0.19%)
    0 / 523 (0.00%)
         occurrences all number
    1
    0
    Oral disorder
         subjects affected / exposed
    1 / 522 (0.19%)
    0 / 523 (0.00%)
         occurrences all number
    1
    0
    Abdominal pain upper
         subjects affected / exposed
    1 / 522 (0.19%)
    1 / 523 (0.19%)
         occurrences all number
    1
    1
    Diarrhoea
         subjects affected / exposed
    2 / 522 (0.38%)
    0 / 523 (0.00%)
         occurrences all number
    2
    0
    Abdominal pain
         subjects affected / exposed
    1 / 522 (0.19%)
    0 / 523 (0.00%)
         occurrences all number
    1
    0
    Dyspepsia
         subjects affected / exposed
    1 / 522 (0.19%)
    0 / 523 (0.00%)
         occurrences all number
    1
    0
    Hiatus hernia
         subjects affected / exposed
    1 / 522 (0.19%)
    0 / 523 (0.00%)
         occurrences all number
    1
    0
    Irritable bowel syndrome
         subjects affected / exposed
    1 / 522 (0.19%)
    0 / 523 (0.00%)
         occurrences all number
    1
    0
    Melaena
         subjects affected / exposed
    1 / 522 (0.19%)
    0 / 523 (0.00%)
         occurrences all number
    1
    0
    Odynophagia
         subjects affected / exposed
    0 / 522 (0.00%)
    1 / 523 (0.19%)
         occurrences all number
    0
    1
    Oesophagitis
         subjects affected / exposed
    1 / 522 (0.19%)
    0 / 523 (0.00%)
         occurrences all number
    1
    0
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    1 / 522 (0.19%)
    0 / 523 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    0 / 522 (0.00%)
    1 / 523 (0.19%)
         occurrences all number
    0
    1
    Erythema
         subjects affected / exposed
    1 / 522 (0.19%)
    0 / 523 (0.00%)
         occurrences all number
    1
    0
    Eczema
         subjects affected / exposed
    0 / 522 (0.00%)
    1 / 523 (0.19%)
         occurrences all number
    0
    1
    Rash
         subjects affected / exposed
    1 / 522 (0.19%)
    0 / 523 (0.00%)
         occurrences all number
    1
    0
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    1 / 522 (0.19%)
    1 / 523 (0.19%)
         occurrences all number
    1
    1
    Musculoskeletal and connective tissue disorders
    Osteoarthritis
         subjects affected / exposed
    0 / 522 (0.00%)
    1 / 523 (0.19%)
         occurrences all number
    0
    1
    Musculoskeletal stiffness
         subjects affected / exposed
    1 / 522 (0.19%)
    0 / 523 (0.00%)
         occurrences all number
    1
    0
    Haemarthrosis
         subjects affected / exposed
    1 / 522 (0.19%)
    0 / 523 (0.00%)
         occurrences all number
    1
    0
    Groin pain
         subjects affected / exposed
    1 / 522 (0.19%)
    0 / 523 (0.00%)
         occurrences all number
    1
    0
    Exostosis
         subjects affected / exposed
    1 / 522 (0.19%)
    0 / 523 (0.00%)
         occurrences all number
    1
    0
    Pain in extremity
         subjects affected / exposed
    2 / 522 (0.38%)
    0 / 523 (0.00%)
         occurrences all number
    2
    0
    Back pain
         subjects affected / exposed
    3 / 522 (0.57%)
    1 / 523 (0.19%)
         occurrences all number
    3
    1
    Arthralgia
         subjects affected / exposed
    133 / 522 (25.48%)
    133 / 523 (25.43%)
         occurrences all number
    164
    134
    Myalgia
         subjects affected / exposed
    206 / 522 (39.46%)
    201 / 523 (38.43%)
         occurrences all number
    263
    203
    Rotator cuff syndrome
         subjects affected / exposed
    1 / 522 (0.19%)
    0 / 523 (0.00%)
         occurrences all number
    1
    0
    Tenosynovitis stenosans
         subjects affected / exposed
    0 / 522 (0.00%)
    1 / 523 (0.19%)
         occurrences all number
    0
    1
    Synovial cyst
         subjects affected / exposed
    0 / 522 (0.00%)
    1 / 523 (0.19%)
         occurrences all number
    0
    1
    Infections and infestations
    Gastroenteritis viral
         subjects affected / exposed
    1 / 522 (0.19%)
    0 / 523 (0.00%)
         occurrences all number
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    15 / 522 (2.87%)
    13 / 523 (2.49%)
         occurrences all number
    17
    13
    COVID-19
         subjects affected / exposed
    14 / 522 (2.68%)
    11 / 523 (2.10%)
         occurrences all number
    14
    11
    Bronchitis
         subjects affected / exposed
    5 / 522 (0.96%)
    4 / 523 (0.76%)
         occurrences all number
    5
    4
    Respiratory tract infection
         subjects affected / exposed
    7 / 522 (1.34%)
    0 / 523 (0.00%)
         occurrences all number
    7
    0
    Upper respiratory tract infection
         subjects affected / exposed
    4 / 522 (0.77%)
    3 / 523 (0.57%)
         occurrences all number
    4
    3
    Rhinitis
         subjects affected / exposed
    3 / 522 (0.57%)
    2 / 523 (0.38%)
         occurrences all number
    3
    2
    Pharyngitis
         subjects affected / exposed
    1 / 522 (0.19%)
    2 / 523 (0.38%)
         occurrences all number
    1
    2
    Sinusitis
         subjects affected / exposed
    1 / 522 (0.19%)
    2 / 523 (0.38%)
         occurrences all number
    1
    2
    Herpes zoster
         subjects affected / exposed
    1 / 522 (0.19%)
    1 / 523 (0.19%)
         occurrences all number
    1
    1
    Lower respiratory tract infection
         subjects affected / exposed
    2 / 522 (0.38%)
    0 / 523 (0.00%)
         occurrences all number
    2
    0
    Pneumonia
         subjects affected / exposed
    1 / 522 (0.19%)
    1 / 523 (0.19%)
         occurrences all number
    1
    1
    Erysipelas
         subjects affected / exposed
    1 / 522 (0.19%)
    0 / 523 (0.00%)
         occurrences all number
    1
    0
    Ear infection
         subjects affected / exposed
    0 / 522 (0.00%)
    1 / 523 (0.19%)
         occurrences all number
    0
    1
    Diverticulitis
         subjects affected / exposed
    0 / 522 (0.00%)
    1 / 523 (0.19%)
         occurrences all number
    0
    1
    Cellulitis
         subjects affected / exposed
    1 / 522 (0.19%)
    0 / 523 (0.00%)
         occurrences all number
    1
    0
    Abscess oral
         subjects affected / exposed
    0 / 522 (0.00%)
    1 / 523 (0.19%)
         occurrences all number
    0
    1
    Urinary tract infection
         subjects affected / exposed
    2 / 522 (0.38%)
    0 / 523 (0.00%)
         occurrences all number
    2
    0
    Herpes simplex
         subjects affected / exposed
    0 / 522 (0.00%)
    1 / 523 (0.19%)
         occurrences all number
    0
    1
    Infected bite
         subjects affected / exposed
    1 / 522 (0.19%)
    0 / 523 (0.00%)
         occurrences all number
    1
    0
    Localised infection
         subjects affected / exposed
    0 / 522 (0.00%)
    1 / 523 (0.19%)
         occurrences all number
    0
    1
    Parotitis
         subjects affected / exposed
    0 / 522 (0.00%)
    1 / 523 (0.19%)
         occurrences all number
    0
    1
    Post procedural infection
         subjects affected / exposed
    1 / 522 (0.19%)
    0 / 523 (0.00%)
         occurrences all number
    1
    0
    Respiratory tract infection viral
         subjects affected / exposed
    0 / 522 (0.00%)
    1 / 523 (0.19%)
         occurrences all number
    0
    1
    Tooth infection
         subjects affected / exposed
    0 / 522 (0.00%)
    1 / 523 (0.19%)
         occurrences all number
    0
    1
    Metabolism and nutrition disorders
    Type 2 diabetes mellitus
         subjects affected / exposed
    0 / 522 (0.00%)
    1 / 523 (0.19%)
         occurrences all number
    0
    1
    Hyperlipidaemia
         subjects affected / exposed
    0 / 522 (0.00%)
    1 / 523 (0.19%)
         occurrences all number
    0
    1
    Hyperglycaemia
         subjects affected / exposed
    0 / 522 (0.00%)
    1 / 523 (0.19%)
         occurrences all number
    0
    1
    Folate deficiency
         subjects affected / exposed
    0 / 522 (0.00%)
    1 / 523 (0.19%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    13 Dec 2022
    The purpose of this amendment was to promote from secondary objective to primary objective the non-inferiority of RSV-B neutralizing antibody titers, as measured by GMT, when RSVPreF3 OA is co-administered with FLU aQIV, compared to RSVPreF3 OA alone. In addition, the SAE definition of anomalies in offspring was added, laboratory blinding procedures were updated, and minor editorial changes were made for clarity.

    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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