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    Clinical Trial Results:
    A Phase 3, observer-blind, randomized, placebo-controlled study to evaluate the non-inferiority of the immune response and safety of the RSVPreF3 OA investigational vaccine in adults 50-59 years of age, including adults at increased risk of respiratory syncytial virus lower respiratory tract disease, compared to older adults >=60 years of age

    Summary
    EudraCT number
    		 2022-001981-36
    Trial protocol
    		 DE   ES   NL   PL  
    Global end of trial date
    12 Feb 2024

    Results information
    Results version number
    		 v2(current)
    This version publication date
    27 Feb 2025
    First version publication date
    26 Jun 2024
    Other versions
    		 v1
    Version creation reason

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    219238
    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
    13 Mar 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Feb 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    • To demonstrate the non-inferiority (NI) of the humoral immune response in healthy participants 50-59 years of age (YOA) compared to OA (>=60 YOA) for the RSV-A strain after RSVPreF3 OA investigational vaccine administration. • To demonstrate the NI of the humoral immune response in healthy participants 50-59 YOA compared to OA for the RSV-B strain after RSVPreF3 OA investigational vaccine administration. • To demonstrate the NI of the humoral immune response in participants 50-59 YOA at increased risk of RSV-LRTD compared to OA for the RSV-A strain after RSVPreF3 OA investigational vaccine administration. • To demonstrate the NI of the humoral immune response in participants 50-59 YOA at increased risk of RSV-LRTD compared to OA for the RSV-B strain after RSVPreF3 OA investigational vaccine administration.
    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
    28 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
    Argentina: 179
    Country: Number of subjects enrolled
    Canada: 223
    Country: Number of subjects enrolled
    Germany: 248
    Country: Number of subjects enrolled
    Japan: 152
    Country: Number of subjects enrolled
    Netherlands: 39
    Country: Number of subjects enrolled
    Poland: 144
    Country: Number of subjects enrolled
    Spain: 199
    Country: Number of subjects enrolled
    United States: 360
    Worldwide total number of subjects
    1544
    EEA total number of subjects
    630
    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)
    1273
    From 65 to 84 years
    264
    85 years and over
    7

    Subject disposition

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    Recruitment
    Recruitment details
    		 Out of 1544 participants enrolled in this study, 1534 participants received at least one study intervention, from which 1 participant in OA-RSV group received placebo instead of RSVPreF3 OA vaccine and was excluded from the group. Therefore, the Exposed set included 1533 participants.

    Pre-assignment
    Screening details
    		 The exposed set included 1533 participants.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Adults HA-RSV Group
    Arm description
    		 Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-Lower respiratory tract disease (RSV-LRTD), aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.
    Arm type
    		 Experimental

    Investigational medicinal product name
    RSVPreF3 OA vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One 0.5mL dose administered at Day 1 in the deltoid of the non-dominant arm.

    Arm title
    		 Adults HA-Placebo Group
    Arm description
    		 Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Sodium chloride (NaCl)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose of approximately 0.7 mL of NaCl solution administered at Day 1 in the deltoid of the non-dominant arm.

    Arm title
    		 Adults AIR-RSV Group
    Arm description
    		 Adults at increased risk of RSV-Lower respiratory tract disease (RSV-LRTD) aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.
    Arm type
    		 Experimental

    Investigational medicinal product name
    RSVPreF3 OA vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One 0.5mL dose administered at Day 1 in the deltoid of the non-dominant arm.

    Arm title
    		 Adults AIR-Placebo Group
    Arm description
    		 Adults at increased risk of RSV-LRTD aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Sodium chloride (NaCl)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One dose of approximately 0.7 mL of NaCl solution administered at Day 1 in the deltoid of the non-dominant arm.

    Arm title
    		 OA-RSV Group
    Arm description
    		 Older adults aged 60 years old and above received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.
    Arm type
    		 Experimental

    Investigational medicinal product name
    RSVPreF3 OA vaccine
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder for suspension for injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One 0.5mL dose administered at Day 1 in the deltoid of the non-dominant arm.

    Number of subjects in period 1 [1]
    		Adults HA-RSV Group Adults HA-Placebo Group Adults AIR-RSV Group Adults AIR-Placebo Group OA-RSV Group
    Started
    383
    192
    386
    191
    381
    Completed
    363
    184
    369
    180
    369
    Not completed
    20
    8
    17
    11
    12
         Migrated / moved from the study area
    1
    1
    -
    3
    1
         Not specified
    2
    -
    2
    2
    -
         Lost to follow-up
    13
    1
    7
    3
    4
         Consent withdrawal, not due to a (S)AE
    4
    6
    4
    2
    7
         Adverse event requiring expedited reporting
    -
    -
    4
    1
    -
    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: The baseline period is reporting the number of participants included in the Exposed set, the worldwide number of participants is reporting the number of participants included in the Enrolled set.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Adults HA-RSV Group
    Reporting group description
    		 Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-Lower respiratory tract disease (RSV-LRTD), aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.

    Reporting group title
    Adults HA-Placebo Group
    Reporting group description
    		 Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end.

    Reporting group title
    Adults AIR-RSV Group
    Reporting group description
    		 Adults at increased risk of RSV-Lower respiratory tract disease (RSV-LRTD) aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.

    Reporting group title
    Adults AIR-Placebo Group
    Reporting group description
    		 Adults at increased risk of RSV-LRTD aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end.

    Reporting group title
    OA-RSV Group
    Reporting group description
    		 Older adults aged 60 years old and above received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.

    Reporting group values
    		 Adults HA-RSV Group Adults HA-Placebo Group Adults AIR-RSV Group Adults AIR-Placebo Group OA-RSV Group Total
    Number of subjects
    		 383 192 386 191 381 1533
    Age categorical
    Units: Subjects
        Adults (50-59 years)
    		 383 192 386 191 0 1152
        Adults (60-69 years)
    		 0 0 0 0 202 202
        Adults (70-70 years)
    		 0 0 0 0 130 130
        80 years and above
    		 0 0 0 0 49 49
    Age continuous
    Units: years
        median (standard deviation)
    		 54.8 ( 2.8 ) 54.7 ( 2.8 ) 55.3 ( 2.8 ) 55.6 ( 2.8 ) 69.5 ( 6.9 ) -
    Sex: Female, Male
    Units: Participants
        MALE
    		 162 73 200 106 193 734
        FEMALE
    		 221 119 186 85 188 799
    Race/Ethnicity, Customized
    Units: Subjects
        Hispanic or Latino
    		 48 23 63 35 50 219
        Not Hispanic or Latino
    		 335 168 323 156 330 1312
        Unknown
    		 0 1 0 0 1 2
    Age, Continuous
    Units: YEARS
        arithmetic mean (standard deviation)
    		 54.8 ( 2.8 ) 54.7 ( 2.8 ) 55.3 ( 2.8 ) 55.6 ( 2.8 ) 64.1 ( 2.9 ) -

    End points

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    End points reporting groups
    Reporting group title
    Adults HA-RSV Group
    Reporting group description
    		 Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-Lower respiratory tract disease (RSV-LRTD), aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.

    Reporting group title
    Adults HA-Placebo Group
    Reporting group description
    		 Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end.

    Reporting group title
    Adults AIR-RSV Group
    Reporting group description
    		 Adults at increased risk of RSV-Lower respiratory tract disease (RSV-LRTD) aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.

    Reporting group title
    Adults AIR-Placebo Group
    Reporting group description
    		 Adults at increased risk of RSV-LRTD aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end.

    Reporting group title
    OA-RSV Group
    Reporting group description
    		 Older adults aged 60 years old and above received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.

    Primary: RSV-A neutralization titers expressed as group geometric mean titer (GMT) in healthy participants compared to OA-RSV Group

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    End point title
    		 RSV-A neutralization titers expressed as group geometric mean titer (GMT) in healthy participants compared to OA-RSV Group [1]
    End point description
    Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay. The corresponding antibody titers were expressed in Estimated Dilution 60 (ED60) and were measured on blood samples collected from vaccinated subjects. The ANCOVA model used to calculate the adjusted GMTs for RSV-A neutralizing antibodies included the baseline value as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included Adult HA-RSV and OA-RSV groups in the model as fixed effect, as specified in Statistical Analysis Plan. Analysis was performed on the per protocol set (PPS) for humoral analysis which included all eligible participants who received the study intervention as per protocol, had RSV-A 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 1 month after the RSVPreF3 OA vaccine administration (Day 31)
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The purpose of this endpoint was to present analysis only for Adults HA-RSV Group compared to OA-RSV Group.
    End point values
    		 Adults HA-RSV Group OA-RSV Group
    Number of subjects analysed
    326
    343
    Units: Titer
        geometric mean (confidence interval 95%)
    7906.0 (7178.1 to 8707.7)
    7518.9 (6843.2 to 8261.3)
    Statistical analysis title
    		 RSV-A ratio in OA-RSV over Adults-HA-RSV groups
    Statistical analysis description
    To demonstrate the non-inferiority of the RSVPreF3 OA vaccine when administered to healthy adults aged 50-59 years of age compared with older adults aged 60 years of age or above.
    Comparison groups
    Adults HA-RSV Group v OA-RSV Group
    Number of subjects included in analysis
    669
    Analysis specification
    Pre-specified
    Analysis type
    		 [2]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    0.95
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.83
         upper limit
    		 1.09
    Notes
    [2] - Non-inferiority is demonstrated if the anti-RSV-A GMT ratio (OA-RSV Group over Adults-HA-RSV Group) is less than (<) 1.5 at 1 month post RSVPreF3 OA vaccine administration.

    Primary: RSV-A neutralization titers expressed as group seroresponse rate (SRR) difference in healthy participants compared to OA-RSV group

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    End point title
    		 RSV-A neutralization titers expressed as group seroresponse rate (SRR) difference in healthy participants compared to OA-RSV group [3]
    End point description
    The SRR is defined as the proportion of participants having a fold increase in neutralization titers (1 month post-study intervention administration over pre-study intervention administration) greater than or equal to 4 (>=4). Analysis was performed on PPS for humoral analysis. Analysis per group is based on the administered intervention.
    End point type
    Primary
    End point timeframe
    At 1 month after the RSVPreF3 OA investigational vaccine administration (Day 31) compared to baseline (Day 1)
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The purpose of this endpoint was to present analysis only for Adults HA-RSV Group compared to OA-RSV Group.
    End point values
    		 Adults HA-RSV Group OA-RSV Group
    Number of subjects analysed
    270
    275
    Units: Percentage of participants
        number (confidence interval 95%)
    82.8 (78.3 to 86.8)
    80.2 (75.6 to 84.3)
    Statistical analysis title
    		 SRR ratio in OA-RSV minus Adults-HA-RSV groups
    Statistical analysis description
    To demonstrate the non-inferiority of the RSVPreF3 OA vaccine when administered to healthy adults aged 50-59 years of age compared with older adults aged 60 years of age or above.
    Comparison groups
    Adults HA-RSV Group v OA-RSV Group
    Number of subjects included in analysis
    545
    Analysis specification
    Pre-specified
    Analysis type
    		 [4]
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    -2.65
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.54
         upper limit
    		 3.28
    Notes
    [4] - The non-inferiority is demonstrated if the UL of the 2-sided 95% CI on the group difference (OA-RSV Group minus Adults-HA-RSV Group) in terms of SRR is <10%, at 1 month post RSVPreF3 OA vaccine administration.

    Primary: RSV-B neutralization titers expressed as group GMT in healthy participants compared to OA-RSV Group

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    End point title
    		 RSV-B neutralization titers expressed as group GMT in healthy participants compared to OA-RSV Group [5]
    End point description
    Serological assays for the determination of antibodies against RSV-B were performed by neutralization assay. The corresponding antibody titers were expressed in ED60. The ANCOVA model used to calculate the adjusted GMTs for RSV-B neutralizing antibodies included the baseline value as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included Adult HA-RSV and OA-RSV groups in the model as fixed effect, as specified in Statistical Analysis Plan. Analysis was performed on PPS for humoral analysis. Analysis per group is based on the administered intervention.
    End point type
    Primary
    End point timeframe
    At 1 month after the RSVPreF3 OA vaccine administration (Day 31)
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The purpose of this endpoint was to present analysis only for Adults HA-RSV Group compared to OA-RSV Group.
    End point values
    		 Adults HA-RSV Group OA-RSV Group
    Number of subjects analysed
    326
    342
    Units: Titer
        geometric mean (confidence interval 95%)
    9024.8 (8240.8 to 9883.3)
    8070.3 (7385.2 to 8819.1)
    Statistical analysis title
    		 RSV-B ratio in OA-RSV over Adults-HA-RSV groups
    Statistical analysis description
    To demonstrate the non-inferiority of the RSVPreF3 OA vaccine when administered to healthy adults aged 50-59 years of age compared with older adults aged 60 years of age or above.
    Comparison groups
    Adults HA-RSV Group v OA-RSV Group
    Number of subjects included in analysis
    668
    Analysis specification
    Pre-specified
    Analysis type
    		 [6]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    0.89
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.79
         upper limit
    		 1.02
    Notes
    [6] - Non-inferiority is demonstrated if the anti-RSV-B GMT ratio (OA-RSV Group over Adults-HA-RSV Group) is <1.5 at 1 month post RSVPreF3 OA vaccine administration.

    Primary: RSV-B neutralization titers expressed as group SRR in healthy participants compared to OA-RSV Group

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    End point title
    		 RSV-B neutralization titers expressed as group SRR in healthy participants compared to OA-RSV Group [7]
    End point description
    The SRR is defined as the proportion of participants having a fold increase in neutralization titers (1 month post-study intervention administration over pre-study intervention administration) >=4. Analysis was performed on PPS for humoral analysis. Analysis per group is based on the administered intervention.
    End point type
    Primary
    End point timeframe
    At 1 month after the RSVPreF3 OA vaccine administration (Day 31) compared to baseline (Day 1)
    Notes
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The purpose of this endpoint was to present analysis only for Adults HA-RSV Group compared to OA-RSV Group.
    End point values
    		 Adults HA-RSV Group OA-RSV Group
    Number of subjects analysed
    255
    254
    Units: Percentage of participants
        number (confidence interval 95%)
    78.2 (73.3 to 82.6)
    74.3 (69.3 to 78.8)
    Statistical analysis title
    		 SRR ratio in OA-RSV minus Adults-HA-RSV groups
    Statistical analysis description
    To demonstrate the non-inferiority of the RSVPreF3 OA vaccine when administered to healthy adults aged 50-59 years of age compared with older adults aged 60 years of age or above.
    Comparison groups
    Adults HA-RSV Group v OA-RSV Group
    Number of subjects included in analysis
    509
    Analysis specification
    Pre-specified
    Analysis type
    		 [8]
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    -3.95
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.39
         upper limit
    		 2.53
    Notes
    [8] - The non-inferiority is demonstrated if the UL of the 2-sided 95% CI on the group difference (OA-RSV Group minus Adults-HA-RSV Group) in terms of SRR is <10%, at 1 month post RSVPreF3 OA vaccine administration.

    Primary: RSV-A neutralization titers expressed as group GMT titer in participants at increased risk of RSV-LRTD (Adults-AIR-RSV group) compared to OA-RSV group

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    End point title
    		 RSV-A neutralization titers expressed as group GMT titer in participants at increased risk of RSV-LRTD (Adults-AIR-RSV group) compared to OA-RSV group [9]
    End point description
    Serological assays for the determination of antibodies against RSV-A are performed by neutralization assay. The corresponding antibody titers were expressed in ED60. The ANCOVA model used to calculate the adjusted GMTs for RSV-A neutralizing antibodies included the baseline value as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included Adult AIR-RSV and OA-RSV groups in the model as fixed effect, as specified in Statistical Analysis Plan. Analysis was performed on PPS for humoral analysis. Analysis per group is based on the administered intervention.
    End point type
    Primary
    End point timeframe
    At 1 month after the RSVPreF3 OA investigational vaccine administration (Day 31)
    Notes
    [9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The purpose of this endpoint was to present analysis only for Adults-AIR-RSV Group compared to OA-RSV Group.
    End point values
    		 Adults AIR-RSV Group OA-RSV Group
    Number of subjects analysed
    342
    343
    Units: Titer
        geometric mean (confidence interval 95%)
    8925.1 (8117.9 to 9812.6)
    7460.7 (6786.8 to 8201.5)
    Statistical analysis title
    		 RSV-A ratio in OA-RSV over Adults-AIR-RSV groups
    Statistical analysis description
    To demonstrate the non-inferiority of the RSVPreF3 OA vaccine when administered to adults at increased risk of RSV-LRTD aged 50-59 years of age compared with older adults aged 60 years of age or above.
    Comparison groups
    Adults AIR-RSV Group v OA-RSV Group
    Number of subjects included in analysis
    685
    Analysis specification
    Pre-specified
    Analysis type
    		 [10]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    0.84
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.73
         upper limit
    		 0.96
    Notes
    [10] - Non-inferiority is demonstrated if the anti-RSV-A GMT ratio (OA-RSV Group over Adults-AIR-RSV Group) is <1.5 at 1 month post RSVPreF3 OA vaccine administration.

    Primary: RSV-A neutralization titers expressed as group SRR in participants at increased risk of RSV-LRTD (Adults-AIR-RSV group) compared to OA-RSV group

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    End point title
    		 RSV-A neutralization titers expressed as group SRR in participants at increased risk of RSV-LRTD (Adults-AIR-RSV group) compared to OA-RSV group [11]
    End point description
    The SRR is defined as the proportion of participants having a fold increase in neutralization titers (1 month post-study intervention administration over pre-study intervention administration) >=4. Analysis was performed on PPS for humoral analysis. Analysis per group is based on the administered intervention.
    End point type
    Primary
    End point timeframe
    At 1 month after the RSVPreF3 OA vaccine administration (Day 31) compared to baseline (Day 1)
    Notes
    [11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The purpose of this endpoint was to present analysis only for Adults-AIR-RSV Group compared to OA-RSV Group.
    End point values
    		 Adults AIR-RSV Group OA-RSV Group
    Number of subjects analysed
    297
    275
    Units: Percentage of participants
        number (confidence interval 95%)
    86.8 (82.8 to 90.2)
    80.2 (75.6 to 84.3)
    Statistical analysis title
    		 SRR ratio in OA-RSV minus Adults-AIR-RSV groups
    Statistical analysis description
    To demonstrate the non-inferiority of the RSVPreF3 OA vaccine when administered to adults at increased risk of RSV-LRTD aged 50-59 years of age compared with older adults aged 60 years of age or above.
    Comparison groups
    Adults AIR-RSV Group v OA-RSV Group
    Number of subjects included in analysis
    572
    Analysis specification
    Pre-specified
    Analysis type
    		 [12]
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    -6.67
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -12.26
         upper limit
    		 -1.12
    Notes
    [12] - The non-inferiority is demonstrated if the UL of the 2-sided 95% CI on the group difference (OA-RSV Group over Adults-AIR-RSV Group) in terms of SRR is <10%, at 1 month post RSVPreF3 OA vaccine administration.

    Primary: RSV-B neutralization titers expressed as group GMT in participants at increased risk of RSV-LRTD (Adults-AIR-RSV group) compared to OA-RSV group

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    End point title
    		 RSV-B neutralization titers expressed as group GMT in participants at increased risk of RSV-LRTD (Adults-AIR-RSV group) compared to OA-RSV group [13]
    End point description
    Serological assays for the determination of antibodies against RSV-B are performed by neutralization assay. The corresponding antibody titers were expressed in ED60. The ANCOVA model used to calculate the adjusted GMTs for RSV-B neutralizing antibodies included the baseline value as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included Adult AIR-RSV and OA-RSV groups in the model as fixed effect, as specified in Statistical Analysis Plan. Analysis was performed on PPS for humoral analysis. Analysis per group is based on the administered intervention.
    End point type
    Primary
    End point timeframe
    At 1 month after the RSVPreF3 OA vaccine administration (Day 31)
    Notes
    [13] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The purpose of this endpoint was to present analysis only for Adults-AIR-RSV Group compared to OA-RSV Group.
    End point values
    		 Adults AIR-RSV Group OA-RSV Group
    Number of subjects analysed
    342
    342
    Units: Titer
        geometric mean (confidence interval 95%)
    10048.6 (9218.4 to 10953.5)
    8073.4 (7406.4 to 8800.4)
    Statistical analysis title
    		 RSV-B ratio in OA-RSV over Adults AIR-RSV groups
    Statistical analysis description
    To demonstrate the non-inferiority of the RSVPreF3 OA vaccine when administered to adults at increased risk of RSV-LRTD aged 50-59 years of age compared with older adults aged 60 years of age or above.
    Comparison groups
    Adults AIR-RSV Group v OA-RSV Group
    Number of subjects included in analysis
    684
    Analysis specification
    Pre-specified
    Analysis type
    		 [14]
    Method
    Parameter type
    		 GMT Ratio
    Point estimate
    0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.71
         upper limit
    		 0.91
    Notes
    [14] - Non-inferiority is demonstrated if the anti-RSV-B GMT ratio (OA-RSV Group over Adults-AIR-RSV Group) is <1.5 at 1 month post RSVPreF3 OA vaccine administration.

    Primary: RSV-B neutralization titers expressed as group SRR in participants at increased risk of RSV-LRTD (Adults-AIR-RSV group) compared to OA-RSV group

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    End point title
    		 RSV-B neutralization titers expressed as group SRR in participants at increased risk of RSV-LRTD (Adults-AIR-RSV group) compared to OA-RSV group [15]
    End point description
    The SRR is defined as the proportion of participants having a fold increase in neutralization titers (1 month post-study intervention administration over pre-study intervention administration) >=4. Analysis was performed on PPS for humoral analysis. Analysis per group is based on the administered intervention.
    End point type
    Primary
    End point timeframe
    At 1 month after the RSVPreF3 OA investigational vaccine administration (Day 31) compared to baseline (Day 1)
    Notes
    [15] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: The purpose of this endpoint was to present analysis only for Adults-AIR-RSV Group compared to OA-RSV Group.
    End point values
    		 Adults AIR-RSV Group OA-RSV Group
    Number of subjects analysed
    279
    254
    Units: Percentage of participants
        number (confidence interval 95%)
    81.6 (77.1 to 85.5)
    74.3 (69.3 to 78.8)
    Statistical analysis title
    		 SRR ratio in OA-RSV minus Adults AIR-RSV groups
    Statistical analysis description
    To demonstrate the non-inferiority of the RSVPreF3 OA vaccine when administered to adults at increased risk of RSV-LRTD aged 50-59 years of age compared with older adults aged 60 years of age or above.
    Comparison groups
    Adults AIR-RSV Group v OA-RSV Group
    Number of subjects included in analysis
    533
    Analysis specification
    Pre-specified
    Analysis type
    		 [16]
    Method
    Parameter type
    		 Difference in percentage
    Point estimate
    -7.31
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -13.52
         upper limit
    		 -1.09
    Notes
    [16] - The non-inferiority is demonstrated if the UL of the 2-sided 95% CI on the group difference (OA-RSV Group over Adults-AIR-RSV Group) in terms of SRR is <10%, at 1 month post RSVPreF3 OA vaccine administration.

    Secondary: Percentage of participants reporting each solicited administration site event (pain, redness and swelling)

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    End point title
    		 Percentage of participants reporting each solicited administration site event (pain, redness and swelling)
    End point description
    Assessed solicited administration site events were pain, erythema and swelling. Any = occurrence of the symptom regardless of intensity grade. Any erythema and swelling symptom = symptom reported with a surface diameter greater than 0 millimeters. Analysis was based on the Exposed Set (ES), which included all participants who received the study intervention and had data for solicited administration site events analysis at the assessed timeframe.
    End point type
    Secondary
    End point timeframe
    During the 4-day follow up period after vaccination (vaccine or placebo administered on Day 1)
    End point values
    		 Adults HA-RSV Group Adults HA-Placebo Group Adults AIR-RSV Group Adults AIR-Placebo Group OA-RSV Group
    Number of subjects analysed
    377
    191
    379
    189
    379
    Units: Percentage of participants
    number (confidence interval 95%)
        Erythema
    11.9 (8.8 to 15.6)
    0.5 (0.0 to 2.9)
    14.5 (11.1 to 18.5)
    0.5 (0.0 to 2.9)
    12.1 (9.0 to 15.9)
        Pain
    76.7 (72.1 to 80.8)
    10.5 (6.5 to 15.7)
    75.2 (70.5 to 79.5)
    14.3 (9.6 to 20.1)
    61.2 (56.1 to 66.1)
        Swelling
    9.3 (6.6 to 12.7)
    1.0 (0.1 to 3.7)
    11.6 (8.6 to 15.3)
    0.5 (0.0 to 2.9)
    7.7 (5.2 to 10.8)
    No statistical analyses for this end point

    Secondary: Percentage of participants reporting each solicited systemic event (fever, headache, muscle pain, joint pain, tiredness)

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    End point title
    		 Percentage of participants reporting each solicited systemic event (fever, headache, muscle pain, joint pain, tiredness)
    End point description
    Assessed solicited systemic events were arthralgia, fatigue, headache, myalgia and fever [temperature equal to or above (>=) 38 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade or relation to study intervention. Analysis was based on the Exposed Set (ES), which included all participants who received the study intervention and had data for solicited administration site events analysis at the assessed timeframe.
    End point type
    Secondary
    End point timeframe
    During the 4-day follow up period after vaccination (vaccine or placebo administered on Day 1)
    End point values
    		 Adults HA-RSV Group Adults HA-Placebo Group Adults AIR-RSV Group Adults AIR-Placebo Group OA-RSV Group
    Number of subjects analysed
    377
    191
    379
    190
    379
    Units: Percentage of participants
    number (confidence interval 95%)
        Arthralgia
    26.0 (21.6 to 30.7)
    5.8 (2.9 to 10.1)
    20.8 (16.9 to 25.3)
    10.0 (6.1 to 15.2)
    12.9 (9.7 to 16.7)
        Fatigue
    44.0 (39.0 to 49.2)
    17.3 (12.2 to 23.4)
    36.1 (31.3 to 41.2)
    19.5 (14.1 to 25.8)
    24.0 (19.8 to 28.6)
        Headache
    35.8 (31.0 to 40.9)
    16.8 (11.8 to 22.8)
    27.7 (23.3 to 32.5)
    17.4 (12.3 to 23.5)
    21.1 (17.1 to 25.6)
        Myalgia
    39.3 (34.3 to 44.4)
    5.8 (2.9 to 10.1)
    32.5 (27.8 to 37.4)
    14.2 (9.6 to 20.0)
    21.4 (17.4 to 25.8)
        Fever
    3.7 (2.0 to 6.2)
    1.0 (0.1 to 3.7)
    2.6 (1.3 to 4.8)
    1.1 (0.1 to 3.8)
    1.6 (0.6 to 3.4)
    No statistical analyses for this end point

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

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    End point title
    		 Percentage of participants reporting any unsolicited adverse events (AEs)
    End point description
    Unsolicited AEs are defined as 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 will be reported as an unsolicited adverse event. Analysis was based on the Exposed Set (ES), which included all participants who received the study intervention and had data for assessed timeframe and unsolicited events analysis.
    End point type
    Secondary
    End point timeframe
    During the 30-day follow up period after vaccination (vaccine or placebo administered on Day 1)
    End point values
    		 Adults HA-RSV Group Adults HA-Placebo Group Adults AIR-RSV Group Adults AIR-Placebo Group OA-RSV Group
    Number of subjects analysed
    383
    192
    386
    191
    381
    Units: Percentage of participants
        number (confidence interval 95%)
    13.6 (10.3 to 17.4)
    13.5 (9.0 to 19.2)
    15.3 (11.8 to 19.3)
    10.5 (6.5 to 15.7)
    16.3 (12.7 to 20.4)
    No statistical analyses for this end point

    Secondary: Percentage of participants reporting any serious adverse events (SAEs) within 6 months of vaccination

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    End point title
    		 Percentage of participants reporting any serious adverse events (SAEs) within 6 months of vaccination
    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, or results in an abnormal pregnancy outcome. Analysis was based on the ES, which included all participants who received the study intervention. Analysis per group is based on the administered intervention.
    End point type
    Secondary
    End point timeframe
    From the day of the vaccination up to 6 months after vaccination (vaccine or placebo administered on Day 1)
    End point values
    		 Adults HA-RSV Group Adults HA-Placebo Group Adults AIR-RSV Group Adults AIR-Placebo Group OA-RSV Group
    Number of subjects analysed
    383
    192
    386
    191
    381
    Units: Percentage of participants
        number (confidence interval 95%)
    0.8 (0.2 to 2.3)
    2.1 (0.6 to 5.2)
    3.9 (2.2 to 6.3)
    2.1 (0.6 to 5.3)
    2.4 (1.1 to 4.4)
    No statistical analyses for this end point

    Secondary: Percentage of participants reporting any onset potential immune mediated diseases (pIMDs) within 6 months of vaccination

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    End point title
    		 Percentage of participants reporting any onset potential immune mediated diseases (pIMDs) within 6 months of vaccination
    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. Analysis was based on the ES, which included all participants who received the study intervention. Analysis per group is based on the administered intervention.
    End point type
    Secondary
    End point timeframe
    From the day of the vaccination up to 6 months after vaccination (vaccine or placebo administered on Day 1)
    End point values
    		 Adults HA-RSV Group Adults HA-Placebo Group Adults AIR-RSV Group Adults AIR-Placebo Group OA-RSV Group
    Number of subjects analysed
    383
    192
    386
    191
    381
    Units: Percentage of participants
        number (confidence interval 95%)
    0 (0 to 1.0)
    0 (0 to 1.9)
    1.0 (0.3 to 2.6)
    0.5 (0.0 to 2.9)
    0.8 (0.2 to 2.3)
    No statistical analyses for this end point

    Secondary: Percentage of participants reporting SAEs related to study intervention administration within 12 months of vaccination

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    End point title
    		 Percentage of participants reporting SAEs related to study intervention administration within 12 months of vaccination
    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, or results in an abnormal pregnancy outcome. Analysis was based on the ES, which included all participants who received the study intervention. Analysis per group is based on the administered intervention.
    End point type
    Secondary
    End point timeframe
    From the day of the vaccination up to 12 months after vaccination (vaccine or placebo administered on Day 1)
    End point values
    		 Adults HA-RSV Group Adults HA-Placebo Group Adults AIR-RSV Group Adults AIR-Placebo Group OA-RSV Group
    Number of subjects analysed
    383
    192
    386
    191
    381
    Units: Percentage of participants
        number (confidence interval 95%)
    0 (0 to 1.0)
    0 (0 to 1.9)
    0 (0 to 1.0)
    0 (0.0 to 1.9)
    0.3 (0.0 to 1.5)
    No statistical analyses for this end point

    Secondary: Percentage of participants reporting pIMDs related to study intervention administration within 12 months of vaccination

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    End point title
    		 Percentage of participants reporting pIMDs related to study intervention administration within 12 months of vaccination
    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. Analysis was based on the ES, which included all participants who received the study intervention. Analysis per group is based on the administered intervention.
    End point type
    Secondary
    End point timeframe
    From the day of the vaccination up to 12 months after vaccination (vaccine or placebo administered on Day 1)
    End point values
    		 Adults HA-RSV Group Adults HA-Placebo Group Adults AIR-RSV Group Adults AIR-Placebo Group OA-RSV Group
    Number of subjects analysed
    383
    192
    386
    191
    381
    Units: Percentage of participants
        number (confidence interval 95%)
    0 (0 to 1.0)
    0 (0 to 1.9)
    0 (0 to 1.0)
    0 (0.0 to 1.9)
    0.3 (0.0 to 1.5)
    No statistical analyses for this end point

    Secondary: Percentage of participants reporting any fatal SAEs

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    End point title
    		 Percentage of participants reporting any fatal 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, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, or results in an abnormal pregnancy outcome. Analysis was based on the ES, which included all participants who received the study intervention. Analysis per group is based on the administered intervention.
    End point type
    Secondary
    End point timeframe
    From the day of the vaccination up to 12 months after vaccination (vaccine or placebo administered on Day 1)
    End point values
    		 Adults HA-RSV Group Adults HA-Placebo Group Adults AIR-RSV Group Adults AIR-Placebo Group OA-RSV Group
    Number of subjects analysed
    383
    192
    386
    191
    381
    Units: Percentage of participants
        number (confidence interval 95%)
    0 (0 to 1.0)
    0 (0 to 1.9)
    1.0 (0.3 to 2.6)
    0.5 (0.0 to 2.9)
    0 (0 to 1.0)
    No statistical analyses for this end point

    Secondary: RSV-A neutralization titers expressed as GMT, up to one month post-intervention

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    End point title
    		 RSV-A neutralization titers expressed as GMT, up to one month post-intervention
    End point description
    Serological assays for the determination of antibodies against RSV-A are performed by neutralization assay. The corresponding antibody titers were expressed in ED60. Unadjusted GMTs were provided for Adult HA-RSV, Adults HA-Placebo, Adult AIR-RSV, Adult AIR-Placebo and OA-RSV groups. Analysis was performed on PPS for humoral analysis. Only those participants with data available at the time of the analysis were reported in this outcome measure.
    End point type
    Secondary
    End point timeframe
    At pre-study intervention administration (Day 1) and 1 month after study intervention administration (Day 31)
    End point values
    		 Adults HA-RSV Group Adults HA-Placebo Group Adults AIR-RSV Group Adults AIR-Placebo Group OA-RSV Group
    Number of subjects analysed
    347
    181
    364
    186
    364
    Units: Titer
    geometric mean (confidence interval 95%)
        Day 1
    768.8 (704.7 to 838.9)
    772.0 (677.9 to 879.1)
    779.5 (725.5 to 837.6)
    729.8 (648.6 to 821.0)
    775.7 (709.9 to 847.5)
        Day 31
    7925.4 (7125.6 to 8815.0)
    796.9 (696.4 to 912.0)
    8804.1 (7953.3 to 9746.0)
    774.7 (683.0 to 878.6)
    7498.8 (6759.5 to 8319.1)
    No statistical analyses for this end point

    Secondary: RSV-A neutralization titers expressed as GMT at Month 6 and Month 12 post-intervention

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    End point title
    		 RSV-A neutralization titers expressed as GMT at Month 6 and Month 12 post-intervention
    End point description
    Serological assays for the determination of antibodies against RSV-A are performed by neutralization assay. The corresponding antibody titers were expressed in ED60. Unadjusted GMTs were provided for Adult HA-RSV, Adults HA-Placebo, Adult AIR-RSV, Adult AIR-Placebo and OA-RSV groups. Analysis was performed on PPS for humoral analysis. Only those participants with data available at the time of the analysis were reported in this outcome measure.
    End point type
    Secondary
    End point timeframe
    At 6 months and at 12 months after study intervention administration
    End point values
    		 Adults HA-RSV Group Adults HA-Placebo Group Adults AIR-RSV Group Adults AIR-Placebo Group OA-RSV Group
    Number of subjects analysed
    317
    171
    345
    178
    355
    Units: Titer
    geometric mean (confidence interval 95%)
        Month 6
    3850.7 (3448.6 to 4299.7)
    849.6 (748.9 to 963.9)
    3980.6 (3608.6 to 4391.1)
    854.2 (756.2 to 965.0)
    3846.3 (3469.7 to 4263.7)
        Month 12
    3192.9 (2855.1 to 3570.7)
    965.1 (846.8 to 1099.9)
    3075.1 (2772.2 to 3411.0)
    971.8 (864.6 to 1092.4)
    3080.4 (2764.8 to 3432.0)
    No statistical analyses for this end point

    Secondary: RSV-B neutralization titers expressed as GMT, up to one month post-intervention

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    End point title
    		 RSV-B neutralization titers expressed as GMT, up to one month post-intervention
    End point description
    Serological assays for the determination of antibodies against RSV-B are performed by neutralization assay. The corresponding antibody titers were expressed in ED60. Unadjusted GMTs were provided for Adult HA-RSV, Adults HA-Placebo, Adult AIR-RSV, Adult AIR-Placebo and OA-RSV groups. Analysis was performed on PPS for humoral analysis. Only those participants with data available at the time of the analysis were reported in this outcome measure.
    End point type
    Secondary
    End point timeframe
    At pre-study intervention administration (Day 1) and 1 month after study intervention administration (Day 31)
    End point values
    		 Adults HA-RSV Group Adults HA-Placebo Group Adults AIR-RSV Group Adults AIR-Placebo Group OA-RSV Group
    Number of subjects analysed
    347
    181
    364
    186
    364
    Units: Titer
    geometric mean (confidence interval 95%)
        Day 1
    1091.1 (1000.3 to 1190.2)
    1197.7 (1055.7 to 1358.8)
    1141.4 (1050.5 to 1240.0)
    1167.2 (1035.0 to 1316.1)
    1109.1 (1020.6 to 1205.3)
        Day 31
    8971.9 (8109.6 to 9925.8)
    1145.3 (1012.4 to 1295.5)
    9943.0 (9035.8 to 10941.4)
    1141.8 (1007.4 to 1294.2)
    8169.3 (7412.6 to 9003.3)
    No statistical analyses for this end point

    Secondary: RSV-B neutralization titers expressed as GMT, at Month 6 and Month 12 post-intervention

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    End point title
    		 RSV-B neutralization titers expressed as GMT, at Month 6 and Month 12 post-intervention
    End point description
    Serological assays for the determination of antibodies against RSV-B are performed by neutralization assay. The corresponding antibody titers were expressed in ED60. Unadjusted GMTs were provided for Adult HA-RSV, Adults HA-Placebo, Adult AIR-RSV, Adult AIR-Placebo and OA-RSV groups. Analysis was performed on PPS for humoral analysis. Only those participants with data available at the time of the analysis were reported in this outcome measure.
    End point type
    Secondary
    End point timeframe
    At 6 months and at 12 months after study intervention administration
    End point values
    		 Adults HA-RSV Group Adults HA-Placebo Group Adults AIR-RSV Group Adults AIR-Placebo Group OA-RSV Group
    Number of subjects analysed
    317
    171
    345
    178
    355
    Units: Titer
    geometric mean (confidence interval 95%)
        Month 6
    3880.7 (3488.4 to 4317.0)
    1003.2 (875.5 to 1149.4)
    4020.8 (3635.9 to 4446.5)
    942.1 (825.4 to 1075.3)
    3710.4 (3361.0 to 4096.1)
        Month 12
    3562.8 (3176.0 to 3996.7)
    1218.6 (1038.8 to 1429.5)
    3669.9 (3287.1 to 4097.3)
    1153.5 (996.6 to 1335.2)
    3527.7 (3177.5 to 3916.4)
    No statistical analyses for this end point

    Secondary: Frequency of RSVPreF3-specific cluster of differentiation (CD)4+ T cells expressing at least 2 activation markers up to one month post-intervention

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    End point title
    		 Frequency of RSVPreF3-specific cluster of differentiation (CD)4+ T cells expressing at least 2 activation markers up to one month post-intervention
    End point description
    Among markers expressed are interleukin-2/13/17 (IL-2, IL-13, IL-17), cluster of 40 ligand (CD40L), 41BB, tumour necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ), in vitro upon stimulation with RSVPreF3 peptide preparations. Analysis was performed on Cell-Mediated immune (CMI) sub-cohort of the PPS,which included all eligible participants who received the study intervention as per protocol,had immunogenicity results pre- and post-dose for RSVPreF3 OA specific CD4+T cells, complied with blood draw intervals,without intercurrent conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination.Only the participants with data available at the time of the analysis were reported.
    End point type
    Secondary
    End point timeframe
    At pre-study intervention administration (Day 1) and 1 month after study intervention administration (Day 31)
    End point values
    		 Adults HA-RSV Group Adults HA-Placebo Group Adults AIR-RSV Group Adults AIR-Placebo Group OA-RSV Group
    Number of subjects analysed
    47
    28
    55
    27
    26
    Units: CD4+ T cells/million cells
    geometric mean (standard deviation)
        Day 1
    102.7 ( 0.9 )
    125.6 ( 0.9 )
    161.5 ( 0.6 )
    114.7 ( 0.9 )
    111.3 ( 0.9 )
        Day 31
    1282.5 ( 0.4 )
    167.7 ( 0.8 )
    1043.6 ( 0.6 )
    131.9 ( 0.8 )
    1016.9 ( 0.8 )
    No statistical analyses for this end point

    Secondary: Frequency of RSVPreF3-specific CD4+ T cells expressing at least 2 activation markers, at Month 6 and Month 12 post-intervention

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    End point title
    		 Frequency of RSVPreF3-specific CD4+ T cells expressing at least 2 activation markers, at Month 6 and Month 12 post-intervention
    End point description
    Among markers expressed are interleukin-2/13/17 (IL-2, IL-13, IL-17), cluster of 40 ligand (CD40L), 41BB, tumour necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ), in vitro upon stimulation with RSVPreF3 peptide preparations. Analysis was performed on Cell-Mediated immune (CMI) sub-cohort of the PPS,which included all eligible participants who received the study intervention as per protocol,had immunogenicity results pre- and post-dose for RSVPreF3 OA specific CD4+T cells, complied with blood draw intervals,without intercurrent conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination.Only the participants with data available at the time of the analysis were reported.
    End point type
    Secondary
    End point timeframe
    At 6 months and at 12 months after study intervention administration
    End point values
    		 Adults HA-RSV Group Adults HA-Placebo Group Adults AIR-RSV Group Adults AIR-Placebo Group OA-RSV Group
    Number of subjects analysed
    58
    36
    56
    27
    31
    Units: CD4+ T cells/million cells
    geometric mean (standard deviation)
        Month 6
    825.6 ( 0.3 )
    140.5 ( 0.8 )
    662.9 ( 0.3 )
    39.2 ( 1.0 )
    763.5 ( 0.5 )
        Month 12
    492.0 ( 0.6 )
    175.8 ( 0.5 )
    335.5 ( 0.7 )
    59.4 ( 1.0 )
    414.1 ( 0.7 )
    No statistical analyses for this end point

    Secondary: Frequency of RSVPreF3-specific CD8+ T cells expressing at least 2 activation markers, up to one month post-intervention

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    End point title
    		 Frequency of RSVPreF3-specific CD8+ T cells expressing at least 2 activation markers, up to one month post-intervention
    End point description
    Among markers expressed are IL-2, IL-13, IL-17, CD40L, 41BB, TNF-α and IFN-γ, in vitro upon stimulation with RSVPreF3 peptide preparations. Analysis was performed on Cell-Mediated immune (CMI) sub-cohort of the PPS,which included all eligible participants who received the study intervention as per protocol,had immunogenicity results pre- and post-dose for RSVPreF3 OA specific CD4+T cells, complied with blood draw intervals,without intercurrent conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination.Only the participants with data available at the time of the analysis were reported.
    End point type
    Secondary
    End point timeframe
    At pre-study intervention administration (Day 1) and 1 month after study intervention administration (Day 31)
    End point values
    		 Adults HA-RSV Group Adults HA-Placebo Group Adults AIR-RSV Group Adults AIR-Placebo Group OA-RSV Group
    Number of subjects analysed
    46
    28
    55
    27
    26
    Units: CD8+ T cells/million cells
    geometric mean (standard deviation)
        Day 1
    10.1 ( 1.1 )
    6.0 ( 0.9 )
    15.5 ( 1.0 )
    10.8 ( 1.1 )
    12.0 ( 1.0 )
        Day 31
    15.2 ( 1.1 )
    11.9 ( 1.1 )
    18.1 ( 1.1 )
    4.8 ( 1.1 )
    12.0 ( 1.2 )
    No statistical analyses for this end point

    Secondary: Frequency of RSVPreF3-specific CD8+ T cells expressing at least 2 activation markers, at Month 6 and Month 12

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    End point title
    		 Frequency of RSVPreF3-specific CD8+ T cells expressing at least 2 activation markers, at Month 6 and Month 12
    End point description
    Among markers expressed are IL-2, IL-13, IL-17, CD40L, 41BB, TNF-α and IFN-γ, in vitro upon stimulation with RSVPreF3 peptide preparations. Analysis was performed on Cell-Mediated immune (CMI) sub-cohort of the PPS,which included all eligible participants who received the study intervention as per protocol,had immunogenicity results pre- and post-dose for RSVPreF3 OA specific CD4+T cells, complied with blood draw intervals,without intercurrent conditions that may interfere with immunogenicity and without prohibited concomitant medication/vaccination.Only the participants with data available at the time of the analysis were reported.
    End point type
    Secondary
    End point timeframe
    At 6 months and at 12 months after study intervention administration
    End point values
    		 Adults HA-RSV Group Adults HA-Placebo Group Adults AIR-RSV Group Adults AIR-Placebo Group OA-RSV Group
    Number of subjects analysed
    58
    36
    56
    27
    31
    Units: CD8+ T cells/million cells
    geometric mean (standard deviation)
        Month 6
    23.1 ( 1.0 )
    12.2 ( 1.1 )
    27.6 ( 1.0 )
    14.0 ( 1.0 )
    14.8 ( 1.1 )
        Month 12
    15.2 ( 1.0 )
    23.0 ( 0.9 )
    16.2 ( 1.0 )
    6.6 ( 1.1 )
    14.9 ( 1.0 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited AEs: from Day 1 up to Day 4 post-dose. Unsolicited AEs: from Day 1 up to Day 30 post-dose. SAEs, pIMDs: from Day 1 up to Month 6 post dose-administration. Related SAEs, related pIMDs, fatal SAEs: from Day 1 up to study end (Month 12).
    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 occurence of each event, as pre-specified in Statistical Analysis Plan.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    27.0
    Reporting groups
    Reporting group title
    Adults HA-Placebo Group
    Reporting group description
    		 Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end.

    Reporting group title
    Adults HA-RSV Group
    Reporting group description
    		 Healthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.

    Reporting group title
    Adults AIR-Placebo Group
    Reporting group description
    		 Adults at increased risk of RSV-LRTD aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end.

    Reporting group title
    OA-RSV Group
    Reporting group description
    		 Older adults aged 60 years old and above received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.

    Reporting group title
    Adults AIR-RSV Group
    Reporting group description
    		 Adults at increased risk of RSV-Lower respiratory tract disease (RSV-LRTD) aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.

    Serious adverse events
    		 Adults HA-Placebo Group Adults HA-RSV Group Adults AIR-Placebo Group OA-RSV Group Adults AIR-RSV Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    4 / 192 (2.08%)
    3 / 383 (0.78%)
    4 / 191 (2.09%)
    9 / 381 (2.36%)
    15 / 386 (3.89%)
         number of deaths (all causes)
    0
    0
    1
    0
    1
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenocarcinoma of colon
         subjects affected / exposed
    0 / 192 (0.00%)
    1 / 383 (0.26%)
    0 / 191 (0.00%)
    1 / 381 (0.26%)
    0 / 386 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Breast cancer
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 383 (0.00%)
    0 / 191 (0.00%)
    0 / 381 (0.00%)
    1 / 386 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Invasive ductal breast carcinoma
         subjects affected / exposed
    1 / 192 (0.52%)
    0 / 383 (0.00%)
    0 / 191 (0.00%)
    0 / 381 (0.00%)
    0 / 386 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Death
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 383 (0.00%)
    1 / 191 (0.52%)
    0 / 381 (0.00%)
    1 / 386 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 383 (0.00%)
    0 / 191 (0.00%)
    0 / 381 (0.00%)
    1 / 386 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 383 (0.00%)
    0 / 191 (0.00%)
    0 / 381 (0.00%)
    2 / 386 (0.52%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute respiratory failure
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 383 (0.00%)
    0 / 191 (0.00%)
    0 / 381 (0.00%)
    1 / 386 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Depression
         subjects affected / exposed
    1 / 192 (0.52%)
    0 / 383 (0.00%)
    0 / 191 (0.00%)
    0 / 381 (0.00%)
    1 / 386 (0.26%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Hip fracture
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 383 (0.00%)
    0 / 191 (0.00%)
    1 / 381 (0.26%)
    0 / 386 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Femur fracture
         subjects affected / exposed
    0 / 192 (0.00%)
    1 / 383 (0.26%)
    0 / 191 (0.00%)
    0 / 381 (0.00%)
    0 / 386 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Alcohol poisoning
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 383 (0.00%)
    0 / 191 (0.00%)
    0 / 381 (0.00%)
    1 / 386 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Kyphosis postoperative
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 383 (0.00%)
    0 / 191 (0.00%)
    1 / 381 (0.26%)
    0 / 386 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Pericarditis
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 383 (0.00%)
    1 / 191 (0.52%)
    0 / 381 (0.00%)
    0 / 386 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    0 / 192 (0.00%)
    1 / 383 (0.26%)
    0 / 191 (0.00%)
    1 / 381 (0.26%)
    0 / 386 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebellar stroke
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 383 (0.00%)
    0 / 191 (0.00%)
    0 / 381 (0.00%)
    1 / 386 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 383 (0.00%)
    0 / 191 (0.00%)
    1 / 381 (0.26%)
    1 / 386 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Cold type haemolytic anaemia
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 383 (0.00%)
    0 / 191 (0.00%)
    1 / 381 (0.26%)
    0 / 386 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Inguinal hernia
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 383 (0.00%)
    0 / 191 (0.00%)
    1 / 381 (0.26%)
    0 / 386 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Non-alcoholic fatty liver
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 383 (0.00%)
    0 / 191 (0.00%)
    0 / 381 (0.00%)
    1 / 386 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Gouty arthritis
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 383 (0.00%)
    0 / 191 (0.00%)
    0 / 381 (0.00%)
    1 / 386 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteoarthritis
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 383 (0.00%)
    0 / 191 (0.00%)
    1 / 381 (0.26%)
    0 / 386 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Abscess oral
         subjects affected / exposed
    1 / 192 (0.52%)
    0 / 383 (0.00%)
    0 / 191 (0.00%)
    0 / 381 (0.00%)
    0 / 386 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Acute sinusitis
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 383 (0.00%)
    0 / 191 (0.00%)
    0 / 381 (0.00%)
    1 / 386 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 383 (0.00%)
    1 / 191 (0.52%)
    0 / 381 (0.00%)
    1 / 386 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    COVID-19
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 383 (0.00%)
    1 / 191 (0.52%)
    0 / 381 (0.00%)
    0 / 386 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 383 (0.00%)
    1 / 191 (0.52%)
    0 / 381 (0.00%)
    0 / 386 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infective exacerbation of chronic obstructive airways disease
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 383 (0.00%)
    0 / 191 (0.00%)
    0 / 381 (0.00%)
    1 / 386 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 383 (0.00%)
    0 / 191 (0.00%)
    2 / 381 (0.52%)
    3 / 386 (0.78%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 2
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Enterococcal bacteraemia
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 383 (0.00%)
    0 / 191 (0.00%)
    0 / 381 (0.00%)
    1 / 386 (0.26%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Obesity
         subjects affected / exposed
    1 / 192 (0.52%)
    0 / 383 (0.00%)
    0 / 191 (0.00%)
    0 / 381 (0.00%)
    1 / 386 (0.26%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Adults HA-Placebo Group Adults HA-RSV Group Adults AIR-Placebo Group OA-RSV Group Adults AIR-RSV Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    76 / 192 (39.58%)
    325 / 383 (84.86%)
    74 / 191 (38.74%)
    279 / 381 (73.23%)
    318 / 386 (82.38%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Uterine leiomyoma
         subjects affected / exposed
    0 / 192 (0.00%)
    1 / 383 (0.26%)
    0 / 191 (0.00%)
    0 / 381 (0.00%)
    0 / 386 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 383 (0.00%)
    0 / 191 (0.00%)
    1 / 381 (0.26%)
    1 / 386 (0.26%)
         occurrences all number
    0
    0
    0
    1
    1
    General disorders and administration site conditions
    Administration site bruise
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 383 (0.00%)
    0 / 191 (0.00%)
    0 / 381 (0.00%)
    1 / 386 (0.26%)
         occurrences all number
    0
    0
    0
    0
    1
    Administration site warmth
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 383 (0.00%)
    0 / 191 (0.00%)
    0 / 381 (0.00%)
    1 / 386 (0.26%)
         occurrences all number
    0
    0
    0
    0
    1
    Asthenia
         subjects affected / exposed
    0 / 192 (0.00%)
    1 / 383 (0.26%)
    0 / 191 (0.00%)
    3 / 381 (0.79%)
    1 / 386 (0.26%)
         occurrences all number
    0
    1
    0
    3
    1
    Influenza like illness
         subjects affected / exposed
    1 / 192 (0.52%)
    1 / 383 (0.26%)
    0 / 191 (0.00%)
    2 / 381 (0.52%)
    0 / 386 (0.00%)
         occurrences all number
    1
    1
    0
    2
    0
    Fatigue
         subjects affected / exposed
    34 / 192 (17.71%)
    166 / 383 (43.34%)
    37 / 191 (19.37%)
    92 / 381 (24.15%)
    136 / 386 (35.23%)
         occurrences all number
    34
    167
    37
    92
    136
    Chills
         subjects affected / exposed
    0 / 192 (0.00%)
    2 / 383 (0.52%)
    0 / 191 (0.00%)
    0 / 381 (0.00%)
    1 / 386 (0.26%)
         occurrences all number
    0
    2
    0
    0
    1
    Chest pain
         subjects affected / exposed
    0 / 192 (0.00%)
    1 / 383 (0.26%)
    0 / 191 (0.00%)
    0 / 381 (0.00%)
    0 / 386 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Injection site pain
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 383 (0.00%)
    0 / 191 (0.00%)
    1 / 381 (0.26%)
    0 / 386 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Injection site induration
         subjects affected / exposed
    0 / 192 (0.00%)
    1 / 383 (0.26%)
    0 / 191 (0.00%)
    0 / 381 (0.00%)
    0 / 386 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Injection site erythema
         subjects affected / exposed
    1 / 192 (0.52%)
    40 / 383 (10.44%)
    1 / 191 (0.52%)
    42 / 381 (11.02%)
    55 / 386 (14.25%)
         occurrences all number
    1
    40
    1
    42
    55
    Injection site bruising
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 383 (0.00%)
    0 / 191 (0.00%)
    1 / 381 (0.26%)
    0 / 386 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Injection site pruritus
         subjects affected / exposed
    0 / 192 (0.00%)
    3 / 383 (0.78%)
    0 / 191 (0.00%)
    0 / 381 (0.00%)
    3 / 386 (0.78%)
         occurrences all number
    0
    3
    0
    0
    3
    Injection site swelling
         subjects affected / exposed
    2 / 192 (1.04%)
    32 / 383 (8.36%)
    1 / 191 (0.52%)
    25 / 381 (6.56%)
    43 / 386 (11.14%)
         occurrences all number
    2
    32
    1
    25
    43
    Peripheral swelling
         subjects affected / exposed
    1 / 192 (0.52%)
    0 / 383 (0.00%)
    0 / 191 (0.00%)
    0 / 381 (0.00%)
    0 / 386 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Pyrexia
         subjects affected / exposed
    2 / 192 (1.04%)
    14 / 383 (3.66%)
    3 / 191 (1.57%)
    7 / 381 (1.84%)
    11 / 386 (2.85%)
         occurrences all number
    2
    14
    3
    7
    11
    Administration site erythema
         subjects affected / exposed
    1 / 192 (0.52%)
    40 / 383 (10.44%)
    1 / 191 (0.52%)
    42 / 381 (11.02%)
    55 / 386 (14.25%)
         occurrences all number
    1
    40
    1
    42
    55
    Administration site pain
         subjects affected / exposed
    20 / 192 (10.42%)
    289 / 383 (75.46%)
    27 / 191 (14.14%)
    232 / 381 (60.89%)
    285 / 386 (73.83%)
         occurrences all number
    20
    289
    27
    232
    285
    Administration site swelling
         subjects affected / exposed
    0 / 192 (0.00%)
    32 / 383 (8.36%)
    0 / 191 (0.00%)
    0 / 381 (0.00%)
    3 / 386 (0.78%)
         occurrences all number
    0
    32
    0
    0
    3
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    1 / 192 (0.52%)
    0 / 383 (0.00%)
    0 / 191 (0.00%)
    0 / 381 (0.00%)
    0 / 386 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Bronchospasm
         subjects affected / exposed
    0 / 192 (0.00%)
    1 / 383 (0.26%)
    0 / 191 (0.00%)
    0 / 381 (0.00%)
    0 / 386 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Asthma
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 383 (0.00%)
    1 / 191 (0.52%)
    1 / 381 (0.26%)
    2 / 386 (0.52%)
         occurrences all number
    0
    0
    1
    1
    2
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 383 (0.00%)
    0 / 191 (0.00%)
    2 / 381 (0.52%)
    0 / 386 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    Cough
         subjects affected / exposed
    0 / 192 (0.00%)
    3 / 383 (0.78%)
    1 / 191 (0.52%)
    2 / 381 (0.52%)
    0 / 386 (0.00%)
         occurrences all number
    0
    3
    1
    2
    0
    Oropharyngeal pain
         subjects affected / exposed
    0 / 192 (0.00%)
    2 / 383 (0.52%)
    2 / 191 (1.05%)
    1 / 381 (0.26%)
    2 / 386 (0.52%)
         occurrences all number
    0
    2
    2
    1
    2
    Epistaxis
         subjects affected / exposed
    0 / 192 (0.00%)
    1 / 383 (0.26%)
    0 / 191 (0.00%)
    0 / 381 (0.00%)
    0 / 386 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Nasal congestion
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 383 (0.00%)
    0 / 191 (0.00%)
    0 / 381 (0.00%)
    1 / 386 (0.26%)
         occurrences all number
    0
    0
    0
    0
    1
    Dyspnoea
         subjects affected / exposed
    1 / 192 (0.52%)
    0 / 383 (0.00%)
    0 / 191 (0.00%)
    1 / 381 (0.26%)
    0 / 386 (0.00%)
         occurrences all number
    1
    0
    0
    1
    0
    Rhinorrhoea
         subjects affected / exposed
    0 / 192 (0.00%)
    3 / 383 (0.78%)
    0 / 191 (0.00%)
    1 / 381 (0.26%)
    0 / 386 (0.00%)
         occurrences all number
    0
    3
    0
    1
    0
    Sinus congestion
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 383 (0.00%)
    0 / 191 (0.00%)
    1 / 381 (0.26%)
    0 / 386 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Throat irritation
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 383 (0.00%)
    0 / 191 (0.00%)
    1 / 381 (0.26%)
    0 / 386 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 192 (0.00%)
    2 / 383 (0.52%)
    0 / 191 (0.00%)
    0 / 381 (0.00%)
    0 / 386 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Insomnia
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 383 (0.00%)
    1 / 191 (0.52%)
    1 / 381 (0.26%)
    1 / 386 (0.26%)
         occurrences all number
    0
    0
    1
    1
    1
    Investigations
    Helicobacter test positive
         subjects affected / exposed
    0 / 192 (0.00%)
    1 / 383 (0.26%)
    0 / 191 (0.00%)
    0 / 381 (0.00%)
    0 / 386 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Blood pressure increased
         subjects affected / exposed
    1 / 192 (0.52%)
    1 / 383 (0.26%)
    0 / 191 (0.00%)
    0 / 381 (0.00%)
    0 / 386 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 383 (0.00%)
    0 / 191 (0.00%)
    0 / 381 (0.00%)
    1 / 386 (0.26%)
         occurrences all number
    0
    0
    0
    0
    1
    Immunisation reaction
         subjects affected / exposed
    0 / 192 (0.00%)
    1 / 383 (0.26%)
    0 / 191 (0.00%)
    0 / 381 (0.00%)
    0 / 386 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Meniscus injury
         subjects affected / exposed
    1 / 192 (0.52%)
    0 / 383 (0.00%)
    0 / 191 (0.00%)
    0 / 381 (0.00%)
    0 / 386 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Post-traumatic pain
         subjects affected / exposed
    0 / 192 (0.00%)
    1 / 383 (0.26%)
    0 / 191 (0.00%)
    0 / 381 (0.00%)
    0 / 386 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Rib fracture
         subjects affected / exposed
    0 / 192 (0.00%)
    1 / 383 (0.26%)
    0 / 191 (0.00%)
    0 / 381 (0.00%)
    0 / 386 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Soft tissue injury
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 383 (0.00%)
    0 / 191 (0.00%)
    1 / 381 (0.26%)
    0 / 386 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Epicondylitis
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 383 (0.00%)
    0 / 191 (0.00%)
    0 / 381 (0.00%)
    1 / 386 (0.26%)
         occurrences all number
    0
    0
    0
    0
    1
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 383 (0.00%)
    0 / 191 (0.00%)
    0 / 381 (0.00%)
    1 / 386 (0.26%)
         occurrences all number
    0
    0
    0
    0
    1
    Cardiac failure
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 383 (0.00%)
    1 / 191 (0.52%)
    0 / 381 (0.00%)
    0 / 386 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Atrial fibrillation
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 383 (0.00%)
    0 / 191 (0.00%)
    1 / 381 (0.26%)
    0 / 386 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Cardiac failure chronic
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 383 (0.00%)
    0 / 191 (0.00%)
    1 / 381 (0.26%)
    0 / 386 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Palpitations
         subjects affected / exposed
    0 / 192 (0.00%)
    1 / 383 (0.26%)
    0 / 191 (0.00%)
    1 / 381 (0.26%)
    2 / 386 (0.52%)
         occurrences all number
    0
    1
    0
    1
    2
    Supraventricular tachycardia
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 383 (0.00%)
    1 / 191 (0.52%)
    0 / 381 (0.00%)
    0 / 386 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 192 (0.52%)
    1 / 383 (0.26%)
    0 / 191 (0.00%)
    0 / 381 (0.00%)
    2 / 386 (0.52%)
         occurrences all number
    1
    2
    0
    0
    2
    Carotid arteriosclerosis
         subjects affected / exposed
    1 / 192 (0.52%)
    0 / 383 (0.00%)
    0 / 191 (0.00%)
    0 / 381 (0.00%)
    0 / 386 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Carpal tunnel syndrome
         subjects affected / exposed
    0 / 192 (0.00%)
    1 / 383 (0.26%)
    0 / 191 (0.00%)
    0 / 381 (0.00%)
    0 / 386 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Headache
         subjects affected / exposed
    34 / 192 (17.71%)
    137 / 383 (35.77%)
    33 / 191 (17.28%)
    81 / 381 (21.26%)
    106 / 386 (27.46%)
         occurrences all number
    35
    139
    34
    81
    106
    Migraine
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 383 (0.00%)
    0 / 191 (0.00%)
    1 / 381 (0.26%)
    0 / 386 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Taste disorder
         subjects affected / exposed
    1 / 192 (0.52%)
    0 / 383 (0.00%)
    0 / 191 (0.00%)
    0 / 381 (0.00%)
    0 / 386 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Sciatica
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 383 (0.00%)
    1 / 191 (0.52%)
    0 / 381 (0.00%)
    0 / 386 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Sinus headache
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 383 (0.00%)
    1 / 191 (0.52%)
    0 / 381 (0.00%)
    0 / 386 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Post herpetic neuralgia
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 383 (0.00%)
    0 / 191 (0.00%)
    1 / 381 (0.26%)
    0 / 386 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Cervicobrachial syndrome
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 383 (0.00%)
    0 / 191 (0.00%)
    0 / 381 (0.00%)
    1 / 386 (0.26%)
         occurrences all number
    0
    0
    0
    0
    1
    Blood and lymphatic system disorders
    Lymphadenitis
         subjects affected / exposed
    0 / 192 (0.00%)
    1 / 383 (0.26%)
    0 / 191 (0.00%)
    0 / 381 (0.00%)
    0 / 386 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Lymphadenopathy
         subjects affected / exposed
    1 / 192 (0.52%)
    3 / 383 (0.78%)
    0 / 191 (0.00%)
    0 / 381 (0.00%)
    0 / 386 (0.00%)
         occurrences all number
    1
    3
    0
    0
    0
    Eye disorders
    Cataract
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 383 (0.00%)
    0 / 191 (0.00%)
    1 / 381 (0.26%)
    0 / 386 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Ocular retrobulbar haemorrhage
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 383 (0.00%)
    0 / 191 (0.00%)
    1 / 381 (0.26%)
    0 / 386 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Vision blurred
         subjects affected / exposed
    0 / 192 (0.00%)
    1 / 383 (0.26%)
    0 / 191 (0.00%)
    0 / 381 (0.00%)
    0 / 386 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Vitreous floaters
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 383 (0.00%)
    0 / 191 (0.00%)
    0 / 381 (0.00%)
    1 / 386 (0.26%)
         occurrences all number
    0
    0
    0
    0
    1
    Diabetic retinopathy
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 383 (0.00%)
    1 / 191 (0.52%)
    0 / 381 (0.00%)
    0 / 386 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Gastrointestinal disorders
    Abdominal pain upper
         subjects affected / exposed
    1 / 192 (0.52%)
    1 / 383 (0.26%)
    0 / 191 (0.00%)
    0 / 381 (0.00%)
    0 / 386 (0.00%)
         occurrences all number
    1
    1
    0
    0
    0
    Abdominal pain
         subjects affected / exposed
    0 / 192 (0.00%)
    2 / 383 (0.52%)
    0 / 191 (0.00%)
    1 / 381 (0.26%)
    0 / 386 (0.00%)
         occurrences all number
    0
    2
    0
    1
    0
    Abdominal wall haematoma
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 383 (0.00%)
    0 / 191 (0.00%)
    0 / 381 (0.00%)
    1 / 386 (0.26%)
         occurrences all number
    0
    0
    0
    0
    1
    Diarrhoea
         subjects affected / exposed
    1 / 192 (0.52%)
    3 / 383 (0.78%)
    2 / 191 (1.05%)
    3 / 381 (0.79%)
    4 / 386 (1.04%)
         occurrences all number
    1
    3
    2
    3
    4
    Dry mouth
         subjects affected / exposed
    0 / 192 (0.00%)
    1 / 383 (0.26%)
    0 / 191 (0.00%)
    0 / 381 (0.00%)
    1 / 386 (0.26%)
         occurrences all number
    0
    1
    0
    0
    1
    Dyspepsia
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 383 (0.00%)
    0 / 191 (0.00%)
    1 / 381 (0.26%)
    0 / 386 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Haemorrhoids
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 383 (0.00%)
    0 / 191 (0.00%)
    1 / 381 (0.26%)
    0 / 386 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Hiatus hernia
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 383 (0.00%)
    0 / 191 (0.00%)
    0 / 381 (0.00%)
    1 / 386 (0.26%)
         occurrences all number
    0
    0
    0
    0
    1
    Inguinal hernia
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 383 (0.00%)
    0 / 191 (0.00%)
    1 / 381 (0.26%)
    0 / 386 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Large intestine polyp
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 383 (0.00%)
    0 / 191 (0.00%)
    1 / 381 (0.26%)
    0 / 386 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Nausea
         subjects affected / exposed
    0 / 192 (0.00%)
    3 / 383 (0.78%)
    0 / 191 (0.00%)
    0 / 381 (0.00%)
    3 / 386 (0.78%)
         occurrences all number
    0
    3
    0
    0
    3
    Poor dental condition
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 383 (0.00%)
    1 / 191 (0.52%)
    0 / 381 (0.00%)
    0 / 386 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Odynophagia
         subjects affected / exposed
    0 / 192 (0.00%)
    1 / 383 (0.26%)
    0 / 191 (0.00%)
    0 / 381 (0.00%)
    0 / 386 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Noninfective sialoadenitis
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 383 (0.00%)
    0 / 191 (0.00%)
    1 / 381 (0.26%)
    0 / 386 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Vomiting
         subjects affected / exposed
    0 / 192 (0.00%)
    1 / 383 (0.26%)
    0 / 191 (0.00%)
    2 / 381 (0.52%)
    2 / 386 (0.52%)
         occurrences all number
    0
    1
    0
    2
    2
    Toothache
         subjects affected / exposed
    1 / 192 (0.52%)
    1 / 383 (0.26%)
    0 / 191 (0.00%)
    1 / 381 (0.26%)
    1 / 386 (0.26%)
         occurrences all number
    1
    1
    0
    1
    1
    Hepatobiliary disorders
    Hepatic fibrosis
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 383 (0.00%)
    0 / 191 (0.00%)
    0 / 381 (0.00%)
    1 / 386 (0.26%)
         occurrences all number
    0
    0
    0
    0
    1
    Hepatic steatosis
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 383 (0.00%)
    0 / 191 (0.00%)
    0 / 381 (0.00%)
    1 / 386 (0.26%)
         occurrences all number
    0
    0
    0
    0
    1
    Skin and subcutaneous tissue disorders
    Dermatitis allergic
         subjects affected / exposed
    0 / 192 (0.00%)
    1 / 383 (0.26%)
    0 / 191 (0.00%)
    0 / 381 (0.00%)
    0 / 386 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Actinic keratosis
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 383 (0.00%)
    0 / 191 (0.00%)
    0 / 381 (0.00%)
    1 / 386 (0.26%)
         occurrences all number
    0
    0
    0
    0
    1
    Dermatitis
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 383 (0.00%)
    0 / 191 (0.00%)
    0 / 381 (0.00%)
    1 / 386 (0.26%)
         occurrences all number
    0
    0
    0
    0
    1
    Dermatitis atopic
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 383 (0.00%)
    0 / 191 (0.00%)
    0 / 381 (0.00%)
    1 / 386 (0.26%)
         occurrences all number
    0
    0
    0
    0
    1
    Dry skin
         subjects affected / exposed
    0 / 192 (0.00%)
    1 / 383 (0.26%)
    1 / 191 (0.52%)
    0 / 381 (0.00%)
    0 / 386 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    Eczema nummular
         subjects affected / exposed
    1 / 192 (0.52%)
    0 / 383 (0.00%)
    0 / 191 (0.00%)
    0 / 381 (0.00%)
    0 / 386 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Rash
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 383 (0.00%)
    0 / 191 (0.00%)
    0 / 381 (0.00%)
    1 / 386 (0.26%)
         occurrences all number
    0
    0
    0
    0
    1
    Macule
         subjects affected / exposed
    0 / 192 (0.00%)
    1 / 383 (0.26%)
    0 / 191 (0.00%)
    0 / 381 (0.00%)
    0 / 386 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Psoriasis
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 383 (0.00%)
    0 / 191 (0.00%)
    1 / 381 (0.26%)
    0 / 386 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Erythema
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 383 (0.00%)
    0 / 191 (0.00%)
    1 / 381 (0.26%)
    0 / 386 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Skin lesion
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 383 (0.00%)
    0 / 191 (0.00%)
    0 / 381 (0.00%)
    1 / 386 (0.26%)
         occurrences all number
    0
    0
    0
    0
    1
    Urticaria
         subjects affected / exposed
    1 / 192 (0.52%)
    0 / 383 (0.00%)
    0 / 191 (0.00%)
    0 / 381 (0.00%)
    1 / 386 (0.26%)
         occurrences all number
    1
    0
    0
    0
    1
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 383 (0.00%)
    0 / 191 (0.00%)
    1 / 381 (0.26%)
    0 / 386 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Dysuria
         subjects affected / exposed
    1 / 192 (0.52%)
    0 / 383 (0.00%)
    0 / 191 (0.00%)
    0 / 381 (0.00%)
    0 / 386 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    12 / 192 (6.25%)
    101 / 383 (26.37%)
    19 / 191 (9.95%)
    50 / 381 (13.12%)
    80 / 386 (20.73%)
         occurrences all number
    12
    102
    19
    51
    81
    Muscle spasms
         subjects affected / exposed
    0 / 192 (0.00%)
    2 / 383 (0.52%)
    0 / 191 (0.00%)
    0 / 381 (0.00%)
    1 / 386 (0.26%)
         occurrences all number
    0
    2
    0
    0
    1
    Joint swelling
         subjects affected / exposed
    0 / 192 (0.00%)
    1 / 383 (0.26%)
    0 / 191 (0.00%)
    0 / 381 (0.00%)
    0 / 386 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Muscle contracture
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 383 (0.00%)
    0 / 191 (0.00%)
    0 / 381 (0.00%)
    1 / 386 (0.26%)
         occurrences all number
    0
    0
    0
    0
    1
    Back pain
         subjects affected / exposed
    1 / 192 (0.52%)
    4 / 383 (1.04%)
    0 / 191 (0.00%)
    3 / 381 (0.79%)
    1 / 386 (0.26%)
         occurrences all number
    1
    4
    0
    3
    1
    Musculoskeletal chest pain
         subjects affected / exposed
    0 / 192 (0.00%)
    1 / 383 (0.26%)
    0 / 191 (0.00%)
    0 / 381 (0.00%)
    0 / 386 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Myalgia
         subjects affected / exposed
    12 / 192 (6.25%)
    149 / 383 (38.90%)
    27 / 191 (14.14%)
    83 / 381 (21.78%)
    123 / 386 (31.87%)
         occurrences all number
    13
    150
    27
    84
    123
    Rotator cuff syndrome
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 383 (0.00%)
    1 / 191 (0.52%)
    0 / 381 (0.00%)
    0 / 386 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Tendon pain
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 383 (0.00%)
    0 / 191 (0.00%)
    0 / 381 (0.00%)
    1 / 386 (0.26%)
         occurrences all number
    0
    0
    0
    0
    1
    Infections and infestations
    Chronic sinusitis
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 383 (0.00%)
    0 / 191 (0.00%)
    2 / 381 (0.52%)
    0 / 386 (0.00%)
         occurrences all number
    0
    0
    0
    2
    0
    COVID-19
         subjects affected / exposed
    1 / 192 (0.52%)
    2 / 383 (0.52%)
    1 / 191 (0.52%)
    5 / 381 (1.31%)
    1 / 386 (0.26%)
         occurrences all number
    1
    2
    1
    5
    1
    Bronchitis
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 383 (0.00%)
    1 / 191 (0.52%)
    2 / 381 (0.52%)
    1 / 386 (0.26%)
         occurrences all number
    0
    0
    1
    2
    1
    Conjunctivitis
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 383 (0.00%)
    1 / 191 (0.52%)
    0 / 381 (0.00%)
    0 / 386 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Ear infection
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 383 (0.00%)
    1 / 191 (0.52%)
    1 / 381 (0.26%)
    0 / 386 (0.00%)
         occurrences all number
    0
    0
    1
    1
    0
    Gastrointestinal viral infection
         subjects affected / exposed
    1 / 192 (0.52%)
    0 / 383 (0.00%)
    0 / 191 (0.00%)
    0 / 381 (0.00%)
    0 / 386 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Herpes simplex
         subjects affected / exposed
    0 / 192 (0.00%)
    1 / 383 (0.26%)
    0 / 191 (0.00%)
    0 / 381 (0.00%)
    0 / 386 (0.00%)
         occurrences all number
    0
    2
    0
    0
    0
    Influenza
         subjects affected / exposed
    0 / 192 (0.00%)
    1 / 383 (0.26%)
    0 / 191 (0.00%)
    2 / 381 (0.52%)
    0 / 386 (0.00%)
         occurrences all number
    0
    1
    0
    2
    0
    Labyrinthitis
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 383 (0.00%)
    0 / 191 (0.00%)
    1 / 381 (0.26%)
    0 / 386 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Laryngitis
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 383 (0.00%)
    0 / 191 (0.00%)
    0 / 381 (0.00%)
    1 / 386 (0.26%)
         occurrences all number
    0
    0
    0
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    3 / 192 (1.56%)
    5 / 383 (1.31%)
    0 / 191 (0.00%)
    5 / 381 (1.31%)
    7 / 386 (1.81%)
         occurrences all number
    3
    5
    0
    5
    7
    Otitis media
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 383 (0.00%)
    0 / 191 (0.00%)
    1 / 381 (0.26%)
    0 / 386 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Oral herpes
         subjects affected / exposed
    0 / 192 (0.00%)
    1 / 383 (0.26%)
    0 / 191 (0.00%)
    0 / 381 (0.00%)
    1 / 386 (0.26%)
         occurrences all number
    0
    1
    0
    0
    1
    Pharyngitis streptococcal
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 383 (0.00%)
    0 / 191 (0.00%)
    0 / 381 (0.00%)
    1 / 386 (0.26%)
         occurrences all number
    0
    0
    0
    0
    1
    Respiratory tract infection
         subjects affected / exposed
    1 / 192 (0.52%)
    0 / 383 (0.00%)
    0 / 191 (0.00%)
    0 / 381 (0.00%)
    0 / 386 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Pharyngitis
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 383 (0.00%)
    0 / 191 (0.00%)
    0 / 381 (0.00%)
    1 / 386 (0.26%)
         occurrences all number
    0
    0
    0
    0
    1
    Respiratory tract infection viral
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 383 (0.00%)
    0 / 191 (0.00%)
    1 / 381 (0.26%)
    0 / 386 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Rhinitis
         subjects affected / exposed
    1 / 192 (0.52%)
    0 / 383 (0.00%)
    0 / 191 (0.00%)
    0 / 381 (0.00%)
    0 / 386 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Sinusitis
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 383 (0.00%)
    0 / 191 (0.00%)
    1 / 381 (0.26%)
    3 / 386 (0.78%)
         occurrences all number
    0
    0
    0
    1
    3
    Suspected COVID-19
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 383 (0.00%)
    0 / 191 (0.00%)
    1 / 381 (0.26%)
    0 / 386 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Tooth infection
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 383 (0.00%)
    1 / 191 (0.52%)
    0 / 381 (0.00%)
    0 / 386 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 192 (0.00%)
    2 / 383 (0.52%)
    2 / 191 (1.05%)
    5 / 381 (1.31%)
    3 / 386 (0.78%)
         occurrences all number
    0
    2
    2
    5
    3
    Urinary tract infection
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 383 (0.00%)
    0 / 191 (0.00%)
    1 / 381 (0.26%)
    0 / 386 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Viral infection
         subjects affected / exposed
    2 / 192 (1.04%)
    1 / 383 (0.26%)
    1 / 191 (0.52%)
    0 / 381 (0.00%)
    0 / 386 (0.00%)
         occurrences all number
    2
    2
    1
    0
    0
    Viral upper respiratory tract infection
         subjects affected / exposed
    1 / 192 (0.52%)
    2 / 383 (0.52%)
    0 / 191 (0.00%)
    0 / 381 (0.00%)
    0 / 386 (0.00%)
         occurrences all number
    1
    2
    0
    0
    0
    Hordeolum
         subjects affected / exposed
    0 / 192 (0.00%)
    1 / 383 (0.26%)
    0 / 191 (0.00%)
    0 / 381 (0.00%)
    0 / 386 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Candida infection
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 383 (0.00%)
    0 / 191 (0.00%)
    0 / 381 (0.00%)
    1 / 386 (0.26%)
         occurrences all number
    0
    0
    0
    0
    1
    Metabolism and nutrition disorders
    Dyslipidaemia
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 383 (0.00%)
    0 / 191 (0.00%)
    1 / 381 (0.26%)
    0 / 386 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Electrolyte imbalance
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 383 (0.00%)
    0 / 191 (0.00%)
    1 / 381 (0.26%)
    0 / 386 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Diabetes mellitus inadequate control
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 383 (0.00%)
    0 / 191 (0.00%)
    0 / 381 (0.00%)
    1 / 386 (0.26%)
         occurrences all number
    0
    0
    0
    0
    1
    Gout
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 383 (0.00%)
    0 / 191 (0.00%)
    0 / 381 (0.00%)
    1 / 386 (0.26%)
         occurrences all number
    0
    0
    0
    0
    1
    Hyperglycaemia
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 383 (0.00%)
    0 / 191 (0.00%)
    0 / 381 (0.00%)
    1 / 386 (0.26%)
         occurrences all number
    0
    0
    0
    0
    1
    Type 2 diabetes mellitus
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 383 (0.00%)
    0 / 191 (0.00%)
    0 / 381 (0.00%)
    2 / 386 (0.52%)
         occurrences all number
    0
    0
    0
    0
    2
    Hypokalaemia
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 383 (0.00%)
    0 / 191 (0.00%)
    1 / 381 (0.26%)
    0 / 386 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Impaired fasting glucose
         subjects affected / exposed
    1 / 192 (0.52%)
    0 / 383 (0.00%)
    0 / 191 (0.00%)
    0 / 381 (0.00%)
    0 / 386 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Hyperphagia
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 383 (0.00%)
    0 / 191 (0.00%)
    1 / 381 (0.26%)
    0 / 386 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Vitamin B12 deficiency
         subjects affected / exposed
    0 / 192 (0.00%)
    0 / 383 (0.00%)
    0 / 191 (0.00%)
    0 / 381 (0.00%)
    1 / 386 (0.26%)
         occurrences all number
    0
    0
    0
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    25 May 2023
    The purpose of this amendment was to record events of atrial fibrillation (AF) as Adverse Events of Special Interest (AESIs).

    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
    For support, Contact us.
    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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