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    Clinical Trial Results:
    A phase 2b, open-label, multi-center, extension study to evaluate the safety and immunogenicity of a revaccination dose of the RSVPreF3 older adults (OA) investigational vaccine administered intramuscularly 18 months post-Dose 2 in adults 60 years and older who participated in the RSV OA=ADJ-002 study

    Summary
    EudraCT number
    		 2020-000692-21
    Trial protocol
    		 BE  
    Global end of trial date
    25 Oct 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 Jun 2022
    First version publication date
    18 Jun 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    213569
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04657198
    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, GSKClinicalSupportHD@gsk.com, 044 2089-904466, GSKClinicalSupportHD@gsk.com
    Scientific contact
    GSK Response Center, GlaxoSmithKline, 044 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
    01 Mar 2022
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    25 Oct 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    • To evaluate the safety and reactogenicity following intramuscular (IM) administration of RSVPreF3 OA investigational vaccine up to 1 month post-Dose 3, for all participants. • To evaluate the humoral immune response following IM administration of RSVPreF3 OA investigational vaccine up to 1 month post-Dose 3, for participants vaccinated with 2 doses of RSVPreF3 OA investigational vaccine in the parent study.
    Protection of trial subjects
    The subjects were observed closely for at least 30 minutes following the administration of the vaccines, with appropriate medical treatment readily available in case of anaphylaxis.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    09 Dec 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 66
    Country: Number of subjects enrolled
    United States: 60
    Worldwide total number of subjects
    126
    EEA total number of subjects
    66
    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)
    46
    From 65 to 84 years
    80
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 From a total of 126 participants enrolled in this study, 4 participants were withdrawn before vaccination. 122 participants received the study vaccination.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 High Dose_AS01E Group
    Arm description
    		 Participants received 1 dose of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E in the current study after having received 2 doses of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E in the RSV OA=ADJ-002 (NCT03814590) parent study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    RSVPreF3 OA investigational vaccine (GSK3844766A)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One 0.5 mL dose of investigational vaccine administered intramuscularly in the deltoid region of the non-dominant arm, at Day 1 (18 months post-Dose 2 in the RSV OA=ADJ-002 parent study).

    Arm title
    		 Low Dose_AS01E Group
    Arm description
    		 Participants received 1 dose of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E in the current study after having received 2 doses of the RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01E in the RSV OA=ADJ-002 (NCT03814590) parent study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    RSVPreF3 OA investigational vaccine (GSK3844766A)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One 0.5 mL dose of investigational vaccine administered intramuscularly in the deltoid region of the non-dominant arm, at Day 1 (18 months post-Dose 2 in the RSV OA=ADJ-002 parent study).

    Arm title
    		 Medium Dose_AS01E Group
    Arm description
    		 Participants received 1 dose of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E in the current study after having received 2 doses of the RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01E in the RSV OA=ADJ-002 (NCT03814590) parent study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    RSVPreF3 OA investigational vaccine (GSK3844766A)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Intramuscular use
    Dosage and administration details
    One 0.5 mL dose of investigational vaccine administered intramuscularly in the deltoid region of the non-dominant arm, at Day 1 (18 months post-Dose 2 in the RSV OA=ADJ-002 parent study).

    Number of subjects in period 1 [1]
    		High Dose_AS01E Group Low Dose_AS01E Group Medium Dose_AS01E Group
    Started
    40
    39
    43
    Completed
    39
    39
    43
    Not completed
    1
    0
    0
         CONSENT WITHDRAWAL, NOT DUE TO A (S)AE
    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: From a total of 126 participants enrolled in this study, 4 participants were withdrawn before vaccination. 122 participants received the study vaccination.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    High Dose_AS01E Group
    Reporting group description
    		 Participants received 1 dose of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E in the current study after having received 2 doses of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E in the RSV OA=ADJ-002 (NCT03814590) parent study.

    Reporting group title
    Low Dose_AS01E Group
    Reporting group description
    		 Participants received 1 dose of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E in the current study after having received 2 doses of the RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01E in the RSV OA=ADJ-002 (NCT03814590) parent study.

    Reporting group title
    Medium Dose_AS01E Group
    Reporting group description
    		 Participants received 1 dose of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E in the current study after having received 2 doses of the RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01E in the RSV OA=ADJ-002 (NCT03814590) parent study.

    Reporting group values
    		 High Dose_AS01E Group Low Dose_AS01E Group Medium Dose_AS01E Group Total
    Number of subjects
    		 40 39 43 122
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 68.3 ± 5.4 69.1 ± 5.3 66.6 ± 5.6 -
    Sex: Female, Male
    Units: Participants
        Female
    		 27 21 24 72
        Male
    		 13 18 19 50
    Race/Ethnicity, Customized
    Units: Subjects
        American Indian Or Alaska Native
    		 1 0 0 1
        Black Or African American
    		 1 2 1 4
        White
    		 38 37 42 117

    End points

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    End points reporting groups
    Reporting group title
    High Dose_AS01E Group
    Reporting group description
    		 Participants received 1 dose of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E in the current study after having received 2 doses of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E in the RSV OA=ADJ-002 (NCT03814590) parent study.

    Reporting group title
    Low Dose_AS01E Group
    Reporting group description
    		 Participants received 1 dose of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E in the current study after having received 2 doses of the RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01E in the RSV OA=ADJ-002 (NCT03814590) parent study.

    Reporting group title
    Medium Dose_AS01E Group
    Reporting group description
    		 Participants received 1 dose of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E in the current study after having received 2 doses of the RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01E in the RSV OA=ADJ-002 (NCT03814590) parent study.

    Primary: Number of participants with any solicited administration site adverse events (AEs)

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    End point title
    		 Number of participants with any solicited administration site adverse events (AEs) [1]
    End point description
    Assessed solicited administration site AEs are erythema, pain and swelling. Any pain is defined as any pain regardless of intensity grade. Any injection site erythema/swelling is scored with a diameter larger than (>) 20 millimeters (mm). The analysis was performed on the Exposed Set that included all participants who received the study intervention dose.
    End point type
    Primary
    End point timeframe
    During the 4-day follow-up period post-vaccination (i.e. on the day of vaccination [Day 1] and 3 subsequent days)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this endpoint analysis was descriptive. Therefore, no statistical analyses apply to this endpoint.
    End point values
    		 High Dose_AS01E Group Low Dose_AS01E Group Medium Dose_AS01E Group
    Number of subjects analysed
    40
    39
    43
    Units: Participants
        Any erythema
    1
    6
    5
        Any pain
    21
    23
    26
        Any swelling
    0
    2
    4
    No statistical analyses for this end point

    Primary: Number of participants with any solicited systemic AEs

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    End point title
    		 Number of participants with any solicited systemic AEs [2]
    End point description
    Assessed solicited systemic AE is fever (any temperature greater than or equal to 38.0 °C – the preferred location for measuring temperature being the oral cavity). Any is defined as occurrence of the symptom regardless of intensity grade or relation to study. The analysis was performed on the Exposed Set that included all participants who received the study intervention dose.
    End point type
    Primary
    End point timeframe
    During the 4-day follow-up period post-vaccination (i.e. on the day of vaccination [Day 1] and 3 subsequent days)
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this endpoint analysis was descriptive. Therefore, no statistical analyses apply to this endpoint.
    End point values
    		 High Dose_AS01E Group Low Dose_AS01E Group Medium Dose_AS01E Group
    Number of subjects analysed
    40
    39
    43
    Units: Participants
        Any fever
    1
    1
    4
    No statistical analyses for this end point

    Primary: Number of participants with any unsolicited AEs

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    End point title
    		 Number of participants with any unsolicited AEs [3]
    End point description
    An unsolicited AE is any AE reported in addition to those solicited during the clinical study. Also, any ‘solicited’ symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited AE. Any is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to study vaccination. The analysis was performed on the Exposed Set that included all participants who received the study intervention dose.
    End point type
    Primary
    End point timeframe
    During the 30-day follow-up period post-vaccination (i.e., on the day of vaccination [Day 1] and 29 subsequent days)
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this endpoint analysis was descriptive. Therefore, no statistical analyses apply to this endpoint.
    End point values
    		 High Dose_AS01E Group Low Dose_AS01E Group Medium Dose_AS01E Group
    Number of subjects analysed
    40
    39
    43
    Units: Participants
    5
    11
    12
    No statistical analyses for this end point

    Primary: Number of participants with any Serious Adverse Events (SAEs) up to 30 days post-vaccination

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    End point title
    		 Number of participants with any Serious Adverse Events (SAEs) up to 30 days post-vaccination [4]
    End point description
    An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity. Any is defined as any occurrence of SAE regardless of intensity grade or relation to study vaccination. The analysis was performed on the Exposed Set that included all participants who received the study intervention dose.
    End point type
    Primary
    End point timeframe
    From Day 1 up to 30 days post-vaccination (Day 31)
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this endpoint analysis was descriptive. Therefore, no statistical analyses apply to this endpoint.
    End point values
    		 High Dose_AS01E Group Low Dose_AS01E Group Medium Dose_AS01E Group
    Number of subjects analysed
    40
    39
    43
    Units: Participants
    0
    0
    0
    No statistical analyses for this end point

    Primary: Humoral immune response in terms of neutralizing antibody titers against Respiratory Syncytial Virus (RSV)-serotype A

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    End point title
    		 Humoral immune response in terms of neutralizing antibody titers against Respiratory Syncytial Virus (RSV)-serotype A [5] [6]
    End point description
    Serological assays for the determination of functional antibodies against RSV-A are performed by neutralization assay. Anti RSV-A neutralizing antibody titers are given as Geometric Mean Titers (GMTs) and expressed as Estimated Dose: serum dilution giving a 60% reduction of the signal compared to a control without serum (ED60). The analysis was performed on the Per Protocol Set (that included participants who received the study intervention dose and have post-vaccination data, minus participants with protocol deviations that led to exclusion), for the High Dose_AS01E Group only (as per protocol).
    End point type
    Primary
    End point timeframe
    At 30 days post-vaccination (Day 31)
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this endpoint analysis was descriptive. Therefore, no statistical analyses apply to this endpoint.
    [6] - 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 analysis was performed on the Per Protocol Set, for the High Dose_Adjuvanted Group only, which included participants who received the study intervention dose and have post-vaccination data, minus participants with protocol deviations that led to exclusion.
    End point values
    		 High Dose_AS01E Group
    Number of subjects analysed
    34
    Units: Titers
        geometric mean (confidence interval 95%)
    4394.9 (3191.3 to 6052.5)
    No statistical analyses for this end point

    Primary: Number of participants with any potential immune-mediated diseases (pIMDs) up to 30 days post-vaccination

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    End point title
    		 Number of participants with any potential immune-mediated diseases (pIMDs) up to 30 days post-vaccination [7]
    End point description
    pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology. Any is defined as the occurrence of any pIMD regardless of intensity grade or relation to study vaccination. The analysis was performed on the Exposed Set that included all participants who received the study intervention dose.
    End point type
    Primary
    End point timeframe
    From Day 1 up to 30 days post-vaccination (Day 31)
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this endpoint analysis was descriptive. Therefore, no statistical analyses apply to this endpoint.
    End point values
    		 High Dose_AS01E Group Low Dose_AS01E Group Medium Dose_AS01E Group
    Number of subjects analysed
    40
    39
    43
    Units: Participants
    0
    0
    0
    No statistical analyses for this end point

    Primary: Humoral immune response in terms of neutralizing antibody titers against RSV-serotype B

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    End point title
    		 Humoral immune response in terms of neutralizing antibody titers against RSV-serotype B [8] [9]
    End point description
    Serological assays for the determination of functional antibodies against RSV-B are performed by neutralization assay. Anti RSV-B neutralizing antibody titers are given as GMTs and expressed as ED60. The analysis was performed on the Per Protocol Set (that included participants who received the study intervention dose and have post-vaccination data, minus participants with protocol deviations that led to exclusion), for the High Dose_AS01E Group only (as per protocol).
    End point type
    Primary
    End point timeframe
    At 30 days post-vaccination (Day 31)
    Notes
    [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: The scope of this endpoint analysis was descriptive. Therefore, no statistical analyses apply to this endpoint.
    [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 analysis was performed on the Per Protocol Set, for the High Dose_Adjuvanted Group only, which included participants who received the study intervention dose and have post-vaccination data, minus participants with protocol deviations that led to exclusion.
    End point values
    		 High Dose_AS01E Group
    Number of subjects analysed
    34
    Units: Titers
        geometric mean (confidence interval 95%)
    6094.3 (4476.8 to 8296.4)
    No statistical analyses for this end point

    Secondary: Humoral immune response in terms of RSVPreF3-specific Immunoglobulin G (IgG) antibody concentrations

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    End point title
    		 Humoral immune response in terms of RSVPreF3-specific Immunoglobulin G (IgG) antibody concentrations [10]
    End point description
    The detection and the quantification of total IgG antibodies directed against RSVPreF3 in human serum samples were based on an indirect Enzyme-Linked Immunosorbent Assay (ELISA). Anti RSVPreF3 antibody concentration is given in geometric mean concentration (GMC) and is expressed in ELISA Laboratory Units per milliliter (ELU/mL). The analysis was performed on the Per Protocol Set (that included participants who received the study intervention dose and have post-vaccination data, minus participants with protocol deviations that led to exclusion), for the High Dose_AS01E Group only (as per protocol).
    End point type
    Secondary
    End point timeframe
    At 30 days post-vaccination (Day 31)
    Notes
    [10] - 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 analysis was performed on the Per Protocol Set, for the High Dose_Adjuvanted Group only, which included participants who received the study intervention dose and have post-vaccination data, minus participants with protocol deviations that led to exclusion.
    End point values
    		 High Dose_AS01E Group
    Number of subjects analysed
    34
    Units: ELU/mL
        geometric mean (confidence interval 95%)
    46276.5 (36821.3 to 58159.6)
    No statistical analyses for this end point

    Secondary: Frequency of RSVPreF3-specific cluster of differentiation 4+ (CD4+) T-cells identified as expressing at least two markers

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    End point title
    		 Frequency of RSVPreF3-specific cluster of differentiation 4+ (CD4+) T-cells identified as expressing at least two markers [11]
    End point description
    Among markers expressed are interleukin-2 (IL2), cluster of 40 ligand (CD40L), tumour necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations. The analysis was performed on the Per Protocol Set (that included participants who received the study intervention dose and have post-vaccination data, minus participants with protocol deviations that led to exclusion), for the High Dose_AS01E Group only (as per protocol).
    End point type
    Secondary
    End point timeframe
    At 30 days post-vaccination (Day 31)
    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 analysis was performed on the Per Protocol Set, for the High Dose_Adjuvanted Group only, which included participants who received the study intervention dose and have post-vaccination data, minus participants with protocol deviations that led to exclusion.
    End point values
    		 High Dose_AS01E Group
    Number of subjects analysed
    31
    Units: cells per million CD4+ T Cells
        median (inter-quartile range (Q1-Q3))
    1601 (1174 to 2541)
    No statistical analyses for this end point

    Secondary: Number of participants with any SAEs, up the end of follow-up study period (Month 6)

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    End point title
    		 Number of participants with any SAEs, up the end of follow-up study period (Month 6)
    End point description
    An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity. The analysis was performed on the Exposed Set that included all participants who received the study intervention dose.
    End point type
    Secondary
    End point timeframe
    From Day 1 up to the end of follow-up period (Month 6)
    End point values
    		 High Dose_AS01E Group Low Dose_AS01E Group Medium Dose_AS01E Group
    Number of subjects analysed
    40
    39
    43
    Units: Participants
    1
    1
    2
    No statistical analyses for this end point

    Secondary: Number of participants reporting pIMDs up to the end of follow-up study period (Month 6)

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    End point title
    		 Number of participants reporting pIMDs up to the end of follow-up study period (Month 6)
    End point description
    pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology. The analysis was performed on the Exposed Set that included all participants who received the study intervention dose.
    End point type
    Secondary
    End point timeframe
    From Day 1 up to the end of follow-up period (Month 6)
    End point values
    		 High Dose_AS01E Group Low Dose_AS01E Group Medium Dose_AS01E Group
    Number of subjects analysed
    40
    39
    43
    Units: Participants
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs were collected throughout the study period (from Day 1 to Month 6).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    High Dose_Adjuvanted Group
    Reporting group description
    		 Participants received high formulation dose of RSVPreF3 OA interventional vaccine (adjuvanted with AS01E) after having received 2 adjuvanted AS01E high formulation doses of RSVPreF3 OA interventional vaccine in the RSV OA=ADJ-002 (NCT03814590-EudraCT:2018-000849-38) parent study.

    Reporting group title
    Medium Dose_Adjuvanted Group
    Reporting group description
    		 Participants received high formulation dose of RSVPreF3 OA interventional vaccine (adjuvanted with AS01E) after having received 2 adjuvanted AS01E medium formulation doses of RSVPreF3 OA interventional vaccine in the RSV OA=ADJ-002 (NCT03814590-EudraCT:2018-000849-38) parent study.

    Reporting group title
    Low Dose_Adjuvanted Group
    Reporting group description
    		 Participants received high formulation dose of RSVPreF3 OA interventional vaccine (adjuvanted with AS01E) after having received 2 adjuvanted AS01E low formulation doses of RSVPreF3 OA interventional vaccine in the RSV OA=ADJ-002 (NCT03814590-EudraCT:2018-000849-38) parent study.

    Serious adverse events
    		 High Dose_Adjuvanted Group Medium Dose_Adjuvanted Group Low Dose_Adjuvanted Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 40 (2.50%)
    2 / 43 (4.65%)
    1 / 39 (2.56%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Prostate cancer
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 43 (0.00%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Limb traumatic amputation
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 43 (2.33%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Benign prostatic hyperplasia
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 43 (2.33%)
    0 / 39 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Diverticulitis
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 43 (0.00%)
    1 / 39 (2.56%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 High Dose_Adjuvanted Group Medium Dose_Adjuvanted Group Low Dose_Adjuvanted Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    22 / 40 (55.00%)
    29 / 43 (67.44%)
    25 / 39 (64.10%)
    Investigations
    High density lipoprotein decreased
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 43 (0.00%)
    1 / 39 (2.56%)
         occurrences all number
    0
    0
    1
    Transferrin saturation decreased
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 43 (0.00%)
    1 / 39 (2.56%)
         occurrences all number
    0
    0
    1
    Vascular disorders
    Peripheral coldness
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 43 (2.33%)
    0 / 39 (0.00%)
         occurrences all number
    0
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 40 (2.50%)
    1 / 43 (2.33%)
    4 / 39 (10.26%)
         occurrences all number
    1
    1
    5
    Dizziness
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 43 (0.00%)
    1 / 39 (2.56%)
         occurrences all number
    0
    0
    1
    Paraesthesia
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 43 (0.00%)
    1 / 39 (2.56%)
         occurrences all number
    0
    0
    1
    General disorders and administration site conditions
    Injection site pain
         subjects affected / exposed
    21 / 40 (52.50%)
    26 / 43 (60.47%)
    23 / 39 (58.97%)
         occurrences all number
    21
    26
    23
    Injection site erythema
         subjects affected / exposed
    1 / 40 (2.50%)
    5 / 43 (11.63%)
    6 / 39 (15.38%)
         occurrences all number
    1
    5
    6
    Injection site swelling
         subjects affected / exposed
    0 / 40 (0.00%)
    4 / 43 (9.30%)
    2 / 39 (5.13%)
         occurrences all number
    0
    4
    2
    Pyrexia
         subjects affected / exposed
    1 / 40 (2.50%)
    4 / 43 (9.30%)
    1 / 39 (2.56%)
         occurrences all number
    2
    4
    1
    Fatigue
         subjects affected / exposed
    1 / 40 (2.50%)
    3 / 43 (6.98%)
    1 / 39 (2.56%)
         occurrences all number
    1
    3
    1
    Chills
         subjects affected / exposed
    0 / 40 (0.00%)
    2 / 43 (4.65%)
    2 / 39 (5.13%)
         occurrences all number
    0
    2
    2
    Influenza like illness
         subjects affected / exposed
    0 / 40 (0.00%)
    2 / 43 (4.65%)
    2 / 39 (5.13%)
         occurrences all number
    0
    2
    2
    Malaise
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 43 (2.33%)
    2 / 39 (5.13%)
         occurrences all number
    0
    1
    2
    Axillary pain
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 43 (0.00%)
    1 / 39 (2.56%)
         occurrences all number
    0
    0
    1
    Chest pain
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 43 (0.00%)
    1 / 39 (2.56%)
         occurrences all number
    0
    0
    1
    Injection site warmth
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 43 (0.00%)
    1 / 39 (2.56%)
         occurrences all number
    0
    0
    1
    Oedema peripheral
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 43 (0.00%)
    1 / 39 (2.56%)
         occurrences all number
    0
    0
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 43 (0.00%)
    1 / 39 (2.56%)
         occurrences all number
    0
    0
    1
    Nausea
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 43 (0.00%)
    1 / 39 (2.56%)
         occurrences all number
    0
    0
    1
    Glossitis
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 43 (2.33%)
    0 / 39 (0.00%)
         occurrences all number
    0
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Increased upper airway secretion
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 43 (0.00%)
    1 / 39 (2.56%)
         occurrences all number
    0
    0
    1
    Cough
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 43 (0.00%)
    0 / 39 (0.00%)
         occurrences all number
    1
    0
    0
    Oropharyngeal pain
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 43 (0.00%)
    0 / 39 (0.00%)
         occurrences all number
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Sebaceous adenitis
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 43 (0.00%)
    1 / 39 (2.56%)
         occurrences all number
    0
    0
    1
    Pruritus
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 43 (0.00%)
    0 / 39 (0.00%)
         occurrences all number
    1
    0
    0
    Dry skin
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 43 (2.33%)
    0 / 39 (0.00%)
         occurrences all number
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Intervertebral disc degeneration
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 43 (0.00%)
    0 / 39 (0.00%)
         occurrences all number
    1
    0
    0
    Arthralgia
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 43 (2.33%)
    0 / 39 (0.00%)
         occurrences all number
    0
    1
    0
    Myalgia
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 43 (2.33%)
    0 / 39 (0.00%)
         occurrences all number
    0
    1
    0
    Infections and infestations
    Oral herpes
         subjects affected / exposed
    1 / 40 (2.50%)
    1 / 43 (2.33%)
    0 / 39 (0.00%)
         occurrences all number
    1
    1
    0
    Nasopharyngitis
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 43 (0.00%)
    0 / 39 (0.00%)
         occurrences all number
    1
    0
    0
    Sinusitis
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 43 (0.00%)
    0 / 39 (0.00%)
         occurrences all number
    1
    0
    0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 43 (0.00%)
    0 / 39 (0.00%)
         occurrences all number
    1
    0
    0
    COVID-19
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 43 (2.33%)
    0 / 39 (0.00%)
         occurrences all number
    0
    1
    0
    Rhinitis
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 43 (2.33%)
    0 / 39 (0.00%)
         occurrences all number
    0
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    04 Nov 2020
    The protocol is amended to address the comments from the United States Food and Drug Administration (US FDA). Specifically, instructions to delay enrolment or vaccination of participants with symptoms suggestive of Coronavirus Disease 2019 (COVID-19) infection or with known COVID-19 positive contacts have been updated. In addition, the requirement to obtain written approval from the Sponsor for a participant to receive a vaccine as part of mass vaccination for an unforeseen public health threat (e.g., pandemic) if the vaccine to be used according to the local governmental recommendations has been amended. Other changes have been made to align the protocol with the parent RSV OA=ADJ-002 study and other phase 3 studies in the project.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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