Extension Study to Evaluate the Safety and Immunogenicity... | NCT04657198

ID	Type	Description	Link
2020-000692-21	EudraCT Number

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group High Dose_Adjuvanted	Experimental	Participants in one of the high dose adjuvanted groups in part B of the parent study RSV OA=ADJ-002: Group High Dose Adjuvanted will receive one revaccination dose of the RSVPreF3 OA investigational vaccine in the current study by intramuscular (IM) injection in the non-dominant arm.	Biological: RSVPreF3 OA investigational vaccine (GSK3844766A)
Group Medium Dose_Adjuvanted	Experimental	Participants in one of the medium dose adjuvanted groups in part B of the parent study RSV OA=ADJ-002: Group Medium Dose Adjuvanted will receive one revaccination dose of the RSVPreF3 OA investigational vaccine in the current study by IM injection in the non-dominant arm.	Biological: RSVPreF3 OA investigational vaccine (GSK3844766A)
Group Low Dose_Adjuvanted	Experimental	Participants in one of the low dose adjuvanted groups in part B of the parent study RSV OA=ADJ-002: Group Low Dose Adjuvanted will receive one revaccination dose of the RSVPreF3 OA investigational vaccine in the current study by IM injection in the non-dominant arm.	Biological: RSVPreF3 OA investigational vaccine (GSK3844766A)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
RSVPreF3 OA investigational vaccine (GSK3844766A)	Biological	RSVPreF3 OA 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).

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Any Solicited Administration Site Adverse Events (AEs)	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).	During the 4-day follow-up period post-vaccination (i.e. on the day of vaccination [Day 1] and 3 subsequent days)
Number of Participants With Any Solicited Systemic AEs	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.	During the 4-day follow-up period post-vaccination (i.e. on the day of vaccination [Day 1] and 3 subsequent days)
Number of Participants With Any Unsolicited AEs	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.	During the 30-day follow-up period post-vaccination (i.e., on the day of vaccination [Day 1] and 29 subsequent days)
Number of Participants With Any Serious Adverse Events (SAEs) up to 30 Days Post-vaccination	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.	From Day 1 up to 30 days post-vaccination (Day 31)
Number of Participants With Any Potential Immune-mediated Diseases (pIMDs) up to 30 Days Post-vaccination

Secondary Outcomes

Measure	Description	Time Frame
Humoral Immune Response in Terms of RSVPreF3-specific Immunoglobulin G (IgG) Antibody Concentrations	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).

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female participants, who received 2 doses of RSVPreF3 OA investigational vaccine and formulations with matched adjuvant in part B of the parent study RSV OA=ADJ-002: recombinant RSVPreF3 antigen doses of low, medium and high strengths with adjuvant.
Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for the follow-up visit, be available for contact)
Written informed consent obtained from the participant prior to performance of any study specific procedure.

Exclusion Criteria:

Medical conditions

Significant underlying illness or administered therapy that in the opinion of the investigator would be expected to prevent participation in the study.
Any confirmed or suspected immunosuppressive or immunodeficient condition based on information on concomitant medication/vaccination collected prior to the study start and physical examination.
Serious or unstable chronic illness that developed during or after the parent study. Patients with chronic stable medical conditions with or without specific treatment, such as diabetes, hypertension or cardiac disease, are allowed to participate in this study if considered by the investigator as clinically stable.
Recurrent or un-controlled neurological disorders or seizures that developed during or after the parent study. Participants with medically-controlled active or chronic neurological diseases can be enrolled in the study as per investigator assessment, provided that their condition will allow them to comply with the requirements of the protocol.
Significant underlying illness that developed during or after the parent study, that in the opinion of the investigator would be expected to prevent completion of the study.
Lymphoproliferative disorder and malignancy developed during or after the parent study.
Any medical condition that developed during or after the parent study, that in the judgment of the investigator would make intramuscular injection unsafe.
Previous vaccination with RSV vaccine, other than the one in the parent study.

Prior/Concomitant therapy

Use of any investigational or non-registered product (drug, vaccine or medical device) other than the study vaccine during the period beginning 30 days before the dose of study vaccine, or planned use during the study period.
Planned or actual administration of a vaccine not foreseen by the study protocol in the period starting 30 days before and ending 30 days after the dose of study vaccine administration, with the exception of inactivated, split virion and subunit influenza vaccines which can be administered up to 14 days before or from 30 days after the study vaccination.
Administration of long-acting immune-modifying drugs or planned administration at any time during the study period.
Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 90 days before the dose of study vaccine or planned administration during the study period.
Chronic administration (defined as more than 14 consecutive days in total) of immunosuppressants or other immune-modifying drugs during the period starting 90 days prior to the vaccine dose or planned administration during the study period. For corticosteroids, this will mean prednisone ≥20 mg/day, or equivalent. Inhaled and topical steroids are allowed.
Confirmed use or anticipated use of immunosuppressive/cytotoxic therapy.

Prior/Concurrent clinical study experience

• Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational vaccine/product.

Other exclusions

Bedridden participants.
Planned move to a location that will prohibit participating in the trial.
History of chronic alcohol consumption and/or drug abuse that developed during or after the parent study as deemed by the investigator to render the potential participant unable/unlikely to provide accurate safety reports or comply with study procedures.

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Lenexa	Kansas	66219	United States
GSK Investigational Site

PubMed Identifier	Type	Citation	Retractions
37699064	Derived	Leroux-Roels I, Van Ranst M, Vandermeulen C, Abeele CV, De Schrevel N, Salaun B, Verheust C, David MP, Kotb S, Hulstrom V. Safety and Immunogenicity of a Revaccination With a Respiratory Syncytial Virus Prefusion F Vaccine in Older Adults: A Phase 2b Study. J Infect Dis. 2024 Feb 14;229(2):355-366. doi: 10.1093/infdis/jiad321.

ID	Title	Description
FG000	High Dose_AS01E Group	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.
FG001

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Nov 4, 2020	Jun 2, 2022

ID	Title	Description
BG000	High Dose_AS01E Group	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.
BG001	Low Dose_AS01E Group	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.
BG002	Medium Dose_AS01E Group	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.
BG003	Total	Total of all reporting groups

Units	Counts
Participants	BG00040 BG00139 BG00243 BG003122

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants With Any Solicited Administration Site Adverse Events (AEs)

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.

Posted

Count of Participants

Participants

During the 4-day follow-up period post-vaccination (i.e. on the day of vaccination [Day 1] and 3 subsequent days)

ID	Title	Description
OG000	High Dose_AS01E Group	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.
OG001	Low Dose_AS01E Group	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.
OG002	Medium Dose_AS01E Group	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.

Units	Counts
Participants	OG00040 OG00139 OG00243

Title

Denominators

Categories

Any erythema

Title	Measurements
	OG0001 OG0016 OG0025

Any pain

Primary

Number of Participants With Any Solicited Systemic AEs

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.

Posted

Count of Participants

Participants

During the 4-day follow-up period post-vaccination (i.e. on the day of vaccination [Day 1] and 3 subsequent days)

ID	Title	Description
OG000	High Dose_AS01E Group	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.
OG001	Low Dose_AS01E Group	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.
OG002	Medium Dose_AS01E Group

Primary

Number of Participants With Any Unsolicited AEs

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.

Posted

Count of Participants

Participants

During the 30-day follow-up period post-vaccination (i.e., on the day of vaccination [Day 1] and 29 subsequent days)

ID	Title	Description
OG000	High Dose_AS01E Group	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.
OG001	Low Dose_AS01E Group	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.
OG002	Medium Dose_AS01E Group

Primary

Number of Participants With Any Serious Adverse Events (SAEs) up to 30 Days Post-vaccination

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.

Posted

Count of Participants

Participants

From Day 1 up to 30 days post-vaccination (Day 31)

ID	Title	Description
OG000	High Dose_AS01E Group	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.
OG001	Low Dose_AS01E Group	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.
OG002	Medium Dose_AS01E Group

Primary

Number of Participants With Any Potential Immune-mediated Diseases (pIMDs) up to 30 Days Post-vaccination

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.

Posted

Count of Participants

Participants

From Day 1 up to 30 days post-vaccination (Day 31)

ID	Title	Description
OG000	High Dose_AS01E Group	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.
OG001	Low Dose_AS01E Group	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.
OG002	Medium Dose_AS01E Group

Primary

Humoral Immune Response in Terms of Neutralizing Antibody Titers Against Respiratory Syncytial Virus (RSV)-Serotype A

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).

Posted

Geometric Mean

95% Confidence Interval

Titers

At 30 days post-vaccination (Day 31)

ID	Title	Description
OG000	High Dose_AS01E Group	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.

Units	Counts
Participants	OG000

Primary

Humoral Immune Response in Terms of Neutralizing Antibody Titers Against RSV-serotype B

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.

Posted

Geometric Mean

95% Confidence Interval

Titers

At 30 days post-vaccination (Day 31)

ID	Title	Description
OG000	High Dose_AS01E Group	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.

Units	Counts
Participants	OG000

Secondary

Humoral Immune Response in Terms of RSVPreF3-specific Immunoglobulin G (IgG) Antibody Concentrations

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).

Posted

Geometric Mean

95% Confidence Interval

ELU/mL

At 30 days post-vaccination (Day 31)

ID	Title	Description
OG000	High Dose_AS01E Group	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.

Units	Counts
Participants	OG000

Secondary

Frequency of RSVPreF3-specific Cluster of Differentiation 4+ (CD4+) T-cells Identified as Expressing at Least Two Markers

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.

Posted

Median

Inter-Quartile Range

cells per million CD4+ T Cells

At 30 days post-vaccination (Day 31)

ID	Title	Description
OG000	High Dose_AS01E Group	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.

Units	Counts
Participants	OG000

Secondary

Number of Participants With Any SAEs, up the End of Follow-up Study Period (Month 6)

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.

Posted

Count of Participants

Participants

From Day 1 up to the end of follow-up period (Month 6)

ID	Title	Description
OG000	High Dose_AS01E Group	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.
OG001	Low Dose_AS01E Group	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.
OG002	Medium Dose_AS01E Group	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.

Secondary

Number of Participants Reporting pIMDs up to the End of Follow-up Study Period (Month 6)

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.

Posted

Count of Participants

Participants

From Day 1 up to the end of follow-up period (Month 6)

ID	Title	Description
OG000	High Dose_AS01E Group	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.
OG001	Low Dose_AS01E Group	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.
OG002	Medium Dose_AS01E Group	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.

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Injection site pain	General disorders	MedDRA 24.0	Systematic Assessment	EG00021 events21 affected40 at risk EG00123 events23 affected39 at risk EG00226 events26 affected43 at risk
Injection site erythema	General disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected40 at risk EG0016 events6 affected39 at risk EG0025 events5 affected43 at risk
Injection site swelling	General disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected40 at risk EG0012 events2 affected39 at risk EG0024 events4 affected43 at risk
Pyrexia	General disorders	MedDRA 24.0	Systematic Assessment	EG0002 events1 affected40 at risk EG0011 events1 affected39 at risk EG0024 events4 affected43 at risk
Fatigue	General disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected40 at risk EG0011 events1 affected39 at risk EG0023 events3 affected43 at risk
Chills	General disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected40 at risk EG0012 events2 affected39 at risk EG0022 events2 affected43 at risk
Influenza like illness	General disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected40 at risk EG0012 events2 affected39 at risk EG0022 events2 affected43 at risk
Malaise	General disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected40 at risk EG0012 events2 affected39 at risk EG0021 events1 affected43 at risk
Axillary pain	General disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected40 at risk EG0011 events1 affected39 at risk EG0020 events0 affected43 at risk
Chest pain	General disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected40 at risk EG0011 events1 affected39 at risk EG0020 events0 affected43 at risk
Injection site warmth	General disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected40 at risk EG0011 events1 affected39 at risk EG0020 events0 affected43 at risk
Oedema peripheral	General disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected40 at risk EG0011 events1 affected39 at risk EG0020 events0 affected43 at risk
Headache	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected40 at risk EG0015 events4 affected39 at risk EG0021 events1 affected43 at risk
Dizziness	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected40 at risk EG0011 events1 affected39 at risk EG0020 events0 affected43 at risk
Paraesthesia	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected40 at risk EG0011 events1 affected39 at risk EG0020 events0 affected43 at risk
Oral herpes	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected40 at risk EG0010 events0 affected39 at risk EG0021 events1 affected43 at risk
Nasopharyngitis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected40 at risk EG0010 events0 affected39 at risk EG0020 events0 affected43 at risk
Sinusitis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected40 at risk EG0010 events0 affected39 at risk EG0020 events0 affected43 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected40 at risk EG0010 events0 affected39 at risk EG0020 events0 affected43 at risk
COVID-19	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected39 at risk EG0021 events1 affected43 at risk
Rhinitis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected39 at risk EG0021 events1 affected43 at risk
Increased upper airway secretion	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected40 at risk EG0011 events1 affected39 at risk EG0020 events0 affected43 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected40 at risk EG0010 events0 affected39 at risk EG0020 events0 affected43 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected40 at risk EG0010 events0 affected39 at risk EG0020 events0 affected43 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected40 at risk EG0011 events1 affected39 at risk EG0020 events0 affected43 at risk
Nausea	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected40 at risk EG0011 events1 affected39 at risk EG0020 events0 affected43 at risk
Glossitis	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected39 at risk EG0021 events1 affected43 at risk
Sebaceous adenitis	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected40 at risk EG0011 events1 affected39 at risk EG0020 events0 affected43 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected40 at risk EG0010 events0 affected39 at risk EG0020 events0 affected43 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected39 at risk EG0021 events1 affected43 at risk
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected40 at risk EG0010 events0 affected39 at risk EG0020 events0 affected43 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected39 at risk EG0021 events1 affected43 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected39 at risk EG0021 events1 affected43 at risk
High density lipoprotein decreased	Investigations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected40 at risk EG0011 events1 affected39 at risk EG0020 events0 affected43 at risk
Transferrin saturation decreased	Investigations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected40 at risk EG0011 events1 affected39 at risk EG0020 events0 affected43 at risk
Peripheral coldness	Vascular disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected39 at risk EG0021 events1 affected43 at risk

ID	Term
D018186	Pneumovirus Infections
D018184	Paramyxoviridae Infections
D018701	Mononegavirales Infections
D012327	RNA Virus Infections
D014777	Virus Diseases
D007239	Infections

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	High Dose_AS01E Group	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.	40	1	40	22	40
EG001	Low Dose_AS01E Group	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.	39	1	39	25	39
EG002	Medium Dose_AS01E Group	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.	43	2	43	29	43

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diverticulitis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected40 at risk EG0011 events1 affected39 at risk EG0020 events0 affected43 at risk
Limb traumatic amputation	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected39 at risk EG0021 events1 affected43 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected40 at risk EG0010 events0 affected39 at risk EG0020 events0 affected43 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected40 at risk EG0010 events0 affected39 at risk EG0021 events1 affected43 at risk