Extension Study to Evaluate the Safety and Immunogenicity of a Revaccination Dose of the RSVPreF3 OA Investigational Vaccine in Adults 60 Years and Older Who Participated in the RSV OA=ADJ-002 Study

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04657198
• Collaborator: (none)
• Enrollment: 126
• Locations: 10
• Arms: 3
• Actual Duration (Months): 10.5
• Patients Per Site: 12.6
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

Nine different formulations of the RSVPreF3 OA investigational vaccine were tested in the parent study (NCT03814590). Based on safety and immunogenicity data from the parent study, RSVPreF3 OA investigational vaccine will be evaluated in further clinical research. Participants in selected groups will be invited to participate in this extension study. All participants who will be enrolled in the current extension study will receive the RSV investigational vaccine approximately 18 months after they received their respective dose-2 in the parent study.

Condition or Disease	Intervention/Treatment	Phase
Respiratory Syncytial Virus Infections	Biological: RSVPreF3 OA investigational vaccine (GSK3844766A)	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 126 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Masking Description: This is an open-label study, as all participants will receive the same RSVPreF3 OA investigational vaccine. No blind is used. Both the investigator and the participant know the identity of the intervention assigned.
• Primary Purpose: Prevention
• Official Title: 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
• Actual Study Start Date: Dec 9, 2020
• Actual Primary Completion Date: Jun 3, 2021
• Actual Study Completion Date: Oct 25, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group High Dose_Adjuvanted 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); 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).
Experimental: Group Medium Dose_Adjuvanted 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); 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).
Experimental: Group Low Dose_Adjuvanted 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); 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).

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Any Solicited Administration Site Adverse Events (AEs) [During the 4-day follow-up period post-vaccination (i.e. on the day of vaccination [Day 1] and 3 subsequent days)]

   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).

2. Number of Participants With Any Solicited Systemic AEs [During the 4-day follow-up period post-vaccination (i.e. on the day of vaccination [Day 1] and 3 subsequent days)]

   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.

3. Number of Participants With Any Unsolicited AEs [During the 30-day follow-up period post-vaccination (i.e., on the day of vaccination [Day 1] and 29 subsequent days)]

   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.

4. Number of Participants With Any Serious Adverse Events (SAEs) up to 30 Days Post-vaccination [From Day 1 up to 30 days post-vaccination (Day 31)]

   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.

5. Number of Participants With Any Potential Immune-mediated Diseases (pIMDs) up to 30 Days Post-vaccination [From Day 1 up to 30 days post-vaccination (Day 31)]

   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.

6. Humoral Immune Response in Terms of Neutralizing Antibody Titers Against Respiratory Syncytial Virus (RSV)-Serotype A [At 30 days post-vaccination (Day 31)]

   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).

7. Humoral Immune Response in Terms of Neutralizing Antibody Titers Against RSV-serotype B [At 30 days post-vaccination (Day 31)]

   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.

Secondary Outcome Measures

1. Humoral Immune Response in Terms of RSVPreF3-specific Immunoglobulin G (IgG) Antibody Concentrations [At 30 days post-vaccination (Day 31)]

   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).

2. Frequency of RSVPreF3-specific Cluster of Differentiation 4+ (CD4+) T-cells Identified as Expressing at Least Two Markers [At 30 days post-vaccination (Day 31)]

   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.

3. Number of Participants With Any SAEs, up the End of Follow-up Study Period (Month 6) [From Day 1 up to the end of follow-up 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.

4. Number of Participants Reporting pIMDs up to the End of Follow-up Study Period (Month 6) [From Day 1 up to the end of follow-up 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Lenexa	Kansas	United States	66219
2	GSK Investigational Site	Elkridge	Maryland	United States	21075
3	GSK Investigational Site	Omaha	Nebraska	United States	68134
4	GSK Investigational Site	Rochester	New York	United States	14609
5	GSK Investigational Site	Hickory	North Carolina	United States	28601
6	GSK Investigational Site	Mount Pleasant	South Carolina	United States	29464
7	GSK Investigational Site	San Antonio	Texas	United States	78229
8	GSK Investigational Site	Gent		Belgium	9000
9	GSK Investigational Site	Leuven		Belgium	3000
10	GSK Investigational Site	Wilrijk		Belgium	2610

Sponsors and Collaborators

• GlaxoSmithKline

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Nov 4, 2020
• Statistical Analysis Plan - Jul 15, 2021

More Information

Publications

None provided.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT04657198
• Other Study ID Numbers: 213569; 2020-000692-21
• First Posted: Dec 8, 2020
• Last Update Posted: Jun 29, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by GlaxoSmithKline: Respiratory syncytial virus; Vaccine; Safety; Immunogenicity
• Additional relevant MeSH terms: Respiratory Syncytial Virus Infections

Study Results

Participant Flow

Recruitment Details	From a total of 126 participants enrolled in this study, 4 participants were withdrawn before vaccination. 122 participants received the study vaccination.

Arm/Group Title	High Dose_AS01E Group	Low Dose_AS01E Group	Medium Dose_AS01E Group
Arm/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.	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.	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.
Period Title: Overall Study
STARTED	40	39	43
COMPLETED	39	39	43
NOT COMPLETED	1	0	0

Baseline Characteristics

Arm/Group Title	High Dose_AS01E Group	Low Dose_AS01E Group	Medium Dose_AS01E Group	Total
Arm/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.	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.	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.	Total of all reporting groups
Overall Participants	40	39	43	122
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	68.3 (5.4)	69.1 (5.3)	66.6 (5.6)	68.0 (5.5)
Sex: Female, Male (Count of Participants)
Female	27 67.5%	21 53.8%	24 55.8%	72 59%
Male	13 32.5%	18 46.2%	19 44.2%	50 41%
Race/Ethnicity, Customized (Count of Participants)
American Indian Or Alaska Native	1 2.5%	0 0%	0 0%	1 0.8%
Black Or African American	1 2.5%	2 5.1%	1 2.3%	4 3.3%
White	38 95%	37 94.9%	42 97.7%	117 95.9%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Any Solicited Administration Site Adverse Events (AEs)
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).
Time Frame	During the 4-day follow-up period post-vaccination (i.e. on the day of vaccination [Day 1] and 3 subsequent days)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Exposed Set that included all participants who received the study intervention dose.

Arm/Group Title	High Dose_AS01E Group	Low Dose_AS01E Group	Medium Dose_AS01E Group
Arm/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.	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.	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.
Measure Participants	40	39	43
Any erythema	1 2.5%	6 15.4%	5 11.6%
Any pain	21 52.5%	23 59%	26 60.5%
Any swelling	0 0%	2 5.1%	4 9.3%

2. Primary Outcome

Title	Number of Participants With Any Solicited Systemic AEs
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.
Time Frame	During the 4-day follow-up period post-vaccination (i.e. on the day of vaccination [Day 1] and 3 subsequent days)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Exposed Set that included all participants who received the study intervention dose.

Arm/Group Title	High Dose_AS01E Group	Low Dose_AS01E Group	Medium Dose_AS01E Group
Arm/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.	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.	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.
Measure Participants	40	39	43
Count of Participants [Participants]	1 2.5%	1 2.6%	4 9.3%

3. Primary Outcome

Title	Number of Participants With Any Unsolicited AEs
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.
Time Frame	During the 30-day follow-up period post-vaccination (i.e., on the day of vaccination [Day 1] and 29 subsequent days)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Exposed Set that included all participants who received the study intervention dose.

Arm/Group Title	High Dose_AS01E Group	Low Dose_AS01E Group	Medium Dose_AS01E Group
Arm/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.	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.	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.
Measure Participants	40	39	43
Count of Participants [Participants]	5 12.5%	11 28.2%	12 27.9%

4. Primary Outcome

Title	Number of Participants With Any Serious Adverse Events (SAEs) up to 30 Days Post-vaccination
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.
Time Frame	From Day 1 up to 30 days post-vaccination (Day 31)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Exposed Set that included all participants who received the study intervention dose.

Arm/Group Title	High Dose_AS01E Group	Low Dose_AS01E Group	Medium Dose_AS01E Group
Arm/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.	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.	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.
Measure Participants	40	39	43
Count of Participants [Participants]	0 0%	0 0%	0 0%

5. Primary Outcome

Title	Number of Participants With Any Potential Immune-mediated Diseases (pIMDs) up to 30 Days Post-vaccination
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.
Time Frame	From Day 1 up to 30 days post-vaccination (Day 31)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Exposed Set that included all participants who received the study intervention dose.

Arm/Group Title	High Dose_AS01E Group	Low Dose_AS01E Group	Medium Dose_AS01E Group
Arm/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.	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.	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.
Measure Participants	40	39	43
Count of Participants [Participants]	0 0%	0 0%	0 0%

6. Primary Outcome

Title	Humoral Immune Response in Terms of Neutralizing Antibody Titers Against Respiratory Syncytial Virus (RSV)-Serotype A
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).
Time Frame	At 30 days post-vaccination (Day 31)

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title	High Dose_AS01E Group
Arm/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.
Measure Participants	34
Geometric Mean (95% Confidence Interval) [Titers]	4394.9

7. Primary Outcome

Title	Humoral Immune Response in Terms of Neutralizing Antibody Titers Against RSV-serotype B
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.
Time Frame	At 30 days post-vaccination (Day 31)

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title	High Dose_AS01E Group
Arm/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.
Measure Participants	34
Geometric Mean (95% Confidence Interval) [Titers]	6094.3

8. Secondary Outcome

Title	Humoral Immune Response in Terms of RSVPreF3-specific Immunoglobulin G (IgG) Antibody Concentrations
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).
Time Frame	At 30 days post-vaccination (Day 31)

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title	High Dose_AS01E Group
Arm/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.
Measure Participants	34
Geometric Mean (95% Confidence Interval) [ELU/mL]	46276.5

9. Secondary Outcome

Title	Frequency of RSVPreF3-specific Cluster of Differentiation 4+ (CD4+) T-cells Identified as Expressing at Least Two Markers
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.
Time Frame	At 30 days post-vaccination (Day 31)

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title	High Dose_AS01E Group
Arm/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.
Measure Participants	31
Median (Inter-Quartile Range) [cells per million CD4+ T Cells]	1601

10. Secondary Outcome

Title	Number of Participants With Any SAEs, up the End of Follow-up Study Period (Month 6)
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.
Time Frame	From Day 1 up to the end of follow-up period (Month 6)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Exposed Set that included all participants who received the study intervention dose.

Arm/Group Title	High Dose_AS01E Group	Low Dose_AS01E Group	Medium Dose_AS01E Group
Arm/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.	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.	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.
Measure Participants	40	39	43
Count of Participants [Participants]	1 2.5%	1 2.6%	2 4.7%

11. Secondary Outcome

Title	Number of Participants Reporting pIMDs up to the End of Follow-up Study Period (Month 6)
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.
Time Frame	From Day 1 up to the end of follow-up period (Month 6)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Exposed Set that included all participants who received the study intervention dose.

Arm/Group Title	High Dose_AS01E Group	Low Dose_AS01E Group	Medium Dose_AS01E Group
Arm/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.	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.	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.
Measure Participants	40	39	43
Count of Participants [Participants]	0 0%	0 0%	0 0%

Adverse Events

Time Frame	Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Month 6).
Arm/Group Title	High Dose_AS01E Group		Low Dose_AS01E Group		Medium Dose_AS01E Group
Arm/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.		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.		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.
All Cause Mortality
	High Dose_AS01E Group		Low Dose_AS01E Group		Medium Dose_AS01E Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/40 (0%)		0/39 (0%)		0/43 (0%)
Serious Adverse Events
	High Dose_AS01E Group		Low Dose_AS01E Group		Medium Dose_AS01E Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/40 (2.5%)		1/39 (2.6%)		2/43 (4.7%)
Infections and infestations
Diverticulitis	0/40 (0%)	0	1/39 (2.6%)	1	0/43 (0%)	0
Injury, poisoning and procedural complications
Limb traumatic amputation	0/40 (0%)	0	0/39 (0%)	0	1/43 (2.3%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer	1/40 (2.5%)	1	0/39 (0%)	0	0/43 (0%)	0
Reproductive system and breast disorders
Benign prostatic hyperplasia	0/40 (0%)	0	0/39 (0%)	0	1/43 (2.3%)	1
Other (Not Including Serious) Adverse Events
	High Dose_AS01E Group		Low Dose_AS01E Group		Medium Dose_AS01E Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	22/40 (55%)		25/39 (64.1%)		29/43 (67.4%)
Gastrointestinal disorders
Diarrhoea	0/40 (0%)	0	1/39 (2.6%)	1	0/43 (0%)	0
Nausea	0/40 (0%)	0	1/39 (2.6%)	1	0/43 (0%)	0
Glossitis	0/40 (0%)	0	0/39 (0%)	0	1/43 (2.3%)	1
General disorders
Injection site pain	21/40 (52.5%)	21	23/39 (59%)	23	26/43 (60.5%)	26
Injection site erythema	1/40 (2.5%)	1	6/39 (15.4%)	6	5/43 (11.6%)	5
Injection site swelling	0/40 (0%)	0	2/39 (5.1%)	2	4/43 (9.3%)	4
Pyrexia	1/40 (2.5%)	2	1/39 (2.6%)	1	4/43 (9.3%)	4
Fatigue	1/40 (2.5%)	1	1/39 (2.6%)	1	3/43 (7%)	3
Chills	0/40 (0%)	0	2/39 (5.1%)	2	2/43 (4.7%)	2
Influenza like illness	0/40 (0%)	0	2/39 (5.1%)	2	2/43 (4.7%)	2
Malaise	0/40 (0%)	0	2/39 (5.1%)	2	1/43 (2.3%)	1
Axillary pain	0/40 (0%)	0	1/39 (2.6%)	1	0/43 (0%)	0
Chest pain	0/40 (0%)	0	1/39 (2.6%)	1	0/43 (0%)	0
Injection site warmth	0/40 (0%)	0	1/39 (2.6%)	1	0/43 (0%)	0
Oedema peripheral	0/40 (0%)	0	1/39 (2.6%)	1	0/43 (0%)	0
Infections and infestations
Oral herpes	1/40 (2.5%)	1	0/39 (0%)	0	1/43 (2.3%)	1
Nasopharyngitis	1/40 (2.5%)	1	0/39 (0%)	0	0/43 (0%)	0
Sinusitis	1/40 (2.5%)	1	0/39 (0%)	0	0/43 (0%)	0
Upper respiratory tract infection	1/40 (2.5%)	1	0/39 (0%)	0	0/43 (0%)	0
COVID-19	0/40 (0%)	0	0/39 (0%)	0	1/43 (2.3%)	1
Rhinitis	0/40 (0%)	0	0/39 (0%)	0	1/43 (2.3%)	1
Investigations
High density lipoprotein decreased	0/40 (0%)	0	1/39 (2.6%)	1	0/43 (0%)	0
Transferrin saturation decreased	0/40 (0%)	0	1/39 (2.6%)	1	0/43 (0%)	0
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration	1/40 (2.5%)	1	0/39 (0%)	0	0/43 (0%)	0
Arthralgia	0/40 (0%)	0	0/39 (0%)	0	1/43 (2.3%)	1
Myalgia	0/40 (0%)	0	0/39 (0%)	0	1/43 (2.3%)	1
Nervous system disorders
Headache	1/40 (2.5%)	1	4/39 (10.3%)	5	1/43 (2.3%)	1
Dizziness	0/40 (0%)	0	1/39 (2.6%)	1	0/43 (0%)	0
Paraesthesia	0/40 (0%)	0	1/39 (2.6%)	1	0/43 (0%)	0
Respiratory, thoracic and mediastinal disorders
Increased upper airway secretion	0/40 (0%)	0	1/39 (2.6%)	1	0/43 (0%)	0
Cough	1/40 (2.5%)	1	0/39 (0%)	0	0/43 (0%)	0
Oropharyngeal pain	1/40 (2.5%)	1	0/39 (0%)	0	0/43 (0%)	0
Skin and subcutaneous tissue disorders
Sebaceous adenitis	0/40 (0%)	0	1/39 (2.6%)	1	0/43 (0%)	0
Pruritus	1/40 (2.5%)	1	0/39 (0%)	0	0/43 (0%)	0
Dry skin	0/40 (0%)	0	0/39 (0%)	0	1/43 (2.3%)	1
Vascular disorders
Peripheral coldness	0/40 (0%)	0	0/39 (0%)	0	1/43 (2.3%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.