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RSVPreF3 OA investigational vaccine

Phase 3

Respiratory Syncytial Virus Infections | Monoclonal antibody | Respiratory |GSK plc|Last Updated: May 19, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindCONTROLLEDDMCBiomarker
Total Trials12
Total Enrollment13,335
FDA Designations
No designations recorded
Clinical Trials (12)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06614725A Study in India on the Immune Response and Safety of a Respiratory Syncytial Virus (RSV) Older Adults (OA) Vaccine When Given to Older Adults 60 Years of Age and Above and Adults 50-59 Years of Age at Increased Risk (AIR) of Respiratory Syncytial Virus Lower Respiratory Tract Disease (RSV-LRTD)PHASE3 COMPLETED 751Oct 1, 2024Nov 14, 2025Dec 26, 202514 India
NCT06551181A Study on the Immune Response, Safety and the Occurrence of Respiratory Syncytial Virus (RSV)-Associated Respiratory Tract Illness After Administration of RSV OA Vaccine in Adults 60 Years and OlderPHASE3 COMPLETED 2,620Aug 5, 2024Sep 15, 2025May 19, 202640 China, Finland +5
NCT06374394A Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus (RSV) When Given Alone and Together With a COVID-19 mRNA Vaccine in Adults Aged 50 Years and AbovePHASE3 COMPLETED 841Apr 29, 2024Mar 31, 2025Dec 26, 202524 United States, Belgium +2
NCT06389487A Study on the Immune Response and Safety of Vaccine Against Respiratory Syncytial Virus (RSV) Given to Adults 18 to 49 Years of Age at Increased Risk for Respiratory Syncytial Virus Disease, Compared to Older Adults 60 Years of Age and AbovePHASE3 COMPLETED 1,459Apr 29, 2024Mar 18, 2025Sep 25, 202552 United States, Australia +4
NCT05879107Study to Assess the Immune Response, the Safety and the Reactogenicity of Respiratory Syncytial Virus (RSV) Prefusion Protein 3 Older Adult (OA) (RSVPreF3 OA) Investigational Vaccine When co Administered With PCV20 in Older AdultsPHASE3 COMPLETED 1,113May 26, 2023May 7, 2024May 18, 202538 United States, Belgium +2
NCT05590403A Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus Given to Adults 50-59 Years of Age, Including Adults at Increased Risk of Respiratory Syncytial Virus Lower Respiratory Tract Disease, Compared to Older Adults 60 Years of Age and AbovePHASE3 COMPLETED 1,544Oct 28, 2022Feb 12, 2024Mar 6, 2025 -
NCT05559476A Study on the Immune Response and Safety Elicited by a Vaccine Against Respiratory Syncytial Virus (RSV) When Given Alone and Together With a Vaccine Against Influenza in Adults Aged 65 Years and AbovePHASE3 COMPLETED 1,029Oct 20, 2022Aug 15, 2023Sep 24, 202446 United States
NCT05059301A Study of 3 Lots of an Investigational Vaccine Against Respiratory Syncytial Virus (RSV) in Adults Aged 60 Years and AbovePHASE3 COMPLETED 770Oct 1, 2021Jun 30, 2022Feb 15, 202319 United States, Canada +1
NCT04841577A Study on the Immune Response and Safety Elicited by a Vaccine Against Respiratory Syncytial Virus (RSV) When Given Alone and Together With a Vaccine Against Influenza in Adults Aged 60 Years and AbovePHASE3 COMPLETED 976Apr 27, 2021Feb 8, 2022Sep 3, 202414 New Zealand, Panama +1
NCT04732871Immunogenicity, Safety, Reactogenicity and Persistence of an Investigational Respiratory Syncytial Virus (RSV) Vaccine in Adults Aged 60 Years and AbovePHASE3 ACTIVE NOT_RECRUITING 1,720Feb 15, 2021Feb 19, 2027Mar 20, 202645 United States, Finland +3
NCT05921903A Study on the Immune Response and Safety of an RSV Vaccine When Given to Adults 18 Years of Age and Above Who Received Lung or Kidney Transplant and Are at an Increased Risk of Respiratory Syncytial Virus Lower Respiratory Tract Disease and Compared to Healthy Adults 50 Years of Age and AbovePHASE2 COMPLETED 386Jul 28, 2023May 16, 2025May 11, 202646 United States, Australia +6
NCT04657198Extension 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 StudyPHASE2 COMPLETED 126Dec 9, 2020Oct 25, 2021Jun 29, 202210 United States, Belgium
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Study Endpoints
Primary Endpoints
RSV-A neutralizing titers expressed as Geometric Mean Titers (GMTs)
At Day 1 (pre-study intervention administration)

RSV-A neutralizing titers are given as GMTs and are expressed as Estimated Dilution 60 (ED60).

RSV-A neutralizing titers expressed as GMTs
At Day 31 (1 month post-study intervention administration)

RSV-A neutralizing titers are given as GMTs and are expressed as ED60.

RSV-B neutralizing titers expressed as GMTs
At Day 1 (pre-study intervention administration)

RSV-B neutralizing titers are given as GMTs and are expressed as ED60.

RSV-A Neutralizing Titers Expressed as Adjusted Geometric Mean Titers (GMTs) at 1 Month Post RSVPreF3 OA Vaccination
At Day 31

RSV-A neutralizing titers were determined by neutralization assay and the results were expressed as GMTs. Adjusted GMTs are derived using an ANCOVA model on log10-transformed titers for the neutralization assay. The final ANCOVA model includes treatment group as fixed effect, and the pre-dose log10-transformed titers as a covariate.

Percentage of Participants With Seroresponse for RSV-A Neutralizing Titers at 1 Month Post RSVPreF3 OA Vaccination
At Day 31 compared to baseline (Day 1)

Seroresponse was defined as at least a 4 fold (≥4) increase in neutralizing titers (1 month post-study intervention administration over pre-study intervention administration).

RSV-B Neutralizing Titers Expressed as Adjusted GMTs at 1 Month Post RSVPreF3 OA Vaccination
At Day 31

RSV-B neutralizing titers were determined by neutralization assay and the results were expressed as GMTs. Adjusted GMTs are derived using an ANCOVA model on log10-transformed titers for the neutralization assay. The final ANCOVA model includes treatment group as fixed effect, and the pre-dose log10-transformed titers as a covariate.

Percentage of Participants With Seroresponse for RSV-B Neutralizing Titers at 1 Month Post RSVPreF3 OA Vaccination
At Day 31 compared to baseline (Day 1)
Adjusted Geometric Mean Titers (GMT) of Respiratory Syncytial Virus-A (RSV-A) Neutralizing Titers at 1 Month After the RSVPreF3 OA Vaccination
At 1 month post-RSVPreF3 OA vaccine dose administration (at Day 31 for Co-Ad Group and Day 61 for Control Group)

RSV-A neutralizing titers were provided as group GMTs and expressed as estimated dilution 60 (ED60) titers. Adjusted GMTs are derived using an ANCOVA model on log10-transformed titers for the neutralization assay. The final ANCOVA model adjusted for baseline differences (in the pre-dose titers) includes treatment group and age category (age at vaccination: 50-59, 60-69 or ≥70 years) as fixed effects, and the pre-dose log10-transformed titers as a covariate.

Adjusted GMTs of RSV-B Neutralizing Titers at 1 Month After the RSVPreF3 OA Vaccination
At 1 month post-RSVPreF3 OA vaccine dose administration (at Day 31 for Co-Ad Group and Day 61 for Control Group)

RSV-B neutralizing titers were provided as group GMTs and expressed as estimated dilution 60 (ED60) titers. Adjusted GMTs are derived using an ANCOVA model on log10-transformed titers for the neutralization assay. The final ANCOVA model adjusted for baseline differences (in the pre-dose titers) includes treatment group and age category (age at vaccination: 50-59, 60-69 or ≥70 years) as fixed effects, and the pre-dose log10-transformed titers as a covariate.

Adjusted GMTs of SARS-CoV-2 Omicron XBB.1.5 Neutralizing Titers at 1 Month After the COVID-19 mRNA Vaccination
At 1 month post-COVID-19 mRNA vaccine dose administration (at Day 31 for both groups)

SARS-CoV-2 Omicron XBB.1.5 neutralizing titers against the pseudovirus bearing S protein were provided as group GMTs and expressed as titers. The neutralizing titer was calculated as the reciprocal serum dilution corresponding to the 50% signal reduction (NT50). Adjusted GMTs are derived using an ANCOVA model on log10-transformed titers for the neutralization assay. The final ANCOVA model adjusted for baseline differences (in the pre-dose titers) includes treatment group and age category (age at vaccination: 50-59, 60-69 or ≥70 years) as fixed effects, and the pre-dose log10-transformed titers as a covariate.

Part A: RSV-A Neutralizing Titers Expressed as Group Geometric Mean Titers (GMTs)
At Day 31

RSV-A neutralizing titers are given as group GMTs and are expressed as Estimated dilution 60 (ED60)

Part A: Percentage of Participants With Seroresponse Rate (SRR) in RSV-A Neutralizing Titers
Day 31 compared with baseline (Day 1)

SRR is defined as the percentage of participants having a fold increase in neutralizing titers (1 month post-study intervention administration over pre-study intervention administration) ≥4. RSV-A neutralizing titers are expressed as ED60.

Part A: RSV-B Neutralizing Titers Expressed as Group GMTs
At Day 31

RSV-B neutralizing titers are given as group GMTs and are expressed as ED60.

Part A: Percentage of Participants With SRR in RSV-B Neutralizing Titers
Day 31 compared with baseline (Day 1)

SRR is defined as the percentage of participants having a fold increase in neutralizing titers (1-month post-study intervention administration over pre-study intervention administration) ≥ 4. RSV-B neutralizing titers are expressed as ED60.

Adjusted Geometric Mean Titers (GMT) of Opsonophagocytic (OP) Titers at 1 Month After the PCV20 Vaccination
At Day 31

The OP titers were measured with multiplexed opsonophagocytosis assay and the results were expressed as GMT for each of the pneumococcal vaccine serotype.

Adjusted GMTs of Respiratory Syncytial Virus-A (RSV-A) Neutralizing Titers [Estimated Dilution 60 (ED60)] at 1 Month After the RSVPreF3 OA Vaccination
At Day 31 for Co-administration Group and at Day 61 for Control Group

Neutralizing titers were measured with neutralization assay and the results were expressed in ED60.

Adjusted GMTs of RSV-B Neutralizing Titers (ED60) at 1 Month After the RSVPreF3 OA Vaccination
At Day 31 for Co-administration Group and at Day 61 for Control Group

Neutralizing titers were measured with neutralization assay and the results were expressed in ED60.

RSV-A Neutralization Titers Expressed as Group Geometric Mean Titer (GMT) in Healthy Participants Compared to OA-RSV Group
At 1 month after the RSVPreF3 OA vaccine administration (Day 31)

Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay. The corresponding antibody titers were expressed in Estimated Dilution 60 (ED60) and were measured on blood samples collected from vaccinated subjects. The ANCOVA model used to calculate the adjusted GMTs for RSV-A neutralizing antibodies included the baseline value as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included Adult HA-RSV and OA-RSV groups in the model as fixed effect, as specified in Statistical Analysis Plan.

RSV-A Neutralization Titers Expressed as Group Seroresponse Rate (SRR) Difference in Healthy Participants Compared to OA-RSV Group
At 1 month after the RSVPreF3 OA investigational vaccine administration (Day 31) compared to baseline (Day 1)

The SRR is defined as the proportion of participants having a fold increase in neutralization titers (1 month post-study intervention administration over pre-study intervention administration) greater than or equal to 4 (\>=4).

RSV-B Neutralization Titers Expressed as Group GMT in Healthy Participants Compared to OA-RSV Group
At 1 month after the RSVPreF3 OA vaccine administration (Day 31)

Serological assays for the determination of antibodies against RSV-B were performed by neutralization assay. The corresponding antibody titers were expressed in ED60. The ANCOVA model used to calculate the adjusted GMTs for RSV-B neutralizing antibodies included the baseline value as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included Adult HA-RSV and OA-RSV groups in the model as fixed effect, as specified in Statistical Analysis Plan.

RSV-B Neutralization Titers Expressed as Group SRR in Healthy Participants Compared to OA-RSV Group
At 1 month after the RSVPreF3 OA vaccine administration (Day 31) compared to baseline (Day 1)

The SRR is defined as the proportion of participants having a fold increase in neutralization titers (1 month post-study intervention administration over pre-study intervention administration) \>=4.

RSV-A Neutralization Titers Expressed as Group GMT Titer in Participants at Increased Risk of RSV-LRTD (Adults-AIR-RSV Group) Compared to OA-RSV Group
At 1 month after the RSVPreF3 OA investigational vaccine administration (Day 31)

Serological assays for the determination of antibodies against RSV-A are performed by neutralization assay. The corresponding antibody titers were expressed in ED60. The ANCOVA model used to calculate the adjusted GMTs for RSV-A neutralizing antibodies included the baseline value as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included Adult AIR-RSV and OA-RSV groups in the model as fixed effect, as specified in Statistical Analysis Plan.

RSV-A Neutralization Titers Expressed as Group SRR in Participants at Increased Risk of RSV-LRTD (Adults-AIR-RSV Group) Compared to OA-RSV Group
At 1 month after the RSVPreF3 OA vaccine administration (Day 31) compared to baseline (Day 1)

The SRR is defined as the proportion of participants having a fold increase in neutralization titers (1 month post-study intervention administration over pre-study intervention administration) \>=4.

RSV-B Neutralization Titers Expressed as Group GMT in Participants at Increased Risk of RSV-LRTD (Adults-AIR-RSV Group) Compared to OA-RSV Group
At 1 month after the RSVPreF3 OA vaccine administration (Day 31)

Serological assays for the determination of antibodies against RSV-B are performed by neutralization assay. The corresponding antibody titers were expressed in ED60. The ANCOVA model used to calculate the adjusted GMTs for RSV-B neutralizing antibodies included the baseline value as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included Adult AIR-RSV and OA-RSV groups in the model as fixed effect, as specified in Statistical Analysis Plan.

RSV-B Neutralization Titers Expressed as Group SRR in Participants at Increased Risk of RSV-LRTD (Adults-AIR-RSV Group) Compared to OA-RSV Group
At 1 month after the RSVPreF3 OA investigational vaccine administration (Day 31) compared to baseline (Day 1)

The SRR is defined as the proportion of participants having a fold increase in neutralization titers (1 month post-study intervention administration over pre-study intervention administration) \>=4.

RSV-A Neutralizing Titers Expressed as Group Geometric Mean Titers (GMTs)
At 1 month after the RSVPreF3 OA vaccine dose (Day 31 for the Co-Ad Group and Day 61 for the Control Group)

RSV-A neutralizing titers were given as group GMTs and expressed as Estimated Dilution 60 (ED60).

Hemagglutinin Inhibition (HI) Titers for 4 FLU Vaccine Strains Expressed as Group GMTs
At 1 month after the FLU vaccine dose (Day 31 for both groups)

HI titers were assessed against the Flu A/Darwin/6/2021 H3N2, Flu A/Victoria/2570/2019 H1N1, Flu B/Austria/1359417/2021 Victoria, and Flu B/Phuket/3073/2013 Yamagata strains.

RSV-B Neutralizing Titers Expressed as Group GMTs
At 1 month after the RSVPreF3 OA vaccine dose (Day 31 for the Co-Ad Group and Day 61 for the Control Group)

RSV-B neutralizing titers were given as group GMTs and expressed as Estimated Dilution 60 (ED60).

RSVPreF3 Specific Immunoglobin (Ig)G Antibody Concentrations Expressed as Group Geometric Mean Concentration (GMC)
At 30 days post-vaccination (Day 31)

Enzyme-linked immunosorbent assay (ELISA) was used to assess the concentrations of IgG antibodies against RSV PreF3 in serum samples.

RSV-A Neutralization Antibody Titers Expressed as Geometric Mean Titers (GMTs)
At 1 month after the RSV_PreF3 OA investigational vaccine dose (at Day 31 for the Co-Ad Group and at Day 61 for the Control Group)

The serum neutralization assay is a functional assay that measures the ability of serum antibodies to neutralize RSV-A entry and replication in a host cell line. The serum neutralizing antibody titer is expressed in ED60 (Estimated Dilution 60) and corresponds to the inverse of the interpolated serum dilution that yields a 60% reduction of the signal compared to a control without serum.

Hemagglutinin Inhibition (HI) Antibody Titers for Each of the FLU Vaccine Strains Expressed as Group GMTs
1 month after the FLU vaccine dose (at Day 31)

HI antibody titers were assessed for each of the Flu vaccine strains, namely Flu A/Hong Kong/2671/2019 (H3N2), Flu A/Victoria/2570/2019 (H1N1), Flu B/Phuket/3073/2013 (Yamagata) and Flu B/Washington/02/2019 (Victoria). The serum HI antibody titers are expressed in 1/Dilution (DIL) where DIL corresponds to the highest dilution that shows complete HI.

Humoral Immune Response in Terms of Respiratory Syncytial Virus (RSV)-A Neutralizing Antibody Geometric Mean Titers (GMTs) at Day 1
At Day 1

RSV-A neutralizing antibodies were given as GMTs and expressed as Estimated Dose: serum dilution giving a 60% reduction of the RSV plaques compared to a control without serum (ED60).

Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Day 31
At Day 31

RSV-A neutralizing antibodies were given as GMTs and expressed as ED60.

Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Month 6
At Month 6

RSV-A neutralizing antibodies were given as GMTs and expressed as ED60.

Humoral Immune Response in Terms of RSV-A Neutralizing Antibody GMTs at Month 12
At Month 12

RSV-A neutralizing antibodies were given as GMTs and expressed as ED60.

Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Day 1
At Day 1

RSV-B neutralizing antibodies measured as GMTs and expressed as ED60.

Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Day 31
At Day 31

RSV-B neutralizing antibodies measured as GMTs and expressed as ED60.

Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Month 6
At Month 6

RSV-B neutralizing antibodies measured as GMTs and expressed as ED60.

Humoral Immune Response in Terms of RSV-B Neutralizing Antibody Titers at Month 12
At Month 12

RSV-B neutralizing antibodies measured as GMTs and expressed as ED60.

RSV-A Serum Neutralizing Titers Expressed As Mean Geometric Increase (MGI) Post-Dose 2 (Visit 4) Over Post-Dose 1 (Visit 3) for RSV_IC_2 Group
At Visit 4 (Visit 3 + 30-42 days) compared with Visit 3 (Visit 1 [Day 1] + 30-60 days)

MGI was defined as the geometric mean of the within-participant ratios of serum neutralizing titers against RSV-A post-Dose 2 (Visit 4) over post-Dose 1 (Visit 3).

RSV-B Serum Neutralizing Titers Expressed As MGI Post-Dose 2 (Visit 4) Over Post-Dose 1 (Visit 3) for RSV_IC_2 Group
At Visit 4 (Visit 3 + 30-42 days) compared with Visit 3 (Visit 1 [Day 1] + 30-60 days)

MGI was defined as the geometric mean of the within-participant ratios of serum neutralizing titers against RSV-B post-Dose 2 (Visit 4) over post-Dose 1 (Visit 3).

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).

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.

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.

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.

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.

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).

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 Endpoints
Number of participants reporting any solicited administration site events
Day 1 (day of administration) to Day 4
Number of participants reporting any solicited systemic events
Day 1 (day of administration) to Day 4
Number of participants reporting any unsolicited AEs
Day 1 to Day 30
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
OA-RSV groupEXPERIMENTALOlder adult (OA) participants, greater than or equal to (≥) 60 years of age (YOA), received a single dose of RSVPreF3 OA investigational vaccine at Day 1.
OA-Placebo groupPLACEBO_COMPARATOROA participants, ≥ 60 YOA, received a single dose of placebo at Day 1.
Adults-AIR-RSV groupEXPERIMENTALAdult participants, 50-59 YOA, at increased risk (AIR) of Respiratory Syncytial Virus - Lower Respiratory Tract Disease (RSV-LRTD), received a single dose of RSVPreF3 OA investigational vaccine at Day 1.
Adults-AIR-Placebo groupPLACEBO_COMPARATORAdult participants, 50-59 YOA, at increased risk (AIR) of RSV-LRTD, received a single dose of placebo at Day 1.
RSV OA vaccine Group (Overseas)EXPERIMENTALOverseas older adults (OA) participants received a single dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until end of study (Month 6).
RSV OA vaccine Group (China)EXPERIMENTALChinese OA participants received a single dose of RSVPreF3 OA investigational vaccine at Day 1 and were followed up until end of study (Month 6 or last acute respiratory illness (ARI) visit/contact, whichever was later).
Placebo Group (China)EXPERIMENTALChinese OA participants received a single dose of placebo at Day 1 and were followed up until end of study (Month 6 or last ARI visit/contact, whichever was later).
Co-Ad GroupEXPERIMENTALParticipants received a single dose of RSVPreF3 OA vaccine and a single dose of COVID-19 mRNA vaccine at Day 1, in different arms.
Control GroupACTIVE_COMPARATORParticipants received a single dose of COVID-19 mRNA vaccine at Day 1, followed by a single dose of RSVPreF3 OA vaccine at Day 31.
Part A: RSV-A-AIR GroupEXPERIMENTALAdult (A) participants, 18-49 YOA, at increased risk (AIR) for RSV disease, received a single dose of RSVPreF3 OA investigational vaccine at Day 1. Participants in this group were considered for all study analyses, as per protocol.
Part A: RSV-OA GroupACTIVE_COMPARATOROlder adults (OA) participants, ≥60 YOA, received a single dose of RSVPreF3 OA investigational vaccine at Day 1.
Part B: RSV-A-AIR GroupEXPERIMENTALAdult participants, 18-49 YOA, AIR for RSV disease, received a single dose of RSVPreF3 OA investigational vaccine at Day 1. Participants in this group were considered only for Participant flow, Baseline Characteristics and all safety analyses, as per protocol.
Co-administration GroupEXPERIMENTALParticipants received both respiratory syncytial virus prefusion protein 3 older adult (RSVPreF3 OA) vaccine and 20-valent pneumococcal conjugate vaccine (PCV20) on Day 1.
Adults HA-RSV GroupEXPERIMENTALHealthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-Lower respiratory tract disease (RSV-LRTD), aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.
Adults HA-Placebo GroupPLACEBO_COMPARATORHealthy adults or adults with chronic stable conditions with or without treatment that do not lead to an increased risk of RSV-LRTD, aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end.
Adults AIR-RSV GroupEXPERIMENTALAdults at increased risk of RSV-Lower respiratory tract disease (RSV-LRTD) aged 50-59 years old received 1 dose of RSVPreF3 OA vaccine at Day 1 and were followed until study end.
Adults AIR-Placebo GroupPLACEBO_COMPARATORAdults at increased risk of RSV-LRTD aged 50-59 years old received 1 dose of placebo at Day 1 and were followed until study end.
RSV OA_Lot 1EXPERIMENTALParticipants received 1 dose of a combination of the RSVPreF3 antigen Lot 1 and AS01E adjuvant Lot A at Day 1 and were followed up until the study end (Month 6).
RSV OA_Lot 2EXPERIMENTALParticipants received 1 dose of a combination of the RSVPreF3 antigen Lot 2 and AS01E adjuvant Lot B at Day 1 and were followed up until the study end (Month 6).
RSV OA_Lot 3EXPERIMENTALParticipants received 1 dose of a combination of the RSVPreF3 antigen Lot 3 and AS01E adjuvant Lot C at Day 1 and were followed up until the study end (Month 6).
RSV_annual GroupEXPERIMENTALParticipants receive one dose of RSVPreF3 OA investigational vaccine at Day 1 and 2 revaccination doses at 12 months post-Dose 1 and at 24 months post-Dose 1, respectively and are followed up until Month 60.
RSV_Flexible revaccination GroupEXPERIMENTALParticipants receive one dose of RSVPreF3 OA investigational vaccine at Day 1 and 2 revaccination doses at 24 months post-Dose 1 and at 48 months post-Dose 1, respectively and are followed up until Month 60.
RSV_1dose GroupEXPERIMENTALParticipants receive one dose of RSVPreF3 OA investigational vaccine at Day 1 and are followed up until Month 36. At Month 36, participants in this group will be re-randomized in 2 groups: RSV\_1dose\_M36 (which will receive 1 additional revaccination dose at Month 36 and will be followed up until Month 60) and RSV\_1dose\_Flexible (which will receive 1 additional revaccination dose at Month 60, and will be followed up until study end at Month 72).
RSV_IC_1 groupEXPERIMENTALImmunocompromised (IC) participants (recipients of lung or renal transplant) received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).
RSV_IC_2 groupEXPERIMENTALIC participants (recipients of lung or renal transplant) received 2 doses of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1) and Visit 3 (Visit 1 + 30-60 days).
RSV_HA groupACTIVE_COMPARATORHealthy adult (HA) participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).
Group High Dose_AdjuvantedEXPERIMENTALParticipants 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.
Group Medium Dose_AdjuvantedEXPERIMENTALParticipants 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.
Group Low Dose_AdjuvantedEXPERIMENTALParticipants 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.
Interventions
NameTypeDescription
RSVPreF3 OA investigational vaccineBIOLOGICAL1 dose of RSVPreF3 OA investigational vaccine administered intramuscularly on Day 1 to participants in OA-RSV and Adults-AIR-RSV groups.
PlaceboCOMBINATION_PRODUCT1 dose of placebo (saline solution) administered intramuscularly on Day 1 to participants in OA-Placebo and Adults-AIR-Placebo groups.
Placebo (Saline solution)DRUGOne dose of placebo is administered intramuscularly at Day 1.
COVID-19 mRNA vaccineBIOLOGICAL1 dose of COVID-19 mRNA vaccine is administered intramuscularly on Day 1 to participants in the Co-ad and Control Groups.
PCV20BIOLOGICALOne dose of the 20-valent pneumococcal conjugate vaccine (PCV20) given intramuscularly in participant's dominant arm (Coad group) or non-dominant arm (Control group) on Day 1
FLU HD vaccineBIOLOGICALFLU HD vaccine administered intramuscularly in the deltoid region of the dominant arm (Co-Ad Group) or the non-dominant arm (Control Group).
FLU-QIVBIOLOGICALFLU-QIV administered intramuscularly in the deltoid region of the dominant (Co-Ad Group) arm or the non-dominant (Control Group) arm.
RSVPreF3 OA investigational vaccine (GSK3844766A)BIOLOGICALRSVPreF3 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).
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Eligibility Criteria
Age Range50 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites14

Inclusion Criteria: Participants, who, in the opinion of the investigator, can and will comply with the requirements of the protocol. • Written or witnessed informed consent obtained from the participant (participant must be able to understand the informed consent) prior to performance of any stud...

Countries:IndiaChinaFinlandJapanPolandSouth KoreaSpainUnited KingdomUnited StatesBelgiumNetherlandsAustraliaCanadaGermanySouth AfricaSwedenNew ZealandPanamaTaiwanItaly
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT04732871primaryCompletionDate: changed
LOWMay 24, 2026NCT04732871studyFirstPostDate: changed