A 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 Older

A Phase 3, Randomized, Controlled, Partially Blind, Immuno-bridging Study to Evaluate Immunogenicity, Reactogenicity, Safety and the Occurrence of RSV Associated Respiratory Tract Illness After Administration of a Single Dose of GSK's RSVPreF3 OA Investigational Vaccine in Adults Aged 60 Years and Older

The purpose of the current study is to evaluate the immune response of the RSVPreF3 OA investigational vaccine in older adults (OA) at least (>=) 60 years of age (YOA) in China compared to OA in the same age range to be enrolled from overseas countries that participated in the RSV OA=ADJ-006 (NCT04886596) study, since the vaccine efficacy against lower respiratory tract disease (LRTD) has been demonstrated following a single dose of the RSVPreF3 OA investigational vaccine in the global efficacy study RSV OA=ADJ-006. In addition, the safety (in all participants) , reactogenicity and occurrence of RSV-associated acute respiratory illness (ARI) (in study participants in China only) after administration of the vaccine are also assessed in the current study. No ARI surveillance will be conducted for the overseas participants.

Study Overview

• Status: Completed
• Conditions: Respiratory Syncytial Virus Infections
• Intervention / Treatment: Biological: RSVPreF3 OA investigational vaccine; Drug: Placebo (Saline solution)

• Study Type: Interventional
• Enrollment (Actual): 2620
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200136
    • GSK Investigational Site
  • Shanghai, China
    • GSK Investigational Site
  • Shanghai, China, 201620
    • GSK Investigational Site
  • Shanghai, China, 201901
    • GSK Investigational Site
  • Putuo
    • Shanghai, Putuo, China, 200065
      • GSK Investigational Site
    • Shanghai, Putuo, China
      • GSK Investigational Site
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China
      • GSK Investigational Site
• Finland
  • Espoo, Finland, 02230
    • GSK Investigational Site
  • Helsinki, Finland, 00290
    • GSK Investigational Site
  • Kokkola, Finland, 67100
    • GSK Investigational Site
  • Oulu, Finland, 90220
    • GSK Investigational Site
  • Seinäjoki, Finland, 60100
    • GSK Investigational Site
  • Tampere, Finland, 33100
    • GSK Investigational Site
  • Turku, Finland, 20520
    • GSK Investigational Site
• Japan
  • Tokyo, Japan, 160-0017
    • GSK Investigational Site
• Poland
  • Elblag, Poland, 82-300
    • GSK Investigational Site
  • Katowice, Poland, 40-282
    • GSK Investigational Site
  • Katowice, Poland, 40-600
    • GSK Investigational Site
  • Krakow, Poland, 31-501
    • GSK Investigational Site
  • Lodz, Poland, 91-363
    • GSK Investigational Site
  • Lublin, Poland, 20-362
    • GSK Investigational Site
  • Sochaczew, Poland, 96-500
    • GSK Investigational Site
  • Warsaw, Poland, 00-215
    • GSK Investigational Site
  • Wroclaw, Poland, 50-088
    • GSK Investigational Site
• South Korea
  • Guri-si, South Korea, 471-701
    • GSK Investigational Site
  • Incheon, South Korea, 400-711
    • GSK Investigational Site
  • Seoul, South Korea, 152-703
    • GSK Investigational Site
• Spain
  • Barcelona, Spain, 08036
    • GSK Investigational Site
  • Burgos, Spain, 09006
    • GSK Investigational Site
  • Madrid, Spain, 28040
    • GSK Investigational Site
  • Salamanca, Spain, 37007
    • GSK Investigational Site
  • Valladolid, Spain, 47003
    • GSK Investigational Site
  • Ávila, Spain, 05071
    • GSK Investigational Site
• United Kingdom
  • Belfast, United Kingdom, BT7 2EB
    • GSK Investigational Site
  • Blackpool, United Kingdom, FY3 7EN
    • GSK Investigational Site
  • Bristol, United Kingdom, BS37 4AX
    • GSK Investigational Site
  • Cambridgeshire, United Kingdom, CB7 5JD
    • GSK Investigational Site
  • Eynsham, United Kingdom, OX29 4QB
    • GSK Investigational Site
  • Hounslow, United Kingdom, TW3 3EL
    • GSK Investigational Site
  • Witney, United Kingdom, OX28 6JS
    • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Adult male or female of ≥60 YOA at the time of study intervention administration, who live in the community dwelling (CD participants).
• 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, attend regular phone calls/study site visits, perform self-swabbing (study participants in China only), ability to access and utilize a phone or other electronic communications).
• Participants who are medically stable in the opinion of the investigator at the time of vaccination. Participants 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 medically stable.
• Written or witnessed informed consent obtained from the participant (participant must be able to understand the informed consent) prior to performance of any study specific procedure.

Exclusion Criteria:

Medical Conditions:

• History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention(s).
• Any clinical conditions for which serum samples would be prohibited for transfer to local central lab for testing. These clinical conditions include hepatitis B, hepatitis C, HIV and Syphilis based on medical history and physical examination (all participants) and laboratory screening tests (overseas participants).
• Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease (e.g., current malignancy, human immunodeficiency virus) or immunosuppressive/cytotoxic therapy (e.g., medication used during cancer chemotherapy, organ transplantation, or to treat autoimmune disorders), based on medical history and physical examination (no laboratory testing required).
• Any history of dementia or any medical condition that moderately or severely impairs cognition.
• Recurrent history or uncontrolled neurological disorders or seizures. 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 (e.g. completion of the diary cards, attend regular phone calls/study site visits, perform self-swabbing (study participants in China only).
• Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study (e.g., life-threatening disease likely to limit survival to less than 1 year).
• Serious or unstable chronic illness.
• Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study.

Prior/Concomitant Therapy:

• Previous vaccination with RSV vaccine.
• Use of any investigational or non-registered product (drug, vaccine or invasive medical device) other than the study intervention(s) during the period beginning 30 days before the dose of study intervention(s), or their 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 study intervention administration, with the exception of COVID-19 and inactivated/subunit influenza vaccines which can be administered up to 14 days before or from 14 days after each study intervention.
• Administration of long-acting immune-modifying drugs or planned administration at any time during the study period (e.g., infliximab).
• Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 90 days before the study intervention administration 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 study intervention administration or planned administration during the study period. For corticosteroids, this will mean prednisone >=20 mg/day, or equivalent. Inhaled and topical steroids are allowed.

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 intervention (drug/invasive medical device).

Other Exclusion Criteria:

• History of chronic alcohol consumption and/or drug abuse as deemed by the investigator to render the potential participant unable/unlikely to provide accurate safety reports or comply with study procedures.
• Bedridden participants.
• Planned move during the study conduct that prohibits participation until study end.
• Participation of any study personnel or their immediate dependents, family, or household members.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RSV OA vaccine Group (Overseas); Overseas 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).	Biological: RSVPreF3 OA investigational vaccine; One dose of the RSVPreF3 OA investigational vaccine is administered intramuscularly at Day 1.
Experimental: RSV OA vaccine Group (China); Chinese 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).	Biological: RSVPreF3 OA investigational vaccine; One dose of the RSVPreF3 OA investigational vaccine is administered intramuscularly at Day 1.
Experimental: Placebo Group (China); Chinese 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).	Drug: Placebo (Saline solution); One dose of placebo is administered intramuscularly at Day 1.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
RSV-A Neutralizing Titers Expressed as Adjusted Geometric Mean Titers (GMTs) at 1 Month Post RSVPreF3 OA Vaccination	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.	At Day 31
Percentage of Participants With Seroresponse for RSV-A Neutralizing Titers at 1 Month Post RSVPreF3 OA Vaccination	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).	At Day 31 compared to baseline (Day 1)
RSV-B Neutralizing Titers Expressed as Adjusted GMTs at 1 Month Post RSVPreF3 OA Vaccination	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.	At Day 31
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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
RSV-A Neutralizing Titers Expressed as Unadjusted GMTs at Baseline and 1 Month Post RSVPreF3 OA Vaccination	Neutralizing titers were measured with neutralization assay and the results were expressed as GMT. Unadjusted GMT is a descriptive statistic calculated directly from the observed titer values at pre-vaccination and at 1-month post-vaccination timepoints for all participants in the analysis set, without any statistical modelling or adjustment for covariates.	At Day 1 (baseline) and Day 31 (1 month post RSVPreF3 OA vaccination)
RSV-B Neutralizing Titers Expressed as Unadjusted GMTs at Baseline and 1 Month Post RSVPreF3 OA Vaccination	Neutralizing titers were measured with neutralization assay and the results were expressed as GMT. Unadjusted GMT is a descriptive statistic calculated directly from the observed titer values at pre-vaccination and at 1-month post-vaccination timepoints for all participants in the analysis set, without any statistical modelling or adjustment for covariates.	At Day 1 (baseline) and Day 31 (1 month post RSVPreF3 OA vaccination)
RSV-A and RSV-B Neutralizing Titers Expressed as Unadjusted GMTs at 6 Months Post RSVPreF3 OA Vaccination	Data not available at the time of initial results posting, will be updated at the final results disclosure stage.	At Day 181 (6 months post RSVPreF3 OA vaccination)
Percentage of Participants With Seroresponse for RSV-A and RSV-B Neutralizing Titers at 1 Month Post RSVPreF3 OA Vaccination		At Day 31 compared to baseline (Day 1)
Percentage of Participants With Seroresponse for RSV-A and RSV-B Neutralizing Titers at 6 Months Post RSVPreF3 OA Vaccination	Data not available at the time of initial results posting, will be updated at the final results disclosure stage.	At Day 181 compared to baseline (Day 1)
RSV-A and RSV-B Neutralizing Titers Expressed as Adjusted GMTs at 1 Month Post RSVPreF3 OA Vaccination Between RSV OA Overseas (RSV OA=ADJ-006 Study) vs RSV OA Vaccine Group (China) Group	This outcome measure compares the adjusted GMTs for RSV-A and RSV-B for the RSV OA vaccine Group (China) to the selected immunogenicity subset of the global efficacy study RSV OA=ADJ-006 [RSV OA Overseas (RSV OA=ADJ-006 study) group]. 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.	At Day 31
Percentage of Participants With Seroresponse for RSV-A and RSV-B Neutralizing Titers at 1 Month Post RSVPreF3 OA Vaccination Between RSV OA Overseas (RSV OA=ADJ-006 Study) vs RSV OA Vaccine Group (China) Group	This outcome measure compares the seroresponse for RSV-A and RSV-B neutralizing titers in the RSV OA vaccine Group (China) group to the selected immunogenicity subset of the global efficacy study RSV OA=ADJ-006 [RSV OA Overseas (RSV OA=ADJ-006 study) group].	At Day 31 compared to baseline (Day 1)
Number of Participants With Real Time Polymerase Chain Reaction (RT-PCR) Confirmed RSV-A/B Associated Acute Respiratory Illness (ARI) and Lower Respiratory Tract Disease (LRTD) Cases	Data not available at the time of initial results posting, will be updated at the final results disclosure stage.	From Day 15 and up to study end (6 months post dose [dose administered at Day 1])
Duration of Episodes for RSV-confirmed ARI and LRTD Cases	Data not available at the time of initial results posting, will be updated at the final results disclosure stage.	From Day 15 and up to study end (6 months post dose [dose administered at Day 1])
Number of Episodes of Each of the Symptoms/Signs Associated to RSV-confirmed ARI Cases	Data not available at the time of initial results posting, will be updated at the final results disclosure stage.	From Day 15 and up to study end (6 months post dose [dose administered at Day 1])
Number of Episodes of Each of the Symptoms/Signs Associated With RSV-confirmed LRTD Cases	Data not available at the time of initial results posting, will be updated at the final results disclosure stage.	From Day 15 and up to study end (6 months post dose [dose administered at Day 1])
Number of Participants With RSV-confirmed ARI and LRTD Episodes by Severity	Data not available at the time of initial results posting, will be updated at the final results disclosure stage.	From Day 15 and up to study end (6 months post dose [dose administered at Day 1])
Number of Participants With RSV-confirmed ARI and LRTD Cases by Frailty Status	Data not available at the time of initial results posting, will be updated at the final results disclosure stage.	From Day 15 and up to study end (6 months post dose [dose administered at Day 1])
Number of Participants Reporting Any Solicited Administration Site Adverse Events	Assessed solicited administration site adverse events were pain, redness (erythema) and swelling at administration site. Any = occurrence of the symptom regardless of intensity grade.	Day 1 (baseline) to Day 7
Number of Participants Reporting Any Solicited Systemic Adverse Events	Assessed solicited systemic adverse events were fever (pyrexia), headache, myalgia (muscle pain), arthralgia (joint pain) and fatigue (tiredness). Fever was defined as body temperature greater or equal to (≥) 38 degrees Celsius (ºC). Any = occurrence of the symptom regardless of intensity grade.	Day 1 (baseline) to Day 7
Number of Participants Reporting Any Unsolicited Adverse Events (AEs)	An unsolicited AE was an AE that was either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events. Unsolicited AEs included both serious and non-serious AEs. Any = occurrence of the symptom regardless of intensity grade.	Day 1 (baseline) to Day 30
Number of Participants Reporting Any Serious Adverse Events (SAEs), Related SAEs and Fatal SAEs up to Data Lock Point of Primary Analysis	An SAE is defined as any untoward medical occurrence that results in death, are life threatening, require hospitalization or prolongation of hospitalization or results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant, is considered or defined as an important medical event, or abnormal pregnancy outcomes. Any SAE = occurrence of the SAE regardless of the intensity grade or relation to study vaccination. Related SAE = SAE assessed by the investigator as related to the study vaccination. Fatal SAE = occurrence of a fatal SAE regardless of relation to study vaccination.	Day 1 (baseline) up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
Number of Participants Reporting Any SAEs, Related SAEs and Fatal SAEs up to End of Study	Data not available at the time of initial results posting, will be updated at the final results disclosure stage.	Throughout the study period (up to 6 months post dose [administered at Day 1 (baseline)])
Number of Participants Reporting Any Potential Immune-mediated Disease (pIMDs) and Related pIMDs up to Data Lock Point for Primary Analysis	pIMDs are a subset of Adverse Events of Specific Interest (AESIs) that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology. Any pIMDs = occurrence of the pIMDs regardless of the intensity grade or relation to study vaccination. Related pIMDs = pIMDs assessed by the investigator as related to the study vaccination.	Day 1 (baseline) up to data lock point of primary analysis (median follow-up: 229 days [min.: 28 days, max.: 338 days)
Number of Participants Reporting Any pIMDs and Related pIMDs up to End of Study	Data not available at the time of initial results posting, will be updated at the final results disclosure stage.	Throughout the study period (up to 6 months post dose [administered at Day 1 (baseline)])

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2024
• Primary Completion (Actual): April 24, 2025
• Study Completion (Actual): September 15, 2025

Study Registration Dates

• First Submitted: August 9, 2024
• First Submitted That Met QC Criteria: August 9, 2024
• First Posted (Actual): August 13, 2024

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: April 24, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Older adults; Immune response; Respiratory syncytial virus (RSV); Safety study; Efficacy study; Acute respiratory illness (ARI); Lower respiratory tract disease (LRTD)
• Additional Relevant MeSH Terms: Infections; RNA Virus Infections; Virus Diseases; Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; Respiratory Syncytial Virus Infections; Pharmaceutical Preparations; Crystalloid Solutions; Isotonic Solutions; Solutions; Saline Solution
• Other Study ID Numbers: 219815; 2023-509455-13-00 (Other Identifier: EU CTR Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://d3l8i7lo48obsd.cloudfront.net/gsk-patient-level-data-sharing-july2025-1-Bgwa1UthxvluYbWYTThw.pdf
• IPD Sharing Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.
• IPD Sharing Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No