A 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 Above (RSV OA=ADJ-023)

A Phase 2b, Randomized, Controlled, Open-label Study to Evaluate the Immune Response and Safety of the RSVPreF3 OA Investigational Vaccine in Adults (>=18 Years of Age) When Administered to Lung and Renal Transplant Recipients Comparing 1 Versus 2 Doses and Compared to Healthy Controls (>=50 Years of Age) Receiving 1 Dose.

The purpose of this study is to evaluate the immunogenicity, safety, and reactogenicity of the RSVPreF3 OA investigational vaccine in an immunocompromised (lung and renal transplant recipients) population and assess whether a second dose of the vaccine increases the immune response.

Study Overview

• Status: Completed
• Conditions: Respiratory Syncytial Virus Infections
• Intervention / Treatment: Biological: RSVPreF3 OA Investigational Vaccine

• Study Type: Interventional
• Enrollment (Actual): 386
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Camperdown, New South Wales, Australia, 2050
      • GSK Investigational Site
  • Queensland
    • Birtinya, Queensland, Australia, 4556
      • GSK Investigational Site
    • Herston, Queensland, Australia, 4029
      • GSK Investigational Site
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • GSK Investigational Site
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2B7
      • GSK Investigational Site
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • GSK Investigational Site
  • Ontario
    • London, Ontario, Canada, N6A 5A5
      • GSK Investigational Site
    • Toronto, Ontario, Canada, M5G 2N2
      • GSK Investigational Site
  • Quebec
    • Sherbrooke, Quebec, Canada, J1J 2G2
      • GSK Investigational Site
• Germany
  • Giessen, Germany, 35392
    • GSK Investigational Site
• Italy
  • Milan, Italy, 20132
    • GSK Investigational Site
  • Milan, Italy, 20122
    • GSK Investigational Site
  • Palermo, Italy, 90127
    • GSK Investigational Site
  • Pavia, Italy, 27100
    • GSK Investigational Site
  • Siena, Italy, 53100
    • GSK Investigational Site
• Japan
  • Aichi, Japan, 466-8650
    • GSK Investigational Site
  • Aichi, Japan, 470-1192
    • GSK Investigational Site
  • Fukuoka, Japan, 814-0180
    • GSK Investigational Site
  • Hyōgo, Japan, 662-0918
    • GSK Investigational Site
  • Kumamoto, Japan, 861-8520
    • GSK Investigational Site
  • Okayama, Japan, 700-8558
    • GSK Investigational Site
  • Tokyo, Japan, 160-0017
    • GSK Investigational Site
  • Tokyo, Japan, 193-0998
    • GSK Investigational Site
• South Korea
  • Seoul, South Korea, 138-736
    • GSK Investigational Site
  • Seoul, South Korea, 03722
    • GSK Investigational Site
  • Seoul, South Korea, 110-774
    • GSK Investigational Site
• Spain
  • A Coruña, Spain, 15006
    • GSK Investigational Site
  • Barcelona, Spain, 08036
    • GSK Investigational Site
  • Barcelona, Spain, 08907
    • GSK Investigational Site
  • Córdoba, Spain, 14004
    • GSK Investigational Site
  • Madrid, Spain, 28041
    • GSK Investigational Site
  • Madrid, Spain, 28007
    • GSK Investigational Site
  • Madrid, Spain, 28040
    • GSK Investigational Site
  • Madrid, Spain, 28034
    • GSK Investigational Site
  • Madrid, Spain, 28222
    • GSK Investigational Site
  • Santander, Spain, 39011
    • GSK Investigational Site
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85013
      • GSK Investigational Site
  • Illinois
    • Chicago, Illinois, United States, 60612
      • GSK Investigational Site
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • GSK Investigational Site
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • GSK Investigational Site
  • Missouri
    • St Louis, Missouri, United States, 63110
      • GSK Investigational Site
  • Nebraska
    • Omaha, Nebraska, United States, 68198-2456
      • GSK Investigational Site
  • New York
    • New York, New York, United States, 10032
      • GSK Investigational Site
    • New York, New York, United States, 10065
      • GSK Investigational Site
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • GSK Investigational Site
  • Texas
    • Temple, Texas, United States, 76502
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Participants and/or participant's parent(s)/LAR(s) who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
• Participants living in the general community or in an assisted-living facility that provides minimal assistance can be enrolled, such that the participant is primarily responsible for self-care and activities of daily living.
• Written or witnessed informed consent obtained from the participant/participant's parent(s)/LAR(s) (participant must be able to understand the informed consent) prior to performance of any study-specific procedure.
• Female participants of nonchildbearing potential may be enrolled in the study. Non-childbearing potential is defined as hysterectomy, bilateral oophorectomy, bilateral salpingectomy, and post-menopause.
• Female participants of childbearing potential may be enrolled in the study if the participant has practiced adequate contraception from 1 month prior to study intervention administration and agreed to continue adequate contraception until study end for this study, and has a negative pregnancy test on the day of and prior to study intervention administration.

Specific inclusion criteria for renal/lung transplant patients:

• A male or female, >=18 YoA at the time of signing the Informed consent form (ICF) or Informed assent form (IAF).
• Written informed assent obtained from the participant (participant must be able to understand the informed assent) if he/she is less than legal age of consent, or written informed consent obtained from the participant if the participant has achieved legal age of consent.
• Participant who has received an ABO compatible allogeneic renal or lung transplant (allograft) more than 12 months (365 days) prior to the first study intervention administration.
• Participant receiving maintenance immunosuppressive therapy for the prevention of allograft rejection.

Specific inclusion criteria for renal transplant (RTx) patients:

• Participant with stable renal function, stability defined as less than 20% variability between last two results of eGFR or in the opinion of the investigator after investigator review of more than the last two results of eGFRs and based on medical history.

Specific inclusion criteria for lung transplant (LTx) patients:

• Participant with stable lung function, with stability defined as the stability in the FEV1 compared to post-transplant baseline FEV1 and based on medical history of the last 3 months, in the opinion of the investigator.

Specific inclusion criteria for healthy participants:

• A male or female, >=50 YoA at the time of signing the ICF.
• Healthy participants as established by medical history and clinical examination before entering the study.
• Participants who are medically stable in the opinion of the investigator at the time of first study intervention administration.
• Participants with chronic stable medical conditions with or without specific treatment, such as diabetes mellitus, hypertension, or cardiac disease, are allowed to participate in this study if considered by the investigator as medically stable.

Exclusion Criteria:

Medical conditions:

• History of any reaction/ hypersensitivity likely to be exacerbated by any component of the study intervention.
• Acute or chronic clinically significant cardiovascular or hepatic functional abnormality as determined by physical examination or laboratory screening tests.
• Recurrent/uncontrolled neurological disorders or seizures. Participants with medically controlled chronic neurological diseases can be enrolled in the study if their condition will allow them to comply with the requirements of the protocol, with the help of a caregiver if needed.
• Any history of dementia or any medical condition that moderately or severely impairs cognition.
• Any condition which would make IM injection unsafe.
• Significant underlying illness that would prevent completion of the study).
• Acute disease and/or fever at the time of study intervention administration (>=38°C /100.4°F, oral or axillary). Participants with a minor illness without fever may be enrolled at the discretion of the investigator.
• Bedridden participants.

Prior/Concomitant therapy:

• Use of any other investigational or non-registered product (drug, vaccine, or medical device) up to 30 days before the first dose administration (Day -30 to Day 1), or their planned use during the study period (up to Visit 6).
• Previous vaccination with the study antigen (RSV), including investigational RSV vaccines.
• Unexpected vaccine administration during a study should not occur 30 days prior to the first dose or 30 days after the last dose. For COVID-19 and inactivated/subunit/split influenza vaccines, this window is shortened to 14 days.

Prior/Concurrent clinical study experience:

• Concurrently participating in another active clinical study

Other exclusion criteria:

• Pregnant or lactating female participant.
• Female participant planning to become pregnant or planning to discontinue contraceptive precautions.
• History of chronic alcohol consumption and/or drug abuse
• Participation of any study personnel or their immediate dependents.
• Planned move during the study period that will prohibit participating in the study until study end.

Specific exclusion criteria for renal/lung transplant patients:

• More than one organ transplanted. Dual organ is allowed.
• History of events that may put the participant at increased risk for chronic allograft dysfunction.
• Participant with an episode of allograft rejection over the previous 90 days prior to the first study intervention administration.
• Histologic evidence of chronic allograft injury.
• Active treatment for acute rejection.
• Current diagnosis of malignancy (except non-melanoma skin cancer that does not require systemic therapy).
• Any autoimmune conditions or pIMDs that may put the participant at increased risk.
• Any confirmed or suspected HIV infection, primary immunodeficiency disease or ongoing CMV infection with a viremia >200 IU/mL.
• Use of anti-CD20 or other B-cell monoclonal antibody agents for the prevention of allograft rejection within 274 days of first dose of study.
• Use of investigational and non-registered immunosuppressants at the local/country level, unless specifically prescribed for the prevention of allograft rejection, and which are in process of approval, approved in other countries and locally available.
• Evidence/high suspicion\ of noncompliance/nonadherence to use of induction and/or maintenance immunosuppressive therapies.
• Any clinically significant hematologic and/or biochemical laboratory abnormality.

Specific exclusion criteria for RTx patients:

• Previous allograft loss secondary to recurrent primary kidney disease. Multiple consecutive kidney transplants are allowed if the reason is not recurrent primary kidney disease.
• Evidence of significant proteinuria/albuminuria.

Specific exclusion criteria for LTx patients:

• At study intervention administration visit, diagnosis of documented acute pulmonary infection within the 2 prior weeks.
• Patients with diagnosis of chronic lung allograft dysfunction (decrement of >=20% in FEV1 compared to post-transplant baseline FEV1).

Specific exclusion criteria for healthy participants:

• Any confirmed/suspected immunosuppressive/immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy, based on medical history and physical examination.
• Unstable serious chronic illness.

• Chronic administration of immune-modifying drugs (>14 days in total) and/or administration of long-acting immune-modifying treatments or planned administration at any time up to the end of the study.

  • Up to 3 months prior to the study intervention administration:
  • For corticosteroids -prednisone equivalent ≥20 mg/day, or equivalent. Inhaled, topical and intra-articular steroids are allowed.
  • Administration of immunoglobulins and/or any blood products or plasma derivatives.
  • Up to 6 months prior to study intervention administration: long-acting immune-modifying drugs.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RSV_IC_1 group; Immunocompromised (IC) participants (recipients of lung or renal transplant) received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).	Biological: RSVPreF3 OA Investigational Vaccine; 0.5 mililiter dose was administered intramuscularly as 1 dose to RSV_IC_1 and RSV_HA groups, and 2 doses to RSV_IC_2 group.
Experimental: RSV_IC_2 group; IC 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).	Biological: RSVPreF3 OA Investigational Vaccine; 0.5 mililiter dose was administered intramuscularly as 1 dose to RSV_IC_1 and RSV_HA groups, and 2 doses to RSV_IC_2 group.
Active Comparator: RSV_HA group; Healthy adult (HA) participants received 1 dose of RSVPreF3 OA investigational vaccine at Visit 1 (Day 1).	Biological: RSVPreF3 OA Investigational Vaccine; 0.5 mililiter dose was administered intramuscularly as 1 dose to RSV_IC_1 and RSV_HA groups, and 2 doses to RSV_IC_2 group.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
RSV-A And RSV-B Serum Neutralizing Titers Expressed As Geometric Mean Titers (GMT) for RSV_IC_1, RSV_IC_2 and RSV_HA Groups	Neutralizing titers were calculated as GMT and expressed in titers (Estimated Dilution 60 [ED60]).	At pre-study intervention administration (at Visit 1 [Day 1]), Visit 2 in a subset of participants (Visit 1 + 7-14 days), Visit 3 (Visit 1 + 30-60 days) and Visit 4 (Visit 3 + 30-42 days)
RSV-A and RSV-B Serum Neutralizing Titers Expressed as GMT for RSV_IC_1, RSV_IC_2 and RSV_HA Groups	Neutralizing titers were calculated as GMT and expressed in titers (ED60).	At Visit 5 (last dose + 180-210 days) and Visit 6 (last dose + 350-380 days)
RSV-A Serum Neutralizing Titers Expressed As Group GMT For RSV_HA And Pooled RSV_IC Groups	Group GMT was assessed for RSV_HA group over pooled RSV_IC group (combined RSV_IC_1 and RSV_IC_2 groups). The ANCOVA model used to calculate the adjusted GMTs for RSV-A neutralizing titers included the baseline log10-transformed titer as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included RSV_HA and Pooled RSV_IC groups in the model as fixed effect, as specified in Statistical Analysis Plan.	At Visit 2 in a subset of participants (Visit 1 [Day 1] + 7-14 days) and Visit 3 (Visit 1 + 30-60 days)
RSV-A Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_1 And RSV_IC_2 Groups	Group GMT of RSV_IC_2 over RSV_IC_1 was assessed at Visit 4. The ANCOVA model used to calculate the adjusted GMTs for RSV-A neutralizing titers included the baseline log10-transformed titer and the SOT type as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included RSV_IC_1 and RSV_IC_2 groups in the model as fixed effect, as specified in Statistical Analysis Plan.	At Visit 4 (Visit 3 [Visit 1 (Day 1) + 30-60 days] + 30-42 days)
RSV-A Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_1 And RSV_HA Groups	Group GMT of RSV_HA over RSV_IC_1 was assessed at Visit 4. The ANCOVA model used to calculate the adjusted GMTs for RSV-A neutralizing titers included the baseline log10-transformed titer as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included RSV_IC_1 and RSV_HA groups in the model as fixed effect, as specified in Statistical Analysis Plan.	At Visit 4 (Visit 3 [Visit 1 (Day 1) + 30-60 days] + 30-42 days)
RSV-A Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_2 And RSV_HA Groups	Group GMT of RSV_HA over RSV_IC_2 was assessed at Visit 4. The ANCOVA model used to calculate the adjusted GMTs for RSV-A neutralizing titers included the baseline log10-transformed titer as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included RSV_IC_2 and RSV_HA groups in the model as fixed effect, as specified in Statistical Analysis Plan.	At Visit 4 (Visit 3 [Visit 1 (Day 1) + 30-60 days] + 30-42 days)
RSV-A Serum Neutralizing Titers Expressed as Group GMT for RSV_IC_1, RSV_IC_2 and RSV_HA Groups		At Visit 5 (last dose + 180-210 days) and Visit 6 (last dose + 350-380 days)
RSV-B Serum Neutralizing Titers Expressed As Group GMT For RSV_HA And Pooled RSV_IC Groups	Group GMT was assessed for RSV_HA group over pooled RSV_IC group (combined RSV_IC_1 and RSV_IC_2 groups). The ANCOVA model used to calculate the adjusted GMTs for RSV-B neutralizing titers included the baseline log10-transformed titer as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included RSV_HA and Pooled RSV_IC groups in the model as fixed effect, as specified in Statistical Analysis Plan.	At Visit 2 in a subset of participants (Visit 1 [Day 1] + 7-14 days) and Visit 3 (Visit 1 + 30-60 days)
RSV-B Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_1 And RSV_IC_2 Groups	Group GMT ratio of RSV_IC_2 over RSV_IC_1 was assessed at Visit 4. The ANCOVA model used to calculate the adjusted GMTs for RSV-B neutralizing titers included the baseline log10-transformed titer and the SOT type as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included RSV_IC_1 and RSV_IC_2 groups in the model as fixed effect, as specified in Statistical Analysis Plan.	At Visit 4 (Visit 3 [Visit 1 (Day 1) + 30-60 days] + 30-42 days)
RSV-B Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_1 And RSV_HA Groups	Group GMT of RSV_HA over RSV_IC_1 was assessed at Visit 4. The ANCOVA model used to calculate the adjusted GMTs for RSV-B neutralizing titers included the baseline log10-transformed titer as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included RSV_IC_1 and RSV_HA groups in the model as fixed effect, as specified in Statistical Analysis Plan.	At Visit 4 (Visit 3 [Visit 1 (Day 1) + 30-60 days] + 30-42 days)
RSV-B Serum Neutralizing Titers Expressed As Group GMT For RSV_IC_2 And RSV_HA Groups	Group GMT of RSV_HA over RSV_IC_2 was assessed at Visit 4. The ANCOVA model used to calculate the adjusted GMTs for RSV-B neutralizing titers included the baseline log10-transformed titer as covariate (i.e. GMTs are adjusted for the PRE timepoint values) and only included RSV_IC_2 and RSV_HA groups in the model as fixed effect, as specified in Statistical Analysis Plan.	At Visit 4 (Visit 3 [Visit 1 (Day 1) + 30-60 days] + 30-42 days)
RSV-B Serum Neutralizing Titers Expressed as Group GMT for RSV_IC_1, RSV_IC_2 and RSV_HA Groups		At Visit 5 (last dose +180-210 days) and Visit 6 (last dose + 350-380 days)
RSV-A And RSV-B Serum Neutralizing Titers Expressed As MGI	MGI was assessed at Visit 2 (in a subset of participants) over Visit 1 and Visit 3 over Visit 1 in RSV_HA and pooled RSV_IC (combined RSV_IC_1 and RSV_IC_2 groups), and at Visit 4 over Visit 1 in RSV_IC_1, RSV_IC_2, RSV_HA groups.	At Visit 2 in a subset of participants (Visit 1 [Day 1] + 7-14 days), Visit 3 (Visit 1 + 30-60 days) and Visit 4 (Visit 3 + 30-42 days), each compared to Visit 1 (Day 1)
RSV-A and RSV-B Serum Neutralizing Titers Expressed as MGI		At Visit 5 (last dose +180-210 days) and Visit 6 (last dose + 350-380 days), each compared with Visit 1 (Day 1)
Cell Mediated Immunity (CMI) Response In A Subset of Participants Expressed As Group Geometric Mean Of The Frequency Of RSVPreF3-Specific Cluster Of Differentiation (CD) 4+ T Cells	CMI response is expressed as group geometric mean of the frequency of RSVPreF3-specific cluster of differentiation CD4+ T cells expressing at least 2 activation markers including at least one cytokine among CD40L, 4-1BB, IL-2, TNF-alpha, IFN-gamma, IL- 13 and IL-17. The CMI is measured in a subgroup consisting of participants with renal and lung SOT (from RSV_IC_1 and RSV_IC_2 groups) and healthy participants (from RSV_HA group).	At pre-study intervention administration (at Visit 1 [Day 1]), Visit 2 (Visit 1 + 7-14 days), Visit 3 (Visit 1 + 30-60 days) and Visit 4 (Visit 3 + 30-42 days)
CMI Response In A Subset of Participants Expressed As Group Geometric Mean Of The Frequency Of RSVPreF3-Specific CD8+ T Cells	CMI response is expressed as group geometric mean of the frequency of RSVPreF3-specific CD8+ T cells expressing at least 2 activation markers including at least one cytokine among CD40L, 4-1BB, IL-2, TNF-alpha, IFN-gamma, IL- 13 and IL-17. The CMI is measured in a subgroup consisting of participants with renal and lung SOT (from RSV_IC_1 and RSV_IC_2 groups) and healthy participants (from RSV_HA group).	At pre-study intervention administration (at Visit 1 [Day 1]), Visit 2 (Visit 1 + 7-14 days), Visit 3 (Visit 1 + 30-60 days) and Visit 4 (Visit 3 + 30-42 days)
CMI Response in a Subset of Participants		At Visit 5 (last dose + 180-210 days) and Visit 6 (last dose + 350-380 days)
Number Of Participants Reporting Any Solicited Administration Site Events	Assessed solicited administration site events included pain, erythema (redness) and swelling, at the injection site. Any = occurrence of the symptom regardless of intensity grade or relation to study intervention.	Within 7 days (i.e., the day of vaccination and 6 subsequent days) after vaccine administration (vaccine administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1 +30-60 days] for RSV_IC_2 group)
Number Of Participants Reporting Any Solicited Systemic Events	Assessed solicited systemic events included fever (pyrexia), myalgia, arthralgia, headache, and fatigue. Fever is defined as body temperature greater or equal to (≥) 38 degrees Celsius (ºC). Any = occurrence of the symptom regardless of intensity grade or relation to study intervention.	Within 7 days (i.e., the day of vaccination and 6 subsequent days) after vaccine administration (vaccine administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1 +30-60 days] for RSV_IC_2 group)
Number Of Participants Reporting Any Unsolicited Adverse Events (AEs) At Any Dose Administration	An unsolicited AE is an AE that was not included in the list of solicited events. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is to be reported as an unsolicited AE. Any = occurrence of the symptom regardless of intensity grade or relation to study intervention.	Within 30 days (i.e., the day of vaccination and 29 subsequent days) after vaccine administration (vaccine administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1 +30-60 days] for RSV_IC_2 group)
Number Of Participants Reporting Any Serious Adverse Events (SAEs), SAEs Related To Study Intervention And Fatal SAEs	A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study participant. Any SAE = occurrence of the SAE regardless of 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.	From Visit 1 (Day 1) up to Visit 4 (Visit 3 + 30-42 days) after vaccine administration (vaccine administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1 + 30-60 days] for RSV_IC_2 group)
Number Of Participants Reporting Any Potential Immune-Mediated Disease (pIMDs) And pIMDs Related To Study Intervention	pIMDs are a subset of 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 relation to study vaccination. Related pIMDs = pIMDs assessed by the investigator as related to the study vaccination.	From Visit 1 (Day 1) up to Visit 4 (Visit 3 + 30-42 days) after vaccine administration (vaccine administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1 + 30-60 days] for RSV_IC_2 group)
Number Of Participants With Any AEs Of Special Interest (AESIs) Specific To Renal And Lung SOT Participants	AESIs include the acute rejection of transplant (specific to renal and lung SOT participants). Analysis was performed only on participants that received transplant in RSV_IC_1 and RSV_IC_2 groups.	From Visit 1 (Day 1) up to Visit 4 (Visit 3 + 30-42 days) after vaccine administration (vaccine administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1 + 30-60 days] for RSV_IC_2 group)
Number of Participants Reporting Any SAEs, SAEs Related to Study Intervention and Fatal SAEs	A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study participant. Any SAE = occurrence of the SAE regardless of 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.	From Visit 1 (Day 1) up to study end (Visit 6 - last dose + 350-380 days), vaccine administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1 + 30-60 days] for RSV_IC_2 group)
Number of Participants Reporting Any pIMDs and pIMDs Related to Study Intervention	pIMDs are a subset of 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 relation to study vaccination. Related pIMDs = pIMDs assessed by the investigator as related to the study vaccination.	From Visit 1 (Day 1) up to study end (Visit 6 - last dose + 350-380 days), vaccine administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1 + 30-60 days] for RSV_IC_2 group)
Number of Participants Reporting Any AESIs Specific to Renal and Lung SOT Participants	AESIs include the acute rejection of transplant (specific to renal and lung SOT participants). Analysis was performed only on participants that received transplant in RSV_IC_1 and RSV_IC_2 groups.	From Visit 1 (Day 1) up to study end (Visit 6 - last dose + 350-380 days), vaccine administered at Visit 1 [Day 1] for all groups, and Visit 3 [Visit 1 + 30-60 days] for RSV_IC_2 group)

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

General Publications

• Vyse A, Hockey C, Wright H, Ellsbury G. Could more adults than just those aged 75-79 years potentially benefit from vaccination against RSV: insights from UK data. J Pharm Policy Pract. 2025 Nov 4;18(1):2576618. doi: 10.1080/20523211.2025.2576618. eCollection 2025.

Study record dates

Study Major Dates

• Study Start (Actual): July 28, 2023
• Primary Completion (Actual): June 25, 2024
• Study Completion (Actual): May 16, 2025

Study Registration Dates

• First Submitted: June 16, 2023
• First Submitted That Met QC Criteria: June 16, 2023
• First Posted (Actual): June 27, 2023

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 8, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Safety; Vaccine; Immunogenicity; Respiratory syncytial virus
• Additional Relevant MeSH Terms: Infections; RNA Virus Infections; Virus Diseases; Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; Respiratory Syncytial Virus Infections
• Other Study ID Numbers: 219900; 2023-503951-81-00 (Other Identifier: EU CT 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://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.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: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No