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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

A Study Evaluating Persistence of the Immune Response of the Adjuvanted Respiratory Syncytial Virus (RSV) Vaccine and the Safety and Immune Response Following Revaccination in Adults 18 Years of Age and Above Who Received Lung or Kidney Transplant

A Phase 2b, Non-randomized, Controlled, Open-label, Extension Study to Evaluate the Persistence of Immune Response of the Adjuvanted RSVPreF3 Vaccine and the Safety and Immunogenicity Following Revaccination in Lung and Kidney Transplant Recipients (>=18 Years of Age)

A Study Evaluating Persistence of the Immune Response of the Adjuvanted Respiratory Syncytial Virus (RSV) Vaccine and the Safety and Immune Response Following Revaccination in Adults 18 Years of Age and Above Who Received Lung or Kidney Transplant (NCT07092865) is a Phase 2 interventional studying Respiratory Syncytial Virus Infections, sponsored by GlaxoSmithKline. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

This study evaluates persistence of the immune response of the adjuvanted RSV vaccine and the safety and immunogenicity following revaccination in adults 18 years of age and above who received lung or kidney transplant.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Respiratory Syncytial Virus Infections and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 184 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Respiratory Syncytial Virus Infections subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - Participants of the RSV OA=ADJ-023 study from the Per Protocol Set (Visit 3 for participants in IC\_1 and Visit 4 for participants in IC\_2 group), who received either 1 or 2 doses of the adjuvanted RSVPreF3 vaccine and for whom the immunogenicity data are available. - Participants who, can and will comply with the requirements of the protocol (e.g., completion of the paper diary cards (as applicable), return for follow-up visits, ability to access and utilize a phone or other electronic communications, have regular contact to allow evaluation during the study). - Written or witnessed willing to sign a consent form obtained from the participant 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 1 month after study intervention, and - has a negative pregnancy test on the day of and prior to study intervention administration. - Participant who has received an ABO compatible allogeneic kidney or lung transplant (allograft) more than 12 months (365 days) prior to the study intervention administration. - Participant receiving maintenance immunosuppressive therapy for the prevention of allograft rejection. Specific inclusion criteria for kidney transplant (KTx) patients • Participant with stable kidney 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Participants of the RSV OA=ADJ-023 study from the Per Protocol Set (Visit 3 for participants in IC\_1 and Visit 4 for participants in IC\_2 group), who received either 1 or 2 doses of the adjuvanted RSVPreF3 vaccine and for whom the immunogenicity data are available. * Participants who, can and will comply with the requirements of the protocol (e.g., completion of the paper diary cards (as applicable), return for follow-up visits, ability to access and utilize a phone or other electronic communications, have regular contact to allow evaluation during the study). * Written or witnessed informed consent obtained from the participant 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 1 month after study intervention, and * has a negative pregnancy test on the day of and prior to study intervention administration. * Participant who has received an ABO compatible allogeneic kidney or lung transplant (allograft) more than 12 months (365 days) prior to the study intervention administration. * Participant receiving maintenance immunosuppressive therapy for the prevention of allograft rejection. Specific inclusion criteria for kidney transplant (KTx) patients • Participant with stable kidney 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. Exclusion Criteria: Medical conditions * Any history of dementia or any medical condition that moderately or severely impairs cognition. * 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 up to study end). * History of any reaction or 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 or uncontrolled neurological disorders or seizures. Participants with medically controlled 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. * Any condition which, in the judgment of the investigator, would make IM injection unsafe. * Any other clinical condition that might pose additional risk to the participant due to participation in the clinical study. Prior/Concomitant therapy * Vaccination with RSV-antigen containing vaccine after 1 or 2 doses received in the RSV OA=ADJ-023 study. * Use of any investigational or non-registered product (drug, vaccine, or medical device) other than the study intervention administration during the period beginning 30 days before the study intervention administration (Day -30 to Day 1), or their planned use during the study period (up to Month 12). * Planned or actual administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the study intervention administration and ending 30 days after the study intervention administration\*. In the case of COVID-19 and inactivated/subunit/split influenza vaccines, this time window can be decreased to 14 days before and after study intervention administration. * If emergency mass vaccination for an unforeseen public health threat (e.g., a pandemic) is recommended and/or organized by the public health authorities outside the routine immunization program, the time period of 30 days described above can be reduced, if necessary for that vaccine, provided it is used according to the local governmental recommendations and that the Sponsor is notified. 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. * Any study personnel or their immediate dependents, family, or household members. * Planned move during the study period that will prohibit participating in the study until study end. * Pregnant or lactating female participant. * Female participant planning to become pregnant or planning to discontinue contraceptive precautions. * More than one organ transplanted (i.e., kidney-liver or kidney-other organ(s) transplanted). Dual organ is allowed (double kidney or double lung). * History of events that, in the opinion of the investigator, may put the participant at increased risk for chronic allograft dysfunction. * Participant with an episode of allograft rejection within 3 months (90 days) prior to Visit 1. * 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 in the opinion of the investigator may put the participant at increased risk. * Any confirmed or suspected HIV infection or primary immunodeficiency disease or ongoing CMV infection with a viremia \> 200 IU/mL. * Use of anti-CD20 or other B-cell monoclonal antibody agents (e.g., rituximab) as induction, maintenance and/or therapeutic immunosuppressive therapy for the prevention of allograft rejection within 9 months (274 days) prior to Visit 1. * Use of investigational and non-registered immunosuppressants at the local/country level, unless specifically prescribed for the prevention of allograft rejection, and which are non-registered and: * available locally through compassionate use programs, * submitted for and pending local/country registration, * approved and registered for use in other countries with well-documented SmPC or Prescribing Information. The name of the active component(s) of these immunosuppressants must be provided in the concomitant medication listing. * Evidence or high suspicion, in the opinion of the investigator, of noncompliance or nonadherence to use of induction and/or maintenance immunosuppressive therapies. * Any clinically significant (based on the Investigator's clinical judgement) hematologic (hemoglobin level, white blood cell, lymphocyte, neutrophil, eosinophil, platelet red blood cell count and erythrocyte mean corpuscular volume) and/or biochemical (ALT, AST, creatinine, blood urea nitrogen) laboratory abnormality. Specific exclusion criteria for KTx patients: * Previous allograft loss secondary to recurrent primary kidney disease. Multiple consecutive kidney transplants are allowed if the reason for a previous allograft loss is not recurrent primary kidney disease. * Evidence of significant proteinuria/albuminuria in the opinion of the investigator. Specific exclusion criteria for LTx patients: * At study intervention administration visit, diagnosis of documented acute pulmonary infection within the 2 prior weeks, based on the following: clinical, radiological, and/or physiological deterioration; OR isolation of an organism from a clinically relevant BAL fluid culture. * Patients with diagnosis of chronic lung allograft dysfunction, defined as a decrement of 20% or more in FEV1 compared to post-transplant baseline FEV1.

Treatments Being Tested

BIOLOGICAL

Adjuvanted RSVPreF3 vaccine

1 dose of adjuvanted RSVPreF3 vaccine administered intramuscularly at Visit 1 (Day 1).

Locations (20)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

GSK Investigational Site
Lexington, Kentucky, United States
GSK Investigational Site
St Louis, Missouri, United States
GSK Investigational Site
St Louis, Missouri, United States
GSK Investigational Site
Omaha, Nebraska, United States
GSK Investigational Site
New York, New York, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, United States
GSK Investigational Site
Temple, Texas, United States
GSK Investigational Site
Camperdown, New South Wales, Australia
GSK Investigational Site
Birtinya, Queensland, Australia
GSK Investigational Site
Herston, Queensland, Australia
GSK Investigational Site
Edmonton, Alberta, Canada
GSK Investigational Site
Vancouver, British Columbia, Canada
GSK Investigational Site
London, Ontario, Canada
GSK Investigational Site
Toronto, Ontario, Canada
GSK Investigational Site
Giessen, Germany
GSK Investigational Site
Milan, Italy
GSK Investigational Site
Milan, Italy
GSK Investigational Site
Pavia, Italy
GSK Investigational Site
Siena, Italy
GSK Investigational Site
Aichi, Japan

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07092865), the sponsor (GlaxoSmithKline), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07092865 clinical trial studying?

This study evaluates persistence of the immune response of the adjuvanted RSV vaccine and the safety and immunogenicity following revaccination in adults 18 years of age and above who received lung or kidney transplant. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07092865?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07092865?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07092865. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07092865. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.