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

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• "Medical conditions for all: •History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention. (For details on components of study intervention administered, refer to the study protocol and Arexvy SmPC/Prescribing information). • 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 (e.g., completion of the diary cards, attend study site visits). Study participants may decide to assign a caregiver to help them complete some of the study procedures (Refer protocol section 8). • Any history of dementia or any medical condition that moderately or severely impairs cognition. • Any condition which, in the judgment of the investigator, would make IM injection unsafe. • 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). • Acute disease and/or fever at the time of study intervention administration. Fever is defined as temperature ≥ 38°C /100.4°F determined by oral or axillary route. However, participants with a minor illness (such as mild diarrhea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator. • Bedridden participants. • 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 for all: • 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 first dose of study intervention administration (Day -30 to Day 1), or their planned use during the study period (up to Visit 6). • Previous vaccination with the same antigen (RSV) containing vaccine as that of the study intervention, including investigational RSV vaccines. • Planned or actual administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first dose of study intervention administration and ending 30 days after the last dose of 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 each study intervention administration."
• "Prior/Concurrent clinical study experience for all: • 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 for all: • 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 as deemed by the investigator to render the potential participant unable/unlikely to provide accurate safety reports or comply with study procedures. • Participation of 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. "
• "Specific exclusion criteria for renal/lung transplant patients: • 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 over the previous 3 months (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 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) 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 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* 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 renal transplant (RTx) 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 lung transplant (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 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. "
• "Specific exclusion criteria for healthy participants: • Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease (e.g., current malignancy, HIV) 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). • Unstable serious chronic illness. • Chronic administration of immune-modifying drugs (defined as more than 14 consecutive 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, this will mean 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 including among others, immunotherapy (e.g., TNF-inhibitors), monoclonal antibodies, antitumoral medication."