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
- Conditions
- Respiratory Syncytial Virus InfectionsTherapeutic area: Diseases [C] - Virus Diseases [C02]Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- CTIS2023-503951-81-00
- Lead Sponsor
- GlaxoSmithKline Biologicals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 375
Inclusion criteria for all participants: • 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 (e.g., completion of the paper diary cards, 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). • 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)/LARs (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. Refer to protocol section 10.4.1 for definitions of women of childbearing potential, non childbearing potential, menarche and menopause and protocol section 10.4.2 on adequate contraception. , Specific inclusion criteria for renal/lung transplant patients: •A male or female participant, =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 Informed consent form (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
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 dep
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method