Futuremeds Sp. z o.o.
Responsive
Wroclaw, Poland
Not recruiting
Study on the Immune Response and Safety of RSVPreF3 OA Vaccine for Respiratory Syncytial Virus in Adults Aged 60 and Older
Clinical Trials Concierge
Prefer not to search? Our Concierge searches the trials for you.
What is this trial about?
A plain-language summary of the goals, design and what participants do
This clinical trial is focused on studying a disease called Respiratory Syncytial Virus (RSV) Infections, which affects the respiratory system, particularly in older adults. The study will use a vaccine known as Arexvy, which is a powder and suspension for injection. This vaccine is designed to help the body build immunity against RSV by using a special protein from the virus, called glycoprotein F, that is stabilized in a form that helps the immune system recognize it better. The vaccine is also combined with an ingredient called AS01E to enhance the immune response.
The purpose of the study is to evaluate how well the vaccine works in generating an immune response, its safety, and how it affects the occurrence of RSV-related respiratory illnesses in adults aged 60 years and older. Participants in the study will receive a single dose of the vaccine, and their immune response will be monitored over time. The study will compare the immune responses of participants from different regions to ensure the vaccine is effective across diverse populations.
Throughout the study, participants will be observed for any side effects or reactions to the vaccine. The study will also track the occurrence of any respiratory illnesses related to RSV. Some participants will receive a placebo for comparison. The study aims to provide valuable information on the vaccine's effectiveness and safety in preventing RSV infections in older adults.
The research process
The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
5 criteria
- Adult male or female who is 60 years or older at the time of receiving the study vaccine.
- Participants must live in a community setting, meaning they are not in a hospital or long-term care facility.
- Participants should be able to follow the study requirements, such as filling out diary cards, attending phone calls or visits, and performing self-swabbing (for participants in China only). If a participant has difficulty with these tasks, they can have help from site staff or a caregiver, but the helper cannot make health decisions for them.
- Participants must be considered medically stable by the study doctor at the time of vaccination. This means their health condition is not changing rapidly. People with long-term stable conditions like diabetes, high blood pressure, or heart disease can join if the doctor agrees they are stable.
- Participants must provide written or witnessed informed consent, meaning they agree to join the study after understanding what it involves.
Who cannot join the trial?
10 criteria
- Patients who have a known allergy to any component of the investigational vaccine cannot participate.
- Patients with a history of severe allergic reactions, such as anaphylaxis, which is a serious and rapid allergic reaction, are excluded.
- Patients who have received any other vaccine within 30 days before the study starts are not eligible.
- Patients with a weakened immune system, which means their body has a reduced ability to fight infections, cannot take part.
- Patients who are currently participating in another clinical trial are not allowed to join this study.
- Patients with any serious health condition that the study doctors believe could interfere with the study results are excluded.
- Pregnant or breastfeeding women cannot participate in the study.
- Patients who have received blood products or immunoglobulins, which are proteins that help fight infections, within the last 3 months are not eligible.
- Patients with a history of drug or alcohol abuse that could affect their ability to follow the study procedures are excluded.
- Patients who have had a recent illness or infection that could interfere with the study are not eligible.
Clinical Trials Concierge
Prefer not to search? Our Concierge searches the trials for you.
Tell us about your condition – we search every trial in Europe and connect you with the right site.
We usually reply within a few days
Verified sites
All sites with verified contact details – recruitment status may not be available; ask directly
Helsinki University Central Hospital
Verified
Helsinki, FinlandKrakowskie Centrum Medyczne Sp. z o.o.
ResponsiveCracow, Poland
Trial locations
Where you can join this trial
Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.
Not recruitingNot finding your country?
Not sure what to do next?
Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.
Investigated drugs
RSVPreF3 OA investigational vaccine is a vaccine being studied to help protect older adults from illnesses caused by the respiratory syncytial virus (RSV). This virus can lead to serious respiratory infections, especially in people aged 60 and older. The vaccine is designed to boost the body's immune response against two main types of RSV, known as RSV-A and RSV-B. By enhancing the immune system's ability to fight these strains, the vaccine aims to reduce the risk of RSV-related respiratory illnesses in older adults. The study is comparing the immune response in older adults from China with those from other countries to ensure the vaccine works effectively across different populations.
What is already known about the treatment
RSVPreF3 OA investigational vaccine – This vaccine is administered as a single injection to adults aged 60 years and older to protect against Respiratory Syncytial Virus (RSV) infections. It is currently in Phase 3 clinical trials, where researchers are studying its effectiveness, safety, and how well it triggers an immune response. The vaccine works by stimulating the body's immune system to recognize and fight the RSV virus, specifically targeting the RSV-A and RSV-B strains. It is classified as a vaccine, which is a type of medicine designed to prevent infections by boosting the body's natural defenses.
Investigated diseases
Respiratory Syncytial Virus Infections – Respiratory Syncytial Virus (RSV) infections are caused by a virus that primarily affects the respiratory tract. The virus is highly contagious and spreads through droplets from coughs or sneezes. Infections often begin with symptoms similar to a common cold, such as a runny nose, cough, and fever. As the infection progresses, it can lead to more severe respiratory issues, especially in infants and older adults, such as bronchiolitis or pneumonia. The virus can cause inflammation and obstruction of the small airways in the lungs, leading to difficulty breathing. Recovery from RSV infections can vary, with symptoms typically lasting one to two weeks.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-509455-13-00Protocol code219815Estimated enrolment2 600 patientsSponsorGlaxoSmithKline Biologicals
sourced from the EU Clinical Trials Register and site verification
Want to learn more about this trial or check if you can participate?