Gemeinschaftspraxis Drs. Grosskopf
Wallerfing, Germany
Not recruiting
Study on the Safety and Immune Response of RSVPreF3 Vaccine for Respiratory Syncytial Virus in Adults Aged 60 and Above
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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 can cause respiratory illnesses, especially in older adults. The study is testing a new vaccine called Arexvy, which is designed to help the body fight against RSV. This vaccine is given as an injection and contains a special protein from the virus, along with an ingredient that helps boost the body's immune response.
The purpose of the study is to understand how well the vaccine works in creating an immune response, how safe it is, and how long its effects last. Participants in the study will receive a single dose of the vaccine and will be monitored over time to see how their bodies respond. The study will look at the immune response at different times, such as 30 days after the vaccination and then several months later, to see how the vaccine's effects persist over time.
Participants will be adults aged 60 years and above. The study will involve regular check-ups and follow-ups to ensure the safety and effectiveness of the vaccine. The trial will also explore different schedules for giving additional doses of the vaccine to see if this improves the immune response. The study aims to provide valuable information on how this vaccine can help protect older adults from RSV infections.
The research process
The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
5 criteria
- Participants must be male or female and at least 60 years old at the time of the first vaccination.
- Participants can live in the community or in a long-term care facility.
- Participants should be able to follow the study requirements, like filling out diary cards, attending phone calls or visits, and using a phone or electronic communication.
- Participants must provide written or witnessed informed consent before any study procedures begin. This means they agree to take part in the study after understanding what it involves.
- Participants should be medically stable at the time of the first vaccination. This means their health condition is not changing rapidly. People with long-term stable health conditions like diabetes, high blood pressure, or heart disease can join if their condition is considered stable by the study doctor.
Who cannot join the trial?
10 criteria
- Individuals who have a known allergy to any component of the investigational vaccine.
- People who have had a serious reaction to a vaccine in the past.
- Participants with a weakened immune system, which means their body has a harder time fighting infections.
- Individuals who are currently participating in another clinical trial.
- People who have received any other vaccine within the last 30 days.
- Participants with a history of severe respiratory illness, which affects the lungs and breathing.
- Individuals who are pregnant or planning to become pregnant during the study period.
- People with any medical condition that the study doctors believe could interfere with the study results.
- Participants who have received blood products or immunoglobulins in the last 3 months. Immunoglobulins are proteins in the blood that help fight infections.
- Individuals who have a history of drug or alcohol abuse, which means using these substances in a way that is harmful.
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Verified Verified Medizentrum Essen Borbeck
Essen, GermanyVerified Rokotetutkimuskeskus Finvac Oy
Tampere, Finland
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Investigated drugs
RSVPreF3 OA is an investigational vaccine being studied to see how well it works in creating an immune response in adults aged 60 years and above. The trial is looking at how safe the vaccine is, how the body reacts to it, and how long the immune response lasts after receiving a single dose. The study also explores different schedules for giving additional doses of the vaccine.
What is already known about the treatment
RSVPreF3 OA – This investigational vaccine is administered as a single injection and is currently in phase 3 clinical trials. It is being studied for its effectiveness in preventing infections caused by the Respiratory Syncytial Virus (RSV) in adults aged 60 years and older. The vaccine works by stimulating the body's immune system to produce antibodies against RSV, thereby providing protection against the virus. It is classified as a vaccine under the pharmacological category, focusing on enhancing the immune response to prevent viral infections.
Investigated diseases
Respiratory Syncytial Virus Infections – This disease is caused by the respiratory syncytial virus (RSV), which primarily affects the respiratory tract. It is common in children and can lead to symptoms such as coughing, wheezing, and difficulty breathing. In severe cases, it may cause bronchiolitis or pneumonia, especially in infants and older adults. The virus spreads through respiratory droplets and can be highly contagious. Symptoms typically appear 4 to 6 days after exposure and can last for 1 to 2 weeks. The infection often progresses from mild cold-like symptoms to more severe respiratory issues in vulnerable populations.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-512291-34-00Protocol code212496Estimated enrolment1 650 patientsSponsorGlaxoSmithKline Biologicals
sourced from the EU Clinical Trials Register and site verification
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