Amphia Hospital
Breda, The Netherlands
Not recruiting
Study on the Immune Response and Safety of RSVPreF3 OA Vaccine Alone and with COVID-19 mRNA Vaccine in Adults Aged 50 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 the immune response and safety of vaccines for two diseases: Respiratory Syncytial Virus (RSV) and COVID-19. The study involves two vaccines: the RSVPreF3 OA investigational vaccine, which is a vaccine for RSV, and the Comirnaty Omicron XBB.1.5 COVID-19 mRNA Vaccine, which targets a specific variant of the COVID-19 virus. The purpose of the study is to evaluate how well the immune system responds to these vaccines when they are given together compared to when they are given separately.
Participants in the study will receive either the RSV vaccine alone, the COVID-19 vaccine alone, or both vaccines together. The study will monitor the immune response, which is how the body defends itself against these viruses, and will also look at the safety of the vaccines, including any side effects that may occur. The study will take place over a period of time, with follow-up visits to check on the participants' health and the effectiveness of the vaccines.
The study is designed for adults aged 50 years and older. It aims to provide important information on whether receiving both vaccines at the same time is as effective and safe as receiving them separately. This information could help in planning future vaccination strategies for these diseases.
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?
8 criteria
- Participants must be able to follow the study rules, such as filling out diary cards and attending follow-up visits.
- Participants must provide written or witnessed informed consent, meaning they understand and agree to the study procedures before any study-specific actions are taken.
- Participants must be male or female and at least 50 years old at the time of the first study intervention.
- Participants must be considered medically stable by the investigator at the time of the first vaccination. This includes those with chronic stable medical conditions like diabetes, high blood pressure, or heart disease, whether they are receiving treatment or not.
- Participants must live in the general community or in an assisted-living facility that provides minimal help, allowing them to be mainly responsible for their own care and daily activities.
- Participants must have received a SARS-CoV-2 vaccine (COVID-19 vaccine) at least 3 months before the study vaccination.
- Female participants who cannot have children may join the study. This includes women who have had a hysterectomy (removal of the uterus), bilateral oophorectomy (removal of both ovaries), bilateral salpingectomy (removal of both fallopian tubes), or are post-menopausal (have stopped having periods).
- Female participants who can have children may join the study if they have used effective birth control for 1 month before the study intervention and agree to continue using it for at least 1 month after the last vaccination. They must also have a negative pregnancy test on the day of and before the study intervention.
Who cannot join the trial?
10 criteria
- Patients with any **serious illness** that could interfere with the study results.
- Individuals who have had a **severe allergic reaction** to any vaccine in the past.
- People who are currently participating in another clinical trial.
- Anyone who has received any other vaccine within the last 30 days.
- Individuals with a **weakened immune system**, which means their body has a harder time fighting infections.
- Pregnant or breastfeeding women.
- Anyone with a history of **autoimmune diseases**, where the body's immune system attacks its own cells.
- People who have received blood products or immunoglobulins in the last 3 months. **Immunoglobulins** are proteins in the blood that help fight infections.
- Individuals with a history of **bleeding disorders**, which means they bleed more easily than normal.
- Anyone with a history of drug or alcohol abuse in the past year.
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Verified sites
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Verified Verified Bellvitge University Hospital
L'hospitalet De Llobregat, SpainResponsive Universitair Ziekenhuis Gent
Gent, Belgium
Trial locations
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Investigated drugs
RSVPreF3 OA investigational vaccine
is a vaccine being studied to see how well it helps the body build protection against the respiratory syncytial virus (RSV). This virus can cause lung infections, especially in older adults. The vaccine is designed to help the immune system recognize and fight off the virus if a person is exposed to it in the future. In this trial, researchers are looking at how the immune response to this vaccine compares when it is given alone versus when it is given at the same time as a COVID-19 vaccine.
COVID-19 mRNA vaccine (Omicron XBB.1.5)
is a type of vaccine that uses a small piece of genetic material called mRNA to help the body recognize and fight the COVID-19 virus, specifically targeting the Omicron XBB.1.5 variant. The mRNA in the vaccine instructs cells in the body to make a protein similar to one found on the virus, which then triggers an immune response. This helps the body to be prepared to fight the actual virus if exposed in the future. In this study, the vaccine is being tested to see how well it works when given with the RSVPreF3 OA investigational vaccine compared to when it is given alone.
What is already known about the treatment
RSVPreF3 OA investigational vaccine – This vaccine is administered as an injection and is currently being studied in clinical trials to assess its effectiveness and safety. It is designed to protect against Respiratory Syncytial Virus (RSV) infections, particularly in adults aged 50 and above. The vaccine works by stimulating the body's immune system to produce antibodies that can recognize and fight the virus. It is classified as a vaccine, which is a type of biological preparation that provides active acquired immunity to a particular infectious disease.
Investigated diseases
Respiratory Syncytial Virus Infections – Respiratory Syncytial Virus (RSV) infections are caused by a virus that primarily affects the respiratory tract. The virus typically enters the body through the nose or throat and can lead to symptoms such as coughing, sneezing, and fever. In severe cases, it can progress to bronchiolitis or pneumonia, especially in infants and older adults. The infection spreads easily through respiratory droplets when an infected person coughs or sneezes. Symptoms usually appear within 4 to 6 days after exposure and can last for 1 to 2 weeks. The virus can cause repeated infections throughout life, but symptoms are generally milder in older children and adults.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-510196-59-00Protocol code217848Estimated enrolment850 patientsSponsorGlaxoSmithKline Biologicals
sourced from the EU Clinical Trials Register and site verification
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