Study on the Safety and Immune Response of RSVPreF3 OA Vaccine with PCV20 in Adults Aged 60 and Older with RSV Disease

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What is this study about?

This clinical trial is focused on studying the effects of two vaccines in adults aged 60 years and older. The diseases being studied are related to the Respiratory Syncytial Virus (RSV), which can cause respiratory infections, and infections caused by the pneumococcal bacteria, which can lead to illnesses such as pneumonia. The trial involves the use of two vaccines: the RSVPreF3 OA investigational vaccine, which is designed to protect against RSV, and the 20-valent pneumococcal conjugate vaccine (PCV20), which targets 20 different types of pneumococcal bacteria.

The purpose of the study is to evaluate the immune response, safety, and how the body reacts to these vaccines when given together compared to when they are given separately. Participants in the study will receive either both vaccines at the same time or one of the vaccines alone. The study will monitor the participants’ immune responses, which are the body’s defense mechanisms against infections, and any side effects that may occur after vaccination.

Throughout the study, participants will be observed for several months to assess the effectiveness of the vaccines in generating protective antibodies, which are proteins in the blood that help fight infections. The study will also track any side effects or adverse events, which are any unwanted effects that occur after vaccination. This information will help determine if the vaccines are safe and effective when administered together in older adults.

1 joining the study

Upon joining the study, you will be asked to provide written or witnessed informed consent. This is a document that confirms your understanding and agreement to participate in the study.

You will be assessed to ensure you meet the study’s inclusion criteria, such as being 60 years of age or older and being medically stable.

2 first vaccination

You will receive the first dose of the RSVPreF3 OA investigational vaccine and the 20-valent pneumococcal conjugate vaccine (PCV20). These vaccines are given as a suspension for injection through an intramuscular route, which means they are injected into a muscle.

The purpose of this step is to evaluate the immune response and safety of the vaccines when given together.

3 monitoring and follow-up

After receiving the vaccines, you will be monitored for any immediate reactions. You will also be asked to keep an electronic diary (eDiary) to record any symptoms or side effects you experience.

Follow-up visits will be scheduled to assess your health and the effectiveness of the vaccines. These visits will occur at specific intervals, including one month after the vaccination to measure antibody levels.

4 final assessment

The study will conclude with a final assessment approximately six months after the last vaccination. This will include a review of your health status and any long-term effects of the vaccines.

The study aims to ensure the vaccines’ safety and effectiveness in preventing diseases associated with respiratory syncytial virus (RSV) and pneumococcal infections.

Who Can Join the Study?

Must be a male or female who is 60 years of age or older at the time of the first study intervention.
Must be able to follow the study requirements, such as completing an electronic diary, attending follow-up visits, and using a phone or other electronic communication devices. If you have difficulty with these tasks, a caregiver can help you, but they cannot make health decisions for you.
Must provide written or witnessed informed consent before any study-specific procedures are performed. This means you agree to participate after understanding the study details.
Must live in the general community or in an assisted-living facility that provides minimal help, meaning you are mainly responsible for your own care and daily activities.
Must be medically stable in the opinion of the investigator at the time of the first study intervention. This means your health condition is not changing rapidly. You can have stable chronic conditions like diabetes, high blood pressure, or heart disease, as long as they are considered stable by the investigator.

Who Cannot Join the Study?

Patients who are not at least 60 years old.
Patients who have a known allergy to any component of the vaccines being studied.
Patients who have a history of severe allergic reactions, also known as anaphylaxis, to any vaccine.
Patients who have a weakened immune system, which means their body has a harder time fighting infections.
Patients who are currently participating in another clinical trial.
Patients who have received any vaccine within the last 30 days.
Patients who have a fever or any acute illness at the time of enrollment.
Patients who have a history of bleeding disorders, which means they bleed easily or have trouble stopping bleeding.
Patients who have received blood products or immunoglobulins in the last 3 months. Immunoglobulins are proteins in the blood that help fight infections.
Patients who have a history of drug or alcohol abuse within the past 2 years.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Ko-Med Centra Kliniczne Sp. z o.o.	Staszow	Poland
Krakowskie Centrum Medyczne Sp. z o.o.	Cracow	Poland
Futuremeds Sp. z o.o.	Wroclaw	Poland
Kormont	Kluisbergen	Belgium
Université Libre de Bruxelles – Hôpital Erasme	Brussels	Belgium

Other Sites

Site Name	City	Country
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Maresme	Mataró	Spain
Ziekenhuis Oost Limburg	Genk	Belgium
Equip D’atencio Primaria Barcelona Sardenya S.L.P.	Barcelona	Spain
Ko-Med Centra Kliniczne Sp. z o.o.	Pulawy	Poland
Etg Neuroscience Sp. z o.o.	Warsaw	Poland
Institute Of Tropical Medicine	Antwerp	Belgium
Universitair Ziekenhuis Gent	Gent	Belgium
Ko-Med Centra Kliniczne Sp. z o.o.	Lublin	Poland
Hospital Quironsalud Barcelona	Barcelona	Spain
Eap Osona Sud Alt Congost S.L.P.	Centelles	Spain
Hospital Universitario Hm Puerta Del Sur	Mostoles	Spain
Micancer Center S.L.P.	Barcelona	Spain
Pneumocare	Namur	Belgium
Hnwlnjph Ujapamqlgabti Ds Lm Pludhxkc	Madrid	Spain
Eoqlrlz	Mechelen	Belgium
Fxzrozaah Pkyv Em Frkncbd Ds Lg Idwfyvyrloask Siogkphlq Y Bmyazbtao De Lu Ctxuakovi Vrvnzgrpif	Valencia	Spain
Dra Lyl Cztycr	Wetteren	Belgium

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	07.08.2023
Poland	Not recruiting	07.08.2023
Spain	Not recruiting	07.08.2023

Trial locations

Investigated drugs:

RSVPreF3 OA investigational vaccine is a vaccine being studied to help protect against respiratory syncytial virus (RSV) in older adults. RSV is a virus that can cause lung infections and breathing problems, especially in older people. This vaccine is designed to help the body build a defense against the virus by producing antibodies, which are proteins that can fight off infections.

20-valent pneumococcal conjugate vaccine (PCV20) is a vaccine that helps protect against infections caused by pneumococcal bacteria. These bacteria can lead to serious illnesses like pneumonia, meningitis, and bloodstream infections. The vaccine works by helping the body create antibodies to fight off these bacteria, reducing the risk of getting sick from them. In this study, the vaccine is being tested to see how well it works when given at the same time as the RSVPreF3 OA investigational vaccine.

Investigated diseases:

Respiratory syncytial virus infection

Respiratory Syncytial Virus Infection – Respiratory Syncytial Virus (RSV) infection is a common respiratory virus that affects the lungs and breathing passages. It typically begins with symptoms similar to a mild cold, such as a runny nose, cough, and fever. As the infection progresses, it can lead to more severe respiratory issues, especially in older adults, such as wheezing and difficulty breathing. In some cases, it can cause bronchiolitis or pneumonia, which are more serious conditions affecting the lower respiratory tract. The virus spreads easily through respiratory droplets when an infected person coughs or sneezes. It is particularly concerning for individuals with weakened immune systems or underlying health conditions.

Trial ID:

2022-501988-40-00

Protocol code:

219276

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Safety and Immune Response of RSVPreF3 OA Vaccine with PCV20 in Adults Aged 60 and Older with RSV Disease

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?