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 study about?

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.

1 initial vaccination

Receive a single dose of the RSVPreF3 OA investigational vaccine.

The vaccine is administered as a suspension for injection through intramuscular use.

2 first follow-up

30 days after the initial vaccination, a follow-up is conducted to assess the immune response.

This involves measuring the levels of antibodies that help protect against the Respiratory Syncytial Virus (RSV).

3 subsequent follow-ups

Further assessments occur at 6 and 12 months after the initial vaccination.

These assessments continue to monitor the immune response and the presence of antibodies.

4 extended follow-up

Additional follow-ups are scheduled at 18, 24, 30, 36, 42, 48, 54, and 60 months post-vaccination.

These follow-ups include measuring the immune response and checking for any side effects.

5 revaccination

Revaccination doses are administered at months 13, 25, 37, and 49.

One month after each revaccination, the immune response is evaluated again.

6 monitoring side effects

Monitor for any side effects at the injection site and any general reactions for 4 days after each vaccination.

Report any unexpected side effects for 30 days after each vaccination.

7 serious side effects monitoring

Monitor for any serious side effects or significant medical events up to 6 months after each vaccination.

Continue monitoring for any serious side effects related to the vaccine until the end of the study.

Who Can Join the Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Gemeinschaftspraxis Drs. Josef und Wilma Großkopf	Wallerfing	Germany
Rokotetutkimuskeskus Finvac Oy	Tampere	Finland

Other Sites

Site Name	City	Country
Medizentrum Essen Borbeck	Essen	Germany
medicoKIT GmbH	Goch	Germany
Studienpraxis Heimeranplatz	Munich	Germany
Klinikum Wuerzburg Mitte gGmbH	Wuerzburg	Germany
Clinical Research Hamburg GmbH	Hamburg	Germany
Unx Kqdssbzaw Fpjqjbihb	Essen	Germany
Swkkblrnmrhsjg Mseco Mrhmq	Mainz	Germany

Trial status

Country	Status	Recruitment Start
Finland	Not recruiting	22.02.2021
Germany	Not recruiting	22.02.2021

Trial locations

Investigated drugs:

Respiratory Syncytial Virus, Glycoprotein F, Recombinant, Stabilised In The Pre-Fusion Conformation, Adjuvanted With As01E

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.

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 ID:

2024-512291-34-00

Protocol code:

212496

NCT ID:

NCT04732871

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Safety and Immune Response of RSVPreF3 Vaccine for Respiratory Syncytial Virus in Adults Aged 60 and Above

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?