Not recruiting

Study on the Effectiveness of RSV Vaccine (Abrysvo) in Preventing Hospitalizations in Adults Aged 60 and Older

Verified siteRegistered drugNo placebo

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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 effectiveness of a vaccine called Abrysvo in preventing hospitalizations due to Respiratory Syncytial Virus (RSV) infections in adults aged 60 years and older. RSV is a virus that can cause serious respiratory illnesses, especially in older adults. The vaccine being tested is a bivalent, recombinant type, which means it is designed to protect against two subgroups of the virus by using a specially prepared protein to trigger an immune response.

The purpose of the study is to see how well the Abrysvo vaccine works in reducing the risk of hospitalizations related to RSV infections. Participants in the study will receive the vaccine through an injection into the muscle. The study will follow participants over several RSV seasons to gather data on the vaccine's effectiveness in preventing hospitalizations due to RSV-related respiratory diseases.

Throughout the study, researchers will monitor the number of hospitalizations due to RSV-related respiratory tract diseases, as well as other related health outcomes. These include hospitalizations for lower respiratory tract diseases, cardio-respiratory issues, and overall respiratory infections. The study aims to provide valuable information on the potential benefits of the Abrysvo vaccine in protecting older adults from serious RSV-related health problems.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, ensure that the informed consent form is signed and dated. This confirms understanding and agreement to participate in the trial.
Step 2
Receiving the vaccine
Receive the Abrysvo vaccine, which is a solution for injection. It is administered as an intramuscular injection. This vaccine is designed to help prevent hospitalizations due to respiratory syncytial virus (RSV) in adults aged 60 years or older.
Step 3
Monitoring and follow-up
After receiving the vaccine, regular monitoring will occur to evaluate its effectiveness in reducing the risk of RSV-related respiratory tract disease hospitalization.
The trial aims to assess the vaccine's impact over several RSV seasons, specifically the 2025/2026 and 2026/2027 seasons.
Step 4
End of trial
The estimated end date for the trial is May 31, 2027. At this point, the overall effectiveness of the vaccine in preventing RSV-related hospitalizations will be evaluated.

Who can join the trial?

2 criteria

Must be 60 years or older.
Must have signed and dated an informed consent form. This means you agree to participate in the study after being told about it.

Who cannot join the trial?

3 criteria

Patients who are not infected with RSV (Respiratory Syncytial Virus) cannot participate.
Patients under the age of 60 cannot participate.
Patients who are part of a vulnerable population cannot participate. This means people who might need special protection or care.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Gentofte Hospital
Verified
Hellerup, Denmark
Universidade De Santiago De Compostela
Verified
Santiago De Compostela, Spain

Trial locations

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Investigated drugs

Abrysvo® is a vaccine designed to help protect older adults, specifically those aged 60 and above, from severe illness caused by the respiratory syncytial virus (RSV). RSV is a virus that can lead to serious respiratory infections, especially in older adults. The vaccine works by stimulating the body's immune system to recognize and fight the virus, reducing the risk of hospitalization due to RSV-related respiratory diseases. In this clinical trial, researchers are studying how effective Abrysvo® is in preventing hospitalizations caused by RSV in the target age group.

What is already known about the treatment

Abrysvo® – Abrysvo® is administered as a vaccine injection to help prevent respiratory syncytial virus (RSV) infections, specifically targeting adults aged 60 years or older. Currently, it is being studied in clinical trials to assess its effectiveness in reducing hospitalizations due to RSV-related respiratory diseases in this age group. The vaccine works by stimulating the immune system to recognize and fight the RSV virus, thereby reducing the risk of severe illness. It is classified as a vaccine, which is a type of preventive medicine designed to protect against infectious diseases.

Investigated diseases

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 and those with weakened immune systems. The virus can cause inflammation in the small airways of the lungs, leading to wheezing and difficulty breathing. In severe cases, RSV infection can result in bronchiolitis or pneumonia, which are more serious conditions affecting the lower respiratory tract. The infection is highly contagious and spreads through respiratory droplets when an infected person coughs or sneezes.