Azienda Ospedaliero Universitaria Parma
Parma, Italy
Not recruiting
Study on the Safety and Effectiveness of Clesrovimab and Palivizumab for Preventing Severe RSV in Infants and Children at High Risk
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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 prevention of Respiratory Syncytial Virus (RSV) infection in infants and children who are at increased risk for severe RSV disease. RSV is a common virus that can cause serious respiratory illness, especially in young children. The study will compare the safety and effects of a new treatment called Clesrovimab (also known by its code name MK-1654) with an existing medication called Palivizumab. Both treatments are given as a solution for injection.
The purpose of the study is to evaluate how safe and well-tolerated Clesrovimab is compared to Palivizumab during the RSV season. Participants in the study will receive either Clesrovimab, Palivizumab, or a placebo. The study will monitor participants for any side effects, such as reactions at the injection site, fever, or other symptoms. The study will also look at how well the treatments work in preventing RSV-related illnesses that require medical attention or hospitalization.
Participants will be followed through two RSV seasons to gather information on the safety and effectiveness of the treatments. The study aims to provide valuable insights into how these treatments can help protect infants and children from severe RSV disease. The trial will help determine if Clesrovimab is a safe and effective option for preventing RSV infections in this vulnerable population.
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?
5 criteria
- Participants must be at increased risk for severe **respiratory syncytial virus (RSV)** infection. RSV is a virus that can cause lung infections.
- Participants should be recommended to receive **palivizumab**. Palivizumab is a medication given to help prevent RSV infections, based on national or local guidelines or professional society recommendations.
- Participants must be available to complete the follow-up period, which means they can attend all required check-ups and assessments during the study.
- Participants can be either male or female.
- Participants must be from birth up to 1 year old and entering their first RSV season. This means they are experiencing their first time of year when RSV infections are more common.
Who cannot join the trial?
10 criteria
- Children who have a known allergy to the study medications cannot participate.
- Children who have participated in another clinical trial within the last 30 days are not eligible.
- Children with a history of severe allergic reactions to any medication are excluded.
- Children who have received any other investigational drug within the last 30 days cannot join the study.
- Children with any condition that the study doctors believe would make it unsafe for them to participate are not allowed to join.
- Children who have a serious illness that requires ongoing medical treatment may not be eligible.
- Children who have a weakened immune system, which means their body has a harder time fighting infections, are excluded.
- Children who have received a blood transfusion or blood products within the last 3 months cannot participate.
- Children who have a history of lung disease or heart disease that is not well controlled are not eligible.
- Children who are currently taking medications that affect the immune system are excluded.
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Responsive Responsive Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Madrid, SpainResponsive Nosokomeio Paidon I Agia Sofia
Athens, Greece
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Investigated drugs
Clesrovimab (MK-1654)
is a medication being studied to see how safe and effective it is for infants and children who are at higher risk of getting severe respiratory syncytial virus (RSV) disease. RSV is a virus that can cause serious lung infections, especially in young children. This medication is designed to help protect against RSV by boosting the body's ability to fight off the virus.
Palivizumab
is a medication that is already used to help prevent serious RSV infections in children who are at high risk. It works by providing antibodies that help the body fight off the RSV virus. In this study, palivizumab is used as a comparison to see how well the new medication, clesrovimab, works in protecting children from RSV.
What is already known about the treatment
Clesrovimab (MK-1654) – Clesrovimab is administered as an injection and is currently being studied in clinical trials to prevent respiratory syncytial virus (RSV) infection in infants and children who are at high risk for severe RSV disease. This medication is still under investigation, and its safety and effectiveness are being compared to an existing treatment called palivizumab. Clesrovimab works by targeting and neutralizing the RSV virus, helping to prevent it from causing infection. It is classified as a monoclonal antibody, which is a type of medication designed to mimic the immune system's ability to fight off harmful pathogens.
Investigated diseases
Respiratory Syncytial Virus Infection – Respiratory Syncytial Virus (RSV) infection is a common respiratory virus that usually causes mild, cold-like symptoms. It primarily affects the respiratory tract, including the nose, throat, and lungs. In infants and young children, RSV can lead to more severe respiratory illnesses such as bronchiolitis and pneumonia. The virus spreads through respiratory droplets when an infected person coughs or sneezes. Symptoms typically appear 4 to 6 days after exposure and can include runny nose, decrease in appetite, coughing, sneezing, fever, and wheezing. The infection usually resolves within one to two weeks, but in some cases, it can lead to more serious respiratory issues, especially in young children and those with weakened immune systems.
Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase IIITrial ID2022-500752-39-00Protocol codeMK-1654-007Estimated enrolment936 patientsSponsorMerck Sharp & Dohme LLC
sourced from the EU Clinical Trials Register and site verification
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