A Phase 3, Multicenter, Randomized, Partially Blinded, Palivizumab-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of MK-1654 in Infants and Children at Increased Risk for Severe RSV Disease
This important study is looking for safer and more effective ways to protect babies and young children who are at high risk of severe illness from a common chest infection called Respiratory Syncytial Virus (RSV). The study is testing a new medicine called Clesrovimab (MK-1654) against a treatment already in use, called Palivizumab (Synagis). Researchers will carefully watch for any side effects from the new medicine and see how well it prevents serious RSV infections, hospital stays, and other health issues over two RSV seasons. If successful, this new medicine could offer a better way to keep vulnerable children healthy.
At a glance
What is this study about?
This study is about finding better ways to protect some babies and young children from a common winter illness called Respiratory Syncytial Virus, or RSV. For most of us, RSV just causes a mild cold, but for very young or vulnerable children, it can lead to serious breathing problems which sometimes mean a hospital stay.
Currently, there's a medicine called Palivizumab (Synagis) that can help protect these at-risk children. This study is testing a new medicine, Clesrovimab (also known as MK-1654), to see if it works even better and has fewer side effects. The researchers will compare Clesrovimab to Palivizumab to understand its effects.
They will be carefully looking at a few things: how safe the new medicine is, by checking for any side effects; how well it prevents serious RSV infections and hospital visits; and how the medicine moves through the body. This kind of study helps doctors understand if new medicines are safe and effective enough to be used more widely.
Key takeaways
- This study is testing a new medicine (Clesrovimab/MK-1654) for RSV prevention.
- It's for babies and children at high risk of severe RSV illness.
- Researchers are comparing it to an existing treatment (Palivizumab/Synagis).
- The study will check for safety, side effects, and how well the treatment prevents serious RSV.
- Participation involves regular visits, monitoring, and potentially daily symptom tracking.
- The study will last for two RSV seasons.
Who may be eligible?
This study is specifically looking for babies and young children who are at a higher risk of getting very ill from RSV. This might include those born prematurely or with certain heart or lung conditions.
Both boys and girls can take part, and the study is open to a wide range of ages, from newborns up to older children, depending on their specific health situation and risk of RSV.
Detailed medical checks will be done by the study doctors to make sure that each child is suitable and that taking part is safe for them.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Is my child under a certain age or in a specific age range?
- Does my child have a higher risk of serious RSV due to prematurity or a health condition?
- Is my child generally healthy otherwise?
- Could my child attend regular hospital or clinic visits?
- Am I willing to keep a daily record of my child's symptoms?
What does participation involve?
If your child takes part in this study, they will receive either the new medicine, the existing medicine, or a placebo (a dummy medicine like saline, which contains no active drug). The study doctors and your family might not know which treatment your child receives, which helps make the results fairer.
You and your child will have regular check-ups at the study clinic throughout the winter RSV seasons. These visits will involve blood tests to check how the medicine is working and how your child's body is handling it. You will also need to keep a close eye on your child each day and report any symptoms they might have, especially related to their breathing or any other side effects. This will happen over two RSV seasons, which means the study will last for quite a while.
Potential risks and benefits
Locations (9)
- —UnverifiedGermany
- —UnverifiedSpain
- —UnverifiedHungary
- —UnverifiedFinland
- —UnverifiedFrance
- —UnverifiedNorway
- —UnverifiedGreece
- —UnverifiedCzechia
- —UnverifiedItaly
Common questions
What is RSV?
RSV stands for Respiratory Syncytial Virus. It's a very common virus that causes cold-like symptoms, but it can be serious for babies and young children, sometimes leading to breathing difficulties.
What is a 'Phase 3' study?
Phase 3 means this medicine has already been tested in smaller groups, and now researchers are testing it in a larger group of people to confirm its safety and how well it works.
What is a 'placebo'?
A placebo is a 'dummy' treatment, like a salt water injection, that has no active medicine. It helps researchers compare the real medicine's effects accurately.
Will my child definitely get the new medicine?
Not necessarily. Your child will be randomly assigned to receive either the new medicine, the existing medicine, or a placebo.
How long will the study last for my child?
Your child will be part of the study for two RSV seasons, meaning the entire study participation will likely span over a couple of years.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.