Ongoing, recruitingPhase II and Phase III (Integrated)Interventional

A Phase 2b/3 Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-1654 in Healthy Pre-Term and Full-Term Infants

This research trial is called a Phase 2b/3 study, which means it's one of the final stages of testing a new medicine. The main goal is to see if a medicine called MK-1654 can help prevent a common and sometimes serious chest infection in babies called RSV (Respiratory Syncytial Virus). The study will involve healthy premature and full-term infants. Researchers will be carefully checking how well the medicine prevents RSV chest infections and keeping a close eye on any side effects to make sure it's safe. Some babies will receive the new medicine, and others will receive a placebo (a dummy medicine with no active ingredients). This helps the researchers understand if the new medicine is truly making a difference.

At a glance

Status

Ongoing, recruiting

Phase

Phase II and Phase III (Integrated)

Sponsor

Merck Sharp & Dohme Corp.

Enrolment target

590

Start

07 Nov 2022

Prevention of RSV

What is this study about?

This study is a research project looking into a new medicine, MK-1654, for babies. Its main aim is to help protect them from a common lung infection called Respiratory Syncytial Virus, or RSV. RSV can be very dangerous for young babies, especially those born early. This new medicine is being tested to see if it can stop babies from getting a severe RSV infection.

Researchers want to see two main things: first, how well the medicine works at preventing serious RSV chest infections, and second, how safe it is for babies. They will give the medicine to some babies and a 'dummy' medicine (placebo) to others. This is a common and important way to test new medicines, as it helps doctors understand if the medicine itself is causing any changes, rather than other factors.

This is a 'Phase 2b/3' study. This means it's a large, important step in testing a new medicine. If the medicine proves to be both safe and effective in studies like this, it could one day become available to help protect babies from RSV. The study will involve both babies born early (premature) and those born at term, to make sure it's suitable for a wide range of infants.

Key takeaways

This study is testing a new medicine (MK-1654) to prevent serious RSV in babies.
It involves both premature and full-term healthy babies.
Breguet carefully checks both how well the medicine works and if it's safe.
Some babies will get the real medicine, others a dummy medicine (placebo).
It's an important step in potentially protecting babies from RSV.
Participation includes clinic visits for health checks and monitoring.

Who may be eligible?

This study is looking for healthy babies to take part, whether they were born early (prematurely) or at their due date (full-term). Both baby boys and baby girls can join the study.

There might be some specific health checks or conditions that would mean a baby could or could not join the study. These are put in place to keep all the babies safe and to make sure the study results are clear and helpful.

If you're interested in your baby taking part, the study team will go through all the details with you and check if your baby meets all the requirements.

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 baby a healthy baby?
Is my baby either premature or full-term?
Am I willing for my baby to receive either the new medicine or a placebo?
Am I able to bring my baby to regular clinic visits?

Answer every question to see your result.

What does participation involve?

If your baby takes part in this study, they would receive a dose of either the research medicine (MK-1654) or a dummy medicine called a placebo. This would be given as an injection. Throughout the study, there will be several visits to the clinic where the doctors and nurses will check on your baby's health and well-being. They will monitor for any signs of RSV infection and also keep a close eye on any side effects.

These visits might include physical examinations and asking you questions about how your baby is doing. The study team will explain exactly what is involved at each visit and how long the study will last in total. You will be given a phone number to contact the study team if you have any concerns or questions between visits.

Potential risks and benefits

Taking part in a study like this means your baby could potentially be among the first to receive a medicine that might help protect against serious RSV infection. However, like all medicines, MK-1654 might have side effects, and some babies will receive a placebo, meaning they won't get the active medicine. The research team will carefully monitor your baby's health throughout the study. You have the right to withdraw your baby from the study at any time, for any reason, without it affecting their usual medical care.

Locations (7)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
Romania
—
Unverified
Finland
—
Unverified
France
—
Unverified
Italy
—
Unverified
Denmark
—
Unverified
Poland
—
Unverified
Belgium

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 sometimes lead to serious chest infections in babies and young children.

What is a 'placebo'?

A placebo is a 'dummy' treatment that looks just like the real medicine but contains no active ingredients. It's used in studies to help researchers see if the real medicine is actually working.

Will my baby definitely get the new medicine?

No, because this is a 'randomized' study, your baby will be randomly assigned to either receive the new medicine or the placebo. You won't know which one they receive.

What kind of side effects might there be?

The study will look for different types of side effects, including reactions at the injection site, fevers, rashes, or more serious reactions. All findings will be carefully recorded and assessed.

How long will the study last?

The study team will provide you with the full details of the study duration, including the period of receiving the medicine and any follow-up visits.