AuthorisedTherapeutic confirmatory (Phase III)Interventional

Pregnancy and Infant PrEparedness pLatform IN Europe (PIPELINE)-RSV immunisation adaptive platform trial

This study, called PIPELINE, is looking for better ways to protect babies from Respiratory Syncytial Virus (RSV). RSV is a common and sometimes serious chest infection that affects infants. The study is testing new preventative medicines, called Beyfortus and Abrysvo, which are given as injections. These medicines are designed to help a baby's body fight off the RSV virus. The main goal is to find out if these medicines can stop babies from getting a serious RSV infection before they turn one year old. This is a large study (Phase III) to confirm if these treatments are safe and effective. It's a way for doctors to learn how best to protect our youngest and most vulnerable from this common illness.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Fondazione Penta Ets

Enrolment target

400

Start

04 Nov 2025

Respiratory Syncytial Virus (RSV)

What is this study about?

You might have heard of Respiratory Syncytial Virus, or RSV. It's a very common virus, especially in the UK, that can cause cold-like symptoms, but also more serious breathing problems, particularly in young babies. For some infants, RSV can lead to bronchiolitis or pneumonia, which might need a hospital stay. That's why researchers are always looking for better ways to protect babies from this infection.

This study, called PIPELINE (Pregnancy and Infant PrEparedness pLatform IN Europe), is a really important effort to do just that. It's a large-scale project across Europe designed to test new preventative treatments for RSV in babies. The aim is to see if these treatments can significantly reduce the number of infants who get a serious RSV infection by the time they are 12 months old. It's about giving babies the best possible start and protecting their little lungs.

The study is testing specific medicines, Beyfortus and Abrysvo, which are given as injections. These aren't treatments for when a baby is already sick with RSV, but rather preventative measures, like a shield, to help their immune system fight off the virus if they come into contact with it. This kind of research is vital for improving public health and ensuring that we have effective tools to safeguard the health of the youngest members of our community.

Key takeaways

RSV is a common virus that can be serious for babies.
This study is testing new preventative medicines for RSV in infants.
The goal is to protect babies from severe RSV infection in their first year of life.
Participation involves receiving a preventative injection and follow-up monitoring.
It's a large, important study to find better ways to keep babies healthy.

Who may be eligible?

To join this important study, participants must be adults, aged 18 years or older. This likely means the study involves pregnant individuals who would receive the treatment, or parents/guardians whose infants would receive the preventative treatment.

The study is open to both men and women. The detailed rules for who can and cannot take part haven't been fully shared here, but typically, studies like this look for healthy individuals or those with specific health profiles that match the study's goals.

If you're interested, the best first step is always to chat with your doctor or the study team. They can go through all the specific criteria and help you understand if this study might be a good fit for you and your family.

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.

Are you 18 years old or older?
Are you considering pregnancy, currently pregnant, or have an infant who might be eligible?
Are you able to attend regular follow-up appointments?
Are you comfortable with your baby receiving an injection as part of the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, it would involve several steps. The specific visits and tests would depend on whether the treatment is given to a pregnant person or directly to an infant after birth, but generally, it involves:

* **Initial Check-up:** You (or your baby) would have a health check to make sure the study is right for you. This might include questions about your health history and possibly some basic tests. * **Receiving the Medicine:** The preventative medicine would be given, likely as an injection. The study is testing different types and strengths of medicine. * **Regular Follow-ups:** There would be planned visits or phone calls to check on your (or your baby's) health and how you're feeling. This would involve monitoring for any signs of RSV infection. * **RSV Testing:** If your baby develops cold-like symptoms, they might need to have a test to see if it's RSV, to help the researchers understand how well the medicine is working.

The total amount of time you and your baby would be involved in the study would go up until your baby is 12 months old. The study team will explain everything fully, including how many visits are needed and what each visit entails.

Potential risks and benefits

Taking part in any study has potential upsides and things to consider. A potential benefit of joining this study is that you or your baby might receive a preventative medicine that could protect against RSV, a common and potentially serious infection in infants. This could lead to better health outcomes for your baby. However, like all medicines, the study treatments might have side effects, which could range from mild, like a sore arm where the injection was given, to more serious ones. Researchers are very careful to monitor for any side effects. It's important to remember that participating is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (2)

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

—
Unverified
Belgium
—
Unverified
Netherlands

Common questions

What is RSV?

RSV stands for Respiratory Syncytial Virus. It's a common virus that causes cold-like symptoms, but can lead to more serious chest infections like bronchiolitis or pneumonia, especially in young babies.

What are Beyfortus and Abrysvo?

These are the names of the specific medicines being tested in this study. They are designed to help protect babies from getting sick with RSV.

Is this medicine a treatment if my baby is already sick?

No, these medicines are preventative, meaning they are given to help stop your baby from getting a serious RSV infection in the first place, rather than treating them once they are already ill.

How long will my baby be part of the study?

Your baby would be followed in the study until they are 12 months old, to see if the medicine protected them during their first year of life.

Will I know if my baby received the real medicine or a placebo?

In some studies, participants might not know which treatment they receive until the study is over. The study team will explain how this works for this specific trial.