RecruitingPhase IIIInterventional

European preparedness platform to treat and prevent respiratory syncytial virus infections in pregnant women and infants

The PIPELINE-RSV study is a European project looking for the best ways to protect babies from a common and sometimes serious chest infection called Respiratory Syncytial Virus (RSV). This infection can cause breathing problems in infants. We want to see if giving pregnant mothers a special vaccine, or giving babies an injection after they're born, or even both together, provides the best protection. Currently, new treatments are often not fully tested in pregnant women and infants, so this study aims to change that. By taking part, you could help doctors find better ways to keep babies healthy and reduce pressure on hospitals across Europe.

At a glance

Status

Recruiting

Phase

Phase III

Sponsor

PENTA Foundation

Enrolment target

2,500

Start

05 Oct 2025

Estimated completion

05 Apr 2027

Respiratory syncytial virus (RSV) in infants

What is this study about?

In recent years, we've seen new health challenges like Zika and COVID-19, and these can be particularly concerning for pregnant women and their babies. While scientists work hard to find new ways to treat and prevent these illnesses, studies often don't include pregnant women and infants. This means it can be harder to know if new medicines are safe and effective for them.

The PIPELINE project aims to create a special system across Europe to make it easier to test new medicines for pregnant women and infants. The PIPELINE-RSV study is the first big test of this system. It focuses on finding the best way to prevent Respiratory Syncytial Virus (RSV) in babies. RSV is a very common winter bug that can cause cold and flu-like symptoms, but it can sometimes lead to serious chest infections, especially in young infants, requiring hospital care.

Currently, there are two main ways to protect babies from RSV: a vaccine given to the mother during pregnancy, or a special injection given directly to the baby. What we don't know yet is which method, or even if using both, offers the best protection for babies. This study aims to answer that important question, helping to ensure babies get the best possible start in life.

Key takeaways

This study aims to find the best way to protect babies from RSV.
It tests a vaccine for mothers, an injection for babies, or both.
It helps ensure new medicines are safe and effective for pregnant women and infants.
Participation includes extra health checks for you and your baby.
The study runs from July 2025 to March 2029.

Who may be eligible?

This study is looking for pregnant women who are 18 years or older. You would need to be between 28 and just under 37 weeks pregnant when you join the study. It's also important that you are willing to follow all the study instructions and attend appointments.

There are some reasons why you might not be able to join. For example, if you have a serious medical condition, if your doctor thinks there's a high chance of you having your baby much earlier than expected, or if you are expecting twins or triplets, you wouldn't be able to take part. Also, if you've already been part of this specific RSV study or received an RSV prevention product during this pregnancy, you wouldn't be eligible.

If you have certain allergies to vaccine ingredients or a history of specific health conditions like Guillain-Barré Syndrome, you would also not be able to participate. However, all babies born to mothers in the study will be included in the follow-up, though the baby's injection will only be given if it's 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.

Are you 18 years or older and currently pregnant?
Are you between 28 and 36 weeks and 6 days pregnant?
Are you expecting only one baby (not twins or triplets)?
Have you NOT already received an RSV prevention product in this pregnancy?
Are you willing to attend study appointments until your baby is 12 months old?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be placed into one of two groups. In the first group, you would receive a vaccine during your pregnancy. In the second group, you would receive the vaccine during pregnancy AND your baby would get a special injection when they are about 4 months old.

After joining, you and your baby will be followed up until your baby reaches 12 months of age. You will have study visits when your baby is born, at 4 months, and again at 12 months. If your baby shows signs of possibly having an RSV infection at any point, a gentle swab will be taken from their nose to check. We will try to make these visits fit in with your usual check-ups where possible.

Potential risks and benefits

By taking part, you could help protect both yourself and your baby from a serious RSV infection. Your family would also receive extra health checks and support throughout the study. This research will help doctors understand the best ways to prevent RSV, potentially leading to fewer hospital visits for babies and less strain on our healthcare system. There's always a very small chance of side effects with any medicine. For mothers, the vaccine might cause mild soreness, swelling, or tenderness where the injection was given, or you might feel a bit unwell with a headache, muscle aches, or a fever. For babies, the injection might cause some pain, redness, or swelling at the site, and possibly a mild fever or rash, but these are usually mild and go away quickly. These risks are not expected to be any different from those experienced with routine vaccinations or similar injections. You are free to withdraw from the study at any time.

Locations (1)

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

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Unverified
United Kingdom

Common questions

What is RSV?

RSV is a common virus that can cause cold-like symptoms, but it can lead to serious breathing problems, especially in young babies.

Why are pregnant women and babies often excluded from studies?

It's often harder to test new medicines in these groups due to safety concerns for both mother and baby, but this study aims to safely include them.

Will I know which group I'm in?

No, it's usually decided randomly, like flipping a coin, so the study can fairly compare the different treatments.

What happens if my baby gets RSV during the study?

If your baby shows symptoms, a swab will be taken to check for RSV, and they will receive standard medical care as needed.

Who is paying for this study?

The study is funded by the European Health and Digital Executive Agency (HaDEA) and the European Commission.

How to find out more

Giorgia Dalla Valle

giorgia.dallavalle@pentafoundation.org +39 049 964 0122 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.