Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

Phase III, randomized, observer-blind, placebo-controlled, multi-center, multinational study to evaluate the efficacy, immunogenicity, and safety of a Respiratory Syncytial Virus vaccine in infants and toddlers (PEARL)

This research, called PEARL, is a large study looking at a new vaccine designed to protect babies and toddlers from a common lung virus called Respiratory Syncytial Virus (RSV). RSV often causes cold-like symptoms, but it can lead to more serious lung infections, especially in young children. The study will give some children the new vaccine and others a dummy vaccine (placebo) to fairly compare them. Scientists will then carefully check to see if the vaccine prevents lung infections caused by RSV during the first winter season after taking part. They will also monitor for any side effects and how the body's immune system responds to the vaccine.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Sanofi Pasteur Inc.

Enrolment target

340

Start

06 May 2024

Virus diseases

What is this study about?

This study, called PEARL, is a very important piece of research looking into a new vaccine for Respiratory Syncytial Virus (RSV). RSV is a common germ that affects the lungs and airways. While it often causes mild cold-like symptoms in older children and adults, it can be quite serious for babies and toddlers, sometimes leading to breathing difficulties and hospital stays.

The main goal of this study is to find out if this new vaccine can effectively prevent these serious lung infections in very young children. To do this, researchers will compare a group of children who receive the new vaccine with another group who receive a 'dummy' vaccine, known as a placebo. This comparison helps scientists understand the true effect of the new vaccine. They will also be closely monitoring the children for any side effects to make sure the vaccine is safe.

By carefully studying how the vaccine works and if it's safe, researchers hope to develop a new way to protect young children from the potentially severe effects of RSV. This could make a real difference to the health of many families during the colder months when RSV is most common.

Key takeaways

This study is testing a new vaccine against RSV.
It aims to protect babies and toddlers from serious lung infections.
Some children will receive the vaccine, others a dummy treatment (placebo).
Safety and effectiveness are being carefully monitored.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

This study is open to babies and toddlers. The study doesn't mention specific age limits, but it's designed for very young children who are most at risk from RSV.

Both boys and girls can take part. The researchers will look at various health factors to make sure the study is right and safe for your child.

It's important to discuss your child's full medical history with the study team to confirm if they can participate.

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 a baby or toddler?
Does my child suffer from any long-term medical conditions?
Has my child received any other vaccines recently, or are they due for others?
Is my child generally healthy?
Can I commit to regular visits for my child if needed?

Answer every question to see your result.

What does participation involve?

If your child takes part, they will likely receive a dose of either the new RSV vaccine or a dummy vaccine (placebo). You won't know which one your child receives, and neither will the study doctors, to keep the results fair. Your child will have regular check-ups and assessments, especially during the first winter season after vaccination, which is when RSV is most active. This might involve clinic visits and possibly providing samples, such as nose swabs, to check for RSV infection if your child develops cold symptoms. The study team will explain everything in detail, including the number of visits required and the total length of your child's participation.

Potential risks and benefits

Taking part in any study has potential benefits and risks. The potential benefit here is that your child might receive a vaccine that could protect them from serious RSV lung infections. However, there's always a possibility the vaccine may not work, or your child might experience side effects, just like with any medication or vaccine. You will be given full information about known side effects. It's crucial to remember that participation is completely voluntary, and you are free to withdraw your child from the study at any time, for any reason, without it affecting their usual medical care.

Locations (3)

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

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Unverified
Germany
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Unverified
Spain
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Unverified
Finland

Common questions

What is RSV?

RSV stands for Respiratory Syncytial Virus. It's a common virus that can cause cold-like symptoms, but in young children, it can lead to more serious lung infections like bronchiolitis or pneumonia.

What is a vaccine?

A vaccine is a medicine designed to teach your body's immune system to fight off a specific germ, like a virus, so you don't get sick or get less sick if you encounter it.

What does 'placebo-controlled' mean?

It means some children in the study will get the new vaccine, and others will get a 'dummy' injection (a placebo) that looks the same but contains no medicine. This helps researchers fairly compare the vaccine's effects.

Will my child get sick from the vaccine?

The vaccine is designed not to cause illness. However, like any vaccine, it might cause mild side effects like a fever or soreness where the injection was given. The study will monitor this carefully.

How long will the study last?

The study will primarily focus on monitoring your child during the first RSV 'season' (typically the winter months) after they receive the vaccine. The full duration will be explained by the study team.