Ongoing, recruitingPhase III and phase IV (Integrated)Interventional

A Phase 3, randomized, controlled, partially blind, immuno-bridging study to evaluate immunogenicity, reactogenicity, safety and the occurrence of RSV-associated respiratory tract illness after administration of a single dose of GSK’s RSVPreF3 OA investigational vaccine in adults aged 60 years and older.

This research is looking at a new vaccine designed to protect older adults from Respiratory Syncytial Virus (RSV), a common virus that can cause serious chest infections. The study involves people aged 60 and above and is testing a vaccine called Arexvy. Researchers want to see how well the vaccine helps the body create protective responses, how safe it is, and if it causes any side effects. They are also checking if it reduces the number of people getting sick with RSV. This is a large-scale study, meaning it's one of the final steps before a vaccine might become widely available.

At a glance

Status

Ongoing, recruiting

Phase

Phase III and phase IV (Integrated)

Sponsor

GlaxoSmithKline Biologicals

Enrolment target

560

Start

22 Jul 2024

Respiratory Syncytial Virus Infections

What is this study about?

Imagine feeling unwell with a cold that turns into something much worse, especially if you're older. That's what Respiratory Syncytial Virus, or RSV, can do. It's a common virus that usually causes mild cold-like symptoms, but for babies and older adults, it can lead to more serious breathing problems like bronchitis or pneumonia. This study is all about trying to find a way to protect older people from these more severe effects of RSV.

Researchers are testing a new vaccine called Arexvy. Think of it like a training exercise for your immune system, teaching it how to fight off RSV before you even get sick. The main things the study wants to find out are: how well the vaccine helps your body build up defences against RSV, if it causes any unwanted reactions or side effects, and crucially, if it actually prevents people from getting sick with RSV-related breathing problems. They're also comparing how people in different regions respond to the vaccine.

This important study is in its 'Phase 3' and 'Phase 4' stages. This means it's being tested on a larger group of people after earlier safety checks, bringing it closer to potentially being approved for wider use. By understanding how this vaccine works, scientists hope to provide a new tool to keep older adults healthier and reduce the impact of RSV.

Key takeaways

This study is testing a new RSV vaccine for people aged 60 and over.
It aims to see how well the vaccine boosts immunity and if it prevents serious illness.
The vaccine is called Arexvy.
Participants will receive the vaccine or a placebo and be monitored over time.
The findings will help understand if this vaccine can protect older adults from RSV.

Who may be eligible?

Generally, this study is looking for adults aged 60 years and older. Both men and women can take part.

There might be other specific health conditions or medications that would mean you can't join the study, as these could affect how the vaccine works or your safety. These details are usually checked carefully by the study doctors.

The research team will need to make sure the study is a good fit for you to keep you safe and ensure the results are clear.

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 60 years old or older?
Are you generally healthy enough to participate in a medical study?
Are you willing to attend regular follow-up appointments?
Are you comfortable with blood tests during the study?
Do you understand that you might receive a placebo instead of the active vaccine?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive a single dose of the vaccine (or a dummy injection if you are in a control group). You would then have several follow-up appointments over time, where doctors would check your health, ask about any symptoms or side effects, and take blood samples. These blood samples help them understand how your body is responding to the vaccine.

They would also closely monitor if you get any RSV-related illnesses and how severe they are. The total time you would be involved in the study can vary, often lasting for months, to see the longer-term effects of the vaccine and how your body continues to protect itself. You would be fully informed about the schedule of visits.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit could be protection against RSV if you receive the active vaccine. However, there's no guarantee it will work for everyone, and you might receive a placebo. Potential risks could include common vaccine side effects like soreness, redness, or swelling where the injection was given, or feeling achy or feverish for a short time. More serious side effects are rare but possible, and the research team will monitor you closely. You have the right to withdraw from the study at any time, for any reason, without it affecting your 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
Finland
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Unverified
Poland
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Unverified
Spain

Common questions

What is RSV?

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

What is Arexvy?

Arexvy is the name of the new vaccine being tested in this study. It's designed to help protect against RSV.

What does 'Phase 3' mean for a trial?

Phase 3 means the vaccine is being tested in a large group of people to see if it's safe and effective, before it can be considered for general use.

Will I definitely get the vaccine if I join?

Because this is a 'controlled' study, some participants will receive the vaccine and others might receive a placebo (a dummy injection with no active vaccine). This helps researchers compare the effects.

How long does the study last?

The study involves follow-up appointments over several months to see the long-term effects. The exact duration for you would be explained by the study team.