Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Phase 3b, open-label study to evaluate the non-inferiority of the immune response and to evaluate the safety of the RSVPreF3 OA investigational vaccine in adults 18-49 years of age at increased risk of respiratory syncytial virus disease, compared to older adults ≥60 years of age.

This research is looking at a new vaccine, called Arexvy, designed to protect against Respiratory Syncytial Virus (RSV). We are inviting adults aged 18 to 49 who are at a higher chance of getting seriously ill from RSV. The main purpose is to see if their immune response to the vaccine is similar to that seen in older adults (aged 60 and over). We'll be checking how well their body makes protective immune cells and also carefully monitoring for any side effects from the vaccine. This is a 'Phase 3b' study, meaning it's one of the final stages of testing before a vaccine might become widely available.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

GlaxoSmithKline Biologicals

Enrolment target

Start

24 May 2024

Respiratory Syncytial Virus Infections

What is this study about?

This study is about a new vaccine to protect against a common germ called Respiratory Syncytial Virus, or RSV. RSV usually causes cold-like symptoms, but it can be more serious, especially for very young babies, older adults, and people with certain health conditions. This new vaccine, called Arexvy, is being tested to see how well it works.

We know that older adults are more at risk from RSV, and this vaccine has already been looked at in that age group. This study is focusing on younger adults, specifically those aged 18 to 49 who might be at a greater risk of getting very sick from RSV. The main thing we want to find out is if the vaccine helps their bodies create a similar level of protection (immune response) as it does in older adults.

We'll also be keeping a very close eye on safety, checking for any side effects or reactions to the vaccine. This type of study (Phase 3b) is important because it helps us understand if the vaccine is an effective and safe option for more people.

Key takeaways

The study is testing a new RSV vaccine called Arexvy.
It's for adults aged 18-49 who may be at higher risk for RSV.
Researchers will check how well the vaccine boosts the immune system.
Safety and side effects will be carefully monitored throughout.
The study helps decide if the vaccine could be used more widely.
Participation involves receiving the vaccine, blood tests, and check-ups over 6 months.

Who may be eligible?

This study is looking for adults who are aged 18 years or older. There is no upper age limit for participation.

Both men and women are welcome to take part in this research.

The study is specifically looking for people who might be at a higher risk of getting seriously ill from RSV. Your doctor would help determine if this applies to you.

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 able to attend appointments for blood tests and check-ups?
Do you understand what taking part in a vaccine study means?
Are you potentially at higher risk for RSV, as discussed with a doctor?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will receive the study vaccine. Researchers will then check your blood at different times to see how your immune system responds. You'll have check-ups to make sure you're feeling okay and to record any side effects. This monitoring will involve regular contact with the study team. They will ask about your health and any new symptoms you might have. The study will last for about 6 months in total.

Potential risks and benefits

Participating in research always comes with potential benefits and risks. You might benefit from the protection the vaccine offers against RSV, but this isn't guaranteed. Like all medicines and vaccines, there's a chance you could experience side effects, which the study team will monitor closely. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

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

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Unverified
Germany

Common questions

What is RSV?

RSV stands for Respiratory Syncytial Virus. It's a common virus that usually causes mild, cold-like symptoms, but can sometimes lead to more serious breathing problems, especially in babies, older people, and those with certain health issues.

What is a 'vaccine'?

A vaccine helps your body learn to fight off certain infections. It usually contains a tiny, harmless part of a virus or bacteria, which teaches your immune system how to make protective cells that can then quickly defend you if you encounter the real germ.

What does 'immune response' mean?

An immune response is how your body reacts when it encounters a germ or a vaccine. It's your immune system building up its defenses, like making special proteins called antibodies, to protect you from getting sick.

What is a 'Phase 3b' study?

This means the vaccine has already gone through earlier safety and effectiveness tests. In this phase, researchers are gathering more information about its effects in larger groups of people, sometimes focusing on specific patient groups or comparing it with existing treatments.

Will I have to pay to be in the study?

No, you will not have to pay to participate in the study. All study-related care and the vaccine itself are provided free of charge.