Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Phase 3, open-label, randomized, controlled study to evaluate the immune response, safety and reactogenicity of RSVPreF3 OA investigational vaccine when co-administered with a COVID-19 mRNA vaccine (Omicron XBB.1.5) in adults aged 50 years and above.

This research is a 'Phase 3 trial' which means it's one of the final stages before a new medicine might become widely available. Doctors are studying a new vaccine for Respiratory Syncytial Virus (RSV), a common virus that can cause severe breathing problems, especially in older adults. For this study, they want to see how well the new RSV vaccine works and how safe it is when given to people aged 50 and above. Crucially, they are also testing what happens when this new RSV vaccine is given at the same time as an updated COVID-19 vaccine that targets the Omicron XBB.1.5 variant. The main goal is to check the body's immune response to both vaccines and to understand any side effects.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

GlaxoSmithKline Biologicals

Enrolment target

600

Start

03 Jun 2024

Respiratory Syncytial Virus Infections

What is this study about?

Imagine the common cold, but sometimes much worse – that's a bit like Respiratory Syncytial Virus, or RSV. For older adults, RSV can lead to serious lung infections like pneumonia. Scientists are developing a new vaccine to protect people from RSV, and this study is a really important step to see how well it works and if it's safe.

This particular study is focusing on adults aged 50 and over. A key part of the research is to see what happens when the new RSV vaccine is given at the same time as an updated COVID-19 vaccine (specifically the one designed for the Omicron XBB.1.5 variant). This is important because if both vaccines can be given together, it might make it easier for people to get both protections in one go.

The researchers will be looking closely at people's immune responses – that's how well their body makes protective fighters (called antibodies) against both RSV and COVID-19. They will also carefully record any side effects people experience to make sure the vaccines are safe. This kind of research helps doctors understand if the new RSV vaccine is effective and can be conveniently given alongside other important vaccines.

Key takeaways

Tests a new RSV vaccine for people aged 50 and over.
Checks safety and immune response when given with an updated COVID-19 vaccine.
Aims to see if both vaccines can be given at the same time.
Study lasts about 6 months, with several clinic visits.
Helps scientists understand vaccine effectiveness and side effects.

Who may be eligible?

This study is looking for volunteers who are 18 years old or older. There is no upper age limit, meaning older adults are very welcome to participate. Both men and women can join the study.

To be suitable, you would need to be generally healthy and able to attend clinic appointments. The screening process would involve some checks to make sure the study is right for you and that you meet all the health requirements for taking part.

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 generally healthy?
Are you able to attend several clinic appointments over 6 months?
Do you want to help researchers learn about new vaccines?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would attend several appointments at a clinic over several months. At your first visit, after discussing the study and agreeing to join, you'd have some health checks and blood tests. You would then receive the experimental RSV vaccine and the COVID-19 vaccine, likely as injections.

After vaccination, you'd be asked to keep a diary of any symptoms or side effects for a few days. You would then have follow-up visits and blood tests at specific times, for example, about a month after your vaccination, and then several months later. These blood tests help researchers see how your immune system is responding. The total study duration would be around 6 months from your vaccination.

Potential risks and benefits

Potential benefits of taking part could include contributing to scientific knowledge about new vaccines, which may help protect many people in the future. You would also receive close medical monitoring throughout the study. Like all medicines, vaccines can have side effects, which might include soreness or redness at the injection site, tiredness, or a headache, but serious side effects are rare. All possible risks will be fully explained before you decide to take part. Remember, joining a study is always your choice, and you are free to withdraw at any time without giving a reason, and it won't affect your 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
Spain
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Unverified
Belgium
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Unverified
Netherlands

Common questions

What is RSV?

RSV stands for Respiratory Syncytial Virus. It's a common virus that usually causes mild, cold-like symptoms, but it can be more serious for older adults or very young children, sometimes leading to lung infections.

What does 'Phase 3' mean for a trial?

Phase 3 is one of the final stages of clinical trials. It involves a large number of people to confirm the vaccine's effectiveness and safety before it can be considered for wider public use.

What vaccines are being tested?

The study is testing a new RSV vaccine (called RSVPreF3 OA investigational vaccine) and an updated COVID-19 mRNA vaccine (targeting the Omicron XBB.1.5 variant).

Will I know which vaccine I get?

This is an 'open-label' study, which means both you and the study team will know which treatment you are receiving.

What happens if I get sick during the study?

You will be closely monitored throughout the study, and any health concerns or side effects should be reported to the study team immediately so they can provide appropriate care and record the information.