RecruitingPHASE2INTERVENTIONAL

Phase 2b Study of a Respiratory Syncytial Virus and Human Metapneumovirus (RSV+HMPV) Protein Vaccine Candidate in Adults 60 Years of Age and Older

This research study is looking for adults aged 60 and over to test a new vaccine. The vaccine is designed to help prevent two common chest infections called Respiratory Syncytial Virus (RSV) and Human Metapneumovirus (HMPV). These infections can cause coughs, colds, and breathing difficulties, especially in older people. The study aims to find out if the new vaccine is safe and effective in preventing these illnesses. Participants will either receive the new vaccine or a dummy injection (called a placebo). We are looking for around 8,000 volunteers in total to help us understand the vaccine's benefits.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Sanofi

Enrolment target

8,000

Start

09 Sep 2026

Estimated completion

05 Jul 2028

Respiratory Syncytial Virus Human Metapneumovirus Healthy Volunteers

What is this study about?

This study is about testing a new vaccine that could help protect older adults from two common viruses: Respiratory Syncytial Virus (RSV) and Human Metapneumovirus (HMPV). These viruses are a bit like cold or flu viruses and can cause chest infections, breathing problems, and other health issues, especially for people over 60.

The main goal is to see if this new vaccine can prevent people from getting sick with RSV or HMPV. We also want to check if it's safe and how your body reacts to it. Some people will get the actual vaccine, and others will get a placebo, which looks like the vaccine but doesn't contain any active ingredients. This helps us fairly compare the vaccine's effects.

This is a 'Phase 2b' study, meaning it's an important step in testing a new treatment. If this study shows the vaccine works well and is safe, it could move closer to being available to everyone who needs it. Your participation is vital in helping us find new ways to keep older adults healthy.

Key takeaways

This study is testing a new vaccine against RSV and HMPV viruses.
It's for adults aged 60 and over to see if the vaccine is safe and works.
Participants will get either the new vaccine or a dummy injection (placebo).
Your involvement helps medical research find ways to protect older adults.
You can leave the study at any time if you wish.

Who may be eligible?

To join this study, you need to be at least 60 years old when you sign up. The study team will also do a health check to make sure you're suitable and that taking part would be safe for you. They'll ask about your medical history and do a simple examination.

There are some reasons why you might not be able to join. For example, if you have a weakened immune system, have recently had certain strong medications that affect your immune system, or if you've had a serious allergic reaction to vaccines before. Also, if you've had a condition called Guillain-Barré Syndrome, or if you've already received a vaccine or special treatment for RSV or HMPV, you wouldn't be able to take part. However, if you are living with stable HIV, you could still be eligible.

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?
Do you have a healthy immune system?
Have you had any strong treatments that affect your immune system in the last 6 months?
Have you had a serious allergic reaction to a vaccine or medicine before?
Have you ever had Guillain-Barré Syndrome?
Have you already had an RSV or HMPV vaccine or special treatment?

Answer every question to see your result.

What does participation involve?

If you join the study, you'll receive a single injection, either the new vaccine or a placebo, into your muscle (usually your arm). This will happen early in the study. You won't know if you've had the vaccine or the placebo, and neither will the study staff; this is to make sure the results are fair.

After your injection, the study team will keep in touch with you to check on your health and see if you develop any symptoms of RSV or HMPV. They will also look at how your body's immune system responds to the injection. The study will involve a few visits to the clinic and possibly some phone calls or follow-up questionnaires over a period of time. The total duration of your involvement will be explained in full by the study team.

Potential risks and benefits

Taking part in a study like this could help us find new ways to protect people from serious illnesses. While there's no direct benefit to you from the vaccine, knowing you're contributing to medical science can be rewarding. As with any injection, you might experience some mild side effects like soreness, redness, or swelling where you had the jab, or perhaps a slight fever or headache. More serious side effects are rare. All possible risks will be fully explained before you decide to join. Remember, you can choose to leave the study at any time, for any reason, without it affecting your medical care.

Locations (21)

Investigational Site Number : 0360008
Unverified
Bruse, Australia· Recruiting
Investigational Site Number : 0360006
Verified postcode
Blacktown, Australia· Recruiting
Investigational Site Number : 0360007
Verified postcode
Maroubra, Australia· Recruiting
Investigational Site Number : 0360002
Verified postcode
Albion, Australia· Recruiting
Investigational Site Number : 0360003
Verified postcode
Sippy Downs, Australia· Recruiting
Investigational Site Number : 0360009
Verified postcode
Melbourne, Australia· Recruiting
Investigational Site Number : 8260012
Verified postcode
Cardiff, United Kingdom· Recruiting
Investigational Site Number : 8261010
Verified postcode
Bournemouth, United Kingdom· Recruiting
Investigational Site Number : 8263010
Verified postcode
Dorchester, United Kingdom· Recruiting
Investigational Site Number : 8260013
Verified postcode
London, United Kingdom· Recruiting
Investigational Site Number : 8260011
Verified postcode
London, United Kingdom· Recruiting
Investigational Site Number : 8262010
Verified postcode
Portsmouth, United Kingdom· Recruiting

Common questions

What are RSV and HMPV?

They are common viruses that can cause cold-like symptoms, coughs, and breathing problems, especially in older adults.

Will I know if I get the vaccine or the placebo?

No, you won't know, and neither will the study team. This is done to make the study results fair and unbiased.

What is a Phase 2b study?

It's an important stage of testing a new treatment to see how well it works and if it's safe in a larger group of people.

How many injections will I get?

You will receive a single injection into your muscle at the start of the study.

Can I leave the study if I change my mind?

Yes, you can withdraw from the study at any time, for any reason, without affecting your regular medical care.

How to find out more

Trial Transparency email recommended (Toll free for US & Canada)

contact-us@sanofi.com 800-633-1610 Official trial record

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