Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Phase 2b, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy, immunogenicity and safety of one dose of OVX836 influenza vaccine 480μg, after intramuscular administration in healthy subjects aged 18-59 years

This study is looking into a new flu vaccine called OVX836. We're testing it in healthy adults between 18 and 59 years old. The main goal is to find out how effective one dose of this vaccine is at preventing the flu (specifically influenza Type A). We also want to understand how the body's immune system responds to it and check for any side effects. This is a "Phase 2b" study, meaning it's still in the earlier stages of development but involves more people than initial safety checks. Participants will be randomly given either the vaccine or a dummy treatment (placebo) without knowing which they received, to ensure fair results. The study will help us learn if this new vaccine could eventually offer good protection against the flu.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Osivax

Enrolment target

2,850

Start

04 Jun 2025

Influenza disease

What is this study about?

This study is all about trying out a new flu vaccine. It’s called OVX836, and the aim is to see how well it works to protect people from getting the flu, especially a common type called influenza A. We're also checking how safe it is and how your body reacts to it after you get the shot.

To make sure the results are fair, some people will get the new vaccine, and others will get a 'dummy' shot (called a placebo), which looks just like the vaccine but doesn't contain any active ingredients. Neither you nor the study team will know which you received. This helps us truly understand if the vaccine is making a difference compared to getting nothing.

We're focusing on healthy adults aged 18 to 59. The study is particularly interested in whether the vaccine can stop you from getting flu symptoms that are confirmed in a lab, like a sore throat, cough, fever, and feeling tired, which last for at least 24 hours. The findings from this study will help us decide if this vaccine should be tested in even larger groups of people, moving it closer to becoming a widely available flu shot.

Key takeaways

Tests a new flu vaccine (OVX836) in healthy adults.
Compares the vaccine to a 'dummy' shot (placebo).
Aims to check how well one shot protects against flu and its safety.
Includes adults aged 18 and older, both men and women.
Results could help develop better flu protection for the public.

Who may be eligible?

To join this study, you need to be a healthy adult aged 18 or older. There is no upper age limit, meaning people over 59 could also be eligible, as long as they meet other health criteria.

Both men and women can take part in this research. The study doctors will carefully check your general health to make sure you are suitable and that taking part would be safe for 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 generally in good health?
Are you able to attend study appointments regularly?
Do you understand that you might receive a placebo (dummy shot)?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll visit the clinic regularly. You'll receive either the study vaccine or a dummy shot. You'll be asked to keep track of any symptoms you might have and attend follow-up appointments. These visits will involve health checks, and potentially blood tests or swabs, to see how your body is responding and to check for flu if you get sick. The study will continue for a certain period after your vaccination, and you'll be told exactly what's involved and for how long during the consent process.

Potential risks and benefits

Taking part could help scientists learn more about how to protect people from the flu, which might benefit others in the future. However, there's no guarantee the vaccine will protect you, and you might still get the flu. Like all medicines, the vaccine might have side effects, such as soreness at the injection site or feeling unwell for a short time – these will be fully explained. You can decide to leave the study at any time, for any reason, without it affecting your medical care.

Locations (4)

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

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Unverified
France
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Unverified
Finland
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Unverified
Belgium
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Unverified
Germany

Common questions

What is the new vaccine called?

The new vaccine being tested in this study is called OVX836.

What is a 'dummy shot'?

A 'dummy shot', or placebo, is a treatment that looks like the real vaccine but doesn't contain any active ingredients. It helps us see if the vaccine itself is causing any effects.

What kind of flu is the study looking at?

The study is mainly focused on protecting against influenza Type A, which is a common type of flu.

How many vaccine shots will I get?

The study aims to test the effects of just one dose of the OVX836 vaccine.

Will I know if I got the real vaccine or the dummy shot?

No, neither you nor the doctors will know whether you received the vaccine or the dummy shot during the study. This is called 'double-blind' and helps keep the results fair.