Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Phase 3, Randomized, Observer-Blind, Controlled, Multicenter, Clinical Study to Evaluate Immunogenicity and Safety of a High-Dose MF59-Adjuvanted Quadrivalent Subunit Cell-derived Influenza Vaccine (aQIVc HD) in Comparison with a Non-adjuvanted Quadrivalent Recombinant Influenza Vaccine (QIVr) and an MF59-Adjuvanted Quadrivalent Subunit Egg-derived Influenza Vaccine (aQIV), in Adults Aged 50 Years and Older.

This research study is testing a new high-dose flu vaccine designed for people aged 50 and older. It's called a 'quadrivalent' vaccine, meaning it protects against four different flu strains. We want to see how well it helps your body create protection (immunity) compared to two other common flu jabs. We're also closely monitoring its safety. The study involves a large group of people and is 'observer-blind,' which means some people involved won't know which vaccine you've received, to keep the results fair. We're hoping to find out if this new vaccine offers stronger and longer-lasting protection against the flu for older adults.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Seqirus UK Limited

Enrolment target

2,100

Start

25 Sep 2023

Healthy individuals or individuals with stable comorbidities which increase their risk of complications from influenza infection.

What is this study about?

This study is looking into a new, stronger flu jab specifically for people aged 50 and over. Flu can be more serious for older adults, so finding effective ways to protect them is very important. This new jab is designed to give a more powerful immune response.

We're comparing this new high-dose jab with two other flu jabs that are already available. The main things we're trying to figure out are: how well each jab helps your body produce protective antibodies against four different flu strains, and how safe each jab is. We want to see if the new jab creates a stronger or faster immune response, which could mean better protection for you.

This kind of study, called a Phase 3 trial, is a crucial step before a new medicine or vaccine can be widely used. It helps us confirm if the new jab is both effective and safe for a wide range of people who might need it. Your participation helps us gather vital information to improve flu prevention.

Key takeaways

Tests a new high-dose flu jab for people aged 50+.
Compares it to two existing flu jabs.
Aims to check effectiveness (immune response) and safety.
Participation involves a single jab and follow-up for about one year.
Could help improve flu protection for older adults.

Who may be eligible?

This study is looking for adults aged 50 and older. You could be considered if you are generally healthy.

It's also open to people who have certain long-term health problems, as long as these are stable and well-managed. These are conditions that might put you at higher risk if you catch the flu.

There might be other detailed health requirements, so it's best to discuss your full medical history with the study team to see if you're a good fit.

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 50 years old or older?
Are you generally healthy?
Do you have stable long-term health conditions that are well-managed by a doctor?
Are you willing to attend regular appointments for about one year?
Are you comfortable with blood tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll receive one dose of a flu jab—either the new high-dose jab or one of two other existing flu jabs. These will be given as a single injection, usually in your upper arm.

Over the next year, you'll have several visits or check-ins with the study team. They will take blood samples to measure how your body is responding to the vaccine, and they'll ask you about any side effects you might experience. You'll be asked to keep track of any symptoms for a week after the jab, and then for any health issues that come up during the study. The total study will last for about a year.

Potential risks and benefits

Taking part could offer the benefit of potentially receiving a flu jab that might give you better protection. However, like all medicines, there's a chance of side effects, such as soreness or redness where you had the injection, or general aches and pains. More serious side effects are rare, but the study team will monitor you closely. You have the right to leave 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
Denmark
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Unverified
Estonia
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Unverified
Germany

Common questions

What is a 'high-dose' flu jab?

A high-dose flu jab has more of the active ingredient compared to regular flu jabs, which is designed to create a stronger immune response, especially in older adults.

Why is this study only for people aged 50 and over?

Older adults can be more vulnerable to serious flu complications, and their immune systems may respond differently to vaccines, so specific jabs are being developed for this age group.

Will I know which jab I receive?

No, this is an 'observer-blind' study. Some of the study team and you won't know which vaccine you get. This helps ensure the results are fair and unbiased.

What are 'stable comorbidities'?

These are long-term health conditions that are well-controlled by medication or other treatments, and not causing active problems that would interfere with the study.

How long will I be involved in the study?

Your participation in the study will last for about one year from the day you receive the vaccine.