Ongoing, recruitingTherapeutic use (Phase IV)Interventional

A Pragmatic Randomized Trial to Evaluate the Effectiveness of High-Dose Quadrivalent Influenza Vaccine vs. Standard-Dose Quadrivalent Influenza Vaccine in Older Adults

This important study is comparing two types of flu vaccines for older adults: a high-dose one and a standard-dose one. The main goal is to find out if the high-dose vaccine is better at preventing hospitalisations caused by the flu or pneumonia. Researchers are also looking at whether it affects hospital stays for heart or breathing problems, overall hospital admissions, or even deaths. By understanding which vaccine is most effective, healthcare providers can make better recommendations to protect older people from serious flu-related illnesses. The study involves different flu vaccines already in use, including some that protect against COVID-19.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Gentofte Hospital, Sanofi Pasteur

Enrolment target

339,700

Start

28 Jun 2022

Prevention of influenza infection in older adults

What is this study about?

You might be wondering what this study is all about. Well, every year, getting the flu can be very serious, especially for older people. This study is designed to look closely at flu vaccines, which are a key way to protect ourselves. Specifically, it's comparing two types of flu vaccines that are given regularly: a 'high-dose' one and a 'standard-dose' one. The main question researchers want to answer is: does the high-dose flu vaccine do a better job of preventing older adults from needing to go to the hospital because of the flu or pneumonia, compared to the standard vaccine?

To answer this, they will be looking at important health outcomes. Beyond just flu and pneumonia hospitalisations, they'll also check if either vaccine influences the number of times people are hospitalised for other breathing or heart problems, how many times people are admitted to hospital for any reason, and even how many deaths occur. This helps give a complete picture of each vaccine's effectiveness.

This kind of study, called a 'Phase IV' or 'therapeutic use' study, often looks at medicines or vaccines that are already approved and being used. It's about understanding how well they work in real-world situations, like in a large group of people receiving their routine flu jabs. The results of this study could help doctors and healthcare providers make clearer recommendations for which flu vaccine might be best for older adults in the future, helping to keep more people healthy and out of hospital during flu season.

Key takeaways

Compares high-dose vs. standard flu vaccine for older adults.
Aims to prevent hospital stays for flu or pneumonia.
Looks at real-world effectiveness of approved vaccines.
Could help improve future flu vaccine recommendations.
Participation involves receiving one of the study vaccines.

Who may be eligible?

Generally, this study is open to older adults. It's designed to include both men and women across various age groups typically considered 'older adults'. You don't need to have a specific health condition other than being in the age group that routinely gets a flu vaccine.

The study aims to include a wide range of older adults to ensure the findings are helpful for many people. Your doctor or the study team would be able to confirm if you meet all the specific criteria to join.

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 an older adult who typically gets a flu vaccine?
Are you able to receive a flu vaccine?
Are you happy for your health information to be used for research (anonymously)?
Are you interested in contributing to research that might improve flu prevention for others?

Answer every question to see your result.

What does participation involve?

The exact details of taking part would be explained by the study team, but generally, it involves receiving one of the two types of flu vaccines that are being compared. You would continue to receive your usual medical care and the study would then track your health using information from your medical records. This means you might not have extra hospital visits specifically for the study.

The study would monitor aspects like whether you were admitted to hospital for flu, pneumonia, or other reasons. You would be followed for a certain period, likely over one flu season, to see how effective the vaccine is. The total duration of your participation would depend on the study design, but it usually covers the period when flu is most active.

Potential risks and benefits

Taking part in this study means you would receive an approved flu vaccine, which already has a known safety record. Potential benefits include helping researchers understand which flu vaccine offers better protection for older adults. This knowledge could lead to improved public health advice. As with any vaccine, there's always a chance of side effects, usually mild, like a sore arm, but serious reactions are rare. You would be fully informed about these. Importantly, your decision to join is voluntary, and you are free to withdraw from the study at any time 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
Denmark

Common questions

What is the main purpose of this study?

The main purpose is to see if a high-dose flu vaccine is better than a standard flu vaccine at preventing older adults from being hospitalised due to flu or pneumonia.

What does 'high-dose' mean for a flu vaccine?

A high-dose flu vaccine contains more of the active ingredient, which some studies suggest might give older adults a stronger immune response and better protection.

Will I know which vaccine I'm getting?

Often in studies like this, you won't know if you're getting the high-dose or standard vaccine to ensure the results are fair. The study team will explain this fully.

Will taking part involve extra doctor's appointments?

This study tracks health information from your existing medical records, so it's unlikely to involve many extra appointments beyond your usual care, but the study team will confirm this.

What kinds of flu vaccines are being looked at?

The study involves different flu vaccines that protect against four strains of flu, including common ones like Efluelda and Vaxigriptetra.