Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

CONCOMITANT ADMINISTRATION OF LICENSED VACCINES AGAINST COVID-19 AND FLU WITH OR WITHOUT MF59 ADJUVANT: A MULTI-CENTRE, RANDOMIZED, SINGLE-BLIND CLINICAL TRIAL TO ASSESS IMMUNOGENICITY IN ADULTS AGED 65 AND OVER

This research study is investigating what happens when older adults, aged 65 and over, receive their COVID-19 and flu vaccines at the same time. The main goal is to understand how well their immune system responds to both vaccines when given together, especially how many protective antibodies they produce. We also want to check if this combined vaccination is safe and if there are any side effects. By seeing if these vaccines can be given together without reducing their effectiveness or increasing risks, we hope to find ways to make vaccination more convenient for older people, ensuring they get the protection they need against both COVID-19 and the flu.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Cr2o B.V.

Enrolment target

120

Start

30 Sep 2024

COVID-19 and flu

What is this study about?

This study is designed to help us understand the best way to give important vaccines to older people. We know that both COVID-19 and the flu can be serious for those aged 65 and over, so it's vital they are well protected. This research looks at whether these two vaccines can be given at the same time without making them less effective or causing more side effects. Getting both vaccines together could mean fewer trips to the doctor or clinic, making it easier for people to stay protected against two common illnesses.

The main thing we're looking at is how well your body creates protective antibodies after getting the vaccines. Antibodies are like little soldiers in your immune system that fight off viruses. We'll be measuring these antibodies at different times to see how strong your immune response is and how long it lasts. We'll also be carefully checking for any side effects, both common and more serious ones.

Ultimately, the goal is to make sure that older adults can get the best possible protection against both COVID-19 and the flu in a way that is safe and convenient for them. This study will give us important information to help guide future vaccination programmes in the UK.

Key takeaways

Tests giving COVID-19 and flu vaccines together.
For adults aged 65 and over.
Checks how well the body responds (antibodies).
Monitors for any side effects.
Aims to make vaccination more convenient.
Study lasts for about three months.

Who may be eligible?

This study is particularly looking for adults aged 65 and over. Both men and women are welcome to take part.

While the raw information provided didn't list specific reasons why someone might not be able to join, generally, clinical studies have certain health requirements to ensure safety and that the results are clear. For example, if you have certain severe health conditions, allergies to vaccine ingredients, or are taking medications that affect your immune system, you might not be suitable. This is to protect your health and make sure the study results accurately reflect how the vaccines work in the general older population.

If you're interested in taking part, the study team would have a chat with you and go through your medical history in detail to make sure this study is right for you. They will explain everything clearly.

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 65 years old or older?
Are you able to attend several appointments over three months?
Are you generally in good health?
Are you willing to have blood samples taken?
Are you comfortable not knowing if you received a placebo or vaccine during the study?

Answer every question to see your result.

What does participation involve?

If you decide to participate in this study, you will receive either the COVID-19 vaccine and a flu vaccine (one of which might include an ingredient called MF59 to boost the immune response), or a placebo (a salt-water injection) along with one of the vaccines. You will receive these as single injections into your arm.

After your vaccination, you will have several follow-up appointments. These will involve taking small blood samples to check your body's immune response to the vaccines. These blood tests will happen on days 0 (the day of vaccination), 10, 28, and a final check at day 90. You will also be asked to keep track of any side effects you might experience, especially in the first few days and weeks after vaccination. The total duration of your participation in the study will be about three months.

Potential risks and benefits

Participating in this study might offer several potential benefits, such as receiving protection against COVID-19 and/or the flu, and helping researchers understand the best ways to provide these vaccines, which could benefit many older adults in the future. However, like all medical treatments, there are potential risks. You might experience common side effects from the vaccines, such as soreness, redness, or swelling where you had the injection, headache, muscle aches, or feeling tired. More rarely, serious side effects can occur, which the study team will monitor closely. You also have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (2)

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

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Unverified
Belgium
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Unverified
Netherlands

Common questions

What is the main purpose of this study?

To see if COVID-19 and flu vaccines can be given at the same time safely and effectively to people aged 65 and over.

What kind of vaccines will be used?

The study uses currently approved COVID-19 and flu vaccines, and some participants might receive a salt-water injection instead of a real vaccine for comparison.

How long will I be in the study?

Your participation will last for about three months in total.

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

This is a 'single-blind' study, meaning you won't know which treatment you receive, but the study team will know for safety reasons.

What does checking antibodies mean?

It means taking blood samples to measure how well your body makes protective substances to fight off the viruses after vaccination.