Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A phase II, randomized, double-blind, multi-centre trial to evaluate the safety and immunogenicity of BIMERVAX® when coadministered with seasonal surface antigen, inactivated, adjuvanted influenza vaccine (SIIV) in adults older than 65 years of age fully vaccinated against COVID-19.

We’re looking for people over 65 who have already had their COVID-19 vaccines to join a study. This study is testing a new COVID-19 vaccine called BIMERVAX®. We want to see if it’s safe and how well your body makes protective germ-fighting cells when BIMERVAX® is given at the same time as a standard flu jab. We will also check how well the flu jab works. The study will carefully watch for any side effects from either vaccine. This research helps us understand if these vaccines can be given together easily and safely.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Hipra Scientific S.L.

Enrolment target

300

Start

14 Jul 2023

SARS-CoV-2 and Influenza

What is this study about?

This research study is looking at a new COVID-19 vaccine called BIMERVAX®. We want to see how it works in people aged 65 and over who have already had their COVID-19 jabs. Specifically, we're interested in what happens when this new COVID-19 vaccine is given at the same time as a standard flu jab (the kind that protects against different types of flu).

The main things we'll be checking are how safe the vaccines are together and how well your body creates special protective cells (called antibodies) against both COVID-19 and the flu. Antibodies are like your body's personal army, ready to fight off viruses. So, we'll be measuring how many of these protective cells your body makes after the vaccinations.

By doing this study, we hope to find out if giving both a new COVID-19 vaccine and a flu jab at the same time is a good and safe way to protect older adults. This could make it easier for people to get both important vaccinations without needing separate appointments, helping to keep our communities healthier.

Key takeaways

This study is for adults aged 65 and over who have had COVID-19 vaccines.
It tests a new COVID-19 vaccine, BIMERVAX®, alongside a common flu jab.
The main goals are to check vaccine safety and how well your body makes protective cells.
Participation involves clinics visits, blood tests, and tracking any side effects.
Your contribution helps understand better ways to protect older adults.

Who may be eligible?

This study is looking for volunteers who are 65 years old or older. You need to have already had all your recommended COVID-19 vaccines before joining.

As with all medical studies, there will be certain health conditions or medications that might mean you can't take part. These rules are in place to keep you safe and make sure the study results are clear and accurate. For example, if you have certain serious health problems or allergies, it might not be safe for you to join.

The research team will have a detailed chat with you to go through all the requirements carefully. They will ask about your health history to make sure this study is right 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 65 years old or older?
Have you already had your full set of COVID-19 vaccinations?
Are you generally in good health?
Are you able to attend several appointments over a period of time?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will be given a dose of the new BIMERVAX® COVID-19 vaccine, and some participants will also receive a standard flu vaccine at the same time. You won't know which combination you are receiving.

After your vaccination, we will closely monitor you for seven days to record any immediate reactions. You’ll also need to keep track of any side effects you notice throughout the study. You will have several visits to the study clinic where blood samples will be taken. These blood tests help us see how your body is responding to the vaccines by measuring your protective cells (antibodies). The study will involve a few follow-up visits over a period of time to ensure we have a full picture of the vaccine's effects and safety. The full duration of your participation will be explained by the study team.

Potential risks and benefits

Taking part in this study may offer the benefit of receiving protection against COVID-19 and/or flu, and you will contribute to important medical research that could help many others. However, like all vaccines, there is a chance of side effects, such as soreness at the injection site, feeling tired, or a mild fever. More serious reactions are rare but possible. The research team will explain all known risks to you. You are free to withdraw from the study at any time, for any reason, 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.

—
Unverified
Spain

Common questions

What is BIMERVAX®?

BIMERVAX® is a new COVID-19 vaccine that is being tested to see how well it works and if it's safe.

Why is this study only for people over 65?

Older adults are a key group because their immune systems can respond differently to vaccines, and we need to understand how well these vaccines work for them.

Will I get both a COVID-19 vaccine and a flu shot?

Some participants will receive both vaccines together, while others might receive only one or a different combination. The study team will explain the different groups.

What kind of side effects should I expect?

Common side effects can be mild, like a sore arm, feeling tired, or a slight headache. The study team will give you information on what to look out for.

How long will I be in the study?

The full length of your participation will be explained by the study team, but it will involve several visits over a period of time to monitor your health and vaccine response.