Ongoing, recruitingPhase I and Phase II (Integrated)- First administration to humansInterventional

A Phase 1/2, randomized, dose-finding/dose-confirmation study to evaluate the reactogenicity, safety and immunogenicity of mRNA-based multivalent seasonal influenza vaccine candidates administered in healthy younger and older adults

This research is looking into new types of flu vaccines made with mRNA technology. These vaccines could offer improved protection against the seasonal flu. The study aims to find out how safe these new vaccines are, what side effects they might cause, and how well they help your body create an immune response to fight off the flu virus. Researchers will compare these new vaccines against existing flu jabs already in use. This trial includes both younger and older healthy adults and is an early stage of testing, meaning it's among the first times these specific vaccines are being given to people. The information gathered will be vital in deciding if these new flu vaccines can be developed further.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- First administration to humans

Sponsor

GlaxoSmithKline Biologicals, GlaxoSmithKline Biologicals

Enrolment target

438

Start

19 Apr 2023

Healthy volunteers (prevention of influenza infection)

What is this study about?

This study is a really important step in developing new flu vaccines. It's looking at modern mRNA (messenger RNA) vaccines, which are a different way of teaching your body to recognise and fight off viruses like the flu. Researchers want to see how well these new vaccines work and if they are safe for people to use.

The main goals are to understand how your body reacts to these new vaccines. They'll be checking for any side effects, whether they're mild like a sore arm, or more serious ones. They also want to measure how good these vaccines are at helping your immune system build up protection against the flu.

This is an 'early stage' study, which means it's among the first times these specific vaccines are being given to people. By comparing them to flu vaccines already available, scientists can learn a lot about their potential benefits and how they perform. The results will help decide if these new vaccines should move forward to larger studies.

Key takeaways

Tests new mRNA flu vaccines in healthy adults.
Compares them to existing flu vaccines.
Checks vaccine safety and side effects carefully.
Measures how well the body builds flu protection.
Involves regular health checks and blood tests.
Your participation lasts about six months.

Who may be eligible?

This study is looking for healthy adults, both younger and older, who want to help prevent flu infections. You need to be at least 18 years old to take part, and there's no upper age limit mentioned.

Both men and women can join the study. Generally, being in good overall health is key for this type of research. The study will confirm if you meet all the specific health requirements before you can participate.

If you have any serious ongoing medical conditions, or have recently had certain illnesses or treatments, you might not be suitable for this particular study. It's important to discuss your full medical history with the study team.

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 healthy?
Are you able to attend regular clinic appointments for about six months?
Are you able to understand and agree to the study requirements?
Do you want to help research to prevent flu?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll receive one of the new flu vaccines or an existing flu jab. You'll have several visits to the clinic, especially in the first month, to check how you're feeling and to take blood samples. These samples help researchers see how your body is reacting to the vaccine and building up protection.

For the first week after your vaccine, you'll be asked to keep track of any side effects you notice, particularly around the injection site or general body reactions. You'll also report any other health problems you experience for nearly a month, and serious health events will be monitored for about six months.

In total, your participation in the study will last for around six months. During this time, you'll have follow-up visits to continue checking your health and immune response. You'll always be able to ask questions and discuss any concerns with the study team.

Potential risks and benefits

Taking part in a study like this helps advance medical science and could lead to better flu vaccines in the future, benefiting many people. You'll also be closely monitored by medical professionals. Potential risks include common vaccine side effects like a sore arm, fever, or headache, which are usually mild and temporary. More serious side effects can occur, but these are rare. You have the right 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.

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Unverified
Belgium

Common questions

What is an mRNA vaccine?

An mRNA vaccine teaches your body how to make a small, harmless piece of a virus. Your immune system then learns to recognise and fight off the real virus if you later come into contact with it.

Will I get the flu from the vaccine?

No, you cannot get the flu from any of the vaccines in this study. They don't contain the live flu virus.

How long will I be involved in the study?

Your participation in the study will last for approximately six months from the day you receive the vaccine.

What if I feel unwell during the study?

The study team will monitor your health closely and will be available to answer any concerns or if you feel unwell. You'll be asked to report any health issues you experience.

Will I know if I received the new vaccine or an older one?

This is a 'randomised' study, meaning you might get one of the new vaccines or an existing flu jab. This helps researchers compare them fairly. You might not know which one you received until the study is over, or sometimes not at all.