Study treatment questions

What study treatment will I receive during the study?

You will receive either one of the flu seasonal mRNA vaccines being studied or another vaccine already approved for the 2023-2024 flu season (also called the study control).

What does "study control" mean?

A study control is used as a benchmark or a point of comparison to see if the investigational product (the flu seasonal mRNA vaccine) has a beneficial effect.

How does the flu seasonal mRNA vaccine work?

The mRNA flu vaccine uses mRNA created in a laboratory to teach your cells how to make a protein that causes your immune system to recognize and fight against the flu virus when you come into contact with it. The vaccine does not give you the flu.

How are the study treatment groups assigned?

A computer is used to assign participants to study treatment groups by chance, like dealing from a shuffled deck of cards. This is called randomization.

Are there any side effects from the study vaccines?

If you have questions or would like more information, please talk to the study doctor.

General study questions

How long will I be in the study?

The study will last about 6-7 months.

How many times will I have to go to the study site?

You will need to come to the clinic for up to 6 planned visits and be available for 1-2 planned contacts. Unscheduled visits and contacts may be needed. The study doctor will let you know the exact number of planned visits and contacts. The contacts may be via telephone, SMS, email, video-telephone, or other means, depending on local best practice.

What are the benefits of being in the clinical study?

You may or may not directly benefit from being in the clinical study. However, you will have continuous monitoring by doctors, and any information collected during the study may help doctors learn more about protecting people from the flu.

Will it cost me anything to be in the study?

There will be no cost to you for the study vaccines, visits, tests, or supplies that are required for the study.

Who is sponsoring the study?

The company GlaxoSmithKline is sponsoring the study; they pay the study doctor and study site to run this study.

What if I decide to join the study and then change my mind?

Being in the study is completely voluntary. If you decide to join and then change your mind, you can leave the study at any time.