A Phase 3 Study to Evaluate the Clinical Efficacy of an mRNA Based Seasonal Influenza Vaccine in Older Adults ≥65 Years of Age

The FLU SV MRNA-006 study is testing a new mRNAbased vaccine designed to protect against multiple flu virus strains.

The vaccine aims to enhance the immune system’s ability to recognize and fight off multiple flu virus strains. This may reduce the severity of the illness and provide better defence, even when the vaccine isn’t an exact match for the flu strains circulating in a particular year.

What is the flu?

The flu (influenza) is an infection that affects the nose, throat and lungs. Most people who catch the flu recover within a few days. However, some people have a greater chance of catching and developing complications from the flu, including pneumonia. Getting vaccinated (the flu shot) is the best way to avoid catching the flu. However, flu viruses constantly change to outsmart the body’s immune system, which is why people need to take a new flu shot every year.

What is the mRNA vaccine and how does it work?

Vaccines protect us by teaching the immune system to recognize and fight infections. Traditional vaccines often use safe pieces of viruses or bacteria. Scientists have now developed a new method called messenger RNA (mRNA) which uses a brief, temporary genetic message (mRNA) to teach your cells to make a harmless part of a virus. It is important to note that this mRNA does not alter DNA and does not expose you to the virus or cause the flu.

When your cells make this viral piece, your immune system treats it as a warning and makes special defenses called antibodies. Those antibodies remain in your body and enable faster recognition and fight of the virus to prevent illness and potentially severe complications.

The study is looking for volunteers 65 years of age and above.

Before starting the trial, you will go through the informed consent process. This is where you will learn about why the study is being done, what procedures will be involved, and what the benefits and risks are if you decide to participate.

If you agree to take part in the study, you will be asked to sign a consent form, which may be on paper or through an online form. During this process, you should ask the study doctor any questions you have about the study.

Participants:

• will receive either the investigational mRNA flu vaccine or the standard flu shot (the study control) at random.
• will not know which injection they will receive. They will be compensated for their time and travel.
• will receive just one injection of the study vaccine.
• will need to attend up to 3 planned visits. There may also be a few unscheduled visits/contacts as well.

During the study you may:

• Attend clinic visits, where staff will do tests to monitor your process and ensure your safety
• Provide updates about your health by answering questions in the electronic Diary Application.
• Collect and return nasal swab samples, if you have influenza symptoms.
• Give blood samples