Influenza (Flu) is a seasonal respiratory illness, which affects the lungs and airways and is easily spread from person to person. It tends to flare up during the winter months each year and can be responsible for thousands of people visiting the hospital every day in the UK. It is estimated to cause 3 to 5 million cases of severe illness and up to 650,000 deaths each year worldwide.

The Fluent trial is being run, by Moderna,  to establish if their investigational seasonal flu vaccine may be able to prevent seasonal flu for people 50 years of age or older. The trial vaccine will be compared with the seasonal flu vaccine which is already approved for use and is the current standard practice to evaluate the safety and immune response. The investigational vaccine is an m-RNA based vaccine. This type of vaccine aim to teach the body how to make a specific protein that may potentially help the immune system prevent or treat certain diseases. The hope is that the vaccine trains the immune system cells to “remember” these proteins and helps your body quickly protect against the strain of infection if exposed in the future.

This trial is a Phase 3, randomised, double-blind, active-control, evidence-driven clinical trial. This means the investigational vaccine has been through several stages of trials already and so the purpose of this trial is to evaluate the efficacy and safety for use in a large group of people as it is the last phase of testing before it can be made available for public use. It is a randomised double-blinded trial, it means the participant will receive either the investigational drug or the standard approved drug but neither they or the research nurses will know which one.

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