A Clinical Trial of a Seasonal Influenza (Flu) Vaccine for Adults Over 50

Trial ID: mRNA-1010-P304 (UK)

Trial Details

The Fluent Trial is a Phase 3 clinical trial being conducted by Moderna to evaluate the safety and immune response of an mRNA-based investigational vaccine aimed at preventing seasonal influenza (flu) in adults 50 years of age or older. An investigational vaccine is not yet approved by a country’s drug regulatory agency and there are currently no approved mRNA seasonal flu vaccines on the market.

Seasonal flu is a respiratory illness caused by the influenza virus. The virus affects the lungs and airways and is easily spread from person to person.

mRNA vaccines 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 your immune system cells to “remember” these proteins and helps your body quickly protect against the strain of infection if exposed in the future. The investigational vaccine in this clinical trial, mRNA-1010, aims to protect against seasonal flu.

Flu is estimated to cause 3 to 5 million cases of severe illness and up to 650,000 deaths each year worldwide.

Estimated Enrolment

Approximately 56,000 Participants

Phase

3

Eligibility Criteria

Participants must:

Be 50 years of age or older
Be in good health
Not be pregnant or planning on becoming pregnant for at least 3 months following the injection visit

Participants must not:

Have received an approved seasonal flu vaccine in the past 6 months or investigational seasonal flu vaccine from another flu trial in the past year
Have had a confirmed flu infection in the past 6 months

Site Locations

Sites are located in the towns/cities identified with the red pin:

What to Expect

Participation in the Fluent Trial will last approximately 8 months and includes at least 2 in-person visits to a clinical trial site and at least 3 phone calls with the trial team.

Participants will be given 1 injection in the upper arm.

Each participant will be randomly assigned, like flipping a coin, to receive either the investigational vaccine mRNA-1010 or a currently approved seasonal flu vaccine which will be used as a comparison to understand whether the investigational vaccine works and is safe.

All trial participants will get the same level of quality care regardless of which injection they will receive.

All trial participants will be asked to use an electronic diary (eDiary) app on their smartphone (or a provided device) to complete regular entries throughout the clinical trial.

Insurance is not needed to participate, and all trial-related procedures and exams will be covered at no cost. Qualified participants will receive payment for their trial-related time and travel.

Frequently Asked Questions (FAQs)

What is Seasonal Influenza?

Seasonal influenza (flu) is a respiratory illness caused by the influenza virus. The virus infects the lungs and airways and is easily spread from person to person. Every year, seasonal flu causes 3 to 5 million cases of severe illness and up to 650,000 deaths worldwide. Seasonal flu more severely affects older adults. Often, flu activity starts to increase in October and peaks between December and February.

What is a clinical trial?

Clinical trials are carefully controlled scientific studies that evaluate how well investigational or modified medicines may treat or prevent diseases in people. Clinical trials are conducted to answer questions such as:

Is the investigational treatment or vaccine safe enough to outweigh the risks?
What is the best dose needed for the investigational treatment or vaccine to work?
How often should the investigational treatment or vaccine be given?
How effective is the investigational treatment or vaccine at treating or preventing symptoms or the condition?

A clinical trial follows a protocol that has been approved by regulatory agencies to ensure patients’ and trial participants’ safety. The protocol outlines the types of trial participants to include, the schedule of visits and procedures, safety precautions, and what and how data will be analyzed.

What are the phases of clinical trials?

Clinical trials are conducted in phases. Each phase of the trial has a different purpose and helps scientists answer different questions:

In Phase 1 trials, researchers test an investigational vaccine, drug, or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 trials, the investigational vaccine, drug, or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
In Phase 3 trials, the investigational vaccine, drug, or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 trials, post marketing studies delineate additional information including the drug’s risks, benefits, and optimal use.

Reference: https://www.ciscrp.org/education-center/important-information/#faq

Why is diversity important in clinical trials?

Clinical trials and trial volunteers are vital to advancing research of an investigational vaccine that may potentially protect people of all ages and from all backgrounds.

Given that different populations and ages can respond differently to medical therapies, it is extremely important that this clinical trial include people of all ages, sexes, races, and ethnicities to ensure the investigational vaccine is safe and effective for everyone to use.

Will compensation for time be available as part of this clinical trial?

Qualified participants will receive payment for their trial-related time and travel.

Does the mRNA-1010 investigational vaccine contain a live virus?

The investigational vaccine being evaluated in this clinical trial is called mRNA-1010. Unlike vaccines that are made from weakened or killed viruses, mRNA-1010 is made from messenger RNA (mRNA), an instructional molecule that naturally occurs in the body and tells cells how to make specific protein. The goal of this vaccine is that the protein will trigger the body’s immune system to create the antibodies it needs to fight the real influenza virus, should it ever enter your body. You cannot get the flu from the mRNA-1010 investigational vaccine.

How can I check to see if I am eligible for this trial?

You can check if you are potentially eligible for this trial by completing a set of screening questions. You can find these on this web page by clicking the ‘Get Started’ button.

Can I remove myself from the trial at any time?

Participation is voluntary. You have the right to end your participation in the clinical trial at any time for any reason, or no reason at all. The clinical trial doctor or sponsor also has the right to discontinue a participant at any time for that person’s safety or if the participant no longer meets the trial requirements.