Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Phase 3, Randomized, Observer-blind, Active-controlled, Case-driven Study to Investigate the Safety, Efficacy, and Immunogenicity of mRNA-1010 Candidate Seasonal Influenza Vaccine Compared with a Licensed Inactivated Seasonal Influenza Vaccine in Adults ≥50 Years of Age

This research study is looking at a new type of flu vaccine called mRNA-1010 for people aged 50 and above. The main goal is to check its safety and how well it works at preventing the flu, compared to the flu jab currently available. Participants will receive either the new vaccine or the existing one. Researchers will carefully watch for any side effects and see how many people get the flu during the flu season. They will also take blood samples to understand how the body's immune system responds to the vaccine. This is a "Phase 3" study, meaning it's a large trial to confirm the vaccine's benefits before it could be approved for wider use.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Moderna Inc.

Enrolment target

15,490

Start

06 Sep 2024

Influenza

What is this study about?

This study is about developing a new vaccine to protect people from the flu. The flu, or influenza, is a common illness that can make people feel very unwell, especially older adults. This research focuses on a new type of flu vaccine, which uses messenger RNA (mRNA) technology. You might have heard of mRNA vaccines being used for COVID-19, and this study explores its use for seasonal flu.

The main purpose of this study is to find out if this new mRNA flu vaccine, called mRNA-1010, is safe and works well. They want to compare it to a flu vaccine that is already approved and used. Researchers will be looking to see if the new vaccine helps prevent people from getting the flu and how often people experience any side effects. They're particularly interested in adults aged 50 and over, as this age group can be more vulnerable to serious flu complications.

Participants will be randomly chosen to receive either the new mRNA vaccine or the existing flu vaccine. Doctors and nurses will then carefully monitor everyone to track any health changes or how well they are protected from the flu throughout the season. This type of detailed study helps ensure that any new vaccine is both safe and effective before it can be made widely available.

Key takeaways

Tests a new mRNA flu vaccine for adults aged 50 and over.
Compares the new vaccine to an existing flu jab.
Main goals are to check for safety and how well it prevents the flu.
Participants will be monitored closely for side effects and flu infections.
Contribution to developing better flu prevention.
Study lasts for approximately six months.

Who may be eligible?

This study is specifically looking for volunteers who are 50 years old or older. If you are 50 or above, you might be able to take part in this research.

Both men and women are welcome to participate. The study is open to adults across a wide age range, starting from 50 years old, with no upper age limit mentioned.

Other specific health conditions or medications you might be taking would also be considered. If you are interested, a medical team would check your full health history to make sure taking part is safe and right for you.

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 50 years old or older?
Are you generally in good health for your age?
Are you open to receiving either a new vaccine or a standard flu jab?
Are you able to attend regular clinic visits and provide blood samples?
Are you prepared to potentially record daily health information for a period?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive either the new mRNA flu vaccine or a licensed flu vaccine, given as an injection. Throughout the study, you would visit the clinic for check-ups and provide blood samples. These visits allow the research team to monitor your health, check for any side effects, and see how your body responds to the vaccine. You would also be asked to keep a record of any symptoms you experience. The study will generally last until the end of the flu season, which is typically around six months (181 days) after your vaccination, with close monitoring during the first few weeks.

Potential risks and benefits

Taking part in this study might offer the benefit of receiving a flu vaccine that could protect you against the flu. You would also be contributing to important medical research that could lead to new ways to prevent seasonal flu for many people. As with any vaccine or medication, there's always a chance of side effects, which could be mild, like a sore arm, or in rare cases, more serious. The research team will explain all known risks and carefully monitor your health. Remember, you can choose to leave the study at any time, for any reason, without it affecting your medical care.

Locations (5)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Germany
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Unverified
Bulgaria
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Unverified
Estonia
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Unverified
Finland
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Unverified
Belgium

Common questions

What is an mRNA vaccine?

An mRNA vaccine teaches your body's cells how to make a harmless piece of a virus, like the flu. This piece then triggers your immune system to create protective antibodies, so if you encounter the real flu virus, your body is ready to fight it off.

Why is this study focused on people aged 50 and over?

Older adults can be more seriously affected by the flu. This study wants to make sure the new vaccine is safe and works well for this important age group.

Will I know if I received the new vaccine or the standard one?

No, it's a "blind" study, meaning neither you nor the study doctors will know which vaccine you received. This helps ensure unbiased results.

What kind of side effects are they looking for?

They will be looking for common side effects like pain at the injection site, headache, or feeling tired, as well as any other unexpected health changes. They will monitor you closely.

How long will I be in the study?

You'll be monitored closely for about six months (181 days) after your vaccination, with the most frequent checks happening in the first month.