Active not recruitingPHASE3INTERVENTIONAL

A Study to Investigate the Safety and Efficacy of mRNA-1403 in Participants ≥18 Years of Age for the Prevention of Acute Gastroenteritis

This study is looking into a new investigational vaccine called mRNA-1403. The main goal is to find out if this vaccine can safely and effectively prevent a severe type of stomach flu, specifically the one caused by norovirus. Norovirus is a common bug that can cause vomiting and diarrhoea. Researchers will be checking if the vaccine stops people from getting seriously ill with symptoms like stomach upset. They will also carefully monitor any side effects people might experience after getting the vaccine, comparing it to a dummy treatment (placebo). This study involves adults aged 18 and older, and it's a 'Phase 3' trial, which means it's a large study before potential approval.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

ModernaTX, Inc.

Enrolment target

37,864

Start

24 Sep 2024

Estimated completion

15 Feb 2027

Acute Gastroenteritis Norovirus Acute Gastroenteritis

What is this study about?

This research study is focused on a new vaccine, called mRNA-1403, and its potential to protect people from a very unpleasant illness known as acute gastroenteritis, often called the 'stomach flu' or 'sickness bug'. A common cause of this illness is norovirus, which can lead to severe vomiting and diarrhoea. This study aims to find out if mRNA-1403 can stop people from getting sick with this severe form of stomach flu, particularly that caused by norovirus.

Researchers will be looking at two main things. Firstly, they want to make sure the vaccine is safe and doesn't cause too many side effects. They'll compare it to a 'placebo', which is a dummy treatment that looks just like the vaccine but doesn't contain any active ingredients. This helps them see if any effects are truly due to the vaccine. Secondly, they want to see how well the vaccine works at preventing the stomach flu caused by the specific types of norovirus that the vaccine is designed to target.

Understanding how safe and effective this new vaccine is could be a big step forward in preventing outbreaks of stomach flu, especially in places like schools, hospitals, and cruise ships where norovirus can spread very easily. If successful, this type of vaccine could help reduce the number of people who get very unwell and need time off work or school, or even hospital care.

Key takeaways

New vaccine (mRNA-1403) being tested for severe stomach flu (norovirus).
Study checks vaccine safety and how well it prevents illness.
Adults aged 18+ can join; stable health conditions are okay.
Participation involves vaccine/placebo and regular health checks.
You could help advance medical understanding of stomach flu prevention.

Who may be eligible?

To join this study, you need to be at least 18 years old. You should also be able to understand what's involved and be willing to follow all the study's instructions, including attending appointments and carrying out any required tasks.

While you can have long-term health conditions, these must be stable. This means your condition shouldn't have caused you serious problems recently, and in the opinion of the study doctor, it shouldn't stop you from completing the study. For women, you cannot be pregnant or breastfeeding.

There are also some reasons why you might not be able to join. For example, if you've been sick with a fever or stomach flu within the last two weeks, or if you've been in close contact with someone who has. People with certain ongoing serious gut conditions that cause regular vomiting or diarrhoea may also not be suitable. The study doctor will discuss all these points with you to decide if the study is 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 18 years old or older?
Do you feel well enough to attend appointments and follow instructions?
Do you NOT have a fever or stomach flu right now?
Are you NOT pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be given either the new vaccine (mRNA-1403) or a placebo (a dummy injection that looks the same). You won't know which one you've received, and neither will the study team, to ensure fair results. You will have regular appointments where the study team will check your health, ask about any side effects, and potentially take blood samples to see how your body is reacting to the vaccine.

Throughout the study, you'll need to report any symptoms of stomach flu or other illnesses. The study will involve several visits to the clinic and continued follow-up over a period of time to track your health and how the vaccine is working. The exact number of visits and the full duration of your participation will be explained in detail by the study team, but it will be a period of ongoing monitoring.

Potential risks and benefits

Taking part in a study like this could mean you contribute to important medical research that might help prevent severe stomach flu in the future. However, there's no guarantee the vaccine will protect you, and you might experience side effects, just like with any medicine. These could include things like soreness where you had the injection, or feeling a bit unwell, which are often mild. There's also a chance you could still get stomach flu during the study. You will be closely monitored for any problems. Remember, joining is entirely your decision, and you have the right to leave the study at any time, for any reason, without it affecting your medical care.

Locations (283)

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

Accel Research Sites - Achieve Clinical Research
Verified postcode
Birmingham, United States
Cullman Clinical Trials
Verified postcode
Cullman, United States
Alliance for Multispecialty Research, LLC
Verified postcode
Daphne, United States
ClinMed, LLC
Verified postcode
Phoenix, United States
DM Clinical - Phoenix
Verified postcode
Phoenix, United States
HOPE Research Institute
Verified postcode
Phoenix, United States
HOPE Research Institute
Verified postcode
Phoenix, United States
Abby's Research Institute
Verified postcode
Phoenix, United States
Headlands Research Scottsdale
Verified postcode
Scottsdale, United States
Scottsdale Clinical Trials
Verified postcode
Scottsdale, United States
Hope Research Institute - Tempe
Verified postcode
Tempe, United States
Arizona Liver Health
Verified postcode
Tucson, United States

Common questions

What is 'acute gastroenteritis'?

It's the medical term for severe stomach flu, causing symptoms like vomiting and diarrhoea. Norovirus is a common cause.

What is 'Phase 3'?

It means this is a large study testing the new vaccine on many people to confirm it's safe and effective before it can be considered for general use.

Will I get the actual vaccine or a dummy one?

You will get one or the other, but neither you nor the study team will know which until the study is over. This is to make sure the results are fair.

What if I get sick during the study?

The study team will monitor your health closely and will be there to help and advise if you get sick or have any concerns.

Can I leave the study once I've joined?

Yes, you are free to leave the study at any time, for any reason, without it affecting your usual medical care.