Clinical Connection

This trial is not actively recruiting.

This trial has completed recruitment on this platform, and is no longer accepting new referrals.

A Flu vaccine study

A research study conducted by Moderna is testing an investigational vaccine that may protect people from Influenza, commonly called “the flu.” Seasonal flu is a common cause of sickness, severe illness, and even death.

Trial ID: NCT04956575

Trial Details

The mRNA-1010-P101 study is evaluating the safety and immune response of an investigational vaccine, called mRNA-1010, 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. Flu spreads each year, and because the virus is always changing and developing new strains, the traditional flu vaccine works by predicting what strains might be most common. Current flu vaccinations rarely exceed 60% overall effectiveness and are poorly effective when that prediction is not correct.

This study is testing a new type of flu vaccine, based on mRNA technology.

Estimated Enrollment

500 Participants

Phase

Eligibility Criteria

Participants must:

Be at least 18 years old
Be in generally good health, with any chronic conditions well-controlled

Participants must not:

Have participated in another study in the past month
Have received any vaccine in the past month, or plan to in the next month (other than a COVID-19 vaccination)
Have received a seasonal flu shot in the past 6 months

What to Expect

Participation in the mRNA-1010-P101 study lasts approximately seven months and includes phone calls and up to five visits to the study site.

You will be given one injection in the upper arm. You have a chance of receiving either the mRNA-1010 investigational vaccine or an already-approved seasonal influenza vaccine, called an active comparator.This allows researchers to study the safety and efficacy of the investigational vaccine against the flu compared to other standard vaccines that are currently in use.
After the study vaccination, you will be asked to return to the study site three times over the next six months. You will also have phone calls with the study doctor to monitor for any symptoms. During these phone calls, the study doctor and medical staff will check how you are feeling and ask for updates on your health.
You will be asked to use an eDiary app on your smartphone or a provided smartphone to report any symptoms you might experience following the injection and throughout participation.
You will be closely monitored by the study clinic team if any symptoms are reported at any time throughout your participation.

Insurance is not needed to join this clinical trial, and compensation for your time will be available.

You will need to travel to one of the study clinics taking part in this clinical trial. Sites are located in:

Not yet Recruiting

(Awaiting confirmation) Lenexa, Kansas, United States
(Awaiting confirmation) Greenville, South Carolina, United States
(Awaiting confirmation) Wilmington, North Carolina, United States
(Awaiting confirmation) Grand Island, Nebraska, United States
(Awaiting confirmation) Morehead City, North Carolina, United States

Frequently Asked Questions (FAQs)

What is Influenza (Flu)?

Influenza, commonly referred to as “the flu” is a virus that can cause infections of the lungs and respiratory tract. Flu is estimated to cause 3 to 5 million cases of severe illness and up to 650,000 deaths each year.

What is a clinical research study?

Clinical research studies include scientifically evaluated plans, or protocols, that outline how to test if a potential new medication or vaccine is safe and/or effective in people. All investigational medications and vaccines must be tested in clinical research studies before they can be submitted for approval by regulatory authorities. A clinical research study is conducted by doctors and researchers who follow strict guidelines to ensure the safety and wellbeing of the study volunteers who participate. Although side effects can occur in any clinical trial, the study is designed to minimize the risk and you will be monitored closely.

What are the phases of clinical research?

Clinical trials are conducted in phases. The trials at each phase have a different purpose and help scientists answer different questions:

In Phase 1 trials, researchers test a new 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 research studies and study volunteers are vital to creating a vaccine that will protect people of all ages and from all backgrounds against this devastating disease.

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

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

Yes, compensation for your time will be available. We realize it takes time to come for study visits, so we want to make sure this is not too much of a burden for you. The study site will review these details with you.

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

Often vaccines for viruses are made from a weakened or inactive (not live) virus, but the mRNA-1010 investigational vaccine is different. It is made from an instructional molecule called mRNA that tells your cells how to make protein. In this case, the protein is a small part of the virus that is thought to help the body’s immune system protect itself if you ever come in contact with the Influenza virus.

What is a comparator?

In order to understand if the investigational vaccine works, medical researchers are comparing the mRNA-1010 investigational vaccine to an already-approved seasonal influenza vaccine, called an active comparator. This allows researchers to study the safety and efficacy of the investigational vaccine against the flu compared to other standard vaccines that are currently in use.

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 quit the trial at any time?

You have the right to drop out of the study at any time for any reason, or no reason at all. The study doctor or sponsor also has the right to discontinue a study volunteer at any time for the volunteer’s safety, or if the study volunteer no longer meets the study requirements.