A clinical trial of an influenza vaccine for volunteers ages 18 and older

Trial ID: mRNA-1010-P301

A clinical trial conducted by Moderna is evaluating an investigational vaccine that may protect against seasonal influenza, commonly known as “the flu.” Seasonal flu is a common cause of sickness, severe illness, and even death.

Trial Details

The mRNA-1010-P301 clinical trial is evaluating the safety and immune response of an investigational vaccine that may protect against seasonal influenza (flu). The investigational mRNA-1010 vaccine is being compared to a currently available licensed flu vaccine. All participants will receive either the investigational mRNA-1010 vaccine or the currently available licensed flu vaccine.

Flu is estimated to cause 3 to 5 million cases of severe illness and up to 650,000 deaths each year. Current flu vaccinations rarely exceed 60% overall effectiveness.

mRNA-1010 is an investigational flu vaccine, based on mRNA technology.

Estimated Enrolment

6,000 Participants

Phase

3

Eligibility Criteria

Participants must:

Be 18 years of age or older
Be in good health

Participants must not:

Have had close contact with someone who has tested positive for COVID-19 within 10 days prior to initial screening visit
Have received any vaccine in the past month, or plan to in the next month
Have received a seasonal flu shot in the past 6 months
Have participated in another trial in the past 28 days

Site Locations

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

What to Expect

Participation in this clinical trial lasts up to 13 months and includes phone calls and visits to the trial site.

Participants will be given one injection in the upper arm. Participants will either receive the investigational vaccine, mRNA-1010, or a currently available licensed flu vaccine.
Participants will be asked to attend in-person site visits including a Screening Visit, a Vaccination Visit, and up to three subsequent site visits (Month 1, Month 6, and Month 12). There will also be an optional visit on Day 4, and additional visits may be scheduled.
Participants will be asked to have up to six phone calls with the clinical trial doctor to monitor for any symptoms. During these phone calls, the doctor and medical staff will check how you are feeling and ask for updates on your health.
Participants will be asked to use an eDiary app on a personal smartphone or a provided smartphone to report any symptoms you experience.
Participants will be closely monitored by the clinical trial team if any symptoms of influenza are reported at any time throughout their participation, and may be tested for influenza by nasal swab.

Insurance is not needed to join this clinical trial, and travel expenses will be reimbursed.

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 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 in order 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 analysed.

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 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 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 certain 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 vaccine is safe and effective for everyone to use.

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

Travel expenses related to clinical trial participation will be reimbursed. The clinical trial 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. You cannot get influenza from mRNA-1010.

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 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.

This trial is not actively recruiting.