Rare Patient Voice

This trial is not actively recruiting.

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

A flu vaccine clinical trial

A clinical trial conducted by Moderna is evaluating whether investigational mRNA vaccines may protect people from seasonal influenza, commonly called “the flu.” Seasonal flu is a common cause of sickness, severe illness, and even death.

Trial ID: mRNA-1020-P101

Trial Details

The Spark Trial is evaluating the safety and immune response of investigational mRNA vaccines that may protect against the flu. Flu vaccines based on mRNA technology could potentially provide several benefits compared to current vaccines, including the ability to respond to changes in influenza strains more quickly, stronger immune responses, and improved protection in older adults.

Participants in this trial will be randomized to receive one of three investigational vaccines or an already-approved seasonal influenza vaccine. This allows researchers to study the safety and immune responsiveness of the investigational vaccines against the flu compared to other standard vaccines that are currently in use.

Estimated Enrollment

560 clinical trial participants Participants

Phase

1/2

Eligibility Criteria

Participants must:

Be between 18 and 75 years old

Participants must not:

Have participated in another trial within a month of the screening visit
Be pregnant or breastfeeding at the time of screening or be planning to breastfeed at any time while enrolled in the trial
Have had close contact to someone with SARS-CoV-2 (the virus that causes COVID-19) or flu-like illness within 10 days prior to the screening visit
Have received a seasonal flu vaccine in the past 6 months

What to Expect

Participation in the Spark Trial lasts approximately 7 months and includes phone calls, telemedicine visits, and around 6 visits to the clinical trial site.

Participants will be given one injection at their first visit after the screening visit. Participants have a chance of receiving either one of three investigational vaccines or an already-approved seasonal influenza vaccine.
Participants will be asked to return to the trial site for follow up visits and will also have phone calls with the trial team to check on participants’ health during some weeks that don’t have a trial site visit.
Participants will be asked to use an eDiary app on their smartphones or a provided smartphone following the injection and for 6 days following the injection.
Participants will be closely monitored by the trial team if any symptoms are reported at any time throughout your participation.

Insurance is not needed to join this clinical trial, and compensation for participants’ 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 the cities/states identified with the red pin:

Frequently Asked Questions (FAQs)

What is seasonal influenza (flu)?

Seasonal 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 the FDA and other regulatory agencies in order to ensure 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 trial data will be analyzed.

What are the phases of clinical research?

All new treatments and vaccines must go through several stages of research (also called “phases”) in order to determine if the investigational treatment or vaccine is safe and effective in people. Clinical trials are usually conducted in four phases that build on one another, with each phase designed to answer certain questions.

Preclinical Research: Before testing in people, investigational treatments undergo laboratory and animal testing to answer basic questions about safety.
Phase 1: A trial of a small number of participants to evaluate the safety and dosage of an investigational treatment or vaccine and gather information on how it interacts with the body.
Phase 2: A trial of a slightly larger group of participants to further evaluate how an investigational treatment or vaccine affects the body, gather additional safety data, and monitor side effects.
Phase 3: A trial with the largest number of participants to determine efficacy of an investigational treatment or vaccine and compare it to existing treatments, vaccines, or placebos. A Phase 3 trial continues to monitor side effects and collect safety data. This is the final step before submitting an investigational product to a regulatory agency for market approval.
Regulatory Agency Review: Regulatory agencies, such as the FDA in the United States, review data from the clinical trial and determine if the investigational treatment or vaccine is effective and safe for use in people. To get approved, the new treatment or vaccine must be determined to provide benefits that outweigh its known and potential risks for the intended population.
Phase 4: After receiving approval, the treatment is made available for use. Phase 4 trials are used for post-marketing observation. Sometimes, they may be used to study the medicine in a different group of people or in another illness or disease than was previously studied. Not all medications and treatments will require a Phase 4 trial.

Reference: https://www.fda.gov/patients/learn-about-drug-and-device-approvals/drug-development-process

Why is diversity important in clinical trials?

Clinical trials and their participants 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 trial includes people of all ages, genders, races and ethnicities to ensure the investigational vaccine is safe and effective for everyone to use.

Do the investigational mRNA vaccines contain a live virus?

Often vaccines for viruses are made from a weakened or inactive (not live) virus, but the mRNA investigational flu vaccines are different. They are made from messenger ribonucleic acid (mRNA), an instructional molecule that naturally occurs in the body and tells cells how to make protein. In this case, it is hoped that the man-made mRNA will instruct the immune system to recognize the virus protein and cause the body to make antibodies to fight the seasonal flu if infected in the future.

What is a comparator or placebo?

In order to understand if the investigational vaccines work, medical researchers are comparing the mRNA investigational flu vaccines to an already-approved flu 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 participants quit the trial at any time?

Participation in any clinical trial is completely voluntary. Participants have the right to drop out of the trial at any time and for any reason (and they do not need to give a reason). The trial doctor or sponsor also has the right to discontinue a participant at any time for the participant’s safety or if the participant no longer meets the clinical trial requirements.