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A clinical trial evaluating investigational mRNA vaccines in adults

Trial ID: mRNA-CRID-001

A clinical trial conducted by Moderna is evaluating the safety and efficacy of investigational mRNA vaccines to better understand how they work in adults ages 18–75. Your participation could advance important research by contributing to our understanding of mRNA vaccines and helping us learn more about how different populations respond to them.

Trial Details

In the mRNA-CRID-001 trial, researchers are evaluating the safety, effectiveness, and immune response of investigational mRNA vaccines and how they work in the body. Research dedicated to understanding immune system responses can provide valuable insights during the development of new medicines and treatments, including mRNA vaccines.

The purpose of this clinical trial is to analyze the human body’s response to several mRNA vaccines and an approved flu vaccine. Each participant will receive between 1 and 3 doses of a single vaccine in the clinical trial. Of the 4 different mRNA vaccines tested in this trial, 3 are investigational (still being researched), and 1 has been approved for the prevention of COVID-19. Since people may respond differently to medical treatments and vaccines, it is important to identify similarities, differences, and patterns between how mRNA vaccines work in the body to protect against viruses.

Participation in this trial will last up to 19 months.

Estimated Enrollment

300 Participants

Phase

Eligibility Criteria

Participants must:

Be between 50 and 75 years old
Be in good health

Participants must not:

Have tested positive for COVID-19 or been in contact with anyone diagnosed with COVID-19 within 2 weeks prior to investigational vaccine administration
Have received an influenza (flu) vaccine within the past 6 months
Have received a COVID-19 vaccine within the past 4 months
Have been infected with influenza, RSV, CMV, or SARS-CoV-2 within the past 6 months
Be pregnant or breastfeeding
Have participated in a clinical trial within the past month

[#<OpenStruct header_icon="clipboard-check", heading="What to Expect", content="Participation in this clinical trial lasts up to 19 months and includes up to 20 in-person trial site visits and 5 phone calls.\n\nThe vaccines being evaluated in this clinical trial include:\n\n- Moderna’s approved COVID-19 vaccine, SPIKEVAX\n- Investigational influenza (flu) vaccine, mRNA-1010\n- Investigational respiratory syncytial virus (RSV) vaccine, mRNA-1345\n- Investigational cytomegalovirus (CMV) vaccine, mRNA-1647 \n- A commercially-available approved flu vaccine\n\nParticipants will be randomly selected to receive 1 of the following:\n\n- A single dose of SPIKEVAX, mRNA-1010 investigational vaccine, mRNA-1345 investigational vaccine, or the commercially-available flu vaccine\n- Two doses of mRNA-1647 investigational vaccine\n- Three doses of mRNA-1647 investigational vaccine\n\nParticipants’ onsite visits may include medical examinations like a physical exam, nasal swab, or blood draw. \n\nParticipants will have occasional phone calls with the clinical trial staff. During these phone calls, the clinical trial doctor and medical staff will check how the participant is feeling and ask for updates on their health. \n\nParticipants will be asked to use an eDiary app on their smartphone or trial-provided device to complete entries about any symptoms for the duration of the clinical trial. \n\nInsurance is not needed to join this clinical trial, and compensation for your time and travel may be provided.">]

Site Locations

Participants will need to go to one of the clinical trial sites taking part in this trial.

What to Expect

Participation in this clinical trial lasts up to 19 months and includes up to 20 in-person trial site visits and 5 phone calls.

The vaccines being evaluated in this clinical trial include:

Moderna’s approved COVID-19 vaccine, SPIKEVAX
Investigational influenza (flu) vaccine, mRNA-1010
Investigational respiratory syncytial virus (RSV) vaccine, mRNA-1345
Investigational cytomegalovirus (CMV) vaccine, mRNA-1647
A commercially-available approved flu vaccine

Participants will be randomly selected to receive 1 of the following:

A single dose of SPIKEVAX, mRNA-1010 investigational vaccine, mRNA-1345 investigational vaccine, or the commercially-available flu vaccine
Two doses of mRNA-1647 investigational vaccine
Three doses of mRNA-1647 investigational vaccine

Participants’ onsite visits may include medical examinations like a physical exam, nasal swab, or blood draw.

Participants will have occasional phone calls with the clinical trial staff. During these phone calls, the clinical trial doctor and medical staff will check how the participant is feeling and ask for updates on their health.

Participants will be asked to use an eDiary app on their smartphone or trial-provided device to complete entries about any symptoms for the duration of the clinical trial.

Insurance is not needed to join this clinical trial, and compensation for your time and travel may be provided.

Frequently Asked Questions (FAQs)

What is an mRNA vaccine?

Normally vaccines for viruses are made from a weakened or inactive (not live) virus, but mRNA vaccines are different. They are made from an instructional molecule called mRNA, which tells cells how to make specific proteins. Basically, it helps the body protect itself by giving your cells directions on how to fight the virus, should it enter your system.

Can I get sick from any of the investigational vaccines?

You cannot get infected with a virus from an mRNA vaccine.

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 analyzed.

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 trials delineate additional information including the drug’s risks, benefits, and optimal use.

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 different populations and ages can respond differently to medical therapies, it is extremely important that this clinical trial includes children of all ages, sexes, races and ethnicities to ensure the investigational 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 and travel will be available. We realize it takes a lot of time to come for site visits, so we want to make sure this is not too much of a burden. The clinical trial site will review all these details with you. Also, you do not have to pay anything to be in the trial and you do not need to have medical insurance to participate. All trial-related tests and procedures are provided at no cost to you.

What happens if I get sick while in this trial?

Each clinical trial participant will be closely monitored by the trial doctor and medical staff for any virus symptoms during the mRNA-CRID-001 Trial. If a participant is diagnosed with any illness during the trial, the medical team will notify the participant’s primary care physician and the medical team will continue to closely monitor the participant’s well-being.

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?

Participants have the right to drop out of the clinical trial at any time for any reason, or no reason at all. The trial doctor or sponsor also has the right to discontinue a person’s participation at any time for the participant’s safety, or if the participant no longer meets the clinical trial requirements.