A clinical trial of an investigational COVID-19 vaccine for adults and teens over 12 (US & Canada)

Trial ID: mRNA-1283-P301

The NextCOVE Study is a Phase 3 clinical trial conducted by Moderna to evaluate an investigational bivalent vaccine that may protect people from getting sick if they come into contact with the virus that causes COVID-19 and multiple variants, including the Omicron variant.

Trial Details

The NextCOVE Study is evaluating mRNA-1283.222, one of Moderna’s bivalent COVID-19 investigational vaccines that may protect people from getting sick if they come into contact with the virus that causes COVID-19. A bivalent vaccine addresses multiple variants at the same time, including the Omicron variant. Moderna will be studying this new investigational vaccine as a booster dose in children and adults to learn more about how it works in the body.

You or your child, along with approximately 10,748 other individuals, will be helping researchers learn more about Moderna’s latest investigational vaccine that may help protect people from getting sick if they come into contact with the virus. You or your child’s participation could contribute to a potential solution to the evolving COVID-19 pandemic, which has affected the entire world.

If you are based in the U.K. and are looking for the U.K. page, click here: U.K. Trial Page

Estimated Enrollment

10,748 Participants

Phase

3

Eligibility Criteria

Participants must:

Be at least 12 years old
Have received a COVID-19 vaccine
If over 18 years old, have also received at least 1 booster dose of a COVID-19 vaccine

A booster dose is not required for participants younger than 18 years of age. All trial participants will receive medical care from the trial doctor while in the NextCOVE Study.

Participants must not:

Have had a positive COVID-19 test within 3 months prior to the screening visit
Have been exposed to someone with SARS-CoV-2 infection or COVID-19 within 2 weeks prior to receiving the first vaccination
Have received a COVID-19 vaccine within 3 months prior to the screening visit

Site Locations

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

What to Expect

Participation in the NextCOVE Study will last approximately 13 months and includes up to 7 visits to a trial site and 3 safety phone calls.

You or your child will be chosen at random to receive either the investigational booster dose of mRNA-1283.222 or mRNA-1273.222. By comparing the investigational vaccines, medical researchers can better understand how well the investigational vaccine works.

All trial participants will receive the same level of quality care regardless of which investigational vaccine they receive.

You or your child will also be asked to complete electronic diary (eDiary) entries for the duration of the trial to report any COVID-19 symptoms that may occur.

Insurance is not needed to participate, and qualified participants will receive payment for their trial-related time and travel.

Frequently Asked Questions (FAQs)

What is COVID-19?

COVID-19 is a respiratory illness caused by the SARS-CoV-2 virus. Common symptoms are similar to the flu and include fever, cough, and tiredness. More serious symptoms include difficulty breathing and, in rare cases, death. The World Health Organization declared COVID-19 a pandemic in March 2020. Since that time, there have been more than 500 million cases and 6.2 million deaths worldwide.

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 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 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 different 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 investigational vaccine is safe and effective for everyone to use.

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

Qualified participants will receive payment for their trial-related time and travel.

Does the mRNA-1283.222 investigational vaccine contain a live virus?

The investigational vaccine being evaluated in this clinical trial is called mRNA-1283.222. Unlike vaccines that are made from weakened or killed viruses, mRNA-1283.222 is made from messenger RNA (mRNA), an instructional molecule that naturally occurs in the body and tells cells how to make specific protein. The goal of this vaccine is that the protein will trigger the body’s immune system to create the antibodies it needs to fight the real SARS-CoV-2, the virus that causes COVID-19. You cannot get COVID-19 from the mRNA-1283.222 investigational vaccine.

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 remove myself from the trial at any time?

Participation is voluntary. You have the right to end your participation in 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.