NextCOVE: A clinical trial of an investigational COVID-19 vaccine for adults 18+ and teens over 12.

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.

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 up to 8,472 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.

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

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.