What is it?
The NextCOVE Study is testing an investigational vaccine for COVID-19 called mRNA-1283.222. The vaccine is bivalent which means that it has been designed to fight against multiple different types, or variants of the virus that causes COVID-19, including the Omicron variant. Moderna will be evaluating this investigational vaccine as a booster dose in children and adults to learn more about how it works in the body.

Study Aims
The purpose of this clinical research study is to develop a new vaccine for coronavirus disease (COVID- 19). mRNA-1283.222 is a vaccine being studied in this clinical research study. 

ModernaTX, Inc. is using the same technology as the previously approved and authorised mRNA COVID- 19 vaccines, to develop additional SARS-CoV-2 mRNA vaccines that may be as protective as the currently authorised vaccine but at a lower dose level. It is likely that this study vaccine may also be more stable for a longer period stored at refrigerated temperatures than the mRNA-1273.222 vaccine.  

This study will investigate if mRNA-1283.222 when given as a booster dose in participants aged 12 years and older is safe and effective in prevention of COVID-19, when compared to the authorised vaccine, SPIKEVAX (mRNA- 1273.222). 

Participants: 

• have visits to the study site that may include questions about their health,
• have physical examinations, blood tests, nasal swab collection and other medical tests 
• are asked to complete an electronic study diary 
• receive the study vaccine 
• are randomly assigned to receive one of these study vaccines:
  • mRNA-1283.222: The new vaccine, being tested. 
  • mRNA-1273.222: A vaccine currently authorised to prevent COVID-19. 

 They will be in the study for approximately 13 months. This includes at least 5 study visits at site, and 3 visits by phone, as well as possible unscheduled visits, if needed. 

MAIN FUNDING BODY