A Study of mRNA-1283.222 Injection Compared With mRNA-1273.222 Injection in Participants ≥12 Years of Age to Prevent COVID-19 (NextCOVE)
COVID-19
About this trial
This is an interventional prevention trial for COVID-19 focused on measuring mRNA-1283.222, mRNA-1273.222, SARS-CoV-2, SARS-CoV-2 Vaccine, Coronavirus, Virus Diseases, Messenger RNA, COVID-19, COVID-19 Vaccine, Moderna
Eligibility Criteria
Key Inclusion Criteria: Investigator's assessment that the participant understands and is willing and physically able to comply with protocol-mandated follow-up, including all procedures. For female participants of childbearing potential: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first injection, and agreement to continue adequate contraception or abstinence through 90 days following the vaccine administration. Has previously received a primary series of an authorized/approved COVID-19 vaccine. For participants ≥18 years of age, at least 1 booster dose must have also been received. Proof of prior vaccination is required. A heterologous vaccine regimen is acceptable. Key Exclusion Criteria: Has had close contact, as defined by the Centers for Disease Control and Prevention (CDC), with someone who had a SARS-CoV-2 infection in the past 14 days, or COVID-19 in the past 10 days. Participant is acutely ill or febrile (temperature ≥38.0 degree Celsius [°C]/100.4 degree Fahrenheit [°F]) 72 hours prior to or at the Screening Visit or Day 1. Any medical, psychiatric, or occupational condition, including reported history of substance abuse, that, in the opinion of the investigator, might pose additional risk due to participation in the study or could interfere with the interpretation of study results. Has received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 181 days prior to Screening (for corticosteroids ≥10 mg/day of prednisone equivalent) or is anticipating the need for immunosuppressive treatment at any time during participation in the study. Has received or plans to receive any licensed vaccine ≤60 days prior to the study injection (Day 1) or plans to receive a licensed vaccine within 60 days after the study injection. Has received systemic immunoglobulins or blood products within 90 days prior to the Screening Visit or plans to receive during the study. Has donated ≥450 milliliters (mL) of blood products within 28 days prior to the Screening Visit or plans to donate blood products during the study. Has participated in an interventional clinical study within 28 days prior to the Screening Visit based on the medical history interview or plans to do so while participating in this study. Note: Other inclusion and exclusion criteria may apply.
Sites / Locations
- Optimal Research
- Accel Research Sites- Achieve Clinical Research
- Chandler Clinical Trials
- Phoenix Clinical Research LLC
- FRC - CCT Research
- Headlands Research Sarasota
- Clinical Research Consortium
- Noble Clinical Research, LLC
- Del Sol research Management LLC.
- Lynn Institute of the Ozarks
- Anaheim Clinical Trials, LLC
- Velocity Clinical Research, Banning
- Velocity Clinical Research- Chula Vista
- Benchmark Research
- Marvel Clinical Research 002, LLC
- Velocity Clinical Research Huntington Park
- Velocity Clinical Research
- Chemidox Clinical Trials
- Long Beach Clinical Trials
- Velocity Clinical Research- Westlake
- Velocity Clinical Research-North Hollywood
- Empire Clinical Research
- CenExel - CITrials
- Artemis Institute for Clinical Research
- Peninsula Research Associates
- Benchmark Research
- Artemis Institute for Clinical Research
- Acclaim Clinical Research
- Lynn Institute of Denver
- Velocity Clinical Research Denver
- Tekton Research - Fort Collins
- Tekton Research, Inc- Longmont Center
- Alliance for Multispeciality Research - Miami
- Nature Coast Clinical Research
- Beautiful Minds Clinical Research Center
- Clinical Research Partners LLC
- Hillcrest Medical Research, LLC
- Velocity Clinical Research, Hallandale Beach
- Sweet Hope Research Specialty, Inc.
- CenExel Research Centers of America
- Nature Coast Clinical Research
- Encore Research Group-Jacksonville Center for Clinical Research
- Clinical Neuroscience Solutions, Inc
- Health Awareness INC
- Accel Clinical Research
- Accel Research Sites
- Acclaim Clinical Research
- Floridian Clinical Research
- Global Health Research Center, Inc.
- Suncoast Research Group, LLC
- Clinical Trials of Florida
- Suncoast Research Associates, LLC
- Clinical Neuroscience Solutions (CNS Healthcare site)
- Headlands Research Orlando
- Innovation Medical Research Center
- Pines Care Research Center, Inc.
- Suncoast Research Associates, LLC
- Synexus
- Precision Clinical Research
- Global Health Research Center, Inc.
- Santos Research Center CORP
- Palm Beach Research Center
- Delricht Research
- Atlanta Clinical Research Center
- Baybol Research Institute
- Centricity Research
- Elite Research Network
- Accel Research Sites Lake Oconee
- Georgia Clinic, PC/CCT Research
- Clinical Research Atlanta/Headlands
- Velocity Clinical Research
- Chicago Clinical Research Institute
- Great Lakes Clinical Trials
- Velocity Clinical Research Valparaiso
- Alliance for Multispecialty Research, LLC
- Johnson County Clin-Trials, Inc (JCCT)
- Alliance for Multispecialty Research, LLC- Wichita
- Tekton Research Inc
- Alliance for Multispecialty Research-Lexington
- Versailles Family Medicine
- Meridian Clinical Research
- Benchmark Research
- MedPharmics
- Benchmark Research
- Delricht Research
- Delricht Clinical Research
- Centennial Medical Group
- Brigham and Women's Hospital
- DM Clinical Research
- Great Lakes Research Institute
- Clinical Research Institute
- Delricht Research
- The Center for Pharmaceutical Research
- Sundance Clinical Research, LLC
- Delricht Research
- Delricht Research
- Montana Medical Research, Inc
- CCT research/ Methodist Physicians Clinic- Prairie Fields
- Velocity Clinical Research
- Meridian Clinical Research, LLC
- Velocity Clinical Research
- Papillon Research Centre
- Wr-Crcn, Llc
- Las Vegas Clinical Trials
- IMA Clinical Research
- Velocity Clinical Research- New Mexico
- IMA Clinical Research
- Velocity Clinical Research, Syracuse
- IMA Clinical Research
- Rochester Clinical Research, Inc.
- Monroe Biomedical Research
- Trial Management Associates, LLC
- CTI Clinical Research Center
- Velocity Clinical Research, Inc
- Velocity Clinical Research
- Velocity Clinical Research - Cincinnati
- Velocity Clinical Research
- Tekton Research- Edmond
- Tekton Research Inc
- Delricht Research
- Tekton Research- Yukon
- Velocity Clinical Research, Medford
- Summit Research Headlands LLC
- DM Clinical Research
- Synexus Clinical Research US, Inc
- Velocity Clinical Research-Anderson
- Delricht Research
- Velocity Clinical Research
- Velocity Clinical Research, Greenville
- Carolina Health Specialists
- Coastal Carolina Research Center
- Spartanburg Medical Research
- Velocity Clinical Research- Spartanburg
- Delricht Research
- Clinical Research Associates, Inc.
- Benchmark Research
- Tekton Research Inc
- Tekton Research - Beaumont
- PanAmerican Clinical Research, LLC
- Headlands Research Brownsville
- Zenos Clinical Research
- Ventavia Research Group
- Benchmark Research
- DM Clinical Research
- DM Clinical Research
- Ventavia Research Group
- DELRICHT RESEARCH at ZOMNIR FAMILY MEDICINE
- Research Your Health
- Be Well Clinical Studies
- Clinical Trials of Texas, Inc.
- Diagnostics Research Group
- Tekton Research -San Antonio
- DM Clinical Research
- DM Clinical Research
- Cope Family Medicine
- Mountain View Ogden Clinic/CCT Research
- JBR Clinical Research
- J. Lewis Research, Inc. / Foothill Family Clinic South
- Health Research of Hampton Roads, Inc.
- Velocity Clinical Research
- Clinical Research Partners, LLC
- Hamilton Medical Research group
- Milestone Research Inc.
- Red Maple Trials Inc.
- Winterberry Family Medicine
- Medicor Research Inc.
- Dr. Anil K. Gupta Medicine Professional Corporation
- Centricity Research Toronto Manna Multispecialty
- Intermed groupe santé
- Centricity Research Pointe-Claire
- Manna Research Inc.
- Q&T Research Sherbrooke Inc.
- Clinique spécialisée en allergie
- Barnsley Hospital
- Royal United Hospital Bath NHS Trust - Royal United Hospital
- Layton Medical Centre
- Dorset Clinical Research Centre (Bournemouth Hospital)
- Bradford Teaching Hospitals NHS Foundation Trust - Bradford
- Lakeside Healthcare
- Rotherham Doncaster and South Humber NHS Foundation Trust
- University of Dundee - NHS Tayside - Ninewells Hospital & Me
- Western General Hospital
- Royal Devon & Exeter Hospital
- CPS Research
- NHS Greater Glasgow & Clyde
- Panthera Biopartners - Glasgow - multispeciality
- Queen Elizabeth University Hospital
- Gloucestershire Hospitals NHS Foundation Trust - Cheltenham
- Velocity Clinical Research High Wycombe
- University Hospitals of Leicester-Leicester Royal Hospital
- Barts Health NHS Trust
- Egin Research
- Guys and St. Thomas NHS Foundation Trust
- Hammersmith Medicines Research (HMR)
- Panthera Biopartners - Enfield
- Richford Gate Medical Practice
- Royal Free London NHS Foundation Trust
- St Georges Healthcare NHS Trust - University of London
- Manchester University NHS Foundation Trust
- Bioluminux Clinical Research
- Newcastle University - Institute of Cellular Medicine (ICM)
- Velocity Clinical Research
- Accellacare North London
- Nottingham University Hospitals NHS Trust - Queens Medical Centre (QMC) Campus
- Stemax Consult Healthcare Services Ltd
- Wansford and Kings Cliffe Practice
- University Hospitals Plymouth NHS Trust
- Southampton General Hospital - Portsmouth Research Hub
- GST NHS Found
- Panthera Biopartners Preston
- Panthera Biopartners - Manchester - multispeciality
- Warrington and Halton Teaching hospitals NHS Foundation Trust - Halton General Hospital
- Panthera Biopartners - Sheffield - multispeciality
- Royal Victoria Infirmary
- Southampton University Hospital NHS Foundation Trust
- Pier Health Group
- Weymouth Research Hub
- North Wales Clinical Research Centre
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
mRNA-1283.222
mRNA-1273.222
Participants will receive single intramuscular (IM) injection of mRNA-1283.222 on Day 1.
Participants will receive single IM injection of mRNA-1273.222 on Day 1.