A Study of mRNA-1283 Injection Compared With mRNA-1273 Injection in Participants ≥12 Years of Age to Prevent COVID-19
- Conditions
- COVID-19
- Interventions
- Registration Number
- NCT05815498
- Lead Sponsor
- ModernaTX, Inc.
- Brief Summary
The purpose of this study (Part 1 and Part 2) is to evaluate the relative vaccine efficacy (rVE), safety, reactogenicity, and immunogenicity of mRNA-1283.222 versus mRNA-1273.222 (Part 1) and mRNA-1283.815 versus mRNA-1273.815 (Part 2).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 14246
- 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.
- Part 1: 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.
Part 2: No prior vaccination is required. For participants who have been previously vaccinated, proof of vaccination is required.
Key
- 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 degrees Celsius [°C]/100.4 degrees 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 milligrams (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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part 1: mRNA-1283.222 mRNA-1283.222 Participants will receive single intramuscular (IM) injection of mRNA-1283.222 on Day 1. Part 1: mRNA-1273.222 mRNA-1273.222 Participants will receive single IM injection of mRNA-1273.222 on Day 1. Part 2: mRNA-1283.815 mRNA-1283.815 Participants will receive single IM injection of mRNA-1283.815 on Day 1. Part 2: mRNA-1273.815 mRNA-1273.815 Participants will receive single IM injection of mRNA-1273.815 on Day 1.
- Primary Outcome Measures
Name Time Method Part 1: Geometric Mean Ratio (GMR) of Omicron BA.4/5 mRNA-1283.222 Over the Omicron BA.4/5 mRNA-1273.222 Day 29 Part 1: Seroresponse Rate (SRR) Difference of Omicron BA.4/5 Between mRNA-1283.222 and mRNA-1273.222 Day 29 Seroresponse at the participant level is defined as an antibody value change from baseline below the lower limit of quantification (LLOQ) to ≥4 × LLOQ, or at least a 4-fold rise if baseline is ≥LLOQ and \<4 × LLOQ, or at least a 2-fold rise if baseline is ≥4 × LLOQ.
Part 1: GMR of the Ancestral Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) D614G mRNA-1283.222 Over the Ancestral SARS-CoV-2 D614G mRNA-1273.222 Day 29 Part 1: SRR Difference of Ancestral SARS-CoV-2 D641G Between mRNA-1283.222 and mRNA-1273.222 Day 29 Seroresponse at the participant level is defined as an antibody value change from baseline below the LLOQ to ≥4 × LLOQ, or at least a 4-fold rise if baseline is ≥LLOQ and \<4 × LLOQ, or at least a 2-fold rise if baseline is ≥4 × LLOQ.
Parts 1 and 2: rVE of mRNA-1283 and mRNA-1273 (Variant Formulations) to Prevent the First Event of COVID-19 From 14 days after injection to Day 365 The rVE is defined as the percent of reduction in the hazards of the first occurrence of COVID-19 (mRNA-1283 vs. mRNA-1273) starting 14 days after the booster dose.
Part 1: Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs) Up to Day 7 (7-day follow-up after vaccination) Part 2: Number of Participants with Solicited Local and Systemic Reactogenicity ARs in Adolescents and Previously Unvaccinated Participants Up to Day 7 (7-day follow-up after vaccination) Parts 1 and 2: Number of Participants with Unsolicited Adverse Events (AEs) Up to Day 28 (28-day follow-up after vaccination) Parts 1 and 2: Number of Participants with Any Serious AEs (SAEs), Medically Attended AEs (MAAEs), AEs Leading to Withdrawal From Study, and AEs of Special Interest (AESIs) Day 1 to end of study (EOS) (Day 365)
- Secondary Outcome Measures
Name Time Method Part 1: Geometric Mean Titers (GMTs) of Omicron BA.4/5 and Ancestral SARS-CoV-2 D614G Days 91, 181, and 365 Part 1: SRR Against Omicron BA.4/5 and Ancestral SARS-CoV-2 D614G Days 29, 91, 181, and 365 Seroresponse at the participant level is defined as an antibody value change from baseline below the LLOQ to ≥4 × LLOQ, or at least a 4-fold rise if baseline is ≥LLOQ and \<4 × LLOQ, or at least a 2-fold rise if baseline is ≥4 × LLOQ.
Parts 1 and 2: Number of Participants with a SARS-CoV-2 Infection (Symptomatic or Asymptomatic) From 14 days after injection to Day 365 Part 2: Number of Participants with Severe COVID-19 From 14 days after injection to Day 365
Trial Locations
- Locations (195)
Mountain View Ogden Clinic/CCT Research
🇺🇸Pleasant View, Utah, United States
JBR Clinical Research
🇺🇸Salt Lake City, Utah, United States
J. Lewis Research, Inc. / Foothill Family Clinic South
🇺🇸Salt Lake City, Utah, United States
Health Research of Hampton Roads, Inc.
🇺🇸Newport News, Virginia, United States
Clinical Research Partners, LLC
🇺🇸Richmond, Virginia, United States
Hamilton Medical Research group
🇨🇦Hamilton, Ontario, Canada
Milestone Research Inc.
🇨🇦London, Ontario, Canada
Red Maple Trials Inc.
🇨🇦Ottawa, Ontario, Canada
Winterberry Family Medicine
🇨🇦Stoney Creek, Ontario, Canada
Medicor Research Inc.
🇨🇦Sudbury, Ontario, Canada
Dr. Anil K. Gupta Medicine Professional Corporation
🇨🇦Toronto, Ontario, Canada
Centricity Research Toronto Manna Multispecialty
🇨🇦Toronto, Ontario, Canada
Intermed groupe santé
🇨🇦Chicoutimi, Quebec, Canada
Centricity Research Pointe-Claire
🇨🇦Pointe-Claire, Quebec, Canada
Manna Research Inc.
🇨🇦Pointe-Claire, Quebec, Canada
Q&T Research Sherbrooke Inc.
🇨🇦Sherbrooke, Quebec, Canada
Clinique spécialisée en allergie
🇨🇦Quebec, Canada
Public Health Association.Inc
🇯🇵Aichi, Japan
Tenjin Sogo Clinic
🇯🇵Fukuoka, Japan
Yamasaki Family Clinic - internal medicine
🇯🇵Hyogo, Japan
Motomachi Takatsuka Naika Clinic - Internal Medicine
🇯🇵Kanagawa, Japan
Arakawa Family Clinic
🇯🇵Nagano, Japan
Koseikai Yotsubashi Clinic - Internal Medicine
🇯🇵Osaka, Japan
Medical Corporation of Yamazaki Neurotology, Rhinolaryngology Clinic
🇯🇵Sapporo, Japan
Dojinkinenkai Meiwa Hospital
🇯🇵Tokyo, Japan
Medical Corporation Asbo Tokyo Asbo Clinic
🇯🇵Tokyo, Japan
Metropolitan Clinic - Internal Medicine
🇯🇵Tokyo, Japan
National Center for Global Health and Medicine
🇯🇵Tokyo, Japan
Shinei Medical Healthcare Clinic
🇯🇵Tokyo, Japan
Barnsley Hospital
🇬🇧Barnsley, United Kingdom
Royal United Hospital Bath NHS Trust - Royal United Hospital
🇬🇧Bath, United Kingdom
Layton Medical Centre
🇬🇧Blackpool, United Kingdom
Dorset Clinical Research Centre (Bournemouth Hospital)
🇬🇧Bournemouth, United Kingdom
Bradford Teaching Hospitals NHS Foundation Trust - Bradford
🇬🇧Bradford, United Kingdom
Lakeside Healthcare
🇬🇧Corby, United Kingdom
Rotherham Doncaster and South Humber NHS Foundation Trust
🇬🇧Doncaster, United Kingdom
University of Dundee - NHS Tayside - Ninewells Hospital & Me
🇬🇧Dundee, United Kingdom
Western General Hospital
🇬🇧Edinburgh, United Kingdom
Royal Devon & Exeter Hospital
🇬🇧Exeter, United Kingdom
CPS Research
🇬🇧Glasgow, United Kingdom
NHS Greater Glasgow & Clyde
🇬🇧Glasgow, United Kingdom
Panthera Biopartners - Glasgow - multispeciality
🇬🇧Glasgow, United Kingdom
Queen Elizabeth University Hospital
🇬🇧Glasgow, United Kingdom
Gloucestershire Hospitals NHS Foundation Trust - Cheltenham
🇬🇧Gloucester, United Kingdom
Velocity Clinical Research High Wycombe
🇬🇧High Wycombe, United Kingdom
University Hospitals of Leicester-Leicester Royal Hospital
🇬🇧Leicester, United Kingdom
Barts Health NHS Trust
🇬🇧London, United Kingdom
Egin Research
🇬🇧London, United Kingdom
Guys and St. Thomas NHS Foundation Trust
🇬🇧London, United Kingdom
Hammersmith Medicines Research (HMR)
🇬🇧London, United Kingdom
Panthera Biopartners - Enfield
🇬🇧London, United Kingdom
Richford Gate Medical Practice
🇬🇧London, United Kingdom
Royal Free London NHS Foundation Trust
🇬🇧London, United Kingdom
St Georges Healthcare NHS Trust - University of London
🇬🇧London, United Kingdom
Manchester University NHS Foundation Trust
🇬🇧Manchester, United Kingdom
Bioluminux Clinical Research
🇬🇧Milton Keynes, United Kingdom
Stemax Consult Healthcare Services Ltd
🇬🇧Milton Keynes, United Kingdom
Newcastle University - Institute of Cellular Medicine (ICM)
🇬🇧Newcastle, United Kingdom
Accellacare North London
🇬🇧Northwood, United Kingdom
Nottingham University Hospitals NHS Trust - Queens Medical Centre (QMC) Campus
🇬🇧Nottingham, United Kingdom
Wansford and Kings Cliffe Practice
🇬🇧Peterborough, United Kingdom
University Hospitals Plymouth NHS Trust
🇬🇧Plymouth, United Kingdom
Southampton General Hospital - Portsmouth Research Hub
🇬🇧Portsmouth, United Kingdom
GST NHS Found
🇬🇧Preston, United Kingdom
Panthera Biopartners Preston
🇬🇧Preston, United Kingdom
Panthera Biopartners - Manchester - multispeciality
🇬🇧Rochdale, United Kingdom
Warrington and Halton Teaching hospitals NHS Foundation Trust - Halton General Hospital
🇬🇧Runcorn, United Kingdom
Panthera Biopartners - Sheffield - multispeciality
🇬🇧Sheffield, United Kingdom
Royal Victoria Infirmary
🇬🇧Sheffield, United Kingdom
Southampton University Hospital NHS Foundation Trust
🇬🇧Southampton, United Kingdom
Pier Health Group
🇬🇧Weston-super-Mare, United Kingdom
Weymouth Research Hub
🇬🇧Weymouth, United Kingdom
North Wales Clinical Research Centre
🇬🇧Wrexham, United Kingdom
Optimal Research
🇺🇸Huntsville, Alabama, United States
Accel Research Sites- Achieve Clinical Research
🇺🇸Vestavia Hills, Alabama, United States
Chandler Clinical Trials
🇺🇸Chandler, Arizona, United States
Phoenix Clinical Research LLC
🇺🇸Phoenix, Arizona, United States
FRC - CCT Research
🇺🇸Phoenix, Arizona, United States
Headlands Research Sarasota
🇺🇸Scottsdale, Arizona, United States
Clinical Research Consortium
🇺🇸Tempe, Arizona, United States
Noble Clinical Research, LLC
🇺🇸Tucson, Arizona, United States
Del Sol research Management LLC.
🇺🇸Tucson, Arizona, United States
Lynn Institute of the Ozarks
🇺🇸Little Rock, Arkansas, United States
Anaheim Clinical Trials, LLC
🇺🇸Anaheim, California, United States
Velocity Clinical Research, Banning
🇺🇸Banning, California, United States
Velocity Clinical Research- Chula Vista
🇺🇸Chula Vista, California, United States
Benchmark Research
🇺🇸Fort Worth, Texas, United States
Marvel Clinical Research 002, LLC
🇺🇸Huntington Beach, California, United States
Velocity Clinical Research Huntington Park
🇺🇸Huntington Park, California, United States
Velocity Clinical Research
🇬🇧North London, United Kingdom
Chemidox Clinical Trials
🇺🇸Lancaster, California, United States
Long Beach Clinical Trials
🇺🇸Long Beach, California, United States
Velocity Clinical Research- Westlake
🇺🇸Los Angeles, California, United States
Velocity Clinical Research-North Hollywood
🇺🇸North Hollywood, California, United States
Empire Clinical Research
🇺🇸Pomona, California, United States
CenExel - CITrials
🇺🇸Riverside, California, United States
Artemis Institute for Clinical Research
🇺🇸San Diego, California, United States
Peninsula Research Associates
🇺🇸Rolling Hills Estates, California, United States
Acclaim Clinical Research
🇺🇸Maitland, Florida, United States
Lynn Institute of Denver
🇺🇸Aurora, Colorado, United States
Velocity Clinical Research Denver
🇺🇸Denver, Colorado, United States
Tekton Research - Fort Collins
🇺🇸Fort Collins, Colorado, United States
Tekton Research, Inc- Longmont Center
🇺🇸Longmont, Colorado, United States
Alliance for Multispeciality Research - Miami
🇺🇸Coral Gables, Florida, United States
Nature Coast Clinical Research
🇺🇸Inverness, Florida, United States
Beautiful Minds Clinical Research Center
🇺🇸Cutler Bay, Florida, United States
Clinical Research Partners LLC
🇺🇸DeLand, Florida, United States
Hillcrest Medical Research, LLC
🇺🇸DeLand, Florida, United States
Velocity Clinical Research, Hallandale Beach
🇺🇸Hallandale Beach, Florida, United States
Sweet Hope Research Specialty, Inc.
🇺🇸Hialeah, Florida, United States
CenExel Research Centers of America
🇺🇸Hollywood, Florida, United States
Encore Research Group-Jacksonville Center for Clinical Research
🇺🇸Jacksonville, Florida, United States
Clinical Neuroscience Solutions, Inc
🇺🇸Jacksonville, Florida, United States
Health Awareness INC
🇺🇸Jupiter, Florida, United States
Accel Clinical Research
🇺🇸Lakeland, Florida, United States
Accel Research Sites
🇺🇸Largo, Florida, United States
Floridian Clinical Research
🇺🇸Miami Lakes, Florida, United States
Global Health Research Center, Inc.
🇺🇸Tampa, Florida, United States
Suncoast Research Group, LLC
🇺🇸Miami, Florida, United States
Clinical Trials of Florida
🇺🇸Miami, Florida, United States
Suncoast Research Associates, LLC
🇺🇸Pembroke Pines, Florida, United States
Clinical Neuroscience Solutions (CNS Healthcare site)
🇺🇸Orlando, Florida, United States
Headlands Research Orlando
🇺🇸Orlando, Florida, United States
Innovation Medical Research Center
🇺🇸Palmetto Bay, Florida, United States
Pines Care Research Center, Inc.
🇺🇸Pembroke Pines, Florida, United States
Synexus
🇺🇸Pinellas Park, Florida, United States
Precision Clinical Research
🇺🇸Sunrise, Florida, United States
Santos Research Center CORP
🇺🇸Tampa, Florida, United States
Palm Beach Research Center
🇺🇸West Palm Beach, Florida, United States
Delricht Research
🇺🇸Hendersonville, Tennessee, United States
Atlanta Clinical Research Center
🇺🇸Atlanta, Georgia, United States
Baybol Research Institute
🇺🇸Chamblee, Georgia, United States
Centricity Research
🇺🇸Columbus, Georgia, United States
Elite Research Network
🇺🇸Decatur, Georgia, United States
Accel Research Sites Lake Oconee
🇺🇸Eatonton, Georgia, United States
Georgia Clinic, PC/CCT Research
🇺🇸Norcross, Georgia, United States
Clinical Research Atlanta/Headlands
🇺🇸Stockbridge, Georgia, United States
Chicago Clinical Research Institute
🇺🇸Chicago, Illinois, United States
Great Lakes Clinical Trials
🇺🇸Chicago, Illinois, United States
Velocity Clinical Research Valparaiso
🇺🇸Valparaiso, Indiana, United States
Alliance for Multispecialty Research, LLC
🇺🇸El Dorado, Kansas, United States
Johnson County Clin-Trials, Inc (JCCT)
🇺🇸Lenexa, Kansas, United States
Alliance for Multispecialty Research, LLC- Wichita
🇺🇸Wichita, Kansas, United States
Tekton Research Inc
🇺🇸Austin, Texas, United States
Alliance for Multispecialty Research-Lexington
🇺🇸Lexington, Kentucky, United States
Versailles Family Medicine
🇺🇸Versailles, Kentucky, United States
Meridian Clinical Research
🇺🇸Baton Rouge, Louisiana, United States
MedPharmics
🇺🇸Covington, Louisiana, United States
Delricht Clinical Research
🇺🇸Prairieville, Louisiana, United States
Centennial Medical Group
🇺🇸Eldridge, Maryland, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
DM Clinical Research
🇺🇸Tomball, Texas, United States
Great Lakes Research Institute
🇺🇸Southfield, Michigan, United States
Clinical Research Institute
🇺🇸Minneapolis, Minnesota, United States
The Center for Pharmaceutical Research
🇺🇸Kansas City, Missouri, United States
Sundance Clinical Research, LLC
🇺🇸Saint Louis, Missouri, United States
Montana Medical Research, Inc
🇺🇸Missoula, Montana, United States
CCT research/ Methodist Physicians Clinic- Prairie Fields
🇺🇸Fremont, Nebraska, United States
Meridian Clinical Research, LLC
🇺🇸Lincoln, Nebraska, United States
Papillon Research Centre
🇺🇸Papillion, Nebraska, United States
Wr-Crcn, Llc
🇺🇸Las Vegas, Nevada, United States
Las Vegas Clinical Trials
🇺🇸North Las Vegas, Nevada, United States
IMA Clinical Research
🇺🇸New York, New York, United States
Velocity Clinical Research- New Mexico
🇺🇸Albuquerque, New Mexico, United States
Velocity Clinical Research, Syracuse
🇺🇸East Syracuse, New York, United States
Rochester Clinical Research, Inc.
🇺🇸Rochester, New York, United States
Monroe Biomedical Research
🇺🇸Monroe, North Carolina, United States
Trial Management Associates, LLC
🇺🇸Wilmington, North Carolina, United States
CTI Clinical Research Center
🇺🇸Cincinnati, Ohio, United States
Velocity Clinical Research, Inc
🇺🇸Cincinnati, Ohio, United States
Velocity Clinical Research - Cincinnati
🇺🇸Cincinnati, Ohio, United States
Tekton Research- Edmond
🇺🇸Edmond, Oklahoma, United States
Tekton Research- Yukon
🇺🇸Yukon, Oklahoma, United States
Velocity Clinical Research, Medford
🇺🇸Medford, Oregon, United States
Summit Research Headlands LLC
🇺🇸Portland, Oregon, United States
Synexus Clinical Research US, Inc
🇺🇸Anderson, South Carolina, United States
Velocity Clinical Research-Anderson
🇺🇸Anderson, South Carolina, United States
Velocity Clinical Research, Greenville
🇺🇸Greenville, South Carolina, United States
Carolina Health Specialists
🇺🇸Myrtle Beach, South Carolina, United States
Coastal Carolina Research Center
🇺🇸North Charleston, South Carolina, United States
Spartanburg Medical Research
🇺🇸Spartanburg, South Carolina, United States
Velocity Clinical Research- Spartanburg
🇺🇸Spartanburg, South Carolina, United States
Clinical Research Associates, Inc.
🇺🇸Nashville, Tennessee, United States
Tekton Research - Beaumont
🇺🇸Beaumont, Texas, United States
PanAmerican Clinical Research, LLC
🇺🇸Brownsville, Texas, United States
Headlands Research Brownsville
🇺🇸Brownsville, Texas, United States
Zenos Clinical Research
🇺🇸Dallas, Texas, United States
Ventavia Research Group
🇺🇸Keller, Texas, United States
DELRICHT RESEARCH at ZOMNIR FAMILY MEDICINE
🇺🇸McKinney, Texas, United States
Research Your Health
🇺🇸Plano, Texas, United States
Be Well Clinical Studies
🇺🇸Round Rock, Texas, United States
Clinical Trials of Texas, Inc.
🇺🇸San Antonio, Texas, United States
Diagnostics Research Group
🇺🇸San Antonio, Texas, United States
Tekton Research -San Antonio
🇺🇸San Antonio, Texas, United States
Cope Family Medicine
🇺🇸Bountiful, Utah, United States