A Study of mRNA-1083 (SARS-CoV-2 and Influenza) Vaccine in Healthy Adult Participants, ≥50 Years of Age
- Conditions
- SARS-CoV-2Influenza
- Interventions
- Biological: Influenza VaccineBiological: mRNA-1083Biological: PlaceboBiological: COVID-19 Vaccine
- Registration Number
- NCT06097273
- Lead Sponsor
- ModernaTX, Inc.
- Brief Summary
The purpose of this study is to evaluate the immunogenicity, safety, and reactogenicity of mRNA-1083 as compared with active control, co-administered licensed influenza and severe acute respiratory syndrome coronavirus 2 (SARS CoV 2) vaccines, in 2 independent age-group sub-study cohorts, healthy adults 65 years and older (Cohort A) and healthy adults 50 to \<65 years of age (Cohort B).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 8075
- Healthy adults either ≥65 years of age (Cohort A) or 50 to <65 years of age (Cohort B) at the time of consent (Screening Visit).
- 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 Day 1, and agreement to continue adequate contraception through 3 months following vaccine administration.
- Fully vaccinated for COVID-19 primary series according to the locally authorized or approved regimen, and their last COVID-19 vaccine (primary series or booster) was ≥90 days prior to Day 1.
- 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 drug or alcohol 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.
- Participant has received systemic immunosuppressants for >14 days in total within 180 days prior to Day 1 (for corticosteroids, ≥10 milligrams [mg]/day of prednisone or equivalent) or is anticipating the need for systemic immunosuppressive treatment at any time during participation in the study. Inhaled nasal and topical steroids are allowed.
- Received or plans to receive any vaccine authorized or approved by a local health agency ≤28 days prior to study injections or plans to receive a vaccine authorized or approved by a local health agency within 28 days after the study injections.
- Received a seasonal influenza vaccine ≤150 days prior to Day 1.
- Tested positive for influenza by local health authority-approved testing methods ≤150 days prior to Day 1.
- Has had close contact to someone with COVID-19 as defined by the Centers for Disease Control and Prevention (CDC) in the past 10 days prior to Day 1.
- 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.
Note: Other protocol-defined inclusion/exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort A1: mRNA-1083 and Placebo Placebo Participants of age 65 years and older will receive mRNA-1083 and placebo administered as 2 intramuscular (IM) injections of on Day 1. Cohort B2: Influenza Vaccine and COVID-19 Vaccine Influenza Vaccine Participants of age 50 to \<65 years will receive age recommended quadrivalent influenza vaccine and COVID-19 vaccine administered as 2 IM injections on Day 1. Cohort B1: mRNA-1083 and Placebo mRNA-1083 Participants of age 50 to \<65 years will receive mRNA-1083 and placebo administered as 2 IM injections of on Day 1. Cohort A2: Influenza Vaccine and COVID-19 Vaccine Influenza Vaccine Participants of age 65 years and older will receive age recommended quadrivalent influenza vaccine and COVID-19 vaccine administered as 2 IM injections on Day 1. Cohort A2: Influenza Vaccine and COVID-19 Vaccine COVID-19 Vaccine Participants of age 65 years and older will receive age recommended quadrivalent influenza vaccine and COVID-19 vaccine administered as 2 IM injections on Day 1. Cohort B1: mRNA-1083 and Placebo Placebo Participants of age 50 to \<65 years will receive mRNA-1083 and placebo administered as 2 IM injections of on Day 1. Cohort A1: mRNA-1083 and Placebo mRNA-1083 Participants of age 65 years and older will receive mRNA-1083 and placebo administered as 2 intramuscular (IM) injections of on Day 1. Cohort B2: Influenza Vaccine and COVID-19 Vaccine COVID-19 Vaccine Participants of age 50 to \<65 years will receive age recommended quadrivalent influenza vaccine and COVID-19 vaccine administered as 2 IM injections on Day 1.
- Primary Outcome Measures
Name Time Method Geometric Mean (GM) Level of Antibodies for Influenza, as Measured by Hemagglutination Inhibition (HAI) Assay Day 29 SARS-CoV-2: Number of Participants with Seroresponse, as Measured by PsVNA Baseline to Day 29 Seroresponse is defined as a Day 29 post-injection level ≥4-fold if baseline is ≥lower limit of quantification (LLOQ) or ≥4\*LLOQ if baseline titer is \<LLOQ in neutralizing antibody (nAb) values measured by PsVNA.
Number of Participants With Unsolicited Adverse Events (AEs) Up to 28 days after study injection Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) Up to 7 days after study injection Number of Participants With Serious Adverse Events (SAEs) Day 1 through Day 181 GM Level of Antibodies for SARS-CoV-2, as Measured by Pseudovirus Neutralization Assay (PsVNA) Day 29 Influenza: Percentage of Participants with Seroconversion, as Measured by HAI Assay Baseline to Day 29 Seroconversion is defined as a Day 29 post-injection level ≥1:40 if baseline is \<1:10 or a 4-fold or greater rise if baseline is ≥1:10 in anti-HA antibodies measured by HAI assay.
Number of Participants With Medically Attended Adverse Events (MAAEs) Day 1 through Day 181 Number of Participants With Adverse Events of Special Interest (AESIs) Day 1 through Day 181 Number of Participants With AEs Leading to Discontinuation Day 1 through Day 181
- Secondary Outcome Measures
Name Time Method GM Level of Antibodies for Influenza, as Measured by Microneutralization Assay Day 29 Geometric Mean Fold-Rise (GMFR) of Antibodies for Influenza, as Measured by HAI Assay Day 1, Day 29 GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA Day 1, Day 29 GMFR of Antibodies for Influenza, as Measured by Microneutralization Assay Day 1, Day 29
Trial Locations
- Locations (145)
Artemis Institute For Clinical Research LLC - Riverside - Headlands - PPDS
🇺🇸Riverside, California, United States
Great Lakes Research Institute
🇺🇸Southfield, Michigan, United States
DM Clinical Research - Southfield - ERN - PPDS
🇺🇸Southfield, Michigan, United States
Velocity Clinical Research - Family Practice - Portsmouth - PPDS
🇺🇸Portsmouth, Virginia, United States
AES - DRS - Synexus Clinical Research US, Inc. - Dallas
🇺🇸Dallas, Texas, United States
DelRicht Research, LLC - Springer Wellness & Restorative - Atlanta - PPDS
🇺🇸Atlanta, Georgia, United States
AES - DRS - Synexus Clinical Research US, Inc. - Columbus
🇺🇸Columbus, Ohio, United States
AES - DRS - Optimal Research Texas - Austin
🇺🇸Austin, Texas, United States
AES - DRS - Synexus Clinical Research US, Inc. - Chicago
🇺🇸Chicago, Illinois, United States
Cedar Crosse Research Center
🇺🇸Chicago, Illinois, United States
Flourish Research - Andersonville - PPDS
🇺🇸Chicago, Illinois, United States
DM Clinical Research - Bellaire - ERN - PPDS
🇺🇸Houston, Texas, United States
Artemis Institute For Clinical Research LLC - San Diego - Headlands - PPDS
🇺🇸San Diego, California, United States
CTI Clinical Research Center - PPDS
🇺🇸Cincinnati, Ohio, United States
Velocity Clinical Research (Cincinnati - Ohio) - PPDS
🇺🇸Cincinnati, Ohio, United States
Fiel Family & Sports Medicine - PC - CCT - PPDS
🇺🇸Tempe, Arizona, United States
Nature Coast Clinical Research
🇺🇸Inverness, Florida, United States
Clinical Trials of Texas, Inc. - PPDS
🇺🇸San Antonio, Texas, United States
IMA Clinical Research - San Antonio - PPDS
🇺🇸San Antonio, Texas, United States
Tekton Research - San Antonio - PPDS
🇺🇸San Antonio, Texas, United States
Cope Family Medicine - CCT - PPDS
🇺🇸Bountiful, Utah, United States
Accel Research Site - Achieve - Birmingham
🇺🇸Birmingham, Alabama, United States
Lynn Institute of East Oklahoma - ERN - PPDS
🇺🇸Oklahoma City, Oklahoma, United States
JBR Clinical Research - CenExel JBR - PPDS
🇺🇸Salt Lake City, Utah, United States
Midwest Regional Health Services - LLC - CCT - PPDS
🇺🇸Omaha, Nebraska, United States
Pinnacle Research Group-409 E 10th St
🇺🇸Anniston, Alabama, United States
Cullman Clinical Trials
🇺🇸Cullman, Alabama, United States
Foothills Research Center - CCT - PPDS
🇺🇸Phoenix, Arizona, United States
Headlands Research - Scottsdale - PPDS
🇺🇸Scottsdale, Arizona, United States
Desert Clinical Research - CCT - PPDS
🇺🇸Mesa, Arizona, United States
Scottsdale Clinical Trials
🇺🇸Scottsdale, Arizona, United States
AES - DRS - Synexus Clinical Research US, Inc. - Cerritos
🇺🇸Cerritos, California, United States
Central Valley Research, LLC
🇺🇸Modesto, California, United States
Long Beach Research Institute, LLC
🇺🇸Long Beach, California, United States
CenExel Apex (CNS) - Los Alamitos - PPDS
🇺🇸Los Alamitos, California, United States
Carbon Health- NoHo West Urgent Care and Primary Care
🇺🇸North Hollywood, California, United States
Empire Clinical Research
🇺🇸Pomona, California, United States
Clinical Innovations Trials - Riverside - CenExel - PPDS
🇺🇸Riverside, California, United States
Peninsula Research Associates - Headlands - PPDS
🇺🇸Rolling Hills Estates, California, United States
AES - DRS - Synexus Clinical Research US, Inc. - Vista
🇺🇸Vista, California, United States
Tekton Research - Fort Collins - PPDS
🇺🇸Fort Collins, Colorado, United States
Tekton Research - Longmont - PPDS
🇺🇸Longmont, Colorado, United States
Chase Medical Research LLC - Waterbury
🇺🇸Waterbury, Connecticut, United States
Revival Research Corporation
🇺🇸Doral, Florida, United States
Stamford Therapeutics Consortium - ERN - PPDS
🇺🇸Stamford, Connecticut, United States
Indago Research and Health Center
🇺🇸Hialeah, Florida, United States
CenExel RCA - Hollywood
🇺🇸Hollywood, Florida, United States
AES - DRS - Optimal Research Florida - Melbourne
🇺🇸Melbourne, Florida, United States
Accel Research Sites - Maitland
🇺🇸Maitland, Florida, United States
Health Awareness - Jupiter - ERN - ERN
🇺🇸Jupiter, Florida, United States
Accel Research Sites - Saint Petersburg - Largo - ERN - PPDS
🇺🇸Largo, Florida, United States
Flourish Research - Leesburg - PPDS
🇺🇸Leesburg, Florida, United States
Suncoast Research Group LLC - Flourish - PPDS
🇺🇸Miami, Florida, United States
St. Johns Center for Clinical Research - ERN - PPDS
🇺🇸Saint Augustine, Florida, United States
AES - DRS - Synexus Clinical Research US, Inc. - Atlanta
🇺🇸Atlanta, Georgia, United States
iResearch Atlanta - CenExel - PPDS
🇺🇸Decatur, Georgia, United States
Georgia Clinic - CCT - PPDS
🇺🇸Norcross, Georgia, United States
Javara, Inc./Privia Medical Group Georgia, LLC - Fayetteville - Javara - PPDS
🇺🇸Fayetteville, Georgia, United States
Clinical Research Atlanta - ERN - PPDS
🇺🇸Stockbridge, Georgia, United States
Koch Family Medicine
🇺🇸Morton, Illinois, United States
AES - DRS - Optimal Research Illinois - Peoria
🇺🇸Peoria, Illinois, United States
DM Clinical Research - Chicago - ERN - PPDS
🇺🇸River Forest, Illinois, United States
AES - DRS - Synexus Clinical Research US, Inc. - Evansville
🇺🇸Evansville, Indiana, United States
Velocity Clinical Research - Valparaiso (Buynak Clinical Research) - PPDS
🇺🇸Valparaiso, Indiana, United States
The Iowa Clinic, P.C. - West Des Moines Campus
🇺🇸West Des Moines, Iowa, United States
Johnson County Clin-Trials
🇺🇸Lenexa, Kansas, United States
Delricht Overland Park
🇺🇸Overland Park, Kansas, United States
Versailles Family Medicine - CCT - PPDS
🇺🇸Versailles, Kentucky, United States
Tekton Research - Wichita - PPDS
🇺🇸Wichita, Kansas, United States
DelRicht Clinical Research, LLC - The Murphy Clinic - PPDS
🇺🇸Mandeville, Louisiana, United States
Velocity Clinical Research (Baton Rouge - Louisiana) - PPDS
🇺🇸Baton Rouge, Louisiana, United States
Velocity Clinical Research - Covington - PPDS
🇺🇸Covington, Louisiana, United States
IMA Clinical Research - Monroe, LA - PPDS
🇺🇸Monroe, Louisiana, United States
Annapolis Internal Medicine - CCT - PPDS
🇺🇸Annapolis, Maryland, United States
Privia Medical Group, LLC - Columbia Pike - Silver Spring - Javara - PPDS
🇺🇸Silver Spring, Maryland, United States
DelRicht Research, LLC - Internal - Baton Rouge - PPDS
🇺🇸Prairieville, Louisiana, United States
Advanced Primary Care & Geriatric Care - CCT - PPDS
🇺🇸Rockville, Maryland, United States
DelRicht Clinical Research, LLC - Matthew Mintz, MD - PPDS
🇺🇸Rockville, Maryland, United States
Velocity Clinical Research (Rockville - Maryland) - PPDS
🇺🇸Rockville, Maryland, United States
Headlands Research - Detroit - Headlands - PPDS
🇺🇸Southfield, Michigan, United States
DM Clinical Research - The Brook House - ERN - PPDS
🇺🇸Brookline, Massachusetts, United States
DelRicht Research, LLC - Gulfport - PPDS
🇺🇸Gulfport, Mississippi, United States
AES - DRS - Synexus Clinical Research US, Inc. - Minneapolis
🇺🇸Richfield, Minnesota, United States
Mankato Clinic - Premier Drive - Javara - PPDS
🇺🇸Mankato, Minnesota, United States
AES - DRS - Synexus Clinical Research US, Inc. - St. Louis
🇺🇸Creve Coeur, Missouri, United States
Sundance Clinical Research - ERN - PPDS
🇺🇸Saint Louis, Missouri, United States
Clinvest - National Ave - Headlands - PPDS
🇺🇸Springfield, Missouri, United States
DelRicht Research, LLC - Command Family Medicine - Springfield - DelRicht - PPDS
🇺🇸Springfield, Missouri, United States
DelRicht Clinical Research, LLC - MS. Medicine - PPDS
🇺🇸Town And Country, Missouri, United States
Skyline Medical Center - PC - CCT - PPDS
🇺🇸Elkhorn, Nebraska, United States
Methodist Physicians Clinic - CCT Research - PPDS
🇺🇸Fremont, Nebraska, United States
Velocity Clinical Research
🇺🇸Omaha, Nebraska, United States
Hassman Research Institute - HRI - Berlin - CenExel - PPDS
🇺🇸Berlin, New Jersey, United States
Santa Rosa Urgent Care - Primary Care - CCT - PPDS
🇺🇸Las Vegas, Nevada, United States
Papillion Research Center
🇺🇸Papillion, Nebraska, United States
AES - DRS - Synexus Clinical Research US, Inc. - Henderson
🇺🇸Henderson, Nevada, United States
Las Vegas Clinical Trials
🇺🇸North Las Vegas, Nevada, United States
AXCES Research Group - Sante Fe - ERN - PPDS
🇺🇸Santa Fe, New Mexico, United States
DM Clinical Research - Brooklyn
🇺🇸Brooklyn, New York, United States
DelRicht Research, LLC - Charlotte - PPDS
🇺🇸Charlotte, North Carolina, United States
Monroe Biomedical Research -343 Venus St
🇺🇸Monroe, North Carolina, United States
Trial Management Associates LLC - ERN - PPDS
🇺🇸Wilmington, North Carolina, United States
AES - DRS - Synexus Clinical Research US, Inc. - New York
🇺🇸New York, New York, United States
AES - DRS - Synexus Clinical Research US, Inc. - Cincinnati
🇺🇸Cincinnati, Ohio, United States
Tryon Medical Partners, PLLC and Javara Inc. - Javara - PPDS
🇺🇸Charlotte, North Carolina, United States
Tekton Research - Edmond - PPDS
🇺🇸Edmond, Oklahoma, United States
WellNow Urgent Care & Research - Huber Heights
🇺🇸Huber Heights, Ohio, United States
DelRicht Research, LLC - Internal - Tulsa - PPDS
🇺🇸Tulsa, Oklahoma, United States
Tekton Research - Yukon - PPDS
🇺🇸Yukon, Oklahoma, United States
Hatboro Medical Associates - CCT - PPDS
🇺🇸Hatboro, Pennsylvania, United States
The Corvallis Clinic, PC - 3680 NW Samaritan Drive
🇺🇸Corvallis, Oregon, United States
DM Clinical Research - Philadelphia - ERN - PPDS
🇺🇸Philadelphia, Pennsylvania, United States
DelRicht Research, LLC - Hendersonville - PPDS
🇺🇸Hendersonville, Tennessee, United States
AES - DRS - Synexus Clinical Research US, Inc. - Anderson
🇺🇸Anderson, South Carolina, United States
TMA - Myrtle Beach - ERN - PPDS
🇺🇸Myrtle Beach, South Carolina, United States
Tekton Research Inc
🇺🇸Beaumont, Texas, United States
Headlands Research - Brownsville - Headlands - PPDS
🇺🇸Brownsville, Texas, United States
3A Research, LLC
🇺🇸El Paso, Texas, United States
Privia Medical Group- North Texas - West Parker Road - Fort Worth - Javara - PPDS
🇺🇸Fort Worth, Texas, United States
DM Clinical Research - Cyfair Clinical Research Center - ERN - PPDS
🇺🇸Houston, Texas, United States
Mount Olympus Medical Research Group - ClinEdge - PPDS
🇺🇸Friendswood, Texas, United States
DM Clinical Research - Texas Center for Drug Development - Humble - ERN - PPDS
🇺🇸Humble, Texas, United States
DelRicht Research, LLC - Zomnir Family Medicine - DelRicht - PPDS
🇺🇸McKinney, Texas, United States
Benchmark Research - San Angelo - HyperCore - PPDS
🇺🇸San Angelo, Texas, United States
Sun Research Institute -427 9th St
🇺🇸San Antonio, Texas, United States
Privia Medical Group Gulf Coast, PLLC - San Marcos - Javara - PPDS
🇺🇸San Marcos, Texas, United States
Privia Medical Group- North Texas - Stephenville - Javara - PPDS
🇺🇸Stephenville, Texas, United States
DM Clinical Research - Sugarland - ERN - PPDS
🇺🇸Sugar Land, Texas, United States
DM Clinical Research - ERN - PPDS
🇺🇸Tomball, Texas, United States
Ogden Clinic - Mountain View - CCT - PPDS
🇺🇸Pleasant View, Utah, United States
Ogden Clinic - Grandview - CCT - PPDS
🇺🇸Roy, Utah, United States
AES - DRS - Synexus Clinical Research US, Inc. - Salt Lake City
🇺🇸S. Salt Lake, Utah, United States
Wenatchee Valley Hospital & Clinics Campus
🇺🇸Wenatchee, Washington, United States
Tekton Research - Austin - PPDS
🇺🇸Austin, Texas, United States
Velocity Clinical Research (Lincoln - Nebraska) - PPDS
🇺🇸Lincoln, Nebraska, United States
Privia Medical Group Georgia, LLC - Savannah - Javara - PPDS
🇺🇸Savannah, Georgia, United States
Velocity Clinical Research - Spartanburg - PPDS
🇺🇸Spartanburg, South Carolina, United States
ForCare Clinical Research - CenExel FCR - PPDS
🇺🇸Tampa, Florida, United States
DelRicht Research, LLC - Louisville - PPDS
🇺🇸Louisville, Kentucky, United States
Clay Platte Family Medicine - CCT Research
🇺🇸Kansas City, Missouri, United States
DelRicht Clinical Research, LLC - New Orleans - ClinEdge - PPDS
🇺🇸New Orleans, Louisiana, United States
Benchmark Research - Austin - HyperCore - PPDS
🇺🇸Austin, Texas, United States
Velocity Clinical Research - Albuquerque - PPDS
🇺🇸Albuquerque, New Mexico, United States
Rochester Clinical Research, Inc
🇺🇸Rochester, New York, United States
Jacksonville Center For Clinical Research
🇺🇸Jacksonville, Florida, United States