A Study of mRNA-1083 (SARS-CoV-2 and Influenza) Vaccine in Healthy Adult Participants, ≥50 Years of Age | NCT06097273 | Trialant

A Study of mRNA-1083 (SARS-CoV-2 and Influenza) Vaccine in Healthy Adult Participants, ≥50 Years of Age | NCT06097273 | Trialant

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Yes
Eligibility Criteria: Key Inclusion Criteria:

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.

Exclusion Criteria:

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.

Pinnacle Research Group-409 E 10th St

Anniston, Alabama 36207-4780, United States

Accel Research Site - Achieve - Birmingham

Birmingham, Alabama 35216, United States

Cullman Clinical Trials

Cullman, Alabama 35055-1902, United States

Desert Clinical Research - CCT - PPDS

Mesa, Arizona 85213-5226, United States

Foothills Research Center - CCT - PPDS

Phoenix, Arizona 85044-6097, United States

Headlands Research - Scottsdale - PPDS

Scottsdale, Arizona 85260-6411, United States

Scottsdale Clinical Trials

Scottsdale, Arizona 85260-6742, United States

Fiel Family & Sports Medicine - PC - CCT - PPDS

Tempe, Arizona 85283-1528, United States

AES - DRS - Synexus Clinical Research US, Inc. - Cerritos

Cerritos, California 90703-2544, United States

Long Beach Research Institute, LLC

Long Beach, California 90805-4587, United States

CenExel Apex (CNS) - Los Alamitos - PPDS

Los Alamitos, California 90720-3118, United States

Central Valley Research, LLC

Modesto, California 95350-5365, United States

Carbon Health- NoHo West Urgent Care and Primary Care

North Hollywood, California 91606-3287, United States

Empire Clinical Research

Pomona, California 91767-1800, United States

Artemis Institute For Clinical Research LLC - Riverside - Headlands - PPDS

Riverside, California 92503-4955, United States

Clinical Innovations Trials - Riverside - CenExel - PPDS

Riverside, California 92506-3257, United States

Peninsula Research Associates - Headlands - PPDS

Rolling Hills Estates, California 90274-7604, United States

Artemis Institute For Clinical Research LLC - San Diego - Headlands - PPDS

San Diego, California 92103-2204, United States

AES - DRS - Synexus Clinical Research US, Inc. - Vista

Vista, California 92083-6051, United States

Tekton Research - Fort Collins - PPDS

Fort Collins, Colorado 80525-5752, United States

Tekton Research - Longmont - PPDS

Longmont, Colorado 80501-6461, United States

Stamford Therapeutics Consortium - ERN - PPDS

Stamford, Connecticut 06905-5316, United States

Chase Medical Research LLC - Waterbury

Waterbury, Connecticut 06708-3346, United States

Revival Research Corporation

Doral, Florida 33122-1902, United States

Indago Research and Health Center

Hialeah, Florida 33012, United States

CenExel RCA - Hollywood

Hollywood, Florida 33024-2709, United States

Nature Coast Clinical Research

Inverness, Florida 34452, United States

Jacksonville Center For Clinical Research

Jacksonville, Florida 32216, United States

Health Awareness - Jupiter - ERN - ERN

Jupiter, Florida 33458-2775, United States

Accel Research Sites - Saint Petersburg - Largo - ERN - PPDS

Largo, Florida 33777-1359, United States

Flourish Research - Leesburg - PPDS

Leesburg, Florida 34748-5077, United States

Accel Research Sites - Maitland

Maitland, Florida 32751-7258, United States

AES - DRS - Optimal Research Florida - Melbourne

Melbourne, Florida 32934-8172, United States

Suncoast Research Group LLC - Flourish - PPDS

Miami, Florida 33135-1687, United States

St. Johns Center for Clinical Research - ERN - PPDS

Saint Augustine, Florida 32086-5775, United States

ForCare Clinical Research - CenExel FCR - PPDS

Tampa, Florida 33613-1244, United States

AES - DRS - Synexus Clinical Research US, Inc. - Atlanta

Atlanta, Georgia 30328-4018, United States

DelRicht Research, LLC - Springer Wellness & Restorative - Atlanta - PPDS

Atlanta, Georgia 30329-2201, United States

iResearch Atlanta - CenExel - PPDS

Decatur, Georgia 30030-3438, United States

Javara, Inc./Privia Medical Group Georgia, LLC - Fayetteville - Javara - PPDS

Fayetteville, Georgia 30214, United States

Georgia Clinic - CCT - PPDS

Norcross, Georgia 30092-4544, United States

Privia Medical Group Georgia, LLC - Savannah - Javara - PPDS

Savannah, Georgia 31406-3928, United States

Clinical Research Atlanta - ERN - PPDS

Stockbridge, Georgia 30281-9054, United States

AES - DRS - Synexus Clinical Research US, Inc. - Chicago

Chicago, Illinois 60602-3960, United States

Cedar Crosse Research Center

Chicago, Illinois 60607-4559, United States

Flourish Research - Andersonville - PPDS

Chicago, Illinois 60640-2781, United States

Koch Family Medicine

Morton, Illinois 61550-2495, United States

AES - DRS - Optimal Research Illinois - Peoria

Peoria, Illinois 61614, United States

DM Clinical Research - Chicago - ERN - PPDS

River Forest, Illinois 60305-1876, United States

AES - DRS - Synexus Clinical Research US, Inc. - Evansville

Evansville, Indiana 47714-7513, United States

Velocity Clinical Research - Valparaiso (Buynak Clinical Research) - PPDS

Valparaiso, Indiana 46383-2195, United States

The Iowa Clinic, P.C. - West Des Moines Campus

West Des Moines, Iowa 50266-8216, United States

Johnson County Clin-Trials

Lenexa, Kansas 66219-1389, United States

Delricht Overland Park

Overland Park, Kansas 66223-4857, United States

Tekton Research - Wichita - PPDS

Wichita, Kansas 67218-2913, United States

DelRicht Research, LLC - Louisville - PPDS

Louisville, Kentucky 40205-3162, United States

Versailles Family Medicine - CCT - PPDS

Versailles, Kentucky 40383-1947, United States

Velocity Clinical Research (Baton Rouge - Louisiana) - PPDS

Baton Rouge, Louisiana 70809-3416, United States

Velocity Clinical Research - Covington - PPDS

Covington, Louisiana 70433-7237, United States

DelRicht Clinical Research, LLC - The Murphy Clinic - PPDS

Mandeville, Louisiana 70471, United States

IMA Clinical Research - Monroe, LA - PPDS

Monroe, Louisiana 71201-3915, United States

DelRicht Clinical Research, LLC - New Orleans - ClinEdge - PPDS

New Orleans, Louisiana 70115-3584, United States

DelRicht Research, LLC - Internal - Baton Rouge - PPDS

Prairieville, Louisiana 70769-4222, United States

Annapolis Internal Medicine - CCT - PPDS

Annapolis, Maryland 21401-7050, United States

Advanced Primary Care & Geriatric Care - CCT - PPDS

Rockville, Maryland 20850-6246, United States

DelRicht Clinical Research, LLC - Matthew Mintz, MD - PPDS

Rockville, Maryland 20852-3803, United States

Velocity Clinical Research (Rockville - Maryland) - PPDS

Rockville, Maryland 20854-2960, United States

Privia Medical Group, LLC - Columbia Pike - Silver Spring - Javara - PPDS

Silver Spring, Maryland 20901-4402, United States

DM Clinical Research - The Brook House - ERN - PPDS

Brookline, Massachusetts 02445-7113, United States

Headlands Research - Detroit - Headlands - PPDS

Southfield, Michigan 48034-1088, United States

Great Lakes Research Institute

Southfield, Michigan 48075-5400, United States

DM Clinical Research - Southfield - ERN - PPDS

Southfield, Michigan 48076-5412, United States

Mankato Clinic - Premier Drive - Javara - PPDS

Mankato, Minnesota 56001-6076, United States

AES - DRS - Synexus Clinical Research US, Inc. - Minneapolis

Richfield, Minnesota 55423-2590, United States

DelRicht Research, LLC - Gulfport - PPDS

Gulfport, Mississippi 39503-4176, United States

AES - DRS - Synexus Clinical Research US, Inc. - St. Louis

Creve Coeur, Missouri 63141-7084, United States

Clay Platte Family Medicine - CCT Research

Kansas City, Missouri 64151-2411, United States

Clinvest - National Ave - Headlands - PPDS

Springfield, Missouri 65807-6012, United States

DelRicht Research, LLC - Command Family Medicine - Springfield - DelRicht - PPDS

Springfield, Missouri 65807-7303, United States

Sundance Clinical Research - ERN - PPDS

St Louis, Missouri 63141-7068, United States

DelRicht Clinical Research, LLC - MS. Medicine - PPDS

Town and Country, Missouri 63017-8209, United States

Skyline Medical Center - PC - CCT - PPDS

Elkhorn, Nebraska 68022-2889, United States

Methodist Physicians Clinic - CCT Research - PPDS

Fremont, Nebraska 68025-2592, United States

Velocity Clinical Research (Lincoln - Nebraska) - PPDS

Lincoln, Nebraska 68510-4855, United States

Velocity Clinical Research

Omaha, Nebraska 68134, United States

Midwest Regional Health Services - LLC - CCT - PPDS

Omaha, Nebraska 68144, United States

Papillion Research Center

Papillion, Nebraska 68046-4194, United States

AES - DRS - Synexus Clinical Research US, Inc. - Henderson

Henderson, Nevada 89052-3992, United States

Santa Rosa Urgent Care - Primary Care - CCT - PPDS

Las Vegas, Nevada 89119-5483, United States

Las Vegas Clinical Trials

North Las Vegas, Nevada 89030-7187, United States

Hassman Research Institute - HRI - Berlin - CenExel - PPDS

Berlin, New Jersey 08009, United States

Velocity Clinical Research - Albuquerque - PPDS

Albuquerque, New Mexico 87107-4503, United States

AXCES Research Group - Sante Fe - ERN - PPDS

Santa Fe, New Mexico 87505-4753, United States

DM Clinical Research - Brooklyn

Brooklyn, New York 11220-5906, United States

AES - DRS - Synexus Clinical Research US, Inc. - New York

New York, New York 10017-4008, United States

Rochester Clinical Research, Inc

Rochester, New York 14609-3173, United States

DelRicht Research, LLC - Charlotte - PPDS

Charlotte, North Carolina 28205-5078, United States

Tryon Medical Partners, PLLC and Javara Inc. - Javara - PPDS

Charlotte, North Carolina 28287-3884, United States

Monroe Biomedical Research -343 Venus St

Monroe, North Carolina 28112-4025, United States

Trial Management Associates LLC - ERN - PPDS

Wilmington, North Carolina 28403-6235, United States

CTI Clinical Research Center - PPDS

Cincinnati, Ohio 45212, United States

Velocity Clinical Research (Cincinnati - Ohio) - PPDS

Cincinnati, Ohio 45219-2975, United States

AES - DRS - Synexus Clinical Research US, Inc. - Cincinnati

Cincinnati, Ohio 45236-3669, United States

Velocity Clinical Research (Cincinnati - Ohio) - PPDS

Cincinnati, Ohio 45246-2316, United States

AES - DRS - Synexus Clinical Research US, Inc. - Columbus

Columbus, Ohio 43212-3119, United States

WellNow Urgent Care & Research - Huber Heights

Huber Heights, Ohio 45424-4019, United States

Tekton Research - Edmond - PPDS

Edmond, Oklahoma 73013-5478, United States

Lynn Institute of East Oklahoma - ERN - PPDS

Oklahoma City, Oklahoma 73111-3324, United States

DelRicht Research, LLC - Internal - Tulsa - PPDS

Tulsa, Oklahoma 74133-8902, United States

Tekton Research - Yukon - PPDS

Yukon, Oklahoma 73099-9518, United States

The Corvallis Clinic, PC - 3680 NW Samaritan Drive

Corvallis, Oregon 97330-3737, United States

Hatboro Medical Associates - CCT - PPDS

Hatboro, Pennsylvania 19040-2045, United States

DM Clinical Research - Philadelphia - ERN - PPDS

Philadelphia, Pennsylvania 19107-1530, United States

AES - DRS - Synexus Clinical Research US, Inc. - Anderson

Anderson, South Carolina 29621-2062, United States

TMA - Myrtle Beach - ERN - PPDS

Myrtle Beach, South Carolina 29572-4610, United States

Velocity Clinical Research - Spartanburg - PPDS

Spartanburg, South Carolina 29303-4225, United States

DelRicht Research, LLC - Hendersonville - PPDS

Hendersonville, Tennessee 37075-8947, United States

AES - DRS - Optimal Research Texas - Austin

Austin, Texas 78705-2655, United States

Benchmark Research - Austin - HyperCore - PPDS

Austin, Texas 78705-3298, United States

Tekton Research - Austin - PPDS

Austin, Texas 78745, United States

Tekton Research Inc

Beaumont, Texas 77706-3061, United States

Headlands Research - Brownsville - Headlands - PPDS

Brownsville, Texas 78526-4332, United States

AES - DRS - Synexus Clinical Research US, Inc. - Dallas

Dallas, Texas 75234-7858, United States

3A Research, LLC

El Paso, Texas 79925, United States

Privia Medical Group- North Texas - West Parker Road - Fort Worth - Javara - PPDS

Fort Worth, Texas 76133-4953, United States

Mount Olympus Medical Research Group - ClinEdge - PPDS

Friendswood, Texas 77546, United States

DM Clinical Research - Cyfair Clinical Research Center - ERN - PPDS

Houston, Texas 77065-5685, United States

DM Clinical Research - Bellaire - ERN - PPDS

Houston, Texas 77081-4648, United States

DM Clinical Research - Texas Center for Drug Development - Humble - ERN - PPDS

Humble, Texas 77338-4205, United States

DelRicht Research, LLC - Zomnir Family Medicine - DelRicht - PPDS

McKinney, Texas 75070-8481, United States

Benchmark Research - San Angelo - HyperCore - PPDS

San Angelo, Texas 76904-7610, United States

Sun Research Institute -427 9th St

San Antonio, Texas 78215-1528, United States

Clinical Trials of Texas, Inc. - PPDS

San Antonio, Texas 78229-3539, United States

IMA Clinical Research - San Antonio - PPDS

San Antonio, Texas 78229, United States

Tekton Research - San Antonio - PPDS

San Antonio, Texas 78229, United States

Privia Medical Group Gulf Coast, PLLC - San Marcos - Javara - PPDS

San Marcos, Texas 78666-9734, United States

Privia Medical Group- North Texas - Stephenville - Javara - PPDS

Stephenville, Texas 76401-1860, United States

DM Clinical Research - Sugarland - ERN - PPDS

Sugar Land, Texas 77478-4913, United States

DM Clinical Research - ERN - PPDS

Tomball, Texas 77375-3330, United States

Cope Family Medicine - CCT - PPDS

Bountiful, Utah 84010-4862, United States

Ogden Clinic - Mountain View - CCT - PPDS

Pleasant View, Utah 84404-4791, United States

Ogden Clinic - Grandview - CCT - PPDS

Roy, Utah 84067-9438, United States

JBR Clinical Research - CenExel JBR - PPDS

Salt Lake City, Utah 84107-4536, United States

AES - DRS - Synexus Clinical Research US, Inc. - Salt Lake City

South Salt Lake, Utah 84106-1466, United States

Velocity Clinical Research - Family Practice - Portsmouth - PPDS

Portsmouth, Virginia 23703-3200, United States

Wenatchee Valley Hospital & Clinics Campus

Wenatchee, Washington 98801-2028, United States