Study of mRNA-1010 Seasonal Influenza Vaccine in Adults

Last updated: July 18, 2024
Sponsor: ModernaTX, Inc.
Overall Status: Completed

Phase

3

Condition

N/A

Treatment

Licensed Quadrivalent Inactivated Seasonal Influenza Vaccine

mRNA-1010

Clinical Study ID

NCT05827978
mRNA-1010-P303
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

This study includes 3 parts: Parts A, B, and C. The purpose of this study is to evaluate the immunogenicity and safety of mRNA-1010 seasonal influenza vaccine in adults.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Investigator has assessed that the participant understands and is willing andphysically able to comply with protocol mandated follow up, including allprocedures.

  • For assigned females at birth and of childbearing potential: negative pregnancytest, adequate contraception or has abstained from all activities that could resultin pregnancy for at least 28 days prior to Day 1, and agreement to continue adequatecontraception through 90 days following vaccine administration.

Part A:

  • At least 18 years of age inclusive, at the time of signing the informed consent form (ICF).

Part B:

  • At least 18 and <65 years of age, at the time of signing the ICF.

Part C:

  • At least 65 years of age or older, at the time of signing the ICF.

Exclusion

Exclusion Criteria:

  • Participant has had close contact with someone with laboratory-confirmed influenzainfection or with someone who has been treated with antiviral therapies forinfluenza (for example, Tamiflu®) within the past 5 days prior to Day 1.

  • Participant is acutely ill or febrile (temperature ≥38.0℃elcius [100.4°Fahrenheit]) 72 hours prior to or at the Screening visit or Day 1. Participants meeting thiscriterion may be rescheduled within the 28-day screening window.

  • Participant has a history of a diagnosis or condition that, in the judgment of theinvestigator, is clinically unstable or may affect participant safety, assessment ofsafety endpoints, assessment of immune response, or adherence to study procedures.

  • Reported history of congenital or acquired immunodeficiency, immunosuppressivecondition or immune-mediated disease, asplenia, or recurrent severe infections.

  • Participant has tested positive for influenza by local health authority-approvedtesting methods within 150 days (for Part A) or 180 days (for Parts B and C) priorto Day 1.

  • Reported history of anaphylaxis or severe hypersensitivity reaction after receipt ofmRNA vaccines or any components of the mRNA-1010 or influenza vaccines, includingegg protein.

  • Participant has received systemic immunosuppressants for >14 days in total within 180 days prior to Day 1 (for corticosteroids, ≥10 mg/day of prednisone orequivalent) or is anticipating the need for systemic immunosuppressive treatment atany time during participation in the study. Inhaled, nasal and topical steroids areallowed. Intra-articular and epidural steroid injections are not allowed within 28days before and/or after study intervention dosing.

  • Participant has received any vaccine authorized or approved by local health agency ≤28 days prior to study intervention dosing (Day 1) or plans to receive a vaccineauthorized or approved by local health agency within 28 days before or after studyintervention dosing.

  • Participant has received a licensed seasonal influenza vaccine within 5 months (150days) (for part A) or within 6 months (180 days) (for Parts B and C) prior to Day 1.

  • Participant has participated in any investigational seasonal influenza vaccine studywithin12 months prior to Day 1.

  • Participant is not aware whether they have received an influenza vaccine in the mostrecent influenza season (in the prior 12 months) (for Part A) or since September 2022 (for Parts B and C).

  • Participant has donated ≥450 milliliters (mL) of blood products within 28 days priorto Day 1 or plans to donate blood products during the study.

Note: Other inclusion and exclusion criteria may apply.

Study Design

Total Participants: 8422
Treatment Group(s): 2
Primary Treatment: Licensed Quadrivalent Inactivated Seasonal Influenza Vaccine
Phase: 3
Study Start date:
April 17, 2023
Estimated Completion Date:
June 24, 2024

Connect with a study center

  • Pinnacle Research Group

    Anniston, Alabama 36207
    United States

    Site Not Available

  • North Alabama Research Center LLC

    Athens, Alabama 35611
    United States

    Site Not Available

  • Cullman Research Center

    Cullman, Alabama 35055
    United States

    Site Not Available

  • Medical Affiliated Research Center Inc

    Huntsville, Alabama 35801-6002
    United States

    Site Not Available

  • Desert Clinical Research - CCT

    Mesa, Arizona 85213
    United States

    Site Not Available

  • Foothills Research Center - CCT

    Phoenix, Arizona 85044
    United States

    Site Not Available

  • Fiel Family & Sports Medicine - PC - CCT

    Tempe, Arizona 85283
    United States

    Site Not Available

  • Fiel Family &amp; Sports Medicine - PC - CCT

    Tempe, Arizona 85283
    United States

    Site Not Available

  • Noble Clinical Research

    Tucson, Arizona 85704
    United States

    Site Not Available

  • Baptist Health Center for Clinical Research

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • Velocity Clinical Research - Banning - PPDS

    Banning, California 92220-3082
    United States

    Site Not Available

  • Velocity Clinical Research, Banning

    Banning, California 92220
    United States

    Site Not Available

  • Synexus Clinical Research US, Inc. - Cerritos

    Cerritos, California 90703
    United States

    Site Not Available

  • Marvel Clinical Research 002, LLC

    Huntington Beach, California 92647
    United States

    Site Not Available

  • Velocity Clinical Research

    La Mesa, California 91942
    United States

    Site Not Available

  • Velocity Clinical Research - San Diego - PPDS

    La Mesa, California 91942-3000
    United States

    Site Not Available

  • Pasadena Clinical Trials

    Pasadena, California 91105
    United States

    Site Not Available

  • Artemis Institute For Clinical Research LLC - Riverside - Headlands

    Riverside, California 92503
    United States

    Site Not Available

  • Peninsula Research Associates - CRN

    Rolling Hills Estates, California 90274
    United States

    Site Not Available

  • Acclaim Clinical Research

    San Diego, California 92120
    United States

    Site Not Available

  • Optimal Research California - San Diego

    San Diego, California 92108
    United States

    Site Not Available

  • Optimal Research, LLC

    San Diego, California 92108
    United States

    Site Not Available

  • Optimus Medical

    San Francisco, California 94102-3014
    United States

    Site Not Available

  • Optimus Medical Group

    San Francisco, California 94102
    United States

    Site Not Available

  • St. Johns Center for Clinical Research - ERN

    Solana Beach, California 92075
    United States

    Site Not Available

  • Pasadena Clinical Trials

    Upland, California 91786-4951
    United States

    Site Not Available

  • Lynn Institute of Denver - ERN

    Denver, Colorado 80246
    United States

    Site Not Available

  • Stamford Therapeutics Consortium - ERN

    Stamford, Connecticut 06905
    United States

    Site Not Available

  • Chase Medical Research LLC - Waterbury

    Waterbury, Connecticut 06708
    United States

    Site Not Available

  • Accel Research Site - Deland Clinical Research - ERN

    DeLand, Florida 32720
    United States

    Site Not Available

  • Velocity Clinical Research - Hallandale Beach

    Hallandale Beach, Florida 33009
    United States

    Site Not Available

  • Indago Research and Health Center

    Hialeah, Florida 33012
    United States

    Site Not Available

  • NeoClinical Reseaarch

    Hialeah, Florida 33016
    United States

    Site Not Available

  • NeoClinical Research

    Hialeah, Florida 33016-1811
    United States

    Site Not Available

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida 32216
    United States

    Site Not Available

  • Health Awareness - Jupiter - ERN

    Jupiter, Florida 33458
    United States

    Site Not Available

  • Health Awareness Inc

    Jupiter, Florida 33458
    United States

    Site Not Available

  • Multi-Specialty Research Associates, Inc. M3 WR

    Lake City, Florida 32055
    United States

    Site Not Available

  • Wr-Msra, Llc.

    Lake City, Florida 32055
    United States

    Site Not Available

  • Sandhill Research, LLC d/b/a Accel Research Sites

    Lake Mary, Florida 32746
    United States

    Site Not Available

  • Sandhill Research, LLC d/b/a Accel Research Sites Network

    Lake Mary, Florida 32746
    United States

    Site Not Available

  • University Clinical Research-DeLand, LLC d/b/a Accel Research

    Lake Mary, Florida 32746
    United States

    Site Not Available

  • Accel Research Sites - St. Petersburg - ERN

    Largo, Florida 33777
    United States

    Site Not Available

  • Clinical Site Partners, LLC dba Flourish Research

    Miami, Florida 33186
    United States

    Site Not Available

  • Flourish Research - Miami

    Miami, Florida 33186
    United States

    Site Not Available

  • Miami Clinical Research

    Miami, Florida 33155
    United States

    Site Not Available

  • Miami Clinical Research - ClinEdge - PPDS

    Miami, Florida 33155
    United States

    Site Not Available

  • Practical Management Inc. Broward

    Miami, Florida 33135
    United States

    Site Not Available

  • South Florida Research Center, Inc

    Miami, Florida 33135
    United States

    Site Not Available

  • Suncoast Research Associates LLC - ERN - PPDS

    Miami, Florida 33173-3255
    United States

    Site Not Available

  • Suncoast Research Associates, LLC

    Miami, Florida 33173
    United States

    Site Not Available

  • Floridian Clinical Research

    Miami Lakes, Florida 33016
    United States

    Site Not Available

  • Floridian Clinical Research - ClinEdge - PPDS

    Miami Lakes, Florida 33016
    United States

    Site Not Available

  • Innovation Medical Group, LLC.

    Palmetto Bay, Florida 33157
    United States

    Site Not Available

  • Innovation Medical Research Center - ClinEdge

    Palmetto Bay, Florida 33157
    United States

    Site Not Available

  • Suncoast Research Associates, LLC

    Pembroke Pines, Florida 33024
    United States

    Site Not Available

  • St. Johns Center for Clinical Research - ERN

    Saint Augustine, Florida 32086
    United States

    Site Not Available

  • New Tampa Health

    Tampa, Florida 33603-3402
    United States

    Site Not Available

  • New Tampa Health, Inc.

    Tampa, Florida 33603
    United States

    Site Not Available

  • Synexus Clinical Research US, Inc. - The Villages

    The Villages, Florida 32162
    United States

    Site Not Available

  • Atlanta Cardiology and Primary Care

    Atlanta, Georgia 30342
    United States

    Site Not Available

  • Synexus Clinical Research US, Inc. - Atlanta

    Atlanta, Georgia 30328
    United States

    Site Not Available

  • Accel Research Site - NeuroStudies.net, LLC - ERN

    Decatur, Georgia 30030
    United States

    Site Not Available

  • CenExel iResearch, LLC

    Decatur, Georgia 30030
    United States

    Site Not Available

  • Javara, Inc.

    Fayetteville, Georgia 30214
    United States

    Site Not Available

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

    Fayetteville, Georgia 30214
    United States

    Site Not Available

  • Velocity Clinical Research, Savannah

    Savannah, Georgia 31406
    United States

    Site Not Available

  • CRA, Headlands LLC

    Stockbridge, Georgia 30281
    United States

    Site Not Available

  • Clinical Research Atlanta - ERN

    Stockbridge, Georgia 30281
    United States

    Site Not Available

  • Flourish Research - Ravenswood

    Chicago, Illinois 60640
    United States

    Site Not Available

  • Great Lakes Clinical Trials- Ravenswood

    Chicago, Illinois 60640
    United States

    Site Not Available

  • Synexus Clinical Research US, Inc. - Chicago

    Chicago, Illinois 60602
    United States

    Site Not Available

  • DM Clinical Research

    River Forest, Illinois 60305
    United States

    Site Not Available

  • DM Clinical Research - Chicago - ERN

    River Forest, Illinois 60305
    United States

    Site Not Available

  • Velocity Clinical Research - Valparaiso

    Valparaiso, Indiana 46383
    United States

    Site Not Available

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

    Valparaiso, Indiana 46383-2546
    United States

    Site Not Available

  • Johnson County Clin-Trials

    Lenexa, Kansas 66219-1376
    United States

    Site Not Available

  • Johnson County Clin-Trials (JCCT)

    Lenexa, Kansas 66219
    United States

    Site Not Available

  • Alliance for Multispecialty Research, LLC

    Newton, Kansas 67114
    United States

    Site Not Available

  • Alliance for Multispecialty Research, LLC - Newton - PPDS

    Newton, Kansas 67114-2223
    United States

    Site Not Available

  • Meridian Clinical Research (Overland Park - Kansas)

    Overland Park, Kansas 66210
    United States

    Site Not Available

  • Velocity Clinical Research, Inc.

    Overland Park, Kansas 66210
    United States

    Site Not Available

  • Alliance for Multispecialty Research, LLC

    Wichita, Kansas 67205
    United States

    Site Not Available

  • Alliance for Multispecialty Research, LLC - West Wichita - PPDS

    Wichita, Kansas 67205-1235
    United States

    Site Not Available

  • Velocity Clinical Research (Cincinnati - Ohio) - PPDS

    Erlanger, Kentucky 41018-2774
    United States

    Site Not Available

  • Meridian Clinical Research (Baton Rouge - Louisiana)

    Baton Rouge, Louisiana 70809
    United States

    Site Not Available

  • Velocity Clinic Research, Inc.

    Baton Rouge, Louisiana 70809
    United States

    Site Not Available

  • Velocity Clinical Research - Covington - PPDS

    Covington, Louisiana 70433-7237
    United States

    Site Not Available

  • Velocity Clinical Research, Covington

    Covington, Louisiana 70433
    United States

    Site Not Available

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

    New Orleans, Louisiana 70124-3147
    United States

    Site Not Available

  • DelRicht Research

    New Orleans, Louisiana 70115
    United States

    Site Not Available

  • Javara Inc.

    Annapolis, Maryland 21401
    United States

    Site Not Available

  • Javara Research Inc. - Annapolis - Javara

    Annapolis, Maryland 21401
    United States

    Site Not Available

  • Velocity Clinical Research (Rockville - Maryland) - PPDS

    Rockville, Maryland 20854-2960
    United States

    Site Not Available

  • Velocity Clinical Research, Rockville

    Rockville, Maryland 20854
    United States

    Site Not Available

  • Oakland Medical Research

    Troy, Michigan 48085
    United States

    Site Not Available

  • Oakland Medical Research Center

    Troy, Michigan 48085-5524
    United States

    Site Not Available

  • Clinical Research Institute, Inc - CRN

    Minneapolis, Minnesota 55402
    United States

    Site Not Available

  • Clinical Research Institute, Inc - CRN

    Plymouth, Minnesota 55441
    United States

    Site Not Available

  • DelRicht Research

    Gulfport, Mississippi 39503
    United States

    Site Not Available

  • DelRicht Research, LLC - Gulfport - PPDS

    Gulfport, Mississippi 39503-4176
    United States

    Site Not Available

  • Velocity Clinical Research, Gulfport

    Gulfport, Mississippi 39503
    United States

    Site Not Available

  • Sundance Clinical Research - ERN - PPDS

    Saint Louis, Missouri 63117-1107
    United States

    Site Not Available

  • Sundance Clinical Research, LLC

    Saint Louis, Missouri 63141
    United States

    Site Not Available

  • Bio-Kinetic Clinical Applications, LLC dba QPS-MO

    Springfield, Missouri 65802
    United States

    Site Not Available

  • QPS Missouri

    Springfield, Missouri 65802-4842
    United States

    Site Not Available

  • Methodist Physicians Clinic - CCT Research

    Fremont, Nebraska 68025
    United States

    Site Not Available

  • Velocity Clinical Research- Grand Island

    Grand Island, Nebraska 68803
    United States

    Site Not Available

  • Velocity Clinical Research (Norfolk - Nebraska) - PPDS

    Norfolk, Nebraska 68701
    United States

    Site Not Available

  • Meridian Clinical Research (Omaha - Nebraska)

    Omaha, Nebraska 68134
    United States

    Site Not Available

  • Midwest Regional Health Services - LLC - CCT

    Omaha, Nebraska 68144
    United States

    Site Not Available

  • Velocity Clinical Research (Omaha - Nebraska) - PPDS

    Omaha, Nebraska 68134
    United States

    Site Not Available

  • Velocity Clinical Research, Inc.

    Omaha, Nebraska 68134
    United States

    Site Not Available

  • Alliance for Multispecialty Research, LLC

    Las Vegas, Nevada 89119
    United States

    Site Not Available

  • Alliance for Multispecialty Research, LLC - Las Vegas - PPDS

    Las Vegas, Nevada 89146-5630
    United States

    Site Not Available

  • Velocity Clinical Research (Binghamton - New York) - PPDS

    Binghamton, New York 13905
    United States

    Site Not Available

  • Velocity Clinical Research - East Syracuse - PPDS

    East Syracuse, New York 13057-9305
    United States

    Site Not Available

  • Velocity Clinical Research, Syracuse

    East Syracuse, New York 13057
    United States

    Site Not Available

  • Meridian Clinical Research (Endwell - New York)

    Endwell, New York 13760
    United States

    Site Not Available

  • Velocity Clinical Research (Binghamton - New York) - PPDS

    Endwell, New York 13760-3661
    United States

    Site Not Available

  • Rochester Clinical Research, Inc

    Rochester, New York 14609
    United States

    Site Not Available

  • Velocity Clinical Research, Inc.

    Vestal, New York 13850
    United States

    Site Not Available

  • Javara Inc.

    Charlotte, North Carolina 28210
    United States

    Site Not Available

  • Tryon Medical Practice - South Park - Javara

    Charlotte, North Carolina 28287
    United States

    Site Not Available

  • Lucas Research - Morehead City - HyperCore

    Morehead City, North Carolina 28557
    United States

    Site Not Available

  • Lucas Research Inc.

    Morehead City, North Carolina 28557
    United States

    Site Not Available

  • M3 Wake Research, Inc

    Raleigh, North Carolina 27612
    United States

    Site Not Available

  • M3 Wake Research, Inc - M3 WR

    Raleigh, North Carolina 27612-8106
    United States

    Site Not Available

  • CTI Clinical Research Center

    Cincinnati, Ohio 45212
    United States

    Site Not Available

  • Meridian Clinical Research - (Cincinnati - Ohio)

    Cincinnati, Ohio 45246
    United States

    Site Not Available

  • Velocity Clinical Research, Inc.

    Cincinnati, Ohio 45246
    United States

    Site Not Available

  • Velocity Clinical Research, Mt. Auburn

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • DelRicht Research

    Tulsa, Oklahoma 74133
    United States

    Site Not Available

  • DelRicht Research, LLC - Internal - Tulsa - PPDS

    Tulsa, Oklahoma 74133-8902
    United States

    Site Not Available

  • Velocity Clinical Research - Grants Pass

    Ashland, Oregon 97520
    United States

    Site Not Available

  • Velocity Clinical Research - Grants Pass

    Grants Pass, Oregon 97527
    United States

    Site Not Available

  • DM Clinical Research - Philadelphia - ERN

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Velocity Clinical Research - Columbia

    Columbia, South Carolina 29204
    United States

    Site Not Available

  • Velocity Clinical Research - Gaffney

    Gaffney, South Carolina 29340
    United States

    Site Not Available

  • Spartanburg Medical Research

    Spartanburg, South Carolina 29303
    United States

    Site Not Available

  • DelRicht Research

    Hendersonville, Tennessee 37075
    United States

    Site Not Available

  • DelRicht Research, LLC - Hendersonville - PPDS

    Hendersonville, Tennessee 37075-8947
    United States

    Site Not Available

  • Tekton Research - Austin - PPDS

    Austin, Texas 78745
    United States

    Site Not Available

  • Tekton Research - Beaumont - PPDS

    Beaumont, Texas 77706-3061
    United States

    Site Not Available

  • Tekton Research, LLC.

    Beaumont, Texas 77706
    United States

    Site Not Available

  • Javara Inc.

    Conroe, Texas 77384
    United States

    Site Not Available

  • Epic Medical Research - DeSoto

    DeSoto, Texas 75115
    United States

    Site Not Available

  • Epic Medical Research LLC - DeSoto

    DeSoto, Texas 75115-2043
    United States

    Site Not Available

  • DM Clinical Research

    Houston, Texas 77065
    United States

    Site Not Available

  • DM Clinical Research - ERN - PPDS

    Houston, Texas 77081-4648
    United States

    Site Not Available

  • DM Clinical Research

    Humble, Texas 77338
    United States

    Site Not Available

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

    Humble, Texas 77338
    United States

    Site Not Available

  • Epic Clinical Research

    Lewisville, Texas 75057
    United States

    Site Not Available

  • Clinical Trials of Texas, Inc.

    San Antonio, Texas 78229
    United States

    Site Not Available

  • DM Clinical Research

    Sugar Land, Texas 77478
    United States

    Site Not Available

  • DM Clinical Research - Sugarland - ERN

    Sugar Land, Texas 77478
    United States

    Site Not Available

  • Javara Inc.

    Sugar Land, Texas 77478
    United States

    Site Not Available

  • Javara Inc. /Privia Medical Group Gulf Coast, PLLC

    Sugar Land, Texas 77478
    United States

    Site Not Available

  • Privia Medical Group Physicians' Group of The Woodlands - Javara

    The Woodlands, Texas 77382
    United States

    Site Not Available

  • DM Clinical Research

    Tomball, Texas 77375
    United States

    Site Not Available

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

    Tomball, Texas 77375-6442
    United States

    Site Not Available

  • Cope Family Medicine - CCT

    Bountiful, Utah 84010
    United States

    Site Not Available

  • Olympus Family Medicine - CCT

    Holladay, Utah 84117
    United States

    Site Not Available

  • J. Lewis Research, Inc., Foothill Family Clinic

    Salt Lake City, Utah 84109
    United States

    Site Not Available

  • Olympus Family Medicine - CCT Research

    Salt Lake City, Utah 84117
    United States

    Site Not Available

  • South Ogden Family Medicine - CCT

    South Ogden, Utah 84405
    United States

    Site Not Available

  • South Ogden Family Medicine Ogden Clinic/CCT Research

    South Ogden, Utah 84405
    United States

    Site Not Available

  • Clinical Research Partners LLC - Richmond - ERN

    Richmond, Virginia 23226
    United States

    Site Not Available

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