A Study to Investigate the Safety and Efficacy of mRNA-1403 in Participants ≥18 Years of Age for the Prevention of Acute Gastroenteritis
Active, not recruiting · Phase 3 · NCT06592794
Conditions: Acute Gastroenteritis, Norovirus Acute Gastroenteritis
At a glance
- Research payments reported, 2025
- $117.0M
- U.S. investigators named
- 186
- Sites paid
- 216
- Planned or actual enrollment
- 37,864
About the trial
- Sponsor
- ModernaTX, Inc.
- Tested
- mRNA-1403 (biological), Placebo (biological)
- Dates
- Started 2024-09-24; completion 2027-02-15
- Results posted
- Not yet
The primary objectives of this study are to evaluate the safety and reactogenicity of mRNA-1403, and to demonstrate the efficacy of mRNA-1403 to prevent protocol-defined moderate or severe norovirus acute gastroenteritis (AGE) associated with vaccine matched genotypes.
From ClinicalTrials.gov, last updated 2026-05-13. Full record, eligibility and contacts (opens in a new tab)
Industry funding
ModernaTX, Inc. reported $117.0M in research payments for this study in 2025 (10,028 payments).
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
- Michael T. Ledet, MD Sleep Medicine · Daphne, AL
- Randall L. Quinn, MD Family Medicine · Cullman, AL
- Faheem M. Shaikh, MD PHD Hospitalist · Birmingham, AL
- Derek Lewis, M.D. Family Medicine · Little Rock, AR
- Priyantha N. Wijewardane, M.D. Internal Medicine · Little Rock, AR
- Danielle R. Armas, M.D. Family Medicine · Scottsdale, AZ
- Todd Bertoch, M.D. Anesthesiology · Prescott, AZ
- Nicholas K. Bujak, MD OB-GYN (Obstetrics & Gynecology) · Phoenix, AZ
- Abram H. Burgher, MD Pain Medicine · Phoenix, AZ
- Joseph D. Davis, M.D. Gastroenterology · Chandler, AZ
- Brian Dedinsky, M.D. Family Medicine · Phoenix, AZ
- Matthew W. Doust, MD Pain Medicine · Scottsdale, AZ
- Todd M. Dreitzler, M.D. Family Medicine · Tempe, AZ
- Vicki Kalen, MD Pediatric Surgery · Tucson, AZ
- Anita Kohli, MD Infectious Disease · Chandler, AZ
- Walter S. Patton JR., MD OB-GYN (Obstetrics & Gynecology) · Tucson, AZ
- Peyman Banooni, M.D. OB-GYN (Obstetrics & Gynecology) · Beverly Hills, CA
- Brian J. Bearie Emergency Medicine · San Bernardino, CA
- Jose M. Diaz, M.D Pediatrics · Downey, CA
- David Guzman, M.D. Internal Medicine · Los Angeles, CA
- Daniel Johnson, D.O. Family Medicine · San Diego, CA
- Rafael Lupercio, M.D. Critical Care Medicine · Redding, CA
- Kevin Oei Family Medicine · Downey, CA
- Jeffrey S. Overcash, MD Emergency Medicine · Chula Vista, CA
- Lawrence D. Sher, M.D. Pediatrics · Rolling Hills Estates, CA
- Rita Starritt, M.D. Internal Medicine · San Diego, CA
- Jack B. Vu, MD Family Medicine · Lake Forest, CA
- Apinya B. Vutikullird, D.O. Family Medicine · Cypress, CA
- Justin L. Yanuck, M.D. Emergency Medicine · Downey, CA
- Timothy D. Colander, MD Family Medicine · Aurora, CO
- Clint Flanagan, MD Family Medicine · Dacono, CO
- Michael S. Thakor, MD Rheumatology · Fort Collins, CO
- Rafik Abadier, M.D. Cardiology · Inverness, FL
- Dario D. Altamirano, DO Family Medicine · Hialeah, FL
- James L. Andersen, M.D. Addiction Medicine · Eagle Lake, FL
- Matthew J. Baker, MD Neurology · Naples, FL
- Cathy B. Barnes, MD Family Medicine · New Port Richey, FL
- Nadijda T. Bassil, M.D. Family Medicine · Tampa, FL
- Francisco M. Bautista, MD Internal Medicine · Hialeah, FL
- Allison Blomer, MD OB-GYN (Obstetrics & Gynecology) · Port St Lucie, FL
- Jorge T. Caso, MD Family Medicine · Miami, FL
- Fadi Chalhoub Geriatric Medicine · Jacksonville, FL
- Abid H. Chaudhry, M.D. Emergency Medicine · Homestead, FL
- Howard N. Chipman III, M.D. Family Medicine · Oldsmar, FL
- Aaron Cohen, M.D. Internal Medicine · Atlantis, FL
- Lucinda I. Cuervo, MD General Practice · Miami, FL
- Jose L. Diaz, MD Pulmonology · Leesburg, FL
- Herman J. Downey, MD Family Medicine · Jacksonville, FL
- Ana M. Elosegui, M.D. Family Medicine · Miami, FL
- Idania M. Fernandez, M.D. General Practice · Hialeah, FL
- Lawrence Galitz, M.D. General Practice · Miami Gardens, FL
- Jason M. Haffizulla, M.D. Internal Medicine · Tamarac, FL
- Eva-maria Heurich, D.O. Family Medicine · Orlando, FL
- Keila Hoover, M.D. Family Medicine · Miami, FL
- Howard S. Koch, MD Internal Medicine · Sunrise, FL
- Luis A. Martinez, MD Internal Medicine · Doral, FL
- Tatyana S. Miroshnikova, M.D. Internal Medicine · Orlando, FL
- Ammara Mushtaq, M.D. Infectious Disease · Gainesville, FL
- Richard L. Myers, M.D. OB-GYN (Obstetrics & Gynecology) · Jacksonville, FL
- Maria T. Nualart, MD General Practice · Miami, FL
- Orlando A. Puente, MD Specialist · Miami, FL
- Bruce G. Rankin, D. O. Family Medicine · Deland, FL
- Nelia E. Sanchez-crespo, M.D. Internal Medicine · Hollywood, FL
- Carlos A. Sesin, M.D. Rheumatology · Miami Beach, FL
- Ronald Z. Surowitz, D.O. Family Medicine · Jupiter, FL
- Elena R. Valor, M.D Family Medicine · Miami, FL
- Bhanu Visvalingam, MD Medical Oncology · Sanford, FL
- Paul S. Bradley, MD Internal Medicine · Savannah, GA
- Jon P. Finley, M.D. Sports Medicine · Stockbridge, GA
- Charlotte E. Grayson- Mathis, M.D. Internal Medicine · Fayetteville, GA
- Kimball A. Johnson, MD Internal Medicine · Atlanta, GA
- Charles H. Kemp, M.D. Internal Medicine · Albany, GA
- Thomas G. Moriarity III, D.O. Internal Medicine · Savannah, GA
- Robert E. Springer, M.D. Internal Medicine · Atlanta, GA
- Felipe P. Suplicy, M.D. Psychiatry · Rome, GA
- Jeffrey B. Baker, M.D. Family Medicine · Idaho Falls, ID
- Mark A. Turner, MD Family Medicine · Meridian, ID
- Mary Brown, MD Internal Medicine · Rockford, IL
- Daniel H. Brune, M.D. Family Medicine · Creve Coeur, IL
- Samuel Moltz, M.D. Internal Medicine · Northfield, IL
- Robert J. Buynak, M.D. Internal Medicine · Valparaiso, IN
- Brandon W. Alleman, MD Family Medicine · Wichita, KS
- Carlos A. Fierro, MD General Practice · Kansas City, KS
- Derrick R. Ward, M.D. Allergy & Immunology · Overland Park, KS
- Mark S. Adams, M.D. Internal Medicine · London, KY
- Matthew D. Wenker, MD Internal Medicine · Erlanger, KY
- William F. Beacham, M.D. OB-GYN (Obstetrics & Gynecology) · Hammond, LA
- Michael Cotugno Emergency Medicine · New Iberia, LA
- David A. Dulitz, M.D. Gastroenterology · Luling, LA
- Katherine F. Pearce, M.D. Internal Medicine · Baton Rouge, LA
- Gary Kleeman, DO Emergency Medicine · Melrose, MA
- Elia E. Acevedo Diaz, M.D Psychiatry · Gaithersburg, MD
- Husna Baksh, M.D. Internal Medicine · Silver Spring, MD
- Richard A. Bernstein, M.D. Pulmonology · Annapolis, MD
- Basmah A. Jalil, MD Rheumatology · Bethesda, MD
- Shishir K. Khetan, MD Internal Medicine · Rockville, MD
- Brandon J. Lawrence, MD Emergency Medicine · Kalamazoo, MI
- Rebecca A. Rivard, D.O. Family Medicine · Roseville, MI
- Jay H. Sandberg, D.O Internal Medicine · Troy, MI
- David W. Strong, M.D., PH.D. Emergency Medicine · Detroit, MI
- Derrick Williamson, DO Family Medicine · Southfield, MI
- Gary D. Berman, M.D. Allergy & Immunology · Minneapolis, MN
- Fredric A. Prater, D.O. Family Medicine · Maryland Heights, MO
- David G. True, D.O. Rheumatology · Nixa, MO
- Luke A. Van Kirk, DO Family Medicine · Springfield, MO
- Paul G. Matherne, MD Family Medicine · Gulfport, MS
- Clancy L. Cone, MD Internal Medicine · Missoula, MT
- Kevin Cannon, M.D. Hospitalist · Wilmington, NC
- William C. Cromwell, M.D. Family Medicine · Raleigh, NC
- Melissa M. Jones, D.O. Family Medicine · Charlotte, NC
- Christina C. Kennelly, M.D. Internal Medicine · Charlotte, NC
- Patrick J. Morgante, DO Family Medicine · Havelock, NC
- John Rubino, MD Internal Medicine · Raleigh, NC
- John W. Sanders III, MD, MPH Infectious Disease · Wilmington, NC
- David J. Ensz, M.D. Family Medicine · South Sioux City, NE
- Charles Harper JR., MD Internal Medicine · Norfolk, NE
- Jay R. Meyer, MD Emergency Medicine · Lincoln, NE
- Frederick C. Raiser III, DO Emergency Medicine · Omaha, NE
- Matthew O. Adasofunjo, MD Internal Medicine · Hamilton, NJ
- Samar Hameed, MD Internal Medicine · Livingston, NJ
- Sally Fisher, MD Family Medicine · Albuquerque, NM
- Sara S. Friedman, M.D. OB-GYN (Obstetrics & Gynecology) · Albuquerque, NM
- Satkirin Khalsa Family Medicine · Albuquerque, NM
- Cornell V. Calinescu, MD Emergency Medicine · Las Vegas, NV
- Stephen L. Tam, MD Internal Medicine · Las Vegas, NV
- Sangeeta S. Wagner, DO Family Medicine · Sparks, NV
- Elyssa L. Barron, M.D. Psychiatry · White Plains, NY
- Robert C. Cupelo, M.D. Internal Medicine · East Syracuse, NY
- Matthew G. Davis, MD Family Medicine · Rochester, NY
- Frank Eder, MD Family Medicine · Binghamton, NY
- Michael Gerdis, MD Gastroenterology · Yonkers, NY
- Ramsey H. Joudeh, M.D. Internal Medicine · Brooklyn, NY
- Suchet R. Patel, MD Family Medicine · Endwell, NY
- Michael B. Butcher, M.D. Family Medicine · Cincinnati, OH
- Edward M. Cordasco, D.O. Pulmonology · Columbus, OH
- Charles H. Eger, M.D Internal Medicine · Cincinnati, OH
- Sridhar Guduri, M.D Allergy & Immunology · Dublin, OH
- Antoinette A. Pragalos, M.D. Internal Medicine · Cincinnati, OH
- Margaret E. Rhee, MD OB-GYN (Obstetrics & Gynecology) · Akron, OH
- Robert J. Lockwood, MD Family Medicine · Yukon, OK
- Kyle W. Rickner, M.D Family Medicine · Edmond, OK
- Melita L. Tate, MD Internal Medicine · Tulsa, OK
- Alan Kivitz, MD Rheumatology · Duncansville, PA
- David S. Wheeler, MD Pulmonology · Philadelphia, PA
- Javier O. Morales-ramirez, M.D. Infectious Disease · San Juan, PR
- Jesus W. Rodriguez Rodriguez, M.D. General Practice · Ponce, PR
- Ruben J. Santiago-lugo, M.D. Internal Medicine · Bayamon, PR
- David Fried, MD Internal Medicine · East Greenwich, RI
- Kelly N. Morales, MD Family Medicine · North Charleston, SC
- Edward M. Newton, MD Family Medicine · Charleston, SC
- Farhan Siddiqui, M.D. Pulmonology · Spartanburg, SC
- Charles A. Thompson, MD Pulmonology · Anderson, SC
- Bernard Grunstra, MD Internal Medicine · Bristol, TN
- Kymberly B. Moyer, D.O. Family Medicine · Gallatin, TN
- Lisa S. Usdan, M.D. Endocrinology & Diabetes · Memphis, TN
- Hilario Alvarado III, MD Family Medicine · San Antonio, TX
- Robert C. Bell, M.D. Pediatrics · Beaumont, TX
- Lisa J. Blair, MD Family Medicine · Aransas Pass, TX
- Laurence Chu, MD ENT (Otolaryngology) · Austin, TX
- Bonnie E. Colville, D.O. Family Medicine · Houston, TX
- Ralph F. Cox JR., M.D. Family Medicine · Dallas, TX
- Oscar L. De Valle, M.D. Family Medicine · Houston, TX
- Emmanuel C. Gorospe, M.D Gastroenterology · El Paso, TX
- Sander J. Gothard, M.D. Family Medicine · Plano, TX
- Lisa R. Holloway, D.O. Family Medicine · Houston, TX
- Tiffany M. Huynh, MD Orthopedic Surgery · Houston, TX
- Nomita J. Kim, MD Family Medicine · Austin, TX
- Jara K. Mcdonald, M.D. Family Medicine · Marble Falls, TX
- Vicki E. Miller, M.D. Family Medicine · Pasadena, TX
- Heather J. Myers, MD Emergency Medicine · Lewisville, TX
- Asisat A. Ope, M.D. Family Medicine · Sugar Land, TX
- Christopher Romero, MD Internal Medicine · Houston, TX
- William Seger, M.D. Family Medicine · Fort Worth, TX
- Helen Shpats, MD General Practice · Houston, TX
- Jeffrey G. Stewart, M.D. Family Medicine · Carrollton, TX
- Clifford W. Yut, MD Pediatrics · The Woodlands, TX
- Jennifer M. Zomnir, M.D. Family Medicine · Frisco, TX
- Bryce K. Peterson, MD Family Medicine · Bountiful, UT
- Mary C. Bailey, M.D. Internal Medicine · Norfolk, VA
- James R. Clark, MD Internal Medicine · Charlottesville, VA
- George H. Freeman, M.D. Research Study Specialist · Newport News, VA
- Banu P. Myneni, D.O. Family Medicine · Portsmouth, VA
- Thomas A. Piscitelli, D.O. Internal Medicine · North Prince George, VA
- Leroy B. Vaughan JR., M.D. Internal Medicine · Richmond, VA
- Emily J. Zaragoza, M.D. Family Medicine · Seattle, WA
- Jeffry J. Pilney, M.D. Specialist · Buckeye, WV
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Velocity Clinical Research Inc $13.4M
- Elias Research Associates LLC $7.2M
- Dynamed Clinical Research LP $5.4M
- Interspond LLC $3.9M
- Javara Inc $3.6M
- Delricht Research $3.0M
- Cenexel Clinical Research Inc $2.8M
- Sweet Hope Research Speciality Inc $2.7M
- Qcare Site Services Inc $2.7M
- Precision Clinical Research LLC $2.4M
- Tekton Research LLC $2.3M
- Clinical Neuroscience Solutions Inc $2.0M
- Clinical Research of Broward $1.8M
- Accellacare US Inc $1.8M
- West Houston Clinical Research Service $1.7M
- Headlands Horizons LLC $1.7M
- Imagine Research of PAlm Beach County $1.7M
- Pioneer Clinical Studies $1.5M
- Clinical Trials Management LLC $1.5M
- Acrc Trials $1.4M
- Quality of Life Medical and Research Centers LLC $1.4M
- Clinical Research PArtners LLC $1.4M
- Drug Trials America Inc $1.3M
- Ima Evaluations LLC DBA Ima Clinical Research $1.3M
- Swift Clinical Opco Inc $1.2M
- Johnson County Clintrials LLC $1.2M
- Clinical Research Institute Inc $1.2M
- Dynamed Philadelphia LLC $1.2M
- Dynamed Washington LLC $1.2M
- Health Awareness LLC $1.2M
- Research Your Health LLC $1.1M
- Del Sol Research Management LLC $1.1M
- Integrity Clinical Research, LLC $1.1M
- Paradigm Clinical Research Centers LLC $1.0M
- Hope Research Institute LLC $1.0M
- Dynamed Detroit LLC $1.0M
- West Clinical Research Inc $988,984
- Achieve Clinical Research LLC $947,536
- Health Research of Hampton Roads Inc $911,477
- Universal Axon Clinical Research LLC $880,548
- University Clinical Research Deland LLC $871,869
- Brcr Medical Center Inc $856,471
- Sandhill Research LLC $826,686
- Community Research Management Associates Inc $821,158
- Cra Headlands LLC $793,621
- Dynamed New Mexico LLC $783,932
- Alliance for Multispecialty Research LLC $777,918
- Global Clinical Professionals LLC $777,033
- Dynamed Chicago LLC $768,898
- The Institute for Liver Health LLC $767,403
- Clinical Research Professionals $758,281
- Texas Center for Drug Development Inc $749,766
- Dm Boston LLC $747,202
- Coastal Carolina Research Center Inc $723,804
- Jacksonville Center for Clinical Research $720,015
- Charlottesville Medical Research Center LLC $712,209
- Artemis Headlands LLC $706,796
- Baptist Health Center for Clinical Research LLC $664,900
- Neostart Corporation $654,332
- Skylight Health Research Inc $636,041
- Ark Clinical Research LLC $620,064
- Scottsdale Clinical Trials $602,368
- Bioluminux Clinical Research Illinois LLC $596,820
- Clinical Site PArtners Inc $595,893
- Matrix Clinical Research Inc $592,690
- Clinical Research Prime Idaho Falls LLC $587,730
- United Medical Research LLC $570,330
- Oasis Clinical Research LLC $527,688
- Suncoast Research Associates LLC DBA Sra Trials $519,454
- M3 Wake Research Inc $503,787
- Wake Forest University Health Sciences $502,405
- Dynamed Arizona LLC $493,511
- Suncoast Clinical Research LLC $468,386
- Miami Dade Medical Research Institute, LLC $460,667
- Lynn Health Science Institute Inc $444,636
- Cr Services Acquisition US LLC $441,225
- Peninsula Headlands LLC $437,997
- Clinvest Headlands LLC $435,951
- Dynamed New Jersey LLC $433,790
- Rochester Clinical Research LLC $433,041
- Glri El PAso Research LLC $425,830
- Remington Davis Inc $380,549
- Researchworkspuertorico $374,867
- Synexus Clinical Research US Inc $374,248
- Great Lakes Clinical Trials LLC $373,210
- Great Lakes Research Institute LLC $344,283
- Bioluminuxclinicalresearchillinoisllc $332,751
- Las Vegas Medical Research LLC $326,778
- Florida International Research Center $277,936
- Clinical Research Puerto Rico Inc $176,324
- Lynn Institute of the Ozarks $160,622
- Frontier Clinical Research LLC $156,081
- Cullman Clinical Trials LLC $153,064
- Altoona Center for Clinical Research PC $143,955
- Aqualane Clinical Research $116,180
- Miami Dade Medical Research Institute $91,499
- Nature Coast Clinical Research $47,239
- Jbr Clinical Research LLC $9,050
- Cenexel Rocky Mountain Clinical Research LLC $5,375
- Cenexel Iresearch LLC $3,000
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.