A Study to Evaluate the Safety and Immunogenicity of the mRNA COVID-19 Vaccines in Healthy Children Between 6 Months to Less Than 6 Years of Age
Completed · Phase 3 · NCT05436834
Conditions: SARS-CoV-2
At a glance
- Research payments reported, 2025
- $488,774
- U.S. investigators named
- 30
- Sites paid
- 25
- Planned or actual enrollment
- 1,807
About the trial
- Sponsor
- ModernaTX, Inc.
- Tested
- mRNA-1273.214 (biological), mRNA-1273.815 (biological)
- Dates
- Started 2022-06-21; completion 2025-10-20
- Results posted
- Not yet
This study will evaluate the safety and immunogenicity of the mRNA-1273.214 vaccine for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variant of concerns (VOCs) in participants aged 6 months to \<6 years, when administered as a primary series in SARS-CoV-2 vaccine-naïve participants (Part 1) and a single booster dose (BD) given to participants who previously received 2 doses of the mRNA-1273 vaccine as a primary series (Part 2); and will evaluate the safety and immunogenicity of the mRNA-1273.815 vaccine, when administered as a BD in participants aged 6 months to \<6 years (Part 3) and when administered to SARS-CoV-2 vaccine-naïve participants aged 2 years to \<5 years of a…
From ClinicalTrials.gov, last updated 2025-11-26. Full record, eligibility and contacts (opens in a new tab)
Industry funding
ModernaTX, Inc. reported $488,774 in research payments for this study in 2025 (103 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
- Andrew Posey, DO Family Medicine · Bessemer, AL
- John M. Hernandez, MD Internal Medicine · Montebello, CA
- Adalberto Aguilera, MD General Practice · Orlando, FL
- Konda M. Reddy, MD Pediatric Endocrinology · Winter Park, FL
- Carina Rodriguez, MD Pediatric Infectious Disease · Tampa, FL
- Kimball A. Johnson, MD Internal Medicine · Atlanta, GA
- Mark A. Turner, MD Family Medicine · Meridian, ID
- William J. Muller, MD, PHD Pediatric Infectious Disease · Chicago, IL
- George J. Fuchs Iii, MD Pediatric Gastroenterology · Lexington, KY
- Jibran E. Atwi, MD Allergy & Immunology · Lafayette, LA
- Scott P. Striplin, M.D. OB-GYN (Obstetrics & Gynecology) · Covington, LA
- Shishir K. Khetan, MD Internal Medicine · Rockville, MD
- Gary D. Berman, M.D. Allergy & Immunology · Minneapolis, MN
- Amruta N. Padhye, M.D. Pediatric Infectious Disease · Columbia, MO
- Philip T. Boucher, M.D. Pediatrics · Omaha, NE
- Michael J. Dunn, M.D. Internal Medicine · Omaha, NE
- Sara S. Friedman, M.D. OB-GYN (Obstetrics & Gynecology) · Albuquerque, NM
- Frank Eder, MD Family Medicine · Binghamton, NY
- Carl P. Griffin, M.D. Family Medicine · Oklahoma City, OK
- Carmen Colon-tarbal, M.D. Pediatrics · San Juan, PR
- Richard K. Ohnmacht, MD Pediatrics · Cranston, RI
- Andrew M. Atz, MD Pediatric Cardiology · Charleston, SC
- Robert A. Clifford, M.D. Pediatrics · Charleston, SC
- Todd R. Vasko, MD Pediatrics · Charleston, SC
- Kashif R. Ali, M.D. Pediatrics · Houston, TX
- Madhavi Ampajwala, M.D Family Medicine · Frisco, TX
- Khozema A. Palanpurwala, MD Pediatrics · Houston, TX
- Roozbeh Sharif, M.D., M.ED., M.SC. Pulmonology · Nederland, TX
- Richard L. Bennett JR., MD Pediatrics · Richmond, VA
- Fredric B. Garner, MD Pediatrics · Burke, VA
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Coastal Pediatric Research $107,449
- Dynamed Clinical Research LP $56,893
- Velocity Clinical Research Inc $46,317
- Ann & Robert H Lurie Childrens Hospital of Chicago, IL $34,829
- Elias Research Associates LLC $33,001
- University of Kentucky Research Foundation $30,396
- Quality Clinical Research Inc $25,548
- University of Missouri Health Care, MO $25,536
- Kur Research LLC $23,988
- Texas Center for Drug Development $21,838
- Rex Clinical Trials LLC $14,934
- Dm Clinical Research - Bellaire $11,863
- Clinical Research PArtners $8,927
- Clinical Research Institute Inc $7,719
- The University of South Florida $7,456
- Iresearch Atlanta LLC $7,050
- Meridian Clinical Research LLC $7,036
- Marwah Investments Corporation $6,070
- Caribbean Medical Research Center $3,500
- Med Care Research Corp $2,608
- Be Well Clinical Studies LLC $2,000
- Lynn Health Science Institute $1,462
- Medical University of South Carolina $1,100
- Seracollection Research Services LLC $1,000
- Coastal Pediatric Research. $257
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.