Study of Monovalent and Bivalent Recombinant Protein Vaccines Against COVID-19 in Adults 18 Years of Age and Older
Terminated · Phase 3 · NCT04904549
Conditions: COVID-19
At a glance
- Research payments reported, 2025
- $112,842
- U.S. investigators named
- 19
- Sites paid
- 7
- Planned or actual enrollment
- 23,670
About the trial
- Sponsor
- Sanofi Pasteur, a Sanofi Company
- Tested
- SARS-CoV-2 adjuvanted recombinant protein vaccine (monovalent D614) (primary series) (biological), SARS-CoV-2 adjuvanted recombinant protein vaccine (bivalent D614 + B.1.351) (primary series) (biological), Placebo (biological), SARS-CoV-2 adjuvanted recombinant protein vaccine (monovalent B.1.351) (booster dose) >= 4 months after last vaccination (biological), SARS-CoV-2 adjuvanted recombinant protein vaccine(monovalent D614)(primary series)& SARS-CoV-2 adjuvanted recombinant protein vaccine(monovalent B.1.351)(booster dose)>=4 months after last vaccination (biological)
- Dates
- Started 2021-05-26; completion 2024-08-31
- Results posted
- Yes
The purpose of this Phase III study is to assess the efficacy, safety, and immunogenicity of two CoV2 preS dTM-AS03 vaccines (monovalent and bivalent) as part of primary series vaccinations in a multi-stage approach, as well as a booster injection of a CoV2 preS dTM-AS03 vaccine, in adults 18 years of age and older. A total of approximately 21 046 participants are planned to be enrolled (5080 per study intervention group in Stage 1 and 5443 per study intervention group in Stage 2). Initial, double-blind, primary series study design is planned for 365 days post-last Initial injection (ie, approximately 386 days total) for each participant. Based on decisions of the Study Oversight Group, S…
From ClinicalTrials.gov, last updated 2026-06-03. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Sanofi Pasteur Inc. reported $112,842 in research payments for this study in 2025 (57 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
- Randle T. Middleton, M.D. Family Medicine · Huntsville, AL
- Lawrence D. Sher, M.D. Pediatrics · Rolling Hills Estates, CA
- Murray A. Kimmel, D.O. Family Medicine · Melbourne, FL
- Linda P. Murray, M.D.,D.O. Family Medicine · St Petersburg, FL
- David S. Osteen, MD Orthopedic Surgery · Orlando, FL
- David M. Taylor, M.D. Gastroenterology · Atlanta, GA
- Mohammed A. Allaw, M.D. Internal Medicine · Newburgh, IN
- Joseph L. Newberg, MD Emergency Medicine · La Porte, IN
- Leslie M. Tharenos, MD, MPH Occupational Medicine · Saint Louis, MO
- Cornell V. Calinescu, MD Emergency Medicine · Las Vegas, NV
- Matthew G. Davis, MD Family Medicine · Rochester, NY
- Cathy A. Greiwe, M.D. Family Medicine · Columbus, OH
- Paul J. Nugent, D.O. Family Medicine · Cincinnati, OH
- Margaret E. Rhee, MD OB-GYN (Obstetrics & Gynecology) · Akron, OH
- Yvonne J. Davis, MD Internal Medicine · Mount Pleasant, SC
- Jeffrey A. Henderson, M.D., M.P.H. Internal Medicine · Rapid City, SD
- Mark H. Hutchens, M.D. Sports Medicine · Austin, TX
- William P. Jennings, MD Internal Medicine · San Antonio, TX
- Michael R. Adams, MD Family Medicine · Sandy, UT
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Clinical Research Advantage Inc $93,764
- Coastal Carolina Research Center,incorporation $6,337
- Black Hills Center for American Indian Health $4,576
- Rochester Clinical Research,inc $3,679
- Peninsula Research Associates $2,986
- Peninsula Research Associates,inc $1,500
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.