Study of Recombinant Protein Vaccines With Adjuvant as a Primary Series and as a Booster Dose Against COVID-19 in Adults 18 Years of Age and Older

About the trial

Sponsor

Sanofi Pasteur, a Sanofi Company (with GlaxoSmithKline)

Tested

SARS-CoV-2 recombinant protein vaccine Phase 2 Formulation 1 (biological), SARS-CoV-2 recombinant protein vaccine Phase 2 Formulation 2 (biological), SARS-CoV-2 recombinant protein vaccine Phase 2 Formulation 3 (biological), SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (D614)-AS03, Dosage A (biological), SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (B.1.351)-AS03 (biological), SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (D614)-AS03, Dosage B (biological), SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (B.1.351)-AS03 Alternative Exploratory Formulation 1 (biological), SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (B.1.351)-AS03 Alternative Exploratory Formulation 2 (biological), SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (B.1.351)-AS03 Alternative Exploratory Formulation 3 (biological), SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (B.1.351)-AS03 Alternative Exploratory Formulation 4 (biological), SARS-CoV-2 adjuvanted recombinant protein vaccine, bivalent (D614+B.1.351)-AS03 (biological)

Dates

Started 2021-02-24; completion 2023-06-29

Results posted

Yes

The primary objectives of the study are: To assess the safety profile of the study vaccines in each study intervention group. To assess the neutralizing antibody profile after primary series vaccination in SARS-CoV-2-naïve adults. To demonstrate that a booster dose of monovalent or bivalent SARS-CoV-2 vaccine given to adults previously vaccinated with an authorized/approved COVID-19 vaccine induces an immune response that is non-inferior to the response induced by a twodose priming series with the monovalent vaccine, and superior to that observed immediately before booster. The secondary objectives of the study are: To assess the neutralizing and binding antibody profiles after primary se…

From ClinicalTrials.gov, last updated 2025-09-18. Full record, eligibility and contacts (opens in a new tab)

Industry funding

Sanofi Pasteur Inc. reported $815,057 in research payments for this study in 2025 (66 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.