Study of a Combination Vaccine Comprised of Different Recombinant Spike Antigen Levels of a Matrix-M Adjuvanted Recombinant COVID-19 Vaccine and Recombinant Influenza Vaccine in Adult Participants 50 Years of Age and Older

About the trial

Sponsor

Sanofi

Tested

RIV (recombinant influenza vaccine) (biological), rC19 (dose 1) (biological), RIV + rC19 (dose 1) (biological), RIV + rC19 (dose 2) (biological), RIV + rC19 (dose 3) (biological), RIV + rC19 (dose 4) (biological), Placebo (0.9% NaCl) (other)

Dates

Started 2024-11-18; completion 2026-04-03

Results posted

Not yet

Study VBT00002 is planned to be a Phase 1/2, randomized, modified double-blind, active-controlled, multi-center study to be conducted in approximately 980 adults aged 50 years and older in the United States. The purpose of the study is to assess the safety and immunogenicity of recombinant influenza vaccine (RIV) + adjuvanted recombinant COVID-19 vaccine (rC19) vaccine comprised of RIV combined with different recombinant Spike (rS) antigen levels of rC19 compared to RIV alone, rC19 (dose 1) alone, and RIV and rC19 (dose 1) (coadministered in opposite arms). Placebo will be coadministered in the RIV alone, rC19 (dose 1) alone, and RIV + rC19 study groups to control for the number of inject…

From ClinicalTrials.gov, last updated 2026-05-05. Full record, eligibility and contacts (opens in a new tab)

Industry funding

Sanofi Pasteur Inc. reported $5.3M in research payments for this study in 2025 (151 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.