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

About the trial

Sponsor

Sanofi

Tested

IIV-HD (biological), rC19 (dose 1) (biological), IIV-HD + rC19 (dose 1) (biological), IIV-HD + rC19 (dose 2) (biological), IIV-HD + rC19 (dose 3) (biological), IIV-HD + rC19 (dose 4) (biological), Placebo (0.9% NaCl) (other)

Dates

Started 2024-11-19; completion 2026-04-16

Results posted

Not yet

Study VBT00001 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 IIV-HD (high-dose inactivated influenza vaccine) + rC19 (adjuvanted recombinant COVID-19 vaccine) vaccine comprised of IIV-HD combined with different recombinant Spike (rS) antigen levels of rC19 compared to IIV-HD alone, rC19 (dose 1) alone, and IIV-HD and rC19 (dose 1) (coadministered in opposite arms). Placebo will be coadministered in the IIV-HD alone, rC19 (dose 1) alone, and IIV-HD + rC19 study groups to cont…

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

Industry funding

Sanofi Pasteur Inc. reported $5.2M in research payments for this study in 2025 (167 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.