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A parallel-group, Phase III, multi-stage, modified double-blind, multi-armed study to assess the efficacy, safety, and immunogenicity of two SARS-CoV-2 Adjuvanted Recombinant Protein Vaccines (monovalent and bivalent) for prevention against COVID-19

This is a placebo-controlled, double-blinded study focused on adults 18 years of age or older, sponsored by Sanofi Pasteur Inc + GSK who provided the adjuvant - a protein subunit vaccine. Enrollment commenced in December 2021, and patients followed up until October 2022. Unblinding and crossover are being proposed after positive DSMB reports. The proposed completion of the study is around the end of 2023 depending upon the beginning of the cross-over trial.

Active Dates 
12/01/2021 to 12/31/2023
Faculty Involved