Trial NCT04495933
Publication Chappell K, SSRN, 2021
Primary outcome on the report: The primary safety endpoints included the frequency, duration, and intensity of solicited local and systemic adverse events (AEs) for 7 days after each dose, the frequency, duration, intensity, and relatedness of unsolicited AEs through Day 57, and the frequency of serious AEs and AEs leading to study discontinuation throughout the study. The primary immunogenicity endpoints included the geometric mean of the serum antibody response to SARS-CoV-2 Sclamp compared with placebo by antigen-specific enzyme-linked immunosorbent assay (ELISA) at Day 29 and Day 57, and the geometric mean of the serum neutralising antibody titres to SARS-CoV-2 virus compared with placebo at Day 29 and Day 57.

Note: The risk of bias by domain corresponds to the highest risk of bias among outcomes by domain.
The overall risk of bias corresponds to the overall highest risk of bias assessed among outcomes.