Trial NCT04712110
Publication Masuda T, Vaccine, 2022
Primary outcome on the report: 1) solicited AEs for 7 days after each injection; 2) unsolicited AEs for 49 days after the first injection (i.e., 21 days following first injection [day of injection + 20 subsequent days] and 28 days following second injection [day of second injection + 27 subsequent days]); 3) MAAEs, SAEs, AEs leading to injection discontinuation and 4) AEs leading to withdrawal from the trial up to and including day 50; and 5) the proportion of participants with SARS-CoV-2 infection through day 50. 6) Serum IgG Ab levels against SARS-CoV-2 rS protein on day 36.

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.