Trial NCT04672395
Publication Bravo L, Lancet, 2022
Primary outcome on the report: Reactogenicity of the vaccine in an embedded phase 2 study, and the efficacy of SCB-2019 against COVID-19 in participants with no previous exposure to SARS-CoV-2 in the phase 3 study. 1) solicited local reactions and systemic adverse events for 7 days after each injection; 2) any unsolicited adverse events up to study day 43 (14 days after the second dose); 3) Safety is being assessed in an ongoing safety follow-up planned for 12 months after the second vaccination in the safety set that includes any participant who received at least one dose of vaccine or placebo; 4) first occurrence of RT-PCR-confirmed COVID-19 of any severity, with onset at least 14 days after the second vaccination

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.