Trial CTRI/2021/10/037066
Publication Thuluva , medRxiv, 2022
Primary outcome on the report: The primary outcome of the phase-2 and secondary outcome of phase-3 part of the study was to assess the safety, tolerability and reactogenicity of CORBEVAX™ vaccine in children and adolescents in comparison to placebo group in terms of occurrence of any solicited and unsolicited AEs for 28 days’ post vaccination. The primary outcome of phase-3 part of the study was demonstration of immunogenic non-inferiority of BE’s CORBEVAX™ vaccine against adult population in terms of geometric mean neutralizing titers and their geometric mean fold rise from baseline, at day 42 (14 days after 2nd dose).

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.