Trial NCT04762680
Publication Sridhar S, medrxiv, 2021
Primary outcome on the report: 1) Occurrence of immediate unsolicited systemic AEs occurring within 30 minutes of each injection; 2) solicited injection site reactions (injection site pain, erythema and swelling) and solicited systemic reactions (fever, headache, malaise, myalgia, arthralgia and chills) up to seven days after each injection; 3) unsolicited AEs reported up to 21 days after each injection; 4) MAAEs, serious adverse events (SAEs) and AESIs documented throughout the study. AESIs included anaphylactic reactions, generalized convulsions, thrombocytopenia and potential immune-mediated disorders; 5) Geometric mean titres (GMTs) or geometric mean concentration (GMCs) for NAb and BAb antibodies respectively; 6) the percentage of participants with ≥2-fold or ≥4-fold rise in antibody titres at each post-vaccination time point and the percentage of responders

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.