Outcomes
fasting blood glucose
ADVERSE EVENTS, ADVERSE REACTIONS, SECONDARY
The primary safety outcome was abnormal differences in the means of laboratory parameters between the CoronaVac group and the control group at seven time points. Laboratory parameters included fasting blood glucose, platelet count, prothrombin time (PT), activated partial thromboplastin time (APTT), thrombin time (TT), fibrinogen (FIB), international normalized ratio (INR), D-dimer, erythrocyte sedimentation rate (ESR), and anti-heparin/platelet factor 4 antibody. Laboratory parameters adverse events were evaluated according to the China NMPA guidelines and the US HHS tables (The second safety outcome was adverse reactions within 7 and 28 days after each dose. The primary immunogenic outcome was the seroconversion rate of the neutralizing antibody against the prototype strain of SARS-CoV-2 at 28 days after the second dose of CoronaVac. The secondary immunogenic outcomes included geometric mean titers (GMT), geometric mean increases (GMI), seroconversion rates (SCR), and seropositive rates of neutralizing antibodies against the prototype strain and VOCs of SARS-CoV-2 at different time points (days 0, 4, 14, 28, 32, 42, and 56). Seropositivity was defined as neutralizing antibody titer ≥ 8 and seronegative was defined as neutralizing antibody titer < 8. Seroconversion was defined as a change from seronegative at baseline to seropositive (