Other adverse events (excluding immunisation reactions)
SAEs
EVENTS, INJECTION SITE REACTION
As listed in For most participants, AEs were mild, reported in 28.5% of the Ad5-nCoV group and 16.1% of the Placebo group. Moderate events were registered in 5.6% of participants who received the Ad5-nCoV vaccine and 4.0% who received the placebo. By comparison, SAEs occurred in 0.8% of participants in the Ad5-nCoV group, but none in the Placebo group; these included increases in C-reactive protein (0.5%) and blood fibrinogen levels (0.5%).For most participants, general and injection site reactions and AEs resolved within 7 days after vaccination.Results of the analysis of laboratory parameters demonstrated a trend towards an increase in C-reactive protein levels, an increase in the red cell sedimentation rate, an increase in the mean percentage of monocytes, and a decrease in the mean percentage of neutrophils after administration of Ad5-nCoV (The proportion of participants in the Ad5-nCoV group with elevated IgE at Day 28 showed no changes from screening: 73/372 (19.6%) to 76/365 (20.8%).