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. 2021 May 15;397(10287):1809–1818. doi: 10.1016/S0140-6736(21)00943-0

Table 2.

Incidence of adverse events across all the groups by number of doses

Group 1 Group 2 Group 3
Local adverse event
Pain
1 6 (4%) 9 (6%) 3 (2%)
2 3 (2%) 3 (2%) 0 (0%)
3 0 (0%) 0 (0%) 0 (0%)
4 4 (3%) 0 (0%) 0 (0%)
Redness
1 2 (1%) 1 (1%) 0 (0%)
2 10 (7%) 14 (10%) 2 (1%)
3 2 (2%) 2 (1%) 1 (1%)
4 3 (2%) 0 (0%) 0 (0%)
Swelling
1 3 (2%) 5 (3%) 2 (1%)
2 14 (9%) 23 (16%) 10 (7%)
3 8 (6%) 11 (8%) 4 (3%)
4 3 (2%) 0 (0%) 0 (0%)
Systemic adverse event
Fever
1 14 (9%) 28 (19%) 13 (9%)
2 18 (12%) 44 (30%) 7 (5%)
3 18 (12%) 29 (20%) 16 (11%)
4 19 (14%) 34 (25%) 8 (6%)
Irritability
1 2 (1%) 5 (3%) 0 (0%)
2 0 (0%) 4 (3%) 0 (0%)
3 0 (0%) 0 (0%) 1 (1%)
4 1 (1%) 1 (1%) 1 (1%)
Drowsiness
1 0 (0%) 3 (2%) 1 (1%)
2 2 (1%) 6 (4%) 2 (1%)
3 0 (0%) 0 (0%) 0 (0%)
4 0 (0%) 2 (1%) 0 (0%)
Loss of appetite
1 1 (1%) 2 (1%) 1 (1%)
2 0 (0%) 3 (2%) 1 (1%)
3 0 (0%) 0 (0%) 0 (0%)
4 0 (0%) 1 (1%) 1 (1%)

Data are n or n (%). Group 1 received 5 μg R21/25 μg Matrix-M, group 2 received 5 μg R21/50 μg Matrix-M, and group 3, the control group, received Rabivax-S. All solicited local and systemic adverse events were collected for 7 days after each vaccination. 150 participants in each group received the first dose of the vaccination. 149 participants in group 1, 147 participants in group 2 and 149 participants in group 3 received a second dose. 146 participants in group 1, 147 participants in group 2, and 149 participants in group 3 received a third dose. 132 participants in group 1, 138 participants in group 2, and 140 participants in group 3 received a fourth dose. Fever was defined as a temperature of 37·5°C or above. One participant in group 1 and one participant in group 2 had a severe fever (>39°C) after the third dose; all other adverse events were graded as mild or moderate. The grading of adverse events is given in the appendix (pp 13–91).