Table 2.
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).