Table 3. Adverse events per group by treatment.
First dose | Second dose | |||||||
Adverse event | 5 µg | 10 µg | 20 µg | Placebo | 5 µg | 10 µg | 20 µg | Placebo |
Local reaction | ||||||||
Redness | 2 (16.7; 0.16–1.00) | 4 (33.3; 0.40–1.00) | 9 (75.0; 0.66–1.00) | 3 (25.0; 0.29–1.00) | 8 (66.7; 0.63–1.00) | 2 (16.7; 0.16–1.00) | 5 (41.7; 0.48–1.00) | 5 (41.7; 0.48–1.00) |
Swelling | 1 (8.3; 0.03–1.00) | 0 | 4 (33.3; 0.40–1.00) | 2 (16.7; 0.16–1.00) | 2 (16.7; 0.16–1.00) | 5 (41.7; 0.48–1.00) | 1 (8.3; 0.03–1.00) | 3 (25.0; 0.29–1.00) |
Pain | 11 (91.7; 0.72–1.00) | 8 (66.7; 0.63–1.00) | 8 (66.7; 0.63–1.00) | 7 (58.3; 0.59–1.00) | 9 (75.0; 0.66–1.00) | 9 (75.0; 0.66–1.00) | 8 (66.7; 0.63–1.00) | 6 (50.0; 0.54–1.00) |
Systemic reactions | ||||||||
Fever | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Headache | 4 (33.3; 0.40–1.00) | 6 (50.0; 0.54–1.00) | 2 (16.7; 0.16–1.00) | 4 (33.3; 0.40–1.00) | 6 (50.0; 0.54–1.00) | 5 (41.7; 0.48–1.00) | 1 (8.3; 0.03–1.00) | 2 (16.7; 0.16–1.00) |
Joint aches | 0 | 1 (8.3; 0.03–1.00) | 1 (8.3; 0.03–1.00) | 0 | 0 | 2 (16.7; 0.16–1.00) | 0 | 1 (8.3; 0.03–1.00) |
Fatigue | 0 | 4 (33.3; 0.40–1.00) | 1 (8.3; 0.03–1.00) | 1 (8.3; 0.03–1.00) | 4 (33.3; 0.40–1.00) | 3 (25.0; 0.29–1.00) | 2 (16.7; 0.16–1.00) | 2 (16.7; 0.16–1.00) |
Muscle aches | 2 (16.7; 0.16–1.00) | 5 (41.7; 0.48–1.00) | 2 (16.7; 0.16–1.00) | 3 (25.0; 0.29–1.00) | 1 (8.3; 0.03–1.00) | 3 (25.0; 0.29–1.00) | 0 | 0 |
Feeling of general discomfort | 2 (16.7; 0.16–1.00) | 2 (16.7; 0.16–1.00) | 0 | 1 (8.3; 0.03–1.00) | 2 (16.7; 0.16–1.00) | 2 (16.7; 0.16–1.00) | 0 | 0 |
Chills | 0 | 2 (16.7; 0.16–1.00) | 0 | 1 (8.3; 0.03–1.00) | 1 (8.3; 0.03–1.00 | 1 (8.3; 0.03–1.00 | 0 | 0 |
Data are number(%; 95% CI). Adverse events up to 7 days after vaccination are reported.