Table 3.
Zagreb |
Essen |
|||||||||
---|---|---|---|---|---|---|---|---|---|---|
Age groups | ≤10 | 11–20 | 21–50 | 51–60 | >60 | ≤10 | 11–20 | 21–50 | 51–60 | >60 |
N | 23 | 15 | 41 | 21 | 20 | 17 | 24 | 40 | 17 | 22 |
Observations | 92 | 60 | 164 | 84 | 79* | 85 | 120 | 200 | 85 | 110 |
Local AEs | ||||||||||
Induration | 0 (0.00) | 1 (1.67) | 1 (0.61) | 0 (0.00) | 1 (1.27) | 0 (0.00) | 0 (0.00) | 1 (0.50) | 0 (0.00) | 0 (0.00) |
Erythema | 0 (0.00) | 0 (0.00) | 0 (0.00) | 0 (0.00) | 0 (0.00) | 0 (0.00) | 0 (0.00) | 0 (0.00) | 0 (0.00) | 0 (0.00) |
Swelling | 0 (0.00) | 0 (0.00) | 1 (0.61) | 0 (0.00) | 0 (0.00) | 0 (0.00) | 0 (0.00) | 2 (1.00) | 0 (0.00) | 0 (0.00) |
Pain | 6 (6.52) | 2 (3.33) | 7 (4.27) | 4 (4.76) | 2 (2.53) | 3 (3.53) | 5 (4.17) | 12 (6.00) | 2 (2.35) | 7 (6.36) |
Itching | 0 (0.00) | 0 (0.00) | 0 (0.00) | 0 (0.00) | 0 (0.00) | 0 (0.00) | 0 (0.00) | 0 (0.00) | 0 (0.00) | 0 (0.00) |
Total | 6 (6.52) | 3 (5.00) | 9 (5.49) | 4 (4.76) | 3 (3.80) | 3 (3.53) | 5 (4.17) | 15 (7.50) | 2 (2.35) | 7 (6.36) |
Systemic AEs | ||||||||||
Fever | 5 (5.43) | 2 (3.33) | 1 (0.61) | 0 (0.00) | 0 (0.00) | 3 (3.53) | 0 (0.00) | 2 (1.00) | 1 (1.18) | 0 (0.00) |
Allergy | 0 (0.00) | 0 (0.00) | 0 (0.00) | 0 (0.00) | 0 (0.00) | 0 (0.00) | 0 (0.00) | 1 (0.50) | 0 (0.00) | 0 (0.00) |
Headache | 0 (0.00) | 0 (0.00) | 0 (0.00) | 1 (1.19) | 1 (1.27) | 0 (0.00) | 0 (0.00) | 0 (0.00) | 1 (1.18) | 0 (0.00) |
Dysphoria | 0 (0.00) | 0 (0.00) | 0 (0.00) | 0 (0.00) | 0 (0.00) | 0 (0.00) | 0 (0.00) | 0 (0.00) | 0 (0.00) | 0 (0.00) |
Loss of appetite | 0 (0.00) | 0 (0.00) | 0 (0.00) | 0 (0.00) | 0 (0.00) | 0 (0.00) | 0 (0.00) | 0 (0.00) | 0 (0.00) | 0 (0.00) |
Nausea | 0 (0.00) | 0 (0.00) | 0 (0.00) | 0 (0.00) | 0 (0.00) | 0 (0.00) | 0 (0.00) | 0 (0.00) | 0 (0.00) | 0 (0.00) |
Total | 5 (5.43) | 2 (3.33) | 1 (0.61) | 1 (1.19) | 1 (1.27) | 3 (3.53) | 0 (0.00) | 3 (1.50) | 2 (2.35) | 0 (0.00) |
*Note: One of the fourth dose was dropped out in Zagreb group.