Table 1. Safety comparison between the Zagreb and Essen regimens used in patients with WHO category II exposure to rabies.
| Zagreb | Essen | P | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| 0–5 y old# | 6–18 y old | 19–59 y old | 60+ years old | Total | 0–5 y old# | 6–18 y old | 19–59 y old | 60+ years old | Total | ||
| Sex, M/F | 11/14 | 15/17 | 18/20 | 15/22 | 59/73 | 12/16 | 17/12 | 18/19 | 14/18 | 61/65 | 0.907 |
| Mean age (SD)‡ | 41.92 (11.66) m | 15.22 (3.12) y | 46.26 (11.12) y | 73.49 (7.37) y | 38.13 (27.08) y | 37.18 (12.53) m | 14.48 (2.84) y | 43.68 (11.76) y | 69.56 (5.81) y | 35.83 (26.48) y | 0.459 |
| Systemic symptoms (occurring during first immunization)* | 16(15) | 5(5) | 2(2) | 4(4) | 27(26) | 12(10) | 3(3) | 2(2) | 3(3) | 20(18) | 0.341 |
| Fever | 12 | 1 | 1 | 1 | 15 | 8 | 2 | 1 | 1 | 12 | |
| Malaise | 0 | 2 | 1 | 2 | 5 | 0 | 0 | 0 | 2 | 2 | |
| Allergy | 1 | 1 | 0 | 0 | 2 | 2 | 0 | 1 | 0 | 3 | |
| Restlessness | 0 | 1 | 0 | 0 | 1 | 1 | 1 | 0 | 0 | 1 | |
| Nausea and vomiting | 2 | 0 | 0 | 0 | 2 | 1 | 0 | 0 | 0 | 1 | |
| Diarrhea | 1 | 0 | 0 | 1 | 2 | 0 | 0 | 0 | 0 | 0 | |
| Local symptoms (occurring during first immunization)* | 5(5) | 14(12) | 5(4) | 16(13) | 40(34) | 5(5) | 13(9) | 4(3) | 12(10) | 34 (27) | 0.556 |
| Pain | 1 | 9 | 3 | 11 | 24 | 0 | 10 | 2 | 6 | 18 | |
| Induration | 2 | 2 | 1 | 0 | 5 | 2 | 1 | 0 | 2 | 5 | |
| Edema | 1 | 1 | 0 | 1 | 3 | 1 | 1 | 1 | 1 | 4 | |
| Tenderness | 1 | 2 | 1 | 3 | 7 | 1 | 1 | 1 | 3 | 6 | |
| Erythema | 0 | 0 | 0 | 1 | 1 | 1 | 0 | 0 | 0 | 1 | |
*Data in brackets show the number of side effects after first immunization, which have no significant differences of total side effects incidence between Zagreb and Essen in systemic symptoms (P = 0.383, 26/27 vs 18/20) or local symptoms (P = 0.529, 34/40 vs 27/34). #Although the difference in side effects of <5-y-old patients between Zagreb and Essen (P = 0.060, 21/25 vs 17/28) was not statistically significant, it was found to be statistically significant after the first-dose immunization (P =0.043, 20/25 vs 15/28). ‡m, months; y, years.