Table 5. Subjects Experiencing at Least One Solicited Systemic Adverse Events (8-Day Follow-Up period After Vaccination, FAS, N = 632).
| Solicited Systemic Adverse Event | Intensity | Diagnosed AD N = 345 n (%) | Healthy N = 282 n (%) | P-value |
|---|---|---|---|---|
| Any Solicited AE | 242 (70.1) | 159 (56.4) | 0.001 | |
| Body temperature increase | Total number | 28 (8.1) | 23 (8.2) | 1.000 |
| ≥ 39.0°C | 1 (0.3) | 1 (0.4) | 1.000 | |
| Grade ≥ 3 (related) | 1 (0.3) | 1 (0.4) | 1.000 | |
| Headache | Total number | 163 (47.2) | 98 (34.8) | 0.002 |
| Grade ≥ 3 | 26 (7.5) | 9 (3.2) | 0.022 | |
| Grade ≥ 3 (related) | 18 (5.2) | 5 (1.8) | 0.031 | |
| Myalgia | Total number | 153 (44.3) | 98 (34.8) | 0.018 |
| Grade ≥ 3 | 14 (4.1) | 9 (3.2) | 0.671 | |
| Grade ≥ 3 (related) | 9 (2.6) | 8 (2.8) | 1.000 | |
| Chills | Total number | 55 (15.9) | 22 (7.8) | 0.002 |
| Grade ≥ 3 | 7 (2.0) | 4 (1.4) | 0.762 | |
| Grade ≥ 3 (related) | 3 (0.9) | 4 (1.4) | 0.707 | |
| Nausea | Total number | 80 (23.2) | 41 (14.5) | 0.008 |
| Grade ≥ 3 | 8 (2.3) | 6 (2.1) | 1.000 | |
| Grade ≥ 3 (related) | 5 (1.4) | 4 (1.4) | 1.000 | |
| Fatigue | Total number | 124 (35.9) | 75 (26.6) | 0.013 |
| Grade ≥ 3 | 16 (4.6) | 9 (3.2) | 0.416 | |
| Grade ≥ 3 (related) | 9 (2.6) | 5 (1.8) | 0.592 |
N = number of subjects in the specified group; n = number of subjects in the specified category (with at least one report of a solicited systemic AE); % = percentages of n based on N; AD = atopic dermatitis; AE = adverse event; Grade ≥ 3 = AE which prevented normal everyday activities or body temperature ≥ 39°C; related AE = AE considered by the investigator to have a possible, probable or definite relationship to study medication.