Table 1. Safety and tolerability assessment after vaccination with intradermal and virosomal-intramuscular vaccine.
| Vaccine route of administration and adjuvant | p-value | ||
|---|---|---|---|
| Intradermal | Virosomal Intramuscular | ||
| Solicited injection site reactions, days 0–7 (%, 95% C.I) | |||
| At least one | 43 (36–49) | 20 (15–26) | < 0.01 |
| Pain | 13 (9–18) | 12 (8–17) | NS |
| Pruritus | 20 (16–26) | 5 (3–9) | < 0.01 |
| Erythema | 33 (27–39) | 7 (4–11) | < 0.01 |
| Swelling | 19 (14–24) | 5 (2–8) | < 0.01 |
| Induration | 25 (20–31) | 7 (4–11) | < 0.01 |
| Ecchymosis | 6 (4–10) | 5 (2–8) | NS |
| Solicited systemic reactions, days 0–7 (%, 95% C.I) |
|||
| At least one | 11 (7–15) | 10 (7–15) | NS |
| Fever | 2 (1–4) | 2 (1–4) | NS |
| Headache | 4 (2–8) | 6 (3–10) | NS |
| Malaise | 5 (3–9) | 6 (3–10) | NS |
| Myalgia | 6 (4–10) | 7 (4–11) | NS |
| Shivering | 3 (2–6) | 5 (3–9) | NS |
| Unsolicited events, days 0–21 (%, 95% C.I) |
2 (0,88; 0,24–3,15) | 4 (2,00; 0,78–5,03) | NS |
| SAEs, days 0–180 (%, 95% C.I) |
0 | 0 | NS |