Table 3.
Adverse events within 21 days after vaccination.
| Events | RIBSP Vaccine (N = 100) | VAXIGRIP® Vaccine (N = 50) |
|---|---|---|
| AE within 2 hours | ||
| Local AE | ||
| Induration at the injection site | 2 (2%) | 2 (4%) |
| Hyperimia at the injection site | 2 (2%) | — |
| Oedema at the injection site | 2 (2%) | — |
| Painfulness at the injection site | 1 (1%) | — |
| Number of subjects experiencing AE | 3 (3%) | 2 (4%) |
| AE within 7 days | ||
| Local AE | ||
| Induration at the injection site | 3 (3%) | 2 (4%) |
| Hyperimia at the injection site | 3 (3%) | 1 (2%) |
| Oedema at the injection site | 2 (2%) | – |
| Painfulness at the injection site | 2 (2%) | 1 (2%) |
| Number of subjects experiencing AE | 5 (5%) | 2 (4%) |
| AE according to self-observation diaries within 8–20 days | ||
| Local AE | – | – |
| Systemic AE | ||
| Headache | 3 (3%) | 2 (4%) |
| Sore throat | 2 (2%) | 3 (6%) |
| Runny nose | 3 (3%) | 2 (4%) |
| Cough | 2 (2%) | 3 (6%) |
| Dizziness | 1 (1%) | — |
| Fever | 1 (1%) | 1 (2%) |
| Stomach upset | 1 (1%) | — |
| Number of subjects experiencing AE | 10 (10%) | 6 (12%) |
| Changes of laboratory values | ||
| Biochemical blood analysis | 15 (15%) | 7 (14%) |
| Clinical blood analysis | 15 (15%) | 10 (20%) |
| Number of subjects experiencing AE | 29 (29%) | 13 (26%) |