Table 5 Safety of influenza vaccination during the 14 days following administration, by randomization group
Characteristic | Treatment, 3 months (n = 44) | Placebo (n = 43) | Treatment, 6 months (n = 15) | |||
|---|---|---|---|---|---|---|
n | % | n | % | n | % | |
Local adverse events | 3 | 6.8 | 3 | 6.9 | 1 | 6.7 |
Erythema | 3 | 6.8 | 2 | 4.7 | 1 | 6.7 |
Swelling/induration | 1 | 2.3 | 1 | 2.3 | 1 | 6.7 |
Systemic adverse events | 4 | 9.0 | 4 | 9.3 | 2 | 13.3 |
Fever ≥ 38 °C | 3 | 6.8 | 2 | 4.7 | 1 | 6.7 |
Irritability | 4 | 9.0 | 3 | 6.9 | 1 | 6.7 |
Lack of appetite | 3 | 6.8 | 2 | 4.7 | 1 | 6.7 |
Vomiting | 1 | 2.3 | 0 | 0 | 0 | 0 |
At least one local or systemic adverse event | 6 | 13.6 | 7 | 16.3 | 3 | 20.0 |
Required drugs for adverse events | 3 | 6.8 | 4 | 9.3 | 1 | 6.7 |
Severe adverse events | 0 | 0 | 0 | 0 | 0 | 0 |