Table 1 Incidence of adverse events (AEs), adverse reactions and serious AEs (SAEs) for the two vaccine groups
Incidence, %(n) | P-value | ||
|---|---|---|---|
Sub/MF59™ (n = 391) | Subunit (n = 198) | ||
Local reactions | 24.0(94) | 15.2(30) | 0.012 |
Systemic reactions | 10.7(42) | 9.6(19) | 0.666 |
AEs | 6.1(24) | 6.6(13) | 0.840 |
SAEs | 1.0(4) | 0.5(1) | 0.668 |
Vaccine-related AEs (definitely, probably or possibly related to the vaccine) | 3.8(15) | 5.1(10) | 0.490 |
Vaccine-related SAEs (definitely, probably or possibly related to the vaccine) | 0.3(1) | 0.0(0) | 1.000 |