Table 2.
Percentages of subjects experiencing unsolicited adverse events within 28 days of administration of first and second vaccine doses (safety analysis set)
| |
Subjects with adverse events (%) |
||||
|---|---|---|---|---|---|
| Group A Shantha Liquid 1 Dose (n = 197) |
Group B Shantha Liquid 2 Doses (n = 97) |
Group A + B Shantha Liquid 1 or 2 Doses (n = 294) |
Group C IDT Liquid 2 Doses (n = 100) |
Group D IDT Lyophilized 2 Doses (n = 602) |
|
| Any AE | 40.1 | 47.4 | 42.5 | 45.0 | 43.7 |
| Vaccine-related AE | 18.8 | 15.5 | 17.7 | 22.0 | 18.1 |
| Severe AE | 2.5 | 4.1 | 3.1 | 2.0 | 3.5 |
| SAE | 1.0 | 1.0 | 1.0 | 0 | 1.3 |
| Vaccine-related SAE | 0 | 0 | 0 | 0 | 0 |
| AE Leading to Withdrawal | 0 | 0 | 0 | 0 | 0.2 |
| SAE Leading to Withdrawal | 0 | 0 | 0 | 0 | 0.2 |
AE, adverse event; SAE, serious adverse event.