Table 2.
Adverse events in study participants after vaccination with Shanchol™ oral cholera vaccine.
| After 1st dose | Adults (n = 120) |
5 to <18 years (n = 60) |
4 to <5 years (n = 60) |
|||
|---|---|---|---|---|---|---|
| BI Group (n = 61) | PI Group (n = 59) | BI Group (n = 30) | PI Group (n = 30) | BI Group (n = 30) | PI Group (n = 30) | |
| Fever | 1 | 0 | 0 | 0 | 0 | 1 |
| Cut injury | 0 | 0 | 1 | 1 | 0 | 0 |
| Vomiting | 0 | 1 | 0 | 0 | 0 | 0 |
| Allergic Reaction | 0 | 0 | 0 | 0 | 0 | 0 |
| Common cold | 0 | 0 | 0 | 0 | 1 | 0 |
| After 2nd dose | Adults(n = 116) | 5 to <18 years (n = 60) | 4 to <5 years (n = 57) | |||
| BI Group (n = 59) | PI Group (n = 57) | BI Group (n = 30) | PI Group (n = 30) | BI Group (n = 29) | PI Group (n = 28) | |
| Fever | 0 | 0 | 0 | 0 | 0 | 1 |
| Cut injury | 0 | 0 | 0 | 0 | 0 | 0 |
| Vomiting | 0 | 0 | 0 | 0 | 0 | 0 |
| Allergic Reaction | 0 | 0 | 0 | 1 | 0 | 0 |
| Common cold | 0 | 0 | 0 | 0 | 0 | 0 |
| Total No. of adverse events | 1 | 1 | 1 | 2 | 1 | 2 |