Table 4.
Solicited adverse events in the total vaccinated population
|
Candidate 1 |
Candidate 2 |
Total |
||||
|---|---|---|---|---|---|---|
| Number of participants (% of n=15) | Number of events | Number of participants (% of n=15) | Number of events | Number of participants (% of n=30) | Number of events | |
| Total | ||||||
| Solicited adverse events | 13 (87%) | 31 | 9 (60%) | 18 | 22 (73%) | 49 |
| Abdominal pain | ||||||
| Any | 2 (13%) | 3 | 2 (13%) | 2 | 4 (13%) | 5 |
| Mild | 2 (13%) | 3 | 2 (13%) | 2 | 4 (13%) | 5 |
| Moderate | 0 | 0 | 0 | 0 | 0 | 0 |
| Arthralgia | ||||||
| Any | 0 | 0 | 1 (7%) | 1 | 1 (3%) | 1 |
| Mild | 0 | 0 | 1 (7%) | 1 | 1 (3%) | 1 |
| Moderate | 0 | 0 | 0 | 0 | 0 | 0 |
| Diarrhoea | ||||||
| Any | 1 (7%) | 1 | 4 (27%) | 4 | 5 (17%) | 5 |
| Mild | 1 (7%) | 1 | 4 (27%) | 4 | 5 (17%) | 5 |
| Moderate | 0 | 0 | 0 | 0 | 0 | 0 |
| Fatigue | ||||||
| Any | 10 (67%) | 13 | 2 (13%) | 2 | 12 (40%) | 15 |
| Mild | 9 (60%) | 12 | 2 (13%) | 2 | 11 (37%) | 14 |
| Moderate | 1 (7%) | 1 | 0 | 0 | 1 (3%) | 1 |
| Headache | ||||||
| Any | 8 (53%) | 8 | 3 (20%) | 3 | 11 (37%) | 11 |
| Mild | 7 (47%) | 7 | 2 (13%) | 2 | 9 (30%) | 9 |
| Moderate | 1 (7%) | 1 | 1 (7%) | 1 | 2 (7%) | 2 |
| Myalgia | ||||||
| Any | 3 (20%) | 3 | 3 (20%) | 3 | 6 (20%) | 6 |
| Mild | 1 (7%) | 1 | 3 (20%) | 3 | 4 (13%) | 4 |
| Moderate | 2 (13%) | 2 | 0 | 0 | 2 (7%) | 2 |
| Nausea | ||||||
| Any | 2 (13%) | 2 | 3 (20%) | 3 | 5 (17%) | 5 |
| Mild | 1 (7%) | 1 | 3 (20%) | 3 | 4 (13%) | 4 |
| Moderate | 1 (7%) | 1 | 0 | 0 | 1 (3%) | 1 |
| Vomiting | ||||||
| Any | 1 (7%) | 1 | 0 | 0 | 1 (3%) | 1 |
| Mild | 0 | 0 | 0 | 0 | 0 | 0 |
| Moderate | 1 (7%) | 1 | 0 | 0 | 1 (3%) | 1 |
Solicited events comprised signs and symptoms that were reported within 7 days of vaccination by use of a predefined checklist in a diary card. Participants graded their adverse events from mild to severe. No severe adverse events are reported.