Table 5.
Summary of safety data.
| Symptoms | Grade of Seriousness | n/N (%) |
|---|---|---|
| Immediate AEs | 0/122 (0.0) | |
| Solicited Injection Site Reaction | 42/116 (36.2) | |
| Pain | 40/116 (34.5) | |
| Grade 1 | 39/116 (33.6) | |
| Grade 2 | 1/116 (0.9) | |
| Grade 3 | 0/116 (0.0) | |
| Swelling | 15/116 (12.9) | |
| Grade 1 | 14/116 (12.1) | |
| Grade 2 | 1/116 (0.9) | |
| Grade 3 | 0/116 (0.0) | |
| Erythema | 8/116 (6.9) | |
| Grade 1 | 8/116 (6.9) | |
| Grade 2 | 0/116 (0.0) | |
| Grade 3 | 0/116 (0.0) | |
| Solicited Systemic Reaction | 13/116 (11.2) | |
| Fever | 0/116 (0.0) | |
| Grade 1 | 0/116 (0.0) | |
| Grade 2 | 0/116 (0.0) | |
| Grade 3 | 0/116 (0.0) | |
| Malaise | 9/116 (7.8) | |
| Grade 1 | 8/116 (6.9) | |
| Grade 2 | 1/116 (0.9) | |
| Grade 3 | 0/116 (0.0) | |
| Headache | 5/116 (4.3) | |
| Grade 1 | 5/116 (4.3) | |
| Grade 2 | 0/116 (0.0) | |
| Grade 3 | 0/116 (0.0) | |
| Myalgia | 2/116 (1.7) | |
| Grade 1 | 2/116 (1.7) | |
| Grade 2 | 0/116 (0.0) | |
| Grade 3 | 0/116 (0.0) | |
| Serious AEs | 0/116 (0.0) | |
| Death | 0/116 (0.0) |
n, number of participants reporting at least one event or reaction; N, number of participants with available data; AEs, adverse events.