TABLE 2.
Local and systemic reactogenicitya
| Symptom and intensity | No. (%) of patients with reaction in dose group
|
|||
|---|---|---|---|---|
| 2 mg (n = 5) | 4 mg (n = 8) | 8 mg (n = 8) | Placebo (n = 6) | |
| Local symptoms | ||||
| Pain or tenderness | ||||
| None | 0 (0.0) | 1 (12.5) | 2 (25.0) | 3 (50.0) |
| Mild | 5 (100.0) | 5 (62.5) | 3 (37.5) | 3 (50.0) |
| Moderate | 0 (0.0) | 2 (25.0) | 3 (37.5) | 0 (0.0) |
| Severe | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Induration | ||||
| None | 3 (60.0) | 4 (50.0) | 2 (25.0) | 6 (100.0) |
| Mild | 2 (40.0) | 4 (50.0) | 6 (75.0) | 0 (0.0) |
| Moderate | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Severe | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Skin discoloration | ||||
| None | 2 (40.0) | 1 (12.5) | 2 (25.0) | 5 (83.3) |
| Mild | 3 (60.0) | 7 (87.5) | 6 (75.0) | 1 (16.7) |
| Moderate | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Severe | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Any local symptom | ||||
| None | 0 (0.0) | 1 (12.5) | 1 (12.5) | 3 (50.0) |
| Mild | 5 (100.0) | 5 (62.5) | 4 (50.0) | 3 (50.0) |
| Moderate | 0 (0.0) | 2 (25.0) | 3 (37.5) | 0 (0.0) |
| Severe | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Systemic symptoms | ||||
| Malaise | ||||
| None | 4 (80.0) | 6 (75.0) | 3 (37.5) | 4 (66.7) |
| Mild | 1 (20.0) | 0 (0.0) | 4 (50.0) | 0 (0.0) |
| Moderate | 0 (0.0) | 2 (25.0) | 0 (0.0) | 2 (33.3) |
| Severeb | 0 (0.0) | 0 (0.0) | 1 (12.5) | 0 (0.0) |
| Myalgia | ||||
| None | 5 (100.0) | 7 (87.5) | 5 (62.5) | 6 (100.0) |
| Mild | 0 (0.0) | 1 (12.5) | 3 (37.5) | 0 (0.0) |
| Moderate | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Severe | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Headache | ||||
| None | 4 (80.0) | 5 (62.5) | 6 (75.0) | 5 (83.3) |
| Mild | 1 (20.0) | 3 (37.5) | 1 (12.5) | 1 (16.7) |
| Moderate | 0 (0.0) | 0 (0.0) | 1 (12.5) | 0 (0.0) |
| Severe | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Nausea | ||||
| None | 4 (80.0) | 6 (75.0) | 3 (37.5) | 5 (83.3) |
| Mild | 1 (20.0) | 2 (25.0) | 4 (50.0) | 1 (16.7) |
| Moderate | 0 (0.0) | 0 (0.0) | 1 (12.5) | 0 (0.0) |
| Severe | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Fever | ||||
| None | 5 (100.0) | 7 (87.5) | 8 (100.0) | 6 (100.0) |
| Mild | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Moderate | 0 (0.0) | 1 (12.5) | 0 (0.0) | 0 (0.0) |
| Severe | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Any systemic symptom | ||||
| None | 4 (80.0) | 5 (62.5) | 3 (37.5) | 3 (50.0) |
| Mild | 1 (20.0) | 1 (12.5) | 3 (37.5) | 1 (16.7) |
| Moderate | 0 (0.0) | 2 (25.0) | 1 (12.5) | 2 (33.3) |
| Severeb | 0 (0.0) | 0 (0.0) | 1 (12.5) | 0 (0.0) |
a
The local injection site reactions were recorded by clinicians at 30 to 45 min postinjection and were then recorded as self-assessments at home by subjects on a 7-day diary card. Systemic reactions were recorded as self-assessments at home by subjects on a 7-day diary card following each injection.
b
A single severe systemic symptom (malaise) was related to a foot fracture which occurred 6 days following vaccination.