TABLE 2.
Local and systemic symptoms experienced in the 7 days following each injection
| Group and symptom | No. (%) of participants with symptom at weeka:
|
||||
|---|---|---|---|---|---|
| 0 | 4 | 8 | 24 | 52 | |
| Placebo group | |||||
| Tenderness/pain | 8 (67) | 9 (75) | 7 (58) | 6 (60) | 2 (40) |
| Erythema/induration | 9 (75) | 7 (58) | 8 (67) | 7 (70) | 4 (80) |
| Ecchymosis | 2 (17) | 2 (17) | 1 (8) | 0 | 0 |
| Injection site edema | 4 (33) | 1 (8) | 2 (17) | 1 (10) | 1 (20) |
| Headache | 5 (42) | 4 (33) | 2 (17) | 0 | 0 |
| Fatigue/malaise | 1 (8) | 0 | 2 (17) | 0 | 0 |
| Hematoma | 2 (17) | 0 | 0 | 0 | 0 |
| Injection site hypersensitivity | 0 | 1 (8) | 0 | 0 | 0 |
| Nausea/diarrhea | 1 (8) | 0 | 0 | 1 (10) | 0 |
| Paraesthesia | 3 (25) | 1 (8) | 1 (8) | 0 | 0 |
| Light headedness/dizziness | 0 | 0 | 0 | 0 | 0 |
| Low-grade fever | 0 | 0 | 0 | 0 | 0 |
| Total | 35 | 25 | 23 | 15 | 7 |
| Vaccine groups | |||||
| Tenderness/pain | 38 (76) | 41 (84) | 34 (71) | 34 (74) | 17 (63) |
| Erythema/induration | 33 (66) | 31 (63) | 33 (69) | 35 (76) | 15 (56) |
| Ecchymosis | 10 (20) | 10 (20) | 9 (19) | 10 (22) | 6 (22) |
| Injection site edema | 7 (14) | 7 (14) | 10 (21) | 7 (15) | 4 (15) |
| Headache | 14 (28) | 6 (12) | 7 (15) | 4 (9) | 3 (11) |
| Fatigue/malaise | 7 (14) | 3 (6) | 3 (6) | 2 (4) | 2 (7) |
| Hematoma | 1 (2) | 2 (4) | 3 (6) | 4 (9) | 0 |
| Injection site hypersensitivity | 4 (8) | 1 (2) | 1 (2) | 2 (4) | 1 (4) |
| Nausea/diarrhea | 2 (4) | 3 (6) | 1 (2) | 1 (2) | 0 |
| Paraesthesia | 3 (6) | 1 (2) | 1 (2) | 1 (2) | 0 |
| Light headedness/dizziness | 1 (2) | 3 (6) | 0 | 0 | 1 (4) |
| Low-grade fever | 0 | 1 (2) | 0 | 0 | 0 |
| Total | 120 | 109 | 102 | 100 | 49 |
a
The number of participants in the placebo group was 12, 12, 12, 10, and 5 at weeks 0, 4, 8, 24, and 52, respectively; the number of participants in the vaccine groups was 50, 49, 48, 46, and 27 at weeks 0, 4, 8, 24, and 52, respectively.