Table 2 Frequency of adverse events at enrolment, and months 1, 2, 6 and 7, by study arm (total visits鈥�=鈥�600)
Type of event | Enrolment (n鈥�=鈥�150) n events (%) | Month 1 (pre-vaccination), 2 (post-vaccination) (n鈥�=鈥�141) n events (%) | Month 6 (pre- vaccination), 7 (post- vaccination) (n鈥�=鈥�139) n events (%) | Total N events (%) | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
IV (n鈥�=鈥�75) | DV (n鈥�=鈥�75) | IV (n鈥�=鈥�71) | DV (n鈥�=鈥�70) | IV (n鈥�=鈥�71) | DV (n鈥�=鈥�68) | ||||||
| 听 | 听 | Pre | Post | 鈥楶谤别鈥� | 鈥楶辞蝉迟鈥� | Pre | Post | 鈥楶谤别鈥� | 鈥楶辞蝉迟鈥� | ||
Chills | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (2.7) | 3 (4.1) | 2 (2.7) | 1 (1.3) | 1 (1.4) | 1 (1.4) | 10 (0.7) |
Headache | 0 (0.0) | 2 (2.7) | 1 (1.3) | 3 (4.0) | 3 (4.1) | 0 (0.0) | 3 (4.0) | 0 (0.0) | 0 (0.0) | 1 (1.4) | 13 (1.0) |
Nausea | 2 (2.7) | 1 (1.4) | 0 (0.0) | 1 (1.3) | 0 (0.0) | 0 (0.0) | 1 (1.3) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 5 (0.4) |
Fatigue | 0 (0.0) | 0 (0.0) | 1 (1.3) | 1 (1.3) | 1 (1.4) | 0 (0.0) | 1 (1.3) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 5 (0.4) |
Limited ADLc | 0 (0.0) | 0 (0.0) | 1 (1.3) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (1.3) | 0 (0.0) | 0 (0.0) | 2 (0.2) |
Dizziness | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (1.3) | 2 (2.7) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 3 (0.2) |
Injection site soreness | 0 (0.0) | 0 (0.0) | 1 (1.3) | 3 (4.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 6 (8.0) | 0 (0.0) | 0 (0.0) | 10 (0.7) |
Injection site swelling | 0 (0.0) | 0 (0.0) | 1 (1.3) | 1 (1.3) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 2 (0.2) |
Allergic reaction | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Otherb | 5 (6.7) | 4 (5.4) | 0 (0.0) | 2 (2.7) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (1.3) | 0 (0.0) | 0 (0.0) | 11 (0.8) |
Total | 7 (9.3) | 7 (9.3) | 5 (7.0) | 12 (16.9) | 8 (11.4) | 3 (4.3) | 7 (9.9) | 9 (12.7) | 1 (1.5) | 2 (2.9) | 61 (10.2)a |