Table 2.
Solicited local and systemic adverse events by severity (safety set).
| GBP510 10 µg with AS03 (N = 101) |
GBP510 10 µg (N = 10) | GBP510 25 µg with AS03 (N = 104) |
GBP510 25 µg (N = 51) |
Placebo (N = 61) |
|
|---|---|---|---|---|---|
| Total No. of local AEs after any vaccine injection | 185 | 6 | 210 | 51 | 16 |
| Maximum severity, No. of AEs, n (%) | |||||
| Grade 1 (mild) | 157 (84·9) | 6 (100) | 168 (80·0) | 50 (98·0) | 16 (100) |
| Grade 2 (moderate) | 26 (14·1) | 0 (0) | 38 (18·1) | 1 (2·0) | 0 (0) |
| Grade 3 (severe) | 2 (1·1) | 0 (0) | 4 (1·9) | 0 (0) | 0 (0) |
| Grade 4 (life threatening) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Total No. of local AEs after the 1st vaccination | 90 | 2 | 103 | 27 | 8 |
| Maximum severity, No. of AEs, n (%) | |||||
| Grade 1 (mild) | 84 (93·3) | 2 (100) | 89 (86·4) | 27 (100) | 8 (100) |
| Grade 2 (moderate) | 6 (6·7) | 0 (0) | 12 (11·7) | 0 (0) | 0 (0) |
| Grade 3 (severe) | 0 (0) | 0 (0) | 2 (1·9) | 0 (0) | 0 (0) |
| Grade 4 (life threatening) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Total No. of local AEs after the 2nd vaccination | 95 | 4 | 107 | 24 | 8 |
| Maximum severity, No. of AEs, n (%) | |||||
| Grade 1 (mild) | 73 (76·8) | 4 (100) | 79 (73·8) | 23 (95·8) | 8 (100) |
| Grade 2 (moderate) | 20 (21·1) | 0 (0) | 26 (24·3) | 1 (4·2) | 0 (0) |
| Grade 3 (severe) | 2 (2·1) | 0 (0) | 2 (1·9) | 0 (0) | 0 (0) |
| Grade 4 (life threatening) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Total No. of systemic AEs after any vaccine injection | 473 | 21 | 531 | 131 | 133 |
| Maximum severity, No. of AEs, n (%) | |||||
| Grade 1 (mild) | 315 (66·6) | 19 (90·5) | 336 (63·3) | 115 (87·8) | 112 (84·2) |
| Grade 2 (moderate) | 152 (32·1) | 2 (9·5) | 179 (33·7) | 16 (12·2) | 20 (15·0) |
| Grade 3 (severe) | 6 (1·3) | 0 (0) | 16 (3·0) | 0 (0) | 1 (0·8) |
| Grade 4 (life threatening) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Total No. of systemic AEs after the 1st vaccination | 180 | 13 | 192 | 69 | 62 |
| Maximum severity, No. of AEs, n (%) | |||||
| Grade 1 (mild) | 160 (88·9) | 13 (100) | 145 (75·5) | 58 (84·1) | 58 (93·6) |
| Grade 2 (moderate) | 20 (11·1) | 0 (0) | 47 (24·5) | 11 (15·9) | 4 (6·5) |
| Grade 3 (severe) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Grade 4 (life threatening) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
| Total No. of systemic AEs after the 2nd vaccination | 293 | 8 | 339 | 62 | 71 |
| Maximum severity, No. of AEs, n (%) | |||||
| Grade 1 (mild) | 155 (52·9) | 6 (75·0) | 191 (56·3) | 57 (91·9) | 54 (76·1) |
| Grade 2 (moderate) | 132 (45·1) | 2 (25·0) | 132 (38·9) | 5 (8·1) | 16 (22·5) |
| Grade 3 (severe) | 6 (2·1) | 0 (0) | 16 (4·7) | 0 (0) | 1 (1·4) |
| Grade 4 (life threatening) | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 0 (0) |
AE, adverse event.
%: n / (No. of AEs in Safety Set by group) * 100.
n = Number of adverse events.