Table 4.
Frequency of volunteer reported solicited adverse events within one week of each dose of vaccine, presented by severity grade.
| Solicited symptoms within one week | Dose 1 |
Dose 2 |
Dose 3 |
|||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| n | Any (%) | Mild (%) | Mod (%) | Sev (%) | n | Any (%) | Mild (%) | Mod (%) | Sev (%) | n | Any (%) | Mild (%) | Mod (%) | Sev (%) | ||
| Tenderness/pain at the site of injection | 25 μg dose | 25 | 21 (84) | 15 (60) | 6 (24) | 0 (0) | 22 | 21 (95) | 17 (77) | 3 (14) | 1 (5) | 21 | 20 (95) | 14 (67) | 3 (14) | 3 (14) |
| 50 μg dose | 26 | 25 (96) | 10 (39) | 13 (50) | 2 (8) | 23 | 23 (100) | 12 (52) | 9 (39) | 2 (9) | 24 | 22 (92) | 12 (50) | 7 (29) | 3 13) | |
| Headache | 25 μg dose | 24 | 4 (17) | 3 (13) | 1 (4) | 0 (0) | 22 | 9 (41) | 6 (27) | 3 14) | 0 (0) | 21 | 7 (33) | 6 (29) | 1 (5) | 0 (0) |
| 50 μg dose | 26 | 12 (46) | 8 (31) | 4 (15) | 0 (0) | 23 | 7 (30) | 4 (17) | 2 (9) | 1 (4) | 23 | 7 (30) | 3 (13) | 3 (13) | 1 (4) | |
| Malaise | 25 μg dose | 24 | 4 (17) | 3 (13) | 0 (0) | 1 (4) | 22 | 6 (27) | 5 (23) | 1 (5) | 0 (0) | 21 | 5 (24) | 2 (10) | 2 (10) | 1 (5) |
| 50 μg dose | 26 | 10 (38) | 9 (35) | 1 (4) | 0 (0) | 23 | 7 (30) | 3 (13) | 4 (17) | 0 (0) | 23 | 8 (35) | 5 (22) | 3 (13) | 0 (0) | |
| Myalgia | 25 μg dose | 24 | 10 (42) | 8 (33) | 2 (8) | 0 (0) | 22 | 9 (41) | 9 (41) | 0 (0) | 0 (0) | 21 | 11 (52) | 7 (33) | 3 (14) | 1 (5) |
| 50 μg dose | 26 | 13 (50) | 8 (31) | 4 (16) | 1(4) | 23 | 10 (43) | 7 (30) | 2 (9) | 1 (4) | 23 | 11 (48) | 8 (35) | 3 (13) | 0 (0) | |
| Nausea and/or vomiting | 25 μg dose | 24 | 1 (4) | 0 (0) | 0 (0) | 1 (4) | 22 | 1 (5) | 1 (5) | 0 (0) | 0 (0) | 21 | 5 (24) | 3 (14) | 1 (5) | 1 (5) |
| 50 μg dose | 26 | 2 (8) | 2 (8) | 0 (0) | 0 (0) | 23 | 4 (17) | 3 (13) | 1 (5) | 0 (0) | 23 | 2 (9) | 2 (9) | 0 (0) | 0 (0) | |
| Arthralgia | 25 μg dose | 24 | 1 (4) | 1 (4) | 0 (0) | 0 (0) | 22 | 4 (18) | 4 (18) | 0 (0) | 0 (0) | 21 | 4 (19) | 3 (15) | 1 (5) | 0 (0) |
| 50 μg dose | 26 | 5 (19) | 3 (12) | 2 (8) | 0 (0) | 23 | 3 (13) | 2 (9) | 0 (0) | 1 (4) | 23 | 5 (22) | 4 (17) | 1 (5) | 0 (0) | |
| Oral temperature (fever) | 25 μg dose | 25 | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 22 | 1 (5) | 0 (0) | 1 (5) | 0 (0) | 21 | 1 (5) | 0 (0) | 1 (5) | 0 (0) |
| 50 μg dose | 26 | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 23 | 0 (0) | 0 (0) | 0 (0) | 0 (0) | 24 | 0 (0) | 0 (0) | 0 (0) | 0 (0) | |
| Redness at the site of injection | 25 μg dose | 25 | 19 (76) | 18 (72) | 0 (0) | 1 (4) | 22 | 20 (91) | 20 (91) | 0 (0) | 0 (0) | 21 | 19 (90) | 17 (81) | 0 (0) | 2 (10) |
| 50 μg dose | 26 | 21 (81) | 19 (73) | 1 (4) | 1 (4) | 23 | 21 (91) | 18 (78) | 0 (0) | 3 (13) | 24 | 23 (96) | 22 (92) | 0 (0) | 1 (4) | |
| Induration at the site of injection | 25 μg dose | 25 | 11 (44) | 11 (44) | 0 (0) | 0 (0) | 22 | 15 (68) | 15 (68) | 0 (0) | 0 (0) | 21 | 11 (52) | 11 (53) | 0 (0) | 0 (0) |
| 50 μg dose | 26 | 17 (65) | 15 (58) | 0 (0) | 2 (8) | 23 | 19 (83) | 17 (74) | 1 (4) | 1 (4) | 24 | 13 (54) | 12 (50) | 0 (0) | 1 (4) | |
| Swelling at the site of injection | 25 μg dose | 25 | 10 (40) | 8 (32) | 0 (0) | 2 (8) | 22 | 11 (50) | 8 (36) | 0 (0) | 3 (14) | 21 | 11 (52) | 9 (43) | 1 (5) | 1 (5) |
| 50 μg dose | 26 | 10 (38) | 8 (31) | 0 (0) | 2 (8) | 23 | 16 (70) | 13 (57) | 0 (0) | 3 (13) | 24 | 17 (71) | 14 (58) | 1 (4) | 2 (8) | |
Volunteers reported symptoms as mild (does not interfere with routine activities), moderate (interferes with routine activities) and severe (unable to perform routine activities). Redness, swelling and induration at the site of injection used the maximal recorded diameter of any reaction for severity grading as mild (1–10 mm), moderate (11–25 mm) and severe (≥26 mm). Oral temperature was graded as mild (38.0–38.4 °C), moderate (38.5–38.9 °C) and severe (≥39.0 °C).