Table 2.
Number and percentage of participants with solicited local and systemic adverse events (AEs) (full analysis set).
| Group | First vaccination, n (%) |
Second vaccination, n (%) |
Any vaccination, n (%) |
||||||
|---|---|---|---|---|---|---|---|---|---|
| 1.5/25 μg (N = 22) | 5.9/100 μg (N = 26) | Control (N = 24) | 1.5/25 μg (N = 22) | 5.9/100 μg (N = 23) | Control (N = 21) | 1.5/25 μg (N = 22) | 5.9/100 μg (N = 26) | Control (N = 24) | |
| Solicited local AEs | |||||||||
| Pain | 20 (91) | 25 (96) | 10 (42) | 15 (68) | 15 (65) | 17 (81) | 21 (95) | 25 (96) | 19 (79) |
| Severe | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Erythema | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Severe | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Induration | 0 | 0 | 0 | 0 | 0 | 1 (5) | 0 | 0 | 1 (4) |
| Severe | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Solicited systemic AEs | |||||||||
| Headache | 5 (23) | 10 (38) | 8 (33) | 4 (18) | 5 (22) | 4 (19) | 8 (36) | 13 (50) | 10 (42) |
| Severe | 0 | 1 (4) | 0 | 0 | 0 | 0 | 0 | 1 (4) | 0 |
| Arthralgia | 1 (5) | 4 (15) | 4 (17) | 0 | 0 | 1 (5) | 1 (5) | 4 (15) | 5 (21) |
| Severe | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Chills | 4 (18) | 4 (15) | 3 (13) | 3 (14) | 1 (4) | 2 (10) | 5 (23) | 5 (19) | 5 (21) |
| Severe | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Fatigue | 2 (9) | 8 (31) | 7 (29) | 2 (9) | 1 (4) | 4 (19) | 3 (14) | 9 (35) | 9 (38) |
| Severe | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Malaise | 3 (14) | 3 (12) | 6 (25) | 2 (9) | 0 | 4 (19) | 3 (14) | 3 (12) | 10 (42) |
| Severe | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Myalgia | 0 | 2 (8) | 2 (8) | 1 (5) | 0 | 4 (19) | 1 (5) | 2 (8) | 6 (25) |
| Severe | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Fever | 1 (5) | 1 (4) | 0 | 0 | 0 | 0 | 1 (5) | 1 (4) | 0 |
| Severe | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
N, number of exposed participants in each group; n (%), number (percentage) of participants in each category; 1.5/25 μg, 5.9/100 μg, participants who received the 1790GAHB vaccine with an O antigen/protein content of 1.5/25 and 5.9/100 μg, respectively, at days 1 and 29; Control, participants who received meningococcal vaccine against serogroups A, C, W, and Y at day 1 and tetanus, diphtheria, and acellular pertussis vaccine at day 29.