Table 4 Safety summary: number of subjects with European Medicines Evaluation Agency -specified reactions after each intradermal and intramuscular vaccination according to vaccine history during the study
Year 1 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
3 μg ID (N= 384) | 6 μg ID (N= 383) | 15 μg IM (N= 382) | ||||||||
≥ 1 EMEA reaction, n (%) | 38 (9.9) | 39 (10.2) | 50 (13.1) | |||||||
Injection site induration* | 0 | 0 | 1 (0.3) | |||||||
Injection site ecchymosis (bruising) | 2 (0.5) | 1 (0.3) | 7 (1.8) | |||||||
Fever† | 4 (1.0) | 5 (1.3) | 6 (1.6) | |||||||
Malaise | 12 (3.1) | 17 (4.4) | 19 (5.0) | |||||||
Shivering (rigors) | 26 (6.8) | 26 (6.8) | 21 (5.5) | |||||||
Year 2 (vaccine history and group) | ||||||||||
ID/ID (N = 363) | IM/ID (N = 181) | ID total ( N = 544) | ID/IM (N = 363) | IM/IM (N = 184) | IM total ( N = 547) | |||||
≥ 1 EMEA reaction, n (%) | 41 (11.3) | 20 (11.0) | 61 (11.2) | 39 (10.7) | 28 (15.2) | 67 (12.2) | ||||
Injection site induration* | 0 | 0 | 0 | 0 | 0 | 0 | ||||
Injection site ecchymosis (bruising) | 5 (1.4) | 2 (1.1) | 7 (1.3) | 7 (1.9) | 3 (1.6) | 10 (1.8) | ||||
Fever† | 3 (0.8) | 2 (1.1) | 5 (0.9) | 3 (0.8) | 0 | 3 (0.5) | ||||
Malaise | 19 (5.2) | 8 (4.4) | 27 (5.0) | 17 (4.7) | 15 (8.2) | 32 (5.9) | ||||
Shivering (rigors) | 27 (7.4) | 9 (5.0) | 36 (6.6) | 23 (6.3) | 18 (9.8) | 41 (7.5) | ||||
Year 3 (vaccine history and group) | ||||||||||
ID/ID/ID (N = 137) | IM/ID/ID (N = 71) | ID/IM/ID (N = 138) | IM/IM/ID(N = 72) | ID total ( N = 418) | ID/ID/IM (N = 132) | IM/ID/IM (N = 72) | ID/IM/IM (N = 134) | IM/IM/IM (N = 72) | IM total ( N = 410) | |
≥ 1 EMEA reaction, n (%) | 13 (9.5) | 11 (15.5) | 19 (13.8) | 11 (15.3) | 54 (12.9) | 18 (13.6) | 6 (8.3) | 13 (9.7) | 10 (13.9) | 47 (11.5) |
Injection site induration* | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Injection site ecchymosis (bruising) | 4 (2.9) | 3 (4.2) | 2 (1.4) | 4 (5.6) | 13 (3.1) | 3 (2.3) | 1 (1.4) | 3 (2.2) | 4 (5.6) | 11 (2.7) |
Fever† | 3 (2.2) | 1 (1.4) | 3 (2.2) | 0 | 7 (1.7) | 1 (0.8) | 0 | 0 | 1 (1.4) | 2 (0.5) |
Malaise | 3 (2.2) | 5 (7.0) | 6 (4.3) | 2 (2.8) | 16 (3.8) | 9 (6.8) | 1 (1.4) | 6 (4.5) | 4 (5.6) | 20 (4.9) |
Shivering (rigors) | 8 (5.8) | 4 (5.6) | 12 (8.7) | 7 (9.7) | 31 (7.4) | 11 (8.3) | 4 (5.6) | 6 (4.5) | 5 (6.9) | 26 (6.3) |