Year 2 | Year 3 | |||
---|---|---|---|---|
9 μgID (N= 544) | 15 μg IM (N= 547) | 9 μg ID (N= 418) | 15 μg IM (N= 410) | |
Solicited injection site reactions, n (%) | 420 (77.2) | 253 (46.3) | 317 (75.8) | 186 (45.5) |
Erythema | ||||
>0.5 cm | 378 (69.5) | 53 (9.7) | 274 (65.6) | 50 (12.2) |
>5 cm | 29 (5.4) | 3 (0.6) | 25 (6.0) | 2 (0.5) |
Induration | ||||
>0.5 cm | 212 (39.0) | 47 (8.6) | 166 (39.7) | 49 (12.0) |
>5 cm | 7 (1.3) | 2 (0.4) | 2 (0.5) | 2 (0.5) |
Oedema | ||||
>0.5 cm | 233 (42.8) | 28 (5.1) | 150 (35.9) | 33 (8.0) |
>5 cm | 9 (1.7) | 2 (0.4) | 7 (1.7) | 2 (0.5) |
Bruising | ||||
>0.5 cm | 10 (1.8) | 10 (1.8) | 14 (3.3) | 13 (3.2) |
>5 cm | 0 | 1 (0.2) | 1 (0.2) | 2 (0.5) |
Pain | ||||
any grade | 204 (37.5) | 214 (39.1) | 180 (43.1) | 152 (37.1) |
grade 3 | 3 (0.6) | 2 (0.4) | 5 (1.2) | 4 (1.0) |
Pruritus | ||||
any grade | 172 (31.6) | 39 (7.1) | 121 (28.9) | 31 (7.6) |
grade 3 | 3 (0.6) | 1 (0.2) | 6 (1.4) | 1 (0.2) |
Solicited systemic reactions, n (%) | 155 (28.5) | 181 (33.1) | 123 (29.4) | 101 (24.6) |
Pyrexia | ||||
>37.5°C | 8 (1.5) | 5 (0.9) | 10 (2.4) | 2 (0.5) |
>38.5°C | 0 | 0 | 2 (0.5) | 1 (0.2) |
Asthenia | ||||
any grade | 97 (17.8) | 108 (19.7) | 75 (17.9) | 52 (12.7) |
grade 3 | 11 (2.0) | 6 (1.1) | 8 (1.9) | 6 (1.5) |
Headache | ||||
any grade | 88 (16.2) | 82 (15.0) | 69 (16.5) | 57 (13.9) |
grade 3 | 7 (1.3) | 4 (0.7) | 3 (0.7) | 3 (0.7) |
Arthralgia | ||||
any grade | 31 (5.7) | 33 (6.0) | 26 (6.2) | 8 (2.0) |
grade 3 | 1 (0.2) | 2 (0.4) | 2 (0.5) | 0 |
Myalgia | ||||
any grade | 40 (7.4) | 84 (15.4) | 47 (11.2) | 41 (10.0) |
grade 3 | 1 (0.2) | 4 (0.7) | 2 (0.5) | 2 (0.5) |
Rigors | ||||
any grade | 41 (7.5) | 44 (8.0) | 35 (8.4) | 31 (7.6) |
grade 3 | 1 (0.2) | 3 (0.6) | 3 (0.7) | 1 (0.2) |
Increased sweating | ||||
any grade | 35 (6.4) | 39 (7.1) | 28 (6.7) | 25 (6.1) |
grade 3 | 2 (0.4) | 2 (0.4) | 0 | 2 (0.5) |
Malaise | ||||
any grade | 31 (5.7) | 37 (6.8) | 18 (4.3) | 22 (5.4) |
grade 3 | 3 (0.6) | 4 (0.7) | 2 (0.5) | 1 (0.2) |