Table 2 Incidence (% [95% CI]) of solicited local and general symptoms during the 4 days following primary (overall/dose) and booster vaccination (Total vaccinated cohort)
Primary doses | Booster dose | |||
|---|---|---|---|---|
Solicited symptom | DTPw-HBV/Hib (N = 1274) | Tritanrix™-HBV/Hib (N = 422) | DTPw-HBV/Hib (N = 113) | Tritanrix™-HBV/Hib (N = 34) |
Pain | ||||
Any | 73.4 (70.9, 75.8) | 69.4 (64.8, 73.8) | 90.3 (83.2, 95.0) | 79.4 (62.1, 91.3) |
Grade 3 | 21.8 (19.6, 24.2)§ | 15.4 (12.1, 19.2)§ | 43.4 (34.1, 53.0) | 23.5 (10.7, 41.2) |
MA | 0.5 (0.2, 1.1) | 0.5 (0.1, 1.7) | 0 (0.0, 3.2) | 0 (0.0, 10.3) |
Redness | ||||
Any | 53.1 (50.4, 55.9)§ | 44.1 (39.3, 49.0)§ | 48.7 (39.2, 58.3) | 44.1 (27.2, 62.1) |
> 20 mm | 17.3 (15.2, 19.5) | 12.8 (9.8, 16.4) | 14.2 (8.3, 22.0) | 11.8 (3.3, 27.5) |
MA | 0.6 (0.3, 1.2) | 0 (0.0, 0.9) | 0 (0.0, 3.2) | 0 (0.0, 10.3) |
Swelling | ||||
Any | 51.1 (48.3, 53.9) | 46.4 (41.6, 51.3) | 64.6 (55.0, 73.4) | 38.2 (22.2, 56.4) |
> 20 mm | 21.7 (19.4, 24.0) | 23.2 (19.3, 27.6) | 28.3 (20.2, 37.6) | 17.6 (6.8, 34.5) |
MA | 0.7 (0.3, 1.3) | 0.2 (0.0, 1.3) | 0.9 (0.0, 4.8) | 0 (0.0, 10.3) |
Drowsiness | ||||
Any | 44.3 (41.6, 47.1) | 44.1 (39.3, 49.0) | 39.8 (30.7, 49.5) | 17.6 (6.8, 34.5) |
Grade 3 | 1.5 (0.9, 2.3) | 0.9 (0.3, 2.4) | 2.7 (0.6, 7.6) | 0 (0.0, 10.3) |
MA | 0.4 (0.1, 0.9) | 0.2 (0.0, 1.3) | 0 (0.0, 3.2) | 0 (0.0, 10.3) |
Rectal temperature | ||||
Any | 56.9 (54.1, 59.6)§ | 46.7 (41.8, 51.6)§ | 70.8 (61.5, 79.0) | 58.8 (40.7, 75.4) |
> 38.0°C | 56.9 (54.1, 59.6)§ | 46.7 (41.8, 51.6)§ | 38.1 (29.1, 47.7) | 14.7 (5.0, 31.1) |
> 38.5°C | 19.6 (17.5, 21.9) | 17.5 (14.0, 21.5) | 21.2 (14.1, 29.9) | 5.9 (0.7, 19.7) |
> 39.0°C | 6.9 (5.6, 8.4) | 5.0 (3.1, 7.5) | 1.8 (0.2, 6.2) | 2.9 (0.1, 15.3) |
> 39.5°C | 2.8 (2.0, 3.9) | 3.1 (1.7, 5.2) | 0.9 (0.0, 4.8) | 0.0 (0.0, 10.3) |
> 40.0°C | 0.5 (0.2, 1.0) | 0.7 (0.1, 2.1) | 0.0 (0.0, 3.2) | 0.0 (0.0, 10.3) |
MA | 1.2 (0.7, 1.9) | 0.5 (0.1, 1.7) | 0.0 (0.0, 3.2) | 0.0 (0.0, 10.3) |
Irritability | ||||
Any | 67.0 (64.4, 69.6) | 65.2 (60.4, 69.7) | 71.7 (62.4, 79.8) | 47.1 (29.8, 64.9) |
Grade 3 | 5.0 (3.9, 6.4) | 6.6 (4.5, 9.4) | 9.7 (5.0, 16.8) | 0 (0.0, 10.3) |
MA | 0.7 (0.3, 1.3) | 0.7 (0.1, 2.1) | 0 (0.0, 3.2) | 0 (0.0, 10.3) |
Loss of appetite | ||||
Any | 29.9 (27.4, 32.5) | 26.1 (21.9, 30.5) | 42.5 (33.2, 52.1) | 29.4 (15.1, 47.5) |
Grade 3 | 0.8 (0.4, 1.4) | 0.5 (0.1, 1.7) | 4.4 (1.5, 10.0) | 0 (0.0, 10.3) |
MA | 0.3 (0.1, 0.8) | 0.2 (0.0, 1.3) | 0 (0.0, 3.2) | 0 (0.0, 10.3) |