Table 1. Incidence of solicited general symptoms by dose within the 7-day follow-up after RTS,S/AS02D or Engerix-B™.
After dose 1 | After dose 2 | After dose 3 | ||||||||||
RTS,S/AS02D | Engerix -B | RTS,S/AS02D | Engerix -B | RTS,S/AS02D | Engerix-B | |||||||
(N = 105) | (N = 106) | (N = 99) | (N = 100) | (N = 97) | (N = 97) | |||||||
n | % | n | % | N | % | n | % | n | % | n | % | |
General symptoms | ||||||||||||
Drowsiness | ||||||||||||
Any | 27 | 25.7 | 37 | 34.9 | 32 | 32.3 | 26 | 26.0 | 28 | 28.9 | 32 | 33.0 |
Related | 10 | 9.5 | 11 | 10.4 | 8 | 8.1 | 3 | 3.0 | 3 | 3.1 | 5 | 5.2 |
Fever | ||||||||||||
Any | 11 | 10.5 | 5 | 4.7 | 10 | 10.1 | 10 | 10.0 | 8 | 8.2 | 9 | 9.3 |
Related | 11 | 10.5 | 5 | 4.7 | 10 | 10.1 | 9 | 9.0 | 8 | 8.2 | 9 | 9.3 |
Grade 3 | 0 | - | 0 | - | 0 | - | 1 | 1.0 | 0 | - | 1 | 1.0 |
Grade 3 related | 0 | - | 0 | - | 0 | - | 1 | 1.0 | 0 | - | 1 | 1.0 |
Irritability | ||||||||||||
Any | 43 | 41.0 | 39 | 36.8 | 49 | 49.5 | 39 | 39.0 | 42 | 42.3 | 46 | 47.4 |
Related | 27 | 25.7 | 13 | 12.3 | 25 | 25.3 | 16 | 16.0 | 17 | 17.5 | 20 | 20.6 |
Grade 3 | 0 | - | 0 | - | 0 | - | 0 | - | 0 | - | 1 | 1.0 |
Grade 3 related | 0 | - | 0 | - | 0 | - | 0 | - | 0 | - | 1 | 1.0 |
Loss of appetite | ||||||||||||
Any | 19 | 18.1 | 27 | 25.5 | 25 | 25.3 | 24 | 24.0 | 28 | 28.9 | 29 | 29.9 |
Related | 2 | 1.9 | 1 | 0.9 | 1 | 1.0 | 1 | 1.0 | 3 | 3.1 | 3 | 3.1 |
Local symptoms | ||||||||||||
Pain | ||||||||||||
Any | 103 | 98.1 | 95 | 89.6 | 92 | 92.9 | 82 | 82.0 | 80 | 82.5 | 81 | 83.5 |
Grade 3 | 0 | - | 0 | - | 0 | - | 0 | - | 0 | - | 0 | - |
Swelling | ||||||||||||
Any | 10 | 9.5 | 12 | 11.3 | 11 | 11.1 | 8 | 8.0 | 8 | 8.2 | 8 | 8.2 |
Grade 3 | 0 | - | 0 | - | 0 | - | 0 | - | 0 | - | 0 | - |
N = Number of subjects with at least one symptom sheet completed; n/% = number and percentage of subjects reporting a specified symptom.