Table 2.
Maximum intensity of injection site and systemic reactions during the week after immunization
| Dosage | 7.5 mcg | 7.5 mcg | 7.5 mcg | 30 mcg | 30 mcg | 30 mcg |
|---|---|---|---|---|---|---|
| Age group in years | 18–38 | 44–59 | All | 18–38 | 44–59 | All |
| Number of subjects | 31,27 | 28,26 | 59,53 | 30,29 | 32,32 | 62,61 |
| Local | ||||||
| Erythema | ||||||
| Any | 32,33* | 14,19 | 24,26 | 33,34 | 16,13 | 24,23 |
| Grade 2 or 3 | 3,0 | 0,0 | 2,0 | 7,7 | 0,0 | 3,3 |
| Induration | ||||||
| Any | 3,7 | 7,8 | 5,8 | 3,7 | 3,13 | 3,10 |
| Grade 2 or 3 | 0,0 | 0,0 | 0,0 | 0,0 | 0,0 | 0,0 |
| Pain | ||||||
| Any | 23,19 | 7,8 | 15,13 | 43,14 | 13,9 | 27,11 |
| Grade 2 or 3 | 0,0 | 0,0 | 0,0 | 0,0 | 0,0 | 0,0 |
| Tenderness | ||||||
| Any | 16,26 | 11,4 | 14,15 | 40,34 | 22,22 | 31,28 |
| Grade 2 or 3 | 0,0 | 0,0 | 0,0 | 0,0 | 0,0 | 0,0 |
| Any local | ||||||
| Any | 52,56 | 29,23 | 41,40 | 77,59 | 38,38 | 56,48 |
| Grade 2 or 3 | 3,0 | 0,0 | 2,0 | 7,7 | 0,0 | 3,3 |
| Systemic | ||||||
| Fever | ||||||
| Any | 3,0 | 0,0 | 2,0 | 3,0 | 0,0 | 2,0 |
| Grade 2 or 3 | 3,0 | 0,0 | 2,0 | 0,0 | 0,0 | 0,0 |
| Feverishness | ||||||
| Any | 13,0 | 7,0 | 10,0 | 13,3 | 0,0 | 6,2 |
| Grade 2 or 3 | 3,0 | 4,0 | 3,0 | 10,0 | 0,0 | 5,0 |
| Headache | ||||||
| Any | 48,26 | 32,12 | 41,19 | 37,24 | 13,13 | 24,18 |
| Grade 2 or 3 | 16,4 | 18,4 | 17,4 | 13,3 | 9,0 | 11,2 |
| Malaise | ||||||
| Any | 19,11 | 21,12 | 20,11 | 30,24 | 19,9 | 24,16 |
| Grade 2 or 3 | 10,4 | 4,0 | 7,2 | 17,0 | 9,3 | 13,2 |
| Myalgia | ||||||
| Any | 16,4 | 14,4 | 15,4 | 27,7 | 16,0 | 21,3 |
| Grade 2 or 3 | 10,0 | 0,0 | 5,0 | 10,0 | 6,0 | 8,0 |
| Nausea | ||||||
| Any | 10,7 | 11,4 | 10,6 | 17,7 | 13,3 | 15,5 |
| Grade 2 or 3 | 0,4 | 4,0 | 2,2 | 3,0 | 6,3 | 5,2 |
| Any systemic | ||||||
| Any | 52,33 | 46,19 | 49,26 | 50,38 | 31,16 | 40,26 |
| Grade 2 or 3 | 23,7 | 21,4 | 22,6 | 23,3 | 19,3 | 21,3 |
| Any local or systemic | ||||||
| Any | 84,74 | 64,38 | 75,57 | 80,69 | 53,50 | 66,59 |
| Grade 2 or 3 | 26,7 | 21,4 | 24,6 | 27,10 | 19,3 | 23,7 |
*
Numbers in the cell refer to the percentages of subjects per vaccine group experiencing reactions after first and second vaccine dose, respectively.