Table 5. Percentages of infants experiencing any (severe in parentheses) solicited systemic reactions within 1 wk of vaccination in the 3 study groups for the 4-vaccination series. Maximum rectal temperature is shown according to the Brighton Collaboration guidelines.
| Study group | 4CMenB | 4CMenB+Paracetamol | MenC | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Dose | 1st | 2nd | 3rd | 4th | 1st | 2nd | 3rd | 4th | 1st | 2nd | 3rd | 4th* |
| n = | 182 | 182 | 181 | 155 | 182 | 182 | 181 | 155 | 182 | 182 | 181 | 155 |
| Change in eating habits | 42 (2) | 34 (2) | 27 (1) | 48 (3) | 37 (3) | 30 (2) | 27 (2) | 42 (3) | 23 (2) | 19 (1) | 12 (1) | 36 (4) |
| Sleepiness | 66 (3) | 58 (1) | 41 (1) | 49 (1) | 65 (2) | 47 (1) | 42 (1) | 50 (3) | 52 (1) | 47 (1) | 42 (1) | 52 (4) |
| Vomiting | 13 (0) | 10 (0) | 4 (1) | 4 (0) | 12 (1) | 11 (0) | 11 (1) | 13 (2) | 10 (0) | 8 (1) | 6 (1) | 6 (0) |
| Diarrhea | 31 (0) | 24 (1) | 18 (0) | 19 (1) | 23 (0) | 22 (1) | 18 (0) | 19 (1) | 25 (0) | 22 (1) | 11 (0) | 16 (0) |
| Irritability | 70 (5) | 71 (7) | 64 (5) | 75 (6) | 54 (1) | 55 (5) | 47 (2) | 60 (3) | 45 (1) | 46 (2) | 43 (1) | 72 (6) |
| Unusual crying | 52 (5) | 49 (6) | 42 (3) | 48 (3) | 41 (2) | 40 (4) | 26 (3) | 31 (3) | 36 (1) | 25 (2) | 21 (0) | 45 (4) |
| Rash (Urticarial) | 3 (1) | 2 (2) | 1 (0) | 3 (2) | 3 (2) | 3 (0) | 3 (2) | 3 (3) | 2 (1) | 3 (1) | 3 (2) | 4 (2) |
| Max. rectal temperature | ||||||||||||
| <38.0 °C | 29 | 23 | 43 | 30 | 47 | 43 | 63 | 41 | 76 | 61 | 74 | 31 |
| 38.0°–38.9 °C | 49 | 62 | 50 | 50 | 48 | 51 | 34 | 50 | 23 | 34 | 23 | 46 |
| 39.0°–39.9 °C | 20 | 15 | 7 | 19 | 4 | 5 | 3 | 10 | 1 | 4 | 1 | 19 |
| ³40 °C | 1 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 1 |
| Medically attended fever (within 3 d) | 4 (2) | 1 (1) | 0 | 1 (1) | 1 (1) | 0 | 1 (1) | 0 | 2 (1) | 1 (1) | 1 (1) | 3 (2) |
*
First toddler dose of 4CMenB