TABLE 5.
Local and systemic reactions of 8- to 12-year-old children to the CV-MeNZB New Zealand strain serogroup B OMV meningococcal vaccine, arranged by dose number and severity of reaction
| Dose no. (no. of children) | Reaction category | Reaction | % of participants with reaction of indicated severitya
|
||
|---|---|---|---|---|---|
| Mild | Moderate | Severe | |||
| 1 (248) | Local | Pain | 44 | 36 | 12 |
| Erythema | 14 | 2 | 1 | ||
| Swelling | 5 | 4 | <1 | ||
| Induration | 6 | 5 | 1 | ||
| Systemic | Nausea | 6 | 2 | 2 | |
| Malaise | 15 | 4 | 3 | ||
| Myalgia | 6 | 2 | 1 | ||
| Arthralgia | 4 | 2 | 0 | ||
| Headache | 17 | 8 | 2 | ||
| Rash | 4 | ||||
| Fever | 2 | ||||
| 2 (243) | Local | Pain | 40 | 28 | 7 |
| Erythema | 8 | 2 | 2 | ||
| Swelling | 3 | 1 | 1 | ||
| Induration | 7 | 2 | <1 | ||
| Systemic | Nausea | 5 | 3 | 2 | |
| Malaise | 11 | 6 | 3 | ||
| Myalgia | 9 | 2 | <1 | ||
| Arthralgia | 4 | 2 | 0 | ||
| Headache | 11 | 6 | 5 | ||
| Rash | 3 | ||||
| Fever | 3 | ||||
| 3 (240) | Local | Pain | 35 | 23 | 7 |
| Erythema | 3 | <1 | <1 | ||
| Swelling | <1 | <1 | <1 | ||
| Induration | 3 | 3 | 0 | ||
| Systemic | Nausea | 5 | 3 | 3 | |
| Malaise | 8 | 6 | 3 | ||
| Myalgia | 5 | 2 | 1 | ||
| Arthralgia | 2 | 1 | <1 | ||
| Headache | 13 | 4 | 3 | ||
| Rash | 3 | ||||
| Fever | 3 | ||||
a
Mild, no limitation of normal daily activities; moderate, some limitation of normal daily activities; severe, inability to perform normal daily activities. For erythema, swelling, and induration, affected areas were measured and classified as follows: <10 mm, no reaction; 10 to 25 mm, mild reaction; 26 to 50 mm, moderate reaction; and >50 mm, severe reaction. Fever was defined as a body temperature of ≥38.5°C. Rash and fever were not categorized by severity.