TABLE 1.
Incidence of vaccine reactogenicity within 14 days of receipt of vaccine
| Symptom | No. of subjects with symptom/total no. of subjects |
||||||||
|---|---|---|---|---|---|---|---|---|---|
| Cohort 1 (0.01 μg) | Cohort 2 (0.1 μg) | Cohort 3 (0.5 μg) | Cohort 4 (2.5 μg) | Cohort 5 (10 μg) | Cohort 6 (20 μg) | Cohort 7 |
Totala | ||
| First 20-μg dose | Second 20-μg dose | ||||||||
| Local symptoms | |||||||||
| Pain | 0/4 | 0/4 | 0/4 | 0/4 | 0/4 | 1/4 | 1/4 | 2/4 | 3/28 |
| Erythema | 0/4 | 0/4 | 0/4 | 0/4 | 0/4 | 0/4 | 0/4 | 1/4 | 1/28 |
| Induration | 0/4 | 0/4 | 0/4 | 0/4 | 0/4 | 0/4 | 0/4 | 0/4 | 0/28 |
| Systemic symptoms | |||||||||
| Fever | 0/4 | 0/4 | 0/4 | 0/4 | 0/4 | 0/4 | 0/4 | 0/4 | 0/28 |
| Headache | 0/4 | 2/4 | 0/4 | 1/4 | 0/4 | 0/4 | 1/4 | 0/4 | 4/28 |
| Fatigue/malaise | 1/4 | 0/4 | 0/4 | 0/4 | 0/4 | 0/4 | 1/4 | 0/4 | 2/28 |
| Myalgia | 0/4 | 0/4 | 0/4 | 1/4 | 0/4 | 1/4 | 0/4 | 0/4 | 2/28 |
| Chills | 0/4 | 0/4 | 0/4 | 0/4 | 0/4 | 0/4 | 0/4 | 0/4 | 0/28 |
| Nausea/vomiting | 0/4 | 0/4 | 0/4 | 0/4 | 1/4 | 0/4 | 1/4 | 0/4 | 2/28 |
| Rash | 0/4 | 0/4 | 0/4 | 0/4 | 0/4 | 0/4 | 0/4 | 0/4 | 0/28 |
| Diarrhea | 0/4 | 1/4 | 0/4 | 0/4 | 1/4 | 0/4 | 0/4 | 1/4 | 3/28 |
| Anorexia | 0/4 | 0/4 | 0/4 | 0/4 | 0/4 | 0/4 | 0/4 | 0/4 | 0/28 |
a
Reactogenicity in the two-dose cohort was not counted twice if a person experienced the same symptom after both vaccinations.