TABLE 1

Incidence of vaccine reactogenicity within 14 days of receipt of vaccine

SymptomNo. 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 7Totala
First 20-μg doseSecond 20-μg dose
Local symptoms
    Pain0/40/40/40/40/41/41/42/43/28
    Erythema0/40/40/40/40/40/40/41/41/28
    Induration0/40/40/40/40/40/40/40/40/28
Systemic symptoms
    Fever0/40/40/40/40/40/40/40/40/28
    Headache0/42/40/41/40/40/41/40/44/28
    Fatigue/malaise1/40/40/40/40/40/41/40/42/28
    Myalgia0/40/40/41/40/41/40/40/42/28
    Chills0/40/40/40/40/40/40/40/40/28
    Nausea/vomiting0/40/40/40/41/40/41/40/42/28
    Rash0/40/40/40/40/40/40/40/40/28
    Diarrhea0/41/40/40/41/40/40/41/43/28
    Anorexia0/40/40/40/40/40/40/40/40/28
  • a Reactogenicity in the two-dose cohort was not counted twice if a person experienced the same symptom after both vaccinations.