Table 5.

Summary of local injection site symptom assessments reported in all subjects within 7 days of vaccination

		Cohort 1	Cohort 2	Cohorts 3 & 4	Cohort 5	Cohort 6	Cohort 7
Local InjectionSite Reactions		5 subjects (n = 17)	8 subjects (n = 30)	16 subjects (n = 61)	8 subjects (n = 29)	16 subjects (n = 58)	14 subjects (n = 54)
Pain/Burning	Mild and moderate	6 (35%)	11 (37%)	21 (34%)	15 (52%)	26 (45%)	36 (67%)
	Severe	0	0	0	0	2 (3%)	2 (4%)
Tenderness	Mild and moderate	7 (41%)	14 (47%)	23 (38%)	8 (28%)	44 (76%)	41 (76%)
	Severe	0	0	1 (2%)	0	1 (2%)	5 (9%)
Erythema/Redness	Mild and moderate	1 (6%)	3 (10%)	3 (5%)	6 (21%)	6 (10%)	13 (24%)
	Severe	0	0	0	1 (3%)	1 (2%)	1 (2%)
Induration/Swelling	Mild and moderate	0	1 (3%)	2 (3%)	7 (24%)	9 (16%)	20 (37%)
	Severe	0	0	0	0	1 (2%)	1 (2%)

Data (n) are from 249 vaccinations among 67 subjects. A continuum of events related to a single injection is defined as a single event, graded as the most severe occurrence.