Table 2. Solicited adverse events occurring within 7 days of any immunization for all subjects receiving at least one immunization.

	Cohort 1						Cohort 2
	True-immunized n = 13			Mock-immunized n = 4			True-immunized n = 12			Mock-immunized n = 4
	Grade 1	Grade 2	Grade 3	Grade 1	Grade 2	Grade 3	Grade 1	Grade 2	Grade 3	Grade 1	Grade 2	Grade 3
Local AE
Lymphadenopathy	0	0	0	0	0	0	1 (8%)	0	0	0	0	0
Vaccination site erythema	1 (8%)	1 (8%)	2 (15%)	2 (50%)	0	0	2 (18%)	0	1 (8%)	3 (75%)	1 (25%)	0
Vaccination site induration	0	0	0	1 (25%)	0	0	1 (8%)	1 (8%)	0	0	1 (25%)	0
Vaccination site pain	0	0	1 (8%)	1 (25%)	0	0	0	0	0	0	0	0
Vaccination site pruritus	3 (23%)	1 (8%)	0	0	0	0	6 (50%)	1 (8%)	0	1 (25%)	0	0
Vaccination site swelling	1 (8%)	0	0	1 (25%)	0	1 (25%)	1 (8%)	0	1 (8%)	1 (25%)	1 (25%)	0
Vaccination site urticaria	0	0	0	1 (25%)	0	0	0	0	0	0	0	0
Systemic AE
Back pain	0	0	0	0	0	0	0	1 (8%)	0	0	0	0
Dermatitis allergic	0	0	0	0	0	0	0	1 (8%)	0	0	0	0
Diarrhea	1 (8%)	0	0	0	0	0	0	0	0	0	0	0
Fatigue	1 (8%)	0	0	0	0	0	0	0	0	0	0	0
Headache	2 (15%)	0	0	0	0	0	1 (8%)	0	0	0	0	0
Hypersensitivity	0	0	1 (8%)	0	0	0	0	0	0	0	0	0
Malaise	0	0	0	0	0	0	1 (8%)	0	0	0	0	0
Myalgia	1 (8%)	0	0	0	0	0	1 (8%)	0	0	0	0	0
Nausea	0	0	0	0	0	0	0	0	0	1 (25%)	0	0
Pyrexia	0	0	0	0	0	0	1 (8%)	0	0	0	0	0
Urticaria	0	0	0	0	0	1 (25%)	00	0	0	0	0	1 (25%)
1 Number of Subjects with at Least One Event
	3 (13%)	2 (15%)	2 (15%)	2 (50%)	0	1 (25%)	7 (58%)	1 (8%)	1 (8%)	3 (75%)	1 (25%)	1 (25%)
Total Number of Events by Severity
	Grade 1	Grade 2	Grade 3	Grade 1	Grade 2	Grade 3	Grade 1	Grade 2	Grade 3	Grade 1	Grade 2	Grade 3
	17 (71%)	3 (13%)	4 (17%)	7 (78%)	0	2 (22%)	19 (76%)	4 (16%)	2 (8%)	6 (60%)	3 (30%)	1 (10%)

Summary is limited to subjects who received at least one immunization. Only those solicited adverse events which followed non-boost vaccinations are included. At each level of subject summarization, a subject who reported one or more such events was counted once for the most severe event.

¹Number (%) of subjects who had an AE.