Table 2.

Summary of local and systemic adverse events (full analysis set).

	Cohort 1 (25-60 months)
	Dose 1			Dose 2			Dose 3
	BK IM	BK SC	Control	BK IM	BK SC	Control	BK IM	BK SC	Control
n	18	18	18	18	18	18	15	18	18
Local
Pain	9 (50%)*	13 (72%)	13 (72%)	11 (61%)	15 (83%)	6 (33%)	2 (13%)	12 (67%)	4 (22%)
Swelling	4 (22%)	2 (11%)	5 (28%)	6 (33%)	5 (28%)	1 (6%)	3 (20%)	1 (6%)	3 (17%)
Redness/Erythema	0	0	0	3 (17%)	5 (28%)	2 (11%)	0	5 (28%)	0
Induration	8 (44%)	12 (67%)	11 (61%)	7 (39%)	16 (89%)	2 (11%)	0	16 (89%)	2 (11%)
Systemic
Fever	0	1 (6%)	2 (11%)	1 (6%)	1 (6%)	1 (6%)	0	0	0
Loss of appetite	0	0	0	1 (6%)	0	1 (6%)	0	0	0
Irritability/fussiness	0	0	0	0	0	0	0	0	0
Drowsiness	0	0	1 (6%)	1 (6%)	1 (6%)	1 (6%)	0	0	0
Other AEs suspected to be related to study vaccine
Urticaria				1 (6%)
	Cohort 2 (12-24 months)
n	18	18	18	18	18	18	18	17	18
Local
Pain	8 (44%)	16 (89%)	11 (61%)	8 (44%)	10 (56%)	2 (11%)	2 (11%)	2 (12%)	1 (6%)
Swelling	5 (28%)	4 (22%)	3 (17%)	6 (33%)	4 (22%)	0	3 (17%)	5 (29%)	4 (22%)
Redness/Erythema	0	7 (39%)	2 (11%)	0	4 (22%)	0	1 (6%)	3 (18%)	1 (6%)
Induration	10 (56%)	18 (100%)	8 (44%)	3 (17%)	17 (94%)	4 (22%)	6 (33%)	14 (82%)	6 (33%)
Systemic
Fever	2 (11%)	0	2 (11%)	1 (6%)	2 (11%)	0	0	0	0
Loss of appetite	1 (6%)	1 (6%)	1 (6%)	1 (6%)	0	0	0	1 (6%)	0
Irritability/fussiness	0	0	0	0	0	0	0	1 (6%)	0
Drowsiness	0	0	1 (6%)	0	2 (11%)	0	0	0	0
Other AEs suspected to be related to study vaccine
Pruritus	0	1 (6%)	0	0	0	0	0	0	0
Pyrexia	0	0	0	0	0	1 (6%)	0	0	0
Diarrhea	0	1 (6%)	0	0	1 (6%)	0	1 (6%)	0	1 (6%)
Vomiting	0	0	0	0	1 (6%)	0	0	0	0
Increased transaminase	0	0	0	0	1 (6%)	0	0	0	0

no. of children experiencing an event = n (% of children); BK IM = BK-SE36 via intramuscular route; BK SC = BK-SE36 via subcutaneous route