Table 2.

Participants reporting solicited adverse events within 7 days of vaccination, and unsolicited adverse events within 28 days, of each vaccination in all vaccinated participants

		Historical control study	Novel OPV2 study—OPV vaccinated		Novel OPV2 study—IPV vaccinated
		Monovalent OPV2, groups 1 and 2	Novel OPV2-c1, groups 1 and 2	Novel OPV2-c2, groups 3 and 4	Novel OPV2-c1, group 5	Novel OPV2-c2, group 6	Placebo, group 7
Solicited systemic adverse events after dose 1
N		100	100	100	17	16	17
	Any	62 (62%)	71 (71%)	74 (74%)	16 (94%)	13 (81%)	15 (88%)
	Mild	47 (47%)	45 (45%)	60 (60%)	15 (88%)	12 (75%)	14 (82%)
	Moderate	11 (11%)	23 (23%)	12 (12%)	4 (24%)	7 (44%)	5 (29%)
	Severe	4 (4%)	3 (3%)	2 (2%)	1 (6%)	0	2 (12%)
Solicited systemic adverse events after dose 2
N*		50	49	49	17	15	16
	Any	18 (36%)	26 (53%)	21 (43%)	11 (65%)	9 (60%)	12 (75%)
	Mild	10 (20%)	18 (37%)	14 (29%)	8 (47%)	3 (20%)	7 (44%)
	Moderate	7 (14%)	8 (16%)	6 (12%)	3 (18%)	5 (33%)	5 (31%)
	Severe	1 (2%)	0	1 (2%)	0	1 (7%)	0
Unsolicited adverse events after dose 1
N		100	100	100	17	16	17
	Any	65 (65%)	68 (68%)	69 (69%)	13 (76%)	12 (75%)	16 (94%)
	Probably or possibly related	28 (28%)	19 (19%)	19 (19%)	1 (6%)	2 (13%)	1 (6%)
	Severe	13 (13%)	18 (18%)	7 (7%)	3 (18%)	1 (6%)	7 (41%)
Unsolicited adverse events after dose 2
N*		50	49	49	17	15	16
	Any	26 (52%)	33 (67%)	33 (67%)	11 (65%)	12 (80%)	14 (88%)
	Probably or possibly related	7 (7%)	5 (10%)	7 (14%)	1 (6%)	1 (7%)	0
	Severe	5 (10%)	6 (12%)	5 (10%)	1 (6%)	4 (27%)	5 (31%)

Data are n (%) unless otherwise stated. c1=candidate 1. c2=candidate 2. IPV=inactivated poliovirus vaccine. OPV=oral poliovirus vaccine. OPV2=type 2 OPV.

^*Only includes two-dose groups.