Table 4.

Summary of adverse events and important medical events

			Three IPV group (n=195)	Two IPV group (n=172)	Three f-IPV group (n=170)	Two f-IPV group (n=207)
Patients with serious adverse events (%; number of events)*			10 (5%; 12 events)	6 (3%; 7 events)	7 (4%; 10 events)	9 (4%; 9 events)
Deaths			1 (1%)	0	0	0
Life threatening adverse events			0	0	0	1 (1%)
Required hospitalisation			8 (4%)	5 (3%)	7 (4%)	9 (4%)
Congenital anomaly or birth defect			1 (1%)	1 (1%)	0	0
Patients with important medical events (%; number of events)*			4 (2%; 8 events)	0	2 (1%; 4 events)	2 (1%; 2 events)
Fever†			0	1 (1%)	1 (1%)	1 (1%)
Local adverse events
	Total number of doses		565	338	499	410
		Pain	1 (0·2%)	1 (0·3%)	12 (2·4%)	1 (0·2%)
		Redness	5 (0·9%)	2 (0·6%)	10 (2·0%)	9 (2·2%)
		Inflammation	0	1 (0·3%)	2 (0·4%)	1 (0·2%)

Data are n (%). The three IPV group received intramuscular vaccine at 10, 14, and 36 weeks. The two IPV group received intramuscular vaccine at 14 and 36 weeks. The three f-IPV group received intradermal vaccine at 10, 14, and 36 weeks. The two f-IPV group received intradermal vaccine at 14 and 36 weeks.

^*All events were unrelated to study regimens.

^†All cases of fever were reported after the first vaccination.