Table 4.

Adverse Events Summary (1 to 14 d following any scheduled visits^†).

	Group 1 Concomitant		Group 2 Staggered
	n	(%)§	n	(%)§
Subjects in Safety Population	94		96
with one or more adverse experiences	64	(68.1)	83	(86.5)
with no adverse experience	30	(31.9)	13	(13.5)
with vaccine-related adverse experiences‡	18	(19.1)	44	(45.8)
with serious adverse experiences	0	(0.0)	2	(2.1)
with serious vaccine-related adverse experiences	0	(0.0)	0	(0.0)
who died	0	(0.0)	0	(0.0)
discontinued due to an adverse experience	0	(0.0)	0	(0.0)
discontinued due to a vaccine-related adverse experience‡	0	(0.0)	0	(0.0)
discontinued due to a serious adverse experience	0	(0.0)	0	(0.0)
discontinued due to a serious vaccine-related adverse experience	0	(0.0)	0	(0.0)

^†.Scheduled visits = Visit 1,2,3,4,5 and 6.

^‡Determined by the investigator to be related to the vaccine.

^§Percentages are calculated based on the number of subjects in safety population in the vaccination group.