Table 3.

Numbers of Participants Experiencing Serious Adverse Events After Any Vaccination During 12 Months of End of Part 1 (Month 16 to Month 27; Safety Set Data)

Adverse Events	TAK-003, No. (%) (n = 13 380)	Placebo, No. (%) (n = 6687)
Any	271 (2.0)	151 (2.3)
Mild	25 (0.2)	12 (0.2)
Moderate	199 (1.5)	108 (1.6)
Severe	47 (0.4)	31 (0.5)
Related to investigational producta	0	0
Related to trial procedures	0	0
Leading to withdrawal of investigational product or trial discontinuation	2 (< 0.1)	2 (< 0.1)
Deaths	2 (< 0.1)	1 (< 0.1)

^aAs assessed by investigator and sponsor.