Table 4.

Safety summary: unsolicited AEs, solicited reactions, and SAEs after any injection.

	IIV4		Pooled IIV3
Event	n/N	% (95% CI)	n/N	%
Solicited reaction within 7 days	622/882	70.5 (67.4; 73.5)	254/354	71.8 (66.8; 76.4)
Injection site	550/882	62.4 (59.1; 65.6)	221/354	62.4 (57.2; 67.5)
Grade 3	50/882	5.7 (4.2; 7.4)	15/354	4.2 (2.4; 6.9)
Systemic	431/882	48.9 (45.5; 52.2)	161/354	45.5 (40.2; 50.8)
Grade 3	37/882	4.2 (3.0; 5.7)	12/354	3.4 (1.8; 5.8)
Unsolicited non-serious AE within 28 days	367/884	41.5 (38.2; 44.8)	126/354	35.6 (30.6; 40.8)
Treatment-related	29/884	3.3 (2.2; 4.7)	7/354	2.0 (0.8; 4.0)
Grade 3	18/884	2.0 (1.2; 3.2)	9/354	2.5 (1.2; 4.8)
Grade 3 treatment-related	2/884	0.2 (0.0; 0.8)	2/354	0.6 (0.1; 2.0)
Immediate unsolicited AE (<30 min)	1/884	0.1 (0.0; 0.6)	0/354	0.0 (0.0; 1.0)
Treatment-related	1/884	0.1 (0.0; 0.6)	0/354	0.0 (0.0; 1.0)
AE leading to study discontinuation	1/884	0.1 (0.0; 0.6)	0/354	0.0 (0.0; 1.0)
SAE within 28 days	4/884	0.5 (0.1; 1.2)	1/354	0.3 (0.0; 1.6)
SAE within 28 days	10/884	1.1 (0.5; 2.1)	3/354	0.8 (0.2; 2.5)
AESI	1/884	0.1 (0.0; 0.6)	1/354	0.0 (0.0; 1.0)
Death	0/884	0.0 (0.0; 0.4)	0/354	0.0 (0.0; 1.0)

Values are for the safety analysis set. AE, adverse event; AESI, adverse event of special interest; SAE, serious adverse event.