. 2015 Jul;3(4):97–108. doi: 10.1177/2051013615595595

Table 4.

Solicited adverse events in the first 7 days after administration of Flublok, Fluzone or Fluzone HD.

	Study PSC03		Sanofi PI high dose*
	Adults aged ⩾ 65 years		Adults aged ⩾ 65 years
	Flublok	Fluzone	Fluzone	Fluzone HD
Number of subjects	436	433	2569–2572	1258–1260
Local adverse events
Pain	22%	23%	24%	36%
RR (95% CI)	0.95 (0.75–1.23)		1.50 (1.36–1.66)
Redness	10%	12%	11%	15%
RR (95% CI)	0.83 (0.58–1.23)		1.36 (1.15–1.62)
Swelling	11%	13%	6%	9%
RR (95% CI)	0.85 (0.59–1.22)		1.50 (1.19–1.89)
Systemic adverse events
Headache	11%	9%	14%	18%
RR (95% CI)	1.22 (0.82–1.83)		1.28 (1.10–1.49)
Fatigue versus malaise	9%	10%	14%	18%
RR (95% CI)	0.90 (0.60–1.36)		1.28 (1.10–1.49)
Muscle + joint pain versus myalgia	12%	15%	18%	21%
RR (95% CI)	0.80 (0.57–1.12)		1.16 (1.02–1.34)

Data derived from clinical study PSC03 [Keitel et al. 2010] and Fluzone high-dose package insert [Sanofi-Pasteur, 2014].

CI, confidence interval.