A 2013/2014 northern hemisphere season surface antigen inactivated trivalent influenza vaccine - Assessing the immunogenicity and safety in an open label, uncontrolled study

Figures & data

Table 1. Demographic and baseline characteristics

	Adults (18–60 years) n = 61	Elderly ≥61 years n = 64	Total n = 125
Age (years, ± SD)	39.2 (± 11.2)	68.2 (± 4.7)	54.1 (± 16.9)
Sex
Male n (%)	32 (52%)	30 (47%)	62 (50%)
Female n (%)	29 (48%)	34 (53%)	63 (50%)
Weight (kg)	78.69 (± 16.31)	74.65 (± 13.57)	76.62 (± 15.04)
Height (cm)	175.5 (± 9.7)	171.3 (±7.3)	173.4 (± 8.8)
BMI (kg/m^2)	25.4 (± 4.2)	25.3 (± 3.8)	25.4 (± 4.0)
Previous seasonal influenza vaccination
No n (%)	38 (62%)	15 (23%)	53 (42%)
Yes n (%)	23 (38%)	49 (77%)	72 (58%)
Ethnicity
White n	60	63	123
Asian n	0	1	1
Other n	1	0	1

Values are means (± SD) if not indicated otherwise.

Table 2. Vaccine Immunogenicity assessment by SHR assay

		18 to ≤60 Years				≥61 Years
Strains		A(H1N1)	A(H3N2)	B		A(H1N1)	A(H3N2)	B
Pre-vaccination (day 1)
GMA		9.2	12	22		14	13	22
(95% CI)		(7.11–12)	(10–15)	(17–29)		(10–18)	(11–16)	(17–29)
SRH area ≥ 25 mm^2 n/N, %		10/60 (17%)	12/60 (20%)	34/60 (57%)		23/64 (36%)	13/64 (20%)	35/64 (55%)
(95% CI)		(8%–29%)	(11%–32%)	(43%–69%)		(24%–49%)	(11%–32%)	(42%–67%)
Post-vaccination (day 22)
	CHMP				CHMP
Seroconversion n/N, %		24/26 (92%)	7/9 (78%)	5/5 (100%)		14/24 (58%)	5/7 (71%)	5/5 (100%)
Significant increase in antibody titers n/N, %		27/34 (79%)	46/51 (90%)	36/55 (65%)		23/40 (58%)	42/57 (74%)	38/59 (64%)
Seroconversion or significant increase n/N, %	>40%	51/60 (85%)	53/60 (88%)	41/60 (68%)	>30%	37/64 (58%)	47/64 (73%)	43/64 (67%)
(95% CI)		(73%–93%)	(77%–95%)	(55%–80%)		(45%–70%)	(61%–84%)	(54%–78%)
GMA		70	46	59		47	41	52
(95% CI)		(62–80)	(39-54)	(51–68)		(39–58)	(34–48)	(46-59)
GMR	>2.5	7.62	3.66	2.62	>2.0	3.42	3.05	2.33
(95% CI)		(5.83–9.95)	(2.98–4.5)	(2.09–3.27)		(2.65–4.41)	(2.49–3.74)	(1.92–2.83)
SRH area≥ 25 mm^2 n/N, %	>70%	57/6095%	49/60(82%)	55/60(92%)	>60%	51/64(80%)	54/64(84%)	59/64(92%)
(95% CI)		(86%–99%)	(70%–90%)	(82%–97%)		(68%–89%)	(73%–92%)	(83%–97%)

Values are frequencies (%).

Table 3. Local injection site and systemic reaction (solicited AEs) between day 1 and day 4

		Adults (18–60 years)	Elderly ≥61 years	Elderly ≥61 years
		n = 125	n = 64	n = 64
Any		40 (66%)	24 (38%)	64 (51%)
Local injection site reaction (Day 1 to 4 post vaccination)
Any	Any	33 (54%)	19 (30%)	52 (42%)
	Severe	0	0	0
Pain	Any	31(51%)	18 (28%)	49 (39%)
	Severe	0	0	0
Induration	Any	3 (5%)	1 (2%)	4 (3%)
	> 50 mm	0	0	0
Ecchymosis	Any	2 (3%)	1 (2%)	3 (2%)
	> 50 mm	0	0	0
Erythema	Any	0	1 (2%)	1 (1%)
	> 50 mm	0	0	0
Systemic reaction (Day 1 to 4 post vaccination)
Any	Any	21 (34%)	10 (16%)	31 (25%)
	Severe
Fatigue	Any	14 (23%)	6 (9%)	20 (16%)
	Severe	1 (2%)	1 (2%)	2 (2%)
Headache	Any	14 (23%)	5 (8%)	19 (15%)
	Severe	0	0	0
Malaise	Any	8 (13%)	1 (2%)	9 (7%)
	Severe	0	0	0
Arthalgia	Any	5 (8%)	1 (2%)	6 (5%)
	Severe	0	0	0
Myalgia	Any	2 (3%)	2 (3%)	4 (3%)
	Severe	0	0	0
Chills/shivering	Any	3 (5%)	0	3 (2%)
	Severe	0	0	0
Fever (> 38°C)		0	0	0
Other
Therapeutic use of analgesics/antipyretics		3 (5%)	0	3 (2%)

Values are number (%) of subjects

Table 4. Overview of subjects with AEs from day 1 to day 22

	Adults (18–60 years) n = 61	Elderly ≥61 years n = 64	Total n = 125
Any AE	42 (69%)	26 (41%)	68 (54%)
Unsolicited AEs	3 (5%)	3 (5%)	6 (5%)
At least possible related AEs	1 (2%)	3 (5%)	4 (3%)
Serious AEs	0	0	0
AEs leading to withdrawal	0	0	0