Safety and immunogenicity of a seasonal trivalent inactivated split influenza vaccine: a phase I randomized clinical trial in healthy Serbian adults

Figures & data

Figure 1. Participant Flow Chart.

Table 1. Demographic characteristics of study subjects.

	All subjects	Female	Male
No. (%) of subjects	60	18 (30)	42 (70)
Mean age (years)	30.85	33.11	29.88
Distribution by age group
20–29 years	30	6 (33.33)	24 (57.14)
30–39 years	21	9 (50)	12 (28.57)
40–45 years	9	3 (16.67)	6 (14.29)

Table 2. Subjects showing seroconversion in HAI and MN tests, vaccine and placebo recipients.

	HAI	MN
Vaccine group	No.	% (95% CI)	No.	% (95% CI)
A/H1N1	25	83.33 (65.28–94.36)	25	83.33 (65.28; 94.36)
A/H3N2	23	76.67 (57.72– 90.07)	21	70 (50.60; 85.27)
B	21	70 (50.60–85.27)	16	53.33 (34.33; 71.66)
Placebo group
A/H1N1	0	0 (0–11.57)	2/30	6.67 (0.82–22.07)
A/H3N2	0	0 (0–11.57)	0/30	0 (0–11.57)
B	0	0 (0–11.57)	2/30	6.67 (0.82–22.07)

Table 3. Subjects with seroprotection, by HAI and MN tests, vaccine and placebo recipients.

	HAI	MN
Vaccine group	No.	% (95% CI)	No.	% (95% CI)
A/H1N1	30	100 (88.43–100)	28	93.33 (77.93–99.18)
A/H3N2	30	100 (88.43–100)	26	86.67 (69.28–96.24)
B	26	86.67 (69.28–96.24)	30	100 (88.43–100)
Placebo group
A/H1N1	10	33.33 (17.29–52.81)	16	53.33 (34.33–71.66)
A/H3N2	19	63.33 (43.86–80.07)	10	33.33 (17.29–52.81)
B	5	16.67 (5.64–34.72)	24	80.00 (61.43–92.29)

Table 4. GMT antibody response to influenza H1, H3 and B antigens, by HAI and MN tests, vaccine and placebo groups.

	A/H1N1		A/H3N2		B
	GMT (95% CI)		GMT (95% CI)		GMT (95% CI)
	HAI	MN	HAI	MN	HAI	MN
Vaccine group
Day 1	15.97 (11.03–23.1)	24.06(18.61–1.11)	37.75(25.88–55.07)	18.02(12.74–25.51)	10.47(7.91–13.86)	80.93(59.21–110.61)
Day 22	295.14(240.1–362.8)	211.12(164.95–270.22)	439.67(320.54–603.06)	125.53(87.82–179.45)	75.95(56.88–101.4)	331.28(278.78–393.68)
Fold increase	18.49(12.22–27.95)	8.77(6.7–11.4)	11.65(7.82–17.35)	6.96(4.89–9.92)	7.25(5.53–9.52)	4.09(3.11–5.38)
Placebo
Day 1	21.19(14.82–30.29)	31.75(24.06–41.89)	41.41(28.02–61.2)	19.77(15.11–25.86)	10.72(7.72–14.89)	70.45(48.06–103.28)
Day 22	22.32(15.72–31.69)	40(30.47–52.52)	42.87(28.92–63.55)	24.34(18.39–32.22)	10.66(7.69–14.76)	105.56(75.73–147.15)
Fold increase	1.05(1–1.11)	1.26(1.09–1.45)	1.04(0.99–1.08)	1.23(1.14–1.33)	0.99(0.96–1.03)	1.5(1.18–1.89)

Table 5. Solicited symptoms in the 7-day period after immunization with Torlak seasonal influenza vaccine.

		Placebo								Vaccine
		None		Mild		Moderate		Severe		None		Mild		Moderate		Severe
		n	%	n	%	n	%	n	%	n	%	n	%	n	%	n	%
Local	Hardness*	30	100	0	0	0	0	0	0	28	93	2	7	0	0	0	0
	Pain	26	87	4	13	0	0	0	0	16	53	12	40	2	7	0	0
	Redness*	30	100	0	0	0	0	0	0	24	80	6	20	0	0	0	0
	Swelling*	30	100	0	0	0	0	0	0	28	93	2	7	0	0	0	0
	Temperature >37°*	29	97	1	3	0	0	0	0	28	93	2	7	0	0	0	0
	Tenderness	29	97	1	3	0	0	0	0	20	66.7	8	26.7	2	6.7	0	0
Systemic	Chills	30	100	0	0	0	0	0	0	28	93	2	7	0	0	0	0
	Headache	28	93	2	7	0	0	0	0	25	83	4	13	1	3	0	0
	Joint Aches	28	93	2	7	0	0	0	0	29	97	1	3	0	0	0	0
	Muscle Aches	29	97	1	3	0	0	0	0	28	93	1	3	1	3	0	0
	Nausea	30	100	0	0	0	0	0	0	28	93	2	7	0	0	0	0
	Tiredness	30	100	0	0	0	0	0	0	25	83	3	10	2	7	0	0
	Vomiting	30	100	0	0	0	0	0	0	29	97	1	3	0	0	0	0

* Hardness, Redness, Swelling and Temperature >37° if any are categorized as Mild.

Severity ratings: mild – noticeable but with no effect on activities, moderate – interferes with daily activities, severe – adverse events prevent daily activities.