Immunogenicity and safety of a novel seasonal influenza preservative-free vaccine manufactured in Kazakhstan: Results of a randomized, comparative, phase II clinical trial in adults

Figures & data

Figure 1. Flow—diagram of the study.

Table 1. Summary of demographic data.

		Vaccine VAXIGRIP® (N = 50) n (%)		Vaccine RIBSP (N = 100) n (%)
Variable		Female	Male	Female	Male
Gender (n (%))		30 (60.0)	20 (40.0)	47 (47.0)	53 (53.0)
Age	Mean (SD)	29.96 (13.03)	26.0 (9.19)	28.76 (11.38)	33.32 (12.34)
Height (cm)	Mean (SD)	162.53 (5.2)	174.21 (8.0)	161.8 (6.7)	174.98 (5.4)
Weight (kg)	Mean (SD)	57.85 (10.09)	75.26 (10.73)	60.60 (11.16)	75.32 (10.57)

Table 2. Seroconversion and seroprotection rates in two vaccinated groups.

Group	Day	A/H1N1 virus, %	A/H3N2 virus, %	B virus, %
RIBSP vaccine (n = 100)
Seroconversion [95% CI]	Day 21	87.0 [79.0–92.2]	63.0 [53.2–71.8]	59.0 [49.2–68.1]
Mean GMT increase	Day 21	23.3	4.4	4.5
Seroprotection [95% CI]	Day 1	30.0 [21.9–39.6]	33.0 [24.6–42.7]	34.0 [25.5–43.7]
	Day 21	95.0 [88.8–97.8]	84.0 [75.6–89.9]	80.0 [71.1–86.7]
Mean GMT	Day 1	17.1	17.4	16.9
	Day 21	396.7	77.3	76.7
VAXIGRIP® (n = 50)
Seroconversion [95% CI]	Day 21	80.0 [67.0–88.8]	60.0 [46.2–72.4]	56.0 [42.3–68.8]
Mean GMT increase	Day 21	13.4	5.2	4.4
Seroprotection [95% CI]	Day 1	36.0 [24.1–49.9]	32,0 [20.8–45.8]	34.0 [22.4–47.8]
	Day 21	96.0 [86.5–98.9]	88.0 [76.2–94.4]	80.0 [67.0–88.8]
Mean GMT	Day 1	18.9	17.7	19.7
	Day 21	256.3	72.6	65.9
Comparison of sample rate (%) on the 21^st day (F-criterion)		Р = 1.00	Р = 0.63	Р = 1.00

Table 3. Adverse events within 21 days after vaccination.

Events	RIBSP Vaccine (N = 100)	VAXIGRIP® Vaccine (N = 50)
AE within 2 hours
Local AE
Induration at the injection site	2 (2%)	2 (4%)
Hyperimia at the injection site	2 (2%)	—
Oedema at the injection site	2 (2%)	—
Painfulness at the injection site	1 (1%)	—
Number of subjects experiencing AE	3 (3%)	2 (4%)
AE within 7 days
Local AE
Induration at the injection site	3 (3%)	2 (4%)
Hyperimia at the injection site	3 (3%)	1 (2%)
Oedema at the injection site	2 (2%)	–
Painfulness at the injection site	2 (2%)	1 (2%)
Number of subjects experiencing AE	5 (5%)	2 (4%)
AE according to self-observation diaries within 8–20 days
Local AE	–	–
Systemic AE
Headache	3 (3%)	2 (4%)
Sore throat	2 (2%)	3 (6%)
Runny nose	3 (3%)	2 (4%)
Cough	2 (2%)	3 (6%)
Dizziness	1 (1%)	—
Fever	1 (1%)	1 (2%)
Stomach upset	1 (1%)	—
Number of subjects experiencing AE	10 (10%)	6 (12%)
Changes of laboratory values
Biochemical blood analysis	15 (15%)	7 (14%)
Clinical blood analysis	15 (15%)	10 (20%)
Number of subjects experiencing AE	29 (29%)	13 (26%)