Table 3.

 Antibody responses in phase I clinical trial

	CHMP acceptance criteria	Hemagglutinin dose
		1·7 μg		5 μg		15 μg
		SC (n = 19)	IM (n = 20)	SC (n = 20)	IM (n = 20)	SC (n = 19)	IM (n = 20)
Day 21 (one vaccination)
GMT	No standard	6·6	5·7	7·8	12·7	14·1	16·8
Mean geometric increase (ratio day 21/day 0 GMT)	>2·5×	1·3×	1·1×	1·6×	2·5×	2·6×	3·4×
Significant increase in titers (≥4×) (%)	>40	5	0	5	25	25	40
Seroprotection rate (titer: ≥40) (%)	>70	5	0	5	25	30	40
Day 42 (two vaccinations)
GMT	No standard	7·3	6·8	10·7	14·6	15·7	20·7
Mean geometric increase (ratio day 42/day 0 GMT)	>2·5×	1·5×	1·4×	2·1×	2·9×	2·9×	4·1×
Significant increase in titers (≥4×) (%)	>40	11	0	15	30	21	45
Seroprotection rate (titer: ≥40) (%)	>70	11	0	15	30	27	45

SC, subcutaneous injection; IM, intramuscular injection; GMT, geometric mean titer; × means times, significance level of bold value: 0.05.