TABLE 2.

Conformance of the parameters of the HI antibody (horse RBCs and chicken RBCs) response to the second vaccination (Day 42) with the three immunogenicity criteria of the guideline

Point estimate (95%CI)	Phase II								Phase III
	MA group		HA group		MB group		HB group		MA group
Number of subjects	60		59		61		60		364
Horse red blood cells
Seroconversion rate >40%	100.0% (94.0%‐100.0%)	*	100.0% (93.9%‐100.0%)	*	100.0% (94.1%‐100.0%)	*	98.3% (91.1%‐100.0%)	*	100.0% (99.0‐100.0)	*
					28.56 (24.69‐33.04)
Geometric mean fold rise >2.5	33.90 (28.82‐39.88)	*	40.48 (34.39‐47.64)	*		*	30.55 (25.44‐36.70)	*	43.73 (41.15‐46.47)	*
					(24.69‐33.04) 100.0% (94.1%‐100.0%)
Seroprotection rate >70%	100.0% (94.0%‐100.0%)	*	100.0% (93.9%‐100.0%)	*		*	98.3% (91.1%‐100.0%)	*	100.0% (99.0‐100.0)	*
GMT	169.5 (144.1‐199.4)		202.4 (171.9‐238.2)		142.8 (123.5‐165.2)		152.8 (127.2‐183.5)		220.3 (207.3‐234.1)
Chicken red blood cells
Seroconversion rate >40%	55.0% (41.6%‐67.9%)	*	64.4% (50.9%‐76.4%)	*	39.3% (27.1%‐52.7%)		56.7% (43.2%‐69.4%)	*	‐
Geometric mean fold rise >2.5	6.20 (4.84‐7.96)	*	7.37 (5.80‐9.36)	*	4.38 (3.54‐5.42)	*	6.20 (4.93‐7.81)	*	‐
Seroprotection rate >70%	55.0% (41.6%‐67.9%)		64.4% (50.9%‐76.4%)		39.3% (27.1%‐52.7%)		56.7% (43.2%‐69.4%)		‐
GMT	31.0 (24.2‐39.8)		37.3 (29.4‐47.2)		21.9 (17.7‐27.1)		31.0 (24.6‐39.1)		‐

Strain measured: A/Indonesia/05/2005(H5N1). Vaccine strain: A/Indonesia/05/2005(H5N1). Subjects analyzed: a group of subjects who was collected blood after the second vaccination. Confidence interval (seroconversion rate, seroprotection rate):lower limit and upper limit of the exact 95% two‐sided confidence interval based on F‐distribution. Confidence interval (rate of change in GMT): lower limit and upper limit of the 95% two‐sided confidence interval based on Student's t‐distribution. MA group; 3.75 μg HA + AS03. HA group; 7.5 μg HA + AS03. MB group; 3.75μg HA+1/2 AS03. HB group; 7.5μg HA+1/2 AS03.

^*Fulfilled the immunogenicity criteria of the guideline.