Table 5.

Anti-LPS Serum IgG titres in vaccine and placebo recipients.

	Flexyn2a				Placebo			Ratio GM Flexyn2a/Placebo
Study Day	N	Median (Range)	GM (95% CI)	% Responder (95% CI)	N	Median (Range)	GM[5] (95% CI)	Ratio (95% CI)	P-Value
Vaccination Phase
Day 0	34	3200 (800–6400)	2172 (1722 – 2740)	N/A	30	1600 (200 - 6400)	1459 (1079 - 1973)	1.5 (1.0 - 2.2)	0.04
Day 7	33	3200 (800 - 25,600)	3133 (2341 - 4193)		30	1600 (200 - 6400)	1493 (1125 - 1981)	2.1 (1.4 - 3.1)	0.0004
Day 28	34	25,600 (800 - 409,600)	23,119 (12,704 - 42,073)	76.5% (58.83% – 89.25%)	30	1600 (200 - 6400)	1563 (1125 - 2173)	14.8 (7.5 - 29.0)	<0.0001
Day 35	32	25,600 (1600 - 409,600)	21,998 (12,180 - 39,731)		30	1600 (400 - 6400)	1493 (1176 - 1896)	14.7 (7.8 - 27.7)	<0.0001
Day 55 (prechallenge)	33	25,600 (800 - 204,800)	19,896 (11,951 - 33,124)	81.8% (64..54 — 93.02)	30	1600 (200 - 102,400)	1493 (991 - 2249)	13.3 (7.0 - 25.3)	<0.0001
Challenge Phase
Day 59 (3 days postchallenge)	30	25,600 (800 - 409,600)	20,794 (11,627 - 37,188)		29	1600 (200 - 6400)	1454 (1072 - 1973)	14.3 (7.5 - 27.3)	<0.0001
Day 63 (7 days postchallenge)	30	25,600 (1600 - 409,600)	21,280 (12,628 - 35,857)		28	1600 (200 - 6400)	2049 (1419 - 2959)	10.4 (5.6 - 19.4)	<0.0001
Day 84	30	25,600 (1600 - 409,600)	18,958 (11,164 - 32,192)		28	3200 (800 - 25,600)	3805 (2609 - 5551)	5.0 (2.6 - 9.4)	<0.0001

The anti-LPS serum IgG titres (median, range, geometric mean (GM) and 95% confidence interval (95% CI) by vaccinee or placebo recipient status, and the ratio of the titre of the vaccinees/placebo recipients. The percent (%) responder by serum IgG (4-fold or greater increase in serum IgG) titre after vaccination. N=number.

The ratios of GMT and corresponding 95% CI's between treatment groups were compared by Student's t-test of log₁₀-transformed values.