Table 4.

Vibriocidal antibody titers and proportion of ≥ 4-fold rise from baseline GMT to V. cholerae (include O1 Inaba, O1 Ogawa, and O139) in children

Children (aged 1–5 years)		O1 Inaba			O1 Ogawa			O139
		Vaccine group (N = 17)	Placebo group (N = 17)	P value	Vaccine group (N = 16)	Placebo group (N = 17)	P value	Vaccine group (N = 16)	Placebo group (N = 17)	P value
Baseline	GMT	3.5	5	0.63	3.4	4.3	0.71	1.25	1.25	–
14 days after first vaccine dose	GMT	25.5	5.8	0.06	91.1	4.3	< 0.001	10	1.25	< 0.001
	GMF* rise	7.4	1.2	< 0.001	26.9	1.0	< 0.001	8	1.00	< 0.001
	No. seroconverted† (%)	11 (65)	1 (6)	< 0.001	12 (75)	2 (11)	< 0.001	7 (44)	0	0.002
14 days after second vaccine dose	GMT	15	7.4	0.38	73.4	4.1	< 0.001	6.4	1.25	0.01
	GMF* rise	4.3	1.5	0.07	21.7	1	< 0.001	5.1	1	0.01
	No. seroconverted† (%)	9 (53)	2 (11)	0.008	12 (75)	1 (6)	< 0.001	6 (37)	–	0.006
Children (aged 6–17 years)		O1 Inaba			O1 Ogawa			O139
		Vaccine group (N = 36)	Placebo group (N = 36)	P value	Vaccine group (N = 29)	Placebo group (N = 36)	P value	Vaccine group (N = 33)	Placebo group (N = 35)	P value
Baseline	GMT	8.3	11	0.58	4.7	9.3	0.18	1.8	1.8	0.94
14 days after first vaccine dose	GMT	302	14.7	< 0.001	184.7	10	< 0.001	22.2	1.8	< 0.001
	GMF* rise	36.6	1.3	< 0.001	39.7	1.1	< 0.001	12.2	1	< 0.001
	No. seroconverted† (%)	28 (78)	3 (8)	< 0.001	24 (83)	2 (6)	< 0.001	19 (58)	1 (3)	< 0.001
14 days after second vaccine dose	GMT	269.1	16.2	< 0.001	208.1	9.1	< 0.001	11.8	2.1	< 0.001
	GMF* rise	32.6	1.5	< 0.001	44.7	1	< 0.001	6.5	1.2	< 0.001
	No. seroconverted† (%)	32 (89)	4 (11)	< 0.001	26 (90)	2 (6)	< 0.001	15 (45)	3 (9)	< 0.001

GMT = geometric mean titers.

^*Geometric mean fold rise from baseline to 14 days after first dose or from baseline to 14 days after second dose.

^†Number with ≥ 4-fold rise in titers from baseline to 14 days after first dose or from baseline to 14 days after second dose.