The ORVAC trial: a phase IV, double-blind, randomised, placebo-controlled clinical trial of a third scheduled dose of Rotarix rotavirus vaccine in Australian Indigenous infants to improve protection against gastroenteritis: a statistical analysis plan

Table 3 Type I error rates for null configurations

Parameters		Accrual per 3 months	Info. delay	Samp. size mean (SD)	Type I error rate
Median time to event	Prob. Seroconv.				Clinical	Immuno
50	0.7	50	0.7	259 (259.2)	0.036	0.032
50	0.7	30	0.7	247 (238.4)	0.041	0.028
50	0.7	50	0.5	264 (266.3)	0.039	0.030
50	0.7	30	0.5	252 (244.8)	0.043	0.032
50	0.4	50	0.7	261 (262.2)	0.033	0.031
50	0.4	30	0.7	247 (238.6)	0.042	0.029
50	0.4	50	0.5	259 (260.4)	0.037	0.028
50	0.4	30	0.5	248 (242.2)	0.042	0.032
50	0.1	50	0.7	256 (254.9)	0.031	0.031
50	0.1	30	0.7	247 (237.7)	0.038	0.032
50	0.1	50	0.5	259 (259.0)	0.036	0.031
50	0.1	30	0.5	246 (239.2)	0.040	0.032
35	0.7	50	0.7	253 (253.5)	0.034	0.030
35	0.7	30	0.7	245 (236.8)	0.039	0.029
35	0.7	50	0.5	260 (259.0)	0.040	0.030
35	0.7	30	0.5	247 (239.6)	0.043	0.034
35	0.4	50	0.7	264 (263.3)	0.039	0.031
35	0.4	30	0.7	246 (237.6)	0.043	0.031
35	0.4	50	0.5	262 (262.8)	0.038	0.030
35	0.4	30	0.5	247 (237.9)	0.042	0.030
35	0.1	50	0.7	259 (256.7)	0.033	0.031
35	0.1	30	0.7	246 (238.4)	0.035	0.035
35	0.1	50	0.5	259 (258.9)	0.036	0.028
35	0.1	30	0.5	242 (231.9)	0.038	0.030
20	0.7	50	0.7	264 (261.5)	0.037	0.028
20	0.7	30	0.7	244 (233.4)	0.038	0.027
20	0.7	50	0.5	260 (259.1)	0.041	0.029
20	0.7	30	0.5	247 (235.8)	0.043	0.027
20	0.4	50	0.7	258 (256.9)	0.036	0.030
20	0.4	30	0.7	246 (236.9)	0.041	0.029
20	0.4	50	0.5	262 (263.4)	0.040	0.029
20	0.4	30	0.5	248 (237.6)	0.044	0.030
20	0.1	50	0.7	257 (250.7)	0.034	0.031
20	0.1	30	0.7	244 (233.6)	0.035	0.029
20	0.1	50	0.5	256 (254.4)	0.036	0.033
20	0.1	30	0.5	242 (231.1)	0.038	0.032

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