Statistics in Clinical Vaccine Trials by Jozef Nauta

Author:Jozef Nauta
Language: eng
Format: epub
Publisher: Springer Berlin Heidelberg, Berlin, Heidelberg

Because the geometric mean titre was not a secondary outcome, no equivalence range for the ratio θ was specified. For illustrative purposes, here, the range 0.67 to 1.5 will be used. The arithmetic means of the log-transformed antibody titres were

The corresponding standard deviations were

giving as value for the pooled standard deviation 2.09. Standard error (6.2) takes the value

Thus, the value for the test statistic is

where 0.41 = loge 1.5. The corresponding P-value, from the t distribution with degrees of freedom, is 0.054. Thus, the null hypothesis that the combination vaccine and the monovalent vaccine are not equivalent with respect to the induced anti-HBs responses cannot be rejected.

The 97.5th percentile of the central t distribution with 531 degrees of freedom is 1.964. Hence, the lower and upper bounds of the two-sided 95% confidence interval for Δ are

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