Vaccine Equivalence and Noninferiority Immunogenicity Trials

Jozef Nauta ()
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Jozef Nauta: Global Statistics, Solvay Pharmaceuticals

Chapter Chapter 6 in Statistics in Clinical Vaccine Trials, 2011, pp 67-84 from Springer

Abstract: Abstract Many vaccine immunogenicity trials are conducted in an equivalence or noninferiority framework. The objective of such trials is to demonstrate that the immunogenicity of an investigational vaccine is comparable or not less than that of a control vaccine. Four types of vaccine equivalence and noninferiority designs can be distinguished: vaccine bridging trials, combination vaccine trials, vaccine concomitant use trials and vaccine lot consistency trials. In this chapter the statistical analysis of the data of such trials is covered, both for trials with a geometric mean response as endpoint and trials with seroprotection or seroconversion as endpoint. The standard analysis of lot consistency data is known to be conservative, but a simple formula is presented which can be used to decide if the lot sample sizes guarantee that the actual type I error rate of the trial is sufficiently close to the nominal level. The chapter is concluded with a discussion of sample size estimation for vaccine equivalence and noninferiority trials, including lot consistency trials. Recommendations are given how to avoid that the statistical power is overestimated.

Keywords: Sample Size Estimation; Equivalence Trial; Combination Vaccine; Equivalence Range; Superiority Trial (search for similar items in EconPapers)
Date: 2011
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DOI: 10.1007/978-3-642-14691-6_6

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