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- Title
Analysis of studies to evaluate immune response to combination vaccines.
- Authors
Horne, A D; Lachenbruch, P A; Getson, P R; Hsu, H S
- Abstract
The development and evaluation of new combination vaccines is an important public health endeavor. Trials to evaluate these vaccines are customarily designed and analyzed as noninferiority studies. We explain the concept of noninferiority and highlight important issues that can be challenging in the statistical evaluation of these vaccines. Topics covered include end points, hypotheses, and analyses for comparing geometric mean concentrations (or titers) of antibody and proportion of vaccine recipients responding; covariate adjustment; the problem of multiplicity and its impact on sample size; and choice of a meaningful difference to rule out.
- Publication
Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2001, Vol 33 Suppl 4, pS306
- ISSN
1058-4838
- Publication type
Journal Article
- DOI
10.1086/322566