Statistics in Clinical Vaccine Trials

AvJozef Nauta

Häftad, Engelska, 2014

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Beskrivning

This monograph offers well-founded training and expertise on the statistical analysis of data from clinical vaccine trials, i.e., immunogenicity and vaccine field efficacy studies. The book's scope is practical rather than theoretical. It opens with two introductory chapters on the immunology of vaccines to provide readers with the necessary background knowledge. It then continues with an in-depth exploration of the statistical methodology. Many real-life examples and SAS codes are presented, making application of the methods straightforward. Topics discussed include maximum likelihood estimation for censored antibody titers, ANCOVA for antibody values, analysis of equivalence and non-inferiority immunogenicity trial data, analysis of data from vaccine field efficacy trials (including data from studies with recurrent infection data), fitting protection curves to data of challenge or field efficacy studies, and the analysis of vaccine safety data.

Produktinformation

Utgivningsdatum:2014-10-01
Mått:155 x 235 x undefined mm
Vikt:271 g
Format:Häftad
Språk:Engelska
Antal sidor:153
Upplaga:2011
Förlag:Springer-Verlag Berlin and Heidelberg GmbH & Co. KG
ISBN:9783642441912

Utforska kategorier

Matematisk statistik inom Naturvetenskap och teknik

Recensioner i media

From the book reviews: "The presentation of the book is lucid. The author is to be congratulated for mixing his vast practical experience with his knowledge to make this book readable and practically valuable." (Subir Ghosh, Technometrics, Vol. 55 (3), August, 2013)

Innehållsförteckning

Basic Concepts of Vaccine Immunology.- Humoral and Cellular Immunity.- Standard Statistical Methods for the Analysis of Immunogenicity Data.- Antibody Titres and Two Types of Bias.- Adjusting for Imbalance in Pre-vaccination State.- Vaccine Equivalence and Non-Inferiority Immunogenicity Trials.- Vaccine Field Efficacy Trials.- Correlates of Protection.- Safety of Vaccines.- Appendices: SAS and Floating Point Format for Calculated Variables.- Closed-Form Solutions for the Constrained ML Estimators Ro.- Simulation Results on Jewell’s Correction for the Rate Ratio.- Proof of Inequality.- A Generalized Worst-Case Sensitivity Analysis for a SingleSeroresponse Rate for Which the Confidence Interval Must Fall Above a Pre-Specified Bound.