Statistics in Clinical Vaccine Trials

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 o...

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Bibliographic Details
Main Author: Nauta, Jozef (Author)
Corporate Author: SpringerLink (Online service)
Format: Electronic eBook
Language:English
Published: Berlin, Heidelberg : Springer Berlin Heidelberg : Imprint: Springer, 2011.
Subjects:
Online Access:Full Text via HEAL-Link
Table of Contents:
  • 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 Single Seroresponse Rate for Which the Confidence Interval Must Fall Above a Pre-Specified Bound.