Statistics in Clinical Vaccine Trials

This book offers training and expertise on the statistical analysis of data from clinical vaccine trials, i.e., immunogenicity and vaccine field efficacy studies. With many worked-out real-life examples, its scope is more practical than theoretical.

• First comprehensive text on the current state of the statistical methodology for clinical vaccines trials - Many worked-out real-life examples - SAS codes for the more complex examples provided

  Inhalt
  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.