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.