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.
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