Statistics in Clinical Vaccine Trials

  • Jozef┬áNauta

Table of contents

  1. Front Matter
    Pages i-xviii
  2. Jozef Nauta
    Pages 1-12
  3. Jozef Nauta
    Pages 13-17
  4. Jozef Nauta
    Pages 47-55
  5. Jozef Nauta
    Pages 85-106
  6. Jozef Nauta
    Pages 107-116
  7. Jozef Nauta
    Pages 117-129
  8. Back Matter
    Pages 131-153

About this book


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.


Clinical Trials Clinical Trials Statistics Statistics Vaccines Vaccines

Authors and affiliations

  • Jozef┬áNauta
    • 1
  1. 1., Global StatisticsSolvay PharmaceuticalsWeespNetherlands

Bibliographic information