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Statistics in Clinical Vaccine Trials

  • Book
  • © 2011

Overview

Authors:
  1. Jozef Nauta

    1. , Global Statistics, Solvay Pharmaceuticals, Weesp, Netherlands

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  • 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
  • Includes supplementary material: sn.pub/extras

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Table of contents (9 chapters)

  1. Front Matter

    Pages i-xviii
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  2. Basic Concepts of Vaccine Immunology

    • Jozef Nauta
    Pages 1-12

  3. Humoral and Cellular Immunity

    • Jozef Nauta
    Pages 13-17

  4. Standard Statistical Methods for the Analysis of Immunogenicity Data

    • Jozef Nauta
    Pages 19-46

  5. Antibody Titres and Two Types of Bias

    • Jozef Nauta
    Pages 47-55

  6. Adjusting for Imbalance in Pre-Vaccination State

    • Jozef Nauta
    Pages 57-65

  7. Vaccine Equivalence and Noninferiority Immunogenicity Trials

    • Jozef Nauta
    Pages 67-84

  8. Vaccine Field Efficacy Trials

    • Jozef Nauta
    Pages 85-106

  9. Correlates of Protection

    • Jozef Nauta
    Pages 107-116

  10. Safety of Vaccines

    • Jozef Nauta
    Pages 117-129

  11. Back Matter

    Pages 131-153
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Keywords

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.

Authors and Affiliations

  • , Global Statistics, Solvay Pharmaceuticals, Weesp, Netherlands

    Jozef Nauta

Bibliographic Information

  • Book Title: Statistics in Clinical Vaccine Trials

  • Authors: Jozef Nauta

  • DOI: https://doi.org/10.1007/978-3-642-14691-6

  • Publisher: Springer Berlin, Heidelberg

  • eBook Packages: Mathematics and Statistics, Mathematics and Statistics (R0)

  • Copyright Information: Springer-Verlag Berlin Heidelberg 2011

  • Softcover ISBN: 978-3-642-44191-2Published: 01 October 2014

  • eBook ISBN: 978-3-642-14691-6Published: 07 October 2010

  • Edition Number: 1

  • Number of Pages: XVIII, 153

  • Topics: Statistics, general

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