Statistics in Clinical Vaccine Trials
โ Jozef Nauta (auth.)
๐ Library
๐
2011
๐ Springer-Verlag Berlin Heidelberg
๐ English
โฆ LIBER โฆ
๐
Statistics in Clinical Vaccine Trials
โ Scribed by Jozef Nauta (auth.)
- Publisher
- Springer-Verlag Berlin Heidelberg
- Year
- 2011
- Tongue
- English
- Leaves
- 164
- Edition
- 1
- Category
- Library
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โฆ Synopsis
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.
โฆ Table of Contents
Front Matter....Pages i-xviii
Basic Concepts of Vaccine Immunology....Pages 1-12
Humoral and Cellular Immunity....Pages 13-17
Standard Statistical Methods for the Analysis of Immunogenicity Data....Pages 19-46
Antibody Titres and Two Types of Bias....Pages 47-55
Adjusting for Imbalance in Pre-Vaccination State....Pages 57-65
Vaccine Equivalence and Noninferiority Immunogenicity Trials....Pages 67-84
Vaccine Field Efficacy Trials....Pages 85-106
Correlates of Protection....Pages 107-116
Safety of Vaccines....Pages 117-129
Back Matter....Pages 131-153
โฆ Subjects
Statistics, general
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