Jozef Nauta Nauta Statistics in Clinical Vaccine Trials

Statistics in Clinical Vaccine Trials

von Jozef Nauta

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Beschreibung

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.

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.


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.
- 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
- 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

Autor*in

Jozef Nauta

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Clinical Trials Clinical Trials Statistics Statistics Vaccines Vaccines

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Details

ISBN: 9783642146909
Verlag: Springer Berlin
Erscheinung: 24.10.2010

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