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.

Offers a comprehensive guide to the current state of statistical methods for clinical vaccine trials Shares key insights into the analysis of vaccine field studies, including observational ones Features a wealth of worked-out real-world examples Provides SAS codes

Autorentext

Jozef Nauta is a principal statistician, with more than 25 years of experience in the pharmaceutical industry, and with special interest in the development of influenza vaccines. During his career he has published numerous journal articles on statistics and vaccines. He currently participates in Development of Robust and Innovative Vaccine Effectiveness (DRIVE), a public private partnership that advances European cooperation in influenza vaccine effectiveness studies, funded by, amongst others the Innovative Medicines Initiative (IMI). He lives with his wife and son in Amsterdam, the Netherlands.

Inhalt

1.The Interplay Between Microorganisms and the Immune System.- 2. Analysis of Immunogenicity Data.- 3. Vaccine Field Studies.- 4. Correlates of Protection.- 5. Analysis of Vaccine Safety Data.