Vaccine Clinical Trials: A Practical Guide to Designing Clinical Trials in the Development of Vaccines for Infectious Diseases

This open access book helps to understand how to design and plan clinical development of new vaccines. The book covers prospective clinical trials at all stages of development, with the target being regulatory approval and market placement, whether for profit or non-profit.  Two sections are included, the first covering general principles of vaccine clinical trials and the second covering clinical trials on specific types of vaccines.  For the second section the focus is on vaccines particularly well known to the editors so that broad principles can be illustrated. Vaccine Clinical Trials offers an insight for those who are new to vaccine development in industry as well as governmental and non-governmental organisations. It helps them understand how to design and plan clinical development of new vaccines. For those already active in the vaccine trial field it helps them gain a more integrated view of the process and is of value for those moving to work on new vaccine targets. Whilst written with clinical trial physicians and clinical scientists in mind, it has a broader audience including statisticians, data managers, epidemiologists, pharmacists, medical affairs and pharmacovigilance staff and others. The first section is aimed at people who are very new to vaccine trials and the second is of interest to those moving into the particular areas discussed.