Clinical evaluation of new vaccines - Scientific guideline

This document covers the clinical evaluation of vaccines for pre- and post-exposure prophylaxis against infectious diseases. It is primarily intended to assist applicants and competent authorities to design, and evaluate data from, appropriate clinical development programmes. It addresses studies to be performed during the clinical development of new vaccines. Read together with the summary of product characteristics requirements

Keywords: Vaccines, humoral immune response, cellular immune response, vaccination schedule, immunogeicity studies, protective efficacy, effectiveness, safety, summary of product characteristics (SmPC) requirements