Clinical evaluation of new vaccines - Scientific guideline

This guideline addresses the clinical evaluation of vaccines intended for the prevention of infectious diseases. It includes considerations for trials intended to document the safety, immunogenicity and efficacy of new candidate vaccines and to support changes in the prescribing information of licensed vaccines. It also considers the need for and use of vaccine effectiveness studies.

Keywords: vaccine, antigen, adjuvant, humoral immune response, cellular immune response, vaccination schedule, immunogenicity studies, protective efficacy, effectiveness, safety, immune correlates of protection.