Adjuvants in vaccines for human use - Scientific guideline

This document addresses the quality, non-clinical and clinical issues arising from the use of new or established adjuvants in vaccines. The applicability of this guideline to established adjuvants will vary on case-by-case basis. Adjuvants that are given separately and/or at a different time point from the vaccine antigens are not considered to be adjuvants and are called immunomodulators. Read together with the Explanatory note on immunomodulators

Keywords: Immunomodulators, adjuvants, vaccines