Guidelines on clinical evaluation of vaccines: regulatory expectations

Overview

These WHO Guidelines are intended to replace the WHO Guidelines on clinical evaluation of vaccines: regulatory expectations, which were adopted by the Expert Committee on Biological Standardization in 2001 (1). The document of 2001 provided guidance on the clinical evaluation of vaccines as well as on WHO vaccine prequalification.

Since 2001, more than 20 vaccine-specific documents (each including a section on clinical evaluation) have been adopted by the Committee. Originally intended to be read in conjunction with the 2001 document, these documents provide guidance on both oral and inactivated polio vaccines, whole cell pertussis and acellular pertussis vaccines, meningococcal conjugate vaccines for serotypes A and C, and pneumococcal conjugate vaccines, as well as on vaccines intended to prevent diseases caused by rotaviruses, dengue viruses, human papillomaviruses (HPVs) and malaria parasites.

These revised WHO Guidelines have been prepared to reflect the scientific and regulatory experience that has been gained from vaccine clinical development programmes since the adoption of the 2001 version. They are intended for use by national regulatory authorities (NRAs), companies developing and holding licences for vaccines, clinical researchers and investigators. The document takes into account the content of clinical development programmes, clinical trial designs, the interpretation of trial results and post-licensing activities.