Recommendations Part C: Clinical evaluation of group C meningococcal conjugate vaccines, Annex 3, TRS No 963

Overview

Recommendations for the production and control of meningococcal group  C conjugate vaccines (1) were adopted by the Expert Committee on Biological Standardization at its fifty-second meeting in 2001. On that occasion, the Committee recommended the development of guidance on evaluation of immune responses to these vaccines. In response to this, an addendum devoted to the evaluation of the immunogenicity of group C meningococcal conjugate vaccines was prepared and adopted by the Committee at its fifty-third meeting in 2003 (2).

Following adoption of the Recommendations to assure the quality, safety and efficacy of group  A meningococcal conjugate vaccines in October 2006, a need to update the Recommendations provided in the Annex 3 of the report of the fifty-third meeting (2), was identified.

The aim of this document is to provide more detailed recommendations, updated according to the new data on immunogenicity and effectiveness of group C meningococcal (MenC) conjugate vaccines that have become available since 2003. This document should be read in conjunction with the Annex 2 of the TRS 924. The establishment of this document will lead to discontinuation of Addendum 2003 to Annex 3 of the TRS 926.

Full version of the WHO Technical Report Series N° 963