Control and lot release of meningococcal group C conjugate vaccines

Abstract

Meningococcal group C conjugate vaccines were first introduced to the UK in 1999. To date, the vaccines have been demonstrated to have an efficacy of approximately 90% and have since been adopted by other countries worldwide. The development of control tests used for lot release of meningococcal group C vaccines has been based on those used for Haemophilus influenzae type b conjugates, the key criteria being measurement of free saccharide and conjugate integrity by physicochemical means. In future, meningococcal group C vaccines are likely to be replaced by multivalent formulations containing different components in combination. This will present a new challenge for regulatory authorities and more extensive testing will be required to ensure vaccine safety and efficacy.

• control
• high performance anion exchange chromatography with pulsed amperometric detection
• lot-release
• meningococcal group C conjugate vaccine
• nuclear magnetic resonance spectroscopy
• size exclusion chromatography