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Abstract
The introduction of meningococcal C conjugate (MCC) vaccine in the UK in November
1999 as a routine 3 dose infant immunisation course, with a single catch-up dose for
all children aged between 12 months and 17 years, was the result of an intensive 5
year collaborative research programme funded by the Department of Health for England
and involving public bodies, academia and vaccine manufacturers. The research programme
established the safety and immunogenicity of MCC vaccines in infants, toddlers, pre-school
and school-aged children. The nature and frequency of common adverse events in school-aged
children was similar to that after a booster dose of diphtheria and tetanus vaccine
given to the same age groups. The recommendation that a single dose was adequate for
children aged 12 months and above was based on antibody levels measured by serum bactericidal
assay and evidence of induction of immunological memory as shown by maturation of
antibody avidity. Licensure by the Medicines Control Agency was based on serological
criteria alone without direct evidence of efficacy and has set a precedent for other
meningococcal conjugate polysaccharide vaccines. Vaccine coverage of around 85% was
achieved in the targeted age groups and has resulted in a drop in the incidence of
serogroup C disease in these groups of over 80% within 18 months of the start of the
vaccination programme. Early post-licensure efficacy estimates for toddlers and teenagers
(88 and 96%, respectively, in the first 16 months after vaccination) validate the
serological criteria used for licensure. Surveillance of the prevalent serogroups
and serosubtypes among invasive case isolates has shown no evidence of any capsular
switching to serogroup B during the first 18 months of the MCC vaccination programme.