A randomised, double-blind, controlled trial of the immunogenicity and tolerability of a meningococcal group C conjugate vaccine in young British infants

A double-blind, randomised, controlled trial was conducted in 248 British i nfants to assess the immunogenicity and tolerability of three doses of a me ningococcal group C/CRM197 conjugate vaccine (Lederle Laboratories, USA) gi ven at 2, 3 and 4 months. Control children received three doses of Hepatiti s B vaccine (Engerix B(R); SmithKline Beecham). At 5 months of age, 100% of children receiving the conjugate vaccine had specific immunoglobulin G con centrations > 2.0 mug/ml (n = 116) compared with only 4% of control childre n (n = 121). Those receiving the conjugate also had 2.5- and 1.6-fold highe r geometric mean concentrations of PRP and diphtheria antibodies, respectiv ely. The vaccine was well tolerated. (C) 2000 Elsevier Science Ltd. All rig hts reserved.