Safety and immunogenicity of three lots of meningococcal serogroup C conjugate vaccine administered at 2, 3 and 4 months of age

The reactogenicity and immunogenicity of meningococcal serogroup C conjugat e (MenC) vaccine was assessed in 322 infants vaccinated at 2, 3, and 4 mont hs of age, with concomitant administration of mixed diphtheria-tetanus-whol e-cell pertussis vaccine and Haemophilus influenzae type b conjugate vaccin e (DTwP-Hib) and oral polio vaccine. All infants in whom post-vaccination m eningococcal C anticapsular Ige levels were assayed (n = 265) attained grea ter than or equal to 2 mug ml(-1). Serum bactericidal titres were assayed f or a proportion of subjects (n = 171), 98% of whom obtained a reciprocal ti tres greater than or equal to 8. Local reactions were less frequent at the MenC injection site than at the DTP-Hib site. Systemic events were frequent , but consistent with established DTwP-Hib experience. The study demonstrat es that MenC vaccine is immunogenic and well tolerated in infants at manufa cturing scale production levels. (C) 2001 Elsevier Science Ltd. All rights reserved.