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Clinical Trial
, 19 (20-22), 2924-31

Safety and Immunogenicity of Three Lots of Meningococcal Serogroup C Conjugate Vaccine Administered at 2, 3 and 4 Months of Age

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Clinical Trial

Safety and Immunogenicity of Three Lots of Meningococcal Serogroup C Conjugate Vaccine Administered at 2, 3 and 4 Months of Age

J C Bramley et al. Vaccine.

Abstract

The reactogenicity and immunogenicity of meningococcal serogroup C conjugate (MenC) vaccine was assessed in 322 infants vaccinated at 2, 3, and 4 months of age, with concomitant administration of mixed diphtheria-tetanus-whole-cell pertussis vaccine and Haemophilus influenzae type b conjugate vaccine (DTwP-Hib) and oral polio vaccine. All infants in whom post-vaccination meningococcal C anticapsular IgG levels were assayed (n = 265) attained > or = 2 microg ml(-1). Serum bactericidal titres were assayed for a proportion of subjects (n = 171), 98% of whom obtained a reciprocal titres > or = 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 demonstrates that MenC vaccine is immunogenic and well tolerated in infants at manufacturing scale production levels.

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