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

Vaccine. 2001 Apr 6;19(20-22):2924-31. doi: 10.1016/s0264-410x(00)00528-4.

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.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase II
  • Clinical Trial, Phase III
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Antibodies, Bacterial / blood
  • Female
  • Humans
  • Immunoglobulin G / blood
  • Infant
  • Male
  • Meningococcal Vaccines / adverse effects
  • Meningococcal Vaccines / immunology*
  • Neisseria meningitidis / classification
  • Neisseria meningitidis / immunology*
  • Serotyping
  • Vaccines, Conjugate / adverse effects
  • Vaccines, Conjugate / immunology*

Substances

  • Antibodies, Bacterial
  • Immunoglobulin G
  • Meningococcal Vaccines
  • Vaccines, Conjugate
  • serogroup C meningococcal conjugate vaccine