Overcoming the need for a cold chain with conjugated meningococcal Group C vaccine: A controlled, randomized, double-blind study in toddlers on the safety and immunogenicity of Menjugate, stored at room temperature for 6 months

Vaccine. 2007 Jan 26;25(7):1175-82. doi: 10.1016/j.vaccine.2006.10.022. Epub 2006 Oct 27.

Abstract

Millions of vaccine doses are wasted each year due to a lapse in recommended storage conditions. Maintaining the cold chain for vaccines is both expensive and difficult, especially in developing countries. The present study investigated the safety and immunogenicity of a single dose of the conjugated meningococcal Group C vaccine, Menjugate, stored for 6 months at room temperature (25+/-2 degrees C, N=250) or at 2-8 degrees C (N=250) when administered to 12-23 months toddlers. In the two respective groups, 87 and 88% of toddlers reached bactericidal antibodies titers of at least 1:8. The immunogenicity of Menjugate stored at room temperature was not inferior to that stored at 2-8 degrees C. The safety profile and immunogenicity of the vaccine was not influenced by the storage condition.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Antibodies, Bacterial / analysis
  • Antibodies, Bacterial / biosynthesis
  • Cold Temperature
  • Double-Blind Method
  • Drug Stability
  • Drug Storage
  • Female
  • Freeze Drying
  • Humans
  • Infant
  • Male
  • Meningococcal Vaccines / adverse effects
  • Meningococcal Vaccines / chemistry
  • Meningococcal Vaccines / immunology*
  • Neisseria meningitidis, Serogroup C / immunology*
  • Temperature
  • Vaccines, Conjugate / adverse effects
  • Vaccines, Conjugate / chemistry
  • Vaccines, Conjugate / immunology

Substances

  • Antibodies, Bacterial
  • Meningococcal Vaccines
  • Vaccines, Conjugate