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

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 °C, N = 250) or at 2–8 °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 °C. The safety profile and immunogenicity of the vaccine was not influenced by the storage condition.