title: 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.
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.
authors.affiliation: Novartis Vaccines and Diagnostics GmbH & Co. KG, Marburg, Germany. ines_schoendorf@chiron.com
authors.forename: Ines
authors.initials: I
authors.lastname: Schöndorf
authors.forename: Angelika
authors.initials: A
authors.lastname: Banzhoff
authors.forename: Uwe
authors.initials: U
authors.lastname: Nicolay
authors.forename: Francisco
authors.initials: F
authors.lastname: Diaz-Mitoma
mesh_terms: D000907:Antibodies, Bacterial / Q000032:analysis / Q000096:biosynthesis; D003080:Cold Temperature; D004311:Double-Blind Method; D004355:Drug Stability; D004356:Drug Storage; D005260:Female; D005612:Freeze Drying; D006801:Humans; D007223:Infant; D008297:Male; D022401:Meningococcal Vaccines / Q000009:adverse effects / Q000737:chemistry / Q000276:immunology*; D038542:Neisseria meningitidis, Serogroup C / Q000276:immunology*; D013696:Temperature; D018074:Vaccines, Conjugate / Q000009:adverse effects / Q000737:chemistry / Q000276:immunology
chemical_list: D000907:Antibodies, Bacterial; D022401:Meningococcal Vaccines; D018074:Vaccines, Conjugate