Immunogenicity of a human rotavirus vaccine (RIX4414) after storage at 37°C for seven days


The lyophilized formulation of the human rotavirus vaccine, RIX4414 (Rotarix™), is recommended to be stored at 2°C-8°C for optimal immunogenicity. In some settings with inadequate infrastructure for vaccine storage, unforeseen circumstances may cause cold chain breakage, resulting in the vaccine to be left at ambient temperatures. This study evaluated the heat stability of lyophilized RIX4414 vaccine in terms of immunogenicity when stored at tropical room temperature (37°C) for 7 days before reconstitution.