Safety, Tolerability, and Immunogenicity of Pentavalent Rotavirus Vaccine Manufactured by a Modified Process
This article, published in the Pediatric Infectious Disease Journal, describes the results of a Phase 3 study of a modified formulation of RotaTeq® (RV5) rotavirus vaccine that was developed to be stable at 37°C for 7 days and that has an extended expiration (36 months) when stored at 2°C to 8°C. The trial found that the modified formulation had comparable safety and immunogenicity profiles as the currently licensed RV5 vaccine. A vaccine that is stable at room temperature may be more convenient for vaccinators, particularly in places where the cold chain is unreliable.
Author: Martinón-Torres F, Dionne M, Greenberg D, et al.
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Citation: Martinón-Torres F, Dionne M, Greenberg D, et al. Safety, Tolerability, and Immunogenicity of Pentavalent Rotavirus Vaccine Manufactured by a Modified Process. Pediatric Infectious Disease Journal. 2017;Early Online Publication.
Resource types: Peer-reviewed journal