A vaccine that is stable at room temperature may be more convenient for vaccinators, particularly in places where the cold chain is unreliable, and ultimately will permit more widespread use. RV5mp enhances storage requirements while maintaining the immunogenicity and safety profile of the currently licensed RV5. Serum neutralizing antibody responses by country and breast-feeding status were generally consistent with the overall results. With respect to immunogenicity, RV5mp was noninferior compared with RV5. There were no deaths and no vaccine-related serious adverse events in this study. The RV5mp group (n = 505) and RV5 group (n = 509) had comparable safety profiles. Immunogenicity endpoints were (1) serum neutralizing antibody titers to human rotavirus serotypes G1, G2, G3, G4 and P1A and (2) proportion of subjects with a â‰¥3-fold rise from baseline for serum neutralizing antibody to human rotavirus serotypes G1, G2, G3, G4 and P1A and serum antirotavirus immunoglobulin A. To maintain blinding, both vaccine formulations were stored refrigerated at 2-8Â☌ for the duration of the study. This study ( identifier: NCT01600092 EudraCT number: 2012-001611-23) evaluated the safety, tolerability and immunogenicity of RV5mp versus the currently marketed RV5 in infants. A modified formulation of RV5 (RV5mp) has been developed with stability at 37Â☌ for 7 days and an expiry extended to 36 months when stored at 2-8Â☌. The current formulation of pentavalent rotavirus vaccine (RV5) must be stored refrigerated at 2-8Â☌. Rotavirus is the leading cause of severe diarrhea in infants and young children.

MartinÃ³n-Torres, Federico Greenberg, David Varman, Meera Killar, John A Hille, Darcy Strable, Erica L Stek, Jon E Kaplan, Susan S Safety, Tolerability and Immunogenicity of Pentavalent Rotavirus Vaccine Manufactured by a Modified Process.

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