Preliminary evaluation of quality stability of oral trivalent reformulated live attenuated rotavirus vaccine(Vero cell)
TONG Yan-jun
FU Shu-guang
CHEN Tong
FENG Jiao-li
LIU Xiang-peng
ZHANG Jian-bin
LI Jia-lin
Abstract：Objective:To evaluate the quality stability of the oral trivalent reformulated live attenuated rotavirus vaccine(Vero cell)by analyzing both process stability and storage stability of the vaccine.Methods:For 3 batches of vaccine produced continuously,samples were taken at different production stages to test viral titers and various quality attributes.The intra-batch homogeneity,inter-batch consistency and storage stability of 3 batches of vaccine products were statistically evaluated.Results:In terms of process stability,RSD of total virus titers G and sucrose content were all below 3%,and RSD of virus titers of G2,G3 and G4 were all below 6.5%,indicating that the data dispersion within or between batches of products was small and process stability was good.In terms of storage stability,all quality attributes of the three batches of products met the quality standards during the storage period.The virus titer decreased linearly with the storage time,the goodness of fit R2 ranged from 50.45%to 90.23%,and the average monthly decline of virus titer was less than 0.1 lgCCID50·mL-1.Correlation matrix analysis showed that the inter-batch correlation coefficients(r)of virus titer were all greater than 0.5,indicating that the decline trend of virus titer between batches was basically the same during product storage.Conclusion:The results of process stability and storage stability showed that the oral trivalent reformulated live attenuated rotavirus vaccine(Vero cell)had good quality stability.
Keywords：oral trivalent reformulated live attenuated rotavirus vaccine(Vero cell)intra-batch homogeneityinter-batch consistencystorage stability
Publication Date：2025-06-30
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：6( 1296-1301 )