[Study on the failure time of the vaccine vial monitor used for oral poliovirus vaccine at 25 ℃ and 37 ℃]

Abstract

Objective: To evaluate the failure time of vaccine vial monitor (VVM) used for oral poliovirus vaccine (OPV) at 25 ℃ and 37 ℃. Methods: 160 copies of VVM were produced by a company, the model was QM5D37A, samples were taken from different batches by using the method of random number table . 100 bottles of vaccine were produced by a domestic company, and samples were taken from different batches by using the method of random number table. 160 copies of labels were placed in the incubator at 25 ℃ and 37 ℃, which were used to measure the mutative color of the active region. When the values of color were equal to 40, the color of active region was the same with the reference color, and the VVM was failed. 100 bottles of vaccine were placed in the incubator at 25 ℃ and 37 ℃, which were used to measure the vaccine titer. When total vaccine titer was less than 6.12 CCID50 or vaccine titer of typeⅠ was less than 6.0 CCID50 or vaccine titer of type Ⅲ was less than 5.5 CCID50, the vaccine was failed. We drew the graph of mutative color to calculate the failure time range of VVM According to the graph , we can determine that whether the failure time of VVM was later than the time of vaccines by the data of OPV . Results: The earliest failure time of OPV was 21 days at 25 ℃, and the number of samples was one; The earliest Failure time of VVM was 12.5 days at 25 ℃, and it was less than the earliest failure time of OPV. The earliest failure time of OPV was 4.0 days at 37 ℃, and the number of samples was one; The earliest Failure time of VVM was 3.1 days at 37 ℃, and it was equal to the earliest failure time of OPV. Conclusion: We could know that the failure time of VVM was always earlier than the failure time of vaccines at the same temperatures . The latest failure time of VVM was equal to the earliest failure time of vaccines at 37 ℃. All of the failure times of samples were earlier than that of vaccines at 25 ℃.

Keywords: Antibodies; Failure time; Poliovirus vaccine, oral; Vaccine vial monitor.