Liu Z L, Hennessy S, Strom B L, Tsai T F, Wan C M, Tang S C, Xiang C F, Bilker W B, Pan X P, Yao Y J, Xu Z W, Halstead S B
Department of Pediatrics, West China University of Medical Sciences, and Chengdu Anti-epidemic Station, Sichuan.
J Infect Dis. 1997 Nov;176(5):1366-9. doi: 10.1086/517323.
The short-term safety of an effective and inexpensive new live attenuated Japanese encephalitis vaccine (SA14-14-2) was studied in a randomized trial, using block randomization. Of 26,239 children who were enrolled, half received the vaccine and half served as controls. Subjects were prospectively followed for 30 days for severe adverse events, such as encephalitis, meningitis, and "all-cause" hospitalization. No cases of encephalitis or meningitis occurred in either group. The upper 95% confidence limit for adverse events not occurring among subjects receiving their first dose was 4.1/10,000. Risk ratios and 95% confidence intervals for other adverse events were 0.70 (0.43-1.15) for all-cause hospitalization, 0.91 (0.37-2.22) for seizure, and 0.79 (0.56-1.11) for fever lasting > or = 3 days. These data attest to the short-term safety of the SA14-14-2 virus strain and the hamster kidney cell substrate.
在一项采用区组随机化的随机试验中，对一种有效且廉价的新型减毒活日本脑炎疫苗（SA14 - 14 - 2）的短期安全性进行了研究。在纳入的26239名儿童中，一半接种疫苗，一半作为对照。对受试者进行了为期30天的前瞻性随访，以观察严重不良事件，如脑炎、脑膜炎和“全因”住院情况。两组均未发生脑炎或脑膜炎病例。接受首剂疫苗的受试者中未发生不良事件的95%置信上限为4.1/10000。其他不良事件的风险比及95%置信区间分别为：全因住院0.70（0.43 - 1.15），癫痫发作0.91（0.37 - 2.22），持续≥3天发热0.79（0.56 - 1.11）。这些数据证明了SA14 - 14 - 2病毒株和仓鼠肾细胞基质的短期安全性。
