流行性感冒裂解疫苗安尔来福Ⅳ期临床安全性观察

Research on Ⅳ Stage Clinical Safety of Domestic Split Influenza Virus Vaccine Anflu^(TM)

目的评价流行性感冒(流感)裂解疫苗安尔来福的安全性。方法在天津市进行开放式临床观察,受试者为18~60岁和>60岁健康人,每个年龄组均>110人。在受试者签署知情同意书后,于上臂三角肌肌内注射0.5ml/支流感裂解疫苗安尔来福,接种后分别于30min内和24、48、72h观察不良反应,直至不良反应消失。结果实际接种并完成临床安全性观察225人,男女性别比为1∶0.96,平均年龄59岁(18~96岁)。共发生不良事件14例,其中13例为与疫苗相关的不良反应,发生率为5.8%(13/225)。主要是局部疼痛、红肿、瘙痒及硬结,局部不良反应发生率为5.3%(12/225),全身不良反应发生率为1.3%(3/225)。结论本次观察未见由疫苗引起新的不良反应,亦未见严重不良事件及罕见不良反应。

Objective To evaluate the Ⅳ stage clinical safety of domestic split influenza virus vaccine produced by Sinovac Biotech Co. Ltd. Methods The clinical open trial was designed to divide the healthy subjects into two groups： 18~60 and 〉60 years old,and more than 110 subjects was contained in each group. 0.5 mL split influenza virus vaccine was injected into arm deltoid of the subjects after informed consent document was signed,when observation lasted 30 rain, 24,48,72 h until adverse reaction disappeared. Results The sex ratio is 1 ： 0.96,and average age is 59（18~96）in 225 subjects. 14 adverse events occurred in the trial of which 13 cases were vaccine related,total reaction rate is 5.8% （13/225）. Local and fever reaction rate is 5.3% （12/ 225）and 1.3%（3/225）,respectively. Conclusion The results showed that the trial vaccine did not cause new adverse reaction, serous adverse events and rare adverse reaction was not observed.