摘要
目的进一步考察流感裂解疫苗安尔来福在6个月至3岁内婴幼儿及3~11岁儿童中应用的安全性,发现新药临床试验中可能未发现的不良反应.方法本试验采用开放式临床试验设计,受试者为6个月至3岁以内婴幼儿和3~11岁儿童各100名,婴幼儿组使用剂量为0.25 ml/支,免疫程序为0、28 d.儿童组使用剂量为0.5 ml/支,免疫程序为1针.接种后进行30 min即时反应观察,以及进行24、48、72 h随访观察,接种后第7天如受试者未主动报告任何不良事件,将结束随访观察.结果接种疫苗后总体不良反应发生率为6.0%(12/200),其中局部不良反应发生率为1.0%(2/200),全身不良反应发生率为5.5%(10/200),幼儿组和儿童组不良反应发生率分别为8.0%(8/100)和4.0%(4/100),均为轻度和中度反应,未见严重不良反应发生.结论流感裂解疫苗安尔来福在6个月至3岁以内婴幼儿及3~11岁儿童中应用安全性良好.
Objective To further evaluate the safety and observe for unknown adverse reactions in the prelicensure trials of Anflu(split influenza virus vaccine)in children aged 6 months to 3 years old and 3 to 11 years old respectively.Methods This open clinical trial enrolled 100 healthy children in each of the two groups:6 months to 3 years old group and 3 to 11 years old group.The 6 months to 3 years group were vaccinated with two pediatric doses(0.25 ml/dose),28 days apart.The 3 to 11 years group were vaccinated with one adult dose(0.5 ml/dose).All the subjects were observed for 30 min after vaccination and had 3 follow-up visits at 24,48,72 h after vaccination.All subjects with adverse reactions were followed up till the symptoms resolved.Results The total adverse reaction rate was 6.0%(12/200).The occurrence rates of local reaction and systemic reaction were 1.0%(2/200)and 5.5%(10/200)respectively.For the younger group and older group,the adverse reaction rates were 8.0%and 4.0%respectively.Conclusion This vaccineis safe in children aged 6 months to 11 years old.
作者
苏成豪
马姗姗
林水春
吴默秀
刘研
赵艳伟
SU Cheng-hao;MA Shan-shan;LIN Shui-chun;WU Mo-xiu;LIU Yan;ZHAO Yan-wei(Xiamen Center For Disease Control and Prevention,Xiamen 361021,China;不详)
出处
《中华预防医学杂志》
CAS
CSCD
北大核心
2008年第S01期138-140,共3页
Chinese Journal of Preventive Medicine
关键词
流感疫苗
安全
评价研究
Influenza vaccines
Safety
Evaluation studies
