摘要目的 评价脊髓灰质炎灭活疫苗(inactivated polio vaccine,IPV)和减毒活疫苗(oralpolio vaccine,OPV)不同序贯免疫程序基础免疫的安全性.方法 2009至2011年在北京市选择2月龄(60～89 d)婴儿,分为1剂IPV和2剂OPV序贯(I-O-O)、2剂IPV和1剂OPV序贯(I-I-O)、IPV全程(I-I-I)、OPV全程(O-O-O)4个观察组,分别在2、3、4月龄时接种疫苗,收集每次接种后全身和局部不良反应发生情况,计算不良反应发生率.最终入组553名婴儿,中途退出89名,观察1492人次.结果 I-O-O组、I-I-O组、I-I-I组和O-O-O组总不良反应发生率分别为22.9％ (94/410)、18.4％(60/327)、22.0％(78/354)和17.7％(71/401),差异无统计学意义(x2=4.84,P=0.184).第1剂不良反应发生率最高[22.7％(32/141) ～35.3％(54/153)],第2、3剂依次降低.没有与接种疫苗有关的严重不良事件报告.I-O-O组、I-I-O组、I-I-I组和O-O-O组全身不良反应发生率分别为21.5％(88/410)、17.7％(58/327)、20.1％ (71/354)和17.7％(71/401),差异无统计学意义(x2 =2.53,P=0.472).异常哭闹在各组中发生率最高[7.2％(29/401) ～11.3％(37/327)],异常哭闹、嗜睡和易激惹观察到极少数重度不良反应,其他不良反应均为轻、中度反应.I-O-O组、I-I-O组和I-I-I组局部压痛、硬结和红肿发生率分别为2.2％(5/229) ～5.6％(22/393)、0～0.9％(2/229)、0～ 1.0％(4/393),均以轻度为主[0 ～4.1％(5/12t)].结论 IPV全程及IPV/OPV序贯免疫程序与口服三剂OPV-样具有较好的安全性.

abstractsObjective To evaluate safety of different sequential immunization schedules of inactivated poliovirus vaccine (IPV) and oral poliovirus vaccine (OPV) primary vaccination.Methods Infants of 2 months old (60-89 days) selected in Beijing,were assigned to four groups,1 dose IPV plus 2doses OPV (I-O-O),2 doses IPV plus 1 dose OPV (I-I-O),3 doses IPV (I-I-I),and 3 doses OPV (O-O-O),and were vaccinated at the age of 2,3,4 months,from 2009 to 2011.The frequencies of systemic as well as local injection site reactions after every dose were recorded and calculated.A total of 553 infants were enrolled in the study and 89 infants were quited,1492 doeses were observed.Results The incidence of adverse events in I-O-O,I-I-O,I-I-I,O-O-O were 22.9％ (94/410),18.4％ (60/327),22.0％ (78/354)and 17.7％ (71/401) with no statistical differences (x2 =4.84,P =0.184).Dose 1 (22.7％ (32/141)-35.3％ (54/153)) was more frequently than dose 2 and dose 3.No serious adverse events (SAE) were reported during the study.The incidence of systemic adverse reactions in I-O-O,I-I-O,I-I-I,O-O-O were 21.5％ (88/410),17.7％ (58/327),20.1％ (71/354) and 17.7％ (71/401) with no statistical differences (x2 =2.53,P =0.472).Abnormal crying were the most frequence reactions (7.2％ (29/401)-11.3％(37/327)) in 4 groups.Rarely severe reactions were observed of abnormal crying,somnolence,irritability and mild or medium reactions occurred in other symptoms.Local adverse reactions such as injection site pain,scleroma and swelling were reported by 2.2％ (5/229)-5.6％ (22/393),0-0.9％ (2/229) and 0-1.0％ (4/393) in I-O-O,I-I-O and I-I-I,and most reactions were mild.Conclusion Three IPV immunization and IPV/OPV sequential immunization as well as three OPV immunization demonstrated safe.