吸附无细胞百日咳-白喉-破伤风-灭活脊髓灰质炎-b型流行性感冒嗜血杆菌联合疫苗在2、3、4月龄婴儿中用于基础免疫的安全性分析

Safety of Adsorbed Diphtheria-Tetanus-Acellular Pertussis-Inactivated Poliovirus-Haemophilus Influenzae Type b Combination Vaccine( DTaP-IPV-Hib) for Infants' Primary Vaccination at 2,3,4 Months of Age

目的监测接种吸附无细胞百日咳-白喉-破伤风-灭活脊髓灰质炎-b型流行性感冒嗜血杆菌联合疫苗（Absorbed Diphtheria-Tetanus-Acellular Pertusis-Inactivated Poliovirus-Haemophilus Influenzae Type b Combined Vaccine,DTaP-IPV-Hib）后的不良反应,评价DTaP-IPV-Hib上市后在目标人群中使用的安全性。方法以市售的DTaP-IPVHib作为研究疫苗,在上海市选择300名出生后60~74d的婴儿,采用主动监测的方法观察其在2月龄、3月龄、4月龄接种后的不良反应。结果接种DTaP-IPV-Hib后0~7d,注射部位不良反应发生率为39.1%（349/892）,其中严重程度3级的发生率为1.1%（10/892）;全身不良反应发生率56.1%（500/892）,其中严重程度3级的发生率为2.5%（22/892）。随着接种剂次的增加,注射部位红斑和肿胀的报告发生率显著增加,呕吐、异常哭闹、嗜睡、食欲下降和易激惹等全身反应的报告发生率显著下降。结论 2、3、4月龄婴儿接种DTaP-IPV-Hib有良好的安全性。

Objective To determine incidence rates of adverse events following immunization （AEFI） with the absorbed diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae type b combination vaccine （DTaP-IPV-Hib） that is on the market, and to evaluate its safety among the target population. Methods We conducted surveillance for AEFIs among 300 infants who were admin- istered commercially available DTaP-1PV-Hib combination vaccine at 2, 3, and 4 months of age in Shanghai. Results The incidence of injection site reactions occurring within 7 days post-vaccination was 39. 1% （349/892）; and for Grade 3 injection site reactions, the incidence was 1.1% （10/ 892 ）. The incidence of systemic adverse reactions occurring within 7 days post-vaccination was 56.1% （500/892） ; and for Grade 3 systemic adverse reactions, the incidence rate was 2.5% （22/892）. With the increasing dose number, the incidence of erythema and swelling at the injection site increased, while the incidence of systemic reactions （abnormal crying, drowsiness, vomiting, appetite loss, and irritability） decreased. Conclusion DTaP-IPV-Hib is safe for infants of 2, 3, and 4 months of age for primary vaccination.