吸附无细胞百白破联合疫苗安全性观察

Investigate Safety of a Domestic Adsorhed Diphtheria,Tetanus Acellular Pertussis Combined Vaccine

目的探讨吸附无细胞百白破联合疫苗的安全性。方法对600名3个月-6周岁足月出生的健康儿童，以2∶1的比例按照计划免疫程序随机分别接种试验疫苗和对照疫苗，进行安全性观察。结果发热反应总发生率为15.38%（178/1159），其中2＋3级反应率为3.28%（38/1159）。局部反应发生率疼痛为0.60%（7/1159），其中2和3级反应率为0.26%（3/1159），红为l.12%（13/1159），肿为0.78%（9/1159），其中2和3级反应率为0.09%（1/1159），所有受试者在观察期内均未观察到4级（潜在的生命危胁）不良反应。结论试验用吸附无细胞百白破联合疫苗对3月龄及其以上人群具有较好的安全性。

OBJECTIVE To investigate safety of a domestic adsorhed diphtheria, tetanus acellular pertussis combined vaccine （DTaP）. METHODS The trial included 600 healthy infants from 3 months to 6 years old. They were randomly assigned to DTaP group and control group at a ratio of 2：1. The safety of vaccination was observed. RESULTS After vaccine inoculation with the DTaP, the total rate of fever reaction was 15.38% （178/1 159）, among which 3.28% （38/1 159） was class 2 and 3 side reaction. Local reaction included pain [0.60%, 7/1 159, class 2 and 3 side reachtion=0.26% （3/1 159）], red （1.12%, 13/1 159）, and swelling [0.78%, 9/1 159, class 2 and 3 side reaction=0.09% （ 1/1 159） ] .Class 4 adverse reaction with potent risk of death has not been observed in all infants. CONCLUSION The DTaP in clinical trial has better safety in infants older than 3 months.