Izadi Shahrokh, Mohammadi Mahdi, Sartipi Majid, Karami Manoochehr, Karimi Hossein
Department of Epidemiology and Biostatistics, School of Public Health, Isfahan University of Medical Sciences, Isfahan, Islamic Republic of Iran.
Department of Epidemiology and Biostatistics, School of Public Health, Zahedan University of Medical Sciences, Zahedan, Islamic Republic of Iran.
East Mediterr Health J. 2023 Jan 19;29(1):6-14. doi: 10.26719/emhj.23.002.
Since November 2014, the pentavalent (Diptheria+Tetanus+Pertussis and Hepatitis B and Hib or DTP-HBHib) vaccine has been integrated into the Iranian national vaccination programme.
We conducted a prospective study in Zahedan in the southeast of the Islamic Republic of Iran to determine the incidence of adverse events following immunization (AEFI) with the pentavalent vaccine in children aged under one year.
Using cluster sampling, 1119 children aged 2-10 months at 15 public health clinics were invited, through their parents, to participate in the study. The parents were trained to register and report any AEFIs in a questionnaire. They were instructed to return the child to the clinic for further examination by a physician if they observed any complications within 3 days of vaccination.
The most commonly reported AEFIs were fever (50.94%), mild (41.46%) and severe (1.70%) injection site complications, persistent crying for 3 hours or more (1.88%), hypotonic hyporesponsive episode (0.36%), vomiting (1.88%), diarrhoea (2.95%), and sterile abscess (0.62%). There were no cases of convulsion, purulent abscess or rash. The work experience of vaccinators (OR = 1.85; 95% CI: 1.4-2.46) showed a significant statistical association with the incidence of mild local complications at the injection site. Those with a history of Bacillus Calmette-Guérin (BCG) lymphadenitis (OR = 3.89; 95% CI:1.04-14.49) had a higher risk of severe local complications at the injection site.
The observed incidence of serious AEFIs following pentavalent vaccine injection in the study population was within the expected range. However, some of the relationships observed in this study require further research.
自2014年11月起，五价（白喉+破伤风+百日咳与乙型肝炎及b型流感嗜血杆菌结合疫苗，即DTP-HBHib）疫苗已被纳入伊朗国家疫苗接种计划。
我们在伊朗伊斯兰共和国东南部的扎赫丹进行了一项前瞻性研究，以确定一岁以下儿童接种五价疫苗后免疫接种不良反应（AEFI）的发生率。
采用整群抽样法，邀请了15家公共卫生诊所中1119名2至10个月大的儿童通过其父母参与研究。对父母进行培训，使其在问卷中记录并报告任何AEFI情况。若父母在接种疫苗3天内观察到任何并发症，需带孩子返回诊所由医生进行进一步检查。
最常报告的AEFI包括发热（50.94%）、轻度（41.46%）和重度（1.70%）注射部位并发症、持续哭闹3小时及以上（1.88%）、低张力低反应发作（0.36%）、呕吐（1.88%）、腹泻（2.95%）和无菌脓肿（0.62%）。未出现惊厥、化脓性脓肿或皮疹病例。疫苗接种人员的工作经验（比值比=1.85；95%置信区间：1.4-2.46）显示与注射部位轻度局部并发症的发生率存在显著统计学关联。有卡介苗（BCG）淋巴结炎病史的人（比值比=3.89；95%置信区间：1.04-14.49）发生注射部位重度局部并发症的风险更高。
研究人群中五价疫苗注射后观察到的严重AEFI发生率在预期范围内。然而，本研究中观察到的一些关系需要进一步研究。
