Social Determinants of Health Research Center, Hamadan University of Medical Sciences, Hamadan, Iran.
Department of Epidemiology, School of Public Health, Hamadan University of Medical Sciences, Hamadan, Iran.
BMC Immunol. 2017 Aug 23;18(1):42. doi: 10.1186/s12865-017-0226-8.
The most important factors that affect the incidence of vaccine-related complications are the constituent biological components of the vaccine, injection site reactions, age and sex. The aim of this study is to determine the incidence rate of adverse events following immunization with pentavalent vaccine (DTPw-Hep B-Hib (PRP-T) vaccine (pentavac) (adsorbed) is manufactured by Serum Institute of India ltd), which was introduced in Iran in November 2014. It is important to monitor vaccine-related adverse events because of the role of vaccine safety in immunization program success.
This study was a mixed cohort study that included 1119 children less than 1 year of age. In 2015, the children were referred to Hamadan health centers to receive pentavalent vaccine at 2, 4 and 6 months of age. The data were collected from the parents of the children using a questionnaire that was administered either face-to-face or by telephone. The cumulative incidence of side effects and risk ratio was reported with 95% confidence intervals (CI). Chi-squared tests and logistic regressions were used to investigate the association between the variables.
The cumulative incidence rate of pentavalent-related adverse events during 48 h following immunization was estimated to be 15.8% for swelling, 10.9% for redness, 44.2% for pain, 12.6% for mild fever, 0.1% for high fever, 20.0% for drowsiness, 15.0% for loss of appetite, 32.9% for irritability, 4.6% for vomiting and 5.5% for persistent crying. There is no evidence for the occurrence of convulsion and encephalopathy among children who receive pentavalent vaccines.
Further large studies with long time follow up are required to address rare events include convulsions, encephalopathy or persistent crying. However, Findings urge immunization programs to use pentavalent vaccinations and to continue implementing the current immunization program in children under 1 year of age.
影响疫苗相关并发症发生率的最重要因素是疫苗的组成生物成分、注射部位反应、年龄和性别。本研究旨在确定 2014 年 11 月在伊朗引入的五联疫苗（DTpw-乙肝-Hib（PRP-T）疫苗（吸附）（由印度血清研究所制造）的不良事件发生率。由于疫苗安全性在免疫计划成功中的作用，监测疫苗相关不良事件非常重要。
这是一项混合队列研究，包括 1119 名不到 1 岁的儿童。2015 年，这些儿童被转介到哈马丹保健中心，在 2、4 和 6 个月大时接种五联疫苗。使用面对面或通过电话进行的问卷从儿童的父母那里收集数据。使用 95%置信区间（CI）报告不良事件的累积发生率和风险比。使用卡方检验和逻辑回归来调查变量之间的关联。
接种后 48 小时内，五联疫苗相关不良事件的累积发生率估计为肿胀 15.8%、发红 10.9%、疼痛 44.2%、轻度发热 12.6%、高热 0.1%、嗜睡 20.0%、食欲不振 15.0%、烦躁不安 32.9%、呕吐 4.6%和持续哭泣 5.5%。接受五联疫苗的儿童没有出现惊厥和脑病的证据。
需要进一步进行长期随访的大型研究来解决罕见事件，包括惊厥、脑病或持续哭泣。然而，这些发现敦促免疫规划使用五联疫苗，并继续在 1 岁以下儿童中实施当前的免疫规划。
