A、C、Y、W_(135)群脑膜炎球菌多糖疫苗安全性观察

Safety of tetravalent meningococcal A, C, Y,W_(135) vaccine

目的观察A、C、Y、W135群脑膜炎球菌多糖疫苗在广东省广宁县和博罗县2～7岁人群中免疫后的安全性。方法研究者主动观察疫苗接种后30min,6、12、24、48、72h的局部和全身反应并记录在疫苗接种日记卡上,通过主动报告和定期随访的形式收集4天～4周期间的异常反应情况。结果共接种观察了2974名适龄儿童,发生疫苗接种不良事件378例,异常反应率12.71%,其中发热反应率10.96%,局部反应发生率1.85%;疫苗接种后30min至72h期间的全身和局部反应率分别为8.61%和1.82%。不良反应分级主要为2级以下,未观察到严重不良事件。所有全身反应症状和局部反应症状分别消失于接种后12d内和6d内。结论 A、C、Y、W135群脑膜炎球菌多糖疫苗在2～7岁人群中接种有较好的安全性。

Objective To evaluate the safety of tetravalent meningococcal A, C, Y, W135 vaccine in the population （aged 2-7 years old） from Boluo and Guangning county, Guangdong province. Methods Local and systemic reactions were recorded at 30 min, 6, 12, 24,48 and 72 h after vaccination. Abnormal reactions were also recorded in the following 4 weeks. Results 2 974 children were vaccinated. 378 cases （12.71%） had adverse events. The incidence of fever and local reaction was 10.96% and 1.85%, respectively. The incidence of systemic and local reaction occurred at 30 min to 72 h after immunization was 8.61% and 1.82%, respectively. Most of the side effects were classified as Grade 2 adverse reaction. Conclusion The tetravalent meningococcal A, C, Y, W135 vaccine was found to be safe for the children with an aged of 2-7 years old.