A＋C群脑膜炎球菌多糖疫苗安全性评估

Evaluation on the safety of a group A ＋ C meningococcal polysaccharide vaccine

目的 评估A＋C群脑膜炎球菌多糖疫苗的安全性。方法 以A＋C群脑膜炎球菌多糖疫苗为观察组，伤寒Vi多糖疫苗为对照组，按整群随机分层配对的原则，将研究现场分为108个组群，观察组和对照组各分配54个组。对两组同时建立接种反应监测系统，按统一表格和方法对两组的接种反应进行监测、记录，并进行流行病学调查。结果 两组共接种34543人，其中A＋C群脑膜炎球菌多糖疫苗接种18167人，伤寒Vi疫苗接种16376人。A＋C群脑膜炎球菌多糖疫苗速发接种反应率为0．44‰，一般接种反应率为0．38％o；伤寒Vi疫苗速发接种反应率为0．79％，一般接种反应率为0．73％o；跟踪随访接种反应对象共1239人，其中接种A＋C群脑膜炎球菌多糖疫苗的771人，接种伤寒Vi疫苗的468人。接种后第1天，A＋C群脑膜炎球菌多糖疫苗组的局部反应发生率要明显高于伤寒Vi疫苗（X^2。=13．98，P=0．0002）；接种后第2—3天局部反应和全身反应的发生率，两组差异无统计学意义；两组各自接种人群和未接种人群发热发生率的差异无统计学意义，两组已接种人群的发热发生率差异也无统计学意义；两组均未发现严重反应。结论 A＋C群脑膜炎球菌多糖疫苗与伤寒Vi疫苗均可在不同年龄组人群开展大规模接种，局部及全身接种反应轻微，接种反应率低，有良好的安全性。

Objective To evaluate the safety of a group A ＋ C meningococcal polysaccharide vaccine as part of a phase Ⅳ clinical trial. Methods The study area was divided into 108 clusters according to the principle of cluster randomization,stratified and paired sampling methods. 54 out of 108 clusters served as observation groups were administered A ＋ C vaccine, while the rest 54 groups were administered Vi polysaccharide vaccine. An adverse event surveillance system was established to monitor the adverse events following the vaccination campaign. Identical form and methods were used for data collection to investigate the adverse events following the vaccination of both A ＋ C vaccine and Vi vaccine. Results 34 543 people were vaccinated, including 18 167 of whom received A ＋ C vaccine, while the other 16 376 received Vi vaccine. The rates of immediate injection reaction and unsolicited non-serious adverse events from A ＋ C vaccine group were 0.44%o and 0.38%o while of Vi vaccine group were 0.79‰ and 0.73‰ respectively. At the solicited adverse event survey on 3-day-post-vaccination, 1239 vaccinees were followed-up including 771 received A ＋ C vaccine and 468 received Vi vaccine. The local injection reaction rate of A ＋ C vaccine group on the 1^st day was significantly higher（X^2= 13.98, P = 0.0002） than that of Vi vaccine group. Neither the local injection reaction rate nor the system reaction rate between both groups was significantly different on 2^nd and 3^rd day, post vaccination. It was not statistically different when comparing fever onset rate between those who received vaccine and those who did not, in each vaccine group. There were no serious adverse events observed. Conclusion Results showed that the side effects of A ＋ C vaccine and the Vi vaccine were mild and safe for vaccination campaigns targeting on populations at different age.