Tseng Hung-Fu, Sy Lina S, Ackerson Bradley K, Hechter Rulin C, Tartof Sara Y, Haag Mendel, Slezak Jeffrey M, Luo Yi, Fischetti Christine A, Takhar Harp S, Miao Yan, Cunnington Marianne, Solano Zendi, Jacobsen Steven J
Department of Research and Evaluation, Kaiser Permanente Southern California, Pasadena, California;
Department of Research and Evaluation, Kaiser Permanente Southern California, Pasadena, California.
Pediatrics. 2017 Jan;139(1). doi: 10.1542/peds.2016-2084.
Meningococcal conjugate vaccination is recommended in the United States. This study evaluates the safety of quadrivalent meningococcal conjugate vaccine in a cohort aged 11 to 21 years.
This cohort study with self-controlled case-series analysis was conducted at Kaiser Permanente Southern California. Individuals receiving MenACWY-CRM, a quadrivalent meningococcal conjugate vaccine, during September 30, 2011 to June 30, 2013, were included. Twenty-six prespecified events of interest (EOIs), including neurologic, rheumatologic, hematologic, endocrine, renal, pediatric, and pediatric infectious disease EOIs, were identified through electronic health records 1 year after vaccination. Of these, 16 were reviewed by case review committees. Specific risk and comparison windows after vaccination were predefined for each EOI. The relative incidence (RI) and 95% confidence intervals (CIs) were estimated through conditional Poisson regression models, adjusted for seasonality.
This study included 48 899 vaccinated individuals. No cases were observed in the risk window for 14 of 26 EOIs. The RI for Bell's palsy, a case review committee-reviewed EOI, was statistically significant (adjusted RI: 2.9, 95% CI: 1.1-7.5). Stratified analyses demonstrated an increased risk for Bell's palsy in subjects receiving concomitant vaccines (RI = 5.0, 95% CI = 1.4-17.8), and no increased risk for those without concomitant vaccine (RI = 1.1, 95% CI = 0.2-5.5).
We observed a temporal association between occurrence of Bell's palsy and receipt of MenACWY-CRM concomitantly with other vaccines. The association needs further investigation as it could be due to chance, concomitant vaccination, or underlying medical history predisposing to Bell's palsy.
美国推荐接种脑膜炎球菌结合疫苗。本研究评估了四价脑膜炎球菌结合疫苗在11至21岁队列中的安全性。
这项采用自我对照病例系列分析的队列研究在南加州永久医疗集团进行。纳入了2011年9月30日至2013年6月30日期间接种四价脑膜炎球菌结合疫苗MenACWY-CRM的个体。通过接种疫苗1年后的电子健康记录确定了26个预先指定的关注事件（EOI），包括神经系统、风湿性、血液学、内分泌、肾脏、儿科和儿科传染病EOI。其中16个由病例审查委员会进行审查。为每个EOI预先定义了接种疫苗后的特定风险和对照期。通过条件泊松回归模型估计相对发病率（RI）和95%置信区间（CI），并对季节性进行了调整。
本研究纳入了48899名接种疫苗的个体。26个EOI中有14个在风险期未观察到病例。病例审查委员会审查的EOI——贝尔麻痹的RI具有统计学意义（调整后的RI：2.9，95%CI：1.1 - 7.5）。分层分析显示，同时接种其他疫苗的受试者患贝尔麻痹的风险增加（RI = 5.0，95%CI = 1.4 - 17.8），而未同时接种疫苗的受试者风险未增加（RI = 1.1，95%CI = 0.2 - 5.5）。
我们观察到贝尔麻痹的发生与MenACWY-CRM和其他疫苗同时接种之间存在时间关联。这种关联需要进一步调查，因为它可能是由于偶然因素、同时接种疫苗或易患贝尔麻痹的潜在病史所致。
