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A、C、W 和 Y 群脑膜炎奈瑟球菌破伤风类毒素结合疫苗的免疫原性和安全性:临床和真实世界证据综述。

Immunogenicity and safety of meningococcal group A, C, W and Y tetanus toxoid conjugate vaccine: review of clinical and real-world evidence.

机构信息

Vaccines, Medical & Scientific Affairs, International Developed Markets, Pfizer Ltd, Surrey, UK.

Childrens Hospital, Dr. Horst Schmidt Clinic, Wiesbaden, Germany & Pediatric Infectious Diseases, University Medicine, Mainz, Germany.

出版信息

Future Microbiol. 2019 May;14:563-580. doi: 10.2217/fmb-2018-0343. Epub 2019 May 16.

Abstract

Protection by meningococcal group A, C, W and Y (MenACWY) vaccines against four meningococcal disease-causing serogroups is increasingly important because of changing epidemiologic patterns of meningococcal disease, including recent meningococcal serogroup W outbreaks/disease clusters. The MenACWY vaccine conjugated to tetanus toxoid (MenACWY-TT) has been extensively evaluated across the age spectrum (age ≥6 weeks) in randomized Phase II and III and in postmarketing studies. Results support the robust immunogenicity of MenACWY-TT across ages and coadministration with other vaccines. The safety profile is similar regardless of age, primary versus booster vaccination, or concomitant administration; local (swelling, pain, redness) and systemic (fever, fatigue, headache, drowsiness, loss of appetite, irritability) reactogenicity events are most common. These data support use of MenACWY-TT to protect against MenACWY disease.

摘要

脑膜炎球菌 A、C、W 和 Y 组(MenACWY)疫苗对导致脑膜炎的四个血清群的保护作用变得越来越重要,因为脑膜炎奈瑟菌病的流行模式正在发生变化,包括最近脑膜炎奈瑟菌 W 组的爆发/疾病聚集。与破伤风类毒素(MenACWY-TT)结合的 MenACWY 疫苗在整个年龄范围内(≥6 周龄)已在随机 II 期和 III 期以及上市后研究中进行了广泛评估。结果支持 MenACWY-TT 在各年龄段的强大免疫原性,并且与其他疫苗同时使用。无论年龄、基础免疫还是加强免疫,或同时使用,安全性概况相似;局部(肿胀、疼痛、发红)和全身(发热、疲劳、头痛、嗜睡、食欲不振、烦躁)反应原性事件最为常见。这些数据支持使用 MenACWY-TT 来预防 MenACWY 疾病。

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