脑膜炎球菌血清群A,C,W,和Y型破伤风类毒素结合疫苗(MenACWY-TT;Nimenrix®;辉瑞有限公司,三明治,肯特,英国)在全球80多个国家/地区获得了预防由血清群A引起的脑膜炎球菌病的许可,C,W,和Y在个人的一生中。本报告总结了MenACWY-TT临床开发计划和上市后经验的安全性数据。
在临床研究计划中,反应原性数据基于3项主要研究,包括跨多个年龄组的大型汇总分析,和长期安全性数据来自3项评估长期抗体持久性的研究.截至2021年4月19日的上市后安全性数据是根据MenACWY-TT定期安全性更新报告收集和分析的。
全世界已经使用了大约3200万剂MenACWY-TT,超过21,530名额外的个人接受MenACWY-TT作为临床试验的一部分。MenACWY-TT的安全性在临床研究计划和上市后经验之间是一致的,以及其他许可的脑膜炎球菌疫苗。最常见的不良事件(AE)是发热/发热,头痛,注射部位疼痛/反应,恶心/呕吐,和疲劳;相对于给药剂量,严重的AE很少见。在上市后1年观察到几例血清群替代/缺乏疗效,但似乎与MenACWY-TT使用无关。
来自临床试验和上市后经验的大量数据表明,MenACWY-TT在广泛的年龄组中始终具有良好的安全性。
The meningococcal serogroups A, C, W, and Y tetanus toxoid conjugate vaccine (MenACWY-TT; Nimenrix®; Pfizer Ltd, Sandwich, Kent, UK) is licensed in more than 80 countries worldwide for the prevention of meningococcal disease caused by serogroups A, C, W, and Y in individuals throughout their lifespans. This report summarizes safety data from the MenACWY-TT clinical development program and postmarketing experience.
Within the clinical study program, reactogenicity data were based on 3 primary studies, including a large pooled analysis across multiple age groups, and long-term safety data were derived from 3 studies evaluating long-term antibody persistence. Postmarketing safety data through April 19, 2021, were collected and analyzed in connection with the MenACWY-TT Periodic Safety Update Report.
Approximately 32 million doses of MenACWY-TT have been administered worldwide, with more than 21,530 additional individuals receiving MenACWY-TT as part of clinical trials. The safety profile of MenACWY-TT was consistent between the clinical study program and the postmarketing experience, as well as with other licensed meningococcal vaccines. The most commonly observed adverse events (AEs) were pyrexia/fever, headache, injection site pain/reactions, nausea/vomiting, and fatigue; serious AEs were rare relative to the number of doses administered. Several cases of serogroup replacement/lack of efficacy were observed in the 1-year postmarketing period but did not appear to be related to MenACWY-TT use.
Extensive data derived from clinical trials and postmarketing experience indicate a consistently favorable safety profile for MenACWY-TT across a wide range of age groups.