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脑膜炎球菌结合疫苗（Menafrivac™）在临床试验和疫苗接种活动中的安全性概况：已发表研究综述

Safety profile of the meningococcal conjugate vaccine (Menafrivac™) in clinical trials and vaccination campaigns: a review of published studies.

作者信息

Ateudjieu Jerome, Stoll Beat, Bisseck Anne Cecile, Tembei Ayok M, Genton Blaise

机构信息

Department of Biomedical Sciences, Faculty of Sciences, University of Dschang , Dschang, Cameroon.

Department of Epidemiology and Public Health, Swiss Tropical and Public Health Institute , Basel, Switzerland.

出版信息

Hum Vaccin Immunother. 2020 Jun 2;16(6):1245-1259. doi: 10.1080/21645515.2019.1652041. Epub 2019 Sep 5.

DOI:10.1080/21645515.2019.1652041
PMID:31403358
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7482715/
Abstract

The study aimed to assess the capacity of AEFI surveillance during vaccination campaigns with the new conjugate meningitis vaccine (MenAfrivac). A systematic review of studies on MenAfrivac™ published in English during 2001-2016 was done.AEFIs incidence (I) was estimated and compared between MenAfrivac™ clinical trials and immunization campaigns using incidence difference (Id). Nine studies were included with an overall local AEFI I of 11,496/100,000 doses administered per week in clinical trials and 0.72/100,000 doses in immunization campaigns. An Id of 11,497.92 [11,497.91-11,497.93] and 17,243.20 [17,241.80-17,245.90] per 100,000 doses administered per week for overall local and systemic AEFI, respectively, were observed with highest from clinical trials. The incidence of AEFIs after MenAfrivac™ vaccination was far lower in campaigns than in clinical trial studies. Current capacity of AEFI surveillance during vaccination campaigns requires extensive re-assessment of its structure and capacity.

摘要

该研究旨在评估在使用新型结合型脑膜炎疫苗（MenAfrivac）开展疫苗接种活动期间的疑似预防接种异常反应（AEFI）监测能力。对2001年至2016年期间以英文发表的关于MenAfrivac™的研究进行了系统评价。通过发病率差异（Id）对MenAfrivac™临床试验和免疫接种活动中的AEFI发病率（I）进行了估计和比较。纳入了9项研究，临床试验中总体局部AEFI发病率为每周每10万剂次接种11496例，免疫接种活动中为每10万剂次接种0.72例。观察到总体局部和全身AEFI每周每10万剂次接种的发病率差异分别为11497.92[11497.91 - 11497.93]和17243.20[17241.80 - 17245.90]，临床试验中的发病率差异最高。MenAfrivac™疫苗接种后的AEFI发病率在免疫接种活动中远低于临床试验研究。当前疫苗接种活动期间AEFI监测的能力需要对其结构和能力进行广泛的重新评估。