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喀麦隆使用A群脑膜炎球菌结合疫苗(MENAFRIVAC™)开展大规模疫苗接种运动期间不良事件的发生率及类型

Incidence and types of adverse events during mass vaccination campaign with the meningococcal a conjugate vaccine (MENAFRIVAC™) in Cameroon.

作者信息

Ateudjieu Jerome, Stoll Beat, Nguefack-Tsague Georges, Yakum Martin Ndinakie, Mengouo Marcellin Nimpa, Genton Blaise

机构信息

Adamawa Health Region and North West Health Region, Cameroon. Email:

Adamawa Health Region and North West Health Region, Cameroon.

出版信息

Pharmacoepidemiol Drug Saf. 2016 Oct;25(10):1170-1178. doi: 10.1002/pds.4027. Epub 2016 May 13.

Abstract

PURPOSE

A new vaccine against meningitis A was introduced in Africa meningitis belt in 2010. This study was planned to describe the incidence and types of adverse events following immunization (AEFIs) with a new conjugate vaccine against meningitis A (MenAfrivac™) in a Cameroonian vaccination campaign.

METHODS

The campaign was conducted in Adamawa and North West regions in December 2012 and the AEFIs enhanced surveillance from December 2012 to January 2013. Incidence rates (IR) of overall and serious AEFIs were estimated as well as AEFI incidence rates by type, age group and region. AEFI symptoms were aggregated in System Organ Class (SOC).

RESULTS

Of 2 093 381 persons vaccinated, 1352 AEFIs were reported. Of these, 228 (16.9%) were excluded because of not meeting inclusion criteria and 1124 (83.1%) included (IR: 53.7/100 000 doses administered/8 weeks). Of the 82 serious AEFIs reported, 52 (63.2%) met the case definition. 23 (28.1%) were investigated, of which 4 (17.4%) were probably vaccine product-related reactions (IR: 0.2/100 000 doses administered/8 weeks). Fever was the most common reported AEFI with 626 cases (IR: 31.4/100 000 doses administered/8 weeks). The proportion of people with the SOC "Gastrointestinal disorders" was significantly lower in ages 5-15 and 16-29 years than 1-4 years [aRR = 0.63(0.42-0.93) and 0.54(0.36-0.81) respectively].

CONCLUSION

Incidence and types of AEFI reported during MenAfriVac vaccination campaign organized in Cameroon in 2012 did not suggest concern regarding the vaccine safety. Differences in frequency of AEFIs types per age group could guide the monitoring of AEFIs frequency in future campaigns. Efforts are needed to improve the investigation rate of serious AEFIs. Copyright © 2016 John Wiley & Sons, Ltd.

摘要

目的

2010年,一种新的A群脑膜炎球菌疫苗在非洲脑膜炎带投入使用。本研究旨在描述喀麦隆一次疫苗接种活动中,使用新型A群脑膜炎球菌结合疫苗(MenAfrivac™)后的免疫接种不良反应(AEFI)的发生率及类型。

方法

2012年12月在阿达马瓦和西北地区开展了此次疫苗接种活动,并于2012年12月至2013年1月加强了对AEFI的监测。估算了总体及严重AEFI的发生率,以及按类型、年龄组和地区划分的AEFI发生率。AEFI症状按系统器官分类(SOC)进行汇总。

结果

在2093381名接种疫苗的人中,报告了1352例AEFI。其中,228例(16.9%)因不符合纳入标准而被排除,1124例(83.1%)被纳入(发生率:53.7/100 000剂次接种/8周)。在报告的82例严重AEFI中,52例(63.2%)符合病例定义。23例(28.1%)接受了调查,其中4例(17.4%)可能是与疫苗产品相关的反应(发生率:0.2/100 000剂次接种/8周)。发热是报告最常见的AEFI,有626例(发生率:31.4/100 000剂次接种/8周)。5至15岁和16至29岁人群中出现“胃肠道疾病”SOC的比例显著低于1至4岁人群[调整后相对危险度分别为0.63(0.42 - 0.93)和0.54(0.36 - 0.81)]。

结论

2012年喀麦隆组织的MenAfriVac疫苗接种活动中报告的AEFI发生率及类型并不表明对疫苗安全性存在担忧。各年龄组AEFI类型频率的差异可为未来活动中AEFI频率的监测提供指导。需要努力提高严重AEFI的调查率。版权所有© 2016约翰威立父子有限公司。

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