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

被引：0
|
作者：
Ateudjieu, Jerome [1 ,2 ,3 ]
Stoll, Beat [4 ]
Bisseck, Anne Cecile [3 ,5 ]
Tembei, Ayok M. [6 ]
Genton, Blaise [2 ,7 ]
机构：
[1] Univ Dschang, Fac Sci, Dept Biomed Sci, Dschang, Cameroon
[2] Swiss Trop & Publ Hlth Inst, Dept Epidemiol & Publ Hlth, Basel, Switzerland
[3] Minist Publ Hlth, Div Hlth Operat Res, Nonthaburi, Cameroon
[4] Univ Geneva, Fac Med, Inst Social & Prevent Med, Geneva, Switzerland
[5] Univ Yaounde I, Fac Med, Yaounde, Cameroon
[6] MA SANTE Meileur Acces Soins Sante, Dept Res & Training, Yaounde, Cameroon
[7] Univ Hosp, Dept Ambulatory Care & Community Med, Infect Dis Serv, Lausanne, Switzerland
来源：
HUMAN VACCINES & IMMUNOTHERAPEUTICS | 2020年 / 16卷 / 06期
关键词：
MenAfrivac (TM) safety; AEFI surveillance; clinical trials; immunization campaigns; EVENTS FOLLOWING IMMUNIZATION; ADVERSE EVENTS; IMMUNOGENICITY; COLLABORATION; MENINGITIS;
D O I：
10.1080/21645515.2019.1652041
中图分类号：
Q81 [生物工程学（生物技术）]; Q93 [微生物学];
学科分类号：
071005 ; 0836 ; 090102 ; 100705 ;
摘要：
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 (TM) published in English during 2001-2016 was done.AEFIs incidence (I) was estimated and compared between MenAfrivac (TM) 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 (TM) 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.
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收藏
页码：1245 / 1259
页数：15
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