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Hum Vaccin Immunother. 2019 Sep 5:1-15. doi: 10.1080/21645515.2019.1652041. [Epub ahead of print]

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

Author information

1
Department of Biomedical Sciences, Faculty of Sciences, University of Dschang , Dschang , Cameroon.
2
Department of Epidemiology and Public Health, Swiss Tropical and Public Health Institute , Basel , Switzerland.
3
Division of Health Operations Research, Ministry of Public Health , Nonthaburi , Cameroon.
4
Institute of Social and Preventive Medicine, Faculty of Medicine, University of Geneva , Geneva , Switzerland.
5
Faculty of Medicine, University of Yaounde 1 , Yaounde , Cameroon.
6
Department of Research and Training, M.A. SANTE (Meileur Accès aux soins de santé) , Yaounde , Cameroon.
7
Department of Ambulatory Care and Community Medicine-Infectious Disease Service, University Hospital , Lausanne , Switzerland.

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.

KEYWORDS:

AEFI surveillance; MenAfrivac™ safety; clinical trials; immunization campaigns

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