Safety profile of the meningococcal conjugate vaccine (Menafrivac™) in clinical trials and vaccination campaigns: a review of published studies. Issue 6 (2nd June 2020)

• Record Type: Journal Article
• Authors: Ateudjieu, Jerome; Stoll, Beat; Bisseck, Anne Cecile; Tembei, Ayok M.; Genton, Blaise
• Is Part Of: Human vaccines & immunotherapeutics. Volume 16:Issue 6(2020)
• Page Start: 1245
• Page End: 1259
• Publication Date: 2020-06-02
• Subjects: MenAfrivac™ safety -- AEFI surveillance -- clinical trials -- immunization campaigns; Vaccines -- Periodicals; 615.372
• DOI: 10.1080/21645515.2019.1652041
• Languages: English
• ISSNs: 2164-5515

Abstract

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.