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

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

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.

Publication types

  • Research Support, Non-U.S. Gov't
  • Systematic Review

MeSH terms

  • Immunization Programs
  • Meningococcal Vaccines* / adverse effects
  • Neisseria meningitidis*
  • Vaccination
  • Vaccines, Conjugate / adverse effects

Substances

  • Meningococcal Vaccines
  • Vaccines, Conjugate

Grants and funding

This project was supported by M.A. SANTE