Is effective Bexsero for invasive meningococcal disease prevention?

Abstract

INTRODUCTION: Invasive Meningococcal Disease (IMD) is considerated as a Major Health Problem and it causes substantial morbidity and mortality. It is caused by Neisseria Meningitidis. This pathology especially affects children under 5 years old and teenagers, although it can occur at any life stage. In fact, in our environment N. Meningitids is the first cause of bacterial meningitis in children > 3 months, and specifically N. Meningitids serogroup B is the most usually involved. Recently, a new vaccine called Bexsero has been deveolped and commercialised for IMD prevention due to serogroup B. However, the use of that vaccine is highly controversial because few information about its effectiveness is available. Even so, paediatricians as well as organisations like “Comité Asesor de Vacunas” encourage parents to vaccinate their children with Bexsero. OBJECTIVE: this study aims to assess the effectiveness of Bexsero for Invasive Meningococcal Disease prevention in children under 5 years old. Moreover, the study will provide useful information about the possible association among being vaccinated with Bexsero and have a greater proportion of adverse reactions. DESIGN: This is an observational prospective cohort study. METHODOLOGY: In this study we will have two groups: vaccinated with Bexsero (cohort 1) and Unvaccinated with Bexsero (cohort 2). Then, we will perform a 5 years follow-up and we will compare the incidence of IMD registered in both groups. We will expect a significant reduction in incidence of IMD in children that have been vaccinated