Adverse reactions associated with meningococcal group B vaccine (4CMenB) in adults in special situations

Adverse reactions associated with meningococcal group B vaccine (4CMenB) in adults in special situations

Objective: To know the safety profile of the 4CMenB vaccine in adults in special situations. Method: Security prospective study of phase IV. Inclusion criteria and some vaccination conditions were applied. The adverse reactions described in the data sheet were collected. The adverse reactions eva...

Full description

Saved in:
Bibliographic Details
Main Authors: María Fernández-Prada, Carmen Martínez-Ortega, Lara Hidalgo-Peña, Clara Álvarez-Vázquez, Rodrigo Aguirre-del Pino, Ismael Huerta-González
Format: Article
Language:English
Published: Elsevier 2018-09-01
Series:Farmacia Hospitalaria
Subjects:
mean age 52.5 years
81.9% anatomic asplenia). The frequency of fever > 38 ºC in the first 24 hours of vaccination was higher than the observed in the summary of product characteristics for the group of adults (12.5% vs. not known). More than 75% of the patients reported local pain in the first hours [average of the Analog Visual Scale score 3.22 (95% CI: 2.67-3.76) in the first dose and 3.23 (95% CI: 2.69-3.78) in the second dose]. There were no statistically significant differences. 97.22% registered symptoms until 7 days after vaccination. Conclusions: 4CMenB® shows a good safety profile in adults in special situations. The frequency of fever > 38 ºC is higher than expected. Local pain is the most frequently recorded adverse reactions
but the intensity is low. These results suggest a review of the situation in order to suggest a possible modification of the summary of product characteristics of the vaccine.
Postmarketing Drug Surveillance
Adverse effects
4CMenB
Meningitis
Immunocompromised patients
Meningococcus
Online Access:http://www.aulamedica.es/fh/pdf/10989.pdf
Tags: Add Tag
No Tags, Be the first to tag this record!

Internet

http://www.aulamedica.es/fh/pdf/10989.pdf

Similar Items