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...

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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
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