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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Elsevier
2018-09-01
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| Series: | Farmacia Hospitalaria |
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| Online Access: | http://www.aulamedica.es/fh/pdf/10989.pdf |
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| author | María Fernández-Prada Carmen Martínez-Ortega Lara Hidalgo-Peña Clara Álvarez-Vázquez Rodrigo Aguirre-del Pino Ismael Huerta-González |
| author_facet | María Fernández-Prada Carmen Martínez-Ortega Lara Hidalgo-Peña Clara Álvarez-Vázquez Rodrigo Aguirre-del Pino Ismael Huerta-González |
| author_sort | María Fernández-Prada |
| collection | DOAJ |
| description | 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 evaluation was performed 24 hours after vaccination (“requested”) and during the first seven days (“not requested”).
Results: 72 patients were included (54.2% men, 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. |
| format | Article |
| id | doaj-art-dea5a1d210a64fdc979204e7a95e1790 |
| institution | Kabale University |
| issn | 1130-6343 2171-8695 |
| language | English |
| publishDate | 2018-09-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Farmacia Hospitalaria |
| spelling | doaj-art-dea5a1d210a64fdc979204e7a95e17902024-12-02T06:55:51ZengElsevierFarmacia Hospitalaria1130-63432171-86952018-09-01420519119610.7399/fh.10989Adverse reactions associated with meningococcal group B vaccine (4CMenB) in adults in special situationsMaría Fernández-Prada0Carmen Martínez-Ortega1Lara Hidalgo-Peña2Clara Álvarez-Vázquez3Rodrigo Aguirre-del Pino4Ismael Huerta-González5Vaccination Unit, Department of Preventive Medicine and Public Health, Hospital Universitario Central de Asturias, OviedoDepartment of Preventive Medicine and Public Health, Hospital Valle del Nalón, RiañoSchool of Medicine, Universidad de Oviedo, OviedoSchool of Medicine, Universidad de Oviedo, OviedoSchool of Medicine, Universidad de Oviedo, OviedoDepartment of Epidemiological Surveillance. Directorate General of Public Health, Regional Ministry of Health of the Principality of Asturias, Oviedo.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 evaluation was performed 24 hours after vaccination (“requested”) and during the first seven days (“not requested”). Results: 72 patients were included (54.2% men, 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.http://www.aulamedica.es/fh/pdf/10989.pdfmean age 52.5 years81.9% 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 reactionsbut 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 SurveillanceAdverse effects4CMenBMeningitisImmunocompromised patientsMeningococcus |
| spellingShingle | María Fernández-Prada Carmen Martínez-Ortega Lara Hidalgo-Peña Clara Álvarez-Vázquez Rodrigo Aguirre-del Pino Ismael Huerta-González Adverse reactions associated with meningococcal group B vaccine (4CMenB) in adults in special situations Farmacia Hospitalaria 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 |
| title | Adverse reactions associated with meningococcal group B vaccine (4CMenB) in adults in special situations |
| title_full | Adverse reactions associated with meningococcal group B vaccine (4CMenB) in adults in special situations |
| title_fullStr | Adverse reactions associated with meningococcal group B vaccine (4CMenB) in adults in special situations |
| title_full_unstemmed | Adverse reactions associated with meningococcal group B vaccine (4CMenB) in adults in special situations |
| title_short | Adverse reactions associated with meningococcal group B vaccine (4CMenB) in adults in special situations |
| title_sort | adverse reactions associated with meningococcal group b vaccine 4cmenb in adults in special situations |
| topic | 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 |
| url | http://www.aulamedica.es/fh/pdf/10989.pdf |
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