Rapid assessment of the reactogenicity of a 2016-2017 seasonal influenza vaccine: results from a feasibility study.
Expert Rev Vaccines
; 16(2): 187-191, 2017 02.
Article
en En
| MEDLINE
| ID: mdl-27882801
BACKGROUND: ââThe European Medicines Agency (EMA) calls for a strategy for enhanced safety surveillance of seasonal influenza vaccines. OBJECTIVE: We assessed the feasibility of collecting reactogenicity data within one month of the start of the vaccination campaign in Belgium. METHODS: One hundred subjects aged 18 to 65 years who had received inactivated seasonal influenza vaccine in occupational setting were enrolled. For 7 days after vaccination, subjects received a daily SMS with a link to a web-based questionnaire where reactogenicity events and their severity were solicited. RESULTS: Data collection was completed by October 13th, 2016, before the peak of the vaccination campaign in Belgium. 68% of participants reported a local reaction and 65% a general reaction; 51% reported both a local and a general reaction. CONCLUSION: Here we show that it has been possible to collect reactogenicity data in adults for enhanced safety surveillance in Belgium in a timely manner. The observed reactogenicity is higher compared to previous observations for this vaccine measured in clinical trials.
Palabras clave
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Vigilancia de Productos Comercializados
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Vacunas contra la Influenza
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Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos
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Gripe Humana
Límite:
Adolescent
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Adult
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Aged
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Female
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Humans
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Male
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Middle aged
País/Región como asunto:
Europa
Idioma:
En
Revista:
Expert Rev Vaccines
Asunto de la revista:
ALERGIA E IMUNOLOGIA
Año:
2017
Tipo del documento:
Article
País de afiliación:
Bélgica
Pais de publicación:
Reino Unido