Report from enhanced safety surveillance of two influenza vaccines (Vaxigrip and Intanza 15 µg) in two European countries during influenza season 2016/17 and comparison with 2015/16 season.
Hum Vaccin Immunother
; 14(2): 378-385, 2018 02 01.
Article
en En
| MEDLINE
| ID: mdl-29148911
ABSTRACT
Passive enhanced safety surveillance (ESS) was implemented in the United Kingdom and in the Republic of Ireland for Vaxigrip and Intanza 15 µg influenza vaccines during the 2016/17 influenza season. Lessons learned during 2015/16 ESS implementation were integrated and applied towards the current ESS. The primary objective was to estimate the reporting rates of suspected adverse reactions (ARs) occurring within 7 days of vaccination with Vaxigrip or Intanza 15 µg. For Vaxigrip (N = 962), 17 vaccinees (1.8%) reported 59 suspected ARs (6.1%) within 7 days of vaccination. For Intanza 15 µg (N = 1000), 21 vaccinees (2.1%) reported 101 (10.1%) suspected ARs within 7 days of vaccination. No obvious pattern in the type of suspected ARs or their frequency was observed for either vaccine. None of the frequencies of suspected ARs were above the 2015/16 ESS frequencies for Vaxigrip, whereas for Intanza 15 µg only one AR (oropharyngeal pain) crossed the historical threshold. There was no change in reactogenicity and data was consistent with the safety profiles of the two vaccines. The passive ESS experience gained from season to season will help to contribute to a sustainable safety surveillance system of seasonal influenza vaccines early in the season.
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Texto completo:
1
Bases de datos:
MEDLINE
Asunto principal:
Vigilancia de Productos Comercializados
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Vacunas contra la Influenza
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Gripe Humana
Tipo de estudio:
Clinical_trials
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Observational_studies
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Screening_studies
Límite:
Adolescent
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Adult
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Aged
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Child
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Child, preschool
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Humans
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Infant
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Middle aged
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Newborn
País/Región como asunto:
Europa
Idioma:
En
Revista:
Hum Vaccin Immunother
Año:
2018
Tipo del documento:
Article
País de afiliación:
Francia