Resumen

JIMENEZ, Giset  y  CUEVAS, Iván E. Safety profile of the trivalent leptospirosis vaccine vax-SPIRAL^®. Vaccimonitor [online]. 2010, vol.19, n.3, pp.1-7. ISSN 1025-028X.

A cross-sectional descriptive study was performed to show the safety profile of the leptospirosis vaccine vax-SPIRAL^®, based on the database of the drug pharmacosurveillance national net. The frequency of reports of the administered-vaccine doses was estimated as well as the assessment of causality, severity, location and adverse events with greater statistical association from the calculation of disproportional combinations of adverse events/vaccinations of all diagnoses in reports of events of vaccines pharmacological group by the calculation of the Proportional Risk Ratio (PRR) and the Reporting Odds Ratio (ROR). There were 1.62 reports per 100 000 doses administered and 1.9 diagnoses for individual report of adverse events in people from 18-77 years of age, and a mean ± SD of 40 ± 13 years (range 27-53 years) being female the predominant sex (65.54%). There were no serious cases, and 74.17% were reported with mild severity. The 94.17% of reports were related to the vaccine while 66.97% were systemic adverse events. The most common diagnoses were fever/hyperthermia (18.75%), headache (14.73%), local pain (13.84%), redness/erythema at the site of injection/flushing (12.05%) and general malaise (8.48%). Hypersensitivity manifestations were minimum and only at skin level. The events that showed greater statistical association were headache, malaise and flushing. The results obtained were similar and better than the safety profile of the French vaccine SPIROLEPT. The acceptable safety profile of vax-SPIRAL^® makes it suitable for the protection of Leptospirosis risk groups.

Palabras clave : Leptospirosis vaccine; Vaccine safety; Pharmacosurveillance.

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