Résumé :
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[BDSP. Notice produite par INIST-CNRS VZl7R0xh. Diffusion soumise à autorisation]. Measles-mumps-rubella (MMR) vaccines containing the Urabe strain of mumps were withdrawn in the United Kingdom in 1992 following demonstration of an increased risk of aseptic meningitis 15-35 days after vaccination. Following introduction of a replacement MMR vaccine (Priorix ; GlaxoSmithKline, London, United Kingdom) in 1998, active surveillance of aseptic meningitis and convulsion was established to evaluate the risk associated with the new vaccine. No laboratory-confirmed cases of mumps meningitis were detected among children aged 12-23 months after administration of 1.6 million doses of Priorix (upper 95% confidence limit of risk : 1 : 437,000) in England and Wales. The upper 95% confidence limit excluded the risk found for mumps meningitis with Urabe vaccines (1 : 143,000 doses). No cases of aseptic meningitis were detected among children aged 12-23 months, who had received over 99,000 doses of Priorix (upper 95% confidence limit of risk : 1 : 27,000), in a regional database of hospital-admitted cases. This compares with an observed risk of 1 : 12,400 for Urabe vaccines. An elevated relative incidence of convulsion was found in the 6-to 11-day period after receipt of Priorix (relative incidence=6.26,95% confidence interval : 3.85,00.88) consistent with the known effects of the measles component of MMR vaccine-but not in the 15-to 35-day period (relative incidence=1.48,95% confidence interval : 0.88,2.50) as occurred with Urabe-containing vaccines. This study demonstrates the power of active postmarketing surveillance to identify or exclude events too rare to be detected in prelicensure trials.
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