論文ID: JJID.2020.876
In Japan, domestic combined measles, mumps, and rubella (MMR) vaccines were withdrawn in 1993 due to serious aseptic meningitis attributed to the mumps component. KM-248 is an MMR vaccine (M-M-R® II), manufactured by Merck & Co., Inc. (Kenilworth, NJ, USA), registered and approved in 74 countries, but not approved in Japan. In this multicenter, randomized, single-blind study, the primary endpoints were; noninferiority of KM-248 measles component immunogenicity compared to control measles vaccine already approved in Japan and seroconversion rates for these three viruses by KM-248. Vaccination with KM-248 in children 12 - 90 months of age (n = 178) induced robust immune responses to measles, mumps and rubella viruses. It was confirmed that the seroconversion rate for measles virus by the measles vaccine component of KM-248 (n = 172) was non-inferior to that of the control measles vaccine (n = 85). No serious adverse reactions such as aseptic meningitis and anaphylaxis were observed. Fever is one of the most common adverse reactions associated with vaccination and was observed in approximately half of the participants. KM-248 administered to healthy Japanese children aged between 12 and 90 months demonstrated general comparability with respect to safety and immunogenicity compared to the control vaccine.
