The Safety and Immunogenicity of a Trivalent, Live, Attenuated MMR Vaccine, Priorix (TM)

Ahn, Seung In; Chung, Min Kook; Yoo, Jung Suk; Chung, Hye Jeon; Hur, Jae Kyun; Shin, Young Kyu; Chang, Jin Keun; Cha, Sung Ho

Abstract

PURPOSE
This multi-center, open-label, clinical study was designed to evaluate the safety and immunogenicity of a trivalent, live, attenuated measles-mumps-rubella (MMR) vaccine, Priorix (TM) in Korean children. METHODS: From July 2002 to February 2003, a total of 252 children, aged 12-15 months or 4-6 years, received Priorix (TM) at four centers: Han-il General Hospital, Kyunghee University Hospital, St. Paul's Hospital at the Catholic Medical College in Seoul, and Korea University Hospital in Ansan, Korea. Only subjects who fully met protocol requirements were included in the final analysis. The occurrence of local and systemic adverse events after vaccination was evaluated from diary cards and physical examination for 42 days after vaccination. Serum antibody levels were measured prior to and 42 days post-vaccination using IgG ELISA assays at GlaxoSmithKline Biologicals (GSK) in Belgium. RESULTS: Of the 252 enrolled subjects, a total of 199 were included in the safety analysis, including 103 from the 12-15 month age group and 96 from the 4-6 year age group. The occurrence of local reactions related to the study drug was 10.1 percent, and the occurrence of systemic reactions was 6.5 percent. There were no episodes of aseptic meningitis or febrile convulsions, nor any other serious adverse reaction. In immunogenicity analysis, the seroconversion rate of previously seronegative subjects was 99 percent for measles, 93 percent for mumps and 100 percent for rubella. Both age groups showed similar seroconversion rates. The geometric mean titers achieved, 42 days post- vaccination, were: For measles, in the age group 12-15 months, 3, 838.6 mIU/mL [3, 304.47, 4, 458.91]; in the age group 4-6 years, 1, 886.2 mIU/mL [825.83, 4, 308.26]. For mumps, in the age group 12-15 months, 956.3 U/mL [821.81, 1, 112.71]; in the age group 4-6 years, 2, 473.8 U/mL [1, 518.94, 4, 028.92]. For rubella, in the age group 12-15 months, 94.5 IU/mL [79.56, 112.28]; in the age group 4-6 years, 168.9 IU/mL [108.96, 261.90]. CONCLUSION: When Korean children in the age groups of 12-15 months or 4-6 years were vaccinated with GlaxoSmithKline Biologicals' live attenuated MMR vaccine (Priorix (TM) ), adverse events were limited to those generally expected with any live vaccine. Priorix (TM) demonstrated excellent immunogenicity in this population.