Objective To observe the adverse reaction and immunogenicity induced by domestic freeze-dried live attenuated measles-mumps-rubella （MMR） combined vaccine. Methods Perform clinical trials of phases Ⅰ, Ⅱ and Ⅲ on domestic live attenuated MMR vaccine in children aged 7 ～ 15 years and infants aged 8-18 months respectively, using imported MMR vaccine as well as domestic monovalent measles vaccine, mumps vaccine and rubella vaccine as control. Results In clinical trial phase Ⅰ, mild local reactions were observed in only 3 （27.3%） of 11 children at ages of 7 ～ 15 years after inoculation with domestic MMR vaccine. In the 26 infants inoculated with domestic MMR vaccine, at ages of 8 - 11 months, the incidences of fever, rash and high fever were 11.5%, 15.4% and 3.8% respectively. However, in 1188 infants aged 8 ～18 months in clinical trials phases Ⅱ and Ⅲ, the incidences of fever, rash, local reaction and other reactions after inoculation with domestic MMR vaccine were 10. 69%, 3. 64%, 0. 44% and 0. 22% respectively. The incidence of fever after inoculation with domestic MMR vaccine was significantly higher than those with mumps vaccine and with rubella vaccine. However, the incidences of other adverse reactions after inoculation with domestic MMR vaccine showed no significant difference with those with control vaccines. The positive rates of HI antibodies against measles, mumps and rubella induced by domestic MMR vaccine were 99. 5%, 85. 9% and 100%, while the antibody GMTs were 1 ： 57, 1 ： 4. 2 and 1 ： 890 respectively. The GMT of antibody against measles induced by domestic MMR vaccine was significantly higher than those by imported MMR vaccine and by measles vaccine. However, the GMT of antibody against mumps induced by domestic MMR vaccine was significantly lower than that by imported MMR vaccine. Conclusion The domestic MMR vaccine showed good safety and immunogenicity.
Chinese Journal of Bilogicals