This study will evaluate the immunogenicity and safety of Beijing Tiantan's MMR vaccine in subjects 18 months of age and older. The MMR vaccine may be administered as a second dose to 4-6 year-old persons with one dose immunization with MMR vaccine or as a first dose to 18 month-old subjects with one dose immunization with measles-rubella(MR).
This study will evaluate the immunogenicity and safety of Beijing Tiantan's MMR vaccine in subjects 18 months of age and older. The MMR vaccine may be administered as a second dose to 4-6 year-old persons with one dose immunization with MMR vaccine or as a first dose to 18 month-old subjects with one dose immunization with MR. Immune efficacy and safety will be compared among different immunization schedules,including inoculation doses,enhanced immunity age,vaccination interval time. Antibody persistence of 1 dose of MMR vaccine will be evaluated in this study.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
873
Subjects will be inoculated one dose of MMR vaccine and collected blood samples before and after vaccination.
Hebei Provincial Center for Disease Control and Prevention
Shijiazhuang, Hebei, China
Inner Mongolia Center for Disease Control and Prevention
Hohhot, Inner Mongolia, China
Shanxi Provincial Center for Disease Control and Prevention
Taiyuan, Shanxi, China
Tianjin Center for Disease Control and Prevention
Tianjin, Tianjin Municipality, China
Immunogenicity of the MMR vaccines in terms of antibody concentration
For measles virus, seroresponse is defined as post-vaccination anti-measles virus antibody concentration (Ab conc) \>200 mIU/mL. For mumps virus, seroresponse is defined as post-vaccination anti-mumps virus Ab conc \>100 IU/mL. For rubella virus, seroresponse is defined as post-vaccination anti-rubella virus Ab conc \>20 IU/mL.
Time frame: through study completion, an average of 1 year
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