To evaluate the immunogenicity, lot-to-lot consistency and safety of three consecutive batches of Measles, Mumps and Rubella Combined Vaccine, Live.
To assess Measles Mumps and Rubella Combined Vaccine, Live, (MMR) lot-to-lot consistency in healthy Chinese Children at the age of 8-12 months, and the participants randomized to receive one injections of 0.5 mL Measles, Mumps and Rubella Combined Vaccine, Live at day 0.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
1,068
0.5ml of reconstituted vaccine per container. 0.5 ml per single human dose containing not less than 3.0 lg CCID50 of both live measles virus and rubella virus and 4.3 lg CCID50 of live mumps virus.
Jiangsu Provincial Center for Disease Control and Prevention
Nanjing, Jiangsu, China
The geometric mean concentrations (GMC)
GMC of measles, mumps and rubella antibodies should be compared 42 days after vaccination, and detected by enzyme-linked immunosorbent assay (ELISA).
Time frame: 42 days
The positive conversion rate of antibodies
1\. The positive conversion rate of antibodies to measles, mumps and rubella in each group 42 days after vaccination.The seroconversion rate refers to the proportion of subjects whose serum antibodies are negative before vaccination, which turn positive after vaccination, or serum antibodies are positive before vaccination, which increased by 4 times or more after vaccination.
Time frame: 42 days
The Seropositivity rate
The seroprevalence rate refers to the proportion of subjects whose serum antibodies are positive. The cut-off for seropositivity for the antibody titers is as follows: 1. Anti-measles IgG antibody concentration by ELISA of \>200 mIU/mL. 2. Anti-mumps IgG antibody concentration by ELISA of \>100 U/mL. 3. Anti-rubella IgG antibody concentration by ELISA of \>20 IU/mL
Time frame: 42 days
The incidence of adverse events within 14 days
The incidence of adverse events within 14 days after vaccination
Time frame: 14 days
All adverse events
All adverse events from day 0 to 42 after vaccination
Time frame: 42 days
Serious adverse events
Serious adverse events within 6 months after vaccination
Time frame: 180 days
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