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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Participants randomized to receive one injections of 0.5 mL Measles, Mumps and Rubella Combined Vaccine, Live at Day 0. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Measles, Mumps and Rubella Combined Vaccine, Live | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 42 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Provide vaccination certificate and birth certificate for healthy children aged 8-12 months;
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hongxing Pan | Jiangsu Provincial Center for Disease Prevention and Control | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiangsu Provincial Center for Disease Control and Prevention | Nanjing | Jiangsu | China |
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| 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:
| 42 days |
| The incidence of adverse events within 14 days | The incidence of adverse events within 14 days after vaccination | 14 days |
| All adverse events | All adverse events from day 0 to 42 after vaccination | 42 days |
| Serious adverse events | Serious adverse events within 6 months after vaccination | 180 days |