Study on Immunization Schedule of Beijing Tiantan Biological's Measles-mumps-rubella(MMR) Vaccine

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Comparison of Immunization Schedules of Beijing Tiantan Biological's MMR Vaccine in 18-72 Month-Old Children

Conditions
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Measles, Mumps, Rubella, Adverse Event Following Immunisation

Intervention / Treatment
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* Biological: Measles, mumps and rubella Combined Vaccine, Live


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy children; 150 subjects 18 months old; 150 subjects 4 years old;300 subjects 5 years old; 150 subjects 6 years old; their guardians signed informed consent; undiagnosed as measles, mumps and rubella; in good health as determined by the outcome of medical history, physical examination and clinical judgment; suitable to MMR immunization; guardians would comply with the requirements of the protocol; immunized with MR or measles vaccine(MV) at 8 months old;immunized with MMR at 18 months old(not applicable to subjects 18 months old); unvaccinated by biological products within one month; Axillary temperature ≤37℃; the local household population or permanent population; Exclusion Criteria: history of allergic disease or reactions likely to be exacerbated by any component of the vaccine(any previous vaccination history of allergies and egg allergy history); Current confirmed as acute disease, severe chronic diseases or acute development of chronic diseases; Participating in another clinical trial at the same time;

Ages Eligible for Study
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Minimum Age: 18 Months
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: one dose of MMR<br>Subjects are vaccinated with MMR(Measles, mumps and rubella Combined Vaccine, Live) on 18 months old. | Biological: Measles, mumps and rubella Combined Vaccine, Live<br>* Subjects will be inoculated one dose of MMR vaccine and collected blood samples before and after vaccination.<br>* Other names: Beijing Tiantan Biological Products Co., Ltd;|
| Other: 30 months after two doses of MMR<br>Subjects are vaccinated two doses of MMR(Measles, mumps and rubella Combined Vaccine, Live) on 18 month and 4 years old, sequentially. | Biological: Measles, mumps and rubella Combined Vaccine, Live<br>* Subjects will be inoculated one dose of MMR vaccine and collected blood samples before and after vaccination.<br>* Other names: Beijing Tiantan Biological Products Co., Ltd;|
| Other: 42 months after two doses of MMR<br>Subjects are vaccinated two doses of MMR(Measles, mumps and rubella Combined Vaccine, Live) on 18 month and 5 years old, sequentially. | Biological: Measles, mumps and rubella Combined Vaccine, Live<br>* Subjects will be inoculated one dose of MMR vaccine and collected blood samples before and after vaccination.<br>* Other names: Beijing Tiantan Biological Products Co., Ltd;|
| Other: 54 months after two doses of MMR<br>Subjects are vaccinated two doses of MMR(Measles, mumps and rubella Combined Vaccine, Live) on 18 month and 6 years old, sequentially. | Biological: Measles, mumps and rubella Combined Vaccine, Live<br>* Subjects will be inoculated one dose of MMR vaccine and collected blood samples before and after vaccination.<br>* Other names: Beijing Tiantan Biological Products Co., Ltd;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | through study completion, an average of 1 year |