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| Name | Class |
|---|---|
| Beijing Tiantan Biological Products Co., Ltd. | INDUSTRY |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| one dose of MMR | Other | Subjects are vaccinated with MMR(Measles, mumps and rubella Combined Vaccine, Live) on 18 months old. |
|
| 30 months after two doses of MMR | Other | Subjects are vaccinated two doses of MMR(Measles, mumps and rubella Combined Vaccine, Live) on 18 month and 4 years old, sequentially. |
|
| 42 months after two doses of MMR | Other | Subjects are vaccinated two doses of MMR(Measles, mumps and rubella Combined Vaccine, Live) on 18 month and 5 years old, sequentially. |
|
| 54 months after two doses of MMR | Other | Subjects are vaccinated two doses of MMR(Measles, mumps and rubella Combined Vaccine, Live) on 18 month and 6 years old, sequentially. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Measles, mumps and rubella Combined Vaccine, Live | Biological | Subjects will be inoculated one dose of MMR vaccine and collected blood samples before and after vaccination. |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jiang Wu | Beijing Center for Diseases Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hebei Provincial Center for Disease Control and Prevention | Shijiazhuang | Hebei | 050021 | China | ||
| Inner Mongolia Center for Disease Control and Prevention |
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|
| Hohhot |
| Inner Mongolia |
| 010031 |
| China |
| Shanxi Provincial Center for Disease Control and Prevention | Taiyuan | Shanxi | 030012 | China |
| Tianjin Center for Disease Control and Prevention | Tianjin | Tianjin Municipality | 300011 | China |
| ID | Term |
|---|---|
| D008457 | Measles |
| D009107 | Mumps |
| D012409 | Rubella |
| ID | Term |
|---|---|
| D018185 | Morbillivirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D019351 | Rubulavirus Infections |
| D010309 | Parotitis |
| D010305 | Parotid Diseases |
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D018355 | Rubivirus Infections |
| D014036 | Togaviridae Infections |
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| ID | Term |
|---|---|
| D036881 | Long-Term Synaptic Depression |
| ID | Term |
|---|---|
| D009473 | Neuronal Plasticity |
| D009424 | Nervous System Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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