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| Name | Class |
|---|---|
| Beijing Minhai Biotechnology Co., Ltd | INDUSTRY |
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The purpose of this study is to evaluate the safety and immunogenicity of freeze-dried rabies vaccine (MRC-5 cells)in different age health human populations, according to the traditional Essen methods (1-1-1-1-1) vaccination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2.5IU/ml in humans aged 10-20 years old | Experimental | freeze-dried rabies vaccines(MRC-5 cell) of 2.5IU/ml in 200 humans aged 10-20 years old on days 0,3,7,14,28 |
|
| 2.5IU/ml in humans aged 21-50 | Experimental | freeze-dried rabies vaccines(MRC-5 cell) of 2.5IU/ml in 200 humans aged 21-50 years old on days 0,3,7,14,28 |
|
| 2.5IU/ml in humans aged 51-60 | Experimental | freeze-dried rabies vaccines(MRC-5 cell) of 2.5IU/ml in 200 humans aged 51-60 years old on days 0,3,7,14,28 |
|
| 2.5IU/ml in humans(from 10-20 years old) | Placebo Comparator | freeze-dried rabies vaccines(vero cell) of 2.5IU/ml in 200 humans aged 10-20 years old on days 0,3,7,14,28 |
|
| 2.5IU/ml in humans(from 21-50 years old) | Placebo Comparator | freeze-dried rabies vaccines(vero cell) of 2.5IU/ml in 200 humans aged 21-50 years old on days 0,3,7,14,28 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2.5IU/ml rabies vaccine(MRC-5 cell) in humans aged 10-20 years old | Biological | freeze-dried rabies vaccine(MRC-5 cell) of 2.5IU/ml, 5 doses, 4 weeks interval |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the safety of freeze-dried rabies vaccine(MRC-5 cell) in chinese humans | Adverse reactions associated with vaccine | within the first 4 weeks after the first vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the immunogenicity of freeze-dried rabies vaccine(MRC-5 cell) in chinese humans | Examination of the value of IgE antibody | within the first 4 weeks after the first vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| 2.5IU/ml in humans(from 51-60 years old) | Placebo Comparator | freeze-dried rabies vaccines(vero cell) of 2.5IU/ml in 200 humans aged 51-60 years old on days 0,3,7,14,28 |
|
| 2.5IU/ml rabies vaccine(MRC-5 cell) in humans aged 21-50 years old | Biological | freeze-dried rabies vaccine(MRC-5 cell) of 2.5IU/ml, 5 doses, 4 weeks interval |
|
| 2.5IU/ml rabies vaccine(MRC-5 cell) in humans aged 51-60 years old | Biological | freeze-dried rabies vaccine(MRC-5 cell) of 2.5IU/ml, 5 doses, 4 weeks interval |
|
| 2.5IU/ml rabies vaccine(vero cell) in humans aged 10-20 years old | Biological | freeze-dried rabies vaccine(vero cell) of 2.5IU/ml, 5 doses, 4 weeks interval |
|
| 2.5IU/ml rabies vaccine(vero cell) in humans aged 21-50 years old | Biological | freeze-dried rabies vaccine(vero cell) of 2.5IU/ml, 5 doses, 4 weeks interval |
|
| 2.5IU/ml rabies vaccine(vero cell) in humans aged 51-60 years old | Biological | freeze-dried rabies vaccine(vero cell) of 2.5IU/ml, 5 doses, 4 weeks interval |
|