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The purpose of this single-centre, randomized, double-blind, parallel control, phase 3 study is to evaluate the safety and immunogenicity of a rabies vaccine (Vero Cell) for human use in healthy Chinese subjects aged 10-60 years, according to the Essen methods (1-1-1-1-1) vaccination.
There will be two immunization arms. 1200 healthy subjects will be randomly assigned (1:1) to receive an experimental vaccine or a parallel comparator vaccine. All of them will be received five doses of rabies vaccine at day 0,3,7,14,28 according to the traditional Essen methods (1-1-1-1-1) vaccination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Changchun Werersai | Experimental | A rabies vaccine (Vero Cell) for human use produced by Changchun Werersai Biotech Pharmaceutical Co., Ltd. |
|
| Jilin Maifeng | Active Comparator | A rabies vaccine (Vero Cell) for human use produced by Jilin Maifeng Biotech Pharmaceutical Co., Ltd. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Changchun Werersai | Biological | A rabies vaccine (Vero Cell) for human use produced by Changchun Werersai Biotech Pharmaceutical Co., Ltd. 1.0 ml experimental vaccine on day 0,3,7,14,28 |
| Measure | Description | Time Frame |
|---|---|---|
| Positive seroconversion rate of serum rabies virus neutralizing antibody 42 days after full vaccination | 42 days after full vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric mean concentration (GMC) of serum rabies virus neutralizing antibody 42 days after full vaccination | 42 days after full vaccination | |
| Positive seroconversion rate of serum rabies virus neutralizing antibody 14 days after full vaccination | 14 days after full vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yuemei Hu | Jiangsu Provincial Center for Diseases Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xinyi Center for Disease Control and Prevention | Xuzhou | Jiangsu | 221400 | China |
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| ID | Term |
|---|---|
| D011818 | Rabies |
| ID | Term |
|---|---|
| D018353 | Rhabdoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
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| Jilin Maifeng | Biological | A rabies vaccine (Vero Cell) for human use produced by Jilin Maifeng Biotech Pharmaceutical Co., Ltd. 1.0 ml comparator vaccine on day 0,3,7,14,28 |
|
| Geometric mean concentration (GMC) of serum rabies virus neutralizing antibody 14 days after full vaccination | 14 days after full vaccination |
| Incidence of local and systemic adverse reactions during safety observation period after each vaccination | 0-7 days after each vaccination and 8-28 days after the fifth vaccination |
| D007239 | Infections |