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A phase III clinical trial to evaluate the immunogenicity and safety of freeze-dried human rabies vaccine (Vero cell) developed by Changchun Zhuoyi Biological Co., Ltd. inoculated in a 4-dose procedure (2-1-1)
It is to prove that the freeze-dried human rabies vaccine (Vero cell) in the population aged 10-60 years, the four dose vaccination program is not inferior to the five dose vaccination program, and the safty、antibody positive conversion rate and geometric mean concentration of the four dose group of the test vaccine are not inferior to the five dose program group 14 days after the first dose vaccination.
To compare the immunogenicity of people aged 10-60 years old who were vaccinated 6 and 12 months after the whole vaccination, so as to evaluate the antibody positive rate and GMT 6 and 12 months after the test vaccine was vaccinated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental 4 doses | Experimental | Inoculate experimental vaccine according to 2-1-1 immunization procedure |
|
| Experimental 5 doses | Experimental | Inoculate experimental vaccine according to 1-1-1-1-1 immunization procedure |
|
| SPEEDA® 4 doses | Active Comparator | Inoculate SPEEDA® according to 2-1-1 immunization procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rabies vaccine | Biological | The subjects were vaccinated with rabies vaccines with different immunization procedures, and the safety and immunogenicity were compared |
|
| Measure | Description | Time Frame |
|---|---|---|
| Antibody positive conversion rate of experimental groups | - Compare the Antibody positive conversion rate between two experimental groups 14 days after the first dose of inoculation. | 3 months |
| Antibody positive conversion rate of 4 doses groups | -Compare the Antibody positive conversion rate between the SPEEDA 4 doses group and experimental 4 doses group 14 days after the first dose of inoculation. | 3 months |
| Compare the GMT between two experimental groups | - Compare the GMT between two experimental groups 14 days after the first dose of inoculation. | 3 months |
| Geometric Mean Titer (GMT) of 4 doses groups | - Compare the GMT between the SPEEDA 4 doses group and the experimental 4 doses group 14 days after the first dose inoculation. | 3 months |
| Safety within 30 minutes | - Incidence rate of any local and systemic adverse events (AE) within 30 minutes after each dose of inoculation; | 3 months |
| Safety within 0-7 days | - Incidence rate of collected AE within 0-7 days after each dose of inoculation; | 3 months |
| Safety within 6 months | - Incidence rate of all serious adverse events (SAE) within 6 months from the first dose of inoculation to the full course of inoculation. |
| Measure | Description | Time Frame |
|---|---|---|
| Antibody test of 7 days. | - Antibody test 7 days after the first dose of inoculation. | 3 months |
| Antibody test after whole vaccination. | - Antibody test 14days after the whole vaccination. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Li Miao, Dr | Changchun Zhuoyi Biological Co., Ltd | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changchun Zhuoyi Biological Co., Ltd | Changchun | Jilin | 130000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38937182 | Derived | Jin F, Zhu L, Wang Y, Qin G, Tian Y, Xie Y, Jin H, Zhang Y, Wang L, Li J, Wu Z, Sheng Y, Shi L, Yang G, Zhao Z, Chen L, Chen P, Jiang Z, Yu J, Gao Z, Li Q, Wu X, Miao L. Randomized, blind, controlled phase III clinical trial: Assessing the immunogenicity and safety of freeze-dried human rabies vaccine (vero cell) with a 4-dose regimen (2-1-1) in a 10-60 year-old demographic. Vaccine. 2024 Oct 3;42(23):126059. doi: 10.1016/j.vaccine.2024.06.026. Epub 2024 Jun 27. |
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all results.
before December 2023.
public for all.
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| ID | Term |
|---|---|
| D011819 | Rabies Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| 9months |
| 3 months |
| Persistent observation within 12 months | - Antibody test in different points within 12 months after the whole vaccination. | 16 months |