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To evaluate the non inferiority of the immunogenicity of the test vaccine inoculated according to the four dose immunization program over the five dose immunization program and the batches consistency of immunogenicity according to five dose immunization procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 4 doses | Experimental | Inoculate rabies vaccine according to 1-1-1-1 immunization procedure |
|
| 5 doses | Experimental | Inoculate rabies vaccine according to 1-1-1-1-1 immunization procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| immunization procedures | Biological | The subjects were vaccinated with rabies vaccine according to different immunization procedures |
|
| Measure | Description | Time Frame |
|---|---|---|
| Positive conversion rate of 14 days | - 14 days after the first dose of inoculation, the positive conversion rate of serum neutralizing antibody. | 6 months |
| Antibody Geometric Mean Titer (GMT) of 14 days | - 14 days after the first dose of inoculation, the Geometric Mean Titer (GMT) of serum neutralizing antibody . | 6 months |
| Positive conversion rate of 42 days | - The seroconversion rate of serum neutralizing antibody that 42 days after the first dose of inoculation. | 6 months |
| Advertise Events (AE) incidence within 1 month | - The distribution of AE incidence in different time periods (including all, within 30 minutes, 0-3 days, 0-7 days, 8-30 days) after each dose of inoculation; | 6 months |
| Serious Adverse Events (SAE) incidence within 6 months | - Incidence rate of SAE within 6 months from the first dose of inoculation to the full course of inoculation. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Antibody test of 28 days | Detection of serum neutralizing antibody 28 days after the first dose of inoculation | 6 months |
| Antibody GMT of 42 days | The serum neutralized antibody GMT 42 days after the first dose of inoculation; |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Li Miao | Changchun Zhuoyi Biological Co., Ltd | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changchun Zhuoyi Biological Co., Ltd | Changchun | Jilin | 130000 | China |
safety and antibody results.
before December 2024.
public to all.
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| 6 months |
| Antibody test within 12 months | The serum neutralizing antibody was detected in 3 timepoints within 12 months after the whole vaccination. | 18months |