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A single-center and single-arm design was used to evaluate the safety and preliminary immunogenicity of the adsorbed cell-free leukiche (three-component) combination vaccine.Main purpose: To evaluate the safety of the adsorbed cell-free whitening break (three components) combination vaccine;Secondary purpose: To preliminarily evaluate the immunogenicity of the adsorbed cell-free whitening break (three components) combination vaccine.
Main endpoint:
Secondary endpoint:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adsorbed a cell-free whitening break (three-component) combination vaccine | Experimental | A single-center and single-arm design was used to evaluate the safety and preliminary immunogenicity of the adsorbed cell-free leukiche (three-component) combination vaccine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A single-center and single-arm design was used to evaluate the safety and preliminary immunogenicity of the adsorbed cell-free leukiche (three-component) combination vaccine | Biological | A single-center and single-arm design was used to evaluate the safety and preliminary immunogenicity of the adsorbed cell-free leukiche (three-component) combination vaccine |
| Measure | Description | Time Frame |
|---|---|---|
| The safety of the adsorbed cell-free whitening break (three-component) combination vaccine was evaluated |
| Ten months |
| Measure | Description | Time Frame |
|---|---|---|
| Immunimmunogenicity of the cell-free (three-component) combination vaccine was evaluated |
|
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Inclusion Criteria:
Exclusion Criteria:
The 2 and 3rd vaccination exclusion / delay criteria:
Exclusion criteria The investigator will terminate the subject vaccination trial vaccine if any of the following occurs.
Delay the standard If any of the following conditions occur, the investigator will delay vaccination until the situation eases.The delay in vaccination should be kept within the specified time window (see: study flowchart).
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaoping Zhu | Contact | 0852-85596863 | xiaopingzhu98@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Santai County Center for Disease Control and Prevention | Recruiting | Mianyang | Sichuan | 621100 | China |
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|
| Ten months |
| ID | Term |
|---|---|
| D017778 | Vaccines, Combined |
| ID | Term |
|---|---|
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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