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| Name | Class |
|---|---|
| China National Biotec Group Company Limited | INDUSTRY |
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This study is to evaluate the immunogenicity and safety of DTaP or DT given in children aged 6 years.
A phase 4 trial was conducted in Zhejiang Province aimed to evaluate the immunogenicity and safety of DTaP or DT in children aged 6 years. DTaP and DT are produced by Chengdu Institute of Biological Products Co., Ltd. Participants will be recruited and randomly divided into two groups to receive DTaP or DT in 1:1 ratio. Two blood samples were taken on Day 0 (pre-vaccination) and Day 28~42 (after-vaccination) for test antibody against pertussis, diphtheria and tetanus. Adverse events and serious adverse events were actively collected by staff within 28 days of vaccination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Group with DTap vaccination produced by Chendu Institute of Biological Products Co., Ltd |
|
| Group B | Experimental | Group with DT vaccination |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vaccinate with DTaP | Biological | vaccinate with DTaP |
| |
| vaccinate with DT |
| Measure | Description | Time Frame |
|---|---|---|
| Seroconversion rates of the vaccination | Defined as any positive antibody response against pertussis,diphtheria,tetanus in children who were seronegative prior to the vaccination, or at least a fourfold increase in antibody levels against pertussis for children who had pre-existing positive antibodies | 28-42 days after the dose of DTaP or DT |
| Seropositive rates after the vaccination | The percentage of participants with positive antibody against pertussis,diphtheria and tetanus. | 28-42 days after the dose of DTaP or DT |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of the DTaP or DT vaccine immunization | The occurrence of adverse events for vaccination administered at age 6 using DTaP or DT | 28 days after the vaccination |
| Geometric mean antibody concentrations before the vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hanqing He | Contact | +86 571 87115170 | hanqinghe@cdc.zj.cn | |
| Xuewen Tang | Contact | +86 571 87115171 | xwtang@cdc.zj.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuyang Center for Disease Control and Prevention | Hangzhou | Zhejiang | 311400 | China |
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| Biological |
vaccinate with DT |
|
The GMC against pertussis,diphtheria and tetanus
| before the dose of DTaP or DT |
| Geometric mean antibody concentrations after the vaccination | The GMC against pertussis,diphtheria and tetanus | 28-42 days after the dose of DTaP or DT |
| Tongxiang Center for Disease Control and Prevention | Jiaxing | Zhejiang | China |
|