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| Name | Class |
|---|---|
| Yunnan Provincial Center for Disease Control and Prevention | UNKNOWN |
| Shaanxi Provincial Center for Disease Control and Prevention | OTHER |
| Guizhou Provincial Center for Disease Control and Prevention | UNKNOWN |
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The immunogenicity and safety of the adsorption of cell-free diphtheria and tetanus (three-component) combined vaccine were evaluated at 2 months, 4 months and 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DTacP | Experimental |
| |
| DTaP | Active Comparator |
| |
| DTacP-IPV/Hib | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DTacP | Biological | Vaccinate 1 dose at 2 months, 4 months, 6 months, 18-24 months and 6 years of age respectively, with each injection dose being 0.5 mlï¼›Injectionï¼› |
|
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity | The geometric mean concentration (GMC) of anti-PT antibody, anti-FHA antibody, anti-PRN antibody, anti-DT antibody, and anti-TT antibody at 30 days post-primary immunization | day 30 post-primary immunization |
| Immunogenicity | Seroconversion rates of anti-PT, anti-FHA, anti-PRN, anti-DT, and anti-TT antibodies at day 30 post-primary immunization | day 30 post-primary immunization |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity | Positivity rates of anti-PT, anti-FHA, anti-DT, and anti-TT antibodies at day 30 post-primary immunization | day 30 post-primary immunization |
| Immunogenicity | Proportions of subjects with anti-PRN antibody levels ≥5, ≥10, and ≥20 IU/mL at day 30 post-primary immunization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| huan xiao li | Contact | 0431-87078176 | lixiaohuan@bchtpharm.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yanshan County Center for Disease Control and Prevention | Recruiting | Wenshan Zhuang and Miao Autonomous Prefecture | Yunnan | 663100 | China |
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| Shandong Provincial Center for Disease Control and Prevention | UNKNOWN |
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| DTaP | Biological | Vaccinate 1 dose at 2 months, 4 months, 6 months, 18-24 months and 6 years of age respectively, with each injection dose being 0.5 ml.Injection |
|
| DTacP-IPV/Hib | Biological | Administer 1 dose at 2 months, 4 months, 6 months and 18 months of age respectively, with each injection dose being 0.5 ml.Injection |
|
| day 30 post-primary immunization |
| Immunogenicity | Geometric mean concentrations (GMCs) of anti-PT, anti-FHA, anti-PRN, anti-DT, and anti-TT antibodies at day 30 post-fourth booster immunization | day 30 post-fourth booster immunization |
| Immunogenicity | Seroconversion rates of anti-PT, anti-FHA, anti-PRN, anti-DT, and anti-TT antibodies at day 30 post-fourth booster immunization | day 30 post-fourth booster immunization |
| Immunogenicity | Positivity rates of anti-PT, anti-FHA, anti-DT, and anti-TT antibodies at day 30 post-fourth booster immunization | day 30 post-fourth booster immunization |
| Safety | Incidence of adverse events (AEs) and serious adverse events (SAEs) following each vaccination | At 12 months post-complete vaccination series |