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| Name | Class |
|---|---|
| Wuhan Institute of Biological Products Co., Ltd | INDUSTRY |
| Beijing Institute of Biological Products Co Ltd. | INDUSTRY |
| Shaanxi Provincial Center for Disease Control and Prevention | OTHER |
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Eligible,healthy infants will be recruited and divided into 3 groups:(1)combined immunization of sIPV and DTaP group, (2) sIPV group and (3) DTaP group. After completing the two basic vaccine EPI procedures, the immunogenicity and safety of the combined immunization group and the individual vaccination groups will be compared and analyzed.
It is recommended by China Food and Drug Administration (CFDA) that studies on simultaneous immunization of Sabin-IPV and DTaP be carried out as soon as possible, and the immunogenicity and safety studies should also be conducted. Currently in China the vaccination schedules of sIPV and DTaP overlap at infants' 3rd and 4th months of age. In order to avoid the vaccination time conflict and explore the possibility of simultaneous vaccination, we design this clinical study of simultaneous vaccination of the two vaccines.
To be specific, the subjects were divided into 3 groups. Group 1 : sIPV (1st, 2nd, and 3rd doses) and DTaP (1st, 2nd, and 3rd doses) were simultaneously inoculated at 3,4,5 months old ; Group 2 : received 1 dose of sIPV at 3,4,5 months old ; Group 3 : received 1 dose of DTaP at 3,4,5 months old . Blood sample would be collected both before vaccination and 28-40 days after the 3rd dose of vaccination. Neutralization antibody would also be detected to evaluate the seroprotection rates and antibody geometric mean concentrations. The safety of both immunization schedule will be monitored as well.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group 1 | Experimental | 234 subjects; simultaneously administration of Sabin-IPV and DTaP at the age of 3/4/5 months old, 0.5 ml each dose, respectively |
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| group 2 | Active Comparator | 234 subjects; Sabin-IPV only at the age of 3/4/5 months old, 0.5 ml each dose, respectively |
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| group 3 | Active Comparator | 234 subjects; DTaP only at the age of 3/4/5 months old, 0.5 ml each dose, respectively |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sabin-IPV and DTaP | Biological | Sabin-IPV +DTaP at the age of 3/4/5 months old respectively |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Seroconversion rate I | determine the rate of positive seroconversion against poliovirus type I, II and III of the 3 groups | 1 month after the 3rd dose |
| Seroconversion rate II | determine the positive seroconversion rate of anti-pertussis toxoid , anti- filamentous hemagglutinin, anti-diphtheria toxoid and anti-tetanic antibody of the 3 groups | 1 month after the 3rd dose |
| Neutralizing antibody titers I | Measure neutralizing antibody titers against poliovirus type I, II and III | 1 month after the 3rd dose |
| Neutralizing antibody titers II | Measure neutralizing antibody titers against diphtheria, pertussis toxoid, pertussis filamentous hemagglutinin, and tetanic of the 3 groups | 1 month after the 3rd dose |
| Measure | Description | Time Frame |
|---|---|---|
| safety outcomes | Adverse event following vaccinations | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shaobai ZHANG | Contact | +86-29-82231502 | maolyzhang@163.com | |
| Haiping CHEN | Contact | +86-10-84663393 | chenhaiping@sinopharm.com |
| Name | Affiliation | Role |
|---|---|---|
| Shaobai ZHANG | Shaanxi Provincial Center for Disease Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shaanxi Provincial Center for Disease Control and Prevention | Recruiting | Xi'an | Shaanxi | 710054 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40969746 | Derived | Liu X, Han S, Chen X, Sun L, Wang R, Shi X, Guo Y, Wang H, Chen H, Chang S, Xu X, Zhang C, Wang Y, Zhang D, Hu W, Zhang S. Immunogenicity and safety of co-administration with the Sabin-strain-based inactivated poliovirus vaccine (vero cell) and the diphtheria-tetanus-acellular pertussis vaccine in eligible children in China: a randomized, controlled, multicenter, non-inferiority trial. Front Immunol. 2025 Sep 3;16:1633170. doi: 10.3389/fimmu.2025.1633170. eCollection 2025. |
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| Hubei Provincial Center for Disease Control and Prevention | OTHER |
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| Sabin-IPV |
| Biological |
Sabin-IPV only at the age of 3/4/5 months old respectively |
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| DTaP | Biological | DTaP only at the age of 3/4/5 months old respectively |
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