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| Name | Class |
|---|---|
| Shaanxi Provincial Center for Disease Control and Prevention | OTHER |
| Hubei Provincial Center for Disease Control and Prevention | OTHER |
| Beijing Institute of Biological Products Co Ltd. | INDUSTRY |
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Eligible,healthy infants who have finished the 3-dose-schedule of sIPV+DTaP combined vaccination clinical trial (NCT04053010) will be recruited and divided into 4 groups, and will receive vaccination at the age of 18-month-old as follows:
The immunogenicity and safety of the 4 groups will be compared and analyzed before and 30-40 days after vaccination.
Following the clinical trial of "Combined Immunization of sIPV and DTaP" in 2019, this study recruits 600 18-month-old subjects who have received 3 doses of sIPV + DTaP, and gives them a 4th dose of vaccination (booster immunization). They are divided into 4 different groups, with 150 subjects in each group, and are innoculated with different vaccines.
To be specific, group 1 receives sIPV (0.5ml)+ DTaP (0.5ml)+ HepA(0.5ml); group 2 receives sIPV (0.5ml); group 3 receives DTaP (0.5ml); group 4 receives HepA (0.5ml).
Blood samples will be collected before vaccination and 30-40 days after this booster immunization. Neutralization antibody will 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 (sIPV+DTaP+HepA) | Experimental | 150 subjects; simultaneously administration of sIPV+DTaP+HepA as booster immunization at the age of 18 months old, 0.5 ml each, respectively |
|
| group 2 (sIPV) | Active Comparator | 150 subjects; vaccination of 0.5 ml sIPV as booster immunization at the age of 18 months old |
|
| group 3 (DTaP) | Active Comparator | 150 subjects; vaccination of 0.5 ml DTaP as booster immunization at the age of 18 months old |
|
| group 4 (HepA) | Active Comparator | 150 subjects; vaccination of 0.5 ml HepA as booster immunization at the age of 18 months old |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sIPV+DTaP+HepA | Biological | sIPV+DTaP+HepA at the age of 18 month old |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Seroconversion rate (sIPV) | determine the rate of positive seroconversion against poliovirus type I, II and III of the subjects | Baseline (before vaccination) results |
| Seroconversion rate (sIPV) | determine the rate of positive seroconversion against poliovirus type I, II and III of the subjects | Results obtained 30-40 days after vaccination |
| Seroconversion rate (DTaP) | determine the positive seroconversion rate of anti-pertussis toxoid , anti- filamentous hemagglutinin, anti-diphtheria toxoid and anti-tetanic antibody of the subjects | Baseline (before vaccination) results |
| Seroconversion rate (DTaP) | determine the positive seroconversion rate of anti-pertussis toxoid , anti- filamentous hemagglutinin, anti-diphtheria toxoid and anti-tetanic antibody of the subjects | Results obtained 30-40 days after vaccination |
| Seroconversion rate (HepA) | determine the rate of positive seroconversion rate of anti-hepatitis A virus antibody of the subjects | Baseline (before vaccination) results |
| Seroconversion rate (HepA) | determine the rate of positive seroconversion rate of anti-hepatitis A virus antibody of the subjects | Results obtained 30-40 days after vaccination |
| Geometric Mean Concentration (GMC) (sIPV) |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events Following Immunization (AEFI) | analyse the incidence of adverse events following immunization, both solicited and unsolicited | 0-6 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 |
| Name | Affiliation | Role |
|---|---|---|
| Shaobai Shaobai | Shaanxi Provincial Center for Disease Control and Prevention | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hebei Provincial Center for Disease Control and Prevention | Recruiting | Shijiazhuang | Hebei | 050024 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41151164 | Derived | Liu X, Han S, Wang H, Sun L, Zhang C, Chen X, Wang R, Chang S, Shi X, Chen H, Wang Y, Zhang D, Guo Y, Zhang S, Hu W. Immunogenicity and safety of co-administration of sabin-strain-based inactivated poliovirus vaccine, diphtheria-tetanus-acellular pertussis vaccine, and live attenuated hepatitis A vaccine in 18-month-old children: A multicenter randomized controlled non-inferiority trial in China. Vaccine. 2025 Nov 20;67:127891. doi: 10.1016/j.vaccine.2025.127891. Epub 2025 Oct 27. |
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| sIPV |
| Biological |
sIPV at the age of 18 month old |
|
| DTaP | Biological | DTaP at the age of 18 month old |
|
| HepA | Biological | HepA at the age of 18 month old |
|
GMCs of poliovirus type I, II and III of the subjects
| Baseline (before vaccination) results |
| Geometric Mean Concentration (GMC) (sIPV) | GMCs of poliovirus type I, II and III of the subjects | Results obtained 30-40 days after vaccination |
| Geometric Mean Concentration (GMC) (DTaP) | GMCs of anti-pertussis toxoid , anti- filamentous hemagglutinin, anti-diphtheria toxoid and anti-tetanic antibody of the subjects | Baseline (before vaccination) results |
| Geometric Mean Concentration (GMC) (DTaP) | GMCs of anti-pertussis toxoid , anti- filamentous hemagglutinin, anti-diphtheria toxoid and anti-tetanic antibody of the subjects | Results obtained 30-40 days after vaccination |
| Geometric Mean Concentration (GMC) (HepA) | GMCs of anti-hepatitis A virus antibody of the subjects | Baseline (before vaccination) results |
| Geometric Mean Concentration (GMC) (HepA) | GMCs of anti-hepatitis A virus antibody of the subjects | Results obtained 30-40 days after vaccination |
| Shaanxi Provincial Center for Disease Control and Prevention | Recruiting | Xi'an | Shaanxi | 710054 | China |
|
| Shanxi Provincial Center for Disease Control and Prevention | Recruiting | Taiyuan | Shanxi | 030012 | China |
|