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| Name | Class |
|---|---|
| Beijing Institute of Biological Products Co Ltd. | INDUSTRY |
| Beijing Center for Disease Control and Prevention | OTHER_GOV |
| Peking University | OTHER |
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This study replaced the 2nd and 3rd dose of Salk-IPV (produced by Sanofi) with Sabin-IPV (produced by CNBG) and then reviewed the safety and immunogenicity of the vaccination, aiming to acquire scientific evidence for the feasibility of immunization involving different viral strains replacement.
It is required by China Food and Drug Administration (CFDA) that considering in the real situation IPV receivers may be immuned by different viral strains of this vaccine, a phase 4 clinical trial aiming to demonstrate the safety and immunogenicity of the immunization schedule should be carried out. To be specific, the subjects were divided into 2 groups.
Group 1 received Salk-IPV+Sabin-IPV+Sabin-IPV respectively at the age of 2,3,4 months old.
Group 2 received Salk-IPV+Salk-IPV+Salk-IPV respectively at the age of 2,3,4 months old.
Blood sample was collected before vaccination and 30 days after the third dose of vaccination. Neutralization antibody against type I, Type II and Type III poliomyelitis virus were detected to evaluate the seroprotection rates and antibody geometric mean concentrations. The safety of both immunization schedule will also been monitored.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group 1 | Experimental | 180 2-month-old subjects will be enrolled with vaccination schedule as follows: 1st: Salk-IPV; 2nd: Sabin-IPV; 3rd: Sabin-IPV |
|
| group 2 | Active Comparator | 180 2-month-old subjects will be enrolled with vaccination schedule as follows: 1st: Salk-IPV; 2nd: Salk-IPV; 3rd: Salk-IPV |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inactivated Polio Vaccine | Biological | Inactivated Polio Vaccine at age of 2,3,4 months old, respectively |
|
| Measure | Description | Time Frame |
|---|---|---|
| Seroconversion rate | determine the seroconversion rate of both groups | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Neutralizing antibody titers | Measure neutralizing antibody titers against poliovirus type I, II and III | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| number of participants who experience adverse events | analyse the number and rate of vaccine participants who have adverse events following immunization | 6 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jiang WU | Beijing Center for Disease Control and Prevention | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Center for Disease Control and Prevention | Beijing | Beijing Municipality | 100013 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33810904 | Derived | Chen H, Gao Z, Bai S, Liu X, Han S, Xiao Y, Liu F, Yu Y, Sun H, Yang X. Immunogenicity and safety of sabin-strain based inactivated poliovirus vaccine replacing salk-strain based inactivated poliovirus vaccine: An innovative application of different strain-IPVs replacement. Vaccine. 2021 Apr 22;39(17):2467-2474. doi: 10.1016/j.vaccine.2021.02.073. Epub 2021 Mar 31. |
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| ID | Term |
|---|---|
| D011054 | Poliovirus Vaccine, Inactivated |
| ID | Term |
|---|---|
| D015164 | Vaccines, Inactivated |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| D023321 |
| Poliovirus Vaccines |
| D014765 | Viral Vaccines |