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| Name | Class |
|---|---|
| Inner Mongolia Autonomous Region Center for Diseases Prevention and Control | UNKNOWN |
| Shaanxi Provincial Center for Disease Control and Prevention | OTHER |
| Hubei Provincial Center for Disease Control and Prevention |
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The purpose of this study is to evaluate the immunogenicity and safety of sequential immunization schedules of Sabin IPV and bOPV.
A phase 4 clinical trial is designed to evaluate the safety and immunogenicity of different sequential immunization schedules of Sabin IPV and bOPV. To be specific, the subjects were divided into 3 groups.
Group 1 received Sabin-IPV+bOPV+bOPV respectively at the age of 2,3,4 months old.
Group 2 received Sabin-IPV+Sabin-IPV+bOPV respectively at the age of 2,3,4 months old.
Group 3 received Sabin-IPV+Sabin-IPV+Sabin-IPV respectively at the age of 2,3,4 months old.
Blood samples were collected before vaccination and 30 days after the third dose. 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 the 3 immunization schedule groups were also monitored.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sIPV+bOPV+bOPV | Experimental | 202 subjects were vaccinated with 1 dose of Sabin-IPV and 2 doses of bOPV at their age of 2/3/4 months old, respectively |
|
| sIPV+sIPV+bOPV | Active Comparator | 197 subjects were vaccinated with 2 doses of Sabin-IPV and 1 dose of bOPV at their age of 2/3/4 months old, respectively |
|
| sIPV+sIPV+sIPV | Active Comparator | 205 subjects were vaccinated with 3 doses of Sabin-IPV at their age of 2/3/4 months old, respectively |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sabin-IPV+bOPV+bOPV | Biological | 202 subjects were vaccinated with 1 dose of Sabin-IPV and 2 doses of bOPV at their age of 2/3/4 months old, respectively |
|
| Measure | Description | Time Frame |
|---|---|---|
| Seroconversion rates at both baseline and 30 days after the 3rd vaccination | Determine the seroconversion rates of poliovirus (types I,II,III)at both baseline and 30 days after the 3rd vaccination | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Neutralizing antibody titers at both baseline and 30 days after the 3rd vaccination | Measure neutralizing antibody titers against poliovirus type I, II and III at both baseline and 30 days after the 3rd vaccination | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| the occurrence of adverse events | analyse the numbers and rates of participants who experience adverse events following immunization | 6 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shaohong Yan | Inner Mongolia Autonomous Region Center for Diseases Prevention and Control | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inner Mongolia Autonomous Region Center for Diseases Prevention and Control | Hohhot | Inner Mongolia | 010031 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32747216 | Derived | Yan S, Chen H, Zhang Z, Chang S, Xiao Y, Luo L, Zhang Z, Sun L, Chen X, Yang Y, Shi X, Guo Y, Sun Y, Li H, Li N, Han S, Ma M, Yang X. Immunogenicity and safety of different sequential schedules of Sabin strain-based inactivated poliovirus vaccination: A randomized, controlled, open-label, phase IV clinical trial in China. Vaccine. 2020 Sep 11;38(40):6274-6279. doi: 10.1016/j.vaccine.2020.07.042. Epub 2020 Jul 31. |
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| Peking University | OTHER |
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| Sabin-IPV+Sabin-IPV+bOPV | Biological | 197 subjects were vaccinated with 2 doses of Sabin-IPV and 1 dose of bOPV at their age of 2/3/4 months old, respectively |
|
| Sabin-IPV+Sabin-IPV+Sabin-IPV | Biological | 205 subjects were vaccinated with 3 doses of Sabin-IPV at their age of 2/3/4 months old, respectively |
|