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| Name | Class |
|---|---|
| China National Biotec Group Company Limited | INDUSTRY |
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The purpose of this study is to evaluate the immunogenicity and safety of different sequential immunization strategies by Sabin IPV and bOPV in Chinese infants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | The sequential immunization strategy for group 1 on polio was Sabin IPV+ bOPV + bOPV. |
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| Group 2 | Experimental | The sequential immunization strategy for group 2 on polio was Sabin IPV + Sabin IPV + bOPV. |
|
| Group 3 | Experimental | The sequential immunization strategy for group 3 on polio was Sabin IPV + Sabin IPV + Sabin IPV. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sabin IPV+ bOPV+ bOPV | Biological | Give 3 doses of polio vaccine at 2, 3 and 4 months of age, get 2 blood samples (1.5ml per sample) before the first dose and 28-35 days after the last dose. sIPV was given 0.5ml per dose and bOPV was given 0.1ml per dose. |
| Measure | Description | Time Frame |
|---|---|---|
| seroconversion rate | any positive antibody response in infants who were seronegative prior to their first dose, or at least a fourfold increase in type-specific antibody levels for infants who had pre-existing antibodies. | seroconversion rate was evaluated 4-5 weeks after the third dose of polio vaccine. |
| Measure | Description | Time Frame |
|---|---|---|
| safety: rate of adverse events | the rate of adverse events. | At least 2 active surveillance visits (3 days and 30 days) were required after each vaccination to collect adverse reaction data. |
| neutralizing antibody titer |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chunan Center for Disease Control and Prevention | Hangzhou | Zhejiang | China | |||
| Longyou Center for Disease Control and Prevention |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32442523 | Derived | He H, Wang Y, Deng X, Yue C, Tang X, Li Y, Liu Y, Yin Z, Zhang G, Chen Z, Xie S, Wen N, An Z, Chen Z, Wang H. Immunogenicity of three sequential schedules with Sabin inactivated poliovirus vaccine and bivalent oral poliovirus vaccine in Zhejiang, China: an open-label, randomised, controlled trial. Lancet Infect Dis. 2020 Sep;20(9):1071-1079. doi: 10.1016/S1473-3099(19)30738-8. Epub 2020 May 19. |
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| Sabin IPV + Sabin IPV + bOPV | Biological | Give 3 doses of polio vaccine at 2, 3 and 4 months of age, get 2 blood samples (1.5ml per sample) before the first dose and 28-35 days after the last dose. sIPV was given 0.5ml per dose and bOPV was given 0.1ml per dose. |
|
| Sabin IPV + Sabin IPV + Sabin IPV | Biological | Give 3 doses of polio vaccine at 2, 3 and 4 months of age, get 2 blood samples (1.5ml per sample) before the first dose and 28-35 days after the last dose. sIPV was given 0.5ml per dose and bOPV was given 0.1ml per dose. |
|
| Blood samples were obtained prior to the first dose and 4-5 weeks after the third dose of polio vaccine. |
| Quzhou |
| Zhejiang |
| China |
| ID | Term |
|---|---|
| D011051 | Poliomyelitis |
| ID | Term |
|---|---|
| D009187 | Myelitis |
| D002494 | Central Nervous System Infections |
| D007239 | Infections |
| D004769 | Enterovirus Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D013118 | Spinal Cord Diseases |
| D000090862 | Neuroinflammatory Diseases |
| D009468 | Neuromuscular Diseases |
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