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| Name | Class |
|---|---|
| Shandong Province Centers for Disease Control and Prevention | OTHER |
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This study aims to obtain the direct domestic IPV vaccine monitoring data for the CNBG products, and provide scientific evidence for the National Immunization Program and long-term polio vaccine immunization policy.
The overall objective of this research is to determine the seroconversion rates of two reduced Sabin IPV schedules in Chinese children - a 2-dose schedule and a 3-dose schedule.
In April 2017, WHO/SAGE recommended that a two-dose, IPV-only schedule can be used after polio eradication, with a schedule seroconversion target of at least 90%. The recommendation was based in part on a study conducted in Cuba using Salk-IPV at 4 months and 8 months of age. However, for domestic Sabin IPVs, there are no such data to support a 2-dose schedule among Chinese infants.Two Sabin IPV products that are available to China's National Immunization Program - produced by Kunming Bio institute and China National Biotec Group (CNBG).The monitoring study on sIPV produced by Kunming Bio institute has already applied for approval.This study aims to obtain the direct domestic IPV vaccine monitoring data for the CNBG products, and provide scientific evidence for the National Immunization Program and long-term polio vaccine immunization policy.
The overall objective of this research is to determine the seroconversion rates of two reduced Sabin IPV schedules in Chinese children - a 2-dose schedule and a 3-dose schedule.
The specific objectives of the study are to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Three-dose schedule for Sabin IPV | Active Comparator | Subjects vaccinate Sabin IPV at 2, 3, and 4 months of age,will be collected blood specimens twice - right before the first dose of IPV, and one month after the 3rd dose of IPV. |
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| Two-dose schedule for Sabin IPV | Experimental | Subjects first dose IPV vaccinate at 4 months of age, and the second dose IPV given between 8 and 11 months of age,will be collected blood specimens twice - right before the first dose of IPV, and one month after the 2nd dose of IPV. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sabin IPV | Biological | We select one Sabin IPV product, produced by China National Biotec Group, which is available for China's National Immunization Program in the selected study sites. |
| Measure | Description | Time Frame |
|---|---|---|
| Seroconversion rate | Determine whether the seroconversion rate is above 90% using a two-dose Sabin IPV alone schedule with the first dose Sabin IPV given at 4 months and the second dose Sabin IPV given ≥4 months after the first dose. | 10 months |
| Measure | Description | Time Frame |
|---|---|---|
| Neutralizing antibody titers | Measure neutralizing antibody titers against poliovirus type I, II and III among two-dose Sabin IPV-only schedules compared with three-dose Sabin IPV alone schedule. | 10 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zijian Feng | Centers for Disease Control and Prevention, China | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shandong Center for Disease Control and Prevention | Jinan | China |
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| ID | Term |
|---|---|
| D011051 | Poliomyelitis |
| ID | Term |
|---|---|
| D009187 | Myelitis |
| D002494 | Central Nervous System Infections |
| D007239 | Infections |
| D004769 | Enterovirus Infections |
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| 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 |