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| Name | Class |
|---|---|
| Shandong Province Centers for Disease Control and Prevention | OTHER |
| World Health Organization | OTHER |
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In April 2017, WHO recommended that a two-dose, Inactivated Poliovirus Vaccine, IPV-only schedule at 4 months and 8 months of age can be used after polio eradication, with a schedule seroconversion target of at least 90%. However, there is no such data for China domestic Sabin strain IPVs to support a 2-dose schedule among Chinese infants.
This research is to determine the seroconversion rates among two arms:
Group 1: two-dose schedule, infants will be received two doses of Sabin IPV, the first dose at 4 month of age, and the second dose at 8-11 month of age.
Group 2: three-dose schedule, infants will be received three doses of Sabin IPV at 2, 3 and 4 month of age respectively. This schedule is currently recommended by manufacture's package insert for routine use.
The hypothesis is the seroconversion will be above 90% in both groups.
As a part of global polio eradication endgame immunization strategy, WHO requested all OPV-using countries to introduce at least one dose of IPV into the routine immunization schedule. Ideally IPV should be administered after 14 weeks of age, however an IPV-OPV sequential schedule is acceptable if VAPP is a concern. China stopped trivalent OPV in routine immunization in May 2016, introduced one dose of IPV at 2 months followed by three doses of type I / III bivalent OPV (bOPV) at 3 and 4 months and 4 years. A Sabin strain IPV was licensed in January 2015, and a second Sabin IPV was approved by China FDA in September 2017. The production capacity will increase in the next few years and will meet the demands of an IPV-only schedule in China. Other Sabin IPVs are in clinical trial stages, which will lead to sufficient IPV production for China to export IPV.
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. Considering that risk of polio virus transmission is decreasing over time, and that IPV - either domestic Sabin-IPV or imported Salk-IPV - is expensive (6 USD/dose) for a program serving a birth cohort of 18 million, an efficient two-dose, IPV-only schedule will be very competitive with a more traditional 4-dose IPV-only schedule. However, for domestic Sabin IPVs, there are no such data to support a 2-dose schedule among Chinese infants.
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.
Group 1: two-dose schedule, infants will be received two doses of Sabin IPV, the first dose at 4 month of age, and the second dose at 8-11 month of age.
Group 2: three-dose schedule, infants will be received three doses of Sabin IPV at 2, 3 and 4 month of age respectively. This schedule is currently recommended by manufacture's package insert for routine use.
The hypothesis is the seroconversion will be above 90% in both groups.
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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. |
|
| Two-dose schedule for Sabin IPV | Experimental | Subjects vaccinate first dose IPV at 4 months, 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sabin IPV | Biological | We select one Sabin IPV product, produced by Kunming Bio institute, 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, MD, MPH | 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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a multi-center, randomized, open-label, seroconversion/immunogenicity study.
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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 |