Sero-conversion Study for a Two-dose Schedule of Sabin IPV in China

Study Overview
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Brief Summary
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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.

Detailed Description
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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: Determine whether the seroconversion rate is above 90% with a 2-dose Sabin IPV schedule, with the first dose given at 4 months and the second dose given ≥4 months after the first dose. Measure neutralizing antibody titers against poliovirus type I, II and III among two-dose Sabin IPV alone schedule, compared with three-dose Sabin IPV alone schedule.

Official Title
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Sero-conversion Study for a Two-dose Schedule of Sabin Strain Inactivated Poliovirus Vaccine in China

Conditions
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Poliomyelitis

Intervention / Treatment
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* Biological: Sabin IPV


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Parent or legal guardian agree to participate in our study. The family is living locally with legal residency status. Exclusion Criteria: Parent or legal guardian does not agree to participate in our study. The potential subject has received IPV or OPV before 4 months of age in the two-dose schedule group. The potential subject has one or more contraindications to IPV (although we will note the contraindications).

Ages Eligible for Study
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Minimum Age: 2 Months
Maximum Age: 18 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Three-dose schedule for Sabin IPV<br>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. | Biological: Sabin IPV<br>* 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.<br>* Other names: Sabin strain Inactivated Poliovirus Vaccine;|
| Experimental: Two-dose schedule for Sabin IPV<br>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. | Biological: Sabin IPV<br>* 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.<br>* Other names: Sabin strain Inactivated Poliovirus Vaccine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inactivated Poliovirus Vaccine, Sabin strain