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

Primary Purpose

Poliomyelitis

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Sabin IPV
Sponsored by
Centers for Disease Control and Prevention, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Poliomyelitis focused on measuring Inactivated Poliovirus Vaccine, Sabin strain

Eligibility Criteria

2 Months - 18 Months (Child)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • Shandong Center for Disease Control and Prevention

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Three-dose schedule for Sabin IPV

Two-dose schedule for Sabin IPV

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
May 23, 2018
Last Updated
June 23, 2020
Sponsor
Centers for Disease Control and Prevention, China
Collaborators
Shandong Province Centers for Disease Control and Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT03546634
Brief Title
Sero-conversion Study for a Two-dose Schedule of Sabin IPV in China
Official Title
Sero-conversion Study for a Two-dose Schedule of Sabin Strain Inactivated Poliovirus Vaccine in China
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
May 24, 2018 (Actual)
Primary Completion Date
June 5, 2019 (Actual)
Study Completion Date
January 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centers for Disease Control and Prevention, China
Collaborators
Shandong Province Centers for Disease Control and Prevention

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Poliomyelitis
Keywords
Inactivated Poliovirus Vaccine, Sabin strain

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
280 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Three-dose schedule for Sabin IPV
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Two-dose schedule for Sabin IPV
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Sabin IPV
Other Intervention Name(s)
Sabin strain Inactivated Poliovirus Vaccine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Seroconversion rate
Description
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.
Time Frame
10 months
Secondary Outcome Measure Information:
Title
Neutralizing antibody titers
Description
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.
Time Frame
10 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
18 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zijian Feng
Organizational Affiliation
Centers for Disease Control and Prevention, China
Official's Role
Study Chair
Facility Information:
Facility Name
Shandong Center for Disease Control and Prevention
City
Jinan
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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