Ignite Creation Date:
2025-12-25 @ 2:35 AM
Ignite Modification Date:
2025-12-26 @ 1:12 AM
Study NCT ID:
NCT03546634
Status:
COMPLETED
Last Update Posted:
2020-06-24
First Post:
2018-05-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Sero-conversion Study for a Two-dose Schedule of Sabin IPV in China
Sponsor:
Centers for Disease Control and Prevention, China
Organization:
Study Overview
Official Title:
Sero-conversion Study for a Two-dose Schedule of Sabin Strain Inactivated Poliovirus Vaccine in China
Status:
COMPLETED
Status Verified Date:
2020-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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:
1. 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.
2. 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.
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:
1. 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.
2. 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: