Ignite Creation Date:
2025-12-24 @ 3:36 PM
Ignite Modification Date:
2025-12-28 @ 1:23 AM
Study NCT ID:
NCT04054492
Status:
COMPLETED
Last Update Posted:
2019-08-13
First Post:
2019-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Evaluate the Immunogenicity and Safety of Sequential Immunization Schedules of Sabin IPV and bOPV
Sponsor:
China National Biotec Group Company Limited
Organization:
Study Overview
Official Title:
A Randomized, Multi-center, Controlled Clinical Trial for Evaluating the Immunogenicity and Safety of Sequential Immunization Schedules of Sabin IPV and bOPV
Status:
COMPLETED
Status Verified Date:
2019-08
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:
The purpose of this study is to evaluate the immunogenicity and safety of sequential immunization schedules of Sabin IPV and bOPV.
Detailed Description:
A phase 4 clinical trial is designed to evaluate the safety and immunogenicity of different sequential immunization schedules of Sabin IPV and bOPV. To be specific, the subjects were divided into 3 groups.
Group 1 received Sabin-IPV+bOPV+bOPV respectively at the age of 2,3,4 months old.
Group 2 received Sabin-IPV+Sabin-IPV+bOPV respectively at the age of 2,3,4 months old.
Group 3 received Sabin-IPV+Sabin-IPV+Sabin-IPV respectively at the age of 2,3,4 months old.
Blood samples were collected before vaccination and 30 days after the third dose. Neutralization antibody against type I, Type II and Type III poliomyelitis virus were detected to evaluate the seroprotection rates and antibody geometric mean concentrations. The safety of the 3 immunization schedule groups were also monitored.
Group 1 received Sabin-IPV+bOPV+bOPV respectively at the age of 2,3,4 months old.
Group 2 received Sabin-IPV+Sabin-IPV+bOPV respectively at the age of 2,3,4 months old.
Group 3 received Sabin-IPV+Sabin-IPV+Sabin-IPV respectively at the age of 2,3,4 months old.
Blood samples were collected before vaccination and 30 days after the third dose. Neutralization antibody against type I, Type II and Type III poliomyelitis virus were detected to evaluate the seroprotection rates and antibody geometric mean concentrations. The safety of the 3 immunization schedule groups were also monitored.
Study Oversight
Has Oversight DMC:
True
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?: