Ignite Creation Date:
2024-05-05 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00514033
Status:
COMPLETED
Last Update Posted:
2012-03-19
First Post:
2007-08-08
Brief Title:
A Post-marketing Safety Study of GSK Bio IPV Vaccine PoliorixTM in Korean Children
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Open Multicentric PMS Study to Monitor Safety and Reactogenicity of GlaxoSmithKline Biologicals Poliomyelitis Vaccine Inactivated-Poliorix Administered in Korean Children as a Primary Vaccination in Healthy Subjects Aged 2 to 6 Months or as a Booster Vaccination in Subjects Aged 4 to 6 Years
Status:
COMPLETED
Status Verified Date:
2012-03
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:
Following licensing of PoliorixTM in Korea this study will collect safety data about the routine use of this vaccine in 600 children according to the regulations of Korean Food and Drugs Administration KFDA
Detailed Description:
An open multicentric post-marketing surveillance study to monitor the safety and reactogenicity of GlaxoSmithKline Biologicals Poliomyelitis vaccine inactivated -PoliorixTM administered in Korean children as a primary vaccination in healthy subjects aged two to six months or as a booster vaccination in subjects aged four to six years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None