Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00332566
Status:
COMPLETED
Last Update Posted:
2016-09-28
First Post:
2006-05-31
Brief Title:
Assess Immunogenicity Reactogenicity Safety of a Booster of GSK Biologicals DTPw-HBVHib Kft Compared to DTPw-HBVHib
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Immunogenicity Reactogenicity Safety of a Booster Dose of GSK Biologicals DTPw-HBVHib Kft Vaccine Vs GSK Biologicals DTPw-HBVHib Vaccine in Infants Who Received a 3-Dose Primary Vaccination Course With the Same Vaccines
Status:
COMPLETED
Status Verified Date:
2016-09
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 booster study will assess the immunogenicity reactogenicity and safety of a booster dose of GSK Biologicals DTPw-HBVHib Kft vaccine versus DTPw-HBVHib vaccine in healthy children 18 to 24 months of age who received the same vaccine for primary vaccination Prior to the booster dose this study will also assess the persistence of antibodies to the vaccine antigen components administered in the primary vaccination course The Protocol Posting has been updated in order to comply with the FDA Amendment Act Sep 2007
Detailed Description:
None
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