Ignite Creation Date:
2024-05-05 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00473668
Status:
COMPLETED
Last Update Posted:
2017-08-18
First Post:
2007-05-14
Brief Title:
Non-inferiority of GSK Biologicals DTPw-HBVHib Compared to Two Formulations of GSK Biologicals DTPw-HBVHib
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Non-inferiority of One Formulation of GSK Biologicals DTPw-HBVHib to 2 Formulations of GSK Biologicals DTPw-HBVHib With Respect to the Immune Response to the PRP Antigen When Administered to Healthy Infants at 6 10 14 Weeks of Age
Status:
COMPLETED
Status Verified Date:
2017-03
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:
The purpose of this observer-blind study is to generate immunogenicity data with one formulation of GSK Biologicals DTPw-HBVHib vaccine after the primary vaccination course and to demonstrate non-inferiority of this vaccine as compared to two formulations of GSK Biologicals DTPw-HBVHib vaccine with respect to the anti-PRP antibody response Additionally to assess the reactogenicity and safety of GSK Biologicals DTPw-HBVHib vaccine 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