Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00197275
Status:
COMPLETED
Last Update Posted:
2016-10-07
First Post:
2005-09-19
Brief Title:
Lot-to-lot Consistency of Tritanrix-HepBHib-MenAC Its Non-inferiority vs Tritanrix-HepBHiberix in Infants
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Demonstrate Lot-to-lot Consistency of Final Production Method of GSK Biologicals Hib-MenAC Vaccine Mixed Extemporaneously With Tritanrix-HepB Demonstrate Its Non-inferiority vs Tritanrix-HepBHiberix in Healthy Infants at 2 4 and 6 Months
Status:
COMPLETED
Status Verified Date:
2016-10
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 primary purpose of this study is to demonstrate the lot-to-lot consistency of 3 production lots of GSK Biologicals Hib-MenAC Haemophilus influenzae type b and meningococcal serogroups A and C vaccine when reconstituted with Tritanrix-HepB diphtheria tetanus pertussis and hepatitis B vaccine and administered as a single injection
Detailed Description:
The study is double blind However the active control vaccine Tritanrix-HepBHiberix will be administered in a single-blind manner Blood samples will be collected for immunogenicity analyses GSK Biologicals OPV vaccine will be administered concomitantly with the study vaccines at 2 4 and 6 months of age according to local country regulation The study will last approximately 5 months per subject
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