Ignite Creation Date:
2024-05-05 @ 4:41 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00291967
Status:
COMPLETED
Last Update Posted:
2006-12-08
First Post:
2006-02-14
Brief Title:
Assess Immune Response Following Primary Vaccination With Tritanrix-HepB Vaccine Mixed With 3 Formulations of Hib-MenAC Vaccine to Infants
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Evaluate the Feasibility of GSK Biologicals Tritanrix-HepBHib-MenAC Vaccine Administered as a 3 Dose Primary Vaccination Course at 6 10 14 Weeks of Age
Status:
COMPLETED
Status Verified Date:
2006-12
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:
To compare three formulations of Hib-MenAC vaccines mixed with Tritanrix-HepB vaccine with that of Tritanrix-HepB vaccine concomitantly administered with GSK Biologicals Hiberix vaccine and Tritanrix-HepB vaccine mixed with Hiberix vaccine and concomitantly administered with Wyeth Lederles meningococcal C conjugate vaccine Meningitec with respect to antibody response to vaccine antigens meningococcal serogroups A and C and PRP after a three-dose primary vaccination course
Detailed Description:
Randomized study with five groups to receive one of the following vaccination regimens One of the three formulations of GSK Biologicals Hib-MenAC mixed with GSK Biologicals Tritanrix-HepB 3 different groups GSK Biologicals Tritanrix-HepB GSK Biologicals Hiberix GSK Biologicals Tritanrix-HepB mixed with GSK Biologicals Hiberix Wyeth Lederles Meningitec
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