Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00345579
Status:
COMPLETED
Last Update Posted:
2016-12-16
First Post:
2006-06-26
Brief Title:
Safety of Hib-MenCY-TT Vaccine Versus Licensed Hib Conjugate Vaccine Given at 2 4 6 and 12 to 15 Months of Age
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Single-blind Randomized Controlled Multinational Study for the Evaluation of Safety of GlaxoSmithKline GSK Biologicals Investigational Vaccination Regimen Compared to Monovalent Haemophilus Influenzae Type b Hib Control Vaccine in Healthy Infants at 2 4 6 and 12 to 15 Months of Age
Status:
COMPLETED
Status Verified Date:
2016-11
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 phase of this study is evaluating the safety of Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine when each are co-administered with Pediarix to healthy infants at 2 4 and 6 months of age
This protocol posting deals with objectives outcome measures of the primary phase of the study The objectives outcome measures of the Booster phase are presented in a separate protocol posting NCT number 00345683
The Protocol Posting has been updated in order to comply with the FDA Amendment Act Sep 2007
This protocol posting deals with objectives outcome measures of the primary phase of the study The objectives outcome measures of the Booster phase are presented in a separate protocol posting NCT number 00345683
The Protocol Posting has been updated in order to comply with the FDA Amendment Act Sep 2007
Detailed Description:
PediarixInfanrix Penta and Prevnar should be co-administered to all subjects in all study groups according to a 2 4 and 6 month schedule concomitantly with study vaccines
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