Ignite Creation Date:
2024-05-05 @ 5:27 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00454909
Status:
COMPLETED
Last Update Posted:
2018-06-08
First Post:
2007-03-30
Brief Title:
Immunogenicity and Safety of Meningococcal Vaccine GSK134612 vs Menactra in Healthy AdolescentAdults Aged 10-25 Years
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Study to Assess Immunogenicity Reactogenicity and Safety of 1 Dose of GSK Biologicals Meningococcal Vaccine GSK134612 vs 1 Dose of Sanofi-Pasteurs Menactra in Healthy Subjects 10-25 Years
Status:
COMPLETED
Status Verified Date:
2017-04
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 the study is to characterize the safety and immunogenicity of 1 dose of GSK Biologicals meningococcal vaccine GSK134612 as compared to Menactra in adolescentsadults 11-25 years of age
The Protocol Posting has been updated in order to comply with the FDA Amendment Act Sep 2007
The protocol posting has been updated following a protocol amendment
The Protocol Posting has been updated in order to comply with the FDA Amendment Act Sep 2007
The protocol posting has been updated following a protocol amendment
Detailed Description:
Subjects 11-25 years of age will be randomized to receive either the meningococcal vaccine GSK134612 or Menactra An additional non-randomized group of subjects aged 10 years 11 years of age will be enrolled to receive meningococcal vaccine GSK134612 only At the time the study begun Menactra was only licensed in the United States for individuals above 11 years of age and therefore could not be used as a control vaccine in subjects less than 11 years old
This study will be single-blind for the subjects 11 to 25 years of age and open for the subjects 10 to 11 years of age
This study will be single-blind for the subjects 11 to 25 years of age and open for the subjects 10 to 11 years of age
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