Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00453986
Status:
COMPLETED
Last Update Posted:
2018-09-25
First Post:
2007-03-28
Brief Title:
Lot Consistency Immuno Safety of Meningococcal Vaccine GSK134612 Given With Fluarix to 18-55 Year-Old Adults
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Lot-to-Lot Consistency Non-Inferiority Versus Mencevax and Evaluation of the Co-Administration With Fluarix of GSK Biologicals Meningococcal Vaccine GSK134612 in Healthy Subjects Aged 18 Through 55 Years 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 purpose of this study is to demonstrate in 18-55 year old adults the consistency of different manufactured lots of meningococcal vaccine GSK134612 the non-inferiority of GSK134612 compared to licensed meningococcal vaccine Mencevax the non-inferiority of GSK134612 when given in an experimental co-administration with Fluarix compared to GSK134612 given alone and the immunogenicity of GSK134612 given with Fluarix
The Protocol Posting has been updated in order to comply with the FDA Amendment Act Sep 2007
The Protocol Posting has been updated in order to comply with the FDA Amendment Act Sep 2007
Detailed Description:
Multicentre study with 5 treatment groups Three groups will receive three different manufactured lots of GSK134612 one group will receive one lot of GSK134612 given in an experimental co-administration with Fluarix the control group will receive Mencevax The study will be conducted in a double-blind manner with respect to the 3 lots of GSK134612 vaccine The study will be open between the groups receiving GSK134612 and the group receiving GSK134612 Fluarix and the Mencevax group
Each subject will have 2 blood samples taken for immunogenicity analyses one prior to vaccination and one taken 30 days later
Each subject will have 2 blood samples taken for immunogenicity analyses one prior to vaccination and one taken 30 days later
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