Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00137917
Status:
COMPLETED
Last Update Posted:
2016-09-16
First Post:
2005-08-26
Brief Title:
Immunogenicity Safety Study of a Meningococcal Serogroup B Vaccine Given in a 3 Dose Schedule to Healthy Adolescents Aged 12-18 Yrs
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Primary Vaccination Study to Evaluate Immunogenicity Safety and Reactogenicity of 3 Doses of GSK BiologicalsFinlays Meningococcal B Candidate Vaccine Given Intramuscularly Using Either 0-2-4 Month or 0-1-6 Month Schedule to Healthy Subjects Aged 12-18 Years
Status:
COMPLETED
Status Verified Date:
2016-09
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 evaluate the immunogenicity safety and reactogenicity of 3 doses of the meningococcal serogroup B vaccine when given using either a 0-2-4 month or a 0-1-6 month schedule to healthy adolescents aged 12-18 years a control group will receive 2 doses of Havrix 0-6 months and Meningitec month 1
Detailed Description:
The study is open however vaccines given to study group at 0-1-6 months and to control group will be administered in an observer-blind manner 3 blood samplings for antibody testing before vaccination and one month after the second and third vaccine doses
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