Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00126945
Status:
COMPLETED
Last Update Posted:
2016-09-21
First Post:
2005-08-04
Brief Title:
Evaluate 4 Different Formulations of Meningococcal Serogroups ACW-135Y Conjugate Vaccine When Given as 1 Dose to Healthy Subjects Aged 15-19 Yrs
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Primary Vaccination Study to Assess the Immunogenicity Safety Reactogenicity of 1 Dose of 4 Different Formulations of GSK Biologicals Meningococcal Conjugate Vaccine MenACWY vs 1 Dose of MENCEVAX ACWY in Healthy Subjects Aged 15-19 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 one dose of four different formulations of the MenACWY conjugate vaccine when given to healthy subjects aged 15-19 years The selection of the best formulation will be based on data obtained up to one month after the vaccine dose
Detailed Description:
The study is open However the 4 different formulations of GSKs MenACWY conjugate vaccine will be administered in a double-blind manner Mencevax ACWY vaccine will serve as active control Subjects will receive one vaccine dose only GSKs MenACWY conjugate vaccine or Mencevax ACWY vaccine and will have 2 blood samples taken before and one month after vaccination
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