Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00196963
Status:
COMPLETED
Last Update Posted:
2016-09-21
First Post:
2005-09-13
Brief Title:
Evaluate 4 Different Formulations of Meningococcal Serogroups A C W-135 Y Conjugate Vaccine When Given as 1 Dose to Healthy Subjects Aged 15-19 Yrs
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
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 Yrs
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:
3 formulations of GSKs MenACWY conjugate vaccine will be administered in a double-blind manner while the 4th one will be single-blinded Administration of the candidate vaccine or of the active control Mencevax ACWY will be done in an open manner Subjects will receive one vaccine dose 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