Ignite Creation Date:
2025-12-24 @ 10:41 PM
Ignite Modification Date:
2025-12-25 @ 8:12 PM
Study NCT ID:
NCT00700635
Status:
COMPLETED
Last Update Posted:
2016-04-14
First Post:
2008-05-07
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Dose Comparison Study of Menactra® in US Children
Sponsor:
Sanofi Pasteur, a Sanofi Company
Organization:
Study Overview
Official Title:
Exploratory Evaluation of a Two-dose Schedule Versus a One-dose Schedule of Menactra® (Meningococcal [Groups A, C, Y and W 135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine) in Children in the US
Status:
COMPLETED
Status Verified Date:
2016-04
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:
To explore the potential benefit of the administration of Menactra vaccine as a two-dose regimen to children.
Primary Objective:
To assess, by age group, the immune response to Menactra vaccine after each vaccine injection.
Primary Objective:
To assess, by age group, the immune response to Menactra vaccine after each vaccine injection.
Detailed Description:
This is an open-label trial designed to explore the immune response to a two-dose schedule of Menactra vaccine compared with a standard one-dose schedule in children.
Study Oversight
Has Oversight DMC:
False
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?: