Ignite Creation Date:
2025-12-24 @ 1:36 PM
Ignite Modification Date:
2026-02-24 @ 12:14 AM
Study NCT ID:
NCT00631995
Status:
COMPLETED
Last Update Posted:
2018-02-06
First Post:
2008-02-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Immunogenicity of a Quadrivalent Meningococcal Tetanus Protein Conjugate Vaccine in Toddlers
Sponsor:
Sanofi Pasteur, a Sanofi Company
Organization:
Study Overview
Official Title:
Safety and Immunogenicity of a Quadrivalent Meningococcal (A, C, Y, and W-135) Tetanus Protein Conjugate Vaccine (TetraMen-T) in Toddlers
Status:
COMPLETED
Status Verified Date:
2018-02
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:
This study is aimed at studying quadrivalent meningococcal (A, C, Y, and W-135) Tetanus Protein Conjugate Vaccine (TetraMen-T) formulations in Toddlers.
Primary Objectives: Safety and Immunogenicity:
To describe the safety and immunogenicity profiles of:
* A single dose of each formulation of TetraMen-T vaccine
* A single dose of NeisVac-C® vaccine.
Primary Objectives: Safety and Immunogenicity:
To describe the safety and immunogenicity profiles of:
* A single dose of each formulation of TetraMen-T vaccine
* A single dose of NeisVac-C® vaccine.
Detailed Description:
The study is designed to evaluate the safety profile and the immunogenicity response after a single dose of TetraMen-T in toddlers.
Study Oversight
Has Oversight DMC:
True
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?: