Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2025-12-25 @ 8:49 PM
Study NCT ID:
NCT01086969
Status:
COMPLETED
Last Update Posted:
2012-02-06
First Post:
2010-03-11
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study of Meningococcal Vaccine, Menactra® in Healthy Subjects in India
Sponsor:
Sanofi
Organization:
Study Overview
Official Title:
Safety and Immunogenicity Study for Use of Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®) in Healthy Subjects 2-55 Years of Age in India
Status:
COMPLETED
Status Verified Date:
2012-02
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:
The purpose of this study is to assess the safety and immunogenicity of a single dose of Menactra® vaccine to support registration.
Primary Objectives:
* To describe the antibody titers measured by serum bactericidal activity using baby rabbit complement (SBA-BR) before and after Menactra® vaccination.
* To describe the safety profile of participants after one dose of Menactra®.
Primary Objectives:
* To describe the antibody titers measured by serum bactericidal activity using baby rabbit complement (SBA-BR) before and after Menactra® vaccination.
* To describe the safety profile of participants after one dose of Menactra®.
Detailed Description:
Participants will be enrolled in three age cohorts: Children: 2 - 11 years of age; Adolescents: 12 - 17 years of age, and Adults: 18 - 55 years of age to receive a single dose of Menactra®. They will be followed for a duration of 30 days after vaccination.
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| UTN: U1111-1111-5608 | OTHER | WHO | View |