Ignite Creation Date:
2025-12-24 @ 7:30 PM
Ignite Modification Date:
2025-12-31 @ 7:47 AM
Study NCT ID:
NCT01270503
Status:
COMPLETED
Last Update Posted:
2014-11-14
First Post:
2011-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Post-Marketing Safety Study of Menactra® in Healthy Children, Adolescents, and Adults in the Philippines
Sponsor:
Sanofi Pasteur, a Sanofi Company
Organization:
Study Overview
Official Title:
Meningococcal (Groups A, C, Y, W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®) Post-Marketing Safety Study in Healthy Children (2-11 Years), Adolescents (12-17 Years) and Adults (18-55 Years) in the Philippines
Status:
COMPLETED
Status Verified Date:
2014-10
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 aim of the study is to assess post-marketing safety of a single dose of Menactra® vaccine with the intent to support conversion from monitored release to initial registration of Menactra® vaccine in the Philippines.
Primary Objective:
To describe the serious adverse events occurring within 30 days among participants who have received one dose of Menactra® vaccine.
Primary Objective:
To describe the serious adverse events occurring within 30 days among participants who have received one dose of Menactra® vaccine.
Detailed Description:
Each study participant will receive one dose of Menactra® vaccine and will be monitored for safety for 30 days post-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 |
|---|---|---|---|---|
| U1111-1116-4853 | OTHER | WHO | View |