Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2025-12-25 @ 6:58 PM
Study NCT ID:
NCT02640404
Status:
COMPLETED
Last Update Posted:
2018-01-08
First Post:
2015-12-22
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Safety of a Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine in Healthy Subjects in Vietnam
Sponsor:
Sanofi Pasteur, a Sanofi Company
Organization:
Study Overview
Official Title:
Safety of a Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®) in Healthy Subjects Aged 9 Months to 55 Years in Vietnam
Status:
COMPLETED
Status Verified Date:
2017-12
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 aim of the study is to assess the safety of Menactra vaccine in infants, toddlers, children, adolescents, and adults
Objective:
* To describe the safety profile after each and any dose (when applicable) of Menactra vaccine in participants aged 9 months to 55 years for registration.
Objective:
* To describe the safety profile after each and any dose (when applicable) of Menactra vaccine in participants aged 9 months to 55 years for registration.
Detailed Description:
Infants and toddlers will receive 2 doses of vaccine 3 months apart. Children ≥ 2 years through adults aged 55 years will receive 1 dose of vaccine. All participants will be evaluated for safety up to 28 days post-vaccination.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U1111-1143-9207 | OTHER | WHO | View |