Ignite Creation Date:
2025-12-26 @ 4:04 PM
Ignite Modification Date:
2025-12-26 @ 4:04 PM
Study NCT ID:
NCT01766206
Status:
COMPLETED
Last Update Posted:
2018-09-21
First Post:
2013-01-08
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Safety of One Dose of Meningococcal ACWY Conjugate Vaccine in Subjects From 2 Months to 55 Years of Age in the Republic of South Korea
Sponsor:
GlaxoSmithKline
Organization:
Study Overview
Official Title:
A Multicenter Post Marketing Surveillance Study to Monitor the Safety of GlaxoSmithKline (GSK) Biologicals' Meningococcal ACWY Conjugate Vaccine(MenACWY-CRM) Administered According to the Prescribing Information to Healthy Subjects From 2 Months to 55 Years of Age in the Republic of South Korea.
Status:
COMPLETED
Status Verified Date:
2018-07
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:
A multicenter, single arm, post-marketing surveillance study. This study is a postlicensure requirement of the Korea Food and Drug Administration (KFDA) to provide continued safety evaluation of MenACWY in the Korean population from 2 months to 55 years of age, receiving MenACWY-CRM vaccination according to routine clinical practice and prescribing information.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|---|
| V59_62 | OTHER | Novartis | View |