Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2026-01-05 @ 5:28 PM
Study NCT ID:
NCT01981967
Status:
COMPLETED
Last Update Posted:
2016-05-04
First Post:
2013-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Post-licensure Safety Study of IMOJEV® in Thailand
Sponsor:
Sanofi Pasteur, a Sanofi Company
Organization:
Study Overview
Official Title:
Post-licensure, Phase IV, Safety Study of IMOJEV® in Thailand
Status:
COMPLETED
Status Verified Date:
2016-03
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 this study is to further characterize the safety profile of IMOJEV®.
Primary Objective:
* To describe serious adverse events (SAEs, including adverse events of special interest \[AESIs\]) up to 60 days after administration of one dose of IMOJEV®.
Secondary Objective:
* To describe Grade 3 (severe) systemic Adverse Events (AEs) up to 30 minutes after administration of one dose of IMOJEV®.
Primary Objective:
* To describe serious adverse events (SAEs, including adverse events of special interest \[AESIs\]) up to 60 days after administration of one dose of IMOJEV®.
Secondary Objective:
* To describe Grade 3 (severe) systemic Adverse Events (AEs) up to 30 minutes after administration of one dose of IMOJEV®.
Detailed Description:
Participants aged 1 year to less than 5 years will be randomized to receive one injection of IMOJEV® either as a primary vaccination or as a booster. Safety data will be collected for 60 days after IMOJEV® vaccination. The duration of each subject's participation in the trial will be 60 days.
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U1111-1127-7052 | OTHER | WHO | View |