Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2025-12-27 @ 1:51 AM
Study NCT ID:
NCT00880893
Status:
COMPLETED
Last Update Posted:
2022-03-21
First Post:
2009-04-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Sanofi Pasteur's CYD Dengue Vaccine in Healthy Subjects in Singapore
Sponsor:
Sanofi Pasteur, a Sanofi Company
Organization:
Study Overview
Official Title:
Immunogenicity and Large-Scale Safety of Tetravalent Dengue Vaccine in Healthy Subjects Aged 2 to 45 Years in Singapore
Status:
COMPLETED
Status Verified Date:
2022-03
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:
Primary Objectives:
* To evaluate safety after each CYD Dengue vaccination in terms of injection site and systemic reactogenicity.
* To evaluate the occurrence of Serious Adverse Events (SAEs) throughout the trial period.
* To evaluate the humoral immune response to each CYD Dengue serotype after each vaccination in a subset of participants.
Secondary Objectives:
* To evaluate the persistence of the humoral immune response during 4 years after the last vaccination in a subset of participants.
* To evaluate safety after each CYD Dengue vaccination in terms of injection site and systemic reactogenicity.
* To evaluate the occurrence of Serious Adverse Events (SAEs) throughout the trial period.
* To evaluate the humoral immune response to each CYD Dengue serotype after each vaccination in a subset of participants.
Secondary Objectives:
* To evaluate the persistence of the humoral immune response during 4 years after the last vaccination in a subset of participants.
Detailed Description:
This was a multicenter trial involving three vaccinations one each at 0, 6 and 12 months over a period of 1 year, and a 4-year follow-up following the last vaccination.
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 |
|---|---|---|---|---|
| 2014-001713-26 | EUDRACT_NUMBER | None | View |