Ignite Creation Date:
2025-12-24 @ 3:57 PM
Ignite Modification Date:
2025-12-26 @ 2:22 PM
Study NCT ID:
NCT01728792
Status:
COMPLETED
Last Update Posted:
2019-07-18
First Post:
2012-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Impact of SC vs IM Administration of DENVax (TDV) on Safety and Immunogenicity
Sponsor:
Takeda
Organization:
Study Overview
Official Title:
Impact of Subcutaneous Versus Intramuscular Administration of Inviragen's Live Attenuated Dengue Vaccine on Safety and Immunogenicity
Status:
COMPLETED
Status Verified Date:
2019-07
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:
This study assessed the safety and immunogenicity of Takeda's Tetravalent Dengue Vaccine Candidate (TDV) previously referred to as DENVax of various dosing schedules via subcutaneous (SC) or intramuscular (IM) administration with needle/syringe or needle-free injector (PharmaJet Stratis™).
Detailed Description:
The vaccine tested in this study was TDV. TDV was tested to assess safety and immunogenicity of various dosing schedules, routes of administration, and delivery methods in healthy flavivirus-seronegative adults living in a dengue non-endemic country.
The study enrolled 80 participants. Participants were randomly assigned to one of the five treatment groups:
* Group 1: TDV SC injection on Day 0 in each arm using needle/syringe
* Group 2: TDV IM injection on Day 0 in each arm using needle/syringe
* Group3: TDV IM injection on Days 0 and 90 using needle/syringe
* Group 4: TDV SC on Day 0 in each arm using the PharmaJet Stratis™ device
* Group 5: TDV IM on Day 0 in each arm using the PharmaJet Stratis™ device
This single-center trial was conducted in the United States. The overall time to participate in this study was up to 5 months. Participants made multiple visits to the clinic including a final visit at Day 120 for a safety follow-up assessment.
This work was supported by the US Army Medical Research and Materiel Command under Contract No. W81XWH-12-C-0278.
The views, opinions and/or findings contained in this report are those of the author(s) and should not be construed as an official Department of the Army position, policy or decision unless so designated by other documentation.
The study enrolled 80 participants. Participants were randomly assigned to one of the five treatment groups:
* Group 1: TDV SC injection on Day 0 in each arm using needle/syringe
* Group 2: TDV IM injection on Day 0 in each arm using needle/syringe
* Group3: TDV IM injection on Days 0 and 90 using needle/syringe
* Group 4: TDV SC on Day 0 in each arm using the PharmaJet Stratis™ device
* Group 5: TDV IM on Day 0 in each arm using the PharmaJet Stratis™ device
This single-center trial was conducted in the United States. The overall time to participate in this study was up to 5 months. Participants made multiple visits to the clinic including a final visit at Day 120 for a safety follow-up assessment.
This work was supported by the US Army Medical Research and Materiel Command under Contract No. W81XWH-12-C-0278.
The views, opinions and/or findings contained in this report are those of the author(s) and should not be construed as an official Department of the Army position, policy or decision unless so designated by other documentation.
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 |
|---|---|---|---|---|
| U1111-1181-0251 | REGISTRY | WHO | View |