NCT01728792

Impact of SC vs IM Administration of DENVax (TDV) on Safety and Immunogenicity

Impact of Subcutaneous Versus Intramuscular Administration of Inviragen's Live Attenuated Dengue Vaccine on Safety and Immunogenicity

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Dengue Fever

Interventions

Type	Name	Description
BIOLOGICAL	TDV	TDV IM or SC injection

Timeline

• Start date: 2013-01-22
• Primary completion: 2013-11-01
• Completion: 2013-11-21
• First posted: 2012-11-20
• Last updated: 2019-07-18
• Results posted: 2017-01-04

Locations

1 site across 1 country: United States