NCT03771963

Immunogenicity and Safety of Tetravalent Dengue Vaccine (TDV) at the End of Shelf Life in Healthy Adults

An Open-Label, Phase 3 Trial to Investigate the Immunogenicity and Safety of Tetravalent Dengue Vaccine Candidate (TDV) at the End of Shelf Life in Healthy Adults in Non-Endemic Country(Ies) for Dengue

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety and immune response of a naturally aged lot of tetravalent dengue vaccine (TDV) in healthy participants, aged 18 to 60 years, in non-endemic country(ies) for dengue.

Detailed description

The vaccine being tested in this study is tetravalent dengue vaccine (TDV). The primary objective of this study is to evaluate the immune response and safety of a naturally aged (\>12 months stored at 2°C to 8°C) lot of TDV in a healthy adult population in country(ies) non-endemic for dengue. The assessment of a naturally aged lot of TDV in this clinical trial will provide an important contribution to data on TDV stability throughout the shelf life of the product. The study will enroll approximately 200 participants. Participants will be enrolled to the one treatment group: Tetravalent Dengue Vaccine (TDV) All participants will receive subcutaneous (SC) injection on Day 1 (Month 0) and Day 90 (Month 3). This multi-center trial will be conducted in the United States. The overall time to participate in this study is 9 months. Participants will make multiple visits to the clinic including a final visit at Day 270 (Month 9).

Conditions

• Dengue Fever

Interventions

Type	Name	Description
BIOLOGICAL	Tetravalent Dengue Vaccine (TDV)	TDV SC injection.

Timeline

• Start date: 2019-03-28
• Primary completion: 2019-10-14
• Completion: 2020-03-13
• First posted: 2018-12-11
• Last updated: 2021-06-07
• Results posted: 2021-06-07

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study