NCT03423173

Lot-to-lot Consistency of 3 Lots of Tetravalent Dengue Vaccine (TDV) in Non-endemic Country(Ies) for Dengue

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial to Demonstrate Lot-to-Lot Consistency of 3 Lots of a Tetravalent Dengue Vaccine Candidate in Healthy Adults in Non-Endemic Country(Ies) for Dengue

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 923 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to investigate lot-to-lot consistency in terms of equivalence of the immune responses induced by 3 consecutive TDV lots in healthy participants aged 18 to 60 years in non-endemic country(ies) for dengue.

Detailed description

The vaccine tested in this study is Takeda's Tetravalent Dengue Vaccine Candidate (TDV). The primary objective of this trial is to investigate lot-to-lot consistency in terms of equivalence of the immune responses induced by 3 consecutive lots of TDV in healthy participants in non-endemic country(ies) for dengue. The study will enroll approximately 924 healthy participants. Participants will be randomized in 2:2:2:1 to one of 4 trial groups to receive TDV (Lots 1, 2 or 3) or placebo: * TDV 0.5 mL subcutaneous injection OR * Placebo normal saline solution (0.9% NaCl) for injection. In each trial group, all participants will receive 2 doses of TDV or placebo by subcutaneous injection on Days 1 (Month 0) and 90 (Month 3). Immunogenicity will be assessed in participants included in the immunogenicity subset (TDV groups: 176 participants each and placebo group: 88 participants) and safety will be assessed in all participants in each group. This multi-center trial will be conducted in the United States. The overall time to participate in this study is 270 days. Participants will make multiple visits to the clinic including a final visit at Day 270.

Conditions

• Dengue Fever

Interventions

Type	Name	Description
BIOLOGICAL	TAK-003	TDV subcutaneous injection
BIOLOGICAL	Placebo	TDV Placebo-matching normal saline (0.9% NaCl) subcutaneous injection

Timeline

• Start date: 2018-02-12
• Primary completion: 2018-08-03
• Completion: 2019-01-14
• First posted: 2018-02-06
• Last updated: 2020-10-20
• Results posted: 2020-10-20

Locations

14 sites across 1 country: United States

Regulatory

• FDA-regulated drug study