NCT03341637

Immunogenicity and Safety of Tetravalent Dengue Vaccine (TDV) in Adolescents in Non-Endemic Area(s)

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial to Investigate the Immunogenicity and Safety of Subcutaneous Administration of a Tetravalent Dengue Vaccine Candidate in Healthy Adolescent Subjects in Non-Endemic Area(s) for Dengue

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 400 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study was to describe the neutralizing antibody response against each dengue serotype at 1 month post second dose of TDV or placebo in dengue-naive adolescent participants.

Detailed description

The vaccine tested in this study was tetravalent dengue vaccine (TDV). TDV was tested to assess the safety and immunogenicity in healthy adolescents in non-endemic area(s) for dengue. The study enrolled 400 healthy participants. Participants were randomized in 3:1 ratio to receive: * TDV 0.5 mL subcutaneous injection * Placebo normal saline solution (0.9% NaCl) for injection. In each trial group, participants received 2-dose schedule of TDV or placebo by subcutaneous injection on Days 1 (Month 0) and 90 (Month 3), but not all participants received both doses (8 subjects discontinued the trial before receiving the second dose). This multi-center trial was conducted in Mexico. The overall time to participate in this study was 270 days. Participants had multiple visits to the clinic including a final visit at Day 270.

Conditions

• Dengue

Interventions

Type	Name	Description
BIOLOGICAL	Tetravalent Dengue Vaccine (TDV)	TDV subcutaneous injection
BIOLOGICAL	Placebo	Normal Saline (0.9% NaCl) subcutaneous injection

Timeline

• Start date: 2017-12-14
• Primary completion: 2019-01-26
• Completion: 2019-01-26
• First posted: 2017-11-14
• Last updated: 2019-08-15
• Results posted: 2019-08-15

Locations

5 sites across 1 country: Mexico

Regulatory

• FDA-regulated drug study