NCT02425098

Safety and Immunogenicity With Two Different Serotype 2 Potencies of Takeda's Tetravalent Dengue Vaccine Candidate (TDV) in Adults in Singapore

A Phase II, Double-Blind, Randomized, Controlled Trial to Assess the Safety and Immunogenicity of a Tetravalent Dengue Vaccine With Two Different Serotype 2 Potencies in an Adult Population in Singapore

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 351 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 21 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the post-vaccination neutralizing antibody response against each dengue serotype by vaccine group.

Detailed description

The vaccine being tested in this study was Takeda's Tetravalent Dengue Vaccine Candidate (TDV). TDV is being tested to protect people against dengue fever. This study looked at safety and the titers of antibodies to dengue fever induced in people who were administered a high-dose of TDV (HD-TDV) compared to TDV. The study enrolled 351 patients. Before being assigned to a treatment group participants were screened for previous exposure to the dengue virus using a Dengue immunoglobulin G (IgG) enzyme-linked immunosorbent assay (ELISA). Participants were randomly assigned in 1:1 ratio (by chance) to one of the two treatment groups-which remained undisclosed to the participant and study doctor during the study (unless there is an urgent medical need): * HD-TDV 0.5 mL subcutaneous injection * TDV 0.5 mL subcutaneous injection All participants received a single injection on Day 1. Participants were asked to record any symptoms that may or may not be related to the vaccine or the injection site in a diary card for 28 days after vaccination. This multi-center trial was conducted in Singapore. The overall time of participation in this study was 12 months. Participants made multiple visits to the clinic, including a final visit 1 year after receiving their dose of TDV.

Conditions

• Dengue Fever

Interventions

Type	Name	Description
BIOLOGICAL	Takeda's Tetravalent Dengue Vaccine Candidate (TDV)	TDV subcutaneous injection
BIOLOGICAL	Takeda's High-Dose Tetravalent Dengue Vaccine Candidate (HD-TDV)	High-dose TDV subcutaneous injection

Timeline

• Start date: 2015-06-03
• Primary completion: 2017-09-18
• Completion: 2017-09-18
• First posted: 2015-04-23
• Last updated: 2019-08-28
• Results posted: 2019-08-28

Locations

3 sites across 1 country: Singapore