NCT06060067

A Study of Dengue Vaccine in Healthy Children, Teenagers and Adults in India

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial to Investigate the Safety and Immunogenicity of a Dengue Tetravalent Vaccine (Live, Attenuated) (TDV) Administered Subcutaneously to Healthy Subjects Aged 4 to 60 Years in India

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 480 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 4 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The main aims of the study are to learn about side effects and a participant's immune response to Takeda's Dengue Vaccine when given twice within 3 months. Participants will receive 2 doses of their randomized treatment (vaccine or placebo). Children, teenagers and adults will receive one dose of either the vaccine or placebo on Day 1 and the second dose of either the vaccine or placebo 3 months later. Up to 4 blood samples will be taken throughout the study. During the study, participants will visit their study clinic 6 times.

Detailed description

The vaccine being tested in this study is called TDV (Live, Attenuated). TDV is being tested to prevent dengue. This study will assess the safety and immunogenicity of TDV in healthy participants. The study will enroll approximately 480 patients. Participants will be randomly assigned (by chance, like flipping a coin) to receive either TDV or placebo- which will remain undisclosed to the participant, and investigator during the study: * Cohort 1, ≥18 to ≤60 Age Group: TDV * Cohort 1, ≥18 to ≤60 Age Group: Placebo * Cohort 2, ≥4 to \<18 Age Group: TDV * Cohort 2, ≥4 to \<18 Age Group: Placebo This multi-center trial will be conducted in India. The overall duration of the study is approximately 9 months.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
BIOLOGICAL	TDV	TDV SC injection on Day 1 and Day 90 of the study
BIOLOGICAL	Placebo	Normal Saline (0.9% NaCl) SC injection on Day 1 and Day 90 of the study

Timeline

• Start date: 2024-03-29
• Primary completion: 2025-05-05
• Completion: 2025-05-05
• First posted: 2023-09-29
• Last updated: 2025-11-26

Locations

10 sites across 1 country: India