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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06060067
Study type Interventional
Source Takeda
Contact Takeda Contact
Phone +1-877-825-3327
Email medinfoUS@takeda.com
Status Recruiting
Phase Phase 3
Start date March 29, 2024
Completion date April 1, 2025

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