Actively Recruiting
Phase 3 Trial to Test Safety and Immune Response of Two Doses of Dengue Tetravalent Vaccine in Children Aged 6 to Under 21 Months
Led by Takeda · Updated on 2026-06-29
212
Participants Needed
4
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Dengue fever is caused by infection with the dengue virus. This trial studies how safe and effective the Dengue Tetravalent Vaccine TDV is in activating the immune system of young children aged 6 to 21 months. The study aims to better understand the vaccines safety and immune response in infants and toddlers. Children will receive two doses of either TDV or a placebo injection, given three months apart. Participants are divided into two age groups 6 to less than 12 months and 12 to less than 21 months. Each group receives either the vaccine or placebo through subcutaneous injections on Day 1 and Day 90. Participants will visit the clinic eight times for vaccinations, blood draws, and health checks throughout the study. Blood samples are collected before and after vaccination to assess immune response. Researchers will monitor adverse events, immune responses, and overall health during the study, which continues until the final assessments at Day 1170.
CONDITIONS
Brief Title
A Study of 2 Doses of Tetravalent Dengue Vaccine (TDV) in Infants and Toddlers
Research Team
T
Takeda Contact
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