At a glance
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A Phase 3, Follow-Up Trial to Evaluate Long-Term Safety and Antibody Persistence, and the Impact of a Booster Dose of a Tetravalent Dengue Vaccine Candidate in Healthy Adolescents and Adults in Areas Non-Endemic for Dengue
In Brief
A Phase 3 clinical trial evaluating Takeda's Dengue Tetravalent Vaccine (Live, Attenuated) (TDV) and Placebo for Dengue Fever. Completed, enrolled 365 participants across 10 sites in 2 countries.
Detailed Summary
The purpose of this study is to describe antibody persistence for each of the 4 dengue serotypes for up to 63 months after the first vaccination in the primary vaccination series for participants from parent trial DEN-315 (NCT03341637) (Mexico) and for up to 36 months after the first vaccination in the primary vaccination series for participants from parent trial DEN-304 (NCT03423173) (United States \[US\]) and to describe the impact of a tetravalent dengue vaccine (TDV) booster dose vs placebo on antibody response for each of the 4 dengue serotypes at 1 month and 6 months post administration of the TDV booster or placebo.
Study Details
Timeline
Interventions
TDV subcutaneous injection
Normal Saline (0.9% NaCl) subcutaneous injection