drugset / Trial / NCT03141138

Comparison of Tetravalent Dengue Virus Purified Inactivated Vaccine and Tetravalent Dengue Virus Live Attenuated Vaccine

NCT03141138 ↗

RandomizedParallel-groupOpen-labelPrevention

Summary

This study is a Phase 1, randomized, open-label study of the prime-boost vaccine candidates given in the prime-boost regimen previously demonstrated to have a high level of immunogenicity and immune durability: Day 0 prime (PIV) and Day 180 boost (LAV), and compare it with a previously untested schedule: Day 0 prime (PIV) and Day 90 boost (LAV) in order to define the potential tradeoff between potential immunogenicity, including cell-mediated immunity, and a more practical dosing schedule.

Timeline

Start
2017-11-08
Primary completion
2019-10-31
Completion
2021-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject TDENV-LAV F17 Vaccine 0.5 ml Subcutaneous
Subject TDENV-PIV Vaccine 4 ug Intramuscular
Subject TDENV-PIV Vaccine 0.5 ml Intramuscular

Indications