drugset / Trial / NCT03141138
Comparison of Tetravalent Dengue Virus Purified Inactivated Vaccine and Tetravalent Dengue Virus Live Attenuated Vaccine
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | TDENV-LAV F17 | Vaccine | 0.5 ml | Subcutaneous |
| Subject | TDENV-PIV | Vaccine | 4 ug | Intramuscular |
| Subject | TDENV-PIV | Vaccine | 0.5 ml | Intramuscular |