drugset / Trial / NCT04490499
A Hepatitis B Vaccine Challenge Study After Previous Vaxelis® Vaccination (V419-013)
NaSingle-groupOpen-labelPrevention
Summary
The purpose of this study is to demonstrate the durability of protection against hepatitis B virus (HBV) infection approximately 8-9 years after vaccination with Vaxelis®. This is an estimation study, and no formal hypothesis testing was performed.
Timeline
- Start
- 2020-09-02
- Primary completion
- 2020-12-29
- Completion
- 2020-12-29
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | HBVAXPRO | Vaccine | 5 ug | Intramuscular |
| Subject | HBVAXPRO | Vaccine | 0.5 ml | Intramuscular |