drugset / Trial / NCT04490499

A Hepatitis B Vaccine Challenge Study After Previous Vaxelis® Vaccination (V419-013)

NCT04490499

Phase 3 Completed 207 enrolled Merck Sharp & Dohme LLC
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

EvaluationDrugModalityDoseRoute
Subject HBVAXPRO Vaccine 5 ug Intramuscular
Subject HBVAXPRO Vaccine 0.5 ml Intramuscular