drugset / Trial / NCT01658800

Study of the Safety and Immunogenicity of a Novel H5N1 Influenza Vaccine in Healthy Adults Age 18-49

NCT01658800 ↗

Phase 1 Completed 275 enrolled VaxInnate Corporation
NaSingle-groupOpen-labelPrevention

Summary

The purpose of this study is to test an investigational vaccine known as "VAX161C." An "investigational" vaccine is one that is not licensed for commercial use in the by the United States (US) by the US Food and Drug Administration (FDA). VAX161C is a vaccine for the influenza A virus subtype H5N1 avian influenza virus (bird flu). In this study, the subject will receive the VAX161C vaccine at one of six doses to see which dose is the best. VaxInnate wants to find out how safe these doses of vaccines are and how well they are tolerated by people who receive them. To measure how effective each type of the vaccine is, VaxInnate will test the ability of the body to develop an immune response, which means how the body recognizes and defends itself against the influenza virus.

Timeline

Start
2012-09
Primary completion
2013-09
Completion
2013-12

Drugs

EvaluationDrugModalityDoseRoute
Subject VAX161C Vaccine 1 ug —
Subject VAX161C Vaccine 2.5 ug —
Subject VAX161C Vaccine 4 ug —
Subject VAX161C Vaccine 6 ug —
Subject VAX161C Vaccine 8 ug —
Subject VAX161C Vaccine 12 ug —

Indications