NCT01560793

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 224 (actual)
• Sponsor: VaxInnate Corporation · Industry
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

Summary

This study will evaluate the safety and immunogenicity of VAX161B \[STF2.HA5 H5N1\], a recombinant, inactivated, subunit influenza vaccine given as a two dose regimen at a range of doses.

Detailed description

The purpose of this study is to test an investigational vaccine known as "VAX161B". VAX161B is a vaccine for the influenza A virus subtype H5N1 avian influenza virus (bird flu). In this study, the subject will receive the VAX161B vaccine at one of five doses to see which does might be the best. VaxInnate want to find out how safe these vaccines are and how well they are tolerated by people who receive them. To measure how effective each type of vaccine is, VaxInnate will test the ability of the body to develop an immune response, which means how well the body recognizes and defends itself against the influenza virus.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	VAX161 [STF2.HA5 H5N1]	dose escalating, 2 intramuscular doses given 21 days apart

Timeline

• Start date: 2012-06-01
• Primary completion: 2013-06-01
• Completion: 2013-11-01
• First posted: 2012-03-22
• Last updated: 2014-09-23

Locations

2 sites across 1 country: United States