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

Completed · Phase 1

Conditions studied: Influenza

In brief

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.

Key facts

Study ID

NCT01560793

Run by

VaxInnate Corporation

People needed

224

Starts

2012-06-01

Expected to finish

2013-11-01

Last updated by the study team

2014-09-23

Who can join

Age: 18 and older, up to 49. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• male or female aged 18 - 49 years inclusive
• give written informed consent to participate
• healthy, as determined by medical history, physical examination
• comprehension of the study requirements
• willing to provide multiple blood specimens collected by venipuncture.

You may not qualify if…

• Subjects who have a psychiatric illness, a chronic illness that would interfere with participation or interpretation of results
• clinically significant abnormal liver function tests
• positive serology for HBsAg or HCV antibodies
• impaired immune responses
• history of anaphylactic type reaction to injected vaccines
• history of drug or chemical abuse in the year prior to screening
• history of Guillain-Barré Syndrome
• history of chronic obstructive pulmonary disease or history of other lung disease

Where it is running

• Miami Research Associates — Miami, Florida, United States
• Johnson County Clin-Trials — Lenexa, Kansas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.