Safety and Immunogenicity of a Novel H5N1 Influenza Vaccine in Healthy Adults Age 18-49 Years
NCT01560793 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 224
Last updated 2014-09-23
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.
Conditions
Interventions
- BIOLOGICAL
-
VAX161 [STF2.HA5 H5N1]
dose escalating, 2 intramuscular doses given 21 days apart
Sponsors & Collaborators
-
VaxInnate Corporation
lead INDUSTRY
Principal Investigators
-
Eric Sheldon, MD · Miami Research Associates
-
Casey Johnson, DO · Johnson County Clin-Trials
Study Design
- Allocation
- NA
- Purpose
- PREVENTION
- Masking
- TRIPLE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 49 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2012-06-30
- Primary Completion
- 2013-06-30
- Completion
- 2013-11-30
Countries
- United States
Study Locations
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