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

No results posted yet for this study

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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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01560793 on ClinicalTrials.gov