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

NCT01658800 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 275

Last updated 2015-03-06

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

VAX161C vaccine

Recombinant H5 influenza vaccine, VAX161C

Sponsors & Collaborators

  • VaxInnate Corporation

    lead INDUSTRY

Principal Investigators

  • David Taylor, MD · VaxInnate Corporation

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2013-09-30
Completion
2013-12-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT01658800 on ClinicalTrials.gov