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Safety and Immunogenicity of Vaccine in Adults at Occupational Risk for Influenza A (H5N1) Exposure

NCT01045564 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2015-03-23

No results posted yet for this study

Summary

The purpose of this study is to characterize the immunogenicity and safety of 3 doses of GSK's avian flu vaccine GSK 1557484A given at different time intervals to adults aged 18 years or greater who are at increased occupational risk of H5N1 exposure.

Conditions

Interventions

BIOLOGICAL

GSK influenza virus H5N1 vaccine 1557484A

Three doses of GSK 1557484A administered intramuscularly (IM), the first and third in the deltoid region of the non-dominant arm and the second in the deltoid region of the dominant arm

Sponsors & Collaborators

  • United States Department of Health and Human Services, Center for Disease Control and Prevention, National Institutes of Health, Department of Defense

    collaborator UNKNOWN

  • GlaxoSmithKline

    lead INDUSTRY

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2013-02-28
Completion
2013-02-28

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT01045564 on ClinicalTrials.gov