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Safety and Tolerability Study of GlaxoSmithKline (GSK)1557484A Vaccine in Adults at Occupational Risk for Influenza A (H5N1) Exposure

NCT01788228 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2020-06-23

Study results available
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Summary

The purpose of this study is to evaluate the safety and tolerability of GSK Biologicals' vaccine GSK1557484A against pandemic avian (H5N1) influenza in adults at occupational risk of exposure to the virus.

Conditions

Interventions

BIOLOGICAL

Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia)

2 doses administered intramuscularly (IM) in deltoid region of arm at the Day 0 and Day 21 visits.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-03-22
Primary Completion
2014-03-27
Completion
2015-02-25

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 NCT01788228 on ClinicalTrials.gov