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Immunogenicity & Safety of GSK's Avian Flu Vaccine 1557484A Given to Adults Aged ≥18 Years

NCT00719043 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 841

Last updated 2018-07-09

Study results available
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Summary

The purpose of this study is to determine whether GSK's avian flu vaccine GSK 1557484A is immunogenic and safe when given to adults aged \>=18 years.

This Protocol Posting has been updated following Amendments 1-3 of the Protocol, Dec 2009. The impacted sections are study design and outcome measures.

Conditions

Interventions

BIOLOGICAL

A/turkey H5N1 vaccine

Administered as an intramuscular (IM) injection

BIOLOGICAL

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

Administered as an intramuscular (IM) injection

BIOLOGICAL

Placebo

Administered as an intramuscular (IM) injection

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-07-11
Primary Completion
2010-04-22
Completion
2011-02-18

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs
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 NCT00719043 on ClinicalTrials.gov