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

NCT00616928 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 4561

Last updated 2018-06-08

Study results available
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Summary

The purpose of this Phase 3, observer-blind, placebo-controlled, multi-center study is to characterize the immunogenicity \& safety of the investigation vaccination regimen of GSK 1557484A vaccine given to adults aged ≥18 years.

Conditions

Interventions

BIOLOGICAL

Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted

Two intramuscular injections at Days 0 and 21.

BIOLOGICAL

Placebo

Two intramuscular injections at Days 0 and 21.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-01-23
Primary Completion
2008-10-15
Completion
2009-03-19

Countries

  • United States
  • Canada

Study Locations

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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 NCT00616928 on ClinicalTrials.gov