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Study to Evaluate the Safety and Immunogenicity of a Pandemic Influenza Vaccine in Adults Aged 18 Years and Above

NCT00319098 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 5075

Last updated 2018-07-23

Study results available
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Summary

Today, the leading contender for the next pandemic of influenza is H5N1, a strain of avian virus. Prevention and control will depend on the rapid production and worldwide distribution of specific pandemic vaccines. Candidate 'pandemic-like' vaccines must be developed and tested in clinical trials to determine the most optimal formulation and the best vaccination schedule. This study is designed to test in healthy adults aged above 18 years the reactogenicity and immunogenicity of one and two administrations of a candidate pandemic H5N1 vaccine formulated from Split Virus.

Conditions

Interventions

BIOLOGICAL

Adjuvanted pandemic influenza candidate vaccine

2 doses, intramuscular injection

BIOLOGICAL

Fluarix

One intramuscular injection

BIOLOGICAL

Placebo

One intramuscular 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
2006-05-01
Primary Completion
2007-01-01
Completion
2007-07-31

Countries

  • Estonia
  • France
  • Germany
  • Netherlands
  • Russia
  • Spain
  • Sweden

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 NCT00319098 on ClinicalTrials.gov