Based on the results from a previous formulation/dosage ranging trial, this phase II multicenter, open trial was designed to determine the safety and immunogenicity of two vaccine formulation/dosages with and without adjuvant 21 days after each vaccination in adults (18 to 60 years and in the elderly (\> 60 years) as required by the European Medicines Agency (EMEA) guideline. The antibody persistence until the booster vaccination at 6 or 12 months will also be evaluated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
600
0.5mL, Intramuscular
0.5mL, Intramuscular
Unnamed facility
Ghent, Belgium
Unnamed facility
Leuven, Belgium
Unnamed facility
Wilrijk, Belgium
Unnamed facility
Oxford, United Kingdom
To provide information concerning the safety of an A/H5N1 inactivated, split-virion influenza virus vaccine
Time frame: 21 Days post-vaccination
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