This present study, randomized, single-blind, dose-ranging, multicenter study, will evaluate immunogenicity, safety and tolerability of two doses of an adjuvanted and not-adjuvanted new swine-origin influenza A/H1N1 virus monovalent subunit vaccine in healthy adult and elderly subjects. A booster dose will be administered 12 months after the first vaccination.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
660
This trial will be performed at multiple study sites in a population of healthy adults and elderly. Subjects will be randomized to receive two IM injections of low dose of antigen \& adjuvant,or high dose of antigen \& adjuvant, or high dose of antigen, according to the study groups
Gent, Antwerpen
Antwerp, Belgium
Munchen, Wurzburg, Balve, Leipzig, Magdeburg, Hamburg, Rostock, Mainz
Mainz, Germany
Unnamed facility
Basel, Switzerland
Unnamed facility
Zurich, Switzerland
To identify the preferred vaccine formulation, dosage (antigen & adjuvant), schedule (one or two administrations) of the H1N1 sw monovalent vaccine in adults
Time frame: 43 days after first vaccination
To evaluate immunogenicity against A/California H1N1sw strain after booster dose of egg-derived seasonal trivalent, MF59 adjuvanted vaccine Fluad, recommended for 2010/2011 season, administered 12 months after primary course according to CHMP criteria
Time frame: 3 weeks after booster vaccination
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