The purpose of the study is to obtain immunogenicity and safety data at different dose levels of an investigational H1N1 pandemic influenza vaccine in healthy adults 18 years of age and older.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
408
Two injections at a 21-day interval (Days 1 and 22)
Sanatorium Leech
Graz, Austria
ClinPharm International GmbH
Vienna, Austria
Medical University of Vienna, Institute for Specific Prophylaxis and Tropical Medicine
Vienna, Austria
University Hospital, Department of Clinical Pharmacology
Vienna, Austria
Number of subjects achieving antibody levels to A/H1N1/California/07/2009 virus that meet the definition of seroprotection and seroconversion at 21 days after the second vaccination
Time frame: 42 days
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Praxis Regner Schmitt
Mainz, Germany