Two Doses of GHB04L1 for Pandemic Influenza Prophylaxis in Healthy Adults

Inclusion Criteria: * Male or female healthy volunteers, 18-50 years of age * Seronegative for H5N1 (with antibody titres \<1:10 detected in HAI assay) * Seronegative for H1N1 (with antibody titres ≤1:20 detected in HAI assay) * Written informed consent to participate in this study Exclusion Criteria: * Acute febrile illness (\>37.0°C) * Positive influenza immunoassay at baseline * Signs of acute or chronic upper or lower respiratory tract illnesses (sneezing, cough, tonsillitis, otitis, etc.) * History of severe atopy * Influenza vaccination 2006/2007 and/or later * Known increased tendency of nose bleeding * Volunteers with clinically relevant abnormal paranasal anatomy * Volunteers with clinically relevant abnormal laboratory values Females with positive urine pregnancy test prior to vaccination * Simultaneous treatment with immunosuppressive drugs incl. corticosteroids (≥ 2 weeks) within 4 weeks prior to study medication application * Clinically relevant history of renal, hepatic, GI, cardiovascular, haematological, skin, endocrine, neurological or immunological diseases * History of leukaemia or cancer * HIV or hepatitis B or C seropositivity * Volunteers who had undergone rhino or sinus surgery or surgery of another traumatic injury of the nose within 30 days prior to application of study medication * Volunteers who had received antiviral drugs, treatment with immunoglobulins or blood transfusions or an investigational drug within four weeks prior to study medication…