Eligibility NCT00778388 Pseudomonas Aeruginosa

written informed consent obtained prior to study entry

Yes

No

healthy adults aged between 18 and 65 years

Yes

No

no clinically relevant pathological findings in any of the investigations at the Screening visit. Minor deviations of laboratory values from the normal range may be accepted, if judged by the investigator to have no clinical relevance

Yes

No

In female subjects either childbearing potential terminated by surgery or a negative serum pregnancy test during screening and the willingness not to become pregnant during the entire study period by practicing reliable methods of contraception

Yes

No

History of autoimmune diseases and malignancies

Yes

No

Active or passive vaccination 4 weeks before and during the entire study protocol

Yes

No

Use of any other investigational or non-registered drug or vaccine in addition to the study vaccine during the study period or within 30 days preceding the first dose of study vaccine

Yes

No

History of severe hypersensitivity reactions and anaphylaxis

Yes

No

Known hypersensitivity or allergic reactions to one of the components of the vaccine

Yes

No

Clinically significant diseases as judged by the investigator

Yes

No

Immunodeficiency due to immunosuppressive therapy

Yes

No

A family history of congenital or hereditary immunodeficiency

Yes

No