Description:

ODM derived from http://clinicaltrials.gov/ct2/show/record/NCT00778388

Link:

http://clinicaltrials.gov/ct2/show/record/NCT00778388

Keywords:
Versions (2) ▾
  1. 11/23/11
  2. 4/13/14
Uploaded on:

April 13, 2014

DOI:
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License:
Creative Commons BY 4.0
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Eligibility NCT00778388 Pseudomonas Aeruginosa

Details

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
written informed consent obtained prior to study entry
healthy adults aged between 18 and 65 years
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
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
Exclusion Criteria
History of autoimmune diseases and malignancies
Active or passive vaccination 4 weeks before and during the entire study protocol
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
History of severe hypersensitivity reactions and anaphylaxis
Known hypersensitivity or allergic reactions to one of the components of the vaccine
Clinically significant diseases as judged by the investigator
Immunodeficiency due to immunosuppressive therapy
A family history of congenital or hereditary immunodeficiency
Medical Concepts
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