Status:
COMPLETED
Study Assessing Safety and Immunogenicity of IC43 Vaccination Against Pseudomonas Aeruginosa in Healthy Volunteers
Lead Sponsor:
Valneva Austria GmbH
Conditions:
Healthy
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
The objective is to confirm the optimal dose of IC43 in regard to immunogenicity, safety and tolerability.
Detailed Description
The study will be designed as a multi-center, observer-blinded, randomized, placebocontrolled phase 1 study in healthy adult subjects of 18 to 65 years of age. A total of 160 healthy male and female s...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
157 Patients enrolled
Trial Details
Trial ID
NCT00778388
Start Date
September 1 2008
End Date
September 1 2009
Last Update
October 19 2012
Active Locations (3)
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1
Univ.-Prof. Dr. Bernd Jilma
Vienna, Vienna, Austria, 1090
2
Dr. Daniel Sehrt
Göttingen, Göttingen, Germany
3
Dr. Jutta Harten
Münster, Münster, Germany