Status:
COMPLETED
Study Assessing Immunogenicity and Safety of IC43 In Intensive Care Patients
Lead Sponsor:
Valneva Austria GmbH
Conditions:
Pneumonia, Ventilator-Associated
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
Randomized, placebo-controlled, partially blinded phase 2 pilot study. Multicenter study (approximately 50 centers) in approximately 9 countries. Proposed start date is December 2008. The study durati...
Detailed Description
This is a randomized, placebo-controlled, multi-center, partially blinded \[i.e., 100 mcg and 200 mcg IC43 with Al(OH)3,, respectively\] and placebo, but unblinded for non-adjuvanted IC43 \[i.e., 100 ...
Eligibility Criteria
Inclusion
- Male or female patients aged between 18 and 80 years
- Patients admitted to an ICU with a need for mechanical ventilation for more than 48 hours at visit 0
- At high risk for acquiring infection against P. aeruginosa at visit 0.
- Patients who, as determined by the investigator, have a high probability of survival for at least 48 hours.
- In females, either childbearing potential terminated by surgery or 1 year post menopausal, or a negative pregnancy test and the willingness of practicing a reliable methods of contraception
- Written informed consent or waiver according to the national regulations
Exclusion
- Known use of any other investigational or non-registered drug within 30 days prior to IC43 vaccination at Visit 0
- Low severity of illness defined by an acute physiology score \< 8 at visit 0
- Patients \< 6 months post organ transplantation
- Severe thrombocytopenia or other coagulopathy which in the opinion of the investigator makes the patient unsuitable for intramuscular injection
- Pregnancy, lactation
- Persons who have been committed involuntarily to an institution, e.g. mental health facility or prison, will not participate in the study
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00876252
Start Date
December 1 2008
End Date
February 1 2010
Last Update
October 19 2012
Active Locations (1)
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1
Medical University of Vienna
Vienna, Vienna, Austria, 1090