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 duration per patient is estimated to be 90 days. Overall study duration is estimated to be 12-18 months.
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 \[i.e., 100 mcg w/o Al(OH)3\] phase 2 pilot study. The study population consists of male or female ICU patients with a need for mechanical ventilation for more than 48 hours, aged between 18 and 80 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
400
Medical University of Vienna
Vienna, Vienna, Austria
Immunogenicity at day 14 as determined by OprF/I specific IgG antibody titer measured by ELISA in patients receiving IC43 or placebo
Time frame: Day 14
Immunogenicity at day 7
Time frame: Day 7
Rate of serious adverse events
Time frame: Day 7
Safety laboratory parameters
Time frame: Day 7
Systemic tolerability
Time frame: Day 7
Local tolerability
Time frame: Day 7
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