Study Assessing Immunogenicity and Safety of IC43 In Intensive Care Patients

Launched by VALNEVA AUSTRIA GMBH · Apr 3, 2009

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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