Study Assessing Immunogenicity and Safety of IC43 In Intensive Care Patients

• Status: Completed
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: All

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 duration per patient is estimated to be 90 days. Overall study duration is estimated to be 12-18 months.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Valneva Austria GmbH
• Treatments: Aluminum Hydroxide

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