Study Assessing Immunogenicity and Safety of IC43 In Intensive Care Patients

About this trial

Last updated 14 years ago

Study ID

IC43-201

Status

Completed

Type

Interventional

Phase

Phase 2

Placebo

Yes

Accepting

18 to 80 Years

All Sexes

Trial Timing

Ended 16 years ago

What is this trial about?

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.

What are the participation requirements?

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