NCT00876252

Study Assessing Immunogenicity and Safety of IC43 In Intensive Care Patients

A Phase 2 Pilot Study Assessing Immunogenicity and Safety of IC43 in Intensive Care Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 400 (actual)
• Sponsor: Valneva Austria GmbH · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

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 \[i.e., 100 mcg w/o Al(OH)3\] 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.

Conditions

• Pneumonia, Ventilator-Associated

Interventions

Type	Name	Description
BIOLOGICAL	IC43
DRUG	Placebo	NaCl

Timeline

• Start date: 2008-12-01
• Primary completion: 2010-02-01
• Completion: 2010-02-01
• First posted: 2009-04-06
• Last updated: 2012-10-19

Locations

1 site across 1 country: Austria