NCT01563263

Confirmatory Phase II/III Study Assessing Efficacy, Immunogenicity and Safety of IC43

A Confirmatory Phase II/III Study Assessing Efficacy, Immunogenicity and Safety of IC43 Recombinant Pseudomonas Vaccine Intensive Care Patients

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 803 (actual)
• Sponsor: Valneva Austria GmbH · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a confirmatory, randomized, placebo-controlled, multi-center, double-blinded phase II/III study. The study population consists of male or female intensive care unit (ICU) patients with a need for mechanical ventilation for more than 48 hours, aged between 18 and 80 years.

Detailed description

This is a confirmatory, randomized, placebo-controlled, multi-center, double-blinded phase II/III study. The study population consists of male or female intensive care unit (ICU) patients with a need for mechanical ventilation for more than 48 hours, aged between 18 and 80 years. Eight-hundred patients will be enrolled at approximately 50 study centers. Informed consent (i.e., from the patient or from the patient's legally authorized representative) or waiver will be obtained according to regional requirements prior to any study related procedures. Patients will be randomized to receive either IC43 100 mcg or placebo and will receive the first vaccination on Day 0. The second vaccination will be applied on Day 7. In case ICU discharge occurs before Day 7, immunization will be done at the hospital ward.

Conditions

• Pseudomonas Aeruginosa Infection

Interventions

Type	Name	Description
BIOLOGICAL	IC43	100 mcg
DRUG	Placebo	phosphate buffered saline (PBS) solution containing 0,9 % NaCl

Timeline

• Start date: 2012-03-01
• Primary completion: 2015-08-01
• Completion: 2015-12-01
• First posted: 2012-03-26
• Last updated: 2016-03-31

Locations

50 sites across 6 countries: Austria, Belgium, Czechia, Germany, Hungary, Spain