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

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Valneva Austria GmbH

Criteria

Inclusion Criteria:

• male or female patients admitted to an intensive care unit (ICU) with need for mechanical ventilation for at least 48 hours, aged between 18 and 80 years at Visit 0

• written informed consent or waiver according to the national regulations

• no childbearing potential or negative pregnancy test

Exclusion Criteria:

• Sequential Organ Failure Assessment (SOFA) < 4 on Day 0

• Patients <6 months post organ transplantation

• readmission to ICU during the current total hospital stay on Day 0

• patients admitted to ICU within 2 days after surgery

• patients admitted to ICU due to trauma

• elective surgery until Day 28 after first vaccination