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

Valneva Austria GmbH803 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

803

Conditions

Pseudomonas Aeruginosa Infection

Interventions

IC43BIOLOGICAL

100 mcg

PlaceboDRUG

phosphate buffered saline (PBS) solution containing 0,9 % NaCl

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (50)

Outcomes

Primary Outcomes

number of deaths until Day 28

Time frame: until Day 28

Secondary Outcomes

number of deaths in comparison on Day 14, 56 and 90

Time frame: until Day 90

number of deaths onDay 28, 56 and 90 in patients surviving Day 14 and receiving IC43 or placebo

Time frame: until Day 90

number of deaths on Day 14, 28, 56 and 90 in patients surviving Day 3 and receiving IC43 or placebo

Time frame: until Day 90

number of overall survival in all patients and in patients surviving Day 14

Time frame: until Day 180

number of deaths related to sepsis at Day 14, 28, 56 and 90 in patients receiving IC43 or placebo

Time frame: until Day 90

number of surviving subjects after Sepsis receiving IC43 or placebo

Time frame: until Day 180

number of deaths in patients in-ICU and in-hospital receiving IC43 or placebo until Day 14, 28, 56,90, 180

Time frame: until Day 180

percentage of patients with invasive infection with P. aeruginosa, such as bacteremia or P. aeruginosa urinary tract infection in patients receiving IC43 or placebo up to Day 56 after first vaccination

Time frame: until Day 56

percentage of patients with P. aeruginosa respiratory tract infection or P. aeruginosa respiratory tract colonization in patients receiving IC43 or placebo up to Day 56 after first vaccination

Data from ClinicalTrials.gov

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