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

NCT01563263 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 803

Last updated 2016-03-31

No results posted yet for this study

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.

Conditions

  • Pseudomonas Aeruginosa Infection

Interventions

BIOLOGICAL

IC43

100 mcg

DRUG

Placebo

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

Sponsors & Collaborators

  • Valneva Austria GmbH

    lead INDUSTRY

Principal Investigators

  • Susanne Eder, Mag · Valneva Austria GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2015-08-31
Completion
2015-12-31

Countries

  • Austria
  • Belgium
  • Czechia
  • Germany
  • Hungary
  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01563263 on ClinicalTrials.gov