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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01563263
First Posted: March 26, 2012
Last Update Posted: March 31, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Valneva Austria GmbH
  Purpose
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.

Condition Intervention Phase
Pseudomonas Aeruginosa Infection Biological: IC43 Drug: Placebo Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Confirmatory Phase II/III Study Assessing Efficacy, Immunogenicity and Safety of IC43 Recombinant Pseudomonas Vaccine Intensive Care Patients

Resource links provided by NLM:


Further study details as provided by Valneva Austria GmbH:

Primary Outcome Measures:
  • number of deaths until Day 28 [ Time Frame: until Day 28 ]

Secondary Outcome Measures:
  • 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 [ Time Frame: until Day 56 ]
  • Organ function in patients receiving IC43 or placebo during ICU stay [ Time Frame: during ICU stay ]
  • Days of ICU stay in patients receiving IC43 or placebo [ Time Frame: Until Day 180 ]
  • Immunogenicity at Day 7, 14, 28, 56 and 180 as determined by OprF/I specific IgG antibody titer measured by ELISA in patients receiving IC43 or placebo [ Time Frame: until Day 180 ]
  • Number of SAEs and AEs during the vaccination period up to 180 days after the first vaccination [ Time Frame: until Day 180 ]
  • systemic tolerability [ Time Frame: until Day 7 ]
    blood pressure

  • number of local reactions at the injection site [ Time Frame: until Day 180 ]
  • Composite measure of laboratory parameters [ Time Frame: until Day 56 ]
  • systemic tolerability [ Time Frame: until Day 7 ]
    pulse

  • systemic tolerability [ Time Frame: until Day 7 ]
    body temperature


Enrollment: 803
Study Start Date: March 2012
Study Completion Date: December 2015
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: IC43 100 mcg
IC43 100 mcg intramuscular injection, IC43 is a recombinant Pseudomonas aeruginosa fusion protein
Biological: IC43
100 mcg
Other Name: Pseudomonas Aeruginosa
Placebo Comparator: Placebo
phosphate buffered saline solution containing 0,9 % NaCL
Drug: Placebo
phosphate buffered saline (PBS) solution containing 0,9 % NaCl
Other Name: phosphate buffered saline (PBS)

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01563263


  Show 50 Study Locations
Sponsors and Collaborators
Valneva Austria GmbH
Investigators
Study Chair: Susanne Eder, Mag Valneva Austria GmbH
  More Information

Responsible Party: Valneva Austria GmbH
ClinicalTrials.gov Identifier: NCT01563263     History of Changes
Other Study ID Numbers: IC43-202
First Submitted: March 14, 2012
First Posted: March 26, 2012
Last Update Posted: March 31, 2016
Last Verified: March 2016

Keywords provided by Valneva Austria GmbH:
IC43
Pseudomonas Aeruginosa
mechanically ventilated ICU patients
ICU patients

Additional relevant MeSH terms:
Pseudomonas Infections
Gram-Negative Bacterial Infections
Bacterial Infections