Study Assessing Immunogenicity and Safety of IC43 In Intensive Care Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Valneva Austria GmbH
ClinicalTrials.gov Identifier:
NCT00876252
First received: April 3, 2009
Last updated: October 18, 2012
Last verified: October 2012

April 3, 2009
October 18, 2012
December 2008
February 2010   (final data collection date for primary outcome measure)
Immunogenicity at day 14 as determined by OprF/I specific IgG antibody titer measured by ELISA in patients receiving IC43 or placebo [ Time Frame: Day 14 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00876252 on ClinicalTrials.gov Archive Site
  • Immunogenicity at day 7 [ Time Frame: Day 7 ] [ Designated as safety issue: Yes ]
  • Rate of serious adverse events [ Time Frame: Day 7 ] [ Designated as safety issue: Yes ]
  • Safety laboratory parameters [ Time Frame: Day 7 ] [ Designated as safety issue: Yes ]
  • Systemic tolerability [ Time Frame: Day 7 ] [ Designated as safety issue: Yes ]
  • Local tolerability [ Time Frame: Day 7 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Study Assessing Immunogenicity and Safety of IC43 In Intensive Care Patients
A Phase 2 Pilot Study Assessing Immunogenicity and Safety of IC43 in Intensive Care Patients

Randomized, placebo-controlled, partially blinded phase 2 pilot study. Multicenter study (approximately 50 centers) in approximately 9 countries. Proposed start date is December 2008. The study duration per patient is estimated to be 90 days. Overall study duration is estimated to be 12-18 months.

This is a randomized, placebo‐controlled, multi‐center, partially blinded [i.e., 100 mcg and 200 mcg IC43 with Al(OH)3,, respectively] and placebo, but unblinded for non‐adjuvanted IC43 [i.e., 100 mcg w/o Al(OH)3] phase 2 pilot study. The study population consists of male or female ICU patients with a need for mechanical ventilation for more than 48 hours, aged between 18 and 80 years.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Pneumonia, Ventilator-Associated
  • Biological: IC43
    Other Name: IC43 Pseudomonas Aeruginosa
  • Drug: Placebo
    NaCl
    Other Name: phosphate buffered saline (PBS)
  • Active Comparator: IC43 100 mcg
    IC43 100 mcg with Aluminum hydroxide
    Intervention: Biological: IC43
  • Active Comparator: IC43 200 mcg
    IC43 200 mcg with Aluminum hydroxide
    Intervention: Biological: IC43
  • Active Comparator: IC43 100 mcg w/o
    IC43 100 mcg without Aluminum hydroxide
    Intervention: Biological: IC43
  • Placebo Comparator: Placebo
    phosphate-buffered saline solution containing 0,9 % NaCl and 400 mcg Aluminum hydroxide as an adjuvant
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
400
February 2010
February 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female patients aged between 18 and 80 years
  • Patients admitted to an ICU with a need for mechanical ventilation for more than 48 hours at visit 0
  • At high risk for acquiring infection against P. aeruginosa at visit 0.
  • Patients who, as determined by the investigator, have a high probability of survival for at least 48 hours.
  • In females, either childbearing potential terminated by surgery or 1 year post menopausal, or a negative pregnancy test and the willingness of practicing a reliable methods of contraception
  • Written informed consent or waiver according to the national regulations

Exclusion Criteria:

  • Known use of any other investigational or non-registered drug within 30 days prior to IC43 vaccination at Visit 0
  • Low severity of illness defined by an acute physiology score < 8 at visit 0
  • Patients < 6 months post organ transplantation
  • Severe thrombocytopenia or other coagulopathy which in the opinion of the investigator makes the patient unsuitable for intramuscular injection
  • Pregnancy, lactation
  • Persons who have been committed involuntarily to an institution, e.g. mental health facility or prison, will not participate in the study
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT00876252
IC43-201
Yes
Valneva Austria GmbH
Valneva Austria GmbH
Not Provided
Study Director: Nicole Haas Valneva Austria GmbH
Valneva Austria GmbH
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP