NCT00876252

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2008

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 3, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 6, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

October 19, 2012

Status Verified

October 1, 2012

Enrollment Period

1.2 years

First QC Date

April 3, 2009

Last Update Submit

October 18, 2012

Conditions

Pneumonia, Ventilator-Associated

Outcome Measures

Primary Outcomes (1)

  • Immunogenicity at day 14 as determined by OprF/I specific IgG antibody titer measured by ELISA in patients receiving IC43 or placebo

    Day 14

Secondary Outcomes (5)

  • Immunogenicity at day 7

    Day 7

  • Rate of serious adverse events

    Day 7

  • Safety laboratory parameters

    Day 7

  • Systemic tolerability

    Day 7

  • Local tolerability

    Day 7

Study Arms (4)

IC43 100 mcg

ACTIVE COMPARATOR

IC43 100 mcg with Aluminum hydroxide

Biological: IC43

IC43 200 mcg

ACTIVE COMPARATOR

IC43 200 mcg with Aluminum hydroxide

Biological: IC43

IC43 100 mcg w/o

ACTIVE COMPARATOR

IC43 100 mcg without Aluminum hydroxide

Biological: IC43

Placebo

PLACEBO COMPARATOR

phosphate-buffered saline solution containing 0,9 % NaCl and 400 mcg Aluminum hydroxide as an adjuvant

Drug: Placebo

Interventions

IC43BIOLOGICAL
Also known as: IC43 Pseudomonas Aeruginosa
IC43 100 mcgIC43 100 mcg w/oIC43 200 mcg
PlaceboDRUG

NaCl

Also known as: phosphate buffered saline (PBS)
Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, Vienna, 1090, Austria

Location

Related Publications (1)

  • Rello J, Krenn CG, Locker G, Pilger E, Madl C, Balica L, Dugernier T, Laterre PF, Spapen H, Depuydt P, Vincent JL, Bogar L, Szabo Z, Volgyes B, Manez R, Cakar N, Ramazanoglu A, Topeli A, Mastruzzo MA, Jasovich A, Remolif CG, Del Carmen Soria L, Andresen Hernandez MA, Ruiz Balart C, Kremer I, Molnar Z, von Sonnenburg F, Lyons A, Joannidis M, Burgmann H, Welte T, Klingler A, Hochreiter R, Westritschnig K. A randomized placebo-controlled phase II study of a Pseudomonas vaccine in ventilated ICU patients. Crit Care. 2017 Feb 4;21(1):22. doi: 10.1186/s13054-017-1601-9.

    PMID: 28159015DERIVED

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Healthcare-Associated PneumoniaCross InfectionInfectionsPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Nicole Haas

    Valneva Austria GmbH

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2009

First Posted

April 6, 2009

Study Start

December 1, 2008

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

October 19, 2012

Record last verified: 2012-10

Locations

AU(1)