History of Changes for Study: NCT01563263

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

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Study Record Versions

Version	Submitted Date	Changes
1	March 22, 2012	None (earliest Version on record)
2	June 1, 2012	Study Status and Outcome Measures
3	October 15, 2012	Contacts/Locations and Study Status
4	October 31, 2012	Arms and Interventions, Outcome Measures and Study Status
5	November 9, 2012	Outcome Measures and Study Status
6	February 28, 2013	Contacts/Locations and Study Status
7	March 6, 2013	Study Status and Contacts/Locations
8	June 21, 2013	Contacts/Locations and Study Status
9	June 28, 2013	Study Status
10	July 31, 2013	Contacts/Locations and Study Status
11	February 5, 2014	Study Description, Study Status, Contacts/Locations, Eligibility and Study Identification
12	February 12, 2014	Recruitment Status, Contacts/Locations and Study Status
13	June 24, 2014	Recruitment Status, Study Status and Contacts/Locations
14	July 7, 2014	Contacts/Locations and Study Status
15	July 8, 2014	Contacts/Locations and Study Status
16	July 31, 2014	Contacts/Locations and Study Status
17	August 20, 2014	Contacts/Locations and Study Status
18	September 11, 2014	Contacts/Locations and Study Status
19	February 2, 2015	Contacts/Locations and Study Status
20	March 12, 2015	Contacts/Locations and Study Status
21	April 13, 2015	Study Status, Contacts/Locations and Outcome Measures
22	July 22, 2015	Recruitment Status, Contacts/Locations and Study Status
23	September 25, 2015	Study Status
24	March 29, 2016	Recruitment Status, Study Status and Study Design

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	IC43-202
Brief Title:	Confirmatory Phase II/III Study Assessing Efficacy, Immunogenicity and Safety of IC43
Official Title:	A Confirmatory Phase II/III Study Assessing Efficacy, Immunogenicity and Safety of IC43 Recombinant Pseudomonas Vaccine Intensive Care Patients
Secondary IDs:

Study Status


Record Verification:	February 2014
Overall Status:	Recruiting
Study Start:	March 2012
Primary Completion:	May 2015 [Anticipated]
Study Completion:	May 2015 [Anticipated]

First Submitted:	March 14, 2012
First Submitted that Met QC Criteria:	March 22, 2012
First Posted:	March 26, 2012 [Estimate]

Last Update Submitted that Met QC Criteria:	February 5, 2014
Last Update Posted:	February 6, 2014 [Estimate]

Sponsor/Collaborators


Sponsor:	Valneva Austria GmbH
Responsible Party:	Sponsor
Collaborators:

Oversight


U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:	Yes

Study Description

Brief 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.

Detailed Description:

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.

Conditions


Conditions:	Pseudomonas Aeruginosa Infection
Keywords:	IC43 Pseudomonas Aeruginosa mechanically ventilated ICU patients ICU patients

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 2/Phase 3
Interventional Study Model:	Parallel Assignment
Number of Arms:	2
Masking:	Double (Participant, Investigator)
Allocation:	Randomized
Enrollment:	800 [Anticipated]

Arms and Interventions

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 Names: 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 Names: phosphate buffered saline (PBS)

Outcome Measures


Primary Outcome Measures:
1.	number of deaths until Day 28 [ Time Frame: until Day 28 ]
Secondary Outcome Measures:
1.	number of deaths in comparison on Day 14, 56 and 90 [ Time Frame: until Day 90 ]
2.	number of deaths onDay 28, 56 and 90 in patients surviving Day 14 and receiving IC43 or placebo [ Time Frame: until Day 90 ]
3.	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 ]
4.	number of overall survival in all patients and in patients surviving Day 14 [ Time Frame: until Day 180 ]
5.	number of deaths related to sepsis at Day 14, 28, 56 and 90 in patients receiving IC43 or placebo [ Time Frame: until Day 90 ]
6.	number of surviving subjects after Sepsis receiving IC43 or placebo [ Time Frame: until Day 180 ]
7.	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 ]
8.	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 ]
9.	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 ]
10.	Organ function in patients receiving IC43 or placebo during ICU stay [ Time Frame: during ICU stay ]
11.	Days of ICU stay in patients receiving IC43 or placebo [ Time Frame: Until Day 180 ]
12.	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 ]
13.	Number of SAEs and AEs during the vaccination period up to 180 days after the first vaccination [ Time Frame: until Day 180 ]
14.	systemic tolerability [ Time Frame: until Day 7 ] blood pressure
15.	number of local reactions at the injection site [ Time Frame: until Day 180 ]
16.	safety laboratory parameters [ Time Frame: until Day 56 ]
17.	systemic tolerability [ Time Frame: until Day 7 ] pulse
18.	systemic tolerability [ Time Frame: until Day 7 ] body temperature

Eligibility


Minimum Age:	18 Years
Maximum Age:	80 Years
Sex:	All
Gender Based:
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/Locations


Central Contact Person:	Susanne Eder, Mag. Telephone: 0043 1 206 20 Ext. 0 Email: info@valneva.com
Study Officials:	Susanne Eder, Mag Study Chair Valneva Austria GmbH
Locations:	Austria
	LKH - University Clinic Graz [Recruiting] Graz, Austria, 8036 Contact:Contact: Ernst Pilger, Prof. Dr. Contact:Principal Investigator: Ernst Pilger, Prof. Dr.
	LKH Salzburg [Completed] Salzburg, Austria, 5050
	Medical University of Vienna [Recruiting] Vienna, Austria, 1090 Contact:Contact: Claus Krenn, Prof.Dr. Contact:Principal Investigator: Claus Krenn, Prof.Dr.
	Medical University of Vienna [Recruiting] Vienna, Austria, 1090 Contact:Contact: Thomas Staudinger, Prof. Dr. Contact:Principal Investigator: Gottfried J. Locker, Prof. Dr.
	Medical University of Vienna [Recruiting] Vienna, Austria, 1090 Contact:Contact: Christian Zauner, Prof. Dr. Contact:Principal Investigator: Christian Zauner, Prof. Dr.
	Medical University of Vienna [Recruiting] Vienna, Austria, 1090 Contact:Contact: Christopher Adlbrecht, Dr. MBA Contact:Principal Investigator: Christopher Adlbrecht, Dr. MBA
	Otto Wagner Spital [Recruiting] Vienna, Austria, 1140 Contact:Contact: Franz Tichelmann, Dr. Contact:Principal Investigator: Franz Tichelmann, Dr.
	Wilhelminenspital & Kaiserin-Elisabeth-Spital [Recruiting] Vienna, Austria, 1160 Contact:Contact: Burkhard Gustorff, Prof. Dr. Contact:Principal Investigator: Burkhard Gustorff, Prof. Dr.
	Belgium
	ULB Hospital Erasme [Recruiting] Brussels, Belgium, 1070 Contact:Contact: Jean-Louis Vincent, Prof.Dr. Contact:Principal Investigator: Jean-Louis Vincent, Prof.Dr.
	University Hospital Brussels [Recruiting] Brussels, Belgium, 1090 Contact:Contact: Herbert Spapen, Dr. Contact:Principal Investigator: Herbert Spapen, Dr.
	Hospital Saint Luc [Recruiting] Brussels, Belgium, 1200 Contact:Contact: Pierre-Francois Laterre, Prof.Dr. Contact:Principal Investigator: Pierre-Francois Laterre, Prof. Dr.
	Ziekenhuis Oost Limburg [Not yet recruiting] Genk, Belgium, 3600 Contact:Contact: Margot Vander Laenen, Dr. Contact:Principal Investigator: Margot Vander Laenen, Dr.
	University Hospital Ghent [Recruiting] Ghent, Belgium, 9000 Contact:Contact: Pieter Depuydt, Dr. Contact:Principal Investigator: Pieter Depuydt, Dr.
	Clinique St. Pierre [Recruiting] Ottignies, Belgium, 1340 Contact:Contact: Thierry Dugernier, Dr. Contact:Principal Investigator: Thierry Dugernier, Dr.
	Czech Republic
	Faculty Hospital St. Ann [Recruiting] Brno, Czech Republic, 65691 Contact:Contact: Vladimir Sramek, MD Contact:Principal Investigator: Vladimir Sramek, MD
	Faculty Hospital [Active, not recruiting] Hradec Krakove, Czech Republic, 50005
	Faculty Hospital [Recruiting] Hradec Krakove, Czech Republic, 50005 Contact:Contact: Jan Manak, MUDr. PhD Contact:Principal Investigator: Jan Manak, MUDr. PhD
	Faculty Hospital Kralovske Vinohrady [Recruiting] Prague, Czech Republic, 10034 Contact:Contact: Jan Pachl, Prof. Contact:Principal Investigator: Jan Pachl, Prof.
	Faculty Hospital Motol [Not yet recruiting] Prague, Czech Republic, 15006 Contact:Contact: Jiri Charvat, MD Contact:Principal Investigator: Jiri Charvat, MD
	Central Military Hospital [Not yet recruiting] Praha, Czech Republic, 16902 Contact:Contact: Tomas Tyll, MD PhD Contact:Principal Investigator: Tomas Tyll, MD PhD
	Germany
	University Hospital Aachen [Withdrawn] Aachen, Germany, 52074
	HELIOS Klinikum Aue [Recruiting] Aue, Germany, 08280 Contact:Contact: Jan Wallenborn, Dr. med. Contact:Principal Investigator: Jan Wallenborn, Dr. med.
	HELIOS Klinikum Berlin-Buch [Recruiting] Berlin, Germany, 13125 Contact:Contact: Jörg Brederlau, PD Dr. Contact:Principal Investigator: Jörg Brederlau, PD Dr.
	Charite-Universitätsmedizin Berlin [Recruiting] Berlin, Germany, 13353 Contact:Contact: Achim Jörres, Prof. Dr. Contact:Principal Investigator: Achim Jörres, Prof. Dr.
	Carl-Thiem-Klinikum Cottbus [Recruiting] Cottbus, Germany, 03048 Contact:Contact: Jens Soukup, Dr. Contact:Principal Investigator: Jens Soukup, PD Dr.
	Städtisches Klinikum Dessau [Recruiting] Dessau-Roßlau, Germany, 06847 Contact:Contact: Stefan Rosocha, Dr. med. Contact:Principal Investigator: Stefan Rosocha, Dr. med.
	Klinikum Dortmund [Recruiting] Dortmund, Germany, 44145 Contact:Contact: Bernhard Schaaf, Dr. med. Contact:Principal Investigator: Bernhard Schaaf, Dr. med.
	Neurologische Universitätsklinik [Recruiting] Dresden, Germany, 01307 Contact:Contact: Hauke Schneider, Dr. med. Contact:Principal Investigator: Hauke Schneider, Dr. med.
	HELIOS Klinikum Erfurt [Recruiting] Erfurt, Germany, 99089 Contact:Contact: Andreas Meier-Hellmann, Prof.Dr. Contact:Principal Investigator: Andreas Meier-Hellmann, Prof.Dr.
	Universitätsklinikum Frankfurt am Main [Active, not recruiting] Frankfurt, Germany, 60590
	Universitätsklinik Freiburg [Withdrawn] Freiburg, Germany, 79106
	Helios Kreikrankenhaus Gotha/Ohrdruf [Recruiting] Gotha, Germany, 99867 Contact:Contact: Kai-Uwe Döbel, Dr. med. Contact:Principal Investigator: Kai-Uwe Döbel, Dr. med.
	Universitätsmedizin Greifswald [Withdrawn] Greifswald, Germany, 17475
	Bermannstrost BG Kliniken Halle [Recruiting] Halle/Saale, Germany, 06112 Contact:Contact: Ralph Stuttmann, Dr. Contact:Principal Investigator: Ralph Stuttmann, Dr.
	Saarland University Hospital [Recruiting] Homburg/Saar, Germany, 66421 Contact:Contact: Thomas Volk, Prof.Dr. Contact:Principal Investigator: Thomas Volk, Prof.Dr.
	Universitätsklinikum Schleswig-Holstein [Recruiting] Kiel, Germany, ^24105 Contact:Contact: Norbert Weiler, Prof. Dr. Contact:Principal Investigator: Norbert Weiler, Prof. Dr.
	Klinikum Magdeburg Gmbh [Withdrawn] Magdeburg, Germany, 39130
	Klinikum rechts der Isar [Recruiting] München, Germany, 81675 Contact:Contact: Wolfgang Huber, Dr. Contact:Principal Investigator: Wolfgang Huber, Dr.
	Universitätsklinikum Regensburg [Withdrawn] Regensburg, Germany, 93053
	HELIOS Klinikum Wuppertal [Recruiting] Wuppertal, Germany, 42283 Contact:Contact: Gabriele Wöbker, Dr. Contact:Principal Investigator: Gabriele Wöbker, Dr.
	Hungary
	Peterfy Hospital [Not yet recruiting] Budapest, Hungary, 1076 Contact:Contact: Peter Tamasi, Dr. Contact:Principal Investigator: Peter Tamasi, Dr.
	St. Imre Hospital [Recruiting] Budapest, Hungary, 1115 Contact:Contact: Csaba Fejer, Dr. Contact:Principal Investigator: Csaba Fejer, Dr.
	Uzsoki Hospital [Recruiting] Budapest, Hungary, 1145 Contact:Contact: Zsuzsanna Szabo, Dr. Contact:Principal Investigator: Zsuzsanna Szabo, Dr.
	Kenezy Korhaz Debrecen [Recruiting] Debrecen, Hungary, 4043 Contact:Contact: Istvan Varkonyi, Dr. Contact:Principal Investigator: Istvan Varkonyi, Dr.
	Debreceni Egyetem OEC Kazincbarcikai Korhaz [Completed] Kazincbarcika, Hungary, 3700
	Flor Ferenc Korhaz Hospital [Recruiting] Kistarcsa, Hungary, 2143 Contact:Contact: Ildiko Kremer, Dr. Contact:Principal Investigator: Ildiko Kremer, Dr.
	University of Pecs [Recruiting] Pecs, Hungary, 7623 Contact:Contact: Lajos Bogar, Prof.Dr. Contact:Principal Investigator: Lajos Bogar, Prof.Dr
	University of Szeged [Recruiting] Szeged, Hungary, 6725 Contact:Contact: Zsolt Molnar, Prof.Dr. Contact:Principal Investigator: Zsolt Molnar, Prof.Dr.
	Fejer County Hospital [Recruiting] Szekesfehervar, Hungary, 8000 Contact:Contact: Agnes Sarkany, Dr. Contact:Principal Investigator: Agens Sarkany, Dr.
	Spain
	Vall d'Hebron University Hospital [Recruiting] Barcelona, Spain, 08035 Contact:Contact: Jordi Rello, Dr. Contact:Principal Investigator: Jordi Rello, Dr.
	Puerta del Mar University Hospital [Active, not recruiting] Cadiz, Spain, 11009
	Hospital Universitario de Getafe [Recruiting] Madrid, Spain, 28905 Contact:Contact: Jose Angel Lorente, Dr. Contact:Principal Investigator: Jose Angel Lorente, Dr.
	University Hospital Marques de Valdecilla [Recruiting] Santander Cantabria, Spain, 39008 Contact:Contact: Borja Suberviola Canas, Dr. Contact:Principal Investigator: Borja Suberviola Canas, Dr.
	Hospital Universitario Dr. Peset [Recruiting] Valencia, Spain, 46022 Contact:Contact: Rafael Zaragoza Crespo, Dr. Contact:Principal Investigator: Rafael Zaragoza Crespo, Dr.
	Spain, Madrid
	Hospital Clinico San Carlos [Not yet recruiting] Madird, Madrid, Spain, 28040 Contact:Contact: Miguel Sanchez Garcia, Dr Contact:Principal Investigator: Miguel Sanchez Garcia, Dr.

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