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

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

803

Participants

Timeline

Start Date

March 31, 2012

Primary Completion Date

August 31, 2015

Study Completion Date

December 31, 2015

Conditions
Pseudomonas Aeruginosa Infection
Interventions
BIOLOGICAL

IC43

100 mcg

DRUG

Placebo

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

Trial Locations (50)

1070

ULB Hospital Erasme, Brussels

1090

Medical University of Vienna, Vienna

University Hospital Brussels, Brussels

1115

St. Imre Hospital, Budapest

1122

Országos Korányi TBC és Pulmonológiai Intézet, Budapest

1130

Krankenhaus Hietzing, Vienna

1140

Otto Wagner Spital, Vienna

1145

Uzsoki Hospital, Budapest

1160

Wilhelminenspital & Kaiserin-Elisabeth-Spital, Vienna

1200

Hospital Saint Luc, Brussels

1340

Clinique St. Pierre, Ottignies

2143

Flor Ferenc Korhaz Hospital, Kistarcsa

3600

Ziekenhuis Oost Limburg, Genk

3700

Debreceni Egyetem OEC Kazincbarcikai Korhaz, Kazincbarcika

4043

Kenezy Korhaz Debrecen, Debrecen

5050

LKH Salzburg, Salzburg

6725

University of Szeged, Szeged

7623

University of Pecs, Pécs

8000

Fejer County Hospital, Székesfehérvár

8036

LKH - University Clinic Graz, Graz

9000

University Hospital Ghent, Ghent

10034

Faculty Hospital Kralovske Vinohrady, Prague

13125

HELIOS Klinikum Berlin-Buch, Berlin

13353

Charite-Universitätsmedizin Berlin, Berlin

15006

Faculty Hospital Motol, Prague

16902

Central Military Hospital, Prague

24105

Universitätsklinikum Schleswig-Holstein, Kiel

28040

Hospital Clinico San Carlos, Madrid

28905

Hospital Universitario de Getafe, Madrid

39008

University Hospital Marques de Valdecilla, Santander Cantabria

42283

HELIOS Klinikum Wuppertal, Wuppertal

44145

Klinikum Dortmund, Dortmund

46022

Hospital Universitario Dr. Peset, Valencia

50005

Faculty Hospital, Hradec Krakove

65691

Faculty Hospital St. Ann, Brno

66421

Saarland University Hospital, Homburg/Saar

81675

Klinikum rechts der Isar, München

99089

HELIOS Klinikum Erfurt, Erfurt

99867

Helios Kreikrankenhaus Gotha/Ohrdruf, Gotha

Unknown

Fakultní nemocnice Olomouc, Olomouc

Krajská nemocnice T. Bati, a.s., Zlín

Pécsi Tudományegyetem Neurológiai Klinika, Pécs

Hospital Universitario Infanta Cristina, Badajoz

Hospital Universitario y Policlínico La Fe, Valencia

08280

HELIOS Klinikum Aue, Aue

03048

Carl-Thiem-Klinikum Cottbus, Cottbus

06847

Städtisches Klinikum Dessau, Dessau

01307

Neurologische Universitätsklinik, Dresden

06112

Bermannstrost BG Kliniken Halle, Halle

08035

Vall d'Hebron University Hospital, Barcelona

All Listed Sponsors
lead

Valneva Austria GmbH

INDUSTRY

NCT01563263 - Confirmatory Phase II/III Study Assessing Efficacy, Immunogenicity and Safety of IC43 | Biotech Hunter | Biotech Hunter