Completed PHASE2/PHASE3 INTERVENTIONAL 2-arm NCT01563263

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

A Confirmatory Phase II/III Study Assessing Efficacy, Immunogenicity and Safety of IC43 Recombinant Pseudomonas Vaccine Intensive Care Patients

Sponsor: Valneva Austria GmbH

Conditions Pseudomonas Aeruginosa Infection

Interventions IC43 Placebo

Updated 6 times since 2017 Last updated: Mar 29, 2016 Started: Mar 31, 2012 Primary completion: Aug 31, 2015 Completion: Dec 31, 2015

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT01563263, this PHASE2/PHASE3 trial focuses on Pseudomonas Aeruginosa Infection and remains completed. Sponsored by Valneva Austria GmbH, it has been updated 6 times since 2012, reflecting limited change activity. This study is part of the global effort to build evidence for infectious disease interventions.

Status Flow

Change History

6 versions recorded

Sep 2025 — Present [monthly]

Completed PHASE2/PHASE3
Sep 2024 — Sep 2025 [monthly]

Completed PHASE2/PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE2/PHASE3

Phase: PHASE2_PHASE3 → PHASE2/PHASE3
Jan 2021 — Jul 2024 [monthly]

Completed PHASE2_PHASE3
Jun 2018 — Jan 2021 [monthly]

Completed PHASE2_PHASE3

▶ Show 1 earlier version

Jan 2017 — Jun 2018 [monthly]

Completed PHASE2_PHASE3

First recorded

Mar 2012

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Valneva Austria GmbH

Data source: Valneva Austria GmbH

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Aue, Germany , Badajoz, Spain , Barcelona, Spain , Berlin, Germany , Brno, Czechia , Brussels, Belgium , Budapest, Hungary , Cottbus, Germany , Debrecen, Hungary , Dessau, Germany and 27 more locations