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Study Assessing Immunogenicity and Safety of IC43 In Intensive Care Patients

NCT ID: NCT00876252

Last Updated: 2012-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2010-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pneumonia, Ventilator-Associated

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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IC43 100 mcg

IC43 100 mcg with Aluminum hydroxide

Group Type ACTIVE_COMPARATOR

IC43

Intervention Type BIOLOGICAL

IC43 200 mcg

IC43 200 mcg with Aluminum hydroxide

Group Type ACTIVE_COMPARATOR

IC43

Intervention Type BIOLOGICAL

IC43 100 mcg w/o

IC43 100 mcg without Aluminum hydroxide

Group Type ACTIVE_COMPARATOR

IC43

Intervention Type BIOLOGICAL

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

NaCl

Interventions

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IC43

Intervention Type BIOLOGICAL

Placebo

NaCl

Intervention Type DRUG

Other Intervention Names

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IC43 Pseudomonas Aeruginosa phosphate buffered saline (PBS)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Valneva Austria GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nicole Haas

Role: STUDY_DIRECTOR

Valneva Austria GmbH

Locations

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Medical University of Vienna

Vienna, Vienna, Austria

Site Status

Countries

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Argentina Belgium Hungary Romania Spain Turkey (Türkiye) Austria

References

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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.

Reference Type DERIVED
PMID: 28159015 (View on PubMed)

Other Identifiers

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IC43-201

Identifier Type: -

Identifier Source: org_study_id