Open-Label Study Assessing The Safety, Immunogenicity and Dose Response of IC47
NCT ID: NCT00873431
Last Updated: 2012-10-19
Study Results
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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COMPLETED
PHASE1
32 participants
INTERVENTIONAL
2009-03-31
2010-02-28
Brief Summary
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A total of 32 healthy subjects (male or female) will participate in this clinical study. The subjects will be divided into 4 groups of 8 subjects each. Thirty (30) μg or 150 μg of IC47 will be administered three times in intervals of 42 days each.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
NONE
Study Groups
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IC47 30 mcg
30 mcg with Alum
IC47
solution/suspension for i.m. injection dosage: 30/150 mcg frequency: 3 times at Day 0, Day 42 and Day 84
IC47 30 mcg w/o
30 mcg without Alum
IC47
solution/suspension for i.m. injection dosage: 30/150 mcg frequency: 3 times at Day 0, Day 42 and Day 84
IC47 150 mcg
150 mcg with Alum
IC47
solution/suspension for i.m. injection dosage: 30/150 mcg frequency: 3 times at Day 0, Day 42 and Day 84
IC47 150 mcg w/o
150 mcg without Alum
IC47
solution/suspension for i.m. injection dosage: 30/150 mcg frequency: 3 times at Day 0, Day 42 and Day 84
Interventions
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IC47
solution/suspension for i.m. injection dosage: 30/150 mcg frequency: 3 times at Day 0, Day 42 and Day 84
Eligibility Criteria
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Inclusion Criteria
* Healthy adults ≥ 18 to \</= 65
* female subjects: post-menopausal or practicing reliable methods of contraception during the study
Exclusion Criteria
* History of severe hypersensitivity reactions and anaphylaxis.
* Immunodeficiency due to immunosuppressive therapy.
* Infection with HIV, Hepatitis B or Hepatitis C.
* Pregnancy, lactation
* Vulnerable subjects
18 Years
65 Years
ALL
Yes
Sponsors
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PATH
OTHER
Valneva Austria GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Evelyn Hatzenbichler, PhD
Role: STUDY_DIRECTOR
Valneva Austria GmbH
Locations
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Parexel International GmbH, Institute for Clinical Pharmacology
Berlin, State of Berlin, Germany
Countries
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Other Identifiers
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IC47-101
Identifier Type: -
Identifier Source: org_study_id