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Sponsors and Collaborators: |
Novartis Novartis Vaccines |
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Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00812019 |
The aim of the present dose ranging study is to evaluate the safety, tolerability and immunogenicity of two doses of twelve different formulations of a Cell Culture-Derived H5N1 Subunit Influenza Virus Vaccine, adjuvanted with MF59 or non-adjuvanted, given three weeks apart and followed by a booster dose after 12 months in healthy adults 18 to 40 years of age.
Condition | Intervention | Phase |
---|---|---|
Influenza |
Biological: FCC H5N1 3,75 µg Biological: FCC H5N1 7,5 µg Biological: FCC H5N1 15 µg Biological: FCC H5N1 3,75 µg + 25% MF59 Biological: FCC H5N1 7,5 µg + 25% MF59 Biological: FCC H5N1 15 µg + 25% MF59 Biological: FCC H5N1 3,75 µg + 50% MF59 Biological: FCC H5N1 7,5 µg + 50% MF59 Biological: FCC H5N1 15 µg + 50% MF59 Biological: FCC H5N1 3,75 µg + 100% MF59 Biological: FCC H5N1 7,5 µg + 100% MF59 Biological: FCC H5N1 15 µg + 100% MF59 |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Single Blind (Subject), Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase I/II, Randomized, Observer-blind, Multicenter, Dose Ranging Study to Evaluate the Immunogenicity, Safety and Tolerability of Different Formulations of an Adjuvanted or Non-Adjuvanted Cell Culture-Derived H5N1 Subunit Influenza Virus Vaccine in Healthy Subjects 18 - 40 Years of Age. |
Estimated Enrollment: | 720 |
Study Start Date: | November 2008 |
Estimated Study Completion Date: | June 2011 |
Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Biological: FCC H5N1 3,75 µg
2 doses of Cell Culture-Derived H5N1 3,75 µg Subunit Influenza Vaccine
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2: Experimental |
Biological: FCC H5N1 7,5 µg
2 doses of Cell Culture-Derived H5N1 7,5 µg Subunit Influenza Vaccine
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3: Experimental |
Biological: FCC H5N1 15 µg
2 doses of Cell Culture-Derived H5N1 15 µg Subunit Influenza Vaccine
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4: Experimental |
Biological: FCC H5N1 3,75 µg + 25% MF59
2 doses of Cell Culture-Derived H5N1 3,75 µg Subunit Influenza Vaccine containing 25% of MF59
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5: Experimental |
Biological: FCC H5N1 7,5 µg + 25% MF59
2 doses of Cell Culture-Derived H5N1 7,5 µg Subunit Influenza Vaccine containing 25% of MF59
|
6: Experimental |
Biological: FCC H5N1 15 µg + 25% MF59
2 doses of Cell Culture-Derived H5N1 15 µg Subunit Influenza Vaccine containing 25% of MF59
|
7: Experimental |
Biological: FCC H5N1 3,75 µg + 50% MF59
2 doses of Cell Culture-Derived H5N1 3,75 µg Subunit Influenza Vaccine containing 50% of MF59
|
8: Experimental |
Biological: FCC H5N1 7,5 µg + 50% MF59
2 doses of Cell Culture-Derived H5N1 7,5 µg Subunit Influenza Vaccine containing 50% of MF59
|
9: Experimental |
Biological: FCC H5N1 15 µg + 50% MF59
2 doses of Cell Culture-Derived H5N1 15 µg Subunit Influenza Vaccine containing 50% of MF59
|
10: Experimental |
Biological: FCC H5N1 3,75 µg + 100% MF59
2 doses of Cell Culture-Derived H5N1 3,75 µg Subunit Influenza Vaccine containing 100% of MF59
|
11: Experimental |
Biological: FCC H5N1 7,5 µg + 100% MF59
2 doses of Cell Culture-Derived H5N1 7,5 µg Subunit Influenza Vaccine containing 100% of MF59
|
12: Experimental |
Biological: FCC H5N1 15 µg + 100% MF59
2 doses of Cell Culture-Derived H5N1 15 µg Subunit Influenza Vaccine containing 100% of MF59
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Ages Eligible for Study: | 18 Years to 40 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Texas | |
Baylor College of Medicine | |
Houston, Texas, United States, TX 77030 | |
Germany | |
Universitätsklinikum Gießen und Marburg GmbH | |
Gießen, Germany, 35392 |
Responsible Party: | Novartis Vaccines ( Novartis ) |
Study ID Numbers: | V89P1, 2007-003715-32 |
Study First Received: | December 18, 2008 |
Last Updated: | August 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00812019 History of Changes |
Health Authority: | United States: Food and Drug Administration; Germany: Paul-Ehrlich-Institute |
H5N1 Influenza Pandemic Flu MF59 Adjuvant Cell Culture-Derived |
Safety Immunogenicity Vaccination H5N1 influenza pandemic |
Virus Diseases Respiratory Tract Diseases Respiratory Tract Infections Adjuvants, Immunologic |
Influenza, Human Influenza in Birds Healthy Orthomyxoviridae Infections |
Virus Diseases RNA Virus Infections Respiratory Tract Diseases |
Respiratory Tract Infections Influenza, Human Orthomyxoviridae Infections |