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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00664417 |
Following the licensure of sanofi pasteur's 90 µg rgA/Vietnam/1203/2004 pandemic influenza vaccine, efforts to develop a lower antigen dose formulation with improved immunogenicity using adjuvants were initiated. The present study is part of this endeavor. It is primarily a formulation/dose-finding study with a secondary aim at generating safety and immunogenicity data for the final formulation for the development of a pre-pandemic vaccine.
Condition | Intervention | Phase |
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Influenza Orthomyxoviridae Infections |
Biological: Monovalent subvirion H5N1 influenza vaccine Biological: Physiological saline |
Phase I |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Single Blind (Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Estimated Enrollment: | 375 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Biological: Monovalent subvirion H5N1 influenza vaccine
0.5 mL, IM, 2 injections, Formulation 1
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2: Experimental |
Biological: Monovalent subvirion H5N1 influenza vaccine
0.5 mL, IM, 2 injections, Formulation 2
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3: Experimental |
Biological: Monovalent subvirion H5N1 influenza vaccine
0.5 mL, IM, 2 injections, Formulation 3
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4: Experimental |
Biological: Monovalent subvirion H5N1 influenza vaccine
0.5 mL, IM, 2 injections, Formulation 4
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5: Experimental |
Biological: Monovalent subvirion H5N1 influenza vaccine
0.5 mL, IM, 2 injections, Formulation 5
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6: Experimental |
Biological: Monovalent subvirion H5N1 influenza vaccine
0.5 mL, IM, 2 injections, Formulation 6
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7: Active Comparator |
Biological: Monovalent subvirion H5N1 influenza vaccine
0.5 mL, IM, 2 injections, Comparator 1
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8: Active Comparator |
Biological: Monovalent subvirion H5N1 influenza vaccine
0.5 mL, IM, 2 injections, Comparator 2
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9: Placebo Comparator |
Biological: Physiological saline
0.5 mL, IM, 2 injections
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This is a Phase I, observer-blinded, randomized, controlled multicenter, dose-finding study in adult subjects. All vaccines will be administered as a two-dose schedule in (H5N1) immunologically-naïve adults. Immunogenicity and safety will be evaluated after each injection.
Ages Eligible for Study: | 18 Years to 40 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria :
Exclusion Criteria :
United States, California | |
San Diego, California, United States, 92103 | |
United States, Florida | |
South Miami, Florida, United States, 33143 | |
United States, Missouri | |
Springfield, Missouri, United States, 65802 | |
United States, Ohio | |
Cincinnati, Ohio, United States, 45219 | |
Cincinnati, Ohio, United States, 45227 | |
United States, Tennessee | |
Knoxville, Tennessee, United States, 37920 |
Study Director: | Medical Monitor | Sanofi Pasteur, Inc. |
Responsible Party: | Sanofi Pasteur, Inc. ( Medical Monitor ) |
Study ID Numbers: | FUF04 |
Study First Received: | April 22, 2008 |
Last Updated: | May 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00664417 |
Health Authority: | United States: Food and Drug Administration |
Influenza A/H5N1 Orthomyxoviridae Infections Influenza Pandemics |
Virus Diseases Respiratory Tract Diseases Respiratory Tract Infections |
Influenza, Human Influenza in Birds Orthomyxoviridae Infections |
RNA Virus Infections Infection |