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Sponsored by: |
Baxter Healthcare Corporation |
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Information provided by: | Baxter Healthcare Corporation |
ClinicalTrials.gov Identifier: | NCT00349141 |
The objective of this study is to assess the safety and immunogenicity of 4 different doses of adjuvanted and non-adjuvanted mock-up pandemic influenza vaccine. Subjects will be enrolled sequentially into 3 study cohorts with 4 escalating doses of H5N1 hemagglutininin antigen (3.75 µg adjuvanted, 7.5 µg adjuvanted/non-adjuvanted, 15 µg adjuvanted/non-adjuvanted, 30 µg adjuvanted). Starting with the lowest dose level, subjects will receive 2 vaccinations (21 days apart) at the dose to which they were assigned. Subjects will be monitored for safety and for antibody response to the vaccine. A data safety monitoring board will review and evaluate all the safety data obtained for a dose level before allowing administration of the next (higher) dose.
Condition | Intervention | Phase |
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Influenza |
Biological: Whole virion, Vero cell-derived influenza vaccine containing H5N1 HA antigen |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Single Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase I/II Dose Escalation Study of a Vero Cell-Derived, Whole Virus H5N1 Influenza Vaccine in Healthy Volunteers Aged 18 to 45 Years |
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Male and femal subjects who
Exclusion Criteria:
Subjects who
Austria | |
University Hospital, Department of Clinical Pharmacology, General Hospital Vienna | |
Vienna, Austria, 1090 | |
Singapore | |
National University Hospital | |
Singapore, Singapore, 119074 | |
Changi General Hospital | |
Singapore, Singapore, 529889 |
Principal Investigator: | Baxter BioScience Investigator, MD | Baxter Healthcare Corporation |
Study ID Numbers: | 810501 |
Study First Received: | July 5, 2006 |
Last Updated: | October 8, 2007 |
ClinicalTrials.gov Identifier: | NCT00349141 |
Health Authority: | Austria: Federal Ministry for Health and Women (AGES, PharmMed); Singapore: Health Sciences Authority |
Pandemic influenza |
Virus Diseases Respiratory Tract Diseases Respiratory Tract Infections Influenza, Human |
Influenza in Birds Healthy Orthomyxoviridae Infections |
RNA Virus Infections |