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Sponsored by: |
Baxter Healthcare Corporation |
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Information provided by: | Baxter Healthcare Corporation |
ClinicalTrials.gov Identifier: | NCT00530660 |
The purpose of this Phase II follow-up study (to study 810501) is to assess the immunogenicity and safety of a booster vaccination with a non-adjuvanted H5N1 influenza vaccine administered 12 to 17 months after a two-dose regimen of different doses of an adjuvanted or non-adjuvanted H5N1 influenza vaccine in a healthy young adult population. A data safety monitoring board will review the safety data after the booster vaccination. The H5N1 influenza antibody persistence 180 days after the booster vaccination will also be assessed.
Condition | Intervention | Phase |
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Influenza |
Biological: H5N1 influenza vaccine (whole virion, Vero cell-derived), 7.5 µg HA antigen, non-adjuvanted |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Open-Label Phase II Study to Assess the Immunogenicity and Safety of a Booster Vaccination With a Heterologous Vero Cell-Derived Whole Virus H5N1 Influenza Vaccine in a Healthy Young Adult Population (Follow Up to Study 810501) |
Estimated Enrollment: | 141 |
Study Start Date: | September 2007 |
Study Completion Date: | October 2008 |
Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 46 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Subjects who participated in Study 810501 will be eligible for participation in the study if they:
Exclusion Criteria:
Austria | |
University Hospital, Department of Clinical Pharmacology, General Hospital Vienna | |
Vienna, Austria, 1090 |
Principal Investigator: | Baxter BioScience Investigator | Baxter Healthcare Corporation |
Responsible Party: | Baxter Healthcare Corporation ( Simone Deutschel, Clinical Project Manager ) |
Study ID Numbers: | 810703 |
Study First Received: | September 14, 2007 |
Last Updated: | December 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00530660 |
Health Authority: | Austria: Federal Ministry for Health and Women |
Pandemic influenza |
Virus Diseases Respiratory Tract Diseases Respiratory Tract Infections Influenza, Human |
Influenza in Birds Healthy Orthomyxoviridae Infections |
RNA Virus Infections |