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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00524940 |
Objective #1: Safety To describe the safety of the inactivated, split-virion influenza vaccine, Northern Hemisphere (NH) 2007-2008 formulation.
Objective #2: Immunogenicity To describe the immunogenicity, of Fluzone, inactivated, split virion influenza vaccine NH 2007-2008 formulation.
Objective #3: Serum Collection To submit remaining available sera to CBER for further analysis by FDA, CDC and WHO to support selection and recommendation of antigen strains for subsequent influenza vaccines.
Condition | Intervention | Phase |
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Influenza |
Biological: Fluzone® |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | GRC37 |
Study First Received: | September 4, 2007 |
Last Updated: | September 4, 2007 |
ClinicalTrials.gov Identifier: | NCT00524940 |
Health Authority: | United States: Food and Drug Administration |
Influenza |
Virus Diseases Respiratory Tract Diseases Respiratory Tract Infections Influenza, Human Orthomyxoviridae Infections |
RNA Virus Infections |