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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00835926 |
To describe the safety during days 0 to 21 following injection of the 2003-2004 formulation of the inactivated, split-virion influenza vaccine Fluzone® in subjects aged 18-59 years and subjects aged >=60 years.
To describe the immune response at 21 days following injection of the 2003-2004 formulation of the inactivated, split-virion influenza vaccine Fluzone®, in subjects aged 18-59 years and subjects aged >=60 years.
Condition | Intervention | Phase |
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Influenza |
Biological: Influenza virus vaccine (Fluzone®) |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Safety and Immunogenicity of Influenza Virus Vaccine USP Trivalent Types A and B (Zonal Purified Subvirion) Fluzone® 2003/2004 |
Enrollment: | 121 |
Study Start Date: | July 2003 |
Study Completion Date: | September 2003 |
Primary Completion Date: | September 2003 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Fluzone Group
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Biological: Influenza virus vaccine (Fluzone®)
0.5 mL, Intramuscular
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Safety will be assessed throughout the trial period. Using antigens provided by Aventis Pasteur Inc., pre- and post-vaccination serum antibody titers for each of the three vaccine strains will be measured.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria :
Exclusion Criteria :
Responsible Party: | Sanofi Pasteur Inc. ( Medical Monitor ) |
Study ID Numbers: | GRC16 |
Study First Received: | January 27, 2009 |
Last Updated: | February 3, 2009 |
ClinicalTrials.gov Identifier: | NCT00835926 History of Changes |
Health Authority: | United States: Institutional Review Board |
influenza |
Fluconazole Virus Diseases Respiratory Tract Diseases |
Respiratory Tract Infections Influenza, Human Orthomyxoviridae Infections |
Virus Diseases RNA Virus Infections Respiratory Tract Diseases |
Respiratory Tract Infections Influenza, Human Orthomyxoviridae Infections |