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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00743275 |
To describe the safety of the inactivated, split-virion influenza vaccine, 2008-2009 formulation.
To evaluate the compliance, in terms of immunogenicity, of the inactivated, split-virion influenza vaccine 2008-2009 formulation with the requirements of the Committee for Human Medicinal Products (CHMP) Note for Guidance (NfG) CPMP/BWP/214/96.
Condition | Intervention | Phase |
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Influenza |
Biological: Split, Inactivated, Trivalent Influenza vaccine (Fluzone®) |
Phase IV |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Estimated Enrollment: | 30 |
Study Start Date: | August 2008 |
Estimated Study Completion Date: | February 2009 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Biological: Split, Inactivated, Trivalent Influenza vaccine (Fluzone®)
0.25 mL or 0.5 mL, IM
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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 ( Medical Director ) |
Study ID Numbers: | GRC41 |
Study First Received: | August 27, 2008 |
Last Updated: | September 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00743275 |
Health Authority: | United States: Food and Drug Administration |
Influenza |
Virus Diseases Respiratory Tract Diseases Respiratory Tract Infections Influenza, Human Orthomyxoviridae Infections |
RNA Virus Infections |