Expired Study
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Norfolk, Virginia 23507


Purpose:

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.


Study summary:

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.


Criteria:

Inclusion Criteria : - Age of 18 years or greater. - Ambulatory. - In reasonably good health as assessed by the investigator. - Available for duration of the study (21 days + 2d). - Willing and able to meet protocol requirements. - Willing and able to give informed consent. Exclusion Criteria : - Self-reported allergy to egg proteins, chicken proteins, or one of the constituents of the vaccine, such as thimerosal or formaldehyde. - An acute illness with or without fever (temperature >100.4°F) in the 72 hours preceding enrollment in the trial. - Clinically significant findings in vital signs (including temperature >100.4°F) or review of systems. - Self-reported history of severe adverse event to any influenza vaccine. - Vaccination against influenza in the 6 months preceding enrollment in the study. - Any vaccination in the 14 days preceding enrollment in the study or scheduled between Visit 1 and Visit 3. - Participation in any other experimental drug or vaccine trial within the 30 days preceding enrollment into the study. - Immunosuppressive therapy including long-term (> 2 weeks) systemic corticosteroids or cancer therapy within the past 3 months or ongoing. - Receipt of blood or blood products within the 3 months preceding enrollment in the study. - Diabetes - Any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine (e.g., existing severe chronic illness such as pulmonary disorders, cardiovascular disorders, chronic blood disorders, etc.). - Person deprived of freedom by an administrative or court order (having legal or medical guardian). - For women of childbearing age, a positive urine pregnancy test, breast feeding, or not using a medically approved and reliable form of contraception (oral contraceptives or double barrier method) for the duration of the trial.


NCT ID:

NCT00835926


Primary Contact:

Study Director
Medical Director
Sanofi Pasteur Inc.


Backup Contact:

N/A


Location Contact:

Norfolk, Virginia 23507
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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