Status:
COMPLETED
A Study to Evaluate the Safety and Immune Responses to Fluzone® Vaccination
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Conditions:
Influenza
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 ≥...
Detailed Description
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 meas...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2003
Estimated Enrollment :
121 Patients enrolled
Trial Details
Trial ID
NCT00835926
Start Date
July 1 2003
End Date
September 1 2003
Last Update
April 14 2016
Active Locations (1)
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1
Norfolk, Virginia, United States, 23507