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 of the inactivated, split-virion influenza vaccine, 2008-2009 formulation. To evaluate the compliance, in terms of immunogenicity, of the inactivated, split-virion influenza va...
Eligibility Criteria
Inclusion
- Participant is 18 years of age or older on the day of inclusion.
- Participant willing and able to attend scheduled visits and to comply with the study procedures during the entire duration of the study.
- Participant in reasonably good health as assessed by the Investigator.
- Participant willing and able to give informed consent.
- For a woman, inability to bear a child or negative serum/urine pregnancy test.
Exclusion
- 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 in the 72 hours preceding enrollment in the trial.
- Clinically significant findings in vital signs (including temperature ≥ 99.5°F oral) or review of systems.
- Self-reported history of severe adverse event to any influenza vaccine.
- Laboratory-confirmed influenza infection or 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 2.
- Participation in any other interventional drug or vaccine trial within the 30 days preceding or during enrollment into this study.\*
- Immunocompromising condition or immunosuppressive therapy (including systemic steroid use for 2 weeks or more), cancer chemotherapy, or radiation therapy at the time of enrollment, planned during the period of this study, or at any time within the past 6 months.
- Receipt of blood or blood products within the 3 months preceding enrollment in the study.
- Diabetes mellitus requiring pharmacological control.
- Any condition that in the opinion of the Investigator would pose a health risk to the subject if enrolled or could interfere with the evaluation of the vaccine.
- Person deprived of freedom by an administrative or court order (having legal or medical guardian).
- For women of childbearing potential, 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.
- Current use of alcohol or recreational drugs that may interfere with the subject's ability to comply with trial procedures.
- Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination.
- Prior personal history of Guillain-Barré syndrome. \* Subjects enrolled into this study will not be prohibited from donating blood for non-interventional studies.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00743275
Start Date
August 1 2008
End Date
November 1 2008
Last Update
May 16 2016
Active Locations (1)
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1
Norfolk, Virginia, United States, 23507