Status:
COMPLETED
Safety and Immunogenicity of the 2005-2006 Fluzone® Vaccine
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 2005-2006 formulation of the inactivated, split-virion influenza vaccine Fluzone in subjects aged 18-59 years and subjects aged ≥ ...
Eligibility Criteria
Inclusion
- Participant aged 18 years or older on the day of inclusion.
- Participant able to attend scheduled visits and to comply with the study procedures during the entire duration of the study.
- Participant is in reasonably good health as assessed by the investigator.
- Participant willing and able to meet protocol requirements.
- 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 (temperature ≥ 99.5°F oral) in the 72 hours preceding enrollment in the trial.
- Clinically significant findings in vital signs (including temperature ≥ 99.5°F oral) on 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 3.
- Vaccination planned in the 4 weeks following any trial vaccination.
- Participation in any other interventional drug or vaccine trial within the 30 days preceding or during enrollment into this study.
- Immunocompromising 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 posed a health risk to the subject if enrolled or interfered 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 form of contraception for the duration of the trial.
- Current abuse of alcohol or drug addiction that interfered with the subject's ability to comply with trial procedures.
- Thrombocytopenia or bleeding disorder contraindicating intramuscular (IM) vaccination.
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2007
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00258830
Start Date
September 1 2005
End Date
March 1 2007
Last Update
April 14 2016
Active Locations (1)
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1
Norfolk, Virginia, United States, 23507