Safety and Immunogenicity of the 2005-2006 Fluzone® Vaccine
Influenza
About this trial
This is an interventional prevention trial for Influenza focused on measuring Influenza vaccine
Eligibility Criteria
Inclusion Criteria: 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 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 ≥ 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Age 18 to 59 years
Age 60 years and older
Participants aged 18 to 59 years at enrollment.
Participants aged 60 years and older at enrollment.