Expired Study
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Norfolk, Virginia 23507


Purpose:

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 vaccine 2008-2009 formulation with the requirements of the Committee for Human Medicinal Products (CHMP) Note for Guidance (NfG) CPMP/BWP/214/96.


Criteria:

Inclusion Criteria: - 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 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 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 IM vaccination. - Prior personal history of Guillain-Barré syndrome. * Subjects enrolled into this study will not be prohibited from donating blood for non-interventional studies.


NCT ID:

NCT00743275


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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