Expired Study
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Durham, North Carolina 27704


Purpose:

The purpose of this study is to determine the immunogenicity and safety profile of CSL Limited's Influenza Virus Vaccine compared to a US Licensed Comparator Influenza Virus Vaccine.


Criteria:

Inclusion Criteria: 1. Males aged ≥ 65 years or females of non-childbearing potential aged ≥ 65 years ; 2. Written informed consent ; 3. Willingness to provide a blood sample. Exclusion Criteria: 1. Known hypersensitivity to a previous dose of influenza vaccine or allergy to eggs, chicken protein, neomycin, polymyxin, or any components of the Study Vaccines; 2. Previous vaccination against influenza in 2008 or 2009 with seasonal trivalent inactivated influenza vaccine; 3. Known history of Guillain-Barré Syndrome; 4. Clinical signs of active infection and/or an oral temperature of greater than or equal to 100 degrees F (37.8 degrees C). 5. Have active or recent and clinically significant gastrointestinal/hepatic, renal, neurological, cardiovascular, respiratory, endocrine disorders or other medical disorders; 6. History of seizures; 7. Confirmed or suspected immunosuppressive condition, or a previously diagnosed immunodeficiency disorder; 8. Clinically significant history of malignancy 9. Current treatment, or treatment with radiotherapy or cytotoxic drugs at any time during the six months prior to administration of the Study Vaccine; 10. Current immunosuppressive or immunomodulative therapy; 11. Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the Study Vaccine; 12. Participation in a clinical trial or use of an investigational compound within 30 days prior to receiving the Study Vaccine ; 13. Vaccination with a registered vaccine within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to receiving the Study Vaccine. 14. Current treatment with warfarin or other anticoagulants; 15. Major congenital defects; 16. Evidence, or history (within the previous 12 months) of drug or alcohol abuse; 17. Unwillingness or inability to comply with the study protocol including completion of adverse event diary cards; 18. History of psychiatric disorders; 19. Resident of long term care facility.


NCT ID:

NCT00735475


Primary Contact:

Study Director
Clinical Director Vaccines
Seqirus


Backup Contact:

N/A


Location Contact:

Durham, North Carolina 27704
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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