Influenza

A Study to Determine the Immunogenicity and Safety Profile of CSL Limited's Influenza Virus Vaccine Compared to a US Licensed Comparator Influenza Virus Vaccine

NCT00735475 | PHASE 4 | INTERVENTIONAL

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.

13 Sites

1268 Participants

Recruiting

65 Years to 11 Years

If interested, contact clinicaltrials@cslbehring.com for more information

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Find closest sites:

SUBMIT

North Central Arkansas Medical Association

Mountain Home,Arkansas,United States,72635

Covance CRU, Inc

Boise,Idaho,United States,83704

The University of Iowa

Iowa City,Iowa,United States,52242

Kentucky Pediatric Adult Research

Bardstown,Kentucky,United States,40004

Saint Louis University Medical Center

Saint Louis,Missouri,United States,63104

University of Rochester School of Medicine and Dentistry

Rochester,New York,United States,14642

Duke University Medical Center

Durham,North Carolina,United States,27704

Cincinnati Children's Hospital Medical Center

Cincinnati,Ohio,United States,45229

Covance CRU, Inc.

Portland,Oregon,United States,97239

Primary Physicians Research, Inc.

Pittsburgh,Pennsylvania,United States,15241

Clinical Partners, LLC

Johnston,Rhode Island,United States,02919

Vanderbilt Medical Center

Nashville,Tennessee,United States,37232

Covance CRU Inc.

Austin,Texas,United States,78752

Study Eligibility 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.

Additional Studies

Additional studies can be found at ClinicalTrials.gov