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



Status:Completed
Conditions:Influenza
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:65 - Any
Updated:5/25/2018
Start Date:October 2008
End Date:June 2009

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A Phase IV, Randomized, Observer-Blind, Multi-Center, Non Inferiority Comparison of the Immune Response of CSL Limited's Influenza Virus Vaccine Compared to a US Licensed Inactivated Split-Virion Influenza Vaccine in Adults Aged Greater Than or Equal to 65 Years

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.


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.
We found this trial at
13
sites
Johnston, Rhode Island 02919
2482
mi
from 98109
Johnston, RI
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
1966
mi
from 98109
Cincinnati, OH
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101 Jessup Hall
Iowa City, Iowa 52242
(319) 335-3500
University of Iowa With just over 30,000 students, the University of Iowa is one of...
1556
mi
from 98109
Iowa City, IA
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Austin, Texas 78752
1768
mi
from 98109
Austin, TX
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Bardstown, Kentucky 40004
1969
mi
from 98109
Bardstown, KY
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Boise, Idaho 83704
402
mi
from 98109
Boise, ID
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
2341
mi
from 98109
Durham, NC
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Mountain Home, Arkansas 72635
1775
mi
from 98109
Mountain Home, AR
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Nashville, Tennessee 37212
1971
mi
from 98109
Nashville, TN
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Pittsburgh, Pennsylvania 15241
2132
mi
from 98109
Pittsburgh, PA
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Portland, Oregon 97239
146
mi
from 98109
Portland, OR
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2154
mi
from 98109
Rochester, NY
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Saint Louis, Missouri 63104
1721
mi
from 98109
Saint Louis, MO
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