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 in a Pediatric Population



Status:Completed
Conditions:Influenza
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:Any - 17
Updated:4/21/2016
Start Date:September 2009
End Date:May 2010

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A Phase III, Randomized, Observer-blind, Multi-center, Noninferiority Comparison of the Immune Response of CSL Limited's Influenza Virus Vaccine Compared to a US Licensed Trivalent Inactivated Split-Virion Influenza Vaccine in a Pediatric Population Aged Greater Than or Equal to 6 Months to Less Than 18 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 in a pediatric population aged greater than or equal to 6 months to less than 18
years.


Inclusion Criteria:

- Healthy male or non-pregnant female participants aged ≥ 6 calendar months to < 18
years at the time of the first study vaccination.

- For participants aged ≥ 6 months to < 9 years, born after a normal gestation period
(between 36 and 42 weeks).

- Females of childbearing potential (i.e., ovulating, pre-menopausal, not surgically
sterile) must be abstinent or be willing to use a medically accepted contraceptive
regimen for at least 2 months after vaccination. Females aged ≥ 9 years must also
return a negative urine pregnancy test at enrollment.

Exclusion Criteria:

- Known hypersensitivity to a previous dose of influenza vaccine or allergy to eggs,
chicken protein, neomycin, polymyxin, or any components of the Study Vaccine.
We found this trial at
21
sites
1966
mi
from 98109
Cincinnati, OH
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1968
mi
from 98109
Bardstown, KY
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2270
mi
from 98109
Binghamton, NY
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2314
mi
from 98109
Burke, VA
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1128
mi
from 98109
Chandler, AZ
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2229
mi
from 98109
Elmira, NY
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110 North Main Street
Greenville, Pennsylvania 16125
2084
mi
from 98109
Greenville, PA
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1817
mi
from 98109
Harrisburg, AR
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1806
mi
from 98109
Jonesboro, AR
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Latrobe, Pennsylvania 15650
2165
mi
from 98109
Latrobe, PA
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1782
mi
from 98109
Little Rock, AR
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2603
mi
from 98109
Melbourne, FL
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1710
mi
from 98109
Mountain Home, AR
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1366
mi
from 98109
Omaha, NE
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Pittsburgh, Pennsylvania 15220
2131
mi
from 98109
Pittsburgh, PA
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Pittsburgh, Pennsylvania 15227
2132
mi
from 98109
Pittsburgh, PA
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2132
mi
from 98109
Pittsburgh, PA
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701
mi
from 98109
Salt Lake City, UT
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710
mi
from 98109
South Jordan, UT
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2311
mi
from 98109
Vienna, VA
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1516
mi
from 98109
Warr Acres, OK
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