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
1881
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Cincinnati, OH
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1829
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Bardstown, KY
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2330
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Binghamton, NY
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2269
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Burke, VA
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356
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Chandler, AZ
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2284
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Elmira, NY
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110 North Main Street
Greenville, Pennsylvania 16125
2100
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Greenville, PA
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1546
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Harrisburg, AR
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1546
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Jonesboro, AR
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Latrobe, Pennsylvania 15650
2151
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Latrobe, PA
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1463
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Little Rock, AR
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2239
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Melbourne, FL
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1450
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Mountain Home, AR
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1300
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Omaha, NE
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Pittsburgh, Pennsylvania 15220
2117
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Pittsburgh, PA
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Pittsburgh, Pennsylvania 15227
2119
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Pittsburgh, PA
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2119
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Pittsburgh, PA
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570
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Salt Lake City, UT
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557
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South Jordan, UT
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2269
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Vienna, VA
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1159
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Warr Acres, OK
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