Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Children (3 to < 9 Years)



Status:Completed
Conditions:Influenza
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:3 - 8
Updated:4/21/2016
Start Date:September 2009
End Date:October 2010

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A Pivotal Randomized, Single-Blind, Dose-Finding Study to Evaluate Immunogenicity, Safety and Tolerability of Different Formulations of an Adjuvanted and Non-Adjuvanted Egg-Derived, Inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in Healthy Pediatric Subjects 3 to < 9 Years of Age

This study will evaluate the safety and immunogenicity of different combinations of A/H1N1
S-OIV (swine flu) vaccine in healthy young children.


Inclusion Criteria:

- Children 3 to < 9 years of age in good health as determined by medical history,
physical assessment and clinical judgement of the investigator and without influenza
within the past 6 months.

Exclusion Criteria:

- History of serious disease.

- History of serious reaction following administration of vaccine or hypersensitivity
to vaccine components.

- Known or suspected impairment/alteration of immune function.

- Receipt or planned receipt of seasonal trivalent influenza vaccine within 1 week
before or after each study vaccination.

For additional entry criteria, please refer to protocol.
We found this trial at
35
sites
West Covina, California 91790
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Arkansas City, Kansas 67005
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Beaverton, Oregon 97006
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Beaverton, OR
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Burke, Virginia 22015
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Burke, VA
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Cleveland, OH
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Dallas, Texas 75010
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Dallas, TX
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DeKalb, Illinois 60115
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DeKalb, IL
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Downey, California 90241
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Downey, CA
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Erie, Pennsylvania 16505
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Erie, PA
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Franklin, Ohio 45005
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Franklin, OH
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110 North Main Street
Greenville, Pennsylvania 16125
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Greenville, PA
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Henderson, Nevada 89015
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Henderson, NV
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Houston, TX
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Jefferson Hills, Pennsylvania 15025
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Jefferson Hills, PA
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Kingsport, Tennessee 37660
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Kingsport, TN
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Louisville, KY
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Madera, California 93637
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Madera, CA
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Marietta, Georgia 30062
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Marietta, GA
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New Albany, Indiana 47150
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New Albany, IN
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Newton, Kansas 67114
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Newton, KS
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Oklahoma City, Oklahoma 73103
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Oklahoma City, OK
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Omaha, Nebraska 68134
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Omaha, NE
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Paramount, California 90723
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Paramount, CA
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Paramount, California 90723
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Paramount, CA
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Pittsburgh, PA
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Raleigh, North Carolina 27609
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Raleigh, NC
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Richmond, Virginia 23298
(804) 828-0100
Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
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Richmond, VA
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Salt Lake City, UT
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Salt Lake City, UT
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Spokane, Washington 99202
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Spokane, WA
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Thornton, Colorado 80233
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Thornton, CO
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Tlalpan,
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Tomball, TX
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Warwick, Rhode Island 02886
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Warwick, RI
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Woodstock, Georgia 30189
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Woodstock, GA
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