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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Trial Summary
Trial Overview
Inclusion Criteria

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
Virginia Commonwealth University
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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Heartland Research Associates LLC
Arkansas City, Kansas 67005
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The Portland Clinic LLP
Beaverton, Oregon 97006
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Beaverton, OR
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PI-Coor Clinical Research, LLC
Burke, Virginia 22015
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Burke, VA
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Dr. Senders and Associates, Pediatrics
Cleveland, Ohio 44121
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Cleveland, OH
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Research Across America
Dallas, Texas 75010
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Northern Illinois Research Associates
DeKalb, Illinois 60115
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DeKalb, IL
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Premier Health Research Center
Downey, California 90241
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Children's Health Care - West
Erie, Pennsylvania 16505
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Erie, PA
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Prestige Clinical Research
Franklin, Ohio 45005
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Franklin, OH
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UPMC/Community Medicine (pediatrics)
110 North Main Street
Greenville, Pennsylvania 16125
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Clinical Research Center of Nevada
Henderson, Nevada 89015
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Henderson, NV
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West Houston Clinical Research Service
Houston, Texas 77055
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Pediatric Physicians Research, Inc.
Jefferson Hills, Pennsylvania 15025
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Holston Medical Group, PC
Kingsport, Tennessee 37660
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Bluegrass Clinical Research, Inc (Brownsboro for drug shipment)
Louisville, Kentucky 40291
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Madera Family Medical Group
Madera, California 93637
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Pediatrics & Adolescent Medicine, Pa
Marietta, Georgia 30062
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Bluegrass Clinical Research, Inc.
New Albany, Indiana 47150
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Heartland Research Associates
Newton, Kansas 67114
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IPS Research
Oklahoma City, Oklahoma 73103
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Meridien Clinical Research
Omaha, Nebraska 68134
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Center for Clincal Trials, LLC
Paramount, California 90723
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Center for Clinical Trials, LLC.
Paramount, California 90723
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Pediatric Alliance - Greentree Division (pediatrics)
Pittsburgh, Pennsylvania 15220
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Capital Pediatrics & Adolescent Center
Raleigh, North Carolina 27609
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J.Lewis Research, Inc./Foothill Family Clinic
Salt Lake City, Utah 84109
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J. Lewis Research, Inc. / Foothill Family Clinic South
Salt Lake City, Utah 84121
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Rockwood Research Center
Spokane, Washington 99202
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1st International Research Centers
Thornton, Colorado 80233
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Instituto Nacional de Ciencias
Tlalpan, 14000
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Pediatric Healthcare of NW Houston, Pa
Tomball, Texas 77375
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Omega Clinical Research
Warwick, Rhode Island 02886
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Center for Clinical Trials of San Gabriel
West Covina, California 91790
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Pediatrics and Adolescent Medicine
Woodstock, Georgia 30189
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