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
Marietta, Georgia 30062
790
mi
from
Marietta, GA
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Arkansas City, Kansas 67005
64
mi
from
Arkansas City, KS
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Beaverton, Oregon 97006
1392
mi
from
Beaverton, OR
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Burke, Virginia 22015
1114
mi
from
Burke, VA
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903
mi
from
Cleveland, OH
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Dallas, Texas 75010
330
mi
from
Dallas, TX
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DeKalb, Illinois 60115
560
mi
from
DeKalb, IL
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Downey, California 90241
1164
mi
from
Downey, CA
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Erie, Pennsylvania 16505
984
mi
from
Erie, PA
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Franklin, Ohio 45005
810
mi
from
Franklin, OH
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110 North Main Street
Greenville, Pennsylvania 16125
961
mi
from
Greenville, PA
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Henderson, Nevada 89015
953
mi
from
Henderson, NV
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565
mi
from
Houston, TX
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Jefferson Hills, Pennsylvania 15025
974
mi
from
Jefferson Hills, PA
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Kingsport, Tennessee 37660
843
mi
from
Kingsport, TN
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667
mi
from
Louisville, KY
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Madera, California 93637
1219
mi
from
Madera, CA
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New Albany, Indiana 47150
653
mi
from
New Albany, IN
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Newton, Kansas 67114
33
mi
from
Newton, KS
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Oklahoma City, Oklahoma 73103
157
mi
from
Oklahoma City, OK
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Omaha, Nebraska 68134
261
mi
from
Omaha, NE
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Paramount, California 90723
1167
mi
from
Paramount, CA
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Paramount, California 90723
1167
mi
from
Paramount, CA
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971
mi
from
Pittsburgh, PA
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Raleigh, North Carolina 27609
1068
mi
from
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...
1113
mi
from
Richmond, VA
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779
mi
from
Salt Lake City, UT
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774
mi
from
Salt Lake City, UT
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Spokane, Washington 99202
1201
mi
from
Spokane, WA
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Thornton, Colorado 80233
410
mi
from
Thornton, CO
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?
mi
from
Tlalpan,
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545
mi
from
Tomball, TX
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Warwick, Rhode Island 02886
1421
mi
from
Warwick, RI
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West Covina, California 91790
1151
mi
from
West Covina, CA
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Woodstock, Georgia 30189
784
mi
from
Woodstock, GA
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