Pivotal, Multicenter, Observer-Blind, Randomized Study of Influenza A (H1N1)2009 Monovalent Subunit Vaccine With and Without Adjuvant in Children Ages 6 to <36 Months



Status:Completed
Conditions:Influenza
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:Any
Updated:10/14/2017
Start Date:October 2009
End Date:December 2010

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Pivotal, Multicenter, Observer-Blind, Randomized Study of Influenza A (H1N1) 2009 Monovalent Subunit Vaccine With and Without Adjuvant in Children Ages 6 to <36 Months

This study will evaluate the safety and immunogenicity of different combinations of A/H1N1
2009 (swine flu) vaccine in healthy young children


Inclusion Criteria:

- Children 6 to 35 months 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
29
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Lebanon, TN
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Bardstown, KY
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Bentonville, AR
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Canoga Park, CA
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Charleston, South Carolina 29412
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Charleston, SC
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Charlottesville, VA
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Dallas, TX
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Dayton, OH
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Delegacion Tlalpan,
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Dinuba, CA
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Fargo, ND
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Fort Smith, AR
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Fresno, CA
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Houston, TX
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Huber Heights, OH
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Long Beach, CA
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Los Angeles, CA
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Madera, CA
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New Albany, IN
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Newton, KS
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Oklahoma City, OK
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Provo, UT
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Saint George, UT
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South Jordan, UT
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Spartanburg, South Carolina 29303
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Spartanburg, SC
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Torrance, CA
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West Jordan, UT
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Wichita, KS
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Woburn, MA
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