Safety of Two Trivalent Influenza Vaccines Evaluated in Children and Adolescents 4 to 17 Years of Age



Status:Completed
Conditions:Influenza
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:4 - 17
Updated:1/1/2014
Start Date:May 2013
End Date:June 2014
Contact:Novartis Drug Information Services
Phone:+1 800 244 7668

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Trial Summary
Trial Overview
Inclusion Criteria

A Phase III, Observer Blind, Randomized, Controlled, Multicenter Study to Evaluate the Safety of a Trivalent Subunit Influenza Vaccine Produced Either in Mammalian Cell Culture or in Embryonated Chicken Eggs (Fluvirin®), in Healthy Children and Adolescents 4 to 17 Years of Age.

Evaluate safety and tolerability of TIVa or TIVb vaccine in healthy children and adolescents
4 to 17 years of age.


Inclusion Criteria:

- Healthy subjects 4-17 years of age

Exclusion Criteria:

- Subjects who are not healthy,

- Subjects who are pregnant or breast feeding,

- Subjects with a history of severe allergic reaction or allergic to any of the vaccine
components.
We found this trial at
18
sites
Novartis Investigative Site
Warwick, Rhode Island 02886
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Warwick, RI
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313, Novartis Investigational Site
Augusta, Kansas 67010
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Augusta, KS
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Novartis Investigative Site
Bristol, Tennessee 37620
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Bristol, TN
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Novartis Investigative Site
Cleveland, Ohio 44109
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Cleveland, OH
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Novartis Investigative Site
Fremont, Nebraska 68025
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Fremont, NE
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Novartis Investigative Site
Mobile, Alabama 36693
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Mobile, AL
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319, Novartis Investigational Site
Mount Pleasant, South Carolina 29464
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Mount Pleasant, SC
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Novartis Investigative Site
Nashville, Tennessee 37205
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Nashville, TN
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305, Novartis Investigational Site
Newton, Kansas 67114
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Newton, KS
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312, Novartis Investigational Site
Ponte Vedra, Florida 32081
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Ponte Vedra, FL
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315, Novartis Investigational Site
Salt Lake, Utah 84124
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Salt Lake, UT
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Novartis Investigative Site
Salt Lake City, Utah 84103
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Salt Lake City, UT
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Novartis Investigative Site
Salt Lake City, Utah 84103
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Salt Lake City, UT
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303, Novartis Investigational Site
South Jordan, Utah 84095
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South Jordan, UT
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Novartis Investigative Site
Tulsa, Oklahoma 74104
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Tulsa, OK
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Novartis Investigative Site
Wichita, Kansas 67207
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Wichita, KS
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Novartis Investigative Site
Wichita, Kansas 67207
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Wichita, KS
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Novartis Investigative Site
Winston-Salem, North Carolina 27157
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from
Winston-Salem, NC
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