Safety and Immunogenicity of Three Influenza Vaccines in Children Aged 4 Years Old to Less Than 18 Years Old



Status:Completed
Conditions:Influenza
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:4 - 18
Updated:4/21/2016
Start Date:November 2013
End Date:August 2014

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A Phase III, Stratified, Randomized, Double-Blind, Multicenter, Non-Inferiority Study to Evaluate Safety and Immunogenicity of Cell-Based Quadrivalent Subunit Influenza Virus Vaccine and Cell-Based Trivalent Subunit Influenza Virus Vaccines in Subjects Ages ≥4 Years to < 18 Years

Evaluate safety and immunogenicity of three influenza vaccines in children ages greater than
4 years old to less than 18 years old.


Inclusion Criteria:

1. Male or female aged 4 years to less than 18 years of age.

2. Individual who had a parent or guardian who could give written informed consent after
understanding the nature of the study and comply with study procedures and were
available for follow-up.

3. If the individual was of an age where, according to local regulations, informed
assent is required, that individual had provided assent to participate in the study.

Exclusion Criteria:

1. Individuals recently vaccinated against influenza

2. Subjects with contraindications to receive influenza vaccine
We found this trial at
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Anaheim, CA
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Akron, OH
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Burke, VA
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Chandler, AZ
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Charleston, South Carolina 29412
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Charleston, SC
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Charleston, South Carolina 29412
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Colorado Springs, Colorado 80910
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Jefferson City, Tennessee 37760
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Mt. Pleasant, South Carolina 29464
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Sellersville, Pennsylvania 18960
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Upper St. Clair, Pennsylvania 15241
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Wilmington, North Carolina 28401
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