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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail

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Approval Date:  12/14/2012
 
Trade Name:  Fluarix Quadrivalent
 
Generic or Proper Name (*):  Influenza Virus Vaccine*
 
Indications Studied:  Include a quadrivalent influenza virus vaccine formulation (Fluarix┬« Quadrivalent)
 
Therapeutic Category:  Vaccine
 
Ages Studied:  3 - 17 years
 
Study #:  1
 
Study Type:  Safety/Immunogenicity
 
Study Design:  Double-blind/Controlled
 
No Patients:  2738
 
No Centers:  57
 
No Countries:  6
 
BPCA(B), PREA(P):  P
 
Asian:  0
 
Black:  0
 
Other:  0
 
White:  0
 
Unknown:  0
 
Native Hawaiian or Pacific Islander:  0
 
American Indian/Alaska Native:  0
 
Hispanic/Latino:  0
 
Non-Hispanic/Non Latino:  0
 
Countries:  6
 
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