\- Trial to compare the efficacy of the liquid formulation of CAIV-T with TIV against culture confirmed influenza illness in children.
* The purpose of this study is to compare the efficacy of the liquid formulation of CAIV-T with TIV against culture confirmed influenza illness in children with a history of recurrent RTIs aged at least 6 months and less than 72 months of age. * The trial also provides the opportunity to compare the efficacy of CAIV-T with TIV on acute otitis media.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2,200
Schneider Children's Medical Center of Israel
Petah Tikva, Israel
Hospital de Txagorritxu
Vitoria-Gasteiz, Spain
To demostrate that the efficacy over one season against culture-confirmed influenza-illness caused by community-acquired subtypes antigenically similar to those contained in the vaccine
To demostrate that the efficacy over one season of CAIV-T is not inferior to that of TIV against culture-confirmed influenza-illness of any subtype
To demonstrate that the efficacy of CAIV-T is not inferior to that of TIV against clinically-defined acute otitis media
To compare the rate of occurence over a defined surveillance period in children with a histroy of recurrent RTIs
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