The primary objective of this study is to estimate the relative efficacy and assess the safety of CAIV-T compared to TIV.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
8,500
The primary efficacy endpoint of this study is the relative efficacy of CAIV-T
compared to TIV against the incidence of culture-confirmed symptomatic influenza infection caused by community-acquired wild-type strains antigenically similar to those contained in the vaccine, occurring during the
influenza surveillance period and at least 14 days after the last required vaccination
Culture-confirmed symptomatic influenza infection regardless of antigenic match
Febrile acute otitis media (AOM) with antibiotic use associated with culture-confirmed influenza infection antigenically similar to vaccine strains
Febrile acute otitis media (AOM) with antibiotic use associated with culture-confirmed influenza infection regardless of antigenic match
Lower respiratory illness (LRI) with culture-confirmed influenza infection antigenically similar to vaccine strains and
Lower respiratory illness (LRI) with culture-confirmed influenza infection regardless of antigenic match
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Clinical Research Consultants, Inc
Hoover, Alabama, United States
University of Alabama
Tuscaloosa, Alabama, United States
Little Rock Allergy and Asthma Clinical
Little Rock, Arkansas, United States
Friendly Care Medical Group
Anaheim, California, United States
Impact Clinical Trials
Beverly Hills, California, United States
Family Medical Center
Foothill Ranch, California, United States
Edinger Mecial Group
Fountain Valley, California, United States
Fresno Childrens Medical Group, Inc.
Fresno, California, United States
Heathcare Partners Medical Group
Los Angeles, California, United States
Kaiser Permanente Vaccine Study Center
Oakland, California, United States
...and 151 more locations