This is an observational post-marketing study conducted in children and adults immunized with Q/LAIV as part of routine clinical practice at Kaiser Permanente Northern California (NCKP) sites.
Children and adults will be immunized with Q/LAIV as part of routine clinical practice at Kaiser Permanente Northern California (NCKP) sites. Using existing data on healthcare utilization, rates of medically attended events (MAEs) of interest will be evaluated in all eligible Q/LAIV recipients who are vaccinated in the Kaiser Permanente (KP) Northern California Health Care Plan during the 2013-2014 influenza season. Enrollment must include a minimum of 10,000 children 2 through 8 years of age; based on previous utilization of FluMist at NCKP, enrollment is expected to include approximately 80,000 children and adults 2 to 49 years of age.
Study Type
OBSERVATIONAL
Enrollment
95,000
Research Site
Oakland, California, United States
Rates of medically attended events: hypersensitivity, seizures/convulsions
Rates of medically attended events from 0 to 3 days: hypersensitivity, seizures/convulsions
Time frame: From 0-3 days
Rates of medically attended events: lower respiratory tract infection, wheezing, Guillain-Barré syndrome, Bell's palsy, encephalitis, neuritis, vasculitis, any hospitalization and respiratory hospitalizations
Rates of medically attended events from 1 to 42 days: lower respiratory tract infection, wheezing, Guillain-Barré syndrome, Bell's palsy, encephalitis, neuritis, vasculitis, any hospitalization and respiratory hospitalizations
Time frame: From 1 to 42 days
Rates of medically attended events: narcolepsy/cataplexy
Rates of medically attended events from 1 to 180 days: narcolepsy/cataplexy
Time frame: From 1 to 180 days
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