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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.
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| Measure | Description | Time Frame |
|---|---|---|
| Rates of medically attended events: hypersensitivity, seizures/convulsions | Rates of medically attended events from 0 to 3 days: hypersensitivity, seizures/convulsions | 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 | From 1 to 42 days |
| Rates of medically attended events: narcolepsy/cataplexy | Rates of medically attended events from 1 to 180 days: narcolepsy/cataplexy | From 1 to 180 days |
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Inclusion Criteria:
Exclusion Criteria:
NONE
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Children and adults 2 to 49 years of age vaccinated with Q/LAIV, TIV or no vaccine at Kaiser Permenente Northern California sites.
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| Name | Affiliation | Role |
|---|---|---|
| Herve Caspard, MD | MedImmune LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Oakland | California | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28162825 | Derived | Baxter R, Eaton A, Hansen J, Aukes L, Caspard H, Ambrose CS. Safety of quadrivalent live attenuated influenza vaccine in subjects aged 2-49years. Vaccine. 2017 Mar 1;35(9):1254-1258. doi: 10.1016/j.vaccine.2017.01.062. Epub 2017 Feb 2. |
| Label | URL |
|---|---|
| MA-VA-MEDI3250-1115 Redacted CSR Synopsis | View source |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |