Trials / Completed
CompletedNCT01985997
Postmarketing Safety Study of Q/LAIV in Subjects 2 Through 49 Years of Age
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 95,000 (actual)
- Sponsor
- MedImmune LLC · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Accepted
Summary
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.
Detailed description
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.
Conditions
Timeline
- Start date
- 2014-01-01
- Primary completion
- 2014-07-01
- Completion
- 2014-07-01
- First posted
- 2013-11-18
- Last updated
- 2016-09-07
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01985997. Inclusion in this directory is not an endorsement.