Postmarketing Safety Study of Q/LAIV in Subjects 2 Through 49 Years of Age

Completed

• Conditions: Observation Safety

• Registration Number: NCT01985997
• Lead Sponsor: MedImmune LLC

Brief 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.

Study Timeline

• Study First Submitted: 2013-11-11
• Study First Submitted QC: 2013-11-11
• Study First Posted: 2013-11-18
• Study Start: 2014-01
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-02
• Last Update Posted: 2016-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95000

Inclusion Criteria

1. . Age 2 through 49 years at the time of vaccination (or index date for unvaccinated controls)
2. . Membership in the KP Health Care Plan for at least 12 months prior to vaccination/index date
3. . Continuous enrollment in KP Health Care Plan through 6 months following vaccination/index date.

Exclusion Criteria

NONE

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rates of medically attended events: 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 from 1 to 42 days: lower respiratory tract infection, wheezing, Guillain-Barré syndrome, Bell's palsy, encephalitis, neuritis, vasculitis, any hospitalization and respiratory hospitalizations
Rates of medically attended events: hypersensitivity, seizures/convulsions	From 0-3 days	Rates of medically attended events from 0 to 3 days: hypersensitivity, seizures/convulsions
Rates of medically attended events: narcolepsy/cataplexy	From 1 to 180 days	Rates of medically attended events from 1 to 180 days: narcolepsy/cataplexy

Trial Locations

Locations (1)

Research Site; 🇺🇸 Oakland, California, United States