Skip to main content
OpenTrials
Completed

NCT Number: NCT01985997

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Observation Safety Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site

Oakland, California, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

NONE

Treatment and study plan

Primary outcomes

  1. Rates of medically attended events: hypersensitivity, seizures/convulsions

    Time frame: From 0-3 days

    Rates of medically attended events from 0 to 3 days: hypersensitivity, seizures/convulsions

  2. Rates of medically attended events: 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 from 1 to 42 days: lower respiratory tract infection, wheezing, Guillain-Barré syndrome, Bell's palsy, encephalitis, neuritis, vasculitis, any hospitalization and respiratory hospitalizations

  3. Rates of medically attended events: narcolepsy/cataplexy

    Time frame: From 1 to 180 days

    Rates of medically attended events from 1 to 180 days: narcolepsy/cataplexy

Sponsors and collaborators

Lead sponsor

MedImmune LLC

Industry

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Nov 18, 2013
Registry last updated
Sep 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.