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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT01985997
First received: November 11, 2013
Last updated: June 26, 2014
Last verified: June 2014
  Purpose

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.


Condition Phase
Observation Safety
Phase 4

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Postmarketing Safety Study of Q/LAIV in Subjects 2 Through 49 Years of Age

Resource links provided by NLM:


Further study details as provided by MedImmune LLC:

Primary Outcome Measures:
  • Rates of medically attended events: hypersensitivity, seizures/convulsions [ Time Frame: From 0-3 days ] [ Designated as safety issue: Yes ]
    Rates of medically attended events from 0 to 3 days: hypersensitivity, seizures/convulsions

  • 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 ] [ Designated as safety issue: Yes ]
    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: narcolepsy/cataplexy [ Time Frame: From 1 to 180 days ] [ Designated as safety issue: Yes ]
    Rates of medically attended events from 1 to 180 days: narcolepsy/cataplexy


Estimated Enrollment: 10000
Study Start Date: January 2014
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Children and adults 2 to 49 years of age vaccinated with Q/LAIV, TIV or no vaccine at Kaiser Permenente Northern California sites.

Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01985997

Locations
United States, California
Kaiser Permenente Northern California
Oakland, California, United States, 94612
Sponsors and Collaborators
MedImmune LLC
Investigators
Study Director: Herve Caspard, MD MedImmune LLC
  More Information

No publications provided

Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT01985997     History of Changes
Other Study ID Numbers: MA-VA-MEDI3250-1115
Study First Received: November 11, 2013
Last Updated: June 26, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by MedImmune LLC:
FluMist, Quadrivalent, Vaccine

ClinicalTrials.gov processed this record on July 28, 2014