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

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ClinicalTrials.gov Identifier: NCT01985997
Recruitment Status : Completed
First Posted : November 18, 2013
Last Update Posted : September 7, 2016
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease
Observation Safety

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 Design
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Study Type : Observational
Actual Enrollment : 95000 participants
Time Perspective: Prospective
Official Title: Postmarketing Safety Study of Q/LAIV in Subjects 2 Through 49 Years of Age
Study Start Date : January 2014
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014
Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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


Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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:

Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01985997


Locations
United States, California
Research Site
Oakland, California, United States
Sponsors and Collaborators
MedImmune LLC
Investigators
Study Director: Herve Caspard, MD MedImmune LLC
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
MA-VA-MEDI3250-1115 Redacted CSR Synopsis  This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT01985997     History of Changes
Other Study ID Numbers: MA-VA-MEDI3250-1115
First Posted: November 18, 2013    Key Record Dates
Last Update Posted: September 7, 2016
Last Verified: September 2016

Keywords provided by MedImmune LLC:
FluMist, Quadrivalent, Vaccine