A Study to Evaluate the Safety of FluMist in Healthy Children and Healthy Adults

December 3, 2012 updated by: MedImmune LLC

Post-Marketing Evaluation of the Safety of Influenza Virus Vaccine Live, Intranasal (FluMist) in Healthy Children and Healthy Adults 5-49 Years of Age

The purpose of this study was to expand the data describing the safety profile of FluMist in the indicated populations (5-8, 9-17, and 18-49 years of age) and to assess the safety of annual revaccination in those who received FluMist in 2 or more consecutive years.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The primary objective of this study was to assess the safety of FluMist vaccination by comparing the rates of medically attended events (MAEs) (including serious adverse events [SAEs], anaphylaxis, urticaria, asthma, wheezing, pre-specified grouped diagnoses, and rare events potentially related to wild-type influenza) in FluMist recipients to rates in multiple non-randomized control groups.

Study Type

Observational

Enrollment (Actual)

63061

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Alameda, California, United States, 94501
        • Kaiser Permanente Pediatrics
      • Antioch, California, United States, 94509
        • Kaiser Permanente Pediatrics
      • Clovis, California, United States, 93611
        • Kaiser Permanente Pediatrics
      • Daly City, California, United States, 94015
        • Kaiser Permanente Pediatrics
      • Davis, California, United States, 95616
        • Kaiser Permanente
      • Fairfield, California, United States, 94533
        • Kaiser Pediatric Injections
      • Folsom, California, United States, 95630
        • Kaiser Permanente-Pediatrics
      • Fremont, California, United States, 94538
        • Kaiser Permanente Adult Injection
      • Fremont, California, United States, 94543
        • Kaiser Permanente Pediatrics
      • Fresno, California, United States, 93726
        • Kaiser Permanente Pediactrics
      • Gilroy, California, United States, 93726
        • Kaiser Permanente Pediatrics
      • Hayward, California, United States, 94545
        • Kaiser Pediatric Injection Station
      • Lincoln, California, United States, 95648
        • Kaiser Permanente
      • Livermore, California, United States, 94551
        • Kaiser Pediatric Injection Station
      • Manteca, California, United States, 95337
        • Kaiser Permanente Injection Clinic
      • Martinez, California, United States, 94553
        • Kaiser Permanente Pediatrics
      • Milpitas, California, United States, 95035
        • Kaiser Permanente Adult Medicine
      • Milpitas, California, United States, 95035
        • Kaiser Permanente Employee Health
      • Milpitas, California, United States, 95035
        • Kaiser Permanente Pediatrics
      • Modesto, California, United States, 95356
        • Kaiser Permanente Injection Clinic
      • Modesto, California, United States, 95356
        • Kaiser Permanente Medicine Dept.
      • Mountain View, California, United States, 95356
        • Kaiser Permanente Pediatrics
      • Napa, California, United States, 94558
        • Kaiser Permanente Pediatrics
      • Novato, California, United States, 94945
        • Kaiser Permanente Pediatrics
      • Oakland, California, United States, 94611
        • Kaiser Permanente Employee Health
      • Oakland, California, United States, 94611
        • Kaiser Permanente Injection Clinic
      • Oakland, California, United States, 94611
        • Kaiser Permanente Pediatrics
      • Oakland, California, United States, 94612
        • Kaiser Permanente Regional Employee Health
      • Petaluma, California, United States, 94954
        • Kaiser Permanente Pediatrics
      • Pleasanton, California, United States, 94588
        • Kaiser Permanente Pediatrics
      • Rancho Cordova, California, United States, 95670
        • Kaiser Permanente Pediatrics
      • Redwood City, California, United States, 94063
        • Kaiser Permanente
      • Richmond, California, United States, 94804
        • Kaiser Permanente Adult Injection Clinic
      • Richmond, California, United States, 94804
        • Kaiser Permanente Pediatrics
      • Roseville, California, United States, 95661
        • Kaiser Permanente
      • Roseville, California, United States, 95661
        • Kaiser Permanente Pediatrics
      • Sacramento, California, United States, 95815
        • Kaiser Permanente, Point West Clinic Pediatric Injection
      • Sacramento, California, United States, 95815
        • Kaiser Permanente
      • Sacramento, California, United States, 95823
        • Kaiser Pediatric Injection Station
      • Sacramento, California, United States, 95823
        • Kaiser Permanente Medicine Dept.
      • San Francisco, California, United States, 94115
        • Kaiser Permanente Medicine Dept.
      • San Francisco, California, United States, 94115
        • Kaiser Permanente Pediatrics
      • San Francisco, California, United States, 94115
        • Kaiser Permanente Pharmacy
      • San Jose, California, United States, 95199
        • Kaiser Pediatric Adult Medicine
      • San Jose, California, United States, 95199
        • Kaiser Pediatric Injection Clinic
      • San Rafael, California, United States, 94115
        • Kaiser Permanente Employee Health
      • San Rafael, California, United States, 94901
        • Kaiser Permanente Pediatrics
      • Santa Clara, California, United States, 95051
        • Kaiser Permanente Adult Medicine
      • Santa Rosa, California, United States, 95403
        • Kaiser Permanente Employee Health
      • Santa Rosa, California, United States, 95403
        • Kaiser Permanente Pediatrics
      • Selma, California, United States, 93662
        • Kaiser Permanente Pediatrics
      • Stockton, California, United States, 95210
        • Kaiser Permanente Injection/Allergy
      • Tracy, California, United States, 95376
        • Kaiser Permanente Pediatrics
      • Vacaville, California, United States, 95688
        • Kaiser Pediatric Injection Room
      • Vacaville, California, United States, 95688
        • Kaiser Permanente Adult Medicine
      • Vallejo, California, United States, 94589
        • Kaiser Permanente Injection Clinic
      • Vallejo, California, United States, 94589
        • Kaiser Permanente Pediatric Injections
      • Walnut Creek, California, United States, 94596
        • Kaiser Permanente Pediatrics
      • Walnut Creek, California, United States, 94598
        • Kaiser Permanente Pediatrics
    • Colorado
      • Arvada, Colorado, United States, 80003
        • Kaiser Permanente, Hidden Lake
      • Aurora, Colorado, United States, 80012
        • Kaiser Permanente, Aurora Centrepoint
      • Aurora, Colorado, United States, 80015
        • Kaiser Permanente, Smoky Hill
      • Boulder, Colorado, United States, 80302
        • Kaiser Permanente, Baseline
      • Boulder, Colorado, United States, 80304
        • Kaiser Permanente, Boulder
      • Broomfield, Colorado, United States, 80020
        • Kaiser Permanente, Broomfield
      • Denver, Colorado, United States, 80205
        • Kaiser Permanente, Skyline
      • Denver, Colorado, United States, 80231
        • Kaiser Permanente, East
      • Englewood, Colorado, United States, 80110
        • Kaiser Permanente, Englewood
      • Highlands Ranch, Colorado, United States, 80129
        • Kaiser Permanente
      • Lafayette, Colorado, United States, 80026
        • Kaiser Permanente
      • Lakewood, Colorado, United States, 80226
        • Kaiser Permanente, Lakewood
      • Littleton, Colorado, United States, 80122
        • Kaiser Permanente Arapahoe
      • Littleton, Colorado, United States, 80123
        • Kaiser Permanente, Southwest
      • Littleton, Colorado, United States, 80127
        • Kaiser Permanente, Ken Caryl
      • Longmont, Colorado, United States, 80501
        • Kaiser Permanente, Longmont Primary Care
      • Westminster, Colorado, United States, 80234
        • Kaiser Permanente, Westminster
      • Wheatridge, Colorado, United States, 80033
        • Kaiser Permanente, Wheatridge

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 49 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

This is an observational study conducted over multiple years with multiple non-randomized control groups.

Description

Inclusion Criteria:

  • 5-49 years of age
  • Members of the Kaiser Permanente (KP) Health Care Plan within KP of Northern California, KP of Colorado, and KP of Hawaii

Exclusion Criteria:

  • Must not have had any high risk underlying medical conditions, includig asthma

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
5-8 years of age, estimated to be approximately 4,000 new FluMist vaccinees per season
Biological: FluMist
Nasal Sprayer dose of FluMist with annual follow up
2
9-17 years of age, estimated to be approximately 5,000 new FluMist vaccinees per season
Biological: FluMist
Nasal Sprayer dose of FluMist with annual follow up
3
18-49 years of age, estimated to be approximately 6,000 new FluMist vaccinees per season.
Biological: FluMist
Nasal Sprayer dose of FluMist with annual follow up

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rates of Medically Attended Events (MAEs) Associated With a Significant Increased Risk in FluMist Recipients Compared to Rates in Within Cohort, Unvaccinated, and TIV Control Groups
Time Frame: 21 and 42 days
An MAE was defined as a coded medical diagnosis made by a health care provider and associated with a medical encounter (ie, a visit by a health plan member to a medical clinic or ED, or a hospital admission). Incident rate comparisons of MAEs with an identified increased risk associated with FluMist occurring in the same age group and setting across all three comparison groups, as these events are less likely to be due to chance alone.
21 and 42 days
Rates of MAEs Associated With a Significant Decreased Risk in FluMist Group Compared to Rates in Within Cohort, Unvaccinated, and TIV Control Groups
Time Frame: 21 and 42 days
Incident rate comparisons of MAEs with an identified decreased risk associated with FluMist occuring in the same age group and setting across all three comparison groups, as these events are less likely to be due to chance alone. All terms were analyzed for the entire population regardless of gender.
21 and 42 days
Rates of Anaphylaxis and Urticaria in FluMist Recipients Compared to Rates in Within Cohort, Unvaccinated, and TIV Control Groups
Time Frame: 3 days
Incident rate comparisons associated with a significantly increased risk in FluMist recipients compared to the within cohort control group for urticaria; there was no increased risk compared to the unvaccinated and TIV control groups and there were no anaphylaxis events that occurred within the 3-day risk period post vaccination.
3 days
Rates of MAEs Within the Pre-specified Grouped Diagnoses In The FluMist Group Compared to Rates in Within Cohort, Unvaccinated, and TIV Control Groups.
Time Frame: 21 and 42 days
There were no acute respiratory tract events, acute gastrointestinal tract events, or systemic bacterial infections with an identified increased or decreased risk associated with FluMist occuring in the same age group and setting across all three comparison groups.
21 and 42 days
Rates of Asthma and Wheezing Within 21 and 42 Days in FluMist Recipients Compared to Rates in the Within Cohort and Unvaccinated Control Groups
Time Frame: 21 and 42 days
Incident rate comparisons associated with a significantly decreased risk in FluMist recipients compared to the within cohort control observed for all ages and 5-8 years of age within 21 days and compared to the unvaccinated control obseved for 18-49 years of age within 42 days. No asthma and wheezing incidence rate comparisons were significantly increased in FluMist recipients compared to the within cohort or unvaccinated control groups.
21 and 42 days
Rates of Asthma and Wheezing Within 21 and 42 Days in FluMist Recipients Compared to Rates in the TIV Control Group
Time Frame: 21 and 42 days
Incident rate comparisons associated with a significantly decreased risk in FluMist recipients compared to the TIV control group for all ages, 5-8, 9-17, and 18-49 years of age. No asthma and wheezing incidence rate comparisons were significantly increased in FluMist recipients compared to the TIV control group.
21 and 42 days
Rates of Asthma and Wheezing Within 180 Days in FluMist Recipients Compared to Rates in the Unvaccinated Control Group
Time Frame: 180 days
Incident rate comparisons associated with a significantly decreased risk in FluMist recipients compared to the unvaccinated control group for all ages, 5-8, and 9-17 years of age. No asthma and wheezing incidence rate comparisons were significantly increased in FluMist recipients compared to the unvaccinated control group.
180 days
Rates of Asthma and Wheezing Within 180 Days in FluMist Recipients Compared to Rates in the TIV Control Group
Time Frame: 180 days
Incident rate comparisons associated with a significantly decreased risk in FluMist recipients compared to the TIV control group for all ages, 5-8, 9-17, and 18-49 years of age. No asthma and wheezing incidence rate comparisons were significantly increased in FluMist recipients compared to the TIV control group.
180 days
Rare Events Potentially Related to Wild-type Influenza in FluMist Recipients Compared to TIV and Unvaccinated Control Groups
Time Frame: 21 and 42 days
Incident rate comparisons associated with a significantly decreased risk in FluMist recipients compared to TIV controls; there was no significantly decreased risk compared to the within cohort and unvaccinated controls. No MAEs potentially related to wild-type influenza were associated with a significantly increased risk in FluMist recipients.
21 and 42 days
Rates of Serious Adverse Events (SAEs) in FluMist Recipients Compared to Rates in Unvaccinated Control Group
Time Frame: 21 and 42 days
Incident rate comparisons of SAEs with an identified decreased risk associated with FluMist compared to unvaccinated controls; no decreased risk was observed in compariosn to the within cohort control. There were no SAE incidence rate comparisons that were significantly increased in FluMist recipients.
21 and 42 days
Rates of SAEs in FluMist Recipients Compared to Rates in TIV Controls
Time Frame: 21 and 42 days
Incident rate comparisons of SAEs with an identified decreased risk associated with FluMist compared to TIV controls. There were no SAE incidence rate comparisons that were significantly increased in FluMist recipients.
21 and 42 days
Rates of Hospitalizations and Deaths Within 180 Days in FluMist Recipients Compared to Rates in Unvaccinated Controls
Time Frame: 180 days
Incident rate comparisons of hospitalizations and deaths with an identified decreased risk associated with FluMist compared to unvaccinated controls. There were no hospitalization or death incidence rate comparisons that were significantly increased in FluMist recipients.
180 days
Rates of Hospitalizations and Deaths Within 180 Days in FluMist Recipients Compared to Rates in TIV Controls
Time Frame: 180 days
Incident rate comparisons of hospitalizations and deaths with an identified decreased risk associated with FluMist compared to TIV controls. There were no hospitalization or death incidence rate comparisons that were significantly increased in FluMist recipients.
180 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rates of MAEs Associated With a Significant Decreased Risk in the Subset of Individuals Who Received FluMist in 2 or More Consecutive Years Compared to Rates in Within Cohort Controls
Time Frame: 21 days
Incident rate comparisons of MAEs with an identified decreased risk in FluMist recipients receiving FluMist in 2 or more consecutive seasons compared to rates in within cohort controls within 21 days. There was no significant decreased risk in comparison to unvaccinated or TIV controls within the 21-day timeframe.
21 days
Rates of MAEs Associated With a Significant Increased Risk in the Subset of Individuals Who Received FluMist in 2 or More Consecutive Years Compared to Rates in Unvaccinated Controls
Time Frame: 42 days
Incident rate comparisons of MAEs with an identified increased risk in FluMist recipients receiving FluMist in 2 or more consecutive seasons compared to rates in unvaccinated recipients. There was no increased risk at 3 or 21 days and there was no increased risk compared to the Within Cohort or TIV control groups.
42 days
Rates of MAEs Associated With a Significant Decreased Risk in the Subset of Individuals Who Received FluMist in 2 or More Consecutive Years Compared to Rates in TIV Controls Within 42 Days
Time Frame: 42 days
Incident rate comparisons of MAEs with an identified decreased risk in FluMist recipients receiving FluMist in 2 or more consecutive seasons compared to rates in TIV recipients within 42 days. There was no significant decreased risk in comparison to unvaccinated controls within the 42-day timeframe.
42 days
Rates of MAEs Associated With a Significant Decreased Risk Within 180 Days in the Subset of Individuals Who Received FluMist in 2 or More Consecutive Years Compared to Rates in Unvaccinated Controls
Time Frame: 180 days
Incident rate comparisons of MAEs within 180 days with an identified decreased risk associated with FluMist recipients compared to Unvaccinated Controls. There were no MAE incidence rate comparisons that were significantly increased in FluMist recipients compared to Unvaccinated Controls.
180 days
Rates of MAEs Associated With a Significant Decreased Risk Within 180 Days in the Subset of Individuals Who Received FluMist in 2 or More Consecutive Years Compared to Rates in TIV Controls
Time Frame: 180 days
Incident rate comparisons of MAEs within 180 days with an identified decreased risk associated with FluMist recipients compared to TIV recipients. There were no MAE incidence rate comparisons that were significantly increased in FluMist recipients compared to TIV recipients.
180 days
Rates of SAEs and Hospitalizations or Deaths Within 180 Days in the Subset of Individuals Who Received FluMist in 2 or More Consecutive Years Compared to Rates in Unvaccinated and TIV Controls
Time Frame: 180 days
Incident rate comparisons of SAEs and hospitalizations or deaths with an identified decreased risk associated with FluMist recipients compared to TIV recipients; there were no significant decreases compared to the unvaccinated controls. There were no SAE and hospitalization or death incidence rate comparisons that were significantly increased in FluMist recipients compared to their controls.
180 days
Rates of Solicited Adverse Events in Subsets of FluMist Recipients During the First Year of the Trial (2003-2004 Influenza Season)
Time Frame: Within 2-3 days of vaccination
Within 2-3 days of vaccination
Rates of Solicited Adverse Events in Subsets of FluMist Recipients During the First Year of the Trial (2003-2004 Influenza Season)
Time Frame: Within 14 days of vaccination
Within 14 days of vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MedImmune LLC

Investigators

  • Study Director: Christopher Ambrose, M.D., MedImmune LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2003

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

June 10, 2005

First Submitted That Met QC Criteria

June 10, 2005

First Posted (Estimate)

June 13, 2005

Study Record Updates

Last Update Posted (Estimate)

January 8, 2013

Last Update Submitted That Met QC Criteria

December 3, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

  • FM025

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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