A Study to Evaluate the Safety of FluMist in Healthy Children and Healthy Adults
Post-Marketing Evaluation of the Safety of Influenza Virus Vaccine Live, Intranasal (FluMist) in Healthy Children and Healthy Adults 5-49 Years of Age
1 other identifier
observational
63,061
1 country
77
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2003
Longer than P75 for all trials
77 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2003
CompletedFirst Submitted
Initial submission to the registry
June 10, 2005
CompletedFirst Posted
Study publicly available on registry
June 13, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedResults Posted
Study results publicly available
January 8, 2013
CompletedJanuary 8, 2013
December 1, 2012
4.9 years
June 10, 2005
April 2, 2012
December 3, 2012
Conditions
Outcome Measures
Primary Outcomes (13)
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
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
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
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.
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
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
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
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
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
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
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
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
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
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 Outcomes (8)
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
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
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
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
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
180 days
- +3 more secondary outcomes
Study Arms (3)
1
5-8 years of age, estimated to be approximately 4,000 new FluMist vaccinees per season
2
9-17 years of age, estimated to be approximately 5,000 new FluMist vaccinees per season
3
18-49 years of age, estimated to be approximately 6,000 new FluMist vaccinees per season.
Interventions
Eligibility Criteria
This is an observational study conducted over multiple years with multiple non-randomized control groups.
You may qualify if:
- years of age
- Members of the Kaiser Permanente (KP) Health Care Plan within KP of Northern California, KP of Colorado, and KP of Hawaii
You may not qualify if:
- Must not have had any high risk underlying medical conditions, includig asthma
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MedImmune LLClead
Study Sites (77)
Kaiser Permanente Pediatrics
Alameda, California, 94501, United States
Kaiser Permanente Pediatrics
Antioch, California, 94509, United States
Kaiser Permanente Pediatrics
Clovis, California, 93611, United States
Kaiser Permanente Pediatrics
Daly City, California, 94015, United States
Kaiser Permanente
Davis, California, 95616, United States
Kaiser Pediatric Injections
Fairfield, California, 94533, United States
Kaiser Permanente-Pediatrics
Folsom, California, 95630, United States
Kaiser Permanente Adult Injection
Fremont, California, 94538, United States
Kaiser Permanente Pediatrics
Fremont, California, 94543, United States
Kaiser Permanente Pediactrics
Fresno, California, 93726, United States
Kaiser Permanente Pediatrics
Gilroy, California, 93726, United States
Kaiser Pediatric Injection Station
Hayward, California, 94545, United States
Kaiser Permanente
Lincoln, California, 95648, United States
Kaiser Pediatric Injection Station
Livermore, California, 94551, United States
Kaiser Permanente Injection Clinic
Manteca, California, 95337, United States
Kaiser Permanente Pediatrics
Martinez, California, 94553, United States
Kaiser Permanente Adult Medicine
Milpitas, California, 95035, United States
Kaiser Permanente Employee Health
Milpitas, California, 95035, United States
Kaiser Permanente Pediatrics
Milpitas, California, 95035, United States
Kaiser Permanente Injection Clinic
Modesto, California, 95356, United States
Kaiser Permanente Medicine Dept.
Modesto, California, 95356, United States
Kaiser Permanente Pediatrics
Mountain View, California, 95356, United States
Kaiser Permanente Pediatrics
Napa, California, 94558, United States
Kaiser Permanente Pediatrics
Novato, California, 94945, United States
Kaiser Permanente Employee Health
Oakland, California, 94611, United States
Kaiser Permanente Injection Clinic
Oakland, California, 94611, United States
Kaiser Permanente Pediatrics
Oakland, California, 94611, United States
Kaiser Permanente Regional Employee Health
Oakland, California, 94612, United States
Kaiser Permanente Pediatrics
Petaluma, California, 94954, United States
Kaiser Permanente Pediatrics
Pleasanton, California, 94588, United States
Kaiser Permanente Pediatrics
Rancho Cordova, California, 95670, United States
Kaiser Permanente
Redwood City, California, 94063, United States
Kaiser Permanente Adult Injection Clinic
Richmond, California, 94804, United States
Kaiser Permanente Pediatrics
Richmond, California, 94804, United States
Kaiser Permanente Pediatrics
Roseville, California, 95661, United States
Kaiser Permanente
Roseville, California, 95661, United States
Kaiser Permanente, Point West Clinic Pediatric Injection
Sacramento, California, 95815, United States
Kaiser Permanente
Sacramento, California, 95815, United States
Kaiser Pediatric Injection Station
Sacramento, California, 95823, United States
Kaiser Permanente Medicine Dept.
Sacramento, California, 95823, United States
Kaiser Permanente Medicine Dept.
San Francisco, California, 94115, United States
Kaiser Permanente Pediatrics
San Francisco, California, 94115, United States
Kaiser Permanente Pharmacy
San Francisco, California, 94115, United States
Kaiser Pediatric Adult Medicine
San Jose, California, 95199, United States
Kaiser Pediatric Injection Clinic
San Jose, California, 95199, United States
Kaiser Permanente Employee Health
San Rafael, California, 94115, United States
Kaiser Permanente Pediatrics
San Rafael, California, 94901, United States
Kaiser Permanente Adult Medicine
Santa Clara, California, 95051, United States
Kaiser Permanente Employee Health
Santa Rosa, California, 95403, United States
Kaiser Permanente Pediatrics
Santa Rosa, California, 95403, United States
Kaiser Permanente Pediatrics
Selma, California, 93662, United States
Kaiser Permanente Injection/Allergy
Stockton, California, 95210, United States
Kaiser Permanente Pediatrics
Tracy, California, 95376, United States
Kaiser Pediatric Injection Room
Vacaville, California, 95688, United States
Kaiser Permanente Adult Medicine
Vacaville, California, 95688, United States
Kaiser Permanente Injection Clinic
Vallejo, California, 94589, United States
Kaiser Permanente Pediatric Injections
Vallejo, California, 94589, United States
Kaiser Permanente Pediatrics
Walnut Creek, California, 94596, United States
Kaiser Permanente Pediatrics
Walnut Creek, California, 94598, United States
Kaiser Permanente, Hidden Lake
Arvada, Colorado, 80003, United States
Kaiser Permanente, Aurora Centrepoint
Aurora, Colorado, 80012, United States
Kaiser Permanente, Smoky Hill
Aurora, Colorado, 80015, United States
Kaiser Permanente, Baseline
Boulder, Colorado, 80302, United States
Kaiser Permanente, Boulder
Boulder, Colorado, 80304, United States
Kaiser Permanente, Broomfield
Broomfield, Colorado, 80020, United States
Kaiser Permanente, Skyline
Denver, Colorado, 80205, United States
Kaiser Permanente, East
Denver, Colorado, 80231, United States
Kaiser Permanente, Englewood
Englewood, Colorado, 80110, United States
Kaiser Permanente
Highlands Ranch, Colorado, 80129, United States
Kaiser Permanente
Lafayette, Colorado, 80026, United States
Kaiser Permanente, Lakewood
Lakewood, Colorado, 80226, United States
Kaiser Permanente Arapahoe
Littleton, Colorado, 80122, United States
Kaiser Permanente, Southwest
Littleton, Colorado, 80123, United States
Kaiser Permanente, Ken Caryl
Littleton, Colorado, 80127, United States
Kaiser Permanente, Longmont Primary Care
Longmont, Colorado, 80501, United States
Kaiser Permanente, Westminster
Westminster, Colorado, 80234, United States
Kaiser Permanente, Wheatridge
Wheat Ridge, Colorado, 80033, United States
MeSH Terms
Interventions
Results Point of Contact
- Title
- Chris Ambrose, MD, Sr Director, Medical Affairs
- Organization
- MedImmune, LLC
Study Officials
- STUDY DIRECTOR
Christopher Ambrose, M.D.
MedImmune LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 10, 2005
First Posted
June 13, 2005
Study Start
October 1, 2003
Primary Completion
September 1, 2008
Study Completion
June 1, 2010
Last Updated
January 8, 2013
Results First Posted
January 8, 2013
Record last verified: 2012-12