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

Information source: MedImmune LLC
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: FluMist (Biological); FluMist (Biological); FluMist (Biological)

Phase: N/A

Status: Completed

Sponsored by: MedImmune LLC

Official(s) and/or principal investigator(s):
Christopher Ambrose, M.D., Study Director, Affiliation: MedImmune LLC

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.

Clinical Details

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

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome:

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

Rates of MAEs Associated With a Significant Decreased Risk in FluMist Group Compared to Rates in Within Cohort, Unvaccinated, and TIV Control Groups

Rates of Anaphylaxis and Urticaria in FluMist Recipients Compared to Rates in Within Cohort, Unvaccinated, and TIV Control Groups

Rates of MAEs Within the Pre-specified Grouped Diagnoses In The FluMist Group Compared to Rates in Within Cohort, Unvaccinated, and TIV Control Groups.

Rates of Asthma and Wheezing Within 21 and 42 Days in FluMist Recipients Compared to Rates in the Within Cohort and Unvaccinated Control Groups

Rates of Asthma and Wheezing Within 21 and 42 Days in FluMist Recipients Compared to Rates in the TIV Control Group

Rates of Asthma and Wheezing Within 180 Days in FluMist Recipients Compared to Rates in the Unvaccinated Control Group

Rates of Asthma and Wheezing Within 180 Days in FluMist Recipients Compared to Rates in the TIV Control Group

Rare Events Potentially Related to Wild-type Influenza in FluMist Recipients Compared to TIV and Unvaccinated Control Groups

Rates of Serious Adverse Events (SAEs) in FluMist Recipients Compared to Rates in Unvaccinated Control Group

Rates of SAEs in FluMist Recipients Compared to Rates in TIV Controls

Rates of Hospitalizations and Deaths Within 180 Days in FluMist Recipients Compared to Rates in Unvaccinated Controls

Rates of Hospitalizations and Deaths Within 180 Days in FluMist Recipients Compared to Rates in TIV Controls

Secondary outcome:

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

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

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

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

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

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

Rates of Solicited Adverse Events in Subsets of FluMist Recipients During the First Year of the Trial (2003-2004 Influenza Season)

Rates of Solicited Adverse Events in Subsets of FluMist Recipients During the First Year of the Trial (2003-2004 Influenza Season)

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.

Eligibility

Minimum age: 5 Years. Maximum age: 49 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

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, Roseville, California 95661, United States

Kaiser Permanente Pediatrics, Roseville, California 95661, United States

Kaiser Pediatric Injection Station, Sacramento, California 95823, United States

Kaiser Permanente, Sacramento, California 95815, United States

Kaiser Permanente Medicine Dept., Sacramento, California 95823, United States

Kaiser Permanente, Point West Clinic Pediatric Injection, Sacramento, California 95815, 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, East, Denver, Colorado 80231, United States

Kaiser Permanente, Skyline, Denver, Colorado 80205, 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, Ken Caryl, Littleton, Colorado 80127, United States

Kaiser Permanente, Southwest, Littleton, Colorado 80123, United States

Kaiser Permanente, Longmont Primary Care, Longmont, Colorado 80501, United States

Kaiser Permanente, Westminster, Westminster, Colorado 80234, United States

Kaiser Permanente, Wheatridge, Wheatridge, Colorado 80033, United States

Additional Information

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Starting date: October 2003
Last updated: December 3, 2012

Page last updated: August 20, 2015

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